chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Feeling hot, Injection site erythema
Clinical narrative: 7 hrs after injection redness and warmth developed, no pain, redness is 8 x 9 cm oral on (L) upper/outer arm on day.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Local swelling
Clinical narrative: Localized swelling and erythema at injection itch of arms & legs.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Patient phoned to say had a rxn size of silver dollar at injection site. Instructed her to see dr. Patient came in and had rx for ALLEGRA & Triamcinolone cream and also stated dr gave her a steroid shot. Pt stated she had no fever.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at site of injection; KEFLEX for 7 days & warm compress.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Development of mild disease from a live vaccine. Redness and tenderness at injection site. Warm to touch. No fever. Spots appearing on torso and arms. Referred to Personal Physician for definitive diagnosis.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt received vaccine 7/10/12 & came in 7/12/12 with redness around injection site (a few inches in diameter). Area was also swollen & hot to touch. Recommended she go to urgent care to rule out cellulitis. Pt received antibiotic - followed up with her 7/18 & her arm was clearing up.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt received vaccine 7/10/12 & came in 7/12/12 with redness around injection site (a few inches in diameter). Area was also swollen & hot to touch. Recommended she go to urgent care to rule out cellulitis. Pt received antibiotic - followed up with her 7/18 & her arm was clearing up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Tenderness, Wound complication, Wound infection
Clinical narrative: Wound infect 7x10cm. Erythematous, warm, tender.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Swollen tongue
Clinical narrative: Swollen tongue 1 hr later went to ER.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Convulsion, Fall, Fatigue, Loss of consciousness, Muscle twitching
Clinical narrative: Within 30 seconds of giving HPV child was sitting, fell back, neck turned to (R) and had rhythmic twitching of neck, head and (L) arm. After 15-20 seconds, child woke and asked what happened and c/o being very tired. Child monitored for 1 hour with continued tiredness but no more sz activity.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Posture abnormal
Clinical narrative: Within 30 seconds of giving HPV child was sitting, fell back, neck turned to (R) and had rhythmic twitching of neck, head and (L) arm. After 15-20 seconds, child woke and asked what happened and c/o being very tired. Child monitored for 1 hour with continued tiredness but no more sz activity.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling, Rash
Clinical narrative: Received a call from patient's mother stating patient had rash from neck down to arms area of injection swollen and no fevers.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Mobility decreased, Pain in extremity
Clinical narrative: Patient said that she had a lot of pain in her arm, can not move her arm, not feeling good.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient presented with flat red rash, approximately 1 1/2 inches in diameter on upper, left arm (tricep area). Patient did not complain of pain, itch, or bump under skin. Approved 3 days after vaccination.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Swelling and itching at injection site.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Patient described injection site as being hot and having a knot under the skin and redness being present in area. Took ibuprofen.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pruritus, Injection site rash, Sleep disorder
Clinical narrative: Patient describes pain in right hip the night 7/26/12 until following day to the point she could not sleep on side. Also, patient experienced rash in area of injection and itching.
Age: 1.03
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Erythema, Skin lesion
Clinical narrative: Pencil eraser size erythematous scattered lesions on face, legs, arms and trunk. No central punctae.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 11 years old female patient. The patient was vaccinated with dose 1 GARDASIL (Lot #, dose ad route not reported) on 12-JUL-2011. The patient received dose 2 GARDASIL (Lot #, dose ad route not reported) on 06-JUN-2012. The patient received dose 3 GARDASIL (Lot #, dose ad route not reported) on 02-MAR-2012, less than 4 weeks after the second dose. No other co-suspects were reported. No concomitant medications were reported. Medical assistant stated that the patient had not experienced any adverse effects. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site swelling
