chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV4
Symptoms: Product use in unapproved indication
Clinical narrative: Hpv vaccine used as treatment for bilateral plantar warts; This literature marketed report has been received from the authors of the published article, concerning a 36 year old male patient. The patient's pertinent medical history included therapy with liquid nitrogen, salicylic acid, candida albicans and curettage. The patient's current conditions and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacture unknown) for bilateral plantar warts (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).   A copy of the published article is attached as further documentation of the patient's experience.  This is one of several records received from the same literature .
Sex: M
Vaccine: HPV4
Symptoms: Product use in unapproved indication
Clinical narrative: HPV vaccine for right foot warts (plantar warts); This literature marketed report has been received from the authors of the published article, concerning a 63 year old male patient. The patient's pertinent medical history include therapy with liquid nitrogen, salicylic acid, candida albicans, duct tape and zinc (unspecified). The patient's current conditions and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for right foot warts (plantar warts) (product use in unappoved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).  This is one of several reports received from the same literature.  Sender's Comments:  US-009507513-1912USA001729:
Sex: M
Vaccine: HPV4
Symptoms: Product use in unapproved indication
Clinical narrative: HPV vaccine for right foot finger warts; This literature marketed report has been received from the authors of the published article, concerning a 32 year old male patient. The patient's pertinent medical history included therapy with liquid nitrogen, duct tape and curettage. The patient's current conditions and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for left foot (plantar) warts (product use in unapproved indication( (strength, dose, frequency, route of administration, lot number and expiration date were not reported).  This is one of several reports received from the same literature.  Sender's Comments:  US-009507513-1912USA001729:
Sex: M
Vaccine: HPV4
Symptoms: Drug effective for unapproved indication
Clinical narrative: Right foot warts (plantar warts) resolved; HPV vaccine for right foot warts (plantar warts); This literature marketed report has been received from the authors of the published article, concerning a 56 year old male patient. The patient's pertinent medical history included therapy with liquid nitrogen, salicylic acid and curettage. The patient's current conditions and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for right foot warts (plantar warts) (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).   On an unspecified date, the patient's right foot warts (plantar warts) resolved (drug effective for unapproved indication).   The outcome of drug effective for unapproved indication was unknown.   The causal relationship between the vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) and drug effective for unapproved indication was considered as related, as the authors hypothesize that effectiveness of the vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) in extragenital warts was due to the cross-protection of extragenital strains.  A copy of the published article is attached as further documentation of the patient's experience.   This is one of several reports received from the same literature.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash, Urticaria
Clinical narrative: hives on arms, legs and face; vaccine site was red; vaccine site was warm; vaccine site was swollen; rash; This report was obtained on request by the Company from the FDA (Agency Number 811846) under the Freedom of Information Act.   This spontaneous report was received from a nurse and refers to a 13-year-old male patient. He had no chronic or long-standing health condition, no other illnesses at the time of vaccination and up to one month prior, no prescriptions, over-the-counter medications, dietary supplements or herbal remedies and no known allergies.  On 16-APR-2019 at 17:30, 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) intramuscularly in the left arm, (strength and exact dose were not reported), (lot # 1602281 verified to be valid, expiry date not reported, but upon internal validation established as 21-JUL-2021) for prophylaxis.  Approximately one hour after vaccination, the patient consumed some potato chips with dip. On the same day, at approximately 20:00, the patient complained of rash. His mother gave him diphenhydramine hydrochloride (BENADRYL) before bed and rash largely disappeared. Next morning, the patient woke up with hives on arms, legs and face and vaccine site was red, warm and swollen. He denied any difficulty breathing. The patient's parent was advised to monitor next few days to help figure what was going on and also to avoid the chips and dip until known cause. The parent was told to come in if the symptoms continue or to visit emergency room (ER) for difficulty breathing or swallowing. The patient recovered from the events on an unknown date in April 2019.   The relatedness between the events and suspect vaccine was not reported.  Follow-up information has been received from the nurse on 25-FEB-2020. The nurse was unable to identify the patient.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Product dose omission, Product preparation error
