chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Cough, Influenza like illness, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 56 years old female patient with unknown relevant medical history or relevant past drug history who on 06-SEP-2012 was vaccinated with a dose of a 56 years old female patient with unknown relevant medical history or relevant past drug history who on 06-SEP-2012 was vaccinated with a dose of ZOSTAVAX (Lot# 0423AE, EXP. 02-APR-2013) (SQ, dose not reported) for prevention of shingles. Concomitant medications included WELLBUTRIN XL, lorazepam, NORVASC, FLONASE spray and PROTONIX. On 08-SEP-2012 the patient experienced injection site was hard, red and swollen. There were no relevant laboratory tests. As of 09-SEP-2012, the patient was not going to receive another ZOSTAVAX. It was unspecified whether the patient sought medical attention or not. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Myalgia, Respiratory disorder
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 56 years old female patient with unknown relevant medical history or relevant past drug history who on 06-SEP-2012 was vaccinated with a dose of a 56 years old female patient with unknown relevant medical history or relevant past drug history who on 06-SEP-2012 was vaccinated with a dose of ZOSTAVAX (Lot# 0423AE, EXP. 02-APR-2013) (SQ, dose not reported) for prevention of shingles. Concomitant medications included WELLBUTRIN XL, lorazepam, NORVASC, FLONASE spray and PROTONIX. On 08-SEP-2012 the patient experienced injection site was hard, red and swollen. There were no relevant laboratory tests. As of 09-SEP-2012, the patient was not going to receive another ZOSTAVAX. It was unspecified whether the patient sought medical attention or not. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Increased upper airway secretion, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 56 years old female patient with unknown relevant medical history or relevant past drug history who on 06-SEP-2012 was vaccinated with a dose of a 56 years old female patient with unknown relevant medical history or relevant past drug history who on 06-SEP-2012 was vaccinated with a dose of ZOSTAVAX (Lot# 0423AE, EXP. 02-APR-2013) (SQ, dose not reported) for prevention of shingles. Concomitant medications included WELLBUTRIN XL, lorazepam, NORVASC, FLONASE spray and PROTONIX. On 08-SEP-2012 the patient experienced injection site was hard, red and swollen. There were no relevant laboratory tests. As of 09-SEP-2012, the patient was not going to receive another ZOSTAVAX. It was unspecified whether the patient sought medical attention or not. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site swelling, Myalgia, Pyrexia, Respiratory disorder
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 56 years old female patient with unknown relevant medical history or relevant past drug history who on 06-SEP-2012 was vaccinated with a dose of a 56 years old female patient with unknown relevant medical history or relevant past drug history who on 06-SEP-2012 was vaccinated with a dose of ZOSTAVAX (Lot# 0423AE, EXP. 02-APR-2013) (SQ, dose not reported) for prevention of shingles. Concomitant medications included WELLBUTRIN XL, lorazepam, NORVASC, FLONASE spray and PROTONIX. On 08-SEP-2012 the patient experienced injection site was hard, red and swollen. There were no relevant laboratory tests. As of 09-SEP-2012, the patient was not going to receive another ZOSTAVAX. It was unspecified whether the patient sought medical attention or not. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician refers to a 60 years old female patient. The patient was vaccinated with ZOSTAVAX (1 vial dose, injection, lot# was unknown) on 27-AUG-2012. Other suspect therapies included PNEUMOVAX 23 (lot# was unknown) on 27-AUG-2012. On 28-AUG-2012 the patient experienced swelling and inflammation, about 10x5cm in size, of the injection site, from after receiving ZOSTAVAX and PNEUMOVAX 23 in the same deltoid area. The patient sought unspecified medical attention, an anti-inflammatory was given for the adverse events. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified number of patients who were vaccinated with 3 doses of RECOMBIVAX HB (lot# not reported) as children. Patients were starting to attend college and had shown no immunity and are seronegative for anti-HBs antibodies. The patients sought medical attention via contacting office. Additional information is note expected.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist concerning a female patient of unknown age on an unspecified date was vaccinated concomitantly on the same day in the same arm with a dose of ZOSTAVAX, subcutaneously and PNEUMOVAX23 (route not provided). It was reported that the patient experienced pain at injection site. At the time of the report, the patient's outcome was not provided. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Oedema peripheral, Pain in extremity
Clinical narrative: This spontaneous report as received from a 67 years old female patient with no drug reactions/allergies and no pertinent medical history concerning herself. The patient reported that after receiving unspecified PNEUMOVAX23 (injection)(manufacturer was unknown) last year in 2011 for routine vaccination, within a couple of days "she developed a reaction in one of her arms, where the arm swelled up, became hot, and was in an incredible amount of pain". The patient did not seek medical attention, no treatment was got for adverse events, no lab diagnostics was performed. "The reaction lasted for approximate 1-2 weeks". The relatedness for arm swelled up, arm was in a incredible amount of pain and arm because hot were unknown for PNEUMOVAX23. