chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a first dose of GARDASIL 9 (exact dose, anatomical location, route of administration, lot# and expiry date were not reported) and for the second dose was administered GARDASIL, intramuscularly (lot# L040459, expiry date on 06-APR-2017, exact dose and anatomical location were not reported), on 02-MAR-2016. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Day after shot given for TDAP at (L) arm TDAP site tiny rash. No redness or fever. Fine rash at dorsal lower arm and thighs st. itchy otherwise not painful.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies and medical history provided. On 15-JUL-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042266, expiration date was not reported) (dose and route of administration were not reported as prophylaxis. 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 was received from a registered nurse, referring to multiple unspecified patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, patients were administrated improperly stored doses of VAQTA (lot # and expiration date were not reported). It was reported that the vaccine was exposed for 270 hours at 9 C degrees. No adverse effects were reported. It was reported that all the vaccines were back in range. Digital data logger was reported as yes.  This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 24.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 24 year old patient of unknown gender. On 06-JAN-2016, the patient was vaccinated with the first, improperly stored dose of GARDASIL 9 (dose, anatomical location and route of administration were not provided, lot # L016429 with expiration date 09-SEP-2017). The second, improperly stored dose of the vaccine was administered on 28-MAR-2016 (lot number L037339 with expiration date: 09-FEB-2018). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 13-JUL-2016, the patient was vaccinated with improperly stored PROQUAD (lot # M010478, expiration date 01-SEP-2017, albumin status therapy type, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot # reported as L038503 with expiry date: 18-DEC-2017, intramuscularly. Administered doses of vaccines experienced the temperature excursion of 32.97 degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursions reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, patients were administered doses of improperly stored PNEUMOVAX 23 (lot # and expiration date were not reported). It was reported that the vaccine was exposed for 270 hours at 9 Celsius degrees. No adverse effects were reported. It was reported that all the vaccines were back in range. The data logger was reported as yes. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 01-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, lot # M021407, expiry date 30-APR-2018 (dose, route of administration and anatomical location were not specified). The administered dose of GARDASIL 9 was stored at 33.4 Fahrenheit degrees for 52 minutes. There was no previous temperature excursion. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On unknown dates theses unspecified patients were vaccinated with improperly stored GARDASIL 9 (strength, dosing details, anatomical location, lot# and expiration date were unknown). No patients reported adverse effects. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored M-M-R II (strength, dosing details, anatomical locations, lot # and expiration date were unknown). No patients reported adverse effects. No product quality complaint was reported. This is one of the several reports 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 Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # L015460, expiration date 20-JUL-2017 and lot # M011116, expiration date 17-JUN-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 18-JUL-2016, the patient was vaccinated with improperly stored (Oka-Merck) PROQUAD (lot # M010478, expiration date 01-SEP-2017, albumin status therapy type, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Swelling, Tenderness
Clinical narrative: Rash and swelling; Tenderness.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Hyperhidrosis, Syncope
Clinical narrative: Fainting, dizzy, sweating, pt stated he fainted for couple minutes. Pt was monitored, lay down x 15min, symptoms went away. Pt recovered and left pharmacy.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient developed a cellulitis reaction in the arm within 48 hours of receiving the vaccination. Patient received medical treatment - received prescription for cephalexin 500 mg TID x 10 days.
Age: 13.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Induration, Injection site erythema, Tuberculin test positive
Clinical narrative: 50 mm x 45 mm, localized redness on area where vaccine was administered (Left posterior upper arm). Patient had positive PPD skin test with 19 mm induration.
Age: 72.0
Sex: U
Vaccine: PNC13
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 8-31-16 3:00 AM woke up with "severe pain" to injection site, pain up into shoulder area left arm. Pain to point of numbness. Ice applied. This AM ache to site only. Three 1/4 inch red warm areas at site.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: 8/26 call from provider DR., right leg was red, swollen, raised and warm to touch in area where vaccine was given. No fever. Mother took pictures, Drs office was to email to Health Dept but have not received them to day. 8/12 Rash started itching, no fever. 8/15 call from parent - allergic reaction - taken by other staff member. 8/31 - still itching getting better still random spots - may leave scarring.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site warmth
Clinical narrative: 8/26 call from provider DR., right leg was red, swollen, raised and warm to touch in area where vaccine was given. No fever. Mother took pictures, Drs office was to email to Health Dept but have not received them to day. 8/12 Rash started itching, no fever. 8/15 call from parent - allergic reaction - taken by other staff member. 8/31 - still itching getting better still random spots - may leave scarring.
