chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Grip strength decreased, Hypoaesthesia, Injection site reaction, Melanocytic naevus, Tenderness
Clinical narrative: Pt stated the vaccine gave her a mole at the injection site also complained of arm tenderness, leg numbness, and dropping things.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Pt stated the vaccine gave her a mole at the injection site also complained of arm tenderness, leg numbness, and dropping things.
Age: 0.7
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Child, age 8 mo, 13 days came to clinic for 6 mo vaccines. ROTATEQ is part of 6 mo vaccines but should not be given after 8 mo. This child was 13 days beyond 8 months.
Age: 20.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Feeling abnormal, Injection site swelling, Lethargy, Throat tightness
Clinical narrative: Tight throat. Abnormal swelling at injection site left upper arm. Felt out of it/lethargic.
Age: 20.0
Sex: M
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Pt was given shot: two hours later noticed some tingling in his Rt. hand and pinky.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Rash on abdomen and back. 5:03pm. Pt stayed 30 min. BENADRYL, steroids per Dr. ordered.
Age: 1.52
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness, warmth and induration surrounding the injection stie on the right upper thigh. No pain. No gait/limp. Given Cephalexin.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pruritus, Rash macular
Clinical narrative: Pt received ZOSTAVAX yesterday, then last night both feet were red, itchy, swollen and "blotchy".
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Headache
Clinical narrative: C/o headache left side head shot given Rt arm x 5 days.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Computerised tomogram, Concussion, Head injury, Syncope, Vomiting
Clinical narrative: Received a call from pt's sister - stating patient had fainted after receiving HPV vaccine and hit his head. Pt was assessed by medical team and sent home. She is now stating he has been vomiting. Recommended he go see PMD.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Adverse reaction, Syncope
Clinical narrative: Pt had adverse reaction syncope episode after receiving HPV vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Swelling
Clinical narrative: Red and swollen, mom notice it Saturday 08/03/13 a little bit symptoms and more Sunday 08/04/13. Today only red 20mm x 30 mm no treatment.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Local swelling
Clinical narrative: Swelling to hands, fingers, and feet rec'd vaccines on 7/18/13 at 11 am - at 4-5 pm mother noticed swelling in one finger. Pt woke up on 7/19 hands/feet very swollen - no resp involvement.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Vulvovaginal burning sensation
Clinical narrative: This spontaneous report was received from a 74 year old, female consumer reporting on herself, with history of having the shingles 20 years ago (approximately in 1993), and who is allergic to sulfa and penicillin. ON 28-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) (dose and route not reported). No other suspect therapies were reported. Concomitant medications included Prednisone (manufacturer unknown) and "aspa cream". On 30-JUN-2013 the patient experienced a burning sensation that rotates from place to place, started happening in the hip and the thigh. Started feeling a burning sensation on the left side wrapping to the front. Also felt the burning sensation on her vagina. The outcome of the above mentioned events was unknown at the time of the report.  The patient reported that unspecified treatment was given for the above mentioned events. No laboratory diagnostic studies were performed. Additional information is not expected.
Age: 5.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 year old patient. On 29-JUL-2013, the patient was accidentally vaccinated with a dose of GARDASIL (route and lot # not reported). No adverse effect was reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a 5 to 6 year old female patient of unknown age. In approximately 1994, "when the patient was 5 or 6 years of age" the patient developed a fever when she received the third dose of M-M-R II (HSA). The patient's mother was a nurse, and she gave the patient a cold bath at that time to help reduced the fever. The dates of administration of all doses of M-M-R II where unknown by the physician. The outcome of fever was reported as recovered/resolved on unspecified date. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Rash, Rash macular
Clinical narrative: This spontaneous report as received from a 61 year old female patient reporting on herself with no drug reactions, allergies or pertinent medical history. Patient with blood pressure. On 29-JUL-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) for the prevention of shingles. Concomitant medication included unspecified blood pressure medication. On 30-JUL-2013, the patient experienced a red blotch (the size of a half-dollar0 at the injection site. The area was warm to touch and she also noticed 2 more small spots nearby. The spots were not blistered. No treatment was given for the event. No lab diagnostic studies were performed. The patient did not seek for medical attention. The outcomes of the events were reported as not recovered. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an 8 year old female patient. In approximately 209, "approximately 4 years ago", the patient was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # not reported) IM two months prior her ninth birthday. No adverse experienced was reported. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified  medical assistant refers to a patient of unknown age. On an unknown dates, unspecified number of patients were vaccinated with 0.5 ml doses of PEDVAXHIB (Lot # not reported) IM which was unsupported due to lack of stability for the temperature storage conditions. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse regarding a patient of unknown age and gender with no pertinent medical history reported. On 06-AUG-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (dose and route not specified). The patient received the second dose of GARDASIL (lot number and expiration date not reported) (dose and route not specified), on 29-JUL-2013 (reported as "today"). No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Malaise
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient of unknown age. On 26-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry not reported) at an unspecified hospital. The pharmacist noted that the patient reported that after receiving ZOSTAVAX he experienced an injection site reaction. On 28-JUL-2013, the patient experienced general malaise, tenderness and warmth at the unspecified injection site. No treatment was given for the events. No medical attention was sought. The outcome of general malaise, tenderness and warmth at the unspecified injection site was reported as recovering. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to a patient of unknown age and gender. On 29-JUL-2013, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # J005575, expiry: 16-DEC-2015) dose 3. Dates of first two doses were unspecified. No adverse event reported. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from nurse (B.S.N.) via a company representative refers to 2 sisters of unknown age. Both of the 2 sisters received their first dose of GARDASIL (lot#, dose and route not reported) 2 years ago (unknown date in 2011). On 08-JUL-2013 they received their second doses of GARDASIL. It was unknown if the patients had sought medical attention. No adverse effect reported. Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to an 83 year old male patient. On an unknown date of January 2013 the patient was vaccinated with ZOSTAVAX VIAL 19400 PFU, subcutaneously, and was diagnosed with shingles "two weeks later". The patient did not have a history of shingles. The patient sought medical attention-office visit. The patient was treated with FAMVIR (manufacturer unspecified). The patient reports that he was also diagnosed and treated for shingles in March 2013 and June 2013 and was again treated with FAMVIR. The outcome of shingles was reported as not recovered. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Cellulitis, Erythema, Induration, Pain in extremity
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 64 year old female patient with osteoarthritis, hyperlipidemia, hypertension, gastrointestinal reflux, allergic rhinitis and no drug allergies. on 18-JUL-2013 the patient was vaccinated with one 0.65ml dose of ZOSTAVAX, in the "back of the arm", in subcutaneous region. The lot number and the expired date were not available as the patient was vaccinated in another pharmacy. Concomitant therapies included CELEBREX, ZOLOFT, ZOCOR and ADVAIR and "PROAIR". On 20-JUL-2013, 3 days after onset of therapy the patient contacted office with complaints of induration, redness going down patient's arm, tenderness and vesicles that developed near injection site. The patient was seen in the office on 22-JUL-2013 and started on antibiotics KEFLEX with cellulitis being diagnosis. The nurse practitioner stated "I was afraid to give antiviral so as not to diminish response to vaccine".The patient was "cultured", a viral culture was requested yet a "HSV culture was performed" which showed negative results. The nurse practitioner spoke to the patient on 29-JUL-2013 and reported "arm was doing better, still a little sore, vesicles and redness nearly gone". Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness, Viral test negative
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 64 year old female patient with osteoarthritis, hyperlipidemia, hypertension, gastrointestinal reflux, allergic rhinitis and no drug allergies. on 18-JUL-2013 the patient was vaccinated with one 0.65ml dose of ZOSTAVAX, in the "back of the arm", in subcutaneous region. The lot number and the expired date were not available as the patient was vaccinated in another pharmacy. Concomitant therapies included CELEBREX, ZOLOFT, ZOCOR and ADVAIR and "PROAIR". On 20-JUL-2013, 3 days after onset of therapy the patient contacted office with complaints of induration, redness going down patient's arm, tenderness and vesicles that developed near injection site. The patient was seen in the office on 22-JUL-2013 and started on antibiotics KEFLEX with cellulitis being diagnosis. The nurse practitioner stated "I was afraid to give antiviral so as not to diminish response to vaccine".The patient was "cultured", a viral culture was requested yet a "HSV culture was performed" which showed negative results. The nurse practitioner spoke to the patient on 29-JUL-2013 and reported "arm was doing better, still a little sore, vesicles and redness nearly gone". Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself via a company representative. Approximately on an unknown date in 2013 (reported as just before 04-JUL-2013), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. Approximately on an unknown date in 2013, the arm of the patient was hot, red and swollen from the shoulder to the elbow after she received the ZOSTAVAX at a clinic. The patient did not seek any medical attention (patient did not contact healthcare provider). No treatment was provided. It was unspecified if any lab tests were performed. The outcome of all the events was unknown. The relatedness for the events was unknown for ZOSTAVAX. Additional information is not expected.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Blood test, Dyspnoea, Fatigue, Influenza like illness
