chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse, referring to an unknown number of patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were vaccinated on unspecified dates  with improperly stored doses of PNEUMOVAX 23, (lot # L019836; expiration date: 24-MAR-2017, lot # M033086; expiration date: 05-MAY-2018). No adverse effect reported. No further information was received. Temperature excursion: 35.2 degrees F for 1 hour and 6 minutes. This is one of two reports received from same reporter. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Dermatitis diaper, Hand-foot-and-mouth disease, Impetigo, Injection site induration, Rash vesicular
Clinical narrative: Left thigh induration, blistering rash on face, trunk, hands, and feet. Diaper rash. DX: 1) Hand, foot, mouth, 2) Impetigo. RX: Cephalexin, mupirocin.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from physician's office via a company employee on 17-NOV-2016. A nurse from the physician's office reported that a patient (demographics unknown, also reported as female) developed shingles at an unspecified time after receiving the ZOSTAVAX (Lot unknown). No other information was provided. Additional information has been requested. This is one of two reports from the same reporter (1612USA001172)
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient. The patient did not have any pertinent medical history and drug reactions or allergies. She was not using any concomitant medications. On 02-NOV-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration were not reported, lot # M033335, expiry date 11-OCT-2017. On an unknown date in November 2016 (also reported as at an unspecified time after receiving the vaccine), the patient noticed that the injection site was red an swollen. The redness and swelling went down. Then, on an unknown date in November 2016 (also reported as a few days ago), the injection site was pink but there was a lump under the skin where the injection was. No treatment was given for the events and no lab diagnostics studies were performed. The patient sought medical attention by coming to the pharmacy. The outcome of injection site lump was reported as not recovered. The outcome of injection site redness and swelling was recovering. The relatedness between events and ZOSTAVAX was not reported. The reporting pharmacist asked for a lot check to see in any other patients had experienced the same adverse reaction. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a nurse via Pfizer concerning a 66 years old female patient with osteoporosis since 2010. The patient's medical history was not reported. On 20-SEP-2016, the patient was vaccinated in her left deltoid with a dose of an unspecified flu vaccine, other concomitant therapies included SYNTHROID, ZOCOR and PRILOSEC. On 13-OCT-2016 (also reported as 23-OCT-2016), the patient was vaccinated in her right deltoid with a dose of PNEUMOVAX 23 injection, 0.5 ml, intramuscular route (lot number reported as: M02286 (which is an invalid lot number for PNEUMOVAX 23); expiration date 09-OCT-2017). No additional vaccines were administered on this date. On 13-OCT-2016 (reported as a few hours after receiving PENUMOVAX 23), the patient experienced extreme pain in her right arm with no redness, warmth or signs of infection where the vaccine was administered. On 14-OCT-2016, the patient returned to the doctor's office and received a shot of TORADOL for immediate relief as well as 10 mg of prednisone (manufacturer unknown). There were no relevant tests performed to the patient. The patient was told to call the office if the pain did not go away and she had not called so they assume the pain had resolved. However, the patient's status at the time of the report was unknown. The causality between the event and the PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: DTAP, FLUX, HIBV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse regarding a patient of unknown demographics. There was no -24-MAY-2018, information about concurrent condition, concomitant medication and historical medication. On 29-NOV-2016, the patient was vaccinated with improperly stored VARIVAX lot # M025867/expiration date-24-MAY-2018, subcutaneous. The vaccine was drawn into a syringe from the vial and stored in the syringe for 24 hours before administration (at an unspecified temperature) which is outside of the prescribing information recommendation. No adverse effects reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Human chorionic gonadotropin positive, Menstruation irregular, Pregnancy test urine positive
Clinical narrative: Pt. came requesting HPV vaccine on 8/1/16. Pt. stated LMP began 6/15/16. Pt. stated periods are irregular and denied any chance of pregnancy. Pt. returned to clinic on 9/8/16 requesting urine pregnancy test, which resulted positive. Pt. then stated LMP began 5/17/16.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from physician's office via a company employee on 17-NOV-2016. A nurse from the physician's office reported that she hear from an unknown source that another patient (demographic unknown) developed shingles after receiving the ZOSTAVAX (Lot unknown). No other information was provided. Additional information has been requested. This is one of two reports from the same reporter (1611USA009264).
