chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alpha 1 foetoprotein normal, Beta haemolytic streptococcal infection, Blood glucose normal, Breech presentation, Caesarean section
Clinical narrative: This spontaneous prospective pregnancy report was received from a medical assistant refers to a 30 year old female patient. On 07-JUL-2014, the pregnant patient was inadvertently vaccinated with GARDASIL lot # J009788, 0.5 ml, intramuscular. The patient sought medical attention in the office. The patient became pregnant with LMP of 23-NOV-2013 and EDD of 30-AUG-2014. No adverse effects reported. No further information provided. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, Pregnancy test urine positive, Rhesus antibodies positive, Streptococcus test positive, Ultrasound scan normal
Clinical narrative: This spontaneous prospective pregnancy report was received from a medical assistant refers to a 30 year old female patient. On 07-JUL-2014, the pregnant patient was inadvertently vaccinated with GARDASIL lot # J009788, 0.5 ml, intramuscular. The patient sought medical attention in the office. The patient became pregnant with LMP of 23-NOV-2013 and EDD of 30-AUG-2014. No adverse effects reported. No further information provided. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Goitre, Injection site pain, Myalgia, Pyrexia, Thyroid disorder
Clinical narrative: This spontaneous report as received from a consumer regarding her friend refers to a 66 year old male patient. Concomitant medications of the patient included many unspecified medications (reported as He's taking a mountain of medications All Unspecified). The pertinent medical history of the patient included lot of unspecified medical issues. Approximately on 13-JUN-2014 (reported as about 2 weeks ago) the patient was vaccinated with PNEUMOVAX 23 at his office route injection for vaccine. The reporter stated that approximately on 13-JUN-2014 (reported as for the first couple of days soon after receiving the vaccine) the patient experienced pain at injection site. Approximately on an unknown date in June 2014 (reported as however the last 10 days) the patient developed slight fever, muscle pain in his shoulders, arms, back and quads described as pain level 6 to 7. On an unknown date the patient developed swelling and heat in his thyroid. Lab diagnostic studies included blood work, X-rays which are scheduled. The outcome of pain at injection site, swelling and heat in his thyroid and slight fever is unknown. The outcome of muscle pain in his shoulders, arms, back and quads described as pain level 6 to 7 was reported as recovering/resolving (reported as muscle pain started feeling a little better last night). The patient sough medical attention. No product quality complaint was involved. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to two patients of unknown age. On 20-JUN-2014, the patients were vaccinated with GARDASIL (dose, route and lot # not provided) that was improperly stored. The product was supported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, since the reporter does not want to be contacted.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified number of patients of unknown age. It was reported that the RECOMBIVAX HB of unknown dose, have undergone a second temperature excursion dated 2-JUL-2014 and have been administered post initial excursion reported as 16-JAN-2014. Excursion supported. It was reported that no adverse events an no concerns are reported by any patients. RECOMBIVAX HB have been administered since date of last excursion of 27-JAN-2014 is with Lot number reported as H017013 and expiry date reported as 01-JUL-2015. This is one of the several reports from the same source: different patients same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified number of patients of unknown age. It was reported that the RECOMBIVAX HB of unknown dose for prophylaxis, have undergone a second temperature excursion dated 2-JUL-2014 and have been administered post initial excursion reported as 16-JAN-2014. Excursion supported. It was reported that no adverse events and no concerns are reported by any patients. RECOMBIVAX HB have been administered since date of last excursion of 27-JAN-2014 is with Lot number reported as H010849 and expiry date reported as 28-FEB-2015. This is one of the several reports from the same source: different patients same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified number of patients of unknown age. It was reported that the ROTATEQ of unknown dose, have undergone a second temperature excursion date 2-JUL-2014 and have been administered post initial excursion reported as 16-JAN-2014. Excursion supported. It was reported that no adverse events and no concerns are reported by any patients. ROTATEQ have been administered since date of last excursion of 27-JAN-2014 is with Lot number reported as J004875 and expiry date 17-OCT-2015. This is one of several reports from the same source: different patients same reporter. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a nurse regarding a 15 year old male patient. There was no information on pertinent medical history. The patient had a current condition of sulfa allergy. On 03-JUL-2014, the patient was vaccinated with first dose of GARDASIL (Product Lot#J012212) 0.5 ml (milliliters) intramuscularly on right arm (reported as right delt). There was no information on concomitant medications. The reporter stated that she called the patient on an unspecified date on JUL-2014, and it was reported that the patient had redness at the injection site. The patient sought medical attention by visiting health care provider's office. The patient had 3 by 3 inch redness at the injection site of right arm. No swelling, no fever, no headache was reported. The nurse stated that the redness at the injection site looks like sunburn that was peeling. No treatment was given. There was no product quality complaint involved. The outcome of redness at the injection site was reported as not recovered. The causality was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to two unspecified patients of unknown age and gender. On 07-JUL-2014 the patients were vaccinated with improperly stored doses of ZOSTAVAX (0.65 ml, subcutaneous, lot# and strength were unspecified). No adverse events were reported. The outcome was unknown. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR
Symptoms: Rash
Clinical narrative: Rash developed within minutes of vaccine administration. Patient given BENADRYL in office. Mother advised that patient will need to be premedicated in the future.
