chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Infection, Oedema peripheral, Skin warm
Clinical narrative: Noticed that arm was red swollen and hot to touch.  Cleaned arm with alcohol and outlined the redness with a sharpie.  Took to clinic in the morning and they prescribed Motrin and Benadryl.  By noon the redness had spread about an inch outside of the sharpie line we had drawn.  We took him to the ER and they determined that it was an infection and prescribed him antibiotics (Cephalexin - 4ml 3x a day for 5 days) Took back to the doctor Wed, Sept 5 because the redness has not completely subsided.  They prescribed him Cephalexin 5ml 3x a day for 7 days. I can report back as to how this treatment works.
Age: 31.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness
Clinical narrative: OVER THE COURSE OF TEN MINUTES FOLLOWING VACCINATION, PATIENT STATED SHE WAS FEELING LIGHTHEADED, BEGAN TO SWEAT PROFUSELY AND NEARLY FELL UNCONSCIOUS.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 8/24/12 Patient developed redness and swelling at site. She presented at office 8/27/12. Swollen area measured 3 1/2 x 4 1/2 inches. Treated with MEDROL dosepak. 8/29/12 - patient reports symptoms resolving.
Age: 49.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Left arm redness, swelling and pain, it also feels warm to the touch. Pt tried some ice, it didn't help. Recommended pt to see MD ASAP.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Contusion, Injection site pain, Joint range of motion decreased
Clinical narrative: Pt. c/o pain in arm where injection was given and decreased ROM and strength in (L) arm. Brought in to be evaluated, physician did not feel there was decreased ROM. Thought to be bruise.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Cough, Dizziness, Flushing, Hyperhidrosis, Nausea
Clinical narrative: Nausea, dizzy, flush followed by cough, throat feeling "funny", pale, sweaty...BENADRYL & EPIPEN given.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Throat irritation
Clinical narrative: Nausea, dizzy, flush followed by cough, throat feeling "funny", pale, sweaty...BENADRYL & EPIPEN given.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Exfoliative rash, Induration, Pruritus, Rash erythematous, Skin exfoliation
Clinical narrative: One week after receiving ZOSTAVAX pt noticed "small red spot" under left eye, enlarged under eye, spread to right eye, on nose, left cheek and then down neck to upper chest. Cycles: red/itching --> hard/scaly, then peals and reports. Seen by PCP & given MEDROL Dose Pack - no improvement. Seen by Derm with Dx allergy.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: On pt. (R) arm, 1 1/2 x 1 1/2 inch area, redness, swollen & warm to touch. Advised pt to take BENADRYL as needed, apply cortizone Cr and apply cool compresses to the site.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: On pt. (R) arm, 1 1/2 x 1 1/2 inch area, redness, swollen & warm to touch. Advised pt to take BENADRYL as needed, apply cortizone Cr and apply cool compresses to the site.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Heart rate abnormal, Heart rate increased, Influenza, Pain in extremity
Clinical narrative: Achy legs/arms/back. Runny nose, flu symptoms chest felt rapid heart beat/strong heart beat.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: Achy legs/arms/back. Runny nose, flu symptoms chest felt rapid heart beat/strong heart beat.
