chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash, Rash vesicular
Clinical narrative: painful bl!stering rash on her right leg/was diagnosed with Herpes Zoster; postherpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for routine health maintenance and for the prevention of shingles. On an unspecified date, pt experienced a painful, blistering rash on her right leg. As a result of these symptoms, she presented to a medical provider and was diagnosed with herpes zoster and post herpetic neuralgia. Thereafter, pt had continued to suffer the effects of herpes zoster and post herpetic neuralgia. As a result, pt had suffered and would continue to suffer significant medical expenses, pain and suffering, and other damages. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine pt's symptoms and diagnoses had resulted in physical limitations not present prior to using the vaccine. As a result of the manufacture, marketing, advertising, promotion, distribution arid/or sale of zoster vaccine live (ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  The outcome of the events of herpes zoster and post herpetic neuralgia was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the events of herpes zoster and post herpetic neuralgia to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 25-JUN-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, exact dose, dose# and route not specified) for the long-term prevention of shingles and/ or zoster-related conditions prescribed and/or administered by a healthcare provider at a pharmacy. On an unspecified date, the patient experienced shingles and was treated by a physician at a hospital. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine use, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; received dose of pneumovax23 that had been improperly stored; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy details were not reported.  On 14-AUG-2019, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength and route of administration were not reported) lot # R033343, expiry date 03-AUG-2020 and lot # S012244 expiry, date 09-FEB-2021 for prophylaxis (Product storage error). The vaccines were exposed to a temperature of 0.0-degree Celsius in a time frame of 23 hours and 30 minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse event was reported. No product quality complaint (PQC) was associated with this report.
Sex: M
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: Contraindication of yeast for this patient; The patient got a rash/ The rash has spread to his chest; This spontaneous report was received from a nurse via company representative refers to a male patient of unknown age. The patient was allergic to unspecified allergies, anaphylactic reaction to unspecified allergy shots (drug hypersensitivity). The patient's concomitant medication was not reported. On 29-JUL-2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milligram, lot # R032766 with an expiration date of 31-AUG-20121 (strength, route was not reported) for protection against HPV (prophylaxis).  On an unspecified date in 2019, the patient got a rash on his right upper arm after receiving the vaccine. The rash had spread to his chest. The representative assumes that the rash was in the arm that the vaccine was received. The nurse stated that they were concerned of the contraindication of yeast for the patient (contraindicated product administered). The patient sought medical attention by calling the physician. No product quality complaint was involved.  The outcome of event was unknown. The reporter's causality assessment was not reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored; no adverse effect; This spontaneous report was received from a nurse regarding a patient of an unknown age and gender. The patient's pertinent medical history, drug reaction and allergies were unknown. On 22-AUG-2019, the patient was vaccinated with one dose of improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (strength, frequency, route was not reported) lot# R033343 expiration date 03-AUG-2020 or lot# S012244 expiration date: 09-FEB-2021, for prophylaxis (product storage error). The vaccine underwent temperature excursion of 0.0 degree Celsius, for 23 hours 30 minutes. Previously no temperature excursion was reported. The call was due to digital data logger. No adverse effects reported (no adverse event). Product quality complaint was not involved. Previously no temperature excursion was reported. The call was due to digital data logger.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea
Clinical narrative: persistent nausea; This spontaneous report was received from a physician assistant and refers to a 15-year-old female patient. The patient had no known concomitant medications, pertinent medical history and drug reactions or allergies.    On 20-AUG-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # S008151, expiration date 20-NOV-2021), intramuscularly (dose, frequency, strength, anatomical location were not provided) for humanpapilloma virus (HPV) prophylaxis. On 22-AUG-2019, the patient's father called the office to report that the patient had persistent nausea. The physician assistant reported that the patient did not have fever or sweats and did not vomit or had diarrhea. She had Zofran prescribed. The outcome of nausea was unknown but the patient would return to the office on 26-AUG-2019 for evaluation.        The causality assessment between the event and the suspect therapy was not provided.
