chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Rotavirus test positive
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an approximately 10 week old patient. On 30-APR-2013 the patient was vaccinated orally with first dose of 2 ml oral ROTATEQ (lot # H010052). the patient developed diarrhea, bloody stool and experienced possible abdominal pain after receiving the first dose of oral ROTATEQ. The infant was breast fed, and was seen in the physician's office on 09-MAY-2013 and on 12-MAY-2013. During the 12-MAY-2013 visit, the patient's stool was negative for blood and positive for rotavirus. Intussusception was suspected and the patient was scheduled to see an unspecified surgeon and had a barium enema. The patient was treated with fluids and dextrose, electrolytes (unspecified) (PEDIALYTE). The patient's father told the physician that he was sure that oral ROTATEQ was the cause of this condition. The action taken of oral ROTATEQ and outcome of the events were unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, pruritus and hot on injection site.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dyspnoea, Heart rate increased, Injection site swelling, Oxygen saturation decreased
Clinical narrative: 104 fever-oxygen saturation 75-difficulty breathing-weak-heart rate 134.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Swelling face
Clinical narrative: 104 fever-oxygen saturation 75-difficulty breathing-weak-heart rate 134.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Dyskinesia, Gaze palsy, Hypotonia, Urinary incontinence
Clinical narrative: Child complained of feeling dizzy; shortly after slumped over in a chair; noted jerky movements of arms, legs, and head; eyes rolled back; incontinent of urine.
Age: 0.17
Sex: M
Vaccine: HIBV, PNC13, RV5
Symptoms: Unevaluable event
Clinical narrative: None known.
Age: 69.0
Sex: F
Vaccine: MMR
Symptoms: Chest discomfort, Chills, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Given MMR vaccine. Approx an hour later patient began having red, raised, hot to touch area on skin where vaccine administered.  The next day pt. arm continued to be red and swollen. Pt reported to have used Benadryl by mouth 25mg. Stated alternating warm and cool compresses on and off.  Size of reaction was approx 6 inches by 3 inches in diameter.  Pt states no changes for several days.  Pt went to Urgent Care facility. She stated she was having tightness in her chest and felt it was her allergies.  She reported having fever/chills. Patient stated she did not take her temperature. She was having congestion as well.  She states on Sunday May 19th. She was at the urgent care and received a dose of Solu-Medrol IV and Levaquin. And also received an inhaler.  She reported on Monday May 20th that the right side of her neck was swollen and she felt it was her lymph nodes.  She stated her arm was no getting better and was not as red and hot feeling. She states she is returning to the Dr. on May 22nd.
Age: 69.0
Sex: F
Vaccine: MMR
Symptoms: Local swelling, Pyrexia, Respiratory tract infection
Clinical narrative: Given MMR vaccine. Approx an hour later patient began having red, raised, hot to touch area on skin where vaccine administered.  The next day pt. arm continued to be red and swollen. Pt reported to have used Benadryl by mouth 25mg. Stated alternating warm and cool compresses on and off.  Size of reaction was approx 6 inches by 3 inches in diameter.  Pt states no changes for several days.  Pt went to Urgent Care facility. She stated she was having tightness in her chest and felt it was her allergies.  She reported having fever/chills. Patient stated she did not take her temperature. She was having congestion as well.  She states on Sunday May 19th. She was at the urgent care and received a dose of Solu-Medrol IV and Levaquin. And also received an inhaler.  She reported on Monday May 20th that the right side of her neck was swollen and she felt it was her lymph nodes.  She stated her arm was no getting better and was not as red and hot feeling. She states she is returning to the Dr. on May 22nd.
Age: 4.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Injection site pruritus
Clinical narrative: Per mom noticed one day after getting shots given on dates 4/8/13 and 5/9/13 in deltoid of arms IM and SQ, child c/o of itching at injection sites for 2-3 days. Mom does not recall what time the child started complaining of itching. No action taken by the mom to alleviate symptoms. Per mom itching only at sites, no other parts of the body. No rash, no swelling at site per mom via interpreter. Parents speak another language.
Age: 41.0
Sex: F
Vaccine: TTOX
Symptoms: Joint injection, Myalgia, Pain in extremity
Clinical narrative: LEFT ARM PAIN IS EXCRUTIATING, SAW PCP 03/13/13 OR 03/14/13.  PER MD IT WAS A SORE BACK MUSCLE AND HAD "ABSOLUTELY NOTHING TO DO WITH HER TETANUS SHOT." RESOLVED WITH IBUPROFEN AND FINE NOW. RECENTLY HAD STEROID INJECTION TO LT SHOULDER, HAS HX OF 2 PREVIOUS INJURIES IN 1990 AND 2010, CURRENTLY NOT IN ANY PAIN.
