chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Blood test, Convulsion, Headache, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a license practice nurse and the patient's mother refers to a now 16 year old female patient. The patient's concurrent condition included learning disability. The patient had no other drug reactions/allergies. On 10-OCT-2009 the patient was vaccinated with the first dose of GARDASIL injection (dose, route and lot# not reported). Then the patient had a delay in receiving her second dose and therefore the physician's office determined that they should restart the GARDASIL series since there was a gap in years from 2009. The patient received another "first" dose of GARDASIL on 27-NOV-2012, her second dose on 27-DEC-2012 and the completion of the GARDASIL series on 05-JUN-2013. The patient's mother reported that the patient had suffered first with constant headaches and "now" continuous seizures. The patient also experiences severe back pain. The patient had been hospitalized many times (dates and length of stay was unspecified). The patient had taken many different medications approximate (12) including a blood pressure medication in effort to prescribe treatment (brand, dose and manufacturer unspecified) for the patient's condition. The patient was still experiencing these symptoms and these adverse events had been occurring over the last two years. The nurse also reported that after the patient received the full series of GARDASIL the patient started to experience intense headaches on an unspecified date. The intensity and pain of the headaches caused the patient to visit an unspecified neurologist on an unspecified date in December 2013. The patient performed spinal tap, magnetic resonance imaging (MRI), X-rays and blood work (result unspecified). At the time of reporting, the patient was not recovered from the event. Upon internal review, the event of continuous seizures was considered to be medically significant event. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: This spontaneous report as received from a license practice nurse and the patient's mother refers to a now 16 year old female patient. The patient's concurrent condition included learning disability. The patient had no other drug reactions/allergies. On 10-OCT-2009 the patient was vaccinated with the first dose of GARDASIL injection (dose, route and lot# not reported). Then the patient had a delay in receiving her second dose and therefore the physician's office determined that they should restart the GARDASIL series since there was a gap in years from 2009. The patient received another "first" dose of GARDASIL on 27-NOV-2012, her second dose on 27-DEC-2012 and the completion of the GARDASIL series on 05-JUN-2013. The patient's mother reported that the patient had suffered first with constant headaches and "now" continuous seizures. The patient also experiences severe back pain. The patient had been hospitalized many times (dates and length of stay was unspecified). The patient had taken many different medications approximate (12) including a blood pressure medication in effort to prescribe treatment (brand, dose and manufacturer unspecified) for the patient's condition. The patient was still experiencing these symptoms and these adverse events had been occurring over the last two years. The nurse also reported that after the patient received the full series of GARDASIL the patient started to experience intense headaches on an unspecified date. The intensity and pain of the headaches caused the patient to visit an unspecified neurologist on an unspecified date in December 2013. The patient performed spinal tap, magnetic resonance imaging (MRI), X-rays and blood work (result unspecified). At the time of reporting, the patient was not recovered from the event. Upon internal review, the event of continuous seizures was considered to be medically significant event. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from Healthcare worker refers to a 60 year old patient. The patient's medical history included chicken pox as a child. On 16-DEC-2013 the patient was vaccinated with the first dose of VARIVAX (merck), 0.5 ml, lot# H016577, exp. 05-SEP-2014, subcutaneous. The patient inadvertently received single (first) dose of VARIVAX (merck) instead of ZOSTAVAX (Merck). The outcome of event was unknown. No adverse effects reported. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Angioedema, Injection site pain
Clinical narrative: Angioedema, pain right upper arm.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from consumer of unknown age refers to herself. The patient's medical history included breast cancer 10 years ago. Approximately in 2013 (reported as 2 to 3 months ago), the patient was vaccinated with ZOSTAVAX, (dose unspecified). Concomitant therapies included VALTREX (Dose and manufacturer unspecified). Approximately in 2013, the patient experienced injection site tenderness. It was reported that it was the only adverse event patient experienced. It was reported that the patient's questions were only surrounding drug interaction. No medical attention sought. There was no hospitalization required for the event. There was no product quality complaint involved. The injection site tenderness has completely stopped. The outcome of injection site tenderness was reported as completely recovered (on an unspecified date). The reporters causality assessment for the event injection site tenderness with the therapy of ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 29-JAN-2014 the patient was inadvertently administered subcutaneously a single dose of ZOSTAVAX lot # J000492 that had expired on 19-JAN-2014. No adverse effects reported. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Pain, Pyrexia, Sinus disorder
Clinical narrative: Fever lasting 4-5 days. Upper body aches lasting 4-5 days. Sinus issues lasting 2 weeks. No tx.
