chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Rash
Clinical narrative: This spontaneous report was received from a physician concerning an approximately 60 year old female patient with allergies (unspecified), latex allergy, LIDODERM patch allergy, sulfa allergy, VERAMYST allergy, BEXTRA allergy, CELEBREX allergy, Nickel allergy and Formaldehyde allergy. On 19-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date reported as H022153 and 18-MAR-2014 respectively, dose unspecified) subcutaneously. Concomitant therapies included metoprolol, lisinopril, alprazolam, sumatriptan, hydromorphone, BACLOFEN and acetaminophen, VICODIN. On 22-MAR-2013, the patient experienced welt at the injection site. On an unknown date in 2013 (reported as at some point after 22-MAR-2013), the patient experienced rash on her face and scalp. The patient sought medical attention (called and spoken with the physician.). No treatment was given. No lab tests were performed. The patient had not recovered from all the events at the time of reporting. The relatedness for all the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Blood thyroid stimulating hormone, Glycosylated haemoglobin, Haemoglobin, Joint range of motion decreased
Clinical narrative: This medically confirmed report (initial receipt: 25-Mar-2013) concerns a 64-year old male patient who had a medical history of drug reaction/allergy to shellfish and elevated homocysteine. On 22-Oct-2012, the patient received AFLURIA (batch number: P51208) intramuscularly in the left deltoid. On 05-Feb-2013, the patient had an office visit and complained of arm pain. He had intermittent sensation in the left arm. The discomfort was very severe when swimming and limited the patient's activities. He had weakness, pain and reduced range of motion. There was no tingling and no numbness. On 18-Feb-2013 the patient had a magnetic resonance imaging (MRI) of the brachial plexus. The patient's physician and radiologist were reviewing the MRI results which were not available at time of reporting. Follow-up lab work included chem panel, hemoglobin, A1C, thyroid stimulating hormone (TSH) and white blood count (WBC), results were not provided. On 20-Mar-2013, the patient returned to the office with progressive left arm and shoulder pain and loss of motion. No further information was available.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test, Limb discomfort, Muscular weakness, Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: This medically confirmed report (initial receipt: 25-Mar-2013) concerns a 64-year old male patient who had a medical history of drug reaction/allergy to shellfish and elevated homocysteine. On 22-Oct-2012, the patient received AFLURIA (batch number: P51208) intramuscularly in the left deltoid. On 05-Feb-2013, the patient had an office visit and complained of arm pain. He had intermittent sensation in the left arm. The discomfort was very severe when swimming and limited the patient's activities. He had weakness, pain and reduced range of motion. There was no tingling and no numbness. On 18-Feb-2013 the patient had a magnetic resonance imaging (MRI) of the brachial plexus. The patient's physician and radiologist were reviewing the MRI results which were not available at time of reporting. Follow-up lab work included chem panel, hemoglobin, A1C, thyroid stimulating hormone (TSH) and white blood count (WBC), results were not provided. On 20-Mar-2013, the patient returned to the office with progressive left arm and shoulder pain and loss of motion. No further information was available.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Sensory disturbance, White blood cell count
Clinical narrative: This medically confirmed report (initial receipt: 25-Mar-2013) concerns a 64-year old male patient who had a medical history of drug reaction/allergy to shellfish and elevated homocysteine. On 22-Oct-2012, the patient received AFLURIA (batch number: P51208) intramuscularly in the left deltoid. On 05-Feb-2013, the patient had an office visit and complained of arm pain. He had intermittent sensation in the left arm. The discomfort was very severe when swimming and limited the patient's activities. He had weakness, pain and reduced range of motion. There was no tingling and no numbness. On 18-Feb-2013 the patient had a magnetic resonance imaging (MRI) of the brachial plexus. The patient's physician and radiologist were reviewing the MRI results which were not available at time of reporting. Follow-up lab work included chem panel, hemoglobin, A1C, thyroid stimulating hormone (TSH) and white blood count (WBC), results were not provided. On 20-Mar-2013, the patient returned to the office with progressive left arm and shoulder pain and loss of motion. No further information was available.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster
Clinical narrative: This spontaneous report was received from a patients wife refers to her 77 year old husband. The patient has cholesterol and also takes heart medicine. On an unknown date in DEC-2011, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date was not reported, route was subcutaneous). On 13-MAR-2013, the patient had shingles after getting the ZOSTAVAX. The patient got it in the left eye. The rash cleared up about 2 weeks ago but the patient still continued to have headaches. Laboratory tests were not performed. Treatment was not provided. The outcome of the events were unknown. The patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning a female patient of unknown age. The patient had a loop electrosurgical excision procedure (LEEP) procedure on an unknown date in December 2011 for low grade squamous cells that appeared on the pap smear of the patient that showed that she was positive for human papilloma virus (HPV) on 18-AUG-2011. On 18-AUg-2011, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified). On 18-OCT-2011, the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date, dose and route unspecified) and on 05-APR-2013 (at the time of reporting), the patient was in the office to receive her third dose of GARDASIL (lot number and expiry date unspecified). No concomitant medications were reported. No adverse symptoms were reported. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Dyspnoea, Hypoxia, Injection site reaction, Laboratory test normal, Local reaction
Clinical narrative: Developed shortness of breath, tachycardia, fever to 101 degrees, wheezing which progressed to some hypoxia & pneumonia (? viral). Hospitalized on 3/14 thru 3/20. Did have localized reaction to tetanus site.
