chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Skin test positive
Clinical narrative: This spontaneous report as received from a physician assistant and a medical assistant refers to a 5 years old male patient with +4 allergy to eggs. The patient was vaccinated with, 0.2 ml M-M-R II on 31-OCT-2012 (not a full dose) lotnumber reported as H011889, expiration date 25-JUN-2012. No other co-suspects were reported. No concomitant medications were reported, On 31-OCT-2012 a skin test with M-M-R-II was performed and the patient experienced wheal at injection site, swelling of the area of injection and exhibiting redness of the area of injection. No treatment information was reported. The outcome of wheal at injection site, swelling of the area of injection and exhibiting redness of the area of injection was reported as not recovered/not resolved. There was no relatedness for wheal at injection site, swelling of the area of injection and exhibiting redness of the area of injection reported for M-M-R II. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot#, route and dose not reported). No concomitant medications were reported. No symptoms were reported. It was unspecified if the patient had sought medical attention. This is one of two reports received from the same reporter. Additional information is not expected.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant that refers to a 4 weeks old patient and unknown gender. On 09-NOV-2012, the patient was inadvertently vaccinated with a single dose of ROTATEQ, oral, (Lot number was not reported)orally. No other co-suspects were reported. Concomitant medications were not reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning to multiple patients of unknown age and gender. On an unknown date, the patients were vaccinated with ZOSTAVAX (dose and route not reported) (Lot#H011332, no exp. date given). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that when reconstituting ZOSTAVAX it bubbles too much. The pharmacist was administering vaccine after this occurred. Also stated that she was able to get the bubbles out prior to injection into patient(s). No adverse effect reported. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Neuropathy peripheral
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 62 years old male patient with hypercholesterolemia, allergic rhinitis and no drug reactions/allergies. The patient was vaccinated subcutaneously with a dose of 0.65 ml ZOSTAVAX (lot number reported as H011052, expiration date 05-SEP-2013) on 28-OCT-2012. Concomitant medications included amitriptyline, atorvastatin and fluticasone nasal spray. The patient developed shingles, started on 13-NOV-2012. He was examined on 16-NOV-2012 by a physician who confirmed that he had an outbreak of vesicles on his right lower back. The patient was also experiencing peripheral neuropathy. The patient consulted the physician for medical attention. No laboratory diagnostics studies were performed. Acyclovir, acetaminophen, PERCOCET and hydroxyzine were given for treatment. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant via company representative. The physician assistant reported that then doses of RECOMBIVAX HB (40 mcg)(lot number, expiration date and route not provided) dialysis formulation had been administered to up to ten unspecified non-dialysis patients on unspecified dates since July, 2012. Company representative did not know if any of the patients could have received more than one dose of RECOMBIVAX HB dialysis formulation. No adverse effects reported. It was unspecified if the patients had sought medical attention. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site extravasation, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 years old female patient who on 16-NOV-2012 was vaccinated with a dose of PNEUMOVAX23 0.5 ml intramuscular in left deltoid (lot number reported as 0709AE, expiration date: 14-JAN-2014). No other co-suspects were reported. No concomitant medications were  reported. The pharmacist reported that when a dose of PNEUMOVAX23 was being administered, part of the dose leaked out of the insertion site. The patient sought medical attention, she consulted the pharmacist. The patient not reported or demonstrated any adverse effects. 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 Pharmacy Student refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX on 14-NOV-2012, which expired on 20-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner that refers to a patient of unknown gender and age. The patient had no pertinent medical history or drug reactions/allergies. In March 2012 approximately or April 2012, the patient was vaccinated with the first dose of VAQTA immunization regimen (dose, route, frequency and lot number were not provided). No other co-suspects were not reported. Concomitant medications were not reported. It was reported that on unknown date described as 4 months later. (In July 2012 approximately) the patient received the second dose of VAQTA. No adverse effect reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash papular
