chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood glucose increased, Blood pressure increased, Bursitis, Condition aggravated, Injected limb mobility decreased
Clinical narrative: On 10/19/2012 claimant entered the pharmacy for the purpose of obtaining an influenza vaccine which was administered and injected in claimant's upper left arm. Within 48 hours claimant experienced itching and hives of the left arm. In the next 48 hours claimant experienced pain which became excruciating. I could not move the fingers of my left hand nor move my left arm. I had to obtain emergency care. X-rays revealed a swelling and inflammation of a fluid-filled sac that overlies and protects the elbow. Follow up care indicated a rise in blood pressure, laboratory data indicated a significant rise in toxins and glycemic levels. Periodic assessment of glaucoma tests indicated significant rise in optic pressure. To date claimant continues to experience weakness and throbbing of the left hand.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Intraocular pressure increased, Intraocular pressure test abnormal, Mobility decreased, Muscular weakness, Pain
Clinical narrative: On 10/19/2012 claimant entered the pharmacy for the purpose of obtaining an influenza vaccine which was administered and injected in claimant's upper left arm. Within 48 hours claimant experienced itching and hives of the left arm. In the next 48 hours claimant experienced pain which became excruciating. I could not move the fingers of my left hand nor move my left arm. I had to obtain emergency care. X-rays revealed a swelling and inflammation of a fluid-filled sac that overlies and protects the elbow. Follow up care indicated a rise in blood pressure, laboratory data indicated a significant rise in toxins and glycemic levels. Periodic assessment of glaucoma tests indicated significant rise in optic pressure. To date claimant continues to experience weakness and throbbing of the left hand.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Pruritus, Toxicologic test abnormal, Urticaria, X-ray limb abnormal
Clinical narrative: On 10/19/2012 claimant entered the pharmacy for the purpose of obtaining an influenza vaccine which was administered and injected in claimant's upper left arm. Within 48 hours claimant experienced itching and hives of the left arm. In the next 48 hours claimant experienced pain which became excruciating. I could not move the fingers of my left hand nor move my left arm. I had to obtain emergency care. X-rays revealed a swelling and inflammation of a fluid-filled sac that overlies and protects the elbow. Follow up care indicated a rise in blood pressure, laboratory data indicated a significant rise in toxins and glycemic levels. Periodic assessment of glaucoma tests indicated significant rise in optic pressure. To date claimant continues to experience weakness and throbbing of the left hand.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood glucose increased, Blood pressure increased, Bursitis, Intraocular pressure increased, Mobility decreased
Clinical narrative: On 10/19/2012 claimant entered the pharmacy for the purpose of obtaining an influenza vaccine which was administered and injected in claimant's upper left arm. Within 48 hours claimant experienced itching and hives of the left arm. In the next 48 hours claimant experienced pain which became excruciating. I could not move the fingers of my left hand nor move my left arm. I had to obtain emergency care. X-rays revealed a swelling and inflammation of a fluid-filled sac that overlies and protects the elbow. Follow up care indicated a rise in blood pressure, laboratory data indicated a significant rise in toxins and glycemic levels. Periodic assessment of glaucoma tests indicated significant rise in optic pressure. To date claimant continues to experience weakness and throbbing of the left hand.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscular weakness, Pain, Pain in extremity, Pruritus, Swelling
Clinical narrative: On 10/19/2012 claimant entered the pharmacy for the purpose of obtaining an influenza vaccine which was administered and injected in claimant's upper left arm. Within 48 hours claimant experienced itching and hives of the left arm. In the next 48 hours claimant experienced pain which became excruciating. I could not move the fingers of my left hand nor move my left arm. I had to obtain emergency care. X-rays revealed a swelling and inflammation of a fluid-filled sac that overlies and protects the elbow. Follow up care indicated a rise in blood pressure, laboratory data indicated a significant rise in toxins and glycemic levels. Periodic assessment of glaucoma tests indicated significant rise in optic pressure. To date claimant continues to experience weakness and throbbing of the left hand.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Toxicologic test abnormal, Urticaria, X-ray limb abnormal
Clinical narrative: On 10/19/2012 claimant entered the pharmacy for the purpose of obtaining an influenza vaccine which was administered and injected in claimant's upper left arm. Within 48 hours claimant experienced itching and hives of the left arm. In the next 48 hours claimant experienced pain which became excruciating. I could not move the fingers of my left hand nor move my left arm. I had to obtain emergency care. X-rays revealed a swelling and inflammation of a fluid-filled sac that overlies and protects the elbow. Follow up care indicated a rise in blood pressure, laboratory data indicated a significant rise in toxins and glycemic levels. Periodic assessment of glaucoma tests indicated significant rise in optic pressure. To date claimant continues to experience weakness and throbbing of the left hand.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Neuralgia, Neuropathy peripheral
Clinical narrative: This medically confirmed report (initial receipt 03-Dec-2013) concerns a 77 year old female patient. On the 07-Nov-2013, the patient received AFLURIA (batch number R52406). On an unspecified date, the patient experienced neuralgias and neuropathy in the injection arm ever since vaccination. The patient had trouble raising her arm. The patient sought medical attention via a physician office visit. She was prescribed unspecified medications for treatment. Outcome was reported as not recovered.