Age: 53.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Pneumonia, Pyrexia, Tachycardia, Wheezing
Clinical narrative: Developed shortness of breath, tachycardia, fever to 101 degrees, wheezing which progressed to some hypoxia & pneumonia (? viral). Hospitalized on 3/14 thru 3/20. Did have localized reaction to tetanus site.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Convulsion, Epilepsy
Clinical narrative: Day 0 after injection my daughter's body was having slight seizures. Got worse until hospitalized. Up to 20 seizures a day for 10 days. Checked into hospital. Diagnosis epilepsy.
Sex: U
Vaccine: PNC
Symptoms: Diabetes mellitus
Clinical narrative: This is a spontaneous report from a contactable nurse based on information received by Pfizer from Merck National Services Center. Service request ID #: 1-6628038210. A 17-year-old patient of unknown gender and ethnicity received the full series of PREVENAR on unknown dates. Relevant medical history and concomitant medications were not reported. The patient developed diabetes on an unknown date. No patient demographics were available and no other information was reported.
Age: 4.0
Sex: F
Vaccine: DTP
Symptoms: Transient ischaemic attack
Clinical narrative: Initial report was received from a healthcare professional on 29 March 2013. A four-year-old patient had received an injection of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (trade name, manufacturer, lot number, route, site and date of administration not reported) and one week later had a "mini-stroke". The patient was hospitalized for two weeks. No additional information was available. Outcome was recovered. Documents held by sender: None.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Blindness, Myalgia, Ocular hyperaemia, Pain, Photopsia
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 03 April 2013. A female patient had received an intramuscular injection in the left deltoid of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (manufacturer and lot number not reported) on 20 January 2012 and an unspecified amount of time following vaccination the patient experienced loss of vision, saw flashes, had red eyes, body aches over whole body and muscle aches. The patient was still being treated for vision problems and was originally diagnosed with panuveitis from immune response. The patient received the Tdap vaccine for "non-blood borne needle stick". The patient's muscle aches resolved but vision problems are ongoing although she has had treatment. The patient had no illness at the time of vaccination and no known allergies. Outcome was not recovered. Documents held by sender: None.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Uveitis
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 03 April 2013. A female patient had received an intramuscular injection in the left deltoid of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (manufacturer and lot number not reported) on 20 January 2012 and an unspecified amount of time following vaccination the patient experienced loss of vision, saw flashes, had red eyes, body aches over whole body and muscle aches. The patient was still being treated for vision problems and was originally diagnosed with panuveitis from immune response. The patient received the Tdap vaccine for "non-blood borne needle stick". The patient's muscle aches resolved but vision problems are ongoing although she has had treatment. The patient had no illness at the time of vaccination and no known allergies. Outcome was not recovered. Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Electrocardiogram T wave inversion, Electrocardiogram abnormal, Troponin I increased, Troponin normal
Clinical narrative: This study case was received from the investigator in a trial on 27 March 2013. A male subject, with no relevant past medical history, was found to have an elevated Troponin result, considered mild in severity, 10 days after he received a left arm injection of ACAM2000, SP Biologics Co., (lot number, route not reported) and concomitantly an injection of ANTHRAX, other manufacturer (lot number, route, site and side not reported) on 11 March 2013. On 21 March, 2013, ten days post vaccination, the subject with negative past medical history, reported no symptoms and Rapid Troponin result was reported as normal; but Troponin I lab value was reported as 1.98 ng/ml. The subject was contacted to repeat lab Troponin I, ECG and referral. The subject did not take any medications to treat the adverse event. The subject's outcome was reported as not recovered, still present being treated. According to the investigator, the event of elevated Troponin was considered an other important event and probably related to the trial product. Follow up information was received from the investigator on 03 April 2013. The 20-year-old male subject returned for unscheduled visit on 28 March 2013 and he was asymptomatic at that time. Troponin I (Tn) on that day was normal, with reported result of < 0.10 ng/mL. The subject was reported as recovered from adverse event of elevated Troponin on 28 March 2013. On 28 March 2013, 17 days post vaccination, an ECG was reported as abnormal, showed inverted T waves, considered mild in severity, (clinical significance was reported as unknown). The ECG was performed due to prior Troponin I result 1.98 ng/mL on 21 March 2013. The subject remained asymptomatic and was referred for care. The subject did not take any medications to treat the adverse event. The reporter was unable to obtain follow-up information, reported as lost to follow-up, and the subject's outcome remained not recovered. According to the investigator, the events of elevated Troponin and abnormal ECG: inverted T waves were considered as other important medical events. The event of elevated Troponin remained considered probably related to the trial product and the event of abnormal ECG: inverted T waves, was considered possibly related to the trial product. This represents a case of potential myopericarditis per the Investigator and has subsequently been referred to the ACAM2000 Myopericarditis Adjudication Committee for assessment. Documents held by sender: Medical Records.
