chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: U
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 30 year old patient of unknown gender. On an unknown date, the patient was vaccinated with unspecified number of doses with MMR II (dose, route, frequency and lot # were not described). The reporter also stated that the patient had low titers for MMR II. The patient did not present any symptoms. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Electrocardiogram normal, Pruritus, Rash, Urticaria
Clinical narrative: Rash and urticaria pruritus. Prednisone 10 mg other.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant, on 14-JUL-2015, concerning to unspecified patients of unknown gender and ages. Since 06-APR-2015, unspecified patients were vaccinated with GARDASIL (dose, route, frequency and lot unknown), which had been exposed to temperatures outside of the recommended range. This is one of several reports received from the same source (1507USA007091 - 1507USA007092). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant, on 14-JUL-2015, concerning to unspecified patients of unknown ages. Since 06-APR-2015, unspecified patients were vaccinated with VAQTA (dose, route, frequency and lot unknown), which had been exposed to temperatures outside of the recommended range. This is one of several reports received from the same source (1507USA006969 - 1507USA007092). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant, on 14-JUL-2015, concerning to unspecified patients of unknown ages. Since 06-APR-2015, unspecified patients were vaccinated with VAQTA (dose, route, frequency and lot unknown), which had been exposed to temperatures outside of the recommended range. This is one of several reports received from the same source (1507USA006969 - 1507USA007091). Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report has been received from a healthcare worker refers to a 31 year old female patient with allergic to LORTAB. There was no pertinent medical history. On 09-JUL-2015 the pregnant patient was vaccinated with the first dose of GARDASIL (confirmed not GARDASIL 9) (dose, frequency, route, lot # and expiration date were unknown) (inappropriate schedule of drug administration). There was no concomitant therapy. On 10-JUL-2015 (the reporting day), the patient was gestation 26 weeks. The last menstrual period (LMP) was estimated as 09-JAN-2015 and estimated date of delivery (EDD) was on 16-OCT-2015. At the time of reporting, the patient was in the office and no lab diagnostic studies were performed. The pregnancy outcome was unknown. No adverse symptoms were reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician referring to a male patient of unknown age. The patient's pertinent medical history and concurrent condition were not reported. On an unspecified date of 2012, the patient was vaccinated with his first dose of GARDASIL (dose, route and lot# were not reported). 1 year later after the first dose, on an unspecified date of 2013, the patient received his second dose of GARDASIL (dose, route and lot# were not reported) (inappropriate schedule of drug administration). Then, 1 month after the second dose, the patient received his third dose of GARDASIL (dose, route and lot# were not reported) (inappropriate schedule of drug administration). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were provided. On an unspecified date, the patients were vaccinated with improperly stored VARIVAX (Lot # K011802, expiry date 21-AUG-2016). At the time of this report, no adverse reactions were reported. This is one of several reports from the same source.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Concurrent condition and medical history were not reported. The nurse reported that on 02-JUL-2015 the patient was vaccinated subcutaneously with a 0.5ml dose of improperly stored PROQUAD (lot # unknown), which was exposed to -14.9 degree Celsius for 2.5 hours. There was no concomitant medication reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unspecified dates the patients were administrated unspecified number of improperly stored doses of ROTATEQ (lot number K006455 - expiration date 10-FEB-2016 and lot number K004468 - expiration date 08-DEC-2015) (oral, strength and dose were unknown). No adverse event was reported. Follow up information has been received from the registered nurse on 27-JUL-2015 concerning a patient of unknown age and gender. On 09-APR-2015, the patient received an improperly stored dose of ROTATEQ (lot# K004468, expiration date 08-DEC-2015, oral, dose was unknown). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: This spontaneous report was received from registered nurse regarding a patient of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided On an unknown dates, the patient was vaccinated with complete series of 3 doses of GARDASIL (dose, route, lot # and expiration date were not reported). On an unknown date (reported as after this), the patient was found to have become infected with an unspecified serotype of HPV (Human Papilloma Virus). The patient's outcome unknown. The relatedness between the event and therapy with GARDASIL was nor provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous reprot as received from a physician via a field representative refers to two patients of unknown age and gender. The patient's concurrent condition and medical history were not reported. On unspecified dates, the patients were each administered two doses of VARIVAX (Merck) (unknown strength, rout and dose). Concomitant medications were no reported. On unspecified dates, each had titers drawn on unspecified dates which were negative for immunity to varicella. The outcome of the event was unknown. No treatment was received in response to the event. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant, on 02-JUL-2015, concerning a patient of unknown age and gender. On 24-JUN-2015, the patient was vaccinated with a dose of PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that underwent 159 hours temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 14-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant, on 02-JUL-2015, concerning a patient of an unknown age and gender. On 27-JUN-2015, the patient was vaccinated with a dose of PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that underwent 159 hours temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to unspecified patients of unknown age. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, 3 doses of improperly stored VARIVAX (lot # K009759, expiry date: 09-JUL-2016) were administered to unspecified patients. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician referring to a male patient of unknown age. The patient's pertinent medical history and concurrent condition were not reported. On an unspecified date of 2012, the patient was vaccinated with his first dose of GARDASIL (dose, route and lot# were not reported). 1 year later after the first dose, on an unspecified date of 2013, route and lot# were not reported)(inappropriate schedule of drug administration). Then, 1 month after the second dose, the patient received his third dose of GARDASIL (dose, route and lot# were not reported) (inappropriate schedule of drug administration). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a researcher, and refers to an unspecified patient of unknown age and gender. Concurrent condition or medical history were not reported. On 28-FEB-2015, the patient received an improperly stored dose of ZOSTAVAX lot # K007548; Exp date 23-AUG-2015, subcutaneously (strength, dose #, dose and anatomical location were not provided). There was not concomitant medication reported. No adverse experiences were reported. There was not a product quality complaint involved. At the time of the report, the outcome of incorrect product storage was unknown. This is one of several reports received from the same reporter (1507USA005687 and 1507USA005686). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a researcher, and refers to an unspecified patient of unknown age and gender. Concurrent condition or medical history were not reported. On 16-MAR-2015, the patient received an improperly stored dose of ZOSTAVAX, subcutaneously, lot # K007548; Exp date 23-AUG-2015 (strength, dose #, dose and anatomical location were not provided). There was not concomitant medication reported. No adverse experiences were reported. There was not a product quality complaint involved. At the time of the report, the outcome of incorrect product storage was unknown. This is one of several reports received from the same reporter (1507USA005587 and 1507USA0055586). Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Local reaction, Skin warm
Clinical narrative: On 7-29-15 pt had a small local reaction to (R) deltoid. Nickle size. Denied any other symptoms. Pt. advised to take BENADRYL and RTC if reactions worsened or spread of SOB occurred. Pt. was notified to go to local ER on 7-30-15. Pt RTC with reaction that had significantly increased in size approx 38 mm by 48 mm area very red and warm to touch, given BENADRYL. All vitals normal. No other symptoms. On 7-31-15 pt. was called to check on symptoms. Pt stated site reaction was going away and getting better.
Age: 1.4
Sex: F
Vaccine: DTAP, HIBV, PNC13, DTAP, HIBV, PNC13
Symptoms: Extra dose administered, Injection site abscess, Staphylococcus test positive
Clinical narrative: Developed small, non-tender "knot" in thigh after vaccine. Two weeks later, had red, warm, tender abscess develop in area of PEDVAXHIB injection site. This required surgical I and D and hospitalization with IV antibiotics.
Age: 1.4
Sex: F
Vaccine: DTAP, HIBV, PNC13, DTAP, HIBV, PNC13
Symptoms: Incisional drainage, Injection site abscess, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Developed small, non-tender "knot" in thigh after vaccine. Two weeks later, had red, warm, tender abscess develop in area of PEDVAXHIB injection site. This required surgical I and D and hospitalization with IV antibiotics.