Clinical narrative: patient may have received only the diluent and not the powder component; patient may have received only the diluent and not the powder component; This spontaneous report was received from a registered nurse via Food And Drug Administration (VAERS ID: 814638) referring to a 17-year-old female patient who was not pregnant. Information about medical history and concurrent conditions were not provided. The patient was not allergic to medications, food or other products. The patient's concomitant therapies included diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL), hepatitis a virus vaccine inactivated (HAVRIX) and sterile diluent (manufacturer unknown). The patient had no adverse events following any previous vaccine.               On 10-AUG-2018 10:45, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # N021572, expiration date was not reported, but upon internal validation established as 01-MAY-2020, dose number 1, intramuscular in the right arm for prophylaxis; dose was not reported) and meningococcal acyw conj vaccine (crm197) (MENVEO) (lot # M17014, dose number 1, intramuscular in the right arm for prophylaxis; dose was not reported).      On the same day, the meningococcal acyw conj vaccine (crm197) (MENVEO) vaccine that this patient received may not have been mixed properly. During inventory at the end of the month there was only 1 vial of powder component left in the box suggesting that only the diluent component might have been administered. It was unsure what patient might have received only the diluent and not the powder component (product preparation error and product dose omission).  Follow-up information has been received from a registered nurse on 26-FEB-2020. An inbound call was received from the registered nurse in response to her receipt of correspondence letter. The registered nurse clarified that the events she reported were related to meningococcal acyw conj vaccine (crm197) (MENVEO) and not to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The registered nurse had no further information to provide. Contact information was shared.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: moderate sore arm,  muscle pain, headache, shivering, nausea, vomiting.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: moderate sore arm,  muscle pain, headache, shivering, nausea, vomiting.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Diarrhoea haemorrhagic, Laboratory test normal, Rotavirus infection, Rotavirus test positive
Clinical narrative: Physician reported that on an unspecified date after receiving the ROTATEQ the patient had a recent diarrheal illness/unspecified test was positive to Rotavirus; Patient is currently actively having bloody diarrhea; This spontaneous report has been received from a physician, via a company representative, concerning a 5-month-old infant (reported as 5 and a half months old) of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medication, previous drug reactions or allergies were unknown to the reporter.  On an unknown date, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally for prophylaxis (reported as routine vaccination) (concentration, frequency of vaccination scheme, lot number, and expiry date were unknown to the reporter).  On an unknown date (reported as recent), after receiving the dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), the patient experienced diarrheal illness (rotavirus infection). On an unknown date, the patient had multiple tests that came back negative and an unknown test that tested positive for rotavirus.  On an unknown day in February 2020 (reported as currently), the patient was actively having bloody diarrhea (haematochezia).  The physician did not know if the patient had received any treatment for the reported events, or if medical attention was sought. However, the physician confirmed that the event was not cancer and that the patient did not overdose.   The outcome of rotavirus infection and haematochezia was reported as not recovered.  The causal relationship between Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ)and the occurrence of the events, was not reported.  Upon internal review, haematochezia was determined to be a medically significant event.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; from 2/14/2020 after closing to 2/17/2020 during the day the data logger malfunctioned; temperature could not be provided, a potential adverse event was recorded; On 2/17/2020, one male patient was administered VARIVAX and M-M-R II; This spontaneous report was received from a medical assistant referring to a 12 month old male patient. Information about patient's concurrent condition, medical history, drug allergy/reaction was not reported.   It was reported that from 14-FEB-2020 to 17-FEB-2020, the data logger was malfunctioned (product storage error). Since the temperature could not be provided, a potential adverse event was recorded (circumstance or information capable of leading to medication error). On 17-FEB-2020, the patient was inadvertently vaccinated (before the discovery of the data logger malfunction) with varicella virus vaccine live (oka/merck)(VARIVAX) lot # S024364, expiry date: 06-AUG-2021 for prophylaxis (strength, dose, dose number, route was not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA) lot # S015284, expiry date: 19-MAY-2021 for prophylaxis (strength, dose, dose number, route was not reported) (inappropriate schedule of product administration). Both the vaccines were reconstituted with properly stored sterile diluent, lot # S025291, expiry date: 23-APR-2022. Temperature was not reported and the time frame was reported as 42 hours and 50 minutes. There was no previous temperature excursion. The call was because of a data logger. No additional adverse effects were reported. No product quality complaint was involved.