Sex: F
Vaccine: HPV4
Symptoms: Simplex virus test positive
Clinical narrative: Information has been received from a physician referring to a female patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy were not provided. On an unknown date (reported as some time ago), the patient was vaccinated with GARDASIL (dose, route, lot number and expiration date were unknown). On an unspecified date, the patient had a sexual transmitted disease (STD) test (unspecified reason) which showed "her Herpes simplex virus (HSV) IgG was positive". The outcome of the event was unknown. Causality was not reported No product quality complaint (PQC) issue was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 15 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-NOV-2016, the patient was vaccinated with an expired dose of (wistar ra 27-3) M-M-R II, expiry date: 12-NOV-2016, subcutaneous (dose, lot# and anatomical location not reported). No adverse effects reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 2 patients of an unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX injection (dose, route of administration, frequency were not reported) lot # M007287, expiration date 12-FEB-2018. No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: FLU4, HEPA, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On an unknown date, the patient inadvertently received a fourth dose of GARDASIL 9 (dose, route, lot # and expiration date were unknown) following completion of the series. No adverse effects were reported in the patient. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients. On unknown dates, the patients were vaccinated with PEDVAXHIB (lot # M032147, expiration date 14-APR-2019; M020100, expiration date 07-MAR-2019), which was improperly stored at 50.9 F for 10 hours. No adverse effect reported. No data logger was involved. There was no previous excursion. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients. On unknown dates, the patients were vaccinated with GARDASIL 9 lot # M018810 (expiration date 28-MAY-2018), which was improperly stored at 50.9 F for 10 hours. No adverse effect reported. No date logger was involved. There was no previous excursion. This is one of several reports received from the same source. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site rash
Clinical narrative: Lump around injection site size of a baseball followed by a rash that extended from injection site to elbow.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HEPA, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Per health department VAERS, patient mom notified by Dr. of vaccine error-no reaction expected, mom to observe and contact if any adverse reaction noted, VAERS completed.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Red round area around inj site. Not warm to touch, no drainage, no fever.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Pruritus, Rash
Clinical narrative: Rash and itch on arms, stomach and back. Treatment: Dexamethasone 2 cc, Diphenhydramine 1/2 cc/prescription ATARAX.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Vaccination site bruising
Clinical narrative: Bruising and redness at site of imms vaccine. Non tender. No fever.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Abasia, Crying, Injection site rash, Injection site swelling
Clinical narrative: Crying non-stop 7.5 hrs. Stopped walking x 2 days. Swelling on (R) leg. Rash on (L) leg. Ice was applied by parent.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient received PREVNAR 13 on 11/15/2016 and she has been having constant pain/redness and soreness in the injected (L) arm despite the lapse in time. The symptoms have not resolved as of now.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient called and said he had a red area starting at injection site about 5-6 inches. It is not hot or itchy. He will take some Ibuprofen.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Significant pain, redness, swelling in arm at injection site. Expanded over Day 2-4 ultimately covering most of posterior upper arm. Patient treated with antibiotics and pain med and resolved over next 10 days.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local reaction, Pain, Pruritus, Skin warm
Clinical narrative: Redness, swelling, hot to the touch, itching, and pain on the same night she received the immunization. She called the next day to ask for recommendation and recommended BENADRYL. She called later that day to say it was feeling better but called the next day to follow up and recommend cold compress.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Redness, swelling, hot to the touch, itching, and pain on the same night she received the immunization. She called the next day to ask for recommendation and recommended BENADRYL. She called later that day to say it was feeling better but called the next day to follow up and recommend cold compress.
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Death, Myocardial infarction, Pain, Seizure, Tachycardia
Clinical narrative: This spontaneous report was received from a patient's mother received through newsletter and refers to a 19 year old female patient. On an unknown date, the patient was vaccinated with GARDASIL (dose, strength, frequency, lot number and expiry date were not reported). The patient's mother reported that the patient was a tall and accomplished student athlete at the time, to receive the quadrivalent GARDASIL. Her health began to decline, and the last 3 years of her life she suffered with terrible pain and she was on a feeding tube. She tragically died at the age of 19. The outcome of pain was unknown. Causality assessment was not reported. Additional information is not expected.