Age: 19.0
Sex: M
Vaccine: VARCEL
Symptoms: Aspiration tracheal, Back pain, Endotracheal intubation, Mechanical ventilation, Pneumonia
Clinical narrative: This spontaneous report as received from a physician and a health professional refers to a 19 (also reported 16) years old "transplant candidate" male patient with allergy to shell fish and allergy to iodine and a long history of IgA nephropathy. The patient's medical history included spinal stenosis, sciatica, herniated disc L spine x2, renal failure, hypertension (HTN), hypercholesterol and tethered spine. On 25-JUL-2012 the patient was vaccinated on left arm with a 0.5 ml dose of VARIVAX (Merck) (lot # 671027/1067AA). Concomitant medications included aluminum hydroxide, heparin sodium, hydrocortisone sodium succinate, levalbuterol hydrochloride, pantoprazole, propofol, sulfamethoxazole, BACTRIM TABLETS AND SUSPENSION, VIROPTIC, acyclovir sodium, epoetin alfa, fentanyl, piperacillin sodium, ZOSYN, sodium chloride, acetaminophen, hydromorphone hydrochloride, ibuprofen, XOPENEX and Lorazepam. The physician reported that on an unknown date the patient developed bilateral pneumonia (hospitalization, disability and life threatening) and zoster type rash all over his trunk, back and face (hospitalization, disability and life threatening) after vaccination. The patient was in the hospital in serious condition. It was reported that the patient was definitely immunocompromised (i.e. on prednisone and CELLCEP) at the time of vaccination approximately 3 weeks ago. The patient was in the process of being worked up for a kidney transplant. The patient was currently hospitalized with varicella, bilateral pneumonia and bilateral pneumothoraxes he was intubated and on a ventilator. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. A sputum sample was collected on 24-AUG-2012. The sample was taken from endotracheal aspirate. The types of adverse experience included rash and back pain. The patient had no recent exposure to chickenpox. At the time of reporting, the outcome of bilateral pneumonia and zoster type rash all over his trunk, back and face was reported as not recovered; the outcome of varicella, bilateral pneumothoraxes, he was on a ventilator, he was intubated, and back pain was unknown. Bilateral pneumonia and zoster type rash all over his trunk, back and face were considered as disabling and life threatening by the reporter. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: VARCEL
Symptoms: Pneumothorax, Rash, Rash vesicular, Sputum test, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician and a health professional refers to a 19 (also reported 16) years old "transplant candidate" male patient with allergy to shell fish and allergy to iodine and a long history of IgA nephropathy. The patient's medical history included spinal stenosis, sciatica, herniated disc L spine x2, renal failure, hypertension (HTN), hypercholesterol and tethered spine. On 25-JUL-2012 the patient was vaccinated on left arm with a 0.5 ml dose of VARIVAX (Merck) (lot # 671027/1067AA). Concomitant medications included aluminum hydroxide, heparin sodium, hydrocortisone sodium succinate, levalbuterol hydrochloride, pantoprazole, propofol, sulfamethoxazole, BACTRIM TABLETS AND SUSPENSION, VIROPTIC, acyclovir sodium, epoetin alfa, fentanyl, piperacillin sodium, ZOSYN, sodium chloride, acetaminophen, hydromorphone hydrochloride, ibuprofen, XOPENEX and Lorazepam. The physician reported that on an unknown date the patient developed bilateral pneumonia (hospitalization, disability and life threatening) and zoster type rash all over his trunk, back and face (hospitalization, disability and life threatening) after vaccination. The patient was in the hospital in serious condition. It was reported that the patient was definitely immunocompromised (i.e. on prednisone and CELLCEP) at the time of vaccination approximately 3 weeks ago. The patient was in the process of being worked up for a kidney transplant. The patient was currently hospitalized with varicella, bilateral pneumonia and bilateral pneumothoraxes he was intubated and on a ventilator. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. A sputum sample was collected on 24-AUG-2012. The sample was taken from endotracheal aspirate. The types of adverse experience included rash and back pain. The patient had no recent exposure to chickenpox. At the time of reporting, the outcome of bilateral pneumonia and zoster type rash all over his trunk, back and face was reported as not recovered; the outcome of varicella, bilateral pneumothoraxes, he was on a ventilator, he was intubated, and back pain was unknown. Bilateral pneumonia and zoster type rash all over his trunk, back and face were considered as disabling and life threatening by the reporter. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling
Clinical narrative: Within 24hrs of vaccination (the next am) pt had about 1 1/2 cm area of raised, fine erythema at our (L) thigh injection site with T 99.1 ear. Checked in office 8/30/2012.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Tetanus shot was done Friday it only looked like a size of a dime and now it has grown bigger and hot to touch and painful and swollen.
Age: 1.69
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Unevaluable event
Clinical narrative: Hepatitis A vaccine.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Hyperhidrosis, Middle insomnia, Pyrexia
Clinical narrative: Patient had "extreme" fever and chills at 9:30 pm after receiving vaccine. She complained that she woke up every 3 hours and needed to use several blankets for chills. At 5:30 am patient woke up soaked and sheets were soaked. At this time fever gone, but feeling weak.