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 67 years old female patient with iodides allergy, penicillin allergy, sulfa allergy and no medical history. The patient was subcutaneously vaccinated with 0.65 ml ZOSTAVAX (lot # 672675/0068AE, exp 03-APR-2013) on 16-AUG-2012. Concomitant medications included: TYLENOL. It was reported that on 17-AUG-2012 the patient developed an inch and a quarter redness at the injection site which extended 6 inches in length and 2 and 1/2 inches in width with puffiness, redness and itchiness. Pharmacist noted that the patient stated that the swelling, redness and puffiness seems to be spreading each day. BENADRYL was given as treatment for the events. No lab diagnostic study was reported. The outcome of patient was reported as not recovered/not resolved. The patient sought medical attention via contacting pharmacist. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. The physician reported that he had a male patient who on an unspecified date experienced break through varicella after the second 0.5 ml dose of subcutaneous VARIVAX (Merck). The rep had very little information about this patient. No treatment was given. The patient sought medical attention; he was seen by the health care professional. The outcome of break through varicella after the second dose of VARIVAX was unknown. The relatedness for break through varicella after the second dose of VARIVAX was unknown for VARIVAX (Merck). Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Haematoma, Injection site erythema, Injection site warmth, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. The physician reported that he had a male patient who on an unspecified date experienced break through varicella after the second 0.5 ml dose of subcutaneous VARIVAX (Merck). The rep had very little information about this patient. No treatment was given. The patient sought medical attention; he was seen by the health care professional. The outcome of break through varicella after the second dose of VARIVAX was unknown. The relatedness for break through varicella after the second dose of VARIVAX was unknown for VARIVAX (Merck). Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 69 years old female patient with no pertinent medical history. The patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) SQ on 01-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that starting on 02-SEP-2012, the patient began to develop a bulge and itching at the injection site. The patient did not receive treatment for the adverse events. The outcome of bulge and itching at the injection site was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with a second dose of VAQTA (25U, lot number not provided) four months after the first dose was administered. No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an adult patient of unknown age. The patient was vaccinated IM with an expired 0.5 ml dose of the pediatric formulation of RECOMBIVAX HB (lot #:666029/1456Y, exp date on 06-AUG-2012) on 15-AUG-2012. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from registered nurse concerning a patient of unknown age and gender. The patient was vaccinated with the first dose of RECOMBIVAX HB (dose, route and lot not reported) on 22-OCT-2008. Second dose of RECOMBIVAX HB (dose, route and lot not reported) was given on 15-APR-2009. Nurse reported that the patient was vaccinated with the third dose of RECOMBIVAX HB (dose, route and lot not reported) only 6 weeks apart from second dose on 22-MAY-2009. Nurse reported that the patient was vaccinated with the third dose of RECOMBIVAX HB (dose, route and lot not reported) only 6 weeks apart from second dose on 22-MAY-2009. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pemphigoid
Clinical narrative: This spontaneous report as received from a consumer refers to his wife 76 years old female patient with high blood pressure, allergy to codeine and allergy to microdenton. The patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided) on an unknown date in 2009 "3 years ago". No other co-suspects were reported. There was high blood pressure medication as a concomitant medication. In November 2011 the patient had been diagnosed with bullous pemphigoid. The patient started taking high doses of steroids, prednisone to alleviate her symptoms. The patient's husband suspected that because the patient had the vaccine and was now taking steroids, there was a contraindication. He mentioned he would be contacting his health care professional . The patient sought unspecified medical attention. No laboratory diagnostics studies were performed. The outcome of bullous pemphigoid was unknown. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Acne, Pruritus, Rash
Clinical narrative: This spontaneous report was received from a 65 years old male consumer reporting on himself with no drug reactions or allergies and a history of bypass surgery twelve years ago who on 28-AUG-2012, was vaccinated on his left arm a dose of ZOSTAVAX (dose, route and lot number not reported). Concomitant medications included finasteride (manufacturer unknown), doxazosin mesylate, amlodipine, benazepril hydrochloride, simvastatin (manufacturer unknown), NIASPAN. Hydrochlorothiazide, irbesartan and aspirin. The consumer reported that on 28-AUG-2012 (reported as Wednesday), he was experiencing a small itching looked like acne. By Thursday of the same week, the consumer had full blown rash on the right hand side of his buttocks as well as the scrotum and penis. Acyclovir was given for the experience for ten days five doses a day. No lab diagnostics studies were performed. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. The relatedness for patient developed full blown rash on the right hand side of his buttocks as well as the scrotum and penis was unknown for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a female patient who on an unknown date was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not provided). On an unknown date, the patient developed shingles. It was reported that the patient sought medical attention, she went to the pharmacy on 28-AUG-2012. At the time of the report, the patent had not recovered from the event. The relatedness for the event was unknown for ZOSTAVAX. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 years old female patient. The patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # not reported) on 20-AUG-2012. If this was the first time the patient had gotten ZOSTAVAX could not be confirmed. Concomitant mediations included: INFLUENZA (unspecified) (manufacturer unknown) vaccinated in the opposite arm on 20-AUG-2012. It was reported that on 21-AUG-2012, "the following day", the patient had developed redness, swelling and warmth at the injection site. The patient came to the pharmacy on 23-AUG-2012 and said that the injection site reaction had gotten larger and there were still redness, warmth and swelling. No rash had been reported. And there was no injection site reaction in the arm vaccinated with the flu vaccine. The patient sought for unspecified medical attention. Treatment given was reported as none. Lab diagnostics studies performed were reported as none. The outcome was reported as not recovered. Additional information is not expected.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry mouth