Age: 1.22
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Rash - started on face, appeared in clusters, spread to involve face and UEs, diffusely. Macular and papular, erythematous. Sibling was also affected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to an unspecified number of patients. On 24-JUN-2014, the patients were vaccinated with PNEUMOVAX 23 (dose, route and lot # not provided) that was improperly stored. The product was supported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, since the reporter does not want to be contacted.
Age: 1.29
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a 15 month old patient (gender unspecified). No pertinent medical history and concurrent condition reported. On 07-JUL-2014 VARIVAX (Merck) [lot # J011125, expiry date 02-SEP-2015] dose 1, 0.5 ml, subcutaneous stored at 22C for 72 hours was administered to the patient. No other concomitant therapies reported. The action taken was unknown. The outcome of the event was unknown. No PQC reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified number of patients of unknown age. It was reported that the ROTATEQ of unknown dose, have undergone a second temperature excursion dated 2-JUL-2014 and have been administered post initial excursion reported as 16-JAN-2014. Excursion supported. It was reported that no adverse events and no concerns are reported by any patients. ROTATEQ have been administered since date of last excursion of 27-JAN-2014 is with Lot number reported as J008740 and expiry date reported as 22-MAR-2018. This is one of several reports from the same source: different patients same reporter. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Visual impairment
Clinical narrative: This spontaneous report as received from the mother of the patient refers to her 13 year old son without pertinent medical history and drug reactions/allergies. On 04-OCT-2013, 22-JAN-2014 and on 01-JUL-2014, the patient was vaccinated with a dose of GARDASIL, injection, "1 single shot", intramuscular, respectively. There was no concomitant medication. The reporter stated that "04-OCT-2013, 22-JAN-2014 and on 01-JUL-2014 are the days the patient received GARDASIL and after every dose the patient experienced difficulty breathing, felt faint and his vision was impaired." The reporter also stated that "these reactions did not last very long." The patient didn't seek medical attention. No lab diagnostics studies were performed. No treatment was given to the adverse events. The outcome of the events was recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to an unspecified number of patients. On 23-JUN-2014, the patients were vaccinated with PNEUMOVAX 23 (dose, route and lot # not provided) that was improperly stored. The product was supported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, since the reporter does not want to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to two unspecified patients of unknown age. On 19-JUN-2014, the patients were vaccinate with GARDASIL (dose, route and lot # not provided) that was improperly stored. The product was supported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, since the reporter does not want to be contacted.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified number of patients of unknown age. It was reported that the RECOMBIVAX HB of unknown dose, have undergone a second temperature excursion dated 2-JUL-2014 and have been administered post initial excursion reported as 16-JAN-2014. Excursion supported. It was reported that no adverse events and no concerns are reported by any patients. RECOMBIVAX HB have been administered since date of last excursion of 27-JAN-2014 is with Lot number reported as J001836 and expiry date reported as 01-FEB-2015. This is one of the several reports from the same source: different patients same reporter. Additional information has been requested.
