chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
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 medical history or concurrent conditions were reported. On an unspecified date in June 2016 (reported as "between 16-JUN-2016 and 17-JUN-2016), the patient was vaccinated with improperly stored ROTATEQ, orally, (which had a lot number of L038536 and an expiration date of 19-AUG-2017; however, the dose, dosage number and anatomical location were unknown). No concomitant medications were reported. The vaccine experienced a temperature excursion of 16.1 degrees C for a time frame of 22 hours and was called out due to a data logger. There were, reportedly, no previous temperature excursions. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported and no product quality complaint was involved. This is one of the 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: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 07-JUN-2016, the patient was vaccinated with improperly stored ROTATEQ lot # L027076 with expiry date: 25-MAY-2017, Lot# L033545 expiry date: 30-MAY-2017 (lot not specified for each patient) (dosing details and route of administration were not reported). No adverse effect was reported. It was reported that the vaccines were exposed to the temperature 55F for 30 minutes. The previous temperature excursion was 32.9F for 17 hours. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm
Clinical narrative: Information has been received from a physician via a company representative referring to a female patient of unknown age. The patient's pertinent medical history and drug reactions/allergies were not provided. On 06-JUN-2016, the patient received an injection of PNEUMOVAX 23 (lot # L035686, expiration date February 2017), subcutaneously. On the same date, the patient had an adverse event which was further specified as arm "became red, hot and her biceps were swollen and hard". The outcome of the events and the causality were not reported. Additional information is not expected since the physician does not want to be contacted.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse prescriber referring to an unspecified number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L048237, expiration date 08-MAY-2017; dose, dose number and route were not reported). No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare student refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 31-MAY-2016 the patient was vaccinated with ZOSTAVAX (Lot# L046897, Expiration date 23-FEB-2017, route and dose not reported). Concomitant therapy was not reported. The ZOSTAVAX was improperly stored under 16 Fahrenheit degree for 19 hours. No previous temperature excursion. Data logger was not involved. No adverse events reported. Additional information has been requested.
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported). During the same visit, the patient was vaccinated with hepatitis A vaccine, inactivated (manufacturer unknown) and MENACTRA (lot #, expiration date, dose, route and site of administration were not reported for both). The patient did not wait the recommended 15 minutes, he just got up to leave immediately administration and he passed out. An ambulance was called. The patient's mother decided that the patient would not receive any further vaccinations. The outcome of syncope was unknown. The relatedness between the syncope and GARDSIL 9 and hepatitis A vaccine, inactivated (manufacturer unknown) was not reported. Additional information is not expected, because the physician cannot be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 07-JUN-2016, the patient was vaccinated with improperly stored ROTATEQ lot# L027076 with expiry date: 25-MAY-2017, Lot# L033545 expiry date: 30-MAY-2017 (lot not specified for each patient) (dosing details and route of administration were not reported). No adverse effect was reported. It was reported that the vaccines were exposed to the temperature 55F for 30 minutes. The previous temperature excursion was 32.9F for 17 hours. There were no product quality complaints (PQC) 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 medical history or concurrent conditions were reported. On an unspecified date in June 2016 (reported as "between 16-JUN-2016 and 17-JUN-2016), the patient was vaccinated with improperly stored VAQTA (which had either a lot number of M003011 with expiration date of 15-NOV-2017 or a lot number reported as M021124 with an expiration date of 02-FEB-2018; however, the dose, dosage number, route of administration and anatomical location were unknown). No concomitant medications were reported. The vaccine experienced a temperature excursion of 16.1 degrees C for a time frame of 22 hours and was called out due to a data logger. There were, reportedly, no previous temperature excursions. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported and no product quality complaint was involved. This is one of the 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 nurse prescriber referring to an unspecified number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L033548, expiration date 14-MAY-2017; oral: dose and dose number were not reported). No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative and refers to a 13 year old patient of unknown gender with acne. No other information regarding the patient's pertinent medical history and drug reactions or allergies was reported. On an unspecified date in December 2014, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, anatomical location, lot # and expiration date were not provided). On 17-MAY-2016, the patient was vaccinated with the second dose of GARDASIL 9 lot # L044475, expiration date 12-MAY-2017 (dose, route of administration and anatomical location were not provided). It was unknown why the patient did not complete the original GARDASIL series. Concomitant therapies included FLONASE nasal spray, DUAC topical acne cream and vitamins (unspecified). On 17-MAY-2016, the same day after getting GARDASIL 9 shot, the patient became lightheaded. It was unknown if the patient was given any treatment and had lab diagnostic studies performed. The patient recovered from the adverse event on an unspecified date in 2016. The relatedness between the adverse event and vaccinations with GARDASIL and GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored M-M-R II (lot # L032181, expiration date 25-AUG-2017; L043702, expired date 03-NOV-2017; route and dose were not reported). The vaccines were exposed to 33 F for 3 hours and 49 F for 50 minutes without previous excursion. The issue was due to data logger. No symptoms were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender for a "data logger". The patient's medical history and concurrent condition was not reported. The patient may have received an improperly stored dose of GARDASIL 9 (dose and route unspecified)(lot # L014415, expired on 25-MAY-2017). It was reported that the time frame was 1 hour and back in range. There was no previous temperature excursion. The reporter stated that 1 dose of GARDASIL 9 was missing from the box and not sure if the vaccine was administered after the excursion. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patient was vaccinated with the first, the second and the third dose of GARDASIL (dose, route of administration, injection site, lot# and expiration date were not reported). On an unknown date, the patient was inadvertently administered a 4th dose of GARDASIL 9 (dose, route of administration, injection site, lot# and expiration date were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with less than a full dose (underdose) of ZOSTAVAX, (Lot number, expiration date, dosage, dose number and route of administration were not reported), due to a needle leak. No other suspect or concomitant therapies were reported. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The reporter stated that the patient missed their scheduled dose of ZOSTAVAX lot # L046897 (exp. date 23-FEB-2017) 0.65 ml because the vial was received broken at the pharmacy. No adverse events were reported. Product quality issue was involved. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # L043213 with expiry: 28-AUG-2018, lot# M004116 with expiry: 12-OCT-2017 (dosing details and route of administration were not reported). No adverse effects were reported. It was reported that the vaccine was exposed to the temperature 55F for 30 minutes. The previous temperature excursion was 32.9F for 17 hours. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Left arm from injection site to hands swelled. The arm felt warm and paint on touch to arm. This occurred the next morning at 10:00 am upon waking up. Patient put cold compress on arm.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Computerised tomogram, Rash erythematous, Skin tightness
Clinical narrative: Tightness in arm, from wrist all the way up to the shoulder. Red spots on upper arm.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # L049532, expiration date on 08-DEC-2017 (route, dose and anatomical location were not reported). Concomitant therapies were not provided. The vaccines were stored in a temperature of 10F for 84 hours; 18.2 F for 30 minutes and 7 F for 1 hour. Digital data logger was involved. No adverse events were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Eye pain, Lymphadenopathy, Neck pain, Oropharyngeal pain, Pain