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Death, Feeding disorder, Generalised tonic-clonic seizure, Hyperacusis, Myocardial infarction
Clinical narrative: This spontaneous report was received from a patient's mother received through newsletter and refers to a 19 year old female patient. On an unknown date, the patient was vaccinated with GARDASIL (dose, strength, frequency, lot number and expiry date were not reported). The patient's mother reported that the patient was a tall and accomplished student athlete at the time, to receive the quadrivalent GARDASIL. Her health began to decline, and the last 3 years of her life she suffered with terrible pain and she was on a feeding tube. She tragically died at the age of 19. The outcome of pain was unknown. Causality assessment was not reported. Additional information is not expected.
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Pain, Parenteral nutrition, Photophobia, Seizure, Tachycardia
Clinical narrative: This spontaneous report was received from a patient's mother received through newsletter and refers to a 19 year old female patient. On an unknown date, the patient was vaccinated with GARDASIL (dose, strength, frequency, lot number and expiry date were not reported). The patient's mother reported that the patient was a tall and accomplished student athlete at the time, to receive the quadrivalent GARDASIL. Her health began to decline, and the last 3 years of her life she suffered with terrible pain and she was on a feeding tube. She tragically died at the age of 19. The outcome of pain was unknown. Causality assessment was not reported. Additional information is not expected.
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a patient's mother received through newsletter and refers to a 19 year old female patient. On an unknown date, the patient was vaccinated with GARDASIL (dose, strength, frequency, lot number and expiry date were not reported). The patient's mother reported that the patient was a tall and accomplished student athlete at the time, to receive the quadrivalent GARDASIL. Her health began to decline, and the last 3 years of her life she suffered with terrible pain and she was on a feeding tube. She tragically died at the age of 19. The outcome of pain was unknown. Causality assessment was not reported. Additional information is not expected.
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Death, Fatigue, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a patient's mother received through newsletter and refers to a 19 year old female patient. On an unknown date, the patient was vaccinated with GARDASIL (dose, strength, frequency, lot number and expiry date were not reported). The patient's mother reported that the patient was a tall and accomplished student athlete at the time, to receive the quadrivalent GARDASIL. Her health began to decline, and the last 3 years of her life she suffered with terrible pain and she was on a feeding tube. She tragically died at the age of 19. The outcome of pain was unknown. Causality assessment was not reported. Additional information is not expected.
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Death, Seizure
Clinical narrative: This spontaneous report was received from a patient's mother received through newsletter and refers to a 19 year old female patient. On an unknown date, the patient was vaccinated with GARDASIL (dose, strength, frequency, lot number and expiry date were not reported). The patient's mother reported that the patient was a tall and accomplished student athlete at the time, to receive the quadrivalent GARDASIL. Her health began to decline, and the last 3 years of her life she suffered with terrible pain and she was on a feeding tube. She tragically died at the age of 19. The outcome of pain was unknown. Causality assessment was not reported. Additional information is not expected.
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Death, Gastrointestinal tube insertion, Pain
Clinical narrative: This spontaneous report was received from a patient's mother received through newsletter and refers to a 19 year old female patient. On an unknown date, the patient was vaccinated with GARDASIL (dose, strength, frequency, lot number and expiry date were not reported). The patient's mother reported that the patient was a tall and accomplished student athlete at the time, to receive the quadrivalent GARDASIL. Her health began to decline, and the last 3 years of her life she suffered with terrible pain and she was on a feeding tube. She tragically died at the age of 19. The outcome of pain was unknown. Causality assessment was not reported. Additional information is not expected.
Age: 87.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cardiac arrest, Death, Dyspnoea, Immediate post-injection reaction, Syncope
Clinical narrative: Patient left pharmacy with no adverse symptoms. Daughter came in later to report she had started difficulty breathing after left pharmacy. She was taken to hospital. Staff at hospital told family it was not related to vaccine ptnt hospitalized ptnt daughter then returned to report death of ptnt.
Age: 87.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Death, Dyspnoea
Clinical narrative: Patient left pharmacy with no adverse symptoms. Daughter came in later to report she had started difficulty breathing after left pharmacy. She was taken to hospital. Staff at hospital told family it was not related to vaccine ptnt hospitalized ptnt daughter then returned to report death of ptnt.
Age: 65.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Mobility decreased, Pain
Clinical narrative: Pt had HAVRIX and ZOSTAVAX vaccines on left arm. Stated that she could not lift the arm above her head 3 days after admin, was extremely painful. ZOSTAVAX on the back of the arm, HAVRIX on "side".
