chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 93.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse refers to a 93-year-old female patient. The patient's medical history was not reported. In August 2015, the patient was vaccinated with a dose of PNEUMOVAX 23 0.5 ml, intramuscular in the arm (lot number not reported). On an unknown date, the patient developed redness and swelling of injection-site arm after receiving PNEUMOVAX 23. the patient sought medical attention and received unspecified treatment for the events. The outcome of the events was reported as recovered/resolved (date unspecified) (also reported as recovering). The relationship between PNEUMOVAX 23 and the events was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Urticaria
Clinical narrative: Hives - all over BENADRYL given. Hives started 9 hrs after admin. of vaccines.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The nurse reported that the patients received improperly stored doses of PROQUAD (Merck) of lot/batch # L024497 with expiry date 01-JAN-2017, lot/batch # L046506 with expiry date 27-MAY-2017 and lot/batch # L042817 with expiry date 26-APR-2017 (dosage, strength, dose number, vaccination site and route of administration not provided) on unspecified dates. Concomitant therapies were not reported. No adverse effects were reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. No further information was provided. This is one of two reports from same reporter link. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Breath holding, Pallor, Presyncope, Tension, Tremor
Clinical narrative: When administering vaccine, patient was tense, shaking and holding his breathe, was advised to breathe, that he could make himself pass out. Mother advised to sit in office for a few minutes to make sure he was not going to pass out. after patient left room, a few mintues later mom called for help.  Patient was pale, and had voiding himself. Layed patient down and then gave him water and crackers. Several Practioners went in to check and explained to mom about this common event (vaso-vagal) with adolescents and follow up care.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Urinary incontinence
Clinical narrative: When administering vaccine, patient was tense, shaking and holding his breathe, was advised to breathe, that he could make himself pass out. Mother advised to sit in office for a few minutes to make sure he was not going to pass out. after patient left room, a few mintues later mom called for help.  Patient was pale, and had voiding himself. Layed patient down and then gave him water and crackers. Several Practioners went in to check and explained to mom about this common event (vaso-vagal) with adolescents and follow up care.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Local reaction, Pyrexia, Urticaria
Clinical narrative: Large local reaction and hives occurring few hours after vaccine. Hives noted on neck, forearm and legs. States had 2 or 3 in each area. Felt lightheaded and feverish for 3 hours post vaccine.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: C-reactive protein, Diarrhoea, Full blood count, Limb discomfort, Myalgia
Clinical narrative: Acute onset of vomiting and foul smelling diarrhea; onset of lower bilateral extremity myalgia and heaviness.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Stool analysis, Vomiting
Clinical narrative: Acute onset of vomiting and foul smelling diarrhea; onset of lower bilateral extremity myalgia and heaviness.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Pyrexia
Clinical narrative: Has a fever of 99.9F and felt very tired, no redness, no swelling and no pain at injection site.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Per patient awoke 4/13/2016 noticed outer (L) arm area red swollen. Warm to touch. When pt. arrived 4/15/16 arm red swollen warm to touch. Pt. able to raise lower arm to problems. Advised follow up with MD. Patient advised to take pain reliever and moist warmth.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. No information has been reported regarding the patient's medical history, current conditions and concomitant medications. On an unknown date in 2016 (also reported as starting on or after 24-MAR-2016) unspecified patients were vaccinated with improperly stored RECOMBIVAX HB (dosing details were not reported) (lot # L023387, with expiry date 22-JUN-2017, lot # L033343 with expiry date of 13-SEP-2017 and lot # L044694 with an expiry date of 04-FEB-2018. the RECOMBIVAX HB vaccine was stored at a temperature of 34 F (Fahrenheit) for a time frame of 20 minutes. There was no previous temperature excursions reported. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Dx 4-15-16 with varicella
Sex: U
Vaccine: HPVX
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via field employee regarding unspecified number of patients of unknown age and gender. The pertinent medical history of the patients and their concurrent conditions, concomitant medications were not reported. The reporter stated that there was general increase in syncope reported with GARDASIL 9 (vaccination, dates, lot, dosing details, route unknown) compared with GARDASIL (vaccination dates, lot, dosing details, route unknown). The outcome of general increase in syncope was unknown. Causality assessment was not provided. Product quality complaint (PQC) was not filed. 