chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Activities of daily living impaired, Herpes zoster, Joint injury, Viral test positive
Clinical narrative: This spontaneous report was received from a nurse practitioner (N.P.) referring to a 19 year old non pregnant female patient allergic to Sulfa (unspecified). On 02-DEC-1996, the patient was vaccinated with the first dose of VARIVAX (Merck) (Lot#, expiration date, dose and route of administration were not reported). On 21-JAN-2010, the patient was vaccinated with the second dose of VARIVAX (Merck) (Lot #, expiration date, dose and route of administration were not reported). Concomitant medication was not reported. Approximately in 2014, reported as "last year", the patient hurt her shoulder an unspecified way while playing a sport and the patient was "no longer able to play unspecified sports because of that". On 16-NOV-2014, the N.P.  saw the patient in the office and she was diagnosed with shingles (herpes zoster) by unspecified lab work that was performed on an unspecified date. The N.P. stated that she thought the shingles developed in the patient due to the "stress the patient had of not being able to play unspecified sports". The patient was prescribed Acyclovir for the shingles and recovered on an unspecified date. On 02-FEB-2015, the patient went to the office and was diagnosed a second time with shingles, she was prescribed with Acyclovir a "second time" and recovered from the shingles again on an unspecified date. The relatedness between herpes zoster and VARIVAX (Merck) was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot number-L018001, expiry date- 19-MAY-2017, lot number-L026408, expiry date- 15-JUL-2017 and batch number-L026407, expiry date- 15-JUL-2017, dosing regimen unknown). No adverse events were reported. No laboratory tests were reported. No product quality complaints (PQC) was involved. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age. Concurrent conditions and medical history of the patient were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored doses of GARDASIL (lot# K007264, expiry date 02-MAR-2017; lot# K007828, expiry date 02-MAR-2017, lot# K009482, expiry date 06-MAR-2017; lot# K010215, expiry date 05-MAY-2017, lot# K010574, expiry date 08-APR-2017; lot# K011562, expiry date 08-APR-2017, lot# K023432, expiry date 08-JUN-2016) (dose, route unspecified). Concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received from the same source. 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 health care professional refers to multiple unspecified patients of unknown demographics. On unspecified dates the patients were vaccinated with improperly stored VAQTA (dosing regimen unspecified) (L023232 (also reported as 1023232), exp: 25-FEB-2017). No concomitant medications reported. No adverse effects reported. No further information was provided. 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 was received from a pharmacist referring to a pharmacy technician of unknown age and gender. Medical history, concurrent conditions Concomitant medications were not reported. On an unknown date, the pharmacy technician suffered an accidental topical to exposure to the powder from a vial of ZOSTAVAX, 1 standard package vial of 1, lot # K018175 and expiration date in January 2016, that may have been leaking. The pharmacist reported also that ZOSTAVAX was stored at room temperature, as it had already been pulled from the freezer some time ago, and was slated for return to the distributor (incorrect product storage). No adverse events were reported. and Product Quality Control (PQC) was filled on 18-NOV-2015. This is one of two reports received from the same source (MARRS # 1511USA009847). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age. Concurrent conditions and medical history of the patient were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored doses of VAQTA (lot# K005958, expiry date 09-FEB-2017; lot# K007791, expiry date 22-AUG-2016; lot# K018181, expiry date 04-JUN-2017; lot# K018182, expiry date 12-FEB-2017; lot# K019560, expiry date 02-JUN-2017; lot# L002717, expiry date 02-JUN-2017; lot# L018499, expiry date 25-FEB-2017) (dose, route unspecified). Concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. On unspecified dates the patients were vaccinated with improperly stored VARIVAX (Merck) (dosing regimen unspecified) (L024252 (also reported as 1024252), exp: 30-JUN-2017). No concomitant medications reported. No adverse effects reported. No further information was provided. 