chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Syncope
Clinical narrative: This spontaneous report was received from a physician refers to a currently 17 years old female patient with drug reactions/allergies: gluten who on 31-AUG-2012 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL and on 06-SEP-2012 was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (Lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The Physician reported that the patient's mother stated her daughter was having several fainting episodes a week. However, physician stated that the fainting episodes started to occur on 05-AUG-2012, before patient was vaccinated with GARDASIL. Patient's outcome was reported as not recovered. Patient sought medical attention, her mother called the office. The relatedness between the event and GARDASIL was unknown. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: DTP
Symptoms: Erythema, Hypersensitivity, Local reaction, Pruritus, Skin exfoliation
Clinical narrative: Delayed type hypersensitivity, localized (L) upper arm, itch & redness about 2 - 3 day, pealing at day #5.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) via a company representative refers to a patient of unknown age and gender. On 23-OCT-2012 the patient was vaccinated with dose 1 GARDASIL (lot # not reported) dose and route not reported. No concomitant medications were reported. The patient received dose 2 GARDASIL (lot # not reported) on 07-NOV-2012. No adverse event reported. No other information to report. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye movement disorder, Lacrimation increased, VIIth nerve paralysis
Clinical narrative: Patient received ZOSTAVAX on 7/9/12 & was diagnosed with Bell's Palsy on 9/16/12. Patient reported tearing & drooping of eye. Reported to pharmacy on 11/17/12.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site oedema, Injection site pain
Clinical narrative: Approx 5 hrs after receiving vaccine, pt started with severe pain in arm that was injected. Pt unable to lift arm. Still in severe pain 3 days later. Some edema at inj. site. Extremely tender to touch.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left thigh began swelling and becoming red at the site of vaccine injection several hours after receiving. Seemed much more swollen and red today (11/16/12).
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Abdominal pain, Crying, Enema administration, Haematochezia, Intussusception
Clinical narrative: Crying 10-14-12; abd. pain w/ blood stool -> intussusception -> air contrast enema -> reduction.
Age: 1.92
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Erythema, Injection site oedema, Rash, Skin warm
Clinical narrative: Within about 15 min of receiving immunizations, child began breaking out in rash on chest just below neck. Child also had slight edema to (L) arm between site of varicella and Hepatitis A vaccination, but more prominent toward varicella. Area with slight head and redness measuring about 20 mm. 6.25 (1/2 tsp) Diphenhydramine oral liquid given. Encouraged f/u with MD. Parents left clinic to take child to MD or E.R.
Sex: U
Vaccine: RV1, RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with an expired dose of ROTATEQ (lot #, dose and route not reported) approximately on 12-NOV-2012. Other suspect therapies included a dose of ROTARIX (lot #, dose and route not reported). No concomitant medications were reported. The medical assistant reported that she was unsure which product was used for administration, between ROTATEQ or ROTARIX. No adverse effects were noted. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying
Clinical narrative: Excessive crying. Cried for more than 3 hrs.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Headache, Oropharyngeal pain, Pyrexia, Streptococcus test negative
Clinical narrative: Fever about 6 hours after. 103 2 days later. Headache worse 1 day later. Sore throat worse 1 day later. Dizzy 1 day later.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Pain and erythema localized on upper arm - extensive.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Pain
Clinical narrative: Redness started 11-05-12 (ass ask pain) ab. 7 am (diameter ab 4 x 4 cm) (ab. 41 hrs after vacc) all symptoms resolved 11-08-12.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Systemic; chills, tiredness Local: (L) upper arm, blushed, swollen, tender to palpation, limited range of motion.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Local reaction
