chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: DTaP vaccine administered intramuscularly to pt on 2/2/15 by LPN. Parents noted swelling and pain of site, on the same date. Parents brought child to clinic for assessment. Pt. afebrile and cold compress applied for swelling. Will continue to monitor. Pt education provided.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. In February 2011, four years ago, the patient was vaccinated with the first dose of GARDASIL. On 02-FEB-2015, also reported as today, the patient received the second dose of GARDASIL (route of administration, lot number and expiration date were not reported). No adverse effect was noted. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant concerning multiple unspecified patients (demographics unknown). On an unknown date the multiple patients were vaccinated with M-M-R II (lot #, dose and route were not provided). The M-M-R II was administered post supported excursion. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to two patients of unknown gender who were under 50 years old. On 02-FEB-2015 the two patients less than 50 years of age were vaccinated with ZOSTAVAX subcutaneous (dose, lot # not reported) in error. There were no known adverse effects. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 08-JAN-2015 the patient was vaccinated with the second dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant concerning multiple unspecified patients (demographics unknown). On an unknown date the multiple patients were vaccinated with VARIVAX (Merck) (lot #, dose and route were not provided). The VARIVAX (Merck) was administered post supported excursion. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, Underdose
Clinical narrative: This case was reported by a pharmacist and described the occurrence of inappropriate age at vaccine administration in a male patient who received INFANRIX. On an unknown date, the patient received INFANRIX at an unknown dose. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced inappropriate age at vaccine administration and vaccine underdose. On an unknown date, the outcome of the inappropriate age at vaccine administration and vaccine underdose were unknown. Additional information received: INFANRIX administered to a 40 decades adult. Reporter did not have any additional details to provide.
Sex: U
Vaccine: DTAP, DTAPIPV, HEP, HEPA, HPV2, TDAP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a unk patient who received BOOSTRIX. Co-suspect products included CERVARIX, ENGERIX B, HAVRIX, INFANRIX, KINRIX, and PEDIARIX. On an unknown date, the patient received BOOSTRIX at an unknown dose, CERVARIX at an unknown dose, ENGERIX B at an unknown dose, HAVRIX at an unknown dose, INFANRIX at an unknown dose, KINRIX at an unknown dose and PEDIARIX at an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX, CERVARIX, ENGERIX B, HAVRIX, INFANRIX, KINRIX and PEDIARIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Potentially up to 50 patients may have received vaccine that was stored below zero degrees celsius. The patients may have received more than one injection of the vaccines on multiple visits. The nurse did not have the specific information when I spoke to her. All she had were the names of the vaccines and an estimate of the number of patients. The vaccines involved were PEDIARIX, INFANRIX, ENGERIX-B, HAVRIX, KINRIX, BOOSTRIX, and CERVARIX.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This spontaneous report as received from a health care worker refers to a 30 year old female patient (who was also a office staff). The patient's pertinent medical history was none and was allergic to CECLOR. On 28-JAN-2015, the patient was vaccinated with RECOMBIVAX HB (dose, frequency and route were not reported) (lot # K006530 and expiry date: February 2016). Concomitant medications were none. On 29-JAN-2015, patient experienced tingling and numbness in the arm in which RECOMBIVAX HB was received. The patient did not sought medical attention and no treatment was provided for the events. The outcome of tingling and numbness in the arm was reported as recovering/resolving. The causality of tingling and numbness in the arm was not reported. No product quality complaint (PQC) was reported for RECOMBIVAX HB. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a health professional concerning a 67 year old female patient. The patient had drug allergies with ZITHROMAX and morphine. On an unknown date the patient was vaccinated with ZOSTAVAX (0.65 ml, lot# not reported, subcutaneous). Concomitant therapies included acyclovir (manufacturer unspecified), SYNTHROID, KLONOPIN, an estrogens patch, progesterone (manufacturer unspecified), testosterone (manufacturer unspecified) and NEXIUM. On 20-JAN-2015, the patient had a titer drawn for immunity to varicella zoster virus, and the titer came back as negative. The patient had been using acyclovir (manufacturer unspecified) (daily for an unspecified reason) at the time she was administered the ZOSTAVAX. There was no treatment given for the event. The patient had not sought medical attention. Additional information is not expected.
