chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Urticaria, White blood cell count normal
Clinical narrative: This is a 67-year-old gentleman with no significant health problems.  The patient receives annual flu vaccine and is current as of 2012/2013.  On Monday 01/14/2013 patient went to his primary care doctor for the pneumonia vaccine.  One day after vaccine (01/15/2013) he was working out and began feeling short of breath.  He noticed swelling in his throat, started coughing and had facial flushing.  He started to notice swelling around the right eye, and developed hives on the right side of the chest.  Patient then came to emergency room at 9 o'clock that evening.  He was treated with hydrocortisone and diphenhydramine and was given a prescription for prednisone. The swelling and angioedema subsided after treatment and he was discharged that night.  The morning of the 16th patient woke up and felt swelling around the right eye, pruritus, erythema on the palms of his hands, and swelling inside the cheeks.  He took the diphenhydramine for itching but he did not take any prednisone.  He felt dizzy so he sat in a chair and lost consciousness.  His wife grabbed him, put him flat on the ground and called 911.  When the patient arrived at the ER his blood pressure was 70/50.  In the ER he was given IV fluids, epinephrine 0.3, famotidine 20 mg, diphenhydramine 50 mg, and hydrocortisone and was admitted for further evaluation.  Patient was admitted and treated for allergic reaction through the 18th.  He was discharged stable with an active allergic reaction controlled with steroids and diphenhydramine and will be further managed as an outpatient.  Patient home medications include: dutasteride .5 mg daily and Cyclosporine eye drops daily, none of which are new medications.
Age: 66.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Anaphylactic reaction, Electrocardiogram, Hypersensitivity, Swelling face, Urticaria
Clinical narrative: This is a 67-year-old gentleman with no significant health problems.  The patient receives annual flu vaccine and is current as of 2012/2013.  On Monday 01/14/2013 patient went to his primary care doctor for the pneumonia vaccine.  One day after vaccine (01/15/2013) he was working out and began feeling short of breath.  He noticed swelling in his throat, started coughing and had facial flushing.  He started to notice swelling around the right eye, and developed hives on the right side of the chest.  Patient then came to emergency room at 9 o'clock that evening.  He was treated with hydrocortisone and diphenhydramine and was given a prescription for prednisone. The swelling and angioedema subsided after treatment and he was discharged that night.  The morning of the 16th patient woke up and felt swelling around the right eye, pruritus, erythema on the palms of his hands, and swelling inside the cheeks.  He took the diphenhydramine for itching but he did not take any prednisone.  He felt dizzy so he sat in a chair and lost consciousness.  His wife grabbed him, put him flat on the ground and called 911.  When the patient arrived at the ER his blood pressure was 70/50.  In the ER he was given IV fluids, epinephrine 0.3, famotidine 20 mg, diphenhydramine 50 mg, and hydrocortisone and was admitted for further evaluation.  Patient was admitted and treated for allergic reaction through the 18th.  He was discharged stable with an active allergic reaction controlled with steroids and diphenhydramine and will be further managed as an outpatient.  Patient home medications include: dutasteride .5 mg daily and Cyclosporine eye drops daily, none of which are new medications.
Age: 66.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Anaphylactic reaction, Chest X-ray, Echocardiogram, Electrocardiogram, Hypersensitivity
Clinical narrative: This is a 67-year-old gentleman with no significant health problems.  The patient receives annual flu vaccine and is current as of 2012/2013.  On Monday 01/14/2013 patient went to his primary care doctor for the pneumonia vaccine.  One day after vaccine (01/15/2013) he was working out and began feeling short of breath.  He noticed swelling in his throat, started coughing and had facial flushing.  He started to notice swelling around the right eye, and developed hives on the right side of the chest.  Patient then came to emergency room at 9 o'clock that evening.  He was treated with hydrocortisone and diphenhydramine and was given a prescription for prednisone. The swelling and angioedema subsided after treatment and he was discharged that night.  The morning of the 16th patient woke up and felt swelling around the right eye, pruritus, erythema on the palms of his hands, and swelling inside the cheeks.  He took the diphenhydramine for itching but he did not take any prednisone.  He felt dizzy so he sat in a chair and lost consciousness.  His wife grabbed him, put him flat on the ground and called 911.  When the patient arrived at the ER his blood pressure was 70/50.  In the ER he was given IV fluids, epinephrine 0.3, famotidine 20 mg, diphenhydramine 50 mg, and hydrocortisone and was admitted for further evaluation.  Patient was admitted and treated for allergic reaction through the 18th.  He was discharged stable with an active allergic reaction controlled with steroids and diphenhydramine and will be further managed as an outpatient.  Patient home medications include: dutasteride .5 mg daily and Cyclosporine eye drops daily, none of which are new medications.