Clinical narrative: This spontaneous report as received from a female patient with diabetes and no allergies  refers to herself. On 10-MAY-2013 the patient was vaccinated with ZOSTAVAX. Concomitant therapies included glimepiride. The patient reported she had been experiencing "flu like symptoms" after receiving the ZOSTAVAX vaccine. Patient stated that her symptoms included fatigue and shortness of breath after receiving the ZOSTAVAX. Patient also stated she had not been able to work because of these adverse events. Laboratory studies performed included routine blood work. Patient sought medical attention by seeing the doctor. At the time of the report, the patient's outcome was reported as not recovered/not resolved. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Breath odour, Chest X-ray, Cough, Decreased appetite, Dysphonia
Clinical narrative: 4-11-2013 Not sure of onset date b/c didn't relate it at first. Difficulty breathing - especially lying down, extreme fatigue, muscle fasciculations, weakness in arms, no appetite, great weight loss, losing muscle, cough, runny nose, voice changing - hoarse, sleep a lot, bad breath with odd smell, hands shaking.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Dyspnoea, Fatigue, Hypersomnia, Muscle atrophy, Muscle contractions involuntary
Clinical narrative: 4-11-2013 Not sure of onset date b/c didn't relate it at first. Difficulty breathing - especially lying down, extreme fatigue, muscle fasciculations, weakness in arms, no appetite, great weight loss, losing muscle, cough, runny nose, voice changing - hoarse, sleep a lot, bad breath with odd smell, hands shaking.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Muscular weakness, Rhinorrhoea, Tremor, Weight decreased
Clinical narrative: 4-11-2013 Not sure of onset date b/c didn't relate it at first. Difficulty breathing - especially lying down, extreme fatigue, muscle fasciculations, weakness in arms, no appetite, great weight loss, losing muscle, cough, runny nose, voice changing - hoarse, sleep a lot, bad breath with odd smell, hands shaking.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Activities of daily living impaired, Antibody test, Asthenia, Blood immunoglobulin M increased, Borrelia test
Clinical narrative: 4-11-2013 Not sure of onset date b/c didn't relate it at first. Difficulty breathing - especially lying down, extreme fatigue, muscle fasciculations, weakness in arms, no appetite, great weight loss, losing muscle, cough, runny nose, voice changing - hoarse, sleep a lot, bad breath with odd smell, hands shaking.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Borrelia test negative, Chest X-ray normal, Clonus, Cough, Decreased activity
Clinical narrative: 4-11-2013 Not sure of onset date b/c didn't relate it at first. Difficulty breathing - especially lying down, extreme fatigue, muscle fasciculations, weakness in arms, no appetite, great weight loss, losing muscle, cough, runny nose, voice changing - hoarse, sleep a lot, bad breath with odd smell, hands shaking.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Decreased appetite, Dysphonia, Dyspnoea, Electromyogram abnormal, Fatigue
Clinical narrative: 4-11-2013 Not sure of onset date b/c didn't relate it at first. Difficulty breathing - especially lying down, extreme fatigue, muscle fasciculations, weakness in arms, no appetite, great weight loss, losing muscle, cough, runny nose, voice changing - hoarse, sleep a lot, bad breath with odd smell, hands shaking.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Head titubation, Laboratory test normal, Muscle atrophy, Muscle contractions involuntary, Muscular weakness
Clinical narrative: 4-11-2013 Not sure of onset date b/c didn't relate it at first. Difficulty breathing - especially lying down, extreme fatigue, muscle fasciculations, weakness in arms, no appetite, great weight loss, losing muscle, cough, runny nose, voice changing - hoarse, sleep a lot, bad breath with odd smell, hands shaking.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Nuclear magnetic resonance imaging spinal normal, Pulmonary function test decreased, Rhinorrhoea
Clinical narrative: 4-11-2013 Not sure of onset date b/c didn't relate it at first. Difficulty breathing - especially lying down, extreme fatigue, muscle fasciculations, weakness in arms, no appetite, great weight loss, losing muscle, cough, runny nose, voice changing - hoarse, sleep a lot, bad breath with odd smell, hands shaking.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Tremor, Weight decreased
Clinical narrative: 4-11-2013 Not sure of onset date b/c didn't relate it at first. Difficulty breathing - especially lying down, extreme fatigue, muscle fasciculations, weakness in arms, no appetite, great weight loss, losing muscle, cough, runny nose, voice changing - hoarse, sleep a lot, bad breath with odd smell, hands shaking.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Death, Malaise