Age: 0.53
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-month-old female patient who received KINRIX (batch number 9AB77, expiry date unknown) and (batch number 9AB77, expiry date 19th October 2015). On 8th December 2014 11:52, the patient received KINRIX .5 ml. On an unknown date, the dose was an unknown dose. On 8th December 2014 11:52, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information:Nurse reports that a KINRIX vaccine was accidentally administered to a 6 month old child. This is maladministration. No AEs reported as a result of this event.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This is a retrospective pregnancy case. This 27-year-old female subject was enrolled in a study. The subject received BOOSTRIX on an unknown date. The subject's last menstrual period was in October 2014 and estimated date of delivery as 15th August 2015. The subject received BOOSTRIX at week 3 of the pregnancy and during the first trimester of pregnancy. In December 2014, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. Additional information: Medical assistant reports that they will be administering a BOOSTRIX vaccine to a pregnant patient either today, 12/11/2014, or tomorrow 12/12/2014. The patient is due in Aug 2015 and she will be about 3 weeks gestation.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to incorrect product storage because on an unknown date multiple unspecified patients of unknown ages and genders were vaccinated with an improperly stored doses of GARDASIL (dose, lot #, expiration date and route were not reported). No adverse effects reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 1.98
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This case was reported by a other health professional and described the occurrence of extra dose administered in a 24-month-old female patient who received HAVRIX (batch number 4735D, expiry date 15th November 2015). Previously administered products included HAVRIX pediatric (dose 1) and HAVRIX pediatric (dose 2). On 5th November 2013, the patient received the 3rd dose of HAVRIX. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional information received: Child got 3 doses of HAVRIX by mistake. 1st dose on 13 November 2012, then 25 July 2013 and 05 November 2013. No adverse event reported.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Joint stiffness, Pyrexia, Rash
Clinical narrative: Patient reports fever (99F), joint pain and stiffness in legs and knees, and "bumps" in her neck that are not itchy. Injection site looks normal per pt report over the phone.
Age: 28.0
Sex: U
Vaccine: TDAP
Symptoms: Gene mutation, Injection site rash
Clinical narrative: Rash at injection site spread to arms, hands, legs, and feet (very mild).
Age: 68.0
Sex: F
Vaccine: IPV
Symptoms: Pyrexia
Clinical narrative: Fever at night 101.7 1/28/15 103.0 2/3/15.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Was given MCV4 vaccine on 2/2/15 to left deltoid. Developed swelling, redness, induration to site today at approx. 10 AM.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cough, Influenza virus test negative, Pyrexia, Respiratory tract congestion, Seizure
Clinical narrative: Seizure with fever - 1/29/15. Seen at ER, fever, cough and congestion. Negative flu and strep.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Streptococcus test negative
Clinical narrative: Seizure with fever - 1/29/15. Seen at ER, fever, cough and congestion. Negative flu and strep.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Local arm pain and swelling.
Age: 31.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Patient was given a peds/adol dose of hepatitis A vaccine instead of an adult dose.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Urticaria at site of injection (R) thigh.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Gastrointestinal viral infection, Oral herpes
Clinical narrative: Within 5 hrs of receiving shot, lower inside lip broke out in cold sores, and upper lip outside, beneath nose, broke out. Have also had an intestinal virus since 12/4/14.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Chest pain, Dizziness, Dyspepsia, Dyspnoea
Clinical narrative: Weakness, SOB, chest pain, gastrointestinal issues; heart burn, headache, dizziness, and severe irritability.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Gastrointestinal disorder, Headache, Irritability
Clinical narrative: Weakness, SOB, chest pain, gastrointestinal issues; heart burn, headache, dizziness, and severe irritability.
Age: 1.2
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure within 24 hours of both vaccines. Lasted 15 minutes. Seen in ER. Has been alternating TYLENOL and ibuprofen to prevent anymore fever.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis (L) deltoid. Cool compress. BENADRYL, antibiotics.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Local site reaction to Hep A. Induration, red, oval size 2.5cm to left thigh. Recommend symptomatic care. Recommend against finishing this series given the significance of involvement.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Rash generalised, Somnolence
Clinical narrative: No fever - sleepy yesterday. PC from APRN - rash generalized - started belly, chest, back, face - none arms/legs - PC to State Epidemiologist - no link to other case afebrile Epi staff report vax assoc. Rash RT MMR.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Streptococcus test negative
Clinical narrative: Redness and swelling of left thigh after immunization. Dx: cellulitis. TX: BACTRIM by mouth 10 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: (R) leg cellulitis, erythema, tenderness at inj. site and 8 cm beyond. (R) thigh only 1st KINRIX.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Rash, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: 15 hrs. after vaccine, red, blotchy itchy rash on face, around mouth.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Extra dose administered, Injection site pain, Mobility decreased
Clinical narrative: This spontaneous report by a contactable pharmacist who reported on behalf of the patient. A female patient of unknown age received on 06Mar2013 at 4.30 PREVNAR 13 along with PNEUMOVAX 23. Relevant medical history and concomitant medications were unknown. On an unspecified date in Mar2013 the patient experienced pain at the site of injection and could not lift her arm above the head. Relevant lab data was unknown. At the time of the report the clinical outcome of the above mentioned events were unknown. Follow-up (17-APR-2013): Follow-up attempts completed. No further information expected.
