chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 21 year old female patient. Information on her concurrent conditions, medical history and drug allergies were not reported. Illness of the patient/sibling at the time of/prior to vaccination was not reported. It was also reported that the patient was not pregnant. On an unknown date in 2009 (about 7 years ago), the patient was vaccinated with GARDASIL (lot, expiry date, dose#, route and anatomical location were not specified). Concomitant medication were not reported. On an unknown date in the year 2009 (about 7 years ago) the patient experienced itching of both arms after administration of a dose of GARDASIL (reporter had confirmed it as not GARDASIL 9). The patient  had sought medical attention by an unknown type. It was unspecified whether lab diagnostic studied were performed for the adverse event. On an unknown date, outcome of the event pruritus was reported as recovered/resolved. There was no Product Quality Complaint (PQC) filed. No further information was provided. Reporter did not provide the causal relationship of the event pruritus with GARDASIL. Additional information is not expected as reporter refused additional contact.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. On unspecified dates the patients were vaccinated with improperly stored doses of VAQTA (lot # L032749, expiration date 04-NOV-2016, dose and route unknown), which were under the temperature of 24 degree Celsius with time frame 838 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Chest X-ray normal, Computerised tomogram head normal, Electroencephalogram normal, Injection site erythema, Injection site pruritus
Clinical narrative: Rec'd KD imm at WCE in office on 01/07/16. (+) 1st time seizure occurred 1/08/16 at daycare approximately 4:00 pm. Taken to hospital - head CT and CXR done = WNL. EEG done 01/21/16 -> normal. Appt with neuro 02/23/16. Local s/s = (+) redness (Rt) arm 01/08/16 -> resolved. (+) red, itchy area (Lt) arm -> seen for F.U. in office 01/14/16.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Seizure
Clinical narrative: Rec'd KD imm at WCE in office on 01/07/16. (+) 1st time seizure occurred 1/08/16 at daycare approximately 4:00 pm. Taken to hospital - head CT and CXR done = WNL. EEG done 01/21/16 -> normal. Appt with neuro 02/23/16. Local s/s = (+) redness (Rt) arm 01/08/16 -> resolved. (+) red, itchy area (Lt) arm -> seen for F.U. in office 01/14/16.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. In approximately January 2016, reported as on multiple unspecified dates following a temperature excursion reported on 15-JAN-2016, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) injection (lot# reported as L039268, expiry date 05-APR-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. The reporter stated that the doses of PROQUAD (Merck) were exposed to the temperature of 6.1 degrees Fahrenheit for 48 hours, 5.5 degrees Fahrenheit for 72 hours, 6.8 degrees Fahrenheit for 15 hours, 6.6 degrees Fahrenheit for 120 hours Fahrenheit for 72 hours, 5.2 hours Fahrenheit for 16 hours and 6.1 degrees Fahrenheit for 70 hours- on unspecified dates). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.75
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt was ordered to receive Hepatitis B and IPV vaccines. The medical assistant administered DTaP, IPV, Hib, PREVNAR and rotavirus. Rotavirus was given out of the recommended max age limit.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pyrexia, Rash
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 67 year old female patient. There was no information about concurrent condition and historical medication. On 17-DEC-2015,t he patient was vaccinated with ZOSTAVAX (Dose/Frequency: 0.65 ml, lot number - L029483, expiration date- 06-NOV-2016, subcutaneous). No concomitant medication was reported. On 06-JAN-2016, the patient a raised rash on her trunk, achy joints and a fever of 99F. No treatment was given to the patient for the adverse event. No laboratory diagnostic tests were done. Patient called pharmacist to seek medical attention. The outcome of raised rash on her trunk was reported as not resolved (continued). The outcome of achy joints and a fever of 99F was reported as resolved. Causality between raised rash on her trunk, achy joints and a fever of 99F and ZOSTAVAX was unknown. Additional information is not expected because does not wants to get contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker refers to unspecified number of patient of unknown demography. On an unknown date, the unspecified number of patients was vaccinated with improperly stored oral, ROTATEQ lot # L008578 (expiry: 14-DEC-2016). No adverse effects have been reported. The temperature for improperly stored oral, ROTATEQ was reported as 30 Fahrenheit. The time frame was reported as one hour. No product complaint (PQC) was reported. The outcome of the events was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. On unspecified dates the patients were vaccinated with improperly stored doses of GARDASIL (lot # K016966, expiration date 10-MAY-2017, dose and route unknown), which were under the temperature of 24 degree Celsius with time frame 838 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Oral mucosal blistering, Pruritus, Rash, Tongue blistering
