chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to two unspecified patients. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (lot # J008799, expiration date 16-APR-2015). The two unspecified patients developed cellulitis after vaccinated with PNEUMOVAX 23. The outcome of cellulitis was unknown. The pharmacist requested a lot check for J008799. This is one of several reports from same source. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from licensed register nurse, concerning a 14 year old male patient. Patient's pertinent medical history, drug reactions/allergies were not provided. On 02-JUN-2014, the patient was vaccinated with a first dose of GARDASIL, right deltoid, lot # J009788 and expiration date on 17-MAR-2016; which was improperly stored. No adverse reaction reported. This is one of several reports received from the same source. Additional information is not expected, all follow ups requested to complete the case were received.
Age: 17.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Eye pain, Headache, Optic neuritis, Visual field tests abnormal
Clinical narrative: The patient suffered from severe headache and eye aches, after he received the vaccine (HPV) shot. He went for a medical evaluation. The diagnostic the doctor gave him was bilateral optical neuritis. He was treated with intravenous steroids during 3 days.
Age: 38.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Erythema, Feeling hot, Swelling, Tenderness
Clinical narrative: Decreased erythema, edema, pain, decreased ROM, rash, minor itching.
Age: 38.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Erythema, Joint range of motion decreased, Oedema, Pain, Pruritus
Clinical narrative: Decreased erythema, edema, pain, decreased ROM, rash, minor itching.
Age: 38.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Rash
Clinical narrative: Decreased erythema, edema, pain, decreased ROM, rash, minor itching.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Swelling face
Clinical narrative: Swollen face.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Migraine, Pruritus
Clinical narrative: Patient experienced an expanded region of about 10 inches with erythema and pruritus within about 6 hours and lasted for 4 days. She also developed a migraine within 10 hours of administration.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Alopecia, Alopecia areata, Anti-thyroid antibody negative, Antinuclear antibody negative, Blood glucose increased
Clinical narrative: The pt. received an Influenza vaccination (IIV) on 9/13/13. About 10 days later he experienced "moderate to severe" generalized muscle aches which lasted about 2-3 weeks and resolved without intervention. The pt. denied experiencing, fever, chills, N, V, headache or arthralgias. The pt. states that when he had his Influenza vaccination (TIV) 5/24/13 (a condition of employment) he noted about 2 weeks of fatigue which started about 10 days after vaccination receipt. Prior to this time the pt. does not recall getting an Influenza vaccination. The pt's daughter and barber noted a "bald spot" at the back of his head in the Dec/Jan timeframe. The pt. visited dermatology 2/24/14. His exam revealed a 3x3 cm well demarcated alopecia patch at the occiput (left side) and was diagnosed with Alopecia Areata. The pt. declined treatment. As of 7/14/14, the pt. has not experienced any additional autoimmune illness. According to the pt, the area of hair loss has expanded slightly.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Blood thyroid stimulating hormone normal, Condition aggravated, Fatigue, Lipids normal, Metabolic function test normal
Clinical narrative: The pt. received an Influenza vaccination (IIV) on 9/13/13. About 10 days later he experienced "moderate to severe" generalized muscle aches which lasted about 2-3 weeks and resolved without intervention. The pt. denied experiencing, fever, chills, N, V, headache or arthralgias. The pt. states that when he had his Influenza vaccination (TIV) 5/24/13 (a condition of employment) he noted about 2 weeks of fatigue which started about 10 days after vaccination receipt. Prior to this time the pt. does not recall getting an Influenza vaccination. The pt's daughter and barber noted a "bald spot" at the back of his head in the Dec/Jan timeframe. The pt. visited dermatology 2/24/14. His exam revealed a 3x3 cm well demarcated alopecia patch at the occiput (left side) and was diagnosed with Alopecia Areata. The pt. declined treatment. As of 7/14/14, the pt. has not experienced any additional autoimmune illness. According to the pt, the area of hair loss has expanded slightly.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Thyroxine free normal
Clinical narrative: The pt. received an Influenza vaccination (IIV) on 9/13/13. About 10 days later he experienced "moderate to severe" generalized muscle aches which lasted about 2-3 weeks and resolved without intervention. The pt. denied experiencing, fever, chills, N, V, headache or arthralgias. The pt. states that when he had his Influenza vaccination (TIV) 5/24/13 (a condition of employment) he noted about 2 weeks of fatigue which started about 10 days after vaccination receipt. Prior to this time the pt. does not recall getting an Influenza vaccination. The pt's daughter and barber noted a "bald spot" at the back of his head in the Dec/Jan timeframe. The pt. visited dermatology 2/24/14. His exam revealed a 3x3 cm well demarcated alopecia patch at the occiput (left side) and was diagnosed with Alopecia Areata. The pt. declined treatment. As of 7/14/14, the pt. has not experienced any additional autoimmune illness. According to the pt, the area of hair loss has expanded slightly.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash with pain/itch to area around where shot was given.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Local swelling, Pyrexia
Clinical narrative: Shoulder and arm area swollen (left). Low grade fever 100.5 treated with TYLENOL, down to 99 degrees this afternoon.
