chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure, Coronary artery occlusion, Coronary artery thrombosis, Immune system disorder, Myocardial infarction
Clinical narrative: Hi, I'm in good shape. I have no cholesterol in my arteries. No sign of heart disease. No sign of circulatory disease. I'm very active. Eat the Mediterranean diet. You name it. 12 days after my Johnson and Johnson shot, a bunch of blood clots went into my LAD and gave me a widow maker heart attack with heart failure. I have an overactive immune system and apparently the J&J shot convinced it to attack my blood and clot it. This went unreported. I have a complete medical history of the event I'm happy to share for the grater good. I nearly died. Everyone at the hospital kept commenting on how they couldn't believe I was in there with a heart attack.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Pyrexia, Rash
Clinical narrative: I received the COVID-19 one-dose vaccine. Day one post vaccination, I felt feverish but that passed after sleeping for 20 hours. Negative arm soreness. Over the next 2 weeks, a very specific rash developed, deepened, and faded: When I removed my athletic socks nearly 1 day post-vaccination, there appeared to be a red sock on my skin (red marks exactly matching the texture of the sock where it touched my skin). I did not need to wear socks after I removed them. The red marks went from being faint pink to deeply pink to burgundy before fading back and going away - this took approximately 2 weeks. The socks were previously washed in the same laundry load as other socks which I wore before and after vaccination (100% cotton socks, washed in laundry detergent with no dye or scent, main named brand), and the issue was not seen pre- or post-vaccination. The rash was not itchy or painful, merely disconcerting as I did not know if it would become itchy or painful or worsen beyond what became its worse point. Overall, no adverse effects - I did feel feverish 1 day post vaccination and slept a LOT, but felt that my reaction was much better than reactions reported publicly by others. The rash was concerning, but ultimately not injurious. If a star rating is allowed without redaction, I would give the vaccine 4.5 out of 5 stars - nearly perfect. But that rash kind of weirded me out, I couldn't find anything online about it. Patient factors: Tomato allergy, no other allergy discovered. Socks from their same original package laundered the same way, problem was not produced prior or reproduced after as of the report date. I do not require follow-up or confirmation personally (feel free to consider this 'customer contact complete' but will be happy to answer any questions. Unfortunately I did not save the photos I had sent to my personal contacts.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity, Thrombosis
Clinical narrative: I have been experiencing clotting, pain and bruising in my legs and arms since receiving the J&J vaccine
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Influenza virus test negative, Nasopharyngitis
Clinical narrative: I received my 2nd shot on 4/7/21 and the first booster on 11/20/21. In late February 2022 I got what was diagnosed as a "bad cold" with a cough. Covid tests were negative. I've had the cough since although it is slowly getting better. The adverse event is just me wondering if this could be from having Covid in August 2021.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood disorder, Erythema, Inflammation
Clinical narrative: hospitalized after taking Pfizer vaccine booster dose on 23Feb2022 and she had an allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 23Feb2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: HYPERSENSITIVITY (hospitalization) with onset Feb2022, outcome "unknown", described as "hospitalized after taking Pfizer vaccine booster dose on 23Feb2022 and she had an allergic reaction".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Pain, Pain in extremity, Rash, Throat tightness
Clinical narrative: hospitalized after taking Pfizer vaccine booster dose on 23Feb2022 and she had an allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 23Feb2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: HYPERSENSITIVITY (hospitalization) with onset Feb2022, outcome "unknown", described as "hospitalized after taking Pfizer vaccine booster dose on 23Feb2022 and she had an allergic reaction".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypersensitivity
Clinical narrative: hospitalized after taking Pfizer vaccine booster dose on 23Feb2022 and she had an allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 23Feb2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: HYPERSENSITIVITY (hospitalization) with onset Feb2022, outcome "unknown", described as "hospitalized after taking Pfizer vaccine booster dose on 23Feb2022 and she had an allergic reaction".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 84.0
Sex: F
Vaccine: PNC13, PPV, PNC13, PPV
Symptoms: Chest X-ray abnormal, Drug ineffective, Pneumonia