Clinical narrative: 4-11-2013 Not sure of onset date b/c didn't relate it at first. Difficulty breathing - especially lying down, extreme fatigue, muscle fasciculations, weakness in arms, no appetite, great weight loss, losing muscle, cough, runny nose, voice changing - hoarse, sleep a lot, bad breath with odd smell, hands shaking.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 68 year old male patient with diabetes mellitus, hypertension, high cholesterol and chronic kidney disease stage III and no known drug allergies. The patient's medical history included herpes zoster on an unspecified date. On 22-JUL-2013 the patient was vaccinated with ZOSTAVAX (lot # J001008, expiration date 24-APR-2014) 0.65 ml subcutaneous in the left arm. Concomitant therapies included COZAAR, JANUVIA, AMARYL, LIPITOR, and NORVASC. The physician reported that patient received ZOSTAVAX and developed a rash the next day (on 23-JUL-2013). Physician stated that patient called the office on 23-JUL-2013 and 25-JUL-2013  because he thought he was having an allergic rash and the physician recommended a steroid cream. Patient stated that steroid cream was ineffective and was seen in the office on 27-JUL-2013. He was diagnosed with herpes zoster and was prescribed VALTREX and pain medications. The lesions were in torso, scalp and between legs. Physician reported that patient was seen in the office on 29-JUL-2013 and that the shingles rash was spreading. A sample from a lesion on the skin was taken on 31-JUL-2013. Patient denied recent exposure to chickenpox or shingles. At the time of the report the patients outcome was reported as not yet recovered. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a licensed vocational nurse (LVN) refers to a 13 year old female patient with no pertinent medical history and no known drug reactions/allergies. On 08-AUG-2011 the patient was vaccinated with GARDASIL lot # 0626AA dose 1 (route and site not reported). On 21-OCT-2011 the patient was vaccinated with GARDASIL lot # 1140AA dose 2 (route and site not reported). There was no concomitant medication. After each dose, on approximately August and October 2011 respectively, the patient experienced lightheadedness. No treatment was given for the adverse event. The patient spoke to physician for medical attention. No lab diagnostic tests were performed. On an unspecified date the patient recovered from lightheadedness. The causal relationship was not reported. Additional information has ben requested.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Drug administered at inappropriate site, Immediate post-injection reaction, Injection site erythema, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Case number PHHY2013US069471, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS Ref: 478946) web site on 03 Jul 2013 with the follow-up received from Quality Assurance Department (reference number: 239091) on 02 Aug 2013: This report refers to 64-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 122102) and PNEUMOVAX (batch number: H016295) both intramuscularly on 13 Dec 2012. It was reported that due to probable intra-articular injection (inappropriate site) the patient experienced increased pain and immediate redness at the vaccination site on 13 Dec 2012. On 15 Dec 2012, he had a magnetic resonance imaging (MRI) that revealed cellulitis along acromioclavicular (AC) and bicep groove. On 17 Dec 2012, events resolved upon treatment with unspecified antibiotics and steroids. Outcome of the events was completely recovered. The causality assessment was not reported. Based on the review performed. QA department stated that, the FLUVIRIN (batch number: 122102) was manufactured in accordance with the approved internal procedures and is in compliance with cGMP requirements. Follow-up from Quality Assurance Department (reference number: 239091) on 02 Aug 2013: Updated batch review report.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Vaccination site pain
Clinical narrative: Case number PHHY2013US069471, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS Ref: 478946) web site on 03 Jul 2013 with the follow-up received from Quality Assurance Department (reference number: 239091) on 02 Aug 2013: This report refers to 64-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 122102) and PNEUMOVAX (batch number: H016295) both intramuscularly on 13 Dec 2012. It was reported that due to probable intra-articular injection (inappropriate site) the patient experienced increased pain and immediate redness at the vaccination site on 13 Dec 2012. On 15 Dec 2012, he had a magnetic resonance imaging (MRI) that revealed cellulitis along acromioclavicular (AC) and bicep groove. On 17 Dec 2012, events resolved upon treatment with unspecified antibiotics and steroids. Outcome of the events was completely recovered. The causality assessment was not reported. Based on the review performed. QA department stated that, the FLUVIRIN (batch number: 122102) was manufactured in accordance with the approved internal procedures and is in compliance with cGMP requirements. Follow-up from Quality Assurance Department (reference number: 239091) on 02 Aug 2013: Updated batch review report.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Chills, Myalgia, Oedema peripheral, Pyrexia
