chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MMR
Symptoms: Autism spectrum disorder
Clinical narrative: This spontaneous report was received from an attorney via company representative refers to his son, a male patient of unknown age. Pertinent medical history and drug allergies were unknown by the reporter. On an unknown date the patient was vaccinated with (not specified MMR or MMR II) M-M-R II (lot and expiry date were not provided by the reporter). Concomitant medications were unknown by the reporter. On an unknown date the patient experienced autism spectrum disorder (medically significant). It was unknown whether the event diagnosed before or after the unspecified MMR vaccine. The outcome of autism spectrum disorder is unknown. The reporter considered autism spectrum disorder to be related to M-M-R II. No PQC filed. Upon internal review the event autism spectrum disorder was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash papular
Clinical narrative: This spontaneous report was received from a Pharmacist via a company representative referring to a female patient of unknown age. Patient's pertinent medical history, drug reaction/allergies or concomitant information were not reported. On 05-AUG-2016 (referred as "on Friday"), the patient was vaccinated with a first dose of ZOSTAVAX, subcutaneously, strength, lot# and expiration date were not reported). On 08-AUG-2016 (reference as "on Monday"), the patient experienced erythema and rash popular (reported as "redness and raised bumps"). The reporter also stated that the physician that administered the vaccine advised her to use a heating pad. There was no product quality complaint (PQC) involved. The patient's outcome regarding the events of erythema and rash popular was unknown. The reporter did not assessed causality between the events and the use of ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician referring to an unspecified number of patients of unknown ages and genders. The patients' concurrent conditions and medical histories were not reported. On unknown dates the patients were vaccinated with improperly stored doses of ROTATEQ (Lot # reported as L008459, expiration date 18-DEC-2016) dose, route and anatomical location were unknown. There was no concomitant medication reported. The vaccines experienced the following temperature excursions on unknown dates: 29 F for 21 days. Reportedly, there had been no previous temperature excursions and the aforementioned ones were not identified due to a data logger. It was reported that ROTATEQ was supported, the product was suitable for use. This is one of several reports received from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a patient's parent, refers to a approximately 18 years old female patient. The patient's concurrent conditions included "little allergy problems, she was allergic to dust". No information on the patient's concomitant medications, pertinent medical history and drug reactions was reported. On an unknown date in early 2015, the patient was vaccinated with the first dose of RECOMBIVAX HB injection, (dose, route of administration, lot number and expiration date were not reported). At the time of vaccination, the patient was a 17 years old female. In fall 2015, the blood test was performed as a routine, because the patient was entering a college as a student in fall of 2015. The blood test confirmed that the first dose was ineffective. The physician stated that the patient did not have any antibodies present to fight off the disease and decided to repeat the dose of RECOMBIVAX HB. On an unknown date in January 2016, the patient was vaccinated with the second dose of RECOMBIVAX HB (dose, route of administration, lot number and expiration date were not reported) (Inappropriate schedule of vaccine administered). On an unknown date in July 2016, the second blood test was performed, which revealed that there were still "no antibodies present". There was no treatment given for the event. The patient did not seek medical attention. The outcome of vaccination failure was considered as not recovered/not resolved. The relatedness between the event and the RECOMBIVAX HB was not reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Sore arm, redness, rash, and itchy arm where flu shot was administered for 3 days.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Infection, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient developed swelling, redness, and pain from injection site down to elbow and wrapping around arm. Patient saw physician, was diagnosed with an infection and given an oral antibiotic.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt states that 1 day after getting Tdap on 9/1/16, she noticed a red, raised, area on her right deltoid that is warm to the touch. Ice pack applied, pt advised to take TYLENOL for pain and to exercise right arm during the day.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chest X-ray, Chest discomfort, Headache, Malaise
Clinical narrative: Within hours increased temp 102.8 degrees - 103 degrees, chest tightness, pneumonia RT LL, aches entire body headache, malaise, headache.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pneumonia
Clinical narrative: Within hours increased temp 102.8 degrees - 103 degrees, chest tightness, pneumonia RT LL, aches entire body headache, malaise, headache.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Limb mass, Peripheral swelling, Pruritus
Clinical narrative: Started same day as imm. administered (9-1-16) extreme swelling from should to below elbow, large protruding lump in arm, bright redness and itching.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Pt developed a rash on right side of her body the day after receiving the ZOSTAVAX vaccine it started in her armpit and ran down the side of her body to her wrist not painful but, very itchy.
