chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from an 18 years old female consumer reporting on herself. The consumer's history of previous pregnancies and live births were not known. The consumer was vaccinated with a dose of MMR II (Lot # and dose not reported) subcutaneous on 22-JUN-2012 while pregnant. On an unspecified date the patient performed a pregnancy test. The patient's last menstrual period was on 06-JUN-2012 and her estimated delivery date would be on 13-MAR-2013. The patient called the doctor to seek medical attention. No treatment was given. Outcome was reported as not recovered. Follow up information has been received (report type unknown) which reported that they were unable to provide information requested, because they never administered an MMR vaccine on this patient. Information was requested to verify. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Eye pruritus, Varicella
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient of unknown age. No medical history was reported. On 16-MAY-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry not reported) 0.65 ml, subcutaneously. No concomitant medications were reported. On 27-MAY-2013, the patient developed a chickenpox bump under an unspecified eye and went to see the pharmacist on 31-MAY-2013 due to his eye beginning to itch. The pharmacist instructed the patient to take BENADRYL. Patient sought medical attention-saw the pharmacist. No laboratory tests were performed. The outcome of eye beginning to itch and chickenpox bump was unknown. 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 an unknown number of patients of unknown age and gender. The pharmacist reported that unknown number of patients might have received ZOSTAVAX (lot number unspecified) that was improperly stored from 20-MAY-2013 to 05-JUN-2013. No adverse effects reported. It was unknown if the patients had sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information has been requested.
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 nurse practitioner refers to a patient of unknown age. The patient was vaccinated with his first, second and third dose of GARDASIL (lot number not provided) on 15-MAR-2012, 16-APR-2013 and 17-MAY-2013, respectively. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Dizziness, Mobility decreased, Movement disorder, Myalgia
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 25 year old female patient. The patient was not pregnant. In 2008 the patient was vaccinated with the first dose of GARDASIL (Lot# and dose not reported) intramuscularly. The second dose of GARDASIL (Lot# and dose not reported) was received intramuscularly in 2010. On 29-MAY-2013 the patient was vaccinated with the third dose of GARDASIL (Lot # and dose not reported) intramuscularly. Concomitant medications included tretinoin cream and erythromycin cream for acne, and "Plan B emergency contraceptive" (14-MAY-2013). On 29-MAY-2013, the day of vaccination, the patient experienced dizziness and nausea. And she felt fine on 2nd day post-vaccination. On 3rd day post-vaccination, on 31-MAY-2013, the patient experienced fever, chills and muscle aches to the point where she could not get out of bed. And she felt fine on 4th day post-vaccination. On 5th day post-vaccination, on 02-JUN-2013, the patient experienced fever, chills and muscle aches to the point where she could not get out of bed. And she felt fine on 6th day post-vaccination. The nurse instructed the patient via phone to take TYLENOL if fever and/or muscle aches re-occur. It was not known if the patient sought medical treatment elsewhere. Outcome and drug causality was not reported. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 25 year old female patient. The patient was not pregnant. In 2008 the patient was vaccinated with the first dose of GARDASIL (Lot# and dose not reported) intramuscularly. The second dose of GARDASIL (Lot# and dose not reported) was received intramuscularly in 2010. On 29-MAY-2013 the patient was vaccinated with the third dose of GARDASIL (Lot # and dose not reported) intramuscularly. Concomitant medications included tretinoin cream and erythromycin cream for acne, and "Plan B emergency contraceptive" (14-MAY-2013). On 29-MAY-2013, the day of vaccination, the patient experienced dizziness and nausea. And she felt fine on 2nd day post-vaccination. On 3rd day post-vaccination, on 31-MAY-2013, the patient experienced fever, chills and muscle aches to the point where she could not get out of bed. And she felt fine on 4th day post-vaccination. On 5th day post-vaccination, on 02-JUN-2013, the patient experienced fever, chills and muscle aches to the point where she could not get out of bed. And she felt fine on 6th day post-vaccination. The nurse instructed the patient via phone to take TYLENOL if fever and/or muscle aches re-occur. It was not known if the patient sought medical treatment elsewhere. Outcome and drug causality was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Intercepted medication error