Age: 66.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Local swelling, Loss of consciousness, Swelling face, Throat irritation, Urticaria
Clinical narrative: This is a 67-year-old gentleman with no significant health problems.  The patient receives annual flu vaccine and is current as of 2012/2013.  On Monday 01/14/2013 patient went to his primary care doctor for the pneumonia vaccine.  One day after vaccine (01/15/2013) he was working out and began feeling short of breath.  He noticed swelling in his throat, started coughing and had facial flushing.  He started to notice swelling around the right eye, and developed hives on the right side of the chest.  Patient then came to emergency room at 9 o'clock that evening.  He was treated with hydrocortisone and diphenhydramine and was given a prescription for prednisone. The swelling and angioedema subsided after treatment and he was discharged that night.  The morning of the 16th patient woke up and felt swelling around the right eye, pruritus, erythema on the palms of his hands, and swelling inside the cheeks.  He took the diphenhydramine for itching but he did not take any prednisone.  He felt dizzy so he sat in a chair and lost consciousness.  His wife grabbed him, put him flat on the ground and called 911.  When the patient arrived at the ER his blood pressure was 70/50.  In the ER he was given IV fluids, epinephrine 0.3, famotidine 20 mg, diphenhydramine 50 mg, and hydrocortisone and was admitted for further evaluation.  Patient was admitted and treated for allergic reaction through the 18th.  He was discharged stable with an active allergic reaction controlled with steroids and diphenhydramine and will be further managed as an outpatient.  Patient home medications include: dutasteride .5 mg daily and Cyclosporine eye drops daily, none of which are new medications.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site streaking, Local reaction, Nausea, Pain
Clinical narrative: Fever, body aches, chills and large local reaction. On 1/19/2012 experienced nausea and vomiting and visited Emergency Department where she was informed symptoms possibly related to vaccine vs flu like illness. 1/21/2012 informed our office of symptoms and related increasing large local reaction "size of a grapefruit" with streak going down to elbow on dorsal aspect of arm, vaccine was administered IM Left Deltoid. Encouraged ice and Tylenol, and if swelling increases return to ER. Office visit scheduled for tomorrow to assess further.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Swelling, Vomiting
Clinical narrative: Fever, body aches, chills and large local reaction. On 1/19/2012 experienced nausea and vomiting and visited Emergency Department where she was informed symptoms possibly related to vaccine vs flu like illness. 1/21/2012 informed our office of symptoms and related increasing large local reaction "size of a grapefruit" with streak going down to elbow on dorsal aspect of arm, vaccine was administered IM Left Deltoid. Encouraged ice and Tylenol, and if swelling increases return to ER. Office visit scheduled for tomorrow to assess further.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Fainted after receiving injection.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Erythema, Oedema peripheral
Clinical narrative: Swelling of the arm and burning/redness lasted for 3 days.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood count normal, Laboratory test normal, Metabolic function test normal, Thyroid function test
Clinical narrative: Prolonged extreme weakness.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hot flush, Malaise
Clinical narrative: CUSTOMER COMPLAINED OF HOT FLASHES, DIZZINESS, "DID NOT FEEL WELL". SHE WAS GIVEN A VACCINATION WITH THIMEROSAL AND WAS WARNED OF THIS BEFORE ADMININSTRATION.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Pain, Pyrexia, Tremor
Clinical narrative: High fever, shaking, can't get warm, aching, fever still persisting at 101 following day.
Age: 25.0
Sex: F
Vaccine: HEP, MEN
Symptoms: Asthenia, Chills, Muscle spasms, Vomiting
Clinical narrative: Vomiting, chills, weakness, cramps.
Age: 15.0
Sex: F
Vaccine: FLUX, HEPA, HPV4, VARCEL
Symptoms: Urticaria
Clinical narrative: Urticaria, mild.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient was sitting down while receiving Influenza vaccine. After the vaccine was administered patient stood up and was looking at some stickers while suddenly the knees bended and the patient fainted. The parent was able to catch the patient before the patient reached the floor. Patient was unconscious for a few seconds (aprox.10 sec), but was breathing and had a pulse. Patient recovered consciousness on her own. Patient was checked by onsite physician who determined patient was oriented and stable.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Hives, itching, redness.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: Patient got shingles on left scalp and neck only hours after the flu vaccine was administered /no prior history of shingles.