Age: 1.4
Sex: F
Vaccine: DTAP, HIBV, PNC13, DTAP, HIBV, PNC13
Symptoms: Injection site warmth
Clinical narrative: Developed small, non-tender "knot" in thigh after vaccine. Two weeks later, had red, warm, tender abscess develop in area of PEDVAXHIB injection site. This required surgical I and D and hospitalization with IV antibiotics.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test, Computerised tomogram, Dehydration, Ear infection, Lethargy
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a 43 year-old female patient who had no medical history and no current illness at the time of vaccination. On 20-Nov-2006, the patient received AFLURIA injection (batch number "2F601411") via the intramuscular route in the left arm. On 24-Nov-2006, the patient experienced an ear infection, vertigo, nausea, vomiting, fever, lethargy, weight loss, and severe dehydration. Over the course of three weeks, the symptoms increased in intensity and frequency. After several trips to the doctor, several prescriptions to ease the symptoms, and the ER (emergency room), the patient was admitted to the hospital for a four day stay on 20-Dec-2007. Blood work, CT (computed tomography) scans, MRI (magnetic resonance imaging) to rule out Multiple Sclerosis. The outcome was not recovered. Reporter's comments: The health authority assessed the case as serious (led to hospitalisation for 3 days and caused permanent disability) and reported the terms of 'Blood test', 'Computerised tomogram' and 'Nuclear magnetic resonance imaging'.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nausea, Nuclear magnetic resonance imaging, Pyrexia, Vertigo, Vomiting
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a 43 year-old female patient who had no medical history and no current illness at the time of vaccination. On 20-Nov-2006, the patient received AFLURIA injection (batch number "2F601411") via the intramuscular route in the left arm. On 24-Nov-2006, the patient experienced an ear infection, vertigo, nausea, vomiting, fever, lethargy, weight loss, and severe dehydration. Over the course of three weeks, the symptoms increased in intensity and frequency. After several trips to the doctor, several prescriptions to ease the symptoms, and the ER (emergency room), the patient was admitted to the hospital for a four day stay on 20-Dec-2007. Blood work, CT (computed tomography) scans, MRI (magnetic resonance imaging) to rule out Multiple Sclerosis. The outcome was not recovered. Reporter's comments: The health authority assessed the case as serious (led to hospitalisation for 3 days and caused permanent disability) and reported the terms of 'Blood test', 'Computerised tomogram' and 'Nuclear magnetic resonance imaging'.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Weight decreased
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a 43 year-old female patient who had no medical history and no current illness at the time of vaccination. On 20-Nov-2006, the patient received AFLURIA injection (batch number "2F601411") via the intramuscular route in the left arm. On 24-Nov-2006, the patient experienced an ear infection, vertigo, nausea, vomiting, fever, lethargy, weight loss, and severe dehydration. Over the course of three weeks, the symptoms increased in intensity and frequency. After several trips to the doctor, several prescriptions to ease the symptoms, and the ER (emergency room), the patient was admitted to the hospital for a four day stay on 20-Dec-2007. Blood work, CT (computed tomography) scans, MRI (magnetic resonance imaging) to rule out Multiple Sclerosis. The outcome was not recovered. Reporter's comments: The health authority assessed the case as serious (led to hospitalisation for 3 days and caused permanent disability) and reported the terms of 'Blood test', 'Computerised tomogram' and 'Nuclear magnetic resonance imaging'.