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 was received from a health care professional refers to multiple unspecified patients of unknown demographics. On unspecified dates the patients were vaccinated with improperly stored ROTATEQ (dosing regimen unspecified) (L008059 (also reported as 1008059), exp: 18-DEC-2016). No concomitant medications reported. No adverse effects reported. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed practical nurse regarding an unknown number of patients of unknown age and unknown gender. No medical history and concurrent conditions were reported. On an 19-NOV-2015, 22-NOV-2015, 25-NOV-2015 and 01-DEC-2015, patients were vaccinated with improperly stored GARDASIL 9 with a lot number # L025737, expiry date: 28-JUL-2017 (dose number, dosing regimen, strength, anatomical location and route unknown) (incorrect product storage). Concomitant medications of the patient were unknown. No other adverse events were reported. 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 physician's assistant refers to a patient of unknown age and gender. On 21-AUG-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. On unspecified dates the patients were vaccinated with improperly stored M-M-R II (dosing regimen unspecified) (L003858 (also reported as 1003858), exp: 05-FEB-2017). No concomitant medications reported. No adverse effects reported. No further information was provided. 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: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age. Concurrent conditions and medical history of the patient were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored doses of GARDASIL 9 (lot# L004014, expiry date 04-MAR-2017; lot# L013429, expiry date 21-JUL-2017) (dose, route unspecified). Concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a physician and refers to three unspecified patients of unknown age and gender. Information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was not provided. On an unknown date, the patients were vaccinated with the first (of two) dose of ROTATEQ orally (dose, lot # and expiration date were not reported). On an unknown date, after the patients were vaccinated with ROTATEQ, all three patients vomited. The patients sought medical attention, they were in the physician's office. No treatment was given to them for the event. Therapy with ROTATEQ was discontinued on an unspecified date. The outcome of vomiting was reported as recovered (date unspecified). The relatedness between the event and ROTATEQ was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. Since 14-OCT-2015 the patients were vaccinated with doses of M-M-R II (lot# reported as L000459 with expiration date of 06-JAN-2017; strength, dosage and frequency unspecified) which were improperly stored (incorrect product storage). 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: Information has been received from a healthcare professional referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. Since an unspecified date in 2015 the patients were vaccinated with doses of ROTATEQ (lot # K024700 with expiration date of 30-JUL-2016, oral; strength, dosage and frequency unspecified) which were improperly stored (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: RAB
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Possible cellulitis. 4x6" red, warm, tender superficial area (L) lateral arm approx. 2" from injection site. No open wounds noted.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: Swollen deltoid, warm, erythema, body aches.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Local reaction, Mass, Rash erythematous, Skin warm
Clinical narrative: Patient received PREVNAR vaccine on 12/3/15. Still had localized reaction (warm, red rash approx. 1 inch, lump). No pain. Suggested ice, BENADRYL and give it a little more time.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: Had imms. 12/14 evening, 12/15 tmp to 103, seen 12/16 noon for (L) upper arm erythema/swelling, axillary nodes. DTAP upper, MMR lower upper arm, bone sites involved, none (R) arm.
Age: 51.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Large red, warm, indurated area on left upper arm.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Pain
Clinical narrative: Soreness, localized warmth and redness.
Age: 73.0
Sex: U
Vaccine: PNC13
Symptoms: Decreased appetite, Dizziness, Erythema, Headache, Nausea
Clinical narrative: Headache, nauseous, fever, arm redness, dizziness, eatless.