Sex: M
Vaccine: SMALL
Symptoms: Bundle branch block right, Chest discomfort, Electrocardiogram abnormal, Troponin I normal
Clinical narrative: This study case was received from the investigator in a trial on 27 March 2013. A male subject (age and birth date not reported) with no relevant past medical history, developed mild chest pressure and bundle branch block, considered mild in severity, three days after he received an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported) on 13 March 2013. On 16 March 2013, three days post vaccination, the subject experienced mild chest pressure one time while supine. On 19 March 2013, Troponin I result was reported as normal, less than (<) 0.10 ng/mL. On 20 March 2013, electrocardiogram (ECG) was reported as abnormal with finding of Right Bundle Branch Block (RBBB). The subject was referred for care. According to reporter, no further information was expected to follow; reporting only because abnormal ECG, but could represent myopericarditis. The subject did not take any medications to treat the adverse event. The chest pressure was considered resolved on 16 March 2013 and the bundle branch block was not resolved. The patient's outcome was reported as not recovered, referred for care. According to the investigator, the events of chest pressure and bundle branch block were considered other important medical events and possibly related to the trial product. Documents held by sender: Medical Records.
Sex: M
Vaccine: ANTH, FLUN3, SMALL
Symptoms: Chest discomfort, Electrocardiogram normal, Headache, Myopericarditis, Troponin normal
Clinical narrative: Initial report was received 27 March 2012 from the investigator for a study. A male subject (age and date of birth not reported) had received ACAM2000, Anthrax and FLUMIST vaccines on 27 September 2012, and nine days later on 06 October 2012, the subject developed a headache and non-radiating chest tightness in the middle of his chest of moderate intensity. Nothing improved or worsened the chest tightness. The subject self medicated with Ibuprofen on 06 October 2012 for headache which resolved that same day. No medications were taken for chest tightness. The subject had no relevant medical history and denied any allergies to medications. Central lab troponin and ECG results were normal. The subject was referred out for follow-up of chest tightness and a cardiology consult. According to the cardiologist, the subject did not need a cardiology work-up. EKG was normal and the study EKG machine had problem with the leads. Per the cardiologist, no suspicion for cardiac etiology. No additional information was provided. According to the investigator, this event was low suspicion for myopericarditis. The subject was referred for care, but lost to follow-up. This represents a case of potential myopericarditis per the Investigator and has subsequently been referred to the ACAM2000 Myopericarditis Adjudication Committee for assessment. Documents held by sender: None.