Clinical narrative: Information has been received from a 67 year old female patient referring to herself with gastrooesophageal reflux disease (GERD), diabetes and arthritis. The patient was allergic to "polyethylene glycol 3350 (MIRALAX) and other stuff they give you before colonoscopy", aspirin, ALEVE, sulfa, "the mycins" and latex. The patient had been vaccinated with a dose of PNEUMOVAX 22 on 17-AUG-2015. On 15-DEC-2015 the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU, 0.65 ml, subcutaneously. Concomitant therapies included LANTUS, HUMALOG, CRESTOR, CYMBALTA, tizanidine, TEKTURNA and "Tricipium Chloride". "Within 24 hours", on 16-DEC-2015, the patient developed tiny blisters on her forehead that turned into blisters and she developed blisters in her mouth and tongue. The patient's lips swelled up and she developed a rash below her ankle that had spread to the middle of her legs. Her neck swelled up too. The patient wen to the emergency room (ER) but the staff there was unable to determine what the cause was, but they told the patient that they didn't think it was due to the ZOSTAVAX. The patient stated that she took BENADRYL for her swollen lips and the swelling went down and on 21-JAN-2016 she used BENADRYL cream for itching she experienced from the rash, and the itching had since stopped. The rash had continued to spread since the event began. The patient's present status was unspecified. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: This spontaneous report as received from a physician via company representative and refers to a 14 year old female patient. The patient's medical history and current conditions were not provided. On an unknown date, the patient was vaccinated with first and second doses of GARDASIL (lot #, expiration date, dose and route were not reported). On an unknown day in July 2015, the patient was vaccinated with a third dose of GARDASIL (lot #, expiration date, dose and route were not reported). The full three dose series was completed. Secondary suspects and concomitant therapies were not reported. On an unknown date, the patient had been diagnosed with postural orthostatic tachycardia syndrome (POTS). The patient seek medical attention via visiting various practices for medical assistance. It was not specified what events prompted the patient to require medical assistance. At the time of the report the patient was "alive and well" however her recovery status regarding her diagnosis of postural orthostatic tachycardia syndrome was unknown. The relatedness between postural orthostatic tachycardia syndrome and GARDASIL was not reported. 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 nurse practitioner refers to 2 unspecified patients of unknown age and gender. There were no information about patients' concomitant medications and pertinent medical history reported. On 14-JAN-2016, the patients might have received improperly stored PEDVAXHIB, intramuscularly, lot# reported as L030871, expiry date: 10-JUN-2018 (dose was not reported). No adverse effects were reported. 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 regarding unspecified number of children of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On an unknown date unspecified amount of children were vaccination with (Oka/Merck) VARIVAX (lot # L0282768, expiry date 28-JUL-2017); L012038, expiry date 07-APR-2017; L035126, expiry date 14-SEP-2017) dose, route unknown. The nurse reported that (Oka/Merck) VARIVAX went through defrost cycling of the freezer. The temperature ranges to which product was exposed during defrost cycling of the freezer were -14.2 C, -14.4 C, -14.7 C, -15.1 C, -13.4 C. The time frame of exposure was cumulative nonconsecutive total combined 5 hours and 45 minutes. It was reported that (Oka/Merck) VARIVAX was not subjected to previous temperature excursion. Concomitant medications were not reported. No adverse event were reported. Product quality complaint (PQC) was not filed. Additional information has not expected as reporter did not wish to contact further.