Age: 1.03
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Exposure to communicable disease, Rash
Clinical narrative: Patient has been exposed on a daily basis to her Aunt who has had a rash that was thought to be auto-immune but with testing discovered to be varicella. She developed a rash on 7/13/14.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient with low thyroid, heartburn and unknown reaction to prednisone (manufacturer unknown). On 04-JUL-2014 the patient was vaccinated with ZOSTAVAX (strength and dose not reported, frequency: single dose) (lot # reported as J016882, exp. date 04-JAN-2015), subcutaneous in the left arm. Concomitant medication included antacid medication and thyroid supplement. On 05-JUL-2014, 2 days after onset of therapy the patient experienced a 3 inch by 3 inch area of redness, itching and swelling at the injection site. No laboratory diagnostics studies were performed. The patient sought medical attention by coming to pharmacy. No treatment was given. No lab diagnostic was performed. The outcome of the event was unknown. The relatedness between the event and suspect drug was not reported. Lot number (J016882) is an invalid lot number for ZOSTAVAX. Additional information has been requested.
Age: 0.1
Sex: F
Vaccine: HEP
Symptoms: Death neonatal
Clinical narrative: Information has been received via social media (website) regarding a 5-week old female, who on an unspecified date received the RECOMBIVAX HB. The parent (not further specified if a mother or father) reported that "My 5-week old daughter died within hours of getting the Hepatitis B vaccine." No further information was reported.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified patient of unknown age and gender. On an unkonwn date two pediatric doses of VAQTA (dose, lot# expiry date and indication were not reported), were administered to unspecified adult patient rather than one adult dose of VAQTA. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to unspecified number of patients with unknown demography. On an unknown date, unspecified number of patients were administered improperly stored VARIVAX (Merck) (dose, route and frequency were not reported) with temperature excursion. No adverse effects reported. No additional information provided. 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 healthcare worker refers to a patient of unknown age and gender. On July 2013, the patient was vaccinated with GARDASIL dose 1 (dose and route not provided). On October 2013, the patient was vaccinated with GARDASIL dose 2 (dose and route not provided). On July 2014, the patient was vaccinated with GARDASIL dose 3 (dose and route not provided). The healthcare worker reported, the patient was in the office to receive the third dose of GARDASIL. No adverse effect was reported. No further information was provided. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a licensed practical nurse, via a sales representative, concerning an unspecified number of patients. The patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, patients were vaccinated with doses of GARDASIL, (dose, route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. It was reported that an unspecified number of patients over the last 8 years had reported that each subsequent dose of GARDASIL hurt more than the previous dose. The reporter did not have any patient specific information available. It was unknown if patients sough medical attention. At the time of report, the patient's outcome and the relatedness between the event and suspect therapy were 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 reporter stated that the patient received the GARDASIL (0.5 ml, intramuscular, anatomical location, lot number were not reported) series as followed: first dose was administered too early. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a female patient of unknown age and demographics. On 04-JUN-2014 the patient was vaccinated with varicella virus vaccine (manufacturer unknown) (dose, route, lot# and expiry date were not reported). The consumer stated that she tested positive for pregnancy three weeks after receiving an unspecified chicken pox vaccine," which is other-than-indicated in the Prescribing Information. No adverse effects were reported. The last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. Additional information is not expected because there is no contact information with the reporter.
Age: 0.47
Sex: F
Vaccine: PNC13
Symptoms: Injection site movement impairment, Reflexes abnormal
Clinical narrative: Child had difficulty moving left leg; was not paralyzed but slower reflexes and not able to kick as with the right.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm at site of vaccination is red, swollen painful and itchy.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting and fever for aprox. 3-4 hours. No residual symptoms on 07/16/14.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site erythema, Injection site rash, Pruritus, Swelling
Clinical narrative: Patient came into pharmacy 10:00am 7-17-14 and presented with a mild red rash at injection site about 1cm by 4cm. She had slight itching and minor swelling. I recommended ice packs for swelling if needed, Tylenol for any mild discomfort and Benadryl if the itching begain or increased in intensity.