Sex: M
Vaccine: VARZOS
Symptoms: Eye pain, Herpes zoster, Ophthalmic herpes zoster, Pain, Vaccination failure
Clinical narrative: Herpes zoster ophthalmicus (left); The vaccine did not prevent shingles, but rather caused a persistent strain of herpes zoster accompanied by pain; The vaccine did not prevent shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for prevention of shingles. The vaccine did not prevent shingles (vaccination failure), but rather caused a persistent strain of herpes zoster accompanied by pain to the patient, then on unknown date, the patient suffered an outbreak of shingles, which was accompanied by sharp pain in his left eye. Therefore, he presented to a physician and was diagnosed with herpes zoster and herpes zoster ophthalmicus (left). As a result, he had suffered and would continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was not reported. The events were considered related to zoster vaccine live (ZOSTAVAX).  Upon internal review, Ophthalmic herpes zoster was considered a medically significant event.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE information; patient was administered a properly stored but expired dose of M-M-R II; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 24-FEB-2020, the patient was vaccinated with a properly stored but expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live rHA (recombinant human albumin) (M-M-R II) (expired product administered), one dose as prophylaxis (lot number N032749 has been verified to be a valid lot number, expiration date reported and validated as 20-NOV-2019) (concentration, dose number, frequency of vaccination scheme, route and anatomical location of vaccination were not reported). Other suspect therapy included the sterile diluent (lot number and expiry date were not reported).   No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; patient was administered MMR II which was reconstituted with STERILE DILUENT which had expired.; patient was administered MMR II which was reconstituted with STERILE DILUENT which had expired; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 24-FEB-2020, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live rHA (recombinant human albumin) (M-M-R II) for prophylaxis (lot number R030809, has been verified to be a valid lot number, expiration date reported and validated as 24-OCT-2020) (concentration, dose, frequency of vaccination scheme, route and anatomical location of vaccination were not reported).  The nurse informed that an expired sterile diluent ( lot number N026287 has been verified to be a valid lot number, expiration date reported and validated as 07-FEB-2020) was used for the reconstitution of the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live rHA (recombinant human albumin) (M-M-R II) (expired product administered, product preparation error).   No additional adverse event was reported.  No further information provided.
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; That patient received improperly stored vaccine; This spontaneous report was received from a nurse referring to patient, age and gender were not reported. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 19-FEB-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (lot # S009759 has been verified to be a valid lot number measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and establish as 27-SEP-2020). Other suspect therapies included sterile diluent (lot # N029157 has been verified to be a valid lot number , expiration date reported and establish as 17-APR-2020).  The temperature of storage and time frame of the excursion were 6° Fahrenheit (F) to 14°F and 5 minutes respectively.  A digital data logger was involved but there was no previous temperature excursion. No adverse effect was reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No further adverse effect reported; Patient received dose of improperly stored VAQTA; This spontaneous report was received from a medical assistant referring to patient, age and gender were not reported. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 18-FEB-2020, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (lot # S025993 has been verified to be a valid lot number hepatitis a vaccine, inactivated, expiration date reported and establish as 17-OCT-2020) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were below 36° Fahrenheit (F) and 27 minutes respectively.  A digital data logger was involved but there was no previous temperature excursion. No adverse effect was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; The patient received a dose of improperly stored Rotateq; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and drug reactions or allergies.  On 21-FEB-2020, the patient received an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 1 dose, lot number S014947, expiration date 10-DEC-2020 for prophylaxis (route of administration was not reported) (product storage error).  The administered dose of the vaccine experienced a temperature excursion below 36°F (34F) degrees Fahrenheit for 27 minutes, as recorded by a data logger. No previous temperature excursion was reported. No further adverse effect reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; The patient received a dose of improperly stored Rotateq; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and drug reactions or allergies.  On 24-FEB-2020, the patient received an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 1 dose, lot number S014947, expiration date 10-DEC-2020 for prophylaxis (route of administration was not reported) (product storage error).  The administered dose of the vaccine experienced a temperature excursion below 36°F (34F) degrees Fahrenheit for 27 minutes, as recorded by a data logger. No previous temperature excursion was reported. No further adverse effect reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further adverse effect; Patient received a dose of improperly stored ROTATEQ; This spontaneous report was received from a medical assistant, refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 20-FEB-2020, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S014947, expiry date: 10-DEC-2020) (route of administration and anatomical location were not reported) for prophylaxis (product storage error). The vaccine was stored at a temperature of below 36°F (34°F) for 27 minutes. The call was because of a data logger and there was no previous temperature excursion. No further adverse effect reported. The outcome of the events was unknown.