Clinical narrative: Systemic; chills, tiredness Local: (L) upper arm, blushed, swollen, tender to palpation, limited range of motion.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 25 years old female medical assistant. The patient was vaccinated with her first dose of GARDASIL (lot number not provided) subcutaneously instead of intramuscularly on 07-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. The patient reported pain, redness and swelling at injection site. No treatment was given for adverse events. The outcome of adverse events was unknown. The patient did not seek medical attention. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: This spontaneous report was received from a licensed vocational nurse regarding an approximately 64 years old female patient. The patient's current conditions included anaemia, Diabetes, hypertension and hyperlipidaemia with no drug reactions or allergies. On an unknown date in the end of August 2012, the patient was vaccinated subcutaneously with a dose if ZOSTAVAX (lot# and dose not reported). No concomitant medications were reported. After administration of ZOSTAVAX at the end of August 2012, the patient developed a stiff neck. The patient stated that the pain was initially a "9 out of 10" in severity but at the time of the office visit on 15-OCT-2012, the pain had decreased in severity to "3 out of 10". The pain was worse with neck movement. The nurse stated that a carotid doppler was ordered due to a carotid bruit but no treatment was prescribed. The patient sought medical attention(office visit). No treatment was given for adverse events. The outcome of stiff neck and carotid bruit was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (C.M.A) refers to a patient of unknown age and gender. On 07-NOV-2012 the patient was vaccinated with a dose of 0.5 milliliter (ml) MMR II (lot # (667964/1508Z, expiration date 02-NOV-2012) subcutaneously. No concomitant medications were reported. The reporter stated that a patient was administered MMR II that was expired. No adverse effects reported. No further information is available. Medical attention was sought. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age. The patient was inadvertently vaccinated an expired dose of ZOSTAVAX (lot # 671659/1255AA, expired date 01-NOV-2012) (dose not reported) subcutaneously on 11-NOV-2012. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: VIIth nerve paralysis
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. On an unknown date between 2007-2008 the patient was vaccinated with ZOSTAVAX (lot # not reported) dose and route not reported. No concomitant medications were reported. The reporter stated that the patient came down with Bell's Palsy sometime on an unknown date in 2007-2012. Patient stated on the advice line that she thought Bell's Palsy was caused by same organism that caused shingles and she thought she should've been protected from Bell's Palsy as well as from receiving ZOSTAVAX. The outcome of the event was unknown at the time of this report. It was unspecified if patient sought medical attention for the event. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Rash, Skin warm, Swelling
Clinical narrative: This spontaneous report as received from an other health professional refers to a 4 years old female patient with no illness at the time of vaccination and unknown pre-existing allergies or birth defects or medical condition. The patient was subcutaneously vaccinated in the left thigh with dose 2 MMR II (Lot number 0648AE and expiry date 24-MAR-2014) on 25-OCT-2012. No other co-suspects were reported. No pre-existing allergies, birth defects and medical conditions were reported. No concomitant mediations were reported. On 26-OCT-2012 the patient experienced swelling, 14 hrs 57 min after onset of therapy, very hot to the touch, redness and rash. The patient required emergency room/doctors visit. The outcome of swelling, very hot to the touch, redness and rash is unknown. The relatedness for swelling, very hot to the touch, redness and rash was unknown for MMR II. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 60 years old patient. The patient was vaccinated with, 1 DF VARIVAX (Merck) subcutaneous (Lot number was not provided) on 02-NOV-2012. The patient also received Influenza Virus Vaccine (manufacturer unknown). No concomitant medications were reported. On an unknown date the patient received VARIVAX instead of ZOSTAVAX. The patient is not experiencing any known symptoms. The outcome of received VARIVAX instead of ZOSTAVAX and the patient is not experiencing any unknown symptoms is unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to possibly 4 adult patients of unknown age. The reporter reported that another nurse gave possibly 4 adults LIQUID PEDVAXHIB (lot# was unknown) instead of hepatitis B virus vaccine(manufacturer was unknown). The patients were not experiencing any known symptoms. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a consumer refer to an approximately 7-year-old male patient. Current conditions included eosinophilic esophagitis and allergy to nuts. Approximately on an unknown date in 2005 (when the patient was 1 year old) was vaccinated with dose 1 VARIVAX (Merck) (lot# and expiration not reported) dose and route not reported. On 26-SEP-2012 he was re-vaccinated with dose 2 VARIVAX (Merck) (lot # and expiration date not reported) dose and route not reported. Concomitant medications included FLONASE. Titers were drawn approximately on an unknown date in 2011 (reported as 5 to 6 years later) which did not show immunity to Varicella, titers drawn showed less than 1 unit. Patient's mother stated that her son had been re-vaccinated but titers have not been drawn yet. Outcome of the event was unknown at the time of the report. The patient sought unspecified medical attention for the events. No further information is available.
