chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 29-AUG-2014 the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 0.5 ml, intramuscularly, lot # J009827, that had expired on 10-AUG-2014. No adverse effects were reported. Additional information is not expected as there was no consent for follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Upper extremity mass
Clinical narrative: This spontaneous report as received from a pharmacist refers to a multiple patients of unknown age and gender. The pharmacist reported that an unspecified number of unspecified patients who received ZOSTAVAX on unspecified dates experienced egg-sized lumps on their arms following ZOSTAVAX administration. The outcome of the event was unknown. The causality of the events with ZOSTAVAX was not reported. This case is linked to #1409USA000505 via same reporter link. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 03-SEP-2014 the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration date were not reported) that was exposed to a temperature excursion with a high temperature of 32 degrees F (Fahrenheit) with an excursion time of 3 hours (date unspecified). This dose of ZOSTAVAX vaccine had a prior temperature excursion up to 39 degrees F for 144 hours (date unspecified). No adverse effect was reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 15 year old patient of unknown gender. On 30-AUG-2014 the 15 year old patient was vaccinated with a dose of PROQUAD (dose, route, lot# and expiration date were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to a 4 year old patient. The patient's medical history and current condition are not reported. On 7-FEB-2014 the patient was vaccinated with second dose of (oka/merck) VARIVAX (strength, dose and frequency not reported). It was reported that the patient returned for an office visit with an unspecified physician on 28-FEB-2014. The patient was vaccinated with another dose (third dose) of (oka/merck) VARIVAX and a second dose of MMR II. The first dose of MMR II was administered when the child was between 12-15 months of age on an unspecified date. No adverse events reported. Product quality complaint was not involved. The outcome of the event is unknown. 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 registered nurse refers to a patient of unknown age and gender. The patient received 2 doses of GARDASIL intramuscularly (dose and lot # not reported) on unspecified dates in 2012 (reported as unspecified dates 2 years ago) and then, on 20-AUG-2014 received the 3rd dose of GARDASIL intramuscular (dose and lot # not reported). There were no known adverse effects. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a consumer refers to a patient of unknown demography. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route and frequency were not reported). On an unknown date, date the patient experienced adverse event. The outcome of adverse event was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Herpes simplex, Pain in extremity, Paronychia
Clinical narrative: This spontaneous report as received from a male physician who is patient currently refers to a 58 year old male patient. The patient's medical history included whitlow and the current condition are not reported. On 20-AUG-2014 the patient was vaccinated with (oka/merck) VARIVAX. It was reported that a day later on 21-AUG-2014, he developed pain in his fingers. Then, 24 hours after onset of pain on his fingers, he developed vesicles on fingers which the reporter described as whitlow, herpes simplex infection. Also reported that he had experienced whitlow 30 years ago on the same fingers and he found it amazing that whitlow recurred after 30 years on the same spot, 2 days after receiving (oka/merck) VARIVAX (which is same herpes family of virus). Product quality complaint was not involved. The outcome of the events was reported as recovering/resolving. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 53 year old female patient. Patient's concurrent conditions and relevant medical history was unknown. History of drug reactions/allergies was none. On 27-AUG-2014 the patient was vaccinated with ZOSTAVAX (dose and frequency unspecified) (lot number: K003601 with expiry date of 19-MAR-2015). Concomitant therapies included thyroid medication. Pharmacist reported that after administration of ZOSTAVAX on 27-AUG-2014, the patient developed pain, itching and redness at the injection site on an unspecified date following the administration. Pharmacist reports that no rash was present. Pharmacist reported that on 29-AUG-2014, the patient reported that the red area appears to be expanding. Pharmacist states that she advised the patient to apply cool compresses to the site. The patient sought medical attention by calling the pharmacist. The outcome of the events was reported as not recovered/not resolved. The causality of the events with ZOSTAVAX was not reported. Product quality issue was not involved. This case is linked to #1409USA002986 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 03-SEP-2014 the patient was vaccinated with PROQUAD, .5 ml, subcutaneous, lot number was reported as K005884 with expiry date of 24-OCT-2015. The nurse reported that PROQUAD was improperly stored and exposed to -6.3 C for 144 hours. No adverse effect was reported. Additional information has been requested.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old patient of unknown gender. Patients concurrent conditions included rheumatoid arthritis. History of drug allergies/reactions was  none. On 26-AUG-2014 the patient was vaccinated with ZOSTAVAX 19400 PFU (dose and frequency unknown) (lot number K003597 with expiry date of 12-MAY-2015). Concomitant therapies included diazepam, pravastatin sodium and hydrochlorothiazide (manufacturer unknown). The pharmacist reported that the patient developed rash after receiving ZOSTAVAX on 26-AUG-2014. No treatment was provided for event. Patient sought medical attention by calling pharmacist. The outcome of rash was reported as not recovered/not resolved. The causality of the events with ZOSTAVAX was not reported. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abortion spontaneous, Exposure during pregnancy, Influenza
Clinical narrative: Light bleeding and discomfort with urination 2 days following flu shot  (9/12/2013-9/16/2013). Prescribed antibiotics on day 5 for a suspected-UTI but never tested positive for A UTI (9/15/2013). Beginning 8 days post-flu shot: ER visit (9/18/2013) with ultrasound and exam with a dx of threatened miscarriage due to signs of cervix shortening/external os opening, heavier bleeding, and cramping. Bed rest for 4 days  (9/18/2013- 9/22/2013). 12 days post-flu shot: intermittent fever, chills, vomiting, contractions, bleeding w/clots  (9/22/2013). 13 days post-flu shot: spontaneous abortion at 16 weeks 2 days gestation. Testing showed no chromosomal abnormalities but did show signs of infection - increased WBC on pathology reports from hospital (9/23/2013).
