chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Anaphylactic reaction, Oedema peripheral
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age. The patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, route and site not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that "several years ago" on an unknown date, the patient experienced anaphylactic reaction along with swelling of the arm after receiving a dose of PNEUMOVAX 23. The patient went to a hospital. At the time of the report, the patient had recovered. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Gastrointestinal tube insertion, Impaired gastric emptying
Clinical narrative: This spontaneous report was received from a pharmacist (also reported as a nurse) concerning her 11 years old daughter with no history of gastrointestinal disease who in April 2012 was vaccinated with the first dose of GARDASIL (dose, route and lot # not provided) and early in June 2012 received the second dose of GARDASIL (dose, route and lot # not provided). In the beginning of June 2012 "early in June 2012", the patient developed severe gastroparesis after her second vaccination with GARDASIL and was hospitalized for 2 weeks. On an unknown date, feeding tube was placed as a treatment for the event. At the time of the report, the patient had not recovered from the event. The relatedness for gastroparesis was unknown for GARDASIL. Gastroparesis was considered to be disabling an other important medical event (because required intervention to prevent serious criteria: feeding tube) by the reporting pharmacist. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (L) arm redness 10+cm round patch w/ mild erythema minimal swelling no warmth, tenderness no fever.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Injection site inflammation, Rash
Clinical narrative: Multifocal rash with inflammation at inoculation site and contralateral arm and chest without fever/chills.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Confusional state, Depressed level of consciousness, Fall, Syncope
Clinical narrative: 10:45 am after receiving vaccine was sitting in room on chair while twin brother got his shots. She fell off chair to her left and appeared to faint. Never completely lost consciousness but appeared confused. Had client lay out flat on floor with legs up - ammonia whiff under nose. Recovered quickly so that could spread to nurse. 10:50 am BP 120/40 pulse 80. No complaints from client. No swelling noted on head or face. Denies pain. 10:55 am BP 100/60 Awake and speaking with nurses. Gave Apple Juice. 11:00 am BP 104/50. Pulse 88. Spoke with Dr., in the building. He recommends once the client stabilized release to mom. Tell mom to report to child's PMD or pediatrician any changes in behavior, swelling on head, that may develop. Nurse conveyed this information to client's mom. Gave Graham crackers and peanut butter. 11:05 am BP 100/48, pulse 80. No complaints. No swelling on head felt. Awake and speaking appropriately to nurse. 11:10 Awake and playing with IPOD. 11:15 am BP 108/50, pulse 88. No lumps felt on head. Denies complaints. 11:30 am nurse walked client to mom's car out nearest exit.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Dizziness, Dyspnoea, Nausea, Vomiting
Clinical narrative: Light headed, nauseous, dizzy, shortness of breath. Vomiting cold sweat.
Age: 22.0
Sex: F
Vaccine: HEPA, IPV, TDAP, TYP, VARCEL, YF
Symptoms: Blood creatine phosphokinase normal, Dizziness, Fibrin D dimer normal, Full blood count normal, Laboratory test normal
Clinical narrative: Rash. Itchy. Dizziness. "Black spots" in vision.
Age: 22.0
Sex: F
Vaccine: HEPA, IPV, TDAP, TYP, VARCEL, YF
Symptoms: Pruritus, Rash, Red blood cell sedimentation rate normal, Visual impairment
Clinical narrative: Rash. Itchy. Dizziness. "Black spots" in vision.
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Culture throat negative, Laboratory test normal, Purulent discharge, Pyrexia, Rash
Clinical narrative: Fever 102, truncal rash and red purulent tonsils.
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Streptococcus test, Tonsillar inflammation
Clinical narrative: Fever 102, truncal rash and red purulent tonsils.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Patient reports pain in muscle in arm and area that vaccination was administered. Pain has continued for 14 days following vaccination.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt noticed a small amount of redness at injection site about 24 hours after administration. Within 48 hours post-injection, redness was about 3" in diameter with sporadic itching.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Contusion, Erythema, Skin warm, Weight increased
Clinical narrative: Bruise- 4 days after injection. Red and hot to touch for approx 2 weeks (started at day 7). Has felt bloated and gained 3 lbs. since she got vaccine.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site erythema
Clinical narrative: Both legs below injection site turned red, both anteriorly & posteriorly for a few minutes. Recovered within about 10 minutes.