Clinical narrative: Case number PHHY2013US069657, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS Ref: 479070) web site on 03 Jul 2013, and with a follow up report received from QA department (quality reference number: 238928) on 01 Aug 2013: This report refers to 64-year-old female patient. Her medical history included penicillin allergy. She was vaccinated with FLUVIRIN (batch number: 1206701) and PNEUMOVAX (other manufacturer, batch number: H009826), both intramuscularly into the left arm on 07 Dec 2012. On 10 Dec 2012, four days after vaccination, patient developed fever, chills, swelling of the arm and muscle aches (site not specified). She went to a hospital emergency room and was treated for cellulitis (site unspecified) on an unspecified date. The final outcome was reported as completely recovered. Seriousness and causality assessment was not reported. Based on the batch review performed, it was concluded that FLUVIRIN batch number 1206701 was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from QA department on 01 Aug 2013: Updated batch review report.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 76 year old female patient. On 24-MAY-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # not reported) SQ. The pharmacist reported that on 24-MAY-2013, in the evening after receiving ZOSTAVAX the patient experienced an injection site reaction. The patient experienced redness, swelling and pain at the injection site. The patient called her physician who prescribed her ALEVE and NEURONTIN to manage her symptoms. The patient was still experiencing some tenderness but her symptoms were improving with each passing day. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 76 year old female patient. On 24-MAY-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # not reported) SQ. The pharmacist reported that on 24-MAY-2013, in the evening after receiving ZOSTAVAX the patient experienced an injection site reaction. The patient experienced redness, swelling and pain at the injection site. The patient called her physician who prescribed her ALEVE and NEURONTIN to manage her symptoms. The patient was still experiencing some tenderness but her symptoms were improving with each passing day. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Burning sensation, Oedema peripheral, Pruritus
Clinical narrative: Pt. called clinic 07-24-13 stating she had woke up at 0300 with burning, itching, redness and swelling to upper arm. Pt. called back 07-25-13 stating swelling and redness had increased and is now from shoulder to elbow. Referred her to physician. To my knowledge she did not see Dr.
Age: 75.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Burning sensation, Erythema, Local swelling, Middle insomnia, Pruritus
Clinical narrative: Pt. called clinic 07-24-13 stating she had woke up at 0300 with burning, itching, redness and swelling to upper arm. Pt. called back 07-25-13 stating swelling and redness had increased and is now from shoulder to elbow. Referred her to physician. To my knowledge she did not see Dr.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Amylase increased, Lipase increased, Pancreatitis acute, Ultrasound abdomen normal
Clinical narrative: This spontaneous report as received from a physician refers to a 17 year old male patient. The patient did not have pertinent medical history or drug reaction/allergies. On 15-JUL-2013, the patient was vaccinated with a first dose of GARDASIL (lot # J003727, expiration date 07-NOV-2015) dose 1, 0.5 ml, intramuscular. No concomitant medication. On 19-JUL-2013 at 12:15pm, the patient developed acute pancreatitis with acute abdominal pain, upper gastric pain and vomiting that was "intractable". On the same date, the patient was admitted to the hospital. While in the hospital, the patient was treated with intravenous (IV) hydration, intravenous (IV) anti-emetics, and intravenous (IV) analgesia". The physician reported that upon admission to the hospital the patient's pancreatic enzymes were elevated. During the patient's hospital stay, the pancreatic enzymes "gradually came down" and "x-ray imaging and ultrasound" had normal results. The physician reported that the patient was "scheduled to have pancreatic enzymes tested again" on an unspecified date. On 21-JUL-2013 "two days later", the patient was discharged from the hospital. At the time of the report the patient was recovering from the events. Upon internal review acute pancreatitis was considered medically significant. The physician considered the patient had significant disability/incapacity because "the patient was incapacitated for two days with vomiting and pain. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Urinary system x-ray normal, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a 17 year old male patient. The patient did not have pertinent medical history or drug reaction/allergies. On 15-JUL-2013, the patient was vaccinated with a first dose of GARDASIL (lot # J003727, expiration date 07-NOV-2015) dose 1, 0.5 ml, intramuscular. No concomitant medication. On 19-JUL-2013 at 12:15pm, the patient developed acute pancreatitis with acute abdominal pain, upper gastric pain and vomiting that was "intractable". On the same date, the patient was admitted to the hospital. While in the hospital, the patient was treated with intravenous (IV) hydration, intravenous (IV) anti-emetics, and intravenous (IV) analgesia". The physician reported that upon admission to the hospital the patient's pancreatic enzymes were elevated. During the patient's hospital stay, the pancreatic enzymes "gradually came down" and "x-ray imaging and ultrasound" had normal results. The physician reported that the patient was "scheduled to have pancreatic enzymes tested again" on an unspecified date. On 21-JUL-2013 "two days later", the patient was discharged from the hospital. At the time of the report the patient was recovering from the events. Upon internal review acute pancreatitis was considered medically significant. The physician considered the patient had significant disability/incapacity because "the patient was incapacitated for two days with vomiting and pain. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Abdominal pain upper, Pancreatic enzymes increased, Pancreatitis acute, Ultrasound scan normal