Age: 7.0
Sex: U
Vaccine: MMR
Symptoms: Hypersensitivity, Reaction to food additive
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 year old patient. On 28-AUG-2001, the patient received first dose of MMR II (lot number, expiry date, dose and route of administration were not reported) and 16-JUN-2008 the patient was vaccinated with the second dose of MMR II (lot number, expiry date, dose and route of administration were not reported). On 15-MAY-2003, patient received one dose of VARIVAX (lot number, expiry date, dose and route of administration were not reported). No concomitant therapies were reported. The reporting nurse could not identify an adverse event when the two doses of MMR II and the one dose of VARIVAX were administered. But it was noted in the patient's chart that the patient had a critical reaction to porcine gelatin on 30-OCT-2009. The reporting nurse has no information at the time of the call on what the critical reaction was or what caused the critical reaction. The outcome of critical reaction to porcine gelatin was recovered. The causality of the events in relation to the two doses of MMR II and the one dose of VARIVAX was unknown. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Burning sensation, Hypothyroidism, Limb discomfort, Paraesthesia
Clinical narrative: This spontaneous report was received from an approximately 67 year old female patient with high blood pressure and high cholesterol concerning herself. The patient did not have drug allergy. On an unknown date the patient was vaccinated with ZOSTAVAX "one shot", subcutaneous. Concomitant therapies included labetalol hydrochloride and lisinopril (+) hydrochlorothiazide (manufacturer unknown). The patient reported that on an unspecified date in May 2013, she "developed extreme itching, burning and tingling" in the left arm after receiving ZOSTAVAX. As treatment, the patient reported that she was prescribed "Hydroxyzine HCL and SARNA topical cream anti-itch lotion" to reduce the itching and discomfort in the left arm. Manufacturers for Hydroxyzine HCL and SARNA are unknown. The patient also stated that on an unspecified date one year after having received ZOSTAVAX, she developed a "poison ivy like rash" on the right arm. The patient was also prescribed Levothyroxine (manufacturer unknown) for hypothyroidism that she developed on an unspecified date after receiving ZOSTAVAX. Lab test included routine blood work. No lab result was reported. The outcome of hypothyroidism, "poison ivy like rash" on the right arm, "extreme itching, burning and tingling" in the arm left arm were unknown. The patient saw the doctor to seek medical attention. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: This spontaneous report was received from an approximately 67 year old female patient with high blood pressure and high cholesterol concerning herself. The patient did not have drug allergy. On an unknown date the patient was vaccinated with ZOSTAVAX "one shot", subcutaneous. Concomitant therapies included labetalol hydrochloride and lisinopril (+) hydrochlorothiazide (manufacturer unknown). The patient reported that on an unspecified date in May 2013, she "developed extreme itching, burning and tingling" in the left arm after receiving ZOSTAVAX. As treatment, the patient reported that she was prescribed "Hydroxyzine HCL and SARNA topical cream anti-itch lotion" to reduce the itching and discomfort in the left arm. Manufacturers for Hydroxyzine HCL and SARNA are unknown. The patient also stated that on an unspecified date one year after having received ZOSTAVAX, she developed a "poison ivy like rash" on the right arm. The patient was also prescribed Levothyroxine (manufacturer unknown) for hypothyroidism that she developed on an unspecified date after receiving ZOSTAVAX. Lab test included routine blood work. No lab result was reported. The outcome of hypothyroidism, "poison ivy like rash" on the right arm, "extreme itching, burning and tingling" in the arm left arm were unknown. The patient saw the doctor to seek medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a medical assistant regarding a female patient of unknown age. Approximately on an unknown date in 2012, the patient was vaccinated with first dose of GARDASIL (Lot number, expiry date, dose, route and frequency not specified). The second dose of the vaccine was taken on an unspecified date in 2012. The third dose of GARDASIL was supposed to be taken in December 2012, but the patient did not receive the third dose within specified time (outside the recommended dosing schedule) and was in the office to receive the third dose. No product quality issue was noted. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to a patient of unknown age and gender. The reporter reported that the patient was vaccinated with GARDASIL (Lot # unspecified) Intramuscular injections, first dose "in 2011", the second dose "in 2012" and the third dose in October 2013 (dose, route and indication unspecified). No adverse effect reported. Outcome of the event was not reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to patients of unknown age. On an unknown date the patients were vaccinated with a dose of ZOSTAVAX (lot/batch#, dose and route unknown). The pharmacist reported that between two and four patients have returned to the pharmacy with active cases of shingles. The reporter stated that the onset date had been anywhere from 2 days to two weeks. The reporter stated that these patients have sought treatment from their physicians. At the time of reporting, the outcome of adverse event was unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. On an unknown date an unspecified number of patients might have been vaccinated with improperly stored dose of LIQUID PEDVAXHIB. Dose, lot and expiry date were unspecified. No adverse effects were reported. This is 2 of several cases from same reporter. Additional information has been requested.