Age: 3.0
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable physician from a non clinical study program. This physician reported for a 3-year-old female patient who was administered a single dose of PREVNAR 13 and a single dose of VARIVAX, both on 27Mar2013 at 11:45 in patient's arm. The patient had no relevant medical history and was taking no concomitant medication. It was reported that on 27Mar2013, five minutes after vaccinations, the patient had hives near the site of injection. Both vaccines were administered two inches apart and hives were half way between both the injection sites. No relevant laboratory data was reported. No therapeutic measures were taken in response to the reported event. The clinical outcome of the reported event was unknown at the time of report. Follow-up (10-MAY-2013): Follow-up attempts completed. No further information expected.
Age: 19.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Rash generalised, Urticaria
Clinical narrative: This case was received on 03 September 2013 via a third party query tool search on the VAERS database, under reference number 490783. A 19 year-old female patient had received on 20 April 2013 a left arm injection of ACAM2000 (lot number VV04003A) and an intramuscular right arm injection of anthrax (Emergent lot number FAV309) and on 21 April 2013, developed a rash over the entire body which worsened with time. Treatment included Solu-medrol and prednisone. The patient was diagnosed with urticaria. The patient had an emergency visit. History, other medications and current illness were reported as none. Lab data and prior vaccinations were not reported. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Age: 74.0
Sex: M
Vaccine: SMALL
Symptoms: Axillary pain, Erythema, Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: This case was received on 03 September 2013 via a third party query tool search on the VAERS database, under reference number 491078. A 74 year-old male patient had received on 17 April 2013 a left arm injection of ACAM2000 (lot number was not reported), and an unspecified amount of time later the same date, experienced axillary pain, erythema, injection site erythema joint swelling and local swelling. The patient had moderate swelling of entire left shoulder deltoid muscle, red stripe leading from shot site toward lymph node, pain in armpit. The pain and swelling lasted for four day in total. Lab data and other medications were not reported. Current illness and history were reported as no. Prior vaccinations was reported verbatim from the report: "Strong reaction-smallpox (no brand name)-2-28.00-Patient/Very strong reaction-smallpox (no brand name)-1-26.00-Patient." No further information was available at the time of the report. The patient's outcome was recovered. Although the manufacturer was reported unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. Documents held by sender: none
Age: 74.0
Sex: M
Vaccine: SMALL
Symptoms: Joint swelling, Local swelling
Clinical narrative: This case was received on 03 September 2013 via a third party query tool search on the VAERS database, under reference number 491078. A 74 year-old male patient had received on 17 April 2013 a left arm injection of ACAM2000 (lot number was not reported), and an unspecified amount of time later the same date, experienced axillary pain, erythema, injection site erythema joint swelling and local swelling. The patient had moderate swelling of entire left shoulder deltoid muscle, red stripe leading from shot site toward lymph node, pain in armpit. The pain and swelling lasted for four day in total. Lab data and other medications were not reported. Current illness and history were reported as no. Prior vaccinations was reported verbatim from the report: "Strong reaction-smallpox (no brand name)-2-28.00-Patient/Very strong reaction-smallpox (no brand name)-1-26.00-Patient." No further information was available at the time of the report. The patient's outcome was recovered. Although the manufacturer was reported unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. Documents held by sender: none
Age: 28.0
Sex: F
Vaccine: SMALL
Symptoms: Urticaria
