chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # M031651, expiration date: 30-MAR-2018, dose, frequency and route were unknown) for prophylaxis(incorrect product storage). The ROTATEQ was exposed to 31 Fahrenheit degree or colder for a time frame of 13 hours. Data logger was involved. No adverse effects reported.; Sender's Comments: US-009507513-1707USA010905:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # M031651, expiration date: 30-MAR-2018, dose, frequency and route were unknown) for prophylaxis(incorrect product storage). The ROTATEQ was exposed to 31 Fahrenheit degree or colder for a time frame of 13 hours. Data logger was involved. No adverse effects reported.; Sender's Comments: US-0009507513-1707USA010905:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # M031651, expiration date: 30-MAR-2018, dose, frequency and route were unknown) for prophylaxis. The ROTATEQ was exposed to 31 Fahrenheit degree or colder for a time frame of 13 hours. Data logger was involved. No adverse effects reported. Sender's Comments: US-009507513-1707USA010905.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 year old patient of unknown gender. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medication were not reported. On 26-JUL-2017, the patient was vaccinated with a dose of PROQUAD for prophylaxis, which was outside of the recommendations in the vaccine prescribing information (inappropriate schedule of drug administration). No adverse effects were reported. This is one of the two reports received from the same reporter (MARRS# 1707USA011604). Additional information has been requested.; Sender's Comments: US-009507513-1707USA011604:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to 5 unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored ZOSTAVAX (lot # M039453 expiration date: M039453; dosage, frequency and route unspecified) for prophylaxis and sterile diluent (lot and expiration date unknown). No adverse effects were reported. Temperature was 6 degree F to 14 degree F. Time frame was 30 minutes. Previous temperature excursion was reported as VARIVAX 15 degree F to 46 degree F for2 hour. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1707USA010585:
Sex: F
Vaccine: MMR
Symptoms: Exposure during breast feeding, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with one dose of M-M-R II injection (route, lot # and expiry date was not reported) reconstituted with a sterile diluent (MSD) (dose, route, lot # and expiry date was not reported) for prophylaxis while she was nursing (Breast feeding). No adverse effects were reported. Product quality complaint was not involved.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age and gender. The patient's medical history, concomitant medication and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with improperly stored dose of VARIVAX from lot # M027886 with expiry: 27-JUL:-2018 and lot# M027886 with expiry: 03-JUN-2018, for prophylaxis which were reconstituted with sterile diluent (MERCK STERILE DILUENT). The product were exposed to temperature of 6°F to l4°F for 40 Minutes; l5°F to 46°F for 3 Hours 10 Minutes. They had no previous temperature excursion. The temperature excursion was detected by digital data logger.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a 45 year old patient of unknown gender. On 26-MAY-2017, the patient received second dose of RECOMBIVAX HB injection 2.5/0.5 (lot # L044707, exp. date: 06-OCT-2018) intramuscularly for prophylaxis, which was a pediatric version (adult use of a child product). No adverse effect was reported. No further information was provided.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an unspecified number of patients of unknown ages and genders. On unknown dates, the patients were vaccinated with RECOMBIVAX (lot # reported as N002922, expiry date: 30-SEP-2018) (route: intramuscular), that was improperly stored (incorrect product storage). The vaccine was stored at a temperature of 32°F to 35°F (34.8F) for 1 hour and 15 minutes, at 32°F to 35°F (35.4F) for 4 hours and 24 minutes, at 32°F to 35°F (35.4F) for 4 hours and 12 minutes, at 32°F to 35°F (35F) for 4 hours and 36 minutes, at 32°F to 35°F (35F) for 4 hours and 18 minutes, at 32°F to 35°F (35F) for 4 hours and 42 minutes, at 32°F to 35°F (35.4F) for 2 hours and 30 minutes, at 