chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: ANTH
Symptoms: Activities of daily living impaired, Grip strength decreased, Hypoaesthesia, Impaired driving ability, Mobility decreased
Clinical narrative: Muscles in shoulder and left arm began twitching this was on a Thursday or Friday on Sat 1-2 days later woke up with stiff muscles as if I slept wrong and arm fell asleep. The more I moved the arm the more severe the shoulder pain became, could not hold an empty coke bottle, raise hand higher than waist, comb hair, or lift hand to steering wheel of car. Pain was so excruciating was unable to properly drive to the ER, gate guard had to allow me in gate the back way to ER. Pain med was given but pain continued physical therapy for 1 year and then surgery the following year. After surgery was placed on a permanent profile and was unable to do pushups again for the physical fitness test. Now when muscles are fatigued they hurt longer than normal recovery time for muscles when working out on weights, sensitive and usually has nerve pain or muscle pain.
Age: 31.0
Sex: F
Vaccine: ANTH
Symptoms: Muscle twitching, Musculoskeletal pain, Musculoskeletal stiffness, Myalgia, Neuralgia
Clinical narrative: Muscles in shoulder and left arm began twitching this was on a Thursday or Friday on Sat 1-2 days later woke up with stiff muscles as if I slept wrong and arm fell asleep. The more I moved the arm the more severe the shoulder pain became, could not hold an empty coke bottle, raise hand higher than waist, comb hair, or lift hand to steering wheel of car. Pain was so excruciating was unable to properly drive to the ER, gate guard had to allow me in gate the back way to ER. Pain med was given but pain continued physical therapy for 1 year and then surgery the following year. After surgery was placed on a permanent profile and was unable to do pushups again for the physical fitness test. Now when muscles are fatigued they hurt longer than normal recovery time for muscles when working out on weights, sensitive and usually has nerve pain or muscle pain.
Age: 31.0
Sex: F
Vaccine: ANTH
Symptoms: Surgery
Clinical narrative: Muscles in shoulder and left arm began twitching this was on a Thursday or Friday on Sat 1-2 days later woke up with stiff muscles as if I slept wrong and arm fell asleep. The more I moved the arm the more severe the shoulder pain became, could not hold an empty coke bottle, raise hand higher than waist, comb hair, or lift hand to steering wheel of car. Pain was so excruciating was unable to properly drive to the ER, gate guard had to allow me in gate the back way to ER. Pain med was given but pain continued physical therapy for 1 year and then surgery the following year. After surgery was placed on a permanent profile and was unable to do pushups again for the physical fitness test. Now when muscles are fatigued they hurt longer than normal recovery time for muscles when working out on weights, sensitive and usually has nerve pain or muscle pain.
Age: 57.0
Sex: M
Vaccine: HEPAB, VARZOS
Symptoms: Rash pruritic, Rash vesicular, Varicella
Clinical narrative: Approximately 72 hours after receiving Zostavax, patient develop diffuse, pruritic vesicular rash on arms, legs, trunk, face. Diagnosed with acute Varicella infection (chickenpox) and treated with Valtrex 1 gm tid x 7 days.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Eye swelling
Clinical narrative: Tdap given in L deltoid. 40 Min. later her L eye was noticibly swollen, but not shut. Given a Benadryl pill and was improved within 30 min. Then her R eye swelled ~45 min later and she received another Benadryl and sent home from school.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Local swelling
Clinical narrative: Tdap given in L deltoid. ~30 min later her L hand was noticably swollen-not her arm. She was given a Benadryl orally and it resolved.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Electromyogram, Gait disturbance, Immunoglobulin therapy, Muscular weakness
Clinical narrative: Progressive symptoms including muscle weakness, loss of balance, and altered gait, of at least six months duration through the present.  Treatments include physical therapy and hospitalization for IV-IG therapy.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Progressive symptoms including muscle weakness, loss of balance, and altered gait, of at least six months duration through the present.  Treatments include physical therapy and hospitalization for IV-IG therapy.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: RASH ON ARMS- SPREADING.  PAIN IN ARM THE VACCINE WAS GIVEN. SHE STATES IT HURTS WHEN SHE LIFTS HER ARM.