Sex: U
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report as received from a nurse via field representative refers to multiple unspecified patients of unknown age and gender. The nurse reported that multiple unspecified patients have come to her with concerned about GARDASIL due to reading unspecified Internet articles that claim multiple unspecified patients had died after receiving GARDASIL (lot#, dose and route not reported). The reporter stated the article was from "someone that claimed to be involved with the development of GARDASIL". The nurse did not have any patients that reported an adverse effect after receiving GARDASIL. The reporter stated "they got a call from the mother of a patient who just got GARDASIL who was crying and in hysterics on the phone because she had heard about all these side effects. This was happening on a daily basis". The reporter stated "I don't have any details about the article". Additional information is not expected.
Age: 0.51
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an approximately 6 month old patient. In August 2013 the infant was vaccinated with a dose of VAQTA (dose, lot# not reported). No adverse effects reported. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Crying, Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This spontaneous report as received from a patient's mother refers to a 12 year old male patient with none pertinent medical history and no drug reactions/allergies. On 14-OCT-2013 the patent was vaccinated in an unspecified arm with a dose of GARDASIL dose, route and lot # not reported. There was none concomitant medication. Immediately after the administration of GARDASIL on 14-OCT-2013 the patient cried and experienced a horrible reaction described as very red, very hard and very painful area at the GARDASIL injection site. There were none lab diagnostic studies performed. The patient was given ADVIL for one week as a treatment. The outcome of adverse events was reported as recovered on 21-OCT-2013, (reported as one week after administration of GARDASIL). The relatedness between adverse events and GARDASIL was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician via field employee refers to a female patient of unknown age. On an unknown date the patient was vaccinated with dose 1 of VAQTA, (strength: 25/0.5 units per milliliter (U/ML)) at the dose of 0.5 milliliter (ml) as a preventative. The physician reported that the patient received second dose of VAQTA, three months after receiving the initial dose of VAQTA (date unspecified). No adverse effect was reported. No further information was provided. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontnaeous rpeort as received from a nurse refers to a 29 year old patient. On 21-DEC-2013 the patient was accidentally administered with a dose of ZOSTAVAX, (0.65 ml, subcutaneous, (lot #, expiration date and indication not reported) instead of VARIVAX (Merck). No adverse effect reported. It was not reported if the patient had sought medical attention. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HEP, HPV4, MNQ
Symptoms: Injection site erythema, Skin warm
Clinical narrative: Client received MCV4 - and HPV - both to (L) arm - Hept. B Rt. arm - came in today stated no pain, arm - warm to touch, redness to site.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site warmth, Pain
Clinical narrative: Site felt "hot" since Monday. Pain 1/10- slight redness 70 mm on underside of rigth arm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: 4 year female was vaccinated 2-4-14 with KINRIX in left lateral thigh, MMR in left arm. She woke 2-5-14 with "small amount" of redness and tenderness in left lateral thigh "quarter" sized. She woke 2-6-14, went to daycare, complained of pain, was noted to have larger area of redness. Exam of left lateral thigh revealed 2 inch area of erythema with darker red ring at outer edge, warm to touch and tender; no fluctuance. No limp. No fever.
Age: 17.0
Sex: F
Vaccine: HIBV, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Patient was given PEDVAX HIB, should have been MCV4, we have MENVEO in the office.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Admin dated 1-23-14. Patient called on 2/4/14 stating outbreak occurred on total Rgt side of face.
Age: 0.32
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture, Culture urine, Full blood count, Lacrimation decreased, Lethargy
Clinical narrative: Vomiting not able to keep down any fluids very lethargic, not making any tears, ER course: IV fluids (normal fluids) CBC, x-ray, and BMP culture.
Age: 0.32
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Metabolic function test, Ultrasound pelvis, Urine analysis, Vomiting, X-ray
Clinical narrative: Vomiting not able to keep down any fluids very lethargic, not making any tears, ER course: IV fluids (normal fluids) CBC, x-ray, and BMP culture.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Pharmacy Technician refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients may had been vaccinated with M-M-R II (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. The pharmacy technician reported that 7 doses of improperly stored M-M-R II may had been administered. No adverse events reported. Additional information is not expected.
Age: 9.0
Sex: M
Vaccine: FLU3, HEP, HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Gaze palsy, Headache, Hypertonia, Pyrexia
Clinical narrative: 2 episodes of eyes rolling back in head and generalized increase in tone, no shaking, mild headache, subjective fever, pt taken to ER temp = 99 degrees given fluids, ibuprofen.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain and limited mobility in shot arm.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Softball size lump to left leg, hot to touch and tender. Size 5.5 x 6.5 cm.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist who reported that on an unknown date an unspecified patient was administered a dose of ZOSTAVAX (dose, route, lot No were not reported). The vaccine went through a temperature excursion. The registered pharmacist reported that through in her house stability data did not support the ZOSTAVAX through the temperature excursion. No adverse effects were reported. Additional information has been requested.
