chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Rash, Urinary tract infection, Urine analysis normal
Clinical narrative: I was administered the 2016 flu vaccine Friday, November 11, 2016 around Noon (Pharmacy).  About an hour later I developed the anticipated mild pain in my right arm.  I also developed pain in the left side of my back.  This pain grew and was persistent, keeping me awake at night. I also noticed a few minor red marks on the left hand side of my back and inner left thigh.  I went to the doctor November 17.  The doctor was unsure of a diagnosis at that time.  The doctor thought that I might have a urinary tract infection.  He prescribed an antibiotic and sent my urine specimen to be tested by a lab.  On Friday November 18, I developed a painful rash on the left side of my body. On Monday, November 21, I returned to my primary care physician's office. Dr.  diagnosed my illness as Shingles and prescribed Gabapentin and Valacyclovir HCL 1. Dr. stated that my urine specimen was negative, and that I did not need to continue with the antibiotic.  I have been in significant pain which began about an hour after the flu vaccine. Unfortunately the Valacyclovir HCL 1 and the Gabapentin have done little to reduce the pain which continues to grow.  I realize that the 2016 flu vaccine did not give me Shingles, however, I do believe that it triggered the virus.
Age: 0.5
Sex: M
Vaccine: DTAPIPV, HEP, PNC13
Symptoms: Pyrexia, Rash erythematous, Rash macular, Vomiting
Clinical narrative: Bright red splotchy rash all over that showed up within the two hour span; fever spiked to 102 and has stayed about high 99s up to 100.7 as of 11/22/2016. Continued to monitor the fever. He hasnt ate much or drank much so we have pushed fluids and tiny amoints of pedialite. We gave one dose of tylenol however it didn't help except take the edge off of fever to about 101 degree Fahrenheit. He has begun puking more since the vaccinations as well.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient still have trouble moving her arm and she still have pain after 3 weeks after the injection.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Cardiac arrest
Clinical narrative: Cardiac arrest on 11/02/2016.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site induration, Swelling
Clinical narrative: Patient presented to pharmacy with following visual symptoms: redness, swelling, hardness at injection site. Patient says area was itchy.
Age: 44.0
Sex: F
Vaccine: MNQ
Symptoms: Dysphagia, Hypoaesthesia, Tongue disorder, Vaccination site swelling
Clinical narrative: Pt has swelling on the left arm where the vaccine was administered. Pt is experiencing numbness in her hand through her fingers. PT is experiencing a break out on her tongue and having a difficult time swallowing food.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Herpes zoster, Pain, Rash
Clinical narrative: Starting having strange pain on my side and upper back then on 10/16/2016, broke out with a rash that was diagnosed as Shingles.  Started on medication.
Age: 71.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt. noted arm that had received vaccines approximately 1 month ago was still sore and he was unable to lift arm over head.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered after expiration date.  Manufactured was notified with lot, expiration date, proper storage condition. Patient and caregiver indicated that there were no adverse events noted.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Influenza virus test negative, Pyrexia, Rash, Rash generalised, Streptococcus test negative
Clinical narrative: Spot on her face. Then a fever that night. The next night she had more spots on her body. Then a much higher fever. Eventually had a fever of 105 on three consecutive days. 5 Days after onset she broke out in rash on face and body. Still mild fever.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Urine analysis normal
Clinical narrative: Spot on her face. Then a fever that night. The next night she had more spots on her body. Then a much higher fever. Eventually had a fever of 105 on three consecutive days. 5 Days after onset she broke out in rash on face and body. Still mild fever.
Age: 64.0
Sex: F
Vaccine: FLU4, PNC
Symptoms: Chills, Injection site rash, Pyrexia
Clinical narrative: Patient complained that 3 days after she received a PREVNAR 13 and FLUZONE QUAD vaccine, she developed a rash on the arm of the PREVNAR 13 injection site.  She said she also developed fever and chills.  She went to her primary doctor and received a steroid injection to treat the symptoms.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Limb discomfort, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Arm began a dull ache and sore under the biceo]p area .  Elbow and arm ached and fingers tingling  Still has almost constant dull ache and heavinessin left arm.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Severe pain in shoulder, unable to life arm up and in front (cannot brush hair, apply make up, etc).