Age: 1.6
Sex: M
Vaccine: HIBV, TDAP
Symptoms: Abnormal behaviour, Aggression, Contusion, Emotional disorder, Injection site pain
Clinical narrative: High fever, pain and swelling in thigh where vaccine was administered, within a couple of hours following vaccine. Fever lasted about 3-4 days, pain and swelling lasted almost 2 weeks. Still has a bruise and pain over 2 weeks later. Behavior changes within a couple of days included severe emotional reactions to anything he didn't like. Continues to scream high pitch screams and tantrums over any dislike to a situation.
Age: 1.6
Sex: M
Vaccine: HIBV, TDAP
Symptoms: Injection site swelling, Pain, Pyrexia, Screaming
Clinical narrative: High fever, pain and swelling in thigh where vaccine was administered, within a couple of hours following vaccine. Fever lasted about 3-4 days, pain and swelling lasted almost 2 weeks. Still has a bruise and pain over 2 weeks later. Behavior changes within a couple of days included severe emotional reactions to anything he didn't like. Continues to scream high pitch screams and tantrums over any dislike to a situation.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Chills, Headache, Injection site swelling, Musculoskeletal pain
Clinical narrative: Severe chills, trembling, fever, swollen shoulder at site of shot; aching shoulders, arms, and lower back; dull headache.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: Severe chills, trembling, fever, swollen shoulder at site of shot; aching shoulders, arms, and lower back; dull headache.
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient of unknown age. Patient concurrent conditions and medical history were not reported. On 26-MAR-2014 the patient was vaccinated with PNEUMOVAX lot # J014401 (Expiry: 26-NOV-2014) (also reported as lot check was requested) by intramuscular route (dose and frequency was not reported). On an unknown date in March 2014 patient experienced severe redness and swelling at the injection site where the PNEUMOVAX was injected. Patient had difficulty in lifting the arm that had received PNEUMOVAX injection. The patient visited physician (reporter also mentioned 3 patients received PNEUMOVAX from same lot# and an unspecified patient among 3 visited an unspecified emergency room). Reporter was not sure whether patient received treatment with either DECADRON or SOLU-MEDROL. The outcome of the event was reported as recovering. The reporter did not provide the causality between event and the suspect drug. Additional information has been requested. This is one of several reports from same reporter and case is linked to same reporter link of case 1403USA014602, 1404USA001442.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demography. On an unknown date, the patient was vaccinated with unspecified number of doses of VARIVAX (Merck) which were administered to the patients which were exposed to the temperature outside of range. The patient was vaccinated with VARIVAX (Merck) Lot# J00754 (Expiry: 27-JUN-2015) which was exposed to 26F for 82 days. No further information was provided. This case is linked to the case 1403USA009275 and 1404USA002681 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demography. On an unknown date, the patient was vaccinated with unspecified number of doses of VARIVAX (Merck) which were administered to the patients which were exposed to the temperature outside of range. The patient was vaccinated with VARIVAX (Merck) Lot # J00891 (Expiry: 19-JUL-2015) which was exposed to 26F for 82 days. No further information was provided. This case is linked to the case 1404USA002681 and 1404USA002682 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On 24-SEP-2014, patient was vaccinated with RECOMBIVAX HB dose 1, 1 ml intramuscular (lot # was not reported). On 24-MAR-2014, the patient was vaccinated with RECOMBIVAX HB dose 2 (route and lot # were not reported). No adverse effects reported. Therapy with RECOMBIVAX HB was continued. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demography. On an unknown date, the patient was vaccinated with unspecified number of doses of VARIVAX (Merck) which were administered to the patients which were exposed to the temperature outside of range. The patient was vaccinated with VARIVAX (Merck) Lot# J009165 (Expiry: 24-JUL-2015) which was exposed to 26F for 82 days. No further information was provided. This case is linked to the case 1403USA009275 and 1404USA002681 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from other health care professional refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot # not reported) dose, route and frequency not reported. No other co suspects were reported. No concomitant therapy was reported. The reporter stated that an unspecified patient had an unspecified adverse reaction with PNEUMOVAX 23. The outcome of the patient had an unspecified adverse reaction was unknown. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report as received from a nurse via Company Representative refers to a 63 year old male patient. Medical history and concurrent conditions were not reported. On 18-MAR-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, strength, route, lot number and expiration date were not reported). Secondary and concomitant therapies were not reported. Nurse reported that a patient received a dose of PNEUMOVAX 23 and was diagnosed with pneumonia on 21-MAR-2014. The outcome of pneumonia was not reported. It was reported that patient sought medical attention. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Full blood count, Rash
Clinical narrative: Information has been received from a physician regarding a male patient of unknown age with no pertinent medical history, drug reactions or allergies. On 12-MAR-2014, the patient was vaccinated with a first dose of M-M-R II (route and lot number were not provided). On 24-MAR-2014, the patient developed a spotted rash that waxed and waned and was not getting worse. Physician mentioned that rash now looks like dark spots on the patient's had and torso. A blood work (CBC) was performed and results were unspecified. The patient did not receive treatment for the adverse event. The patient sought medical attention, at office visit. At the time of the report, the patient had not recovered from the adverse event. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Pt received 2nd MMR vaccine and 2nd VARIVAX vaccine - on 4/2/14 developed hives "all over" 2 yo after receiving vaccines. (Previous vaccines MMR#! 6/22/11, VX #1 6/22/11 no reaction).