Age: 54.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Erythema, Injection site pain, Injection site pruritus, Injection site streaking, Pruritus
Clinical narrative: Felt burning and itching at site of injection---removed blouse to inspect area and noticed a long/broad area of redness that measured 7 inches long by 1 inch wide.  Started at injection site and extended all the way down arm. The large reddended area remained there for a little over a month.  It has just finally started to fade out now.  It still itches quite a bit but is no longer red.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Hot flush, Paraesthesia oral
Clinical narrative: SHE FELT TINGLING SENSATION IN HER MOUTH AND HOT FLASH AROUND HER JAW AND FELT WEAK.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Feeling hot, Oedema peripheral, Rash, Rash erythematous, Vaccination complication
Clinical narrative: I received a call from the daycare indicating that my son had a rash larger than a 3x5 card on his arm. I picked him up and he had a hot, red rash from his elbow up to his shoulder. His arm was also swollen. The next day his rash had grown more and was still very hot. His arm was 2x the size. I took him by the hospital and they said that it was a reaction to his vaccine and I should report it.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Joint range of motion decreased, Oedema peripheral, Pyrexia
Clinical narrative: 1. Bruising at injection site 5/7/2013. 2. Swelling of left arm 5/7/2013. 3. Low grade temp- states noticed 5/12/2013. 4. Limited range of motion- physical therapy initiated.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Bed rest, Myalgia, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: High fever of 103, muscle aches, vaccine sight swelling and sore, continued lesser fever for three days. Treatments: ibuprofen and bed rest.
Age: 20.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Fall
Clinical narrative: Client started to feel dizzy about 30 minutes after receiving vaccine and client alledged that he feel on floor in front lobby and was able to get up with no assistance. Client assesed by a nurse, vital signs done. Client able to walk and verbalize understanding.
Age: 42.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: ITCHY, SORE, TENDERNESS, SWOLLEN, HOT TO THE TOUCH, RED. TYLENOL AND MOTRIN WERE TAKEN.
Age: 42.0
Sex: F
Vaccine: VARCEL
Symptoms: Tenderness
Clinical narrative: ITCHY, SORE, TENDERNESS, SWOLLEN, HOT TO THE TOUCH, RED. TYLENOL AND MOTRIN WERE TAKEN.
Age: 35.0
Sex: M
Vaccine: FLU3, HEPAB, MMR, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Pt fainted during vaccine administration.  Recovered within 30 seconds.  Ice pack to back of neck. Fruit juice provided.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Rash erythematous, Rash papular
Clinical narrative: NOTICED RED, RAISED RASH ON FACE AROUND MOUTH, CHEST, AND ABDOMEN.  PATIENT OTHERWISE APPEARED HIS NORMAL SELF AND THE RASH DID NOT SEEM TO BOTHER HIM.
Age: 50.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Erythema, Local swelling, Malaise, Pain, Pruritus
Clinical narrative: The area (examined by me) is raised, red, painful, itchy, and causing general malaise.  No fever is noted.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Myalgia, Palpitations, Throat tightness, Vomiting
Clinical narrative: Throat closed up, heart racing, vomiting, sore muscles.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Decreased appetite, Dyspepsia, Functional gastrointestinal disorder, Gastrointestinal hypomotility
Clinical narrative: Difficulty with intestinal functions: digestion/motility slowed, loss of appetite, food limitations (possible Guillain-Barre Syndrome.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal distension, Blood test, Decreased appetite, Dyspepsia, Gastrointestinal disorder
Clinical narrative: Difficulty with intestinal functions: digestion/motility slowed, loss of appetite, food limitations (possible Guillain-Barre Syndrome.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Gastrointestinal motility disorder, Hypophagia, Weight decreased
Clinical narrative: Difficulty with intestinal functions: digestion/motility slowed, loss of appetite, food limitations (possible Guillain-Barre Syndrome.