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Paraesthesia
Clinical narrative: 4 hours after receiving a tetanus diphtheria vaccine I started getting tingling in my fingers and hands.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 years old female patient with CIPRO allergy and BENTYL allergy, who on 14-JAN-2013, was vaccinated on left arm with live ZOSTAVAX (lot #, dose and route not provided). No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated that a client was vaccinated with live ZOSTAVAX called pharmacy on 17-JAN-2013 and reported she had round, red rash at the injection site of her left arm. No other information provided. The outcome of she has round, red rash at the injection site of her left arm was reported as not recovered/not resolved. The relatedness for she has round, red rash at the injection site of her left arm was unknown for live ZOSTAVAX. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 years old female patient with CIPRO allergy and BENTYL allergy, who on 14-JAN-2013, was vaccinated on left arm with live ZOSTAVAX (lot #, dose and route not provided). No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated that a client was vaccinated with live ZOSTAVAX called pharmacy on 17-JAN-2013 and reported she had round, red rash at the injection site of her left arm. No other information provided. The outcome of she has round, red rash at the injection site of her left arm was reported as not recovered/not resolved. The relatedness for she has round, red rash at the injection site of her left arm was unknown for live ZOSTAVAX. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Dehydration, Syncope
Clinical narrative: Around 5:30pm, pt fainted after a few minutes of getting the vaccine. EMT transport to hospital. Faint because gotten severe dehydrated from academy physical training not because of Flu vaccine.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient receive vaccine in Pharmacy & 30-40 min later patient fainted while in the store shopping. Paramedics were called & patient was taken to E.R.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Bradyphrenia, Computerised tomogram head normal, Diplegia, Encephalopathy, Motor dysfunction
Clinical narrative: Post injection symmetrical intermittent paralysis of arms & legs x 2 x10 min. Then 7d of encephalopathy, sl fever, generalized global slowing of speech, thinking & motor function.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Slow speech
Clinical narrative: Post injection symmetrical intermittent paralysis of arms & legs x 2 x10 min. Then 7d of encephalopathy, sl fever, generalized global slowing of speech, thinking & motor function.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Excessive eye blinking, Urticaria
Clinical narrative: Had hives on face within a day. Hives resolved with BENADRYL. Repetitive eye blinking (forceful) started within 2-3 days of vaccine. This lasted about 2 weeks then stopped.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: A few minutes after pt given flu shot came back to pharmacy saying "somebody help me" asked her if she was having difficulty breathing stated no and passed out. Pt came to a few minutes later. EMS was called and took her to hospital. Called to ck on pt and was fine. Stated this happen sometime when nervous.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pruritus
Clinical narrative: At area of shot itching still persist after 1 week, no rash just itching at injection site, immediately after shot.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site warmth
Clinical narrative: Pt reported 4 inch x 2 inch hot, itchy, inflamed area around injection site for 4-5 days after injection. Pt now has a quarter size red spot on skin at injection site but has no pain at this site. Report per wife pt will not see doctor despite our recommendations because "it is not a big deal" pt just wanted to let pharmacy & mgf. know.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site warmth
Clinical narrative: Pt reported a 4 inch x 2 inch injection site reaction that was hot, itchy and inflamed for about 4-5 days after the injection. Pt still has red spot at injection site about the size of a quarter but has no pain at this site. Patient wanted pharmacy & manufacturer know. Pt said "it is not a big deal" and will not see doctor despite our recommendations.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Swelling at injection site - immediately to hardness. Tenderness.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Neuralgia
Clinical narrative: Patient complaint of nerve pain in arm where vaccine was administered.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cold sweat, Cough, Diarrhoea, Headache
Clinical narrative: Dry cough -> nausea, vomiting & diarrhea, "clammy skin". Next morning -> headache & weakness.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Dry cough -> nausea, vomiting & diarrhea, "clammy skin". Next morning -> headache & weakness.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site erythematous, hot to touch - size of a fist.
Age: 20.0
Sex: U
Vaccine: FLU3
Symptoms: Hypoaesthesia, Limb discomfort, Paraesthesia
Clinical narrative: Numbness & tingling noted in (L) arm on 1/11/13, increasing evening. Evening of 1/12/13 - progressed to (L) thigh - no improvement with Ibuprofen tried cold - no improvement - numbness, tingling continued & increased on 1/13/13. 1-13-2013 Saw Dr. Advised to rest & take Ibuprofen. Info per father of client. 1-21-2013 Follow-up conversation with father of client. Patient is improved, however has intermittent discomfort in (L) arm.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Patient was given AFLURIA vaccine on 1/18/13 at 11:45 am. Patient's father called back several hours to let us know he has been experiencing headaches.