Age: 30.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 30 year old patient (gender unspecified). Patients concurrent conditions and historical conditions were unspecified. Approximately in 2012 (two years ago), the patient has received first dose of GARDASIL Intramuscular Injection. On 05-FEB-2013, the patient was vaccinated with GARDASIL dose 2, Intramuscular Injection. Concomitant therapy unspecified. No adverse event effect reported. The physician queried when patient should receive third dose of GARDASIL. Product quality complaint was not involved. The outcome of event was unknown. No further information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown gender that was over 50 years old. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX. Dose, route and lot number were not reported. No co-suspect and concurrent therapies were reported. On an unknown date the patient developed shingles. The patient recently went to the pharmacy on an unspecified date stating that their unspecified physician had prescribed for them to be administered another dose of ZOSTAVAX. A second dose of ZOSTAVAX was not administered. At the time of this report the outcome of shingles was unknown. The patient sought medical attention, went to see unspecified physician. The causality was not reported. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain in left deltoid since vaccine administration. No treatment. No mass, edema, warmth. See attached office note.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Acute respiratory distress syndrome, Angina pectoris, Bronchitis, Candida infection, Chest discomfort
Clinical narrative: 10/16/13 Urinary retention post-hemorrhoidectomy. 10/19/13 Hemorrhoid prolapse, leg pain, scrotal pain chest discomfort 11/12/13 Angina 11/18/13 Angina 11/22/13 angina 11/24/13 hematuria 11/26/13 sleep apnea 12/12/13 chest pain 12/23/13 acute bronchitis 1/11/14 pneumonitis 1/19/14 intubated.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Endotracheal intubation, Haematuria, Haemorrhoid operation, Haemorrhoids
Clinical narrative: 10/16/13 Urinary retention post-hemorrhoidectomy. 10/19/13 Hemorrhoid prolapse, leg pain, scrotal pain chest discomfort 11/12/13 Angina 11/18/13 Angina 11/22/13 angina 11/24/13 hematuria 11/26/13 sleep apnea 12/12/13 chest pain 12/23/13 acute bronchitis 1/11/14 pneumonitis 1/19/14 intubated.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Pneumonitis, Scrotal pain, Sleep apnoea syndrome, Urinary retention
Clinical narrative: 10/16/13 Urinary retention post-hemorrhoidectomy. 10/19/13 Hemorrhoid prolapse, leg pain, scrotal pain chest discomfort 11/12/13 Angina 11/18/13 Angina 11/22/13 angina 11/24/13 hematuria 11/26/13 sleep apnea 12/12/13 chest pain 12/23/13 acute bronchitis 1/11/14 pneumonitis 1/19/14 intubated.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Viral infection
Clinical narrative: 10/16/13 Urinary retention post-hemorrhoidectomy. 10/19/13 Hemorrhoid prolapse, leg pain, scrotal pain chest discomfort 11/12/13 Angina 11/18/13 Angina 11/22/13 angina 11/24/13 hematuria 11/26/13 sleep apnea 12/12/13 chest pain 12/23/13 acute bronchitis 1/11/14 pneumonitis 1/19/14 intubated.
Age: 1.51
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Fever.
Age: 13.0
Sex: F
Vaccine: HPV2, MNQ, TDAP, VARCEL, HPV2, MNQ, TDAP, VARCEL
Symptoms: Blood test, Complex regional pain syndrome, Fibromyalgia, Hypoaesthesia, Local swelling
Clinical narrative: On June 10 got HPV shot on Tues woke up with left arm in pain from elbow all the way down to middle finger it was numb and to hold it close to her body, use pain, ice, heat till 13th she went to the doctor. Hand and arm was swollen. Hand shaking and hurt to move fingers.
Age: 13.0
Sex: F
Vaccine: HPV2, MNQ, TDAP, VARCEL, HPV2, MNQ, TDAP, VARCEL
Symptoms: Nuclear magnetic resonance imaging, Pain, Pain in extremity, Tremor, X-ray
Clinical narrative: On June 10 got HPV shot on Tues woke up with left arm in pain from elbow all the way down to middle finger it was numb and to hold it close to her body, use pain, ice, heat till 13th she went to the doctor. Hand and arm was swollen. Hand shaking and hurt to move fingers.
Age: 19.0
Sex: F
Vaccine: HEP, MMR, TD, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had 4 vaccines and TB skin test placed on 01/31/14. Site of (L) deltoid (Hep B) has some redness and swelling. Site of (R) arm (Varicella vaccine) has some redness and swelling and hot to touch. Does not feel sick, started a day after the vaccines were placed.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain
Clinical narrative: Localized erythema pain.
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Furuncle, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: On January 28, 2014, patient informed me that he developed redness, swelling and a pus filled boil at injection site approximately a week after his influenza vaccine on November 1,2013.