Age: 0.13
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PPV, RV5
Symptoms: Diarrhoea, Gastrointestinal infection, Screaming
Clinical narrative: Screaming upon nursing and defecating.  Diarrhea. Doctor described as an intestinal infection. Lasted for 6 days.  Advised to give Tylenol every 4 hours for pain and Pedialyte if he became dehydrated.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Facial spasm
Clinical narrative: Developed facial spasms 3 hours after vaccine administration.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Feeling hot, Heart rate increased, Malaise, Vomiting
Clinical narrative: FELT SICK THROWING UP HEART BEATING OUT OF CONTROL WEAK HOT.
Age: 1.61
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Local reaction
Clinical narrative: Local reaction to immunization.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Injection site pruritus, Pruritus, Vaccination site vesicles
Clinical narrative: Case of an 18 yo female who present with an apparent varicella vaccine reaction - vesicle at area around vaccine around mouth at cheek - with itching. Tx with ZOVIRAX and was ordered titers.
Age: 1.5
Sex: M
Vaccine: HIBV, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Tdap given to early vaccine error.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender who on 14-JUL-2014, was inadvertently vaccinated with a single dose of ZOSATAVAX (lot # J000436) subcutaneously that was expired 01-APR-2014. No adverse effects were reported. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Dyspnoea, Erythema, Feeling hot, Injection site pruritus, Pain
Clinical narrative: Varicella vaccine 7/15/14. Today at about 11:45 began fever, hot, facial swelling, redness, increased itching at vaccination site. (+) SOB, terrible pain given famotidine 20 mg, BENADRYL 25 MG po, DEPO-MEDROL 80 mg IM with resolution of symptoms.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Swelling face
Clinical narrative: Varicella vaccine 7/15/14. Today at about 11:45 began fever, hot, facial swelling, redness, increased itching at vaccination site. (+) SOB, terrible pain given famotidine 20 mg, BENADRYL 25 MG po, DEPO-MEDROL 80 mg IM with resolution of symptoms.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Crying
Clinical narrative: Mother reports prolonged crying for 3 1/2 hrs after injections. Afebrile, ate well resolved spontaneously. Void and stooling WNL.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Antinuclear antibody negative, Borrelia test negative, Erythema multiforme, Haematocrit normal, Haemoglobin normal
Clinical narrative: 7/2/14 Tdap administered. 7/3/14 (L) deltoid/arm swelling - resolved over a few days. 7/12/14 Parent noted swelling and red rash on hands and feet. 7/13/14 Multiple red, non painful papules went to urgent care. 7/14/14 Report fading c/w erythema multiforme minor.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Local swelling, Papule, Parvovirus B19 test negative, Platelet count normal
Clinical narrative: 7/2/14 Tdap administered. 7/3/14 (L) deltoid/arm swelling - resolved over a few days. 7/12/14 Parent noted swelling and red rash on hands and feet. 7/13/14 Multiple red, non painful papules went to urgent care. 7/14/14 Report fading c/w erythema multiforme minor.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Rash erythematous, Respiratory syncytial virus test negative, Streptococcus test negative, White blood cell count increased
Clinical narrative: 7/2/14 Tdap administered. 7/3/14 (L) deltoid/arm swelling - resolved over a few days. 7/12/14 Parent noted swelling and red rash on hands and feet. 7/13/14 Multiple red, non painful papules went to urgent care. 7/14/14 Report fading c/w erythema multiforme minor.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a physician refers to a now 19 year old female patient. On an unknown date the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, lot# reported as "K001389", expiration date: 29-JAN-2016, 0.5 ml, subcutaneous for routine immunization. On an unknown date "2 to 3 days after" the unspecified patient received (Oka/Merck) VARIVAX, she developed significant erythema, pruritus and pain at the injection site. The patient was taken to an unspecified Emergency Room where she received unspecified antibiotics, "for possible cellulitis", and BENADRYL. The physician stated the patient was still experiencing "some" of the reported symptoms. The outcome of the events was reported as not recovered. The physician is requesting a Lot Check for the (Oka/Merck) VARIVAX. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Cellulitis, Injection site swelling, Vaccination complication
Clinical narrative: 07/15/2014 to first aid temp 100.00. Right deltoid a little swollen, says temp. went as high as 102 degrees F. 07/16/2014 to walk in clinic with IZ diagnosis and restrictions on use of right arm. Follow up 07/18/2014.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (CMA). It was reported that 7 improperly stored doses of GARDASIL injection 120 Y (dose, route, lot# not reported) had been administered to 7 patients on unspecified dates. No adverse effects were reported. No PQC was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On unknown dates, the patients may have received doses of GARDASIL (dose and lot #s were not reported) that were improperly stored. No adverse events reported. Additional information has been requested.