Clinical narrative: This case was received on 03 September 2013 via a third party query tool search on the VAERS database, under reference number 491898. A 28-year-old female patient had received on 16 May 2013 a dose of ACAM200 (lot number not reported) and on 17 May 2013, developed urticaria on left face, around left upper arm chest and back. The patient had an emergency visit. History and current illness were reported as none. Lab data, other medications and prior vaccinations were not reported. No further information was available at the time of the report. The patient's outcome was recovered. Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. Documents held by sender: none
Age: 34.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Erythema, Pyrexia
Clinical narrative: This case was received on 03 September 2013 via a third party query tool search on the VAERS database, under reference number 491928. A 34 year-old male patient had received on 06 May 2013 a left arm injection of ACAM2000, (lot number VV04003A) and eight days later on 14 May 2013, experienced chills, erythema, and pyrexia. The patient reported having the chills and a fever. Patient went to primary medical doctor (PMD) on 14 May 2013 when noticing red lines running sown his arm and a continued fever. Treatment included BACTRIM for five days. lab data was reported as none and other medications were "none reported by patient". Prior vaccinations were not reported. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: This case was received on 03 September 2013 via a third party query tool search on the VAERS database, under reference number 491935. A 20 year-old female patient had received on 07 may 2013 a left arm injection of ACAM2000, (lot number VV04003A) and a dose one intramuscular right arm injection of BIOTHRAX (lot number FAV317A) and on 18 may 2013, developed a red raised rash on trunk and arm. The patient was diagnosed with post vaccine urticaria and advised to take BENADRYL. The patient had an emergency visit. History and current illnesses were reported as none. Other medications were denied. lab data was N/A and prior vaccinations were not reported. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: This case was received on 03 September 2013 via a third party query tool search on the VAERS database, under reference number 491937. A 29 year-old male patient had received on 06 May 2013 a left arm injection of ACAM2000 (lot number VV04003A) and on 15 May 2013, presented with swelling, pain and redness around vaccination site. The patient had an emergency visit. History, other medications and current illnesses were reported as none. Lab data and prior vaccinations were not reported. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Lymphadenopathy, Pain, Pyrexia, Rash, Rash macular
Clinical narrative: This case was received on 03 September 2013 via a third party query tool search on the VAERS databaswe, under reference number 492919. A 26 year-old male patient with a history of allergy to amoxicillin had received on 20 May 2013 a dose 0 left arm injection of ACAM2000 (lot number not reported) and 10 days later on 30 May 2013, developed a low grade fever, body aches, axillary lymphadenopathy and a diffuse macular rash to the torso. Treatment included MOTRINA and TYLENOL. According to the report, the reaction mabe allergi in nature or may represnt mild diffuse vaccinia; symptomatic management with close patient follow-up was reported. Current illnesses were reported as none. Lab data was reported as none obtained. Other medications and prior vaccinations were not reported. No further information was available at the time of the report. The patient's outcome was unknown. Although the manufacturer was reported as unknown in this case ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. Documents held by sender: none.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Rash pustular
Clinical narrative: This case was received on 17 September 2013 via a third party query tool search on the VAERS database, under reference number 493444. A 31-year-old male patient had received an injection of ACAM2000 (SP Biologics Co. lot number VV04003A) in the left arm on 22 May 2013 and began developing small pustules on the right side of the neck, chest and behind the right ear around 6:00 PM the same day. The pustules behind the right ear grew larger and the pustules on the neck and chest were about 1/2 centimeter in clusters. The patient is being evaluated at the facility. Lab data, other medications, current illnesses and history were reported as none. Outcome was not recovered. Documents held by sender: none.