Age: 2.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient is not experiencing any additional adverse symptoms.; The patient is a two-year old female who was administered GARDASIL 9 on 02/25/2020; This spontaneous report has been received from a consumer (the patient's grandmother), referring to a 2 years old female patient. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not provided.    On 25-FEB-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (1 injection; strength, frequency, lot# and expiration date were unknown) intramuscularly for prophylaxis (product administered to patient of inappropriate age). The patient was not experiencing any additional adverse symptoms (no adverse event).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further adverse effect reported; patient received a dose of improperly stored ROTATEQ; Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided.  On 21-FEB-2020, the patient received a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (orally; lot number S014947, expiration date 10-DEC-2020; strength and frequency unknown) for prophylaxis (incorrect product storage).   The storage temperature of the vaccine was below 36 degrees Fahrenheit (34 degrees Fahrenheit) for a time frame of 27 minutes. There was no previous temperature excursion. The call was because of a data logger. No further adverse effect was reported. No product quality complaint (PQC) was reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Medical assistant called to report that on 2/20/2020 patient received a dose of improperly stored VAQTA.; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 20-FEB-2020, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) 1 dose, lot # S025993, expiry date 17-OCT-2020 for prophylaxis (strength, vaccination site, route of administration unspecified). The temperature excursion was reported as below 36 degrees Fahrenheit (34 F) for a time frame of 27 minutes. Digital data logger was involved. There was no previous temperature excursion. No further adverse effects were reported. Product quality complaint (PQC) was not involved.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse symptoms reported; 15-month old patient was inadvertently administered an additional dose of MMR II; This spontaneous report has been received from a physician, referring to a 15 months old patient. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not provided.     In November 2019 (reported as 3 months ago), the patient was initially vaccinated one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, frequency, lot# and expiration date were unknown) subcutaneously for prophylaxis at the 12-month well-check visit. On 25-FEB-2020, the patient was inadvertently vaccinated an additional dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, frequency, lot# and expiration date were unknown) subcutaneously for prophylaxis for their 15-month check-up (inappropriate schedule of product administration). No additional adverse symptoms were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further adverse effect reported; patient received a dose of improperly stored ROTATEQ; Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 20-FEB-2020, the patient received a dose of ROTATEQ (strength, dose detail and route were not reported) (lot # S014947, expiration date 10-DEC-2020) for prophylaxis, which was reported as improperly stored (temperature below 36 degrees Fahrenheit (34 Fahrenheit), time frame was 27 minutes) (product storage error). There was no previous temperature excursion. Data logger was involved. No further adverse effect was reported.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Serum sickness
Clinical narrative: some sort of reaction; Serum sickness; This spontaneous report was received from a physician via company representative referring to a 20 year old female patient. The patient's historical condition included reaction to meningitis shot. The patient's concurrent conditions and concomitant medications were unknown.     On 31-JAN-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, anatomical location, route, lot # and expiry date not reported). On an unknown date in 2020, the patient developed serum sickness. On 03-FEB-2020, the patient called physician's office and she claimed that she had experienced some sort of reaction (adverse reaction). The patient received treatment for the events. The treatment drugs included dexamethasone (DECADRON), depo-medrol and hydroxyzine. The reporter also stated that the physician had anticipated a reaction after the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) shot. On an unknown date in February 2020, the events of serum sickness and adverse reaction were recovered. The reporter's causality assessment was not provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events; Improperly Stored Rotateq; This spontaneous report as received from a other health professional refers to a patient of unknown age.    On 24-FEB-2020 the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (therapy type: digital data logger) (ROTATEQ) lot # S014947 for prophylaxis.       On 24-FEB-2020, 1 day after onset of therapy the patient experienced product storage error.  On an unknown date the patient experienced no adverse event.    The outcome of product storage error and no adverse event is unknown.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No further adverse effect reported.; patient received a dose of improperly stored VAQTA.; This spontaneous report was received from a medical assistant refereing to a patient of unknown age and unknown gender. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.  On 21-FEB-2020, the medical assistant called to report that the patient received a dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S025993, expiration date 17-OCT-2020; strength, dose detail and route was not reported) for prophylaxis (improper storage of product in use). No further adverse effect reported. NO PQC. No additional information provided. The vaccine was exposed to temperature excursion of below 36 Fahrenheit degree (also reported as 34 Fahrenheit degree) for 27 minutes. No previous temperature excursion. No further adverse effect was reported. Data logger was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Systemic lupus erythematosus
Clinical narrative: patient had lupus before first dose of Shingrix but between doses there was an exacerbation; This case was reported by a pharmacist via call center representative and described the occurrence of systemic lupus erythematosus syndrome aggravated in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included systemic lupus erythematosus.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced systemic lupus erythematosus syndrome aggravated (serious criteria GSK medically significant). The patient was treated with prednisone. On an unknown date, the outcome of the systemic lupus erythematosus syndrome aggravated was unknown.   The reporter considered the systemic lupus erythematosus syndrome aggravated to be unrelated to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had lupus before 1st dose of Shingrix but between doses there was an exacerbation.  The health care provider asked for information regarding the administration of the 2nd dose of Shingrix. The reporter did not want to provide any details regarding the patient or the vaccine. The reporter consented for follow up.