Age: 0.8
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a 9 month old male patient. No pertinent medical history and concurrent conditions reported. On an unknown date the 9-month-old patient was vaccinated with VAQTA, intramuscular (dose not reported). No other concomitant therapies reported. The outcome of the event was unknown. The causality was not provided. No PQC reported. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified number of patients of unknown age. It was reported that the ROTATEQ of unknown dose, have undergone a second temperature excursion dated 2-JUL-2014 and have been administered post initial excursion reported as 16-JAN-2014. Excursion supported. It was reported that no adverse events and no concerns are reported by any patients. ROTATEQ have been administered since date of last excursion of 27-JAN-2014 is with Lot number reported as J006562 and expiry date reported as 29-JAN-2015. This is one of the several reports from the same source: different patients same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to unspecified number of patients. On 04-JUN-2014, the patients were vaccinated with PNEUMOVAX 23 (dose, route and lot # not provided) that was improperly stored. The product was supported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, since the reporter does not want to be contacted.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Developed a rash at the injection site.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On 06-JUN-2014 the patient was vaccinated with expired dose of M-M-R II, Lot # H01013G 0.5 ml, subcutaneous. No adverse effect reported. No further information was provided. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash vesicular, Varicella post vaccine
Clinical narrative: Pt. got varicella vaccine on 6/24/14 at well child check up. She developed fever on 6/30/14 and rash characteristic of chickenpox. Seen at urgent care 7/5/14 and diagnosed with chickenpox.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received vaccination on Friday 8/16/2013. Contacted clinic on Monday 8/19/2013 complaining of pain, redness, and swelling at injection site. Patient was prescribed cephalexin and advised to take OTC NSAID (not specified) and follow up with provider. Cephalexin 500 mg QID.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Patient seen three days after vaccination for swelling of his right upper arm with redness and rash up to his elbow. Swelling started the day after receiving vaccination. Patient was started on cephalexin and prednisone for reaction. Prednisolone 5 mg other, Ibuprofen 600 mg TID.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Patient contacted provider the day following vaccination to report a red area approximately 6 inches at the injection site. Area was raised with a few welts around injection site and under the arm. No red streaks reported. Area was also warm to the touch.
Age: 70.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Back pain, Chest pain, Electrocardiogram normal, Injection site pain
Clinical narrative: Shortly after patient received both PNEUMOVAX and Tdap, experienced severe pain in right arm and shoulder, down his back, in the center of his chest. Stat EKG showed no changes from 2010 EKG. Patient denied radiating pain to left arm or jaw. After several minutes pain subsided and patient was released AMA.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Rash, Rash papular
Clinical narrative: Patient experienced a fine papular rash over the trunk the day following his Tdap injection. Patient began taking diphenhydramine over the weekend and symptoms started to clear. Diphenhydramine.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Patient has itchy rash, pink/raised/no fever to left lower and upper extremities/torso. Denies shortness of breath at this time.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient had been to local ED on 7/21/13 for bee sting and was treated with prednisone and famotidine tablets. On 7/22/13, patient received zoster vaccination. Patient waited in clinic for over 30 minutes with no reaction. Several hours later, patient contacted clinic with complaints of rash developing. Patient opted to hold prednisone and contact office if any further problems. Patient did not contact office, no further issues reported.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On an unknown dates, the patients were vaccinated with doses of ROTATEQ  orally (dose, dose number and lot number were not reported), which were exposed to temperatures outside of range. No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information is not expected, because the permission to contact was not given.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 86 year old male patient with no pertinent medical history and concurrent conditions. On 30-JUN-2014 the patient was vaccinated with ZOSTAVAX. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The pharmacist reported that the patient presented to the pharmacist today on 03-JUL-2014, with a red, oval area around the injection site. This red area developed on an unspecified date. The outcome of red, oval area around the injection site was unknown. The patient sought medical attention. No treatment was given for adverse event. No lab diagnostics studies were performed. This is one of two reports from the same source (other case # 1407USA004360). Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 34 year old female patient. Medical history and concurrent conditions were not reported. On 01-JUL-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, strength, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The pharmacist reported that a patient inadvertently received dose of ZOSTAVAX on 01-JUL-2014. The patient should have received her first dose of VARIVAX (Merck) on this date. No adverse effect reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a 13 year old male patient. On an unknown date the patient was vaccinated with GARDASIL (dose, route and lot # were not provided). The patient was also vaccinated concomitantly with VAQTA (dose, route and lot # were not provided). The reporter stated that 2 to 3 days after the patient was vaccinated with GARDASIL and VAQTA, he developed hives. The physician gave to the patient unspecified antihistamines to treat the reaction. The reporter stated that the doctor said the hives were all cleared up now. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Swelling. Diphenhydramine unknown.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia, Rash generalised, Vomiting
Clinical narrative: Generalized rashes about 3hr after shots, with fever and vomiting.
Age: 19.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Jaundice, Transaminases increased, Ultrasound abdomen normal
Clinical narrative: Transaminitis - 200's. Abdominal pain. Jaundice (Tbili 2.0).
