chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Maternal exposure before pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: Information has been received from a 17 year old female patient, for  VARIVAX (Merck), a Pregnancy Registry product who on 28-DEC-2012 was vaccinated with VARIVAX (Merck) (therapy dose, route and site unknown). She had no relevant past medical history, relevant concomitant drugs or relevant past drug history. On 18-FEB-2011 she had a pregnancy test and she discovered that she was pregnant with an estimated due date of 23-NOV-2011. No other relevant laboratory testing had been performed. She would not receive any more VARIVAX (Merck) and she was currently not experiencing any adverse effects from this event. Addiitonal informaton is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients. The Licensed Practical Nurse reported that a medical office might had administered VARIVAX (Merck), which may have under went an unsupported excursion, to an unspecified number of patients. No adverse effects reported. At the time of report, the event outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: This spontaneous report was received from a registered nurse, who reported that she saw a report on the Internet (unspecified Internet sites) of unspecified patients, who on an unknown date were vaccinated with a dose of GARDASIL (Lot # not reported) (dose and route not reported). Concomitant medications were not reported. On an unknown date, the patients developed plantar warts after receiving GARDASIL. At the time of the report the outcome of the unspecified patient was unknown. This case is related with MARRS # 1307USA010279 and 1307USA012822. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: This spontaneous report as received from a registered nurse who was the patient's mother, refers to a 16 year old male patient (reporter's son), with no pertinent medical history or drug reaction allergies. On 14-JUN-2013 the patient was vaccinated with the first dose of GARDASIL (Lot # not reported) (dose and route not reported) since "the doctor recommended it". There was no concomitant medication. On 02-JUL-2013, reported as 2 and a half weeks after 14-JUN-2013, the patient developed a cluster of plantar warts broke out on his unspecified foot. The patient sought medical attention, went to a physician who burned/froze the plantar warts last week. Laboratory diagnostics studies were not performed. At the time of the report the patient's outcome was recovering. This case is related with MARRS 1207USA012821 and 1307USA012822. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Case number PHHY2013US044492, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 485610) web site on 06 May 2013 with the follow up received from the Quality Assurance Department (reference number: 227442) on 17 Jul 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M12010) and with BOOSTRIX (other manufacturer, batch number: AC52B090AA) both intramuscularly into the left arm on 25 Feb 2013. On same date he was also vaccinated with FLUZONE (other manufacturer, batch number: UH733A) and with GARDASIL (other manufacturer, batch number: H016960) both intramuscularly into the right arm. On 25 Feb 2013, he was dizzy and passed out. Outcome of event was reported as completely recovered on an unspecified date. The causality and seriousness of the events were not reported. Based on the document review, it was concluded that the concerned batch of MENVEO (batch number: M12010) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from the Quality Assurance Department on 17 Jul 2013: Updated batch review report.
Age: 65.0
Sex: F
Vaccine: PPV, TD, PPV
Symptoms: Chills, Erythema, Nausea, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 65 year old female patient with hypertension, mitral valve prolapse and contrast dye allergy. On 08-JUL-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # J004058, EXP 22-JUN-2014), 0.5 ml, intramuscular in the right deltoid. Concomitant therapies included lisinopril (manufacturer unknown), hydrochlorothiazide(manufacturer unknown), spironolactone, PRIMPERAN and chlordiazepoxide (manufacturer unknown). The patient developed shaking and chills, accompanied by body aches on the following day, 09-JUL-2013. The nurse was asking for a lot check for the lot that the patient received, J004058, EXP 22-JUN-2014. The patient was going to be seen by her attending physician on 10-JUL-2013. The outcome of the events was reported as not recovered/not resolved. Separate AE filed during the same call for the same PNEUMOVAX23 lot# J004058, in SR# 1-7745906978 (MARRS #1307USA006188). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, TD, PPV
Symptoms: Tremor
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 65 year old female patient with hypertension, mitral valve prolapse and contrast dye allergy. On 08-JUL-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # J004058, EXP 22-JUN-2014), 0.5 ml, intramuscular in the right deltoid. Concomitant therapies included lisinopril (manufacturer unknown), hydrochlorothiazide(manufacturer unknown), spironolactone, PRIMPERAN and chlordiazepoxide (manufacturer unknown). The patient developed shaking and chills, accompanied by body aches on the following day, 09-JUL-2013. The nurse was asking for a lot check for the lot that the patient received, J004058, EXP 22-JUN-2014. The patient was going to be seen by her attending physician on 10-JUL-2013. The outcome of the events was reported as not recovered/not resolved. Separate AE filed during the same call for the same PNEUMOVAX23 lot# J004058, in SR# 1-7745906978 (MARRS #1307USA006188). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, TD, PPV
Symptoms: Chills, Pain, Tremor
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 65 year old female patient with hypertension, mitral valve prolapse and contrast dye allergy. On 08-JUL-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # J004058, EXP 22-JUN-2014), 0.5 ml, intramuscular in the right deltoid. Concomitant therapies included lisinopril (manufacturer unknown), hydrochlorothiazide(manufacturer unknown), spironolactone, PRIMPERAN and chlordiazepoxide (manufacturer unknown). The patient developed shaking and chills, accompanied by body aches on the following day, 09-JUL-2013. The nurse was asking for a lot check for the lot that the patient received, J004058, EXP 22-JUN-2014. The patient was going to be seen by her attending physician on 10-JUL-2013. The outcome of the events was reported as not recovered/not resolved. Separate AE filed during the same call for the same PNEUMOVAX23 lot# J004058, in SR# 1-7745906978 (MARRS #1307USA006188). Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Headache, Injection site induration, Injection site swelling