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abortion spontaneous, Abortion threatened, Bed rest, Chills, Chromosome analysis normal
Clinical narrative: Light bleeding and discomfort with urination 2 days following flu shot  (9/12/2013-9/16/2013). Prescribed antibiotics on day 5 for a suspected-UTI but never tested positive for A UTI (9/15/2013). Beginning 8 days post-flu shot: ER visit (9/18/2013) with ultrasound and exam with a dx of threatened miscarriage due to signs of cervix shortening/external os opening, heavier bleeding, and cramping. Bed rest for 4 days  (9/18/2013- 9/22/2013). 12 days post-flu shot: intermittent fever, chills, vomiting, contractions, bleeding w/clots  (9/22/2013). 13 days post-flu shot: spontaneous abortion at 16 weeks 2 days gestation. Testing showed no chromosomal abnormalities but did show signs of infection - increased WBC on pathology reports from hospital (9/23/2013).
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysuria, Exposure during pregnancy, Haemorrhage in pregnancy, Haemorrhage urinary tract, Pyrexia
Clinical narrative: Light bleeding and discomfort with urination 2 days following flu shot  (9/12/2013-9/16/2013). Prescribed antibiotics on day 5 for a suspected-UTI but never tested positive for A UTI (9/15/2013). Beginning 8 days post-flu shot: ER visit (9/18/2013) with ultrasound and exam with a dx of threatened miscarriage due to signs of cervix shortening/external os opening, heavier bleeding, and cramping. Bed rest for 4 days  (9/18/2013- 9/22/2013). 12 days post-flu shot: intermittent fever, chills, vomiting, contractions, bleeding w/clots  (9/22/2013). 13 days post-flu shot: spontaneous abortion at 16 weeks 2 days gestation. Testing showed no chromosomal abnormalities but did show signs of infection - increased WBC on pathology reports from hospital (9/23/2013).
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Shortened cervix, Ultrasound antenatal screen abnormal, Urinary tract infection, Uterine contractions during pregnancy, Uterine spasm
Clinical narrative: Light bleeding and discomfort with urination 2 days following flu shot  (9/12/2013-9/16/2013). Prescribed antibiotics on day 5 for a suspected-UTI but never tested positive for A UTI (9/15/2013). Beginning 8 days post-flu shot: ER visit (9/18/2013) with ultrasound and exam with a dx of threatened miscarriage due to signs of cervix shortening/external os opening, heavier bleeding, and cramping. Bed rest for 4 days  (9/18/2013- 9/22/2013). 12 days post-flu shot: intermittent fever, chills, vomiting, contractions, bleeding w/clots  (9/22/2013). 13 days post-flu shot: spontaneous abortion at 16 weeks 2 days gestation. Testing showed no chromosomal abnormalities but did show signs of infection - increased WBC on pathology reports from hospital (9/23/2013).
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: Light bleeding and discomfort with urination 2 days following flu shot  (9/12/2013-9/16/2013). Prescribed antibiotics on day 5 for a suspected-UTI but never tested positive for A UTI (9/15/2013). Beginning 8 days post-flu shot: ER visit (9/18/2013) with ultrasound and exam with a dx of threatened miscarriage due to signs of cervix shortening/external os opening, heavier bleeding, and cramping. Bed rest for 4 days  (9/18/2013- 9/22/2013). 12 days post-flu shot: intermittent fever, chills, vomiting, contractions, bleeding w/clots  (9/22/2013). 13 days post-flu shot: spontaneous abortion at 16 weeks 2 days gestation. Testing showed no chromosomal abnormalities but did show signs of infection - increased WBC on pathology reports from hospital (9/23/2013).