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Patient returned to pharmacy 2 months after vaccination to tell he developed rash on entire arm where received vaccination and rash still persists. Saw doctor and was told to take BENADRYL.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Vasculitic rash
Clinical narrative: Vasculitis rash treated with triamcinolone 0.025% ointment.
Age: 1.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 month old male patient. The patient's current conditions or medical history were not reported. On 26-MAR-2014, the patient was mistakenly vaccinated with a dose of ZOSTAVAX vial (dose, route, lot number and expiration date were not reported) instead of VARIVAX (Merck). No adverse effects reported. Additional information has been requested.
Age: 0.28
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Dermatitis contact, Hyporeflexia, Injection site vesicles, Irritability
Clinical narrative: Pt rec'd 1st PREVNAR 13 in (R) thigh 3/27/14. Pt was fussy with decreased flexs x 48 hrs. Mom left band aid in place x 4 days. When bandaid removed she noted a square-shaped area of blisters where the nonadhesive portion of bandaid covered vaccice site. Appeared to be contact dermatitis.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site rash, Pain
Clinical narrative: Patient came back 3 days after vaccine administration with a rash/bruise at the injection site. Patient said the rash is painful and about 1 1/2" in radius. Patient was advised by M.D to use cold compress.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Joint swelling, Local swelling, Skin warm
Clinical narrative: Client received Tdap vaccine IM in left deltoid on 3/20 the following day she noticed her arm shoulder was swollen and warm - this persisted for several days. She sought medical advise on 3/24. No treatment needed. Has resolved.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Decreased eye contact, Screaming
Clinical narrative: Screamed after shots for 2 days per parents, was not consolable. Acted different after vaccines. Less eye contact for a while. Still doesn't seem to have as much eye contact as before shots (per parents). No fever reaction per parents.