Clinical narrative: This spontaneous report as received from a Registered Pharmacist concerning a 65 years old male patient who had a little subcutaneous fat and very taught skin was vaccinated with ZOSTAVAX (Dose, route and lot # not reported) on 17-JUL-2012, the pharmacist stated that when he was trying to administer ZOSTAVAX subcutaneously an unknown amount of vaccine went "into and under the skin". No other co-suspects were reported. No concomitant medications were reported. The pharmacist described that on 17-JUL-2012 the patient developed a raised area the size of nickel at the injection site. No treatment information was reported. The outcome of patient developed a raised area the size of nickel at the injection site was reported as not recovered/not resolved. The patient sought medical attention "Happened in pharmacy". The relatedness for patient developed a raised area the size of nickel at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a patient of unknown age. The patient was vaccinated with the first dose of (Merck) VARIVAX (Lot #, dose and route not reported) in 2008. The patient received the second dose of (Merck) VARIVAX (Lot #, dose and route not reported) in 2012, 4 years after the first dose. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were 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 Registered Nurse who reported that unknown number of patients were vaccinated on unknown date with improperly stored (32 degrees F for 24 hours) dose of oral ROTATEQ. (Batches # 0059AE, Expiry date 23-SEP-2013 and 1710AA, Expiry date 11-JUL-2013), (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. No treatment was reported. No adverse effects were reported. This is one of two reports received from the same source. 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 Registered Nurse who reported that unknown number of patients were vaccinated with an improperly dose (47-48 deg F for 72 hours) of MMR II, (lot# 669840/0446AA, Exp 28-MAR-2013), (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Retching, Underdose, Vomiting
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 4 months old male patient with no pertinent medical history, drug reactions or allergies. The patient was vaccinated orally with (lot # 1673AA) dose 1 of ROTATEQ on 01-MAY-2012 (dose not reported) and was vaccinated orally with dose 2 of ROTATEQ on 17-JUL-2012 (lot number and dose not reported). No other co-suspects were reported. There was no concomitant medications. The medical assistant reported that on 19-JUL-2012 the patient began to gag and then vomited. The patient only received a partial dose. The patient did not seek medical attention and no lab diagnostic tests were performed. No treatment was given for the reported events. The patient recovered from the urge to gag and vomit on 19-JUL-2012. The relatedness for began to gag and vomited was not provided for ROTATEQ. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of unknown age who on an unspecified date, one year ago in 2011, was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL and on 19-JUL-2012, was vaccinated with the second 0.5 ml dose of GARDASIL (lot number not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician's assistant refers to patients ages 1 thru 4. The patients were vaccinated with a dose of (Merck) VARIVAX (Lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The physician's assistant reported that he had seen an increase in chicken pox in children age 1 thru 4 who had been vaccinated with (Merck) VARIVAX. The physician's assistant also was seeing natural shingles on the rise in patients. The shingles were not due to any vaccinations. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: This spontaneous report as received from a registered nurse refers to an about 22 years old female patient. The patient was vaccinated with dose 3 GARDASIL (Lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The nurse reported that the patient, a friend of her daughter, recently got all 3 doses of GARDASIL and on 11-JUL-2012, "about a week ago", was diagnosed with human papilloma virus infection. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a consumer concerning her currently 26 year old daughter with penicillin allergy who on an unspecified date was vaccinated with a dose of GARDASIL (site, dose and lot# not reported). The patient's mother reported that her daughter had "lost about 1/4 of her hair amount, mostly at the crown", after receiving the second dose of GARDASIL. At the time of the report, the patient was recovering. The patient did not seek medical attention. The relationship between GARDASIL and the adverse event was unknown. No further information is available.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Fall, Fatigue, Head injury, Headache, Loss of consciousness