Clinical narrative: This spontaneous report as received from a doctor of pharmacy concerning a 58 years old male patient with no drug reactions/allergies who on 24-AUG-2012, was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (lot # not reported). Concomitant medications included LAMICTAL, TRILEPTAL and hydroxyzine. The pharmacist reported that the patient experienced "extreme dry mouth"as of 24-AUG-2012 when he received his shot of ZOSTAVAX. The patient did not have any lab diagnostic performed and any treatment given. The patient sought medical attention-went to the emergency room. At the time of the report, the patient had not recovered. The relatedness for extreme dry mouth for ZOSTAVAX. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 years old female patient. The patient was vaccinated with ZOSTAVAX (lot# was unknown) in 2006 or in 2007 (exact date unspecified) and then developed shingles about 2 or 3 years later (exact date of shingles unspecified). The patient visit office for medical attention and got unspecified antiviral medication and pain medication to treat the adverse event. The outcome of shingles was reported as recovered/resolved. The pharmacist did not administer the ZOSTAVAX to the patient in 2006 or 2007 and the name of the site the vaccine was administered at in 2006 or 2007 was unspecified. Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Incorrect storage of drug, Syringe issue
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 51 year old female patient with a history of cervical disk problem who 22-AUG-2012 was vaccinated with a dose of ZOSTAVAX (lot number 672675/0068AE, expiration date 03-APR-2012) (route not provided). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 23-AUG-2012, the patient experienced headaches after receiving an improperly store dose of ZOSTAVAX. The vaccine was exposed to 75 degrees F for 12 hours. She also mentioned that some of the solution leaked out from the syringe during the administration of ZOSTAVAX and the patient got some of the solution on their skin. The patient was given TYLENOL as treatment. On 24-AUG-2012, the patient recovered from the events. This is one of several reports received from the same source (Other case number 1209USA005351). Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a patient of unknown age. The reported stated that the patient was vaccinated with the first dose, of 0.5 ml VAQTA (lot # not reported) on 27-JAN-2009 and 3 months later on 27-APR-2009, was vaccinated with the second dose, of 0.5 ml VAQTA (lot # not reported). No adverse effect reported. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot, dose and route not reported) on 31-AUG-2012 that expired on 26-JUL-2012. No other co-suspects reported. No concomitant medications were reported. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injection site mass
Clinical narrative: Information has been received from a pharmacist concerning a 61 year old male patient. The patient  had no pertinent medical history and no known drug allergies. On 24-AUG-2012, the patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX. Concomitant therapy included an unspecified "intraarticular" injection patient received on 23-AUG-2012. On 24-AUG-2012, the patient developed a lump under their skin at the injection site, after receiving ZOSTAVAX. Patient sought medical attention by contacting pharmacist. No treatment was given for the event. No lab diagnostic studies were performed. On 27-AUG-2012, the patient had recovered from lump under their skin at the injection site. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site mass
Clinical narrative: Information has been received from a pharmacist concerning a 61 year old male patient. The patient  had no pertinent medical history and no known drug allergies. On 24-AUG-2012, the patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX. Concomitant therapy included an unspecified "intraarticular" injection patient received on 23-AUG-2012. On 24-AUG-2012, the patient developed a lump under their skin at the injection site, after receiving ZOSTAVAX. Patient sought medical attention by contacting pharmacist. No treatment was given for the event. No lab diagnostic studies were performed. On 27-AUG-2012, the patient had recovered from lump under their skin at the injection site. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: TD
Symptoms: Burning sensation, Gait disturbance, Guillain-Barre syndrome, Immediate post-injection reaction, Pain
Clinical narrative: Very soon after getting the Tetanus shot I began to feel a burning sensation in my legs and very painful. I received this shot in Dr. office at 1:15PM and came home in so much pain. I called his office for 6 days only to hear he's very busy with patients and will leave him a message to call me...Nothing happpened until I called him after hours to tell him why has he ignored me all week? So he came to my house and prescribed gabapentin for the pain and burning along with oxycodone 15mg and told me to come to his office on Monday morning Aug. 27, 2012 which I did. My Son and daughter-in-law had to drive me there since I can not properly without a walker...What will happen to me, when will this go away??