Age: 66.0
Sex: U
Vaccine: FLU3
Symptoms: Feeling abnormal, Injection site erythema, Injection site warmth, Pyrexia, Tenderness
Clinical narrative: Notices tenderness after shot AM 8/29 Really not feeling good. Red & hot at the site about a dollar size area told to take TYLENOL & cold pack by doctor There was a fever 8/29 but gone on 8/30 and has been gradually better since.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Approx 12 hrs after PNEUMOVAX administration, patient developed redness, swelling and pain in (R) upper arm. Also reported fever, chills, headache and lethargy.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Lethargy, Pyrexia
Clinical narrative: Approx 12 hrs after PNEUMOVAX administration, patient developed redness, swelling and pain in (R) upper arm. Also reported fever, chills, headache and lethargy.
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Hypersensitivity, Rash erythematous, Rash pruritic
Clinical narrative: Very itchy rash across abdomen, under breast, on buttocks, upper legs (small red spots w/dark center). Spread to neck, arm pits on 8/25/12. Called local urgent care 8/25/12 -said likely allergic reaction. Has been taking Chlorpheniramine - recommended Diphenhydramine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Cold sweat, Confusional state, Feeling cold, Hyperhidrosis
Clinical narrative: Numbness in hands & feet, BP up 157/89 cold, but sweating & clammy, confusion, restlessness call doctor on call around 10 pm.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Restlessness
Clinical narrative: Numbness in hands & feet, BP up 157/89 cold, but sweating & clammy, confusion, restlessness call doctor on call around 10 pm.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling, Pruritus, Rash, Skin reaction
Clinical narrative: Patient reported oval rash over chest. No open skin - slight itch within a few days of vaccination. The raised red area resolved on its own 2 months later.
Age: 84.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Oedema, Pruritus
Clinical narrative: Progressing over 24 - 48 hours -> pt reported itching followed by edema & erythema which prescribed diagnosed as cellulitis.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Rash
Clinical narrative: Rash developed 3 days after shot given. Rash on legs/extremities.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Pruritus, Rash
Clinical narrative: Day after getting his 3rd GARDASIL shot broke out in rash to upper back, quickly spread to trunk the extremities. Very itchy.
Age: 56.0
Sex: F
Vaccine: FLU3, HEPAB, TYP
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Itchy rash covering entire body below neck treated with Prednisone, antacid and antihistamine by walk in clinic MD. Rash began but barely noticeable 2 days post vaccination. Pt started applying CORTAID, then Calamine lotion day 4 and 5. Then went to Dermatologist prior to walk in clinic for above mentioned tx.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Indurated erythematous area around injection site. Recommend warm compresses to thigh with antibiotics BACTRIM DS BID x 5 days.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Extreme redness > 6 inches in diameter at site of injection, soreness > 7 days & slight fever.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt received Tdap at clinic Sunday 9-2-2012. Pt called from school to report left upper arm swollen to size of tennis ball with fluid, red, warm and tender. Pt states she will see health provider today.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient complained of generalized pain in her arm. She stated it radiated from her upper arm to her elbow. It ached continually with no relief after many weeks.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dysphagia, Injected limb mobility decreased, Injection site discolouration, Injection site pain
Clinical narrative: 1) Left arm swollen, painful, turned brown color could not lift arm for 2 days (at injection site). 2). Chills. 3) Throat swollen such that can hardly swallow.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pharyngeal oedema
Clinical narrative: 1) Left arm swollen, painful, turned brown color could not lift arm for 2 days (at injection site). 2). Chills. 3) Throat swollen such that can hardly swallow.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Product taste abnormal, Pruritus, Rash, Rash erythematous
Clinical narrative: Arm starting itching the evening of dose and developing bumpy, red rash. On 9/5/12 awoke with rash on other arm and chest. Patient states within 10 minutes after getting shot had a medicine like taste develop in mouth.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: Redness and warmth approx 2 inches diam below and spreading medial to vaccination site.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed redness and swelling around the area where she received a ZOSTAVAX about 10 (ten) minutes prior. She well advised to take BENADRYL and go to the ER - no problem breathing.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient is believed to have extensive site reaction at time of administration no significant reaction slight pink area after 15 minutes. Patient states it became red & stretched 4" x 1" feels like persistent bee sting/sore after 3 days. However she feels it may go down.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Anxiety, Dizziness, Nausea, Night sweats