Age: 0.22
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Haematocrit normal, Haemoglobin normal, Platelet count decreased, Purpura
Clinical narrative: Pt present with purpura on bilat lower extremities approx 2 hrs post PENTACEL injection. We had a CBC performed to check blood count which was normal.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Some swelling at the site of injection, and since then it's been growing increasing erythematous. It itches a little. Area, red, raised and hot and hard. No treatment (L) thigh.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Gaze palsy, Immediate post-injection reaction, Syncope, Unresponsive to stimuli
Clinical narrative: Immediately after injection, patient eyes rolls, fainted, unresponsive for a short while. Attempted by caller her name, help her to exam table, head raised - observed x 30 minutes.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Influenza like illness, Nausea, Pyrexia
Clinical narrative: Sudden onset of flu-like symptoms during evening: high fever, chills, headache, nauseous. Ran 102 degree temp throughout following day (perceived improvement from prior night). Symptoms abated about 6:00pm. Lingering minor symptoms 12/10/11.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site hot itchy and swollen 4 inch big raised area, worst on day 3, it got smaller on Aug 6.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Blood culture, Cellulitis, Erythema, Oedema peripheral
Clinical narrative: See ER notes- treated with 1. Clindamycin 300mg 4xdaily/900mg IV 2. BENADRYL Cap 2 25 mg at Bedtime 3. Prednisone 40mg po.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site reaction, Pyrexia, Rash erythematous
Clinical narrative: 08/04/2012 Mild Other. Fever on night of the 08/03/2012. Was 100.6 afternoon of 08/04/2012. No fever on 08/07/2012. Rash (small red dots) 8/7/12 at sight of injection, on her back, and chest. Mother called physician on 8/7/12 and reported fever and rash.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, PNC
Symptoms: Burning sensation, Erythema, Swelling face
Clinical narrative: 20 minutes after vaccine, child c/o night chills, "burning". Developed erythema and swelling of cheeks and chin. Mother gave BENADRYL with minimal change.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Paraesthesia, Rash, Skin warm, Somnolence
Clinical narrative: This spontaneous report as received from a healthcare student refers to a 67 years old male patient with benign prostatic hyperplasia (BPH), elevated cholesterol, gynecomastia, Gastrooesophageal reflux disease (GERD), hypertension, diabetes, bilateral renal cysts. Patient's drug reactions/allergies included TORADOL and STADOL. The patient was intramuscularly vaccinated with PNEUMOVAX 23 (lot# 672781/1706AA, exp 03-OCT-2013) on 13-JUL-2012. Concomitant medications included TRICOR (unspecified), LIPITOR, FLOMAX (unspecified), levothyroxine, ARICEPT, multivitamins (unspecified), fish oil, baby aspirin, vitamin E, alprazolam, SEROQUEL, CLARITIN, EFFEXOR, lisinopril (manufacturer unknown) and NAMENDA. On 14-JUL-2012, "the following day" of vaccination, the patient developed rash. The patient also stated that his arm was warm, painful, and tender and he felt drowsy. On 26-JUL-2012 the patient called the office and mentioned he felt tingling and pain in his right hand. No treatment was given for the events. No lab diagnostic was performed. The outcome of patient was reported as recovering/resolving. The patient sought unspecified medical attention. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: This spontaneous report as received from a healthcare student refers to a 67 years old male patient with benign prostatic hyperplasia (BPH), elevated cholesterol, gynecomastia, Gastrooesophageal reflux disease (GERD), hypertension, diabetes, bilateral renal cysts. Patient's drug reactions/allergies included TORADOL and STADOL. The patient was intramuscularly vaccinated with PNEUMOVAX 23 (lot# 672781/1706AA, exp 03-OCT-2013) on 13-JUL-2012. Concomitant medications included TRICOR (unspecified), LIPITOR, FLOMAX (unspecified), levothyroxine, ARICEPT, multivitamins (unspecified), fish oil, baby aspirin, vitamin E, alprazolam, SEROQUEL, CLARITIN, EFFEXOR, lisinopril (manufacturer unknown) and NAMENDA. On 14-JUL-2012, "the following day" of vaccination, the patient developed rash. The patient also stated that his arm was warm, painful, and tender and he felt drowsy. On 26-JUL-2012 the patient called the office and mentioned he felt tingling and pain in his right hand. No treatment was given for the events. No lab diagnostic was performed. The outcome of patient was reported as recovering/resolving. The patient sought unspecified medical attention. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a nurse refers to a 62 years old female patient with allergy to amoxicillin and none medical history. The patient was vaccinated subcutaneously with a 0.6 ml dose of ZOSTAVAX lot # (671611/1161AA), on 02-MAR-2012. The nurse reported that the patient had a rash and blister for a couple of days in 2012 (exactly onset date not provided). The patient was diagnosed with shingles. The patient sought unspecified medical attention via clinic visiting and received unspecified antiviral for adverse event treatment. None lab diagnostic tests were performed. At the time of the report the patient's state was not recovered. Additional information has been requested. PQC has been involved.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus, Pyrexia, Rash, Rash generalised
