chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.53
Sex: M
Vaccine: 6VAX-F, RVX
Symptoms: Unevaluable event
Clinical narrative: My son is on his vaccination schedule for 6 months. He received the oral rotavirus and I believe this caused my mastitis. He had the vaccines on 7/8 and I got mastitis on 7/9. This happened before with my first son at the exact same time. He had his 6 months shot then next day I got mastitis. I realize that he has had these shots prior however he did not have teeth then. Also I understand mastitis is caused by scraping of the skin and by the babies mouth. I just find it such a coincidence that I got mastitis twice each time the day after the 6 month shots. I do not know if any one else is having this problem. Just wanted to report this and you all could look into it. Thank you.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Exposure during pregnancy, Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: I have experienced intense shoulder pain in my shoulder joint. I don't have pain and never did at the injection site only in the joint. I am 35 weeks pregnant and have to sleep completely upright because the pain is so bad. It causes radiating pain down my entire arm and limits my mobility. I cannot even pull a quilt up with my left arm because the pain is excruciating. I am desperate for someone to tell me this will get better soon or something I can do to correct, because I have an infant coming in a few weeks. I have never had this happen with a vaccine in the past.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pain
Clinical narrative: Patient developed large painful red mark on arm. Went to doctor and was diagnosed with cellulitis and put on antibiotics.
Age: 6.0
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Swelling and redness at injection site (Right deltoid muscle). Fever of 101 F. Treatment: Loratadine: 10 mg by mouth daily and Prednisone 45 mg by mouth daily.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Injection site erythema
Clinical narrative: This spontaneous report as received from a medical assistant regarding her daughter via company representative refers to a 11 year old non pregnant female patient. The patient is allergic to sulfa drugs. On 03-JUN-2015 the patient was vaccinated with GARDASIL (dose strength unspecified) dose 1, intramuscularly. Other suspect included GARDASIL 9 ((dose strength unspecified) dose 1, intramuscularly). The reporter also stated that the patient received first dose of GARDASIL and she has not had the other two doses yet. On 03-JUN-2015, the patient experienced "extended" redness at the injection site and down the left arm after receiving GARDASIL. The patient was not treated for the event reported. The outcome of the erythema and injection site erythema was reported as recovered/resolved on 10-JUN-2015. It was not confirmed whether the product involved was with GARDASIL or GARDASIL 9. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 08-JUL-2015, the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot # J013555, expiration date 02-MAY-2015, strength, dose and route unknown) (expired vaccine administered). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
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 who on 25-JUN-2015 was vaccinated with a dose of GARDASIL lot # K006960 (route and dose were not provided) was exposed to temperatures outside of the recommended range during 63 hours excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: UNK
Symptoms: Abdominal pain upper, Asphyxia, Back pain, Bowel movement irregularity, Dyskinesia
Clinical narrative: chronic reflux, inability to be laid on back, irregular and painful bowel movements (sometimes 8 days apart), cross-eyed irregularities, sharp body jerks/reactions inconsistent with normal infant reflexes, chronic arching of back due to stomach pain, frightening irregularities of breathing conflicts that have required intervention to correct (almost as if he has forgotten how to breathe and is suffocating, causing facial discoloration)
Sex: M
Vaccine: UNK
Symptoms: Gastrooesophageal reflux disease, Painful defaecation, Skin discolouration, Strabismus
Clinical narrative: chronic reflux, inability to be laid on back, irregular and painful bowel movements (sometimes 8 days apart), cross-eyed irregularities, sharp body jerks/reactions inconsistent with normal infant reflexes, chronic arching of back due to stomach pain, frightening irregularities of breathing conflicts that have required intervention to correct (almost as if he has forgotten how to breathe and is suffocating, causing facial discoloration)