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Furuncle, Injection site erythema, Vaccination site reaction, Vaccination site swelling
Clinical narrative: On January 28, 2014, patient informed me that he developed redness, swelling and a pus filled boil at injection site approximately a week after his influenza vaccine on November 1,2013.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Lip disorder, Pruritus, Rash macular, Throat irritation
Clinical narrative: 7 mins. after 3rd GARDASIL given patient's mother stated patient red blotches on chest, bra line. No other symptoms noted at this time per patient. 7 more mins. patient reporting that her skin feeling more itchy, throat feeling funny and lips feeling funny - BENADRYL 12.5 per 5 mls-10 ml given orally by mouth - oxygen at 2L per NC applied - transferred to E.R. with wheelchair.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Soreness, bump silver dollar size red, itchiness.
Age: 39.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Aphasia, Blood test normal, Computerised tomogram normal, Dizziness, Flushing
Clinical narrative: Immediately after receiving the shots he became flushed and light-headed.  States it was hard to formulate his thought into words at the time.  He layed down with feet elevated for approximately 15 minutes.  Color returned to normal and no longer c/o light-headedness when he left.  States at 1 PM the same day, he developed a headache that lasted all day.  That night he slept 18 hours and woke up with a severe headache.  Temp was 96.7.  Went to ER- CT scan and "blood work" were reported to be normal.  ER Dr told him it was probably a reaction to one of the shots- probably Typhoid injection.  Dr told him it was OK to get #2 dose of Twinrix next week.  Was given Toradol for severe headache pain.  Headache was gone the next day.
Age: 39.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Headache, Immediate post-injection reaction
Clinical narrative: Immediately after receiving the shots he became flushed and light-headed.  States it was hard to formulate his thought into words at the time.  He layed down with feet elevated for approximately 15 minutes.  Color returned to normal and no longer c/o light-headedness when he left.  States at 1 PM the same day, he developed a headache that lasted all day.  That night he slept 18 hours and woke up with a severe headache.  Temp was 96.7.  Went to ER- CT scan and "blood work" were reported to be normal.  ER Dr told him it was probably a reaction to one of the shots- probably Typhoid injection.  Dr told him it was OK to get #2 dose of Twinrix next week.  Was given Toradol for severe headache pain.  Headache was gone the next day.
Age: 17.0
Sex: M
Vaccine: HPVX
Symptoms: Anxiety, Panic disorder
Clinical narrative: Pateient received HPV vaccines on 7/17/13, 9/18/13, and 1/20/14 through another provider.  He started having significant panic and anxiety symptoms requiring psychologist follow up on 8/16/13 and again on 1/24/14.  The second episode more significant and patient was placed on medication for anxiety.  Sister also had the same type of reaction from one of her HPV vaccines.  There is FH of anxiety, so difficult to tell if vaccine related, but mom reports that before this vaccine. Child exhibited no signs of anxiety or panic.
Age: 19.0
Sex: F
Vaccine: HPVX
Symptoms: Anxiety, Condition aggravated, Panic attack, Panic disorder
Clinical narrative: Pateient received HPV vaccines on 8/14/13 and 10/25/13 through another provider.  She started having significant panic and anxiety symptoms requiring medication that began ion 11/27/2013.  Brother also had the same type of reaction from two of his HPV vaccines.  There is FH of anxiety, and patient has some anxiety baseline, so difficult to tell if vaccine related.
Age: 17.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, Unevaluable event
Clinical narrative: None.
Age: 17.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, Unevaluable event
Clinical narrative: None.
Age: 15.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 12.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, Unevaluable event
Clinical narrative: None.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Dizziness, Flushing, Headache, Oesophageal spasm
Clinical narrative: Client experienced throat spasm for 1-2 seconds, dizziness, flushing, tingling, and back pain about 10 minutes after vaccination. Client immediately seated and cold rags applied. BP 116/76, pulse 60. Started feeling better within 5 minutes of onset of symptoms. Back pain and tingling resolved. Gave juice. About 20 minutes after incident client states symptoms resolved except mild headache.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Client experienced throat spasm for 1-2 seconds, dizziness, flushing, tingling, and back pain about 10 minutes after vaccination. Client immediately seated and cold rags applied. BP 116/76, pulse 60. Started feeling better within 5 minutes of onset of symptoms. Back pain and tingling resolved. Gave juice. About 20 minutes after incident client states symptoms resolved except mild headache.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV4, VARCEL
Symptoms: Injection site discharge