Age: 8.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Alopecia, Alopecia areata
Clinical narrative: Information has been received from a consumer referring to her daughter, an 8 year old female patient without pertinent medical history or drug reactions/allergies. On 30-JAN-2015 the patient was vaccinated with a dose of M-M-R II in her right arm (dose, lot # and route unknown). There was no concomitant therapy taken. In February 2015, reported as within 2 to 3 weeks of receiving the vaccine, the patient experienced hair loss which results in  bald spots on her head that were about 1 inch round. The patient was taken to see a physician and was diagnosed as alopecia on 24-MAR-2015. No lab diagnostic studies were performed and no treatment was given for the event. At the time of the report, the patient was recovering. Causality was not provided. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Alopecia
Clinical narrative: Information has been received from a consumer referring to her daughter, an 8 year old female patient without pertinent medical history or drug reactions/allergies. On 30-JAN-2015 the patient was vaccinated with a dose of M-M-R II in her right arm (dose, lot # and route unknown). There was no concomitant therapy taken. In February 2015, reported as within 2 to 3 weeks of receiving the vaccine, the patient experienced hair loss which results in  bald spots on her head that were about 1 inch round. The patient was taken to see a physician and was diagnosed as alopecia on 24-MAR-2015. No lab diagnostic studies were performed and no treatment was given for the event. At the time of the report, the patient was recovering. Causality was not provided. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a 59 year old female patient regarding herself. Medical history was not reported. The patient is allergic to sulfa. On 20-JUL-2015, the patient was vaccinated with ZOSTAVAX (1 vial/one time dose) (lot # unknown) in the left arm. Concomitant medication included unspecified therapy. the same day upon vaccination, it hurt like the dickens, felt like someone had put a prod in her arm, it was so painful, felt like she had a head of nails in her arm. The patient reported that these sensations had started right away at the point of insertion and has spread out. She did not feel well and felt nauseous and did not go to work on 22-JUL-2015 because of how bad she felt. She felt like she wanted to cry from discomfort and on 23-JUL-2015, the area was hard to touch like a big bump (she compared it to a tennis ball, approximately 2 inches wide) and there was redness that has spread to 7 by 5 inch area around the point of insertion. The patient had sought medical attention by contacting the pharmacist. Treatment included heat and hydrocortisone cream (manufacturer unspecified). Her pharmacist commented that this was an exceptional adverse reaction and that he has only seen one other person have this bad a reaction (unspecified on which therapy). The outcome of the events were reported as not recovered. Causality assessment was not reported. There was no product quality complaint. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injection site discomfort, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This spontaneous report as received from a 59 year old female patient regarding herself. Medical history was not reported. The patient is allergic to sulfa. On 20-JUL-2015, the patient was vaccinated with ZOSTAVAX (1 vial/one time dose) (lot # unknown) in the left arm. Concomitant medication included unspecified therapy. the same day upon vaccination, it hurt like the dickens, felt like someone had put a prod in her arm, it was so painful, felt like she had a head of nails in her arm. The patient reported that these sensations had started right away at the point of insertion and has spread out. She did not feel well and felt nauseous and did not go to work on 22-JUL-2015 because of how bad she felt. She felt like she wanted to cry from discomfort and on 23-JUL-2015, the area was hard to touch like a big bump (she compared it to a tennis ball, approximately 2 inches wide) and there was redness that has spread to 7 by 5 inch area around the point of insertion. The patient had sought medical attention by contacting the pharmacist. Treatment included heat and hydrocortisone cream (manufacturer unspecified). Her pharmacist commented that this was an exceptional adverse reaction and that he has only seen one other person have this bad a reaction (unspecified on which therapy). The outcome of the events were reported as not recovered. Causality assessment was not reported. There was no product quality complaint. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Malaise, Nausea
Clinical narrative: This spontaneous report as received from a 59 year old female patient regarding herself. Medical history was not reported. The patient is allergic to sulfa. On 20-JUL-2015, the patient was vaccinated with ZOSTAVAX (1 vial/one time dose) (lot # unknown) in the left arm. Concomitant medication included unspecified therapy. the same day upon vaccination, it hurt like the dickens, felt like someone had put a prod in her arm, it was so painful, felt like she had a head of nails in her arm. The patient reported that these sensations had started right away at the point of insertion and has spread out. She did not feel well and felt nauseous and did not go to work on 22-JUL-2015 because of how bad she felt. She felt like she wanted to cry from discomfort and on 23-JUL-2015, the area was hard to touch like a big bump (she compared it to a tennis ball, approximately 2 inches wide) and there was redness that has spread to 7 by 5 inch area around the point of insertion. The patient had sought medical attention by contacting the pharmacist. Treatment included heat and hydrocortisone cream (manufacturer unspecified). Her pharmacist commented that this was an exceptional adverse reaction and that he has only seen one other person have this bad a reaction (unspecified on which therapy). The outcome of the events were reported as not recovered. Causality assessment was not reported. There was no product quality complaint. Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash generalised, Seizure
Clinical narrative: Child spiked a fever at 9:00 pm on 7/17/15 and at 1:00 am on 7/18/15 fever was 103.8 and child had a seizure.  Was taken by ambulance to ER where he was released a few hours later. Child also had a full body rash.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Delayed Onset Reaction - reddened, swollen area at injection site.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Electrocardiogram, Erythema, Pain in extremity, Peripheral swelling, Pharyngeal oedema
Clinical narrative: Went to movies after vaccine. During movie patient stated her arm was sore, red, swollen and had some itching. She continues to watch the movie and afterwards felt like she had swelling in her throat. Presented to the Emergency room at 8:42PM. Treatment in ED consisted of Benadryl, toradol, Pepcid & Solumedrol.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus
Clinical narrative: Went to movies after vaccine. During movie patient stated her arm was sore, red, swollen and had some itching. She continues to watch the movie and afterwards felt like she had swelling in her throat. Presented to the Emergency room at 8:42PM. Treatment in ED consisted of Benadryl, toradol, Pepcid & Solumedrol.