Age: 1.58
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient presents for redness and swelling to her right leg. Area is warmth to the touch, hard and red.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (CMA) concerning an unspecified patient. It was reported that 1 improperly stored RECOMBIVAX HB (dose, route, lot# not reported) had been administered to the patient on unspecified date. No adverse effects were reported. No PQC was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (CMA). It was reported that 13 improperly stored doses of PEDVAXHIB (dose, route, lot# not reported) had been administered to 13 patients on unspecified dates. No adverse effects were reported. No PQC was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pyrexia
Clinical narrative: Fever (101.5) inability to move arm Continued for a week.
Age: 62.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Injection site swelling, Pain, Pruritus, Skin warm
Clinical narrative: Large red swollen area on Lt. deltoid. Measures 5 3/4 in width and 4 in long. C/O itching and soreness. Area warm to touch. Started on Sunday 7/13/14, area continues to get larger. Advised to apply hydrocortisone cream for itching.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, pain, and heat at injection site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: 3cm patch of erythema with some induration without excoriation, fever, pruritis or any other problem.
Age: 20.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Abdominal distension, Erythema, Local reaction
Clinical narrative: Client came into office to have tst read.  Client state she just noticed localized reaction of approsimately 4"x3" redness and swelling on backside of left arm.  Advised cool compress, ibuprofen for pain and swelling and to contact the pcp if signs and symptoms persist or worsen.
Age: 18.0
Sex: F
Vaccine: IPV, TYP
Symptoms: Rash
Clinical narrative: Rashes on Left forearm poss from IMMS PPD<Typhoid IPV> c  a procedure x1 mos ago for implantable from NEXPLANON.  .TX: HCTC  cream Apply TID; Ranitidine 150mg 1 tab bid; Benadry 25mg 1 capsule Q4H
Age: 10.0
Sex: M
Vaccine: MEN
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Severe swelling of upper arm with redness and itching.  Lasted 36 hours.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (CMA). It was reported that 15 improperly stored doses of VAQTA (dose, route, lot# not reported) had been administered to 15 patients on unspecified dates. No adverse effects were reported. No PQC was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MEN, TD
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, raised circle where shot was administered.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Throat irritation
Clinical narrative: Burning in the throat after receiving HPV #2.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Redness, hot, swelling, pain.
Age: 1.61
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Erythema, Induration, Local swelling
Clinical narrative: hardness redness, swelling on right arm, legal guardian went to ER, there provider prescribed antibiotic and circulated the area. Patient came 07/16/14 to our clinic to check what vaccine was given in that arm, we informed that was Pediarix vaccine, also we notice that the in duration is getting smaller.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Patient complaint dizziness and shortness of breath 5 minutes after injection. Then she recovered 5 seconds later. We checked her pulse and BP and checked her vital sign after 911 arrived. OK.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in jaw, Rash
Clinical narrative: This spontaneous report as received from a physician via field representative refers to a 70 year old male patient. On 20-AUG-2013, the patient was vaccinated with ZOSTAVAX 1 single shot, subcutaneous injection. 09-JUL-2014, the patient came into the physician's office experiencing jaw pain while using ZOSTAVAX. On 11-JUL-2014, the patient developed a rash on the right side of his face and through the eye, went to ER (emergency room) and was diagnosed with shingles. On an unknown date, the patient was treated for the adverse event with prednisone (manufacturer unknown) and acyclovir. The outcome of the patient developed rash on the right side of his face and through the eye, went to ER and was diagnosed with shingles and jaw pain while using ZOSTAVAX was reported as recovering/resolving. The reporter considered the events as disabling. Additional information is not expected because reporter refused additional contact.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist regarding a patient of unknown age and gender. On 16-JUL-2014, the patient inadvertently received a dose of VARIVAX (Merck) (0.5 ml, subcutaneous), when they were supposed to received ZOSTAVAX. No adverse effects reported. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse to a 77 year old female patient. The nurse reported that, on an unknown date, a 77 year old patient was administered GARDASIL (dose, frequency, lot# and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. No pertinent medical history, drug reactions or allergies were reported. On an unknown date (reported as a few years ago) the patient was vaccinated with the first and second dose of GARDASIL and recently received the third dose of GARDASIL (strength, dose, dose schedule, route, lot number and expiration date were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome of the event was unknown. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A) and a nurse refers to a 12 months old patient (gender unknown). On 30-MAY-2014, the patient was vaccinated with (Oka/Merck) VARIVAX lot #J0009990; expiration date: 13-AUG-2015 (also reported as 12-AUG-2015), which was improperly exposed to 10F for 3 days, exposed to 16 degrees F for 120 hours and to 5-9.6F for 360 hours, subcutaneously. No known adverse effects. This is one of the several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pain, Injection site rash, Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported). On an unknown date, the patient experienced a painful rash, at the injection site, one week after receiving ZOSTAVAX. The patient saw unspecified physician who diagnosed the rash at the injection site as shingles. At the time of the report, the patient's outcome of shingles was unknown. Additional information has been requested (correspondence containing a request for additional information is scheduled).