Clinical narrative: Mother calling to report child developed "pus" running from injection site.  Mother took child to Dr. and child was placed on antibiotics.  All information was given to clerk.  Mother has declined to return all requests for follow up information.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Muscle twitching, Strabismus, Tic
Clinical narrative: Motor tic, child twitching his head from left to right with a slight squinting in eye, gets worse with watching TV or videos. Sending him to neurologist for tests.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Swelling face
Clinical narrative: Client had coughing and facial swelling.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Expired ADACEL was given to patient. No reaction. CDC was contacted - they said to re-administer. Parent wants to wait. Expired 1-18-2014.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Expired ADACEL was given to patient. No reaction. CDC was contacted - they said to re-administer. Patient wants to wait. Expired 1-18-2014.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Pyrexia, Rash
Clinical narrative: Fever, swelling at injection site, rash.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Diarrhoea, Erythema, Injected limb mobility decreased, Local swelling
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to herself as a 68 year old female patient. On 22-JAN-2014, at 2 PM, the patient was vaccinated with PNEUMOVAX23 lot # J010396 (Expiry: 16-FEB-2015) in the right deltoid. Concomitant medications included SYNTHROID, vitamins (unspecified), flaxseed and XANAX. The patient had pertinent medical history of thyroid problem and some arthritis. The patient was allergic to tetanus serum, sulfa, caffeine, Z-PAK and leproxine (this was how they spelled the medication). On 22-JAN-2014, at 6 PM, the patient experienced that she could not move her right arm and it was painful when she had used her other arm to move the right arm to an arm rest. The patient pulled down her shirt and noticed that her arm was swollen solid and had a really large red, hotspot on arm (Like cellulitis). It was reported that from 22-JAN-2014 to 25-JAN-2014, the swollen part of the top of her arm had moved down below the elbow until it disappeared that evening of 25-JAN-2014. The patient stated that she also had diarrhea all through the adverse experience, but she still has it at time. The patient sought medical attention and called the physician. The patient put ice. The outcome of the events was reported as recovered on 25-JAN-2014. The reporter did not provide the causality between the events and the suspect drug. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Skin warm
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to herself as a 68 year old female patient. On 22-JAN-2014, at 2 PM, the patient was vaccinated with PNEUMOVAX23 lot # J010396 (Expiry: 16-FEB-2015) in the right deltoid. Concomitant medications included SYNTHROID, vitamins (unspecified), flaxseed and XANAX. The patient had pertinent medical history of thyroid problem and some arthritis. The patient was allergic to tetanus serum, sulfa, caffeine, Z-PAK and leproxine (this was how they spelled the medication). On 22-JAN-2014, at 6 PM, the patient experienced that she could not move her right arm and it was painful when she had used her other arm to move the right arm to an arm rest. The patient pulled down her shirt and noticed that her arm was swollen solid and had a really large red, hotspot on arm (Like cellulitis). It was reported that from 22-JAN-2014 to 25-JAN-2014, the swollen part of the top of her arm had moved down below the elbow until it disappeared that evening of 25-JAN-2014. The patient stated that she also had diarrhea all through the adverse experience, but she still has it at time. The patient sought medical attention and called the physician. The patient put ice. The outcome of the events was reported as recovered on 25-JAN-2014. The reporter did not provide the causality between the events and the suspect drug. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood glucose normal, Chest X-ray normal, Chills, Computerised tomogram normal, Dyspnoea
Clinical narrative: CC:PATIENT PRESENTS WITH FEVER, CHILLS AND SOB SINCE LAST NIGHT. HPI:PATIENT STATES PRIOR EVENING, SHE SUDDENLY STARTED HAVING SHAKING CHILLS AND FEVER AND HER SOB GOT WORSE. IN FACT, THIS HAS BEEN INCREASINGLY WORSE OVER THE PAST COUPLE OF DAYS. NO REAL COUGH OR PRODUCTIVE SPUTUM NOTED. SHE ALSO DROVE HERSELF TO PHARMACY AND GOT A FLU SHOT YESTERDAY. SHE DENIES ANY OTHER SYMPTOMS.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Full blood count normal, Pyrexia, Sinus tachycardia, Tremor, White blood cell count increased
Clinical narrative: CC:PATIENT PRESENTS WITH FEVER, CHILLS AND SOB SINCE LAST NIGHT. HPI:PATIENT STATES PRIOR EVENING, SHE SUDDENLY STARTED HAVING SHAKING CHILLS AND FEVER AND HER SOB GOT WORSE. IN FACT, THIS HAS BEEN INCREASINGLY WORSE OVER THE PAST COUPLE OF DAYS. NO REAL COUGH OR PRODUCTIVE SPUTUM NOTED. SHE ALSO DROVE HERSELF TO PHARMACY AND GOT A FLU SHOT YESTERDAY. SHE DENIES ANY OTHER SYMPTOMS.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood glucose normal, Blood pressure increased, Chest X-ray normal, Chills, Computerised tomogram normal