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 healthcare worker refers to unspecified patients of unknown age and gender. No information has been reported regarding the patient's medical history, current conditions and concomitant medications. On an unknown date in 2016 (also reported as starting on or after 24-MAR-2016) unspecified patients were vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # L008054 with expiry date 30-NOV-2016, lot # M002252 with expiry date of 28-FEB-2017, lot # L020862 with expiry date of 05-MAR-2017 and lot # L029618 with an expiry date of 20-MAY-2017). The ROTATEQ vaccine was stored at a temperature of 34 F (Fahrenheit) for a time frame of 20 minutes. There was no previous temperature excursions reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. No information has been reported regarding the patient's medical history, current conditions and concomitant medications. On an unknown date in 2016 (also reported as starting on or after 24-MAR-2016) unspecified patients were vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # L045713 with expiry date 14-JAN-2017 and lot # L029618 with expiry date of 20-MAY-2017). VAQTA vaccine was stored at a temperature of 34 F (Fahrenheit) for a time frame of 20 minutes. There was no previous temperature excursions reported. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reported received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker, refers to two patients of unknown ages and genders. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 18-MAR-2016, the patients were vaccinated with an improperly stored dose of GARDASIL 9, which ad a lot # of L016428 and an expiration date of 30-AUG-2017 (dose, dosage number, route of administration and anatomical location were not reported). It was stated that the temperature excursion was 28.9 F for a time frame of 7 hours. This excursion was found due to a data logger. Additionally, it was stated that no previous temperature excursion had occurred. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history,  concurrent conditions or drug reactions/allergies were reported. On 15-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, which had a lot # of L016428 and an expiration date of 30-AUG-2017 (dose, dosage number, route of administration and anatomical location were not reported). It was stated that the temperature excursion was 28.9 for a time frame of 7 hours. This excursion was found due to a data logger. Additionally, it was stated that no previous temperature excursions had occurred. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker, refers to three patients of unknown ages and genders. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 22-MAR-2016, the patients were vaccinated with an improperly stored dose of GARDASIL 9, which had a lot # of L016428 and an expiration date of 30-AUG-2017 (dose, dosage number, route of administration and anatomical location were not reported). It was stated that the temperature excursion was 28.9 for a time frame of 7 hours. This excursion was found due to a data logger. Additionally, it was stated that no previous temperature excursions had occurred. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/ allergies were reported. On 21-MAR_2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, which had a lot # L016428 and an expiration date of 30-AUG-2017 (dose, dosage number, route of administration and anatomical location were not reported). It was stated that the temperature excursion was 28.9 F for a time frame of 7 hours This excursion was found due to a data logger. Additionally, it was stated tat no previous temperature excursions had occurred. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/ allergies were reported. On 07-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, which had a lot # of L016428 and an expiration date of 30-AUG-2017 (dose, dosage number, route of administration and anatomical location were not reported). It was stated that the temperature excursion was 28.9 F for a time frame of 7 hours. This excursion was found due to a data logger. Additionally, it was stated that no previous temperature excursions had occurred. This is one of the 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. The pertinent medical history and concurrent conditions of patients were not reported. On unknown dates, the patients were vaccinated with incorrectly stored ZOSTAVAX lot # L039096, expiry date 08-JAN-2017 and Lot # L0395505 expiry 16-DEC-2016 (dose and route not reported). The vaccine was exposed to the temperature of -10 degree Centigrade for 10 days. There were no previous excursion reported. The reporting healthcare worker was not aware of any adverse events. No additional information was reported. This case is one of the several reports from same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 08-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, which had a lot of L016428 and an expiration date of 30-AUG-2017 (dose, dosage number, route of administration and anatomical location were not reported). It was stated that the temperature excursion was 28.9 F for a time frame of 7 hours. This excursion was found due to a data logger. Additionally, it was stated that no previous temperature excursion had occurred. This is one of the several reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 01-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, which had a lot # of L016428 and an expiration date of 30-AUG-2017 (dose, dosage number, route of administration and anatomical location were not reported). It was stated that the temperature excursion was 28.9 F for a time frame of 7 hours. This excursion was found due to a data logger. Additionally, it was stated that no previous temperature excursions had occurred. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 01-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, which had a lot # of L016428 and an expiration date of 30-AUG-2017 (dose, dosage number, route of administration and anatomical location were not reported). It was stated that the temperature excursion was 28.9 F for a time frame of 7 hours. This excursion was found due to a data logger. Additionally, it was stated that no previous temperature excursions had occurred. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Child developed swelling, redness, tenderness, and itching at injection site.