Age: 73.0
Sex: U
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Headache, nauseous, fever, arm redness, dizziness, eatless.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist via a field employee refers to a 65 year old male patient. The patients concurrent conditions include diabetes mellitus. On 07-DEC-2015 the patient was vaccinated with ZOSTAVAX, vial dry SD, 0.65 ml, subcutaneous. Concomitant therapies included metformin and atenolol. On 07-DEC-2015, following vaccination, the patient experienced itching around the injection site for which the patient was not treated. No laboratory tests were reported. Cancer and overdose were not involved. No product quality complaint (PQC) was involved. The outcome of injection site pruritus was reported as not recovered/not resolved. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Urticaria
Clinical narrative: Received shingle vac 2014-or 2015 develop large amount of clear raised areas on back, upper lt side same on (lt) face itching profusely in these area. Whelps. MD stated had shingles.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Immediate post-injection reaction, Pain, Pyrexia
Clinical narrative: Pt immediately felt burning/stinging after admin. By 6pm, noted to be hot, swollen, red, sore. Took BENADRYL applied ice packs throughout evening/night. Fever reached 100.0 orally. This morning at 1120 has area of (R) arm.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Swelling
Clinical narrative: Pt immediately felt burning/stinging after admin. By 6pm, noted to be hot, swollen, red, sore. Took BENADRYL applied ice packs throughout evening/night. Fever reached 100.0 orally. This morning at 1120 has area of (R) arm.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Left thigh swelling, warm to touch, painful, raise. Treatment-warm compresses.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 01-OCT-2015, the patient was vaccinated with a dose of GARDASIL intramuscular (dose, anatomical location or lot # were unspecified). Later, on 06-OCT-2015, the patient was vaccinated with another dose of GARDASIL intramuscular (dose, anatomical location or lot # were unspecified); additionally the reporter informed that the patient was going to receive another dose on 15-DEC-2015 (inappropriate schedule of drug administration). No concomitant medications were reported. No adverse effects were informed. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of oral, ROTATEQ lot # L008054 with expiration date 30-NOV-2016 or lot # L013192 with expiration date 19-JAN-2017 (it was unspecified which lot was administered) (dose and route of administration were not reported). No adverse effects reported. This is one of two reports from the same source. Additional information is not expected as no consent for further contact was given.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to five patients of unknown age and gender. Information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L030865, expiration date 27-AUG-2017 (dose and route of administration were not reported). No adverse effects reported. This is one of two reports from the same source. Additional information is not expected as no consent for further contact was given.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a non-health professional reporter via a company representative refers to a patient of unknown age and gender. On 29-OCT-2015, the patient was in the office to receive influenza virus vaccine (unspecified) and received GARDASIL instead (lot # K010215) (dose and route not reported) instead. The reporter could not verify if the patient received GARDASIL or GARDASIL 9 however the lot number indicated that the patient received GARDASIL. This was outside the age indications for this vaccination as well. No adverse effects reported. 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 nurse refers to 12 patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # K007781 with expiration date: 28-MAY-2016 and lot # K009759 with expiration date: 09-JUL-2016. No adverse effects were reported. 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 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 PROQUAD (Merck) human serum albumin (HSA), lot # L014401, expiration date 23-OCT-2016 (dose and route of administration were not reported) or PROQUAD (Merck) recombinant human albumin (rHA), lot # L026728, expiration date 15-JAN-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: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to an unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (lot # L023230, expiration date 28-JUL-2017, dose and route of administration were not provided). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information is not expected as no consent to contact Health Care Professional was given.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to unspecified number of patients of unknown age and gender. It was reported that between 01-NOV-2015 and 03-DEC-2015, the patients received unspecified doses of VARIVAX (Merck) (lot number L004651, expiration date 11-FEB-2017; lot number L025208, expiration date 07-JUL-2017) (dose and route not reported) that were improperly stored. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to an unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # L024252 with expiration date 30-JUN-2017 and lot# reported as L026406 with expiration date 12-NOV-2015 (which was expired at the time of the report, however it was not expired when administered) (dose and route of administration were not provided). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information is not expected as no consent to contact Health Care Professional was given.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On 14-NOV-2015, the patients were vaccinated with doses of VARIVAX (Merck) (dose and route of administration were not reported, lot number was reported as L025209, expiry date: 07-JUL-2017). The nurse reported that the doses had been reconstituted with sodium chloride instead of sterile water diluent. She stated that the sodium chloride diluent is manufactured by Sanofi and there is 0.6 ml in each dose of diluent. No adverse events were reported. Product quality complaint (PQC) was not 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 as received from a pharmacy technician refers to unspecified number of patients of unknown age and gender. It was reported that between 01-NOV-2015 and 03-DEC-2015, the patients received unspecified doses of PROQUAD (Merck) (lot # L031600, expiration date 18-FEB-2017) (dose and route not reported) that were improperly stored. No adverse effects reported. This is one of 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 as received from a pharmacy technician refers to unspecified number of patients of unknown age and gender. It was reported that between 01-NOV-2015 and 03-DEC-2015, the patients received unspecified doses of GARDASIL 9 (lot number L016429, expiration date 09-AUG-2017) (dose and route not reported) that were improperly stored. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. Since 14-OCT-2015 the patients were vaccinated with doses of GARDASIL 9 (lot # L007560 with expiration date of 15-JUN-2017; strength, dosage and frequency unspecified) which were improperly stored (incorrect product storage). No adverse effects were 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 receive from a registered nurse concerning to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On an unknown date, the patients' were vaccinated with improperly stored doses of ZOSTAVAX, lot # L024998, expiration date: 06-OCT-2016, (dose, route and anatomical location were unspecified). No concomitant medications were reported. No adverse symptoms were reported. 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 pharmacy technician refers to unspecified number of patients of unknown age and gender. It was reported that between 01-NOV-2015 and 03-DEC-2015, the patients received unspecified doses of ROTATEQ orally (lot number K017575, expiration date 01-JUN-2016, lot # K011952, expiration date 17-JUN-2016, L008059, expiration date 18-DEC-2016) that were improperly stored. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Right shoulder pain at end ranges since received flu shot one week ago.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Local swelling, Pain
Clinical narrative: PAIN, LOCALIZED SWELLING AND REDNESS.