Clinical narrative: This spontaneous report as received from a female patient of unknown age, with no reaction/allergies and no pertinent medical history, concerning herself. On 26-APR-2012 the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, subcutaneously (lot number not reported). No other co-suspects were reported. Concomitant medications included: unspecified thyroid medication, vitamins (unspecified) and unspecified hormone pills. The reporter stated that she had a rash after getting the ZOSTAVAX which lasted a few weeks. The patient reported that on 28-APR-2012 ("by the following Saturday") she developed a slight temperature. On 15-MAY-2012 her arms were "itchy like crazy" first on the left forearm and then the right forearm. The patient developed lesions that when scratched burst and had clear liquid come out of them. Her rash then spread toward upper arms, legs, chest and back, and appeared at different places and different times with a burning itching sensation. Unspecified antihistamine was took to counteract the rash symptoms. It has been reported that the rash has gone away at that point. The patient was recovered from the events. No laboratory diagnostic studies were performed. The patient did not seek medical attention. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Secretion discharge, Skin lesion
Clinical narrative: This spontaneous report as received from a female patient of unknown age, with no reaction/allergies and no pertinent medical history, concerning herself. On 26-APR-2012 the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, subcutaneously (lot number not reported). No other co-suspects were reported. Concomitant medications included: unspecified thyroid medication, vitamins (unspecified) and unspecified hormone pills. The reporter stated that she had a rash after getting the ZOSTAVAX which lasted a few weeks. The patient reported that on 28-APR-2012 ("by the following Saturday") she developed a slight temperature. On 15-MAY-2012 her arms were "itchy like crazy" first on the left forearm and then the right forearm. The patient developed lesions that when scratched burst and had clear liquid come out of them. Her rash then spread toward upper arms, legs, chest and back, and appeared at different places and different times with a burning itching sensation. Unspecified antihistamine was took to counteract the rash symptoms. It has been reported that the rash has gone away at that point. The patient was recovered from the events. No laboratory diagnostic studies were performed. The patient did not seek medical attention. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age. The patients might have received VAQTA (Lot# unspecified) on a schedule other than what was in the prescribing information. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patients had sought medical attention. This is one of the reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. The patient was vaccinated with the first, second and the third dose of 0.5 ml VAQTA (Lot# unspecified) on 23-JUL-2009, 22-AUG-2009 and 01-FEB-2010. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. It was unspecified if the patient had sought medical attention. This is one of the reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. The patient was vaccinated with, 0.5 ml VAQTA (lot# unspecified). No other co-suspects were reported. No concomitant medications were reported. The patient received a second dose of VAQTA 1 month after the first dose of VAQTA, and then received a third dose of VAQTA, 6 months after the first dose. No adverse effect reported. It was unspecified if the patient had sought medical attention. This is one of the reports from the same source. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to a "65 years old" patient. The patient was vaccinated with VARIVAX (Merck) (lot# 1216AA) instead of ZOSTAVAX. It was reported that the vaccine was indicated for the prevention of shingles. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a 65 years old female patient with penicillin allergy, getting migraines after tetracycline, with shingles about 3 years ago and still experiencing residual postherpetic neuralgia. The patient was vaccinated with lot # (671775/0466AE, exp. 28-FEB-2013), 0.65 ml ZOSTAVAX, SC, left arm on 29-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 31-JUL-2012, the patient developed pain at the SI (sacroiliac) joint. No treatment was provided. The outcome of pain at the sacroiliac joint was reported as not recovered. The patient sought medical attention by calling pharmacy. The relatedness for pain at the sacroiliac joint is unknown for ZOSTAVAX. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a female consumer of unknown age reporting on herself. The consumer was vaccinated with ZOSTAVAX on 20-JUL-2012, in her arm (dose, route and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the consumer's arm swelled to tennis ball size at injection site. No treatment information was reported. At the time of report, the swelling was starting to subside. It is unknown if the patient sought medical attention. The relatedness for arm swelled to tennis ball size at injection site is unknown for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: VARZOS