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Gait disturbance, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Mom called and reports has a red, raised knot on left thigh, size of golf ball. It sore and limping. Denies fever, has tried TYLENOL and MOTRIN. Mom states MOTRIN helped some. 5/22/13 called mom site doing fine.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Cheilitis, Lip pain, Lip swelling, Ulcer
Clinical narrative: Pt experienced swelling of upper lip morning after vaccine. Pt took BENADRYL and reported a decrease in swelling. The day after that, both lips were swollen and has an ulcer on her upper frenulum under her upper lip. Pt reports continued swollen lips along with redness and pain on the lips inside the mouth. Pt is trying to get an appt with her physician. Incident was reported to us on 5/21/13 in the afternoon when the pt presented to our office.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Patient reports that the vaccine was painful and she is still experiencing pain from it. (It was given > 7 months ago).
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Syncope
Clinical narrative: Patient received Tdap vaccination to left deltoid then patient received HPV vaccination to right deltoid after vaccination given pt had syncopal episode.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: (L) UE KINRIX inj. site 3 cm x 4 cm erythema and edema, mildly tender.
Age: 11.0
Sex: F
Vaccine: HPV4, MEN, TDAP
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a physician refers to a 11 or 12 year old female patient. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot number not reported) (dose and route not reported, in the upper deltoid exact location unspecified). Concomitant therapy included DTaP and meningitis (manufacturer unknown). On an unknown date after receiving the GARDASIL, the patient became dizzy and felt faint. The patient's outcome was reported as recovered on an unspecified date. Additional information has been requested.
Age: 1.26
Sex: M
Vaccine: DTAP, MMR, PNC
Symptoms: Wrong drug administered
Clinical narrative: Patient given incorrect immunization. Given PPV. Should have had PREVNAR no reaction.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Rash generalised, Upper extremity mass
Clinical narrative: Patient complained of large, red, painful lump in her arm (she pointed to her left arm but the vaccine had been given in the right) followed by a diffuse body rash.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Back pain, Dizziness, Eyelid ptosis
Clinical narrative: Patient called reporting blurred vision and eyelid droop within 24hrs of vaccine administration. Three to four days later started getting neck, joint, and back pain, weakness, dizziness and insomnia, which hes continued without improvement since 5/8/13. Similar to past experience with actual shingles virus.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Neck pain, Vision blurred
Clinical narrative: Patient called reporting blurred vision and eyelid droop within 24hrs of vaccine administration. Three to four days later started getting neck, joint, and back pain, weakness, dizziness and insomnia, which hes continued without improvement since 5/8/13. Similar to past experience with actual shingles virus.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 51 year old female patient. On 10-MAY-2013, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (dose and frequency were not reported) (Lot # and expiration date were not reported). On 10-MAY-2013, the patient experienced severe localized reaction at the injection site receiving the ZOSTAVAX. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age who on 24-APR-2013, was vaccinated with a dose of VAQTA (dose, route and lot number not reported) that was expired. No adverse effects were reported. Additional information has been requested.
Age: 0.54
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a physician refers to a 6 month old male patient who on 17-MAY-2013, was vaccinated with a dose of VAQTA (dose, route and lot number not reported). Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Autonomic neuropathy, Bradyarrhythmia, Electrocardiogram abnormal, Laboratory test normal, Platelet count decreased
Clinical narrative: Developed multiple symptoms of an autonomic nervous system disorder, symptoms starting 2 weeks after receiving 8 vaccines in Apr 2010. Symptoms have progressed to include most body systems. Patient has received the intranasal flu vaccine in 2011 and 2012 and has developed worsening symptoms after each dose. Pending medical board and separation from his job.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report has been received from a female patient of unknown age, for VARIVAX (Merck), a Pregnancy Registry product, concerning herself. On 15-MAY-2013 the patient was vaccinated with VARIVAX (Merck). Lot# and administration route was unspecified. On 15-MAY-2013, the patient found out she was pregnant after receiving VARIVAX (Merck). Patient's Gravida and Para was unspecified. Last menstrual period(LMD), estimated due date (EDD), and date of pregnancy were unspecified. The pregnancy outcome was unspecified. No further information was provided. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL (dose and lot# not reported) subcutaneous. The patient received his second dose of GARDASIL (dose and lot# not reported) approximately 2 years after he received his first dose in the series. No adverse effect reported. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
Age: 43.0
Sex: M
Vaccine: MMR
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a company representative refers to her 43 year old husband with LEVAQUIN allergy to leukopenia. On 10-MAY-2013 the patient was vaccinated subcutaneously with one shot of M-M-R II (lot # H013042, expiry date reported as 31-JUL-2014, dose and site unspecified). There was no concomitant medication. On 12-MAY-2013, 3 days after vaccination the patient experienced fever, chills and body aches. The patient had not sought medical attention. No treatment was given. No laboratory diagnostics studies were performed. The outcome of chills, fever and body aches was reported as not recovered/not resolved. Additional information has been requested.