Age: 79.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Asthenia, Erythema, Feeling hot, Peripheral swelling
Clinical narrative: Swelling Right arm, Redness 4x4 inches upper arm, weakness, hot.
Age: 16.0
Sex: F
Vaccine: HPVX
Symptoms: Fatigue, Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: Pain at injection site, fever, nausea, tired, headache.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Feeling abnormal, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Complete body numbness. Unability to walk. Felt something was very wrong. Its almost impossible to describe here.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture abnormal, Plasmapheresis
Clinical narrative: Complete body numbness. Unability to walk. Felt something was very wrong. Its almost impossible to describe here.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Body temperature increased, Mobility decreased, Musculoskeletal pain
Clinical narrative: Severe pain in shoulder and difficulty moving arm/shoulder. Ice applied, OTC MOTRIN administered. Slightly elevated temp also (99.4 up from 97 at time of admin).
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Swelling face
Clinical narrative: Cheek & lip swelling appeared in the night after the vaccination. Patient waited until morning and visited clinic. She was given a Depo Medrol injection and prescribed Benadryl for q4h for first day, q6h for the next 2-3 days. She was also prescribed Epi-Pens.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient broke out in red, itchy rash taht started from area of injection left arm that spread to torso and belly. Patient took otc Benadryl to help with rash and itching. Went to primary doctor and was prescribed a Medrol dose pack.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Fever, chills, nausea, body aches for 24 hrs.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 2 days following Zostavax immunization patient reported redness, swelling at site in injection. The area was slightly raised and warm to the touch.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea
Clinical narrative: Developed cough 4 hours after vacation then started to have shortness of breath, went to ER, received prednisone.
Age: 76.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Escherichia test positive, Nasopharyngitis
Clinical narrative: Started feeling chills, cold like symptoms.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Started with some redness, swelling, minor rash, and warmth at site of injection. Progressed to more severe redness, swelling and over a larger area. Also, pt started complaining of numbness down her arm, side and leg on the same side as where she received the vaccination.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Rash
Clinical narrative: Patient had sore arm with mild skin rash around the arms and chest. The rash is being fading since then. Patient is doing fine.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Patient reported a red circle about 1-2 inches in circumference as well as a little bit of warmth to the touch.  Other than that she is not bothered by it.  We discussed using a cold compress and will be calling her daily to check on her until it resolves.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Chills, Dizziness, Fatigue, Feeling of body temperature change
Clinical narrative: Lasting all day: stomach pain, nausea, headache, fatigue, muscle pain, dizziness, hot flashes. At night: symptoms listed above, both hot and cold flashes, chills, could not sleep, fever.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Hot flush, Myalgia, Nausea, Pyrexia
Clinical narrative: Lasting all day: stomach pain, nausea, headache, fatigue, muscle pain, dizziness, hot flashes. At night: symptoms listed above, both hot and cold flashes, chills, could not sleep, fever.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Sleep disorder
Clinical narrative: Lasting all day: stomach pain, nausea, headache, fatigue, muscle pain, dizziness, hot flashes. At night: symptoms listed above, both hot and cold flashes, chills, could not sleep, fever.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Raised rash 3" x 1.5" w/aching, itching, and warmth at the site of inoculation.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Sore and redness and itching at injection site of left deltoid, size about 3 x 5 inches.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Redness, warmth, hardness, and pain at site of injection. Patient having difficulty lifting arm above shoulder height when palm facing upward. Symptoms have very slowly improved but still present 5 days later.
Age: 61.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Fatigue, Pyrexia
Clinical narrative: Felt feverish, fatigue, within a few hours of getting vaccine.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Decreased appetite, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Shaking chills, teeth chattering, Headache--drenched in sweat over night-had to change clothes twice over night. Next day-poor appetite all day, muscle aches, night sweats. Third day, symptoms were resolved.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Night sweats
Clinical narrative: Shaking chills, teeth chattering, Headache--drenched in sweat over night-had to change clothes twice over night. Next day-poor appetite all day, muscle aches, night sweats. Third day, symptoms were resolved.