Sex: F
Vaccine: HPV4
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient of unknown demographics. The patient's current conditions or medical history were not reported. On 21-JAN-2014, the patient was vaccinated with the first dose of GARDASIL 0.5 ml intramuscular (lot number and expiration date were not reported). The patient may had an unspecified reaction after receiving the vaccine. On 25-MAR-2014, the patient was vaccinated with the second dose of GARDASIL 0.5 ml intramuscular (lot number and expiration date were not reported). On 25-MAR-2014, after receiving her second dose of GARDASIL the patient developed chills, headache and possible fever. At the time of the report the patient was not recovered from the chills, fever, and possible fever. Outcome for unspecified reaction was unknown. The patient did not sought medical attention for the event experienced after the first dose of GARDASIL. The patient visit the office for medical attention for the events experienced after the second dose of GARDASIL. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Health professional refers to a 13 year old female patient. On 18-MAR-2014 the patient was vaccinated with an expired VARIVAX (Merck) (lot # 0572AE, expiration date 15-MAR-2014). There was no concomitant medication reported. No adverse effects reported. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: FLUX, HPV4, UNK, FLU3, HPV4
Symptoms: Accidental exposure to product, Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a 25 year old female pregnant patient. There was no drug reaction/allergies. On 20-MAR-2014 the patient was vaccinated with a dose of GARDASIL. Secondary suspect therapies included flu vaccine (manufacturer unknown). Concomitant therapies included a third vaccine (name, manufacturer unknown). The patient received a call from the administered health center to inform the patient that the vaccine was inadvertently administered. "No adverse events are being reported". The patient was pregnant seven months at the time of reporting. The LMP was approximately on 09-SEP-2013 and EDD was approximately on 16-JUN-2014. Initial exposure to GARDASIL was at about 27 week(s). The patient's inquiry was what if any are the adverse effects of receiving the GARDASIL while pregnant. No treatment was given. Blood work was performed on 20-MAR-2014 without result provided. The patient didn't sought medical attention. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: FLUX, HPV4, UNK, FLU3, HPV4
Symptoms: Caesarean section, Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a 25 year old female pregnant patient. There was no drug reaction/allergies. On 20-MAR-2014 the patient was vaccinated with a dose of GARDASIL. Secondary suspect therapies included flu vaccine (manufacturer unknown). Concomitant therapies included a third vaccine (name, manufacturer unknown). The patient received a call from the administered health center to inform the patient that the vaccine was inadvertently administered. "No adverse events are being reported". The patient was pregnant seven months at the time of reporting. The LMP was approximately on 09-SEP-2013 and EDD was approximately on 16-JUN-2014. Initial exposure to GARDASIL was at about 27 week(s). The patient's inquiry was what if any are the adverse effects of receiving the GARDASIL while pregnant. No treatment was given. Blood work was performed on 20-MAR-2014 without result provided. The patient didn't sought medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Tooth disorder
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. A couple of days ago, the patient was vaccinated with a dose of ZOSTAVAX (dose and route unknown). The patient called the pharmacist and asked him if she could get her tooth extracted for scheduled dental appointment. Pharmacist did not know if patient had existing tooth problem or if tooth problem started after receiving ZOSTAVAX. The outcome of the patient was unknown. The causality was not assessed. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: HPV4, MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 5 year old patient of unknown gender. On an unknown date the patient was vaccinated with GARDASIL. Other suspect therapies included MENACTRA. On an unknown date the patient received GARDASIL in error, rather than MENACTRA as prescribed. The physician indicated that the nurse who administered the dose made an error, and the physician was not certain why GARDASIL was confused with MENACTRA. It was reported that the child was not demonstrating any adverse effects. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from an employee refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with M-M-R II (route, dose number, dosage and lot number unknown). Other suspect therapies included VARIVAX (Merck) (route, dose number, dosage and lot number unknown). It was reported the patient received the vaccines too early. No adverse symptoms reported. Additional information is not expected.
Age: 33.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a healthcare professional regarding a 33 year old patient of an unkonwn gender. On 31-MAR-2014, the patient received VAQTA dose that equal to two adult doses of VAQTA instead of intended one adult dose of VAQTA and one adult dose of Hepatitis B vaccine. Nurse gave two doses of pediatric, VAQTA (lot number J000985, exp 20-AUG-2015 for both vials( for total of 1 ml for an adult dose and intended to give an adult dose of Hepatitis B vaccine but inadvertently gave another adult dose of VAQTA (lot number reported as J014587, exp 15-JAN-2016) to patient. No adverse effects reported. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Myalgia, Nausea, Pain