Age: 0.83
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 10 month old patient. On 24-APR-2013 the patient was vaccinated with a third dose of ROTATEQ, 2 ml, orally. Nurse practitioner stated that the first dose of ROTATEQ (2 ml, oral) was given on 03-OCT-2012 and the second dose of ROTATEQ (2ml, oral) was given on 06-NOV-2012. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age (no demographics were provided for the patient). On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot # not reported). The pharmacist had a patient, who received ZOSTAVAX and then got a headache. The patient talked to the pharmacist for medical attention. No treatment was given for headache. No lab diagnostics studies were performed. The outcome of headache is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a currently 59 years old female registered nurse reporting on herself. "Recently", on an unknown date, the nurse was vaccinated with a dose of ZOSTAVAX (Lot # not reported) under the fatty part of the left underarm. The nurse reported that she was experiencing adverse effects after vaccination. The nurse stated that she had developed redness, itchiness and perfect round silver dollar swelling at the injection site, flu like symptoms, no rash. The nurse stated that her husband had a milder of the symptoms, but hers were more pronounced. The outcome of itchiness and perfect round silver dollar swelling at the injection site and flu like symptoms was reported as not recovered/not resolved. This is one of several reports received from the same source. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to her husband of unknown age. . "Recently", on an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) under the fatty part of the left underarm. The nurse reported that the patient was experienced adverse effects after vaccination. The nurse stated that he had developed redness, itchiness and perfect round silver dollar swelling at the injection site, flu like symptoms, no rash. The nurse stated that the patient had a milder case of the symptoms. The outcome of redness at the injection site, flu like symptoms, perfect round silver dollar swelling at the injection site and itchiness at the injection site was reported as not recovered/not resolved. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 19-MAR-2010 the patient was subcutaneously vaccinated with the first dose of RECOMBIVAX HB (dose and lot # not reported). Approximately on 25-JUN-2010, the patient received the third dose of RECOMBIVAX in the immunization series at an interval of 13 weeks from the first dose instead of the recommended interval of 16 weeks. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unknown number of patients. Pharmacist reported that ZOSTAVAX has been stored in their facility and temperatures had never been recorded. Some ZOSTAVAX was stored at an unknown temperature for an unknown period of time and administered to an unknown number of patients. Other ZOSTAVAX (Lot#J000853 with expiration of 23-APR-2014 & Lot# J000494 with an expiration of 14-APR-2014 was stored since about 30-APR-2013 at unknown temperatures. During this whole time period 20-30 patients were vaccinated. No adverse effect reported. Outcome was unknown. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: FLUN3, MNQ
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Case number PHHY2013US012483 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 476336) on 08 Feb 2013 with a follow-up received on 21 May 2013: This report refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M11051) into the left arm along with FLUMIST (other manufacturer, batch number: AJ2025) intranasal on 19 Nov 2012. On 21 Nov 2012, he developed cellulitis down left deltoid which was approximately 13 cm width x 14 cm length; the area was red and warm to touch. Treatment included cold compress to site so that the reaction did not spread and BENADRYL as needed. He was instructed to call the pharmacy office if required. He visited the Emergency Room (ER) following these events. Final outcome was reported as condition unchanged as on 21 Nov 2012. No further information about causality and seriousness was provided. The quality assurance department stated that, based on the review performed, MENVEO batch number: M11051, was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from the quality assurance department (QA reference number: 210525) on 21 May 2013: Updated batch review report.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Cellulitis, Erythema, Pain in extremity, Skin warm, Tenderness
Clinical narrative: Case number PHHY2013US012273, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 477024) web site on 08 Feb 2013 with a follow up information received from quality assurance department (reference number: 209921) on 21 May 2013: This report refers to 14 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A11082) IM into left arm on 14 Nov 2012. On the same day she was also vaccinated with GARDASIL (batch number: 1561AA) IM into right arm and HAVRIX (batch number: AHAVB586BA) IM into left arm. On 15 Nov 2012, she experienced left arm pain, erythema, the area was warm, which was tender upon palpation. She was diagnosed with cellulitis. She visited the emergency department. Outcome of the event was condition unchanged. Seriousness and causality of the event was not reported. The quality assurance department registered a complaint with reference number 209921. Based on the documents review, it was stated that the MENVEO batch A11082 was manufactured in accordance with the approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from quality assurance department (reference number: 209921) on 21 May 2013: Batch summary updated.