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 17 year old female patient. She had, reportedly, not been feeling well on 16-MAY-2016. Apart from this, information regarding her pertinent medical history and drug reactions/ allergies was unknown. On 17-MAY-2016, the patient was vaccinated with an unspecified dose of GARDASIL 9 (which had a lot number of M003659 and an expiration date of 20-SEP-2017), intramuscularly. Her concomitant therapies included DAYQUIL, which was administered on 16-MAY-2016 since she was not feeling well. Subsequently, on 19-MAY-2016, 2 days the vaccination, the patient came to the physician for follow up visit which comprised of complaints relating to an unspecified neck pain, soreness in her eyes and behind the ears, a sore throat, an unspecified rash, itchy skin and swollen lymph nodes. These events had an onset of an unspecified date in May 2016. No treatment was provided for the adverse events and no product quality complaint was involved. At the time of reporting, the outcome of all the events were unknown. Furthermore, no causal relationship was provided between the events and the vaccination with GARDASIL 9. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Pruritus, Rash
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 17 year old female patient. She had, reportedly, not been feeling well on 16-MAY-2016. Apart from this, information regarding her pertinent medical history and drug reactions/ allergies was unknown. On 17-MAY-2016, the patient was vaccinated with an unspecified dose of GARDASIL 9 (which had a lot number of M003659 and an expiration date of 20-SEP-2017), intramuscularly. Her concomitant therapies included DAYQUIL, which was administered on 16-MAY-2016 since she was not feeling well. Subsequently, on 19-MAY-2016, 2 days the vaccination, the patient came to the physician for follow up visit which comprised of complaints relating to an unspecified neck pain, soreness in her eyes and behind the ears, a sore throat, an unspecified rash, itchy skin and swollen lymph nodes. These events had an onset of an unspecified date in May 2016. No treatment was provided for the adverse events and no product quality complaint was involved. At the time of reporting, the outcome of all the events were unknown. Furthermore, no causal relationship was provided between the events and the vaccination with GARDASIL 9. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a 68 year old female patient concerning on herself. The patient's medical history included an unspecified cancer. She had not drug reactions or allergies. Information regarding hers concurrent conditions were not reported. On 07-JUN-2016, the patient was vaccinated with "1 shot" of PNEUMONVAX 23, subcutaneously (lot number, dose and anatomical location was not provided). The patient was taking unspecified concomitant medications. Later, on 07-JUN-2016, the patient was contacted by her pharmacy and she was told that the vaccine administered was expired at "the end of March 2016". She was advised to contact her physician or pharmacist in order to decide if a revaccination would be needed. No adverse effect was reported. The patient did not seek for medical attention, there was no treatment given and none laboratory diagnostic studies were performed. There was not product quality issue involved. Additional information is not expected because the reporter contact details were not provided.
Age: 32.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 32 year old patient of unknown age and gender. Concurrent conditions included tobacco user and diabetes mellitus. No medical history, allergy/drug reactions and concomitant medications were reported. On 07-JUN-2016, the patient was vaccinated with improperly stored PNEUMOVAX 23 lot # L035882 expiry date: 19-APR-2017 (dosing details and route of administration were not reported). No adverse effects were reported. It was reported that the vaccine was exposed to the temperature 55F for 30 minutes. The previous temperature excursion was 32.9F for 17 hours. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown gender and age. Concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with RECOMBIVAX HB 2.5/0.5 (units not provided), lot # L027733, expiration date: 13-SEP-2017, 0.5 ml (frequency and route were not provided). There were no concomitant medications reported. The reporter stated that, on an unknown date, the RECOMBIVAX HB was improperly stored (incorrect product storage), it was exposed to a temperature of 30.79 Fahrenheit for 31 minutes, before being administrated to the patient. No adverse event was reported. This is one of two reports received from the same reporter. Additional information is not expected as the reporter did not consent for follow-up attempts.