Clinical narrative: This spontaneous report as received from a physician refers to a 17 year old male patient. The patient did not have pertinent medical history or drug reaction/allergies. On 15-JUL-2013, the patient was vaccinated with a first dose of GARDASIL (lot # J003727, expiration date 07-NOV-2015) dose 1, 0.5 ml, intramuscular. No concomitant medication. On 19-JUL-2013 at 12:15pm, the patient developed acute pancreatitis with acute abdominal pain, upper gastric pain and vomiting that was "intractable". On the same date, the patient was admitted to the hospital. While in the hospital, the patient was treated with intravenous (IV) hydration, intravenous (IV) anti-emetics, and intravenous (IV) analgesia". The physician reported that upon admission to the hospital the patient's pancreatic enzymes were elevated. During the patient's hospital stay, the pancreatic enzymes "gradually came down" and "x-ray imaging and ultrasound" had normal results. The physician reported that the patient was "scheduled to have pancreatic enzymes tested again" on an unspecified date. On 21-JUL-2013 "two days later", the patient was discharged from the hospital. At the time of the report the patient was recovering from the events. Upon internal review acute pancreatitis was considered medically significant. The physician considered the patient had significant disability/incapacity because "the patient was incapacitated for two days with vomiting and pain. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Vomiting, X-ray normal
Clinical narrative: This spontaneous report as received from a physician refers to a 17 year old male patient. The patient did not have pertinent medical history or drug reaction/allergies. On 15-JUL-2013, the patient was vaccinated with a first dose of GARDASIL (lot # J003727, expiration date 07-NOV-2015) dose 1, 0.5 ml, intramuscular. No concomitant medication. On 19-JUL-2013 at 12:15pm, the patient developed acute pancreatitis with acute abdominal pain, upper gastric pain and vomiting that was "intractable". On the same date, the patient was admitted to the hospital. While in the hospital, the patient was treated with intravenous (IV) hydration, intravenous (IV) anti-emetics, and intravenous (IV) analgesia". The physician reported that upon admission to the hospital the patient's pancreatic enzymes were elevated. During the patient's hospital stay, the pancreatic enzymes "gradually came down" and "x-ray imaging and ultrasound" had normal results. The physician reported that the patient was "scheduled to have pancreatic enzymes tested again" on an unspecified date. On 21-JUL-2013 "two days later", the patient was discharged from the hospital. At the time of the report the patient was recovering from the events. Upon internal review acute pancreatitis was considered medically significant. The physician considered the patient had significant disability/incapacity because "the patient was incapacitated for two days with vomiting and pain. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia, Convulsion, Loss of consciousness, Malaise
Clinical narrative: This spontaneous report as received from a physician refers to a 16 year old female patient with allergy to penicillin. The patient did not have any pertinent medical history. The patient that had received the second dose of GARDASIL (dose and lot # were unknown) intramuscularly on an unspecified date a year ago in 2012. The patient was now being treated for chronic pain syndrome, migraines, weakness, joint pain and general malaise. Physician stated that the onset of adverse effects occurred approximately 8 months ago (in November 2012) on an unspecified date. The patient had a seizure on 18-JUL-2013. Physician believes this was an isolated case. The patient had "passed out" and then experienced the seizure. The physician started treating the patient in January 2013 on an unspecified day. The treatment included: Amitriptyline hydrochloride, FLEXERIL and MOTRIN. The outcome of events was reported as not recovered/not resolved. The patient sought unspecified medical attention. Upon internal review, seizure was considered to be medically significant event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine, Pain