Age: 15.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Cold sweat, Head injury, Loss of consciousness
Clinical narrative: Patient was given influenza & HPV vaccine. Walked to reception area, briefly passed out, fell hit back of head on water cooler. BP taken 112/50 examined by Dr, lasted less than 1 minute/no treatment necessary, was clammy.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Itchy rash to elbow and under arm. Red spots, warm, took BENADRYL on night of 1/20 and it helped itch. Rash getting worse every day since administration.
Age: 0.63
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site papule, Injection site reaction, Skin exfoliation, Skin plaque
Clinical narrative: Erythematous papular scaling plaque at administration sites of all vaccines, starting day of injection through 2 weeks.
Age: 0.55
Sex: F
Vaccine: DTAPIPV, HEP, HIBV, PNC13
Symptoms: No adverse event
Clinical narrative: KINRIX (Dtap-IPV) administered to 6 month old female. No adverse effect reported.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site rash
Clinical narrative: Developed a rash 5 cm diameter around the injection site and less confluent rash up to 6 1/2 cm from site. Started > 1 1/2d after the vaccine. Shot 1/16 AM. Woke up with rash 1/18/13. Rash was around site of KINRIX.
Age: 26.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: 1/21/13 Pt. c/o dizziness, fatigue, & postprandial nausea without emesis. Began 1/18/13 & has continued to present.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient received vaccine at 2:30 pm and when she got up she fainted. She came to quickly & sat in pharmacy for 10 min. Was given water. Pt was fine and it has happened before. Stated by mother.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Myalgia
Clinical narrative: Itching, big rise up bump and muscle pain at the site of injection.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Injection site movement impairment, Injection site pain, Weight bearing difficulty
Clinical narrative: Cannot bear wt on (L) leg x 72 hrs after vaccine. FROM, tender at site. Slight resistance to (L) external rotation.
Age: 36.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL, TYP
Symptoms: Aphasia, Arthralgia, Astigmatism, Carpal tunnel syndrome, Disorientation
Clinical narrative: Joint aches - since 2008. Disorientation - since 2008. Numbness (fingers/toes) - since 2007. Astigmatism - since 2008. Lack of concentration - since 2008. Difficulty recalling or remembering words - since 2008. Receiving tx since 2008. Treated for Carpal Tunnel syndrome since 2011.
Age: 36.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL, TYP
Symptoms: Disturbance in attention, Hypoaesthesia
Clinical narrative: Joint aches - since 2008. Disorientation - since 2008. Numbness (fingers/toes) - since 2007. Astigmatism - since 2008. Lack of concentration - since 2008. Difficulty recalling or remembering words - since 2008. Receiving tx since 2008. Treated for Carpal Tunnel syndrome since 2011.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Administered ID dose to patient under 18 - patient had no adverse effects. We realized the ID dose had been given & let mom know. Mom said patient had no problems.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient received his first dose of GARDASIL (route, dose and lot # were unknown) on an unspecified date one year ago (in 2012) and now stated he would like to receive the second and third doses. No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms reported. The outcome of the event is unknown.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Musculoskeletal stiffness, Paraesthesia, Pruritus
Clinical narrative: This spontaneous report as received from a 72 years old female consumer with no pertinent medical history drug allergies refers to herself. The patient was vaccinated with a dose of ZOSTAVAX (lot number unspecified)on 29-AUG-2012 from a Pharmacy with a prescription issued by her physician. No other co-suspects were reported. There was no concomitant medications. The next day, on 30-AUG-2012, the patient felt a prickly, itchiness on the lower right leg, that evening, her arm and neck was extremely stiff and prickly and injection site area hardened. She contacted her physician(also reported as "the patient did not sought medical attention") and he prescribed a corticosteroid cream (manufacturer unspecified). No lab diagnostic studies performed. By a few days later all symptoms had disappeared. The relatedness for the adverse events were unknown for ZOSTAVAX. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Papule, Rash, Varicella virus test