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects were reported in the patient; Patient was inadvertently given third dose of VAQTA; Patient was inadvertently given third dose of VAQTA; This spontaneous report was received from a healthcare professional referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug allergies/reactions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) 25/0.5 vial, dose 3 lot # S007770, expiry date: 24-JUL-2020 (dose/frequency, route were not reported) for prophylaxis. On 26-AUG-2019 the patient was inadvertently given a third dose of hepatitis a vaccine, inactivated(VAQTA) extra dose administered and inappropriate schedule of product administration. On an unknown date, the patient experienced no adverse event. The outcome of extra dose administered, no adverse event and inappropriate schedule of product administration was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Improperly stored dose; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, drug reaction and allergies were unknown. On 26-AUG-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency, route not reported) lot number S006018 and expiry date 27-FEB-2021 for prophylaxis (Product storage error). The vaccine underwent temperature excursion of total time in range from -14 degree celsius to -10 degree Celsius (-12.9 degree Celsius) for 55 minutes. Previously no temperature excursion was reported. The call was due to digital data logger. No adverse effects reported (no adverse event). Product quality complaint was not involved.
Sex: F
Vaccine: HPV9
Symptoms: Swelling face
Clinical narrative: swelling in her jaw; This spontaneous report was received from a nurse practitioner via company representative and refers to a female patient of unknown age. Concomitant therapies included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and other unspecified vaccines. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route of administration, anatomical location, lot number and expiration date was not provided) for prophylaxis. After the vaccination, she experienced swelling in her jaw described as "like she had her wisdom teeth pulled out". As a result, the nurse practitioner withheld the patient's subsequent dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The outcome of swelling in her jaw  was not provided.     The causality assessment between the event and the suspect therapy was not provided.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect; Was administered expired dose; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 27-AUG-2019, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # N034400/expiration date: 10-MAY-2019) for prophylaxis. On 27-AUG-2019, the reporter informed that the patient inadvertently received an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (expired product administered). The reporter informed that no other adverse effects was reported. This case does not involve any product quality complaint. The outcome of event was unknown.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects reported; inadvertently received an expired dose; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications and drug reactions/allergies were not reported. On 27-AUG-2019, the patient was inadvertently vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # N034400 and expiration date: 10-MAY-2019) via oral route (default route) for prophylaxis (strength, dose and unit was not reported) (expired product administered). No adverse effects were reported. Outcome of expired product administered was unknown. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a female patient of unknown age and a lawyer referring to the patient. The patient's medical history, concurrent condition and concomitant therapy were not reported.   On or about 27-AUG-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced shingles. The outcome of the event was not recovered. The patient had received treatment. The reporter considered the event was disability.   The reporter considered the event was related to zoster vaccine live (ZOSTAVAX)
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect; Expired vaccine used; This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. The reporter stated that on 23-AUG-2019, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (expired product administered) lot # N029867 and expiry date 06-JUN-2019, (strength, dose, route were not reported) for prophylaxis. The reporter described that rotavirus vaccine, live, oral, pentavalent(ROTATEQ) did not have any temperature excursions prior to administration. No adverse symptoms reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect; M-M-R II, that was expired; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy details were not reported.     On 26-AUG-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, route of administration were not reported) lot # N023024 and expiry date 23-AUG-2019 for prophylaxis. It was reported that the administered vaccine was expired (Expired product administered). No adverse event was reported. There was no product quality complaint(PQC). No further information was available.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects reported; an unspecified patient received V ARIV AX one week before age of one year old; This spontaneous report was received from a nurse and refers to a patient of unknown gender, who was one week before 1-year-old. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2015, one week before the patient was 1-year-old, he or she was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route of administration, injection site, lot # and expiration date were not reported) reconstituted with sterile diluent for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; The patient was administered one dose of improperly stored Varivax; This spontaneous report was received from a nurse regarding a patient of an unknown age and gender. The patient's pertinent medical history, drug reaction and allergies were unknown. The concomitant therapy included sterile diluent. On 26-AUG-2019, the patient was vaccinated with one dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (reported as injection) (strength, frequency, route was not reported) (lot No S005077 has been verified to be a valid lot number, expiration date reported as 19-JUN-2021, but upon internal validation established as 19-FEB-2021) for prophylaxis (Product storage error). The vaccine underwent temperature excursion of 15 degree Fahrenheit to 46 degree Fahrenheit (36.392 F) for 2.5 hours and 6 degree Fahrenheit to 14 degree Fahrenheit for 1 hour. Previously no temperature excursion was reported. The call was due to digital data logger. No adverse effects reported (no adverse event). Product quality complaint was not involved. Previously no temperature excursion was reported. The call was due to digital data logger.