Age: 22.0
Sex: F
Vaccine: HEPA, MNQ, RAB
Symptoms: Muscle rigidity, Seizure like phenomena
Clinical narrative: Patient received a Rabies vaccine in one arm and in the other arm received Menactra and Hep A. After the Hep A patient became very rigid, experiencing seizure like activity. Provider was immediately notified and evaluated the patient.
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis per mother. Tx with anthx. inpatient.
Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site streaking, Injection site swelling, Injection site warmth
Clinical narrative: Pt states the site was red, streaky, hot to the touch, swollen and that the ancillary lymphnodes were very swollen. PT was seen by Urgent care provider and was prescribed antibiotics.
Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Lymphadenopathy
Clinical narrative: Pt states the site was red, streaky, hot to the touch, swollen and that the ancillary lymphnodes were very swollen. PT was seen by Urgent care provider and was prescribed antibiotics.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Chest discomfort, Chest pain, Cough, Pain
Clinical narrative: Severe coughing, body aches. OTC meds taken. One month later, same occurrence. Prescribed Zpac. Started feeling better. About 4 weeks and same thing. Tightness in chest & burning sensation in upper lungs. Took another Zpac and got better. I am currently having another attack of the coughing & burning in my chest. Doctor prescribed Levaquin. Adverse reaction to drug after 2 days and had to discontinue.
Sex: U
Vaccine: PNC13
Symptoms: Injection site necrosis
Clinical narrative: This is a spontaneous report obtained from a contactable nurse. A patient of unspecified age and gender received on unknown date PREVNAR 13 at single dose. Relevant medical history and concomitant medication were not reported. The patient developed fat necrosis at the injection site. Event outcome was unknown.
Age: 2.0
Sex: M
Vaccine: RAB
Symptoms: Body temperature increased, Urticaria
Clinical narrative: Child got rabies post exposure on sat. On Sunday he started with large amount of hives all over his body. Per his mother-she said she was told they were very severe. She was given antihistamine to ber given to her son x3 days. Child was due on Day 7 (on Wednesday). She called HD beacsue since she lived so far away, she didn't want to get to HD and to be told that the child could not get the vaccine that day. Other than that she had no problems having her son get the vaccine. Mother said child had bad hives, Temp 100.9 and she was giving him Tyenlol. Called to HD FNP. She said to call state DOH. Did so. Was told by DOH she should follow what was said by clinician. Mother brought the child in on Wed. 7/29/2015. Child tolerated vaccine well. It was also stated to try another Rabies vaccine which was done. From Novartis Rabavert to SP Imovax. Called mother several times to see how child did after this past vaccine and she has not returned any calls.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: R edness at injection area, swelling and redness around upper arm from injection area to elbow, advised patient to seek medical attention and prescription antibiotics if necessary.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HEP, PNC13, RV5
Symptoms: Extra dose administered
Clinical narrative: Realized that Pediarix was ordered and given with Hepatitis B.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Rash erythematous
Clinical narrative: Swollen arm, raised red bumps on arm.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Syncope
Clinical narrative: After administering HPV vaccine patient fainted while sitting in chair. No harm was caused to the patient. Two other nurses came and assisted. Patient was carried to the exam table and legs were lifted up. Patient was given water and orange juice. Patient stated was feeling better and was dismissed after 30 minutes.