Clinical narrative: Flu vaccine was administered approx 5 pm 4/2/14. Patient reports waking up at 1 am 4/3/14 lasting until 4 am (approx 3 hrs) with severe body aches and nausea. Now with mild persistent both muscle pain.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Laboratory test normal, Lumbar puncture normal, Neurological symptom, Palpitations
Clinical narrative: Developed unilateral neurological sx - (R) arm and leg radiating to fingers and toes. (R) foot falling asleep. Palpitations noticed 11/13/13. Neurology work-up. Spinal tap - Guillain Barre ruled out. Upcoming f/u to r/o M.S. Hx undocumented spleen pain Fall '12 flu vaccine.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Vitamin D decreased
Clinical narrative: Developed unilateral neurological sx - (R) arm and leg radiating to fingers and toes. (R) foot falling asleep. Palpitations noticed 11/13/13. Neurology work-up. Spinal tap - Guillain Barre ruled out. Upcoming f/u to r/o M.S. Hx undocumented spleen pain Fall '12 flu vaccine.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Disturbance in attention, Feeling abnormal, Headache, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a consumer (reported as patient's mother) refers to a 13 year old female patient with medical history of two ruptured ovarian cyst (reported as x2) and grade 2 concussion that occurred approximately in 2013 (reported as approximately one year ago). The patient had no history of drug allergies. On 04-OCT-2013 the patient was vaccinated with the first dose of GARDASIL injection (a recalled one, lot # J007354, expiration date: 20-FEB-2016, dose was not reported) and on 21-JAN-2014 she was vaccinated with her 2nd dose of GARDASIL (lot #, expiration date and dose was not reported) for prevention HPV. The reporter stated that on unspecified date the patient experienced some headaches and a lapse of her menstrual cycle after receiving the first dose of GARDASIL. Immediately after receiving the second dose of GARDASIL on 21-JAN-2014 the patient experienced powerful headaches and incredible reaction at the injection site. On an unspecified date of 2014 the patient experienced severe headache with spinning that woke patient from sleep. It was reported that MRI was done on 30-JAN-2014 and results of MRI showed "a clear head and no damage and a 'slight rise' in the pituitary gland". The reporter stated that the patient had no further headaches. The patient did seek medical attention by calling the physician. The outcome of all events was unknown. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Injection site reaction, Menstrual disorder, Nuclear magnetic resonance imaging brain abnormal, Pituitary enlargement
Clinical narrative: This spontaneous report as received from a consumer (reported as patient's mother) refers to a 13 year old female patient with medical history of two ruptured ovarian cyst (reported as x2) and grade 2 concussion that occurred approximately in 2013 (reported as approximately one year ago). The patient had no history of drug allergies. On 04-OCT-2013 the patient was vaccinated with the first dose of GARDASIL injection (a recalled one, lot # J007354, expiration date: 20-FEB-2016, dose was not reported) and on 21-JAN-2014 she was vaccinated with her 2nd dose of GARDASIL (lot #, expiration date and dose was not reported) for prevention HPV. The reporter stated that on unspecified date the patient experienced some headaches and a lapse of her menstrual cycle after receiving the first dose of GARDASIL. Immediately after receiving the second dose of GARDASIL on 21-JAN-2014 the patient experienced powerful headaches and incredible reaction at the injection site. On an unspecified date of 2014 the patient experienced severe headache with spinning that woke patient from sleep. It was reported that MRI was done on 30-JAN-2014 and results of MRI showed "a clear head and no damage and a 'slight rise' in the pituitary gland". The reporter stated that the patient had no further headaches. The patient did seek medical attention by calling the physician. The outcome of all events was unknown. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vertigo
Clinical narrative: This spontaneous report as received from a consumer (reported as patient's mother) refers to a 13 year old female patient with medical history of two ruptured ovarian cyst (reported as x2) and grade 2 concussion that occurred approximately in 2013 (reported as approximately one year ago). The patient had no history of drug allergies. On 04-OCT-2013 the patient was vaccinated with the first dose of GARDASIL injection (a recalled one, lot # J007354, expiration date: 20-FEB-2016, dose was not reported) and on 21-JAN-2014 she was vaccinated with her 2nd dose of GARDASIL (lot #, expiration date and dose was not reported) for prevention HPV. The reporter stated that on unspecified date the patient experienced some headaches and a lapse of her menstrual cycle after receiving the first dose of GARDASIL. Immediately after receiving the second dose of GARDASIL on 21-JAN-2014 the patient experienced powerful headaches and incredible reaction at the injection site. On an unspecified date of 2014 the patient experienced severe headache with spinning that woke patient from sleep. It was reported that MRI was done on 30-JAN-2014 and results of MRI showed "a clear head and no damage and a 'slight rise' in the pituitary gland". The reporter stated that the patient had no further headaches. The patient did seek medical attention by calling the physician. The outcome of all events was unknown. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised, Rash morbilliform
Clinical narrative: Fever for 4 days following measle rash all over the body for another 4 days.