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. The pertinent medical history and concurrent conditions of patients were not reported. On an unknown dates, the patients were vaccinated with incorrectly stored PROQUAD (Merck) lot # L040411, expiry date 13-APR-2017 (dose and route not reported). The vaccine was exposed to the temperature of -10 degree Centigrade for 10 days. There were no previous excursion reported. The reporting healthcare worker was not aware of any adverse events. No additional information was reported. This case is one of the several reports from same reporter. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Pneumothorax, Vaccination complication
Clinical narrative: This spontaneous report was received from a 74 year old female patient concerning on herself. Information regarding pertinent medical history and drug reactions/allergies were not provided. On an unspecified date, approximately in 1980, reported as "about 30 years ago", "sometime between 1979 and 1981", the patient was concomitant vaccinated with a dose of PNEUMOVAX (dose, lot number, expiration date, route of administration and anatomical location were not reported) (she would had given a vaccine reported as "PNEUMOVAX 5" because PNEUMOVAX 23 did not come out until 1983) and an unspecified flu vaccine (dose, lot number, expiration date, route of administration and anatomical location were not reported). There were no concomitant therapies reported. On an unknown date, the patient had an unspecified reaction to one of the vaccines, she also stated that her lungs "collapsed" (pneumothorax) after she received both vaccines, but she could not determine which one caused the adverse events. On an unspecified date, the patient visited her physician for medical attention and received an unspecified treatment. The patient was inquiring as to whether PNEUMOVAX 30 year ago was a live virus vaccine. She also stated that her provided was recommending PNEUMOVAX 23 at the reporting time, and she was concerned as to whether she should receive it. At the reporting time, the patient had recovered from the events of pneumothorax and adverse reaction. The reporter did not assess the relatedness of the adverse event with the PNEUMOVAX. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Hypersensitivity, Pneumothorax
Clinical narrative: This spontaneous report was received from a 74 year old female patient concerning on herself. Information regarding pertinent medical history and drug reactions/allergies were not provided. On an unspecified date, approximately in 1980, reported as "about 30 years ago", "sometime between 1979 and 1981", the patient was concomitant vaccinated with a dose of PNEUMOVAX (dose, lot number, expiration date, route of administration and anatomical location were not reported) (she would had given a vaccine reported as "PNEUMOVAX 5" because PNEUMOVAX 23 did not come out until 1983) and an unspecified flu vaccine (dose, lot number, expiration date, route of administration and anatomical location were not reported). There were no concomitant therapies reported. On an unknown date, the patient had an unspecified reaction to one of the vaccines, she also stated that her lungs "collapsed" (pneumothorax) after she received both vaccines, but she could not determine which one caused the adverse events. On an unspecified date, the patient visited her physician for medical attention and received an unspecified treatment. The patient was inquiring as to whether PNEUMOVAX 30 year ago was a live virus vaccine. She also stated that her provided was recommending PNEUMOVAX 23 at the reporting time, and she was concerned as to whether she should receive it. At the reporting time, the patient had recovered from the events of pneumothorax and adverse reaction. The reporter did not assess the relatedness of the adverse event with the PNEUMOVAX. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 14-MAR-2016, the patient was vaccinated with an improperly stored dose of GARADSIL 9, which had a lot # of L016428 and an expiration date of 30-AUG-2017 (dose, dosage number, route of administration and anatomical location were not reported). It was stated that the temperature excursion was 28.9 F for a time frame of 7 hours. This excursion was found due to a data logger. Additionally, it was stated that no previous temperature excursions had occurred. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: No adverse event
Clinical narrative: No symptoms as per mom.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Myalgia, Neck pain, Spinal pain
Clinical narrative: Could not lift arm on injection side for days, resolved top of neck all the way down spine hurt starting morning after injection sore muscles all over starting night of vaccine admin.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Pain
Clinical narrative: Pt c/o of pain when moving arm up and down where vaccine was given. No redness no swelling no induration noted.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Swelling, Ultrasound scan, Upper extremity mass
Clinical narrative: Lump in her right upper forearm which pt states developed a few days after vaccine. She developed swelling. Nontender to touch at painful with rotation no fever or chills or redness.