Age: 5.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Somnolence
Clinical narrative: Child could no longer stay awake all day, would nap and sleep in car, and after school sleep for 14 hours at a time.
Age: 0.59
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Death, Full blood count
Clinical narrative: Patient has extreme prematurity 25 wks. Has Hx of Apnea, Tracheomalacia, GER, Breath-holding spell. Infant died on the same day vaccines were administered. Infant died in her sleep.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A) referring to a child patient of unknown age and gender. No relevant history or concurrent conditions were reported. On an unknown date the patient was vaccinated with improperly stored   ROTATEQ (lot # K004468, expiration date 08-DEC-2015, 2ml oral). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 04-MAY-2015, the patient was vaccinated with a dose of VAQTA (lot # K007827) 0.5 ml (expiration date, route and site of administration were not reported) that underwent temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified number of patients. On an unknown date, the unspecified patients were vaccinated with improperly stored VARIVAX (Merck) (lot# J013733 and expiry date: 30-OCT-2015, lot# L007226 and expiry date: 03-MAR-2015, Lot# K002047 and expiry date: 10-FEB-2015) (dose, frequency and route were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A) referring to a child patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 28-APR-2015 the patient was vaccinated with 2 ml ROTATEQ (lot # J007436, expiration date 05-MAR-2015, oral) (expired product administered). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse referring to an 11 year old female patient with none pertinent medical history and none drug reactions/allergies. On 20-JUL-2015 the patient was vaccinated with VARIVAX (Merck) (lot # L004652, expiration date: 11-FEB-2017, 0.5 ml/once, subcutaneous). There was none concomitant medication. On 21-JUL-2015, the patient experienced redness, warmth and swelling at the injection site. The patient sought medical attention via office visit. None treatment was given or lab diagnostics studies were performed. The outcome of the events was reported as not recovered/not resolved. The causality was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The nurse called to have the stability of improperly stored GARDASIL (lot # and dose unspecified) evaluated; there was in-house stability data which did support the vaccine. The nurse also stated during the telephone call that there was an unspecified patient in the office at that time who needed a dose of GARDASIL administered. It was unknown if this improperly stored vaccine was actually administered to this unspecified patient. No adverse effect was reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Mother phone on 7/29/15 3 pm stating red area on (L) shoulder. Mother and pt came to our facility. (L) shoulder red, hard area 2" x 2", sore to touch. Afebrile.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to 3 patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the 3 patients might have possibly been vaccinated with 3 doses of improperly stored PROQUAD (Merck) (dose, route, lot# and expiration date were not reported). Concomitant drug was not reported. No adverse effect reported. It was unknown whether the patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Myalgia
Clinical narrative: Information has been received from a nurse practitioner via a company representative concerning a female patient of unknown age. The patient's medical history or concurrent condition was not provided. On unknown dates, the patient was vaccinated with the first and second dose of GARDASIL (intramuscular; dose, lot number and expiration date were unspecified). The nurse practitioner reported to the company representative that on an unknown date the patient had prolong pain in the deltoid muscle that lasted for at least 2 weeks after receiving the second dose of GARDASIL. It was confirmed that the vaccine was GARDASIL and not GARDASIL 9. The patient sought unspecified medical attention. At the time of reporting, the outcome of the events and causality were unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of unknown age and gender. On 25-MAR-2015, the patient was vaccinated with a dose of VAQTA (lot # K007827) 0.5 ml (expiration date, route and site of administration were not reported) that underwent temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Injection site swelled, reddened "cellulitis" and broke out in vesicles (R) arm.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Pruritus, Rash erythematous
Clinical narrative: Both arms developed itching and a bright red maculopapular lacy rash from shoulder to hands. No hives no respiratory or systemic sx.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rash maculo-papular
Clinical narrative: Both arms developed itching and a bright red maculopapular lacy rash from shoulder to hands. No hives no respiratory or systemic sx.