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Circumstance or information capable of leading to medication error, Injection site reaction, Scratch
Clinical narrative: Initial unsolicited misuse report received from a non-healthcare professional (medical assistant) on 17 November 2016. This case involves a 3-years-old male patient who was vaccinated with a 0.5 ml dose of FLUZONE QIV (batch number- U5691AB expiration date-27 March-2017) (route of administration was not reported) in left thigh on 17 November 2016. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as none. Concomitant medications were not reported. On 17 November 2016, it was reported administered product into left thigh while mother was holding child and after needle entered leg, mother let go of child, and he pulled the needle out of his leg before the product was administered and the patient sustained a scratch on leg. Relevant laboratory data was reported as none. It was reported Band Aid was applied as corrective treatment. The outcome of event was reported as unknown. List of documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Skin discolouration
Clinical narrative: Initial unsolicited report received from a consumer on 17 November 2016. This case involves a 57-years-old female patient who was vaccinated with a dose of Fluzone (batch number UH893AB, expiry date, dose, site of administration were not reported) via intramuscularly route on 26 November 2013. Illness at time of vaccination reported as no and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not reported. On 26 November 2013, same day following the vaccination patient felt itchy and on 27 November 2013 (next day), patient experienced itchy rashes. On unspecified date, following the vaccination patient experienced skin discoloration where the rash had been. It was reported that patient did see an allergist for symptoms. Lab data was and corrective treatment was not reported. On unspecified date, patient recovered from events. List of documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Eye discharge, Eye irritation, Mucosal discolouration, Ocular hyperaemia
Clinical narrative: Initial unsolicited report received from a pharmacist on 22 Nov 2016. This case involves a 70 years old female patient who was vaccinated with a dose of FLUZONE HD (batch number- UI700AA, expiry date- 03 May 2017; dose in series and route of administration- unknown) in right arm on 11 Nov 2016. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Any other vaccinations within 4 weeks of vaccination was reported as none. The patient's other concomitant medications were not reported. On 11 Nov 2016, one hour following the vaccination, the patient's both eyes began to burn and within 6 hours after receiving vaccine, clear mucous was present in both eyes, and then the mucous turned to yellow in color. On 12 Nov 2016 in the morning, one day following vaccination,patient's both eyes were reddened. Laboratory investigations was reported as none. The patient corrective treatment were not reported. On 12 Nov 2016 in the evening, patient was recovered from reddened eyes. On an unspecified date, the patient was recovered from other events. List of documents held by sender: none.
Age: 27.0
Sex: F
Vaccine: RAB
Symptoms: Enlarged uvula, Rash
Clinical narrative: Patient broke out in Rash and felt that uvula was swollen. Patient is currently on antihistamine, NSAIDS, and an H2 blocker. Stable.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Sensory loss
Clinical narrative: Loss of Sensation down neck across chest and shoulder. Saw Internist and Neuroligst.  Took steroids and getting MRI.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Oedema peripheral, Ultrasound Doppler normal
Clinical narrative: Patient reported 11/30/2016 her Left arm was swollen and painful from the elbow up to the injection site. Edema traveling down to her wrist and hand.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Pharyngeal oedema
Clinical narrative: PATIENT C/O SLIGHT SWELLING IN THROAT AND DIFFICULTY SWALLOWING.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Discomfort, Peripheral swelling, Pruritus, Rash pustular, Skin reaction
Clinical narrative: Patient's Left arm became deep red, warm to touch and swollen. On 11/08/2016 He presented with raised, pustules the spread on torso, and legs. Patient complained of itching and discomfort.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Skin warm
Clinical narrative: Patient's Left arm became deep red, warm to touch and swollen. On 11/08/2016 He presented with raised, pustules the spread on torso, and legs. Patient complained of itching and discomfort.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Anaphylactic shock, Diarrhoea, Fatigue, Vomiting
Clinical narrative: Anaphylactic shock, could not even make it home before diarrhea occurred. For 10 weeks now - extreme diarrhea - extreme fatigue - random vomiting.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt stating soreness of arm, unable to lift.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Limb injury, Pain in extremity
Clinical narrative: Arm pain, diagnosed with arm injury due to injection, visited DR. given Ibuprofen Rx and physical therapy.