Age: 18.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: When Afluria was injected IM, the patient said she felt light headed. Instructed patient to remain sitting. When she was feeling better, she and her mother walked to front of store where she collapsed.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Heart rate increased, Lacrimation increased, Lip swelling, Ocular hyperaemia
Clinical narrative: At 3:30 p.m. reaction began with red watery eyes and coughing, by 5:00 p.m., face, throat and lip swelling, accelerated heart rate with body aches and restlessness.  Began to improve by approximately 7:00 p.m.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pharyngeal oedema, Restlessness, Swelling face
Clinical narrative: At 3:30 p.m. reaction began with red watery eyes and coughing, by 5:00 p.m., face, throat and lip swelling, accelerated heart rate with body aches and restlessness.  Began to improve by approximately 7:00 p.m.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt was immunized with MENACTRA vaccine upon requesting meningitis vaccines for school. Pt received MENACTRA 3 yrs prior. Pt had form indicating pt needed TRUMENBA (Men B vaccine for school). No adverse effects have been reported to pharmacy by pt.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: PT. got FLUZONE High Dose on 9/3/16 at 4:20pm. Next morning 9/4/16 at 3:00AM PT. got chills, nausea, fever - vomited once. Ok now 9/4/16 10:30AM
Age: 19.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Feeling abnormal, Syncope
Clinical narrative: Patient administered FLUARIX and ADACEL IM. Patient collapsed upon arising shortly after vaccine administration, did not loose consciousness. Complained of "feeling it move through his shoulder and heart".
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Pain in extremity, Paraesthesia
Clinical narrative: Moderate to severe arm pain. Tingling sensation running down the arm. Occurring within 1 hour of administration. States vaccine given too close to shoulder. (reported by representative)
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: Patient got flu vaccine at 12:30pm. Called pharmacy at 3:00pm. He stated both hands are swelling. Pharmacist told him to come in but patient stated he was busy. Pharmacist stated he may need to go to ER. Called patient at 3:30 to check and patient said swelling went down.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Swelling
Clinical narrative: Swelling. redness (L) deltoid -  cm.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever of 101.2, BP 131 at 7:20, BP 103 at 9 AM, BP 124 at 8:30 PM, on 09/05/2016 BP 85 at 7:20 AM, BP at 95 at 8:20 AM. ALL BP are resting systolic. On 09/04/2016 headache, body aches, fatigue, appetite loss.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Fatigue, Induration, Pain, Pain in extremity
Clinical narrative: Large hard area above elbow, hot, red rash, approx. 3X5, not near shot administration spot, entire arm sore and achy, body aches and tiredness.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Large hard area above elbow, hot, red rash, approx. 3X5, not near shot administration spot, entire arm sore and achy, body aches and tiredness.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Fever, Hives, rash.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Hypersensitivity, Pain in extremity, Peripheral swelling
Clinical narrative: Pt came into pharmacy 11AM on 9/3/16. Pt complained of pain in her injection arm. I notice some slight redness. I recommended: Ibuprofen, Diphenhydramine, and to go to ER if condition worsened. Pt came in 9/4 around 12 noon. They said they had gone to ER and the doctor treated the allergic reaction with dexamethasone, diphenhydramine, and ibuprofen. With instructions to come back if condition worsened. At the time the pt visited the pharmacy their injection arm was still somewhat swollen and red.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: Redness, warmness, red whelps. Pt informed to take BENADRYL, pain reliever/fever reducer and apply cool compresses.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Pain
Clinical narrative: Shooting pain radiating from shoulder to fingertips of the arm with injection.  Patient tried oral otc aleve, motrin and topical analgesic and cold compresses.  None of these treatment helps.  His pain level has remain the same since the morning after the injection of the afluria trivalent vaccine.