Clinical narrative: This spontaneous report was received from an 63 year old female consumer reporting on herself. On an unspecified date the patient was vaccinated with one dose of ZOSTAVAX injection (lot number and route were not provided). Concomitant medications were not provided. On 16-JUL-2013 the patient experienced chills, nauseous feeling, rash on back of legs, slight headache and fever. Patient did not seek medical attention. The outcome of the events were not reported. The relationship between ZOSTAVAX and the events was not reported. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Malaise, Nausea, Pyrexia
Clinical narrative: This spontaneous report was received from an 63 year old female consumer reporting on herself. On an unspecified date the patient was vaccinated with one dose of ZOSTAVAX injection (lot number and route were not provided). Concomitant medications were not provided. On 16-JUL-2013 the patient experienced chills, nauseous feeling, rash on back of legs, slight headache and fever. Patient did not seek medical attention. The outcome of the events were not reported. The relationship between ZOSTAVAX and the events was not reported. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia, Rash
Clinical narrative: This spontaneous report was received from an 63 year old female consumer reporting on herself. On an unspecified date the patient was vaccinated with one dose of ZOSTAVAX injection (lot number and route were not provided). Concomitant medications were not provided. On 16-JUL-2013 the patient experienced chills, nauseous feeling, rash on back of legs, slight headache and fever. Patient did not seek medical attention. The outcome of the events were not reported. The relationship between ZOSTAVAX and the events was not reported. Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Axillary mass, Differential white blood cell count normal, Erythema, Injection site erythema, Lymph node pain
Clinical narrative: Arm was painful (8/10), redness noted to injection site, redness noted to front of shoulder very painful to move and redness to about middle of clavicle with a red raised lump on the clavicle; the next morning, red lump to left axilla lymph node, very painful (8/10) to touch.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Arm was painful (8/10), redness noted to injection site, redness noted to front of shoulder very painful to move and redness to about middle of clavicle with a red raised lump on the clavicle; the next morning, red lump to left axilla lymph node, very painful (8/10) to touch.
Age: 0.5
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from register nurse refers to a 6 month old patient gender unknown. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dose and route were not reported). Concomitant therapy was not reported. The patient was administered PNEUMOVAX23 instead of PREVNAR on an unspecified date. No adverse effects were reported. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a 14 year old female patient (physician's daughter). The physicians daughter fainted in the office of her unspecified treating pediatrician after having received the first shot in the GARDASIL (lot #, expiration date and route not reported) series on an unspecified date in July 2012 (last year). She received unspecified treatment for fainting. She remained dizzy for a week after having received this shot, and then she was fully recovered. It was not specified whether she sought medical attention for the dizziness. It was unspecified whether lab diagnostic tests were performed for the event. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients. Demographic information was not provided. The nurse reported that an unspecified number of patients were "probably" administered an improperly stored dose of ROTATEQ (lot number not provided). Dose, dose strength and therapy dates were not provided. The minimum temperature the ROTATEQ was exposed to was 31 degrees Fahrenheit for an unspecified number of hours and the maximum temperature the ROTATEQ was exposed to was 55 degrees Fahrenheit for an unspecified number of hours. No adverse effect was reported. This is one of multiple reports from the same source. Other case IDs 1307USA012447 and 1307USA013320. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients. Demographic information was not provided. The nurse reported that an unspecified number of patients were "probably" administered an improperly stored dose of M-M-R II (lot number not provided). Dose, dose strength and therapy dates were not provided. The minimum temperature the M-M-R II was exposed to was 31 degrees Fahrenheit for an unspecified number of hours and the maximum temperature the M-M-R II was exposed to was 55 degrees Fahrenheit for an unspecified number of hours. No adverse effect was reported. This is one of multiple reports from the same source. Other case IDs 1307USA012447 and 1307USA013319. 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 nurse refers to an unspecified number of patients. Demographic information was not provided. The nurse reported that an unspecified number of patients were "probably" administered an improperly stored dose of GARDASIL (lot number not provided). Dose, dose strength and therapy dates were not provided. The minimum temperature the GARDASIL was exposed to was 31 degrees Fahrenheit for an unspecified number of hours and the maximum temperature the GARDASIL was exposed to was 55 degrees Fahrenheit for an unspecified number of hours. No adverse effect was reported. This is one of multiple reports from the same source. Other case IDs 1307USA013319 and 1307USA013320. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a 24 year old female patient refers to herself. In 2007 the patient was vaccinated with 2 doses of GARDASIL, intramuscular for prevention of HIV. The patient stated that she had never completed the series. No adverse effect was reported. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Incorrect route of drug administration, Product reconstitution issue