Age: 71.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Blood creatine phosphokinase normal, Full blood count normal, Metabolic function test normal, Myalgia, Red blood cell sedimentation rate normal
Clinical narrative: Wide spread myalgias.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 5 day old patient of an unknown gender. The patient's medical history, concurrent condition and concomitant medications were unknown. On an unknown date, a 5 day old patient was vaccinated with a dose of VAQTA 25/0.5 (units not provided), dose and route of administration were not reported, lot # M009377 with expiration date: 17-JUN-2017). No adverse effects were reported. Follow-up information has been received from the registered nurse on 07-NOV-2016 and 10-NOV-2016. The patient had no pre-existing allergies, birth defects and medical conditions. No adverse events following prior vaccination were reported. On 19-SEP-2016 at 11:30 am, the patient received the first dose of RECOMBIVAX HB lot # reported as M009377 (dose, route of administration and anatomical location were not reported) (not VAQTA as previously reported) and on 18-OCT-2016 at 11:55 am, she received the second dose of RECOMBIVAX HB lot # M010671 (dose, route of administration and anatomical location were not specified). Additional information is not expected as all scheduled follow up information has been received. Sender's Comments: MERCK 1609USA009694:Mfr number.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patient of unknown age and gender. No information about the patients medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with an improperly stored dose of PROQUAD (lot# L046509, expiration date: 17-MAY-2017) (dose and route of administration were not reported) for prophylaxis. Concomitant therapy was not reported. There was no adverse event reported. Follow-up information has been received on 29-NOV-2016, indicating that all telephone attempts to obtain follow-up information have been unsuccessful. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA002775: MERCK 1610USA006328: Mfr number.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot # K010215,expiration date 05-MAY-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced temperature excursion of -1 degrees Celsius for 30 hours. Data logger was involved. There was previous excursion reported as 8.6 degrees Celsius for 11 hours. 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-009507513-1611USA011947: US-009507513-1611USA011948: US-009507513-1611USA011949.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reaction/allergies or concomitant medication was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot #: M033209 with expiration date: 09-JAN-2018, lot #: M031942 with expiration date: 27-DEC-2017, lot #: M015698 with expiration date: 26-SEP-2017 and lot #: M002053 with expiration date: 11-JUL-2017 (all of them invalid lot numbers for varicella virus vaccine live (oka/merck)) (doses and routes of administration were not reported) for prophylaxis. There were no adverse effects reported. The administered doses of vaccine experienced a temperature excursion of maximum 15.2 Fahrenheit for 2 hours and 8 minutes. Data logger was involved and there was no previous temperature excursion reported. There was no Product Quality Complaint (PQC) involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA014218.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Pain
Clinical narrative: This spontaneous report was received from a patient referring to himself a currently 55 year old male patient. The patient did not have pertinent medical history or concurrent condition and was not taking a concomitant medication. On approximately 11-OCT-2016 (referred as about "4 or 5 weeks ago"), the patient was vaccinated with ZOSTAVAX in the right upper arm (route, dosage schedule, lot # and expiration date were not reported) for prophylaxis. On approximately 25-OCT-2015 (reported as "2 weeks later"), the patient started experiencing pain with a burning sensation on torso. The patient sought for medical attention but did not received any treatment for the event. Laboratory test were not performed. The outcome for the patient's pain with burning sensation on torso was unknown at the reporting time. The reporter did not assess causality between the event and the use of ZOSTAVAX. There was not a product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from an unknown reporter via Pfizer concerning a patient of unknown age and gender. No concurrent conditions, medical history and concomitant medications were reported. On an unknown date, the patient was vaccinated with GARDASIL dosing (details, lot# and expiry date were not reported). On an unknown date, the patient experienced an unspecified adverse event. The outcome of the event was unknown. The reporter did not provide the causality between the event and GARDASIL. Additional information is not expected as no reporter contact details were provided.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patent's concurrent conditions, concomitant allergies or medical history provided. On 06-OCT-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX23, intramuscularly, batch# reported as M023460 for prophylaxis (anatomical location, dose and expiration date were not reported). On 16-NOV-2016, the patient was vaccinated with another dose of PNEUMOVAX23 intramuscularly (dose, anatomical location, lot # and expiration date were not provided) in error. No adverse events were 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 healthcare worker and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of vaccinated with GARDASIL 9 lot # M020103, expiration date 15-FEB-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced temperature excursion of -1 degrees Celsius for 30 hours. Data logger was involved. There was previous excursion reported as 8.6 degrees Celsius for 11 hours. 