Sex: M
Vaccine: PPV
Symptoms: Seroconversion test negative, Therapy non-responder
Clinical narrative: failed to sero-convert; This spontaneous report was received from a physician regarding to a 13 year-old male patient. The patient's medical history and concomitant medications were not reported. Current conditions included the patient has immunodeficiency for unspecified reasons. On an unknown date the patient was vaccinated with 2 doses of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose, frequency, route, lot # and expiry date were not reported) for prophylaxis and failed to sero-convert (seroconversion test negative). The physician stated the patient had no additional doses administered. The outcome of seroconversion test negative was unknown. The causality assessment between suspect product and event was not provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect reported; a patient received expired MMRII; This spontaneous report was received from a registered nurse and refers to a patient of an unknown age an gender. There was no information about the patient's concurrent conditions or medical history provided. Concomitant therapies were not reported.  On 26-AUG-2019, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), recombinant human albumin (rHA), lot # N023142 with an expiration date 24-AUG-2019 for prophylaxis (dose, route of administration and anatomical location were not reported). No adverse effect reported. No additional information provided.
Sex: F
Vaccine: HPV9
Symptoms: Exposure via skin contact, Product quality issue, Skin haemorrhage, Skin laceration, Syringe issue
Clinical narrative: An unspecified Nurse cut her hand on an unspecified finger on the date of 8/21/2019 and it was bleeding after the GARDASIL 9 syringe broke while giving an injection to a patient; An unspecified Nurse cut her hand on an unspecified finger on the date of 8/21/2019 and it was bleeding after the GARDASIL 9 syringe broke while giving an injection to a patient; An unspecified Nurse cut her hand on an unspecified finger on the date of 8/21/2019 and it was bleeding after the GARDASIL 9 syringe broke while giving an injection to a patient; An unspecified Nurse cut her hand on an unspecified finger on the date of 8/21/2019 and it was bleeding after the GARDASIL 9 syringe broke while giving an injection to a patient; An unspecified Nurse cut her hand on an unspecified finger on the date of 8/21/2019 and it was bleeding after the GARDASIL 9 syringe broke while giving an injection to a patient; An unspecified Nurse cut her hand on an unspecified finger on the date of 8/21/2019 and it was bleeding after the GARDASIL 9 syringe broke while giving an injection to a patient; This spontaneous report was received from a field representative refers to a female patient (unspecified nurse) of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were unknown by the reporter. On 21-AUG-2019, the patient cut her hand on an unspecified finger and it was bleeding after the syringe broke while giving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R020948, expiry date was not reported (upon internal validation expiry date was validated as 04-MAY-2021) to a patient for prophylaxis (wound, product quality issue, exposure via skin contact, occupational exposure to product, accidental exposure to product and wound haemorrhage). The field representative reports that the patient, whom she was injecting did not have any adverse events and that the patient received the correct dosage of the vaccine. The nurse was treated by an unspecified physician and the treatment received was as follows: Superglue for the cut of the unknown finger". As 26-AUG-2019, the nurse was seeking treatment at employee health today. In addition the administrator stated that it was a vaccine pre-filled syringe was discarded and thrown away in the sharp container. Administrator stated that they took a photo of the syringe and will email the photo along with the case number. Administrator answered some of the product quality questions and then abruptly hung up as she had a conference call. The outcome of wound, exposure via skin contact, occupational exposure to product, accidental exposure to product, product quality issue and wound haemorrhage was unknown at the time of report. The causality assessment of the events product quality issue, wound haemorrhage and wound with respect to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Influenza like illness, Injection site pain, Muscle spasms, Product preparation error