Age: 16.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Asthenia, Loss of consciousness, Nervousness
Clinical narrative: Patient states she "blacked out" approx. 25 mins after vaccines given. She was sitting, regained consciousness on her own. Pt feels weak and shaky after.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Headache, Myalgia, Rash, Swelling
Clinical narrative: 1 day after administration of pneumococcal vaccine (PPV-23) pt reports myalgia, weakness, swelling, rash. Headache. Was treated with 5 days of prednisone. Improvement noted 2nd day of prednisone.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site rash, Pharyngeal hypoaesthesia, Swollen tongue
Clinical narrative: After 48 hours pt said she developed  a 1" x 3" rash at the injection site, accompanied by severe itching at site of rash and mild tongue swelling and slight throat numbness. BENADRYL taken orally for 2-3 days.
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left arm red and swollen starting 24hrs after vacc given.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, patients were administrated improperly stored doses of GARDASIL (lot # and expiration date were not reported). It was reported that the vaccine was exposed for 270 hours at 9 C degrees. No adverse effects were reported. It was reported that all the vaccines were back in range. The data logger was reported as yes. 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, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, patients were administered improperly stored doses of RECOMBIVAX HB (lot # and expiration date were not reported). It was reported that the vaccine was exposed for 270 hours at 9 C degrees. No adverse effects were reported. It was reported that all vaccines were back in range. The data logger was reported as yes. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HIBV, MMRV, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: None. Patient given PROQUAD instead of MMR.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm turned bright red and swelled to twice normal size with red lines going down arm. PNEUMOVAX injection.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: No adverse event, Vaccination error
Clinical narrative: Live MMR and live VARICELLA both given in same thigh, also both given IM. 9/1 3:17pm RMA called home, left message to call back to see how pt is doing, any reactions? No return call as of 9/2 5pm. No adverse events reported.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: (L) arm swelling, redness, pain.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patient's concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (dose and route were unknown, lot # K016966 with expiration date 10-MAY-2017, lot # K010214 with expiration date 05-MAY-2017, and lot # K011562 with expiration date 08-APR-2017). The vaccines were exposed to temperature excursion of 57.0 degrees Fahrenheit (F) for 1 hour and 50.8 degrees Fahrenheit (F) for 1 hour. No previous temperature excursion was reported. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions and concomitant medication were not provided. On 03-SEP-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (expiration date: 06-AUG-2016) (dose, route of administration and lot # were not provided). Additional information is not expected as reporter declined to participate in follow-up collection process.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M019706, expiration date 24-OCT-2017 and lot # M025565, expiration date 06-NOV-2017 (dose was not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 year old patient of unknown gender. On 13-FEB-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, anatomical location and route of administration were not provided, lot # L027282 with expiration date 21-SEP-2017). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to 2 patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 30-AUG-2016, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M012991, expiration date 14-MAR-2018, site, doses and route of administration were not reported). No adverse effects were reported. This is one of two reports received from the same source. Additional information is not expected due to lack of the reporter's contact details.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistance refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-JUL-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042266, expiration date was not reported) (dose and route of administration were not reported). 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 unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # M002268 with expiration date: 20-SEP-2017 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 35.6 degrees Fahrenheit for 10 minutes and 36.6 degrees Fahrenheit for 10 minutes. Data logger was involved. There were no previous excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-JUL-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042266, expiration date was not reported) (dose and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # L014458 with expiration date: 11-FEB-2017 and lot # L034335 with expiration date: 18-MAY-2017 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 35.6 degrees Fahrenheit for 10 minutes and 36.6 degrees Fahrenheit for 10 minutes. Data logger was involved. There were no previous excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L029934 with expiration date: 01-MAY-2017 and lot # M019690 with expiration date: 02-NOV-2017 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 35.6 degrees Fahrenheit for 10 minutes and 36.6 degrees Fahrenheit for 10 minutes. Data logger was involved. There were no previous excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 01-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, lot # M021407, expiry date 30-APR-2018 (dose, route of administration and anatomical location were not specified). The administered dose of GARDASIL 9 was stored at 33.4 Fahrenheit degrees for 52 minutes. There was no previous temperature excursion. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-JUL-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042266, expiration date was not reported) (dose and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistance refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-JUL-2016, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # L42266, expiration date was not reported) (dose and route of administration were not reported). This is one of several 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 pharmacist refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored ZOSTAVAX (strength, dosing details, anatomical location, lot# and expiration date were unknown). No patients reported adverse effects. No product quality complaint was reported. This is one of the several reports 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 as received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L016427 with expiration date: 13-APR-2017, lot # L038018 with expiration date: 19-SEP-2017 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 35.6 degrees Fahrenheit for 10 minutes and 36.6 degrees Fahrenheit for 10 minutes. Data logger was involved. There were no previous excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M003659 with expiration date: 20-SEP-2017, lot # L026602 with expiration date: 19-OCT-2017 and lot # L038503 with expiration date: 18-DEC-2017 (dose and route of administration were not reported). Administered doses of vaccine experienced the temperature excursion of 35.6 degrees Fahrenheit for 10 minutes and 36.6 degrees Fahrenheit for 10 minutes. Data logger was involved. There were no previous excursions. No adverse effects were reported. This is one of several 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 pharmacist refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored PEDVAXHIB (strength, dosing details, anatomical location, lot# and expiration date were unknown). No patients reported adverse effects. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored PROQUAD (strength, dosing details, anatomical location, lot# and expiration date were unknown). No patients reported adverse effects. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site haemorrhage, Injection site pain
Clinical narrative: This spontaneous report as received from a 56 year old female patient, who was also a pharmacist, refers to herself. The patient's concurrent conditions included asthma. She had no drug reactions or allergies. On 26-AU2016, the patient was vaccinated with PNEUMOVAX 23, intramuscularly in the deltoid (dose, lot # and expiry date were not reported). Concomitant therapies included CLIMARA, DULERA, Astelin, NASOCORT, vitamin D and calcium and magnesium supplements. The patient reported that injection hurt like the dickens when it was going in and she had bleeding at the injection site. There was no treatment given for the events. The outcome of the events was reported as not recovered/not resolved (she reported that she continued to have pain at the injection site). The relatedness between the events and PNEUMOVAX 23 was not provided. Additional information is not expected, as reporter did not provide consent to contact physician.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored PNEUMOVAX 23 (strength, dosing details, anatomical location, lot# and expiration date were unknown). No patients reported adverse effects. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistance refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-JUL-2016, the patient was vaccinated with an improperly stored VARIVAX (lot # L042266, expiration date was not reported) (dose and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored VARIVAX lot # L000454, expiry date 06-JAN-2017, lot # M004326, expiry date 25-JAN-2018, lot # L049535, expiry date 08-DEC-2017, lot # M006731, expiry date 09-FEB-2018, lot # L013395, expiry date 16-APR-2017, subcutaneously (dose and site of administration were not reported). No adverse effects were reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Fall, Poor quality sleep, Restlessness, Vaccination site pain
Clinical narrative: Pt had some tenderness at vaccination site later that day. Felt a little dizzy, had very restless night sleep and fell in the am due to feeling dizzy. No loss of conscious no vomiting.
Sex: U
Vaccine: MENB
Symptoms: Blister, Erythema, Pain
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in a patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced pain, blister and erythema. On an unknown date, the outcome of the pain, blister and erythema were recovered/resolved. It was unknown if the reporter considered the pain, blister and erythema to be related to BEXSERO. Additional details were provided as follows: This case was reported by a medical assistant. The age at vaccination was not reported. The size of erythema and blister was explained as the size of a silver dollar. The Medical Science Liaison (MSL) did not have the reporter's telephone number and was unable to provide any further details regarding the adverse events described.