Age: 35.0
Sex: F
Vaccine: ANTH, HEP
Symptoms: Alanine aminotransferase normal, Arthralgia, Aspartate aminotransferase normal, Basophil count normal, Basophil percentage
Clinical narrative: Patient is a 41-year-old female who presents to the Vaccine Healthcare Center for further evaluation and recommendations regarding possible adverse reaction to anthrax vaccine. Patient describes being in her normal state of health until August 2007. Patient describes receiving anthrax #4 on 21 August 2007 (reports no problems with anthrax #1-3). That evening, the patient developed a large local reaction as well as flu like symptoms of fatigue, low-grade fever, myalgias, and arthralgias as well as a bad headache. The following morning she went to the local Medical Clinic and was instructed that her symptoms were a normal reaction. However, she notes a distinct change in quality of headaches that began within one day of the vaccine. She describes the headaches as "an electric current in my head constantly". She further describes this as an ice pick constantly in her brain. She denies the pain being a throbbing quality. She localizes the headaches to the top of the bilateral parietal bone area of her head. She endorses associated photophobia, phonophobia, nausea, and vomiting associated with headache. The headache may also be exacerbated by strong smells and exertion. She states she has not been headache free since March 2008. However, the headache does wax and wane. At its worst, the headache is 10 out of 10 in intensity and at its best it is 2/10 in intensity. Before August 2007 the headaches were in a different location, more throbbing in nature, near the temple area (but bilateral) and not associated with any emesis, nausea, photophobia or phonophobia. Additionally, prior to August 2007 the medications responded to MOTRIN. Currently, the headaches are well controlled with prophylactic medicines to include LYRICA and CYMBALTA and abortive therapy with IMITREX. Additionally, the patient describes deploying in December 2007 with the headaches continuing. However, when she redeployed in March 2008 she noted the headaches became increasingly more severe and "never went away". She describes being hospitalized in May 2008 for these headaches. She has been followed by a neurologist at the headache clinic for several years now and has been diagnosed with "new daily persistent headaches". The patient went on to have anthrax #5 on 9 June 2011 and anthrax #6 on 30 May 2012 with no significant change in her headache syndrome. However, she does endorse developing generalized fatigue, malaise, as well as generalized arthralgias and myalgias that began within one week after anthrax #5. The symptoms have persisted and an intermittent nature she ever since. She states "I have good days and bad days". She was recently diagnosed with fibromyalgia by her internist in February 2014.