Age: 65.0
Sex: F
Vaccine: HEP
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: This spontaneous report was received from a 65 year old female health care professional reporting on herself. Concomitant medication: none. Drug reactions/allergies included: penicillin and unspecified sulfa drugs. In 2006 the patient was vaccinated with RECOMBIVAX HB (dosing regimen unspecified). Concomitant Medication: none. Patient reports that on an unspecified date "around 10 years ago" (approximately in 2006) she received an unspecified dose of RECOMBIVAX HB vaccine due to healthcare employment requirements. Patients reported that within "4 to 6 hours" after receiving the vaccine she experienced "a high fever of 103 degrees and for the next 3 days she felt like she had a bad flu. Lab diagnostics studies performed: none. Patient was seen by the physician. The manufacturer of the vaccine was unspecified therefore RECOMBIVAX HB could not be ruled out. No further information was provided. The outcome of the events was reported as resolved approximately in 2006. Causality assessment was not reported. 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 multiple unspecified patients of an unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored GARDASIL 9 lot # L013429, expiration date: 21-JUL-2017 (dose and route of administration were not reported). The vaccines were stored at 1 degree Celsius within 23 hours. There was no previous temperature excursion. There were no adverse effects reported. Product quality complaint was involved. 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 healthcare worker refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. In approximately January 2016, reported as multiple unspecified dates following a temperature excursion reported on 15-JAN-2016, the patients were vaccinated with improperly stored doses of ZOSTAVAX injection (lot# reported as L027327, expiry date 21-OCT-2016; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. The reporter stated that the doses of ZOSTAVAX were exposed to the temperature of 6.1 degrees Fahrenheit for a period of 70 hours on an unknown date (with previous temperature excursions: 5.9 degrees Fahrenheit for 15 hours, 6.8 degrees Fahrenheit for 48 hours, 5.5 degrees Fahrenheit for 72 hours, 6.8 degrees Fahrenheit for 15 hours, 6.6 degrees Fahrenheit for 120 hours, 5.9 degrees Fahrenheit for 72 hours, 5.2 degrees Fahrenheit for 16 hours and 6.1 degrees Fahrenheit for 70 hours- on unspecified dates). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered, Viral titre decreased
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. Information about the patient's pertinent medical history, concurrent conditions and drug reactions/allergies was not reported. The reporter stated that the patient was administered three doses of MMR II, (route of administration, lot # and expiration date were not provided). The first dose was administered on an unspecified date, when the patient was 16 months old. The second dose was administered on an unspecified date, when the patient was 18 months old. On an unspecified date in 2015, reported as "last year", when the patient was 25 years old, she was administered a booster dose of MMR II. Concomitant medication was not reported. On an unknown date, th patient had titers drawn and the titers for rubella "came back low" (viral titre decreased). At the time of reporting, the outcome of the viral titre decreased was unknown. The reporter did not assess the relatedness between viral titre decreased and MMR II. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of unspecified patients. On unknown dates, the patients were vaccinated with doses of improperly stored VAQTA (Lot#: K005958, expiry date: 09-FEB-2017; K007791, expiry date: 22-AUG-2016; K018182, expiry date: 12-FEB-2017; K019560, expiry date: 02-JUN-2017, exposure on 57 F for 85.75 hours from 22-APR-2015 to 29-NOV-2015; L002717, expiry date: 02-JUN-2017; L009445, expiry date: 01-JUN-2017; L018499, expiry date: 25-FEB-2017; K018181, expiry date: 04-JUN-2017). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: FLU4
Symptoms: Chest X-ray normal, Choking, Crying, Dyspnoea, Stridor
Clinical narrative: Choking, gasping, stridor while infant was in car seat and mother was driving. Lasted a "few minutes" - self resolved with crying and return to baseline. No oral intake since vaccination. No known objects in car seat. Taken to urgent care center. Examination including chest x-ray without findings.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Pt has swelling from injection site, in right upper arm down to elbow, injection site pain, and entire arm pain.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Alopecia