Age: 0.18
Sex: F
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: This spontaneous report as received from nurse refers to a 2 month old female patient. On 09-DEC-2013, the patient was vaccinated with ROTATEQ, 2 ml, oral. No concomitant medication reported. It was reported that the patient has no medical history and allergies. It was reported that mother of child was at the health department yesterday feed the child her formula, and then ROTATEQ was administered. The mother of child called the doctors office and stated on 09-DEC-2013 (yesterday), the child vomited after a dose of ROTATEQ and spit up everything including the formula and ROTATEQ. The patient sought medical attention (called doctors office). The outcome of child spit up everything and vomited after a dose of ROTATEQ was unknown. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a physician via field representative refers to a 66 year old male patient. On 13-NOV-2013 reported as a month ago, the patient was vaccinated with ZOSTAVAX, dose 0.65 milliliters. Route, lot and expiry date were not reported. On 13-DEC-2013, the patient came into the HCP office to seek medical attention, where he was diagnosed with shingles. He had a painless rash on his abdomen. The outcome of events was unknown. Lab tests were not performed. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a third party claims administrator on behalf of a pharmacy concerning a female patient who was vaccinated with PNEUMOVAX23 (lot # J004747, with expiration date 20-Jul-2014) and a influenza virus vaccine (unspecified) (manufacturer unspecified) and had an adverse reaction. It was unknown which vaccine she had the reaction to. Treatment and outcome of the adverse reaction were unknown. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 52 year old female patient. There were no known drug reactions reported. On 04-DEC-2013 the patient was vaccinated with ZOSTAVAX subcutaneous (strength not reported, lot # J011211, dose: 0.65 ml in the right arm). Other suspect therapies included influenza virus vaccine (manufacturer unknown) (also injected in the right arm). On 04-DEC-2013 the patient reported that ZOSTAVAX vaccination site was red, swollen and warm to touch. No treatment was given. No lab diagnostics studies were performed. The patient did not seek medical attention. The outcome of events was reported as not recovered/not resolved. The relatedness between ZOSTAVAX and influenza virus vaccine (manufacturer unknown) and events was not reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Pt called in complaining area around shot was hot, red, and hard.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a Licensed Practical Nurse, for HPV vaccine, a Pregnancy Registry product, concerning a teenager female who on 16-AUG-2011 intramuscularly received the third dose of HPV vaccine (lot# unspecified). The nurse reported that the patient's mother just called the office to report the patient was approximately 3 weeks pregnant (positive pregnancy test, LMP approximately on 19-AUG-2011, EDD: approximately on 25-MAY-2012). The nurse reported this patient had not been seen in the office for years and was no longer a patient. They did not vaccinate her with HPV vaccine. It was unknown if the patient had sought any medical attention. Follow up information has been received. The health care professional did not have any information of this patient. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Information has been received from a 27 year old female consumer with nausea, no drug reactions or allergies and no pertinent medical history who refers to herself, for GARDASIL, a Pregnancy Registry Product, who on 13-FEB-2012, was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). The consumer stated that she was administered GARDASIL on 13-FEB-2012, (dose in vaccination schedule was unknown) and it was subsequently determined on 15-FEB-2012, that she was six weeks pregnant. Her last menstrual period was on approximately 04-JAN-2012. Her estimated delivery date was approximately 10-OCT-2012. Urine test was performed at physician's office to determine pregnancy. The patient sought medical attention in physician's office. Follow up information received. Three attempts was made at follow up with no response. The case is lost to follow up. The pregnancy outcome is unknown. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot# and route not of reported), standard dose (estimated as 0.65 ml). On an unknown date the patient experienced shingles accompanied by pain after receiving ZOSTAVAX. Patient sought medical attention via office visit. The outcome of the events was unknown. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Blood test, Herpes zoster, Pruritus
Clinical narrative: This spontaneous report as received from a 79 year old male patient and refers to himself. The patient had allergy to penicillin and his concurrent condition included rheumatoid arthritis. On an unknown date in 2012 (within last year), the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, route of administration, dose and frequency not provided). Concomitant therapies included methotrexate (manufacturer unknown), ibuprofen and PLAQUENIL. On 21-OCT-2013 (reported as "4 weeks ago") the patient developed shingles. The patient explained that the outbreak was itchy, however he has not had the nerve pain that he's heard was often related to the shingles. Patient stated that he still had blisters at that point, however they were "drying up". He also stated that he has been a patient on methotrexate (manufacturer unknown) 2.5 mg for approximately 10 years for the treatment of the onset of his shingles symptoms. Lab diagnostic studies were performed and included: routine blood work done every 6 weeks (results not reported). The patient was treated for the event with an unspecified antiviral medications given for 7 days. The outcome of shingles was reported as recovering/resolving at the time of the report. The patient sought medical attention via taking with physician. The relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested. This is one of several reports received from the same source (other: MARRS # 1312USA001250 - Same patient link).