Age: 0.01
Sex: M
Vaccine: HEP, HEP
Symptoms: Convulsion, Electroencephalogram abnormal
Clinical narrative: Seizures started a few hours after vaccine was given. Patient is now taking Phenobarb and DILANTIN.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an unspecified healthcare professional concerning an unspecified number of patients of unknown age and gender. Since an unknown date between September 2012 and November 2012, patients were vaccinated with the doses of improperly stored (exposed for 28 hours and 30 Fahrenheit) PEDVAXHIB (lot number and expiry date reported as 0692AA and 13-AUG-2013 respectively. dose and route unspecified). No concomitant medications were reported. No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Myalgia
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 29 year old female patient with amoxicillin allergy and TOPAMAX allergy. No medical history was reported. On 27-APR-2012 12:40 PM, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # 672962/0025AE, expiry: 18-OCT-2013) intramuscularly in the left arm. No concomitant medication was reported. On 27-APR-2012 03:00 PM, the patient experienced significant pain after receiving PNEUMOVAX23 consisting of severe muscle pain with minor use of left arm and event minor use of forearm. The outcome of severe muscle pain with minor use of left arm and event minor use of forearm was reported as recovered on 28-APR-2012. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 11-OCT-2010 the patient was vaccinated with first dose of GARDASIL (dose, lot number unspecified). The patient received second dose of GARDASIL late on 03-APR-2013. The patient was not experienced any known symptoms. The outcome of the patient was unknown. It was unknown if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist. He stated that he had unspecified number of doses of (Merck) VARIVAX which had been exposed to 70F for 18 hours. The pharmacist declined to provide lot numbers and expiration dates for doses to be evaluated. It was unclear as to whether or not doses were administered to patients after exposure. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist. He stated he had unspecified number of doses of ZOSTAVAX which had been exposed to 70F for 18 hours. The pharmacist declined to provide lot numbers and expiration dates for doses to be evaluated. It was unclear as to whether or not doses were administered to patients after exposure. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a healthcare worker who reported that an adult patient with an unknown vaccination history with M-M-R II had a negative titer test for Measles, Mumps and Rubella. The healthcare worker did not have any demographics for the patient. The healthcare worker did not know the patient's history of vaccination with M-M-R II, which component of the M-M-R II resulted in the negative titer or when the titer test was performed. No adverse event reported other than the negative titer test. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an adult patient of unknown age. In December 2012 the patient was vaccinated with a dose of VARIVAX (lot number unspecified) and a dose M-M-R II (lot number unknown). The physician reported that the patient never received their second dose of VARIVAX (Merck)  M-M-R II. No adverse effects reported. It was unknown if the patient had sought medical attention. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Throat tightness
Clinical narrative: This spontaneous report as received from an office medical assistant via company representative referring a currently 40 year old female patient, who on an unknown date, was vaccinated with PNEUMOVAX23 (dose, route of administration and lot # not reported). Concomitant medications were not reported. Office medical assistant informed the company representative that on an unknown date, the patient started itching and her throat started to close with PNEUMOVAX23. Time later, the patient had a similar type of response with M-M-R II (Lot # 672759/0234AE), which is referred in the MARRS case # 1303USA001795. The patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a female patient of unknown age. On 04-APR-2013, the patient was vaccinated with a dose of PNEUMOVAX23, (lot number, expiry date and route was not reported). Concomitant medications were not reported. On 05-APR-2013, the patient developed pain at the injection site during administration and was still present when the patient left the office. The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Pruritus generalised, Rash
Clinical narrative: This spontaneous report was received from a physician regarding to a female patient of unknown age that had a prior positive history of tuberculosis on an unspecified date. No drug reactions or allergies were specified by the reporter. In October 2012 the patient was vaccinated with ZOSTAVAX (lot number and expiration date were not specified) (0.65mL, subcutaneous, no anatomical site reported). No other co-suspect medications or concomitant medications were reported. The physician reported that the patient experienced hot burning sensation on her chest as well as developed tiny bubbles on her chest on an unspecified date. The patient also complained of her whole body feeling itchy. The patient used a cold pack on an unspecified date to alleviate the hotness she felt on her chest. It was reported that the patient was no longer experiencing the hotness or bubbles on her chest. She continued to experience the overall itchiness. It was not specified if the patient sought medical attention. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report as received from a healthcare worker referred to a 69 year old female patient with medical history of hyperglycemia, irritable bowel syndrome, hypertension, rheumatic fever and with drug reactions/allergies to NORVASC(caused peripheral edema in lower extremities). On 14-MAR-2013 the patient was vaccinated with ZOSTAVAX (lot#J000432, exp date 10-APR-2014, 0.65 ml, subcutaneous). Concomitant therapies included DITROPAN XL, potassium and LASIX. Patient was seen in the office on 16-MAR-2013 because she had developed an induration of 5 cm and erythema of 10 cm surrounding injection site. She stated that there were no lesions at injection site, declined VZV packet. No lab diagnostics studies performed. The outcome of events were unknown. Drug relationship was not provided. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 69 year old female patient. The patient had no pertinent medical history. The patient had experienced several drug reactions or allergies in the past. Doxycycline (unspecified dose, manufacturer and dates of administration) caused the patient to have diarrhea, stomach ache and headache. Famotidine (unspecified dose, manufacturer and dates of administration) caused the patient to feel sick (unspecified symptoms). Zoloft (unspecified dose and dates of administration), caused the patient to have increased anxiety, major heart burn and nightmares. LEXAPRO (unspecified dose and dates of administration) caused the patient to experience nausea, decreased appetite and heart palpitations. EFFEXOR (unspecified dose and dates of administration) caused the patient to experience nausea, burning in throat, weakness and headaches. BIAXIN (unspecified dose and dates of administration) caused an unspecified reaction. Approximately on an unknown date in 2004 (reported as 10 years ago), the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). Concomitant medications were unknown. On 26-MAR-2013, the patient visited an eye doctor who found a shingles like rash located on patients eye brown. The patient was seen in the emergency room either between 29-MAR-2013 or 31-MAR-2013 due to unspecified reason related to shingles like rash. The patient was diagnosed with shingles and treated with acyclovir and was released on the same day. The outcome of the event was reported as not recovered. The patient sought medical attention. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient states she contracted shingles after receiving the ZOSTAVAX vaccine.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Unknown - diagnosed with Guillain-Barre Syndrome.