Sex: M
Vaccine: HPV4
Symptoms: Decreased activity, Fatigue, Muscular weakness, Myalgia, Neck pain
Clinical narrative: This spontaneous non-valid social media report was received from a consumer (patient's mother) and refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the second dose of GARDASIL (exact dose, route, lot # and expiration date were not reported). On an unknown date, after this second shot, patient became ill. He had extreme fatigue and muscle aches. At times he developed upper neck pain and muscle weakness, especially in his legs. His life completely changed and physical activity was very difficult for him. It was reported that the patient still suffered at the time of the report and those events were a long term effects. The patient's mother reported her son's reaction to Vaccine Adverse Event Reporting System (VAERS). The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and GARDASIL was not reported. Additional information is not expected as no contact details were provided.
Sex: U
Vaccine: HPVX
Symptoms: Pain, Pain in extremity
Clinical narrative: This spontaneous non-valid social media report was received from a patient of unknown age and gender reporting on themselves. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of HPV (manufacturer unknown) (exact dose, route, lot # and expiration date were not reported). Right when the sot went in, the patient experienced pain and his/her arm was sore for days. The patient went back to the doctor and complained about the soreness and decided not to continue with the doses of HPV (manufacturer unknown). The outcome of the events was unknown. The relatedness between the events and HPV (manufacturer unknown) was unknown, but the patient wished he/she was more informed about the vaccine and the possible side effects that could result. This is one of several reports received from the same source. Additional information is not expected as no contact details were provided.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: Soreness at injection site, fever (103F), headache, joint aches, nausea.
Age: 9.0
Sex: M
Vaccine: HEPA, MMRV, TDAP
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: After vaccinations received, patient became dizzy, pale, and diaphoretic.  Patient was placed in reclined position with feet elevated, cool compress applied to nape of neck, and patient felt fully recovered after 10 minutes.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pain, Rash pustular
Clinical narrative: Pt came in to the pharmacy with a prescription for Acyclovir on 04/12/2016.  She stated she had woke up the morning with 5 pustules around her left collarbone and they hurt.  She said she remembered me (the pharmacist) counseling her that there was a possibility she could get a shingles like rash and if she did, get a shingles like rash, she should go to the doctor.  She visited the doctor that morning.  By the time she came to the pharmacy the pustules had disappeared.  I did see one red mark about the size of a nickel on her left collarbone that was in the area she stated.  She said the area still hurt a little.  I inspected the injection site (below left deltoid area, on lateral/rear side of arm sub q) and there was no visible mark... we dispensed the Acyclovir and the patient went home.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Gave 3+ yr Fluzone instead of 6-35month Fluzone shot. No Adverse side-effects noted in office.
Age: 2.0
Sex: F
Vaccine: FLUN4
Symptoms: Body temperature increased, Seizure like phenomena
Clinical narrative: Seizure like shaking.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Site reaction. Red area a little larger than an egg.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Swelling face
Clinical narrative: Father calls states that patient woke up this morning with a swollen face. No breathing or swallowing difficulties. Father gave her BENADRYL. Health Dept nurse instructs him to take her to her doctor.
