chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19-2, PNC20
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Heart rate irregular, Myocarditis
Clinical narrative: Heart flutter, chest tightness and pain , irregular heartbeat  Myocarditis?
Age: 1.17
Sex: M
Vaccine: COVID19-2
Symptoms: Crying, Decreased appetite, Hand-foot-and-mouth disease, Hypophagia, Irritability
Clinical narrative: Sept 23 - 2nd covid vaccine (Pfizer) Sept 24 - Normal Sept 25 - Fever by the end of day and no appetite  Sept 26 - Fussy, high fever, non stop crying, not eating Sept 27 - Fussy, high fever,  inconsolable crying, not eating and drinking milk, lesion on mouth Sept 28 - Mild fever, fussy Sept 29 - Fussy Sept 30  - Fussy
Age: 1.17
Sex: M
Vaccine: COVID19-2
Symptoms: Oral disorder, Pyrexia
Clinical narrative: Sept 23 - 2nd covid vaccine (Pfizer) Sept 24 - Normal Sept 25 - Fever by the end of day and no appetite  Sept 26 - Fussy, high fever, non stop crying, not eating Sept 27 - Fussy, high fever,  inconsolable crying, not eating and drinking milk, lesion on mouth Sept 28 - Mild fever, fussy Sept 29 - Fussy Sept 30  - Fussy
Age: 84.0
Sex: F
Vaccine: PNC20, UNK
Symptoms: Breast pain, Breast swelling, Erythema, Groin pain, Pain in extremity
Clinical narrative: pain, redness, swelling on arms, breast, crotch
Age: 84.0
Sex: F
Vaccine: PNC20, UNK
Symptoms: Peripheral swelling, Swelling
Clinical narrative: pain, redness, swelling on arms, breast, crotch
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness, Swelling face
Clinical narrative: Face is swelled up/eyes feels closed/eyes shut; Patient got sick everytime like she had COVID; This spontaneous case was reported by a patient and describes the occurrence of SWELLING FACE (Face is swelled up/eyes feels closed/eyes shut) and ILLNESS (Patient got sick everytime like she had COVID) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058f21a and 058f21a) for COVID-19 vaccination.     Concurrent medical conditions included Allergic to cats.   On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2022, the patient experienced SWELLING FACE (Face is swelled up/eyes feels closed/eyes shut) and ILLNESS (Patient got sick everytime like she had COVID). At the time of the report, SWELLING FACE (Face is swelled up/eyes feels closed/eyes shut) and ILLNESS (Patient got sick everytime like she had COVID) had not resolved.      The concomitant and treatment medication was not reported. Patient stated that since receiving the 1st dose on Sep 8 2021 he had adverse effects and from that date still has the same symptoms. Patient's face was swelled up, her eyes feels closed, her eyes shut and this happens twice a month. Patient got sick every time like she had COVID and it affected her life, currently she had been 8 days absent to her work as a teacher. Patient never had COVID positive test. No vaccines were given within one month prior to Moderna COVID-19 vaccine. AE had caused patient to seek medical care (office visit, Urgent care, ER, hospitalized) Yes, office visits, her doctor told her to go yesterday to the ER if it got worse but she had not gone. The patient had no experienced a similar event in the past.   This case was linked to MOD-2022-652193 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Eye swelling, Malaise, Swelling face
Clinical narrative: Face is swelled up/eyes feels closed/eyes shut; Patient got sick everytime like she had COVID; This spontaneous case was reported by a patient and describes the occurrence of SWELLING FACE (Face is swelled up/eyes feels closed/eyes shut) and ILLNESS (Patient got sick everytime like she had COVID) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058f21a and 058f21a) for COVID-19 vaccination.     Concurrent medical conditions included Allergic to cats.   On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2022, the patient experienced SWELLING FACE (Face is swelled up/eyes feels closed/eyes shut) and ILLNESS (Patient got sick everytime like she had COVID). At the time of the report, SWELLING FACE (Face is swelled up/eyes feels closed/eyes shut) and ILLNESS (Patient got sick everytime like she had COVID) had not resolved.      The concomitant and treatment medication was not reported. Patient stated that since receiving the 1st dose on Sep 8 2021 he had adverse effects and from that date still has the same symptoms. Patient's face was swelled up, her eyes feels closed, her eyes shut and this happens twice a month. Patient got sick every time like she had COVID and it affected her life, currently she had been 8 days absent to her work as a teacher. Patient never had COVID positive test. No vaccines were given within one month prior to Moderna COVID-19 vaccine. AE had caused patient to seek medical care (office visit, Urgent care, ER, hospitalized) Yes, office visits, her doctor told her to go yesterday to the ER if it got worse but she had not gone. The patient had no experienced a similar event in the past.   This case was linked to MOD-2022-652193 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness, Swelling face