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a patient of unknown age. A physician reported to the pharmacy student that an unspecified patient came to the primary care office on an unspecified date to receive an unspecified vaccination (that was not supposed to be ZOSTAVAX). By mistake, a syringe that contained ZOSTAVAX was inserted into the patient's arm but not administered. While inserted, an unspecified healthcare provider realized it was the incorrect vaccine and immediately removed the needle from the patient's arm. Though the patient did not actually receive any ZOSTAVAX vaccine, she reported soreness at the injection site and chills. According to the pharmacy student, the patient was no longer feeling these symptoms and recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter of unknown age. On an unknown date the patient was vaccinated with her third shot of GARDASIL (lot number not provided), one week prior to the recommended third dose administration date. It was reported that this was a misuse adverse event (AE) in regarding to GARDASIL. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On 04-JUN-2013 the patient was vaccinated with the first dose of RECOMBIVAX HB (lot# and route not reported). Patient was administered RECOMBIVAX HB twice within a 2 hour period. No adverse effect reported. It was unknown if the patient sought medical attention. At the time of report, the status of patient was unknown. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician refers to a 34 year old female patient with allergy to azithromycin and migraines. In 2006 the patient was vaccinated with VARIVAX (merck) (lot# and route unknown). No other co-suspects were reported. No concomitant medications were reported. Physician reported that a patient received two doses of VARIVAX (merck) "four weeks apart" on an unspecified date. Physician reports that titers were drawn on 12-MAY-2013 and resulted "low". The physician reported that the patient was administered the two doses of VARIVAX (merck) in 2006 at a different physician's office and the reason the patient received the two doses of VARIVAX (merck) was due to the patient having negative titers at an unspecified time that was prior to the administration of the VARIVAX (merck). It was unknown if the patient had sought medical attention. The outcome was unknown. Action taken was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a female patient of unknown age reporting on herself. Approximately in MAY 2010 ("about 3 weeks ago") the patient was vaccinated with ZOSTAVAX (route and lot number not reported). Approximately in MAY 2011 ("approximately 1 year after") after receiving the vaccine the patient experienced a case of shingles. The outcome of shingles is unknown. Additional information is not expected.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site bruising, Local reaction
Clinical narrative: This spontaneous report was received from a medical assistant via a sales representative concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (manufacturer unknown) (lot number, expiry date, dose and route unspecified) (unknown details and unknown arm). Other suspect therapy included a dose of KINRIX (unknown details and unknown arm). Both the vaccines were given in the same arm (arm unspecified). No concomitant medications were reported. On an unknown date, after the vaccination, the patient experienced bruise injection site. The reporter stated that the patient experienced a local reaction (Injection site bruising) to KINRIX. A dose of VARIVAX (Merck) (manufacturer unknown) was also received in the same arm, so it could be a reaction to reaction to both. The reporter described the local reaction was looking like a bruise. The mother of the patient provided pictures to the office of the physician. At the time of reporting, the outcome of the event was unspecified. The reporter considered the event to be related to VARIVAX (Merck) (manufacturer unknown) and KINRIX (reported as it could be a reaction to both). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse. On 21-MAY-2013, multiple unspecified patients were vaccinated with GARDASIL (lot # H014645, exp. 27-MAR-2015). The nurse reported the dose of GARDASIL were exposed to 30.1 degrees fahrenehit for three hours, which was unsupported by stability data. No adverse effects reported. This is one of several cases received from same source. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: DTAP
Symptoms: Cardiac murmur, Injection site reaction
Clinical narrative: Here for injection site reaction to DTAP shot given Tues. He denies any fever, GI or respiratory sx. He was noted to have murmur on exam and is followed by cardiologist. He is with GM at encounter and few details are known about this.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: This spontaneous report as received from an approximately 87 years male patient with none drug reactions/allergies and none pertinent medical history. In November 2010 the patient was vaccinated with ZOSTAVAX (dose and strength were unknown). Concomitant therapies included gabapentin. About a year later (onset on 2011) the patient got a case of the shingles which in his upper arm going towards the armpit, going towards his back, and ever since then (2 years now) has had the nerve pain. No lab diagnostics studies performed. The patient sought medical attention. The outcome of the nerve pain was reported as not recovered/not resolved. The outcome of shingles was unknown. Action taken and the causality of events and ZOSTAVAX were not provided. Additional information has been requested.