Age: 20.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Cough, Erythema, Pneumonia, Pyrexia
Clinical narrative: Developed fever, cough, (L) arm redness. Dx cellulitis & pneumonia, hosp x 2 days for IV antibiotics disch on oral antibiotics x 7 days.
Age: 58.0
Sex: F
Vaccine: MMR
Symptoms: Anti-cyclic citrullinated peptide antibody negative, Erythema, Feeling hot, Haematocrit normal, Hypoaesthesia
Clinical narrative: In the evening on the date the vaccine was given, patient developed pain in bilat. fingers and hands. The fingers are numb during the day, and at night she has pain in 2nd and 3rd fingers on (R) hand. Hands get hot, red and swollen.
Age: 58.0
Sex: F
Vaccine: MMR
Symptoms: Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Metabolic function test normal
Clinical narrative: In the evening on the date the vaccine was given, patient developed pain in bilat. fingers and hands. The fingers are numb during the day, and at night she has pain in 2nd and 3rd fingers on (R) hand. Hands get hot, red and swollen.
Age: 58.0
Sex: F
Vaccine: MMR
Symptoms: Oedema peripheral, Pain in extremity, Platelet count normal, Red blood cell count normal, Red blood cell sedimentation rate normal
Clinical narrative: In the evening on the date the vaccine was given, patient developed pain in bilat. fingers and hands. The fingers are numb during the day, and at night she has pain in 2nd and 3rd fingers on (R) hand. Hands get hot, red and swollen.
Age: 58.0
Sex: F
Vaccine: MMR
Symptoms: Red cell distribution width normal, White blood cell count normal
Clinical narrative: In the evening on the date the vaccine was given, patient developed pain in bilat. fingers and hands. The fingers are numb during the day, and at night she has pain in 2nd and 3rd fingers on (R) hand. Hands get hot, red and swollen.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Had HPV #3 4/9/13 - woke up 2AM with headache, fever, dizzy, nausea. Pt. seen in office, symptoms resolving.
Age: 0.49
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, RV5, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: 5 month old child was inadvertently administered vaccines. Child should have received Rotavirus, Hib, PREVNAR and Pdx (DTAP, Hep B, IPV). Child was also administered MMR, Varicella, Hep A in error. No adverse reaction reported to date.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain in left arm starting 3-5 days (patient unsure of exact time frame) after vaccine. Described as a dull ache that is constant. Has been self-treating with ibuprofen. Doctor visit on 4/9/13, prescribed meloxicam.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pruritus generalised
Clinical narrative: Itching all over 2 hours later.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Oral mucosal eruption, Rash generalised, Rash papular, Rash pustular, Rash vesicular
Clinical narrative: Rash (papular, vesicular, pustular and crusting lesions scattered over body) mainly over diaper area, and extremities as well as lesions in oral mucosa.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Scab, Skin lesion
Clinical narrative: Rash (papular, vesicular, pustular and crusting lesions scattered over body) mainly over diaper area, and extremities as well as lesions in oral mucosa.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Nodule, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Vaccine received on 3-8-13. Pt noticed pain and knot in arm on 9th. Fever up to 100.8. Knot increased in size on 10th to size of fist, red, hot to touch. Pt states TYLENOL brought temp down to 100.2. Instructed pt to f/u with PCP or go to ER with any s/sx SOB or trouble breathing.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Rash vesicular
Clinical narrative: Vaccine administered 4-6-13. Notified of "chicken pox-like" rash on arms / legs on 4/9/13 4:30pm. Contacted MSD to report rxn - advised patient to notify MD. Followed up with patient 4/10/13 4:45pm rash ? coming to "blister" head.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Rash pruritic, Rash vesicular, Varicella
Clinical narrative: Vaccine administered 4-6-13. Notified of "chicken pox-like" rash on arms / legs on 4/9/13 4:30pm. Contacted MSD to report rxn - advised patient to notify MD. Followed up with patient 4/10/13 4:45pm rash ? coming to "blister" head.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Redness and swelling at site, diffuse myalgias, fever and chills.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 3" red raised diameter at injection site, warm to touch.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Lump (1/2 dollar in size) redness and itching at site.