Sex: U
Vaccine: MMR
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 medical history or concurrent conditions were reported. On an unspecified date in June 2016 (reported as "between 16-JUN-2016 and 17-JUN-2016), the patient was vaccinated with improperly stored M-M-R II (which had a lot number of L027591 and an expiration date of 23-JUL-2017; however, the dose, dosage number, route of administration and anatomical location were unknown). No concomitant medications were reported. The vaccine experienced a temperature excursion of 16.1 degrees C for a time frame of 22 hours and was called out due to a data logger. There were, reportedly, no previous temperature excursions. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 57.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 57 years old patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 08-JUN-2016, the patient was vaccinated with improperly stored PNEUMOVAX 23 (dosing details, lot# and expiry and route of administration were not reported). No adverse effects were reported. It was reported that the vaccines were exposed to the temperature 55F for 30 minutes. The previous temperature excursion was 32.9F for 17 hours. There were no product quality complaints (PQC) involved. This is one of the 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: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On an unspecified date in June 2016 (reported as "between 16-JUN-2016 and 17-JUN-2016), the patient was vaccinated with improperly stored ROTATEQ (which had a lot number of L038536 and an expiration date of 19-AUG-2017; however, the dose, dosage number, route of administration and anatomical location were unknown). No concomitant medications were reported. The vaccine experienced a temperature excursion of 16.1 degrees C for a time frame of 22 hours and was called out due to a data logger. There were, reportedly, no previous temperature excursions. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported and no product quality complaint was involved. This is one of the 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 medical history or concurrent conditions were reported. On an unspecified date in June 2016 (reported as "between 16-JUN-2016 and 17-JUN-2016), the patient was vaccinated with improperly stored VAQTA (which had either a lot number of M003011 with expiration date of 15-NOV-2017 or a lot number reported as M021124 with an expiration date of 02-FEB-2018; however, the dose, dosage number, route of administration and anatomical location were unknown). No concomitant medications were reported. The vaccine experienced a temperature excursion of 16.1 C for a time frame of 22 hours and was called out due to a data logger. There were, reportedly, no previous temperature excursions.. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a physician referring to a patient of unknown age and gender. The patient's concurrent condition and medical history were not reported. On an unspecified date, the patient was inadvertently vaccinated with a fourth dose of GARDASIL (lot number, expired date, dose, frequency and route were known). Concomitant therapy was not reported. No adverse effects was reported. Additional information has been requested.
Age: 20.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse referring to a 20 year old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 11-AUG-2015, the patient was vaccinated with ZOSTAVAX (lot # L006381, expiration date 25-MAY-2016) (route and dose were not provided) instead of VARIVAX (wrong vaccine administered). No adverse events were reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: red, hot to the touch, very painful, swelling. Prescription given for pain meds and antibiotic and prednisone. Pt seen 1 week ago for WWE and was given PREVNAR vaccine. She stated the next day she began having pain in the arm vaccine was given. She developed redness, swelling and warmth over the last 3-4 days. She woke up this morning and pain is getting worse. Her husband had the same vaccine the same day and has no symptoms.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 08-JUN-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # L040164 with expiration date of 20-FEB-2018; strength, dosage, frequency and route unspecified) (incorrect product storage). The patient did not experience any adverse effects. This is one of three 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 referring to a patient of unknown age and gender. On 07-JUN-2016 the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L013827 with expiration date of 21-APR-2017; strength, dose, frequency and route unspecified). The patient did not experience any adverse effects. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner regarding an unknown number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date in 2016, the several patients were vaccinated with improperly stored PEDVAXHIB lot # L051124/expiration date - 14-OCT-2018. No concomitant medication was reported. No adverse event was reported. Vaccine had a temperature excursion to 8.5 C for 32 hours total on 11-MAY-2016, 12-MAY-2016, and 15-MAY-2016. Making it improperly stored at 8.5 degrees C for a period of time. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, MMRV, VARCEL
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Pt was erroneously given MMR, VARIVAX and PROQUAD at well exam on 6/8/16. One week later had fever 103.7 was seen in office and dx with fever, unspecified. On 6/18/16 was seen in office for a "measles-like rash"; afebrile, no other symptoms.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Scab, Skin lesion
Clinical narrative: Pt was vaccinated with PNEUMOVAX 23. Pt was tx in the ER due to the development of a scab producing lesion and potentially cellulitis. Similar to that of smallpox vaccine.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Sensation of foreign body, Throat tightness
Clinical narrative: 10-15 min after receiving her 1st Men B izz, pt c/o tightness in her throat "like I have a lump in my throat", VS stable; given BENADRYL 25 mg liquid PO and sx resolved w/in 20 min; VS stable throughout; Repeat dose needed later for same sx.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pruritus, Rash
Clinical narrative: Pt. received MENVEO #2 and MEN B #1 on 5/3/16 - on 5/4/16 Mom called complaint of pt. has rash on body - next day - pt. received shot at 4 pm. - at 6 pm. - pt. took shower because itchy - then rash next day. Seen on 5/4/16 pt. given steroid and hydroxyzine.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site - progressing.  Possible cellulitis.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Eye swelling, Swelling face, Urticaria
Clinical narrative: Per NP pt had urticaria, facial swelling and eye swelling. Pt was treated at hospital. Was given epinephrine, BENADRYL, and prednisone. Pt returned to clinic for ER follow up.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: Morning after injection left 4th and 5th digits are numb and weak and he is not able to fully extend fingers even months after.