Age: 1.28
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site rash, Rash, Rash erythematous
Clinical narrative: Rash #1 HPV on leg - red spot at site of Varicella vacc. - lasted 1 week. Dev. rash on left leg spread to trunk - both legs.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse. On 23-APR-2013, multiple unspecified patients were vaccinated with VAQTA (lot # 0273AE exp. 06-DEC-2014 and lot # H012669, exp. 17-APR-2015). The nurse reported the dose of VAQTA were exposed to 30.1 degrees Fahrenheit for three hours, which was unsupported by stability data. No adverse effects reported. This is one of several cases received from same source. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Confusional state, Full blood count, Influenza A virus test negative
Clinical narrative: Began feeling ill approximately 27 hours after vaccination with fever, body aches, sore throat, joint pain, generalized weakness and confusion. Symptoms resolved on Day 3 (5/31/13) without treatment. Patient was advised to stop his LIPITOR and restart when symptoms resolved.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Influenza B virus test, Influenza virus test negative, Malaise, Oropharyngeal pain, Pain
Clinical narrative: Began feeling ill approximately 27 hours after vaccination with fever, body aches, sore throat, joint pain, generalized weakness and confusion. Symptoms resolved on Day 3 (5/31/13) without treatment. Patient was advised to stop his LIPITOR and restart when symptoms resolved.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Streptococcus test negative
Clinical narrative: Began feeling ill approximately 27 hours after vaccination with fever, body aches, sore throat, joint pain, generalized weakness and confusion. Symptoms resolved on Day 3 (5/31/13) without treatment. Patient was advised to stop his LIPITOR and restart when symptoms resolved.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse. On 29-APR-2013, multiple unspecified patients were vaccinated with VAQTA (lot # 0273AE exp. 06-DEC-2014 and lot # H012669, exp. 17-APR-2015). The nurse reported the dose of VAQTA were exposed to 30.1 degrees fahrenheit for three hours, which was unsupported by stability data. No adverse effects reported. This is one of several cases received from same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse. On 24-MAY-2013, multiple unspecified patients were vaccinated with VAQTA (lot # 0273AE exp. 06-DEC-2014 and lot # H012669, exp. 17-APR-2015). The nurse reported the dose of VAQTA were exposed to 30.1 degrees Fahrenheit for three hours, which was unsupported by stability data. No adverse effects reported. This is one of several cases received from same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse. On 13-MAY-2013, multiple unspecified patients were vaccinated with GARDASIL (lot # H014645, exp. 27-MAR-2015). The nurse reported the dose of GARDASIL were exposed to 30.1 degrees Fahrenheit for three hours, which was unsupported by stability data. No adverse effects reported. This is one of several cases received from same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse. On 02-MAY-2013, multiple unspecified patients were vaccinated with VAQTA (lot # 0273AE exp. 06-DEC-2014 and lot # H012669, exp. 17-APR-2015). The nurse reported the dose of VAQTA were exposed to 30.1 degrees Fahrenheit for three hours, which was unsupported by stability data. No adverse effects reported. This is one of several cases received from same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse. On 25-APR-2013, multiple unspecified patients were vaccinated with VAQTA (lot # 0273AE exp. 06-DEC-2014 and lot # H012669, exp. 17-APR-2015). The nurse reported the dose of VAQTA were exposed to 30.1 degrees Fahrenheit for three hours, which was unsupported by stability data. No adverse effects reported. This is one of several cases received from same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse. On 06-MAY-2013, multiple unspecified patients were vaccinated with VAQTA (lot # 0273AE exp. 06-DEC-2014 and lot # H012669, exp. 17-APR-2015). The nurse reported the dose of VAQTA were exposed to 30.1 degrees Fahrenheit for three hours, which was unsupported by stability data. No adverse effects reported. This is one of several cases received from same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse. On 29-APR-2013, multiple unspecified patients were vaccinated with GARDASIL (lot # H014645, exp. 27-MAR-2015). The nurse reported the dose of GARDASIL were exposed to 30.1 degrees Fahrenheit for three hours, which was unsupported by stability data. No adverse effects reported. This is one of several cases received from same source. Additional information has been requested.