Age: 72.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered pharmacist regarding a patient of unknown age and gender. On 07-NOV-2012, the patient was vaccinated subcutaneously with 0.5 ml VARIVAX (lot # not reported) instead of ZOSTAVAX. The pharmacist stated that this was related to a staff error and not product confusion. No concomitant mediations were reported. No adverse effect was reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning a patient, who on 08-NOV-2012 was inadvertently vaccinated with a dose of VARIVAX (merck), 0.5ml, subcutaneously, that had expired on 29-OCT-2012 (lot # 668975/1474Z). No adverse effects were reported. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from an immunization Officer concerning an unknown number of patients who, on unspecified dates might have received a dose of ROTATEQ, Oral (dose, route and lot # not specified), which had been exposed to 11 degrees C for 137 hours. No adverse effects reported. This is one of five reports form the same source. The other linked reports are: 1211USA005919, 1211USA006714, 1211USA006715 and 1211USA006717. Attempts are being made to obtain additional identifying information to distinguish individual patients mentioned in this report. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from an Immunization Officer concerning an unknown number of patients who, on unspecified dates might have received a dose of VAQTA (dose, route and lot # not specified), which had been exposed to 11 degrees C for 137 hours. No adverse effects reported. This is one of five reports from the same source. The other linked reports are: 1211USA005919, 1211USA006714, 1211USA006716 and 1211USA006717. Attempts are being made to obtain additional identifying information to distinguish individual patients mentioned in this report. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a 6 months old female patient. The patient was vaccinated with dose 1 of ACTHIB (lot #, dose and route not reported) at 2 months of age (approximately in July 2012). She then switched providers and was vaccinated a first dose of LIQUID PEDVAXHIB (lot #, dose and route not reported) at 4 months (approximately in September 2012) and was vaccinated with a second dose of LIQUID PEDVAXHIB (lot #, dose and route not reported) at 6 months on 14-NOV-2012. The patient's mother was reporting that she was concerned about the dosing regimen and was worried her daughter had been given too much of the vaccine. She did not mention an AE. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from an Immunization Office concerning an unknown number of patients who, on unspecified dates might have received a dose of MMR II (dose, route and lot # not specified), which had been exposed to 11 degrees C for 137 hours. No adverse effects reported. This is one of five reports from the same source. The other linked reports are: 1211USA005919, 1211USA006715, 1211USA006716 and 1211USA006717. Attempts are being made to obtain additional identifying information to distinguish individual patients mentioned in this report. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood creatinine increased, Malaise
Clinical narrative: Information has been received from a physician concerning a 67 year old male patient, who on an unknown date was placed on therapy with ZOSTAVAX (route and lot # not reported). It was reported that, on an unknown date after receiving ZOSTAVAX, the patient's creatinine level "spiked up to 3.6" and was "now 1.8". It was also reported that the patient had not felt well since he had received the vaccine. The patient sought an unspecified medical attention on an unknown date. The outcome of patient's creatinine level spiked up and feeling unwell was reported as not recovered. The relatedness for patient's symptoms was unknown for ZOSTAVAX. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fear, Local reaction, Oedema peripheral, Pain in extremity
Clinical narrative: This spontaneous report as received as part of a marketing research program from a physician assistant refers to a 30 years old female patient with asthma. The patient was seen more than 5 years ago. The patient was vaccinated with PNEUMOVAX23 (lot number, dose, route, site not reported) on an unknown date. No other co-suspects were reported. Concomitant medication included unspecified asthma medication. On an unknown date a year after the vaccination, the patient experienced large local reaction on her arm, redness, swelling and pain. The patient had forgotten about the vaccination. She got the local reaction and called the physician assistant because she was scared. The patient was prescribed pain medications and short course of oral steroids. No diagnostic tests were performed. The outcome of the events was reported as recovered/resolved on an unknown date. The reporter felt the events were related to PNEUMOVAX23. Additional information is not expected.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Hot flush
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning to a 37 years old female patient. On 08-NOV-2012, the patient was vaccinated with lot # (H010661, Exp. date: 02-FEB-2014), with 0.5 ml PNEUMOVAX23 (route not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the patient felt hot and flushed within 15 min of receiving PNEUMOVAX23. Pharmacist observed the patient for 45 minutes afterwards and patient flushing improved. No treatment information was reported. No labs were performed. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown gender and age. The patient had no pertinent medical history or drug reactions/allergies. On 10-NOV-2012, the patient was vaccinated with PNEUMOVAX23 intramuscularly (Lot # 0453AA, Expiration date: 03-AUG-2012) (dose not reported). No other co-suspects were reported. No concomitant medications were reported. On the same date, the pharmacist noted that patient was inadvertently administered an expired dose of PNEUMOVAX23 also reported did not know if this was the first or second dose of PNEUMOVAX23 for this patient has been administered. No adverse effect reported. Additional information has been requested.