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a male patient of unknown age with no drug reactions or allergies and a medical history of previous smoker. In approximately 2006 (5 or 6 years ago) the patient was vaccinated with dose 1 PNEUMOVAX23 (dose, route and lot # not reported). On unspecified date, the patient was vaccinated intramuscular with 0.5 ml dose 2 PNEUMOVAX23 (lot # 1420AA exp: 11-APR-2013). Concomitant medications included: FLUZONE. The nurse practitioner reported that on unspecified date, a patient developed warmth, redness and swelling of his right arm at the injection site after receiving PNEUMOVAX23. The patient also developed a fine, pink, papular rash on his upper chest after receiving PNEUMOVAX23. The nurse practitioner stated that this patient had received a dose of PNEUMOVAX 5 or 6 years ago, and experienced no problems. The patient was put on treatment with over the counter antihistamine (unspecified) and over the counter analgesic (unspecified). The patient sought medical attention by having a office visit. Laboratory and diagnostics were not performed. The outcome of adverse events was unknown. The relatedness for all adverse events was unknown for PNEUMOVAX23. 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 physician refers to an unknown number of patients. Case 1 of 6 of the same reporter (related cases 1211USA005837, 1211USA005838, 1211USA005839, 1211USA005840 and 1211USA005841). An unknown number of patients was vaccinated with VAQTA in 2012. No other co-suspects were reported. No concomitant medications were reported. The patients were administered vaccines that had been improperly stored for the last six months. No treatment information was reported. No adverse event was reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a certified medical assistant (CMA) refers to a currently 71 year old female patient. Current conditions included hypertension and Irritable Syndrome (IBS). Drug reactions/allergies included allergy to codeine and IVP dye. On an unknown age in 2007 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # not reported) intramuscularly. No concomitant medications were reported. On an unknown date after receiving PNEUMOVAX23 the patient developed rash near the site of injection. The patient recovered on an unknown date. It was unspecified whether patient sought medical attention. No further information is available.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unknown number of patients. Case 4 of 6 the same reporter (related cases 1211USA005695, 1211USA005837, 1211USA005838, 1211USA005840 and 1211USA005841). The patient was vaccinated with COMVAX in 2012. No other co-suspects were reported. No concomitant medications were reported. The patients were administered vaccines that had been improperly stored for the last six months. No treatment information was reported. No adverse event was reported. Additional information has been requested.
Age: 0.7
Sex: U
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 9 months old patient. The patient was subcutaneously vaccinated with 0.5 MMR II on 31-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 31-OCT-2012 a 9 month old patient was administered MMR II and no adverse effects. No additional information is expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a physician regarding a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot#, route and dose not reported). No concomitant medications were reported. It was unspecified if the patient had sought medical attention. This is one of two reports received from the same reporter. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a physician concerning to currently 62 years old male patient. On 17-NOV-2012, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and not not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that a patient stated he received PNEUMOVAX23 at an unspecified healthcare facility by an unspecified physician and developed redness, swelling and tenderness at the injection site area from his upper triceps down to his elbow. The outcomes of events were reported as not recovered/not resolved. The relatedness for the events was unknown for PNEUMOVAX23. Additional information is not expected.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unknown number of patients. Case 3 of 6 of the same reporter (related cases 1211USA005695, 1211USA005837, 1211USA005839, 1211USA005840 and 1211USA005841). The patient was vaccinated with haemophilus B conjugate vaccine in 2012. No other co-suspects were reported. No concomitant medications were reported. The patients were administered vaccines that had been improperly stored for the last six months. No treatment information was reported. No adverse event was 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 physician refers to an unknown number of patients. Case 2 of 6 of the same reporter (related cases 1211USA005695, 1211USA005838, 1211USA005839, 1211USA005840, and 1211USA005841. The patient was vaccinated with RECOMBIVAX HB in 2012. No other co-suspects were reported. No concomitant medications were reported. The patients were administered vaccines that had been improperly stored for the last six months. No treatment information was reported. No adverse event was reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a 63 years old female patient concerning herself with allergies to PERCOCET and penicillin. The patient had no pertinent medical history. On 13-NOV2012, the patient was vaccinated with PNEUMOVAX23 intramuscularly (dose, lot number were not provided). No other co-suspects were reported. Concomitant medications were reported as blood pressure medications. The patient reported she experienced injection site redness and injection site tenderness after receiving the PNEUMOVAX23. On 14-NOV-2012, the patient reported that redness spread into a "larger area" surrounding the injection site. The patient did not received treatment for the adverse events, and no lab diagnostics studies were performed. The patient did not seek medical attention. At the time of the report, the patient had not recovered from injection site redness and injection site tenderness but she described her current status as fine. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient (age and gender not reported), who on 16-NOV-2012 was vaccinated with a dose of ZOSTAVAX, that had previously been exposed to 65 degrees F (dose, route and lot # not reported). No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Limb discomfort