Age: 11.0
Sex: M
Vaccine: HPVX
Symptoms: Abdominal pain, Abdominal pain upper, Chest X-ray normal, Dizziness postural, Electrocardiogram normal
Clinical narrative: Subjective fever, stomach pain, headache on the night of 4.12 after getting the shot; the next day, she had similar symptoms. The following morning, however, she felt fine, but then she sat down and started having stomach pain again.  When she stood up, she felt dizzy and then passed out, per mom; mom thinks she was shaking a bit, but mom had caught her and then thought her eyes were slightly opened and looking up; that lasted about 30 secs, no head injury. She came to right away; mom doesn't think she was completely back to her normal self, but she doesn't describe a post-ictal state of sleepiness. Mom took her right away to the hospital on 4.14 after the episode of syncope; her tests and imagining all came back neg. also had shoulder pain and continued to have abdominal pain.
Age: 11.0
Sex: M
Vaccine: HPVX
Symptoms: Headache, Loss of consciousness, Musculoskeletal pain, Pregnancy test urine negative, Pyrexia
Clinical narrative: Subjective fever, stomach pain, headache on the night of 4.12 after getting the shot; the next day, she had similar symptoms. The following morning, however, she felt fine, but then she sat down and started having stomach pain again.  When she stood up, she felt dizzy and then passed out, per mom; mom thinks she was shaking a bit, but mom had caught her and then thought her eyes were slightly opened and looking up; that lasted about 30 secs, no head injury. She came to right away; mom doesn't think she was completely back to her normal self, but she doesn't describe a post-ictal state of sleepiness. Mom took her right away to the hospital on 4.14 after the episode of syncope; her tests and imagining all came back neg. also had shoulder pain and continued to have abdominal pain.
Age: 11.0
Sex: M
Vaccine: HPVX
Symptoms: Syncope, Tremor, Urine analysis normal
Clinical narrative: Subjective fever, stomach pain, headache on the night of 4.12 after getting the shot; the next day, she had similar symptoms. The following morning, however, she felt fine, but then she sat down and started having stomach pain again.  When she stood up, she felt dizzy and then passed out, per mom; mom thinks she was shaking a bit, but mom had caught her and then thought her eyes were slightly opened and looking up; that lasted about 30 secs, no head injury. She came to right away; mom doesn't think she was completely back to her normal self, but she doesn't describe a post-ictal state of sleepiness. Mom took her right away to the hospital on 4.14 after the episode of syncope; her tests and imagining all came back neg. also had shoulder pain and continued to have abdominal pain.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Pain in extremity
Clinical narrative: Initial unsolicited pregnancy report received from consumer on 12 August 2015. A 32-year-old female patient, whose concomitant medications were not reported, had received a dose of ADACEL (batch number, route of administration were not reported) in shoulder on 11 August 2015. On 11 August 2015, same day after injection the patient had experienced sore arm. The last menstrual period was not reported and estimated date of delivery was reported as 01 November 2015. At the time of vaccination the patient was pregnant. It was unknown whether patient received any treatment for infertility and patient had no current pregnancy history. At the time of report, outcome of the event sore arm was unknown. Documents held by sender: none. Follow up report received from consumer on 20 November 2015. No new information reported.
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Based on additional information received on 31 August 2015, this case became medically confirmed. Initial unsolicited report received from a non healthcare professional on 19-Aug-2015. A female patient (age not reported), had received a dose of ADACEL (batch number: U5271AA, expiry date: 10 February 2018, dose details, route and site of administration were not reported) on an unspecified date. The illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Concomitant medications were not provided. On an unspecified date post-vaccination, the patient experienced swelling and redness that resolved in one week. Laboratory investigations and corrective treatments were not provided. The patient recovered from the above mentioned events on an unspecified date. Follow-up information received from a nurse on 31 August 2015. This case was linked to 2015SA126700, 2015SA126832, 2015SA126715 (same reporter, same vaccine, different patient). No new information reported. Documents held by sender: none.