Age: 0.53
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 68 days old patient. The patient was vaccinated with the first, second and third dose of RECOMBIVAX HB on 31-JUL-1995, 10-OCT-1995 and 02-DEC-1995, respectively. No adverse event reported. It was unknown if the patient sought medical attention. At the time of report, the patient status was unknown. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to a patient of unknown age. On 12-NOV-2012 the patient was vaccinated orally with a dose of 2 ml ROTATEQ (lot # reported as 0075AA), that had expired on 25-OCT-2012. No adverse effect was reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician concerning to multiple patients of unknown age and gender. The patients were vaccinated with a dose of ZOSTAVAX (dose, route and lot not reported). The physician reported that he had seen several cases of breakthrough shingles in people who received ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. Additional information has been requested. This is one of several cases received from the same reporter. (MARRS#1211USA002353).
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Oropharyngeal pain, Pain in extremity, Pruritus, Rash erythematous
Clinical narrative: This spontaneous report (IRMS US12-052952) as received from a consumer refers to a 72 years old female patient with possible celiac and hypertension. The patient's medical history included alcoholic and smoker and a possibility of having had a PNEUMOVAX23 before in the past. The patient was vaccinated with PNEUMOVAX23 on 23-OCT-2012. Route of administration and dose is not provided. No other co-suspects were reported. Concomitant medications included DIOVAN, diltiazem hydrochloride and atenolol for unknown indication. Date, route, dose and frequency were not provided. On 23-OCT-2012 the patient noticed her arm started to swell and hurt. On 24-OCT-2012 her trunk of her body, front and back had a red rash and it was hot. On 25-OCT-2012 the rash spread to her legs, arms and face. On 25-OCT-2012 the swelling and hurt in her arm resolved. On 26-OCT-2012 she started the rash started to fade. On 26-OCT-2012 the patient experienced itching. On an unknown date the patient experienced sore throat. No treatment information was reported. It is unknown if there is any relevant laboratory data. As of 29-OCT-2012 she will not have another PNEUMOVAX23 and the rash is resolved and itching is better but not gone. The relatedness for arm swelling, itching, the rash spread to her legs, arms and face, hot. her trunk of her body, front and back had a red rash, sore throat and hurt in arm is unknown for PNEUMOVAX23. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Rash generalised, Skin warm
Clinical narrative: This spontaneous report (IRMS US12-052952) as received from a consumer refers to a 72 years old female patient with possible celiac and hypertension. The patient's medical history included alcoholic and smoker and a possibility of having had a PNEUMOVAX23 before in the past. The patient was vaccinated with PNEUMOVAX23 on 23-OCT-2012. Route of administration and dose is not provided. No other co-suspects were reported. Concomitant medications included DIOVAN, diltiazem hydrochloride and atenolol for unknown indication. Date, route, dose and frequency were not provided. On 23-OCT-2012 the patient noticed her arm started to swell and hurt. On 24-OCT-2012 her trunk of her body, front and back had a red rash and it was hot. On 25-OCT-2012 the rash spread to her legs, arms and face. On 25-OCT-2012 the swelling and hurt in her arm resolved. On 26-OCT-2012 she started the rash started to fade. On 26-OCT-2012 the patient experienced itching. On an unknown date the patient experienced sore throat. No treatment information was reported. It is unknown if there is any relevant laboratory data. As of 29-OCT-2012 she will not have another PNEUMOVAX23 and the rash is resolved and itching is better but not gone. The relatedness for arm swelling, itching, the rash spread to her legs, arms and face, hot. her trunk of her body, front and back had a red rash, sore throat and hurt in arm is unknown for PNEUMOVAX23. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown gender and age. The patient was vaccinated with lot# (669467/0005AA) M-M-R II on an unknown date in 2012, subsequent to 08-OCT-2012. Route of administration was not provided. No other co-suspects were reported. No concomitant medications were reported. Prior to administration of the vaccine M-M-R II, the vaccine had been exposed to storage at 47 degrees Fahrenheit for 12 hours. No adverse event was reported. Additional information has been requested.