Sex: U
Vaccine: MMR
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 11-APR-2013, the patient was vaccinated with M-M-R II lot # 0515AA, .5 ml, intramuscular. On 11-APR-2013, the patient received an expired dose of M-M-R II. The pharmacist is unsure if the dose is the patient's first or second dose. No adverse effects reported. The outcome of patient received an expired dose and no adverse effect is unknown. The reporter considered patient received an expired dose and no adverse effect to be not related to M-M-R II. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Mom stated previous DTaP vaccines resulted in fevers -> 105 and child was seen by the ER. No medical intervention needed. Mom did not report this event until 6/5/2013. States no fever when child only got PREVNAR 13 and ACTHIB on 4/3/2013.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt states she received vaccine 6/7/2013 at the ER. Later that night she developed redness, warmth and pain at the site. Presents today with 8 x 4 cm area of redness, swelling, warmth and pain. Antibiotics given for suspected cellulitis.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse. On 28-MAY-2013, multiple unspecified patients were vaccinated with VAQTA (lot # 0273AE exp. 06-DEC-2014 and lot # H012669, exp. 17-APR-2015) for prophylaxis. The nurse reported the dose of VAQTA were exposed 30.1 degrees Fahrenheit for three hours, which was unsupported by stability data. No adverse effects reported. This is one of several cases received from same source. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site reaction, Middle insomnia, Pyrexia, Rash, Rash vesicular
Clinical narrative: Low grade fever (100.7, 99.9, etc.) for several days. After fever, rash on body first on front then on back. Then 2 chicken pox-like bumps on arm at vaccine injection site developed. (Also, went from sleeping through the night to waking every 1-2 hours for the past 2 nights.)
Age: 16.0
Sex: M
Vaccine: JEV1, TYP
Symptoms: Disorientation
Clinical narrative: Disoriented, began on waking the morning of June 10, 2013.  No fever.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, HEPA, HPV4, MNQ
Symptoms: Altered state of consciousness, Gaze palsy, Joint contracture, Malaise, Opisthotonus
Clinical narrative: While checking out she said she did not feel well, and went pale. Receptionist had her sit in chair. She then arched her back, hands turned inwards clenched and urinated herself, head down and eyes rolled. Lasted about 2 -3 minutes and doctor came out and she had repeated action, pale, clenched first and completely out of it for 1 minute and came to. Patient does not remember the event at all. Doctor carried to exam room and observed for about 10 minutes and then wheelchaired to ER in same building.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, HEPA, HPV4, MNQ
Symptoms: Pallor, Posture abnormal, Urinary incontinence
Clinical narrative: While checking out she said she did not feel well, and went pale. Receptionist had her sit in chair. She then arched her back, hands turned inwards clenched and urinated herself, head down and eyes rolled. Lasted about 2 -3 minutes and doctor came out and she had repeated action, pale, clenched first and completely out of it for 1 minute and came to. Patient does not remember the event at all. Doctor carried to exam room and observed for about 10 minutes and then wheelchaired to ER in same building.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, HEPA, HPV4, MNQ
Symptoms: Blood test, Chest X-ray, Computerised tomogram head, Convulsion, Culture urine
Clinical narrative: While checking out she said she did not feel well, and went pale. Receptionist had her sit in chair. She then arched her back, hands turned inwards clenched and urinated herself, head down and eyes rolled. Lasted about 2 -3 minutes and doctor came out and she had repeated action, pale, clenched first and completely out of it for 1 minute and came to. Patient does not remember the event at all. Doctor carried to exam room and observed for about 10 minutes and then wheelchaired to ER in same building.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, HEPA, HPV4, MNQ
Symptoms: Gaze palsy, Joint contracture, Opisthotonus, Pallor, Posture abnormal
Clinical narrative: While checking out she said she did not feel well, and went pale. Receptionist had her sit in chair. She then arched her back, hands turned inwards clenched and urinated herself, head down and eyes rolled. Lasted about 2 -3 minutes and doctor came out and she had repeated action, pale, clenched first and completely out of it for 1 minute and came to. Patient does not remember the event at all. Doctor carried to exam room and observed for about 10 minutes and then wheelchaired to ER in same building.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, HEPA, HPV4, MNQ
Symptoms: Tremor, Urinary incontinence
Clinical narrative: While checking out she said she did not feel well, and went pale. Receptionist had her sit in chair. She then arched her back, hands turned inwards clenched and urinated herself, head down and eyes rolled. Lasted about 2 -3 minutes and doctor came out and she had repeated action, pale, clenched first and completely out of it for 1 minute and came to. Patient does not remember the event at all. Doctor carried to exam room and observed for about 10 minutes and then wheelchaired to ER in same building.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, HEPA, HPV4, MNQ
Symptoms: Gaze palsy, Nausea, Opisthotonus, Pallor, Posture abnormal
Clinical narrative: While checking out she said she did not feel well, and went pale. Receptionist had her sit in chair. She then arched her back, hands turned inwards clenched and urinated herself, head down and eyes rolled. Lasted about 2 -3 minutes and doctor came out and she had repeated action, pale, clenched first and completely out of it for 1 minute and came to. Patient does not remember the event at all. Doctor carried to exam room and observed for about 10 minutes and then wheelchaired to ER in same building.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, HEPA, HPV4, MNQ
Symptoms: Posturing, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: While checking out she said she did not feel well, and went pale. Receptionist had her sit in chair. She then arched her back, hands turned inwards clenched and urinated herself, head down and eyes rolled. Lasted about 2 -3 minutes and doctor came out and she had repeated action, pale, clenched first and completely out of it for 1 minute and came to. Patient does not remember the event at all. Doctor carried to exam room and observed for about 10 minutes and then wheelchaired to ER in same building.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site dryness, Injection site erythema, Injection site pruritus, Rash erythematous, Rash pruritic
Clinical narrative: At sight had 2 inch dry, very itchy, scaly red circle. Looked like ringworm. Used hydrocortisone cream. About 1 month later had exact same circle on back of my left thigh. Used hydrocortisone cream, turned to white circle and dissappeared. In Jan 2013 developed a itchy rash on my big toe used hydorcortisone cream did not go away. Turned BRIGHT red and rashy looking. It would subside and come back again. Went to a dermatologist in April and started on.