Age: 35.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Wrong product administered
Clinical narrative: Patient was scheduled to get revaccination at clinic. It was documented that patient needed to be revaccinated with MMR, Varicella, Hep A, Hep B. I received the lot numbers because of the revaccination and saw patient was given Hep A, Hep B and MMRV. In speaking with employee at the health department she said that it is counted as a valid dose but that it was a med error.
Sex: M
Vaccine: HPV4
Symptoms: Death, Product use in unapproved indication
Clinical narrative: HPV vaccine used for hands warts; This literature marketed report has been received from the authors of the published article, titled as stated above concerning a 50 year old male patient. The patient's pertinent medical history included therapy with liquid nitrogen, curettage and topical fluoracil (reported as 5-FU). The patient's current conditions and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for hands warts (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).   The authors informed that on an unspecified date, the patient died due to natural causes.   A copy of the published article is attached as further documentation of the patient's experience.   This is one of several reports received from the same literature.  Sender's Comments:  US-009507513-1912USA001729:
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test abnormal
Clinical narrative: The patient reported that after recieving VARIVAX her "titer exam came back inconclusive"; This spontaneous report was received from a female patient of unknown age reporting on herself. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) reconstituted with a sterile diluent (strength, dose, batch/lot# and expiry date were not reported for all the suspects) via subcutaneous route for prophylaxis. On an unknown date, the patient had titer examination performed which came back inconclusive (antibody test abnormal). The outcome of antibody test abnormal was unknown. The causality assessment was not provided. There was no product quality complaint (PQC).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further adverse effect reported; Patient received a dose of Improperly stored Rotateq; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/ allergies and concomitant medications were not reported. On 19-FEB-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot number S014947 and expiry date 10-DEC-2020 for prophylaxis (strength, route and anatomical location were not reported) (product storage error). It was reported that there were no adverse effects. The administered dose of the vaccine experienced a temperature excursion of below 36 fahrenheit degrees (°F) (34F) for 27 minutes, as recorded by a data logger. The vaccines had no previous temperature excursion. No product quality complaint (PQC) was reported.
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: The wife of the patient stated "my husband has to get a booster shot of MMR II because there is an outbreak in our area; circumstances or information capable of leading to medication error; This spontaneous report was received from a consumer (patient's wife) referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions/ allergies were unknown.      On an unknown date the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, anatomical location, route, lot # and expiry date not reported). The reporter stated that on an unknown date, the patient had to get a booster shot of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) because there is an outbreak in their area (product administered to patient of inappropriate age and circumstance or information capable of leading to medication error).
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Product administered at inappropriate site
Clinical narrative: received the second dose of Shingrix vaccine in the joint of the arm and not in the deltoid; that a patient complained an had pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number N2E73, expiry date 19th March 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 15th February 2020, the patient received Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced pain. On 15th February 2020, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the pain and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provide as follows: No information provided from first dose of Shingrix was provided. The batch number was provided N2376, however was updated to N2E73 as per sales data sheet. The pharmacist reported that a patient complained pain as received the dose of Shingrix vaccine in the joint of the arm and not in the deltoid, which led to vaccine administered at inappropriate site. Consent to follow up was provided.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Injection site swelling, Pyrexia, Swelling, Tenderness
Clinical narrative: Mom called stating patient had redness, swelling, tenderness with low grade fever 24 hrs post getting DTAP in (L) Deltoid swelling went down after 3 days.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Hep A #2 given too soon. Needs to be 6 months between first and second dose in series.