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 71 years old male patient. The patient's medical history included stent put in, however did not know date or where stent was inserted. On 07-JAN-2012, the patient was vaccinated with ZOSTAVAX (lot# H017449; expiration date on 20-DEC-2013) subcutaneously. No other co-suspects were reported. Concomitant medications included blood pressure medication and cholesterol lowering medication. On 11-JAN-2013 (less than 6 days prior to outbreak), the patient visited his primary care physician and physician diagnosed patient with an active case of shingles. No treatment information was reported. No labs or diagnostics test were performed. The patient presented dermatome right side back to front. Follow-up information and questionnaire was received from the Physician. The patient's current conditions included sulfa allergy, penicillin allergy, E-MYCIN allergy, hypertension, coronary artery disease (CAD), dyslipidemia, prostatic melanoma and loss memory. Medical history included and chickenpox (5 or 6 years old). The dose of ZOSTAVAX was 0.65ml one dose. The concomitant medication included folic acid, metoprolol, simvastatin (manufacturer unknown) and NEXIUM, MAXALT. Past drug history included sulfa, penicillin (unknown) and E-MYCIN. On 10-JAN-2013, the patient developed rash which developed into shingles with spreading of rash and vesicles appearing. The body temperature was 98.3. VZVIP specimen was obtained from vesicle and papule. At the time of the report, the outcome of shingles was not recovered. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site nodule, Nodule, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report as received from a 59 years old female consumer refers to herself with no pertinent medical history and no drug reactions or allergies. On 30-DEC-2012 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot# not reported). There was no concomitant medication. It was reported that she received a dose of PNEUMOVAX 23 on 30-DEC-2012. Consumer reported that on 01-JAN-2013 she developed a fever of 101 degrees Fahrenheit, that her arm was very sore and swollen, and felt "as if a baseball had hit it". Consumer reported that a large knot, the size of a grapefruit developed three inches below the injection site on the back of the arm, approximately 3 inches above the elbow. Consumer reported that the soreness and fever persisted through Thursday, 03-JAN-2013. Consumer reported that the large knot had now (by the time of the call on 01/10/2013) shrunk to the size of a silver dollar. No treatment was given for the events. The patient did not seek medical attention. The outcome of all the events was reported as not recovered. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: This spontaneous report as received from a consumer refers to a 70 years old female patient. The patient's medical history included chickenpox as a child. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot # not reported). It was reported that the patient had a red and swollen inflamed area for two days at the injection site. The patient did not seek medical attention. No treatment was given. The outcome of red and swollen inflamed area at the injection site was reported as recovered/resolved. The relatedness for red and swollen inflamed area at the injection site was unknown for ZOSTAVAX. Additional information is not expected.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Biopsy, Lymphadenopathy, Vaccination complication
Clinical narrative: This spontaneous report was received from a company representative refers to a 18 years old female patient who on 24-AUG-2007, 14-OCT-2007 and 20-FEB-2008 was vaccinated with the first, second and third dose, respectively of GARDASIL (dose, lot # and route not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, after being vaccinated with GARDASIL. The patient developed swollen lymph nodes and the patient still suffered from an adverse reaction to GARDASIL. A biopsy was performed (result not provided). The patient sought medical attention, she went to the doctor office. The relatedness for the event was unknown for GARDASIL. Additional information is not expected.