Age: 19.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin, Jaundice
Clinical narrative: Transaminitis - 200's. Abdominal pain. Jaundice (Tbili 2.0).
Age: 19.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Transaminases increased, Ultrasound abdomen normal
Clinical narrative: Transaminitis - 200's. Abdominal pain. Jaundice (Tbili 2.0).
Age: 44.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, Diarrhoea, Headache, Pyrexia
Clinical narrative: Headache, fever, abdominal pain, diarrhea
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain in upper left arm and shoulder, worsening to limited range of motion within 24 hours. Sustained for at least 7 days (to present).  Treated with acetaminophen with minimal resolution.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Dyspnoea
Clinical narrative: Patient developed shortness of breath less than an hour after vaccine that lasted for several days.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Dizziness, Musculoskeletal stiffness, Syncope, Urinary incontinence
Clinical narrative: Patient was given varicella and meningococcal vaccines.  After vaccination patient stated "I feel lightheaded."  While still seated, pt began to rest head on arm and began to faint.  She became stiff and voided.  An ammonia capsule was broken and placed under pts nose.  She was then alert and had no knowledge of what had happened.  Pt was assisted onto a cot with legs raised.  BP taken.  O2 sat taken.  EMS called.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Activities of daily living impaired, Dysstasia, Mass, Pain, Pruritus
Clinical narrative: Fever, large itchy lump, very sore all over, couldn't stand for long, had to stay home from work, extreme soreness that lasted 36 hours.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever, large itchy lump, very sore all over, couldn't stand for long, had to stay home from work, extreme soreness that lasted 36 hours.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Activities of daily living impaired, Influenza like illness, Local swelling, Pruritus, Pyrexia
Clinical narrative: Fever, large itchy lump, very sore all over, couldn't stand for long, had to stay home from work, extreme soreness that lasted 36 hours.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Swelling
Clinical narrative: Fever, large itchy lump, very sore all over, couldn't stand for long, had to stay home from work, extreme soreness that lasted 36 hours.
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Rash
Clinical narrative: Administed MMR and Varicella Vaccines - one in each thigh.  Patient within five minutes developed erythema on both extremities around sites of injection.  On varicella side- rash spread down lower extremity. Benadryl administered within 10 minutes.  5 minutes after giving Benadryl, rash started to resolve.
Age: 11.0
Sex: F
Vaccine: DTAP, MEN
Symptoms: Angioedema, Lip swelling, Local swelling
Clinical narrative: Swelling of arm occurred 7/4/2014. and then 36hrs later angioedema. Severe swelling of lips (2 hrs and worsening) given shot of epinephrine and Prednisolone. Sent home with Prednisolone for 5 days, Epipen and  Benadryl.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Pain to right arm. Redness, warmth to area.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: The area around and slightly above the injection site was red in color. The area was warm to touch and pruritic. The area was not swollen or raised. The patient presented to the pharmacy where the immunization was delivered approximately 24 hours after the adverse event was first noticed.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Eye movement disorder, Nuclear magnetic resonance imaging, Ophthalmological examination, VIth nerve paralysis
Clinical narrative: Patient's left eye crossed inward and he could not move his eye to look to the left, only straight ahead or crossed.  Was diagnosed with 6th nerve palsy.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates, the patients were vaccinated with doses of GARDASIL (dose, dose number, lot number and route of administration were not reported), which were exposed to temperatures outside of range. No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information is not expected, because the permission to contact was not given.
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Dental caries, Gingival swelling, Headache, Pain, Swelling face
Clinical narrative: Teeth are rotting, pieces breaking off. Toothaches, pain, headaches, 2 pulled teeth, maybe more soon, swollen gums and cheeks.