Clinical narrative: This spontaneous report received from a 15 years old female patient with colitis (mild). The patient was vaccinated  with dose 1, dose 2 and dose 3 GARDASIL on 12-AUG-2010, 12-OCT-2012 and 16-AUG-2011. No other co-suspects were reported. Concomitant medications included: LIALDA for colitis. In September 2011, the patient experienced nausea, dizziness, tremors, heat intolerance, night sweats, fainting, 4 inch ovarian cyst, upper right quadrant pain and anxiety (seeing therapist). The patient saw spots when she stood up. The patient sought medical attention from obstetrician/gynecologist. Colonoscopy was performed. The outcome of upper right quadrant pain, spots, anxiety, tremors, heat intolerance, night sweats, fainting, 4 inch ovarian cyst, dizziness and nausea was unknown. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Ovarian cyst, Syncope, Temperature intolerance, Tremor, Visual impairment
Clinical narrative: This spontaneous report received from a 15 years old female patient with colitis (mild). The patient was vaccinated  with dose 1, dose 2 and dose 3 GARDASIL on 12-AUG-2010, 12-OCT-2012 and 16-AUG-2011. No other co-suspects were reported. Concomitant medications included: LIALDA for colitis. In September 2011, the patient experienced nausea, dizziness, tremors, heat intolerance, night sweats, fainting, 4 inch ovarian cyst, upper right quadrant pain and anxiety (seeing therapist). The patient saw spots when she stood up. The patient sought medical attention from obstetrician/gynecologist. Colonoscopy was performed. The outcome of upper right quadrant pain, spots, anxiety, tremors, heat intolerance, night sweats, fainting, 4 inch ovarian cyst, dizziness and nausea was unknown. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to a female patient of unknown date. The healthcare worker reported that the patient was vaccinated with the first dose, 0.5 ml GARDASIL on 01-AUG-2011 and received the second dose 0.5 GARDASIL on 21-AUG-2012. No adverse effect was reported. This is one of reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a licensed practice nurse refers to unspecified patients. Due to an error in her temperature recording process, the nurse discovered that GARDASIL (Lot#, dose and route not reported) was stored at -5C (or 23F) for an indefinite period of time. The nurse was aware that administration of these improperly stored doses of vaccine would need to be reported and evaluated for possible readministration. She did not have the specific patient information or period of time of misexposure at the time of administration at the time of this report. It was not known if the patients sought for medical attention. Action taken and patients' statuses were unknown. This is one of several reported received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a licensed practice nurse refers to unspecified patients. Due to an error in her temperature recording process, the nurse discovered that oral ROTATEQ (Lot #, dose and route not reported) was stored at -5C (or 23F) for an indefinite period of time. The nurse was aware that administration of these improperly stored doses of vaccine would need to be reported and evaluated for possible readministration. She did not have the specific patient information or period of time of misexposure at the time of administration at the time of this report. It was not known if the patient sought for medical attention. Action taken and patients' statuses were not known. This is one of several reported received from a same source. Attempts are being made to obtain identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (lot number, dose, route and injection site were not reported) one year ago, in approximately August 2011. No other co-suspects were reported. No concomitant medications were reported. On 27-AUG-2012 the patient was getting the second dose of GARDASIL. No adverse effects reported. The outcome was unknown at the time of report. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 0.42
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 months old patient. The patient was vaccinated with dose 1 ROTATEQ, oral (lot # not reported) on 04-JUN-2012. On 28-AUG-2012 the patient experienced received an expired second dose of ROTATEQ (lot # 669070/1268Z, expiration date 13-AUG-2012). No adverse symptoms reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to a female patient of unknown age. The health care worker reported that the patient was vaccinated with the first dose, 0.5 ml GARDASIL on 01-AUG-2011 and received the second dose 0.5 ml GARDASIL on 21-AUG-2012. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received form a healthcare worker refers to a female patient of unknown age who on 13-JUN-2011, was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL, on 20-SEP-2011, was vaccinated intramuscularly with the second 0.5 ml dose GARDASIL and the patient was in the office on 26-JUL-2012, to receive her third dose of GARDASIL (lot numbers not reported). No adverse effects were reported. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a 25 years old female patient who "a couple of years ago" was vaccinated with the first two doses of GARDASIL and who was in the physician's practice on 26-JUL-2012, requesting to receive her third dose of GARDASIL (dose, routes and lot numbers not reported). No adverse effect had been observed or reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant who was also the office manager refers to a gender unspecified patient of unspecified age with no pertinent medical history or any drug reactions/allergies. Medical assistant reported that sometime in September 2008, the patient received the first dose of GARDASIL (dose, route and lot # not reported). Sometime in February 2009, the patient received the second dose of GARDASIL (dose, route and lot # not reported) which was late. The third dose had not been administered at the time of report. No other co-suspects were reported. No concomitant medications were reported. No symptoms reported. No treatment information was reported. Laboratory tests were reported as not applicable. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL on 14-FEB-2011, the second dose on 23-JUL-2012, and the third dose on 23-AUG-2012. No lot # and administration route was reported. No adverse event was reported. The outcome of patient was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning an unspecified patient of unknown age and tender. Two years ago in 2010, the patient was vaccinated with a dose of GARDASIL, (dose, route, frequency and lot number were not provided) and the vaccine was exposed to unspecified extreme temperature conditions prior to administration. No adverse effect reported. No treatment information was reported. The patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age who in 2011, was vaccinated with the first dose of GARDASIL and today, on 07-JUL-2012, received the second dose of GARDASIL (Doses, routes and lot numbers not reported). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Nausea
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 24 years old female patient with no pertinent medical history and no drug reactions or allergies who on 10-MAR-2011, was vaccinated with the first dose of GARDASIL (lot number 667930/1561Z, Exp. Date 23-MAR-2013) (dose and route not reported), on an unspecified date in May 2012, the patient received the second dose of GARDASIL and on 17-JUL-2012, the patient was vaccinated with the third dose of GARDASIL (dose, routes and lot numbers for second and third doses were not reported). No other co-suspects were reported. Concomitant medications included VYVANSE and prenatal vitamins, it was reported that the patient was not pregnant. The registered nurse reported that on 18-JUL-2012, the patient reported joint pain, nausea and sore hips. No lab diagnostics studies were performed. No treatment was given for the experience. At the time of the report, the patient's outcome was unknown. The registered nurse stated and confirmed that the patient received GARDASIL 'for ClN2". The relatedness for patient reported joint pain, sore hips and nausea was unknown for GARDASIL. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Initial report received from a healthcare professional on 27 May 2012. A 43-year-old female patient whose medical history and concomitant medications were unknown, received a dose of TENIVAC (Lot number: C4114BA), intramuscularly in the left arm on 25 May 2012. On 27 May 2012, 2 days post vaccination, the patient complained of tingling and numbness in left arm, left leg and up into the jaw. She did not have any complain of shortness of breath or anaphylactic reaction. Corrective medication was not reported. As of May 2012, the events had not recovered. List of documents held by sender: none.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 17 years old male patient with no pertinent medical history, no drug reactions/allergies, no birth defects, no medical conditions and no illness at the time of vaccination. The patient was vaccinated IM with the left arm with dose 1, 0.5 ml GARDASIL (Lot number 0629AE) on 18-JUL-2012 at 11:00 A.M approximately. No other co-suspects were reported. There were no concomitant. The patient waited 15-20 minutes and was fine. He then went directly from the office to work as a lifeguard in 105F ambient temperature. The temperature outdoor was reported as 104. At approximately 2:40 - 2:45 the patient fainted while at work. The paramedics were called to the office. The patient revived quickly without required medical intervention and fully recovered on the same day. The was no treatment given for the event and no Lab Diagnostics were performed. It The patient sought medical attention called to the office. The relatedness for fainted was unknown for GARDASIL. It was also unknown if heat was related to the event. It has been determined that case # 1207USA009638 (serious case) is a duplicate of case # 1207USA008776 (non serious case) Therefore, case # 1207USA009638 (serious case) is being deleted from our files and the cases consolidated into case # 1207US008776 (non serious case). Additional information is not expected. This is one of several reports from the same source.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Paraesthesia oral
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 years old female patient with no known reactions or allergies. The patient was subcutaneously vaccinated with ZOSTAVAX (lot # 671901/0421AE, Exp date: 21-MAR-2013, dose/frequency unspecified) on 26-AUG-2012. It was reported that the patient experienced immediate tingling of the lower lip after administration of ZOSTAVAX on 26-AUG-2012. The patient declined the suggestion that she went to a local emergency room for evaluation. The patient took oral BENADRYL and left the pharmacy. The pharmacist contacted the patient for follow-up later in the day and she had fully recovered without additional symptoms. Additional information is not expected.