Clinical narrative: pneumonia; pneumonia; This spontaneous report was received from a 84-year-old White female patient concerning herself via Pfizer. The patient's medical history included colitis. The patient's concurrent conditions included allergies, compromised immune status,  respiratory illness, genetic/chromosome abnormalities,  diabetes mellitus, and obesity. Concomitant therapies were not reported.  On 26-JUN-2015, the patient was vaccinated with pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (strength, dose, frequency, lot # and expiration date were not provided, the anatomical location was reported probably on the left). On 15-DEC-2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, lot #, expiration date and route of administration were not provided) for prophylaxis.  The patient went to the pharmacy in other city for her booster shot (unspecified) and got it that day. She asked the pharmacist if they could give a pneumonia vaccine that day, and they told her to wait. They said she didn't think she needed it. Then, someone said they expire. The patient was confused but she didn't want to get back to Medical Information for clarification. The patient had been on the phone long enough, and she had an appointment she could not cancel. She was unsure of the manufacturer. The patient confirmed the details were provided to the transferring agent and declined email since she said was too old for email. In November 2021, January or February 2022, the patient experienced the first event of pneumonia. Then a few months after she got it again. She had the event twice in a few months. She went to urgent care, and an x-ray was performed to find out. She had no history of these vaccines and she had never had pneumonia before. The patient wanted to know if it was recommended that she get the 20-valent Pneumococcal Conjugate Vaccine (PCV20).  At the time of reporting, the outcome of both events of pneumonia was unknown.   The causal relationship between both events of pneumonia and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) was not reported.  Upon internal review, the events of pneumonia were determined to be medically significant.
Age: 84.0
Sex: F
Vaccine: PNC13, PPV, PNC13, PPV
Symptoms: Chest X-ray abnormal, Pneumonia
Clinical narrative: pneumonia; pneumonia; This spontaneous report was received from a 84-year-old White female patient concerning herself via Pfizer. The patient's medical history included colitis. The patient's concurrent conditions included allergies, compromised immune status,  respiratory illness, genetic/chromosome abnormalities,  diabetes mellitus, and obesity. Concomitant therapies were not reported.  On 26-JUN-2015, the patient was vaccinated with pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (strength, dose, frequency, lot # and expiration date were not provided, the anatomical location was reported probably on the left). On 15-DEC-2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, lot #, expiration date and route of administration were not provided) for prophylaxis.  The patient went to the pharmacy in other city for her booster shot (unspecified) and got it that day. She asked the pharmacist if they could give a pneumonia vaccine that day, and they told her to wait. They said she didn't think she needed it. Then, someone said they expire. The patient was confused but she didn't want to get back to Medical Information for clarification. The patient had been on the phone long enough, and she had an appointment she could not cancel. She was unsure of the manufacturer. The patient confirmed the details were provided to the transferring agent and declined email since she said was too old for email. In November 2021, January or February 2022, the patient experienced the first event of pneumonia. Then a few months after she got it again. She had the event twice in a few months. She went to urgent care, and an x-ray was performed to find out. She had no history of these vaccines and she had never had pneumonia before. The patient wanted to know if it was recommended that she get the 20-valent Pneumococcal Conjugate Vaccine (PCV20).  At the time of reporting, the outcome of both events of pneumonia was unknown.   The causal relationship between both events of pneumonia and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) was not reported.  Upon internal review, the events of pneumonia were determined to be medically significant.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac murmur, Chest pain, Dizziness, Electrocardiogram ST segment elevation, Electrocardiogram abnormal
Clinical narrative: Patient describes fairly typical reaction around 24 hours post-vaccination (body aches, fever). Around 72 hours post-vaccination, reports dizziness, light-headedness, chest pain. Approximately 48 hours later, patient was feeling better and went to exercise. This seemed to trigger a rapid exacerbation of symptoms, after which patient presented to urgent care. On May 6 patient reports that symptoms are still present but not constant. He is following up with PCP on May 10.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: Patient describes fairly typical reaction around 24 hours post-vaccination (body aches, fever). Around 72 hours post-vaccination, reports dizziness, light-headedness, chest pain. Approximately 48 hours later, patient was feeling better and went to exercise. This seemed to trigger a rapid exacerbation of symptoms, after which patient presented to urgent care. On May 6 patient reports that symptoms are still present but not constant. He is following up with PCP on May 10.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Pain