Sex: M
Vaccine: TDAP
Symptoms: Peripheral swelling
Clinical narrative: Based on additional information received on 31 August 2015, this case became medically confirm. Initial unsolicited report received from a non-healthcare professional on 19 August 2015. A male patient, whose age, medical history and concomitant medications were not reported, had received a dose of ADACEL (batch number- U5271AA, expiry date: 10 February 2018, route and site of administration were not reported) on unspecified date. On an unspecified date, after vaccination, the patient experienced swelling arm. Laboratory investigations and corrective treatments were not reported. At the time of this report, swelling of arm had resolved in one week and patient had recovered from the event on an unspecified date. Documents held by sender: none. Follow up report received from a nurse on 31 August 2015. This case is linked to case ID: 2015SA126700, 2015SA126707, 2015SA126715. No new information reported.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site atrophy, Injection site pain
Clinical narrative: Initial unsolicited report received from a physician on 28 August 2015. This case involves a 57 years male patient who was vaccinated with an intramuscular dose of ADACEL (batch number U5189AA, expiration date 28 October 2017) in left deltoid on 30 June 2015. The patient did not have any illness at the time of vaccination. Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as diabetes, hyperlipidemia, sleep apnea. Concomitant medications were not reported. On 30 June 2015, same day following the vaccination, the patient experienced persistent pain at the left deltoid, muscle seems to be wasting. When compare the size of his upper arms there is clearly a difference. Deltoid area was tender to touch. It was reported that on ROM (range of motion) when the patient abducts his movement was limited, but more likely due to the pain. No redness or swelling at the left deltoid. Patient required Emergency Room/physician visit. Lab data and corrective treatments were not reported. The patient had not recovered. List of documents held by sender: none.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea
Clinical narrative: Initial unsolicited report received from a nurse (who was reporting for self) on 31 August 2015. This case involves a 63-year-old female patient who was vaccinated with a dose of ADACEL (batch number, dose, dose in series and expiry date were not reported) intramuscularly in left deltoid on 29 August 2015. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions reported as asthma, numerous allergies with chicken, beta blockers, cephalosporins, penicillin, amoxicillin, opiates, Mucomyst, NEURONTIN, compazine, Coumadin, bisphosphonates, Synthroid, Tylenol, medocatopm, oral contrast dye, coffee, corn, almonds, perfumes, pesticides, smoke. Concomitant medications were not reported. On 29 August 2015, same day following the vaccination, the patient experienced troubled breathing that lasted for the next 24 hours. Thereafter she did not have any other symptoms. Laboratory data and corrective treatment were not reported. On an unknown date (after 24 hours), the patient recovered from the event. List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Unevaluable event
Clinical narrative: Initial unsolicited pregnancy report received from the literature on 16 November 2015. The following is verbatim from the article: OBJECTIVE: To determine whether receipt of Tdap vaccine during pregnancy administered in close intervals from prior tetanus-containing vaccinations is associated with acute adverse events in mothers and adverse birth outcomes in neonates. EXPOSURES: Women who received Tdap in pregnancy following a prior tetanus-containing vaccine less than 2 years before, 2 to 5 years before, and more than 5 years before. MAIN OUTCOMES AND MEASURES: Acute adverse events (fever, allergy, and local reactions) and adverse birth outcomes (small for gestational age, preterm delivery, and low birth weight) were evaluated. Women who were vaccinated with Tdap in pregnancy and had a prior tetanus-containing vaccine more than 5 years before served as controls. RESULTS: There were no statistically significant differences in rates of medically attended acute adverse events or adverse birth outcomes related to timing since prior tetanus-containing vaccination. CONCLUSIONS AND RELEVANCE: Among women who received Tdap vaccination during pregnancy, there was no increased risk of acute adverse events or adverse birth outcomes for those who had been previously vaccinated less than 2 years before or 2 to 5 years before compared with those who had been vaccinated more than 5 years before. These findings suggest that relatively recent receipt of a prior tetanus-containing vaccination does not increase risk after Tdap vaccination in pregnancy. This case involves a 29155 female patient who was vaccinated with a dose TDAP (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, 10 patients had developed fever, 15 patients had developed local reaction (cellulitis), 3 patients had allergic reaction/allergy, 8 patients had urticaria, 2 patients had local reaction (lymphadenitis), 8 patients had local reaction (limb swelling), 23 patients had local reaction (limb pain). There was a preterm delivery (unknown number of patients). It was a vaccine exposure during pregnancy. At the time of this report, 29084 patients had not experienced any adverse events. Relevant laboratory test results and corrective treatment was not reported. The outcomes of all the events were unknown. Documents held by sender: none.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Dyspnoea