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 and gender. The patient was vaccinated with lot # (670754/0621AA, exp. 26-JUL-2012) ZOSTAVAX on 30-JUL-2012 (dose, route and site of administration not reported) and the product was found to have expired on 26-JUL-2012. No adverse symptoms noted. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to two patients of unknown age. The two patients were each administered an expired dose of PNEUMOVAX 23 (lot number of each dose: unknown; expiration date of each dose: 25-FEB-2012) intramuscularly on 14-JUL-2012. It was unknown if this was the first dose of PNEUMOVAX 23 for either patient. No adverse effect reported. It was unspecified if the patients had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with dose 1 of ROTATEQ (Lot # not reported) orally on 21-SEP-2011, dose 2 of ROTATEQ (Lot # not reported) orally on 23-JAN-2012 and dose 3 ROTATEQ (Lot # not reported) orally on 03-AUG-2012 when the child was greater than 32 weeks of age. No adverse effect was reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female patient with no pertinent medical history and no drug reactions/allergies who on 05-JUN-2012 was vaccinated SC with a 0.5ml dose of VARIVAX (Merck) (Lot #: 669193/0096AE, expired date: 11-NOV-2012). On the same day, she was also vaccinated with a dose of KINRIX at the same arm. There was no concomitant medication. The patient developed a small vesicular, skin colored (with possibly a slight yellow tinge) rash that appeared to be closer to the KINRIX injection site, rather than the VARIVAX (Merck) injection site. The patient had sought unspecified medical attention. At the time of report, the patient was recovering. Follow-up information has been received from a registered nurse concerning a 4 year old female patient (35 lbs, 42") with no known allergies who on 05-JUN-2012 was vaccinated subcutaneously in left arm with the second 0.5ml dose of VARIVAX (Merck) (Lot #: 669193/0096AE, expired date: 11-NOV-2012) as well as a dose of KINRIX also in the left arm. On the same date, the patient was vaccinated subcutaneously in the right arm with a dose of M-M-R II (manufacturer not specified). The left arm had gotten red and swollen. On 07-JUN-2012, the patient was seen by the physician. The patient's mother reported that she had used a cool pack to the patient's arm twice the previous day for about ten minutes each. The previous night, her mother noticed a dime sized area of water blisters that had spread. No itching was noted, although the arm was sore and swollen. No induration noted. The child was using both arms, although she was sensitive to touch at shot sites. Her mother had given her some ibuprofen. Physical exam showed 3 1/2 x 5 cm pinpoint, vesiculations. Location was on the arm (upper), on left. The problem was spreading. Assessment included vaccination reaction. The Physician would expect that the rash was related to the vaccine, but not a typical reaction. The patient was to increase the dose of ibuprofen for pain, apply cool compresses to vesicles and consult with dermatology. At the time of report, the patient had recovered. Other medications included PROAIR HFA as needed. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, VARCEL
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female patient with no pertinent medical history and no drug reactions/allergies who on 05-JUN-2012 was vaccinated SC with a 0.5ml dose of VARIVAX (Merck) (Lot #: 669193/0096AE, expired date: 11-NOV-2012). On the same day, she was also vaccinated with a dose of KINRIX at the same arm. There was no concomitant medication. The patient developed a small vesicular, skin colored (with possibly a slight yellow tinge) rash that appeared to be closer to the KINRIX injection site, rather than the VARIVAX (Merck) injection site. The patient had sought unspecified medical attention. At the time of report, the patient was recovering. Follow-up information has been received from a registered nurse concerning a 4 year old female patient (35 lbs, 42") with no known allergies who on 05-JUN-2012 was vaccinated subcutaneously in left arm with the second 0.5ml dose of VARIVAX (Merck) (Lot #: 669193/0096AE, expired date: 11-NOV-2012) as well as a dose of KINRIX also in the left arm. On the same date, the patient was vaccinated subcutaneously in the right arm with a dose of M-M-R II (manufacturer not specified). The left arm had gotten red and swollen. On 07-JUN-2012, the patient was seen by the physician. The patient's mother reported that she had used a cool pack to the patient's arm twice the previous day for about ten minutes each. The previous night, her mother noticed a dime sized area of water blisters that had spread. No itching was noted, although the arm was sore and swollen. No induration noted. The child was using both arms, although she was sensitive to touch at shot sites. Her mother had given her some ibuprofen. Physical exam showed 3 1/2 x 5 cm pinpoint, vesiculations. Location was on the arm (upper), on left. The problem was spreading. Assessment included vaccination reaction. The Physician would expect that the rash was related to the vaccine, but not a typical reaction. The patient was to increase the dose of ibuprofen for pain, apply cool compresses to vesicles and consult with dermatology. At the time of report, the patient had recovered. Other medications included PROAIR HFA as needed. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female patient with no pertinent medical history and no drug reactions/allergies who on 05-JUN-2012 was vaccinated SC with a 0.5ml dose of VARIVAX (Merck) (Lot #: 669193/0096AE, expired date: 11-NOV-2012). On the same day, she was also vaccinated with a dose of KINRIX at the same arm. There was no concomitant medication. The patient developed a small vesicular, skin colored (with possibly a slight yellow tinge) rash that appeared to be closer to the KINRIX injection site, rather than the VARIVAX (Merck) injection site. The patient had sought unspecified medical attention. At the time of report, the patient was recovering. Follow-up information has been received from a registered nurse concerning a 4 year old female patient (35 lbs, 42") with no known allergies who on 05-JUN-2012 was vaccinated subcutaneously in left arm with the second 0.5ml dose of VARIVAX (Merck) (Lot #: 669193/0096AE, expired date: 11-NOV-2012) as well as a dose of KINRIX also in the left arm. On the same date, the patient was vaccinated subcutaneously in the right arm with a dose of M-M-R II (manufacturer not specified). The left arm had gotten red and swollen. On 07-JUN-2012, the patient was seen by the physician. The patient's mother reported that she had used a cool pack to the patient's arm twice the previous day for about ten minutes each. The previous night, her mother noticed a dime sized area of water blisters that had spread. No itching was noted, although the arm was sore and swollen. No induration noted. The child was using both arms, although she was sensitive to touch at shot sites. Her mother had given her some ibuprofen. Physical exam showed 3 1/2 x 5 cm pinpoint, vesiculations. Location was on the arm (upper), on left. The problem was spreading. Assessment included vaccination reaction. The Physician would expect that the rash was related to the vaccine, but not a typical reaction. The patient was to increase the dose of ibuprofen for pain, apply cool compresses to vesicles and consult with dermatology. At the time of report, the patient had recovered. Other medications included PROAIR HFA as needed. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a nurse refers to a 16 years old female patient. The patient was intramuscularly vaccinated with the first dose GARDASIL (lot # 673256/0629AE, exp 16-DEC-204) on 27-JUL-2012. On 27-JUL-2012, the patient had her first dose GARDASIL and fainted for about 15 seconds. No treatment was given for the event. The outcome of patient was reported as recovering/resolving. The patient did not seek medical attention. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Doctor of Pharmacy refers to a patient of unknown age. The patient was vaccinated with lot # (1013Z expiration 30-JUL-2012) of M-M-R II (dose and route not reported) on 03-AUG-2012. No adverse effect were reported. Additional information has been requested.
Age: 1.24
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: This spontaneous report as received from a consumer refers to her son a 14 months old male patient with drug allergy of BACTRIM and no pertinent medical history. The patient was vaccinated with first dose of both M-M-R II (Lot#, dose/frequency and route unspecified) and VARIVAX (Merck) (Lot#, dose/frequency and route unspecified) on 19-APR-2012 and second dose of both with Lot#, dose/frequency and route unspecified on 12-JUL-2012. No concomitant medication was used. On 22-JUL-2012 the patient started to develop a high fever up to 103F and swollen glands in his neck that continued to persist and has not recovered. The patient had sought medical attention via contacting physician. No lab diagnostics studies performed and no treatment was given for AE. The outcome was reported as not recovered/not resolved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a health care worker refers to a currently 17 years old female patient with drug hypersensitivity to acetaminophen, VICODIN. The patient was vaccinated with dose 1 GARDASIL (lot #, dose and route not reported) over 5 years ago. No other co-suspects were and no concomitant medications were reported. The health care worker reported that the patient fainted in the physician's office after receiving the first dose of vaccine. This did not occur at the reported physician's office. No treatment information was reported. The patient sought medical attention while she was still at the physician's office. The outcome of fainted in the physician's office after receiving first dose of vaccine was reported as recovered on an unspecified date. The relatedness for the reported event was not provided for GARDASIL. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: This spontaneous report as received from a physician's nurse refers to a 24 years old female patient who on 18-JUN-2012,was vaccinated with a 0.5 ml dose of GARDASIL (lot number 0754AE) (route not reported). No other co-suspects were reported. No concomitant medications were reported. It was stated that about an hour after the vaccination, on 18-JUN-2012, the patient developed an excruciating headache that lasted about 8 hours. No lab diagnostics studies were performed. Ibuprofen was given as a treatment for the experience. At the time of the report, the patient had recovered (date of recovery reported as 18-JUN-2012 or 19-JUN-2012). The patient sought unspecified medical attention. The relatedness for patient developed an excruciating headache was unknown for GARDASIL. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient was vaccinated with dose 1 of GARDASIL (lot #, dose and route not reported) on 24-OCT-2008. The patient was in the office on 06-AUG-2012 for the second dose of GARDASIL (lot #, dose and route not reported). No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
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. The patient was vaccinated with lot # (665547/1318Y: expired on 12-JUN-2012) dose 1 GARDASIL (dose and route not reported) on 06-AUG-2012. No adverse symptoms were reported. Additional  information has been requested.