Age: 1.28
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 15 months old male patient. On 31-OCT-2012 the patient was vaccinated with 0.5 ml of M-M-R II (Lot# reported as 0183, Exp date 18-JAN-2014, subcutaneous) that was exposed to 53F for 12 hours, due to hurricane Sandy. No adverse effects reported. No treatment information was reported. The outcome was unknown. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient was vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck) on 18-OCT-2012. Route of administration and dose were not provided. No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms were reported. No treatment information was reported. Additional information is requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a registered pharmacist concerning a patient, who, on 05-NOV-2012, was vaccinated with a dose of ZOSTAVAX, lot # 671074/1199AA, that expired on 25-OCT-2012 (dose and route not reported). No adverse reactions were reported. This is one of two reports from the same source. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Malaise
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 72 years old female patient with no drug reactions or allergies and no pertinent medical history. In 2006, the patient was vaccinated with first dose of PNEUMOVAX 23 (dose, route and lot # not reported). On 09-NOV-2012, the patient was vaccinated intramuscular with second dose of PNEUMOVAX 23 (lot # H013399 exp: 07-MAR-2012) (dose not reported). No concomitant medications were reported. The physician assistant stated that, a patient who received PNEUMOVAX 23 on 09-NOV-2012, developed an injection site reaction and generally did not feel well. The patient did not seek medical attention. No treatment for the adverse event was given. Lab diagnostics studies were not provided. The outcome of generally did not feel well and injection site reaction was reported as not recovered/not resolved. The relatedness for generally did not feel well and injection site reaction was unknown for PNEUMOVAX 23. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers two patients of unknown ages and genders. On 12-NOV-2012, the patient was vaccinated with PNEUMOVAX23 (exp: 11-NOV-2012) (dose, route and lot # not provided). No concomitant medications were reported. The nurse stated that on 12-NOV-2012, two patients were administered a PNEUMOVAX23 were administered one day after expiration date. No adverse effect reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Thrombosis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 years old male patient. The patient was vaccinated with ZOSTAVAX (subcutaneous)(lot number 0257AE, exp. date 15-MAR-2013) on 02-OCT-2012. No other co-suspects were reported. Concomitant medications included: aspirin. On an unknown date the patient developed a blood clot in an unspecified anatomical location after receiving ZOSTAVAX. The patient sought unspecified medical attention. Treatment included heat. No lab diagnostics studies were performed. The outcome of the adverse event was reported as not recovered/not resolved. The relatedness for the adverse event is unknown for ZOSTAVAX. The pharmacist mentioned the patient reported having "problems with AFLURIA (case number 1211USA007429) as well as with other unspecified vaccine in the past", but did not have any information to clarify what those problems were. This is one of several reports received from the same source. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Induration, Pain in extremity, X-ray limb
Clinical narrative: This spontaneous report as received from a 52 years old female consumer refers to herself who on 02-OCT-2012 was vaccinated on the right arm with a dose of PNEUMOVAX23 (dose, route, indication and lot number were not reported) and a dose of Influenza Virus Vaccine (manufacturer unknown) (dose, route, indication and lot number were not reported). No concomitant medications were reported. The pharmacist reported that she developed large sore and hard area (6 cm by 10 cm) after receiving PNEUMOVAX23 and Influenza Virus Vaccine (manufacturer unknown) on the right arm. No treatment information was reported. An x-ray of the arm was performed as lab diagnostic studies (results was not provided). The patient sought medical attention, she saw the physician. At the time of the report, the patient's outcome for the adverse event was unknown. The relatedness for the adverse event was unknown for PNEUMOVAX23 and Influenza Virus Vaccine (manufacturer unknown). Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with vaccination. The patient was vaccinated with, .65 ml ZOSTAVAX on 09-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced pink colored, raised area that is warm to touch. The raised area is as long as a palm of the hand, but not as wide. No treatment information was reported. The outcome of pink colored, raised area that is warm to touch was reported as not recovered/not resolved. The relatedness for pink colored, raised area that is warm to touch is unknown for ZOSTAVAX. No other information provided. Additional information is not expected.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 08-NOV-2012 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # 668614/1276Z), expiration date 30-SEP-2012) which was expired. No concomitant medications were reported. No adverse effect reported. No other information provided. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The patient was vaccinated with, .5 ml M-M-R II on 09nov2012 that expired on 10/26/2012. Lot # 1426Z. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced expired drug administered. No treatment information was reported. The outcome of expired drug administered is unknown. Expired drug administered is not related to M-M-R II. No adverse effects have been observed or reported. No additional information currently available.  Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a company representative refers to a 58 years old female patient with prevention of shingles. The patient was vaccinated with, .65 ml ZOSTAVAX on 25-OCT-2012. No other co-suspects were reported. Concomitant medications included: influenza virus vaccine (unspecified). On 25-OCT-2012 the patient experienced injection site erythema, 1 day after onset of therapy and itching at injection site. No treatment information was reported. The outcome of injection site erythema and itching at injection site is unknown. The relatedness for injection site erythema and itching at injection site is unknown for ZOSTAVAX. No other AE information reported.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Pain
