chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Mydriasis, Pallor
Clinical narrative: Patient became pale and diaphoretic, lost consciousness with pupils dilated, able to converse appropriately after he came to within 20-30 seconds, no neuro defects noted after consciousness returned.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Bruising spot near elbow on left arm 4 days after injection. Bruising still ongoing in same area.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Caesarean section, Cardiac failure congestive, Delivery, Echocardiogram abnormal, Exposure during pregnancy
Clinical narrative: Congestive heart failure, currently in hospital. 1st dose while pregnant, 2nd dose 2 months after delivering twins via c-section. Symptoms began around the week of 2nd dose.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Exercise tolerance decreased, Hypertension, Peripheral swelling, Skin warm
Clinical narrative: I had the Moderna Vaccine on December 6th and within a short time, my arm swelled from shoulder to elbow and stayed hot for a couple weeks. I also developed chest pain the first day at about 6-12 hours after and it was severe enough that I thought I was having a heart attack and started taking baby aspirin. This was severe for some time and when I went in for the second shot, they said I needed a medical evaluation to receive a second dose. I developed High blood pressure and have been put on BP meds 2x daily to keep it in a safe but not great range. I see a doctor and they don't have time for the patients and sent me to urgent care and then really nothing to assure me that I will be okay or that I can get help for the issue I am dealing with ever since the vaccine. I am sure they have not reported it to anyone because  they treat me like I am an anti vaxer and minimize my life changing issue.  I used to be a runner and worked out every day. I can not anymore but do walk again but can not run any longer as my bp goes up too high.  Who should I report this to or do you even care as the rest of the medical people I have been treated by if you can call it that.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Immune system disorder
Clinical narrative: I just received my 2nd booster of Pfizer on March 31 and as I have reported with all 3 Pfizer Covid-19 vaccinations before, I had an outbreak of herpes zoster on my left upper arm about 6 days after receiving it.  I have applied acyclovir ointment since it erupted on 4/6/2022 and is now almost resolved.  I have reported this to my physician and thinks that my "immune system is possibly weak."
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: It has been discovered that patient was given an expired dose of Moderna vaccine. The patient has not experienced an adverse event to the knowledge of clinical staff. Moderna has been contacted to assess the viability of vaccine.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: It has been discovered that patient was given an expired dose of Moderna vaccine. The patient has not experienced an adverse event to the knowledge of clinical staff. Moderna has been contacted to assess viability of vaccine.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: It has been discovered that patient was given an expired dose of Moderna vaccine. The patient has not experienced an adverse event to the knowledge of clinical staff. Moderna has been contacted to assess viability of vaccine.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: It has been discovered that patient was given an expired dose of MODERNA vaccine. The patient has not experienced an adverse event to the knowledge of clinical staff. MODERNA has been contacted to assess viability of vaccine.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: It has been discovered that patient was given an expired dose of MODERNA vaccine. The patient has not experienced an adverse event to the knowledge of clinical staff. MODERNA has been contacted to assess viability of vaccine.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: It has been discovered that patient was given an expired dose of Moderna vaccine. The patient has not experienced an adverse event to the knowledge of clinical staff. Moderna has been contacted to assess vaccine viability.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: It has been discovered that patient was given an expired dose of Moderna vaccine. The patient has not experienced an adverse event to the knowledge of clinical staff. Moderna has been contacted to assess viability of vaccine.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: It has been discovered that patient was given an expired dose of Moderna vaccine. The patient has not experienced an adverse event to the knowledge of clinical staff. Moderna has been contacted to assess viability of vaccine.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blister
Clinical narrative: Blisters on six of my toes use Bacitracin when blisters break & wear white cotton socks. If any change call & see M.D. immediately
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: It has been discovered that patient was given an expired dose of Moderna vaccine. The patient has not experienced an adverse event to the knowledge of clinical staff. Moderna has been contacted to asses vaccine viability.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: It has been discovered that patient was given an expired dose of Moderna vaccine. The patient has not experienced an adverse event to the knowledge of clinical staff. Moderna has been contacted to assess vaccine viability.