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Radiating pain down arm; achy and painful x 4 weeks; cannot raise arm over head.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site rash
Clinical narrative: After vaccination patient experienced soreness and and small bump at injection site for approximately 1 month. Now the pain comes and and goes sometimes. Advised patient to see a physician. According to pt still has a small bump, can't be seem but she can feel it. Pt did not report this until 6wks post vaccination (today).
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Influenza, Pain, Sinus disorder
Clinical narrative: Diarrhea, body aches, flu symptoms. Patient had a sinus problem on the day of the flu shot, but his doctor told him it was still ok to get the vaccine.
Age: 0.58
Sex: F
Vaccine: DTAPIPV, FLU4, PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMRV
Symptoms: Erythema, Pruritus, Rash macular, Swelling, Urticaria
Clinical narrative: Red, blotchy face 20-30 min. after vaccines given. Hives all over body. Ears red, swollen, itchy. Lung sounds clear. 12.5 ml BENADRYL by mouth given around 10:30 am. Good response by 11:00 am. Rash completely resolved 3 pm.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Nausea, Pyrexia, Vomiting
Clinical narrative: Within a few hours of shot, developed a fever, arm where shot was given became erythematous from shoulder blade down. The following day had nausea and vomiting.
Age: 65.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Headache, Throat tightness
Clinical narrative: Patient reported adverse reaction to pharmacist at a pharmacy where she did not receive vaccines. She reported pain in head and fullness in throat. Pharmacist advised her to seek medical attention, and other palliative treatments.
Age: 85.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Skin warm
Clinical narrative: Patient came in 2 days after I gave her FLUAD flu shot. She had redness and warmth on the medial side of her arm, opposite of her deltoid muscle.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Hypoaesthesia, Paraesthesia, Peripheral swelling
Clinical narrative: Swelling of entire arm and hand of vaccinated (L) arm. Cellulitis and lymphedema ruled out, per MD. Allergic reaction that caused extreme swelling and numbness + tingling in (L) arm. Tingling decreased w/swelling decrease.
Age: 45.0
Sex: F
Vaccine: FLUR3
Symptoms: Musculoskeletal pain
Clinical narrative: Reports on 11-17-16 anterior portion of shoulder painful since few days after flu shot. No fall or bump or bang to arm. OTC MOTRIN helpful but deep persistent ache continues. No problem with range of motion. Concerned maybe related to vaccine or not. Pain worsens when lying down. No tenderness to palpation in A-C Junction 11/18/16.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Muscle twitching, Sleep disorder
Clinical narrative: 1 week after influenza injection, pt. experienced pain in Left deltoid region after exercise. Pain is now intermittent with movement and has isolated non painful sporadic twitches of deltoid muscle that are not painful but keep him awake at night. From shoulder, neck, arm.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site pain, Malaise
Clinical narrative: Had pain and redness at site of immunization. Had flu like symptoms (chills, fever, malaise for 3 days after immunization.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Had pain and redness at site of immunization. Had flu like symptoms (chills, fever, malaise for 3 days after immunization.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On an unknown date, reported as between 12-AUG-2016 and 20-AUG-2016, the patients were vaccinated subcutaneously with doses of improperly stored (Oka/Merck) VARIVAX (lot # 019127 with expiration date on 27-MAY-2017; dose and anatomical location were not reported), which were exposed to temperature excursions. No adverse effects were reported. The details of the temperature excursions are: 1st excursion (date unspecified): 13.1 degrees Fahrenheit for 48 hours 2nd excursion (date unspecified): 11.5 degrees Fahrenheit for 1 hour and 52 minutes. This is one of several reports received from the same reporter. Lot number 019127 is an invalid lot number for (Oka/Merck) VARIVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Dental discomfort, Hyperaesthesia, Jaw disorder, Paraesthesia