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 68 years old female patient with asthma, osteopenia, hypertension, hypercholesterolemia, hypothyroidism, rheumatoid arthritis, melanoma, allergy to sulfa drugs, allergy to NORVASC, allergy to nystatin, allergy to LIPITOR and allergy to lisinopril. The patient's medical history included tachycardia, abnormal thyroid tests, carotid artery stenosis and abnormal liver function tests. On 24-JUL-2009, the patient was vaccinated subcutaneously with dose 1, 0.65 milliliter (ml) ZOSTAVAX. On 01-NOV-2012, the patient was vaccinated subcutaneously with dose 2, 0.65 ml ZOSTAVAX (lot# reported as 013017, expiry 09-OCT-2013). Concomitant medications included SYNTHROID, nitroglycerin (manufacturer unknown), PLAQUENIL, fluticasone propionate, ADVAIR DISKUS, CRESTOR, PROAIR HFA, omeprazole (manufacturer unknown), felodipine (manufacturer unknown) and atenolol (manufacturer unknown). On 01-NOV-2012, after administration of second dose the patient experienced body aches, chills, diarrhea, fatigue and headache. The patient sought medical attention (called Healthcare professional (HCP)). No treatment was given for the events. On 05-NOV-2012, the patient called her physician and reported that the adverse reactions had abated. The relatedness for body aches, chills, diarrhea, fatigue and headache was unknown for ZOSTAVAX. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: C-reactive protein, Echocardiogram abnormal, Ejection fraction decreased, Myocarditis, Red blood cell sedimentation rate
Clinical narrative: This case was received on 13 July 2012 via a third party query tool search on the VAERS database, under reference number 453198. A 34-year-old male patient with no current illnesses, occasional use of creatinine and increased caffeine intake received the following vaccination on 05 April 2012: ACAM2000 (lot number VV04003A). The patient had history of irregular heart beat in 2005, negative cardiac work up due to increased caffeine intake, and per the patient, family history of mother who had very unhealthy lifestyle that died of cardiac causes at age 55. Four days post inoculation, the patient developed symptomatic ventricular tachycardia that was converted to NSR (normal sinus rhythm) with IV (intravenous) amiodarone. ECHO (echocardiogram) to rule out MI (myocardial infarction) revealed 45% EF (ejection fraction) that was consistent with myocarditis. ESR (erythrocyte sedimentation rate) and CRP (C-reactive protein) were pending. The event was considered life threatening. Hospitalization was reported. The patient recovered. Documents held by sender: None.
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Ventricular tachycardia
Clinical narrative: This case was received on 13 July 2012 via a third party query tool search on the VAERS database, under reference number 453198. A 34-year-old male patient with no current illnesses, occasional use of creatinine and increased caffeine intake received the following vaccination on 05 April 2012: ACAM2000 (lot number VV04003A). The patient had history of irregular heart beat in 2005, negative cardiac work up due to increased caffeine intake, and per the patient, family history of mother who had very unhealthy lifestyle that died of cardiac causes at age 55. Four days post inoculation, the patient developed symptomatic ventricular tachycardia that was converted to NSR (normal sinus rhythm) with IV (intravenous) amiodarone. ECHO (echocardiogram) to rule out MI (myocardial infarction) revealed 45% EF (ejection fraction) that was consistent with myocarditis. ESR (erythrocyte sedimentation rate) and CRP (C-reactive protein) were pending. The event was considered life threatening. Hospitalization was reported. The patient recovered. Documents held by sender: None.
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Blood albumin normal, Blood alkaline phosphatase normal
Clinical narrative: This case was received on 13 July 2012 via a third party query tool search on the VAERS database, under reference number 453198. A 34-year-old male patient with no current illnesses, occasional use of creatinine and increased caffeine intake received the following vaccination on 05 April 2012: ACAM2000 (lot number VV04003A). The patient had history of irregular heart beat in 2005, negative cardiac work up due to increased caffeine intake, and per the patient, family history of mother who had very unhealthy lifestyle that died of cardiac causes at age 55. Four days post inoculation, the patient developed symptomatic ventricular tachycardia that was converted to NSR (normal sinus rhythm) with IV (intravenous) amiodarone. ECHO (echocardiogram) to rule out MI (myocardial infarction) revealed 45% EF (ejection fraction) that was consistent with myocarditis. ESR (erythrocyte sedimentation rate) and CRP (C-reactive protein) were pending. The event was considered life threatening. Hospitalization was reported. The patient recovered. Documents held by sender: None.