Clinical narrative: Patient describes fairly typical reaction around 24 hours post-vaccination (body aches, fever). Around 72 hours post-vaccination, reports dizziness, light-headedness, chest pain. Approximately 48 hours later, patient was feeling better and went to exercise. This seemed to trigger a rapid exacerbation of symptoms, after which patient presented to urgent care. On May 6 patient reports that symptoms are still present but not constant. He is following up with PCP on May 10.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, X-ray
Clinical narrative: Patient describes fairly typical reaction around 24 hours post-vaccination (body aches, fever). Around 72 hours post-vaccination, reports dizziness, light-headedness, chest pain. Approximately 48 hours later, patient was feeling better and went to exercise. This seemed to trigger a rapid exacerbation of symptoms, after which patient presented to urgent care. On May 6 patient reports that symptoms are still present but not constant. He is following up with PCP on May 10.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Chills, Fatigue, Influenza like illness
Clinical narrative: flu like reactions; weakness; chills; exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like reactions), ASTHENIA (weakness), CHILLS (chills) and FATIGUE (exhaustion) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery. Concurrent medical conditions included Immunocompromised.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like reactions), ASTHENIA (weakness), CHILLS (chills) and FATIGUE (exhaustion). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] in January 2021 for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) in January 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like reactions), ASTHENIA (weakness), CHILLS (chills) and FATIGUE (exhaustion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that events started later the same day as or the next day after receiving first dose.   This case was linked to MOD-2022-557646, MOD-2022-557622 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Chills, Fatigue, Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: flu like reactions; weakness; chills; exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like reactions), ASTHENIA (weakness), CHILLS (chills) and FATIGUE (exhaustion) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery. Concurrent medical conditions included Immunocompromised.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like reactions), ASTHENIA (weakness), CHILLS (chills) and FATIGUE (exhaustion). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] in January 2021 for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) in January 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like reactions), ASTHENIA (weakness), CHILLS (chills) and FATIGUE (exhaustion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that events started later the same day as or the next day after receiving first dose.   This case was linked to MOD-2022-557646, MOD-2022-557622 (Patient Link).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Chills, Dyspnoea, Electrocardiogram
Clinical narrative: I had chest pain accompanied by racing heart, shortness of breath,  fever, chills, fatigue,  profuse perspiration. I saw my primary care physician the following day and was told it was possible pericarditis . I was given an EKG, blood work and provided a course of prednisone.  2 months later and the chest pain has continued. Scheduled to see cardiologist May 19th 2022.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Palpitations, Pyrexia
Clinical narrative: I had chest pain accompanied by racing heart, shortness of breath,  fever, chills, fatigue,  profuse perspiration. I saw my primary care physician the following day and was told it was possible pericarditis . I was given an EKG, blood work and provided a course of prednisone.  2 months later and the chest pain has continued. Scheduled to see cardiologist May 19th 2022.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dizziness
Clinical narrative: dizziness, chest pain
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: The first three shots I received successfully, with no adverse outcome, had been Pfizer, which was not available in my town for the second booster, so I had the Moderna shot instead at the Pharmacy. The day after the shot, I developed raging tinnitus in my right ear. I have had some tinnitus in the past, but nothing like this, that would prevent my being able to sleep. The reason I know it was caused by the shot is that the same thing has happened to a friend, who never had tinnitus before, and is now afraid to have her second booster. I am equally afraid to have the next one, now that my hearing is involved.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Heart rate increased, Impaired work ability, Malaise