Age: 70.0
Sex: F
Vaccine: TD
Symptoms: Pain in extremity, Walking aid user
Clinical narrative: Very soon after getting the Tetanus shot I began to feel a burning sensation in my legs and very painful. I received this shot in Dr. office at 1:15PM and came home in so much pain. I called his office for 6 days only to hear he's very busy with patients and will leave him a message to call me...Nothing happpened until I called him after hours to tell him why has he ignored me all week? So he came to my house and prescribed gabapentin for the pain and burning along with oxycodone 15mg and told me to come to his office on Monday morning Aug. 27, 2012 which I did. My Son and daughter-in-law had to drive me there since I can not properly without a walker...What will happen to me, when will this go away??
Age: 1.09
Sex: F
Vaccine: FLU3, MMR
Symptoms: Convulsion, Full blood count normal, Laboratory test normal, Urine analysis normal
Clinical narrative: Seizure, no fever.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Adenovirus test, Blood immunoglobulin G increased, Blood immunoglobulin M, Pain, Parvovirus B19 test
Clinical narrative: Rash in all body and articulating pain, fever.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Rash in all body and articulating pain, fever.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Convulsion, Pyrexia
Clinical narrative: Fever (102 degrees) & seizure within 36 hours of administration of vaccine. No prior seizures ever.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Musculoskeletal stiffness
Clinical narrative: "Stiffness in Legs".
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Pyrexia, Urticaria
Clinical narrative: Fever, swollen lymph nodes, hives.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy normal, Smear cervix abnormal
Clinical narrative: I underwent routine PAP test which came back abnormal for the first time in my life.  There was no lifestyle change that could have caused the abnormal results.  To further investigate the abnormal PAP test, I had to have an invasive colposcopy performed one month later, the results of which were normal.  I feel the Gardasil vaccine caused false positive PAP test results.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Enema administration, Intussusception
Clinical narrative: Intusussception.  Per report was reduced by air contrast enema (but I did not speak to provider directly)
Age: 71.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Immediate post-injection reaction, Oedema peripheral, Skin reaction
Clinical narrative: Arm immediately turned red and swelled upon administration of Zostavax. Swelling and redness began to decrease within 10 minutes. Symptoms were gone within one hour. Patient was not concerned and did not report any other problems.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test abnormal, Chills, Eye swelling, Feeling abnormal, Lacrimation increased
Clinical narrative: 1 1/2 hours after receiving intramuscular injection had "lump in throat, watery swollen reddened eyes without pain, fever to max 100.2 and chills and feeling "bad" with eventual tachycardia to 132 bpm.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Neutrophil count increased, Ocular hyperaemia, Pyrexia, Sensation of foreign body, Tachycardia
Clinical narrative: 1 1/2 hours after receiving intramuscular injection had "lump in throat, watery swollen reddened eyes without pain, fever to max 100.2 and chills and feeling "bad" with eventual tachycardia to 132 bpm.
Age: 1.26
Sex: F
Vaccine: DTAP, MMR
Symptoms: Ataxia, Blood culture, Febrile convulsion, Urine analysis
Clinical narrative: Febrile seizure, 2 days later ataxia.