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hypoaesthesia, Myalgia
Clinical narrative: This spontaneous report as received from a consumer refers to a currently 12 year old female patient who was not pregnant. On an unknown date the patient was vaccinated with second dose in the series of GARDASIL intramuscular (dose, strength and site of administration not reported). On an unknown date in December 2013 (reported as sometime last week) the patient experienced headaches, numbness and muscle aches. No treatment was given. The advising physician told the patient to visit a psychiatrist. The outcome of numbness, muscle aches and headaches was reported as not recovered/not resolved. The relatedness between GARDASIL and events was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. On an unknown date an unspecified number of patients might have been vaccinated with improperly stored dose of RECOMBIVAX HB. Dose, lot and expiry date were unspecified. No adverse effects were reported. This is 1 of several cases from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. On an unknown date an unspecified number of patients might have been vaccinated with improperly stored dose of VAQTA. Dose, lot and expiry date were unspecified. No adverse effects were reported. This is 3 of several cases from same reporter. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: MMR
Symptoms: Allergy test positive, Food allergy, Hypersensitivity, Injection site erythema, Injection site urticaria
Clinical narrative: This spontaneous report as received from a lab technician to a 12 month old female patient. The patient did not have pertinent medical history or drug allergy. On 20-SEP-2013 the patient was vaccinated with M-M-R II lot # H018947, exp 18-OCT-2014, 0.5 ml, subcutaneous. There was no concomitant therapy. On 20-SEP-2013, patient had an allergic reaction within 5 minutes of receiving M-M-R II on 20-SEP-2013. Patient developed redness and welts around injection site and was given 4ml BENADRYL for treatment and reaction subsided quickly. Patient was sent to an allergist (name unspecified), allergy test was done, and patient was diagnosed with an egg allergy. Patient recovered on 20-SEP-2013. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vaccination site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. On 02-DEC-2013 the patient was vaccinated with a dose of PNEUMOVAX23 lot # J009827, expiration date 10-AUG-2014, intramuscularly in the arm. It was unspecified if this was the only dose of PNEUMOVAX23 this patient has ever been administered. Other suspect therapies included FLUVIRIN administered concomitantly on the same arm on 02-DEC-2013. On 04-DEC-2013 the patient presented at the pharmacy with rash on the arm where the vaccines were administered. It was unspecified when this rash developed. The patient sought medical attention. The patient was prescribed oral prednisone by his physician. The outcome of the rash on the arm where the vaccines were administered was unknown. The relatedness between the rash on the arm where the vaccines were administered and PNEUMOVAX23 and FLUVIRIN was not reported. Additional information has been requested.
Age: 1.57
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Immediate post-injection reaction, Injection site urticaria
Clinical narrative: Child was given vaccines as follows: Hepatitis A and PREVNAR in right deltoid Hep A upper and PREVNAR 1" lower and over, MMR upper left arm and VARIVAX 2" lower on upper left arm. Flu vaccine left anterior thigh. Hives developed immediately above MMR site.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: This spontaneous report as received from a 66 year old male patient refers to himself with cholesterol, bipolar and acid reflux. His medical history included hand tremor. The patient had no drug reactions/allergies. On 10-DEC-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # unspecified) (1 injection, location and frequency unspecified) for prevention of shingles. Concomitant therapies included with LIPITOR 40mgx1, CORGARD 40mgx1, WELLBUTRIN 350x1, PREVACID 30mgx2. On 13-DEC-2013 ("3 days after the vaccine was given" as reported) the patient noticed a raised red bump about a quarter size without a rash. The patient did not seek medical attention. At the time of report, the outcome of the events was unknown. Additional information has been requested.