Clinical narrative: This spontaneous report as received from a consumer refers to a male patient of unknown age. On 04-NOV-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) dose and route not reported. No concomitant medications were reported. The reported stated that on 06-NOV-2012 her husband (patient) noticed his arm felt tight. He had redness, swelling and warmth to touch at the injection site. The patient's wife stated that he spoke with the doctor and was told to take CLARITIN by mouth and use BENADRYL cream and ice packs to relieve the symptoms. Outcome of the reported events were unknown. Additional information is not expected.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to numerous unspecified patients. It was reported that the patients might have vaccinated with ZOSTAVAX (dose, route and lot # not reported) and PNEUMOVAX 23 (dose, route and lot # not reported) either concomitantly or separated by less than 4 weeks. No adverse event reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 years old female patient with allergy to albuterol, Demerol, percocet. The patient was vaccinated with ZOSTAVAX (0.65 ml, lot # was reported as H012521, expiration date was 09-OCT-2013) subcutaneously on 31-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 01-NOV-2012 the patient developed a painful, large, red, warm raised area on her arm at the injection site. Unspecified antibiotic and steroid pack were given for treatment. The outcome of events were reported as recovered/resolved. The patient sought medical attention via office visiting to physician. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 years old female patient with allergy to albuterol, Demerol, percocet. The patient was vaccinated with ZOSTAVAX (0.65 ml, lot # was reported as H012521, expiration date was 09-OCT-2013) subcutaneously on 31-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 01-NOV-2012 the patient developed a painful, large, red, warm raised area on her arm at the injection site. Unspecified antibiotic and steroid pack were given for treatment. The outcome of events were reported as recovered/resolved. The patient sought medical attention via office visiting to physician. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Erythema, Induration, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: This spontaneous report was received from a 67-year-old female patient regarding herself with no pertinent medical history and no drug reactions/allergies. On 02-NOV-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # H013944 in verification process, expiration date 25-OCT-2013) in the right arm. Other suspect therapies included a dose of PNEUMOVAX 23 (lot # H010515 in verification process, expiration date 13-FEB-2014) on 02-NOV-2012 in her left arm. No concomitant medications were reported. The patient stated that both of her arms swelled, bruised and both arm became warm on 02-NOV-2012. No lab studies were performed. No medical attention was sought for the events. No additional information were reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Skin warm
Clinical narrative: This spontaneous report was received from a 67-year-old female patient regarding herself with no pertinent medical history and no drug reactions/allergies. On 02-NOV-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # H013944 in verification process, expiration date 25-OCT-2013) in the right arm. Other suspect therapies included a dose of PNEUMOVAX 23 (lot # H010515 in verification process, expiration date 13-FEB-2014) on 02-NOV-2012 in her left arm. No concomitant medications were reported. The patient stated that both of her arms swelled, bruised and both arm became warm on 02-NOV-2012. No lab studies were performed. No medical attention was sought for the events. No additional information were reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Contusion, Oedema peripheral, Skin warm
Clinical narrative: This spontaneous report was received from a 67-year-old female patient regarding herself with no pertinent medical history and no drug reactions/allergies. On 02-NOV-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # H013944 in verification process, expiration date 25-OCT-2013) in the right arm. Other suspect therapies included a dose of PNEUMOVAX 23 (lot # H010515 in verification process, expiration date 13-FEB-2014) on 02-NOV-2012 in her left arm. No concomitant medications were reported. The patient stated that both of her arms swelled, bruised and both arm became warm on 02-NOV-2012. No lab studies were performed. No medical attention was sought for the events. No additional information were reported. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Feeling hot, Oedema peripheral, Rash
Clinical narrative: SWOLLEN ARM AND RASH ON ARM HEAT IN RASH.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Chills, Feeling hot, Headache, Influenza like illness, Myalgia
Clinical narrative: Severe muscle aches in lower back, shoulders, right side of neck. When I cough my head hurts. Symptoms felt flu-like. Around 6:00 PM I started to feel very chilled and started shaking. Then I would get very warm. This occurred off-and-on all night.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Tremor
Clinical narrative: Severe muscle aches in lower back, shoulders, right side of neck. When I cough my head hurts. Symptoms felt flu-like. Around 6:00 PM I started to feel very chilled and started shaking. Then I would get very warm. This occurred off-and-on all night.