Age: 11.0
Sex: F
Vaccine: FLUX, HPV9, TDAP, UNK
Symptoms: Balance disorder, Dizziness
Clinical narrative: About 1 minute later the patient started to say she was dizzy and slowing losing her balance; patient was caught and attendet by provider; About 1 minute later the patient started to say she was dizzy and slowing losing her balance; patient was caught and attendet by provider; Information was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act via the Agency (VAERS # 858732).  This spontaneous report was received from an unknown reporter concerning a 11-year-old female patient. It was reported that the patient had not illness at the time of vaccination and no pre-existing physician diagnosed allergies, birth defects or medical condition.  On 29-JAN-2020 at 1:30 post-meridiam (pm), the patient was vaccinated with the first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (reported as human papilloma virus (HPV) 9, SANOFI PASTEUR holder, conflicting information) administered in the right deltoid as prophylaxis (lot number 1621929 has been verified to be a valid lot number, expiration date not provided but established as 06-DEC-2021) (strength, dose, vaccination scheme, vaccination scheme frequency were not provided). Other vaccines administered on that same date were: meningococcal conjugate vaccine (MCV4) administered in the right deltoid (lot number U6565AB), diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) administered in the left deltoid (lot number U6273AA) and flu vaccine administered in the left deltoid (lot number 97S5T).  On 29-JAN-2020 at 1:31 pm, patient was administered below vaccines and about 1 minute later patient started to say she was "dizzy" and slowing losing her balance. Patient was caught and attended by provided and was back to normal state in about 30 min. patient prior to vaccines was scared and nervous. Patient also had not ate.   The outcome of the events was reported as recovered.   The causality assessment between the events and the suspect therapies was not provided.  Follow up information was received on 23-MAR-2022 from the registered nurse. The reporter advised that without any patient demographics (name and date of birth) they could not complete the form. No further information was available.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral
Clinical narrative: Patient states that she had "loss of vision in her right eye" that developed 1-2 days after her vaccine was given and was resolved in 24 hours. Nothing has been done at this time.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: Pharmacy staff provided pt. with a Covid-19 vaccine on 10/27/21.  On 4/13/2022, pt. came into the pharmacy requesting medical payment for a treatment for a shoulder infection. pt. stated that he believed the infection was due to the injection. Intends to follow up in writing with the patient to complete its continuous quality improvement (CQI) process by discussion with the patient and requesting additional information. In addition, we intend to direct the patient to the (withheld) and will cooperate with any requests for records or facilitation (as permissible).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Headache, Myalgia, Pain
Clinical narrative: Several hours after the injection the patient woke with fever over 100 degrees, cold sweats, headache, nausea, muscle aches, and body aches.  This lasted over 48 hours after which he continued to have severe fatigue and body aches.   These symptoms continued until October 14 when he received his first ozone treatment.  After the second ozone treatment on 10/21/21 the symptoms resolved.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Several hours after the injection the patient woke with fever over 100 degrees, cold sweats, headache, nausea, muscle aches, and body aches.  This lasted over 48 hours after which he continued to have severe fatigue and body aches.   These symptoms continued until October 14 when he received his first ozone treatment.  After the second ozone treatment on 10/21/21 the symptoms resolved.