Age: 51.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injected limb mobility decreased, Vaccination site pain
Clinical narrative: Pain in right arm at vaccination site. Limited range of motion. Treated with pain medication. Referred to Orthopedic doctor by primary physician. Diagnosis: Impingement syndrome of right shoulder (M75.41) X ray, steroids, Physical therapy and Orthoscopic surgery (out Patient surgery).
Age: 51.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthroscopic surgery, Joint range of motion decreased, Rotator cuff syndrome, Vaccination site pain, X-ray limb abnormal
Clinical narrative: Pain in right arm at vaccination site. Limited range of motion. Treated with pain medication. Referred to Orthopedic doctor by primary physician. Diagnosis: Impingement syndrome of right shoulder (M75.41) X ray, steroids, Physical therapy and Orthoscopic surgery (out Patient surgery).
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Back pain, CSF protein increased, CSF white blood cell count negative, Caesarean section, Electromyogram abnormal
Clinical narrative: Pregnant 30 YO beneficiary received a TDaP at 35 weeks 3 days gestation on 29 FEB. On 13 MAR, she developed lower extremity paresthesia that progressed to over weakness then difficulty swallowing. She was hospitalized the same day and placed on a ventilator. Her baby was delivered via C-section the following day, 14 MAR. To date, the baby appears to be fine. Mother diagnosed with GBS and has been transferred to another hospital on 4 May '16 for long term rehab. Has gastric tube and still needs almost total care. Has made some improvement and can lift hands to mouth now and almost totally close eyes. Still needs bowel and bladder regime. Unable to stand or ambulate.
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, Guillain-Barre syndrome, Intensive care, Mechanical ventilation, Muscular weakness
Clinical narrative: Pregnant 30 YO beneficiary received a TDaP at 35 weeks 3 days gestation on 29 FEB. On 13 MAR, she developed lower extremity paresthesia that progressed to over weakness then difficulty swallowing. She was hospitalized the same day and placed on a ventilator. Her baby was delivered via C-section the following day, 14 MAR. To date, the baby appears to be fine. Mother diagnosed with GBS and has been transferred to another hospital on 4 May '16 for long term rehab. Has gastric tube and still needs almost total care. Has made some improvement and can lift hands to mouth now and almost totally close eyes. Still needs bowel and bladder regime. Unable to stand or ambulate.
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Nuclear magnetic resonance imaging normal, Obstructive airways disorder, Pain in extremity, Paraesthesia
Clinical narrative: Pregnant 30 YO beneficiary received a TDaP at 35 weeks 3 days gestation on 29 FEB. On 13 MAR, she developed lower extremity paresthesia that progressed to over weakness then difficulty swallowing. She was hospitalized the same day and placed on a ventilator. Her baby was delivered via C-section the following day, 14 MAR. To date, the baby appears to be fine. Mother diagnosed with GBS and has been transferred to another hospital on 4 May '16 for long term rehab. Has gastric tube and still needs almost total care. Has made some improvement and can lift hands to mouth now and almost totally close eyes. Still needs bowel and bladder regime. Unable to stand or ambulate.