Clinical narrative: 04/07/22 - 6 PM began feeling unwell.  10 PM severe chills.   04/08/22 - Approximately 1 AM through 5 AM elevated heart rate (140-155 bpm while lying down and trying to sleep.  Elevated heart rate and fever waking me up.  Unable to go to work.   04/08/22 through  04/10/22 - Fatigue.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 04/07/22 - 6 PM began feeling unwell.  10 PM severe chills.   04/08/22 - Approximately 1 AM through 5 AM elevated heart rate (140-155 bpm while lying down and trying to sleep.  Elevated heart rate and fever waking me up.  Unable to go to work.   04/08/22 through  04/10/22 - Fatigue.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Endoscopy, Gastric disorder
Clinical narrative: Gastro issues around February
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Urticaria chronic
Clinical narrative: Chronic spontaneous urticaria 10 days after receiving my Covid 19 booster. Started January 1st of 2022 and has not stopped occurring since onset. Was aggravated by cold initially but now hives occur in the evening around 9pm every night. Antihistamines seem to have no effect.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Bundle branch block right, COVID-19, Electrocardiogram abnormal
Clinical narrative: Hi,  I recently received an EKG and they identified a Right Bundle Branch block in my heart.  I received an EKG for work 10 years ago and they didn?t identify any issues as far as I?m aware.  I never had myocarditis  and had no heart issues.  My PCP did the EKG because I turned 40 as a routine exam.  Ihad 3 shots of Moderna and caught COVID after my third shot.  No one knows if my Right Bundle Branch block is linked to COVID or the vaccine but I thought I would report it as I know there have been cases of MYocarfitis in males after vaccination.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: PT RECIEVED PFIZER FOR 12+ INSTEAD OF PEDIATRIC PFIZER DOSE FOR AGE 5-11. NO SIGNS/SYMPTOMS OUT OF THE ORDINARY.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Muscle pain upper left arm,Rotator cuff pain,  Treatment  - Prednisone pack taken for 5 days and 7 weeks of Physical Therapy.  Hot and cold pack used . Taken Tylenol tabs.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Customer called and reported that ROTATEQ expired on 12/29/2021 and was administered on 1/5/2022.; This spontaneous report was received from a nurse, regarding a patient of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.   On 05-JAN-2022, the patient was vaccinated with and expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 2 milliliter (ml) (strength was not provided; lot number was unknown by the reporter, with an expiration date reported as 23-DEC-2021) for prophylaxis (expired product administered.  There was no previous temperature excursion. No additional adverse event (AE) was reported (no adverse event).
Age: 1.17
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; Nurse called and reported that a 12 month old consumer received VARIVAX on 3/16/2022 and MMR-II today, 4/6/2022; This spontaneous report was received from a registered nurse concerning a 14-month-old male patient. Information regarding the patient's current conditions, medical history and historical drug was not provided.   On 16-MAR-2020, patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX.)  On 06-APR-2022, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 milliliters subcutaneous route on the left thigh, lot number U006485 (rHA) expiration date 26-FEB-2023 administered as prophylaxis (Inappropriate schedule of product administration.)  No additional adverse events were reported.
Age: 11.0
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: No additional adverse events reported/ There were no adverse reactions or experiences; His daughter received an extra dose of MMR II / She had previously completed MMR II series.; She was supposed to get GARDASIL 9 but received MMR II instead; This spontaneous report was received from a pharmacist and from the father of the patient (also reported as a health care professional), concerning an 11-year-old female patient. She had no primary diagnosis, no comorbidities, and no reported drug allergies; concomitant medications were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and it was reported that she completed the vaccine series (strength, dose, route of administration, anatomical location, lot number, and expiration date of any of the vaccine were provided). On 06-APR-2022 (approximately at 12:40), the patient was vaccinated with an extra dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (extra dose administered); dose reported as 1 dose, administered as prophylaxis, on her left deltoid, by a pharmacy tech, (lot number: U006488 has been verified to be a valid lot number, and expiration date: 26-FEB-2023; strength and route of administration were not provided). She was supposed to get hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), but she received another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) instead (wrong product administered).  On 19-APR-2022, through the continued follow-up with the patient, it was reported that there were no adverse experiences (also reported as no additional adverse events reported); and that the father was more concerned about long-term effects.