Age: 95.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Confusional state, Fatigue, Malaise, Somnolence
Clinical narrative: Confusion, anxiety, fatigue. Patient stated "I feel sick I do not know what is going on with me I am sleepy all the time".
Age: 25.0
Sex: F
Vaccine: FLUN3
Symptoms: Unevaluable event
Clinical narrative: My daughter became weak in the legs severely where she fell and hurt her ankle severely. She has severe nerve damage in her feet, legs, and upper extremities.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Heart rate increased, Heart rate irregular, Hypertension, Influenza like illness
Clinical narrative: On 11-16-12 - Large 4" diameter warm, swollen red reaction at injection site.  Malaise, flu like symptoms began and lasted until 11-22-12 AM. Most concerning: On 11-19-12 woke up at 6:00 AM with racing heatbeat.  Blood pressure cuff read EE initially.  Then had readings as high as 178/158 with 118 heart rate and the irregular heartbeat symbol showing on monitor.  Blood pressure went down to almost normal by 10:00 AM but I still have a diastolic reading range of 90-115 4 days later.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Malaise
Clinical narrative: On 11-16-12 - Large 4" diameter warm, swollen red reaction at injection site.  Malaise, flu like symptoms began and lasted until 11-22-12 AM. Most concerning: On 11-19-12 woke up at 6:00 AM with racing heatbeat.  Blood pressure cuff read EE initially.  Then had readings as high as 178/158 with 118 heart rate and the irregular heartbeat symbol showing on monitor.  Blood pressure went down to almost normal by 10:00 AM but I still have a diastolic reading range of 90-115 4 days later.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Blood culture negative, Human rhinovirus test positive, Increased upper airway secretion, Pyrexia, Ultrasound scan normal
Clinical narrative: Mom thought location of vaccination looked irritated.  Told a doctor both 11/19 and 11/20/12.  Patient started to have intermittent fevers, however also had some increased secretions through trach and tested rhinovirus positive. Evening of 11/20/12 he had higher fevers (39.5) and the area around the vaccine site developed a cellulitis, which spread across thigh quickly.  Has a h/o MRSA.  Was given one dose of Clinda, but due to h/o of Clinda resistent MRSA in past, high fevers, and quick spread, was started on IV Vanc, after which clinical improvement was noted.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Vaccination site cellulitis, Vaccination site irritation
Clinical narrative: Mom thought location of vaccination looked irritated.  Told a doctor both 11/19 and 11/20/12.  Patient started to have intermittent fevers, however also had some increased secretions through trach and tested rhinovirus positive. Evening of 11/20/12 he had higher fevers (39.5) and the area around the vaccine site developed a cellulitis, which spread across thigh quickly.  Has a h/o MRSA.  Was given one dose of Clinda, but due to h/o of Clinda resistent MRSA in past, high fevers, and quick spread, was started on IV Vanc, after which clinical improvement was noted.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Pain, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Runny nose, congestion, fever, aches, body pains, chills.