Age: 1.6
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an approximately 19 months old patient of an unknown gender. The patient was vaccinated subcutaneously with the first dose of MMR II (dose and lot number not reported) on their first birthday in November 2009. No other co-suspects were reported. No concomitant medications were reported. In June 2010 the patient was vaccinated with the second dose of MMR II (dose and lot number not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to three patients in their 30's and unknown genders who on unspecified date were vaccinated with GARDASIL (dose, lot # and route not provided). No other co-suspects were reported. No concomitant medications were reported. The Nurse Practitioner stated that on unspecified date, the patients did not experienced any adverse effects. No additional information provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a male patient of unknown age who on an unknown date was vaccinated with ZOSTAVAX (dose, route, and lot not reported). No other co-suspects were reported. No concomitant medications were reported. The patient reported that ZOSTAVAX was stored in a syringe for more than 30 minutes prior to administration. No adverse symptoms reported. The outcome of the event was unknown. The event was not related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician regarding to a female patient of unknown age. The patient's medical history, drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with the second dose of VAQTA (dose, route and lot number were not provided), six days before the required 6 month interval from the first dose. No adverse effect reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a 25 years old female consumer regarding herself. Patient had no pertinent medical history and drug reactions or allergies. On 15-NOV-2012, the patient was vaccinated with her first and only dose of GARDASIL (lot#, dose and route not reported). No concomitant medications were reported. Subsequently on 28-NOV-2012, the patient found out that she was pregnant with an LPM of 28-OCT-2012 and an EDD of 04-AUG-13. She was not going to have the second or third shot until the pregnancy was completed. No treatment was given. No laboratory test were performed. Patient sought medical attention (called the Healthcare professional). No adverse reactions were reported. Initial exposure to GARDASIL was at 2 weeks. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a consumer who was a 69 years old female patient. The patient was vaccinated subcutaneously with a dose of ZOSTAVAX on 14-JAN-2013 (reported as today). The patient questioned the efficacy of the product today. The vaccine was kept for 35 to 40 minutes after being reconstituted and administered. She stated she was not having any side effects only wanted to be sure the product was good. She also stated the vaccine was kept on ice. The patient did not seek medical attention and no treatment was given to patient. At the time of report, the patient's status was unknown. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 55 years old female patient with renal failure requiring peritoneal dialysis, diabetes, hypertension, right benign renal mass, atrial fibrillation and rheumatoid arthritis. The patient's medical history included left nephrectomy and chicken pox in childhood. The patient was accidentally vaccinated with a dose of VARIVAX (merck) instead of prescribed ZOSTAVAX on 29-OCT-2012. Concomitant medications included furosemide, folic acid and methotrexate. Historical drug included PNEUMOVAX 23 (lot # 671001/0843AA, exp. Date: 07-MAR-2013) one injection 0.5 ml in 2008. There was no relevant laboratory data. As of 29-OCT-2012, it was unknown if the patient continued to take VARIVAX (merck) and the status of the patient after accidental administration of VARIVAX (merck) was unknown. Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a one month and 12 days (approximately 42 days) old male patient. The patient was inadvertently vaccinated intramuscularly in left lateral thigh with a 0.5 ml dose of VAQTA (lot number 0273AE, expiration date: 06-DEC-2014) on 10-JAN-2013 instead of RECOMBIVAX HB. No other co-suspects were reported. No concomitant medications were reported. It was staff error only. No adverse effects were reported at that time. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age and gender. The patient was vaccinated intramuscularly with the first dose of GARDASIL (dose and not number not reported) in 2011, about a year and a half ago. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient would be vaccinated intramuscularly with the second dose of GARDASIL (dose and lot number not reported) on 10-JAN-2013. No adverse effect was reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arrhythmia, Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: The spontaneous report as received from a medical assistant refers to a 58 years old female patient with seasonal allergies and no known drug allergies. The patient's medical history included depression and headaches. The patient was vaccinated subcutaneously into left arm with a dose of ZOSTAVAX (lot # H018497, exp 10-JAN-2014) on 11-JAN-2013. No other co-suspects were reported. Concomitant medications included tramadol hydrochloride and IMITREX. On 13-JAN-2013 the patient experienced redness and tenderness at the injection site as well as arrhythmia. The patient sought medical attention by visiting an unspecified emergency room on 13-JAN-2013. The unspecified emergency room physician diagnosed the patient with cellulitis at the injection site of the ZOSTAVAX. The patient was treated with VALTREX and ANCEF in the emergency room. Upon discharge from the emergency room the patient was taken off the VALTREX and prescribed KEFLEX and VICODIN. Patient was recovering. Patient had a follow up visit on 14-JAN-2013, to physician's office and the injection site was much improved with very little redness still visible. No lab diagnostic studies completed. The relatedness for cellulitis at injection site and arrhythmia was unknown for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist concerning a female patient of unknown age who on 15-JAN-2013 was vaccinated with a dose of PNEUMOVAX23 (route, lot number and expiration date were not provided) and on unknown date, prior to the administration of PNEUMOVAX23, she was vaccinated with a dose of Influenza Virus Vaccine (manufacturer unknown) (route, lot number and expiration date were not provided). No concomitant medications were reported. The pharmacist reported that on 15-JAN-2013, the patient developed tenderness, pain and erythema at the injection site. She was given arm compresses as treatment for the event. At the time of the report, the patient was recovering from the events. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report was received from a 74 year old male consumer with penicillin allergy and sulfa allergy and no pertinent medical history, on an unknown day, approximately in 2010, 3 years ago was vaccinated with a dose of PNEUMOVAX23, intramuscular (lot number and expiration date were not provided). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that on an unknown date. 6 months to a year later, he developed pneumonia. He was seen in a urgent care clinic and was given prednisone (manufacturer unknown) and azithromycin (manufacturer unknown) and was not admitted to the hospital. On an unknown date, the pneumonia resolved. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Disorientation, Skin discolouration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 years old female patient with no pertinent medical history and drug allergies reported, who on 12-DEC-2012, was vaccinated subcutaneously with lot # (H016765 exp date: December 2013) ZOSTAVAX. No other co-suspects were reported. Concomitant medications included Antiviral (Unspecified). The pharmacist stated that on 12-DEC-2012, while on ZOSTAVAX, the patient became disoriented, and had a discoloration on her arm. No further information obtained for this AE. The outcome of the patient became disoriented and the patient had a discoloration on her arm was unknown. The relatedness for the patient became disoriented and the patient had a discoloration on her arm was unknown for ZOSTAVAX. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received form a registered nurse concerning to a male patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (dose, route and lot not reported) on 07-AUG-2012. The patient was vaccinated with the second dose of GARDASIL (dose, route and lot not reported) on 07-AUG-2012. The patient was vaccinated with the second dose of GARDASIL (dose, route and lot not reported) on 13-NOV-2012 and with the third dose of GARDASIL (dose, route and lot not reported). N other co-suspects were reported. No concomitant medications were reported. No adverse symptoms reported. The outcome of the event was unknown. The event was not related to GARDASIL. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: This spontaneous report as received from a 60 years old female consumer reporting on herself with no pertinent medical history or drug reactions/allergies who on 14-JAN-2013 was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. On 15-JAN-2013, a day later, the patient noticed that she had a red rash that was spreading down her right arm. The patient sought medical attention by going to her doctor's office; but her doctor told her that he was not familiar with injection site reactions for ZOSTAVAX. The patient did not receive treatment. The outcome of the event was unknown. The relatedness for the event was unknown for ZOSTAVAX. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning to a patient of unknown age and gender. The physician reported that the patient received her first and second doses of GARDASIL (dose, route and lot not reported) on an unspecified dates in another unspecified facility and missed the third dose due to pregnancy. The physician stated that the patient was no longer pregnant and would like to receive her third dose. No adverse symptoms reported. No other co-suspects were reported. No concomitant medications were reported. The outcome of event was unknown. The event was not related to GARDASIL. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral disorder
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 years old female patient with allergy to sulfa. The patient's medical history included shingles in July of 2012. On 01-DEC-2012 the patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot #: H016230). Concomitant therapies included amoxicillin (dosage and manufacturer unspecified) prophylactically for dental work. On 03-DEC-2012 (also reported as 03-DEC-2013) the patient developed lesions on the roof of her mouth two days later. She was seen by the physician and was given acyclovir (manufacturer unspecified). It was reported that she had had recurring cases of shingles, the previous being in July of 2012. The patient discontinued amoxicillin on 27-NOV-2012, 4 days before receiving injection. The outcome of lesions was reported as recovering. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: This spontaneous report as received from a physician refers to an adolescent female patient. On unknown date, the patient was vaccinated a dose of with GARDASIL (lot #, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient experienced alopecia which occurred after each dose of GARDASIL (generalized hair thinning). No treatment information was reported. The outcome of alopecia was unknown. The relatedness for alopecia was unknown for GARDASIL. Additional information has been requested. This is one of several reports from the same source.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 12 years old male patient with ADD (Attention deficit disorder), autistic disorder, allergic rhinitis and penicillin allergy. The patient's medical history included hives after using penicillin. The patient was vaccinated with first dose of GARDASIL (lot number unspecified) intramuscularly on 25-JUL-2012. The patient was vaccinated with second dose of GARDASIL (lot number H010915, exp 13-FEB-2015) intramuscularly on 07-JAN-2013. No other co-suspects were reported. Concomitant medications included TENEX and ADDERALL TABLETS. On some unspecified date after 07-JAN-2013, the patient experienced right knee pain. No treatment information was given for AE. The outcome of right knee pain was unknown. The relatedness for right knee pain was unknown for GARDASIL. No lab diagnostic studies performed. The patient's mother had called the physician assistant for medical attention. Additional information is not expected.