Clinical narrative: This spontaneous report as received from a physician refers to a 16 year old female patient with allergy to penicillin. The patient did not have any pertinent medical history. The patient that had received the second dose of GARDASIL (dose and lot # were unknown) intramuscularly on an unspecified date a year ago in 2012. The patient was now being treated for chronic pain syndrome, migraines, weakness, joint pain and general malaise. Physician stated that the onset of adverse effects occurred approximately 8 months ago (in November 2012) on an unspecified date. The patient had a seizure on 18-JUL-2013. Physician believes this was an isolated case. The patient had "passed out" and then experienced the seizure. The physician started treating the patient in January 2013 on an unspecified day. The treatment included: Amitriptyline hydrochloride, FLEXERIL and MOTRIN. The outcome of events was reported as not recovered/not resolved. The patient sought unspecified medical attention. Upon internal review, seizure was considered to be medically significant event. Additional information has been requested.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Systemic lupus erythematosus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 93 year old female patient (at the time of report) with none pertinent medical history and none drug reactions or allergies. On 19-OCT-2012 the patient was vaccinated with ZOSTAVAX, 0.65 ml, injection (lot number # H013018, exp. date 09-OCT-2013, subcutaneously). Concomitant therapies included TRAVATAN, AZOPT, ESTRACE cream, fluoxetine, SYNTHROID, ranitidine, "FERROCITE", metoprolol, furosemide (manufacturer unknown) and losartan potassium (manufacturer unknown). At an unspecified time after receiving ZOSTAVAX the patient developed a lupus. The patient sought medical attention went to her physician on an unspecified date and received prednisone (manufacturer unknown) on 18-JUN-2013 for lupus. The outcome of lupus was reported as not recovered/not resolved. Upon internal review the lupus was considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Cancer in remission, Chemotherapy, Neoplasm malignant
Clinical narrative: This spontaneous report as received from a Nurse Practitioner via Company representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated with an unspecified Hepatitis B series which may have been RECOMBIVAX HB thimerosal status not provided (route, dose no., dosage and lot number unknown). On an unspecified date, the Patient was diagnosed with an unspecified cancer which was treated with unspecified chemotherapeutic agents and was in remission. The outcome of the event was unknown. Upon internal review cancer was considered as medically significant. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a male patient of unknown age. Two weeks ago (Approximately on 17-JUL-2013) the patient was vaccinated with the first dose of GARDASIL (dose, route, lot# not reported). The patient "had 2 seizures within 30 minutes" while still in the Physician's office after having received the first dose of GARDASIL. The physician sent the patient to an unspecified hospital, where the patient stayed for an unspecified length of time. It was not specified whether or not the patient was hospitalized. The out come of the events and action taken with GARDASIL was not provided. Upon internal review, had 2 seizures within 30 minutes was considered to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. Two weeks ago (approximately on 17-JUL-2013) the patient had a seizure after having left the physician's office, where she had received her first dose of GARDASIL (dose, route, lot# not reported). This patient was brought back to the physician's office for observation and appeared to be fully recovered. Action taken with GARDASIL was not provided. Upon internal review, the event was considered to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients (sex and age not reported). On an unknown date the patients were vaccinated with a dose of improperly stored GARDASIL (lot# and dose not reported). The GARDASIL was exposed to 30F for 18.5 hours. No adverse effect reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Approximately 2 minutes after administration the patient fainted.
Age: 52.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Asthenia, Back pain, Blood product transfusion, Blood test
Clinical narrative: Paralysis in legs, face, prolonged numbness in hands - still current weakness, soreness in back and hips, legs. Plasma replacement - physical therapy.
Age: 52.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Diplegia, Hypoaesthesia, Lumbar puncture, Nerve conduction studies, Pain in extremity
Clinical narrative: Paralysis in legs, face, prolonged numbness in hands - still current weakness, soreness in back and hips, legs. Plasma replacement - physical therapy.
Age: 52.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Paralysis in legs, face, prolonged numbness in hands - still current weakness, soreness in back and hips, legs. Plasma replacement - physical therapy.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, IPV
Symptoms: Incorrect dose administered
Clinical narrative: Pt. was given KINRIX then given Polio. Pt. given 2 doses of Polio at once.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Employee received Tdap vaccine 7/15/13 1:30 PM. Within a few hours, D/V redness and swelling at injection site. Area was itchy and tender. Area became progressively reddened, warm to touch, extending down arm. At 9 AM 7/16 employee came for treatment. Dx was cellulitis. Prescribed KEFLEX 500mg BID x 7 days. Pt. lost 3 days of work d/t pain and swelling. Area of cellulitis improved after 3 days and patient returned to work.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Pain, Swelling
Clinical narrative: Employee received Tdap vaccine 7/15/13 1:30 PM. Within a few hours, D/V redness and swelling at injection site. Area was itchy and tender. Area became progressively reddened, warm to touch, extending down arm. At 9 AM 7/16 employee came for treatment. Dx was cellulitis. Prescribed KEFLEX 500mg BID x 7 days. Pt. lost 3 days of work d/t pain and swelling. Area of cellulitis improved after 3 days and patient returned to work.