Clinical narrative: This spontaneous report as received from an 81 year old male consumer refers to himself with no pertinent medical history or drug reactions/allergies. On 15-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported), intramuscularly (dose not reported). Concomitant therapies included metformin, LOTRIL, simvastatin (manufacturer unknown), omeprazole (manufacturer unknown) and aspirin. The patient reports that he developed stomach pains and diarrhea on an unspecified amount of hours afterwards on 15-JUL-2013. The patient reported that he was "certain" that the ZOSTAVAX was administered intramuscularly. He also reported that he did not see the nurse that administered the ZOSTAVAX to him "mix anything" with the ZOSTAVAX so he stated that he was missing a second part to the shot. There was no treatment given for the events. No lab diagnostics studies were performed. At the time of reporting, the outcome of stomach pains and diarrhea was reported as not resolved. The patient did not seek medical attention. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report as received from a 58 year old female patient refers to herself. Year half ago on an unknown date in 2012 the patient was vaccinated with ZOSTAVAX (one time injection, injection, lot# was not reported). Year half ago on an unknown date in 2012 the patient experienced a raised rash which comes and goes and is very itchy, the area on left arm does not tan. The patient did visit dermatologist who did not know how to treat condition. The outcome of a raised rash was reported as not recovered/resolved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye irritation, Iritis, Lacrimation increased, Ocular hyperaemia, Rash
Clinical narrative: This spontaneous report was received from an approximately 65 year old female registered nurse (patient) regarding herself. Current conditions of the patient included atrial fibrillation, colon polyps, gastritis and TALWIN allergy which caused her hallucinations. The medical history of the patient included hysterectomy and gallbladder removal. On 08-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant therapies included RYTHMOL (150 milligrams, three times per day), aspirin (325 milligrams, daily), chondroitin sulfate sodium, glucosamine sulfate (reported as glucosamine with chondroitin), vitamin D (unspecified), calcium (unspecified) and vitamins (unspecified) (reported as multivitamin). On 09-JUL-2013, the patient developed a rash which she specified as little red bumps that were located below her elbow and her forearm after receiving ZOSTAVAX. It was reported that the little red bumps itched but the itching went away on an unspecified date. It was reported that the little red bumps were dried up at the time of report and she was recovering (reported as almost recovered). On 13-JUL-2013, she developed tearing in both of her eyes, the right eye being worse than the left. She sought medical attention. She went to an unspecified optometrist on 15-JUL-2013 due to her right eye being irritated and red. Optometrist diagnosed her with iritis of the right eye and prescribed her PRED FORTE and cyclopentolate hydrochloride for her right eye. On 18-JUL-2013, she called her physician and notified him over the phone about her eye. She stated that she was scheduled to see the optometrist again on 22-JUL-2013. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report was received from an approximately 65 year old female registered nurse (patient) regarding herself. Current conditions of the patient included atrial fibrillation, colon polyps, gastritis and TALWIN allergy which caused her hallucinations. The medical history of the patient included hysterectomy and gallbladder removal. On 08-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant therapies included RYTHMOL (150 milligrams, three times per day), aspirin (325 milligrams, daily), chondroitin sulfate sodium, glucosamine sulfate (reported as glucosamine with chondroitin), vitamin D (unspecified), calcium (unspecified) and vitamins (unspecified) (reported as multivitamin). On 09-JUL-2013, the patient developed a rash which she specified as little red bumps that were located below her elbow and her forearm after receiving ZOSTAVAX. It was reported that the little red bumps itched but the itching went away on an unspecified date. It was reported that the little red bumps were dried up at the time of report and she was recovering (reported as almost recovered). On 13-JUL-2013, she developed tearing in both of her eyes, the right eye being worse than the left. She sought medical attention. She went to an unspecified optometrist on 15-JUL-2013 due to her right eye being irritated and red. Optometrist diagnosed her with iritis of the right eye and prescribed her PRED FORTE and cyclopentolate hydrochloride for her right eye. On 18-JUL-2013, she called her physician and notified him over the phone about her eye. She stated that she was scheduled to see the optometrist again on 22-JUL-2013. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 0.75
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of 9 month old. On 19-JUL-2013, the patient was vaccinated with a dose of 0.5 ml (milliliter) VAQTA (lot # H019104, expiry date 19-JUL-2015, route intramuscular). The patient received a dose of VAQTA before the patient was 12 months old and no adverse effect was reported. Additional information has been requested.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (manufacturer unknown) on 29-JUL-1992, the second dose of ENGERIX-B (manufacturer SmithKline Beecham) on 11-Sep-1992, and the third dose of hepatitis b vaccine (recombinant) (manufacturer unknown) on 27-APR-1993. The nurse reported that the patient had an anti-HBs concentrations of <5 mIU/mL after the primary vaccine series with Hepatitis B vaccine. No adverse event reported other than the low titer. The patient contacted office for medical attention. The outcome of anti-hbs concentrations of <5 mIU/ml (low titer) is unknown. Additional information is not expected.