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age. Patients' drug reaction and medical history were not reported. On unknown dates the patients were vaccinated with VAQTA (lot # K007827 with expiration date 09-DEC-2016 and lot # K005323 with expiration date 10-FEB-2017) (route and dose unknown) which have been exposed to temperature outside of the recommended range). The nurse also reported VAQTA (lot # K007827) exposed to a maximum temperature of 52.28F for cumulative time of 7 hours and 50 minutes and 11 doses with this lot # were administered. There was no concomitant medication reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Cerebral palsy, Injection site mass, Injection site swelling, Ophthalmoplegia, VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender who on 02-JUL-2015 was vaccinated with a dose of ZOSTAVAX, dose of 0.65 ml, subcutaneous. On 02-JUL-2015 (reported as "almost immediately"), the patient experienced a raised bump at the injection site. On 06-JUL-2015, the patient experienced symptoms of cerebral palsy, including paralysis of the facial and eye muscles. At the time of this report, the outcome of cerebral palsy and injection site mass was unknown. The reporting pharmacist did not assess the relatedness between the events and the therapy with ZOSTAVAX. It was also stated that the patient had seen a physician who believed these symptoms could be due to ZOSTAVAX. Upon internal review the event of cerebral palsy was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Cerebral palsy, Injection site mass, Ophthalmoplegia, VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender who on 02-JUL-2015 was vaccinated with a dose of ZOSTAVAX, dose of 0.65 ml, subcutaneous. On 02-JUL-2015 (reported as "almost immediately"), the patient experienced a raised bump at the injection site. On 06-JUL-2015, the patient experienced symptoms of cerebral palsy, including paralysis of the facial and eye muscles. At the time of this report, the outcome of cerebral palsy and injection site mass was unknown. The reporting pharmacist did not assess the relatedness between the events and the therapy with ZOSTAVAX. It was also stated that the patient had seen a physician who believed these symptoms could be due to ZOSTAVAX. Upon internal review the event of cerebral palsy was considered to be medically significant. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Papilloma viral infection, Vaccination failure
Clinical narrative: This spontaneous report was received from a currently 25 year old female patient. The patient's concurrent conditions and medical history were not reported. In approximately 2007 (reported as "when I was 17"), the patient was vaccinated with GARDASIL (lot #, expiration date, dose and route were not reported). Then she was vaccinated with the second and third dose of GARDASIL (lot #, expiration date, dose and route were not reported) on an unspecified date. She reported she had all three injections of GARDASIL in the right interval. No concomitant therapies were reported. On an unknown date, the patient experienced condyloma. The gynecologist told her that she could not explain to herself why it could be happen that the patient got human papilloma virus infection (HPV). She told her that GARDASIL injection was not just to prevent the girls from cervix cancer, but also from condyloma. The patient was not very happy about it and felt "kidded" (vaccination failure). The outcome of condyloma and human papilloma viral (HPV) infection was unknown. The causality between the adverse events and GARDASIL was not reported. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information as received from a certified medical assistant (CMA) refers to a 12-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-JUN-2015, the patient was vaccinated with a dose of GARDASIL (lot number K014191 and expiration date 10-MAY-2017) (dose and route not reported) which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information as received from a certified medical assistant (CMA) refers to an 18-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-JUN-2015, the patient was vaccinated with a dose of GARDASIL (lot number K014191 and expiration date 10-MAY-2017) (dose and route not reported) which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information as received from a certified medical assistant (CMA) refers to a 13-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-JUN-2015, the patient was vaccinated with a dose of GARDASIL (lot number K014191 and expiration date 10-MAY-2017) (dose and route not reported) which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test normal, Muscle spasms, Tremor
Clinical narrative: Information has been received from Sanofi Pasteur (manufacturer control # E2015-07945) as part of business agreement on 10-JUL-2015. Case received from Health Authority (case n. 317064) on 08 and 09-JUL-15. Case initially reported by other health professional. Case medically confirmed. An 11 year old female patient was vaccinated on 27-JAN-15 with the second dose of GARDASIL, lot batch n. K003185, expiration date-31-MAY-2016) IM. On 08-JUL-15 the mother referred that since she started sleeping with her daughter (23-JUN-15) she observed her having nocturnal spasms and tremors. The patient was evaluated by a neurologist, investigations were performed (NOS), excluded the presence of an epileptic disorder. Other investigations are pending. The outcome is not recovered. The case is closed.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product use issue
Clinical narrative: Information has been received from a physician referring to a 16 years old male patient. On an unknown date the patient was vaccinated with a first dose in the series of GARDASIL 9 (dose, frequency and lot# were not reported). No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates the patients were administered improperly stored GARDASIL (unknown route and strength). Concomitant medications were not reported there was no known adverse effect. The outcome of th event was unknown. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site reaction, Musculoskeletal stiffness, Myalgia, Pain in extremity