Age: 27.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Rash, Urticaria
Clinical narrative: Case number PHHY2013US044395 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS Ref: 485710) web site on 06 May 2013 with the follow-up information received from the Quality Assurance department (QA reference number: 226798) on 17 May 2013. This report refers to a 27 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into right arm on 14 Jan 2013. On 15 Jan 2013, she experienced severe rash and hive. After the flu shot, she found out that she was pregnant and later had miscarriage. She visited the emergency. The outcome of the events was completely recovered. Since the batch number was not reported, a batch specific review could not be performed. Based on the Annual Product Review (APR) of FLUVIRIN vaccine, it was concluded that FLUVIRIN manufacturing process was operated at a good level of overall control and the supporting systems were effective in supporting the complaint production, testing and supply processes of FLUVIRIN vaccine. From this conclusion there was no reason or explanation to account for the reported adverse event. Seriousness and causality assessment was not reported. Follow-up information received from quality assurance department on 17 May 2013: Since the batch number was not available for this case, the batch review was based on a general review of quality requirements of FLUVIRIN.
Age: 27.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abortion spontaneous, Exposure during pregnancy, Rash, Urticaria
Clinical narrative: Case number PHHY2013US044395 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS Ref: 485710) web site on 06 May 2013 with the follow-up information received from the Quality Assurance department (QA reference number: 226798) on 17 May 2013. This report refers to a 27 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into right arm on 14 Jan 2013. On 15 Jan 2013, she experienced severe rash and hive. After the flu shot, she found out that she was pregnant and later had miscarriage. She visited the emergency. The outcome of the events was completely recovered. Since the batch number was not reported, a batch specific review could not be performed. Based on the Annual Product Review (APR) of FLUVIRIN vaccine, it was concluded that FLUVIRIN manufacturing process was operated at a good level of overall control and the supporting systems were effective in supporting the complaint production, testing and supply processes of FLUVIRIN vaccine. From this conclusion there was no reason or explanation to account for the reported adverse event. Seriousness and causality assessment was not reported. Follow-up information received from quality assurance department on 17 May 2013: Since the batch number was not available for this case, the batch review was based on a general review of quality requirements of FLUVIRIN.
Age: 1.0
Sex: U
Vaccine: MMR, PPV, PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 1 year old patient. Healthcare worker reported that patient was schedules to receive M-M-R II but instead received PNEUMOVAX23 (strength, formulation, lot #, dose/frequency, route were unspecified) on 20-MAY-2013. No adverse effect reported. Outcome was unknown. Additional informational is not expected.
Age: 1.0
Sex: U
Vaccine: MMR, PPV, PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 1 year old patient. Healthcare worker reported that patient was schedules to receive M-M-R II but instead received PNEUMOVAX23 (strength, formulation, lot #, dose/frequency, route were unspecified) on 20-MAY-2013. No adverse effect reported. Outcome was unknown. Additional informational is not expected.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Erythema, Papule, Rash
Clinical narrative: Onset of rash 5/20/13. Seen that day - a few papules on face and chest. Seen again 5/22/- many more papules/vesicles in different stages. Pink papules, vesicles on erythematous base, some crusted.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Breath holding, Electrocardiogram normal, Electroencephalogram normal, Metabolic function test normal, Seizure like phenomena
Clinical narrative: Breath holding with related seizure-like unresponsiveness x 40 seconds.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Unresponsive to stimuli
Clinical narrative: Breath holding with related seizure-like unresponsiveness x 40 seconds.