Clinical narrative: Information has been received from a registered nurse concerning a female patient (age not reported), (patient was not in pregnant) with none pertinent medical history and none drug reactions/allergies who on 04-MAY-2012, was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (lot # 672233/1561AA), (exp. date 28-AUG-2014). There was no concomitant medication. On 05-MAY-2012, the patient experienced an episode of syncope. On the morning of 05-MAY-2012, the patient's mother called the office and reported patient experienced syncope and hit her head and fell. After the fall, patient's mother described her daughter as "she was shaking with her arm pulled up for about 2 minutes and she was unconscious". After about 2 minutes, patient was better and shaking stopped but she did not remember what happened. After the syncope incident, patient continued to have headaches and fatigue. The patient sought medical attention via doctor office visit. No treatment was given for adverse events. No lab diagnostic studies were performed. At the time of the report the patient's status was not recovered. Follow up information has been received from registered nurse, initial reporter, concerning the 15 year old female patient with none pre-existing allergies, birth defects and medical conditions who on 04-MAY-2012 was vaccinated intramuscularly in right arm with a first dose of GARDASIL (lot # 672233/1561AA). Secondary suspect therapy included VAQTA (received intramuscularly in left arm), (dose not reported), (lot #672470/1697AA). On 05-MAY-20112 the patient experienced body shaking, patient felt tired, was standing syncope (1 minute) not rhythmic, fell, hit head on door, and for next 3 days was "very" fatigued and had headaches. The patient required doctor visit. No lab diagnostic test were performed. At the time of the report the patient's status was recovered. No further information is available.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Posture abnormal, Syncope, Tremor
Clinical narrative: Information has been received from a registered nurse concerning a female patient (age not reported), (patient was not in pregnant) with none pertinent medical history and none drug reactions/allergies who on 04-MAY-2012, was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (lot # 672233/1561AA), (exp. date 28-AUG-2014). There was no concomitant medication. On 05-MAY-2012, the patient experienced an episode of syncope. On the morning of 05-MAY-2012, the patient's mother called the office and reported patient experienced syncope and hit her head and fell. After the fall, patient's mother described her daughter as "she was shaking with her arm pulled up for about 2 minutes and she was unconscious". After about 2 minutes, patient was better and shaking stopped but she did not remember what happened. After the syncope incident, patient continued to have headaches and fatigue. The patient sought medical attention via doctor office visit. No treatment was given for adverse events. No lab diagnostic studies were performed. At the time of the report the patient's status was not recovered. Follow up information has been received from registered nurse, initial reporter, concerning the 15 year old female patient with none pre-existing allergies, birth defects and medical conditions who on 04-MAY-2012 was vaccinated intramuscularly in right arm with a first dose of GARDASIL (lot # 672233/1561AA). Secondary suspect therapy included VAQTA (received intramuscularly in left arm), (dose not reported), (lot #672470/1697AA). On 05-MAY-20112 the patient experienced body shaking, patient felt tired, was standing syncope (1 minute) not rhythmic, fell, hit head on door, and for next 3 days was "very" fatigued and had headaches. The patient required doctor visit. No lab diagnostic test were performed. At the time of the report the patient's status was recovered. No further information is available.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient was vaccinated with the first dose of MMR II (lot #, dose and route not reported) on 02-JUN-2009. On 05-JUL-2012, the patient received the second dose of MMR II (lot #, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. Medical assistant reported that the second dose received was expired. No symptoms were reported. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Paraesthesia
Clinical narrative: This spontaneous report as received from a 80 years old male consumer reporting on himself with no drug reactions or allergies and a history of defibrillator and a pacemaker, who on 16-JUL-2012, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. Concomitant medications included COREG and Ramipril (manufacturer unspecified). The consumer reported that on 16-JUL-2012, his feet, hands and ankles began tingling and became warm. No treatment was given for the experience. No lab diagnostics studies were performed. At the time of the report, the consumer had not recovered. The consumer did not seek medical attention. The relatedness for feet, hands and ankles began tingling and became warm was unknown for ZOSTAVAX. Additional information is not expected.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 71 years old male patient. The patient was vaccinated intramuscularly on right deltoid with 0.5 ml expired PNEUMOVAX 23 (lot # 667269/113Z, expiration date 10-DEC-2011) on 20-JUL-2012. No adverse effects reported at the time of the report. It was unspecified whether the patient had sought medical attention. Additional information has been requested.