Age: 22.0
Sex: M
Vaccine: FLUN3
Symptoms: Chest discomfort, Lip swelling, Oedema peripheral, Rash pruritic
Clinical narrative: Itchy rash, lips swelling, fingers and hands swelling, chest heaviness. Symptoms started 12 after vaccination and continued for 12 hours.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PT PRESENTED SWOLLEN INJECTION SITE, ABOUT 5 INCHES IN DIAMETER. IT WAS ALSO RED AND WARM.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Dysarthria, Guillain-Barre syndrome, Mobility decreased, Vertigo
Clinical narrative: Patient was up about 2 AM with slurred speech, head spinning & around 6 AM pt could not move from waist down. She was taken to ER & admitted to hospital & given fluids. Patient was told that the symptoms are consistent with Guillain-Barre.
Age: 25.0
Sex: F
Vaccine: HPVX
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Small clusters of itchy red bumps on the side of the body where vaccine was administered. One on lower leg, one on hip.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injury associated with device
Clinical narrative: Needle stick during imm. process.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Cough, Decreased appetite, Disorientation, Dizziness, Erythema
Clinical narrative: Case number PHEH2012US016438 is a spontaneous report received initially from a nurse on 17 Aug 2012 and 20 Aug 2012 with a follow up information received from a nurse on 05 Sep 2012. This case refers to an 11-years-old female patient. Her medical history was not reported. Her concomitant vaccinations included ADACEL (other manufacturer, batch number: C4247AA,) and VARIVAX (other manufacturer, batch number: 0435A2) at a dose of 0.5 ml intramuscularly on 01 Aug 2012. She was vaccinated with MENVEO (batch number: M11075) intramuscularly on to left arm on 01 Aug 2012. On 03 Aug 2012, nurse reported that the patient experienced swollen, painful, bright red area 'size' of hand on three-quarters of the arm. The patient came to doctor's office on 06 Aug 2012, for evaluation of adverse events following MENVEO vaccine and her mother reported that the patient had onset of dizziness, fever with temperature of 104 degree F, nausea, decreased appetite, disorientation and sore throat with cough on and off all weekend. The area on arm was still slightly red and swollen. The reporter stated that she had a pretty remarkable local reaction; her arm was swollen all the way down to the elbow and it was kind of splotchy. She was still having fever during the doctor's visit. On 10 Aug 2012, she came back to doctor's office because of cold and upper respiratory symptoms, however her other symptoms had resolved. She only had a little residual rash at that time. On an unspecified date, she was hospitalized (date and duration of hospitalization was not reported). The outcome of the event was reported as complete recovery. The causality was not reported. Follow up information received on 05 Sep 2012: Patient demographics (initials, age, height and weight), concomitant vaccines, site of administration of MENVEO, events (dizziness, nausea, decreased appetite, disorientation, sore throat with cough, cold, upper respiratory symptoms and painful arm), seriousness and events outcome updated.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Local reaction, Nasopharyngitis, Nausea, Oedema peripheral, Oropharyngeal pain
Clinical narrative: Case number PHEH2012US016438 is a spontaneous report received initially from a nurse on 17 Aug 2012 and 20 Aug 2012 with a follow up information received from a nurse on 05 Sep 2012. This case refers to an 11-years-old female patient. Her medical history was not reported. Her concomitant vaccinations included ADACEL (other manufacturer, batch number: C4247AA,) and VARIVAX (other manufacturer, batch number: 0435A2) at a dose of 0.5 ml intramuscularly on 01 Aug 2012. She was vaccinated with MENVEO (batch number: M11075) intramuscularly on to left arm on 01 Aug 2012. On 03 Aug 2012, nurse reported that the patient experienced swollen, painful, bright red area 'size' of hand on three-quarters of the arm. The patient came to doctor's office on 06 Aug 2012, for evaluation of adverse events following MENVEO vaccine and her mother reported that the patient had onset of dizziness, fever with temperature of 104 degree F, nausea, decreased appetite, disorientation and sore throat with cough on and off all weekend. The area on arm was still slightly red and swollen. The reporter stated that she had a pretty remarkable local reaction; her arm was swollen all the way down to the elbow and it was kind of splotchy. She was still having fever during the doctor's visit. On 10 Aug 2012, she came back to doctor's office because of cold and upper respiratory symptoms, however her other symptoms had resolved. She only had a little residual rash at that time. On an unspecified date, she was hospitalized (date and duration of hospitalization was not reported). The outcome of the event was reported as complete recovery. The causality was not reported. Follow up information received on 05 Sep 2012: Patient demographics (initials, age, height and weight), concomitant vaccines, site of administration of MENVEO, events (dizziness, nausea, decreased appetite, disorientation, sore throat with cough, cold, upper respiratory symptoms and painful arm), seriousness and events outcome updated.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pain in extremity, Pyrexia, Rash macular, Respiratory disorder