Age: 1.09
Sex: M
Vaccine: VARCEL
Symptoms: Rash maculo-papular, Rash pustular, Rash vesicular, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 21 month old patient who on 28-JUL-2011 was vaccinated with a dose of VARIVAX (Merck) (lot# 668543/1696Z). The nurse mentioned that on 19-APR-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. Follow-up information was received from a nurse refers to a 21 months old male patient (child) with abnormality of gait and no illness at the time of vaccination. The patient's medical history included infantile seborrheic dermatitis (date unspecified). On 28-JUL-2011 at 17:30 PM, the patient was vaccinated with the first dose of VARIVAX (Merck subcutaneously (SC.) in right leg (dose not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on19-APR-2012, the patient came to clinic with a rash described as "mild macular, papules, vesicular and pustulas on face, upper extremities and lower extremities diagnosed with varicella. No testing was done. No treatment information was reported. The outcome of patient had outbreaks of varicella was reported as recovered/resolved. The relatedness of patient had outbreaks of varicella is unknown for VARIVAX (Merck). This was one of the several reports from the same source. A lot check has been initiated. Additional information is not expected.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to a 80 years old female patient with no drug reactions or allergies. The patient was vaccinated subcutaneously with lot # (671786/0254AE; expiration 08-MAR-2013), 0.65 ml dose of ZOSTAVAX on 05-AUG-2012. No other co-suspects were reported. Concomitant medications included verapamil (manufacturer unknown) and lovastatin (manufacturer unknown). On 06-AUG-2012 the patient developed redness, a warm sensation and burning pain at the injection site. The patient went to the pharmacy on 08-AUG-2012, no treatment was given and no lab diagnostic tests were performed. The outcome of the events was reported as not recovered. The relatedness for the reported events was not provided for ZOSTAVAX. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report as received from a health care worker refers to a 16 years old male patient with no pertinent medical history, drug reactions or allergies. The patient was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (lot # not reported) on 06-AUG-2012. No other co-suspects were reported. There were no concomitant medications. On 07-AUG-2012 the patient developed red rashes on his arms and abdomen after having GARDASIL administered. The patient sought medical attention by contacting physician and was given treatment with BENADRYL and prednisolone (manufacturer unknown). No lab diagnostic tests were performed. The outcome of red rashes on his arms an abdomen was unknown. The relatedness for the reported event was not provided for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of expired ZOSTAVAX (lot # 670616/0617AA, exp. date 27-Jul-2012) on 01-AUG-2012. No adverse symptoms reported. It was unknown if the patient sought medical attention or not. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARZOS
Symptoms: Medication error, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 months old patient. On 01-AUG-2012 the patient was vaccinated with a dose of ZOSTAVAX in error. No product confusion discovered, just medication (nursing) error. No adverse event reported. It was unknown if the patient sought medical attention or not. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV2
Symptoms: Fatigue, Immediate post-injection reaction, Nausea, Presyncope, Somnolence
Clinical narrative: This case was reported by a consumer and described the occurrence of drowsiness in a 18-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. There were no concurrent medications. On 13 June 2012 at 13:00 the subject received 1st dose of CERVARIX. On 13 June 2012, immediately after vaccination with CERVARIX, the subject experienced drowsiness, nausea, almost fainted and tiredness. At the time of reporting the events were unresolved.