Age: 14.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 14 year old was given Moderna (not yet approved for 14 year olds) and now has recurring, intermittent facial redness, hives and swelling
Age: 14.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Erythema, Product administered to patient of inappropriate age, Swelling, Urticaria
Clinical narrative: 14 year old was given Moderna (not yet approved for 14 year olds) and now has recurring, intermittent facial redness, hives and swelling
Age: 69.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Hepatitis B, Inappropriate schedule of product administration, Pain
Clinical narrative: little soreness; little soreness; Information was received from a lawyer via a Plaintiff Fact Sheet, concerning a 69-year-old female patient.   Patient was a non-smoker. Her concurrent conditions included allergies, asthma, coronary artery disease, diabetes mellitus type II, hyperlipidemia/ high cholesterol, hypertension, insomnia, nasal obstruction, peripheral edema, secondary hyperparathyroidism, gastric bypass and gastrooesophageal reflux disease (GERD). Medical history included shingles (in 2012, after zoster vaccine live (ZOSTAVAX) vaccination, captured in case 2108USA004335), mid urethral sling and chickenpox. Historical drugs/vaccines included zoster vaccine live (ZOSTAVAX), diphtheria vaccine toxoid (+) pertussis vaccine acellular 5-component (+) tetanus vaccine toxoid (ADACEL), influenza vaccine, pneumococcal vaccine 23-valent (manufacturer unknown), influenza vaccine (FLUCELVAX), tetanus (+) diphtheria vaccine and acyclovir.   On 19-MAR-2015, the patient was vaccinated with hepatitis A vaccine (manufacturer unknown) (lot#, expiration date, dose, route of administration and anatomical location were not reported). Concomitant vaccines included pneumococcal vaccine conj 13v (crm197)(PREVNAR 13) and typhoid vaccine. Other concomitant therapies included famotidine, atorvastatin, glipizide and empagliflozin (JARDIANCE). On an unknown date in approximately 2015, the patient experienced little soreness. On 21-SEP-2015, patient was vaccinated with another dose of hepatitis A vaccine (manufacturer unknown) (lot#, expiration date, dose, route of administration and anatomical location were not reported) and on an unknown date, she experienced little soreness again.  The outcome of both episodes of soreness was unknown. The relatedness between the events and hepatitis A vaccine (manufacturer unknown) was not reported.; Sender's Comments:  US-009507513-2108USA004335:
Age: 69.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Pain, Vaccine positive rechallenge
Clinical narrative: little soreness; little soreness; Information was received from a lawyer via a Plaintiff Fact Sheet, concerning a 69-year-old female patient.   Patient was a non-smoker. Her concurrent conditions included allergies, asthma, coronary artery disease, diabetes mellitus type II, hyperlipidemia/ high cholesterol, hypertension, insomnia, nasal obstruction, peripheral edema, secondary hyperparathyroidism, gastric bypass and gastrooesophageal reflux disease (GERD). Medical history included shingles (in 2012, after zoster vaccine live (ZOSTAVAX) vaccination, captured in case 2108USA004335), mid urethral sling and chickenpox. Historical drugs/vaccines included zoster vaccine live (ZOSTAVAX), diphtheria vaccine toxoid (+) pertussis vaccine acellular 5-component (+) tetanus vaccine toxoid (ADACEL), influenza vaccine, pneumococcal vaccine 23-valent (manufacturer unknown), influenza vaccine (FLUCELVAX), tetanus (+) diphtheria vaccine and acyclovir.   On 19-MAR-2015, the patient was vaccinated with hepatitis A vaccine (manufacturer unknown) (lot#, expiration date, dose, route of administration and anatomical location were not reported). Concomitant vaccines included pneumococcal vaccine conj 13v (crm197)(PREVNAR 13) and typhoid vaccine. Other concomitant therapies included famotidine, atorvastatin, glipizide and empagliflozin (JARDIANCE). On an unknown date in approximately 2015, the patient experienced little soreness. On 21-SEP-2015, patient was vaccinated with another dose of hepatitis A vaccine (manufacturer unknown) (lot#, expiration date, dose, route of administration and anatomical location were not reported) and on an unknown date, she experienced little soreness again.  The outcome of both episodes of soreness was unknown. The relatedness between the events and hepatitis A vaccine (manufacturer unknown) was not reported.; Sender's Comments:  US-009507513-2108USA004335:
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cancer surgery, Computerised tomogram, Lip and/or oral cavity cancer, Oral disorder, Oral soft tissue biopsy
Clinical narrative: About two weeks after the first Moderna shot, a small growth, about the size of a grain of rice, developed on the floor of the left side of my mouth.   About two weeks after the second Moderna shot the growth started rapidly growing larger to about the size of an olive,  and three weeks after that it had to be surgically removed.  The growth was malignant and required a second surgery and radiation.  When I asked the oncologist if the shot could have triggered the growth of the tumor they said it was possible.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oral surgery, Radiotherapy, Squamous cell carcinoma of the oral cavity, Ultrasound scan