Clinical narrative: Case number PHEH2012US016438 is a spontaneous report received initially from a nurse on 17 Aug 2012 and 20 Aug 2012 with a follow up information received from a nurse on 05 Sep 2012. This case refers to an 11-years-old female patient. Her medical history was not reported. Her concomitant vaccinations included ADACEL (other manufacturer, batch number: C4247AA,) and VARIVAX (other manufacturer, batch number: 0435A2) at a dose of 0.5 ml intramuscularly on 01 Aug 2012. She was vaccinated with MENVEO (batch number: M11075) intramuscularly on to left arm on 01 Aug 2012. On 03 Aug 2012, nurse reported that the patient experienced swollen, painful, bright red area 'size' of hand on three-quarters of the arm. The patient came to doctor's office on 06 Aug 2012, for evaluation of adverse events following MENVEO vaccine and her mother reported that the patient had onset of dizziness, fever with temperature of 104 degree F, nausea, decreased appetite, disorientation and sore throat with cough on and off all weekend. The area on arm was still slightly red and swollen. The reporter stated that she had a pretty remarkable local reaction; her arm was swollen all the way down to the elbow and it was kind of splotchy. She was still having fever during the doctor's visit. On 10 Aug 2012, she came back to doctor's office because of cold and upper respiratory symptoms, however her other symptoms had resolved. She only had a little residual rash at that time. On an unspecified date, she was hospitalized (date and duration of hospitalization was not reported). The outcome of the event was reported as complete recovery. The causality was not reported. Follow up information received on 05 Sep 2012: Patient demographics (initials, age, height and weight), concomitant vaccines, site of administration of MENVEO, events (dizziness, nausea, decreased appetite, disorientation, sore throat with cough, cold, upper respiratory symptoms and painful arm), seriousness and events outcome updated.
Age: 60.0
Sex: M
Vaccine: TDAP
Symptoms: Bradycardia, Cardiac pacemaker insertion, Electrocardiogram, Electrocardiogram ambulatory, Heart rate irregular
Clinical narrative: Diagnosed with bradycardia and an irregular heartbeat. Received a pacemaker on 8/20/12.
Age: 1.01
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Encephalitis, Neurological symptom, Pyrexia
Clinical narrative: Started with fevers around June 1, had fever off & on. On 6/28 was seen with severe neurological symptoms and admitted with positive encephalitis. Father convinced this was from vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN3, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pain, Skin lesion
Clinical narrative: Noted redness, swelling & lesions at right thigh injection site. Skin is warm to the touch. Painful. Patient does not have fever.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN3, IPV, MMR, VARCEL
Symptoms: Skin warm
Clinical narrative: Noted redness, swelling & lesions at right thigh injection site. Skin is warm to the touch. Painful. Patient does not have fever.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Rash
Clinical narrative: Rash & bruise near injection site. About 3 inches x 2 inches in size.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: 24 hours post pneumococcal vaccine injection (L) deltoid reddened, raised, warm to the touch. Red rash on back, legs and abdomen.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Swelling & redness to left hand.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Irritability
Clinical narrative: Excessive fussiness.
Age: 12.0
Sex: F
Vaccine: FLUN3, HEPA, HPV4
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient received Hep A, HPV & LAIV influenza vaccine at 11:30am. At approx. 2pm received a call that a red raised rash had developed over patient's trunk & extremities.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red swollen site reaction.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Nausea
Clinical narrative: Pt. felt nausea and lightheaded immediately after immunizations.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed shingles ten days after receiving ZOSTAVAX vaccination.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patient received vaccine 8/28/12. She is having symptoms of redness 3 by 5" swelling and hot to touch. NP prescribed ice packs and BENADRYL. If continues or gets worse got to ER.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Convulsion, Full blood count normal, Lethargy, Postictal state
Clinical narrative: Afebrile seizure lasting approximately 10-15 sec, tonic-clonic posturing, postictal lethargy approximately 30 min. This happened 47 hrs after influenza vaccine (on 9/8/12).
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Posture abnormal, Smooth muscle antibody negative
Clinical narrative: Afebrile seizure lasting approximately 10-15 sec, tonic-clonic posturing, postictal lethargy approximately 30 min. This happened 47 hrs after influenza vaccine (on 9/8/12).