Clinical narrative: During preparation of this dose, the GARDASIL 9 pre-filled syringe was not shaken at all; she developed flu like symptoms; muscle cramps ("which felt like pinching") throughout the body; a fever (temperature unknown); burning at the injection site; This spontaneous report was received from a pharmacist referring to a 32-year-old female patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported.  On unknown date in June 2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R025725, 25-MAY-2021); intramuscularly to prevent human papillomavirus (HPV) infection (prophylaxis). Immediately after this dose, the patient had burning at the injection site which recovered on unknown date (approximately in 2019).  On 19-AUG-2019, the patient was vaccinated with another dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R025725, 25-MAY-2021); intramuscularly to prevent HPV infection (prophylaxis). It was reported that the during preparation of this dose, the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe was not shaken at all (product administration error). After that on unknown date in (approximately in August 2019), the patient developed flu-like symptoms, a fever (temperature unknown) and muscle camps (which felt like pinching) throughout the body. The patient was recovering from the events. No treatment was given for adverse events. No laboratory diagnostics/ studies were performed. The patient did not sought medical attention. No PQC (product quality complaint) present. The reporter's causality assessment was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: During preparation of this dose, the GARDASIL 9 pre-filled syringe was not shaken at all; she developed flu like symptoms; muscle cramps ("which felt like pinching") throughout the body; a fever (temperature unknown); burning at the injection site; This spontaneous report was received from a pharmacist referring to a 32-year-old female patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported.  On unknown date in June 2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R025725, 25-MAY-2021); intramuscularly to prevent human papillomavirus (HPV) infection (prophylaxis). Immediately after this dose, the patient had burning at the injection site which recovered on unknown date (approximately in 2019).  On 19-AUG-2019, the patient was vaccinated with another dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R025725, 25-MAY-2021); intramuscularly to prevent HPV infection (prophylaxis). It was reported that the during preparation of this dose, the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe was not shaken at all (product administration error). After that on unknown date in (approximately in August 2019), the patient developed flu-like symptoms, a fever (temperature unknown) and muscle camps (which felt like pinching) throughout the body. The patient was recovering from the events. No treatment was given for adverse events. No laboratory diagnostics/ studies were performed. The patient did not sought medical attention. No PQC (product quality complaint) present. The reporter's causality assessment was not provided.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Medical assistant called and reported that an expired ROTATEQ was administered to patient.; No adverse affects reported.; This spontaneous report was received from a Medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.    On an unknown date, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) per oral route (strength, dose, frequency, and anatomical location were unknown) with  lot # R012957 and expiration date 11-JUN-2019. No adverse affects were reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; the patient was "inadvertently administered an expired dose of ROTATEQ"; This spontaneous report has been received from a medical assistant concerning to a 9-week-old patient of unknown gender.  The patient's concurrent condition, medical history, past drug reactions or allergies and concomitant medications were not reported.  On 26-AUG-2019, the patient was inadvertently administered an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (strength, dose not reported) (lot#: N022015, expiration date: 10-MAR-2019) administered orally for prophylaxis (Expired product administered). No adverse effects were reported.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: The primary reporter reports patient had injection site swelling after PNEUMOVAX 23; This spontaneous report was received from a medical assistant concerning a 63-year-old female patient. The patient's concomitant medications included unspecified vitamins. The patient's drugs or allergies reactions included sulfasalazine. No information was provided regarding the patient's pertinent medical history or concurrent conditions.   On 28-AUG-2019, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) injection, by intramuscular route, (lot number S012822 has been verified to be a valid lot number, expiration date as 21-FEB-2021), for vaccination (strength, dose number and anatomical site of injection were not reported).   On the same day, the patient had injection site swelling after Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was administered. It was reported that the patient recovered from the swelling "after rubbing the area", on the same day. No information was provided if the patient performed laboratory diagnostics or studies performed. The patient sought medical attention.   The causality assessment between Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) and the event was unknown.