Clinical narrative: About two weeks after the first Moderna shot, a small growth, about the size of a grain of rice, developed on the floor of the left side of my mouth.   About two weeks after the second Moderna shot the growth started rapidly growing larger to about the size of an olive,  and three weeks after that it had to be surgically removed.  The growth was malignant and required a second surgery and radiation.  When I asked the oncologist if the shot could have triggered the growth of the tumor they said it was possible.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Computerised tomogram, Contusion, Gait disturbance
Clinical narrative: Confusion, weakness, difficulty walking
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urine analysis, X-ray
Clinical narrative: Confusion, weakness, difficulty walking
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Erythromelalgia
Clinical narrative: Erythromelalgia, possible small fiber neuropathy
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Lethargy, Lymph node pain
Clinical narrative: Swollen and painful lymph node in injected arm. Extremely painful injection site. Fever 99.6.Aches and pain in joints.  Sore all over especially in injected arm. Lethargy. Lasting  8am upon waking up due to pain. Lasting until 9:30pm so far at time of submitting this form.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Swollen and painful lymph node in injected arm. Extremely painful injection site. Fever 99.6.Aches and pain in joints.  Sore all over especially in injected arm. Lethargy. Lasting  8am upon waking up due to pain. Lasting until 9:30pm so far at time of submitting this form.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic spontaneous urticaria, Mechanical urticaria, Rash, Rash pruritic, Scratch
Clinical narrative: Between 2-3 weeks after receiving the Moderna booster I developed intensely itchy chronic spontaneous urticarial rashes on random areas of my body (including my scalp). These hives continued in various bouts daily for a month. I also developed daily wheal and flare lesions anytime light pressure/scratching is applied to my skin. I continue to suffer from dermatographism three months after the booster.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Skin lesion, Urticaria
Clinical narrative: Between 2-3 weeks after receiving the Moderna booster I developed intensely itchy chronic spontaneous urticarial rashes on random areas of my body (including my scalp). These hives continued in various bouts daily for a month. I also developed daily wheal and flare lesions anytime light pressure/scratching is applied to my skin. I continue to suffer from dermatographism three months after the booster.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Rash macular, Skin exfoliation
Clinical narrative: looks like burn blotches under his right vaccinated arm, below elbow. he rubbed one and the skin fell off.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Magnetic resonance imaging
Clinical narrative: Severe shoulder pain
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Psychotic disorder
Clinical narrative: Psychosis: began on post-vaccination day 3.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Severe itching of palms of hands. Some itching of feet.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak; This spontaneous report was received from a currently 78-year-old male patient, via GlaxoSmithKline. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On an unspecified date in 2016 (reported as "6 years ago"), the patient received vaccination with zoster vaccine live (ZOSTAVAX) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not provided). Other suspect vaccines included varicella zoster vaccine rge (cho) (SHINGRIX) also administered for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not provided).   The patient reported that on an unspecified date in approximately in 2022, reported as a few weeks ago, he went to a doctor appointment for other problems and when the doctor looked at his back, the doctor informed that he was having a shingles outbreak.   At the time of reporting, the outcome of shingles outbreak was not provided.   The patient did not provide any causality assessment between the vaccination with zoster vaccine live (ZOSTAVAX) and with varicella zoster vaccine rge (cho) (SHINGRIX).
Sex: U
Vaccine: HPV9
Symptoms: Product prescribing issue
Clinical narrative: Pharmacist informed that it is not recommended to administer per prescribing information/AE filed for the potential that the doctor may still give it; This spontaneous report was received from a pharmacist and refers to a 49-years-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was prescribed with  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mg intramuscularly (IM) x 1 dose for prophylaxis (frequency, lot number and expiration date were not provided) for a 49 years old patient (product prescribing issue). She also informed that the vaccine was not administered at the time. Pharmacist informed that it was not recommended to administer per prescribing information.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE reported; A four year old received an intramuscular injection of PROQUAD instead of subcutaneous; This spontaneous report has been received from a registered nurse, referring to a 4-year-old patient of unknown gender. The patient's medical history, the patient's concurrent conditions, concomitant therapies, allergies and drugs reactions were not provided.  On 17-MAR-2022, the patient was vaccinated with mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) as prophylaxis at dose of 0.5 mL (lot number U022728 has been verified to be a valid lot number, expiration date reported as established as: 16-JAN-2023) and was given intramuscularly instead of subcutaneously (incorrect route of product administration). No additional adverse event was reported.