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Oedema peripheral, Pruritus
Clinical narrative: Redness, warm to touch at injection site, itching, arm swollen.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Injection given (L) deltoid on 9/10/2012 pt was seen 9/13/2012 w/ redness, pain, & warmth below area of injection - Dx 451.82; given Rx for Ibuprofen 600 mg every 8 hrs as needed for pain & swelling.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abnormal behaviour, Crying, Irritability
Clinical narrative: Vaccines administered at 12 PM with 'some fussiness" x 5 hours crying continually and "not acting normal" from 5 pm till 11 PM slept for 8 hours from 11 PM till 7 AM (9-7-12) fed well patient was not examined for fussiness/crying episode.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Mobility decreased, Oedema peripheral, Pain in extremity, Urticaria
Clinical narrative: Generalized hives, arm pain and swelling, inability to rais arm, redness beyond site. Treated with Ranitidine 150mg, Diphenhydramine, heat to site.
Age: 51.0
Sex: F
Vaccine: TDAP, VARZOS, VARZOS
Symptoms: Blister, Papule, Skin lesion
Clinical narrative: Developed lesions of various morphologies 3 days after vaccination on hands and arms after shingles vaccine. Some papule and vesicles. Pt started on Valtrex on 9/7/12 and continues to have new lesions each day.
Age: 51.0
Sex: F
Vaccine: TDAP, VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Developed lesions of various morphologies 3 days after vaccination on hands and arms after shingles vaccine. Some papule and vesicles. Pt started on Valtrex on 9/7/12 and continues to have new lesions each day.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Felt hard below injection, they had me stay, site turned red, hot, very swollen I returned 4 times for them to check it all said O.K. Went to someone else who said I was allergic to something in it. Took BENADRYL had lots of itching.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Felt hard below injection, they had me stay, site turned red, hot, very swollen I returned 4 times for them to check it all said O.K. Went to someone else who said I was allergic to something in it. Took BENADRYL had lots of itching.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dyspnoea, Lip swelling, Swollen tongue, Urticaria
Clinical narrative: Within 15 min. after administering vaccine child started with swelling of lips, tongue; hives over body, difficulty breathing - administered BENADRYL by mouth; 0.3 ml Epinephrine; albuterol sulfate via nebulizer.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Pain
Clinical narrative: Some allergic activity begins evening of vaccine received 8/27/12 continue through 9/10/12. Symptoms - itching, redness from site of injection down to elbow. Mild/moderate pain. Has no known allergy to vaccine components.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Rash
Clinical narrative: Local pump, swelling and redness.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The morning after shingles vaccine, woke up with very swollen, red, hot, (R) upper arm. Area gradually increased in size. Very painful, ice applied. Saw Dr about it 3 days later as it was not improving.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Mobility decreased, Swelling
Clinical narrative: Pt c/o severe redness, swelling, heat, and inability to fully move arm for about 5 days.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Mobility decreased, Swelling
Clinical narrative: Pt c/o severe redness, swelling, heat, and inability to fully move arm recovery ongoing.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Injection site erythema, Nausea, Pain
Clinical narrative: Fever (102), chills, nausea, headache, body aches, vaccination site red and sore.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Fever (102), chills, nausea, headache, body aches, vaccination site red and sore.
Age: 12.0
Sex: F
Vaccine: FLUN3, HEPA, HPV4, TDAP, VARCEL
Symptoms: Pallor, Syncope
Clinical narrative: Patient was pale, had syncope.
Age: 44.0
Sex: F
Vaccine: TD, TD
Symptoms: Mobility decreased, Muscle disorder, Oedema peripheral, Pain in extremity
Clinical narrative: Swollen, any time I moved my arm it felt like a needle was cutting through my muscle about 1.5 inches deep. I have taken tylenol a few times and have limited my use of the arm. It still aches one week later and shooting pain in some positions.
Age: 44.0
Sex: F
Vaccine: TD, TD
Symptoms: Pain, Pain in extremity
Clinical narrative: Swollen, any time I moved my arm it felt like a needle was cutting through my muscle about 1.5 inches deep. I have taken tylenol a few times and have limited my use of the arm. It still aches one week later and shooting pain in some positions.
Age: 66.0
Sex: F
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Arm where vaccine was administered is red and swollen and itching.
Age: 51.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Arm where injection stated to be painful and swelled. Within 8 hrs I stated to experience a fever body aches head and neck pain chills nausea. I contacted a nurse the next morning and asked her if I should go to the emergency room. She said they would only give me ibuprofen and send me home. She also told me the symptoms would subside in 24 to 48 hours. it has been 72 hours and I am still sick from the flu vaccine. I dont know if I should go to the emergency room.
Age: 51.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Nausea, Neck pain, Pain, Pyrexia
Clinical narrative: Arm where injection stated to be painful and swelled. Within 8 hrs I stated to experience a fever body aches head and neck pain chills nausea. I contacted a nurse the next morning and asked her if I should go to the emergency room. She said they would only give me ibuprofen and send me home. She also told me the symptoms would subside in 24 to 48 hours. it has been 72 hours and I am still sick from the flu vaccine. I dont know if I should go to the emergency room.