Clinical narrative: CC:PATIENT PRESENTS WITH FEVER, CHILLS AND SOB SINCE LAST NIGHT. HPI:PATIENT STATES PRIOR EVENING, SHE SUDDENLY STARTED HAVING SHAKING CHILLS AND FEVER AND HER SOB GOT WORSE. IN FACT, THIS HAS BEEN INCREASINGLY WORSE OVER THE PAST COUPLE OF DAYS. NO REAL COUGH OR PRODUCTIVE SPUTUM NOTED. SHE ALSO DROVE HERSELF TO PHARMACY AND GOT A FLU SHOT YESTERDAY. SHE DENIES ANY OTHER SYMPTOMS.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Full blood count normal, Heart rate increased, Pyrexia, Sinus tachycardia
Clinical narrative: CC:PATIENT PRESENTS WITH FEVER, CHILLS AND SOB SINCE LAST NIGHT. HPI:PATIENT STATES PRIOR EVENING, SHE SUDDENLY STARTED HAVING SHAKING CHILLS AND FEVER AND HER SOB GOT WORSE. IN FACT, THIS HAS BEEN INCREASINGLY WORSE OVER THE PAST COUPLE OF DAYS. NO REAL COUGH OR PRODUCTIVE SPUTUM NOTED. SHE ALSO DROVE HERSELF TO PHARMACY AND GOT A FLU SHOT YESTERDAY. SHE DENIES ANY OTHER SYMPTOMS.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tremor, White blood cell count increased
Clinical narrative: CC:PATIENT PRESENTS WITH FEVER, CHILLS AND SOB SINCE LAST NIGHT. HPI:PATIENT STATES PRIOR EVENING, SHE SUDDENLY STARTED HAVING SHAKING CHILLS AND FEVER AND HER SOB GOT WORSE. IN FACT, THIS HAS BEEN INCREASINGLY WORSE OVER THE PAST COUPLE OF DAYS. NO REAL COUGH OR PRODUCTIVE SPUTUM NOTED. SHE ALSO DROVE HERSELF TO PHARMACY AND GOT A FLU SHOT YESTERDAY. SHE DENIES ANY OTHER SYMPTOMS.
Age: 21.0
Sex: M
Vaccine: ADEN_4_7, FLU3, HEPA, MNQ, TDAP, VARCEL
Symptoms: Lip swelling, Nausea
Clinical narrative: C/o swelling of upper lip and nausea only.
Age: 14.0
Sex: F
Vaccine: FLU3, HEP, HPV4, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Erythema, Headache, Injection site pruritus, Injection site warmth, Local swelling
Clinical narrative: Today, the patient presented back to the immunization clinic and reported that the reaction started three days ago with itchiness and warmth on her left posterior, upper arm where she received her Varicella vaccination on January 21, 2014. The patient reports that two days ago she had a headache and then she noticed a red, raised area on her lower, right, anterior neck. The patient reports that the next day she had two additional red, raised areas on the lower, left quadrant of her abdomen. The two areas are about one-half inch apart from each other. One of the areas appears to have an entry point. Today, she noticed that had a red, flat area on her left, upper shoulder. All of the red areas previously noted were closed and dry and approximately the size of a quarter. Patient's mother was given driving directions to the nearest emergency room and instructed to go there immediately after leaving here.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Blister
Clinical narrative: NOTICED BLISTER ON FACE AFTER 1 WK OF RECEIVING SMALLPOX VACCINATION.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: SWELLING OF INJECTION SITE WITH PRURITUS. SEEN THE NEXT DAY, RECOMMENDED COLD COMPRESS AND BENARYL 25 MG Q 6-8 HOURS PRN SCRATCHING.
Age: 57.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Death
Clinical narrative: Death.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: Patient received Zostavax 2/4/14 and began to develop itching, redness, somewhat firm area to posterior left arm on 2/6/14.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Decreased appetite, Lethargy, Pruritus, Rash
Clinical narrative: Extreme lethargy and sleepiness, difficult to wake up, slept for long time, loss of appetite, rash that slowly spread up his body, itchy skin, deep cough.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Somnolence
Clinical narrative: Extreme lethargy and sleepiness, difficult to wake up, slept for long time, loss of appetite, rash that slowly spread up his body, itchy skin, deep cough.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Alopecia, Arthralgia, Chest pain, Dyspnoea
Clinical narrative: Joint pain, leg and body pain, auto-immune symptoms, losing hair, extreme fatigue, difficulty breathing, lung pain, chest pain, shaking, memory problems (brain fog), etc.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Feeling abnormal, Laboratory test normal, Malaise, Memory impairment
Clinical narrative: Joint pain, leg and body pain, auto-immune symptoms, losing hair, extreme fatigue, difficulty breathing, lung pain, chest pain, shaking, memory problems (brain fog), etc.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pain in extremity, Tremor
Clinical narrative: Joint pain, leg and body pain, auto-immune symptoms, losing hair, extreme fatigue, difficulty breathing, lung pain, chest pain, shaking, memory problems (brain fog), etc.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Chills, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: First, painful, hot arm; difficult to lift. Then by 9:00 PM, chills and fever. Next day fever peaked at 103.4 degrees with severe joint pain; fever subsided but did not return to normal until 2/6/14. Took Naproxen, applied ice and silver gel.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Skin warm
Clinical narrative: First, painful, hot arm; difficult to lift. Then by 9:00 PM, chills and fever. Next day fever peaked at 103.4 degrees with severe joint pain; fever subsided but did not return to normal until 2/6/14. Took Naproxen, applied ice and silver gel.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Back pain, Body temperature increased, Chills, Dizziness, Local swelling