Age: 0.45
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Electroencephalogram normal, Head titubation, Tremor
Clinical narrative: Onset increased head bobbing, arms legs shaking lasts 30-60 sec. No v/d/F/decreased appetite/crying. Parent states increase movement cleared by 2 wks. later. Evaluated at Hospital for poss. infantile spasms 4/12/13. Neg EEG. Mom did not make F up neurology appointment.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Rash, Urticaria
Clinical narrative: Welt-like rash on torso, legs and feet. No itching, no pain, no fever. Patient had questionable vaccine reaction after receiving MMR at 15 months. Rash and fever 13 days following vaccine administration in 2009.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site irritation
Clinical narrative: Left thigh irritation. 7 x 6.5 cm erythematous and firm.
Age: 19.0
Sex: M
Vaccine: ADEN_4_7, DTAP, FLU3, HEPA, MNQ, ADEN_4_7, DTAP, FLU3, HEPA, MNQ
Symptoms: Breath sounds abnormal, Breath sounds absent, Chest pain, Dyspnoea, Feeling hot
Clinical narrative: Recruit complaining of shortness of breath and chest pain. Breathing labored. Upper lung sounds diminished. Lower lung sounds absent. Skin hot. No itching/redness/hives present. Recruit given 0.3ml epinephrine at 0950 and 25mg Benadryl at 0952, both injections given IM.
Age: 19.0
Sex: M
Vaccine: ADEN_4_7, DTAP, FLU3, HEPA, MNQ, ADEN_4_7, DTAP, FLU3, HEPA, MNQ
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Recruit complaining of shortness of breath and chest pain. Breathing labored. Upper lung sounds diminished. Lower lung sounds absent. Skin hot. No itching/redness/hives present. Recruit given 0.3ml epinephrine at 0950 and 25mg Benadryl at 0952, both injections given IM.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Irritability, Rash
Clinical narrative: Seen 4/25 for 12 mo WCC and vaccines.  3-4 days later developed red dots on torso, not itchy.  Spots would last 1-2 days and then fade a reappear elsewhere.  No fevers.  Mildly fussy and fighting sleep more.  3 days ago developed redness and swelling on L thigh with raised bumps on it.  Also not itching, but has grown slightly since first appeared.  Twin sister with same rashes for same time.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL, MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Seen 4/25 for 12 mo WCC and vaccines.  3-4 days later developed red dots on torso, not itchy.  Spots would last 1-2 days and then fade a reappear elsewhere.  No fevers.  Mildly fussy and fighting sleep more.  3 days ago developed redness and swelling on L thigh with raised bumps on it.  Also not itching, but has grown slightly since first appeared.  Twin sister with same rashes for same time.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL, MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling, Irritability, Sleep disorder
Clinical narrative: Seen 4/25 for 12 mo WCC and vaccines.  3-4 days later developed red dots on torso, not itchy.  Spots would last 1-2 days and then fade a reappear elsewhere.  No fevers.  Mildly fussy and fighting sleep more.  3 days ago developed redness and swelling on L thigh with raised bumps on it.  Also not itching, but has grown slightly since first appeared.  Twin sister with same rashes for same time.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Eyelid oedema, Influenza like illness, Nasal congestion, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Puffy eyes, fever over 102, nasal congestion, sore throat, sneezing.  Appeared like a bad cold/flu.  All symptoms cleared within 24 hours.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia, Sneezing
Clinical narrative: Puffy eyes, fever over 102, nasal congestion, sore throat, sneezing.  Appeared like a bad cold/flu.  All symptoms cleared within 24 hours.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: Severe muscle soreness - entire left arm, front of underarm and left front of chest.