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, RV5
Symptoms: Abscess neck, Blood culture, C-reactive protein increased, Cellulitis, Computerised tomogram abnormal
Clinical narrative: Got vaccines AM of 9/7/12. Fever started PM of 9/7/12 and continued for one week. Neck erythema/swelling started on 9/12/12.
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, RV5
Symptoms: Erythema, Full blood count abnormal, Local swelling, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Got vaccines AM of 9/7/12. Fever started PM of 9/7/12 and continued for one week. Neck erythema/swelling started on 9/12/12.
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, RV5
Symptoms: White blood cell count increased
Clinical narrative: Got vaccines AM of 9/7/12. Fever started PM of 9/7/12 and continued for one week. Neck erythema/swelling started on 9/12/12.
Age: 0.31
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Disorientation, Pyrexia, Somnolence, Tremor
Clinical narrative: Had the Tdap and Hep A shot at 16 mo. Shot was taken at 830am afterwards he was fine. He look drowsy around 5 so I laid him down for a nap. Nap till 8pm that night. When he woke up he was over heated and looked disoriented. I warped him in a blanket and try to cool him down with a wet towel, also gave him water to hydrate. I put him back to sleep at 930pm. At 1130pm he woke up with a 103 fever and he started to shake. Called the EMT. They told us to give him Tylenol. We gave it to him and his fever and shakes went slowly away.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Fatigue, Oropharyngeal pain, Rash papular, Weight decreased
Clinical narrative: Mild papular rash across chest which progressed over 4 days before reporting.  also c/o sore throat, fatigue, mild appetite loss. States had similar reaction, only worse, following MMR #1 on 8/1/12, but did not report at that time or before dose 2 was given. States rash progressed to abdomen and back, and lost 5 lbs due to anorexia following that dose.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Had a syncopal event the day of the initial HPV vaccine and has had syncopal events since.  Incident disclosed on 9/14/12.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Dyspnoea, Heart rate increased, Pain
Clinical narrative: Rapid heart beat, fever 102, extreme body aches, heaviness in chest, short breaths with cough.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Rapid heart beat, fever 102, extreme body aches, heaviness in chest, short breaths with cough.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Chills, fever, vomiting.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Maternal exposure during pregnancy
Clinical narrative: School nurse contacted HD to let HD know that the patient is pregnant, and received confirmation of pregnancy 09/14/2012.
Age: 30.0
Sex: M
Vaccine: TTOX
Symptoms: Pain, Pruritus, Rash erythematous
Clinical narrative: RED RASH WITH BUMPS AND ITCH. SLIGHT PAIN.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Bronchitis, C-reactive protein, Condition aggravated, Erythema, Full blood count
Clinical narrative: It began with a small swollen area on the upper arm near the injection site that was painful. Diagnosed with Arthus Reaction on 9/12/2012. Progressed to large swollen, tender, red area and caused sinusitis to become aggravated and then lead to bronchitis. Grew to 3.5" wide and 4.5" tall in size. Required treatment with Prednisone and antibiotics to resolve on 9/13/2012. Patient began feeling less swelling but still pain on 9/14/2012.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Immune complex assay, Injection site pain, Injection site swelling, Laboratory test, Red blood cell sedimentation rate
Clinical narrative: It began with a small swollen area on the upper arm near the injection site that was painful. Diagnosed with Arthus Reaction on 9/12/2012. Progressed to large swollen, tender, red area and caused sinusitis to become aggravated and then lead to bronchitis. Grew to 3.5" wide and 4.5" tall in size. Required treatment with Prednisone and antibiotics to resolve on 9/13/2012. Patient began feeling less swelling but still pain on 9/14/2012.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Sinusitis, Swelling, Tenderness, Type III immune complex mediated reaction
Clinical narrative: It began with a small swollen area on the upper arm near the injection site that was painful. Diagnosed with Arthus Reaction on 9/12/2012. Progressed to large swollen, tender, red area and caused sinusitis to become aggravated and then lead to bronchitis. Grew to 3.5" wide and 4.5" tall in size. Required treatment with Prednisone and antibiotics to resolve on 9/13/2012. Patient began feeling less swelling but still pain on 9/14/2012.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Crying, Diarrhoea, Flatulence, Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site, high fever, extreme irritability, non-stop crying, diarrhea, vomiting, excessive gas, unable to sleep.