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEPA, MMRV, PNC13
Symptoms: Abnormal behaviour, Aphasia, Childhood disintegrative disorder, Decreased appetite, Fatigue
Clinical narrative: She became sick, vomited, lack of appetite, fever, fatigue, and had to be hospitalized. Stopped interacting with anyone, was withdrawn. Lost all her learned words/speech and skills. Stopped interacting with family and did not make any sounds. Behavior changed drastically.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEPA, MMRV, PNC13
Symptoms: Malaise, Pyrexia, Social avoidant behaviour, Vomiting
Clinical narrative: She became sick, vomited, lack of appetite, fever, fatigue, and had to be hospitalized. Stopped interacting with anyone, was withdrawn. Lost all her learned words/speech and skills. Stopped interacting with family and did not make any sounds. Behavior changed drastically.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Fall, Laceration, Loss of consciousness, Spinal X-ray
Clinical narrative: Dizziness, passed out, fell from standing position to floor. Cut chin, fractured front teeth.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Tooth fracture
Clinical narrative: Dizziness, passed out, fell from standing position to floor. Cut chin, fractured front teeth.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Decreased appetite, Insomnia, Pyrexia
Clinical narrative: Fever, loss of appetite, loss of sleep, lasted 4 days.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Rash, Rash pruritic
Clinical narrative: Itching rash and slight swelling around throat and rash on forearms.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dry eye, Dysphonia, Eye pruritus, Fatigue
Clinical narrative: Symptoms began with scratchy throat and hoarseness, dry itchy eyes, after about 1 hour chills and fever began, fever maxed out at 102 degrees and continued through the night. Upon awaking at 7 am hives began and continued until about 1 hour after administration of t capsule  25 mg Benadryl, fatigue and muscle aches continued throughout the day 09/07/2014.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pyrexia, Throat irritation, Urticaria
Clinical narrative: Symptoms began with scratchy throat and hoarseness, dry itchy eyes, after about 1 hour chills and fever began, fever maxed out at 102 degrees and continued through the night. Upon awaking at 7 am hives began and continued until about 1 hour after administration of t capsule  25 mg Benadryl, fatigue and muscle aches continued throughout the day 09/07/2014.
Age: 66.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Moderate-severe muscle pain in deltoid evening after then pain subsided and soreness remains in bicep and warmth, redness and swelling seen in tricep area.
Age: 68.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Dyspnoea, Eye discharge, Eye pruritus, Eye swelling, Ocular hyperaemia
Clinical narrative: Swollen tongue, throat, mouth, trouble breathing, red swollen itchy eyes with discharge, sore throat, shaking.
Age: 68.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Oedema mouth, Oropharyngeal pain, Pharyngeal oedema, Swollen tongue, Tremor
Clinical narrative: Swollen tongue, throat, mouth, trouble breathing, red swollen itchy eyes with discharge, sore throat, shaking.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Rash
Clinical narrative: Patient developed loaclized rash/erythema on left arm.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Chills, Condition aggravated, Confusional state, Pain
Clinical narrative: Fever, chills, body aches, confusion, anxiety.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever, chills, body aches, confusion, anxiety.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Fatigue, Feeling abnormal, Full blood count normal, Gait disturbance
Clinical narrative: At approximately 12 noon on 09/04/2014 (approx 5 hrs after flu vaccine) I began to have extreme nasal congestion and general feelings of fatigue. That night symptoms progressed to fever of 100-101 degrees with extreme chills and rigors. The next morning on 09/05/2014 I was extremely dizzy, continued with rigors, chills, and fever, "foggy" mental status, and could hardly walk due to weakness in my legs. Nasal congestion continued to be present. Thinking I had a virus of some kind, I went to an urgent care clinic. They immediately sent me to an ER where I received 2 Liters of Normal Saline IV. I tested negative for influenza & WBC was 11,000. UA was negative, the rest of my CBC was normal, CMP was normal. The fluids improved my symptoms, but did not make them completely go away & I was sent home. I was in the ER for approximately 5-6hrs. I continued the rest of that day and night of 09/05/14 with weakness, severe chills and rigors, and fever. Vital signs showed tachycardia & temp of 100.1 on ER visit. BP, SPO2 normal. On 09/06/2014 my symptoms were completely resolved.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza virus test negative, Metabolic function test, Metabolic function test normal, Muscular weakness, Nasal congestion
Clinical narrative: At approximately 12 noon on 09/04/2014 (approx 5 hrs after flu vaccine) I began to have extreme nasal congestion and general feelings of fatigue. That night symptoms progressed to fever of 100-101 degrees with extreme chills and rigors. The next morning on 09/05/2014 I was extremely dizzy, continued with rigors, chills, and fever, "foggy" mental status, and could hardly walk due to weakness in my legs. Nasal congestion continued to be present. Thinking I had a virus of some kind, I went to an urgent care clinic. They immediately sent me to an ER where I received 2 Liters of Normal Saline IV. I tested negative for influenza & WBC was 11,000. UA was negative, the rest of my CBC was normal, CMP was normal. The fluids improved my symptoms, but did not make them completely go away & I was sent home. I was in the ER for approximately 5-6hrs. I continued the rest of that day and night of 09/05/14 with weakness, severe chills and rigors, and fever. Vital signs showed tachycardia & temp of 100.1 on ER visit. BP, SPO2 normal. On 09/06/2014 my symptoms were completely resolved.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Urine analysis normal, White blood cell count increased