Age: 12.0
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Extra dose administered
Clinical narrative: HCP reports no further AE's; A 12 year old inadvertently received a 3rd dose of Hepatitis A vaccine; This spontaneous report has been received from a medical assistant, regarding a 12-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concomitant medications, concurrent conditions and previous drug reactions or allergies was unknown.  On 22-MAR-2011, the patient was vaccinated with the first one dose of hepatitis A vaccine (manufacturer unknown) and on 16-FEB-2012 with the second dose of hepatitis A vaccine (manufacturer unknown) (formulation, strength, exact dose, vaccination scheme, route of administration and anatomical location, indication, lot number and expiration date were not provided).    Moreover, on 17-MAR-2022, the patient was vaccinated inadvertently with a third dose of hepatitis A vaccine (VAQTA) syringe, at a dose of 0.5 milliliters (mL) one time as prophylaxis (lot number U004366 was verified as valid, expiration date reported and established as 01-OCT-2022) (route of administration and anatomical location date were not provided) (extra dose administered); on that same day the patient was also vaccinated with human papilloma virus (HPV) vaccine (manufacturer unknown) and with meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA). No adverse events reported (no adverse event).
Age: 0.75
Sex: M
Vaccine: HPV9
Symptoms: Product use issue
Clinical narrative: 9 month old baby received GARDASIL 9; patient not experiencing symptoms/ no further AE; This spontaneous report has been received from a consumer, referring to a 9-month-old male. The patient's concurrent conditions, medical history and concomitant therapies 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, lot #T039467, expiration date: 20-MAY-2023, administered for prophylaxis (strength and route of administration were not provided) (product use issue) no additional adverse event were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No further adverse event (AE) was reported.; a dose of PROQUAD that experience temperature excursion was administered to 1 patient; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, drug reactions or allergies were not provided.    On 17-MAR-2022, the patient was vaccinated with the first dose of an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) administered as prophylaxis (lot number U029320 was verified to be a valid lot number, expiration date: 19-MAR-2023; therapy type rHA (dose, route of administration, vaccination scheme frequency, and anatomical location were not reported) (product storage error). No further adverse event (AE) was reported.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the patient was vaccinated with susuepct vaccine on 23-JUN-2011 and 25-FEB-2016; This spontaneous report has been received from a lawyer, via a Plaintiff from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2111USA004909), concerning to a 70 years old female patient. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 23-JUN-2011 and 25-FEB-2016, the patient was vaccinated with pneumococcal vaccine (+) polyvalent (23-valent) (manufacturer unknown), respectively, both for prophylaxis (inappropriate schedule of product administration). The dose, strength, route, lot number and expiration date were unknown. The patient did not recall adverse reaction.  This is one of three cases concerning the same patient.; Sender's Comments:  US-009507513- 2111USA004909: US-009507513- 2203USA006291:
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the patiient was vaccinated with suspect vaccine on 10-APR-2001, 13-JUN-2001; This spontaneous report has been received from a lawyer, via a Plaintiff from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2111USA004909), concerning to a 55 years old female patient. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 10-APR-2001, 13-JUN-2001 and 17-OCT-2001, the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown), respectively, all for prophylaxis (inappropriate schedule of product administration). The dose, strength, route, lot number and expiration date were unknown. The patient did not recall adverse reaction.  This is one of three cases concerning the same patient.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Injection site pain, Injection site pruritus, Injection site swelling, Nausea