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Teeth brittle, Tooth extraction, Toothache
Clinical narrative: Teeth are rotting, pieces breaking off. Toothaches, pain, headaches, 2 pulled teeth, maybe more soon, swollen gums and cheeks.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On an unknown dates, the patients were vaccinated with VAQTA (dose, dose number, lot number and route of administration were not reported), which were exposed to temperatures outside of range. No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information is not expected, because the permission to contact was not given.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Burning sensation, Erythema, Local swelling, Oedema peripheral
Clinical narrative: Pt came for nursing school shots. Reported h/o chicken pox and presented titer with results stating "unequivocal". Administered VARIVAX and pr reports next day arm warm red swollen about 2-3 cm diam. Did not take ibuprofen/BENADRYL/ice and on Wed 7/2/14 redness, swelling began to worsen with increased itching and burning. Reports fever of 100 degrees on 7/4/14 and began taking ibuprofen. Arm continued to worsen w/increasing redness and edema and reports measured at 11-12 cm by 7/7/14.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Pyrexia, Skin warm
Clinical narrative: Pt came for nursing school shots. Reported h/o chicken pox and presented titer with results stating "unequivocal". Administered VARIVAX and pr reports next day arm warm red swollen about 2-3 cm diam. Did not take ibuprofen/BENADRYL/ice and on Wed 7/2/14 redness, swelling began to worsen with increased itching and burning. Reports fever of 100 degrees on 7/4/14 and began taking ibuprofen. Arm continued to worsen w/increasing redness and edema and reports measured at 11-12 cm by 7/7/14.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's medical history was not reported. On an unknown date the patient was vaccinated with GARDASIL that was improperly stored. Concomitant medications were not reported. The nurse reported that an improperly stored GARDASIL most likely had been administered. The GARDASIL reached a temperature as low as 30 Fahrenheit (F) for an unspecified amount of hours. The nurse stated that she thought that the proper storage range for GARDASIL was 35 F to 46 F because she reports that they have always been considered in range at her office. No adverse effects were reported. The outcome of the events was unknown. Follow-up information as received from a Licensed Practical Nurse refers to 14 year old patient. On 11-JUN-2014, the patient was vaccinated with a dose of GARDASIL (lot# J009788, expiration date 17-MAR-2016) that was improperly stored. This case is linked to 1406USA009397, 1406USA009396, 1406USA009398, 1406USA009399 and 1406USA009282. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a "young adult" male patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23. Lot number and expiration date were not reported. Dose and route reported "as directed". No co-suspect and concomitant therapies were reported. The physician reported that the patient developed a localized reaction at the injection site (reported as sight) that included significant pain (on an unknown date). The outcome of localized reaction at the injection site (sight) that included significant pain was reported as recovered (an unknown date). The patient sought medical attention. This is one of two reports from the same source (other case # 1407USA004383). Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from a 23 year old female patient with no pertinent medical history or drug allergies/reactions refers to herself. On 03-JUL-2014 the patient was accidentally vaccinated with a dose of GARDASIL (dose and routed unspecified) (lot # J009788, expired date 17-MAR-2016). There is no concomitant therapy. The patient was 7 month pregnant. LMP was on approximately 03-DEC-2013 and EDD was on 09-SEP-2014. The vaccine the patient scheduled to received was ADACEL. No adverse event reported. No treatment was given. No lab diagnostic studies performed. The patient did not seek any medical attention. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates, the patients were vaccinated with doses of LIQUID PEDVAXHIB (dose, dose number, lot number and route of administration were not reported), which were exposed to temperatures outside of range. No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information is not expected, because the permission to contact was not given.
Sex: U
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a several patients of unknown age and gender. medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with PNEUMOVAX23. Dose, route reported, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The physician reported that in general, this office had seen several patients with negative responses to PNEUMOVAX23. The outcome of the adverse event was unknown. This is on of two reports from the same source (other case # 1407USA002434). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates, the patients were vaccinated with doses of M-M-R II (dose, dose number, lot number and route of administration were not reported), which were exposed to temperatures outside of range. No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information is not expected, because the permission to contact was not given.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 32 year old female patient (nursing student). The reporter reported that on 16-JUN-2014 she administered the second dose of VARIVAX (Merck) (lot # H010958, Exp date: 31-MAY-2014, 0.5 ml) subcutaneous in the left arm. However, the VARIVAX (merck) was expired. No adverse events reported at this time. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site hypertrophy, Injection site pain, Injection site urticaria