32°F to 35°F (35.4F) for 3 hours and 18 minutes, at 32°F to 35°F (35.2F) for 4 hours and 54 minutes, at 32°F to 35°F (35.2F) for 4 hours and 42 minutes, at 32°F to 35°F (35.2F) for 4 hours, at 32°F to 35°F (35.4F) for 2 hours and 24 minutes, at 32°F to 35°F (35.4F) for 2 hours, at 32°F to 35°F (35F) for 4 hours and 6 minutes, at 32°F to 35°F (35F) for 5 hours and 24 minutes, at 32°F to 35°F (35.2F) for 5 hours and 6 minutes, at 32°F to 35°F (35.2F) for 5 hours and 18 minutes, at 32°F to 35°F (35.4F) for 3 hours. There was no previous temperature excursion. The call was because of a data logger. No adverse symptoms reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA011419: US-009507513-1707USA011601: US-009507513-1707USA011607: US-009507513-1707USA011615:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an unspecified number of patients of unknown ages and genders. On unknown dates, the patients were vaccinated with GARDASIL 9 (lot # reported as N013695, expiry date: 21-MAR-2019, lot # M035486, expiry date: 05-JUN-2019, lot # M040412, expiry date: 30-JUN-2019), that was improperly stored. The vaccine was stored at a temperature of 32°F to 35°F (34.8F) for 1 hour and 15 minutes, at 32°F to 35°F (35.4F) for 4 hours and 24 minutes, at 32°F to 35°F (35.4F) for 4 hours and 12 minutes, at 32°F to 35°F (35F) for 4 hours and 36 minutes, at 32°F to 35°F (35F) for 4 hours and 18 minutes, at 32°F to 35°F (35F) for 4 hours and 42 minutes, at 32°F to 35°F (35.4F) for 2 hours and 30 minutes, at 32°F to 35°F (35.4F) for 3 hours and 18 minutes, at 32°F to 35°F (35.2F) for 4 hours and 54 minutes, at 32°F to 35°F (35.2F) for 4 hours and 42 minutes, at 32°F to 35°F (35.2F) for 4 hours, at 32°F to 35°F (35.4F) for 2 hours and 24 minutes, at 32°F to 35°F (35.4F) for 2 hours, at 32°F to 35°F (35F) for 4 hours and 6 minutes, at 32°F to 35°F (35F) for 5 hours and 24 minutes, at 32°F to 35°F (35.2F) for 5 hours and 6 minutes, at 32°F to 35°F (35.2F) for 5 hours and 18 minutes, at 32°F to 35°F (35.4F) for 3 hours. There was no previous temperature excursion. The call was because of a data logger. No adverse symptoms reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA011555: US-009507513-1707USA011607: US-009507513-1707USA011615: US-009507513-1707USA011419.
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 year old patient of unknown gender. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medication were not reported. On 26-JUL-2017, the patient was vaccinated with a dose of PROQUAD for prophylaxis, which was outside of the recommendations in the vaccine prescribing information (inappropriate schedule of drug administration). No adverse effects were reported. This is one of the two reports received from the same reporter (MARRS# 1707USA011306). Additional information has been requested. Sender's Comments: US-009507513-1707USA011306.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an unspecified number of patients of unknown ages and genders. On unknown dates, the patients were vaccinated with ROTATEQ (lot # reported as N005617, expiry date: 03-OCT-2018), that was improperly stored (incorrect product storage). The vaccine was stored at a temperature of 32°F to 35°F (34.8F) for 1 hour and 15 minutes, at 32°F to 35°F (35.4F) for 4 hours and 24 minutes, at 32°F to 35°F (35.4F) for 4 hours and 12 minutes, at 32°F to 35°F (35F) for 4 hours and 36 minutes, at 32°F to 35°F (35F) for 4 hours and 18 minutes, at 32°F to 35°F (35F) for 4 hours and 42 minutes, at 32°F to 35°F (35.4F) for 2 hours and 30 minutes, at 32°F to 35°F (35.4F) for 3 hours and 18 minutes, at 32°F to 35°F (35.2F) for 4 hours and 54 minutes, at 32°F to 35°F (35.2F) for 4 hours and 42 minutes, at 32°F to 35°F (35.2F) for 4 hours, at 32°F to 35°F (35.4F) for 2 hours and 24 minutes, at 32°F to 35°F (35.4F) for 2 hours, at 32°F to 35°F (35F) for 4 hours and 6 minutes, at 32°F to 35°F (35F) for 5 hours and 24 minutes, at 32°F to 35°F (35.2F) for 5 hours and 6 minutes, at 32°F to 35°F (35.2F) for 5 hours and 18 minutes, at 32°F to 35°F (35.4F) for 3 hours. There was no previous temperature excursion. The call was because of a data logger. No adverse symptoms reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA011555: US-009507513-1707USA011601: US-009507513-1707USA011419: US-009507513-1707USA011615:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an unspecified number of patients of unknown ages and genders. On unknown dates, the patients were vaccinated with PEDVAXHIB (lot # L042836, expiry date: 24-AUG-2018) (route: intramuscular), that was improperly stored. The vaccine was stored at a temperature of 32°F to 35°F (34.8F) for 1 hour and 15 minutes, at 32°F to 35°F (35.4F) for 4 hours and 24 minutes, at 32°F to 35°F (35.4F) for 4 hours and 12 minutes, at 32°F to 35°F (35F) for 4 hours and 36 minutes, at 32°F to 35°F (35F) for 4 hours and 18 minutes, at 32°F to 35°F (35F) for 4 hours and 42 minutes, at 32°F to 35°F (35.4F) for 2 hours and 30 minutes, at 32°F to 35°F (35.4F) for 3 hours and 18 minutes, at 32°F to 35°F (35.2F) for 4 hours and 54 minutes, at 32°F to 35°F (35.2F) for 4 hours and 42 minutes, at 32°F to 35°F (35.2F) for 4 hours, at 32°F to 35°F (35.4F) for 2 hours and 24 minutes, at 32°F to 35°F (35.4F) for 2 hours, at 32°F to 35°F (35F) for 4 hours and 6 minutes, at 32°F to 35°F (35F) for 5 hours and 24 minutes, at 32°F to 35°F (35.2F) for 5 hours and 6 minutes, at 32°F to 35°F (35.2F) for 5 hours and 18 minutes, at 32°F to 35°F (35.4F) for 3 hours. There was no previous temperature excursion. The call was because of a data logger. No adverse symptoms reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA011555: US-009507513-1707USA011601: US-009507513-1707USA011419: US-009507513-1707USA011607.
Sex: U
Vaccine: PNC
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report from a non-contactable consumer.  A patient of unspecified age, ethnicity and gender received PREVNAR, via an unspecified route of administration, on an unspecified date, as single dose for immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced rash on an unspecified date.  The clinical outcome of rash was unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: CHOL
Symptoms: Incorrect product formulation administered
Clinical narrative: This spontaneous case report was received from a consumer (PVX2017-1843) on 06-Jun-2017. The report describes a female patient who "took VAXCHORA without buffer". The patient was receiving oral VAXCHORA for an unknown indication. It was reported that the patient took VAXCHORA in water, without the buffer. The action taken with VIVOTIF with respect to the event "took VAXCHORA without buffer" was not applicable. The clinical outcome of the event "took VAXCHORA without buffer" was unknown. Company's comment: The causality of the event "took VAXCHORA without buffer" was considered as not applicable. Reporter's Comments: The causality of the event "took VAXCHORA without buffer" was considered as not applicable. Sender's Comments: The causality of the event "took VAXCHORA without buffer" was considered as not applicable.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2014043725) on 14-Jul-2017. This case involves a 82-year-female patient, who was vaccinated with a dose of INFLUENZA VACCINE (FLU VACCINE) (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On 15-Oct-2014, following vaccination, the patient experienced allergy. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 60.0
Sex: M
Vaccine: TYP
Symptoms: Asthenia, Back pain, Dizziness, Fatigue, Malaise
Clinical narrative: Initial unsolicited report received from health care professional (nurse) on 14-Jul-2017. This case was linked to 2017SA107230. This case involves 60-year-old male patient who was vaccinated with a dose of TYPHIM VI (Batch number: M1572, expiration date: 24 Oct 2018, dose was not reported) via intramuscular route in left deltoid on 07 Jul 2017. The patient had a medical history of asthmatic and had restless leg syndrome. Concomitant medications included Trazadone 75 mg via oral route for restless leg syndrome and Albuterol inhaled for asthma. On 07 Jul 2017, same day following the vaccination, the patient experienced generalized weakness and malaise. On same day, the patient also had neck and back pain, dizziness, increased tiredness, had increased need of sleep, led stiff and weak. Patient had no fever, HA, SOB and localized reactions. Lab data and corrective treatment were not reported. The patient was recovering (resolving slowly) from the events. It was reported that, there was marked improvement from July 13 to July 14. List of documents held by sender: none.