Age: 35.0
Sex: F
Vaccine: ANTH, HEP
Symptoms: Bilirubin urine, Blood albumin normal, Blood alkaline phosphatase normal, Blood calcium normal, Blood chloride normal
Clinical narrative: Patient is a 41-year-old female who presents to the Vaccine Healthcare Center for further evaluation and recommendations regarding possible adverse reaction to anthrax vaccine. Patient describes being in her normal state of health until August 2007. Patient describes receiving anthrax #4 on 21 August 2007 (reports no problems with anthrax #1-3). That evening, the patient developed a large local reaction as well as flu like symptoms of fatigue, low-grade fever, myalgias, and arthralgias as well as a bad headache. The following morning she went to the local Medical Clinic and was instructed that her symptoms were a normal reaction. However, she notes a distinct change in quality of headaches that began within one day of the vaccine. She describes the headaches as "an electric current in my head constantly". She further describes this as an ice pick constantly in her brain. She denies the pain being a throbbing quality. She localizes the headaches to the top of the bilateral parietal bone area of her head. She endorses associated photophobia, phonophobia, nausea, and vomiting associated with headache. The headache may also be exacerbated by strong smells and exertion. She states she has not been headache free since March 2008. However, the headache does wax and wane. At its worst, the headache is 10 out of 10 in intensity and at its best it is 2/10 in intensity. Before August 2007 the headaches were in a different location, more throbbing in nature, near the temple area (but bilateral) and not associated with any emesis, nausea, photophobia or phonophobia. Additionally, prior to August 2007 the medications responded to MOTRIN. Currently, the headaches are well controlled with prophylactic medicines to include LYRICA and CYMBALTA and abortive therapy with IMITREX. Additionally, the patient describes deploying in December 2007 with the headaches continuing. However, when she redeployed in March 2008 she noted the headaches became increasingly more severe and "never went away". She describes being hospitalized in May 2008 for these headaches. She has been followed by a neurologist at the headache clinic for several years now and has been diagnosed with "new daily persistent headaches". The patient went on to have anthrax #5 on 9 June 2011 and anthrax #6 on 30 May 2012 with no significant change in her headache syndrome. However, she does endorse developing generalized fatigue, malaise, as well as generalized arthralgias and myalgias that began within one week after anthrax #5. The symptoms have persisted and an intermittent nature she ever since. She states "I have good days and bad days". She was recently diagnosed with fibromyalgia by her internist in February 2014.
Age: 35.0
Sex: F
Vaccine: ANTH, HEP
Symptoms: Blood creatinine normal, Blood glucose normal, Blood potassium, Blood sodium normal, Blood urea normal
Clinical narrative: Patient is a 41-year-old female who presents to the Vaccine Healthcare Center for further evaluation and recommendations regarding possible adverse reaction to anthrax vaccine. Patient describes being in her normal state of health until August 2007. Patient describes receiving anthrax #4 on 21 August 2007 (reports no problems with anthrax #1-3). That evening, the patient developed a large local reaction as well as flu like symptoms of fatigue, low-grade fever, myalgias, and arthralgias as well as a bad headache. The following morning she went to the local Medical Clinic and was instructed that her symptoms were a normal reaction. However, she notes a distinct change in quality of headaches that began within one day of the vaccine. She describes the headaches as "an electric current in my head constantly". She further describes this as an ice pick constantly in her brain. She denies the pain being a throbbing quality. She localizes the headaches to the top of the bilateral parietal bone area of her head. She endorses associated photophobia, phonophobia, nausea, and vomiting associated with headache. The headache may also be exacerbated by strong smells and exertion. She states she has not been headache free since March 2008. However, the headache does wax and wane. At its worst, the headache is 10 out of 10 in intensity and at its best it is 2/10 in intensity. Before August 2007 the headaches were in a different location, more throbbing in nature, near the temple area (but bilateral) and not associated with any emesis, nausea, photophobia or phonophobia. Additionally, prior to August 2007 the medications responded to MOTRIN. Currently, the headaches are well controlled with prophylactic medicines to include LYRICA and CYMBALTA and abortive therapy with IMITREX. Additionally, the patient describes deploying in December 2007 with the headaches continuing. However, when she redeployed in March 2008 she noted the headaches became increasingly more severe and "never went away". She describes being hospitalized in May 2008 for these headaches. She has been followed by a neurologist at the headache clinic for several years now and has been diagnosed with "new daily persistent headaches". The patient went on to have anthrax #5 on 9 June 2011 and anthrax #6 on 30 May 2012 with no significant change in her headache syndrome. However, she does endorse developing generalized fatigue, malaise, as well as generalized arthralgias and myalgias that began within one week after anthrax #5. The symptoms have persisted and an intermittent nature she ever since. She states "I have good days and bad days". She was recently diagnosed with fibromyalgia by her internist in February 2014.