Age: 32.0
Sex: U
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Stated arm hurt can use it but painful to move. MD said not cause by flu injection. Hx of neuropathy time 1 year in both hands. Stop going to neurologist.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure before pregnancy
Clinical narrative: Information has been received from a physician via company representative regarding 16-year old female patient. In August 2008 the patient was vaccinated with the first dose GARDASIL (lot number, route and site of administration were not reported) as a prevention of HPV. In September 2011 the patient got her second dose of GARDASIL 0.5 ml (lot number, route and site of administration were not reported) as a prevention of HPV. The doctor told that the patient became pregnant (October 2011) after receiving her second dose of GARDASIL. The patient was as 6 months gestation at time of report and LMP was approximately on 18-OCT-2011, Estimated Delivery Date (EDD) was approximately on 24-JUL-2012. No adverse event was reported. The patient has not yet received her third dose yet. The patient sought medical attention. No treatment was given for the event. The patient sought unspecified medical attention. The outcome of adverse events was not reported. The relatedness between therapy with GARDASIL and adverse events was not reported. Follow-up retrospective pregnancy report was received from a physician refers to a 16 year old female patient. It was reported that the Estimated Delivery Date (EDD) was on 20-JUL-2012. The pregnancy outcome was reported as: normal infant, without congenital anomaly. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacy student who noted that an unspecified number of unspecified patients had experienced injection site reactions after being vaccinated with ZOSTAVAX (lot # not reported) on an unspecified dates. The outcome of injection site reactions was unknown. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Urticaria
Clinical narrative: Mother called on phone and stated son said he had broken out in hive on trunk and was coughing.
Age: 12.0
Sex: M
Vaccine: FLU3, HEPA, MNQ
Symptoms: Convulsion, Electrocardiogram, Loss of consciousness, Nausea, Tremor
Clinical narrative: Pt awoke on morning after vaccines were administered, felt nauseated, had a loss of consciousness, shaking followed.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling hot, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Came to office 9/7/13 with 4.8 x 5.9 cm red, warm area of Rt deltoid area at injection site. She states she was hot/chills and achy - did not take temp - evening of 9/4, and swelling and redness at site as above. 9/6 swelling gone - temp 9/7 - 98.6.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Came to office 9/7/13 with 4.8 x 5.9 cm red, warm area of Rt deltoid area at injection site. She states she was hot/chills and achy - did not take temp - evening of 9/4, and swelling and redness at site as above. 9/6 swelling gone - temp 9/7 - 98.6.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: 5 days after Shingles vaccine pain in multiple muscles, that has increased in intensity and has not subsided. I do have a condition that causes muscle pain, but these are sharp and pronounced since the vaccine. Have been forced to take painkillers which I had avoided.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling abnormal, Myalgia, Nodule, Rash generalised
Clinical narrative: Patient received a flu vaccine injection on 11/13/2013. Patient states that she felt lousy for 1 week, erythema near the injection site, rash all over her body, muscle pain and soreness described as "being punched in the arm". Patient denied any fever, patient still has a nodule near the injection site. Muscle soreness, and a slight rash on the arm of the injection site.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Aphasia, Hypertension, Musculoskeletal disorder
Clinical narrative: I am writing you this letter, as far as name of drug used will have to be checked out by the department. I could not get info from pharmacy of the drug used in flu shot received on 11/4/2013. I do not know if proper care was done to insure safety of drug, that is why inspector will have to check this out. I still can not believe this drug used for the flu has contains weed killer in it. I read on and I found out that even the doctors do not know about this. My reaction to the flu shot was devastating. I could not talk, use my hands, legs and arms, my blood pressure was extremely high, uc care doctor would nothing for me sent me to ER where again the doctors did not know even when I felt my body come back the doctor said tell you did not have a stroke, which I have worked for Doctor and even I know that I was not a stroke. It was from the flu shot. I have used weed kill in my yard once and reading cover eyes nose mouth wear rubber gloves if you get any on bare skin wash asap with soap and water. I feel this drug should be taken off the market asap. I almost died not to mention a large Hospital bill which I feel Food and Drug should pay for knowing all along there was a DANGEROUS NEUROTOXIN IN THE FLU SHOT!!!!!! I have also found out that people have died. My question to you how many more people will go through what I did or die before Food and Drug will take this dangerous shot off the market!!!!!! I thought that food and drug was looking out for our safety in the shots or meds we are taking was safe for all ages, guess I was wrong. Oh about Hospital bill I have been told that Food and Drug does have a responsible for allowing a dangerous drug to be left on shelf or shot that have a dangerous neurotoxin in them. Response to letter requested. Please help me save any more people from going through what I did or dying!!!!!!!