Age: 60.0
Sex: M
Vaccine: TYP
Symptoms: Muscular weakness, Musculoskeletal stiffness, Neck pain, Somnolence
Clinical narrative: Initial unsolicited report received from health care professional (nurse) on 14-Jul-2017. This case was linked to 2017SA107230. This case involves 60-year-old male patient who was vaccinated with a dose of TYPHIM VI (Batch number: M1572, expiration date: 24 Oct 2018, dose was not reported) via intramuscular route in left deltoid on 07 Jul 2017. The patient had a medical history of asthmatic and had restless leg syndrome. Concomitant medications included Trazadone 75 mg via oral route for restless leg syndrome and Albuterol inhaled for asthma. On 07 Jul 2017, same day following the vaccination, the patient experienced generalized weakness and malaise. On same day, the patient also had neck and back pain, dizziness, increased tiredness, had increased need of sleep, led stiff and weak. Patient had no fever, HA, SOB and localized reactions. Lab data and corrective treatment were not reported. The patient was recovering (resolving slowly) from the events. It was reported that, there was marked improvement from July 13 to July 14. List of documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site pain, Injection site reaction, Urticaria
Clinical narrative: Reaction: Mild reaction resulting in welt, pain to touch and moderate muscle soreness around injection site. Treatment: Ice pack Outcome: none yet - waiting for welt and soreness to subside Pregnancy hx: Gestational diabetes Due date: 09/03/2017.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Mom brought the child to clinic on 7/27/2017 at 4:30pm . 3" diameters reddened area with swelling and itches on left upper arm noted. stated that it started the night of 7/26/2017.  Mom was advised to give  Benadryl liquid form according to the package directed and to put ice on the area. If symptom not better by 2-3 days to return to the clinic.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Mother brought child in on 7/27/17. Redness, swelling and itching to right upper thigh area. Redness measured 12 cm x 10 cm. Mother instructed that she can given child Benadryl and Ibuprofen prn and use cold compresses to area. No complaint of headache, fever, vomiting, or difficulty  breathing. Mother instructed to call or go to ER with any worsening symptoms.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient received her Tdap dose early, at 25 2/7 weeks, instead of >27 weeks. EDD is 10/21/17.
Sex: U
Vaccine: HEP, HEPA, HIBV, HPV9, PPV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 14-JUL-2017 from a medical assistant regarding an unspecified patient (age and gender not reported). Medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date, the patient may have received an improperly stored dose of one of the following vaccines, but she is not sure which of the vaccines the unspecified patient received. The names of the vaccines involved included GARDASIL 9 (lot # M028323, exp 26-SEP-2018); PEDVAXHIB (lot # N000236, exp 24-OCT-2019); PNEUMOVAX 23 (lot # N005096, exp 22-OCT-2018); RECOMBIVAX HB (lot # M029233, exp 09-AUG-2018); ROTATEQ (lot # M016918, exp 15-FEB-2018); or VAQTA (lot # M021124, exp 02-FEB-2018) (dose, route, and site of administration not reported). Temperature: In the range (9 degrees Celsius to 25 degrees Celsius). Time frame: 5 hours and 23 minutes. Previous temperature excursion? No. Was call because of a data logger? (Y/N). No adverse effect reported. No additional information was provided. Additional information has been requested.