Age: 0.8
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13
Symptoms: Crying, Rash papular
Clinical narrative: Parent, Father, reported child kept crying during the  night. Reported bumps on skin and worsening. No med given. Reported fever after vacciatnnion. P. Enc observe for signs of distress and to go to clinic. Enc. walk in for screening 07/25/13 to see MD. Enc TYLENOL for crying.
Age: 34.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Lip swelling, Local reaction, Urticaria
Clinical narrative: 2 vaccines given 7/15/13. 2nd dose first 4/30/13 Rt arm - VARIVAX - local reaction erythema 6 x 10 cm. 3 days after vaccine lips swelling - resolved. Urticaria - extremities onset 7/18/13.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site pruritus
Clinical narrative: 4 days after shot, site inflamed and very itchy. Recommended BENADRYL and have the Dr look at it. Dr felt it was due to her having shingles several times before.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient developed erythema, swelling, tenderness at site of vaccine administration.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a pharmacist concerning a patient who, on 19-APR-2013, was vaccinated with the first dose of GARDASIL, intramuscularly (dose and lot # not reported). It was reported that the patient would be administered the 2nd dose of GARDASIL, approximately one month later than what was specified in the prescribing information. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Mass, Rash
Clinical narrative: This spontaneous report as received from a other health professional refers to a 75 year old male patient. The patient's medical history included shingles on an unspecified date approximately on July 2012 (reported as last year). On 19-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J001005, expiration date and route not reported) in the left arm. On an unknown date in July 2013, the patient experienced rash and lump. The event resolved on an unknown date in July 2013. Causality was not reported. Additional information has been requested.
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Paralysis
Clinical narrative: This serious, medically confirmed report (initial receipt 09-JUL-2013) concerns a female patient who had a medical history of diabetes and unspecified drug reactions/allergies to CYMBALTA, DAYPRO, ZOLOFT. On an unspecified date, the patient received the swine flu vaccine (manufacturer and batch number not provided) as a  yearly flu shot. On an unspecified date, the patient developed temporary paralysis. Outcome was reported as recovered.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. Approximately one year ago in July 2012, the patient was vaccinated with the first dose of VARIVAX (dose, route and lot not reported) and required a second dose. No adverse effect reported. The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age. On 19-JUL-2013, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX (lot number 0151Z, expiry date 28-MAR-2011, route was subcutaneous). Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination, Nausea, Pyrexia, Radioallergosorbent test positive, Rash
Clinical narrative: The pt received oral Typhoid on 3/12/13. She delayed the first dose until 3/14/13 because she ahd a low grade fever (no other associated symptoms). She took the 3rd dose on 3/18/13 at 0700. At 0800 she noted a flat, red, itchy, "splotchy" rash (lesions were about 3mm) on her left arm (wrist to shoulder). She also noted nausea (no vomiting, or diarrhea) and throat "irritation" which she described as her throat "closing". This sensation laed to her feeling" which she described as her throat "closing". This sensation lead to her feeling the need to clear her throat frequently--she denied SOB or difficulty swallowing. The pt does not recall consuming any unusual foods or drink--in fact she has consumed the same food/drink since this time without similar symptoms. The pt does note that the rash is similar to the rash that she gets immediately after coming in contact with grass although this does not cause the sensation that her throat is closing. Also, the rash that she experiences after contact with grass typically occurs within 2 hours and resolves within 10-12 hours without treatment. The pt went to medical for evaluation of her symptoms and according to the pt she was told to increase her fluid intake which she did and the symptoms resolved within 48 hours. The pt was instructed not to take dose #4.