Sex: U
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. It was reported "a patient received first and second dose of GARDASIL (lot # was not reported) 4 years ago in 2008, the patient is in the office today on 16-JUL-2012 for the third dose". No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age who on 20-JUN-2011 was vaccinated with the first dose of GARDASIL (lot number not reported). Physician mentioned "a patient was received the 2nd dose of GARDASIL (lot # is unknown) early on 08-AUG-2011, and the 3rd dose of GARDASIL (lot # is unknown) late on 14-JUL-2012". "The patient is not experiencing any known symptom". No treatment information was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with one dose of 0.65 ml ZOSTAVAX (lot number 672429/1606AA< expiration date 13-JAN-2013) (expiration date 30-APR-2012 as reported) subcutaneously on 16-MAY-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Eye swelling, Eyelid oedema, Headache, Herpes zoster
Clinical narrative: Information has been received concerning a 64 year old female consumer who in October 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (site, dose and lot # not provided). It was reported that 2 weeks after receiving the ZOSTAVAX (Merck), the consumer developed shingles. She underwent antiviral therapy for the shingles episode and no specific drug names, doses and frequencies were given. The consumer stated that the episode of shingles was mild in nature. She had also recently developed some styes around her eyes and was not sure if this had anything to do with ZOSTAVAX (Merck). The consumer was planning to see an ophthalmologist in regards to the styes but had not seen them as of today's call. At the time of the report, the patient's outcome was unknown. The patient sought medical attention. At the time of the report, the patient's outcome was unknown. Follow up information of has been received from a physician refers to a 64 years old female patient. The patient was vaccinated with ZOSTAVAX (lot number 06962) subcutaneously on 07-SEP-2010(in October 2010 as previously reported). Concomitant medications included TRILEPTAL. On 15-SEP-2010 the patient experienced ocular shingles and was seen in system headache pain, left eye and lid swelling. Perhaps blister note left forehead. STATICIN and FLUMADINE (5 mg, oral, qd*7d, from 15-SEP-2010 to 23-SEP-2010, antivirus) were given as treatment for the events. The patient saw ophthalmologist as well. The outcome was reported as recovered/resolved on 1-OCT-2010. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster ophthalmic, Hordeolum
Clinical narrative: Information has been received concerning a 64 year old female consumer who in October 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (site, dose and lot # not provided). It was reported that 2 weeks after receiving the ZOSTAVAX (Merck), the consumer developed shingles. She underwent antiviral therapy for the shingles episode and no specific drug names, doses and frequencies were given. The consumer stated that the episode of shingles was mild in nature. She had also recently developed some styes around her eyes and was not sure if this had anything to do with ZOSTAVAX (Merck). The consumer was planning to see an ophthalmologist in regards to the styes but had not seen them as of today's call. At the time of the report, the patient's outcome was unknown. The patient sought medical attention. At the time of the report, the patient's outcome was unknown. Follow up information of has been received from a physician refers to a 64 years old female patient. The patient was vaccinated with ZOSTAVAX (lot number 06962) subcutaneously on 07-SEP-2010(in October 2010 as previously reported). Concomitant medications included TRILEPTAL. On 15-SEP-2010 the patient experienced ocular shingles and was seen in system headache pain, left eye and lid swelling. Perhaps blister note left forehead. STATICIN and FLUMADINE (5 mg, oral, qd*7d, from 15-SEP-2010 to 23-SEP-2010, antivirus) were given as treatment for the events. The patient saw ophthalmologist as well. The outcome was reported as recovered/resolved on 1-OCT-2010. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with one dose of 0.65 ml ZOSTAVAX (lot number 672429/1606AA, expiration date 13-JAN-2013) (expiration date 30-APR-2012 as reported) subcutaneously on 21-MAY-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Muscular weakness, Rash
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 17 years old female patient with allergy to mold. The patient's medical history included anxiety and rush. The patient was vaccinated with the first dose of 0.5 ml GARDASIL lot number 0214AE intramuscularly in left deltoid on 26-JUN-2012. No other co-suspects were reported. Concomitant medications included LAMICTAL. On 26-JUN-2012 the patient experienced pain at the injection site as the dose was being administered. Later that evening the patient developed a rash on her left forearm. The patient said it is the same type of rash she had gotten in the past when she came in contact with mold. The patient also developed "subjective weakness" of her left arm. There was no loss of strength according to the physician's notes. The patient had sought medical attention via an office visit. BENADRYL and ice were given as treatment for the events. No laboratory diagnostic studies were performed. The outcome was reported as recovered on an unspecified date. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Skin lesion, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician refers to a 12 months old male patient with no pertinent medical history and no drug reaction or allergies. The patient was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck) (Lot# reported as 0316AE, expired date 16-MAR-2012) on 11-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 15-JUL-2012, "4 days after receiving" VARIVAX the patient experienced chickenpox lesion. Lesions were on patient's arms, legs and lower abdomen and one lesion on his face and fever was also reported. The patient visited office for medical attention. No lab diagnostics were performed. The patient was given BENADRYL and TYLENOL as treatment. At the time of this report the patient's status was not known. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients without demographics information. It was reported that the patient might have received expired ZOSTAVAX (Lot # 665528/0710Z, expiration date 28-APR-2011), but was unsure if there were additional patients or when they would have received the expired vaccine. No other co-suspects were reported. No concomitant medications were reported. Follow up information via telephone call also stated that the pharmacist did not have any information regarding the unspecified number of patients. She was attempting to identify the patients if there were any, because they would need to be re-vaccinated. The outcome of received expired ZOSTAVAX was unknown. This is one of two reports from the same source (the other report MARRS # 1207USA006024). All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a patient of unknown age. The patient was vaccinated with improperly stored ZOSTAVAX (lot # 671075/1197AA, exp date 25-OCT-2012) on 23-JUL-2012. No adverse event reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a female patient of unknown age. The patient was vaccinated with a first and a second doses of GARDASIL, (doses, route and lot numbers not reported) on 2008. On 17-JUL-2012, the patient was in the nurse's office and received a third dose of doses of GARDASIL, (dose, route and lot numbers not reported). No adverse event reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of the age over 26 years. On an unknown date, the numerous (exact number unspecified) patients over 26 years were vaccinated with GARDASIL (lot# not provided). No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. The nurse did not wish follow up for the purpose of safely report. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Blood test, Computerised tomogram, Convulsion, Electroencephalogram abnormal, Loss of consciousness
Clinical narrative: Mom states = "About" 5 min. after receiving Tdap - client c/o feeling lt headed - then she stopped talking - arm/legs began contracting - head turned to the side - lasted "seconds" mom called health dept - was instructed to go to ER.