Clinical narrative: At approximately 12 noon on 09/04/2014 (approx 5 hrs after flu vaccine) I began to have extreme nasal congestion and general feelings of fatigue. That night symptoms progressed to fever of 100-101 degrees with extreme chills and rigors. The next morning on 09/05/2014 I was extremely dizzy, continued with rigors, chills, and fever, "foggy" mental status, and could hardly walk due to weakness in my legs. Nasal congestion continued to be present. Thinking I had a virus of some kind, I went to an urgent care clinic. They immediately sent me to an ER where I received 2 Liters of Normal Saline IV. I tested negative for influenza & WBC was 11,000. UA was negative, the rest of my CBC was normal, CMP was normal. The fluids improved my symptoms, but did not make them completely go away & I was sent home. I was in the ER for approximately 5-6hrs. I continued the rest of that day and night of 09/05/14 with weakness, severe chills and rigors, and fever. Vital signs showed tachycardia & temp of 100.1 on ER visit. BP, SPO2 normal. On 09/06/2014 my symptoms were completely resolved.
Age: 26.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash maculo-papular, Tenderness
Clinical narrative: Maculo-papular rash on area, tender and itching after varicella vaccine. CLARITIN advice and sent to PCP.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Inflammation, Injection site pain
Clinical narrative: Pt. reported achiness, soreness around the injection site. Red, inflamed area on the biceps. Went to ER just in case - MD suggested ice, TYLENOL and CLARITIN.
Age: 76.0
Sex: F
Vaccine: FLUC3
Symptoms: Blood glucose increased, Chills, Dizziness, Fatigue, Flushing
Clinical narrative: Started 2 days after vaccine, headache, low grade fever, nausea (mild), dizziness, exhaustion, malaise, sleeplessness, throat irritation, chills, flushing, symptoms have occurred since 2 days after having the vaccine; blood sugar also more elevated. Currently being treated with magic mouthwash for throat irritation.
Age: 76.0
Sex: F
Vaccine: FLUC3
Symptoms: Headache, Insomnia, Malaise, Nausea, Pyrexia
Clinical narrative: Started 2 days after vaccine, headache, low grade fever, nausea (mild), dizziness, exhaustion, malaise, sleeplessness, throat irritation, chills, flushing, symptoms have occurred since 2 days after having the vaccine; blood sugar also more elevated. Currently being treated with magic mouthwash for throat irritation.
Age: 76.0
Sex: F
Vaccine: FLUC3
Symptoms: Throat irritation
Clinical narrative: Started 2 days after vaccine, headache, low grade fever, nausea (mild), dizziness, exhaustion, malaise, sleeplessness, throat irritation, chills, flushing, symptoms have occurred since 2 days after having the vaccine; blood sugar also more elevated. Currently being treated with magic mouthwash for throat irritation.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Local swelling, Pain in extremity, Skin warm
Clinical narrative: When given shot it hurt that night arm was sore next morning it became swollen, hot, and red. 3 days later area is still swollen and red and the bruising has spread down the arm.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, red, swelling around injection site. Seem to have spread from injection site. Been about a week since injection.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to an 8 year old patient. On 14-JUL-2014 the patient was vaccinated with VARIVAX (Merck) (lot # J013905, EXP 30-OCT-2015, dose and route not reported) which was stored improperly. On 29-MAY-2014 M-M-R II (HSA, lot # J003785, EXP 28-MAR-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haemorrhage, Injection site mass, Injection site pain
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of approximately 55 years age. No current condition was reported. It was reported that there was no pertinent medical history. Patient had no drug allergies. On 29-AUG-2014 the patient was vaccinated with ZOSTAVAX (lot number reported K007986 expiration date 03-SEP-2015), (dose strength and route was unknown). It was reported that patient was had no other medications. On an unknown date approximately in 2014, the patient experienced raised bumps around the injection site 24 hours after the administration of the ZOSTAVAX. As reported, the nurse practitioner saw the patient today, 02-SEP-2014, and the injection site had an ecchymotic area around it but no redness or raised areas and no vesicles. The patient did not experience any itching at injection. No treatment was given. No further information provided. The outcome of raised bumps around the injection site and injection site pain had an ecchymotic area was reported as resolving. Patient sough Medical Attention. Causality was unknown. No PQC involved. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 year old patient. On 28-JUL-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # J014229, expiration date 08-NOV-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Cellulitis, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Case number PHHY2014US092323 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 516343) website on 24 Jul 2014, and with a follow-up information received from Quality Assurance Department (reference number: 316053) on 25 Aug 2014. This report refers to a 13 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M13058 and expiry date: May 2014) and GARDASIL (other manufacturer, batch number: J012212); both vaccines administered intramuscularly in the right arm on 09 Dec 2013. On 10 Dec 2013, she experienced pain, redness and swelling below the vaccination site of the right upper arm at 3 pm. It was reported that the redness spread and started to become indurated and warm in the site. She also had some tenderness on palpation of the site. She also experienced headache and nausea, but had no fever. She went to emergency room and was diagnosed with cellulitis. She was treated with DURICEF. The event outcome was reported as unknown. The event was reported as non-serious, but was internally upgraded by the agency. The causality was not reported. Based on the investigation performed, the QA department stated that, MENVEO vaccine (batch number: M13058) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 316053) on 31 Jul 2014: Updated QA number. Follow-up information received from Quality Assurance Department (reference number: 316053) on 25 Aug 2014: Updated batch review report.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site warmth, Nausea, Vaccination site pain, Vaccination site swelling