Age: 50.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site.
Age: 1.06
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Lymphadenopathy, Rash
Clinical narrative: Got MMR (L thigh) and Varicella (R thigh) last week.  Got swelling in groin lymph nodes L>R for 5 days.  Yesterday red swelling on R thigh.  Little rash on arms by elbows but nowhere else.  No fevers.  Little less wet diapers but drinking and eating well.  No fevers. Happy, smiling and playful like normal.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Left arm quarter size red and warm induration.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Drooling, Erythema, Injection site erythema, Irritability, Pyrexia
Clinical narrative: Developed fever to 102.2 last 2 days - treated with Tylenol & Advil.  Red spot on L thigh where got vaccines for 2-3 days.  Red spot on face also that is less now.  No cough or runny nose.  No V or D.  Drooling more.  Appetite and energy level are good.  Little fussy with temp yesterday.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Pyrexia
Clinical narrative: Developed fever to 102.2 last 2 days - treated with Tylenol & Advil.  Red spot on L thigh where got vaccines for 2-3 days.  Red spot on face also that is less now.  No cough or runny nose.  No V or D.  Drooling more.  Appetite and energy level are good.  Little fussy with temp yesterday.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient developed oval red spot around site of injection measuring approximately 2x4 inches.
Age: 1.11
Sex: F
Vaccine: MMR, PPV
Symptoms: Decreased appetite, Pyrexia, Rash, Rash generalised, Rhinorrhoea
Clinical narrative: Runny nose, fever of 101.7, on 06/08/2013 rash appeared, loss of appetite and fever spike of 102.9 Saturday evening. Currently (06/10/2013) has a full body rash, still maintains loss of appetite.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Induration, Pruritus, Swelling
Clinical narrative: Itching swelling induration.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient developed an oval red spot around site of injection measuring approximately 2x4 inches.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient developed oval red spot around site of injection measuring approximately 2x4 inches.
Age: 72.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Injection site bruising, Pyrexia
Clinical narrative: High fever (102 degrees) and large bruise at site.
Age: 72.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Feeling abnormal, Injection site bruising, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: High fever (102 degrees) and large bruise at site.
Age: 72.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Pyrexia
Clinical narrative: High fever (102 degrees) and large bruise at site.
Age: 72.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Chest X-ray, Erythema, Face and mouth X-ray, Fatigue, Headache
Clinical narrative: High fever (102 degrees) and large bruise at site.
Age: 72.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Injection site nodule, Pyrexia, Skin warm, Urine analysis, Vomiting
Clinical narrative: High fever (102 degrees) and large bruise at site.
Age: 72.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: White blood cell count increased
Clinical narrative: High fever (102 degrees) and large bruise at site.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Rash erythematous, Vomiting
Clinical narrative: About 1 hour after receiving the HPV injection pt got a severe headache, vomited and developed red spots on his face. Symptoms lasted for about 2 hours.
Age: 1.81
Sex: M
Vaccine: DTAP, PNC
Symptoms: Grand mal convulsion, Lumbar puncture normal, Mental status changes, Nuclear magnetic resonance imaging normal, Toxicologic test normal
Clinical narrative: Altered mental status, later had generalized tonic/clonic seizures.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 5.5 x 6 cm round reddened, firm area on upper right thigh, warm to touch, but not hot. Pediarix given, was DTaP #3.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, pain to left lateral deltoid.