Age: 35.0
Sex: F
Vaccine: ANTH, HEP
Symptoms: C1 esterase inhibitor test, Carbon dioxide normal, Chromaturia, Complement factor decreased, Computerised tomogram head normal
Clinical narrative: Patient is a 41-year-old female who presents to the Vaccine Healthcare Center for further evaluation and recommendations regarding possible adverse reaction to anthrax vaccine. Patient describes being in her normal state of health until August 2007. Patient describes receiving anthrax #4 on 21 August 2007 (reports no problems with anthrax #1-3). That evening, the patient developed a large local reaction as well as flu like symptoms of fatigue, low-grade fever, myalgias, and arthralgias as well as a bad headache. The following morning she went to the local Medical Clinic and was instructed that her symptoms were a normal reaction. However, she notes a distinct change in quality of headaches that began within one day of the vaccine. She describes the headaches as "an electric current in my head constantly". She further describes this as an ice pick constantly in her brain. She denies the pain being a throbbing quality. She localizes the headaches to the top of the bilateral parietal bone area of her head. She endorses associated photophobia, phonophobia, nausea, and vomiting associated with headache. The headache may also be exacerbated by strong smells and exertion. She states she has not been headache free since March 2008. However, the headache does wax and wane. At its worst, the headache is 10 out of 10 in intensity and at its best it is 2/10 in intensity. Before August 2007 the headaches were in a different location, more throbbing in nature, near the temple area (but bilateral) and not associated with any emesis, nausea, photophobia or phonophobia. Additionally, prior to August 2007 the medications responded to MOTRIN. Currently, the headaches are well controlled with prophylactic medicines to include LYRICA and CYMBALTA and abortive therapy with IMITREX. Additionally, the patient describes deploying in December 2007 with the headaches continuing. However, when she redeployed in March 2008 she noted the headaches became increasingly more severe and "never went away". She describes being hospitalized in May 2008 for these headaches. She has been followed by a neurologist at the headache clinic for several years now and has been diagnosed with "new daily persistent headaches". The patient went on to have anthrax #5 on 9 June 2011 and anthrax #6 on 30 May 2012 with no significant change in her headache syndrome. However, she does endorse developing generalized fatigue, malaise, as well as generalized arthralgias and myalgias that began within one week after anthrax #5. The symptoms have persisted and an intermittent nature she ever since. She states "I have good days and bad days". She was recently diagnosed with fibromyalgia by her internist in February 2014.
Age: 35.0
Sex: F
Vaccine: ANTH, HEP
Symptoms: Eosinophil count normal, Eosinophil percentage, Epstein-Barr virus antibody negative, Epstein-Barr virus antibody positive, Epstein-Barr virus antigen positive
Clinical narrative: Patient is a 41-year-old female who presents to the Vaccine Healthcare Center for further evaluation and recommendations regarding possible adverse reaction to anthrax vaccine. Patient describes being in her normal state of health until August 2007. Patient describes receiving anthrax #4 on 21 August 2007 (reports no problems with anthrax #1-3). That evening, the patient developed a large local reaction as well as flu like symptoms of fatigue, low-grade fever, myalgias, and arthralgias as well as a bad headache. The following morning she went to the local Medical Clinic and was instructed that her symptoms were a normal reaction. However, she notes a distinct change in quality of headaches that began within one day of the vaccine. She describes the headaches as "an electric current in my head constantly". She further describes this as an ice pick constantly in her brain. She denies the pain being a throbbing quality. She localizes the headaches to the top of the bilateral parietal bone area of her head. She endorses associated photophobia, phonophobia, nausea, and vomiting associated with headache. The headache may also be exacerbated by strong smells and exertion. She states she has not been headache free since March 2008. However, the headache does wax and wane. At its worst, the headache is 10 out of 10 in intensity and at its best it is 2/10 in intensity. Before August 2007 the headaches were in a different location, more throbbing in nature, near the temple area (but bilateral) and not associated with any emesis, nausea, photophobia or phonophobia. Additionally, prior to August 2007 the medications responded to MOTRIN. Currently, the headaches are well controlled with prophylactic medicines to include LYRICA and CYMBALTA and abortive therapy with IMITREX. Additionally, the patient describes deploying in December 2007 with the headaches continuing. However, when she redeployed in March 2008 she noted the headaches became increasingly more severe and "never went away". She describes being hospitalized in May 2008 for these headaches. She has been followed by a neurologist at the headache clinic for several years now and has been diagnosed with "new daily persistent headaches". The patient went on to have anthrax #5 on 9 June 2011 and anthrax #6 on 30 May 2012 with no significant change in her headache syndrome. However, she does endorse developing generalized fatigue, malaise, as well as generalized arthralgias and myalgias that began within one week after anthrax #5. The symptoms have persisted and an intermittent nature she ever since. She states "I have good days and bad days". She was recently diagnosed with fibromyalgia by her internist in February 2014.