Clinical narrative: The patient could not breathe; Patient felt sick; Patient face and eyes were swollen; Patient face and eyes were swollen; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (The patient could not breathe), MALAISE (Patient felt sick), SWELLING FACE (Patient face and eyes were swollen) and EYE SWELLING (Patient face and eyes were swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068n21a, 058f21a and 058f21a) for COVID-19 vaccination.     Concurrent medical conditions included Allergic to cats (cats allergy).   On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2022, the patient experienced DYSPNOEA (The patient could not breathe), MALAISE (Patient felt sick) and SWELLING FACE (Patient face and eyes were swollen). 27-Sep-2022, the patient experienced EYE SWELLING (Patient face and eyes were swollen). The patient was treated with PREDNISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (The patient could not breathe), MALAISE (Patient felt sick), SWELLING FACE (Patient face and eyes were swollen) and EYE SWELLING (Patient face and eyes were swollen) had not resolved.            No concomitant medication was given to the patient.  Patient was not planning to receive a second booster. Patient eyes was shut. Patient did not want to take any more vaccines. Patient did not have any COVID test or diagnosis. The patient did not have any medical history relating to mention adverse event and both acute and chronic illnesses at the time of vaccination. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient did not experience a similar event in the past. Patient symptoms were worsened.  The patient consulted with cardiologist, the patient required more vaccines, but patient denied.  Treatment medications prednisone and Benadryl was not working, and patient went to a couple doctors.   .   This case was linked to MOD-2022-652162 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Eye swelling, Malaise, Swelling face
Clinical narrative: The patient could not breathe; Patient felt sick; Patient face and eyes were swollen; Patient face and eyes were swollen; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (The patient could not breathe), MALAISE (Patient felt sick), SWELLING FACE (Patient face and eyes were swollen) and EYE SWELLING (Patient face and eyes were swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068n21a, 058f21a and 058f21a) for COVID-19 vaccination.     Concurrent medical conditions included Allergic to cats (cats allergy).   On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2022, the patient experienced DYSPNOEA (The patient could not breathe), MALAISE (Patient felt sick) and SWELLING FACE (Patient face and eyes were swollen). 27-Sep-2022, the patient experienced EYE SWELLING (Patient face and eyes were swollen). The patient was treated with PREDNISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (The patient could not breathe), MALAISE (Patient felt sick), SWELLING FACE (Patient face and eyes were swollen) and EYE SWELLING (Patient face and eyes were swollen) had not resolved.            No concomitant medication was given to the patient.  Patient was not planning to receive a second booster. Patient eyes was shut. Patient did not want to take any more vaccines. Patient did not have any COVID test or diagnosis. The patient did not have any medical history relating to mention adverse event and both acute and chronic illnesses at the time of vaccination. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient did not experience a similar event in the past. Patient symptoms were worsened.  The patient consulted with cardiologist, the patient required more vaccines, but patient denied.  Treatment medications prednisone and Benadryl was not working, and patient went to a couple doctors.   .   This case was linked to MOD-2022-652162 (Patient Link).