Sex: F
Vaccine: PPV
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's relevant medical history included morphine allergy. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, dose number, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date after receiving PNEUMOVAX 23 the patient experienced a severe anaphylactic reaction and the patient was hospitalized (date not provided). No treatment information was reported. It was unknown if there were relevant lab tests performed. The outcome of the severe anaphylactic reaction was unknown. A reporter causality for anaphylactic reaction was not provided for PNEUMOVAX 23. The reporter did not have the patient's chart at the time of reporting, but informed he would call back with more information. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from a registered nurse refers to one of twin female patients of unknown age. The twin patients were vaccinated with VARIVAX (Merck) (lot number and injection site were not reported) (0.5 ml, subcutaneous) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date one of the twins "had a seizure, the other did not" but it was unspecified by the reporter as to which one of the twins referenced experienced the adverse event. The patient who had the seizure "had to go to a Neurologist". The outcome of the patient was unknown. Upon internal review, seizure was considered to be a medically significant event. Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Bursitis, Inflammation, Musculoskeletal pain
Clinical narrative: Patient reported on 11/19/12 experiencing pain and inflammation in the right shoulder. Patient went to a physician and diagnosed with bursitis of the right shoulder.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Jaw disorder, Sleep disorder, Swelling face, Toothache, X-ray
Clinical narrative: Took flu shot on 11/2/12. That night my tooth began to bother me. The next day it was swollen & hurting badly. The left side of my jaw began to swell. By night it began to swell my chin and the right side of my face. I could not sleep and went to the hospital. If it were just my tooth on my left side, my whole head should not swell up.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 14-year-old female patient. On 03-JUN-2010 the patient was vaccinated with dose 1 GARDASIL (lot#, expiration date and route not reported). No concomitant medications were reported. On 21-OCT-2010 the patient was vaccinated with dose 2 GARDASIL (lot #, expiration date, and route not reported). Nurse stated that patient was administered dose 3 GARDASIL (lot #, expiration date and route not reported) on 05-JAN-2011 which was early. No adverse effects reported. No other information provided. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Dizziness, Hypoaesthesia, Sensation of heaviness
Clinical narrative: Information has been received from a registered nurse refers to a 16 years old male patient. On 07-NOV-2012, the patient was vaccinated with the first dose of 0.5 ml GARDASIL (lot number not provided) intramuscularly in his left deltoid. No other co-suspects were reported. No concomitant medications were reported. On 07-NOV-2012, seconds after received the vaccine, the patient reported that his left arm felt numb and heavy. Within next 10 to 20 minutes, the patient commented that he felt dizzy. No treatment information was reported. The patient did not seek medical attention. At the time of the report, the outcome of left arm felt numb and heavy and felt dizzy was reported as recovering/resolving. The relatedness for felt dizzy and left arm felt numb was unknown for GARDASIL. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding a 17 years old female patient. On 28-OCT-2009, the patient was vaccinated with dose 1 GARDASIL (lot #, expiry, route and dose not reported). No concomitant medications were reported. On 17-SEP-2012, the patient received her second dose of GARDASIL (lot#, expiry, route and dose not reported). No adverse effect has been observed or reported. It was unspecified if the patient had sought medical attention. 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 registered nurse regarding a patient of unknown age and gender. On 24-JUN-2008, the patient was vaccinated with dose 1 of GARDASIL (lot# and expiry not reported). No concomitant medications were reported. On 20-JUN-2012, the patient received dose 2 of GARDASIL (lot# and expiry not reported). Dose 3 had not yet been administered. No symptoms were reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 19-year-old female patient. On 06-NOV-2012 the patient was vaccinated with dose 3 GARDASIL (lot # not reported, expiration date 17-OCT-2012). No concomitant medications were reported. Patient was administered an expired dose of GARDASIL. No adverse effect reported. No further information is available. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Vulvovaginal discomfort, Vulvovaginal pruritus