Age: 20.0
Sex: F
Vaccine: TYP
Symptoms: Rash erythematous, Rash macular, Rash pruritic, Skin lesion, Throat irritation
Clinical narrative: The pt received oral Typhoid on 3/12/13. She delayed the first dose until 3/14/13 because she ahd a low grade fever (no other associated symptoms). She took the 3rd dose on 3/18/13 at 0700. At 0800 she noted a flat, red, itchy, "splotchy" rash (lesions were about 3mm) on her left arm (wrist to shoulder). She also noted nausea (no vomiting, or diarrhea) and throat "irritation" which she described as her throat "closing". This sensation laed to her feeling" which she described as her throat "closing". This sensation lead to her feeling the need to clear her throat frequently--she denied SOB or difficulty swallowing. The pt does not recall consuming any unusual foods or drink--in fact she has consumed the same food/drink since this time without similar symptoms. The pt does note that the rash is similar to the rash that she gets immediately after coming in contact with grass although this does not cause the sensation that her throat is closing. Also, the rash that she experiences after contact with grass typically occurs within 2 hours and resolves within 10-12 hours without treatment. The pt went to medical for evaluation of her symptoms and according to the pt she was told to increase her fluid intake which she did and the symptoms resolved within 48 hours. The pt was instructed not to take dose #4.
Age: 20.0
Sex: F
Vaccine: TYP
Symptoms: Throat tightness
Clinical narrative: The pt received oral Typhoid on 3/12/13. She delayed the first dose until 3/14/13 because she ahd a low grade fever (no other associated symptoms). She took the 3rd dose on 3/18/13 at 0700. At 0800 she noted a flat, red, itchy, "splotchy" rash (lesions were about 3mm) on her left arm (wrist to shoulder). She also noted nausea (no vomiting, or diarrhea) and throat "irritation" which she described as her throat "closing". This sensation laed to her feeling" which she described as her throat "closing". This sensation lead to her feeling the need to clear her throat frequently--she denied SOB or difficulty swallowing. The pt does not recall consuming any unusual foods or drink--in fact she has consumed the same food/drink since this time without similar symptoms. The pt does note that the rash is similar to the rash that she gets immediately after coming in contact with grass although this does not cause the sensation that her throat is closing. Also, the rash that she experiences after contact with grass typically occurs within 2 hours and resolves within 10-12 hours without treatment. The pt went to medical for evaluation of her symptoms and according to the pt she was told to increase her fluid intake which she did and the symptoms resolved within 48 hours. The pt was instructed not to take dose #4.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Blood creatine phosphokinase increased, Lymphadenopathy, Myalgia
Clinical narrative: MUSCLE ACHES, SWELLING NODES, ELEVATED CK.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR
Symptoms: Allergy test, Blood test, Eye pruritus, Feeling abnormal, Rash
Clinical narrative: Rash all over face and body; eyes itchy; drowsy; spacing out.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR
Symptoms: Rash generalised, Somnolence, Streptococcus test
Clinical narrative: Rash all over face and body; eyes itchy; drowsy; spacing out.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Enema administration, Haematochezia, Hypophagia, Imaging procedure, Intussusception
Clinical narrative: Awoke on 7/23/13 with fussiness, poor PO intake and began vomiting.  Had blood flecks in stool in evening.  Was seen in ER and diagnosed with intussusception that was reduced with an air enema.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Laboratory test abnormal, Vomiting
Clinical narrative: Awoke on 7/23/13 with fussiness, poor PO intake and began vomiting.  Had blood flecks in stool in evening.  Was seen in ER and diagnosed with intussusception that was reduced with an air enema.
Age: 75.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Burning sensation, Oedema peripheral, Pruritus
Clinical narrative: Pt. c/o waking up with burning, itching, and swelling to the extremitiy in which the vaccination was received.
Age: 75.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Burning sensation, Erythema, Local swelling, Middle insomnia, Pruritus
Clinical narrative: Pt. c/o waking up with burning, itching, and swelling to the extremitiy in which the vaccination was received.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (L) arm redness and swelling underneath injection site. Advised to take CLARITIN during day and BENADRYL at nights along with hydrocortisone for itchiness per Dr.
Age: 24.0
Sex: F
Vaccine: PPV, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site urticaria, Pyrexia
Clinical narrative: Woke up in morning and noticed burning pain to shot area and quarter size "hive" type red area. Red area slowly got bigger on 7/16 and 7/17 and ran a fever (101.6) approx 3:00 am and went to Emergency Department. Was told to take Benadryl and Ibuprofen. The fever over 101 lasted from 7/17 to 7/19. Friday morning went to Dr. and was prescribed an antibiotic normally used for treating staph. Reaction at shot site was approx 100mm wide and 95mm in length with induration and redness. On 7/24 shot area is faded and some induration remains approx 45 mm wide and 45mm length.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Mass, Skin warm
Clinical narrative: Pt came in the pharmacy concerned she felt a small lump on the back of her left arm where she received her vaccine. Upon examination is was red, inflamed (size of lemon) and warm. Her doctor was called who informed her to come in so they could look at it. Cephalexin was prescribed and OTC Ibuprofen.