Age: 11.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Alopecia, Blood thyroid stimulating hormone normal, Hepatitis A antibody negative, Hepatitis B antibody negative, Thyroxine free normal
Clinical narrative: 2 patches of hair loss on scalp. 3 in x 2 in near nape of neck and 1 in on top of head. No treatment started for his alopecia. Mom noted it 5/15/13. She is quite sure it was not there 6-8 weeks before that date.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Arthralgia, Blood test, Dyspnoea, Eye swelling
Clinical narrative: This spontaneous report as received from a mother concerning her 13 year old daughter. In June 2012, the patient was vaccinated with GARDASIL dose 1, intramuscular. On October 2012, the patient was vaccinated with GARDASIL dose 2, intramuscular. Concomitant therapy  included birth control and allergy medication. In June 2012, "soon after receiving her first dose of GARDASIL", the patient experienced various symptoms including nausea and vomiting, stomach cramping with severe stomach pain which was "constant and debilitating", joint pain, intermittent swelling around eyes, intermittent rashes and shortness of breath. The mother stated that her daughter was "significantly incapacitated due to the constant pain". The patient was unrelieved of these symptoms at this time and there was no diagnosis or resolution to her symptoms post-testing, including "multiple" hospitalizations. Ultrasound, x-ray and blood work were performed with no result provided. The hospital's name and lengths of stay were undisclosed. The events were considered to be other important medical events. Stomach cramping with severe stomach pain which was "constant and debilitating" and joint pain were considered disabling. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Rash, Ultrasound scan, Vomiting, X-ray
Clinical narrative: This spontaneous report as received from a mother concerning her 13 year old daughter. In June 2012, the patient was vaccinated with GARDASIL dose 1, intramuscular. On October 2012, the patient was vaccinated with GARDASIL dose 2, intramuscular. Concomitant therapy  included birth control and allergy medication. In June 2012, "soon after receiving her first dose of GARDASIL", the patient experienced various symptoms including nausea and vomiting, stomach cramping with severe stomach pain which was "constant and debilitating", joint pain, intermittent swelling around eyes, intermittent rashes and shortness of breath. The mother stated that her daughter was "significantly incapacitated due to the constant pain". The patient was unrelieved of these symptoms at this time and there was no diagnosis or resolution to her symptoms post-testing, including "multiple" hospitalizations. Ultrasound, x-ray and blood work were performed with no result provided. The hospital's name and lengths of stay were undisclosed. The events were considered to be other important medical events. Stomach cramping with severe stomach pain which was "constant and debilitating" and joint pain were considered disabling. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Heart rate increased, Tachycardia, Urticaria
Clinical narrative: (No strength), hives in the face, dizziness, accelerated heart beats. These events started the next day after the administration of the vaccine, Sunday 19 of May of 2013 in the afternoon.  To this day, I have not been able to get a general doctor. Tachycardia continues.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: (Lt) upper arm with redness and tenderness at site of injection given on 5/20/13 (area app. 7 1/2 cm x 8 cm) s/s began 5/21/13, seen at office 5/22/13 - some (+) warmth at that time. Afebrile; no hives. Tx with PRN BENADRYL and return if s/s increase.
Age: 1.3
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Rash maculo-papular, Tonsillitis
Clinical narrative: Generalized maculopapular rash developed 5-4-13. The rash increased on 5-5-13. Has been the same since. On 4/26/13 had severe and was seen at a Clinic. Treated with Antibiotic (unknown none) for 8 days. Completed treatment by Fri 5/3/13. Rash started 5-4-13. Seen 5-5-13 at clinic. Started on Azythromycin for a Tonsillitis.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site warmth, Pruritus, Pyrexia, Urticaria
Clinical narrative: 48 hrs after varicella and PPD placement client presented w/(R) tricep swelling, warmth about 50 mm, fever. States she had hives on (R) arm day before very itchy. States she had hx of varicella disease as a child, didn't mention it before she said. No fever of hives today (5/16/13). Education provided.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site pain, Pain in extremity, Skin burning sensation
Clinical narrative: Patient reports burning/shooting pain in left upper arm radiating down to hand. Associated with some numbness. It is aggravated by driving/grasping/gripping. Some relief with Ibuprofen but has not improved signficantly over past 2 months.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Large area of redness and inflammation at the injection site. Red area was warm to the touch and the patient was also experiencing a headache.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site on left thigh.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Aphonia, Dysphonia, Head injury, Joint injury, Syncope
Clinical narrative: I received the shot, and about 20 mins after I fainted. Hitting my head and knee. After I had extreme head rushes. 5/14/2013- I lost my voice when I woke up and had a hoarse voice for the following 3 days.