Age: 8.0
Sex: F
Vaccine: FLUN4
Symptoms: Face injury, Fall, Loss of consciousness, Muscle twitching, Seizure
Clinical narrative: Pt received vaccine, 5 minutes later pt's brother reported pt was having seizure. Arrived and found pt awake and alert on the ground. Bystanders reported was running and fell, hitting face on ground and chipping tooth. Bystanders reported pt was unconscious and twitching. Mother of pt denies any allergies or medical conditions, reported older brother had epilepsy. Pt remembered event, had not vomited. EMS arrived and took pt to hospital.
Age: 8.0
Sex: F
Vaccine: FLUN4
Symptoms: Tooth fracture
Clinical narrative: Pt received vaccine, 5 minutes later pt's brother reported pt was having seizure. Arrived and found pt awake and alert on the ground. Bystanders reported was running and fell, hitting face on ground and chipping tooth. Bystanders reported pt was unconscious and twitching. Mother of pt denies any allergies or medical conditions, reported older brother had epilepsy. Pt remembered event, had not vomited. EMS arrived and took pt to hospital.
Age: 55.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 55 y/o healthy male was admistered a live internasal influenza vaccine lot number: FK2037 manufacturer MedImmune. Patient waited 15 minutes after vaccine was administered before departing clinic.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Discomfort, Erythema, Peripheral swelling, Pruritus
Clinical narrative: CLIENT STATES ON THE EVE OF 12/11/15 SHE DEVELOPED A FEVER OF 99.8-100.8 WHICH LASTED IN TO MONDAY (12/14). MONDAY AM SHE NOTICED HER RT. ARM WAS RED, HOT AND SWOLLEN AND ALSO ITCHY. DENIES ANY PROBLEM WITH MOVEMENT OTHER THAN DISCOMFORT. WAS SEEN BY MD MONDAY NIGHT AND DIAGNOSED WITH CELLULITIS AND PRESCRIBED BACTRIM AND KEFLEX. TODAY (12/16) SHE STATES IT IS IMPROVING.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Skin warm
Clinical narrative: CLIENT STATES ON THE EVE OF 12/11/15 SHE DEVELOPED A FEVER OF 99.8-100.8 WHICH LASTED IN TO MONDAY (12/14). MONDAY AM SHE NOTICED HER RT. ARM WAS RED, HOT AND SWOLLEN AND ALSO ITCHY. DENIES ANY PROBLEM WITH MOVEMENT OTHER THAN DISCOMFORT. WAS SEEN BY MD MONDAY NIGHT AND DIAGNOSED WITH CELLULITIS AND PRESCRIBED BACTRIM AND KEFLEX. TODAY (12/16) SHE STATES IT IS IMPROVING.
Age: 32.0
Sex: F
Vaccine: YF, HEPA, YF
Symptoms: Erythema, Pruritus
Clinical narrative: Redness, itchy.
Age: 32.0
Sex: F
Vaccine: YF, HEPA, YF
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Redness, itchy.
Age: 32.0
Sex: F
Vaccine: YF, HEPA, YF
Symptoms: Erythema, Pruritus
Clinical narrative: 7.5 x 8.0 cm local reaction over Yellow Fever vaccine injection site on 12/08/2015. The arm is soft and non-tender. She has full range of motion. She is comfortable. Injection site was left tricep.