Age: 44.0
Sex: M
Vaccine: TYP
Symptoms: Back pain, Blood calcium normal, Blood thyroid stimulating hormone normal, Chills, Computerised tomogram head normal
Clinical narrative: 48 year old patient reported receipt of routine typhoid Vi (#5 and lot # not documented) on 2/11/2011 to left arm. He remembers having a frontal 3/10 dull headache <24 hours later that progress to 6/10 headache within 72 hours that encircled his head and "flu like symptoms" -malaise and increaing fatigue. On 2/14/2011 he reported to medical complaining of generalized malaise and body aches (neck, back) x 3 days. He advise medical he felt "run down 7 days ago, recovered 5 days ago, then worse after typhoid shot". He denied any fever, sweats, chills, photo/phonophobia, neck rigidity, gait imbalance, rash, breathing difficulty or any other systemic complaints. The  provider documented he looked uncomfortable, pale and tired, temp 97.2F, normal vitals and exam (including neuro). He was diagnosed with generalized malaise of viral etiology (mono, viral syndrome, dehydration) and adverse reaction to typhoid immunization. Labs for TSH, CBC, mon, UA, BMP were all normal and he was rehydrated with 1000 mL normal saline, given 30 mg TORADOL IM, and prescription for Naproxyn 500 mg twice a day and oral TORADOL. A VAERS was filed by this provider (2/14/2011). On 2/15/2011 he advised his headache worsened (6/10) and he began to experience chills and a stiff neck. His wife transported him to emergency department where he advised his initial headache began 6 days ago (2/9/2013) and resolved 2/13/2013 only to return on 2/14/2013 after receipt of typhoid vaccine as a generalized headache with back pain, neck stiffness and nausea. Repeat labs 2/15/2013 showed normal CBC, BMP, Calciusm, and CT head w/o contrast. His physical exam was normal (including neuro). He was diagnosed with a headache secondary to typhoid vaccination and treated with IV DILAUDID, PHENERGAN and TORADOL with easing of headache (4/10). He was discharged with prescriptions for VICODIN, and PHENERGAN. Providers advised patient to return for spinal tap if headache did not improve or symptoms worsened. He followed up with ships medical on 2/16/2012 advising symptoms were improving. He advised his headaches completely resolved about one week later without reoccurrence as of 2013. Patient reported no adverse reactions following 2011 and 2012 flu vaccines. On 7/10/2013, patient was sent to clinic for clearance on headache after receipt of 2011 typhoid vaccine.
Age: 44.0
Sex: M
Vaccine: TYP
Symptoms: Fatigue, Feeling abnormal, Full blood count normal, Headache, Influenza like illness
Clinical narrative: 48 year old patient reported receipt of routine typhoid Vi (#5 and lot # not documented) on 2/11/2011 to left arm. He remembers having a frontal 3/10 dull headache <24 hours later that progress to 6/10 headache within 72 hours that encircled his head and "flu like symptoms" -malaise and increaing fatigue. On 2/14/2011 he reported to medical complaining of generalized malaise and body aches (neck, back) x 3 days. He advise medical he felt "run down 7 days ago, recovered 5 days ago, then worse after typhoid shot". He denied any fever, sweats, chills, photo/phonophobia, neck rigidity, gait imbalance, rash, breathing difficulty or any other systemic complaints. The  provider documented he looked uncomfortable, pale and tired, temp 97.2F, normal vitals and exam (including neuro). He was diagnosed with generalized malaise of viral etiology (mono, viral syndrome, dehydration) and adverse reaction to typhoid immunization. Labs for TSH, CBC, mon, UA, BMP were all normal and he was rehydrated with 1000 mL normal saline, given 30 mg TORADOL IM, and prescription for Naproxyn 500 mg twice a day and oral TORADOL. A VAERS was filed by this provider (2/14/2011). On 2/15/2011 he advised his headache worsened (6/10) and he began to experience chills and a stiff neck. His wife transported him to emergency department where he advised his initial headache began 6 days ago (2/9/2013) and resolved 2/13/2013 only to return on 2/14/2013 after receipt of typhoid vaccine as a generalized headache with back pain, neck stiffness and nausea. Repeat labs 2/15/2013 showed normal CBC, BMP, Calciusm, and CT head w/o contrast. His physical exam was normal (including neuro). He was diagnosed with a headache secondary to typhoid vaccination and treated with IV DILAUDID, PHENERGAN and TORADOL with easing of headache (4/10). He was discharged with prescriptions for VICODIN, and PHENERGAN. Providers advised patient to return for spinal tap if headache did not improve or symptoms worsened. He followed up with ships medical on 2/16/2012 advising symptoms were improving. He advised his headaches completely resolved about one week later without reoccurrence as of 2013. Patient reported no adverse reactions following 2011 and 2012 flu vaccines. On 7/10/2013, patient was sent to clinic for clearance on headache after receipt of 2011 typhoid vaccine.