Clinical narrative: This spontaneous report as received from a physician and from a Registered Nurse refers to a 12 years old female patient. On an unknown date, the patient was vaccinated with GARDASIL (dose, route, site of administration and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on an unknown date, the patient had 2 days of vaginal discomfort, minimal. On 12-SEP-2012 ("last night"-reported on 13-SEP-2012), the patient noticed several spots in vulva somewhat pruritic but mostly uncomfortable. The reporter requested information on possible vulval ulcerations after receiving the GARDASIL. No treatment information was reported. It is unknown if the patient sought medical attention. The outcome of several spots in vulva somewhat pruritic but mostly uncomfortable is unknown. The relatedness for 2 days of vaginal discomfort, minimal, several spots in vulva somewhat pruritic but mostly uncomfortable was not reported for GARDASIL. 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 nurse practitioner via a company representative regarding a patient of unknown age and gender. On an unknown date in 2006 (6 years ago), the patient was vaccinated with the initial 2 doses of GARDASIL (lot #, dose and route not reported). No concomitant medications were reported. The patient had not completed the series six years ago. No adverse effect was reported. It was unknown if the patient was in the office at the time of call or not. No treatment information was reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 years old female patient with no pertinent medical history and with drug allergy to penicillin. The patient was subcutaneously vaccinated with a single dose of ZOSTAVAX (lot number reported as H013022, expiry date: 09-OCT-2013) into the left arm on 06-NOV-2012. No other co-suspects were reported. There were no concomitant medications. On 07-NOV-2012 the patient developed a large, red, raised, itchy, hard area at the injection site. The patient had sought medical attention via coming to pharmacy. No treatment was prescribed. No lab test was done. The outcome of developed a large, red, raised, itchy, hard area at the injection site was reported as recovering/resolving. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Culture, Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient. The patient was vaccinated intramuscularly or subcutaneously with a 0.5 ml dose of PNEUMOVAX 23 (Lot # not reported) about a month ago in October 2012. In October 2012, 2 days after receiving PNEUMOVAX 23, the patient developed swelling, pain and redness in her injection site arm. Patient went to a clinic and saw a doctor who said that the symptoms on the arm looked like cellulitis, but was not. Patient's arm was swabbed, but no result was reported. Patient received pain reliever for treatment, but no antibiotics. At the time of this report patient had recovered. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. It was reported that "recently" the patient was vaccinated with a dose of VARIVAX (Merck) (lot # not reported) that expired in 2009. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding an unknown number of patients of unknown age and gender. On an unknown date, the pharmacist reported that an unknown number of doses of PNEUMOVAX23 (lot# and expiry not reported) were exposed to 70 degrees Fahrenheit(F) for a 2 week period may have been administered. No adverse effect was reported. It was unspecified if the patients had sought medical attention. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR, PPV, RV5, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding a 12 months old infant. The physician reported that an unspecified 12 month old infant was vaccinated with a dose of PNEUMOVAX23 (lot#, expiry, route and dose not reported) on 15-NOV-2012. On the same day on 15-NOV-2012, the patient was concomitantly vaccinated with a dose of M-M-R II (lot# and expiry not reported), VARIVAX (lot# and expiry not reported) and ROTATEQ (Oral) (lot# and expiry not reported). No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is 1 of 2 reports regarding the same patient. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial pain, Herpes zoster, Paraesthesia, Stomatitis
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 years old male patient with no drug reactions or allergies. The patients medical history was not specified by the reporter. The patient was vaccinated (dosing route unknown) with ZOSTAVAX (lot number and expiry date were not provided) on 2006. No other co-suspects were reported. Concomitant medications included: aspirin and TYNALON. On 06-NOV-2012 the patient nose stated to get soar, later on he did start getting in upper lip, right hand side of the face, and on the roof of the mouth. Did develop a case of the shingles. No treatment information was reported. The outcome of nose started to get soar, did develop a case of shingles, he did start getting tingling on the roof of the mouth, he did start getting tingling right had side of the face and start getting tingling in upper lip is unknown. The relatedness for nose started to get soar, did develop a case of the shingles, he did start getting tingling on the roof of the mouth, he did start getting right hand side of the face and start getting tingling in upper lip is unknown for ZOSTAVAX. The patient did not receive any treatment for the event. No additional information is not expected.