Age: 62.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Abasia, Arthralgia, Diarrhoea, Dizziness, Dysstasia
Clinical narrative: On September 27, 2013 I had my annual physician visit to refill my prescriptions. During the course of this visit I received 2 shots. One was a flu vaccine. The other was the shingles vaccine (ZOSTAVAX). Within 12 hours I was taken to the medical center emergency room. I had the following symptoms: I was very dizzy and I was unable to walk or stand, extreme nausea, extreme diarrhea, extreme body and joint aches and pains to the point where I was just writhing in misery I was able to call a friend for help who took me to the emergency room. After treating me, the physicians told me I had a severe reaction to the shingles vaccine I received by my medical provider about 12 hours earlier. I was very ill and thought I may die. I believe I have died had I not gone to the emergency room. In addition, I think the shot adversely affected my immune system. I haven't gone to see a doctor for an illness in years. Since the adverse reaction to the shot, I've had some ongoing health issues. I'm very disappointed in what happened to me. I had to pay $389 for my share of the emergency room visit. I will no longer have any sort of preventative vaccine again except a flu vaccine.
Age: 62.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Feeling abnormal, Nausea, Pain, Vaccination complication
Clinical narrative: On September 27, 2013 I had my annual physician visit to refill my prescriptions. During the course of this visit I received 2 shots. One was a flu vaccine. The other was the shingles vaccine (ZOSTAVAX). Within 12 hours I was taken to the medical center emergency room. I had the following symptoms: I was very dizzy and I was unable to walk or stand, extreme nausea, extreme diarrhea, extreme body and joint aches and pains to the point where I was just writhing in misery I was able to call a friend for help who took me to the emergency room. After treating me, the physicians told me I had a severe reaction to the shingles vaccine I received by my medical provider about 12 hours earlier. I was very ill and thought I may die. I believe I have died had I not gone to the emergency room. In addition, I think the shot adversely affected my immune system. I haven't gone to see a doctor for an illness in years. Since the adverse reaction to the shot, I've had some ongoing health issues. I'm very disappointed in what happened to me. I had to pay $389 for my share of the emergency room visit. I will no longer have any sort of preventative vaccine again except a flu vaccine.
Age: 88.0
Sex: M
Vaccine: RAB
Symptoms: Condition aggravated, Expired drug administered, Gout, Haemoptysis, Incorrect dose administered
Clinical narrative: Case number PHEH2013US014789 is an initial spontaneous report received from a pharmacist on 09 Jul 2013, with a follow-up received from a consumer (patient's wife) on 06 Dec 2013. This report refers to an 88-years-old male patient. He was administered an expired dose of post-exposure RABAVERT (batch number: not reported, expiry date: May 2013) intramuscularly on 09 Jul 2013 (last dose). Therefore, he was told to come back in the next day and was given another dose of RABAVERT. It was reported that he used to get gout once a year but since RABAVERT was given, his gout had constantly flared up where he was experiencing gout more frequently than normal in Jul 2013. When he was off the medication for gout, he used to have excruciating pain. He was coughing up blood at night on 05 Dec 2013. His wife thought he was having pneumonia and planned to visit the emergency room on 06 Dec 2013. Outcome of the events was not reported. Seriousness and causality of the events were reported. Follow-up was received on 06 Dec 2013: New events (gout flare, coughing up blood, and suspected pneumonia) and other clinical information were updated.