Clinical narrative: Hair is falling out after second Hep B vaccine administered.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from nurse practitioner refers to two unspecified patients of unknown demography. On an unknown date, the two patients were inadvertently administered improperly stored VARIVAX (Merck) (Lot # L015045 (29-APR-2017), lot # L035129 (14-SEP-2017) (dose and frequency were not reported). No adverse effects reported. The nurse reported that it was not known whether one or both lot numbers were administered. The temperature of VARIVAX (Merck) storage was reported as -13.5 degree Celsius. Time frame was reported as 30 minutes. No product quality complaint (PQC) was involved. The outcome of the events was unknown. The reporter did not provide the causality between the events and the suspect therapy. Additional information is not expected as the reporter did not wish to be contacted.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a nurse practitioner via company representative refers to a male patient of unknown age. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patient was vaccinated with ZOSTAVAX 0.65 ml, once, subcutaneous (site of administration, lot and expiration date were not reported). On an unknown date, two weeks later, the patient returned to the doctor's office with a severe shingles rash. The patient sought medical attention. He was given unspecified antivirals to treat the rash. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not 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 medical assistant refers to multiple unspecified patients of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored ROTATEQ orally, lot # L013204, expiration date: 28-JAN-2017 (dose was not reported). The vaccines were stored at 1 degree Celsius within 23 hours. There was no previous temperature excursion. There were no adverse effects reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: False negative investigation result
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with RECOMBIVAX HB (dose and route of administration was not provided). No concomitant therapy was reported. On an unknown date the patient had Hepatitis B titers drawn following administration of vaccine which exhibited "false negative" responses to the vaccines. The outcome of the event was unknown. The causality assessment was not reported. No product quality issue was involved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: Information has been received from a healthcare worker (certified medical assistant) referring to a currently 23 years old female patient. The patient had no medical history, concomitant therapy or drug reactions. On an unspecified date, the patient was vaccinated with a dose of M-M-R II (unspecified lot, unspecified expiry date, dose and route were not provided). As a child, recently, the patient got titers drawn at the office resulting in no immunity to Rubella. Outcome of the event was unknown. No other adverse effect was reported. Additional information is not expected because of no consent to contact the physician.
Age: 16.0
Sex: M
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Blood bilirubin increased, Blood thyroid stimulating hormone, Irritability, Metabolic function test, Photophobia
Clinical narrative: Pt developed stria, elevated bilirubin and has become light sensitive and more irritable since getting HPV series. Will refer to peds endocrinology -> done -> dx thyroiditis.
Age: 16.0
Sex: M
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Skin striae, Thyroiditis, Thyroxine, Tri-iodothyronine
Clinical narrative: Pt developed stria, elevated bilirubin and has become light sensitive and more irritable since getting HPV series. Will refer to peds endocrinology -> done -> dx thyroiditis.
Age: 44.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Antinuclear antibody negative, Asthenia, C-reactive protein normal, Fatigue, Full blood count normal
Clinical narrative: Neck weakness and pain with noted difficulty in rotating head from left to right and vice versa. 1-2 weeks later full body fatigue and constant pain radiating down left shoulder/arm.
Age: 44.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Neck pain, Nuclear magnetic resonance imaging spinal normal, Pain in extremity, Red blood cell sedimentation rate normal
Clinical narrative: Neck weakness and pain with noted difficulty in rotating head from left to right and vice versa. 1-2 weeks later full body fatigue and constant pain radiating down left shoulder/arm.
Age: 44.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Rheumatoid factor increased, Spinal X-ray normal, Thyroid function test normal
Clinical narrative: Neck weakness and pain with noted difficulty in rotating head from left to right and vice versa. 1-2 weeks later full body fatigue and constant pain radiating down left shoulder/arm.
Age: 44.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal pain, Neck pain, Nuclear magnetic resonance imaging spinal normal, Pain in extremity, Posture abnormal
Clinical narrative: Neck weakness and pain with noted difficulty in rotating head from left to right and vice versa. 1-2 weeks later full body fatigue and constant pain radiating down left shoulder/arm.