Age: 36.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Hypoaesthesia, Pain in extremity, Peripheral swelling
Clinical narrative: Patient had pain, numbness, and swelling in arm that recieved flu vaccine.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site reaction, Malaise, Peripheral swelling, Pyrexia
Clinical narrative: Patient woke up feeling sick and developed a very large ring around the area of the shot. Patient also carried a fever. Later he developed redness, swelling and red strips down his arm and the arm was hot to touch.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Patient woke up feeling sick and developed a very large ring around the area of the shot. Patient also carried a fever. Later he developed redness, swelling and red strips down his arm and the arm was hot to touch.
Age: 69.0
Sex: F
Vaccine: FLU4, PNC
Symptoms: Injection site pain, Oropharyngeal pain, Pyrexia
Clinical narrative: Patient experienced soreness on the injection site and a small low grade fever and sore throat the next day after vaccination, only one for day. Patient said s/s cleared up on the 3rd day.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred, Vomiting
Clinical narrative: A COUPLE OF MINUTES AFTER ADMINISTRATION THE CUSTOMER EXPERIENCED A BIT OF BLURRED VISION (WHICH QUICKLY RETURNED TO NORMAL) AND THEN SHE EXPERIENCED SOME VOMITING.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site extravasation, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with ZOSTAVAX vial 19400 PFU (dosing details wer not reported). The reporter stated that during administration of a dose of ZOSTAVAX to an unspecified patient on an unknown date, after withdrawing the needle from the patient's arm, some of the ZOSTAVAX may have leaked back out of the injection site, possibly resulting in administration of a partial dose of ZOSTAVAX (injection site leaking and under dose). No adverse effect reported. The reporter did not provide the causality assessment between the event (injection site leaking) and the suspect therapy. There was no product quality complaint 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 pharmacist referring to unspecified patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On unspecified dates, the patients were administered with improperly stored PEDVAXHIB (lot # M001813, expiration date 14-OCT-2018, dose and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to three patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 16-AUG-2016 the patient's were inadvertently administered an expired dose of GARDASIL (dose details were not reported) (lot # J013324, expiry date 12-FEB-2016) (expired vaccine administered). The patients were each intended to receive GARDASIL 9,however the expired doses of GARDASIL were mistakenly administered instead. No adverse effect reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. The patients concurrent conditions, medical histories and concomitant therapies were not provided. On 30-AUG_2016, the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot # M018593, expiration date 28-JUN-2017; strength , dose, frequency and route were unknown). No adverse reactions were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. the patient's pertinent medical history and drug reactions or allergies were not reported. On 26-AUG-2016, the patient was inadvertently vaccinated with a dose of M-M-R II (lot number L043702 and expiration date 03-NOV-2017, dose and route of administration were not reported) and a dose of PROQUAD (lot number M012985 and expiration date 12-SEP-2017, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report was received from a nurse via company representative refers to a three number of male patients of unknown age. Pertinent medical history and drug allergies were unknown by the reporter. On an unknown date, the three patients were vaccinated with GARDASIL 9 (lot and expiry date was not reported). Concomitant medications were unknown by the reporter. On an unknown date, the 3 patients passed out after receiving the GARDASIL 9. The outcome of the event loss of consciousness was unknown by the reporter. The causality assessment was not provided by the reporter. No PQC filed. Upon internal review the event loss of consciousness was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unknown number of unspecified 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 30-JUN-2016, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M014544 with expiration date 27-NOV-2017, lot # L048857 with expiration date 15-OCT-2017; dose unknown; oral). It was reported that the vaccine was improperly stored at 34.4 Fahrenheit (F) for 18 minutes and at 51.5 F for 2 hours 50 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On unspecified dates, the patients were administered with improperly stored ROTATEQ (lot # L013206 with expiration date of 29-JAN-2017, lot # L035510 with expiration date of 13-MAY-2017, dose unknown, oral). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a non-pregnant female patient of unknown age. The patient's pertinent medical history included she had asplenia. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dosing details were not reported), intramuscularly. No information was reported regarding concomitant medications. On an unknown date while on PNEUMOVAX 23 the patient experienced swelling of her whole left arm. The patient received treatment for the event, sought medical attention by visiting the doctor. The outcome of the event was reported as recovered. The reporter did not provide the causality assessment between the event and the suspect therapy. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On unspecified dates, the patients were administered with improperly stored GARDASIL 9 (lot # L018351, expiration date 11-AUG-2017, dose and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to an unspecified number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot #, expiration date, dose and route were not reported). No adverse symptoms were reported. This is one of two reports received 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 nurse practitioner referring to an unspecified number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot #, expiration date, dose and route were not reported). No adverse symptoms were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a pharmacist referring to a 67 year old female patient. The pertinent medical history and concomitant therapy were not reported. On 25-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX, "subcutaneously in the back of her arm" (lot#, expiration date and dose were unspecified). Subsequently, the patient developed a rash at the injection site. No treatment was given for the event and no lab diagnostics studies performed. The outcome of event was reported as not recovered/not resolved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy cervix abnormal, Cervical dysplasia, Smear cervix abnormal
Clinical narrative: Information has been received from a consumer referring to her approximately 19 year old daughter. The patient had no pertinent medical history, concomitant medication or drug allergies/drug reactions. The patient received the GARDASIL 3-dose series (strength, dose, frequency and route unknown) in approximately August 2011 (reported as 5 years ago). On an unspecified date in 2016 (reported as a couple months ago), the patient had an abnormal Papanicolaou (PAP) smear, which came back as irregular and no further clarifying information was provided. The patient had an unspecified biopsy performed (unspecified date in 2016) which determined she had cervical dysplasia. No treatment was given for the events. Action taken with suspect therapy was not applicable (It was also reported that therapy with GARDASIL was continued). The outcome of the events and causality assessment were not reported. Additional information is not expected as no consent for follow-up was given.
Age: 13.0
Sex: M
Vaccine: HPVX
Symptoms: Abasia, Asthenia, Blood creatine phosphokinase increased, Blood electrolytes normal, Myalgia
Clinical narrative: This spontaneous report was received from a physician regarding a 13 year old male patient. Patient's pertinent medical history, allergic reactions and concomitant medications were unknown by the reporter. On 25-AUG-2016, the patient was vaccinated second dose in a series and the physician was unsure if GARDASIL or GARDASIL 9 was administered intramuscularly (dose, strength, vaccination location, expiry date and lot# were unknown). On 26-AUG-2016, the patient played basketball and experienced muscle pain, weakness and he could not walk. On the same day the patient was moved to emergency room by his family where his laboratory values of electrolytes were normal but his creatinine kinase (CK) was very high. The patient was admitted to the Hospital. The physician felt that the patient had rhabdomyolysis. The patient required intravenous (IV) fluids and his electrolytes remained normal throughout his hospital stay. On 29-AUG-2016, his creatinine kinase (CK) values were normalized and he was discharged from the hospital. The patient recovered from rhabdomyolysis on 29-AUG-2016. Causality was not reported. Upon internal review the event rhabdomyolysis was considered to be medically significant. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPVX
Symptoms: Rhabdomyolysis
Clinical narrative: This spontaneous report was received from a physician regarding a 13 year old male patient. Patient's pertinent medical history, allergic reactions and concomitant medications were unknown by the reporter. On 25-AUG-2016, the patient was vaccinated second dose in a series and the physician was unsure if GARDASIL or GARDASIL 9 was administered intramuscularly (dose, strength, vaccination location, expiry date and lot# were unknown). On 26-AUG-2016, the patient played basketball and experienced muscle pain, weakness and he could not walk. On the same day the patient was moved to emergency room by his family where his laboratory values of electrolytes were normal but his creatinine kinase (CK) was very high. The patient was admitted to the Hospital. The physician felt that the patient had rhabdomyolysis. The patient required intravenous (IV) fluids and his electrolytes remained normal throughout his hospital stay. On 29-AUG-2016, his creatinine kinase (CK) values were normalized and he was discharged from the hospital. The patient recovered from rhabdomyolysis on 29-AUG-2016. Causality was not reported. Upon internal review the event rhabdomyolysis was considered to be medically significant. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Inappropriate schedule of drug administration, Miller Fisher syndrome, Product use issue