Age: 1.1
Sex: U
Vaccine: PNC13, VARCEL
Symptoms: Febrile convulsion, Hypopnoea, Irritability, Laboratory test, Pyrexia
Clinical narrative: ER 5/16/13 - Febrile seizure - 103.9 fever in ER ER notes included. Over weekend after vaccines, low grade fever - fussy then temp spike on 5/16/13. Pt here for an ER recheck from last night after having a febrile seizure. Pt was eating but had felt warm to dad prior to episode. He was in high chair and father saw him shaking and not breathing. He took him outside asking neighbors to help and called 911. Pt was not choking which father thought initially and by the time the ambulance got there he had stopped seizing but breathing was shallow and he was sleeping until he was poked in ER. Fever noted in ER to be 103.9. Pt here last Friday and had PREVNAR and VARIVAX shots. Father recalls that ad ter his 9 month visit getting PREVNAR and hep B he developed a high fever and had red blisters all over face that eventually went down to chest. Patient feeling well. Onset was sudden. Has not occurred before. Date of last seizure seizure.
Age: 1.1
Sex: U
Vaccine: PNC13, VARCEL
Symptoms: Respiratory arrest, Skin warm, Tremor
Clinical narrative: ER 5/16/13 - Febrile seizure - 103.9 fever in ER ER notes included. Over weekend after vaccines, low grade fever - fussy then temp spike on 5/16/13. Pt here for an ER recheck from last night after having a febrile seizure. Pt was eating but had felt warm to dad prior to episode. He was in high chair and father saw him shaking and not breathing. He took him outside asking neighbors to help and called 911. Pt was not choking which father thought initially and by the time the ambulance got there he had stopped seizing but breathing was shallow and he was sleeping until he was poked in ER. Fever noted in ER to be 103.9. Pt here last Friday and had PREVNAR and VARIVAX shots. Father recalls that ad ter his 9 month visit getting PREVNAR and hep B he developed a high fever and had red blisters all over face that eventually went down to chest. Patient feeling well. Onset was sudden. Has not occurred before. Date of last seizure seizure.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Local swelling
Clinical narrative: 24 hrs erythema-swelling > 2 inch. No anorexia, can move limbs.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Back pain, Pruritus
Clinical narrative: 6 days after receiving vaccine - pt called to say she had severe itching/pain starting in arm pits - traveling around bacK and turso.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site discolouration, Local swelling, Skin exfoliation
Clinical narrative: Pt received ZOSTAVAX SQ in arm on 09/12. Pt developed a red area. Per pt, area swelled like a balloon for 2 weeks and then resolved. Patient stated the skin of the swollen area peeled off. Pt contacted her PCP and her daughter, a physician, who both described it as a normal reaction. Patient still has an area of discoloration 2 inches, oval shaped, at site.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Chest X-ray abnormal, Fatigue, Headache, Injection site reaction, Lung infiltration
Clinical narrative: Localized injection site reaction with significant arm pain that developed the night of the injection. Nausea, fatigue, headache developed within a few hrs of injection.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Neutrophil count decreased, Pain in extremity, White blood cell count increased
Clinical narrative: Localized injection site reaction with significant arm pain that developed the night of the injection. Nausea, fatigue, headache developed within a few hrs of injection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature, Injection site erythema, Injection site pain, Pain
Clinical narrative: Woke up 5/21/13, felt achy, had low grade temp < 100 degrees F, took TYLENOL that evening and felt better by the next day. Also, sore red area above injection site measures 75 mm x 40 mm today - oval shaped.
Age: 1.7
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC13
Symptoms: Swelling, Urticaria
Clinical narrative: Patient given varicella vaccine in left thigh. Within 10 minutes areas of swelling approximately 5-6 cm in size with a large weal in the center of it. Ice was applied, BENADRYL.