Clinical narrative: Severe pain and stiffness in shoulder, arm, muscles, and fingers of injection site lasting over a week.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported.On unspecified dates the patients were administered improperly stored PEDVAXHIB (unknown strength and route). Concomitant medications were not reported. There was no known adverse effect. The outcome of the event was unknown. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, Pain in extremity
Clinical narrative: This spontaneous report was received from a Healthcare worker refers to an unspecified patients of unknown demographics. It was reported that on an unknown date since December 2014 the patients were vaccinated with improperly stored RECOMBIVAX HB (dose, route, lot # and frequency unspecified). No concomitant medications were reported. Healthcare worker stated that on an unknown date, some complaints may have been made with regards to sore arms but that's nothing out of the ordinary. Healthcare worker could not provide information regarding any specific patient(s) who may have experienced the symptom. She stated that they "always" received complaints regarding sore arms after administration of vaccines. No further information was provided. The outcome of sore arm and incorrect product storage was unknown. Causality assessment for the event sore arm not reported. There was no product quality complaint involved. This is one of several reports received from the same source. 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 healthcare worker refers to a patients of unknown age and gender. No concurrent condition or medical history was reported. The healthcare worker reported that on an unknown date between April 2015 through June 2015, 17 doses of (Oka/Merck) VARIVAX (lot # L001325, dose and route of administration not provided) that was improperly stored had been administered. No adverse effects was reported. The outcome of the event was unknown. No product quality issue was involved. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, Pain in extremity
Clinical narrative: This spontaneous report was received from a Healthcare worker refers to an unspecified patients of unknown demographics. It was reported that on an unknown date Since December 2014 the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (dose, route, lot # and frequency unspecified). No concomitant medications were reported. Healthcare worker stated that on an unknown date, some complaints may have been made with regrets to sore arms but that's nothing out of the ordinary. Healthcare worker could not provide information regarding any specific patient (s) who may have experienced the symptom. She stated that they "always" received complaints regarding sore arms after administration of vaccines. No further information was provided. The outcome of sore arm and incorrect product storage was unknown. Causality assessment for the event sore arm not reported. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, Pain in extremity
Clinical narrative: This spontaneous report was received from a Healthcare worker refers to an unspecified patients of unknown demographics. It was reported that on an unknown date since December 2014 the patients were vaccinated with improperly stored PROQUAD (Merck) (dose, route, lot # and frequency unspecified). No concomitant medications were reported. Healthcare worker stated that on an unknown date, some complaints may have been made with regards to sore arms but that's nothing out of the ordinary. Healthcare worker could not provide information regarding any specific patient(s) who may have experienced the symptom. She stated that they "always' received complaints regarding sore arms after administration of vaccines. No further information was provided. The outcome of sore arm and incorrect product storage was unknown. Causality assessment for the event sore arm not reported. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information of pertinent medical history and drug reactions/allergies were not reported. On 20-FEB-2015 the patients was vaccinated with expired MMR II (dose, strength and route unknown) albumin status of rHA, lot # H016132 with expiration date of 31-Aug-2014. Concomitant medication was not reported. No adverse symptoms were reported. 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 as received from a certified medical assistant (CMA) refers to a 12-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-JUN-2015, the patient was vaccinated with a dose of GARDASIL (lot number K014191 and expiration date 10-MAY-2017) (dose and route not reported) which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient of unknown age and gender. The patient's concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot# K005183, expiry date 10-APR-2016; dose and route of administration were not reported). Additional information is not expected as all the scheduled correspondence has been obtained. This is one of several reprots from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a licensed practical nurse concerning 2 patients of unknown age and gender. The patients' concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot# J013904, expiry date 30-OCT-2015; dose and route of administration were not reported). Additional information is not expected as all the schedule correspondence has been obtained. This is one of several reports from the same reporter.