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no additional AEs; Caller reports 2 patients received doses of VARIVAX vaccine on 8/9/22 while improperly stored outside recommended storage temperature range; This spontaneous report has been received from a registered nurse regarding two patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, and drug reactions/ allergies were not reported.  On 03-AUG-2022, varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to -14 Fahrenheit (F) up to 46 F (14F) for 4 hours 15 minutes. On 09-AUG-2022, the vaccine was exposed to 14 F up to 46 F (45F) for 4 hours 45 minutes. On the same day, doses of improperly stored outside recommended storage temperature range, varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (0.5 ml, lot number: W011626, expiration date 06-APR-2024; strength and route of administration were not reported) were administered to the patients (product storage error). The reporter called for evaluation of vaccine temperature stability. There was no additional adverse event (AE) reported, and no further information was provided.  This is a non-valid case due to lack of patients' identifiers.  Follow-up information has been received from the registered nurse on 28-SEP-2022.  Patient's details were provided. It was updated that not properly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) was administered to a 15 years old patient of unknown gender who was vaccinated subcutaneously on right deltoid.    This is one of several reports from the same reporter.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Healthcare business professional is reporting the administration of improperly stored vaccines; No additional AE reported.; This spontaneous report was received from an office manager regarding to an unknown number of patients of unspecified age and gender. Their medical history, concurrent conditions and concomitant therapies were not reported  On unknown dates, the patients were vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human Albumin (rHA) (M-M-R II) lot #U017524, expiration date reported as 26-FEB-2023 but upon internal review established as 03-JUN-2023 and lot #U006489, expiration date reported as 03-JUN-2023 but upon internal review established as 26-FEB-2023 (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis; and/or varicella virus vaccine live (oka/merck) (VARIVAX) lot #U019904, expiration date: 24-JUN-2023 and lot #U039948, expiration date: 16-DEC-2022 (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis (Product storage error).  The improperly stored doses underwent a temperature excursion (temperature was not provided) for an unknown time frame. No adverse events were reported.  This is a non-valid report due to lack of patient's identifiers.  Follow-up information has been received from an office manager on 14-SEP-2022 concerning a 5-year-old female patient.  On 30-AUG-2022, the vaccines measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human Albumin (rHA) (M-M-R II) (lot# U017524) and varicella virus vaccine live (oka/merck) (VARIVAX) (lot# U039948) were administered subcutaneously on left deltoid (LD) and right deltoid (RD) respectively. The patient had one previous dose of each vaccine (unknown dates of administration).  This case was previously considered non-valid but per follow-up information it was determined to be valid as patient's details were provided.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other adverse events reported; Caller reports that an expired dose of GARDASIL 9 was administered to a patient today. Caller confirmed that dose was properly stored up through the time of administration. No other adverse events reported. No product quality complaints. No further i; This spontaneous report was received from a nurse and refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-SEP-2022, the patient was vaccinated with properly stored, expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot #1687292, expiration date: 25-AUG-2022 (both confirmed to be valid), administered for prophylaxis (strength, route and site of administration were not provided). There were no other adverse events reported (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; the improperly stored vaccine was administered on 08/19/22; This spontaneous report was received from a nurse and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On 19-AUG-2022, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) syringe,  lot # T029522, expiration date 13-MAR-2023 (dose, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The suspect vaccine was stored at a temperature of -39.8 Fahrenheit (F) for 3 hours and 27 minutes. There was no previous temperature excursion. No adverse events were reported (no adverse event).
Sex: U
Vaccine: PPV
Symptoms: Anti-HLA antibody test positive
Clinical narrative: human leukocyte antigen (HLA) sensitization subsequent to vaccination;  This literature marketed report has been received from authors of the literature article entitled as stated above and refers to an unspecified pediatric patient waiting for kidney transplant. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date after vaccination, the patient's anti-HLA antibody test was positive; the patient experienced human leukocyte antigen (HLA) sensitization subsequent to vaccination. The outcome of the event was unknown. The authors considered the event to be related to suspect vaccine.  This is one of five reports derived from the same literature article.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2209USA010290: US-009507513-2209USA010293: US-009507513-2209USA010291: US-009507513-2209USA010292:
Age: 17.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AEs were reported; Medical assistant reported that a patient received an expired MMRII vaccine today 9/7/2022.; This spontaneous report has been received from a medical assistant concerning to a 17-year-old- patient of an unknown gender.   The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies were not reported.   On 07-SEP-2022, the medical assistant reported that a patient was vaccinated with one dose of an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA] (M-M-R II), prophylaxis, (lot number T027935 that was verified to be valid with an expiration date reported and established as 18-AUG-2022; (dose vaccination scheme, route of administration and anatomical location were not provided) (expired product administered) in combination with sterile diluent (dose not reported) (lot number T020663 had been verified to be a valid number wiht an expiration date reported as and established as 02-FEB-2023).  No additional adverse event (AE) was reported.