Age: 24.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Full blood count, Laboratory test, Malaria antibody test, Myalgia
Clinical narrative: Dizziness, myalgias, syncope (apart from time of vaccine), subjective high fever, paresthesias.
Age: 24.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Nitrite urine present, Paraesthesia, Pyrexia, Syncope, White blood cells urine positive
Clinical narrative: Dizziness, myalgias, syncope (apart from time of vaccine), subjective high fever, paresthesias.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Fall, Head injury, Nausea, Swelling
Clinical narrative: At 11:05 am this client received two vaccines one was MCV given in Left deltoid, HPV 9 given in right deltoid, client stood up walked towards her mother and fell forward hitting her head on chairs then mother held her and LVN helped mother roll onto her back, she responded immediately and asked mother "what happened?" RN came into the room and helped with elevating her feet, applying cool pack to injuries which swelling showed up on bridge of nose and forehead. Blood pressure was 107/82, pulse 100 at 11:15 RN checked pupils and they were equal/reactive. Mother gave client two puffs of her personal inhaler at 11:20 am at 11:24 am pulse was 96, Res-20. Advised to seek medical attention at this time for injury to nose. Client received Coke to drink, has a c/o nausea no vomiting at this time. At 11:33 is sitting up talking with mother, cool rag to neck drinking a Coke. At 11:40 am client was able to ambulate to vehicle with assist from Mom and RN, kept cool packs to apply as needed. A copy of nursing note involving incident sent with mother. Mother did state during the episode that "she has never passed out before."
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Mother called clinic and reported that on 7/30/15 when she got home from work, that patient's arm was warm, swollen, red and painful to touch. Provider prescribed cephalexin 500 mg twice a day for 10 days. Instructed mother to place cold compress on site.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperaesthesia, Nodule
Clinical narrative: Knot in neck, sensitive to touch.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: Left arm tender/edema, afebrile. Plan: Ice to area 20 min per hour, increase arm movement.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: (R) arm redness, pain and swelling x 2 days s/s starting approximately 24 hrs. s/p vaccine advised cool compress, OTC pain reliever OTC H1 and H2 blocker, Prednisone taper and BACTRIM BID.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Ligament sprain
Clinical narrative: Patient felt dizzy, became pale and twisted his arm and sat on the floor. Recovered quickly after lying flat on floor, but felt tired, and had headache next day also had diarrhea.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Pallor
Clinical narrative: Patient felt dizzy, became pale and twisted his arm and sat on the floor. Recovered quickly after lying flat on floor, but felt tired, and had headache next day also had diarrhea.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Tdap given 7/29/15-arm has 3" area that is red and swollen. Not hot to touch.
Age: 1.03
Sex: M
Vaccine: HEPA, HIBV, PNC13, VARCEL
Symptoms: Rash generalised, Rash vesicular
Clinical narrative: Generalized varicella-like rash.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Patient reported that he had fever, swelling in the vaccination area, nausea, muscle aches, headache, redness in the entire arm.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Vaccination site swelling
Clinical narrative: Patient reported that he had fever, swelling in the vaccination area, nausea, muscle aches, headache, redness in the entire arm.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Redness, swelling, hot, growng, pulsing pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site urticaria, Urticaria
Clinical narrative: Shots administered at 11:30 on 7/30/15. Mom noticed a large red hive around injection area immediately after. Hives continued to spread throughout entire body, worst on trunk.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site urticaria
Clinical narrative: Pt was given Hep A vaccine in (R) thigh and developed hives around injection site within 5 minutes. Hives started going down before 5 ml of BENADRYL was given.