Age: 52.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Erythema, Fatigue, Headache, Hyperhidrosis
Clinical narrative: This is a spontaneous report from a contactable nurse and a contactable physician. A 52-year-old male patient received PREVNAR 13, intramuscular at 0.5 ml, syringe on 05Jun2013. Medical history included ongoing hypersensitivity taking unspecified medication, pharyngitis, strep throat as a child, pneumonia as a child, hypersensitivity, seasonal allergy, sensitisation. The concomitant medication included unspecified medication since an unknown date at unknown dose and frequency for allergy. The patient experienced sweat, aches and fatigue in Jun2013 with outcome of unknown, arm was red on 06Jun2013 with outcome of unknown, headache, chills, edema and erythema on 05Jun2013 with outcome of recovered with sequelae. The therapeutic measures included MOTRIN at 40mg. Follow-up (09AUg2013): Follow-up attempts completed. No further information expected. Follow-up (20Aug2013): New information obtained from a contactable physician included: date of vaccination and anatomical location; additional medical history; additional events (edema, erythema); outcome. Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: M
Vaccine: PNC13
Symptoms: Oedema, Pain
Clinical narrative: This is a spontaneous report from a contactable nurse and a contactable physician. A 52-year-old male patient received PREVNAR 13, intramuscular at 0.5 ml, syringe on 05Jun2013. Medical history included ongoing hypersensitivity taking unspecified medication, pharyngitis, strep throat as a child, pneumonia as a child, hypersensitivity, seasonal allergy, sensitisation. The concomitant medication included unspecified medication since an unknown date at unknown dose and frequency for allergy. The patient experienced sweat, aches and fatigue in Jun2013 with outcome of unknown, arm was red on 06Jun2013 with outcome of unknown, headache, chills, edema and erythema on 05Jun2013 with outcome of recovered with sequelae. The therapeutic measures included MOTRIN at 40mg. Follow-up (09AUg2013): Follow-up attempts completed. No further information expected. Follow-up (20Aug2013): New information obtained from a contactable physician included: date of vaccination and anatomical location; additional medical history; additional events (edema, erythema); outcome. Follow-up attempts completed. No further information expected.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Skin ulcer, Vaccination site reaction
Clinical narrative: This case was received on 17 September 2013 via a third party query tool search on the VAERS database, under reference number 494018. A 20 year-old male patient had received on 30 May 2013 a right arm dose of ACAM2000 (lot number VV04003A), and on 10 June 2013, experienced sores breaking out away from vaccination site (chest). The patient had an emergency visit. Treatments were not required. History was reported as no allergies, no chronic medical conditions. Lab data, other medications and current illnesses were reported as none. Prior vaccinations were not reported. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Pruritus, Rash macular
Clinical narrative: This case was received on 17 September 2013 via a third party query tool search on the VAERS database, under reference number 494541. A 23-year-old male patient had received an injection of ACAM200, (SP Biologics Co.) (lot number VV04003A) in the left arm on 07 June 2013 and 8 days later on 15 June 2013 noted a diffuse macular rash to arms bilaterally. The patient presented to the facility on 18 June 2013 with complaints of rash spreading and itching. The patient had diffuse macular type rash to face, neck anterior and posterior (a&p), torso a&p, and limbs x4 a&p. The rash was consistent with that seen in early onset vaccinia. The patient was sent to the emergency room. Final disposition was to home with an anti itching medication. No follow-up or referrals were given. Lab data, other medications, current illnesses and history were reported as none. Outcome was unknown. Documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: PNC13
Symptoms: Hypersensitivity
Clinical narrative: A 4-years-old male patient received PREVNAR 13 (Lot Number: G69332; Expiration Date: Aug2014) at single dose intramuscular on left thigh as immunization on 15Jul2013 at 9:00am. Relevant medical history was none. Relevant concomitant medications were none. Vaccination history included PREVNAR 7. Vaccines given on the same day were none. Vaccines taken within the last four weeks were none. On 15Jul2013 at 11:25am the patient experienced allergic reactions which were not at the site of administration. On 15Jul2013 he visited emergency room in response to the above mentioned event. Relevant lab data was none. At the time of the report the clinical outcome of the above mentioned event was unknown. Follow-up (07-AUG-2013) Follow-up attempts completed. No further information expected.
Age: 1.19
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Blood test normal, Injection site urticaria, Urticaria