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to 14 anonymous patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates between 12-APR-2015 and 30-JUN-2015, the 14 patiens were vaccinated with expired GARDASIL (lot # H016238 expiry date 11-APR-2015, dose and route were not provided). The physician reported that the GARDASIL had previous temperature excursions on unknown dates and was unable to provide the excursion details at this time. No adverse symptoms were reported. The physician called back on 09-JUL-2015 and provided the names of 14 patients administered improperly stored and expired doses of GARDASIL. Physician did not specify what dose in the GARDASIL series was administered to each patient. One of the patients was administered the vaccine on 08-JUN-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, Pain in extremity
Clinical narrative: This spontaneous reprot was received from a Healthcare worker refers to an unspecified patients of unknown demographics. It was reported that on an unknown date since December 2014 the patients were vaccinated with improperly stored VAQTA (dose, route, lot # and frequency unspecified). No concomitant medications were reported. Healthcare worker stated that on an unknown date, some complaints may have been made with regards to sore arms but that's nothing out of the ordinary. Healthcare worker could not provide information regarding any specific patient(s) who may have experienced the symptom. She sated that they "always" received complaints regarding sore arms after administration of vaccines. No further information was provided. The outcome of sore arms and incorrect product storage was unknown. Causality assessment for the event sore arm not reported. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, Pain in extremity
Clinical narrative: This spontaneous report was received from a Healthcare worker refers to an unspecified patients of unknown demographics. It was reported that on an unknown date since December 2014 the patients were vaccinated with improperly stored ZOSTAVAX (dose, route, lot # and frequency unspecified). No concomitant medications were reported. Healthcare worker stated that on an unknown date, some complaints may have been made with regards to sore arms but that's nothing out of the ordinary. Healthcare worker could not provide information regarding any specific patient(s) who may have experienced the symptom. She stated that they "always" received complaints regarding sore arms after administration of vaccines. No further information as provided. The outcome of sore arm and incorrect product storage was unknown. Causality assessment for the event sore arm not reported. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Diarrhoea, Myalgia, Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a 19 year old female patient. The patient had no known drug allergies or reactions, there was no patient medical history. On 12-DEC-2014, the patient was vaccinated with a first dose of GARDASIL (lot #, expiration date, dose and route were not reported) with no adverse effects. On 10-FEB-2015, the patient was vaccinated with a second dose of GARDASIL (lot #, expiration date, dose and route were not reported) with no adverse effects. On an unknown date 2015, the patient was vaccinated with a dose of GARDASIL 9 lot # reported as L007495, expiration date 24-FEB-2017 for the third dose of the vaccination series, intramuscular in the left deltoid. On 08-JUL-2015, the patient experienced fever of 100 F, bad stomach cramps, diarrhea and generalized muscle aches. There was no lab diagnostics studies performed. The patient was treated with NORCO. The outcome of adverse events was unknown. The patient sought medical attention via visiting physician. The relatedness between adverse events, GARDASIL and GARDASIL 9 was not reported. 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 nurse and refers to an unspecified number of patients of unknown age and genders. No medical history, concurrent conditions and concomitant therapies were reported. On unknown dates, the patients received improperly stored ROTATEQ orally (lot #, expiration date and dose were not reported). No adverse effects were reported. No PQC (product quality issue) was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On 08-JUL-2015, the patient was vaccinated with an expired dose of (Oka/Merck) PROQUAD injection (lot # J006867, expiration date: 14-DEC-2014) (strength, dose and route unspecified). No concomitant medications were reported. No known adverse effect was reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further information  was provided. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injected limb mobility decreased, Injection site reaction, Musculoskeletal stiffness, Myalgia
Clinical narrative: Severe muscle pain at injection site, pain so bad I still can't move my arm.  Stiff neck, chills and fever, nausea.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pyrexia
Clinical narrative: Severe muscle pain at injection site, pain so bad I still can't move my arm.  Stiff neck, chills and fever, nausea.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Syncope episode after vaccines administered.