Age: 48.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Information has been received from a registered nurse concerning a 48 years old female patient with no drug reactions/allergies and gastroesophageal reflux disease (GERD) who on 04-OCT-2012, was vaccinated with a dose of PNEUMOVAX23 0.5 ml IM, at right arm (lot #672366/1723AA, Exp: 27-JUL-2013). No other co-suspects were reported. Concomitant medications included: unspecified flu vaccine (manufacturer Sanofi) given on the same day (left arm), and omeprazole. On 04-OCT-2012, the patient experienced dizziness and nausea, and soreness, redness and swelling of her right arm at the injection site after receiving PNEUMOVAX23. The patient made phone call to office and was advised to use ice packs and to elevate her arm. The outcome of the events was reported as recovered/resolved (in 2012 exact date unspecified). No diagnostic laboratory studies were performed. The relatedness for the events was unknown for PNEUMOVAX23. This is one of several reports received from the same source (related MARRS # 1211USA005870). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Skin lesion
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age who was wife of an employee of the pharmacy. The patient was vaccinated with ZOSTAVAX (lot number, route and dose not reported) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. The patient developed painful lesions on her leg after administration of ZOSTAVAX. It was unspecified if the patient had sought medical attention. No treatment information was reported. The outcome of the painful lesions was unknown. This is one of reports from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Rash, Skin lesion
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age who was an employee of the pharmacy. The patient was vaccinated with ZOSTAVAX (lot number, route and dose not reported) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. The patient developed a rash after the administration of ZOSTAVAX. The patient subsequently developed scattered pink, raised lesions on his left arm and on his face. The lesions were not painful or itchy. The patient was evaluated by his unspecified physician and was prescribed an unspecified topical ointment for treatment. The patient fully recovered from the events (date unspecified). This is one of reports from the same source. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site inflammation, Injection site pain, Injection site warmth, Limb discomfort
Clinical narrative: This spontaneous report was received from a 53-year-old female patient regarding herself with no pertinent medical history and too many allergic reactions that could not be documented. On 10-NOV-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) in her right arm, dose and route not reported. Concomitant medications included LITHIUM, SEROQUEL, OMEPRAZOLE, ATENOLOL and ZENPEP. On 11-NOV-2012, next day after vaccination, the patient started to feel the pain, heat and inflammation at the site of injection. She then noticed a red patch and since doubled in size to the size of a baseball. She contacted her health care professional and was told to take an antihistamine and ALEVEL for the pain. Patient also stated she felt a pulling sensation when she stretched out her right arm all the way under her arm pit and the lymph nodes. No rash visible, patient said it was just a red patch on her right arm. No lab studies were performed. Outcome of the reported event was unknown. Additional information has been requested.