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Lumbar puncture abnormal, Meningitis, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Initial report was received from a healthcare professional on 16 May 2013. A male patient (age and date of birth not reported) had received a dose one intramuscular injection of MENACTRA, lot number not reported) in 2008. In April of 2013, the patient was diagnosed with meningitis after a spinal tap was done because of the symptoms of fever and stiff neck. As of the date of the report, the patient had no symptoms and was going to the doctor for clearance to return to college. Illness at the time of vaccination and past medical history was unknown. Outcome was recovered. Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker and a licensed practical nurse refers to a 13 year old female patient. On 15-JUN-2012 the patient was vaccinated with first dose of GARDASIL (strength, formulation, lot#, dose/frequency, route and duration were unspecified). On 20-MAY-2013 the patient was vaccinated with second dose of expired GARDASIL (injection, lot # 668554/0306AA, exp date 10-MAY-2013, 0.5 ml, intramuscular in the left arm). No adverse effects reported. Patient had sought unspecified medical attention. The outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: This spontaneous report as received from a pharmacist refers to a now 76 year old female patient with no drug reactions or allergies. The patient's medical history included "some type of orthopedic surgery". On an unknown date the patient was vaccinated with a dose of pneumonia vaccine (manufacturer unknown). Concomitant drugs included "several medications" (not specified). On an unknown date the patient experienced arm swelled up after receiving the pneumonia vaccine. It was not known if the patient sought medical attention. The outcome of arm swelled up was unknown. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 20-MAY-2013 the patient possibly may have received an expired dose of PNEUMOVAX23 (lot # 671405/1420AA; expired date 11-APR-2013) (dose, route, strength and indication were not reported). No symptoms reported. The action taken and outcome were not reported. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Injection site erythema, Injection site pain, Malaise
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 year old female patient. The patient had no pertinent medical history. The patient had no drug allergies. On 13-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot # not reported) (strength and total daily dose not reported). Concomitant therapies included alprazolam. It was reported that the patient had redness and pain at injection site on an unspecified date in approximately May 2013. The patient sought for medical attention by visiting her physician on 16-MAY-2013 and was prescribed VALTREX, prednisone and CIPRO (as treatment). The patient also stated that she "had blisters drained" and was still feeling ill. It was unknown as to what he blisters were or where on her body. The patient was not recovered. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Genital herpes, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 year old female patient. The patient had no pertinent medical history. The patient had no drug allergies. On 13-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot # not reported) (strength and total daily dose not reported). Concomitant therapies included alprazolam. It was reported that the patient had redness and pain at injection site on an unspecified date in approximately May 2013. The patient sought for medical attention by visiting her physician on 16-MAY-2013 and was prescribed VALTREX, prednisone and CIPRO (as treatment). The patient also stated that she "had blisters drained" and was still feeling ill. It was unknown as to what he blisters were or where on her body. The patient was not recovered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. In 2009, the patient was vaccinated with GARDASIL dose 1. On 08-MAY-2013 the patient was vaccinated with GARDASIL (lot # h016238, exp 11-APR-2015) dose 2, 0.5 ml, subcutaneous. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a register nurse in physician's office refers to a 17 year old female patient. On 12-DEC-2012 the patient was vaccinated with first dose of GARDASIL (lot number unspecified) intramuscularly. On 14-MAR-2013 the patient was vaccinated with second dose of GARDASIL (lot number unspecified) intramuscularly. The outcome of the patient was unknown. It was unknown if the patient had sought medical attention. Additional information has been requested.
Age: 0.9
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 11 month old patient. On 08-SEP-2008, the patient was vaccinated with VARIVAX (merck) dose 1, .5 ml, subcutaneous (lot number and expiry date not provided). Other suspect therapies included M-M-R II (lot number and expiry date not provided). On 08-SEP-2008, the patient was given the first dose of VARIVAX (merck) at 11 months of age. The patient is not experiencing any known symptoms. The outcome of first dose of VARIVAX at 11 months age and patient is not experiencing any known symptom is unknown. The reporter considered first dose of VARIVAX at 11 months of age and patient is not experiencing any known symptom to be not related to M-M-R II and VARIVAX (Merck). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report have been received from healthcare worker who reported that unknown number of doses of VARIVAX (merck) that were stored at -75.3 C for 39 days and 2 hours, may have been administered (date unspecified by reporter). No adverse effect reported. No PQC involved. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: HEPA
Symptoms: Hepatitis A antibody negative, No therapeutic response
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an 8 year old child patient. On unknown dates the patient was vaccinated with both dose of VAQTA (lot # not reported) (strength 25/0.5 U/mL, total daily dose not reported). It was reported that the patient was administered both doses in the pediatric formulation series but did not seroconvery. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Gaze palsy, Syncope
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse via a company representative refers to a female patient of unknown age. No medical history was reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot#, expiry not reported), intramuscularly. No concomitant medications were reported. On an unknown date, the patient experienced syncope and her eyes rolled back into her head when GARDASIL was administered. The outcome of the events were reported as recovered. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pustule
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with none drug reactions/allergies. On an unknown date the patient was vaccinated with VARIVAX (merck) (strength, dose and frequency were not provided) for vaccination. On an unknown date the patient developed a severe reaction of a large bubble with pus in at the injection site after receiving a dose of VARIVAX (merck). The outcome of event was reported as recovered/resolved. The pharmacist reported that because of the patient's age, she was unsure if the patient actually received VARIVAX (merck) in the past. Additional information has been requested.