Age: 44.0
Sex: M
Vaccine: TYP
Symptoms: Malaise, Metabolic function test normal, Mononucleosis heterophile test negative, Musculoskeletal stiffness, Nausea
Clinical narrative: 48 year old patient reported receipt of routine typhoid Vi (#5 and lot # not documented) on 2/11/2011 to left arm. He remembers having a frontal 3/10 dull headache <24 hours later that progress to 6/10 headache within 72 hours that encircled his head and "flu like symptoms" -malaise and increaing fatigue. On 2/14/2011 he reported to medical complaining of generalized malaise and body aches (neck, back) x 3 days. He advise medical he felt "run down 7 days ago, recovered 5 days ago, then worse after typhoid shot". He denied any fever, sweats, chills, photo/phonophobia, neck rigidity, gait imbalance, rash, breathing difficulty or any other systemic complaints. The  provider documented he looked uncomfortable, pale and tired, temp 97.2F, normal vitals and exam (including neuro). He was diagnosed with generalized malaise of viral etiology (mono, viral syndrome, dehydration) and adverse reaction to typhoid immunization. Labs for TSH, CBC, mon, UA, BMP were all normal and he was rehydrated with 1000 mL normal saline, given 30 mg TORADOL IM, and prescription for Naproxyn 500 mg twice a day and oral TORADOL. A VAERS was filed by this provider (2/14/2011). On 2/15/2011 he advised his headache worsened (6/10) and he began to experience chills and a stiff neck. His wife transported him to emergency department where he advised his initial headache began 6 days ago (2/9/2013) and resolved 2/13/2013 only to return on 2/14/2013 after receipt of typhoid vaccine as a generalized headache with back pain, neck stiffness and nausea. Repeat labs 2/15/2013 showed normal CBC, BMP, Calciusm, and CT head w/o contrast. His physical exam was normal (including neuro). He was diagnosed with a headache secondary to typhoid vaccination and treated with IV DILAUDID, PHENERGAN and TORADOL with easing of headache (4/10). He was discharged with prescriptions for VICODIN, and PHENERGAN. Providers advised patient to return for spinal tap if headache did not improve or symptoms worsened. He followed up with ships medical on 2/16/2012 advising symptoms were improving. He advised his headaches completely resolved about one week later without reoccurrence as of 2013. Patient reported no adverse reactions following 2011 and 2012 flu vaccines. On 7/10/2013, patient was sent to clinic for clearance on headache after receipt of 2011 typhoid vaccine.
Age: 44.0
Sex: M
Vaccine: TYP
Symptoms: Neurological examination normal, Pain, Pallor, Urine analysis normal
Clinical narrative: 48 year old patient reported receipt of routine typhoid Vi (#5 and lot # not documented) on 2/11/2011 to left arm. He remembers having a frontal 3/10 dull headache <24 hours later that progress to 6/10 headache within 72 hours that encircled his head and "flu like symptoms" -malaise and increaing fatigue. On 2/14/2011 he reported to medical complaining of generalized malaise and body aches (neck, back) x 3 days. He advise medical he felt "run down 7 days ago, recovered 5 days ago, then worse after typhoid shot". He denied any fever, sweats, chills, photo/phonophobia, neck rigidity, gait imbalance, rash, breathing difficulty or any other systemic complaints. The  provider documented he looked uncomfortable, pale and tired, temp 97.2F, normal vitals and exam (including neuro). He was diagnosed with generalized malaise of viral etiology (mono, viral syndrome, dehydration) and adverse reaction to typhoid immunization. Labs for TSH, CBC, mon, UA, BMP were all normal and he was rehydrated with 1000 mL normal saline, given 30 mg TORADOL IM, and prescription for Naproxyn 500 mg twice a day and oral TORADOL. A VAERS was filed by this provider (2/14/2011). On 2/15/2011 he advised his headache worsened (6/10) and he began to experience chills and a stiff neck. His wife transported him to emergency department where he advised his initial headache began 6 days ago (2/9/2013) and resolved 2/13/2013 only to return on 2/14/2013 after receipt of typhoid vaccine as a generalized headache with back pain, neck stiffness and nausea. Repeat labs 2/15/2013 showed normal CBC, BMP, Calciusm, and CT head w/o contrast. His physical exam was normal (including neuro). He was diagnosed with a headache secondary to typhoid vaccination and treated with IV DILAUDID, PHENERGAN and TORADOL with easing of headache (4/10). He was discharged with prescriptions for VICODIN, and PHENERGAN. Providers advised patient to return for spinal tap if headache did not improve or symptoms worsened. He followed up with ships medical on 2/16/2012 advising symptoms were improving. He advised his headaches completely resolved about one week later without reoccurrence as of 2013. Patient reported no adverse reactions following 2011 and 2012 flu vaccines. On 7/10/2013, patient was sent to clinic for clearance on headache after receipt of 2011 typhoid vaccine.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Swelling
Clinical narrative: Patient developed a rash at the point of injection.  At worst point, rash reached 3 inches across.  She said there was also swelling associated with reaction.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site streaking, Injection site swelling, Injection site warmth
Clinical narrative: Patient had swelling over the next few days from injection that progressed to swelling 3 inches in all directions around injection site. There was also obvious streaking and warmth at the site. Patient visited physician and was diagnosed with cellulitis and given medications.