Age: 51.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Feeling hot, Hyperhidrosis, Injection site erythema, Injection site swelling, Pain
Clinical narrative: 7/29/15 approx 5-6:00pm client noted soreness and took TYLENOL (500mg) x2. 7/30/15 more soreness noted at 7:00AM-7:30AM. At 7:00pm after work took TYLENOL (500mg x 2) for relief. Between 10:00-10:30pm noted continued soreness-Band-Aid removed. 7/31/15 8:00AM after shower noted redness and raised area at injection site. After arrival to work referred by employee to Health Dept for review. C/O sweating and hot. C/O wetness to neck and butt area. Very sore still.
Age: 22.0
Sex: M
Vaccine: VARCEL
Symptoms: Arthropod bite, Injection site cellulitis, Injection site vesicles
Clinical narrative: Cellulitis with blisters at vaccine site. (L) arm (diagnosed as "spider bite").
Age: 55.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Blood pressure increased, Diarrhoea, Headache, Heart rate increased, Muscle spasms
Clinical narrative: Face and tongue tingling, slight fever, elevated pulse and BP, severe cramping diarrhea, headache (began w/in 1/2 hour only headache).
Age: 55.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Paraesthesia, Paraesthesia oral, Pyrexia
Clinical narrative: Face and tongue tingling, slight fever, elevated pulse and BP, severe cramping diarrhea, headache (began w/in 1/2 hour only headache).
Age: 1.05
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Rash maculo-papular, Rash pustular, Rash vesicular
Clinical narrative: 10-20 maculopapular lesions, primarily on forehead and scalp, with a few being vesicular/pustular, starting about 12 hours after below vaccines. I suspect mild reaction to VARIVAX.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: After shot could not move because of pain in shoulder. Went to urgent care received MEDROL dose pack 4 mg. NORCO 5-325 mg. FLEXERIL 10 mg after that course of treatment it did not help. Went to my orthopedic Dr and was given a shot of steroids.
Age: 10.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Red, hot, firm to touch 10cm x 7 cm in diameter. Worsening daily (area getting bigger) symptoms began 7/18. Pt returned to clinic 7/20/15.
Age: 9.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Wrong drug administered
Clinical narrative: Pt was administered KINRIX when he should have received DTaP and IPV separately, due to his age.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling
Clinical narrative: Redness under arm and little swelling around and below injection site. She only noticed it this morning when removing Band-Aid. She has had reaction before with other vaccinations.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Back pain, Chest pain, Chills, Myalgia, Pain in extremity
Clinical narrative: Vaccine on 7/29/15-Arm sore on 7/31/15-chills, muscle aches, back ache, chest ache 7/31/15-symptom, improving a little.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Chills
Clinical narrative: Vaccine on 7/29/15-Arm sore on 7/31/15-chills, muscle aches, back ache, chest ache 7/31/15-symptom, improving a little.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 19-MAR-2015, the patient was vaccinated with a dose of VAQTA (lot # K007827) 0.5 ml (expiration date, route and site of administration were not reported) that underwent temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Pruritus
Clinical narrative: Pt. claimed itching and burning of skin was give 25 mg Diphenhydramine (at pt's request).
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Haemorrhage, Induration, Mass, Swelling
Clinical narrative: Injected PREVNAR 13 and a hard lump appeared and swelled almost immediately. A capillary was hit and blood did (small amount) come out. No pussing or redness appeared.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, pain, redness. BENADRYL, hydrocortisone.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. Between the dates 05-JUN-2015 and 27-JUL-2015, the patients were vaccinated with an unspecified doses of GARDASIL lot # K014891 with expiration date 10-MAY-2017 and lot# K011562 with expiration date 08-APR-2017 (dose, strength, route of administration and expiration date were not reported) which were improperly stored. No information on patients concomitant medication was provided. No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-JUL-2015, the patient was suppose to receive a dose of (Oka/Merck) PROQUAD, (dose, route of administration, injection site, lot number and expiration date were not reported) but instead was vaccinated with a dose of M-M-R II (dose, route of administration, injection site, lot number and expiration date were not reported). No symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of GARDASIL (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects reported. Concomitant therapies were not reported. This is one of several reports received from the same reporter. Additional information has been requested.