Age: 11.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: Mom states = "About" 5 min. after receiving Tdap - client c/o feeling lt headed - then she stopped talking - arm/legs began contracting - head turned to the side - lasted "seconds" mom called health dept - was instructed to go to ER.
Age: 11.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Aphasia, Computerised tomogram normal, Dizziness, Muscle contracture, Posture abnormal
Clinical narrative: Mom states = "About" 5 min. after receiving Tdap - client c/o feeling lt headed - then she stopped talking - arm/legs began contracting - head turned to the side - lasted "seconds" mom called health dept - was instructed to go to ER.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Disorientation, Syncope
Clinical narrative: Patient fainted and experienced a seizure that lasted 3 to 4 seconds. This episode occurred less than five minutes after receiving her GARDASIL vaccination at 12:25 pm on 7/23/12.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Patient fainted and experienced a seizure that lasted 3 to 4 seconds. This episode occurred less than five minutes after receiving her GARDASIL vaccination at 12:25 pm on 7/23/12.
Age: 1.24
Sex: F
Vaccine: HEPA, MMR
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Activities of daily living impaired, Asthenia, Balance disorder, Computerised tomogram
Clinical narrative: Week prior to 12/29/2011, general weakness. 12/29 Abnormal gait, "rubbery" legs bilaterally. Within 30 minutes after onset, unable to walk. Unable to perform ADL. Hospitalized > 1 wk. High dose steroids. Dx of GBS after 4 wks with LP, tx of IVIG - 5 consecutive doses. Ongoing PT. Severe leg pain, limp.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Electromyogram, Gait disturbance, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture
Clinical narrative: Week prior to 12/29/2011, general weakness. 12/29 Abnormal gait, "rubbery" legs bilaterally. Within 30 minutes after onset, unable to walk. Unable to perform ADL. Hospitalized > 1 wk. High dose steroids. Dx of GBS after 4 wks with LP, tx of IVIG - 5 consecutive doses. Ongoing PT. Severe leg pain, limp.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Week prior to 12/29/2011, general weakness. 12/29 Abnormal gait, "rubbery" legs bilaterally. Within 30 minutes after onset, unable to walk. Unable to perform ADL. Hospitalized > 1 wk. High dose steroids. Dx of GBS after 4 wks with LP, tx of IVIG - 5 consecutive doses. Ongoing PT. Severe leg pain, limp.
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Lip swelling, Urticaria
Clinical narrative: Significant hives & lip swelling Trmt: BENADRYL 25mg/5ml - 1 tsp po q 6 x3.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh - 10 cm diameter redness had swelling, redness, and very hot to touch.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 5 cm x 6 cm area of erythema at injection site, mild tenderness & warmth.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Development of Herpes Zoster "shingles".
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature, Headache, Nausea, Vomiting
Clinical narrative: Severe Headache, Vomiting, Tactile Temperature started 7/30/12 in the evening. Still with headache and nausea on 7/31/12.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Red circle around injection site-painful, itchy and burning (approximately 2 inches in diameter).