Age: 14.0
Sex: M
Vaccine: MMR, MMRV, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported.; PROQUAD AE: 1 dose administered on 07/27/2022 while the patient was over the age of 12 years; This spontaneous report was received from a medical assistant and refers to a 14-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient started therapy with sterile diluent, solution for injection/infusion (strength, lot #, expiry date, route of administration, and indication were not provided).  On 23-APR-2009, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, first dose, for prophylaxis (strength, lot #, expiry date, anatomical location, and route of administration were not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, first dose, for prophylaxis (strength, lot #, expiry date, anatomical location, and route of administration were not provided).  On 02-FEB-2010, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, second dose, for prophylaxis (strength, lot #, expiry date, anatomical location, and route of administration were not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, second dose, for prophylaxis (strength, lot #, expiry date, anatomical location, and route of administration were not provided).  On 27-JUL-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 1 dose, lot #W007747, expiration date: 04-SEP-2023, for prophylaxis (strength, anatomical location, and route of administration were not provided).The patient was over the age of 12 years, and after patient was already vaccinated with 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) an 2 doses of varicella virus vaccine live (oka/merck) (VARIVAX) (product administered to patient of inappropriate age).  There were no adverse events reported (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: no adverse event; Patient was administered expired GARDASIL 9; This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 14-SEP-2022, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1687290 exp date reported as 09-SEP-2022 but upon internal validation established as 06-SEP-2022).
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Caller reports patient vomited after the administration of ROTATEQ vaccine.; This spontaneous report was received from physician, referring to a 2-month-old male. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient  was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter PO, (lot #W004504 has been verified to be valid lot, expiration date: 16-JUN-2023), for prevention of rotavirus (strength, and indication were not provided).  08-SEP-2022, the patient vomited. Then, on an unspecified date in 2022, he was recovered from the event.  The causal relationship between the event and rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  was unknown.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No adverse event; He received the first dose of GARDASIL 9 on 19JUL2022 and was scheduled for a 2nd dose today on 20SEP2022, but the patient states the administration of the 2nd dose was rescheduled to 23-SEP-2022; This spontaneous reported was received from a 45-year-old male patient, reporting on himself. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On an 19-JUL-2022, the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not provided).   The patient informed that his second dose was scheduled for 20-SEP-2022, however the administration of the second dose was rescheduled to 23-SEP-2022. No additional adverse event was reported.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: No additional AE information provided.; the product was diluting the PEDVAXHIB with 0.5mL of normal saline and then drawing up 0.5mL; the product was diluting the PEDVAXHIB with 0.5mL of normal saline and then drawing up 0.5mL; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 10-AUG-2022, the patient was vaccinated with the second dose of haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 mL (route of administration was not provided) lot # W002453, expiration date: 24-JUN-2024, administered as prophylaxis which was accidentally diluted with 0.5 mL of normal saline (Incorrect dose administered) (Product preparation error). No additional adverse event (AE) information provided.  This is one of several cases received from the same reporter.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no aditional AE; patient ws vaccinated with VARIVAX that experienced a temperature excursion; This spontaneous report was received from a medical assistant and refers to a 15-month-old female patient.  The patient's medical history, concurrent conditions and previous drugs reactions or allergies were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 18-AUG-2022, the patient was vaccinated with an unproperly stored  varicella virus vaccine live (oka/merck) (VARIVAX) lot number U029794, expiration date reported as 23-SEP-2023, administered subcutaneously on the right thigh as  prophylaxis (strength, and lot # were not provided) (product storage error). No additional adverse event was reported.; Sender's Comments:  US-009507513-2208USA008462: US-009507513-2209USA008838: US-009507513-2209USA008836: US-009507513-2209USA008837: US-009507513-2209USA008834: US-009507513-2209USA008835:
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; administration of expired PROQUAD vaccine to 2 patients on 9/20/22.; This spontaneous report has been received from a nurse concerning a 6-year-old male patient. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 20-SEP-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD), 0.5 milliliter (ml) (lot # U009260, has been verified to be a valid lot number for measles, mumps, rubella and varicella [oka-merck] virus vaccine live [rHA] [PROQUAD], expiration date reported and upon internal validation established as 19-SEP-2022) (anatomical location and route of administration were not provided) for prophylaxis (Expired product administered).  No additional adverse event was reported.