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 71 year old female patient. The patient's pertinent medical history and concomitant medications were not reported. In approximately 2013 (reported as "2 to 3 years ago"), the patient received a dose of ZOSTAVAX one time injection (dose, route of administration, lot # and expiration date were not provided) and a dose of PNEUMOVAX23(dose, frequency, route of administration, lot # and expiration date were not provided) at the same time. On an unknown date (reported as "a couple of weeks later"), the patient was diagnosed with Miller Fisher Syndrome involving cranial nerve VI of the right eye (reported as "Miller Fisher Syndrome and with cranial nerve VI of the right eye"). The patient sought medical attention. The outcome of Miller Fisher syndrome involving cranial nerve VI of the right eye was reported as recovering at the time of this report. The reporter did not provide a causal relationship between the event of Miller Fisher syndrome involving cranial nerve VI of the right eye and the vaccination with ZOSTAVAX as well as with the vaccination with PNEUMOVAX23. Upon internal review Miller Fisher Syndrome involving cranial nerve VI of the right eye was determined to be medically significant. Upon internal review Miller Fisher Syndrome involving cranial nerve VI of the right eye was determined to be medically significant. Additional information is not expected as the reporting physician did not wish further contact.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager, referring to multiple unspecified patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, patients were administered doses of improperly stored ROTATEQ (lot # L037574, expiration date 01-JUL-2017). It was reported that the vaccine was exposed for 22 hours at 30.9 F degrees. No adverse effects were reported. This is one of the 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: Information has been received from a registered nurse and refers to a multiple unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M004116 with an expiration date: 12-OCT-2017 (dose and route of administration were not reported). Administered doses of the vaccine experienced temperature excursion of 53. 8 degrees Fahrenheit for 23 hours, on an unknown date. There was previous temperature excursion which took 12 hours and 30 minutes with the temperature of 54.6 degrees Fahrenheit. No adverse effects were reported. Data logger was involved. This is one of several reports received form the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse and refers to a multiple unspecified patients of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M019708 with an expiration date: 25-OCT-2017, orally (dose was not reported). Administered doses of the vaccine experienced temperature excursion of 53.8 degrees Fahrenheit for 23 hours, on an unknown date. There was previous temperature excursion which took 12 hours and 30 minutes with the temperature of 54.6 degrees Fahrenheit. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse and refers to a multiple unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL lot # K007264 with an expiration date: 02-MAR-2017 (dose and route of administration were not reported). Administered doses of the vaccine experienced temperature excursion of 53.8 degrees Fahrenheit for 23 hours, on an unknown date. There was previous temperature excursion which took 12 hours and 30 minutes with the temperature of 54.6 degrees Fahrenheit. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
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. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. In October 2015, the patient was vaccinated with an improperly stored dose of VAQTA injection (dose, route of administration, anatomical location, lot # and expiry date were not specified). The medical assistant was unable to provide the temperature and time frame for the improperly stored VAQTA, but she stated that the vaccine was stored outside of the recommended temperature range and it was found to be unsupported. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant and refers to an unknown number of unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions or allergies were not reported. In approximately 2016, reported as on unknown dates starting on or after 11-JUL-2016, the patients were administered an unspecified number of improperly stored VAQTA lot # M003011, expiration date: 15-NOV-2017 and lot # M021124, expiration date: 02-FEB-2018 (dose and route of administration were not reported). Administered doses of vaccine experienced temperature excursion of 48 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. No adverse effects were reported. Data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 13 year old patient of an unknown gender. Patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 17-AUG-2016, the patient was inadvertently vaccinated with a dose of PROQUAD, (Lot #, expiration date and dose were not reported) via subcutaneous and also with a dose of VARIVAX (Lot #, expiration date and dose were not reported) via subcutaneous. Patient's concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a practitioner nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concurrent conditions, concomitant medication or drug reaction described. On 29-OCT-2013, the patient received a second dose of RECOMBIVAX HB (route, strength, dosage schedule, lot # and expiration date were not reported). Then, on 10-DEC-2013, the patient was vaccinated with a third dose of RECOMBIVAX HB (route, strength, dosage schedule, lot # and expiration date were not reported), on a date so less than the recommended dosage schedule of 8 weeks. At the time of reporting, there was no adverse event reported. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a pharmacist referring to an 86 years old female patient. There was no pertinent medical history. The patient's concurrent condition and concomitant therapy were unknown. On 21-AUG-2016, the patient was vaccinated with ZOSTAVAX (strength and frequency were unknown; lot number M003488 and expiration date 27-MAR-2017) 0.65 ml subcutaneously. On 23-AUG-2016, the patient had experienced an itchy rash starting out in dime size from her elbow extending down to the front of her arm. The patient did not see medical attention. Treatment was not given for the event and there was no lab diagnostics studies performed. The patient was recovering.  The causal relationship between ZOSTAVAX and the event was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Immunodeficiency, Infection