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. The patient's medical history included shingles 22 years age before she received the vaccine and high blood pressure. The patient had CELEBREX allergy. On 2012, the patient was vaccinated with ZOSTAVAX. Concomitant therapies included EVISTA and unspecified high blood pressure medication. On an unknown date in 2012 (reported as 4years ago) the patient developed a sensitive scalp that would result in tingling and burning sensation. The patient also mentioned that about a year ago she developed teeth and jaw discomfort. No treatment was rendered for the event. The outcome of the events were reported as not recovered/not resolved. The patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report has been received from a female patient of unknown age referring to herself. Information about concurrent condition, medical history or concomitant therapy was not reported. On approximately 08-NOV-2016 the patient was vaccinated with ZOSTAVAX (injection, dose, frequency, route and lot# not reported). On 15-NOV-2016 the patient was experiencing redness and itching at the site of where the ZOSTAVAX vaccine was given. It was unknown if the patient sought any medical attention. The outcome of the event was unknown. The causality was not reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. In approximately May 2012 (reported as "about 4 and a half years ago"), the patient might have received a dose of ZOSTAVAX injection (dose, route of administration, anatomical location, lot # and expiry date were not provided). On 04-NOV-2016, the patient was vaccinated with the second dose of ZOSTAVAX injection (dose, route of administration, anatomical location, lot # and expiry date were not provided). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HIBV, HPV9
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a 17 years old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was inadvertently vaccinated with a properly stored dose of PEDVAXHIB, lot # K015464, expiration date 09-JUL-2016 (dose number, route and anatomical location of administration were unknown), instead of the vaccine ordered, which was GARDASIL 9, lot # M021407, expiration date: 30-APR-2018. Additionally, the patient had already completed his PEDVAXHIB vaccine series at the recommended times earlier in his childhood. No adverse effect was reported. Additional information is not expected, no permission for further contact was provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number of patients of an unknown age and gender. The patients relevant medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in October-2015, unspecified number of patients received improperly stored VARIVAX, lot number reported as K002918 with expiration date on 26-FEB-2016 (dose, strength and frequency were not provided). No doses were administered past the expiration date. No symptoms reported. According to the reporter, there were no previous temperature excursions and the temperature and time frame excursions were reported as: -11.2C for 360 hours, -11.1C for 480 hours and -10.7C for 1296 hours. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. On 07-NOV-2016, All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Herpes zoster, Occupational exposure to product
Clinical narrative: This spontaneous report was received from a female nurse via company representative regarding herself. On an unknown date, the nurse had accidentally been contaminated with a drop of ZOSTAVAX, and she cleaned the surface with an alcohol wipe. On an unknown date, a few days later, she developed shingles. The severity of infection, treatment provided, outcome of the shingles and causality assessment were not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with ZOSTAVAX injection. On an unknown date, the patient experienced injection site reaction of redness and swelling for two days that went down. The outcome of the events was not reported however the patient's present status was reported as "fine". The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with ZOSTAVAX injection. The pharmacist reported that he was "seeing generally more injection site reactions than he thought he would" after ZOSTAVAX administration. The outcome of the events and the relatedness between the events and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Loop electrosurgical excision procedure, Precancerous cells present
Clinical narrative: Information was received from a physician assistant via a company representative concerning a 24 year old female patient. The patient's medical history, concurrent conditions, and concomitant medication was not provided. On an unknown date, the patient was vaccinated with GARDASIL (dose number, lot number, dosage, and route of administration were not provided). After receiving the GARDASIL, on an unknown date, the patient developed cervical dysplasia. The patient was seeing an OB/GYN. It was reported that the patient was planning on getting a loop electrosurgical excision procedure (LEEP) done "to remove the precancerous tissue" that was found. The outcome of the cervical dysplasia and precancerous tissue is unknown. Additional information is not expected.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-NOV-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # M005287, expiration date: 08-OCT-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 16.3 degrees Celsius for 8 hours and 38 minutes. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of VARIVAX lot # M024680 18-MAY-2018, M025870 24-MAY-2018. There was no previous temperature excursion. Temperature of 10F for 3 hours, 6F for 2 hours, 6.6F for 20 minutes. The vaccine was administered. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies were reported. On an unknown dates, the patients might have been vaccinated with improperly stored doses of ROTATEQ oral liquid (dose, lot # and expiry date were not specified). The administered doses of ROTATEQ underwent a temperature excursion at 30 Fahrenheit degrees for 14 days. There were no previous temperature excursions reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received from an office administrator concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications. It was reported that on 02-AUG-2016, the patient was vaccinated with VAQTA (dosage, lot number, and route of administration not provided), and on 01-NOV-2016 was inadvertently vaccinated with VAQTA injection "25/0.5", lot# M027879, expiration date 24-JAN-2018 (dosage and route of administration not provided). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD lot # M006104, 01-AUG-2017, M022399 01-NOV-2017. There was no previous temperature excursion. Temperature of 10F for 3 hours, 6F for 2 hours, 6.6 F for 20 minutes. The vaccine was administered. This is one of the two reports received from the same reporter. 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 certified medical assistant and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies were reported. On an unknown dates, the patients might have been vaccinated with improperly stored doses of GARDASIL 9 injection (dose, route of administration, anatomical location, lot # and expiry date were not specified). The administered doses of GARDASIL 9 underwent a temperature excursion at 30 Fahrenheit degrees for 14 days. There were no previous temperature excursions reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies were reported. On an unknown dates, the patients might have been vaccinated with improperly stored doses of PNEUMOVAX 23 injection (dose, route of administration, anatomical location, lot # and expiry date were not specified). The administered doses of PNEUMOVAX 23 underwent a temperature excursion at 30 Fahrenheit degrees for 14 days. There were no previous temperature excursions reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown dates since 31-AUG-2016, the patients were vaccinated with a dose of improperly stored PNEUMOVAX 23 with either lot number L019835 and expiration date of 23-MAR-2017 or lot number L014458 with expiration date of 11-FEB-2017 (strength, dose and route of administration were not reported), which were stored at 67 Fahrenheit degrees for 10.5 hours. There was no previous temperature excursion. The temperature excursion was not detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 09-NOV-2016, the patient was vaccinated with an expired dose of ZOSTAVAX injection, lot # K020185, expiry date 27-JAN-2016 (dose, route of administration and anatomical location were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, X-ray limb
Clinical narrative: This spontaneous report as received from registered nurse refers to a 56 year old male patient. The patient current condition included smoker. On 29-OCT-2016, midday, the patient received the first dose of PNEUMOVAX (Lot # L003189, expiry date: 23-JUN-2016). The patient was seen in the emergency room on the evening of 29-OCT-2016 for left shoulder pain which was the same arm of the vaccination with PNEUMOVAX. The patient mentioned that he also lifted a whole trailer of wood that day. The patient was given an injection of TORADOL and dispensed oral TORADOL. The patient was not admitted to the hospital. On an unknown date in 2016, the patient underwent left shoulder x-ray and the results were unknown. The outcome of the event Vaccination site pain was unknown. The reporter did not provide the causality between the event Vaccination site pain and the suspect therapy. No product quality complaint (PQC) involved. 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 a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # M011117, expiration date: 07-DEC-2017) (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 34 degrees Fahrenheit for four hours. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (route, lot # and expiration date were not reported). On an unknown date, the patient developed an unspecified injection site reaction. The outcome of injection site reaction was not reported. The causality assessment between the event and the suspect therapy was not reported. No product quality complaint (PQC) was involved. This is one of several reports, received from the same reporter. 