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 34 year old female patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 11-JUL-2017 the patient was vaccinated with PROQUAD, subcutaneous for prophylaxis. No adverse event reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reactions or allergies was provided. On unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot# N001533 with expiration date 16-OCT-2019, lot# M042853 with expiration dates of 07-JUL-2019 and 17-JUL-2019 and lot# reported as M042843 with expiration date: 17-JUL-2019 (dose and route of administration were not reported) as prophylaxis. The sterile diluent (manufacturer unknown) used was stored properly. The doses of vaccine were stored between 47 degrees Fahrenheit (F) to 77F for 3 hours and 18 minutes. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006289: US-009507513-1707USA009050: US-009507513-1707USA009051: US-009507513-1707USA009053: US-009507513-1707USA009054: US-009507513-1707USA009055: US-009507513-1707USA009056: US-009507513-1707USA009057.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 24-JUL-2017 from an attorney regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's medical history, concurrent conditions and concomitant medications. In or about 25-SEP-2012, the patient was vaccinated at a local pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-OCT-2013, the patient was treated by a physician, for the onset of a painful vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed acyclovir for management of her persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received concerning the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 19-MAR-2010 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-MAR-2013, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed acyclovir for treatment of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other refers to a patient of unknown age. On 31-MAY-2017 the patient was vaccinated with GARDASIL 9 lot # M032650, 1 DF for prophylaxis. On 31-MAY-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Additional information is not expected as there was no consent to contact reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report received from the medical assistant referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. Medical assistant reported that an unspecified patient might have received an improperly stored dose of VARIVAX (lot: M048203; expiry date: 07-DEC-2018) (incorrect product storage). Temperature range was -14"C to-10"C for a time frame of 30 minutes. There was no previous temperature excursions. The call was because of a digital data logger. Medical assistant VARIVAX did not have a temperature excursion. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: UNK
Symptoms: Allergy to vaccine, Drug hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable other HCP. A currently 91-year-old female patient of an unspecified ethnicity received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration from an unspecified date to an unspecified date at a single dose for immunization. The patient started to receive atenolol, acetylsalicylic acid (ASPIRIN), omeprazole, hydrochlorothiazide, triamterene (DYAZIDE) and lisinopril: all via unspecified routes of administration from unspecified dates of therapy at unspecified doses and for unspecified indications. The patient's medical history and concomitant medications were not reported.  The patient had allergies with aspirin, atenolol, omeprazole, dyazide (triamterene-hydrochlorothiazide), lisinopril and pneumococcal vaccine on an unspecified date. The action taken in response to the event for pneumococcal 13-val conj vac (dipht crm197 protein) was not applicable while unknown for atenolol, acetylsalicylic acid, omeprazole, hydrochlorothiazide, triamterene and lisinopril. Outcome of the event was unknown. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) and atenolol in the reporter's country. This may be duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) and atenolol has submitted the same report to the regulatory authority.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Therapeutic response unexpected
Clinical narrative: This is a spontaneous report from a contactable consumer. A 68-year-old-male patient received PREVNAR 13, via an unspecified route of administration in Jul2017 at 0.5 ml, single for immunisation. Medical history included chronic bacterial sinusitis for nearly 50 years treated with antibiotic therapy 3- 5 times every year, diabetes mellitus, nasal congestion with nasal passages almost always blocked. Concomitant medication included metformin, carvedilol, hydrochlorothiazide, valsartan (DIOVAN HCT), insulin (INSULIN) for diabetes. The patient noted an unexpected positive effect. About 4 days after vaccination, his nasal passages became completely clear, drainage and purulent discharge completely disappeared, and overall he felt much better about his sinuses.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Headache, Injection site erythema, Injection site warmth, Myalgia
Clinical narrative: This a spontaneous report from a contactable consumer reporting on behalf of her daughter. A 19-year-old female patient received TRUMENBA, via an unspecified route of administration on the left arm at single dose on 10Jul2017 for immunization. The patient had no medical history. The patient concomitant medications were unknown. On 11Jul2017 the patient experienced headache, fever that reached 101.5 degrees, bad muscle and body aches, really tired, site reddish and site warm and nausea. The outcome of the events was reported as recovered for Headache, tiredness and bad muscle and body aches on 16Jul2017, for fever on 14Jul2017, for site reddish and site warm on unknown date. The patient received treatment for the events.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: This a spontaneous report from a contactable consumer reporting on behalf of her daughter. A 19-year-old female patient received TRUMENBA, via an unspecified route of administration on the left arm at single dose on 10Jul2017 for immunization. The patient had no medical history. The patient concomitant medications were unknown. On 11Jul2017 the patient experienced headache, fever that reached 101.5 degrees, bad muscle and body aches, really tired, site reddish and site warm and nausea. The outcome of the events was reported as recovered for Headache, tiredness and bad muscle and body aches on 16Jul2017, for fever on 14Jul2017, for site reddish and site warm on unknown date. The patient received treatment for the events.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: Minor itchy rash about the size of a dollar bill around the injection site. No pain.