Age: 1.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Child has not had any adverse effects or symptoms; dose of GARDASIL 9 was given to a 1-year-old.; This spontaneous report has been received from physician and refers to an 1-year-old patient of unknown gender.  The patient's medical history, concurrent conditions previous drugs reactions or allergies and concomitant therapies were not reported.  On 06-APR-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, as prophylaxis at dose of 0.5 milliliter (route of administration and anatomical location were not provided) (product administered to patient of inappropriate age). Lot number 17775808 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Lot number 17775808 does not match any company product as confirmed by lot verification team (product administered to patient of inappropriate age).   It was reported that child had no adverse effects or symptoms following administration of the vaccine.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: patient was administered and expired dose of ROTATEQ; This spontaneous report has been received from a licensed professional nurse and refers to a patient of unknown age and gender.  The patient's pertinent medical history, current conditions, previous drugs reactions or allergies and concomitant medications were not reported.  On 07-APR-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot number 1707449 has been verified to be valid, expiration date: 28-MAR-2022), administered orally for prophylaxis (expired product administered).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported; A vaccine coordinator reported VARIVAX were administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions and allergies were not reported.  On 23-MAR-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number U022320 with expiration date: 15-JUL-2023), for prophylaxis (strength, dose, frequency, route of administration and anatomical location were not provided) (product storage error). It was reported that the suspect vaccine was exposed to a temperature excursion of minus 11.83 degrees Celsius for a time frame of 15 minutes. Previous temperature excursion was at 9.37 degree Celsius for a time frame of 2 hours and 30 min.   No additional adverse events (AE) reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2204USA004005:
Sex: F
Vaccine: MMR, MMRV
Symptoms: Antibody test abnormal
Clinical narrative: A medical assistant reported a patient's titers for the Mumps was low, less then 9. The medical assistant states the measles and rubella titers were good. The caller states it was unknown if the patient previously received the MMR vaccine since the; This spontaneous report was received from a medical assistant referring to a 65-year-old female patient. The patient's medical history included  mastectomy. The patient's concurrent conditions, drug and allergy history or concomitant therapies were not provided.  On an unknown date, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (Manufacturer unknown) (strength, dose description, route of administration, lot # and expiry date, were not provided).  On 16-MAR-2022, the Medical assistant reported that the patient's titers for the Mumps was low, less then 9 (Antibody test abnormal). The reporter stated the measles and rubella titers were good (Normal). Additionally, it was reported that it was unknown if the patient previously received the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (Manufacturer unknown) vaccine since the patient was born outside country and they do not have her immunization record.  At the reporting time, the outcome for Antibody test abnormal  was not provided. The causal relationship between Antibody test abnormal  and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (Manufacturer unknown) was unknown.
Sex: U
Vaccine: RV5
Symptoms: Incorrect route of product administration, No adverse event, Product use issue
Clinical narrative: No adverse effects or symptoms reported; patient received ROTATEQ intramuscularly rather than orally; This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not provided.  08-APR-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1742463, expiration date was reported as 20-AUG-2022, but upon internal validation established as 20-SEP-2022) intramuscularly rather than orally (Product use issue) for prophylaxis. The patient received full 2 ml dose in one leg as two separate injections of 1 ml each. No adverse effects or symptoms reported (No adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; administration of expired VAQTA; This spontaneous report was received from medical assistant and concerns a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.   On 19-APR-2022, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) in dose of 1 ml, lot number: U004367 was confirmed to be valid, expiration date: 11-APR-2022 (route and site of administration were not reported) for prophylaxis (expired product administered).   No additional adverse event was reported (no adverse event).