Clinical narrative: 9vHPV "allergy"; nausea; vomiting; injection site pain, swelling, and pruritus; injection site pain, swelling, and pruritus; injection site pain, swelling, and pruritus; the second dose 2 years prior; 9vHPV 0.05 mL intramuscular was then administered followed 15 minutes later with the remaining 0.45 mL; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 22-year-old female patient. The patient's medical history, concurrent condition and concomitant medication were not provided.  On unknown dates, the patient was vaccinated with the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (also reported as 9vHPV) (strength, dose, route, lot# and expiration date were not provided) for prophylaxis.  On an unknown date, after the second dose vaccination, the patient self-referred for allergy to vaccine after experiencing nausea and vomiting associated with injection site pain, swelling, and pruritus (vaccination site pruritus, vaccination site swelling, vaccination site pain). She had been advised by the gynecology nursing staff not to receive the third dose due to her reaction. The outcome of all events were recovered.  2 years after the second dose in the office of her gynecologist, during her allergy consultation, she had negative prick test with full-strength 9vHPV followed by a negative 1:100 dilution 9vHPV intradermal test. Then the patient was administered the third dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.05 mL followed 15 minutes later with the remaining 0.45 mL via intramuscular route (strength, route, lot# and expiration date were not provided) for prophylaxis (product administration error and inappropriate schedule of product administration) without adverse reaction during a 2-hour observation.  The reporter considered allergy to vaccine, vaccination site pruritus, vaccination site swelling, vaccination site pain, vomiting and nausea to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).  A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: HPV9
Symptoms: Product administration error, Vomiting
Clinical narrative: 9vHPV "allergy"; nausea; vomiting; injection site pain, swelling, and pruritus; injection site pain, swelling, and pruritus; injection site pain, swelling, and pruritus; the second dose 2 years prior; 9vHPV 0.05 mL intramuscular was then administered followed 15 minutes later with the remaining 0.45 mL; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 22-year-old female patient. The patient's medical history, concurrent condition and concomitant medication were not provided.  On unknown dates, the patient was vaccinated with the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (also reported as 9vHPV) (strength, dose, route, lot# and expiration date were not provided) for prophylaxis.  On an unknown date, after the second dose vaccination, the patient self-referred for allergy to vaccine after experiencing nausea and vomiting associated with injection site pain, swelling, and pruritus (vaccination site pruritus, vaccination site swelling, vaccination site pain). She had been advised by the gynecology nursing staff not to receive the third dose due to her reaction. The outcome of all events were recovered.  2 years after the second dose in the office of her gynecologist, during her allergy consultation, she had negative prick test with full-strength 9vHPV followed by a negative 1:100 dilution 9vHPV intradermal test. Then the patient was administered the third dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.05 mL followed 15 minutes later with the remaining 0.45 mL via intramuscular route (strength, route, lot# and expiration date were not provided) for prophylaxis (product administration error and inappropriate schedule of product administration) without adverse reaction during a 2-hour observation.  The reporter considered allergy to vaccine, vaccination site pruritus, vaccination site swelling, vaccination site pain, vomiting and nausea to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).  A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE reported; a dose of MMR II was administered intramuscularly; This spontaneous report has been received from a registered pharmacist referring to a patient of an unreported age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.  On 18-MAR-2022, the patient was administered 0.5 milliliters (ml) of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) intramuscularly for prophylaxis (dose number, vaccination scheme, anatomical location, lot number, and expiration date were not provided) (incorrect route of product administration). No additional adverse events (AE) were reported.