Age: 44.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Red blood cell sedimentation rate normal, Rheumatoid factor increased, Spinal X-ray normal, Thyroid function test normal
Clinical narrative: Neck weakness and pain with noted difficulty in rotating head from left to right and vice versa. 1-2 weeks later full body fatigue and constant pain radiating down left shoulder/arm.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy was not provided. On unspecified dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 (Lot # L013429, expiry date: 29-JUL-2017; Lot # L017407, expiry date: 15-AUG-2017). The temperature excursion details for vaccine were as follows: temperature 27.4 F, time frame 37.36 hours. The nurse reported a temperature excursion for the following products: GARDASIL 9 (Lot # L013429, expiry date: 29-JUL-2017; Lot # L017407, expiry date: 15-AUG-2017), M-M-R II (Lot # L012480, expiry date: 10-APR-2017) and PEDVAXHIB (lot # L030872, expiry date: 11-JUN-2018), however only GARDASIL 9 dose was administered. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Burning sensation, Injected limb mobility decreased, Pain
Clinical narrative: Had extreme burning at time of flu shot. Then could not move arm without pain for 6 hrs. Its been a month and Im still in pain and can not lift arm.
Age: 43.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Had extreme burning at time of flu shot. Then could not move arm without pain for 6 hrs. Its been a month and Im still in pain and can not lift arm.
Age: 26.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Swelling
Clinical narrative: 1/7/16 PCV23 received on Rt Deltoid. 1/8/16 Redness and swelling 3 hrs after injection. Treated with antibiotic and warm compress sx resolved on 1/9/16.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On an unknown date in 1997 or 1998, the patient was vaccinated with three doses of Hepatitis B vaccine (manufacturer unknown) (routes of administration, doses, frequency, lot numbers and expiration dates were not reported). On 18-JAN-2016, the patient was vaccinated with a dose of RECOMBIVAX HB (route of administration, dose, frequency, lot number and expiration date were not reported) (initially reported as an unspecified vaccine administered in error). The reporter additionally stated that the event was reported since the patient received four doses of Hepatitis B vaccine (both Hepatitis B vaccine (manufacturer unknown) and RECOMBIVAX HB counted together), which was outside of RECOMBIVAX HB prescribing information. No adverse effects were reported. Additional information is not expected as no consent for correspondence contact was reported.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphonia, Headache, Pain in extremity
Clinical narrative: Approximately one hour after vaccination he became hoarse and had pain in his legs and head.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of oral, ROTATEQ (lot # K022993, expiration date 20-OCT-2016; lot # L000568, expiration date 10-SEP-2016, dose and route unknown). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.29
Sex: F
Vaccine: MMR
Symptoms: Eye movement disorder, Seizure
Clinical narrative: Child stood still.  Child's eyes went back into her head.  Seizure lasted about 25 seconds.  Doctor said to watch for reoccurrence.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash generalised, Urticaria
Clinical narrative: Received flu vaccine at approx. 10 am on 1/20/16. Developed generalized, severe rash, hives, and itching approx. 24 hrs later. Denied swelling or trouble breathing. Started BENADRYL 1/22/16 and improved.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Musculoskeletal pain, Sleep disorder, Weight bearing difficulty
Clinical narrative: Shoulder pain, arm not mobile, cannot lift weight, can't sleep on side of vaccination.