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Incorrect dose administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 35 year old male patient with no drug reactions/allergies or pertinent medical history. The nurse stated that the patient was vaccinated with 6 doses of RECOMBIVAX HB (Lot# and route not reported) on an unknown date and had negative titers for immunity. The patient sought medical attention by an office visit. No treatment was given. At the time of reporting, the patient had not recovered from negative titers for immunity. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: DTOX, VARZOS
Symptoms: Balance disorder, Brachial plexopathy, Hypoaesthesia, Tinnitus
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to a 60 years old male patient with hypertension. The patient had none drug allergies. The patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # 6716601/1254AA, expiration date 01-NOV-2012) subcutaneously in right arm on 13-MAR-2012. Concomitant medications included: diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (reported as TDaP, manufacturer unknown) vaccinated in left arm on 13-MAR-2012. It was reported that the patient developed numbness in his thumb (unspecified if it was the rigth or left thumb) and was diagnosed with brachial plexopathy after receiving ZOSTAVAX. The patient had also been experiencing tinnitus and balance disturbance since he received ZOSTAVAX. The patient sought for medical attention via an office visit. The outcome was reported as not recovered. Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 months old male patient with no pertinent medical history and drug reactions/allergies. The patient was vaccinated with the first 0.5 ml dose of M-M-R II (lot# not reported), SQ on 20-JUL-2012. No other co-suspects were reported. No concomitant medications were included. On 24-JUL-2012 the patient experienced widespread rash, which started on his trunk and then extended to both legs and face, 5 days after onset of therapy. The rash was accompanied by a low-grade fever. The patient was seen in a local emergency room and was prescribed unspecified oral steroids and BENADRYL. No lab diagnostics study was performed. The patient was seen in the office on 23-AUG-2012 and the rash in persistent but the patient was afebrile. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated subcutaneously with a 0.5 ml dose of ZOSTAVAX (lot # not reported) on 23-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the patient went back and presented with an "injection site reaction with tenderness and warmth at injection site and swelling that went to her elbow". No treatment information was reported. The outcome of tenderness and warmth at injection site and swelling that went to her elbow was reported as not recovered. The relatedness for the reported events was not provided for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 04-FEB-2008, the patient was vaccinated with dose 1 of LIQUID PEDVAXHIB (lot #, dose and route not reported). On 11-APR-2008, the patient was vaccinated with dose 2 of LIQUID PEDVAXHIB (lot #, dose and route not reported). On 04-JUN-2008, the patient was vaccinated with dose 3 of LIQUID PEDVAXHIB (lot #, dose and route not reported. No adverse event was reported. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a Licensed practical nurse refers to a 72 years old female patient with no pertinent medical history, drug reaction or allergies. The patient was vaccinated subcutaneously with a dose of ZOSTAVAX (lot # H009779: exp date 31-MAR-2013; dose not reported) on 22-AUG-2012. No other co-suspects were reported. There were no concomitant medications. The patient presented to the office on 24-AUG-2012 "with a two-inch-by-two-inch, red, swollen area at the injection site". The patient was given over the counter BENADRYL and cortisone cream. No lab diagnostic tests were performed. At the time of the report the outcome of two-inch-by-two-inch, red, swollen area at the injection site was reported as not recovered. The relatedness for the reported events was not provided for ZOSTAVAX. 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 licensed practical nurse refers to a patient of unknown age. The patient was vaccinated subcutaneously with lot # (671004/0729AA: exp date 17-AUG-2012), 0.65 ml dose of ZOSTAVAX on 24-AUG-2012. The patient experienced the patient was not experiencing any known symptoms. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an unknown number of patients who on an unknown date were vaccinated with a 0.5 ml dose of RECOMBIVAX HB (doses, routes and lot numbers not reported) that were improperly stored. It was stated that the vaccines were possibly exposed to 26 degrees F. No adverse effects were reported. Attempts are being made to obtain additional information identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age with an active case of shingles. The patient was vaccinated with a dose of ZOSTAVAX (lot number, route, dose and injection site were not known) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient a patient with shingles came to the office to be evaluated. The physician provided the patient with a prescription for ZOSTAVAX to be administered at a pharmacy "after the shingles had resolved." The patient misunderstood the physician's directions, went directly to a pharmacy after the office visit, and was administered ZOSTAVAX. The physician added that the shingles "became worse" after administration of ZOSTAVAX. The outcome was unknown at the time of report. The patient had visited the office for medical attention. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 80 years old female patient. The patient was vaccinated SQ with a dose of ZOSTAVAX. On 28-AUG-2012 the patient experienced shingles. VALTREX was given for adverse event. The patient visited the office to seek medical attention. The outcome of shingles was unknown. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Tenderness
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 61 years old male patient. The patient was vaccinated with lot #/exp date (0240AE, 15-MAR-2013 date), 0.65 ml ZOSTAVAX on 07-AUG-2012. No other co-suspects were reported. Concomitant medications included: pravastatin sodium. On 09-AUG-2012, the patient experienced outbreak of shingles after getting ZOSTAVAX. The reaction was tender rash on the upper eyelid, right eyebrow, scalp and forehead. The patient outcome of outbreak of shingles after getting ZOSTAVAX was reported as not recovered/not resolved at the time of the report. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypokinesia, Pain
Clinical narrative: 2 hrs. post vacc. - increasing pain & inability to use left arm, lift left arm. Worsened for 5 days - thereafter improving slightly each day. Occ. ADVIL.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: 2 hrs. post vacc. - increasing pain & inability to use left arm, lift left arm. Worsened for 5 days - thereafter improving slightly each day. Occ. ADVIL.