Age: 65.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Headache, Pruritus, Skin warm
Clinical narrative: Hot, hive like redness size of grapefruit; itching; low grade headache. Treated with ice pack; Benadryl; Cortisone cream. As of 7/14/2015 redness and itching continue but not as bad.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site pain, Syncope
Clinical narrative: This spontaneous report was received from a nurse refers to a 11 year old male patient. The patient had a fear of needles. The patient had collapsed after the use of an unspecified vaccine on unspecified date. On an unknown date, within the last 1-2 year, the patient was vaccinated with GARDASIL, (intramuscular, dose not provided). No concomitant therapy was reported. The patient complained about stinging at the site of injection immediately after vaccination. The stinging only lasted for a few seconds and the patient recovered. The patient also experienced delayed syncope that caused him to collapse in the hallway right outside the nurse's officer after vaccination. The patient recovered within a few minutes from the syncope and did not sustain any injuries. No treatment was given for the events. No product quality issue was involved. This is one of the two reports from same reporter link (1507USA005854). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 09-JUL-2015, the patient was vaccinated with an expired dose of M-M-R II (LOT # J007155, expiration date: 20-JUN-2015) dose and route were not reported. No symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Medical Assistant refers to an adult patient of unknown age and gender who on 01-MAY-2015 was vaccinated with an improperly stored dose of GARDASIL (lot # K006960) (exp date and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product narrative were updated.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a certified medical assistant (CMA) refers to an 18-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-JUN-2015, the patient was vaccinated with a dose of GARDASIL (lot number K014191 and expiration date 10-MAY-2017) (dose and route4 not reported) which was improperly stored. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Rash, Therapeutic response unexpected
Clinical narrative: This spontaneous report as received from a health professional (healthcare worker) refers to a female patient of unknown age. Patient's medical history included an unspecified rash on an unspecified location on her body. Concurrent conditions and drug reactions/allergies were not reported. On an unknown date the patient received a dose of ZOSTAVAX (strength, dose/frequency, lot # not reported), after the rash was resolved (therapeutic response unexpected). No adverse effect was reported. Outcome of the event, therapeutic response unexpected was unknown. Reporting healthcare worker did not assessed the causality of the event with respect to vaccination with ZOSTAVAX. Additional information is not expected as no reporter details were provided.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and genders. No medical history, concurrent conditions and concomitant therapies were reported. On unknown dates, the patients received improperly stored GARDASIL (lot #, expiration date, dose and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) 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
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 01-MAY-2015 was vaccinated with an improperly stored dose of GARDASIL (lot # K006960) (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker and a nurse refers to unspecified number of patients. Medical history and concomitant medications were unknown. It was reported that, improperly stored doses of PNEUMOVAX 23 (single dose vials, route of administrations, dose, lot numbers and expiry dates were not reported) were given to unspecified patients on unspecified dates. No adverse experience was reported. No product quality complaint (PQC) was involved. Follow up has been received from a healthcare worker on 06-JUL-2015: It was reported that on 13-JAN-2014, the patient of unknown age and gender was vaccinated with improperly stored PNEUMOVAX 23 (Lot number: J005011, Expiry date: 04-DEC-2014). This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitants were reported. On 02-JUL-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J011338, expiration date 19-DEC-2014) (dose, route of administration and indication were not reported). No adverse effect was reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Blood culture negative, Chest X-ray normal, Febrile convulsion, Full blood count normal, Metabolic function test normal
Clinical narrative: Complex febrile seizures.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Urine analysis normal
Clinical narrative: Complex febrile seizures.
Age: 26.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Migraine, Pain, Pyrexia
Clinical narrative: Email sent to provider on 7/11 complaining of body aches, fever and migraine. Seen in ED on 07/12 and diagnosed with cellulitis.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Diffuse hives without mucosal involvement or other systemic symptoms.
Age: 13.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Headache, Injection site pain, Pain, Pyrexia, Syncope
Clinical narrative: Pt had headache, bilateral injection site pain in arms and body aches 7/8/15. Pt had syncope episodes 7/9/15 and fever 7/9/15.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria, Wheezing
Clinical narrative: At 45 minutes after injection-generalized urticaria and wheezing-seen RTC-treated EPIPEN, Prednisone, BENADRYL, Albuterol and transport to ED.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Culture throat negative, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 1 day after receiving PREVNAR vaccine pt. c/o pain to (L) deltoid, redness and swelling to (L) deltoid and feet bilat and pain to (L) deltoid. Symptoms persisted x 2 wks. No treatment as pt. reported symptoms 2 wk. after vaccine. No cellulitis present per MD.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: Localized wheal at site of injection w/pruritus and warmth at right deltoid. No fever, no vomiting. No syncope or dizziness..