Age: 75.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Haematuria, Herpes zoster, Pain, Urine analysis abnormal
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning an approximately 76 year old female patient with no drug reactions or allergies and no pertinent medical history who on 30-SEP-2011, was vaccinated with a dose of ZOSTAVAX (Merck) SC (lot number 670820/0660AA, expiration date 04-AUG-2012). Concomitant therapy included MAXZIDE, metoprolol, sertraline HCl, vitamin D (unspecified), tramadol HCl, omeprazole, diltiazem HCL (manufacturer unknown), LIPITOR, alprazolam, aspirin, calcium (unspecified) and FLONASE. It was reported that on an unknown date, the patient developed shingles after receiving ZOSTAVAX (Merck). The patient also had "micro-hematuria". Prednisone, VALTREX and VICODIN were given as treatment for the adverse events. There was "urine test" performed which revealed "micro-hematuria". The patient sought medical attention, she saw the physician. At the time of the report, the patient's outcome was not recovered. Follow-up information has been received from a physician via herpes zoster questionary concerning the 76 year old female retired patient with no known drug allergies and no history of chickenpox or recent exposure to herpes zoster who on 30-SEP-2011, was vaccinated with a first dose of ZOSTAVAX (Merck) 0.65ml, in the site of the right deltoid (lot number 670820/0660AA) and with the third dose of FLUZONE (lot number 1725) in the left deltoid as a concomitant therapy. It was reported that on 13-MAY-2012, the patient developed "significant zoster outbreak", on the right side, T4 - multiple lesions. No other symptoms occurred. The patient rated the pain as 9 on a zero (least) to ten (most) scale. No rash occurred at the site of the injection or elsewhere within 42 days of the vaccination. Maximum temperature was 98 (date unspecified). There was no direct fluorescent antibody done and no specimen collected for PCR and a photo was not taken. It was reported that the patient did not seek medical attention (previously reported as "she saw physician"). At the time of the report, the patient's outcome was recovering from Zoster outbreak. The relationship between the events and ZOSTAVAX (Merck) was unknown. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Malaise, Tinnitus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 years old female patient with no medical history and no illness at time of vaccination was vaccinated IM into left arm with lot # (668261/1397AA dose 1 GARDASIL on 24-FEB-2012. No other co-suspects were reported. No concomitant medications were reported. On 24-FEB-2012 the patient complained of headache, tinnitus and "not feeling well" for 24 hours after vaccine. The outcome of headache, tinnitus and not feeling well was unknown. The original reporting source was not provided. The VAERS ID # is 450885-1. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Otitis media, VIIth nerve paralysis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 20 years old female patient with prophylaxis was vaccinated IM with first dose of GARDASIL (lot # 666121/1778Y, expired date: 19-AUG-2012) on 23-FEB-2012. No other co-suspects were reported. Concomitant medications included: HAVRIX vaccinated IM on the same day. On 24-FEB-2012 the patient was diagnosed with otitis media and Bell's palsy at emergency room. The patient's outcome was unknown. This report was considered not serious, required ER visit by agency. The original reporting source was not provided. The VAERS ID # is 450950-1. No further information is available.
Age: 27.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electrocardiogram, Palpitations, Ventricular extrasystoles
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 27 years old female patient with no illness at time of vaccination was vaccinated IM into left arm with lot # (667866/1437Z) dose 2 GARDASIL on 06-MAR-2012. No other co-suspects were reported. There was no concomitant medication. The patient reported on 06-MAR-2012 she had "PVC's" a few hours after receiving GARDASIL. She stated that she was having heart palpitations and was given electrocardiogram at her mom's job that showed PVC's. The patient denied dizziness, headache, shortness of breath, difficulty breathing or local reactions. The outcome of the events was unknown. The original reporting source was not provided. The VAERS ID # is 451494-1. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electrocardiogram abnormal, Palpitations, Ventricular extrasystoles
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 27 years old female patient with no illness at time of vaccination was vaccinated IM into left arm with lot # (667866/1437Z) dose 2 GARDASIL on 06-MAR-2012. No other co-suspects were reported. There was no concomitant medication. The patient reported on 06-MAR-2012 she had "PVC's" a few hours after receiving GARDASIL. She stated that she was having heart palpitations and was given electrocardiogram at her mom's job that showed PVC's. The patient denied dizziness, headache, shortness of breath, difficulty breathing or local reactions. The outcome of the events was unknown. The original reporting source was not provided. The VAERS ID # is 451494-1. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Erythema, Local swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 18 year old female patient treated with the first dose of GARDASIL (lot number 672653/1860AA) (dose and route were not reported) on left arm on 03-MAR-2012 experienced localized swelling and erythema on 03-MAR-2012. The patient had no laboratory data and no history. No further information is available. The original reporting source was not provided. The VAERS ID # is 451775-1.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A unknown age male patient was vaccinated GARDASIL (lot# reported as 670050/1229AA of unknown route into right arm with the first dose on an unknown date. The patient's medical history included syncope. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced syncope. The listing indicated that the events as nonserious. The patient had visit emergency room. The outcome was unknown. No further information is available. The original reporting source was not provided. The VAERS ID # is 451877-1.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Condition aggravated, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A unknown age male patient was vaccinated GARDASIL (lot# reported as 670050/1229AA of unknown route into right arm with the first dose on an unknown date. The patient's medical history included syncope. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced syncope. The listing indicated that the events as nonserious. The patient had visit emergency room. The outcome was unknown. No further information is available. The original reporting source was not provided. The VAERS ID # is 451877-1.