Clinical narrative: This spontaneous report was received from a patient's wife, who is also a physician refers to her husband of unknown age. Medical history was not reported. On 18-JUN-2014 the patient was vaccinated with ZOSTAVAX vial 19,400 unit 1 standard package vial of 1, intradermal, dosage, lot number, expiration date were not reported. Concomitant therapy was not reported. The reporter informed that she believed that the ZOSTAVAX given 18-JUN-2014 may have been administered to the patient intradermal. She also reported that injection was painful to the patient, the patient developed wheal measuring 3 inches by 2 inches along with thickening to the injection site since 20-JUN-2014, the events remains ongoing. It was unknown if the patient sought medical attention. The patient's outcome with the event was not recovered. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a physician refers to a 69 year old male patient without drug reactions or allergies. The patient's medical history included mild renal failure and hypertension. On 26-JUN-2014 the patient was vaccinated with PNEUMOVAX 23, 0.5 ml, one dose, intramuscular, lot # K005957, Expiration date not reported, in the right arm. Concomitant therapies included hydrochlorothiazide (manufacturer unknown), NIFEDICAL XL and simvastatin (manufacturer unknown). On 27-JUN-2014 (within 24 hours of receiving PNEUMOVAX 23) the patient developed massive swelling, warmth and discomfort at the injection site. The patient was treated with ice and ADVIL. There were not laboratory diagnostics studies performed. Caller also stated the patient was in the office during a routine physical when he was administered the vaccine and then followed up with the office soon after to schedule an appointment to be seen due to the AE. Caller stated it was noted that the swelling had slightly improved by the time the patient was seen in the office. Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: TDAP, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report as received from a medical technologist (other health professional) refers to a 10 year old patient of unknown gender with no pertinent medical history or drug reactions/allergies. On 24-JUN-2014, the patient was vaccinated with a booster dose of VARIVAX (merck) INJ (lot # J014228; expiration date 08-NOV-2015), 0.5 ml, once, subcutaneous in the left arm. No co-suspect therapies were reported. Concomitant therapies included ADACEL, on 24-JUN-2014. On 24-JUN-2014, the patient experienced "pain at (injection) site, welts to it, erythema, swelling". The reporter stated it was considered an immediate reaction". At the time of the report, the outcome of the events was recovering/resolving (also reported as patient was "doing good"). The patient sought medical attention by office visit. No treatment was given and the patient was told to contact again if it got worse. No lab diagnostics studies were performed. Two more patients presented adverse events with the same lot of VARIVAX (Merck). This case is linked to case MARRS # 1407USA000221 (same reporter link). Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: TDAP, VARCEL
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a medical technologist (other health professional) refers to a 10 year old patient of unknown gender with no pertinent medical history or drug reactions/allergies. On 24-JUN-2014, the patient was vaccinated with a booster dose of VARIVAX (merck) INJ (lot # J014228; expiration date 08-NOV-2015), 0.5 ml, once, subcutaneous in the left arm. No co-suspect therapies were reported. Concomitant therapies included ADACEL, on 24-JUN-2014. On 24-JUN-2014, the patient experienced "pain at (injection) site, welts to it, erythema, swelling". The reporter stated it was considered an immediate reaction". At the time of the report, the outcome of the events was recovering/resolving (also reported as patient was "doing good"). The patient sought medical attention by office visit. No treatment was given and the patient was told to contact again if it got worse. No lab diagnostics studies were performed. Two more patients presented adverse events with the same lot of VARIVAX (Merck). This case is linked to case MARRS # 1407USA000221 (same reporter link). Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood pressure, Heart rate normal, Loss of consciousness, Syncope
Clinical narrative: Pt. received vaccines, waited 15 minutes, denied any symptoms. While at check out, scheduling second HPV, stated "he was going to faint". By time receptionist got out of her chair, he fell backwards, hit head on wall, slid down wall. MA's came receptionist got Dr. BP, BS was done, pulse. He was in exam room for another 40 minutes before Dr released him. MA walked him to car.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 07-JUL-2014 the patient was vaccinated with M-M-R II lot # H012571. The vaccine was expired (expiration date 29-JUN-2014), but the patient experienced no adverse symptoms. The outcome of the patient having received expired M-M-R II lot # H012571 is unknown. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Rash generalised, Vaccination complication
Clinical narrative: General body rash began approximately 9 hrs after MMR immunization given. Went to PCP for evaluation; told reaction to medication. Rash never blistered. Resolving 7-9-14.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Syncope.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 56 years old male patient. The patient's medical history included shingles prior July 2013. In July 2013, the patient was vaccinated with ZOSTAVAX lot # J000443; expiration date: 11-APR-2014, 0.65 ml, subcutaneous. Secondary and concomitant therapies were not reported. The patient's wife reported to the pharmacist that since the vaccination in July 2013, the patient had an unknown number of outbreaks of shingles, but these outbreaks were less severe than his outbreaks of shingles prior to receiving ZOSTAVAX. The outcome of shingles was reported as recovered on an unknown date. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Extraocular muscle paresis, Facial paresis, Oral discomfort, Pain in jaw, VIIth nerve paralysis