Sex: U
Vaccine: HEP, HPV4, PPV, UNK
Symptoms: Anti-HLA antibody test positive, Sensitisation
Clinical narrative: human leukocyte antigen (HLA) sensitization subsequent to vaccination;  This literature marketed report has been received from authors of the literature article entitled as stated above and refers to an unspecified pediatric patient waiting for kidney transplant. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with pneumococcal vaccine conj, hepatitis b vaccine (recombinant) (manufacturer unknown), quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) and  influenza vaccine inact  (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) all for prophylaxis. On an unknown date after vaccination, the patient's anti-HLA antibody test was positive; the patient experienced human leukocyte antigen (HLA) sensitization subsequent to vaccination. The outcome of the event was unknown. The authors considered the event to be related to suspect vaccines.  This is one of five reports derived from the same literature article.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2209USA010290: US-009507513-2209USA001761: US-009507513-2209USA010292: US-009507513-2209USA010293:
Sex: U
Vaccine: HEPA, MMR, PPV, VARCEL
Symptoms: Anti-HLA antibody test positive, Sensitisation
Clinical narrative: human leukocyte antigen (HLA) sensitization subsequent to vaccination;   This literature marketed report has been received from authors of the literature article entitled as stated above and refers to an unspecified pediatric patient waiting for kidney transplant. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), varicella virus vaccine live (oka/merck) (manufacturer unknown) and hepatitis a vaccine, inactivated (manufacturer unknown) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) all for prophylaxis. On an unknown date after vaccination, the patient's anti-HLA antibody test was positive; the patient experienced human leukocyte antigen (HLA) sensitization subsequent to vaccination. The outcome of the event was unknown. The authors considered the event to be related to suspect vaccines.  This is one of five reports derived from the same literature article.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2209USA001761: US-009507513-2209USA010290: US-009507513-2209USA010291: US-009507513-2209USA010293:
Sex: U
Vaccine: PPV
Symptoms: Anti-HLA antibody test positive
Clinical narrative: human leukocyte antigen (HLA) sensitization subsequent to vaccination; Literature report:   This literature marketed report has been received from authors of the literature article entitled as stated above and refers to an unspecified pediatric patient waiting for kidney transplant. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date after vaccination, the patient's anti-HLA antibody test was positive; the patient experienced human leukocyte antigen (HLA) sensitization subsequent to vaccination. The outcome of the event was unknown. The authors considered the event to be related to suspect vaccines.  This is one of five reports derived from the same literature article.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2209USA001761: US-009507513-2209USA010292: US-009507513-2209USA010291: US-009507513-2209USA010290:
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Underdose
Clinical narrative: No additional AE reported; Patient received a smaller than recommended dose; This spontaneous report was received from a registered nurse referring to a 65-year-old patient of unspecified gender. Information regarding the patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 27-SEP-2022, the patient was vaccinated with a smaller than recommended dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (exact dose, route of administration, vaccine scheme, and anatomical site of vaccination were not reported; lot number U035117 has been verified to be valid, expiration date reported and established as 18-AUG-2023) (incorrect dose administered).  No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; VARIVAX expired was administered; This spontaneous report was received from a medical assistant and refers to an unknown age and gender patient. The patient's medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 27-SEP-2022, the patient was vaccinated with an expired varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #T032319, expiration date: 22-SEP-2022, administered subcutaneously for prophylaxis (strength, dose, anatomical site were  not provided) (expired product administered).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: HCP reporting improperly stored VARIVAX was administered to 2 patients on 26SEP2022.; This spontaneous report has been received from a nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 26-SEP-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter (ml) once (valid lot number W003818 [expiration date 02-FEB-2024]) for prophylaxis, after a temperature excursion of 25.1 degrees Fahrenheit (F) with a time frame of 4 hours (h), 45 minutes (min), 0 seconds (sec) (product storage error) (vaccination scheme, and frequency were not provided). No previous temperature excursions were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA010474:
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Dysstasia, Hypertension, Vomiting
Clinical narrative: At 8pm, thery began to feel very dizzy; could not stand; had very high blood pressure; was vomiting; This spontaneous report has been received from a consumer referring to himself a 56-year-old male patient. The patient's medical history, concurrent conditions, previous drug allergies or reaction, and concomitant therapies were not provided.  On 23-SEP-2022 around noon, the patient started therapy with zoster vaccine live (ZOSTAVAX) subcutaneous injection, one dose, administered for prophylaxis as injection (strength, lot number, expiry date, and anatomical site of administration were not provided).  On 23-SEP-2022 08:00:00, the patient started feeling very dizzy, could not stand (dysstasia), had very high blood pressure (hypertension), and was vomiting. The patient visited the emergency room on the same night. He stated that the events lasted a few days and that he was doing better, however he was still experiencing dizziness.  The causal relationship between the vaccine and all the events was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP reporting improperly stored VARIVAX was administered to 2 patients on 26SEP2022. No additional details provided. See additional AE 02256046. No PQC.         ?    Names of vaccines involved VARIVAX (Lot: W003818, Expiration Date: 2FEB2024); This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient.s pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.   On 26-SEP-2022, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, 0.5 milliliters once as prophylaxis (lot number: W003818, which was determined to be valid, with an expiration date on 02-FEB-2024) (route and anatomical location of administration were not reported) (product storage error). The administered dose underwent a temperature excursion of 25.1 degrees Fahrenheit (F) for 4 hours and 45 minutes. It was reported there was not any previous temperature excursion. No additional adverse event was reported.   This case is one of two reports form the same reporter.; Sender's Comments:  US-009507513-2209USA010432:
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Inappropriate schedule of product administration, No adverse event, Syringe issue, Underdose
Clinical narrative: the patient received her first dose of PNEUMOVAX 23 on an unknown date in 2020; No other AE; the patient may not hace received full dose of PNEUNOMAX 23; The caller said the product leaked from the syringe; This spontaneous report has been received from a nurse and refers to a 67-year-old female patient. The patient's concurrent conditions included smoker. The patient's medical history, previous drug allergies or reactions, and concomitant therapies were not reported.  On an unknown date in 2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, lot number, expiry date, route of administration, and anatomical site of administration were not provided). On 15-SEP-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 1 dose, lot number u026796, expiration date reported as 28-JAN-2023, administered for prophylaxis (strength, route of administration, and anatomical site of administration were not provided); at the moment of the administration the product leaked from the syringe, and the patient may not have received the full dose of the vaccine (syringe issue, incorrect dose administered, inappropriate schedule of product administration). No other adverse event occurred.
Age: 40.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE or PQC reported.; a 40 year old patient was inadvertently administered PROQUAD.; This spontaneous report was received from a nurse and refers to a 40-year-old patient.  The patient's medical history, concurrent conditions, concomitant therapies and previous drugs reactions or allergies were not reported.  On 20-SEP-2022, the 40 old year patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) administered for prophylaxis lot #W007743  was found as a valid lot, expiration date reported as 04-SEP-2023 (strength  and route of administration were not provided) (Product administered to patient of inappropriate age). No additional adverse event were reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details were provided.; a patient received a dose of ROTATEQ on 26SEP2022 that expired on 19SEP2022.; This spontaneous report was received from a nurse and refers to an unknown patient of unspecified age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 26-SEP-2022, the patient received a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (2ml, lot # 1742462, expiration date: 19-SEP-2022) orally for prophylaxis (expired product administered). The product had no temperature excursions and the patient had no reported symptoms. No additional adverse event details were provided.