Clinical narrative: Case number PHHY2014US092323 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 516343) website on 24 Jul 2014, and with a follow-up information received from Quality Assurance Department (reference number: 316053) on 25 Aug 2014. This report refers to a 13 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M13058 and expiry date: May 2014) and GARDASIL (other manufacturer, batch number: J012212); both vaccines administered intramuscularly in the right arm on 09 Dec 2013. On 10 Dec 2013, she experienced pain, redness and swelling below the vaccination site of the right upper arm at 3 pm. It was reported that the redness spread and started to become indurated and warm in the site. She also had some tenderness on palpation of the site. She also experienced headache and nausea, but had no fever. She went to emergency room and was diagnosed with cellulitis. She was treated with DURICEF. The event outcome was reported as unknown. The event was reported as non-serious, but was internally upgraded by the agency. The causality was not reported. Based on the investigation performed, the QA department stated that, MENVEO vaccine (batch number: M13058) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 316053) on 31 Jul 2014: Updated QA number. Follow-up information received from Quality Assurance Department (reference number: 316053) on 25 Aug 2014: Updated batch review report.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cochlea implant, Deafness, Hypoacusis
Clinical narrative: Case number PHHY2014US090181 is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 531591) website on 22 Jul 2014 and a follow up report received from the consumer via VAERS on 27 Aug 2014 and a follow up report from the VAERS received on 03 Sep 2014. This report refers to a 45-year-old female patient. Her medical history included hard of hearing. Concomitant medications included NEXIUM and PROZAC. She was vaccinated with FLUVIRIN, (batch number: not reported) in the left arm on 27 Oct 2013. On the same date after vaccination, sounds starting sounding muffled and then next day she was completely deaf. She went to a hearing specialist and she received cortisone shot in the ear drum which did not help. She had a cochlear implant. The final outcome of the event was reported as condition unchanged. The consumer reported the events as serious due to permanent disability. The causality of the event was not reported. Follow up report received from the consumer via VAERS on 27 Aug 2014: Updated suspect vaccine coding from Seasonal Influenza vaccine to FLUVIRIN. Follow up report received from the consumer via VAERS on 03 Sep 2014: Added concomitant medications.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Condition aggravated, Deafness, Hypoacusis
Clinical narrative: Case number PHHY2014US090181 is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 531591) website on 22 Jul 2014 and a follow up report received from the consumer via VAERS on 27 Aug 2014 and a follow up report from the VAERS received on 03 Sep 2014. This report refers to a 45-year-old female patient. Her medical history included hard of hearing. Concomitant medications included NEXIUM and PROZAC. She was vaccinated with FLUVIRIN, (batch number: not reported) in the left arm on 27 Oct 2013. On the same date after vaccination, sounds starting sounding muffled and then next day she was completely deaf. She went to a hearing specialist and she received cortisone shot in the ear drum which did not help. She had a cochlear implant. The final outcome of the event was reported as condition unchanged. The consumer reported the events as serious due to permanent disability. The causality of the event was not reported. Follow up report received from the consumer via VAERS on 27 Aug 2014: Updated suspect vaccine coding from Seasonal Influenza vaccine to FLUVIRIN. Follow up report received from the consumer via VAERS on 03 Sep 2014: Added concomitant medications.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL, HEPA, MNQ, VARCEL
Symptoms: Convulsion, Loss of consciousness
Clinical narrative: Case number PHHY2014US112682 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 535263) website on 03 Sep 2014. This report refers to a 13-year-old female patient. Historical conditions were none. Concomitant medications were none. Vaccination history included DTP vaccine (unknown manufacturer, batch number: not reported), IVP (unknown manufacturer, batch number: not reported) and MMR disease vaccine (unknown manufacturer, batch number: not reported). She was vaccinated with MENVEO, (batch number: M13030) intramuscularly into the right arm along with HAVRIX, (batch number: 9K22D) intramuscularly into the left arm and VARIVAX, (batch number: J013728) subcutaneously into the left arm on 03 Jun 2014. On the same day after vaccination, she became unconscious and had two seizures post receiving the MCV, Hep A and Varicella. She was transferred to the hospital via ambulance then on to another Hospital on 06 Jun 2014 but was released at 4:00 AM. Neurologist said it was from having a Varicella at 4 years then one on 03 Jun 2014. However child did not have Varicella at 4 years. Her mom was requesting cardiology referral from PCP as child father had a similar issue at a young age. She was hospitalized for one day. The final outcome of the events was complete recovery. Causality was not reported.