Age: 16.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Musculoskeletal pain, Rotator cuff syndrome
Clinical narrative: Patient reports (R) shoulder pain starting on same day as vaccines given. Dr examined - stated not related to vaccines. Refer to ortho for Rotator cuff evaluation.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Convulsion, Erythema, Induration, Oedema peripheral, Skin warm
Clinical narrative: 4-9-13 830 (L) arm swollen, red & warm to touch. 10cm indurated in center with erythema/tenderness. Rec to use cool compresses to arm & TYLENOL . 4-10-13 2 pm mom called & said child had 4 1/2 min seizure this morning at school. Has concern could be due to meds vaccine.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Tenderness
Clinical narrative: 4-9-13 830 (L) arm swollen, red & warm to touch. 10cm indurated in center with erythema/tenderness. Rec to use cool compresses to arm & TYLENOL . 4-10-13 2 pm mom called & said child had 4 1/2 min seizure this morning at school. Has concern could be due to meds vaccine.
Age: 1.19
Sex: M
Vaccine: MMR
Symptoms: Abasia, Blood test abnormal, Inability to crawl, Inflammatory marker increased, Nuclear magnetic resonance imaging
Clinical narrative: He woke up after sleeping all night and could no longer walk or crawl, up till this date he was walking, crawling, climbing.
Age: 1.19
Sex: M
Vaccine: MMR
Symptoms: X-ray
Clinical narrative: He woke up after sleeping all night and could no longer walk or crawl, up till this date he was walking, crawling, climbing.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain
Clinical narrative: Sharp abdominal pain for 2-3 days.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Incorrect dose administered
Clinical narrative: After administration of vaccinations, it was found that patient received 2 doses of Gardasil.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Injection site pain, Pyrexia
Clinical narrative: Patient waited for 15 minutes after shot, felt fine, walked out to waiting room and felt dizzy, brought her back in and gave her juice and crackers, took her blood pressure, waited 15 minutes, took her blood pressure again.  She felt fine, and left.  Called in this morning, is dizzy, has a fever and pain at the injection site, as well as a headache.  Patient's father has a virus, could be coincidental.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Eye pruritus, Eyelid oedema
Clinical narrative: Extremely itchy eyes. Area around eyes swelled up. Eyes were still itchy the next day. Took antihistamine and used eye drops.
Age: 1.41
Sex: F
Vaccine: DTAPIPVHIB, FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth
Clinical narrative: REDNESS, BRUISING AND WARMNESS AROUND THE INJECTION SITE.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Hypertonia, Pyrexia
Clinical narrative: FEVER STARTED THAT PM AFTER SHOTS ON 3/29/13. MAX FEVER 105. MOM GAVE TYLENOL TEMP DECREASE TO 103 THAN 99. MOM GAVE TYLENOL EVERY 4 HOURS. ON SAT AND SUNDAY HE WAS ALMOST UNCONSOLABLE AND ONCE ALMOST LOST HIS BREATH.
Age: 5.0
Sex: F
Vaccine: DTPIPV, MMR, VARZOS, DTAPIPV, MMR, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Patient was given a Zostavax by Medical Assistant, when Varicella was ordered.  No complications noted by person who gave vaccine as well as physician.  Parent is aware.
Age: 5.0
Sex: F
Vaccine: DTPIPV, MMR, VARZOS, DTAPIPV, MMR, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was given a Zostavax by Medical Assistant, when Varicella was ordered.  No complications noted by person who gave vaccine as well as physician.  Parent is aware.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain, Clostridium test negative, Diarrhoea, Lymphocyte percentage decreased, Myalgia
Clinical narrative: Sore throat; Abd pain; Nausea; Explosive, liquid diarrhea; Muscle aches.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Nausea, Neutrophil percentage increased, Oropharyngeal pain, White blood cell count increased
Clinical narrative: Sore throat; Abd pain; Nausea; Explosive, liquid diarrhea; Muscle aches.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Abnormal behaviour, Disturbance in attention, Psychomotor hyperactivity, Speech disorder
Clinical narrative: Change in behavior, became extremely hyperactive and talking excessively and her attention span was very short. It was a drastic change from her previous behavior.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Presyncope
Clinical narrative: Patient was given PPD and HPV Immunization and had vasovagal reaction 10 mins later. Patient got up on his own and was sent to ED for further evaluation.
Age: 77.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Chills, Pain, Vomiting
Clinical narrative: Severe pain in stomach and then 12 hours later threw up.  24 hours later again threw up.  Called family doctor and she said it likely is from the shot.  Also have felt chilled and achy.  Had previously visited family Dr. two days prior for check up.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Large red, very itchy area to left thigh that is warm to touch.