Age: 6.0
Sex: M
Vaccine: HEPA, VARCEL, VARCEL
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Redness and swelling from armpit to middle of forearm along with itching, fever, pain.
Age: 6.0
Sex: M
Vaccine: HEPA, VARCEL, VARCEL
Symptoms: Cellulitis, Erythema, Infection, Pain, Pruritus
Clinical narrative: Redness and swelling from armpit to middle of forearm along with itching, fever, pain.
Age: 6.0
Sex: M
Vaccine: HEPA, VARCEL, VARCEL
Symptoms: Pyrexia, Swelling
Clinical narrative: Redness and swelling from armpit to middle of forearm along with itching, fever, pain.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Crying
Clinical narrative: Within a couple hours of Tdap administration, experienced uncontrollable, inconsolable, non-stop crying for ~4 hours.  Also experienced low grade temperature of about 100 with same onset.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Arthritis, Asthenia, Blood test, Fatigue
Clinical narrative: Information has been received from a 63 year old female patient with an allergy to MINOCIN. The patient was vaccinated with .65ml of ZOSTAVAX on 28Oct2011. Concomitant medications reported included: prednisone and anti-inflammatory medications. The patient had pain in her left hand which started right after the injection. In mid November the left hand had gotten worse. The patient felt tired and feverish as well. The patient went to a rheumatologist where blood work and rheumatoid arthritis test (unspecified) was completed. The patient was diagnosed with arthritis and was placed on methotrexate. The patient continues to experience pain with tiredness and lack of energy (considered to be symptoms of arthritis). The patient believes the ZOSTAVAX is directly responsible for her arthritis. It was reported the patient sought medical attention and was treated with a cortisone shot. The claimed event has improved some on methotrexate. It was reported the patient could not work. The patient is recovering. Arthritis was considered disabling. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pain in extremity, Pyrexia, Rheumatoid factor
Clinical narrative: Information has been received from a 63 year old female patient with an allergy to MINOCIN. The patient was vaccinated with .65ml of ZOSTAVAX on 28Oct2011. Concomitant medications reported included: prednisone and anti-inflammatory medications. The patient had pain in her left hand which started right after the injection. In mid November the left hand had gotten worse. The patient felt tired and feverish as well. The patient went to a rheumatologist where blood work and rheumatoid arthritis test (unspecified) was completed. The patient was diagnosed with arthritis and was placed on methotrexate. The patient continues to experience pain with tiredness and lack of energy (considered to be symptoms of arthritis). The patient believes the ZOSTAVAX is directly responsible for her arthritis. It was reported the patient sought medical attention and was treated with a cortisone shot. The claimed event has improved some on methotrexate. It was reported the patient could not work. The patient is recovering. Arthritis was considered disabling. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Blood test, Cheilitis, Coma, Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to a 81 years old female patient with high cholesterol, asthma, seasonal rhinitis, GERD and coronary artery disease. In approximately 2010, "about 2 and a half years ago", the patient was vaccinated with a dose of ZOSTAVAX (lot number not reported) under the skin. Concomitant medications included SINGULAIR, ZYRTEC, ZETIA, ZOCOR and PRILOSEC. In January 2012 the patient was found unconscious in her home. She had been there about a day or two when the police found her after responding to a welfare check requested by her niece. She was admitted to the hospital where she stayed in a coma for about 3-4 days. She was diagnosed with Bacterial Meningitis. Antibiotics were provided for the Meningitis through a PICC line. She says that after she came out the coma her daughter notices blisters on her face, in her face, and up her nose. There was no one on any other part of her body. The patient said no medication was given but she believes this was the shingles but she could not provide clear answer who diagnosed her with the shingles. The patient was moved to a nursing home after the hospital for about a month. The patient was still experiencing a part of her upper lip being pink and numb still. Also, the patient said she went to the dermatologist and was told that since he did not see her while she was experiencing the symptoms there was nothing he could do for her. The patient had blood work every three months. In March 2012, the patient had recovered. The patient had sought medical attention on unknown date. The patient's events were considered to be disabling and life-threatening by the reporter. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia oral, Loss of consciousness, Meningitis bacterial