Clinical narrative: First, painful, hot arm; difficult to lift. Then by 9:00 PM, chills and fever. Next day fever peaked at 103.4 degrees with severe joint pain; fever subsided but did not return to normal until 2/6/14. Took Naproxen, applied ice and silver gel.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Nausea, Pain, Tenderness, Vaccination complication
Clinical narrative: First, painful, hot arm; difficult to lift. Then by 9:00 PM, chills and fever. Next day fever peaked at 103.4 degrees with severe joint pain; fever subsided but did not return to normal until 2/6/14. Took Naproxen, applied ice and silver gel.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Chills, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Pt. received PNEUMOVAX 2/3/2014 and around dinner time c/o (L) arm hurting severely to touch, swollen, not red or warm, temp 100/chills. 2/4/14 Pt. awoke feeling achy all over and c/o severe pain in lower back/tailbone area, 8/10 intense ache, only relief with standing. When standing or sitting up felt lightheaded like she would pass out, no vertigo, no vision changes. Iced helped tailbone. Took NAPROSYN and eventually kicked in and pt able to fall asleep. Back pain gone but feels a little achy. Had some nausea no vomiting. No leg weakness or numbness. No trouble breathing. No lip or tongue swelling. No recent injury to back or tailbone. Never had anything like this before and no h/o immunization reactions.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Skin warm
Clinical narrative: Pt. received PNEUMOVAX 2/3/2014 and around dinner time c/o (L) arm hurting severely to touch, swollen, not red or warm, temp 100/chills. 2/4/14 Pt. awoke feeling achy all over and c/o severe pain in lower back/tailbone area, 8/10 intense ache, only relief with standing. When standing or sitting up felt lightheaded like she would pass out, no vertigo, no vision changes. Iced helped tailbone. Took NAPROSYN and eventually kicked in and pt able to fall asleep. Back pain gone but feels a little achy. Had some nausea no vomiting. No leg weakness or numbness. No trouble breathing. No lip or tongue swelling. No recent injury to back or tailbone. Never had anything like this before and no h/o immunization reactions.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Back pain, Body temperature increased, Chills, Dizziness, Local swelling
Clinical narrative: Pt. received PNEUMOVAX 2/3/2014 and around dinner time c/o (L) arm hurting severely to touch, swollen, not red or warm, temp 100/chills. 2/4/14 Pt. awoke feeling achy all over and c/o severe pain in lower back/tailbone area, 8/10 intense ache, only relief with standing. When standing or sitting up felt lightheaded like she would pass out, no vertigo, no vision changes. Iced helped tailbone. Took NAPROSYN and eventually kicked in and pt able to fall asleep. Back pain gone but feels a little achy. Had some nausea no vomiting. No leg weakness or numbness. No trouble breathing. No lip or tongue swelling. No recent injury to back or tailbone. Never had anything like this before and no h/o immunization reactions.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Nausea, Pain, Tenderness, Vaccination complication
Clinical narrative: Pt. received PNEUMOVAX 2/3/2014 and around dinner time c/o (L) arm hurting severely to touch, swollen, not red or warm, temp 100/chills. 2/4/14 Pt. awoke feeling achy all over and c/o severe pain in lower back/tailbone area, 8/10 intense ache, only relief with standing. When standing or sitting up felt lightheaded like she would pass out, no vertigo, no vision changes. Iced helped tailbone. Took NAPROSYN and eventually kicked in and pt able to fall asleep. Back pain gone but feels a little achy. Had some nausea no vomiting. No leg weakness or numbness. No trouble breathing. No lip or tongue swelling. No recent injury to back or tailbone. Never had anything like this before and no h/o immunization reactions.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Local reaction
Clinical narrative: Local reaction began 2 hours after vaccination. Progressively spread. To about 10 cm oval the next day. Then 12x15 cm oval on 2/7/2014. So basically a large cellulitis-like reaction.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria, VIIth nerve paralysis
Clinical narrative: Pt. reported hives on the face, and right side of face had slightly dropped.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Paraesthesia, Sleep disorder
Clinical narrative: Severe soreness at site of injection, enough to awaken pt from sleep. Site (R arm) sore, R axilla, R scapular area sore, extension of arm difficult, raising arm difficult. Slight tingling R little finger. No erythema, swelling, loss of function or systemic complaints.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Cystitis interstitial
Clinical narrative: Symptoms of Interstitial Cystitis.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Condition aggravated, Iritis
Clinical narrative: Patient describes an exacerbation of "iritis" 8 hours after administration. His last exacerbation was 6 years ago (per patient).
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Condition aggravated, Eye inflammation, Iritis, Vitreous floaters
Clinical narrative: Patient describes an exacerbation of "iritis" 8 hours after administration. His last exacerbation was 6 years ago (per patient).