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS, VARZOS
Symptoms: Erythema, Injection site warmth, Malaise, Pain, Swelling
Clinical narrative: Patient complained of "feeling ill", had pain, area of redness and swelling 7mm x5mm. Site felt very hot.
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS, VARZOS
Symptoms: Feeling abnormal, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient complained of "feeling ill", had pain, area of redness and swelling 7mm x5mm. Site felt very hot.
Age: 13.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Incoherent, Moaning, Pallor, Tremor
Clinical narrative: Skin pallor.  Patient starts to moan after immunizations administered.  Patient is incoherent for short period of time.  Legs and arms start to shake uncontrollably for 12 seconds.
Age: 50.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Localized soreness, redness around injection site.
Age: 8.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: When I gave the Hep A vaccine, there was resistance so I withdrew the needle while only delivering half the dose.
Age: 16.0
Sex: F
Vaccine: HPV4, IPV, MNQ, HPV4, IPV, MNQ
Symptoms: Blood creatinine increased, Face oedema, Feeling abnormal, Oropharyngeal pain, Pharyngeal oedema
Clinical narrative: Patient presented to the ER - feeling weird - throat hurt and felt swollen.  Facial edema.  Patient given Benadryl 50mg IV, Duoneb, Epi x2, Pepcid 20mg IV, Solumedrol 125mg IV.  Labs were drawn in ER and she was kept in overnight as an observation patient.
Age: 16.0
Sex: F
Vaccine: HPV4, IPV, MNQ, HPV4, IPV, MNQ
Symptoms: Blood creatinine increased, Blood test, Face oedema, Feeling abnormal, Oropharyngeal pain
Clinical narrative: Patient presented to the ER - feeling weird - throat hurt and felt swollen.  Facial edema.  Patient given Benadryl 50mg IV, Duoneb, Epi x2, Pepcid 20mg IV, Solumedrol 125mg IV.  Labs were drawn in ER and she was kept in overnight as an observation patient.
Age: 16.0
Sex: F
Vaccine: HPV4, IPV, MNQ, HPV4, IPV, MNQ
Symptoms: Pharyngeal oedema
Clinical narrative: Patient presented to the ER - feeling weird - throat hurt and felt swollen.  Facial edema.  Patient given Benadryl 50mg IV, Duoneb, Epi x2, Pepcid 20mg IV, Solumedrol 125mg IV.  Labs were drawn in ER and she was kept in overnight as an observation patient.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Computerised tomogram, Cough, Headache, Immediate post-injection reaction
Clinical narrative: Lot of pain at injection site immediately after the IM Flu shot in upper arm. Around 11/25/2012, severe flu like syndrome developed with low grade fever, cough, cold, running nose, body-ache and headache.  It lasted for two weeks. Gradual development of intense pain in right shoulder and arm and restriction of movements of right arm and shoulder akin to frozen shoulder from 11/15/2012 until 07/24/2013. Extreme pain and disability and weakness of the arm persists.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Injected limb mobility decreased, Injection site pain, Muscular weakness, Nasopharyngitis
Clinical narrative: Lot of pain at injection site immediately after the IM Flu shot in upper arm. Around 11/25/2012, severe flu like syndrome developed with low grade fever, cough, cold, running nose, body-ache and headache.  It lasted for two weeks. Gradual development of intense pain in right shoulder and arm and restriction of movements of right arm and shoulder akin to frozen shoulder from 11/15/2012 until 07/24/2013. Extreme pain and disability and weakness of the arm persists.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain, Pyrexia, Rhinorrhoea, X-ray
Clinical narrative: Lot of pain at injection site immediately after the IM Flu shot in upper arm. Around 11/25/2012, severe flu like syndrome developed with low grade fever, cough, cold, running nose, body-ache and headache.  It lasted for two weeks. Gradual development of intense pain in right shoulder and arm and restriction of movements of right arm and shoulder akin to frozen shoulder from 11/15/2012 until 07/24/2013. Extreme pain and disability and weakness of the arm persists.