Age: 29.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: Right shoulder pain- worse some days than others. Relieved with 2-3 ibuprofen each morning. Pain at 90 degree forward motion. Provider suggested continuing ibuprofen and abstraining from physical activity requiring related movements.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient received HPV 9 in R deltoid.  Remained on the exam table in a laying position for 5 minutes and in room for 10 minutes post vaccination.  Patient felt faint and mother assisted patient to table. Patient loss of consciousness for 1 second approximatly.  BP taken, juice, and crackers given.  Patient remained for observation and provider examined prior to release.  Chart alert placed.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction with heat, redness, and swelling plus headache and fatigue. Panic attacks reported 9 days after vaccine administration.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Panic attack
Clinical narrative: Injection site reaction with heat, redness, and swelling plus headache and fatigue. Panic attacks reported 9 days after vaccine administration.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody negative, Arthralgia, Fibrin D dimer increased, Imaging procedure, Oedema peripheral
Clinical narrative: Diffuse unbearable joint pain, lower extremity edema, pain, fever. Treatment consisted of lab work, imaging, antibiotics, prednisone, ibuprofen. Condition lasted 2 months.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Red blood cell sedimentation rate increased, Rheumatoid factor negative
Clinical narrative: Diffuse unbearable joint pain, lower extremity edema, pain, fever. Treatment consisted of lab work, imaging, antibiotics, prednisone, ibuprofen. Condition lasted 2 months.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Tenderness pain swelling on left deltoid. Txd with Keflex 500mg 2x a day x 5 days.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Diarrhoea, Dizziness, Headache, Vomiting
Clinical narrative: 4 hrs after vaccine -had diarrhea, then vomiting; headache and some dizziness. No fever. No localized reaction.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Arm swelled and was red in 2 inch radius around vaccine site. It was extremely sensitive to light touching.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Pharyngeal oedema
Clinical narrative: Difficulty breathing, swelling of throat, dizziness.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Dysstasia, Guillain-Barre syndrome, Incontinence, Limb discomfort, Muscular weakness
Clinical narrative: Started with tingling and weakness in legs (felt heavy), then rapidly progressed to complete lower body paralysis, including incontinence.  (Diagnosis-Guillain-Barre Syndrome).
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Paralysis
Clinical narrative: Started with tingling and weakness in legs (felt heavy), then rapidly progressed to complete lower body paralysis, including incontinence.  (Diagnosis-Guillain-Barre Syndrome).
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Headache, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Presented to ED with C/O pain, swelling, redness, to Right arm status post receiving flu shot on 1/19/2016 in clinic. Also c/o Headache, fever, and hives to her face and right shoulder.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Presented to ED with C/O pain, swelling, redness, to Right arm status post receiving flu shot on 1/19/2016 in clinic. Also c/o Headache, fever, and hives to her face and right shoulder.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Bacterial infection, Cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: The patient awoke the next morning with a red swollen itchy wheal at the injection site.  The wheal slowly expanded until she presented to the pharmacy after her dr appt on Monday 1/25.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: The patient awoke the next morning with a red swollen itchy wheal at the injection site.  The wheal slowly expanded until she presented to the pharmacy after her dr appt on Monday 1/25.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Back pain, Chest pain, Cough, Dizziness, Gait disturbance
Clinical narrative: Swelling in arm, rash under arm, knot at injection site, dizziness, throat swelling, trouble walking, coughing, flu-like symptoms, chest and upper back pain, headaches.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Influenza like illness, Injection site nodule, Peripheral swelling, Pharyngeal oedema
Clinical narrative: Swelling in arm, rash under arm, knot at injection site, dizziness, throat swelling, trouble walking, coughing, flu-like symptoms, chest and upper back pain, headaches.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Swelling in arm, rash under arm, knot at injection site, dizziness, throat swelling, trouble walking, coughing, flu-like symptoms, chest and upper back pain, headaches.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Lethargy
Clinical narrative: Per mother, reported that patient was "lethargic" within two days after administration of vaccine.  She did not seek care or evaluation during that time.
Age: 71.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site rash, Rash, Rash pruritic
Clinical narrative: Pt said rash started on right shoulder (Prevnar was administered on that side) and worked itself down to spead all around waist.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray normal, Injection site pain, Joint range of motion decreased, X-ray limb normal
Clinical narrative: Excruciating pain at injection site with no range of motion in shoulder. No fever and no visual sign of redness or rash. Patient went to the ER to get an X-ray of arm and chest but findings were inconclusive. Patient was prescribed Norco and Zofran and will follow-up with PCP on 1/27/16 AM.