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Abasia, Activities of daily living impaired, CSF protein increased, Caesarean section, Dysphagia
Clinical narrative: Pregnant 30 YO beneficiary received a TDaP at 35 weeks 3 days gestation on 29 FEB. On 13 MAR, she developed lower extremity paresthesia that progressed to over weakness then difficulty swallowing. She was hospitalized the same day and placed on a ventilator. Her baby was delivered via C-section the following day, 14 MAR. To date, the baby appears to be fine. Mother diagnosed with GBS and has been transferred to another hospital on 4 May '16 for long term rehab. Has gastric tube and still needs almost total care. Has made some improvement and can lift hands to mouth now and almost totally close eyes. Still needs bowel and bladder regime. Unable to stand or ambulate.
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Dysstasia, Exposure during pregnancy, Gastrointestinal tube insertion, Guillain-Barre syndrome, Mechanical ventilation
Clinical narrative: Pregnant 30 YO beneficiary received a TDaP at 35 weeks 3 days gestation on 29 FEB. On 13 MAR, she developed lower extremity paresthesia that progressed to over weakness then difficulty swallowing. She was hospitalized the same day and placed on a ventilator. Her baby was delivered via C-section the following day, 14 MAR. To date, the baby appears to be fine. Mother diagnosed with GBS and has been transferred to another hospital on 4 May '16 for long term rehab. Has gastric tube and still needs almost total care. Has made some improvement and can lift hands to mouth now and almost totally close eyes. Still needs bowel and bladder regime. Unable to stand or ambulate.
Age: 30.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: Pregnant 30 YO beneficiary received a TDaP at 35 weeks 3 days gestation on 29 FEB. On 13 MAR, she developed lower extremity paresthesia that progressed to over weakness then difficulty swallowing. She was hospitalized the same day and placed on a ventilator. Her baby was delivered via C-section the following day, 14 MAR. To date, the baby appears to be fine. Mother diagnosed with GBS and has been transferred to another hospital on 4 May '16 for long term rehab. Has gastric tube and still needs almost total care. Has made some improvement and can lift hands to mouth now and almost totally close eyes. Still needs bowel and bladder regime. Unable to stand or ambulate.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a pharmacist referring to a 63 year old female patient. The patient's concurrent condition included high cholesterol, high blood pressure, depression, and overactive bladder. The patient's relevant past drug history was unknown. On 29-MAY-2016 the patient was vaccinated with ZOSTAVAX 11940 units (0.65 ml, once, lot#: reported as L046896, expiry date: 23-FEB-2017) in her arm. The patient's concomitant medications included medications for her blood pressure, depression and overactive bladder. On 31-MAY-2016, the patient came back to the pharmacy and her arm was really red. On 02-JUN-2016 (reported as today), the patient came to the pharmacy again and the area that was initially red because rashy and scaly in the middle. The pharmacist stated that it looked like shingles, was really big and looked bad. The patient stated that it was getting worse. No relevant lab work had been done. As of 02-JUN-2016, it was unknown if the patient would continue on the ZOSTAVAX, and she had not recovered from the redness, rashy, and scaly symptoms that looked like shingles. Causality was not provided. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Rash, Rash vesicular, Skin exfoliation
Clinical narrative: Information has been received from a pharmacist referring to a 63 year old female patient. The patient's concurrent condition included high cholesterol, high blood pressure, depression, and overactive bladder. The patient's relevant past drug history was unknown. On 29-MAY-2016 the patient was vaccinated with ZOSTAVAX 11940 units (0.65 ml, once, lot#: reported as L046896, expiry date: 23-FEB-2017) in her arm. The patient's concomitant medications included medications for her blood pressure, depression and overactive bladder. On 31-MAY-2016, the patient came back to the pharmacy and her arm was really red. On 02-JUN-2016 (reported as today), the patient came to the pharmacy again and the area that was initially red because rashy and scaly in the middle. The pharmacist stated that it looked like shingles, was really big and looked bad. The patient stated that it was getting worse. No relevant lab work had been done. As of 02-JUN-2016, it was unknown if the patient would continue on the ZOSTAVAX, and she had not recovered from the redness, rashy, and scaly symptoms that looked like shingles. Causality was not provided. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Band neutrophil percentage increased, Enterococcus test positive, Injection site cellulitis, Sepsis, Shift to the left