Clinical narrative: This is an initial spontaneous report by a contactable Medical Assistant (Other HCP). This female Medical Assistant called on behalf of physician for a 14 month old female patient who was administered with PREVNAR 13 unknown dose unknown frequency unknown route on an unknown site at an unknown time on 11Oct2012. She was again administered with PREVNAR 13 (Lot number, G36322, Expiration Date: 31Jul2014, NDC#: 005197102) unknown dose injection unknown frequency intramuscular on right thigh at 14:30 on 22Jul3013. Relevant medical history included septo-optic dysplasia and panhypopituitarism which were ongoing during event onset. Relevant concomitant medications included SYNTHROID, DIURIL and she was still taking them during event onset. Vaccines given on the same day included haemophilus influenzae type B manufactured by Pasteur (lot # UH794AB) on 22Jul2013 injection intramuscular on left thigh. Vaccines taken within the last four weeks were none. On 22Jul2013 at 14:30 she had hives on right side of her body, hives on right side of trunk, hives on right arm and more hives on right thigh. Therapeutic measures taken in response to above mentioned events included BENADRYL. The patient did not have any siblings. Relevant lab data included unspecified blood work on 22Jul2013 and the results were normal. At the time of report she had not recovered from above mentioned events. Follow-up (30Aug2013): Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was received on 04 DECEMBER 2013 via a third party query tool search on the VAERS database, under reference number 501708. A 26-year-old male patient had received on 26 AUGUST 2013 a left arm injection of ACAM200 (lot number VV04003AA), and 10 days later on 05 September 2013 experienced redness and swelling at the injection site. The site was checked on 03 September 2013 and was normal. On 05 September 2013, the site started to become red and very swollen with a raised break in the middle of the site. The patient was seen in the clinic and was treated for a possible infection on 06 September 2013. Current illness and history were reported as none. Lab data, other medications and prior vaccinations were not reported. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Age: 33.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: This case was received on 04 December 2013 via a third party query tool search on the VAERS database, under reference number 501872. A 33 year-old female patient had received the following vaccinations on 30 July 2013: an injection ACAM2000 (lot number V04003A, site of administration not reported) and an injection of anthrax (Biothrax, Emergent lot number FAV310) and 30 days later, was found to have a positive HCG. Other medications, current illnesses and history were reported as none. Prior vaccinations were not reported. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Age: 25.0
Sex: M
Vaccine: SMALL, YF, SMALL, YF
Symptoms: Activities of daily living impaired, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: This case was received on 05 December 2014 via a third party query tool search on the VAERS database, under reference number: 502706. A 25-year-old male patient had received the following vaccinations on 04 SEPTEMBER 2014: ACAM2000 (lot number VV04003A) in the left arm and YF_VAX (lot number: UH670AA) in the right arm. On 07 SEPTEMBER 2013, the patient experienced fever, body aches, extreme fatigue and headaches. The patient missed one day of work and caused him to go home early on the second day. The patient had symptoms for three days. The events required an emergency visit. Lab data, other medication, current illnesses and history were reported as none. Outcome was recovered. Documents held by sender: None
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Blister, Papule, Rash erythematous
Clinical narrative: This case was received on 07 January 2014 via a third party query tool search on the VAERS database, under reference number 505883. A 20-year-old male patient had received an injection of ACAM2000 (SP Biologics Co. lot number VV04003A) in the left arm on 27 September 2013. One day post-vaccination on 28 September 2013 the patient experienced little red bumps and a after a few days it became erythematous with papule and vesicle formations. Lab data, other medications, history and prior vaccinations were not reported, current illnesses were none. Outcome was unknown. Documents held by sender: none.
Age: 36.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: This case was received on 07 January 2014 via a third party query tool search on the VAERS database, under reference number 507264. A 36-year-old male patient had received the following vaccinations on 02 October 2013: ACAM2000 (SP Biologics Co. lot number VV04003A) in the left arm and anthrax vaccine (Biothrax, Emergent, lot number FAV335A) via the intramuscular route in the right arm. On 12 October 2013, the patient experienced swelling, erythema, warmth in area of erythema and tenderness. The events required an emergency visit. Concomitant medication included Ventolin inhaler, OTC TYLENOL and OTC MOTRIN. History included hypertension (HTN). Lab data was not reported. Current illnesses were reported as none. Outcome was unknown. Documents held by sender: none.
Age: 39.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Arthralgia, Chest discomfort, Chest pain, Chills, Confusional state
Clinical narrative: This case was received on 07 JANUARY 2014 via a third party query tool search on the VAERS database, under reference number 510237. A 39-year-old male who recently had an x-ray due to past positive TB exposures had received the following vaccines on 08 OCTOBER 2013: a left arm injection of ACAM2000 (lot number VV04003A) and an intramuscular right arm injection of EMERGENT (lot number FAV323A) on an unspecified amount of time later the same date, experienced disorientation and confusion for several hours, headache, joint pain, loss of appetite, occasional chest pain and heaviness, severe chills and shortness of breath which continued until 19 OCTOBER 2013. The patient had an emergency visit. Lab data, other medications, history and prior vaccination were not reported. No further information was available at the time of the report. Outcome was recovered. Documents held by sender: none
Age: 39.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Decreased appetite, Disorientation, Dyspnoea, Headache