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-009507513-1611USA006995: US-009507513-1611USA011948: US-009507513-1611USA011949.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On approximately 23-SEP-2016 (also reported as "two months ago"), the patient was vaccinated with the first dose of the human papillomavirus  (hpv) series with GARDASIL lot number, expiration date, dose, route and anatomical location were not provided for prophylaxis, at the time of the report, the patient was on the pharmacist's facility to receive the 2nd dose with GARDASIL 9 (interchange of vaccine products). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On unknown dates (reported as since 18-NOV-2016), the patients might have been administered with GARDASIL 9 (lot # M018810, expiry date: 28-MAY-2018, lot # M026306, expiry date: 30-APR-2018) (incorrect product storage). The vaccine was stored at a temperature of 9 C for 176 hours (a maximum temperature reading of 9 C in the morning for 11 days, from 18-NOV-2016 to 28-NOV-2016 evaluated for 16 hours each day). There was no previous temperature excursion. Data logger was not involved. No adverse effects have been 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.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema multiforme, Mycoplasma test negative
Clinical narrative: Erythema Multiforme.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site oedema, Injection site vesicles, Injection site warmth
Clinical narrative: (R) upper arm injection site with approx 12CM diameter of erythema, edema, warmth and a few fluid filled (serous) blisters. Treated with cephalexin x 1 wk.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Received FLUZONE High Dose on 11/24/20126. The day after a medium sized bump occurred at injection site and significant bruising also. Patient came in on 12/5/16 and the bump and bruising has not improved much. She was concerned. It did not cause much pain but I referred her to her Doctor.
Age: 82.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Malaise, Pyrexia, Walking aid user
Clinical narrative: Malaise, mild fever, generalized weakness, reverted to using a walker from not using it the weeks prior.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Blood test normal, Dyskinesia, Fatigue, Headache
Clinical narrative: Joint pain and swelling a few hours after vaccine on 11/30/2016 at 04:30 PM. Right sided headache same date at 08:00 PM. 12/01/2016 those symptoms continued and extreme fatigue at 09:45 AM, then muscle twitching at 02:30 PM. 12/02/2016 joint issues and muscle twitching continued. 12/03/2106 at 09:00 AM severe headache, 11:21 AM Parkinsonian hand tremors. I went to urgent care and at 12:20 PM severe flailing of lower extremities, witnessed by medical staff. They called ambulance and I was sent to ED. Blood work was drawn and normal, so I was discharged at 04:30 PM. I saw Dr on 12/05/2106 at 02:30 PM. He witnessed my legs moving uncontrollably.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Joint swelling, Muscle twitching, Tremor
Clinical narrative: Joint pain and swelling a few hours after vaccine on 11/30/2016 at 04:30 PM. Right sided headache same date at 08:00 PM. 12/01/2016 those symptoms continued and extreme fatigue at 09:45 AM, then muscle twitching at 02:30 PM. 12/02/2016 joint issues and muscle twitching continued. 12/03/2106 at 09:00 AM severe headache, 11:21 AM Parkinsonian hand tremors. I went to urgent care and at 12:20 PM severe flailing of lower extremities, witnessed by medical staff. They called ambulance and I was sent to ED. Blood work was drawn and normal, so I was discharged at 04:30 PM. I saw Dr on 12/05/2106 at 02:30 PM. He witnessed my legs moving uncontrollably.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Blood pressure increased, Heart rate increased, Paraesthesia, Respiratory rate increased, Tremor
Clinical narrative: Increased Heart Rate, Increased Blood Pressure, Tingling of bottom lip, chin and cheeks, hand tremors, rapid breathing.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site discolouration, Injection site erythema
Clinical narrative: Black and Blue at injection site, with redness and heat below the injection site above elbow.
Age: 26.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Hypoacusis, Syncope
Clinical narrative: Syncope episode after receiving vaccinations, patient reports having dull hearing that eventually returned to normal after laying down with feet up.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Breast disorder female, Tremor
Clinical narrative: Her left breast stopped developing. She developed tremors.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Local swelling, Pain, Skin warm
Clinical narrative: Area became red, swollen, harder, painful, warm to touch.  No treatment.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Injection site erythema, Injection site inflammation
Clinical narrative: Vaccine was received on Monday. On Wednesday redness and inflammation around site of injection that spread throughout entire arm from shoulder to elbow. On Saturday patient felt weak and could not get out of bed.
Age: 29.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site bruising, Injection site nodule
Clinical narrative: Patient had bruise and "knot" at injection site with FLUZONE QUAD MDV injection.