Clinical narrative: This spontaneous report was received from a pharmacist via company representative regarding a 69 year old male patient. The patient has concurrent condition of diabetes. Drug reactions or allergies were not reported. On 01-JUN-2016, the patient was vaccinated with PNEUMOVAX 23 (dosage information was not reported) lot # M005287, expiry date 08-OCT-2017, intramuscular. On 02-JUN-2016, the patient experienced cellulitis. The patient sought medical attention and was hospitalized for 5 days. The patient was treated for the event (unspecified). The reporter has requested a lot check for PNEUMOVAX 23 lot # M005287. The outcome of cellulitis was unknown. Causality assessment was not provided. No product quality complaint was reported. Upon internal review cellulitis was determined to be medically significant. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV, PPV
Symptoms: White blood cell count increased
Clinical narrative: This spontaneous report was received from a pharmacist via company representative regarding a 69 year old male patient. The patient has concurrent condition of diabetes. Drug reactions or allergies were not reported. On 01-JUN-2016, the patient was vaccinated with PNEUMOVAX 23 (dosage information was not reported) lot # M005287, expiry date 08-OCT-2017, intramuscular. On 02-JUN-2016, the patient experienced cellulitis. The patient sought medical attention and was hospitalized for 5 days. The patient was treated for the event (unspecified). The reporter has requested a lot check for PNEUMOVAX 23 lot # M005287. The outcome of cellulitis was unknown. Causality assessment was not provided. No product quality complaint was reported. Upon internal review cellulitis was determined to be medically significant. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a pharmacist via company representative regarding a 69 year old male patient. The patient has concurrent condition of diabetes. Drug reactions or allergies were not reported. On 01-JUN-2016, the patient was vaccinated with PNEUMOVAX 23 (dosage information was not reported) lot # M005287, expiry date 08-OCT-2017, intramuscular. On 02-JUN-2016, the patient experienced cellulitis. The patient sought medical attention and was hospitalized for 5 days. The patient was treated for the event (unspecified). The reporter has requested a lot check for PNEUMOVAX 23 lot # M005287. The outcome of cellulitis was unknown. Causality assessment was not provided. No product quality complaint was reported. Upon internal review cellulitis was determined to be medically significant. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV4
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a healthcare worker, refers to a 11 year old female patient. Patient was not pregnant. Patient had sulfa drugs reactions/Allergies. Pertinent medical history and concomitant medication were reported as none. On 23-MAR-2016, the patient was vaccinated with first dose of GARDASIL, 0.5 ml (at 0 day), intramuscularly. On 23-MAY-2016 (at 2 month), the patient was vaccinated with second dose of GARDASIL, lot M003659, expiry date 20-SEP-2017, 0.5 ml, intramuscularly. On 28-MAY-2016, the patient developed an "itchy rash" on both arms and legs. Healthcare worker stated that the patient began using an "over-the-counter hydrocortisone cream" before she was seen in the office on 01-JUN-2016, and that the rash had begun to improve. Patient was seen in the office on 01-JUN-2016. Physician prescribed another hydrocortisone cream for the patient on 01-JUN-2016. Lab diagnostics studies performed was reported as none. The outcome of the event was recovering. Causality assessment was not provided. Patient sought medical attention. No product quality complaint (PQC) was involved. No additional information was provided. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV4