Clinical narrative: (R) side of face is weak, pain in jaw. Weakness in (R) eye and (R) side of mouth. Dx: Bell's palsy.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 60 year old female patient with phenothiazine and bispho allergy. The patient was not pregnant. On 26-JUN-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous, lot # reported as J016258 and expiration date reported as 26-FEB-2015, in the left arm. In June-2014 the patient developed red area in back of left arm (the arm injection was given into) which was warm to touch. On 06-30-2014 the patient was seen in urgent care and prescribed three days of BACTRIM and prednisone. There was not laboratory diagnostics studies performed. The outcome of patient developed red area in back of left arm (the arm injection was given into) which was warm to touch was reported as not recovered/not resolved. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 75 year old female patient with no pertinent medical history and concurrent conditions. On 30-JUN-2014 the patient was vaccinated with ZOSTAVAX. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The pharmacist reported that the patient had an injection site reaction which began on an unspecified date in 2014. Pharmacist reported that the patient would be coming into the pharmacy later on 03-JUL-2014 for the pharmacist to assess. The outcome of injection site reaction was unknown. The patient sought medical attention. No treatment was given for adverse event. No lab diagnostics studies were performed. This is one of two reports from the same source (other case # 1407USA002415). Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Started with fever of 103.4 degrees the day following vaccine with headache and generalized aches.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: 1015pm "dizziness" after immunizations - lasting 5-10 mins.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site mass
Clinical narrative: Started as small lump around the site of injection, has grown in size for no reason. No pain associated. 7/9/14 - pt came back and now has a bruise on area where lump is. Appeared for "no reason".
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history was not reported. The reporter informed that an unspecified dates since 22-MAY-2014, the patients received GARDASIL, (lot # H020901, expiration date 05-JUL-2015 and lot# J006236; expiration date: 25-FEB-2016) via intramuscular, dosage and strength were not reported. Concomitant therapy was not reported. The reporter stated that from 22-MAY-2014 until 27-MAY-2014 the GARDASIL were improperly stored at 66 F (the total duration of exposure was 5 days). No known adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Fainted immediately, recovered quickly, was only out for a few seconds. Dr. called in and spoke with him. Took B/P had him stay down for 10 min, sat him up and gave water. Dr. took at look before we d/c.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Local rxn of erythema to (R) deltoid about 8 cm diameter.
Age: 0.63
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient was seen on 7/8/14 and was given duplicate PEDIARIX (DTaP-IPV, HBV) and PREVNAR. Pt rec'd on 5/22/14. We are in a new EMR and all records not loaded nor did MA cross check old EMR and child profile until after imms given and MA went to load into child profile.
Age: 1.37
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Pyrexia, Rash
Clinical narrative: Mother reports child developed fever and rash on bilateral feet and hands after immunization. Rash is improving - but today developed bright red area on (R) ant thigh at injection site. Has cellulitis of (R) thigh. Rx - antibiotics and follow up in 2 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Pt presented two days after getting a shingles vaccine with an elevated circular red area where the vaccine was admin. MD prescribed MEDROL dose pack.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red, warm to the touch leg where area of vaccines were given.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a 53 year old female patient (a pharmacist) via company representative refers to herself. At the time of this report, the patient was not pregnant. On 23-MAY-2014 the patient was vaccinated with ZOSTAVAX (0.65 ml, once, subcutaneously, lot # J014851, expiration date: 24-OCT-2014). On approximately 23-MAY-2014, reported as, within 24 hours after vaccination the patient experienced headache and injection site reaction. Reaction was further described as warm, red, raised two inches by 3 inches in diameter. The patient stated that pictures of injection site reaction were available upon request. There was no treatment given for the adverse events. The patient did not seek medical attention. The outcome of headache and injection site reaction described as warm, red, raised two inches by 3 inches in diameter was reported as not recovered. The relatedness between reported adverse events and ZOSTAVAX was not reported. Additional information is not expected because the reporter did not want to be contacted.
Age: 94.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 94 year old female patient. On 19-JUN-2014 the patent was vaccinated with an expired dose of PNEUMOVAX 23 lot # H014196, expiration date: 19-MAR-2014, strength, dosage, route and indication unknown. No adverse effect reported. The outcome of the event was unknown. Additional information has been requested.