Age: 35.0
Sex: F
Vaccine: ANTH, HEP
Symptoms: Fatigue, Fibromyalgia, Glucose urine absent, Haematocrit normal, Haemoglobin normal
Clinical narrative: Patient is a 41-year-old female who presents to the Vaccine Healthcare Center for further evaluation and recommendations regarding possible adverse reaction to anthrax vaccine. Patient describes being in her normal state of health until August 2007. Patient describes receiving anthrax #4 on 21 August 2007 (reports no problems with anthrax #1-3). That evening, the patient developed a large local reaction as well as flu like symptoms of fatigue, low-grade fever, myalgias, and arthralgias as well as a bad headache. The following morning she went to the local Medical Clinic and was instructed that her symptoms were a normal reaction. However, she notes a distinct change in quality of headaches that began within one day of the vaccine. She describes the headaches as "an electric current in my head constantly". She further describes this as an ice pick constantly in her brain. She denies the pain being a throbbing quality. She localizes the headaches to the top of the bilateral parietal bone area of her head. She endorses associated photophobia, phonophobia, nausea, and vomiting associated with headache. The headache may also be exacerbated by strong smells and exertion. She states she has not been headache free since March 2008. However, the headache does wax and wane. At its worst, the headache is 10 out of 10 in intensity and at its best it is 2/10 in intensity. Before August 2007 the headaches were in a different location, more throbbing in nature, near the temple area (but bilateral) and not associated with any emesis, nausea, photophobia or phonophobia. Additionally, prior to August 2007 the medications responded to MOTRIN. Currently, the headaches are well controlled with prophylactic medicines to include LYRICA and CYMBALTA and abortive therapy with IMITREX. Additionally, the patient describes deploying in December 2007 with the headaches continuing. However, when she redeployed in March 2008 she noted the headaches became increasingly more severe and "never went away". She describes being hospitalized in May 2008 for these headaches. She has been followed by a neurologist at the headache clinic for several years now and has been diagnosed with "new daily persistent headaches". The patient went on to have anthrax #5 on 9 June 2011 and anthrax #6 on 30 May 2012 with no significant change in her headache syndrome. However, she does endorse developing generalized fatigue, malaise, as well as generalized arthralgias and myalgias that began within one week after anthrax #5. The symptoms have persisted and an intermittent nature she ever since. She states "I have good days and bad days". She was recently diagnosed with fibromyalgia by her internist in February 2014.
Age: 35.0
Sex: F
Vaccine: ANTH, HEP
Symptoms: Headache, Influenza like illness, Local reaction, Lymphocyte count normal, Lymphocyte percentage
Clinical narrative: Patient is a 41-year-old female who presents to the Vaccine Healthcare Center for further evaluation and recommendations regarding possible adverse reaction to anthrax vaccine. Patient describes being in her normal state of health until August 2007. Patient describes receiving anthrax #4 on 21 August 2007 (reports no problems with anthrax #1-3). That evening, the patient developed a large local reaction as well as flu like symptoms of fatigue, low-grade fever, myalgias, and arthralgias as well as a bad headache. The following morning she went to the local Medical Clinic and was instructed that her symptoms were a normal reaction. However, she notes a distinct change in quality of headaches that began within one day of the vaccine. She describes the headaches as "an electric current in my head constantly". She further describes this as an ice pick constantly in her brain. She denies the pain being a throbbing quality. She localizes the headaches to the top of the bilateral parietal bone area of her head. She endorses associated photophobia, phonophobia, nausea, and vomiting associated with headache. The headache may also be exacerbated by strong smells and exertion. She states she has not been headache free since March 2008. However, the headache does wax and wane. At its worst, the headache is 10 out of 10 in intensity and at its best it is 2/10 in intensity. Before August 2007 the headaches were in a different location, more throbbing in nature, near the temple area (but bilateral) and not associated with any emesis, nausea, photophobia or phonophobia. Additionally, prior to August 2007 the medications responded to MOTRIN. Currently, the headaches are well controlled with prophylactic medicines to include LYRICA and CYMBALTA and abortive therapy with IMITREX. Additionally, the patient describes deploying in December 2007 with the headaches continuing. However, when she redeployed in March 2008 she noted the headaches became increasingly more severe and "never went away". She describes being hospitalized in May 2008 for these headaches. She has been followed by a neurologist at the headache clinic for several years now and has been diagnosed with "new daily persistent headaches". The patient went on to have anthrax #5 on 9 June 2011 and anthrax #6 on 30 May 2012 with no significant change in her headache syndrome. However, she does endorse developing generalized fatigue, malaise, as well as generalized arthralgias and myalgias that began within one week after anthrax #5. The symptoms have persisted and an intermittent nature she ever since. She states "I have good days and bad days". She was recently diagnosed with fibromyalgia by her internist in February 2014.