Age: 2.0
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Cough, Pyrexia, Rhinorrhoea
Clinical narrative: 2 d after vaccine pt. developed runny nose and cough. Next day F > 101. Seen 5th d after w/f = 103.5.
Age: 56.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Headache, Inadequate aseptic technique in use of product, Malaise
Clinical narrative: Awakened not feeling well, worsened over the course of the day. Reports massive headache, severe nausea and vomiting, continual swelling of arm with severe redness, hot to touch and pain with red bumps inside red area and one sole blister near the center. Patient states administrator did NOT cleanse the administration site with anything prior to giving her the vaccine.
Age: 56.0
Sex: F
Vaccine: VARCEL
Symptoms: Nausea, Oedema peripheral, Pain in extremity, Rash erythematous, Skin warm
Clinical narrative: Awakened not feeling well, worsened over the course of the day. Reports massive headache, severe nausea and vomiting, continual swelling of arm with severe redness, hot to touch and pain with red bumps inside red area and one sole blister near the center. Patient states administrator did NOT cleanse the administration site with anything prior to giving her the vaccine.
Age: 56.0
Sex: F
Vaccine: VARCEL
Symptoms: Vomiting
Clinical narrative: Awakened not feeling well, worsened over the course of the day. Reports massive headache, severe nausea and vomiting, continual swelling of arm with severe redness, hot to touch and pain with red bumps inside red area and one sole blister near the center. Patient states administrator did NOT cleanse the administration site with anything prior to giving her the vaccine.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Chest pressure/tightness; Shortness of Breath; Pt transported to Urgent Care for an evaluation and given Benadryl with good effect.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pallor, Rash, Rash maculo-papular
Clinical narrative: MACULAR PAPULAR RASH B LEGS/GROIN WITH ERYTHEMA + BLANCHES SOLU-MEDROL 0.2ML.
Age: 1.06
Sex: M
Vaccine: DTAPHEPBIP, PNC13, VARCEL
Symptoms: Blood culture negative, Computerised tomogram head normal, Culture urine negative, Electroencephalogram abnormal, Endotracheal intubation
Clinical narrative: Patient presented to outside hospital with tactile fever and generalized tonic clonic seizure; was in status epilepticus, intubated for airway protection, resolved.
Age: 1.06
Sex: M
Vaccine: DTAPHEPBIP, PNC13, VARCEL
Symptoms: Grand mal convulsion, Lumbar puncture normal, Nuclear magnetic resonance imaging normal, Pyrexia, Status epilepticus
Clinical narrative: Patient presented to outside hospital with tactile fever and generalized tonic clonic seizure; was in status epilepticus, intubated for airway protection, resolved.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Rash for 2 days on face, neck, chest, abd., and back. Fever 101.0 F T-max 103.4F.
Age: 31.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Arthralgia, Fatigue, Immunology test, Myalgia, Pyrexia
Clinical narrative: Fatigue, muscle soreness, fever 103-started Malarone and Vivotif day prior-fevers for 20 days accompanied by rash, joint aches, still occassional fevers.
Age: 31.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Rash
Clinical narrative: Fatigue, muscle soreness, fever 103-started Malarone and Vivotif day prior-fevers for 20 days accompanied by rash, joint aches, still occassional fevers.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Activities of daily living impaired, Arthralgia, Inflammation, Joint range of motion decreased
Clinical narrative: Hives covering entire body, extreme swelling of skin, itchiness, inflammation. Followed by extreme joint paint and inflammation-could not walk or use joints. Fever. Treated with cortisone, steroid tablets, Zyrtec, and Benadryl. Missed entire week of work.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Pyrexia, Skin swelling, Urticaria
Clinical narrative: Hives covering entire body, extreme swelling of skin, itchiness, inflammation. Followed by extreme joint paint and inflammation-could not walk or use joints. Fever. Treated with cortisone, steroid tablets, Zyrtec, and Benadryl. Missed entire week of work.
Age: 16.0
Sex: M
Vaccine: MNQ, MEN, MNQ
Symptoms: Road traffic accident
Clinical narrative: After leaving the clinic patient was invloved in motor vechicle accident where he was air-lifted to hospital.
Age: 16.0
Sex: M
Vaccine: MNQ, MEN, MNQ
Symptoms: Hip fracture, Intensive care, Pneumothorax, Pulmonary contusion, Road traffic accident
Clinical narrative: After leaving the clinic patient was invloved in motor vechicle accident where he was air-lifted to hospital.