Age: 22.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Injection site reaction, Pyrexia
Clinical narrative: Fever, chill, injection site reaction on the left arm.
Age: 13.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: No symptoms, patient left in stable condition. But dosage was given at an early age, than recommended.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient called to report pain at injection site as well as redness and swelling that is warm to the touch. She was advised to use anti-inflammatories and ice. If swelling persists and/or gets worse to contact her PCP in case of skin infection.
Age: 15.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Injection site swelling, Insomnia, Mobility decreased, Tenderness
Clinical narrative: Swelling and pain around injection site and radiating around. Unable to lift arm fully. Unable to sleep or lean on arm.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Oral mucosal eruption, Rash, Rash generalised, Rash morbilliform, Rash pruritic
Clinical narrative: Mom called our office on 07-26-17 to with concerns of patient having a rash. Mom stated they are on vacation camping in the woods and when patient broke out with his rash she thought it was hives. He was still taking the Amoxicillin for his +Strep. Mom now concerned the rash no longer looked like hives, rash seemed itchy, rash was around his mouth and it would go away at night but would present back in the morning. He was Afebrile. No other symptoms on this day. Symptoms were discussed with Nurse Practitioner and Mom was advised probable viral rash, something related to environment most likely, continue to take Amoxicillin, may give OTC BENADRYL, if rash persists or worsens to take to local urgent care or ER.  Mom call office again on 07/27/17 stating rash became worse and they were currently in a local urgent care facility at Lake of the Ozarks in Missouri.  Urgent care doctor said the rash looked like Measles.  Mom said he was covered head to toe with red spots and he had so many they were touching.  His behavior was still normal.  Mom stated the urgent care doctor was consulting with another doctor to confirm if Measles.  Mom stated the urgent care doctor told her , push fluids, Tylenol for comfort, continue Benadryl PRN.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Viral rash
Clinical narrative: Mom called our office on 07-26-17 to with concerns of patient having a rash. Mom stated they are on vacation camping in the woods and when patient broke out with his rash she thought it was hives. He was still taking the Amoxicillin for his +Strep. Mom now concerned the rash no longer looked like hives, rash seemed itchy, rash was around his mouth and it would go away at night but would present back in the morning. He was Afebrile. No other symptoms on this day. Symptoms were discussed with Nurse Practitioner and Mom was advised probable viral rash, something related to environment most likely, continue to take Amoxicillin, may give OTC BENADRYL, if rash persists or worsens to take to local urgent care or ER.  Mom call office again on 07/27/17 stating rash became worse and they were currently in a local urgent care facility at Lake of the Ozarks in Missouri.  Urgent care doctor said the rash looked like Measles.  Mom said he was covered head to toe with red spots and he had so many they were touching.  His behavior was still normal.  Mom stated the urgent care doctor was consulting with another doctor to confirm if Measles.  Mom stated the urgent care doctor told her , push fluids, Tylenol for comfort, continue Benadryl PRN.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information was received on 14-JUL-2017 from a registered nurse regarding a patient (age and gender not reported).  Medical history, concurrent conditions and concomitant medications were not reported.  On 12-JUL-2017, the patient was inadvertently administered a dose of PROQUAD (lot # M036158, exp 12-FEB-2018) and a dose of VARIVAX (lot # M046926, exp 28-NOV-2018)  (dose, route, site of administration not reported for either vaccine) at the same time. No adverse effects reported. No further information provided. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received on 14-JUL-2017 from an office manager regarding multiple unspecified patients (age and gender not reported). Medical history, concurrent conditions and concomitant medications were not reported. On multiple unreported dates, the patients were inadvertently administered improperly stored doses of VARIVAX (lot # M032495, exp 06-JUL-2018) and ZOSTAVAX (lot # M035695, exp 07-NOV-2017)(dose, route, and site of administration not reported) for prophylaxis. No side effects reported. The outcome of the events were not reported. Temperature: 15 degrees Fahrenheit to 46 degrees Fahrenheit Time frame: 1 hour Previous temperature excursion?: No Was call because of a data logger?: Yes. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 04-AUG-2015, the patient was vaccinated with a dose of GARDASIL for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The patient later received a dose of GARDASIL 9 lot number M013636, expiration date of 15-FEB-2018 ("unknown by reporter") for prophylaxis (dose and route of administration were not reported) on 05-AUG-2016. No adverse effects were reported. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 13-JUL-2017 from a registered nurse concerning an unspecified number of patients. No medical history or concomitant medications were reported. The nurse reported that on unspecified dates, the unspecified number of patients were inadvertently administered improperly stored reconstituted PROQUAD (lot # N000678, expires 05-JUL-2018) and VARIVAX (lot # N002204, expires 19-JAN-2019)(dose, route and injection sites not reported). No adverse effects reported. The temperature was between 6 degrees F. and 14 degrees F. (13.1 degrees F.) for 40 minutes. There was a previous temperature excursion  between -14 degrees C. to -10 degrees C for 5 hours and 40 minutes. Dilutent was not involved in temperature excursion (lot and expiration were not reported). The was not as a result of data logger. No additional information was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 lot # M032650 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to an unspecified number of patients of unknown demographics. On unknown dates, the patients were vaccinated with VAQTA lot # M039202, lot# reported as N005796, lot# M012261 and M032492 for prophylaxis. The vaccines were improperly stored at 47 degrees Fahrenheit to 77F for 4 hours, with previous temperature excursions of between 47F and 77F for 5 hours and between 9 degrees Celsius (C) and 25C for 8 minutes. On unknown dates, the patients experienced no adverse event. The reporter considered incorrect product storage to be not related to VAQTA. Additional information has been requested.; Sender's Comments: US-009507513-1707USA011012: US-009507513-1707USA011013: US-009507513-1707USA011014: US-009507513-1707USA011015:
Sex: F
Vaccine: VARZOS
Symptoms: Renal failure
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, route of administration, lot number and expiration date were not provided) for prevention of Shingles. On an unknown date in 2016 (also reported as about a year ago, after receiving ZOSTAVAX), the patient developed renal failure. It was further reported, that on an unknown date, the patient sought medical attention and the patient was admitted to an unspecified hospital for 4 days. The company representative stated, that she believed that the event of renal failure was life threatening. The outcome of renal failure was reported as recovered on an unknown date. The relatedness between the event of renal failure and vaccination with ZOSTAVAX was not provided. Upon internal review the event of renal failure was considered to be medically significant. Additional information is not expected since there was no consent to contact reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On or about 11-OCT-2011, the patient was vaccinated with ZOSTAVAX (lot number, dosage and route of administration unknown) as recommended for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-JUN-2013, the patient was treated by a physician for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further and proximate result, the patient has suffered and will continue to suffer significant, medical expenses, pain and suffering, and other damages. The outcome of the events was not recovered. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to patients of unknown age. On an unknown date the patients were vaccinated with an improperly stored dose of GARDASIL 9 for prophylaxis which was stored from 9 Celsius degrees (°C) to 25°C. On an unknown date the patients experienced no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9.; Sender's Comments: US-009507513-1707USA011790: US-009507513-1707USA011791: US-009507513-1707USA011792; US-009507513-1707USA011793:
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a office manager on behalf of physician assistant refers to a patient less than one year old (gender not reported). The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX (strength, dose, frequency, route, lot number and expiry date were not reported) reconstituted with sterile diluent (DILUENT MRK) (strength, dose, frequency, route, lot number and expiry date were not reported)  for prophylaxis. The patient received the VARIVAX before the patient was one year of age on an unspecified date (drug administered to patient of inappropriate age). Officer manager refused to answer additional questions. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to patients of unknown age. On an unknown date the patients were vaccinated with an improperly stored dose of M-M-R II for prophylaxis which was stored from 9 Celsius degrees (°C) to 25°C. On an unknown date the patients experienced no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to M-M-R II).; Sender's Comments: US-009507513-1707USA011791: US-009507513-1707USA011793: US-009507513-1707USA011792: US-009507513-1707USA011201:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to patients of unknown age. On an unknown date the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB for prophylaxis which was stored from 9 Celsius degrees (°C) to 25°C. On an unknown date the patients experienced no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to RECOMBIVAX HB. Sender's Comments: US-009507513-1707USA011793: US-009507513-1707USA011201: US-009507513-1707USA011790: US-009507513-1707USA011792.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to patients of unknown age. On an unknown date the patients were vaccinated with an improperly stored dose of ROTATEQ, oral for prophylaxis which was stored from 9 Celsius degrees (°C) to 25°C. On an unknown date the patients experienced no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. Sender's Comments: US-009507513-1707USA011793: US-009507513-1707USA011201: US-009507513-1707USA011790: US-009507513-1707USA011791.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to patients of unknown age. On an unknown date the patients were vaccinated with an improperly stored dose of VAQTA for prophylaxis which was stored from 9 Celsius degrees (°C) to 25°C. On an unknown date the patients experienced no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to VAQTA. Sender's Comments: US-009507513-1707USA011201: US-009507513-1707USA011790: US-009507513-1707USA011791: US-009507513-1707USA011792.
Age: 1.33
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Abnormal behaviour, Decreased appetite, Diarrhoea, Fatigue, Pyrexia
Clinical narrative: Mom calls on 7/28/17 and reports that child is not acting right. States that child developed symptoms on 7/27/16 of a rash (neck, check, stomach, and back), decreased appetite, Diarrhea, Vomiting, fever (controlled by Tylenol), and excessive tiredness. Is drinking fluids.
Age: 1.33
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash, Vomiting
Clinical narrative: Mom calls on 7/28/17 and reports that child is not acting right. States that child developed symptoms on 7/27/16 of a rash (neck, check, stomach, and back), decreased appetite, Diarrhea, Vomiting, fever (controlled by Tylenol), and excessive tiredness. Is drinking fluids.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Ec'd HPV dose 1 L deltoid on 7/20/17; Hurt a little off and on since got the vaccine, improving  and now only sore to touch right where she got the shot; Noticed swelling L upper arm yesterday, can see it most if abducts shoulder a little; Since noticed, staying same size; No paresthesias; R handed for writing, L for sports; Otherwise well, no recent illness; No rash; Feels well overal, no changes in appetite, activity; No fever; Approx 1 cm area induration at injection site L deltoid, no erythema, mod tenderness, surrounded by 5 x 6 cm area boggy swelling, no erythema, nontender (most noticeable with shoulder abducted approx 45 degrees); No fluctuance throughout; Normal cap refill, motor, sens no pain to active or resisted should ab- or ad-duction nor to internal or external rotation strength 5/5 thoughout B shoulder movements.
Age: 25.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Inflammation, Skin warm, Swelling
Clinical narrative: Both injections given in the L arm. Two days after the injections, localized redness, swelling, heat and inflamed area on L arm.