Clinical narrative: Initial unsolicited report received from a pharmacist on 19 November 2015. This case involves a 56-year-old male patient who was vaccinated with an intramuscular dose of ADACEL (batch number U5292AA, expiration date 14 April 2018, dose, dose in series, site of administration were not reported) on 13 November 2015. Illness at time of vaccination was not reported and patient had an allergy to tetracycline. Concomitant medications were not reported. On 16 November 2015, three days following the vaccination, the patient experienced shortness of breath. Lab data and corrective treatments were not reported. The patient was not recovered from event as it was reported that event continues till 19 November 2015. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Had Pneumovax in R arm on 04/11. Pt reports R arm/shoulder pain, inflammation, warmth and redness. Denies drainage, fever. TX: Aleve.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Had Pneumovax in R arm on 04/11. Pt reports R arm/shoulder pain, inflammation, warmth and redness. Denies drainage, fever. TX: Aleve.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle tightness, Pain, Tenderness
Clinical narrative: Patient complained of muscle tightness, soreness, tender, pain.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Red bump on inj. site.
Age: 36.0
Sex: F
Vaccine: FLUC3
Symptoms: Arthralgia, Musculoskeletal pain
Clinical narrative: Shoulders ache, pain in joints.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Eye discharge, Irritability, Urticaria, Viral rash, Vomiting
Clinical narrative: 4/2/16 Vomited after antibiotic dose given. Phone advice. 4/3/16 Eye discharge, fussy, Phone advice. 4/4/16 Eye discharge, office visit, tobramycin ophthalmic sol'n. 4/12/16 Viral exanthema on chest, urticaria, persistent ROM. Last dose amox. 4/11. Started cefdinir.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Nausea, Pyrexia, Urticaria
Clinical narrative: She spiked a 104.5 fever. Ibuprofen only brought it down to 102. She broke out in hives starting at 1:30 PM on 04/15/2016 and has been extremely nauseous.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Nasal discharge discolouration, Pyrexia, Sinus congestion
Clinical narrative: Day or two after FLUMIST pt. started having thick cloudy, sometimes yellow nasal discharge. Fever off and on. Lasting over 1 mo. No allergies in past. Continues to snort trying to clear sinuses.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Mom called office on 04-08-16 regarding (L) deltoid area - red, hot, swollen (3 inch diameter). Advised mom to use ibuprofen for pain and ice/cool packs QID. Mom to call if Sx persist. 5pm called mom. Swelling decreasing in size.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Within 48 hours of oral vaccine visible blood in stool x 2. Heme (+) samples.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Pain
Clinical narrative: Next day patient experienced sweating, pain, drawing up of hands, as well as other symptoms. Pt has continued to have pain that has been untreatable locally. Being referred to clinic. He said hospital/Dr didn't report vaccine adverse event.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Pain in extremity
Clinical narrative: Pt developed a knot on her arm at the injection site and reported that the pain continued to her elbow.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pain and swelling with redness at vaccine injection site followed by itching.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: Pain in right arm spreading to left arm and shoulders. Could not lift arms.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Ultrasound scan, X-ray
Clinical narrative: Pain in right arm spreading to left arm and shoulders. Could not lift arms.
Age: 1.05
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Injection site induration, Injection site nodule, Pyrexia, Rash, Urticaria
Clinical narrative: PT developed rash and fever of 100.0. Seen at a facility where hives were diagnosed. Pt was given Benadryl. Pt contacted PCP office d/t rash spreading and becoming worse. Pt rash spread to face, chest, buttocks, and LE's. Pt also has hard nodules beneath immunization site the size of silver dollars. Pt's mom using ice packs, heat, and Benadryl.