Age: 32.0
Sex: F
Vaccine: YF, HEPA, YF
Symptoms: Injection site reaction, Local reaction
Clinical narrative: 7.5 x 8.0 cm local reaction over Yellow Fever vaccine injection site on 12/08/2015. The arm is soft and non-tender. She has full range of motion. She is comfortable. Injection site was left tricep.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site urticaria, Pruritus, Urticaria
Clinical narrative: Hives on chest, upper back, upper arms, and face, red and itchy, subsided with Childrens Benadryl (7.5 ml). Hives occurred again the following three nights, subsiding with Benadryl or Allegra doses of 5 ml each time.
Age: 22.0
Sex: M
Vaccine: HEPAB, MMR, VARCEL
Symptoms: Chest X-ray normal, Chest discomfort, Chills, Cough, Dyspnoea
Clinical narrative: Evening of 12/5 he felt hot with chills, rhinorrhea and cough.  On 12/6/2015 he had an episode of acute SOB/chest tightness/cough with O2 sat 77%.  Complete recovery in ED with SABA treatment and steroid.  No history of asthma.
Age: 22.0
Sex: M
Vaccine: HEPAB, MMR, VARCEL
Symptoms: Feeling hot, Full blood count normal, Laboratory test normal, Rhinorrhoea
Clinical narrative: Evening of 12/5 he felt hot with chills, rhinorrhea and cough.  On 12/6/2015 he had an episode of acute SOB/chest tightness/cough with O2 sat 77%.  Complete recovery in ED with SABA treatment and steroid.  No history of asthma.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse concerning to unspecified number of patients of unknown age or gender. No concurrent condition, medical history or allergy/drug reactions were reported. On an unknown date, the patients' were vaccinated with improperly stored doses of VARIVAX (lot # L011084, expiration date: 01-APR-2017, lot # L003775, expiration date: 04-FEB-2017, lot # K009759, expiration date: 09-JUL-2016, and lot # L019124, expiration date: 27-MAY-2017), (dose, route and anatomical location were unspecified). No concomitant medications were reported. No adverse symptoms were reported. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to an adult female patient of unknown age. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown dates, the patient received the 3 dose series of RECOMBIVAX HB (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. On an unknown date, the patient was found to have no immunity to hepatitis B. The patient had unspecified blood work performed on an unknown date with no result reported. The outcome of the event was not reported. The patient sought unspecified medical attention. The relatedness between the event and RECOMBIVAX HB was not reported. 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 registered nurse concerning to unspecified number of patients of unknown age or gender. No concurrent condition, medical history or allergy/drug reactions were reported. On an unknown date, the patients' were vaccinated with improperly stored doses of PROQUAD (lot # L019996, expiration date: 02-DEC-2016, lot # L007230, expiration date: 03-SEP-2016, and lot #K011312, expiration date: 14-FEB-2016), (dose, route and anatomical location were unspecified). No concomitant medications were reported. No adverse symptoms were reported. 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 licensed practical nurse (L.P.N.) regarding an unknown number of patients of unknown age and unknown gender. No medical history and concurrent conditions were reported. On 19-NOV-2015, 22-NOV-2015, 25-NOV-2015 and 01-DEC-2015, these patients were vaccinated with improperly stored RECOMBIVAX HB (dose number, anatomical location frequency and route unknown) with a lot number # K009953 and expiry date 03-APR-2016. Concomitant medications of the patient were unknown. No other adverse events were reported. 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: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age. Concurrent conditions and medical history of the patient were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot# J013394, expiry date 25-AUG-2016; lot# K010216, expiry date 17-SEP-2016; lot# K010535, expiry date 27-AUG-2016; lot# K018180, expiry date 17-SEP-2016; lot# K021444, expiry date 17-SEP-2016; lot# L004757 (invalid), expiry date 10-NOV-2016; lot# L016427, expiry date 13-APR-2017; lot# L018501, expiry date 22-JUN-2017; lot# L025738, expiry date 14-AUG-2017) (dose, route unspecified). Concomitant therapies were not reported. No adverse effect were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discharge, Injection site rash, Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 year old male patient. The patient was being treated for an unspecified rash on unspecified places on the body, with unspecified medications, prior to receiving ZOSTAVAX. There was no history of drug allergies or reactions. On 09-DEC-2015 the patient was vaccinated with ZOSTAVAX lot # L027322 and expiry date of 21-OCT-2016 at 0.65 ml, subcutaneous. On 12-DEC-2015, the patient came back to the pharmacy because, on an unspecified date in December 2015, after he received the ZOSTAVAX, the patient developed "swelling and a blistering rash with dried, yellow pus" at the injection site. No lab tests were performed. No treatment was received in response to the events. The outcome of the events was not resolved. Causality assessment was not provided. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 5 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-DEC-2015, the patient was inadvertently vaccinated with an additional 0.5 ml dose of VARIVAX (Merck) (lot # was not provided; subcutaneously) concomitant with second 0.5 ml dose in VARIVAX (Merck) immunization series. No adverse effects were 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 certified medical assistant referring to a patient of unknown age and gender. The patient concurrent condition and medical history were unknown. On 23-NOV-2015 the patient was vaccinated with an improperly stored dose of M-M-R II (Lot # K024036, expiration date 26-NOV-2016) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an unspecified number of patients of unknown gender who had shingles. Among the patient, some were as young as 48 years old. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the reporter vaccinated the patients with ZOSTAVAX (dose, route, lot# and expiration date were not reported) (inappropriate schedule of drug administration). Concomitant drug was not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history, concurrent conditions or concomitant medications was provided. On an unknown dates, unspecified amount of patient presented with shingles after receiving the doses of ZOSTAVAX injection (dates, dose, lot# and expiration date were not reported). The outcome of shingles and the causality between shingles and ZOSTAVAX were not provided. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL (lot # L006549 with expired date 06-APR-2017, dose and route were unknown). No concomitant therapy was provided. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # L019126 with expired date 27-MAY-2017, K007784 with expired date 28-MAY-2016, K005182 with expired date 10-APR-2016; dose and route were unknown). No concomitant therapy was reported. No adverse effects were reported. This is one of two reports received from the same reporter (1512USA006790). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a female patient of unknown age. Medical history and concurrent condition of the patient were not reported. On 10-DEC-2015 the patient was vaccinated with a dose of ZOSTAVAX, (lot#, expiration date and dose not reported), subcutaneously. On 11-DEC-2015 the patient called the pharmacist stating she had soft ball size redness and hardening at site of the injection developing on an unspecified date in December 2015. The patient was administered BENADRYL (manufacturer unspecified) as treatment. The outcome of the events was unknown. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: This spontaneous report was received from other refers to a 5 year old female patient via market research. No concurrent condition or medical history was reported. On an unknown date in 2003, the patient was vaccinated with VARIVAX (Merck) (dose 1, shot, dose and route of administration not provided). No concomitant therapy was reported. On an unknown date in 2003, the patient experienced chickenpox after vaccination but not right after vaccination. The outcome of the event was reported as recovered. The reporter considered the event to be non serious and not related to suspect therapy. 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 Licensed practical nurse (L.P.N) regarding an unknown number of patients of unknown age and unknown gender. No medical history and concurrent conditions were reported. On 19-NOV-2015, 22-NOV-2015, 25-NOV-2015 and 01-DEC-2015, these patients were vaccinated with improperly stored PNEUMOVAX 23 (dose number, dosing regimen, strength, anatomical location and route unknown) with a lot number # L018503, expiry date 16-MAR-2017 (incorrect product storage). No other adverse events were reported. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Pruritus, Rash
Clinical narrative: Started getting itchy behind ears and itching all night long. Took antihistamine, didn't work. To medical center. No shortness of breath, cough. No difficulty swallowing, eating or talking. Rash mostly upper trunk some on arms and face, neck and ears. Give BENADRYL and prednisone for couple days.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Neck pain
Clinical narrative: Patient developed pain, swelling and area of erythema at the placement site, starting a few hours after administration of vaccine. Pain does radiate to back of neck.