Age: 84.0
Sex: M
Vaccine: TDAP
Symptoms: Abasia, Bacterial test positive, Computerised tomogram head, Computerised tomogram normal, Dizziness
Clinical narrative: The patient is an 84-year-old gentleman who presented on July 13, 2012, with unresponsiveness. He had been doing well up until July 9, when he had a minor dog bite in his left calf. The following day he went to get a tetanus shot and was also placed on antibiotics. However, following this seemed to have dizziness and become weak. He fell twice and after the second fall was not able to get up on his own and thus ambulance was summoned. He was taken to the ER where he was admitted. While at the hospital, he underwent CT scan of his brain which showed no acute abnormality. He also had a carotid duplex scan which did not show any significant abnormalities. Lower extremity Doppler showed a nonocclusive thrombus in the right mid lower femoral vein which was thought to be chronic. During his hospital stay where he continued to have difficulty with walking. He could stand briefly but not walk then he developed speech disturbance, became progressively less responsive. At the time of transfer, he was completely unresponsive and unable to give history and subsequently was transferred to another hospital for further evaluation. While here he underwent an MRI of the brain and shortly after admission had an EEG and lumbar puncture. Infectious disease was consulted. He was intubated given his altered mental status and inability to protect his airway. Multiple studies were obtained. LP showed no significant findings. Several serologies were sent including Q fever. He was able to be extubated on July 17, 2012, then from that point did progress in terms of his mental status as significantly improved. He was still severely deconditioned at time of discharged and will need subsequent therapies for strengthening. His Q fever came back positive after he was dismissed back to the swing bed. He was maintained on multiple antibiotics and antivirals and ID did recommended completing a 2-week course and actually would have been on doxycycline for 3 weeks. This would be sufficient for his Q fever. As mentioned at time of discharge, he was deemed hemodynamically stable. His mental status had improved. He was up to the chair with assistance of 2 with PT. He remained on oxygen but a previous history of nocturnal oxygen was used. Vital signs at time of discharge include temp 98.2, pulse 83, respirations 24, blood pressure 145/68, O2 saturation was 92% on room air.
Age: 84.0
Sex: M
Vaccine: TDAP
Symptoms: Electroencephalogram, Endotracheal intubation, Fall, Lumbar puncture normal, Mental status changes
Clinical narrative: The patient is an 84-year-old gentleman who presented on July 13, 2012, with unresponsiveness. He had been doing well up until July 9, when he had a minor dog bite in his left calf. The following day he went to get a tetanus shot and was also placed on antibiotics. However, following this seemed to have dizziness and become weak. He fell twice and after the second fall was not able to get up on his own and thus ambulance was summoned. He was taken to the ER where he was admitted. While at the hospital, he underwent CT scan of his brain which showed no acute abnormality. He also had a carotid duplex scan which did not show any significant abnormalities. Lower extremity Doppler showed a nonocclusive thrombus in the right mid lower femoral vein which was thought to be chronic. During his hospital stay where he continued to have difficulty with walking. He could stand briefly but not walk then he developed speech disturbance, became progressively less responsive. At the time of transfer, he was completely unresponsive and unable to give history and subsequently was transferred to another hospital for further evaluation. While here he underwent an MRI of the brain and shortly after admission had an EEG and lumbar puncture. Infectious disease was consulted. He was intubated given his altered mental status and inability to protect his airway. Multiple studies were obtained. LP showed no significant findings. Several serologies were sent including Q fever. He was able to be extubated on July 17, 2012, then from that point did progress in terms of his mental status as significantly improved. He was still severely deconditioned at time of discharged and will need subsequent therapies for strengthening. His Q fever came back positive after he was dismissed back to the swing bed. He was maintained on multiple antibiotics and antivirals and ID did recommended completing a 2-week course and actually would have been on doxycycline for 3 weeks. This would be sufficient for his Q fever. As mentioned at time of discharge, he was deemed hemodynamically stable. His mental status had improved. He was up to the chair with assistance of 2 with PT. He remained on oxygen but a previous history of nocturnal oxygen was used. Vital signs at time of discharge include temp 98.2, pulse 83, respirations 24, blood pressure 145/68, O2 saturation was 92% on room air.