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site vesicles
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced injection site pain (serious criteria other: serious as per reporter), injection site blisters (serious criteria other: serious as per reporter), injection site rash (serious criteria other: serious as per reporter) and injection site redness (serious criteria other: serious as per reporter). On an unknown date, the outcome of the injection site pain, injection site blisters, injection site rash and injection site redness were unknown. It was unknown if the reporter considered the injection site pain, injection site blisters, injection site rash and injection site redness to be related to BEXSERO. Additional details were provided as follows: This case was reported by a certified medical assistant (CMA). The patient experienced pain, redness and blistering red spots at injection site (unknown deltoid) of the vaccine. The responsible physician and the person administering vaccine to the patient were unknown. The patient information was not available. No vaccine date was available.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC13, RV5
Symptoms: Muscle twitching
Clinical narrative: Developed twitching approximately 3 hrs. after vaccines given. Has continued to have movements, worse when supine. None while asleep. Referred to neurology.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age and gender. Patients medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On unknown dates these unspecified patient were vaccinated with improperly stored ROTATEQ (strength, dosing details, anatomical location, lot# and expiration date were unknown). No patients reported adverse effects. No product quality complaint was reported. This is one of the several reports from the same reported. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Arthralgia, Asthenia, Chills, Erythema, Malaise
Clinical narrative: Chills immediately - muscle and joint pain temp 102. Went to bed for temp and ache and pain and fever - itching all over body arm (red) and lump and swollen drank a lot of water no food - weak - too ill to realize I should go to hosp was in bed and hurting. Still lymp arm itching - discolored.
Age: 79.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Mass, Myalgia, Pain, Pruritus generalised, Pyrexia
Clinical narrative: Chills immediately - muscle and joint pain temp 102. Went to bed for temp and ache and pain and fever - itching all over body arm (red) and lump and swollen drank a lot of water no food - weak - too ill to realize I should go to hosp was in bed and hurting. Still lymp arm itching - discolored.
Age: 79.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Swelling
Clinical narrative: Chills immediately - muscle and joint pain temp 102. Went to bed for temp and ache and pain and fever - itching all over body arm (red) and lump and swollen drank a lot of water no food - weak - too ill to realize I should go to hosp was in bed and hurting. Still lymp arm itching - discolored.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored VAQTA (strength, dosing details, anatomical location, lot# and expiration date were unknown). No patients reported adverse effects. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Mobility decreased, Pain
Clinical narrative: Very bad pain in left shoulder. Could only move arm so far. Before pain ret. went to the doctor give me something pain. Tried to do exercise. Might have to have physical therapy.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus
Clinical narrative: After, about 3 days it got very red and itchy on my entire inside arm. Nothing seemed to help except ice pack. It would fade and then come back for almost 2 weeks.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Lethargy, Nausea, Nervousness, Pallor
Clinical narrative: At 11:00 patient came in our office for annual well exam and go MenB vaccine (1st) dose. Pt. called at 2:49 pm same day c/o feeling dizzy, nausea, shaky, lethargic and pale. Advised pt to hydrate and have a snack and rest. C/B in AM to check in.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (strength, dosing details, anatomical location, lot# and expiration date were unknown). No patients reported adverse effects. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Body temperature increased, Peripheral swelling, Vaccination site warmth
Clinical narrative: 9/1/16-Swelling (L) upper arm. No pain vaccinated area hot to touch, Temp 100-parents gave MOTRIN yesterday but none today.
Age: 25.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Burning sensation, Headache, Injection site bruising, Injection site pruritus
Clinical narrative: Started off w/upset stomach, lethargy and headache. This progressed to localized bruising at the site. On Monday there was a large hive at the site and some itching. On Tuesday, 8/16, she complained of severe itching all over, "feeling on fire"!
Age: 25.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Lethargy, Pruritus generalised
Clinical narrative: Started off w/upset stomach, lethargy and headache. This progressed to localized bruising at the site. On Monday there was a large hive at the site and some itching. On Tuesday, 8/16, she complained of severe itching all over, "feeling on fire"!
Age: 25.0
Sex: F
Vaccine: HEPA
Symptoms: Loss of consciousness, Muscle twitching, Snoring, Tremor
Clinical narrative: After being administered 1 ml of HAVRIX 14400 the patient lost consciousness and had uncontrollable twitching/shaking and was making snoring noises. This lasted approximately 30 seconds.