Age: 0.58
Sex: U
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, RV5
Symptoms: Rash
Clinical narrative: Rash on face/torso. BENADRYL 12.5mg/5ml - 2.5 ml given PO.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema
Clinical narrative: Redness near injection site that traveled to L chest and down L arm stopping at the elbow.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Arthralgia, Muscular weakness, Pyrexia
Clinical narrative: Severe muscle weakness impairing patient's ability to perform ADL, joint pain, and 101F fever. Resolved without intervention.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Muscle contractions involuntary, Muscle twitching, Muscular weakness
Clinical narrative: DONOR REPORTS HIS SYMPTOMS BEGAN THIS MORNING. HE STATED THAT THESE SYMPTOMS BEGAN WITH THE TWICHING OF HIS RIGHT THUMB. DONOR STATES THAT SHORTLY AFTER THIS HE BEGAN TO FEEL WEAKNESS IN HIS RIGHT ARM. DONOR ALSO COMPLAINS OF LOSS OF MUSCLE CONTROL IN HIS RIGHT ARM. DONOR HAS NOT YET BEEN TREATED BUT WAS ENCOURAGED TO SEEK MEDICAL ATTENTION RIGHT AWAY.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right upper arm swollen, red and warm.
Age: 17.0
Sex: F
Vaccine: HPVX
Symptoms: Ovarian cyst, Pain, Salpingo-oophorectomy unilateral
Clinical narrative: Growth on my right ovary, my left ovary and tube removed due to abnormalities, re occurring cysts, monthly, debilitating pain.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Antinuclear antibody, Blood creatine phosphokinase, C-reactive protein, Full blood count, Inflammatory marker test
Clinical narrative: Severe pain to left arm unrelieved with narcotic pain med. Seen in office, xrays of clavicle humerus and forearm done-negative. To ER on 12-14-15 again with pain to left arm. US Doppler done to left arm-negative. Labs done. Inflammatory markers negative. Referred to neurologist and pain clinic.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Laboratory test normal, Pain in extremity, Red blood cell sedimentation rate, Rheumatoid factor, Ultrasound Doppler normal
Clinical narrative: Severe pain to left arm unrelieved with narcotic pain med. Seen in office, xrays of clavicle humerus and forearm done-negative. To ER on 12-14-15 again with pain to left arm. US Doppler done to left arm-negative. Labs done. Inflammatory markers negative. Referred to neurologist and pain clinic.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: X-ray limb normal, X-ray normal
Clinical narrative: Severe pain to left arm unrelieved with narcotic pain med. Seen in office, xrays of clavicle humerus and forearm done-negative. To ER on 12-14-15 again with pain to left arm. US Doppler done to left arm-negative. Labs done. Inflammatory markers negative. Referred to neurologist and pain clinic.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Soreness in arm, decreased movement in arm (left). Patient called her place of employment on 11/30/15 to report she was having complications from the influenza vaccine from 11/24/2015. She went to her primary care physician for treatment. She reported that she was prescribed pain medication and allowed to go home.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed Shingles on chest and back 6 days after having Zostavax shot.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: REDNESS AROUND INJECTION SITE. TOOK BENADRYL AND SYMPTOMS IMPROVED.
Age: 32.0
Sex: F
Vaccine: TYP
Symptoms: Chest X-ray normal, Colitis microscopic, Headache, Immune system disorder, Laboratory test normal
Clinical narrative: Patient wrote: "I had the typhoid capsules vaccine from you guys in January 2015. Ever since then I have had major headaches. My immune system is attacking my body and was recently hospitalized and diagnosed with lymphocytic colitis. I do not know what the cause of all of this has been, but it all started after the typhoid vaccine. Please advise if anyone else has had this reaction also what information you may have relating to typhoid vaccine and autoimmune disease. Ive been tested for SLE and all MRI to neck and brain were negative for cxr. I need to provide my family doctor, neurologist, and GI doctor with as much information as possible. As my symptoms are rare, and cure and cause unknown." Spoke to ct. HA started om 1/20/15. She had breast implant surgery 1 yr. ago.
Age: 32.0
Sex: F
Vaccine: TYP
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Patient wrote: "I had the typhoid capsules vaccine from you guys in January 2015. Ever since then I have had major headaches. My immune system is attacking my body and was recently hospitalized and diagnosed with lymphocytic colitis. I do not know what the cause of all of this has been, but it all started after the typhoid vaccine. Please advise if anyone else has had this reaction also what information you may have relating to typhoid vaccine and autoimmune disease. Ive been tested for SLE and all MRI to neck and brain were negative for cxr. I need to provide my family doctor, neurologist, and GI doctor with as much information as possible. As my symptoms are rare, and cure and cause unknown." Spoke to ct. HA started om 1/20/15. She had breast implant surgery 1 yr. ago.