Age: 22.0
Sex: M
Vaccine: ANTH, FLUX, SMALL
Symptoms: Electrocardiogram, Encephalitis, Nuclear magnetic resonance imaging brain
Clinical narrative: This study case was received from the investigator in the trial on 09 January 2013. An 22 year-old male subject whose past medical history included headaches was found to have unspecified cause of encephalitis 16 days after the subject had received the following vaccines on 01 October 2012: an injection of ACAM2000 (lot number, route and site of administration not reported), Influenza, split inj vaccine (manufacturer, lot number, route and site of administration not reported), MMR (manufacturer, lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). An ECG and MRI of the brain were not available. Troponin I result, Echocardiogram, Lumbar puncture (spinal tap) and MRI of the spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Pericarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator on 09 January 2013. A 22-year-old male subject received on the following vaccinations: an injection of ACAM2000 (SP Biologics Co., lot number not reported) on 29 October 2012; and concomitant vaccines: INFLUENZA, SEASONAL, INJ, PRESERVATIVE FREE (manufacturer unknown and lot number not reported) on 03 October 2012, and ANTHRAX 1 (other manufacturer and lot  number not reported) on 03 October 2012, and a TYPHOID ORAL vaccine (other manufacturer, lot number not reported) on 16 October 2012. The subject had no significant medical history. On 21 November 2012, twenty-three days post vaccination, the subject was diagnosed with acute pericarditis, unspecified. Laboratory testing included a Troponin I blood test on 10 November 2012 with an abnormal result of highest value of 24.30 (unit not reported). On 09 November 2012, an electrocardiogram (ECG) and Echocardiogram were both reported as abnormal. Treatments were not reported. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 89.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Death, Diarrhoea, Viral infection, Vomiting
Clinical narrative: Initial report was received on 09 January 2013 from a health care professional. An 89 year-old male patient with unknown past medical history had received on 07 January 2013 a first dose intramuscular injection of FLUZONE HIGH-DOSE, lot number U4542AA and on 08 January 2013, was found dead in his home covered in vomit and diarrhea. According to the reporter, the family is debating on having an autopsy performed due to the patient's age. Also stated by the reporter, a gastrointestinal virus was currently wide spread affecting many people in the area. No further information was available at the time of report. The patient's outcome was fatal. Documents held by sender: none.
Age: 89.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Death, Diarrhoea, Gastroenteritis viral, Vomiting
Clinical narrative: Initial report was received on 09 January 2013 from a health care professional. An 89 year-old male patient with unknown past medical history had received on 07 January 2013 a first dose intramuscular injection of FLUZONE HIGH-DOSE, lot number U4542AA and on 08 January 2013, was found dead in his home covered in vomit and diarrhea. According to the reporter, the family is debating on having an autopsy performed due to the patient's age. Also stated by the reporter, a gastrointestinal virus was currently wide spread affecting many people in the area. No further information was available at the time of report. The patient's outcome was fatal. Documents held by sender: none.
Age: 89.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Death, Diarrhoea, Vomiting
Clinical narrative: Initial report was received on 09 January 2013 from a health care professional. An 89 year-old male patient with unknown past medical history had received on 07 January 2013 a first dose intramuscular injection of FLUZONE HIGH-DOSE, lot number U4542AA and on 08 January 2013, was found dead in his home covered in vomit and diarrhea. According to the reporter, the family is debating on having an autopsy performed due to the patient's age. Also stated by the reporter, a gastrointestinal virus was currently wide spread affecting many people in the area. No further information was available at the time of report. The patient's outcome was fatal. Documents held by sender: none.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Death
Clinical narrative: FATHER REPORTS CHILD WAS PLACED IN HER SWING IN THE MORNING AND SEEMED FINE; HE SAYS MOM LEFT ROOM FOR A SHORT TIME AND FOUND CHILD UNRESPONSIVE UPON HER RETURN.  WHEN ASKED HOW CHILD SEEMED ON PREVIOUS DAY, HE SAYS THE CHILD WAS A LITTLE FUSSY AFTER SHOTS, BUT THAT FUSSINESS RESOLVED. HE REPORTED NO OTHER SIGNS OF ILLNESS OR DISTRESS.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Unresponsive to stimuli
Clinical narrative: FATHER REPORTS CHILD WAS PLACED IN HER SWING IN THE MORNING AND SEEMED FINE; HE SAYS MOM LEFT ROOM FOR A SHORT TIME AND FOUND CHILD UNRESPONSIVE UPON HER RETURN.  WHEN ASKED HOW CHILD SEEMED ON PREVIOUS DAY, HE SAYS THE CHILD WAS A LITTLE FUSSY AFTER SHOTS, BUT THAT FUSSINESS RESOLVED. HE REPORTED NO OTHER SIGNS OF ILLNESS OR DISTRESS.