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Blood bilirubin normal, Blood cholesterol normal, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Blood glucose normal
Clinical narrative: This case was received on 13 July 2012 via a third party query tool search on the VAERS database, under reference number 453198. A 34-year-old male patient with no current illnesses, occasional use of creatinine and increased caffeine intake received the following vaccination on 05 April 2012: ACAM2000 (lot number VV04003A). The patient had history of irregular heart beat in 2005, negative cardiac work up due to increased caffeine intake, and per the patient, family history of mother who had very unhealthy lifestyle that died of cardiac causes at age 55. Four days post inoculation, the patient developed symptomatic ventricular tachycardia that was converted to NSR (normal sinus rhythm) with IV (intravenous) amiodarone. ECHO (echocardiogram) to rule out MI (myocardial infarction) revealed 45% EF (ejection fraction) that was consistent with myocarditis. ESR (erythrocyte sedimentation rate) and CRP (C-reactive protein) were pending. The event was considered life threatening. Hospitalization was reported. The patient recovered. Documents held by sender: None.
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Blood lactate dehydrogenase increased, Blood magnesium normal, Blood phosphorus normal, Blood potassium normal, Blood sodium normal
Clinical narrative: This case was received on 13 July 2012 via a third party query tool search on the VAERS database, under reference number 453198. A 34-year-old male patient with no current illnesses, occasional use of creatinine and increased caffeine intake received the following vaccination on 05 April 2012: ACAM2000 (lot number VV04003A). The patient had history of irregular heart beat in 2005, negative cardiac work up due to increased caffeine intake, and per the patient, family history of mother who had very unhealthy lifestyle that died of cardiac causes at age 55. Four days post inoculation, the patient developed symptomatic ventricular tachycardia that was converted to NSR (normal sinus rhythm) with IV (intravenous) amiodarone. ECHO (echocardiogram) to rule out MI (myocardial infarction) revealed 45% EF (ejection fraction) that was consistent with myocarditis. ESR (erythrocyte sedimentation rate) and CRP (C-reactive protein) were pending. The event was considered life threatening. Hospitalization was reported. The patient recovered. Documents held by sender: None.
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Blood thyroid stimulating hormone, Blood triglycerides decreased, Blood urea decreased, C-reactive protein increased, Cardiac enzymes increased
Clinical narrative: This case was received on 13 July 2012 via a third party query tool search on the VAERS database, under reference number 453198. A 34-year-old male patient with no current illnesses, occasional use of creatinine and increased caffeine intake received the following vaccination on 05 April 2012: ACAM2000 (lot number VV04003A). The patient had history of irregular heart beat in 2005, negative cardiac work up due to increased caffeine intake, and per the patient, family history of mother who had very unhealthy lifestyle that died of cardiac causes at age 55. Four days post inoculation, the patient developed symptomatic ventricular tachycardia that was converted to NSR (normal sinus rhythm) with IV (intravenous) amiodarone. ECHO (echocardiogram) to rule out MI (myocardial infarction) revealed 45% EF (ejection fraction) that was consistent with myocarditis. ESR (erythrocyte sedimentation rate) and CRP (C-reactive protein) were pending. The event was considered life threatening. Hospitalization was reported. The patient recovered. Documents held by sender: None.
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Cardiac imaging procedure abnormal, Catheterisation cardiac normal, Chest discomfort, Cold sweat, Condition aggravated
Clinical narrative: This case was received on 13 July 2012 via a third party query tool search on the VAERS database, under reference number 453198. A 34-year-old male patient with no current illnesses, occasional use of creatinine and increased caffeine intake received the following vaccination on 05 April 2012: ACAM2000 (lot number VV04003A). The patient had history of irregular heart beat in 2005, negative cardiac work up due to increased caffeine intake, and per the patient, family history of mother who had very unhealthy lifestyle that died of cardiac causes at age 55. Four days post inoculation, the patient developed symptomatic ventricular tachycardia that was converted to NSR (normal sinus rhythm) with IV (intravenous) amiodarone. ECHO (echocardiogram) to rule out MI (myocardial infarction) revealed 45% EF (ejection fraction) that was consistent with myocarditis. ESR (erythrocyte sedimentation rate) and CRP (C-reactive protein) were pending. The event was considered life threatening. Hospitalization was reported. The patient recovered. Documents held by sender: None.