Age: 1.25
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Abdominal pain, Eating disorder, Enema administration, Influenza like illness, Intussusception
Clinical narrative: Intussusception was resolved by pneumatic enema. Symptoms started 1 day after vaccine with runny nose and cranky and flu like symptoms then stoppped eating on 12/2 vomiting and abdominal pain on 12/3 ER in 12/3 @ midnight.
Age: 1.25
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Irritability, Rhinorrhoea, Vomiting
Clinical narrative: Intussusception was resolved by pneumatic enema. Symptoms started 1 day after vaccine with runny nose and cranky and flu like symptoms then stoppped eating on 12/2 vomiting and abdominal pain on 12/3 ER in 12/3 @ midnight.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Headache, Neck pain, Pain, Paraesthesia
Clinical narrative: Itching, tingling, prodrome like symptoms, progressively getting worse and painful; no lesions seen, some erythema, headache and neck pain.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: Itching, tingling, prodrome like symptoms, progressively getting worse and painful; no lesions seen, some erythema, headache and neck pain.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Neuritis, Neuropathy peripheral, Paraesthesia
Clinical narrative: Itching, tingling, prodrome like symptoms, progressively getting worse and painful; no lesions seen, some erythema, headache and neck pain.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and warmth to site of the injection.
Age: 17.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain and swelling at site of injection. Diameter of swelling approx. 1.5 inches. Following day, swelling increased to 2.5 inches.
Age: 17.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, pain and swelling at site of injection. Diameter of swelling approx. 1.5 inches. Following day, swelling increased to 2.5 inches.
Age: 10.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site mass
Clinical narrative: There was bump at first in the upper arm part portion but then it went away then towards the bottom where the shot was taken at there was a lump but it doesn't hurt.
Age: 3.0
Sex: F
Vaccine: DTP
Symptoms: Pain in extremity, Pyrexia, Somnolence, Urticaria
Clinical narrative: Child complained of sore leg. I thought this was because of injection site, but later complained both legs and arms were sore. Child has fever of 102 degrees F currently. Child broke out in hives this afternoon around face and is sleeping before usual nap time.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Pain
Clinical narrative: Achy, totally drained of energy.
Age: 40.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Asthenia, Computerised tomogram, Confusional state, Dizziness, Headache
Clinical narrative: Started with pain in his ankles, that moved up his body over the course of a few hours. Severe HA, dizziness, and confusion. Followed by admission to the hospital from the ER. The initial dx was Guillian Barre syndrome, then changed to aseptic meningitis. 5 day hospital course. Patient continues to have neurological symptoms including severe HAs, weakness, and numbness in his left arm, and numbness on the bottom of both feet. He is being followed by a neurologist, and primary care physician.
Age: 40.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Hypoaesthesia, Laboratory test, Meningitis aseptic, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Started with pain in his ankles, that moved up his body over the course of a few hours. Severe HA, dizziness, and confusion. Followed by admission to the hospital from the ER. The initial dx was Guillian Barre syndrome, then changed to aseptic meningitis. 5 day hospital course. Patient continues to have neurological symptoms including severe HAs, weakness, and numbness in his left arm, and numbness on the bottom of both feet. He is being followed by a neurologist, and primary care physician.