Age: 1.62
Sex: F
Vaccine: VARCEL
Symptoms: Ear infection, Pyrexia, Rash generalised
Clinical narrative: Initial information was received from a consumer concerning her daughter, an approximately 20 months old female patient without pertinent medical history or drug reaction / allergies, who on 09-NOV-2012, was vaccinated with a dose of VARIVAX (merck) and need if for school (dose, route and lot number were not reported). No other co-suspects were reported. Concomitant medications included: amoxicillin. It was reported that after receiving the injection, she began to experienced adverse reactions. On 10-NOV-2012, she had fever and a rash that started on her legs. It was reported that the patient looked like a "bug bite" on her left knee cap. The patient was taken to healthcare care professional where she was given amoxicillin (manufacturer unknown). The patient also had a double ear infection. The health care professional informed that the rash would go away in about one week. It was reported that at the time of report, the rash has spread and was all over her body. No treatment was given for the events. No laboratory test was performed. It was reported that the patient sought medical attention by contacting the office on 12-NOV-2012. At the time of report, the patient had not recovered from the events. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Physician Assistant refers to a 42 years old female patient with allergy to penicillin. The patient's medical history included migraines and vertigo. The patient was vaccinated with PNEUMOVAX23 (0.1 ml, intradermal, left forearm, lot # was reported as H013847, expiration date was 15-MAR-2014) on 14-NOV-2012. No other co-suspects were reported. Unspecified medication for migraines as needed. On 14-NOV-2012 the patient received 0.1 ml of PNEUMOVAX23 administered intradermally. PNEUMOVAX23 was inadvertently administered instead of a tuberculin purified protein derivative (PPD) related to an error by a staff member. The patient was experiencing significant left hand and left arm swelling (on 14-NOV-2012). The outcome of significant left hand and left arm swelling was reported as not recovered. No lab diagnostics studies performed. The patient sought medical attention via visiting office. Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Injection site rash, Musculoskeletal pain
Clinical narrative: This spontaneous report as received from a 85 years old male patient with leukemia refers to himself. The patient did not have any drug reactions/allergies. The patient was vaccinate with ZOSTAVAX (1 time injection, route, dose and lot # and expiration date were unknown) on 03-SEP-2012. No other co-suspects were reported. Concomitant medications included LIPITOR, metformin, BENICAR (reported as BENECAR) and heart medication (unspecified). On 06-NOV-2012 the patient experienced a rash around the injection site and soreness in his shoulder. He stated that the rash extends down to his elbow. No treatment was given for adverse events. The outcome of events were reported as recovering/resolving. The patient did the blood tests for leukemia. The patient had sought unspecified medical attention. Additional information is not expected.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a 48-year-old female patient with no pertinent medical history. Patient was allergic to soy. On 06-NOV-2012 the patient was vaccinated with, 0.5 milliliter PNEUMOVAX 23 (lot # and expiration not reported) intramuscularly. No concomitant medications were reported. On 06-NOV-2012 patient experienced swelling, slight redness, pain and warmth to touch at the injection site area and whole upper right arm. Pharmacist also noted that the patient stated that she had shortness of breath on 06-NOV-2012. Treatment was rendered for the events. Patient was given BENADRYL, CLARITIN, ALEVE and cool compress. No lab studies were performed. Patient did not recover from the events at the time of this report. Patient sought medical attention for the events by contacting the pharmacist. No further information is available. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist concerning 71 years old female patient without drug reactions or allergies. (pertinent medically history was not reported). On 02-NOV-2012, the patient was vaccinated with a dose of PNEUMOVAX23 (lot H010515 exp 13-FEB-2014) intramuscular (dose and indication were not reported). No other co-suspects were reported. No concomitant medications were reported. On 03-NOV-2012, the patient developed a fever, pain and decreased arm mobility after receiving PNEUMOVAX23. The patient was treated with ice and TYLENOL. Laboratory tests were not performed. At the time of report, the patient had not recovered from fever, pain and decreased arm mobility. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a 70 years old male patient with high blood pressure, diabetes and penicillin allergy refers to himself. The patient had a shingles outbreak on his foot (side unspecified) a few years ago. The size of a "half dollar" and it cleared up in 6 weeks. The patient was vaccinated with ZOSTAVAX (lot # unspecified) subcutaneously one month ago (16-OCT-2012). No other co-suspects were reported. Concomitant medications included some unspecified high blood pressure and diabetes medications. The next day after vaccination (17-OCT-2012) the patient had a very severe rash across his back. Two days after vaccination (18-OCT-2012) he had a shingles outbreak on his right shoulder that spread to his chest and down his right arm. The patient contacted his physician and was being treated with steroids. The patient described his condition was recovering. The physician did a culture with no result provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. No medical history or concurrent conditions were reported. The patient was vaccinated intramuscularly with VAQTA on 18-JUN-2012. No lot number was reported, No other co-suspects or concomitant medications were reported. On 04-OCT-2012 the patient was administered with the booster dose. No adverse events was reported. No further information was provided. Additional information has been requested.