Clinical narrative: This spontaneous report as received from a consumer refers to a 81 years old female patient with high cholesterol, asthma, seasonal rhinitis, GERD and coronary artery disease. In approximately 2010, "about 2 and a half years ago", the patient was vaccinated with a dose of ZOSTAVAX (lot number not reported) under the skin. Concomitant medications included SINGULAIR, ZYRTEC, ZETIA, ZOCOR and PRILOSEC. In January 2012 the patient was found unconscious in her home. She had been there about a day or two when the police found her after responding to a welfare check requested by her niece. She was admitted to the hospital where she stayed in a coma for about 3-4 days. She was diagnosed with Bacterial Meningitis. Antibiotics were provided for the Meningitis through a PICC line. She says that after she came out the coma her daughter notices blisters on her face, in her face, and up her nose. There was no one on any other part of her body. The patient said no medication was given but she believes this was the shingles but she could not provide clear answer who diagnosed her with the shingles. The patient was moved to a nursing home after the hospital for about a month. The patient was still experiencing a part of her upper lip being pink and numb still. Also, the patient said she went to the dermatologist and was told that since he did not see her while she was experiencing the symptoms there was nothing he could do for her. The patient had blood work every three months. In March 2012, the patient had recovered. The patient had sought medical attention on unknown date. The patient's events were considered to be disabling and life-threatening by the reporter. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Eyelid oedema, Flushing, Hyperhidrosis, Lymph node pain
Clinical narrative: Swollen & painful Glands, Flushing, Profuse Sweating, Eyes Swolen Shut, Difficulty breathing, blurred vision, feverish. This all started at about 5:30 PM and progressively got worse until a benadryl and advil were taken and I went to bed and and went to sleep. I woke up several hours later feeling much better. All I have this morning is puffy eyes.
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Lymphadenopathy, Pyrexia, Vision blurred
Clinical narrative: Swollen & painful Glands, Flushing, Profuse Sweating, Eyes Swolen Shut, Difficulty breathing, blurred vision, feverish. This all started at about 5:30 PM and progressively got worse until a benadryl and advil were taken and I went to bed and and went to sleep. I woke up several hours later feeling much better. All I have this morning is puffy eyes.
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Eye swelling, Flushing, Hyperhidrosis, Impaired driving ability
Clinical narrative: Swollen & painful Glands, Flushing, Profuse Sweating, Eyes Swolen Shut, Difficulty breathing, blurred vision, feverish. This all started at about 5:30 PM and progressively got worse until a benadryl and advil were taken and I went to bed and and went to sleep. I woke up several hours later feeling much better. All I have this morning is puffy eyes.
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen & painful Glands, Flushing, Profuse Sweating, Eyes Swolen Shut, Difficulty breathing, blurred vision, feverish. This all started at about 5:30 PM and progressively got worse until a benadryl and advil were taken and I went to bed and and went to sleep. I woke up several hours later feeling much better. All I have this morning is puffy eyes.
Age: 19.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Confusional state, Hypoaesthesia, Spinal pain
Clinical narrative: This spontaneous report as received from a nurse refers to a 19 years old male patient. The patient was vaccinated with the first dose of GARDASIL intramuscularly and experienced numbness, spine pain and confusion on 25-AUG-2012. The patient also got the second dose of MENACTRA on the same day. The patient went to the emergency room. The outcome of confusion, spine pain and numbness was reported as recovered. Confusion was considered to be significant disability by the reporter. Additional information has been requested.