Age: 14.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE details provided; Medical assistant calling would like to know if PROQUAD administered to a 14 year old counts as a valid dose.; This spontaneous report was received from a medical assistant and refers to a 14-year-old female patient. The patient's concomitant medications included hepatitis a vaccine inact (HAVRIX) and polio vaccine inact 3v (vero) (IPOL POLIO VACCINE). Concurrent conditions, pertinent medical history and drug reactions or allergies were not reported.  On 18-APR-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection, administered subcutaneously in the left arm, lot # U019289 was confirmed to be valid, expiration date 15-DEC-2022 (strength and exact dose not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse event details provided (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No addiitional adverse events were reported; received possibly improperly stored vaccines due to lack of temperature readings; This spontaneous report was received from a healthcare worker, referring to a patient of unspecified age and gender. The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 12-APR-2022, the patient was vaccinated with a dose of  varicella virus vaccine live (oka/merck) (VARIVAX)  lot #u010396, expiration date: 01-APR-2023,  administered for prophylaxis (strength, dose, route of administration and anatomical location 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 by the reporter. There was no previous temperature excursion. No additionally adverse events were reported, and no further information was provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA000544: US-009507513-2205USA000533: US-009507513-2205USA000524: US-009507513-2205USA000540: US-009507513-2205USA000467:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events were reported; patients received possibly improperly stored vaccines due lack of temperature readings; This spontaneous report was received from a healthcare worker, referring to a patient of unspecified age and gender. The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 17-MAR-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U010396, expiration date: 01-APR-2023, administered for prophylaxis (strength, dose, route of administration and anatomical location 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 by the reporter. There was no previous temperature excursion. No additionally adverse events were reported, and no further information was provided.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No adverse event; 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.  The refrigerator and freezer temperatures were not recorded since 10-JAN-2022 and temperature was unknown to the reporter. On 10-FEB-2022, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (recombinant human albumin-rHA) subcutaneous injection, valid lot # U015476, valid expiration date: 13-NOV-2022, 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). There was no previous temperature excursion. No adverse events (AE) were reported, and no further information was provided.   Causal assessment between measles, mumps, rubella and varicella (Oka Merck) virus vaccine live (PROQUAD) regarding the events was not provided.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA000524: US-009507513-2205USA000533: US-009507513-2205USA000464: US-009507513-2205USA000467: US-009507513-2205USA000503: US-009507513-2205USA000540: US-009507513-2205USA000564: US-009507513-2205USA000560:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: No additional adverse events; expired doses of PROQUAD were administered to 3 different patients; This spontaneous report was received from a registered nurse referring to a 4-year-old male patient. No information about the patient's pertinent medical history and drug reactions or allergies was provided. Concurrent conditions included chronic otitis media, and concomitant vaccines included diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (KINRIX).   On 18-APR-2022 at 09:08, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneously in his left arm for prophylaxis (dose, vaccine scheme and lot number were not reported; expiration date 14-APR-2022) (expired product administered).  Product had never experienced temperature excursion and had supported outcome.   No adverse event reported.; Sender's Comments:  US-009507513-2204USA007779:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine stored outside of recommended range were administered to patient; No additional AE details; This spontaneous report was received from an administrator and referred to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. Concomitant medication included sterile diluent.  On an unknown date, the patient was vaccinated with the improperly stored (stored outside of recommended range) measles, mumps, rubella and varicella (oka-merck) virus vaccine (live recombinant human albumin (rHA)) (PROQUAD) (lot #U039258, expiration date: 09-JUN-2023) for prophylaxis (strength, dose, and route of administration were not provided) (product storage error).  It was reported that the suspect vaccine was exposed to a temperature of 6 Fahrenheit (F) up to 14 F (7.9 F) for a time frame of 4 hours, 8 minutes, and 0 second. There were no previous temperature excursions. No digital data logger was reported.  No additional adverse event (AE) details was provided (no adverse event).   This is one of the several cases reported by the same reporter.; Sender's Comments:  US-009507513-2205USA001202:
Sex: U
Vaccine: HIBV
Symptoms: Epiglottitis, Vaccination failure