Age: 1.34
Sex: F
Vaccine: DTAP, DTAPHEPBIP, HEP, IPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 14.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Pruritus, Rash, Scrotal swelling, Swelling face
Clinical narrative: Patient had out break of rash on face, with swelling, itching. Swelling and rash on scrotal area, Prednisone p.o. BENADRYL p.o. initial injection.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient stated experiencing pain in the arm on which she was administered flu vaccine. The patient is still experiencing pain. The pain started 3 days after the immunization.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. On unknown dates the patient were vaccinated with improperly stored ROTATEQ lot # L008031, expiration date: 03-AUG-2016; lot # L008574, expiration date: 22-NOV-2016, orally (dose, dose # and application site were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a pharmacist referring an unspecified patient. On unknown dates the patient was vaccinated with 3 doses of series of RECOMBIVAX HB (dose and route unknown). On an unknown date, the patient experienced negative titers. The outcome was unknown. This is one of the two cases received from the same reporter. 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 multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored VAQTA lot # K012457, expiration date: 06-APR-2017; lot # K012457, expiration date: 04-JUN-2017, (dose, dose #, route and application site were not reported). No adverse effects reported. This is one of several reports received from the same source. 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 multiple unspecified patients of unknown age and gender. On unknown dates the patient were vaccinated with improperly stored RECOMBIVAX HB lot # K021444, expiration date: 19-SEP-2016; lot # L009195 which was not a valid lot #, expiration date reported as: 29-OCT-2016, (dose, dose #, route and application site were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a pharmacist referring her daughter, a 20 year old female patient with sulfur allergy. There was no pertinent medical history. On unknown dates when the patient was a baby, she was vaccinated with 3 doses of series of RECOMBIVAX HB (dose and route unknown). There was no concomitant therapy. On 18-JAN-2016 the patient had titers drawn which showed "she was negative, she had nothing, no protection". The patient was seen by an unspecified physician. No treatment was given for the event. The outcome was unknown. This is one of the two cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On 21-JAN-2016 the patient was inadvertently administered with an expired dose of M-M-R II (lot # J016232, expiry date: 19-DEC-2015) (dose and route unspecified). Other suspect and concomitant therapies were not reported. No adverse event reported. Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to a 7 month old patient. On 22-JAN-2016, the patient was inadvertently administered the first dose of VAQTA (lot # L036300, expiration date 04-NOV-2016, route and indication not provided) series (Inappropriate schedule of vaccine administered). No adverse effects were reported. There was no product quality issue (PQC) involved. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 82 year old female patient. The patient's concurrent conditions and medical history were not reported. On 13-OCT-2015 at 11:45AM, the patient was vaccinated with ZOSTAVAX after temperature excursion (lot # L012475, left arm, subcutaneous, dose 1). No adverse event was reported in the patient after receiving ZOSTAVAX after a temperature excursion on 22-SEP-2015. This is one of several reports received from the same reporter (ZOSTAVAX was given between 22-SEP-2015 to 09-NOV-2015 after temperature excursion). Additional information is not expected as follow up already received (this was received as a follow up for the related master case).
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a male patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. On 13-JAN-2016, the patient was vaccinated with unspecified dose of PNEUMOVAX 23 (Lot # and dose not provided). Concomitant medications were not reported. On 22-JAN-2016, 10 days after being vaccinated, the patient received another dose of PNEUMOVAX 23 (Lot # and dose not reported). No adverse events were reported. Additional information is not expected as no contact details were provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from healthcare student in pharmacy referring to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On 14-JAN-2016, the patient was vaccinated with expired doses of M-M-R II lot # J010601 and expiration date on 30-AUG-2015, (route, frequency, dose and strength were not reported). No concomitant medications were not reported. No adverse event was reported and no product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 month old female patient. No medical history or concurrent conditions were reported. On 19-JAN-2016, the patient was vaccinated with VARIVAX (Merck) (dosage, dose number, lot #, expiration date and route of administration were not reported) as well as PROQUAD (Merck) (0.5 ml administered subcutaneously in the patient's left thigh; lot # and expiration date were not reported). No concomitant medications were reported. The reporter stated that there was no adverse effects. This is one of the two reports received from the same reporter (1601USA007587). Additional information is not expected since consent to contact the physician was not provided.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 61 year old male patient. The patient's concurrent conditions and medical history were not reported. On 19-OCT-2015 at 07:30 AM, the patient was vaccinated with ZOSTAVAX after temperature excursion (lot # L012475, right arm, subcutaneous, dose 1). No adverse event was reported in the patient who received ZOSTAVAX after a temperature excursion on 22-SEP-2015. This is one of several reports received from the same reporter (ZOSTAVAX was given between 22-SEP-2015 to 09-NOV-2015) after temperature excursion. Additional information is not expected as this was received as a follow up from the related master case.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 65 year old female patient. The patient's concurrent conditions and medical history were not reported. On 06-OCT-2015 at 03:00 PM, the patient was vaccinated with ZOSTAVAX after temperature excursion (lot # L012475, right arm, subcutaneous, dose 1). No adverse event was reported in the patient after receiving viable ZOSTAVAX after a temperature excursion on 22-SEP-2015. This is one of several reports received from the same reporter (ZOSTAVAX) was given between 22-SEP-2015 to 09-NOV-2015 after temperature excursion). Additional information is not expected as follow up already received (this was received as a follow up for the related master case).