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Cyanosis, Cytomegalovirus test negative, Diastolic dysfunction, Dizziness, Dyspnoea
Clinical narrative: This case was received on 13 July 2012 via a third party query tool search on the VAERS database, under reference number 453198. A 34-year-old male patient with no current illnesses, occasional use of creatinine and increased caffeine intake received the following vaccination on 05 April 2012: ACAM2000 (lot number VV04003A). The patient had history of irregular heart beat in 2005, negative cardiac work up due to increased caffeine intake, and per the patient, family history of mother who had very unhealthy lifestyle that died of cardiac causes at age 55. Four days post inoculation, the patient developed symptomatic ventricular tachycardia that was converted to NSR (normal sinus rhythm) with IV (intravenous) amiodarone. ECHO (echocardiogram) to rule out MI (myocardial infarction) revealed 45% EF (ejection fraction) that was consistent with myocarditis. ESR (erythrocyte sedimentation rate) and CRP (C-reactive protein) were pending. The event was considered life threatening. Hospitalization was reported. The patient recovered. Documents held by sender: None.
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram T wave inversion, Electrocardiogram abnormal, Exercise tolerance decreased
Clinical narrative: This case was received on 13 July 2012 via a third party query tool search on the VAERS database, under reference number 453198. A 34-year-old male patient with no current illnesses, occasional use of creatinine and increased caffeine intake received the following vaccination on 05 April 2012: ACAM2000 (lot number VV04003A). The patient had history of irregular heart beat in 2005, negative cardiac work up due to increased caffeine intake, and per the patient, family history of mother who had very unhealthy lifestyle that died of cardiac causes at age 55. Four days post inoculation, the patient developed symptomatic ventricular tachycardia that was converted to NSR (normal sinus rhythm) with IV (intravenous) amiodarone. ECHO (echocardiogram) to rule out MI (myocardial infarction) revealed 45% EF (ejection fraction) that was consistent with myocarditis. ESR (erythrocyte sedimentation rate) and CRP (C-reactive protein) were pending. The event was considered life threatening. Hospitalization was reported. The patient recovered. Documents held by sender: None.
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Fatigue, Headache, Heart rate increased, High density lipoprotein normal, Hypokinesia
Clinical narrative: This case was received on 13 July 2012 via a third party query tool search on the VAERS database, under reference number 453198. A 34-year-old male patient with no current illnesses, occasional use of creatinine and increased caffeine intake received the following vaccination on 05 April 2012: ACAM2000 (lot number VV04003A). The patient had history of irregular heart beat in 2005, negative cardiac work up due to increased caffeine intake, and per the patient, family history of mother who had very unhealthy lifestyle that died of cardiac causes at age 55. Four days post inoculation, the patient developed symptomatic ventricular tachycardia that was converted to NSR (normal sinus rhythm) with IV (intravenous) amiodarone. ECHO (echocardiogram) to rule out MI (myocardial infarction) revealed 45% EF (ejection fraction) that was consistent with myocarditis. ESR (erythrocyte sedimentation rate) and CRP (C-reactive protein) were pending. The event was considered life threatening. Hospitalization was reported. The patient recovered. Documents held by sender: None.
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Hypotension, Injection site pain, Intensive care, Low density lipoprotein normal, Myocarditis
Clinical narrative: This case was received on 13 July 2012 via a third party query tool search on the VAERS database, under reference number 453198. A 34-year-old male patient with no current illnesses, occasional use of creatinine and increased caffeine intake received the following vaccination on 05 April 2012: ACAM2000 (lot number VV04003A). The patient had history of irregular heart beat in 2005, negative cardiac work up due to increased caffeine intake, and per the patient, family history of mother who had very unhealthy lifestyle that died of cardiac causes at age 55. Four days post inoculation, the patient developed symptomatic ventricular tachycardia that was converted to NSR (normal sinus rhythm) with IV (intravenous) amiodarone. ECHO (echocardiogram) to rule out MI (myocardial infarction) revealed 45% EF (ejection fraction) that was consistent with myocarditis. ESR (erythrocyte sedimentation rate) and CRP (C-reactive protein) were pending. The event was considered life threatening. Hospitalization was reported. The patient recovered. Documents held by sender: None.