Sex: F
Vaccine: HEPA
Symptoms: Syringe issue
Clinical narrative: another Nurse was administering VAQTA to a patient and while pushing the plunger to the barrel flange, a piece of the barrel flange broke and a shard of glass broke through the administering Nurse's glove and cut her finger; another Nurse was administering VAQTA to a patient and while pushing the plunger to the barrel flange, a piece of the barrel flange broke and a shard of glass broke through the administering Nurse's glove and cut her finger; This spontaneous report has been received from a registered nurse, referring to another female administering nurse of unreported age. The administering nurse's relevant medical history was not reported.  According to the reporting registered nurse, the other nurse was administering hepatitis A vaccine, inactivated (VAQTA) 0.5 milliliter (ml) syringe formulation to a patient on 10-MAR-2022 (valid lot number U024504 and expiration date 15-OCT-2022) (case # 2203USA006289). While pushing the plunger to the barrel flange, a piece of the barrel flange broke (syringe issue), and a shard of glass broke through the administering nurse's glove and cut her finger (wound).  The administering nurse was seen by the facility's occupational health and was not hospitalized. The administering nurse's outcome from the wound was not provided.  The reporting registered nurse did not provide a causality assessment for the wound. ; Sender's Comments:  US-009507513-2203USA006289:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE information reported; revaccination of PNEUMOV AX 23 vial that was administered to patient today 23MAR2022 and had expired on 15MAR2022; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 23-MAR-2022, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) formulation vial, dose 0.5 milliliters, lot # T024557, expiration date: 15-MAR-2022 (dose number and route of administration were not reported) for prophylaxis (expired product administered). The outcome of expired product administration was unknown. No additional adverse event information was reported (no adverse event). The reporter inquired about revaccination.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE; a patient, who was originally on the 2 dose regimen of GARDASIL 9, received a third dose inadvertently.; 1st Dose: Administered on 24JUL2017; 2nd Dose: Administered on 28-AUG-2018; This spontaneous report was received from a medical assistant, referring to a 16-year-old male patient. Information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was not provided.  On 24-JUL-2017, the patient was vaccinated with the first dose of hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vial, dose at 0.5 mL, lot number M041990 was confirmed to be valid, expiration date 28-JUN-2019 (route of administration and anatomical location were not reported) for prophylaxis.  On 28-AUG-2018, the patient was vaccinated with the second dose of hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vial, dose at 0.5 mL, lot number N025429 was confirmed to be valid, expiration date was reported as 21-MAY-2020 but upon internal validation process, it was established as 21-JUL-2020 (route of administration and anatomical location were not reported) for prophylaxis (inappropriate schedule of product administration). On 21-MAR-2022, the patient was inadvertently vaccinated with the third dose of hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, dose at 0.5 mL, lot number 1687293 was confirmed to be valid (discrepant information, also reported as 1678293; lot number 1678293 is an invalid lot number for hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Lot number 1687293 does not match any Company product as confirmed by Lot Verification team), expiration date 30-APR-2023 (route of administration and anatomical location were not reported) for prophylaxis (extra dose administered). The caller also stated the 1st and 2nd dose were not administered at their clinic. The patient was originally on the 2 dose regimen of the vaccine. No additional adverse event (AE) (no adverse event).
Sex: U
Vaccine: PPV, PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional AE reported; received a dose of PNEUMOVAX 23 today after they received a dose of PNEUMOVAX 23 approximately 8 to 10 weeks ago; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On an unknown date approximately in January 2022 (reported as 'approximately 8 to 10 weeks ago'), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, dose number, strength, lot #, expiry date and route of administration were not provided) for prophylaxis.  On 25-MAR-2022, the patient received another dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot #U027357, expiration date: 25-MAR-2023 (dose, dose number, strength and route of administration were not provided) for the same indication (Inappropriate schedule of product administration).  No additional adverse events were reported (No adverse event).
Sex: F
Vaccine: HPV4
Symptoms: Chills, Conjunctivitis, Ear infection, Headache, Immediate post-injection reaction
Clinical narrative: body aches; chills; headache; sore throat; swollen glands; stuffy nose; runny nose,; ear infection; pink eye; This spontaneous report was received from a consumer and refers to a currently 22-year-old female patient. The patient's medical history, concomitant medications and concurrent conditions were not reported.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, formulation, route of administration, injection site, lot number and expiration date were not reported) for prophylaxis (reported as "vaccine"). Immediately after the vaccination, the patient experienced body aches, chills, headache, sore throat, swollen glands, stuffy nose, runny nose and ear infection. It was reported, that the patient was prescribed with unspecified antibiotics for ear infection. On an unknown date reported as "then" the patient experienced pinkeye. The outcome of all events was unknown.  The relatedness between all of the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not reported.