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Redness and swelling-2" dia. tender. Resolving.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Eye swelling, Fatigue, Rash generalised, Swelling face
Clinical narrative: Swollen face/eyes. Hives. Rash all over. Weight gain. Hair loss. Fatigue.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria, Weight increased
Clinical narrative: Swollen face/eyes. Hives. Rash all over. Weight gain. Hair loss. Fatigue.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a certified medical assistant (CMA) refers to a 16-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-JUN-2015, the patient was vaccinated with a dose of GARDASIL (lot number K014191 and expiration  date 10-MAY-2017) (dose and route not reported) which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.33
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Aphasia, Electroencephalogram normal, Immediate post-injection reaction, Nuclear magnetic resonance imaging normal, Staring
Clinical narrative: Vaccines given 3/20/14, parents reported immediate change in child and showed signs of staring spells and stopped talking. Parents state son has not been the same since vaccines that day. They wonder if 2 of same vaccine given since twin was given shots too in same room.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker and a nurse refers to unspecified number of patients. Medical history and concomitant medications were unknown. It was reported that, improperly stored doses of PNEUMOVAX23 (single dose vials, route of administrations, doses, lot numbers and expiry dates were not reported) were given to unspecified patients on unspecified dates (Incorrect product storage). No adverse experience was reported. No product quality complaint (PQC) was involved. Follow up has been received form a healthcare worker on 06-JUL-2015: It was reported that on 13-JAN-2014, the patient of unknown age and gender was vaccinated with improperly stored PNEUMOVAX23 (Lot number: J005011, Expiry date: 04-DEC-2014). This is one of several reports from the same reporter. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13
Symptoms: Drug administered to patient of inappropriate age, Rash
Clinical narrative: 7/1/15 routine vaccines-adult Hep A given in error. 7/2/15 wellness check revealed rash on torso. Diphenhydramine given. F/U scheduled. 7/3/15 seen at F/U appt. Afebrile; no rash, resolved. 7/4/15 no fever no site reaction. 7/5/15 asymptomatic. 7/6/15 no systemic issues noted.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker and a nurse refers to unspecified number of patients. Medical history and concomitant medications were unknown. It was reported that, improperly stored doses of PNEUMOVAX23 (single dose vials, route of administrations, doses, lot numbers and expiry dates were not reported) were given to unspecified patients on unspecified dates (Incorrect product storage). No adverse experience was reported. No product quality complaint (PQC) was involved. Follow up has been received from a healthcare worker on 06-JUL-2015. It was reported that on 12-FEB-2014, the patient of unknown age and gender was vaccinated with improperly stored PNEUMOVAX23 (Lot number: J010654, Expiry date: 17-OCT-2014). This is one of several reports 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 healthcare worker and a nurse refers to unspecified number of patients. Mdical history and concomitant medications were unknown. It was reported that, improperly stoerd doses of PNEUMOVAX23 (single dose vials, route of administrations, doses, lot numbers and expiry dates were not reported) wer given to unspecified patients on unspecified dates (Incorrect product storage). No adverse experience was reported. No product quality complaint (PQC) was involved. Follow up has been received from a healthcare worker on 06-JUL-2015: It was reported that on 11-MAR-2014, the patient of unkonwn age and gender was associated with improperly stored PNEUMOVAX23 (Lot number: J010654, Expiry date: 17-OCT-2014). This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles
Clinical narrative: Site of injection red, hard, quarter sizied blister (sveral blisters). Denes fever. Denies difficulties breathing.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV
Symptoms: Injection site vesicles
Clinical narrative: Site of injection red, hard, quarter sizied blister (sveral blisters). Denes fever. Denies difficulties breathing.