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 registered nurse concerning an unspecified number of patients of an unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in July 2015, unspecified number of patients received improperly stored VARIVAX, lot number reported as L015416 with expiration date on 01-AUG-2016 (dose, strength and frequency were not provided). No doses were administered past the expiration date. No symptoms reported. According to the reporter, there were no previous temperature excursions and the temperature and the time frame excursions were reported as: -11.2C for 360 hours, -11.1C for 480 hours and -10.7C for 1296 hours. No Product Quality Complaint (PQC) was involved. Lot numbers L015416 is an invalid lot number for VARIVAX. On 07-NOV-2016, All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same reporter. 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 registered nurse concerning an unspecified number of patients of an unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in May-2015, unspecified number of patients received improperly stored VARIVAX, lot number reported as L003216 with expiration date on 30-APR-2016 (dose, strength and frequency were not provided). No doses were administered past the expiration date. No symptoms reported. According to the reporter, there were no previous temperature excursions and the temperature and time frame excursions were reported as: -11.2C for 360 hours, -11.1C for 480 hours and -10.7C for 1296 hours. No Product Quality Complaint (PQC) was involved. Lot number L003216 is an invalid lot number for VARIVAX. This is one of several reports received from the same reporter. On 07-NOV-2016, All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: UNK
Symptoms: Adverse reaction, Incorrect product storage
Clinical narrative: This is a spontaneous report received 02-NOV-2016 from a nurse via a telephone call. The nurse reported that multiple unspecified patients were vaccinated with improperly stored GARDASIL 9 (lot # M023169, expiration 13-JUN-2018 or PEDVAXHIB (lot # M025192, expiration 21-MAR-2019) on multiple unspecified dates. No adverse effects were reported. The nurse also reported GARDASIL 9 (lot # M023169, expiration 13-JUN-2018) and PEDVAXHIB (lot # M025192, expiration 21-MAR-2019) excursion information: temperature 47.50 F for 4 minutes and temperature 33.60 F for 5 minutes. There was no previous temperature excursion. The phone call was not a result of a data logger. Additionally, the nurse reported that an unspecified patient was vaccinated with an unspecified vaccine on an unspecified date and experienced an unspecified adverse reaction. No further information was provided. Additional information was requested.
Age: 74.0
Sex: M
Vaccine: FLU4, PPV, VARZOS
Symptoms: Injection site pain, Malaise
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 74 year old male patient. Pertinent medical history and concomitant medication was unknown by reporter. Patient had none drug allergies or reactions. On 15-NOV-2016, patient received a dose of unspecified flu vaccine (unspecified manufacturer/intramuscular) and a dose of ZOSTAVAX 19400 PFU, subcutaneous in the same arm (unspecified arm) and a dose of PNEUMOVAX 23 in the opposite arm (unspecified arm) on the same day. On an unknown date in November 2016 the patient experienced soreness at all of the injection sites and became quite ill. The patient was feeling a lot better when asked about present status. The outcome of soreness at all of the injection sites and became quite ill was reported as resolving. Causality was unknown. Additionall information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 01-APR-2016, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L024253 with expiration date 01-JUL-2017, lot # L024256 with expiration date 01-JUL-2017, lot # L001328 with expiration date 13-JAN-2017, lot # L016123 with expiration date 06-MAY-2017; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion and data logger was involved. No adverse effect was reported. This is one of two reports received from the same reporter. Follow up information has been received from the physician on 24-OCT-2016. On 24-OCT-2016, a call was placed to the physician. The call was received by another physician. The physician reported that she would have to research the request made for patient identifies, lot number and expiration date and dates of vaccination. The correspondence details were reviewed with the physician, if information becomes available. Follow-up information was received on 09-NOV-2016 from an unspecified reporter, who provided the patient's demographics, and stated that the patient (of unknown age and gender) was vaccinated with an improperly stored dose of VARIVAX with lot number L001328 (expiration date 13-JAN-2017). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to an unspecified number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions drug reactions or allergies were not reported. On an unknown dates in 2016, the patients were vaccinated with improperly stored GARDASIL 9, lot number as reported M026306, expiration date 30-APR-2018, by intramuscular route, (frequency and anatomical location were not provided). No adverse effects were reported. The temperature and time frames were: on 24-AUG-2016, 34 Fahrenheit degrees for 14 hours, and, on 29-AUG-2106, 30 Fahrenheit degrees for 14 hours; there no were any previous excursion and digital data logger was not involved. Product quality complain was not involved. No other suspect or concomitant therapies were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies were not reported. On unknown dates, on or after 01-APR-2016, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L024253 with expiration date 01-JUL-2017, lot # L024256 with expiration date 01-JUL-2017, lot # L001328 with expiration date 13-JAN-2017, lot # L016123 with expiration date 06-MAY-2017; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion and data logger was involved. No adverse effect was reported. This is one of two reports received from the same reporter. Follow up information has been received from the physician on 24-OCT-2016. On 24-OCT-2016, a call was placed to the physician. The call was received by another physician. The physician reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. The correspondence details were reviewed with the physician, if information becomes available. Follow-up information was received on 09-NOV-2016 from an unspecified reporter, who provided the patient's demographics, and stated that the patient (of unknown age and gender) was vaccinated with an improperly stored dose of VARIVAX 0.5 ml (unspecified dose) with lot number lot # L024256 (expiration ate 01-JUL-2017). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, (lot # M029233, expiration date 09-AUG-2018) (lot # M018625, expiration date 11-AUG-2018), (dose number, route and anatomical location of administration were unknown). The temperature excursions reported was 10.7 C for 1.5 hours. There was no previous temperature excursion. The temperature excursion was detected by a digital data logger. No adverse effect was reported. This is one of several reports received from the same reporter. 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 registered nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9, (lot # L037554, expiration date 25-DEC-2017) (lot # reported as M031557, expiration date 07-APR-2019) (lot # reported as M032650, expiration date 31-MAR-2019) (lot # M030380, expiration date 01-FEB-2019) (lot # L043214, expiration date 30-AUG-2017), (dose number, route and anatomical location of administration were unknown). The temperature excursions reported was 10.7 C for 1.5 hours. There was no previous temperature excursion. The temperature excursion was detected by a digital data logger. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered
Clinical narrative: Information has been received from a medical assistant referring to a 6 month old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. The patient was vaccinated with doses of PEDVAXHIB (intramuscular; dose, lot # and expiration date were unknown) on 01-FEB-2001, 04-APR-2001, 06-JUN-2001 and 20-MAR-2002. On 14-NOV-2016, the patient was administered another dose of PEDVAXHIB (intramuscular, lot # M032147, expiration date 14-APR-2019; dose was unknown). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner regarding multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medication were not reported. On unknown dates the patients were vaccinated with improperly stored ROTATEQ batch # M0045444 and expiry date: 18-OCT-2017 (dose and route were not reported). The vaccine was exposed to a temperature of 34 Fahrenheit for a time frame of 50 hours. There was no data logger and no previous excursions. No adverse events were reported. There was no product quality complaint involved. This is one of the several cases reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of PEDVAXHIB, (lot # reported as M027883, expiration date 15-APR-2019) (lot # M010440, expiration date 09-DEC-2018) (lot # M025193, expiration date 21-MAR-2019) (lot # reported as M032149, expiration date 18-APR-2019), (dose number, route and anatomical location of administration were unknown). The temperature excursions reported was 10.7 C for 1.5 hours. There was no previous temperature excursion. The temperature excursion was detected by a digital data logger. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This is a spontaneous report received 31-OCT-2016 via a telephone call from a physician. The physician reported that an unspecified patient received a dose of GARDASIL (lot #, expiration date unspecified) on an unspecified date for their first dose. The patient then received the second dose of the series of GARDASIL 9 (lot #, expiration date unspecified) on an unspecified date. Then, on 31-OCT-2016 the patient received the third dose of the series as GARDASIL (lot #, expiration date unspecified). No adverse effect was reported. No additional information was available. Additional information was requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to an unspecified number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions drug reactions or allergies were not reported. On an unknown dates in 2016, the patients were vaccinated with improperly stored RECOMBIVAX HB, lot number M001578, expiration date 21-NOV-2018, by intramuscular route, (frequency and anatomical location were not provided). No adverse effects were reported. The temperature and time frames were: on 24-AUG-2016, 34 Fahrenheit degrees for 14 hours, and, on 29-AUG-2016, 30 Fahrenheit degrees for 14 hours; there no were any previous excursion and digital data logger was not involved. Product quality complain was not involved. No other suspect or concomitant therapies were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On an unknown dates, on or after 01-APR-2016, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L024253 with expiration date 01-JUL-2017, lot # L024256 with expiration date 01-JUL-2017, lot # L001328 with expiration date 13-JAN-2017, lot # L016123 with expiration date 06-MAY-2017; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion and data logger was involved. No adverse effect was reported. This is one of two reports from the same reporter. Follow up information has been received from the physician on 24-OCT_2016. On 24-OCT-2016, a call was placed to the physician. The call was received by another physician. The physician reported that she would have to research the request made for the patient identifiers, lot number and expiration date and dates of vaccination. The correspondence details were reviewed with the physician, if information becomes available. Follow-up information was received on 09-NOV-2016 from an unspecified reporter, who provided the patient's demographics, and stated that the patient (of unknown age and gender) was vaccinated with an improperly stored dose of VARIVAX with lot number L001328 (expiration date 13-JAN-2017). No adverse experienced were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 01-APR-2016, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L024253 with expiration date 01-JUL-2017, lot # L024256 with expiration date 01-JUL-2017, lot # L001328 with expiration date 13-JAN-2017, lot # L016123 with expiration date 06-MAY-2017; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion and data logger was involved. No adverse effect was reported. This is one of two reports received from the same reporter. Follow up information has been received from the physician on 24-OCT-2016. On 24-OCT-2016, a call was placed to the physician. The call was received by another physician. The physician reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. The correspondence details were reviewed with the physician, if information becomes available. Follow-up information was received on 09-NOV-2016 from an unspecified reporter, who provided the patient's demographics, and stated that the patient (of unknown age and gender) was vaccinated with an improperly stored dose of VARIVAX 0.5ml (unspecified dose) with lot # L024256 (expiration date 01-JUL-2017). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions drug reactions or allergies were not reported. On an unknown dates in 2016, the patients were vaccinated with improperly stored ROTATEQ lot number M014318, expiration date 30-SEP-2017, by oral route, (frequency was not provided). No adverse effects were reported. The temperature and time frames were: on 24-AUG-2016, 34 Fahrenheit degrees for 14 hours, and, on 29-AUG-2016, 30 Fahrenheit degrees for 14 hours; there no were no previous excursion and digital data logger was not involved. Product quality complain was not involved. No other suspect or concomitant therapies were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 08-NOV-2016, the patient was inadvertently administered PNEUMOVAX 23 (lot # L022795) that was expired on 05-NOV-2016. No adverse effects were reported. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to an unspecified number of patients of unknown ages and gender. The patients' pertinent medical history, concurrent conditions drug reactions or allergies were not reported. On an unknown date in 2016, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # M020521, expiration date 17-NOV-2017, by intramuscular route, (frequency and anatomical location were not provided). No adverse effects were reported. The temperature and time frames were: 24-AUG-2016, 34 Fahrenheit degrees for 14 hours, and, on 29-AUG-2016, 30 Fahrenheit degrees for 14 hours; there no were any previous excursion and digital data logger was not involved. Product quality complain was not involved. No other suspect or concomitant therapies were reported. This is one of several reports from the same reporter. Additional information has been requested.