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Convulsion, Diarrhoea, Rotavirus infection, Rotavirus test positive
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of seizure in a child subject around 2 months of age of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline), PEDIARIX, PREVNAR (non-gsk) and PEDVAXHIB (non-gsk). On an unspecified date, around 2 months of age, the subject received 1st dose of ROTARIX (oral), 1st dose of PEDIARIX (unknown details), 1st dose of PREVNAR (unknown details), 1st dose of PEDVAXHIB (unknown details). On an unspecified date, around 4 months of age, the subject received 2nd dose of ROTARIX (oral), 2nd dose of PEDIARIX (unknown details), 2nd dose of PREVNAR (unknown details), 2nd dose of PEDVAXHIB (unknown details). It was not specified as to which vaccination was co-suspect to the events. No dates of administration were provided. The physician reported that the subject "got their normal schedule of pediatric vaccines (2, 4 months schedule)." The "second dose of ROTARIX was administered around 4 months of age." On an unspecified date and an unspecified time after vaccination with the 1st dose of ROTARIX, PEDIARIX, PEDVAXHIB, and PREVNAR, the subject experienced seizure. On an unspecified date, 4 days after vaccination with 2nd dose of ROTARIX, PEDIARIX, PEDVAXHIB, and PREVNAR, the subject experienced diarrhea and rotavirus infection. This case was assessed as medically serious by GSK. Relevant test results included a stool sample of the diarrhea. The "stool sample showed child was positive for rotavirus." At the time of reporting the outcome of the events was unspecified.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient developed a red streak 1" wide and 2" long in vicinity of shingles shot. It because itchy and faded over the course of 1 week.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Abdominal X-ray, Abdominal pain, Arthralgia, Pain, Vaginal haemorrhage
Clinical narrative: Presented to local ER with joint pain, severe abdominal pain, achiness, vaginal bleeding, no relief with OTC MIDOL.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: X-ray normal
Clinical narrative: Presented to local ER with joint pain, severe abdominal pain, achiness, vaginal bleeding, no relief with OTC MIDOL.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness, Visual impairment
Clinical narrative: After well visit, pt. received his 1st GARDASIL vaccine and in about 30 sec. after vaccine he had LOC for 5-10 seconds. No seizure activity. Recovered quickly, recalled shot, things "going black" and waking up.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse. On 29-APR-2013, multiple unspecified patients were vaccinated with GARDASIL (lot # H014645, exp. 27-MAR-2015). The nurse reported the dose of GARDASIL were exposed to 30.1 degrees fahrenheit for three hours, which was unsupported by stability data. No adverse effects reported. This is one of several cases received from same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse. On 30-APR-2013, multiple unspecified patients were vaccinated with VAQTA (lot # 0273AE exp. 06-DEC-2014 and lot # H012669, exp. 17-APR-2015). The nurse reported the dose of VAQTA were exposed to 30.1 degrees Fahrenheit for three hours, which was unsupported by stability data. No adverse effects reported. This is one of several cases received from same source. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site warmth
Clinical narrative: Varicella and MMR given and immediately red area observed approximately 6 cm circle on (R) thigh. Red area warm to touch. Given oral diphenhydramine and ibuprofen. Redness decreased within 30 min.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse. On 29-MAY-2013, multiple unspecified patient were vaccinated with GARDASIL (lot # H014645, exp. 27-MAR-2015) for prophylaxis. The nurse reported the dose of GARDASIL were exposed to 30.1 degrees Fahrenheit for three hours, which was unsupported by stability data. No adverse effects reported. This is one of several cases received from same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth, Oedema peripheral, Pyrexia
Clinical narrative: The patient arm had edema and fever. The site was red and warm to touch. Mom was instructed to give TYLENOL or MOTRIN for pain and edema. Also instructed to give BENADRYL for reaction. Instructed to call back if any other symptom or problems PRN.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: Fever of 103 degrees once after receiving shots. Fever reduced with infant TYLENOL.
Age: 1.02
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever for 5 days getting to over 102.0 degrees F. Rash. Began on day 4 s/p vaccinations.
Age: 0.37
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Unevaluable event
Clinical narrative: None reported.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Urticaria
Clinical narrative: Hives on bilat. arms, (L) cheek chest - CLARITIN given 15 min.
Age: 32.0
Sex: F
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: Pt. received vaccine at 0745 and returned at 0935 with hives located on her back. Pt was examined by Dr. and given oral BENADRYL and an EPIPEN to take home. Pt followed up next day w/ doctor and was fine.
Age: 2.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Rash
Clinical narrative: Rash, under arms, on chest.