Age: 83.0
Sex: M
Vaccine: DTAP
Symptoms: Mobility decreased, Nuclear magnetic resonance imaging, Pain in extremity, Rotator cuff syndrome, Tendon rupture
Clinical narrative: My husband woke up with severe pain in his right arm the morning after the injection. He saw Dr. a couple of weeks later at which time the Dr said the tetanus injection could not have caused the pain.  After xray and MRI it was found that he had a partially torn bicep and rotator cuff which could not have been caused by injection.  But somehow it has affected his arm.  He has been on physical therapy for several weeks now but has lost some motion in that arm and has some pain in the left arm also which started at the same time as the arm of injection.
Age: 83.0
Sex: M
Vaccine: DTAP
Symptoms: X-ray
Clinical narrative: My husband woke up with severe pain in his right arm the morning after the injection. He saw Dr. a couple of weeks later at which time the Dr said the tetanus injection could not have caused the pain.  After xray and MRI it was found that he had a partially torn bicep and rotator cuff which could not have been caused by injection.  But somehow it has affected his arm.  He has been on physical therapy for several weeks now but has lost some motion in that arm and has some pain in the left arm also which started at the same time as the arm of injection.
Age: 1.26
Sex: F
Vaccine: DTAP, MMR, VARCEL, VARCEL
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site rash, Injection site vesicles
Clinical narrative: Blistering rash at injection site, fever of 100.3 aux. temp, body aches, generalized discomfort, soreness at injection site, redness around the blisters, affected area size of quarter.
Age: 1.26
Sex: F
Vaccine: DTAP, MMR, VARCEL, VARCEL
Symptoms: Pain, Pyrexia
Clinical narrative: Blistering rash at injection site, fever of 100.3 aux. temp, body aches, generalized discomfort, soreness at injection site, redness around the blisters, affected area size of quarter.
Age: 1.26
Sex: F
Vaccine: DTAP, MMR, VARCEL, VARCEL
Symptoms: Abnormal behaviour, Conjunctival oedema, Eye discharge, Injection site erythema, Injection site pain
Clinical narrative: Blistering rash at injection site, fever of 100.3 aux. temp, body aches, generalized discomfort, soreness at injection site, redness around the blisters, affected area size of quarter.
Age: 1.26
Sex: F
Vaccine: DTAP, MMR, VARCEL, VARCEL
Symptoms: Injection site reaction, Injection site vesicles, Lethargy, Lymphadenopathy, Pyrexia
Clinical narrative: Blistering rash at injection site, fever of 100.3 aux. temp, body aches, generalized discomfort, soreness at injection site, redness around the blisters, affected area size of quarter.
Age: 1.26
Sex: F
Vaccine: DTAP, MMR, VARCEL, VARCEL
Symptoms: Skin lesion
Clinical narrative: Blistering rash at injection site, fever of 100.3 aux. temp, body aches, generalized discomfort, soreness at injection site, redness around the blisters, affected area size of quarter.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Chest pain, Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: Chest pain, leg pain, aching muscles, muscle weakness.
Age: 73.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site rash, Injection site swelling
Clinical narrative: Swelling, redness, rash and irritation to left upper arm from shoulder down to elbow.
Age: 28.0
Sex: F
Vaccine: TTOX
Symptoms: Chills, Headache, Influenza like illness, Pain
Clinical narrative: Donor described flu like symptoms. Chills. Body ache. Headache.
Age: 9.0
Sex: M
Vaccine: DTP
Symptoms: Fatigue, Headache, Injection site discomfort, Lethargy, Migraine
Clinical narrative: At first he had a mild fever, complaints of discomfort where the shot was given, slight headache.  By late that evening, he had an intense migraine and a high fever of about 103.  He had an incredible headache that was making him vomit.  In the middle of the night his fever spiked to 104.5.  He was lethargic, unable to understand me when I spoke with him.  I asked him to swallow some Motrin tablets.  He chewed them.  He didn't even have a reaction that they tasted awful.  He didn't seem to understand anything I would say to him.  It was scary! He had this terrible fever, migraine headaches and EXTREME fatigue for 2 days!  I should have gone to the hospital.  It was very scary!
Age: 9.0
Sex: M
Vaccine: DTP
Symptoms: Pyrexia, Vomiting
Clinical narrative: At first he had a mild fever, complaints of discomfort where the shot was given, slight headache.  By late that evening, he had an intense migraine and a high fever of about 103.  He had an incredible headache that was making him vomit.  In the middle of the night his fever spiked to 104.5.  He was lethargic, unable to understand me when I spoke with him.  I asked him to swallow some Motrin tablets.  He chewed them.  He didn't even have a reaction that they tasted awful.  He didn't seem to understand anything I would say to him.  It was scary! He had this terrible fever, migraine headaches and EXTREME fatigue for 2 days!  I should have gone to the hospital.  It was very scary!