Age: 68.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Significant swelling (patient described as egg-shaped) with redness, itching, burning, and hot to the touch.  Patient went to her primary care physician who recommended diphenhydramine oral until symptoms subsided.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt had swelling, redness and warm on arm where injection was administered.  Location of reaction was not at injection site.  It was on the under aspect of the upper arm.  Gravity appeared to draw the swelling down.
Age: 0.58
Sex: M
Vaccine: DTAPH, IPV, PNC13
Symptoms: Blood test, Electroencephalogram, Seizure, X-ray
Clinical narrative: Seizure.
Age: 20.0
Sex: F
Vaccine: RAB, TDAP, TYP
Symptoms: Fall, Loss of consciousness, Muscle rigidity, Muscle spasms, Pain
Clinical narrative: Patient lost consciousness and passed out. She fell down in the process. Patient also developed a small seizure and had muscle rigidity and cramping. Patient eventually regained consciousness and report pain due the fall. I gave her some water and pain medication. Patient was observed for 30 minutes before releasing her to her guardian.
Age: 20.0
Sex: F
Vaccine: RAB, TDAP, TYP
Symptoms: Seizure
Clinical narrative: Patient lost consciousness and passed out. She fell down in the process. Patient also developed a small seizure and had muscle rigidity and cramping. Patient eventually regained consciousness and report pain due the fall. I gave her some water and pain medication. Patient was observed for 30 minutes before releasing her to her guardian.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Computerised tomogram, Mobility decreased, Pain, Skin warm, Swelling
Clinical narrative: Severe pain. Warmth, swelling, unable to lift arm. Blood pressure 180/140.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via direct contact, No adverse event, Syringe issue
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 14-APR-206 (reported as "today"), the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (which had a lot # of L040445 and an expiration date of 15-JAN-2017; however dose, dosage number and anatomical location were not reported). While the vaccination was taking place, about a quarter of the ZOSTAVAX dose leaked out of the syringe onto the patient's arm. Nevertheless, no adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site reaction, Injection site vesicles, Rash macular, Rash papular
Clinical narrative: This spontaneous report was received from a physician who read on a web site about an unspecified number of patients of unknown demographics. Information regarding about the patients' concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with GARDASIL (dose, lot number, expiration date, route of administration and anatomical location were not reported). There were not concomitant medications provided. On an unknown date, the patients developed macular and popular rashes, blisters and vesicles near the injection site. The outcome of application site vesicles and application site rash was not reported. The reporter did not assess the relatedness of the events with GARDASIL. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and allergies were not reported. Since unspecified dates in September 2014, the patients were vaccinated with doses of RECOMBIVAX HB (lot # K010535, expiration date: 27-AUG-2016), (strength, dose, frequency, route and anatomical location were not reported), which were improperly stored. The excursion details indicated that the temperature was at 54.7 Fahrenheit (F), maximum for 838 hours, 59 minutes cumulatively and 19 F minimum for 838 hours, 59 minutes cumulatively. No adverse events were reported and product quality complaint (PQC) was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and allergies were not reported. Since unspecified dates in September 2015, the patients were vaccinated with doses of GARDASIL (lot # K006960, expiration date: 19-FEB-2017), (strength, dose, frequency, route and anatomical location were not reported), which were improperly stored. The excursion details indicated that the temperature was at 54.7 Fahrenheit (F), maximum for 838 hours, 59 minutes cumulatively and 19 F minimum for 838 hours, 59 minutes cumulatively. No adverse events were reported and product quality complaint (PQC) was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The nurse reported that the patients received improperly stored (temperature excursion: 8.2 C, time frame: 13 hours) doses of PROQUAD (Merck) of lot/batch # L042818 with expiry date 26-APR-2017 and lot/batch # L041629 with expiry date 22-APR-2017 (Dose, strength, dose number, vaccination site and route of administration not provided) on unspecified dates. Concomitant therapies were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. No further information was provided. This is one of two reports from same reporter link. Additional information has been requested.