Clinical narrative: This case was received on 07 JANUARY 2014 via a third party query tool search on the VAERS database, under reference number 510237. A 39-year-old male who recently had an x-ray due to past positive TB exposures had received the following vaccines on 08 OCTOBER 2013: a left arm injection of ACAM2000 (lot number VV04003A) and an intramuscular right arm injection of EMERGENT (lot number FAV323A) on an unspecified amount of time later the same date, experienced disorientation and confusion for several hours, headache, joint pain, loss of appetite, occasional chest pain and heaviness, severe chills and shortness of breath which continued until 19 OCTOBER 2013. The patient had an emergency visit. Lab data, other medications, history and prior vaccination were not reported. No further information was available at the time of the report. Outcome was recovered. Documents held by sender: none
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Induration
Clinical narrative: This case was received on 07 January 2014 via a third party query tool search on the VAERS database, under reference number 510548. A 23-year-old male patient had received an injection of ACAM2000 (lot number VV04003A) in the right arm on 22 October 2013 and the same day experienced large induration on the opposite arm of vaccination site. Lab data, other medications, current illnesses and history were reported as none. Outcome was unknown. Documents held by sender: none.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Back pain, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: This case was received on 12 February 2014 via a third party query tool search on the VAERS database, under reference number 512543. A 24 year-old male patient with a history of post shoulder SX (surgery) of four months had received on 30 October 2013 a left arm injection of ACAM2000 (lot number VV04003A) and eight day later on 07 November 2013, experienced headache, back pain, shortness of breath, chills, and fatigue. Treatment included TYLENOL given at the emergency room. Lab data and current illnesses were reported as none. Other medications and prior vaccinations were not reported. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Age: 36.0
Sex: F
Vaccine: SMALL
Symptoms: Rash
Clinical narrative: This case was received on 12 February 2014 via a third party query tool search on the VAERS database, under reference number 513010. A 36 year-old female patient had received a left arm injection of ACAM2000 (lot number VV04003A) on 06 November 2013 and 1 day later on 07 November 2013, she experienced a rash reported as "bilateral nucal xantham well defined circular in nature. Intact, total of 7." Previous medications, medical history and lab tests were reported as none; concomitant medications were not reported. The patient's outcome was not reported. Additional information was not available at the time of this report. Documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Ear pain, Fatigue, Lymphadenopathy, Nausea
Clinical narrative: This case was received on 12 February 2014 via a third party query tool search on the VAERS database, under reference number 513794. A 22-year-old male patient received a right arm percutaneous injection of ACAM2000 (lot number VV04003A) on 25 October 2013. The patient had no known allergies and concomitant medications were not reported. Ten days post-vaccination, on 03 November 2013, the patient reported chills, fever, body aches, sore throat, earache, lymphadenopathy, nausea, and fatigue. He was seen in the emergency room, and subsequently given 24 hours SIQ (sick in quarters). He had no other current illness, and no laboratory testing was done. Outcome was reported as unknown. Documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: This case was received on 12 February 2014 via a third party query tool search on the VAERS database, under reference number 513794. A 22-year-old male patient received a right arm percutaneous injection of ACAM2000 (lot number VV04003A) on 25 October 2013. The patient had no known allergies and concomitant medications were not reported. Ten days post-vaccination, on 03 November 2013, the patient reported chills, fever, body aches, sore throat, earache, lymphadenopathy, nausea, and fatigue. He was seen in the emergency room, and subsequently given 24 hours SIQ (sick in quarters). He had no other current illness, and no laboratory testing was done. Outcome was reported as unknown. Documents held by sender: none.
Age: 49.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chest X-ray normal, Dyspnoea, Electrocardiogram normal, Palpitations
Clinical narrative: Initial report received on 12 February 2014 via a third party query tool search on the VAERS database, under reference number 514206. A 49 year old male patient had received on 12 November 2013 a left arm percutaneous injection of ACAM2000 (lot number VV04003A) and a right arm intramuscular injection of ANTHRAX (Emergent lot number FAV335A). Three days later on 15 November 2013 he experienced a viral syndrome with diarrhea following vaccination with RECOMBIVAX and a rash following vaccination with DAPTACEL, manufacturer, dates, lot number, route and site of administration not reported. He required a visit to an emergency visit on an unreported date. An electrocardiogram and chest x-ray was performed, results and dates not reported. No further information was available at the time of this report. The patient outcome was recovered. Documents held by sender: None.
Age: 36.0
Sex: F
Vaccine: SMALL
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site warmth, Lymph node pain
Clinical narrative: This case was received on 12 February 2014 via a third party query tool search on the VAERS database, under reference number 514664. A 36-year-old female patient received a left upper extremity injection of ACAM2000, lot number VV04003A on 13 August 2013. Medical history and concomitant medications were not reported. Eight days post-vaccination, on 21 August 2013, the patient reported streaking going toward the left axilla with left axillary node enlargement and tenderness. She also complained of general malaise, with injection site warm, red, and itchy. She was still able to work. Outcome was reported as recovered. Documents held by sender: None.