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report was received from a healthcare worker, refers to a 11 year old female patient. Patient was not pregnant. Patient had sulfa drugs reactions/Allergies. Pertinent medical history and concomitant medication were reported as none. On 23-MAR-2016, the patient was vaccinated with first dose of GARDASIL, 0.5 ml (at 0 day), intramuscularly. On 23-MAY-2016 (at 2 month), the patient was vaccinated with second dose of GARDASIL, lot M003659, expiry date 20-SEP-2017, 0.5 ml, intramuscularly. On 28-MAY-2016, the patient developed an "itchy rash" on both arms and legs. Healthcare worker stated that the patient began using an "over-the-counter hydrocortisone cream" before she was seen in the office on 01-JUN-2016, and that the rash had begun to improve. Patient was seen in the office on 01-JUN-2016. Physician prescribed another hydrocortisone cream for the patient on 01-JUN-2016. Lab diagnostics studies performed was reported as none. The outcome of the event was recovering. Causality assessment was not provided. Patient sought medical attention. No product quality complaint (PQC) was involved. No additional information was provided. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Patient developed 101.7 fever that evening after vaccine along with body aches, chills and joint pain. Muscle aches have persisted x 3d, fever stopped after 24 hours. Mother wanted reaction reported.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Arthralgia, Chills, Myalgia, Pain, Pyrexia
Clinical narrative: Patient developed 101.7 fever that evening after vaccine along with body aches, chills and joint pain. Muscle aches have persisted x 3d, fever stopped after 24 hours. Mother wanted reaction reported.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Urine analysis normal
Clinical narrative: Patient developed 101.7 fever that evening after vaccine along with body aches, chills and joint pain. Muscle aches have persisted x 3d, fever stopped after 24 hours. Mother wanted reaction reported.
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Anaphylactic reaction, Dyspnoea, Injection site swelling, Peripheral swelling, Respiratory distress
Clinical narrative: Large localized reaction within hours. By 24 hrs had spread to encompass elbow, shoulder with heat spreading across to scapula and chest. Pt then developed wheezing not relieved with inhaler. Mom gave EPIPEN and activated EMS. Seen in local ER. D/C'd with steroids and BENADRYL.
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Wheezing
Clinical narrative: Large localized reaction within hours. By 24 hrs had spread to encompass elbow, shoulder with heat spreading across to scapula and chest. Pt then developed wheezing not relieved with inhaler. Mom gave EPIPEN and activated EMS. Seen in local ER. D/C'd with steroids and BENADRYL.
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Feeling hot, Local reaction, Rubber sensitivity, Wheezing
Clinical narrative: Large localized reaction within hours. By 24 hrs had spread to encompass elbow, shoulder with heat spreading across to scapula and chest. Pt then developed wheezing not relieved with inhaler. Mom gave EPIPEN and activated EMS. Seen in local ER. D/C'd with steroids and BENADRYL.
Age: 4.0
Sex: M
Vaccine: DTPIPV, MMRV, MMRV
Symptoms: Abscess neck, Cough, Dysphagia, Injection site abscess, Pruritus
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old male patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unspecified. On 16-JUN-2016, the patient was vaccinated with PROQUAD (Merck) injection (strength, lot# and dose# unspecified) 0.5 ml, subcutaneously, in physician's office. The reporter stated that, on 16-JUN-2016, immediately after receiving the injection, the patient had a reaction and began getting itchy over his entire body. The patient also developed a rash over his body, and had a hard time swallowing. The patient sought medical attention, he was treated with epinephrine 0.15 ml, and BENADRYL 5 ml. The patient was then still in the office being monitored and appeared to be recovering. Product quality complaint (PQC) was not involved. The reporter did not provide the causality assessment between the events and the suspect therapy PROQUAD (Merck). No further information was provided. Upon internal review, the events 'immediate post-injection reaction, pruritus generalised and rash generalised' was determined to be medically significant. Additional information has been requested.