Sex: M
Vaccine: PNC13
Symptoms: Cardiac flutter, Palpitations
Clinical narrative: This is a spontaneous report from a contactable physician from a non-clinical-study program Customer Service received via a Pfizer vaccine sales representative. An adult male patient was vaccinated with 0.5mL single dose in a pre-filled syringe of PREVENAR 13, at 0.5 mL via an unspecified route of administration on 12Feb2014. Vaccines given on the same day and vaccines given within the last four weeks were unknown. Illness at the time of vaccination was none. Concomitant medications were not reported. Relevant sibling information was unknown. On 12Feb2014 while being vaccinated, the patient experienced heart flutter and heart palpitation. Relevant lab data was unknown. The clinical outcome for the events of heart flutter and heart palpitation was recovered on 13Feb2014.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 15 years old female patient. On an unknown date (also reported as the other day), the patient was vaccinated with GARDASIL, one dose, route of administration (unknown), for unknown indication. No concomitants were reported. Physician stated that the patient reported that she may have received a dose previously, months or years in the past. No adverse effects reported. Physician disconnected call before additional information could be collected. No product quality compliant was involved. No further information reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old female patient. On 07-MAR-2014 the patient was vaccinated with VARIVAX lot # J008170, subcutaneous in the right arm (dosing information was not provided). It was stated that no. of previous doses was 1. On 08-MAR-2014 the patient experienced entire upper right arm hot, swollen and painful. The patient used ibuprofen, cold compresses and BENADRYL. The outcome of entire upper right arm hot, swollen, painful was reported as recovered/resolved on 09-MAR-2014 - 10-MAR-2014. The causal relationship was not provided. Linked to MARRS 1305USA003206 (same reporter). Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Off label use
Clinical narrative: This spontaneous report as received via company representative, from a registered nurse refers to a female patient of unknown age. The patient's medical history included multiple sclerosis. On 04-MAR-2014 the patient was vaccinated with ZOSTAVAX (dose unknown) lot # J011548 dose 1 in the right arm. No other suspect therapy or concomitant medication was reported. On an unspecified date in March 2014 the patient experienced an injection site reaction that was warm, but not raised and about 2 inches in diameter after receiving ZOSTAVAX. And needed to have varicella titers or receive the chickenpox vaccine before starting GILENYA (manufacturer unspecified) not ZOSTAVAX. The reporter specified that the vaccine was not given in the recommended deltoid region of the arm, but underneath the upper right arm. The reporter also stated that the patient was diagnosed with Multiple Sclerosis and was instructed by the physician that she had to be vaccinated before receiving GILENYA (manufacturer unspecified) however when the Field Representative reviewed the product information it stated the patient needed to have varicella titers or receive the chickenpox vaccine before starting GILENYA (manufacturer unspecified) not ZOSTAVAX (off label use). The physician instructed the patient to follow up with the office in 4 weeks. The reporter also reported that the patient stated she's been having reactions to a lot of different things recently (unspecified). The outcome of injection site reaction that was warm is unknown. The reporters relatedness of an injection site reaction that was warm to ZOSTAVAX is unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Nasopharyngitis
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown demography. On an unknown date, the patient was vaccinated with M-M-R II (dose, route and frequency were not reported). On an unknown date, the patient experienced cold-like symptoms. No further description of symptoms was provided. The outcome of the event was unknown. The reporter did not provide the casualty between the event and the suspect drug. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Local swelling
Clinical narrative: She stated she began to have spams and tingling in her left shouler down to fingers. Then her fingers became swollen. The injection site has redness, swelling and tender to touch. Began to feel dizzy, lightheaded with mild wheezing.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Muscle spasms, Paraesthesia, Wheezing
Clinical narrative: She stated she began to have spams and tingling in her left shouler down to fingers. Then her fingers became swollen. The injection site has redness, swelling and tender to touch. Began to feel dizzy, lightheaded with mild wheezing.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Swelling and redness since time of injection.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Ear swelling, Injection site swelling, Rash papular
Clinical narrative: Swelling at left thigh (where injection given), left ear swelling, erythematous papular rash at left/ midline chest. Given ibuprofen with improvement in swelling. On exam I did not see ear swelling.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Baseball sized swelling and redness at injection site on left arm. Mom states she is treating with Motrin and Benadryl. Ice for swelling and comfort.