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. On unknown dates the patient were vaccinated with improperly stored GARDASIL 9 lot # L023230, expiration date: 28-JUL-2017, (dose, dose #, route and application site were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Erythema, Feeling hot, Headache, Mobility decreased
Clinical narrative: Arm starting hurting really bad-getting hot-headache-fever-dizzy-nausea-redness about 8" on arm-really hurting could hardly move arm all this continued for 2 weeks then skin peeled from the red spot on my arm -Dr said to never get this again.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain in extremity, Pyrexia, Skin exfoliation
Clinical narrative: Arm starting hurting really bad-getting hot-headache-fever-dizzy-nausea-redness about 8" on arm-really hurting could hardly move arm all this continued for 2 weeks then skin peeled from the red spot on my arm -Dr said to never get this again.
Age: 0.21
Sex: M
Vaccine: HEPA, MMR, VARCEL, FLU3, HEPA, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: NO SYMPTOMS
Age: 71.0
Sex: F
Vaccine: FLUX, UNK, FLUX, UNK
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, X-ray
Clinical narrative: Arm/shoulder hurt times 2 1/2 months. Gradually getting better. Still not full range of motion without pain.
Age: 11.0
Sex: F
Vaccine: MEN, TD
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever of 100.5 and vomiting.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Back pain, Chest pain, Chills, Pain, Pain in extremity
Clinical narrative: Telephone encounter 1/26/16 - Patient states she has a very sore arm the next day after receiving injection - no redness nor swelling; States has body ache (chest and back), chills x 24 hours.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Erythema, Influenza like illness, Rash, Skin warm
Clinical narrative: On 1st day experienced mild flu-like symptoms: Redness, warmth, swelling, joint pain. Now rash seems to be spreading, 5 days after vaccine was administered.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: On 1st day experienced mild flu-like symptoms: Redness, warmth, swelling, joint pain. Now rash seems to be spreading, 5 days after vaccine was administered.
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician via company representative refers to unspecified number of male patients of unknown age. No concurrent conditions, medical history or allergy/drug reactions were reported. Physician reported that he had already been administering GARDASIL 9 (dose, frequency, lot number not reported) in boys older than 15 years of age, way before new indicated age (that included boys 16-26 years of age) was approved. No concomitant medication was reported. No adverse effects were reported. Number of patients was unspecified. No additional information was provided. Additional information is not expected as the reporter did not wish further contact.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Dizziness, Erythema, Swelling face
Clinical narrative: Information has been received from a physician referring to a 24 years old female patient with sinusitis and seasonal allergy. The patient had penicillin and cephalosporin allergies. On 25-JAN-2016 the patient was vaccinated with a dose of PNEUMOVAX 23 (strength: 25/0.5Y; lot # L014876, expiration 03-JAN-2017, 1 shot, route was unspecified). Concomitant therapies included SINGULAIR, CLARINEX, ALLEGRA and nasal spray. On 25-JAN-2016, the patient developed redness on the body, chest tightness, dizziness and swelling of the face. The patient got medical attention for the adverse reaction and was treated with BENADRYL, prednisone (manufacturer unknown), epinephrine, and albuterol. No lab diagnostics studies were performed. The outcome of these events was reported as recovering/resolving. Causality was not reported. Additional information has been requested.