Age: 10.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Wheezing
Clinical narrative: Mom reports that pt recently received his MMR and within about 10 minutes he started coughing and the coughing progressed, mom then noted he had developed hives and they returned to the clinic where upon arrival he was noted to be wheezing, he was given Benadryl and a nebulizer treatment containing Albuterol, but it continued so they decided to administer Epinephrine, 0.2mg IM in thigh.  Mom states that from the time the presented until all was stable was approx 30 minutes or less. Mom states they typically do not vaccinate but due to his heart problems he has received several of his vaccines and never had a problem. Mom states he has even had a flu shot and no problems. Mom states they are vegan but on occasion he will eat products that contain eggs without any problems. Pt has not had any problem with any of his other vaccines that he has received:  DTaP, Pneumovax, Flu Shot.
Sex: U
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a medical assistance and refers to a multiple patients of an unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with a GARDASIL 9 injection (dose, route of administration, frequency, lot # and expiration date were not reported). Immediately, after receiving a GARDASIL 9, while the patients were still in the office, they developed episodes of syncope, which usually lasted for about 45 minutes. No treatment was given to the patients for the event. There was no product quality complaint involved. Subsequently, the patients were fully recovered and went home. The causality between event of syncope and GARDASIL 9 was not provided. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA002620.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products
Clinical narrative: This spontaneous report as received from a nurse 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, at the age of 11 years the patient received her first dose of vaccination with an unspecified human papillomavirus vaccine (dose, and route not reported) for prophylaxis however a quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) could not be ruled out. On an unknown date, when she was turning 15 years of age she received her second dose of properly stored GARDASIL 9 (dose, route, lot # and expiry date unknown) for prophylaxis (inappropriate schedule of drug administration, interchange of vaccine products). No adverse effects were noted. No product quality complaint was involved. Additional information is not expected as consent to contact was not provided by the reporter.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of unspecified patientsof unknown demographics. The patients' concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally (lot # L048854, expiry date 31-AUG-2017, lot # L033694, expiry date 16-JUN-2017 and lot # M019707, expiry date 25-OCT-2016; dose was not reported). The doses of the vaccine were exposed to a temperature excursion of 32.3 degrees Fahrenheit for a time frame of 67 hours, 8 minutes (date unspecified), which was detected by a data logger. There were no previous temperature excursions. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA012930.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M018810, expiration date 28-MAY-2018 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 33.4 degrees Fahrenheit for 60 hours and 35 minutes. There were no previous excursions. It was unsure if data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA002635.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and a pharmacy technician and refers to an unspecified number of unspecified patients. No information regarding the patients' pertinent medical histories, drug reactions or allergies, concurrent conditions and concomitant therapies was provided. On 21-NOV-2016, the patients were vaccinated with doses of improperly stored ZOSTAVAX lot # M034765, expiration date 26-NOV-2017 (dose, route and site of administration were not reported) for prophylaxis. There were no adverse effects reported. Administered doses of ZOSTAVAX vaccines were exposed to temperature excursion of 43.3 degrees Fahrenheit for an unknown time frame. At the time of the report the temperatures were not back within the recommended range. Data logger was involved. There were no previous excursions reported. Additional information is not expected because there was no consent to contact the reporting pharmacist.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a four unspecified patients of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On 28-NOV-2016, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M028551 and expiry date 07-MAY-2018) for prophylaxis. No adverse reactions were reported. The vaccine was exposed to temperature excursion of 34.3 F for 5 hours. The vaccine was previously exposed to temperature excursion of 25.2 F for 3.5 hours. No product quality complaint was filed. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse and refers to a female patient of unknown age. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 29-NOV-2016, the patient was vaccinated with a dose of M-M-R II, lot number reported as M011666, expiration date 08-MAR-2016, (dose, route and anatomical location were not reported) for prophylaxis. There was no concomitant medication reported. On the same date after administration, the patient notified the nurse that she was 16-17 weeks pregnant. The last menstrual period was on 03-AUG-2016 and the exposure was at the second trimester. No adverse effect was reported. At the time of the report, the pregnancy outcome was pending and the fetal outcome was unknown. 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 medical assistant refers to multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9 (route and dose were not reported) lot # L016428 and expiry date:30-JUL-2017 for prophylaxis. The vaccine was exposed to 47.85 F for 8 hours. A data logger was not used to log temperatures, and there were no prior excursions. No adverse were reported. There was no product quality complaint involved. Additional information has been requested.