Age: 84.0
Sex: M
Vaccine: TDAP
Symptoms: Nuclear magnetic resonance imaging brain, Q fever, Speech disorder, Ultrasound Doppler, Ultrasound Doppler abnormal
Clinical narrative: The patient is an 84-year-old gentleman who presented on July 13, 2012, with unresponsiveness. He had been doing well up until July 9, when he had a minor dog bite in his left calf. The following day he went to get a tetanus shot and was also placed on antibiotics. However, following this seemed to have dizziness and become weak. He fell twice and after the second fall was not able to get up on his own and thus ambulance was summoned. He was taken to the ER where he was admitted. While at the hospital, he underwent CT scan of his brain which showed no acute abnormality. He also had a carotid duplex scan which did not show any significant abnormalities. Lower extremity Doppler showed a nonocclusive thrombus in the right mid lower femoral vein which was thought to be chronic. During his hospital stay where he continued to have difficulty with walking. He could stand briefly but not walk then he developed speech disturbance, became progressively less responsive. At the time of transfer, he was completely unresponsive and unable to give history and subsequently was transferred to another hospital for further evaluation. While here he underwent an MRI of the brain and shortly after admission had an EEG and lumbar puncture. Infectious disease was consulted. He was intubated given his altered mental status and inability to protect his airway. Multiple studies were obtained. LP showed no significant findings. Several serologies were sent including Q fever. He was able to be extubated on July 17, 2012, then from that point did progress in terms of his mental status as significantly improved. He was still severely deconditioned at time of discharged and will need subsequent therapies for strengthening. His Q fever came back positive after he was dismissed back to the swing bed. He was maintained on multiple antibiotics and antivirals and ID did recommended completing a 2-week course and actually would have been on doxycycline for 3 weeks. This would be sufficient for his Q fever. As mentioned at time of discharge, he was deemed hemodynamically stable. His mental status had improved. He was up to the chair with assistance of 2 with PT. He remained on oxygen but a previous history of nocturnal oxygen was used. Vital signs at time of discharge include temp 98.2, pulse 83, respirations 24, blood pressure 145/68, O2 saturation was 92% on room air.
Age: 84.0
Sex: M
Vaccine: TDAP
Symptoms: Ultrasound scan normal, Unresponsive to stimuli, Venous thrombosis limb
Clinical narrative: The patient is an 84-year-old gentleman who presented on July 13, 2012, with unresponsiveness. He had been doing well up until July 9, when he had a minor dog bite in his left calf. The following day he went to get a tetanus shot and was also placed on antibiotics. However, following this seemed to have dizziness and become weak. He fell twice and after the second fall was not able to get up on his own and thus ambulance was summoned. He was taken to the ER where he was admitted. While at the hospital, he underwent CT scan of his brain which showed no acute abnormality. He also had a carotid duplex scan which did not show any significant abnormalities. Lower extremity Doppler showed a nonocclusive thrombus in the right mid lower femoral vein which was thought to be chronic. During his hospital stay where he continued to have difficulty with walking. He could stand briefly but not walk then he developed speech disturbance, became progressively less responsive. At the time of transfer, he was completely unresponsive and unable to give history and subsequently was transferred to another hospital for further evaluation. While here he underwent an MRI of the brain and shortly after admission had an EEG and lumbar puncture. Infectious disease was consulted. He was intubated given his altered mental status and inability to protect his airway. Multiple studies were obtained. LP showed no significant findings. Several serologies were sent including Q fever. He was able to be extubated on July 17, 2012, then from that point did progress in terms of his mental status as significantly improved. He was still severely deconditioned at time of discharged and will need subsequent therapies for strengthening. His Q fever came back positive after he was dismissed back to the swing bed. He was maintained on multiple antibiotics and antivirals and ID did recommended completing a 2-week course and actually would have been on doxycycline for 3 weeks. This would be sufficient for his Q fever. As mentioned at time of discharge, he was deemed hemodynamically stable. His mental status had improved. He was up to the chair with assistance of 2 with PT. He remained on oxygen but a previous history of nocturnal oxygen was used. Vital signs at time of discharge include temp 98.2, pulse 83, respirations 24, blood pressure 145/68, O2 saturation was 92% on room air.