Age: 31.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 31 year old female patient. None of pertinent medical history and none of drug reactions/allergies were reported. On 05-AUG-2014 the patient was vaccinated with a dose of 0.5 ml VARIVAX (Merck) (lot# K002919, expiration date: 26-FEB-2016), once, subcutaneously and a dose of M-M-R II (strength, dose, frequency and lot# unknown) in separate arms (also reported as for going to nursing school). None of concomitant medication was reported. The patient called in to the pharmacy on 07-AUG-2014, stating she developed a rash at the VARIVAX (Merck) injection site on 06-AUG-2014 and on 07-AUG-2014 when she work up it was worse, it had spread. No treatment was given for adverse event. None of lab diagnostics studies was performed. The outcome of event was not recovered. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 31 year old female patient. None of pertinent medical history and none of drug reactions/allergies were reported. On 05-AUG-2014 the patient was vaccinated with a dose of 0.5 ml VARIVAX (Merck) (lot# K002919, expiration date: 26-FEB-2016), once, subcutaneously and a dose of M-M-R II (strength, dose, frequency and lot# unknown) in separate arms (also reported as for going to nursing school). None of concomitant medication was reported. The patient called in to the pharmacy on 07-AUG-2014, stating she developed a rash at the VARIVAX (Merck) injection site on 06-AUG-2014 and on 07-AUG-2014 when she work up it was worse, it had spread. No treatment was given for adverse event. None of lab diagnostics studies was performed. The outcome of event was not recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Loss of consciousness, Malaise, Nausea, Seizure like phenomena, Somnolence
Clinical narrative: Case number PHEH2014US017016 is an initial spontaneous report received from a nurse on 21 Aug 2014, with a combined follow up report received from a nurse on 26 Aug 2014 and 27 Aug 2014 respectively. This report refers to a 17 year old female patient. She had no known allergies to any food, medications or vaccinations and had no medical history of seizures in the past. Her concomitant medications were not reported. On 14 Aug 2014, she was vaccinated with MENVEO (batch number: X14031) intramuscularly into his left arm, with ADACEL (batch number: not reported) into his right arm and GARDASIL (batch number: not reported) into his left arm. On the same day after vaccination, she expressed that she did not feel well and then passed out after 10-15 seconds of the vaccination. It was reported that 911 was called immediately when she passed out. The nurse brought ammonia to help wake the patient up after passing out, but she had no response to the ammonia. She immediately had a seizure that lasted anywhere from 30-60 seconds. She was not hospitalized. The final outcome of the events was unknown. The seriousness and causality was not reported. Following an internal review for the data received on 21 Aug 2014 a non-significant correction was performed: The initial MRD was changed from 21 Aug 2014 to 20 Aug 2014. Combined follow up report was received from nurse on 26 Aug 2014 and on 27 Aug 2014 respectively: patient demographics, batch number of MENVEO, new events (passed out and did not feel well) and other clinically  relevant information were updated. Non-significant follow-up information received from the Quality Assurance Department (reference number: 323446) on 05 Sep 2014: Updated QA reference number only.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Convulsion, Immediate post-injection reaction, Loss of consciousness, Malaise, Unresponsive to stimuli
Clinical narrative: Case number PHEH2014US017016 is an initial spontaneous report received from a nurse on 21 Aug 2014, with a combined follow up report received from a nurse on 26 Aug 2014 and 27 Aug 2014 respectively. This report refers to a 17 year old female patient. She had no known allergies to any food, medications or vaccinations and had no medical history of seizures in the past. Her concomitant medications were not reported. On 14 Aug 2014, she was vaccinated with MENVEO (batch number: X14031) intramuscularly into his left arm, with ADACEL (batch number: not reported) into his right arm and GARDASIL (batch number: not reported) into his left arm. On the same day after vaccination, she expressed that she did not feel well and then passed out after 10-15 seconds of the vaccination. It was reported that 911 was called immediately when she passed out. The nurse brought ammonia to help wake the patient up after passing out, but she had no response to the ammonia. She immediately had a seizure that lasted anywhere from 30-60 seconds. She was not hospitalized. The final outcome of the events was unknown. The seriousness and causality was not reported. Following an internal review for the data received on 21 Aug 2014 a non-significant correction was performed: The initial MRD was changed from 21 Aug 2014 to 20 Aug 2014. Combined follow up report was received from nurse on 26 Aug 2014 and on 27 Aug 2014 respectively: patient demographics, batch number of MENVEO, new events (passed out and did not feel well) and other clinically  relevant information were updated. Non-significant follow-up information received from the Quality Assurance Department (reference number: 323446) on 05 Sep 2014: Updated QA reference number only.