Age: 36.0
Sex: F
Vaccine: SMALL
Symptoms: Lymphadenopathy, Malaise
Clinical narrative: This case was received on 12 February 2014 via a third party query tool search on the VAERS database, under reference number 514664. A 36-year-old female patient received a left upper extremity injection of ACAM2000, lot number VV04003A on 13 August 2013. Medical history and concomitant medications were not reported. Eight days post-vaccination, on 21 August 2013, the patient reported streaking going toward the left axilla with left axillary node enlargement and tenderness. She also complained of general malaise, with injection site warm, red, and itchy. She was still able to work. Outcome was reported as recovered. Documents held by sender: None.
Age: 38.0
Sex: M
Vaccine: SMALL
Symptoms: Unevaluable event
Clinical narrative: This case was received on 13 March 2014 via a third party query tool search on the VAERS database, under reference number 517042. A 38 year-old male patient with a history of eczema and atopic dermatitis had received on 17 December 2013 a left arm injection of ACAM2000 (lot number VV04003A), and an unspecified amount of time later the same date, experienced an unevaluable event. According to the report, "the patient should have permanent exemption for the vaccination due to contraindication of eczema". The patient had no known illness at the time of vaccination. Lab data, other medications and prior vaccinations were not reported. Outcome was not reported. Documents held by sender: none.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Rash
Clinical narrative: This case was received on 15 April 2014 via a third party query tool search on the VAERS database, under reference number 518200. A 20 year old male patient had received an injection of ACAM2000, lot number VV04-003A) on 02 December 2013 and 20 days later on 22 December 2013, he developed a rash. The patient's medical history and concomitant medications were not reported. Laboratory tests were not reported. The event resolved without complications on an unreported date and the patient went back to work. The patient outcome is recovered. Documents held by sender: None
Age: 22.0
Sex: F
Vaccine: SMALL
Symptoms: Pruritus, Rash
Clinical narrative: This case was received on 15 April 2014 via a third party query tool search on the VAERS database, under reference 518563. This case involves a 22-year-old female patient who had received the following vaccination on 19 December 2013: ACAM2000 (SP Biologics Co. lot number VV04003A) in the left arm. On 04 January 2014, the patient experienced small bumps on her hands and then which developed into a rash on both hands and then which developed into a rash on both hands. The rash is also located on her right upper arms and both thighs with itching. Lab data was reported as none. The patient required an emergency visit. Other medication, current illnesses and history were reported as none. The patient outcome was unknown. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Rash pruritic, Urticaria
Clinical narrative: This case was received on 15 April 2014 via a third party query tool search on the VAERS database, under reference number 5186121. A 21 year-old male patient had received the following vaccination on 20 December 2013: ACAM2000 (SP Biologics Co. lot number VV04003A) in the left arm. On 02 January 2014, the patient experienced itchy rash and hives. Lab data was reported as allergy testing has been ordered, but has not been accomplished yet. The patient required an emergency visit. The patient was treated with steroid injections, not specified which helped. The patient was also given ZANTAC and ATARAX in the clinic. Other medication, current illnesses and history were reported as none. Outcome was unknown. Documents held by sender: none.
Age: 43.0
Sex: M
Vaccine: ANTH, HEP, SMALL
Symptoms: Impaired healing, Injection site reaction, Rash
Clinical narrative: This case was received on 15 April 2014 via a third party query tool search on the VAERS database, under reference number 518200. a 43 year old male patient, with a history of codeine allergy, received the following vaccines on 12 December 2013: a left arm injection of ACAM2000 (lot number VV04003A); an intramuscular right arm injection of ENGERIX B (GlaxoSmithKline, lot number AHBVC046CA); and a right arm intramuscular injection of Anthrax vaccine (Biothrax, Emergent, lot number FAV324A). The patient was not taking any known concomitant medications, and was not ill at the time of vaccination. On 23 December 2013, i.e. 11 days post-vaccination, he presented to the clinic complaining of a non-itchy rash on both forearms and upper thighs. He also noted that the smallpox vaccination site was not scabbing. He was referred to a physician, who prescribed topical hydrocortisone and precautionary SEPTRA; the physician reported "no major concerns". The patient recovered on an unspecified date. Documents held by sender: None.