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Rash
Clinical narrative: Patient experienced bumps all over head, neck, and face on 4/19/13 in the evening. Mother called and reported to immunization RN. Patient denies itching, redness, fever (temp 97.9 fever by mother) or warmth. RN instructed mom that this is not a common reaction to MENVEO and to follow up with PCP.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Chills, fever, body aches, swollen lymph nodes.
Age: 73.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Soreness, like a rash on left upper arm. Redness on upper left arm. Took BENADRYL and put ice on arm.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Phone call received from patient's mother, stating daycare noted redness, swelling, warm to touch of (L) arm 4-5-13 upon arrival at daycare. Patient taken to doctor for evaluation. Advised to give BENADRYL for allergic reaction and report reaction to health dept. Encouraged cool compress and ibu. Stated patient doing well.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Skin lesion
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 78 year old male patient. In 2013, the patient was vaccinated with ZOSTAVAX 19400 PFU (Lot# and exp date not reported) 0.65 ml, subcutaneous. No other co suspects were reported. No concomitant therapy was reported. The pharmacist reported that late January, early February, a few days after the patient developed a severe rash all over torso, arms and legs. Patient reported lesions and severe itching since the rash developed. The patient went to see physician three times, and no diagnosis was made. Treatment with anti-itch cream SARNA (manufacturer unknown) was prescribed. Lab diagnostics were not performed. The patient stated that the cream relieved itching for a few hours at a time. Rash has not currently resolved. The outcome of the patient developed a severe rash all over, torso, arms and legs was reported as not recovered/not resolved. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a 53 years old, female consumer reporting on herself, with no pertinent medical history reported. On 05-APR-2013 the patient was vaccinated with the second dose in the series of (Merck) VARIVAX (lot number and expiration date not reported) (dose, route and anatomical location not reported) for prevention of chicken pox. No other co-suspect therapies or concomitant medications were reported. On an unknown date in April 2013, reported as "shortly following" administration of the second dose of (Merck) VARIVAX, the patient experienced "a large painful bump" at the injection site. The patient reported that she also experienced "a large painful bump" after administration of an unspecified influenza vaccination on an unspecified date. (MARRS 1304USA004699). The outcome for the large painful bump at the injection site was reported as not recovered. The patient stated that no treatment was given for the large painful bump at the injection site. The patient did not seek medical attention. The patient declined to provide healthcare professional information. This is one from several reports from the same reporter. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Rash, Skin warm
Clinical narrative: Left upper arm swelling, redness, painful arm, warm to the touch. Patient described "goose flesh" rash.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt's (L) leg became swollen from thigh to below the knee, red, hot and sore to touch. Patient took three BENADRYL the evening of 4/9/13. Today, it is better, but still swollen.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Swelling
Clinical narrative: Vaccine of ZOSTAVAX on 3/26/13. 3/27/13 noticed red mark on vaccine site. 3/28 swelling, redness, erythema.
Age: 89.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal
Clinical narrative: He said 2 hrs after the vaccination he felt something unusual and it lasted for 19 days. He did not call pharmacy or physician regarding this discussed with MD & RPh on 4/8/13.
Sex: F
Vaccine: MMR
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report was received from healthcare student referring to an unspecified female patient of unknown age, who on an unknown date, was vaccinated with an unspecified vaccine that contained albumin. The healthcare student reported that the patient had an allergic reaction to an unspecified vaccine that contained albumin. The healthcare student did not knew the name of the vaccine, however there was no information that identified the albumin containing vaccine as M-M-R II, or when the patient might had been administered the vaccine that contained albumin. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, No adverse event
Clinical narrative: This spontaneous report as received from a female pharmacist of unknown age (reporting on herself). It was reported that in 1996 the patient was vaccinated with the first dose of VARIVAX (Merck) (lot number and expiration date not reported) (dose and route not reported). Also, in 2009 the patient received the second dose of VARIVAX (Merck) (lot number and expiration date not reported) (dose and route not reported). Concomitant therapies were not reported. The patient had two negative titers for Varicella immunity, the first negative titer was in 2008 and the second negative titer was in 2010. The pharmacist did not know what titer test was used to provide the negative titers of Varicella. No adverse event reported, other than the negative titers. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: 3 x 5 cm central area raised and red within a 18 x 13 cm area of redness. Experiencing with no pain.