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, VIIth nerve paralysis
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 21-Jul-2012) concerns an over 50-year-old female patient. On an unknown date the patient received a flu shot (brand, manufacturer and batch number were not provided). After receiving the flu shot the patient experienced Bell's Palsy and had since been diagnosed with Guillain Barre. The event outcome was not reported.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Crying, Feeling abnormal, Hyperhidrosis, Pallor
Clinical narrative: Child very anxious prior to vaccination. Per Mom - "He is very scared of needles." Cried during shot. Walked back to front of clinic. 5 min after shot, appeared pale, sweaty. "I don't feel good." Laid on the floor ft/knees raised. Cool cloth to forehead. P=92. Drank juice box. 2 min. later - skin color pink, P=92, felt "better."
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Cellulitis, Excoriation, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt. c/o swelling, itching and blisters at site of injection on 7/25/12. By early AM 7/26/12 the upper (R) arm is red, swollen, warm to touch. Skin was excoriated with open areas very painful. Size of area was approx. 5" X 4". Pt. admits to scratching area. Dx with cellulitis at hospital. Given IV antibiotics - also given ointment and oral antibiotics.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site vesicles, Injection site warmth, Pain of skin
Clinical narrative: Pt. c/o swelling, itching and blisters at site of injection on 7/25/12. By early AM 7/26/12 the upper (R) arm is red, swollen, warm to touch. Skin was excoriated with open areas very painful. Size of area was approx. 5" X 4". Pt. admits to scratching area. Dx with cellulitis at hospital. Given IV antibiotics - also given ointment and oral antibiotics.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Body temperature increased, Irritability, Rash, Rash erythematous
Clinical narrative: Single spot near umbilicus 7/20/12; next day multiple spots top of hands & feet, scattered on limbs & around mouth. Faint red rash trunk - T 100.8, fussier than usual. 7-23-12 physician noted erythematous blistery rash top of hands & feet, shoulders, arms; faint fine erythematous macular rash on legs (pictures available).
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash macular
Clinical narrative: Single spot near umbilicus 7/20/12; next day multiple spots top of hands & feet, scattered on limbs & around mouth. Faint red rash trunk - T 100.8, fussier than usual. 7-23-12 physician noted erythematous blistery rash top of hands & feet, shoulders, arms; faint fine erythematous macular rash on legs (pictures available).
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Dyspnoea, Hyperhidrosis, Myocarditis, Pallor
Clinical narrative: Gradual to sudden onset shortness of breath with chest pain, diaphoresis and pallor.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Injection site reaction, Skin lesion
Clinical narrative: 6X8 cm lesion with erythema and punctuate lesions on injection site.
Age: 31.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Arthralgia, Blood test normal, Computerised tomogram abnormal, Gait disturbance, Laboratory test abnormal
Clinical narrative: Woke up in the A.M. and all joints were aching. The aching progressed to difficulty walking. Patient currently prescribed medication, which he started taking in June.
Age: 31.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Nuclear magnetic resonance imaging abnormal, Rheumatoid arthritis
Clinical narrative: Woke up in the A.M. and all joints were aching. The aching progressed to difficulty walking. Patient currently prescribed medication, which he started taking in June.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed shingles after zoster vaccination.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Dyspnoea, Erythema, Rash
Clinical narrative: Breathing problem & rash & red area on arm 2 1/4 x 1 1/4 in deltoid reported by school nurse lasted several hours.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Band neutrophil percentage decreased, Blood culture negative, Carbon dioxide decreased, Faeces discoloured, Occult blood positive
Clinical narrative: 7/19/12 vomit x3. 7/23 vomiting large volumes. Stool greenish, breast fed. Mom on dairy-soy avoidance. Stools positive blood. ER 7/28 IV fluids stools positive blood.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Vomiting, White blood cell count normal
Clinical narrative: 7/19/12 vomit x3. 7/23 vomiting large volumes. Stool greenish, breast fed. Mom on dairy-soy avoidance. Stools positive blood. ER 7/28 IV fluids stools positive blood.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Convulsion
Clinical narrative: According to dad baby had an afebrile seizure the evening shots were administered. Baby taken to ED where baby was admitted to hospital.
Age: 1.25
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Blister, Rash
Clinical narrative: Rash developed 3-4 days ago (approx.) no fever. Few vesicles on trunk & upper extremities.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Pt stated arm started itching about 5 hrs after shot & by next morning arm was red and swollen around injection site. She came to the Pharmacy on day 3 after shot to show me and the red area was about the size of a soft ball & was swollen & warm. Told her to take BENADRYL & arm was back to normal within a week.