Age: 0.25
Sex: F
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: None per pt MOC, pt is very happy.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Asthenia, Neck pain, Pain, Pain in extremity
Clinical narrative: Shooting pain in knee, neck pain, borderline fever, sore arm, general weakness and red blotch on arm. Symptoms resolved after approximately 1 week.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Rash macular
Clinical narrative: Shooting pain in knee, neck pain, borderline fever, sore arm, general weakness and red blotch on arm. Symptoms resolved after approximately 1 week.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Dyspnoea, Laboratory test normal, Palpitations
Clinical narrative: Diarrhea, racing heart, shortness of breath day after injection onset of symptoms. Symptoms come and go intermittent symptoms.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Left deltoid red 6x7 cm area. Shot given 7-1-15. Seen 7-6-15.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Conjunctivitis, Cough, Rash, Upper respiratory tract infection
Clinical narrative: 7/1/15 Adult Hep A administered in error. 7/2/15 Present to after hours sick call with rash (mild) to torso; cough also reported. Diphenhydramine ordered. 7/4/15 Seen by pediatrician for F/U on rash. Rash resolved URI symptoms remained. 7/6/15 Seen by pediatrician. URI s/s continue dx conjunctivitis.
Age: 2.0
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Computerised tomogram head normal, Febrile convulsion, Neurological symptom, Rash
Clinical narrative: Pt. had vaccines given on 7-1-15 in my office. Pt had 2 febrile seizures on 7-2-15 requiring 2 ER visits. Pt. also had transient neurological symptoms and rash until 7-5-15. Mother and father report neurological symptoms after vaccinations.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Body temperature increased, Drug administered to patient of inappropriate age
Clinical narrative: 6/30/15 Adult Hep A dose given in error. 7/3/15 wellness check revealed temp of 101.4. Given TYLENOL & PEDIALYTE. F/U appt scheduled. 7/4/15 Afebrile but URI s/s noted - not attributed to vaccine. 7/5/15 Asymptomatic.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13
Symptoms: Incorrect dose administered, Pyrexia, Upper respiratory tract infection
Clinical narrative: 6/30/15 Adult dose Hep A administered in error. 7/3/15 Patient seen in sick call for 101.1 temp. 7/4/15 Patient seen by pediatrician for fever and URI symptoms. 7/6/15 Seen by pediatrician. No fever or rash noted. URI symptoms improving.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Decreased appetite, Irritability, Pyrexia
Clinical narrative: Fever, fussy, decreased appetite.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: No adverse symptoms or signs. Employee administered PENTACEL reconstituted with wrong diluent.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Weight increased
Clinical narrative: This spontaneous report was received from a physician and the patient's parents via a company representative and refers to a 10 week old female patient. Pertinent medical history or drug allergies/drug reactions were not reported. On 03-JUN-2015, the patient was vaccinated with ROTATEQ, oral (lot number, expiration date, dose, strength and frequency were not reported) (reported as "age appropriate"). Concomitant therapies included PREVNAR and PENTACEL. On that same day, after vaccination, the patient experienced diarrhoea and weight increased (units were not specified). The reporter specified that the patient did not have blood in her stool. At the reporting time, the outcome of diarrhoea and weight increased was reported as recovered on 17-JUN-2015. The patient's parents believed that diarrhoea and weight increased were associated to the dosage of oral, ROTATEQ. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This spontaneous report was received from a nurse refers to more than 30 patients (exact number unspecified) of unknown age and gender. The patients were an unspecified mixture of both males and females. No females were pregnant. No concurrent condition or medical history was reported. On an unknown date, within the last 1-2 year, the patients were vaccinated with GARDASIL, (intramuscular, dose not provided). No concomitant therapy was reported. The patients complained about stinging at the site of injection immediately after vaccination. The stinging only lasted for a few seconds and the patients recovered. No treatment was given for the events. No product quality issue was involved. This is one of the two reports from same reporter link (1507USA005819). 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 medical assistant refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates the patients were administered improperly stored ROTATEQ oral (unknown strength). Concomitant medications were not reported. There was no known adverse effect. The outcome of the event was unknown. There was no product quality complaint involved. This is one of the 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 nurse referring to an unspecified number of patients of unknown age and gender. Patients' drug reaction and medical history were not reported. On unknown dates the patients were vaccinated with GARDASIL (lot # K006960 with expiration date 19-FEB-2017) (dose and route unknown). which have been exposed to temperatures outside of the recommended range. There was no concomitant medication reported. No adverse effects were reported. At the time of the report, no adverse effects were reported. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information as received from a certified medical assistant (C.M.A.) refers to a 13-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-JUN-2015, the patient was vaccinated with a dose of GARDASIL (lot number K014191 and expiration date 10-MAY-2017) (dose and route not reported) which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.