Age: 50.0
Sex: M
Vaccine: DTAP
Symptoms: Arthralgia, Malaise, Myalgia
Clinical narrative: Diffuse myalgia, arthralgia, malaise for 2 days, not sure if fever. OTC meds only.
Age: 70.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dyspepsia, Gastrooesophageal reflux disease, Urticaria pressure
Clinical narrative: Pressure urticarial on buttocks and hands.  Also indigestion like acid reflux.
Age: 70.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Urticaria
Clinical narrative: Pressure urticarial on buttocks and hands.  Also indigestion like acid reflux.
Age: 70.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dyspepsia, Gastrooesophageal reflux disease, Hypersensitivity, Swelling, Urticaria
Clinical narrative: Pressure urticarial on buttocks and hands.  Also indigestion like acid reflux.
Age: 70.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dyspepsia, Gastrooesophageal reflux disease, Urticaria pressure
Clinical narrative: Urticaria - as named by patient. Topical and oral antihistamine. Patient to visit doctor on 9-9-14.
Age: 70.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Urticaria
Clinical narrative: Urticaria - as named by patient. Topical and oral antihistamine. Patient to visit doctor on 9-9-14.
Age: 70.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dyspepsia, Gastrooesophageal reflux disease, Hypersensitivity, Swelling, Urticaria
Clinical narrative: Urticaria - as named by patient. Topical and oral antihistamine. Patient to visit doctor on 9-9-14.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Acne, Rash
Clinical narrative: 08/08/14-Mom reported rash on trunk of body with "zit-like" spots on his side. No fever, good PO. She also called to say rash ongoing for 2 weeks. No medical treatment sought.
Age: 11.0
Sex: M
Vaccine: DTAP, FLUN4, HPV4, MNQ
Symptoms: Abdominal pain upper, Dizziness, Dystonia, Headache, Vomiting
Clinical narrative: Severe stomach pain, vomiting, severe headache at top of head, lightheadedness, dystonic movement of legs and shoulders.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Full blood count, Injection site erythema, Injection site pain, Injection site warmth, Laboratory test
Clinical narrative: Patient began complaining of leg pain where injection given.  Leg was red and warm.  Patient started running fever the evening of the injection.  Advised warm compresses and tylenol and return if no better. Presented to the ED 9/5 and received IM and IV antibiotics and sent home with PO antibiotics.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Pyrexia, X-ray limb
Clinical narrative: Patient began complaining of leg pain where injection given.  Leg was red and warm.  Patient started running fever the evening of the injection.  Advised warm compresses and tylenol and return if no better. Presented to the ED 9/5 and received IM and IV antibiotics and sent home with PO antibiotics.
Age: 48.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Loss of consciousness
Clinical narrative: A 48 year-old male patient had received on 18 August 2014 an intramuscular injection of Tdap vaccine, lot number FL2P2 (not a valid Sanofi Pasteur lot number, site of administration not reported) and one day later on 19 August 2014, the patient reported passing out. The patient's last Tdap was over 10 years ago. The patient's has a history of multiple vaccinations (illegible). Other medication, illness at time of vaccination and pre-existing conditions were none. No further information was provided at the time of the report. Outcome was recovered. Documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Chronic inflammatory demyelinating polyradiculoneuropathy, Computerised tomogram, Dysstasia, Electromyogram
Clinical narrative: Weakness in arms, legs and hands. Could not stand or walk without assistance, pain, numbness. Diagnosis: GBS (Guillain-Barre syndrome) CIDP (chronic inflammatory demyelinating polyneuropathy). (IVIG infusion).