Age: 1.03
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Local erythema, edema at sites of MMR and Varicella vaccines. MMR - right thigh; varicella - left thigh.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site rash, Injection site swelling
Clinical narrative: Patient presented w/ swollen rash at injection site. Pt. instructed to apply cold compresses and take BENADRYL. Pt. complained of mild discomfort. Pt. also instructed to contact MD.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain upper, Injection site erythema, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Redness and swelling 2" diameter appeared 6/8/13 getting smaller by 6/10/13 (L) thigh. Fever 99.8-100.1 started 6/8/13 and still present 6/10/2013. Nausea and stomach ache onset 6/9/13 and is present 6/10/2013.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash generalised
Clinical narrative: Bumps all over.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Biopsy gingival, Biopsy site unspecified abnormal, Fungal skin infection, Oral lichen planus
Clinical narrative: I am a retired RN and based on information available to me, I requested the vaccine. Hx of chix pox and and shingles x5 over 10 years. After vaccination have had 5 outbreaks. Severe skin yeast infection and an onset of the auto immune disease, lichen planus. Believe due to vac.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Biopsy gingival, Biopsy site unspecified abnormal, Fungal skin infection, Gingival bleeding, Laboratory test abnormal
Clinical narrative: I am a retired RN and based on information available to me, I requested the vaccine. Hx of chix pox and and shingles x5 over 10 years. After vaccination have had 5 outbreaks. Severe skin yeast infection and an onset of the auto immune disease, lichen planus. Believe due to vac.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Lichen planus, Urinary tract infection
Clinical narrative: I am a retired RN and based on information available to me, I requested the vaccine. Hx of chix pox and and shingles x5 over 10 years. After vaccination have had 5 outbreaks. Severe skin yeast infection and an onset of the auto immune disease, lichen planus. Believe due to vac.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Biopsy gingival, Condition aggravated, Fungal infection, Fungal skin infection, Fungal test positive
Clinical narrative: I am a retired RN and based on information available to me, I requested the vaccine. Hx of chix pox and and shingles x5 over 10 years. After vaccination have had 5 outbreaks. Severe skin yeast infection and an onset of the auto immune disease, lichen planus. Believe due to vac.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Gingival bleeding, Herpes zoster, Laboratory test abnormal, Oral lichen planus, Pain
Clinical narrative: I am a retired RN and based on information available to me, I requested the vaccine. Hx of chix pox and and shingles x5 over 10 years. After vaccination have had 5 outbreaks. Severe skin yeast infection and an onset of the auto immune disease, lichen planus. Believe due to vac.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Urinary tract infection fungal
Clinical narrative: I am a retired RN and based on information available to me, I requested the vaccine. Hx of chix pox and and shingles x5 over 10 years. After vaccination have had 5 outbreaks. Severe skin yeast infection and an onset of the auto immune disease, lichen planus. Believe due to vac.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Hives like rash few hours after vaccine given. Hives resolved w/in 30 minutes.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea, Irritability, Vomiting
Clinical narrative: Vomited twice 24 hrs post vaccination and then diarrhea for 1 month, (4 times a day). No fever. Also, more irritable and fussy during this time frame.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ
Symptoms: Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: Itching, warmth, edematous around injection site.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Local reaction
Clinical narrative: Itching, warmth, edematous around injection site.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pyrexia, Swelling
Clinical narrative: Pt developed a fever and swelling on 5/22 after receiving Tdap and MENACTRA.
Age: 81.0
Sex: M
Vaccine: UNK
Symptoms: Chest pain
Clinical narrative: Minor chest pain.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 4 1/2" x 3 1/4" erythema/firm red, warm Rt upper arm.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Recurring herpetic type rash on foot. No pain or pruritus, never had before.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Rash showed up on Sunday June 2nd. It gradually got bigger to the size of a salad plate, rash was on Rt. side from under breast to near umbilicus. It was slightly itchy.
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Full blood count normal, Nausea, Urine analysis normal
Clinical narrative: Nausea and diarrhea 10 mins after admin
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt received PENTACEL in (R) ant lat thigh. The next morning injection site was warm, raised and red 11 cm x 11 cm. Sharpie line drawn on perimeter. Resolved this morning.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis contact
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient with no medical history and no drug reactions/allergies. On 31-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot # J000429, Exp date as 10-APR-2014, 0.65 ml, subcutaneous. On an unspecified date in June 2013, "a few days later, she was working in her yard and developed a poison oak/ivy rash on her hands and lower arms". The pharmacist reported that the patient went to an unspecified physician who visually inspected  the rash ans stated "the rash was either poison oak or poison ivy" and the unspecified physician advised her to use "topical corticosteroid cream". No lab diagnostics studies were performed. VZVIP packet faxed. The outcome of poison oak/ivy rash on her hands and lower arms was reported as not recovered/not resolved. Additional information has been requested.
Age: 56.0
Sex: F
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 and gender. No medical history provided. On 23-MAY-2013 the patient was vaccinated with ZOSTAVAX (vial, lot# 0240AE, exp date 15-MAY-2013, subcutaneous). No concomitant medications were provided. The patient was administered an expired vaccine. The patient experienced no adverse effect. No outcome reported. Additional information has been requested.