Sex: M
Vaccine: MMR
Symptoms: Blood test, Facial pain, Mandibular mass, Pyrexia
Clinical narrative: facial pain; a golf ball size lump on the left side of the face near the jaw line; the patient developed  fever; This spontaneous report has been received from a pharmacist concerning to a 3-year-old male patient.  The patient's concurrent conditions, medical history, past drug reactions or allergies and concomitant medications were not reported.  On 14-AUG-2019, the patient received a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) subcutaneously (anatomical location, lot# and expiration date were not reported) to prevent measles, mumps and rubella (prophylaxis).  On 25-AUG-2019, the patient developed a fever (pyrexia) (the temperature was unknown), facial pain and a golf ball sized lump on the left side of the face near the jaw line (mandibular mass). The patient sought medical attention; the patient's family called the pharmacist and went to see a physician. An unspecified blood tests were performed; however, the results were unknown. No treatment was given for the events. At the reporting time, the patient had not recovered from the events of pyrexia, facial pain and mandibular mass.  The causal relationship between the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and the events was unknown.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect reported; Giving a patient an expired dose of M-M-R II; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. Concomitant therapy included diluent, 1 dose.  On 22-AUG-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) one dose of 0.5 ml, in the right posterior deltoid, lot# N013279, expiration date: 28-APR-2019, (expired product administered). No adverse effect reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; Names of vaccines involved: PROQUAD; This spontaneous report was received from a licensed vocational nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 14-AUG-2019, the patient received an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) Virus Vaccine Live rHA (PROQUAD) 0.5 mL, for prophylaxis lot number R022566 and expiration date 04-FEB-2020 (anatomical location and route of administration were not reported) which was diluted with sterile diluent. No adverse effects reported.  It was reported that on an unspecified date, the vaccine was exposed to a temperature between 47 Fahrenheit degrees and 77 Fahrenheit degrees for 11 hours and 30 minutes. The vaccine was also exposed to a temperature between 6 Fahrenheit degrees and 14 Fahrenheit degrees for 30 minutes; and in the recommended frozen range between 58 Fahrenheit degrees and 5 Fahrenheit degrees for 30 minutes (conflicting information). The call was placed because of a Digital Data logger report.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; patient received unspecified dose of PEDVAXHIB that was improperly stored/experienced excursion on 5/10/2018; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  The reporter stated that unspecified dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) experienced temperature excursion on 10-MAY-2018 (time included more than 1 excursion). Then on 18-JUN-2018, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # N003536 and expiration date 02-NOV-2019 (strength, dose, frequency and anatomical location were unknown) for prophylaxis. The administered dose of the vaccine was stored with a temperature of 8.72 degrees centigrades for 1 hour and 35 minutes and multiple excursions (more than 1 excursion). There was a digital data logger involved. No adverse effect reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; the patient was administered improperly stored Gardasil 9; This spontaneous report was received from a registered nurse refers to a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 20-AUG-2019 the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R016970, expiry date: 22-MAR-2021, anatomical location and route was not reported) for prophylaxis (product storage error). The vaccine was exposed to an unknown temperature for an unknown time frame. Previous temperature excursion was noted as follows at a temperature of 15.3 C for 5 hours 13 minutes. No digital data logger was recorded. No adverse effects reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Patient was administered improperly stored GARDASIL 9; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug allergy/ reactions and concomitant medications were not reported. On 21-AUG-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, formulation, route, dose/frequency were not reported) lot # R016970, expiry date: 22-MAR-2021 for prophylaxis. On 21-AUG-2019, the patient was administered with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (product storage error). No adverse effects reported. The outcome of product storage error and no adverse event was unknown.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; patient received a dose of MMR II that expired; This spontaneous report as received from a medical assistant refers to a patient of unknown age.and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 27-AUG-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), albumin status rHA, lot # N023153, expiration date 24-AUG-2019 (dose and route of administration were not reported) for prophylaxis, diluted in a sterile diluent. The administered expired vaccine did not have any temperature excursion. There was no adverse event reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; the patient inadvertently received an expired dose of MMR II; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 28-AUG-2019, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) injection, lot # N023146, expiration date: 24-AUG-2019 (exact dose, injection site, and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK) lot number N028091, expiration date: 10-MAR-2020. No adverse event was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  In 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: felt like crap; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced feeling bad. In August 2019, the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient received her dose of Shingrix last week and felt like crap for 2 days. The patient did not consent to follow-up.  It is 1 of 5 cases reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Eye infection, Ocular hyperaemia, Swelling of eyelid