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The pharmacist reported that a patient received a dose of ZOSTAVAX, subcutaneously (dose 1), from an unspecified pharmacy on 17-MAR-2014. The pharmacist reported that this patient was inadvertently administered a second dose of ZOSTAVAX on 18-MAR-2014. No adverse effects reported. The outcome of inadvertently second dose administered, one day after first dose and no adverse event is unknown. The reporter considered inadvertently second dose administered, one day after first dose and no adverse event to be not related to ZOSTAVAX. No further information provided. Additional information will be requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Local swelling, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 81 year old female patient with no pertinent medical history and no drug reactions/allergies. On 26-MAR-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J0103134, Exp date: 17-JAN-2015), 0.65 ml, once, subcutaneous. On 28-MAR-2014, they developed an "allergic reaction" on 28-MAR-2014. On 28-MAR-2014 the patient developed a "very red and swollen arm" after receiving ZOSTAVAX. "The redness continued to spread and eventually turned bright purple and covered almost the whole back side of her arm and it was painful". The patient came back in to the pharmacy on 29-MAR-2014 to report the event. The pharmacist stated the patient had been using BENADRYL and hydrocortisone cream to treat the reaction however "neither was working for the patient". The pharmacist stated he told the patient to go to an unspecified "urgent care facility" to seek medical attention. There was no laboratory studies performed. The outcome of events was unknown. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Herpes zoster, Injection site reaction, Tenderness
Clinical narrative: This spontaneous report was received from a Physician assistant refers to a 59 year old female patient. The patient had a pertinent medical history of breast cancer. On 31-MAR-2014, the patient was vaccinated with ZOSTAVAX lot # J013133 (dose and frequency were not reported). Concomitant medication included ARIMIDEX. On 01-APR-2014, 2 days after onset of therapy the patient experienced injection site reaction after receiving ZOSTAVAX. The patient has an area that looks like cellulitis or a local shingles outbreak, and a cobblestone like appearance that has grown from a silver dollar size to three inches in diameter, center of area was tender to touch. The patient sought medical attention and seen in the office. The patient was not treated. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other healthcare worker refers to a female patient of unknown age. On an unspecified date in approximately March 2013, "about a year ago", the patient was vaccinated with first dose of GARDASIL (injection, lot#, dose, route and duration were unspecified). Patient would receive her second dose of GARDASIL (injection, lot#, dose, route and duration were unspecified) today, 27-MAR-2014. No adverse effect reported. The outcome was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, concentration and Lot number not reported). On an unknown date, the patient experienced shingles in the T-10 dermatome on the right flank. The outcome of shingles was unknown. Relatedness between shingles and ZOSTAVAX was not reported. The physician was unable to obtain a sample from the patient for VZVIP (Varicella Zoster Virus Identification Program). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site irritation, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL, (lot # J007354, expiry date: 20-FEB-2016). On an unknown date the patient experienced injection site irritation and injection site swelling. The outcome of injection site irritation and swelling is unknown. The relatedness between the GARDASIL and the events was not provided. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt reports continued arm pain following vaccine administration to Lt arm on 10/17/13.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and unknown sex. The nurse reported that on an unknown date, unspecified number of patients were vaccinated with the dose 2 of GARDASIL (lot#, dose/frequency and route unknown) approximately one year after receiving dose 1. No symptom required. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a register nurse concerning an adult female patient (age not provided, described as being in her teens) who on her childhood, on unknown dates, completed the full vaccination series of RECOMBIVAX HB or hepatitis B vaccine (manufacturer unknown) (route and lot number was not provided). Secondary suspect or concomitant medications were not provided. The register nurse reported that the patient, had a negative or low titer test following completion of hepatitis B vaccine (manufacturer unknown) but RECOMBIVAX HB could not be ruled out at the time of the call. No other adverse events were reported. At the time of the report the patient's outcome was not provided. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product odour abnormal
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to 1 or 2 patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date approximately in March 2014, the patients were vaccinated with a dose of PNEUMOVAX 23 lot H021941 expiration date 11-JUL-2014 (route was not reported). On 26-MAR-2014, the nurse reported that she noticed some odor from opened PNEUMOVAX 23 multi-dose vial. Nurse reported that normally, she would not smell anything from the vial but as she was withdrawing a dose that day (26-MAR-2014), some doses leaked out from the dispensing hole in the rubber stopper, where needle was inserted, and she was able to smell and there was that odor that she never smelled before. Nurse described the odor as "medicine-like" but stated that odor was not foul. Nurse reported that only reason she smelled anything was because some drops leaked out and she mentioned that this odor might be normal for PNEUMOVAC 23, she had never smelled this odor from PNEUMOVAX 23 vial before. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Hepatitis B test negative
Clinical narrative: This spontaneous report was received from a registered nurse concerning an adult female patient (age not provided, described as being in her teens) who on her childhood, on unknown dates, completed the full vaccination series of RECOMBIVAX HB or hepatitis B vaccine (manufacturer unknown) (route and lot number was not proved). Secondary suspect or concomitant medications were not provided. The register nurse reported that the patient, had a negative or low titer test following completion of hepatitis B vaccine (manufacturer unknown) but RECOMBIVAX HB could not be ruled out at the time of the call. No other adverse events were reported. At the time of the report the patient's outcome was not provided. This is one of several reports received from the same source. Additional information is not expected.