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Nasal congestion, Oropharyngeal pain, Pain, Rhinorrhoea
Clinical narrative: body aches; chills; headache; sore throat; swollen glands; stuffy nose; runny nose,; ear infection; pink eye; This spontaneous report was received from a consumer and refers to a currently 22-year-old female patient. The patient's medical history, concomitant medications and concurrent conditions were not reported.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, formulation, route of administration, injection site, lot number and expiration date were not reported) for prophylaxis (reported as "vaccine"). Immediately after the vaccination, the patient experienced body aches, chills, headache, sore throat, swollen glands, stuffy nose, runny nose and ear infection. It was reported, that the patient was prescribed with unspecified antibiotics for ear infection. On an unknown date reported as "then" the patient experienced pinkeye. The outcome of all events was unknown.  The relatedness between all of the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not reported.
Sex: U
Vaccine: MMRV, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; Caller reported expired dose of PROQUAD was administered.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report was received from an unspecified reporter and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not provided.  On 29-MAR-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) subcutaneous injection, 0.5 ml, lot #T030479 was confirmed to be valid, expiration date: 07-MAR-2022, administered subcutaneously (anatomical location not provided) for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: MMRV, MMRV
Symptoms: Expired product administered
Clinical narrative: No additional AEs; Caller reported expired dose of PROQUAD was administered.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report was received from an unspecified reporter and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not provided.  On 29-MAR-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) subcutaneous injection, 0.5 ml, lot #T030479 was confirmed to be valid, expiration date: 07-MAR-2022, administered subcutaneously (anatomical location not provided) for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AE reported.; Medical assistant reported that a patient was administered an expired dose of VAQTA. Caller stated the administered VAQTA expired on 28MAR2022, but was administered to a patient today, 30MAR2022.; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-MAR-2022, the patient was inadvertently administered an expired dose of hepatitis a vaccine, inactivated (VAQTA) 1 milliliter, lot # T034003, expiration date on 28-MAR-2022 (dose number, route of administration and anatomical location were not provided), for prophylaxis. It was reported that the vaccine had no temperature excursions. No adverse event reported.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect dose administered, Product administered at inappropriate site
Clinical narrative: No additional AEs or PQC reported; Caller reported VARIVAX was administered subcutaneously in the abdomen to a 40 year old patient. No other information provided.  No additional AEs or PQC reported.; dose: 1 ml; This spontaneous report was received from a pharmacist referring to a 40 years old male patient. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.   On 30-MAR-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength was not reported;  lot# U016864, which was not valid, expiration date: 20-MAY-2023) 1 ml, subcutaneously (sq) for prophylaxis in the abdomen (product administered at inappropriate site and incorrect dose administered).       No additional adverse events were reported.
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: incorrect product storage; No additional AE; a dose of ROTATEQ was inadvertently administered after it's expiration date; This spontaneous report was received from a licensed practical nurse, referring to a 6-month-old male patient. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 29-MAR-2022, the patient was vaccinated with the third dose of expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1707459, expiration date 27-MAR-2022, previous dose#: 2, 2 milliliter, strength was not provided) orally for prophylaxis (expired product administered). Other suspect therapies included hepatitis b vaccine (recombinant)(manufacture unknown) (lot# 7574E, expiration date: 29-DEC-2022, intramuscular (IM)), pneumococcal vaccine conj 13v (crm197)(PREVNAR 13) (also reported as PCV13)(lot# ej4559, expiration date: 30-JUN-2023, IM) and diphtheria vaccine toxoid, hib vaccine, pertussis vaccine, polio vaccine inact, tetanus vaccine toxoid(DTPA IPV HIB VACCINE) (lot# U5544AA, expiration date: 10-JUL-2022, IM). The medication error occurred in the storage in clinical Practice (product storage error). The operator of vaccine was a healthcare professional, who was trained. The patient had no adverse reaction from occurrence. No additional adverse event details.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Medical assistant calling to report expired vaccine was administered to patient. Vaccine did not experience any prior temperature excursions. Permission to follow-up with HCP. No additional AE information. No PQC.; This spontaneous report was received from a medical assistant and refers to a 4 year old female patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 30-MAR-2022, the patient was vaccinated with an expired by 10 days dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 mL (lot # T032150, expiration date: 20-MAR-2022), subcutaneously in the right thigh, once, for prophylaxis.  No additional adverse event was reported.