Clinical narrative: Swelling of eyelid; eyes red; eyes infection; This case was reported by a consumer via call center representative and described the occurrence of swelling of eyelid in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced swelling of eyelid, eye red and eye infection. On an unknown date, the outcome of the swelling of eyelid, eye red and eye infection were unknown.   It was unknown if the reporter considered the swelling of eyelid, eye red and eye infection to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient asked if there been any reports of eye lids swelling, eyes red and infected after receiving this injection. The patient also asked this problem could be related to this medication. The patient had never had the events before.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort
Clinical narrative: Discomfort; This case was reported by a consumer and described the occurrence of discomfort in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2019, the patient received Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced discomfort. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the discomfort was unknown.   It was unknown if the reporter considered the discomfort to be related to Shingrix.  Additional case details were reported as follows: The patient asked could she take Tylenol for the discomfort of the Shingrix vaccine she received on day before reporting. The reporter gave permission to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: body aches; chills; This case was reported by a nurse via call center representative and described the occurrence of general body pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2019, the patient received the 1st dose of Shingrix. On 19th August 2019, less than a day after receiving Shingrix, the patient experienced general body pain and chills. On an unknown date, the outcome of the general body pain and chills were unknown.   It was unknown if the reporter considered the general body pain and chills to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient reported that, received vaccine day before the reporting and was told about the possible side effects but, was sure that could not get them. On the day of reporting, the patient wondering about how she could expect the achiness and chills to last.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Dry eye, Fatigue, Urticaria
Clinical narrative: Fatigue; Hives; severely dry eyes; extreme joint pain; This case was reported by a nurse via call center representative and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fatigue, hives, eye dryness and joint pain. On an unknown date, the outcome of the fatigue, hives, eye dryness and joint pain were unknown.   It was unknown if the reporter considered the fatigue, hives, eye dryness and joint pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient experienced fatigue, hives, severely dry eyes, and extreme joint pain. The reporter declined to offer any more data.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Muscle fatigue, Myalgia
Clinical narrative: Feel tired; Muscle fatigue; This case was reported by a consumer and described the occurrence of tiredness in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th August 2019, the patient received Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced tiredness and muscle fatigue. On an unknown date, the outcome of the tiredness and muscle fatigue were unknown.   It was unknown if the reporter considered the tiredness and muscle fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had feel tired with muscle pain.
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Area where the shot was given was red; Area where the shot was given was itching; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced injection site erythema and injection site itching. On an unknown date, the outcome of the injection site erythema and injection site itching were unknown.   It was unknown if the reporter considered the injection site erythema and injection site itching to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported, but the patient was 70 years old at the time of reporting. The patient received Flu vaccine from the same pharmacist who had administered Shingrix and Pneumonia vaccines. It was reported that, the area where the vaccine was administered was red and itchy. This case has been linked with case US2019093267 reported by the same reporter for the same patient.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Herpes zoster, Influenza like illness, Pain, Vaccination failure
Clinical narrative: vaccination failure; shingles on his right forehead, scalp, and temple; Body aches; Fatigue; flu like; Body aches; Fatigue; flu like; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles two years before the date of reporting). Previously administered products included Shingles vaccine (had a shingles vaccination sometime before that outbreak).   In March 2018, the patient received the 1st dose of Shingrix. In September 2018, the patient received the 2nd dose of Shingrix. In March 2018, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced general body pain, fatigue and influenza-like symptoms. In September 2018, the patient experienced general body pain, fatigue and influenza-like symptoms. In August 2019, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure, shingles, general body pain, fatigue and influenza-like symptoms were unknown and the outcome of the general body pain, fatigue and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, general body pain, fatigue and influenza-like symptoms to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles, general body pain, fatigue and influenza-like symptoms to be related to Shingrix.  Additional details were reported as follows: At the time of reporting, the patient experienced shingles on his right forehead, scalp, and temple. Within a few hours after receiving both the doses of Shingrix, the patient experienced flu-like symptoms which included body aches and fatigue. The symptoms lasted for 1.5 days after receiving 1st dose of Shingrix.  The reporter gave permission for his physician to be contacted. The reporter was unable to obtain additional information.