Age: 7.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a 7 year old female patient. On 17-MAR-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (dose, route and lot number not reported). It was reported that the vial was expired by 2 months. Right after the expired vaccine was administered that day, 17-MAR-2014, the child was given another dose of PNEUMOVAX 23 that was not expired. There were no adverse effects reported at that time. There were no laboratory studies performed. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 4 yo booster given on 4-1-14. Left thigh became markedly red and swollen. Pt seen in Urgent Care 4-2-14 and in our office 4-3-14 = improving on BENADRYL. DTaP and Polio given in left thigh.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning a patient of unknown age and gender who on an unknown date in March 2012 received their first dose of GARDASIL; the second dose in June 2013 and the third dose in November 2013. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a unspecified number of patients of unknown age and gender. Nurse stated that on an unkonwn date, a provider may have vaccinated the patients with improperly stored ROTATEQ (lot#, expiry not reported). No adverse effects were reported. Nurse did not want to be contacted regarding this report. No PQC involved. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a unspecified number of patients of unknown age and gender. Nurse stated that on an unknown date, a provider may have vaccinated the patients with improperly stored GARDASIL (lot#, expiry not reported). No adverse effects were reported. Nurse did not want to be contacted regarding this report. No PQC involved. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 1.02
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: My daughter was fine all day the day of the vaccine but she then started vomiting at 2 am at night and continued to vomit 4 times until 6 am and again the following night. She has no stomach virus and has not been exposed to one and has never vomited before in her life.
Age: 24.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Fatigue, Injection site pain
Clinical narrative: Severe pain where the shot was given lasting several days, tiredness.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Axillary pain, Injection site inflammation, Injection site reaction, Injection site warmth, Pain
Clinical narrative: Started 31 March with moderate pain to left armpit, increased to sharp pain with movement.  Red linear elevated/inflammation rash from site wrapping around to left armpit. temperature of skin is warm around bicep.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Rash erythematous
Clinical narrative: Started 31 March with moderate pain to left armpit, increased to sharp pain with movement.  Red linear elevated/inflammation rash from site wrapping around to left armpit. temperature of skin is warm around bicep.
Age: 3.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Erythema, Local swelling
Clinical narrative: 5" x 7" erythemous and swollen patch near injection site on left leg.
Age: 33.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Pain, Rash papular, Skin lesion
Clinical narrative: The following history was presented to the Healthcare Center: The pt received his primary SPV on 3/21/14 in preparation for work. The pt was recovering from a cold at that time. He received his SPV in his upper left arm. The pt denies chest pain, neck pain, malaise, painful lymph nodes. On 3/31/14 he noted a painful lesion on his left wrist. It was "round, raised" with a surrounding area of erythema of about 4cm. This lesion was seen by a provider on 4/1/14 at the clinic just prior to the pt transferring. The pt was told that it looked like a staph infection and he was prescribed PCN. Also, on 4/1/14 the pt noted a papular-vesicular rash on his chest and back which is not painful or pruritic. On 4/2/14 the pt noted a "pimple" on the right side of his neck "which he popped" but it has "returned".