Clinical narrative: This spontaneous report as received from a 43 year old female patient refers to herself. The patient had no pertinent medical history and no drug allergies. There was no concomitant medication. On 19-JUN-2015, the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot # not reported). It was reported that "while on PNEUMOVAX 23" (date unspecified), the patient was diagnosed with having an unknown immunodeficiency issue. The patient experienced more infections. The patient did not seek medical attention. No lab diagnostics studies were performed. No treatment was given. At the reporting time, the patient was still fighting some of these infections. The outcome of the event was reported as not recovered. Upon internal review, unknown immunodeficiency issue was considered to be medically significant. Additional information is not expected because we are not allowed to contact the reporter and her physician.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Erythema multiforme, Injection site swelling, Skin warm
Clinical narrative: Erythema multiform and swelling at injecting site as big as baseball, redness warm to touch.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to an adult patient of unknown age and gender. Patient's pertinent medical history, drug reaction/allergies or concomitant information were not reported. On an unknown date, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB 5/0.5 micro-g/ml (Lot #, expiration date, dose and route were not provided) (drug administered to patient of inappropriate age). No adverse event was reported. There was 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 was received from an office manager, referring to multiple unspecified patients of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, patients were administered doses of improperly stored GARDASIL 9 (lot # L026602, expiration date 19-OCT-2017). It was reported that the vaccine was exposed for 22 hours at 30.9 F degrees. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, and refers to a 2 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were unknown. The patient's past drug history included PREVNAR 13 administration. On 09-AUG-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23, lot # L003228, expiration date 30-JUL-2016, 0.5 ml, intramuscular (anatomical location was unspecified). No adverse effects were reported since the administration of the expired vaccine. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning multiple unspecified patient of unknown age and gender. the patients' concurrent conditions, medical histories and concomitant therapies were not provided,. On unspecified dates, since June  2016 through 31-AUG-2016, the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # L013429, expiration date 21-JUL-2017; strength, dose, frequency and route were unknown), which were exposed to temperature excursion of 0 degree centigrade for 1 minute, max 7 degree centigrade for a worst case scenario of 450 hours. There were no previous temperature excursions. No data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a patient's mother refers to a 32 year old female patient. The patient's concurrent conditions included sulfa drugs reaction or allergy. The patient had none pertinent medical history. On an unspecified date in summer months in 1995, when the patient was 11 years old, she was vaccinated with VARIVAX injection, (dose, route, lot number and expiration date were not reported). There were no concomitant medications. Approximately on 12-AUG-2016 (reported as "about week ago"), the patient had her titre checked and it was found that her level for immunity for varicella was low with the result of 0.3 (units not provided). The physician wanted the patient to have higher immunity level, at least 0.8 (units not provided). No other lab diagnostics studies were performed. No treatment was given for the event. The patient sought an unspecified medical attention. The outcome of the event was reported as not recovered. The relatedness between the event and the VARIVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unspecified dates, since June 2016 through 31-AUG-2016, the patients were vaccinated with doses of improperly stored ROTATEQ (lot # L037574, expiration date 01-JUL-201 or lot # L038536, expiration date 19-AUG-2017; strength, dose, frequency and route were unknown), which were exposed to temperature excursion of 0 degree centigrade for 1 minute, max 7 degree centigrade for a worst case scenario of 450 hours. There were no previous temperature excursions. No data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved). This is one of several reports received from the same reporter. Additional information has been requested.