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture
Clinical narrative: Weakness in arms, legs and hands. Could not stand or walk without assistance, pain, numbness. Diagnosis: GBS (Guillain-Barre syndrome) CIDP (chronic inflammatory demyelinating polyneuropathy). (IVIG infusion).
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Nerve conduction studies, Pain, Walking aid user
Clinical narrative: Weakness in arms, legs and hands. Could not stand or walk without assistance, pain, numbness. Diagnosis: GBS (Guillain-Barre syndrome) CIDP (chronic inflammatory demyelinating polyneuropathy). (IVIG infusion).
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site mass, Mass excision
Clinical narrative: Surgical removal of mass at injection site.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Dizziness, Tinnitus, Vomiting
Clinical narrative: Dizzy, no balance, could not hold down any food, starting 2 hrs after shot, lasting 4 days, ears still ring.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Skin infection
Clinical narrative: Patient treated for skin infection following ZOSTAVAX administration.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: Swelling, redness, hot to touch, arm pain. Treatment: Depo-Medrol 80 mg - injection - one time. Clindamycin 300 mg 1 tab - 3 times a day.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever, chills, swelling and redness tenderness at injection site.
Age: 65.0
Sex: M
Vaccine: TDAP
Symptoms: Blindness unilateral, Cough, Impaired work ability, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: I received the tetanus pertussis shot in Oct 30, 2013. In Jan I got a cough that lasted til April. My body stiffened up neck, jaw, shoulders, hips, legs and I lost my vision in my right eye. Only 20/100 vision. I was medically disqualified from my job.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever, chills, redness and swelling, tenderness at injection site.
Age: 51.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Diarrhoea, Fatigue, Headache, Pyrexia, Rash
Clinical narrative: Pt received MMR 8-20-14. EE notified his  supervisor on 9-4-14 of symptoms and DX from Dr. Symptoms: Rash over chest, back, abd, fatigue, fever, HA, diarrhea. F/U appt 9/8/14.
Age: 51.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Headache, Irritability, Malaise, Measles, Night sweats
Clinical narrative: Pt received MMR 8-20-14. EE notified his  supervisor on 9-4-14 of symptoms and DX from Dr. Symptoms: Rash over chest, back, abd, fatigue, fever, HA, diarrhea. F/U appt 9/8/14.
Age: 51.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Pt received MMR 8-20-14. EE notified his  supervisor on 9-4-14 of symptoms and DX from Dr. Symptoms: Rash over chest, back, abd, fatigue, fever, HA, diarrhea. F/U appt 9/8/14.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: REDNESS, SWELLING & ITCHING.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Flatulence, Malaise, Pyrexia
Clinical narrative: Severe flatulence [atypical for me] lasting about four hours; followed by intense, profuse diarrhea.  Diarrhea lasted another four hours or so.  Also had minor fever/chills, which are not a concern.  Still feel 'under-the-weather' twenty-four hours later [at time of this reporting].
Age: 24.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt was inadvertently given Tdap instead of Gardasil.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a Nurse Practitioner refers to a 21 year old pregnant female patient with acne and "behavior health issue" and no drug reactions or allergies. On 25-AUG-2014 the patient was vaccinated with a first dose in the GARDASIL (dose, route, lot # and expiration date were not reported) series. Concomitant therapies included doxycycline and RETIN-A. The patient was determined to be pregnant (unspecified pregnancy test) during the same visit she ws vaccinated with GARDASIL (on 26-AUG-2014). The patient's LMP (last menstrual period) was on an unspecified date, in July 2014 and EDD (estimated date of delivery) was not reported. No adverse effect was reported. The patient was not treated for the event. At the time of the report the pregnancy outcome was pending and the fetal outcome was unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a Nurse Practitioner refers to a 21 year old pregnant female patient with acne and "behavior health issue" and no drug reactions or allergies. On 25-AUG-2014 the patient was vaccinated with a first dose in the GARDASIL (dose, route, lot # and expiration date were not reported) series. Concomitant therapies included doxycycline and RETIN-A. The patient was determined to be pregnant (unspecified pregnancy test) during the same visit she ws vaccinated with GARDASIL (on 26-AUG-2014). The patient's LMP (last menstrual period) was on an unspecified date, in July 2014 and EDD (estimated date of delivery) was not reported. No adverse effect was reported. The patient was not treated for the event. At the time of the report the pregnancy outcome was pending and the fetal outcome was unknown. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Mom called on 8/29/14 reported area of MMRV was red, swollen and area was hard. Describes size 2 in x 1 in. Mom states he is acting alright since he got home from school. Per Dr tx with BENADRYL, TYLENOL and apply ice.