Age: 88.0
Sex: M
Vaccine: RAB
Symptoms: Pain, Pneumonia
Clinical narrative: Case number PHEH2013US014789 is an initial spontaneous report received from a pharmacist on 09 Jul 2013, with a follow-up received from a consumer (patient's wife) on 06 Dec 2013. This report refers to an 88-years-old male patient. He was administered an expired dose of post-exposure RABAVERT (batch number: not reported, expiry date: May 2013) intramuscularly on 09 Jul 2013 (last dose). Therefore, he was told to come back in the next day and was given another dose of RABAVERT. It was reported that he used to get gout once a year but since RABAVERT was given, his gout had constantly flared up where he was experiencing gout more frequently than normal in Jul 2013. When he was off the medication for gout, he used to have excruciating pain. He was coughing up blood at night on 05 Dec 2013. His wife thought he was having pneumonia and planned to visit the emergency room on 06 Dec 2013. Outcome of the events was not reported. Seriousness and causality of the events were reported. Follow-up was received on 06 Dec 2013: New events (gout flare, coughing up blood, and suspected pneumonia) and other clinical information were updated.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Coma
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 80 year old male patient. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 plaque forming units (PFU) (Lot number, dose and route were not reported). Concomitant therapy was not reported. On an unknown date, the patient received ZOSTAVAX, and then fell into a coma (medically significant). The patient sought unspecified medical attention. The primary reporter stated that he was unsure if the patient had died. The outcome of the event was unknown. Relatedness between the event and ZOSTAVAX was not reported. Upon internal review the event was considered medically significant. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Hyperhidrosis, Hypotension, Immediate post-injection reaction, Nausea, Orthostatic hypotension
Clinical narrative: Patient received BOOSTRIX and PREVNAR 13 vaccine (same office visit) injections in office - different syringes/sites. Pt. immediately became diaphoretic, hypotensive and nauseated. Diaphoresis and hypotension resolved over 30-60 min. Orthostatic hypoten. Nausea persisted x 1 hrs.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Induration, Local swelling, Pruritus
Clinical narrative: A day after the vaccine my arm swollen; very hard and red but no fever; Swelling last five days and it itches a lot.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: (L) shoulder pain with limited range of motion. Treatment: cortisone injection in bursa of shoulder.
Age: 28.0
Sex: M
Vaccine: TYP, YF
Symptoms: Staphylococcal scalded skin syndrome, Urticaria
Clinical narrative: Hive and scalded skin.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Infection, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This spontaneous report as received from a registered Nurse refers to a 23 year old female patient, with kidney stones and a rash due to BACTRIM. On 02-DEC-2013 the patient was vaccinated with VARIVAX (Merck) (lot J006359, expiration date 23-May-2013), subcutaneous in the left arm. Concomitant therapies included drospirenone, YASMIN. On 02-DEC-2013, within 1 hour after patient was vaccinated with she developed a 50 cent piece size hard, red swelling at the injection site. Over the last two days the area has increased to 7 inches by 12 inches. She also has a fever of 100 F, with itching and pain at the injection site, body aches and malaise. Patient was diagnosed with an infection and cellulitis. At the time of the report the patient has not recovered from the events. The patient went to the emergency room and was treated with Clindamycin (manufacturer unknown). A urine lab diagnostic was performed on an unknown date and the results were not provided. The nurse is requesting a lot check on VARIVAX (Merck) (lot J006359, expiration date 23-May-2015), due to this adverse experience. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site swelling, Malaise, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a registered Nurse refers to a 23 year old female patient, with kidney stones and a rash due to BACTRIM. On 02-DEC-2013 the patient was vaccinated with VARIVAX (Merck) (lot J006359, expiration date 23-May-2013), subcutaneous in the left arm. Concomitant therapies included drospirenone, YASMIN. On 02-DEC-2013, within 1 hour after patient was vaccinated with she developed a 50 cent piece size hard, red swelling at the injection site. Over the last two days the area has increased to 7 inches by 12 inches. She also has a fever of 100 F, with itching and pain at the injection site, body aches and malaise. Patient was diagnosed with an infection and cellulitis. At the time of the report the patient has not recovered from the events. The patient went to the emergency room and was treated with Clindamycin (manufacturer unknown). A urine lab diagnostic was performed on an unknown date and the results were not provided. The nurse is requesting a lot check on VARIVAX (Merck) (lot J006359, expiration date 23-May-2015), due to this adverse experience. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Urine analysis
Clinical narrative: This spontaneous report as received from a registered Nurse refers to a 23 year old female patient, with kidney stones and a rash due to BACTRIM. On 02-DEC-2013 the patient was vaccinated with VARIVAX (Merck) (lot J006359, expiration date 23-May-2013), subcutaneous in the left arm. Concomitant therapies included drospirenone, YASMIN. On 02-DEC-2013, within 1 hour after patient was vaccinated with she developed a 50 cent piece size hard, red swelling at the injection site. Over the last two days the area has increased to 7 inches by 12 inches. She also has a fever of 100 F, with itching and pain at the injection site, body aches and malaise. Patient was diagnosed with an infection and cellulitis. At the time of the report the patient has not recovered from the events. The patient went to the emergency room and was treated with Clindamycin (manufacturer unknown). A urine lab diagnostic was performed on an unknown date and the results were not provided. The nurse is requesting a lot check on VARIVAX (Merck) (lot J006359, expiration date 23-May-2015), due to this adverse experience. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a healthcare professional regarding an unspecified number of patients of unknown age and gender. On an unknown date, unspecified patients may have received improperly stored M-M-R II (dose, route and lot number were not provided). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 03-DEC-2013, the patient was vaccinated with PROQUAD. No co-suspect and concurrent therapies were reported. The pharmacist reported that an unspecified patient was administered a dose of PROQUAD on 03-DEC-2013 instead of the intended MMR II. The patient's first dose of VARIVAX was administered in an unspecified date 3 months ago, approximately in September 2013. No adverse effect reported. Additional information has been requested.