Clinical narrative: vaccination failure; This literature marketed report has been received from the authors of a published article, titled as stated below, and refers to a school-aged child patient of unknown gender, whose HIb isolates were ere analyzed using whole-genome sequencing (WGS) in order to evaluate a Cluster and the Overall Trend of Invasive Haemophilus influenzae Serotype b 20052019. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On unknown dates, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) (dose, route of administration and lot # were not provided).The child was fully vaccinated based on guidelines.  On unknown date in September 2019, the patient experienced vaccination failure. They developed epiglottitis (Haemophilus influenzae serotype b (Hib) infection). The reporter considered the event vaccination failure to be related to Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports derived from the same literature article (cross-referenced # 2205USA001507). Sender's Comments:  US-009507513- 2205USA001507:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: not adverse event; Customer called and reported that PROQUAD was inadvertently administered to a 46 year old patient. No additional AE reported. No PQC reported. No additional information provided.; This spontaneous report as received from a other health professional refers to a 46 years old patient of unknown gender.   The patient's concurrent condition, medical history and concomitant medication were not reported.   On an unknown date,  the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # U039255, expiration date 09-JUN-2023. route was not provided).         It was reported that on 06-APR-2022, that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was inadvertently administered to a 46 -year -old patient. No additional AE reported
Sex: U
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site
Clinical narrative: the nurse who did the shot got it in the wrong place, very near to my shoulder joint; This case was reported by a physician via interactive digital media and described the occurrence of vaccine administered at inappropriate site in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2022, the patient received Shingrix. On 26th April 2022, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site was unknown.   Additional Information: GSK receipt date: 26-Apr-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient was also a Doctor of medicine (MD) and received Shingrix on the day of reporting at pharmacy. The nurse who did the shot got the vaccine in the wrong place, very near to patient's shoulder joint.  The patient asked that was it supposed to be concerned. Additional Supportive Information: The patient received the vaccine in the wrong place, which led to vaccine administered at inappropriate site. The follow-up could not be possible as no contact details were available. Note: Facility type was captured as Pharmacy conservatively as patient had received the vaccine at pharmacy.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 102.7 fever last night; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2022, the patient received Shingrix. On 27th April 2022, 1 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-APR-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received dose of Shingrix vaccine on Tuesday and had all side effects including 102.7 (unspecified unit) fever on last night before the reporting. The patient asked when side effects would stop. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Infanrix on 12Apr2022, then Boostrix on 27Apr2022; Infanrix instead of boostrix; 11 year old given Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3A745, expiry date 12th March 2024) for prophylaxis.   Co-suspect products included DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th April 2022, the patient received Boostrix. On 12th April 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 12th April 2022, not applicable after receiving Boostrix and unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On 27th April 2022, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short, wrong vaccine administered and inappropriate age at vaccine administration were 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: 28-APR-2022 Reporter's Comments: The medical assistant reported that a patient inadvertently received dose of Infanrix vaccine instead of Boostrix. The reporter consented to follow up. Additional Supportive Information: The health care professional reported that a patient received Infanrix vaccine instead of Boostrix at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration. The patient received the Boostrix dose earlier than the recommended interval, which led to shortening of vaccination schedule. This case is linked with case US2022073866 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022073866:Same reporter
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Hepatitis A adult vaccine to a 16 year old patient; Hepatitis A adult vaccine to a 16 year old patient; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 16-year-old female patient who received HAV (Havrix 1440) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th April 2022, the patient received the 1st dose of Havrix 1440 (intramuscular) and Havrix Pre-Filled Syringe Device. On 25th April 2022, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were 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: 26-APR-2022 Reporter's Comment: The patient received Havrix in right deltoid. She mentioned that, the patient received Menveo in left arm same day. The reporter stated that, she gave the patient a Hepatitis A adult vaccine instead of the Hepatitis A pediatric vaccine to a 16 year old patient. Additional Supportive Information:The reporter stated that, she gave the patient a Hepatitis A adult vaccine instead of the Hepatitis A pediatric vaccine to a 16 year old patient, which led to overdose and inappropriate age at vaccine administration.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070226:Same reporter - FU1 - Deleted