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Developed fever 101.4, body ache and headache, lasted 36-48 hours.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Axillary pain, Erythema, Induration, Local swelling
Clinical narrative: Fever of 101.0 F on 2/6/14, swelling of (R) arm with 2 in. induration and redness w/ pain from elbow to armpit and swollen lymph nodes in armpit.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Fever of 101.0 F on 2/6/14, swelling of (R) arm with 2 in. induration and redness w/ pain from elbow to armpit and swollen lymph nodes in armpit.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Patient presented w/ cellulitis of arm where injection was given.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 10+ cm induration and redness of the deltoid.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: (L) deltoid redness, pain.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Vaccination complication
Clinical narrative: Cellulitis, complication of immunization.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Needle issue
Clinical narrative: Needle bent at 90 degree angle when attempted to administer Flu shot. Vanish Point syringe 3 cc 25G x 1" Lot: A790A. No vaccine was administered w/ this needle. New needle and new vaccine administered.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt. called to discuss 2/5/14 PNEUMOVAX. Took call on 2/6/14 at 3:40 PM. Pt c/o painful left deltoid, red, hot, swollen and (L) axillary pain. Chills, feels shaky.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Nervousness
Clinical narrative: Pt. called to discuss 2/5/14 PNEUMOVAX. Took call on 2/6/14 at 3:40 PM. Pt c/o painful left deltoid, red, hot, swollen and (L) axillary pain. Chills, feels shaky.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Erythema, Pain, Rash, Swelling
Clinical narrative: Reported pain, rash, swelling and redness on left side of her body.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Tendonitis
Clinical narrative: Pt complained of pain on shoulder where flu shot was given - especially when they lift up left arm - feels like tendonitis pain for 4 week now.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from an office supervisor who reported that a patient of an unknown age and gender received their 1st dose of VAQTA (route and lot # not reported) on 01-MAR-2006 and their 2nd dose of VAQTA (route and lot # not reported) today, 05-FEB-2014. No adverse effects reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Tendonitis
Clinical narrative: Pt complained of pain on shoulder where flu shot was given - painful when they lift up arm feeling like tendonitis pain.
Age: 23.0
Sex: M
Vaccine: FLU3, HEPA, TDAP, FLU3, HEPA, TDAP
Symptoms: Dizziness, Loss of consciousness, Pallor, Snoring, Tremor
Clinical narrative: He became lightheaded approximately 1 min after vaccine administration, then extremely pale. Approximately 1 min later he lost consciousness, was shaking and snoring. He regained consciousness after approximately 15 seconds.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Lumbar puncture normal, Myalgia, Papilloedema, Vision blurred
Clinical narrative: This spontaneous report was received from a physician refers to a 19 year old male patient. On an unknown date, the patient was vaccinated with first dose of GARDASIL (strength and frequency was not reported). Concomitant therapies included SEROQUEL. On an unknown date, the following day after administration of GARDASIL, the patient experienced blurred vision, headache and muscle aches. The patient sought medical attention and visited the neuro ophthalmologist who noted that the patient had extreme papilledema and an extremely high opening pressure. On an unknown date, a lumbar puncture was done and the result was reported as negative. The outcome of the event blurred vision, headache, muscle aches and extreme papilledema and an extremely high opening pressure was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a consumer refers to herself as a 27 year old female patient. On an unknown date, the patient was vaccinated with first shot of GARDASIL (strength and frequency was not reported). The patient reported that she was 27 year old and received first shot of GARDASIL. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Secondary transmission, Varicella
Clinical narrative: This spontaneous report as received from a physician via a Company representative refers to a "less than a 1 year old" patient of unknown gender. Medical and concurrent conditions were not reported. On an unknown date, the patient was exposed through his/her grandparent was vaccinated with ZOSTAVAX (dose, strength, route and lot number were not reported). Secondary and concomitant therapies were not reported. The physician reported that after ZOSTAVAX was administered to a consumer, the consumer's "unvaccinated" grandchild developed a "significant" case of chickenpox. According to physician, the chickenpox resulted in "complications" for the grandchild. It was reported that the patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. The physician considered that chickenpox and the chickenpox resulted in "complications" caused to the patient a significant disability or incapacity. It was noted that the physician attributed the child's chickenpox to the ZOSTAVAX administered to grandparent being around the "less than 1 year old" grandchild. The physician was now telling patient vaccinated with ZOSTAVAX to avoid contact with children less than a year old for "six weeks" after getting the shot. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 months old patient of unknown demographics. The patient's current conditions or medical history were not reported. The nurse reported that the patient received the first, second and third the second doses of LIQUID PEDVAHIB at 2 months of age, at 4 months of age and at 6 months of age, respectively. No adverse experiences were reported. At the time of the report the outcome was unknown. Additional information has been requested.