Sex: U
Vaccine: MMRV
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 age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 14-JUL-2016, the patient was vaccinated with improperly stored PROQUAD (lot # M010478, expiration date 01-SEP-2017, albumin status therapy type, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and redness and warmth around the site. Started at 8:30 pm.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Feeling cold, Headache, Hyperhidrosis
Clinical narrative: Patient seen for physical 8/30/16. Patient said his joints are achy, sweating profusely, chills, headache. No arm redness, no swelling, not hot to touch. Pt seen for appt. 8/30/16, called office 9/1/16 11:24 am.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 prefilled syringes lot # reported as M98916 with expiry date: 17-SEP-2016 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 32.97 degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursion reports. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX  23 lot # L010598, expiry date 16-AUG-2016, lot # L019836, expiry date 24-MAR-2017, lot # L014458, expiry date 11-FEB-2017 and lot # reported as K101522, expiry date 25-FEB-2016 (strength, dose, route and site of administration were not reported). No adverse effects were reported. All vaccines were administered after being stored improperly but prior to their labeled expiration dates. This is one of several cases received from the same reporter. Lot number K101522 is an invalid lot number of PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (dose was unknown, lot # L046318 with expiration date 28-SEP-2017, and lot # L039640 with expiration date 24-AUG-2017) orally. The vaccines were exposed to temperature excursion of 57.0 degrees Fahrenheit (F) for 1 hour and 50.8 degrees Fahrenheit (F) for 1 hour. No previous temperature excursion was reported. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Blister, Injection site erythema, Injection site swelling, Pruritus, Rash
Clinical narrative: Itchiness, Redness and swelling around injection site the day after vaccines administered. Blister and rash 2 days after administration of vaccines.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site rash
Clinical narrative: Bilat rash upper thighs 24 hours after vaccines - fine raised rash in a patch.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Asthenia, Chest discomfort, Dizziness, Oropharyngeal discomfort, Secretion discharge
Clinical narrative: GARDASIL 9, MENACTRA given 2 pm, 2:05 pm. Pt. c/o dizziness, weak. Pt. placed in supine position, cold compress. Vitals taken BP 140/80 pt proceeded to vomit small amt. mucus. BP at 2:15 150/90, pulse 106, O2 SAT 98. C/O throat and chest discomfort, examined by MD. Monitored x 30 min. vitals at 2:41 BP 122/86, P92, O2 SAT 97. Felt better, discharged. Called 4 pm and doing well. Will F/U in AM.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Vomiting
Clinical narrative: GARDASIL 9, MENACTRA given 2 pm, 2:05 pm. Pt. c/o dizziness, weak. Pt. placed in supine position, cold compress. Vitals taken BP 140/80 pt proceeded to vomit small amt. mucus. BP at 2:15 150/90, pulse 106, O2 SAT 98. C/O throat and chest discomfort, examined by MD. Monitored x 30 min. vitals at 2:41 BP 122/86, P92, O2 SAT 97. Felt better, discharged. Called 4 pm and doing well. Will F/U in AM.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received form a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (dose and route were unknown, lot # M009745 with expiration date 23-AUG-2017, and lot # M011664 with expiration date 08-SEP-2017. The vaccines were exposed to temperature excursion of 7.8 degrees Fahrenheit (F) for 5 hours and 30 minutes, and 17.4 degrees Fahrenheit (F) for 4 hours and 30 minutes. No previous temperature excursion was reported. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose and route were unknown, lot # M010485 with expiration date 01-MAR-2018, and lot # L043622 with expiration date 03-NOV-2017). The vaccines were exposed to temperature excursion of 7.8 degrees Fahrenheit (F) for 5 hours and 30 minutes, and 17.4 degrees Fahrenheit (F) for 4 hours and 30 minutes. No previous temperature excursion was reported. Data logger was involved. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refer to multiple unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored VAQTA lot # L045713, expiry date 14-JAN-2017 (strength, dose, route and site of administration were not reported). No adverse effects were reported. This is one of several cases 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 medical assistant referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB which had lot # M001578 with expiry date: 21-NOV-2018, (dosing details not reported). No adverse effects and no product quality complaint (PQC) reported. No further information provided. This is one of the several reports received from the same reporter. Additional information has been requested.