Age: 89.0
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: No additional AE reported; Nurse reported that PNEUMOVAX 23 was administered to a couple twice. This AE is for the husband. Please see AE case  02256651 for the wife. Patient received one dose of PNEUMOVAX 23 on 9/19/2022 and was accidently given a dose again of PNEUMOVAX 23 o; This spontaneous report was received from a registered nurse and refers to a 89 year old male patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On 19-SEP-2022, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and on 27-SEP-2022, he accidentally received another dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # U027357, expiration date: 25-MAR-2023), 0.5 mL (route of administration, anatomical location not provided) for prophylaxis (extra dose administered). No additional adverse event was reported.     This is one of 2 cases reported by the same reporter.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE; vaccines were administered following a temperature excursion.; This spontaneous report has been received from a vaccine coordinator, concerning a 2-month-old patient of unknown gender.  Information regarding the patient's medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies was not provided.  On 27-SEP-2022, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot number W004501 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ), expiration date reported and confirmed as 20-APR-2023) (exact dose was not provided) administered orally as prophylaxis. The vaccine administered had been suffered a temperature excursion of 8.6 Celsius (C) degrees for a time frame of 18 minutes and had also suffered the following previous temperature excursions: 11.5C for 1 hour 6 minutes; 8.8C for 21 minutes; and 9.6C for 6 hours 41 minutes (Product storage error).   No other information was available. No other adverse event (AE) or product quality complaint (PQC) were reported.  This is one of nine reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA010935: US-009507513-2209USA010921: US-009507513-2209USA010910: US-009507513-2209USA010908: US-009507513-2209USA010884: US-009507513-2209USA010833: US-009507513-2209USA010983: US-009507513-2209USA010940:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; have received this product following the temperature excursion; 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 reported.  On an unknown date, doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent a temperature excursion of 8.6 Celsius degrees for 18 minutes. It was reported that the doses underwent previous temperature excursion of 11.5 Celsius degrees for 1 hour and 6 minutes, 8.8 Celsius degrees for 21 minutes, and 9.6 Celsius degrees for 6 hours and 41 minutes.  On 28-SEP-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #W004501, expiration date: 20-APR-2023 (strength and dosage regimen were not provided) as prophylaxis. No adverse event was reported.  This is one of 9 cases reported by the same reporter.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Caller stated now her daughter is working on a cancer floor and had titers done which showed again no immunity; Her daughter had the VARIVAX booster in 2015 and in 2020 due to not having any titers for the vaccine/ 2015 where she had to have titers done that showed no immunity/ In 2020 where she had titers done again which showed no immunity again; Her daughter had the VARIVAX booster in 2015 and in 2020 due to not having any titers for the vaccine/ 2015 where she had to have titers done that showed no immunity/ In 2020 where she had titers done again which showed no immunity again; This spontaneous report has been received from a consumer, regarding a female patient of unknown age. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On unspecified dates (reports as "as a child"), the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) two shots as prophylaxis (doses, routes and anatomical locations of administration, lot numbers and expiration dates were not reported)  On an unspecified date in 2015, the patient was tested for titers which showed no immunity (Antibody test negative), therefore she had to receive a booster of varicella virus vaccine live (Oka/Merck) (VARIVAX) as prophylaxis (dose, route and anatomical location of administration, lot number and expiration date were not reported). On an unspecified date in 2020, the patient had titers done which showed again no immunity (Antibody test negative), therefore she received a fourth booster of varicella virus vaccine live (Oka/Merck) (VARIVAX) as prophylaxis (dose, route and anatomical location of administration, lot number and expiration date were not reported). On an unspecified date in 2022 (reported as now), the patient got titers test again and no immunity was found again Antibody (Antibody test negative). Reporter stated the patient was not sure if she should get another booster since each time, she has shown no immunity to the vaccine and by the time of the report she has gotten four doses of varicella virus vaccine live (Oka/Merck) (VARIVAX). The outcome of Antibody test negative was not reported.  The causal relationship between Antibody test negative and varicella virus vaccine live (Oka/Merck) (VARIVAX) was not provided.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient that received an expired dose of GARDASIL 9.; This spontaneous report was received from a pharmacist (also reported as a "physician"), via a company representative, referring to a 22-year-old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On an unknown date, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, route of administration, anatomical location, lot # ad expiration date were not reported). No additional adverse event (AE) details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Cellulitis, Rash, Rash vesicular
Clinical narrative: Cellulitis (horrific reaction); Arm still flares; This case was reported by a consumer via interactive digital media and described the occurrence of cellulitis in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant) and burning sensation. On an unknown date, the outcome of the cellulitis was unknown and the outcome of the burning sensation was not recovered/not resolved.   It was unknown if the reporter considered the cellulitis and burning sensation to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-Sep-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had a horrific reaction which had turned into Cellulitis from the reaction.   The patient's arm still had flares. The patient remembered when his/her friends had shingles. The pain and suffering they went through it sounded unbearable. They never wanted to experience that kind of pain, which had made the patient who wanted to learn more about this painful, blistering rash. The patient educated himself about the risk for developing shingles, especially for people 50 years or older, and what the patient could do for prevention. The patient had taken action. The patient wanted to find out more about the risk of shingles and take steps to help and prevent this painful rash. The reporter did not agreed that the company's safety team who may contact their Healthcare professional to gather information. The permission for consent to follow-up was denied.