Age: 1.4
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Ataxia
Clinical narrative: Ataxia.
Age: 66.0
Sex: F
Vaccine: HEPAB, IPV, TYP
Symptoms: Arthralgia, Flushing
Clinical narrative: Facial flushing noted several hours after vaccination. Primary MD ordered BENADRYL. Joint pain, and achiness since. No fever.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Chest discomfort, Decreased appetite, Dyspnoea, Flank pain
Clinical narrative: The symptoms began with a side ache when I went to bed. The pain progress quickly to tightness in my rib cage and difficulty in breathing I could not sleep lying down or sitting up. I was with my husband on his semi-truck so had to walk across the truck stop parking lot to use the restroom around 3:30a.m. it was extremely cold, when I return to the truck I vomited a very little. I was still in pain but finally dosed a little and at 6:00 a.m. I again crossed the parking lot to the restroom and had a normal bowel movement, upon returning to the truck I again vomited a small amount tried to rest awhile and then drove myself to our home clinic 18 miles away. At the clinic the nurse and PA checked me out and then sent me to the hospital for lab and ex-rays followed by putting me on an IV. The PA found nothing in the lab or x-ray results and sent me home to rest with an anti-nausea medicine. I again vomited green fluids on the way home around 11:00 a.m. Throughout the remained of the day I was in pain and had difficulty breathing and vomited again at 6:00 p.m. I had no appetite but drank fluids for the next 3 days. Since then I have still had some tightness of the rib cage off and on none as severe as on that Wednesday evening and Thursday.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Insomnia, Vomiting, X-ray
Clinical narrative: The symptoms began with a side ache when I went to bed. The pain progress quickly to tightness in my rib cage and difficulty in breathing I could not sleep lying down or sitting up. I was with my husband on his semi-truck so had to walk across the truck stop parking lot to use the restroom around 3:30a.m. it was extremely cold, when I return to the truck I vomited a very little. I was still in pain but finally dosed a little and at 6:00 a.m. I again crossed the parking lot to the restroom and had a normal bowel movement, upon returning to the truck I again vomited a small amount tried to rest awhile and then drove myself to our home clinic 18 miles away. At the clinic the nurse and PA checked me out and then sent me to the hospital for lab and ex-rays followed by putting me on an IV. The PA found nothing in the lab or x-ray results and sent me home to rest with an anti-nausea medicine. I again vomited green fluids on the way home around 11:00 a.m. Throughout the remained of the day I was in pain and had difficulty breathing and vomited again at 6:00 p.m. I had no appetite but drank fluids for the next 3 days. Since then I have still had some tightness of the rib cage off and on none as severe as on that Wednesday evening and Thursday.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Herpes zoster, Scar, Viral titre
Clinical narrative: This spontaneous report was received from a physician referring about a 1 year old female patient. Medical history and concurrent diseases were not reported. On 02-JUL-2013, the patient was vaccinated with PROQUAD (Merck) lot # J002307, expiration date 22-AUG-2014, 0.5 ml, subcutaneous, also reported as "one year birthday". Co-suspect and secondary therapies were not reported. On 13-NOV-2013, the physician reports that patient received PROQUAD (Merck) and had an outbreak of shingles, 135 days after onset of therapy. On 04-DEC-2013, the patient recovered with minimum scarring. The patient did seek medical attention at the office visit and she was treated with ACYCLOVIR. Lab diagnostics studies performed were herpes titers and varicella titers, and they were referred to an unspecified dermatologist to confirm shingles. No results provided. Causality was not provided at the time of the report. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a third party claims administrator for a pharmacy concerning a female patient. On an unspecified date the patient was vaccinated with ZOSTAVAX (lot # J010447, exp. date 22APR2014). On 27NOV2013 the patient experienced an adverse reaction. The outcome of adverse reaction is unknown. Additional information has been requested.