Age: 57.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Misadministration (patient was supposed to receive Tdap not Dtap). No AEs following the injection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Fever occurred the day after both Shingrix vaccines along with body aches
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Injection site erythema
Clinical narrative: About 11 hours after the vaccine (in addition to red, hot, swelling at site, which happened with the first vaccine as well), I experienced a headache, spine ache, chills, tired - felt like I had the flu.  In addition, this morning, the 27th, my breast nipples are a purplish color (which I found very odd.)  After 36 hours, the flu like symptoms have dissipated, other than fatigue.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Skin discolouration, Spinal pain, Vaccine positive rechallenge
Clinical narrative: About 11 hours after the vaccine (in addition to red, hot, swelling at site, which happened with the first vaccine as well), I experienced a headache, spine ache, chills, tired - felt like I had the flu.  In addition, this morning, the 27th, my breast nipples are a purplish color (which I found very odd.)  After 36 hours, the flu like symptoms have dissipated, other than fatigue.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm pain, swelling, redness, and hot to the touch
Age: 60.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Chills, Dizziness, Myalgia, Pyrexia
Clinical narrative: Fever, chills, muscle aches, weakness, lightheadedness
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered
Clinical narrative: Facility is unsure if the proper dose was given to the pt.  Contacted health dept who confirmed to revaccinate after 8 wks.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered
Clinical narrative: Facility is unsure if the proper dose was given to the pt.  Contacted health dept who confirmed to revaccinate after 8 wks.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE information; administered a properly stored but expired dose of GARDASIL 9; 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 13-FEB-2020, the patient was vaccinated with a properly stored, but expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R022422, expiration date 25-NOV-2019 (exact dose and route of administration were not reported) for prophylaxis. No additional adverse event information.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Eyelid rash, Facial paralysis, Facial paresis, Herpes zoster
Clinical narrative: Bell's Palsy; postherpetic nervous system involvement; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 09-MAR-2017, patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, patient suffered blisters and rash over the left upper eyelid and left upper nose area and was diagnosed with shingles and postherpetic nervous system involvement. Patient also suffered blurred vision and weakness on her left side and was diagnosed with Bell's Palsy. As a direct and proximate result of Company's defective zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using Company's product. Patient also expenences mental and emotional distress due  o resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient 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. As a direct and proximate result of Company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The events were considered to be disabling.
Sex: U
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Rash, Vision blurred
Clinical narrative: Bell's Palsy; postherpetic nervous system involvement; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 09-MAR-2017, patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, patient suffered blisters and rash over the left upper eyelid and left upper nose area and was diagnosed with shingles and postherpetic nervous system involvement. Patient also suffered blurred vision and weakness on her left side and was diagnosed with Bell's Palsy. As a direct and proximate result of Company's defective zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using Company's product. Patient also expenences mental and emotional distress due  o resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient 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. As a direct and proximate result of Company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The events were considered to be disabling.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: was administered the 1st dose of GARDASIL 9 when she was 15 years old and returned to the office 1 year later at the age of 16 years old to receive the 2nd dose; was administered the 1st dose of GARDASIL 9 when she was 15 years old and returned to the office 1 year later at the age of 16 years old to receive the 2nd dose; This spontaneous report as received from a physician refers to a 16-year-old female patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On an unknown date in 2019, at the age of 15 years, 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) (strength, dosing schedule, route of administration, lot# and expiration date were not provided) for prophylaxis. On an unspecified date in 2020 (reported as after a year) the 16-year-old patient returned to the office to receive the second dose of vaccine.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further adverse effect reported; patient received a dose of improperly stored ROTATEQ; This spontaneous report was received from a medical assistant, referring to patient of unknown age and gender. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drugs reactions or allergies were not provided.  On 20-FEB-2020, the patient was vaccinated with a improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 1 dose as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; lot number  S014947 has been verified to be a valid, expiration date reported and validated as 10-DEC-2020). No adverse effects were reported for the patient  According to the reporter, the temperature excursion was 36 degrees Fahrenheit (34 degrees Fahrenheit) for a time frame of 27 minutes on an unspecified date (product storage error), without any previous temperature excursion; which was detected by a digital data logger.; Sender's Comments:  US-009507513-2002USA009991:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No further adverse effect reported; patient received a dose of improperly stored ROTATEQ; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history, concomitant medications and concurrent conditions was provided.  On 24-FEB-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dose, lot # S014947, expiration date 10-DEC-2020 (route of administration not provided) for prophylaxis. No further adverse effect reported.  Digital Data logger was involved. The vaccine was stored at the temperature below 36 degrees of F (34 degrees of F), the time frame reported as 27 minutes. There was no previous temperature excursion reported.