chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 year old male patient. Patients medical history includes allergy to PERCOCET. Concurrent conditions include diabetes, high cholesterol and high blood pressure. On 07-JUL-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J014812, expiry: 20-FEB-2015) 0.65 ml, subcutaneous. Concomitant medications include unspecified blood thinner. On 09-JUL-2014 the patient experienced developed redness and itchiness after receiving ZOSTAVAX. The patient had taken BENADRYL on 07-JUL-2014 after ZOSTAVAX. The patient sought medical attention went into the pharmacy and informed the pharmacist on 10-JUL-2014. No treatment was given for the events. No laboratory tests were performed. The reporter stated that the patient had a white area on an unspecified location on his arm but states that is from when they used to do punch cards for vaccinations when the patient was a child. The outcome of developed redness and itchiness after receiving ZOSTAVAX was reported as not recovered. Causality was not reported. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HEPAB
Symptoms: Hypoaesthesia
Clinical narrative: Numbness on right side of face.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood pressure decreased, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Got the shot, as walking to the desk to check out patient started to feel dizzy and her throat was bothering her and sat down and put her head down. Was offered water.  After check out she was walking out of the front door of the building and claimed that she was starting to get tunnel vision and not feel right.  She passed out and was caught by me (mom) she was very pale and was sweating.  I have asked her and she told me she felt cold as well and that her ears were ringing and she couldn't feel her arms or legs.  Blood pressure was taken by a nurse and was extremely low, somewhere around 70/30 I believe.  Then she was escorted back into the doctors office to lay down for approximately 10 minutes.  As of right now, at 2:37PM the same day, she has a strong headache and feels very sore, weak, and exhausted. The full extent of event outcomes remain to be seen.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling cold, Headache, Hyperhidrosis, Hypoaesthesia, Loss of consciousness
Clinical narrative: Got the shot, as walking to the desk to check out patient started to feel dizzy and her throat was bothering her and sat down and put her head down. Was offered water.  After check out she was walking out of the front door of the building and claimed that she was starting to get tunnel vision and not feel right.  She passed out and was caught by me (mom) she was very pale and was sweating.  I have asked her and she told me she felt cold as well and that her ears were ringing and she couldn't feel her arms or legs.  Blood pressure was taken by a nurse and was extremely low, somewhere around 70/30 I believe.  Then she was escorted back into the doctors office to lay down for approximately 10 minutes.  As of right now, at 2:37PM the same day, she has a strong headache and feels very sore, weak, and exhausted. The full extent of event outcomes remain to be seen.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pallor, Throat irritation, Tinnitus, Tunnel vision
Clinical narrative: Got the shot, as walking to the desk to check out patient started to feel dizzy and her throat was bothering her and sat down and put her head down. Was offered water.  After check out she was walking out of the front door of the building and claimed that she was starting to get tunnel vision and not feel right.  She passed out and was caught by me (mom) she was very pale and was sweating.  I have asked her and she told me she felt cold as well and that her ears were ringing and she couldn't feel her arms or legs.  Blood pressure was taken by a nurse and was extremely low, somewhere around 70/30 I believe.  Then she was escorted back into the doctors office to lay down for approximately 10 minutes.  As of right now, at 2:37PM the same day, she has a strong headache and feels very sore, weak, and exhausted. The full extent of event outcomes remain to be seen.
Age: 25.0
Sex: M
Vaccine: RAB
Symptoms: Rash
Clinical narrative: Nonpurulent rash b/l forearms, resolved with po diphenhydramine, did not recur.
Age: 1.03
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever of 101-103 degrees through 07/14/14.  Spotty rash appears heavy on lower abdomen, groin and spreads to belly, back and neck.
Age: 1.2
Sex: M
Vaccine: DTAP
Symptoms: Vomiting
Clinical narrative: Vomiting multiple times.
Age: 0.18
Sex: M
Vaccine: DTAP
Symptoms: Agitation neonatal, Dyskinesia, Hypertonia, Irritability, Muscle spasms
Clinical narrative: Leg tremors/spasms for several seconds during sleep followed by extreme leg stiffness. Baby was jittery during sleep & very restless night of vaccine and next two nights. The leg tremors took place following 2 nights following vaccine and then a week later. He had tense muscles during day, with jerking reactions and unusual fussiness. Hypertonia in legs throughout the day for next couple weeks.
Age: 0.18
Sex: M
Vaccine: DTAP
Symptoms: Muscle tightness, Musculoskeletal stiffness, Restlessness, Tremor
Clinical narrative: Leg tremors/spasms for several seconds during sleep followed by extreme leg stiffness. Baby was jittery during sleep & very restless night of vaccine and next two nights. The leg tremors took place following 2 nights following vaccine and then a week later. He had tense muscles during day, with jerking reactions and unusual fussiness. Hypertonia in legs throughout the day for next couple weeks.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 60 year old female patient with drug reaction/allergies to ibuprofen, iodine, sulfa drugs; presented GERD, asthma and depression. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, frequency, strength, lot number, expiration date and route were not reported. Concomitant therapies included SEREVENT, SINGULAIR, FLONASE, nortriptyline, albuterol sulfate, ranitidine, BENADRYL, aluminum hydroxide, GAVISCON antacid tablets, Vitamin D (unspecified) and mineral (unspecified) CENTRUM vitamins. Pharmacist reported that patient experienced a large "injection site" reaction after receiving PNEUMOVAX23 at an unspecified date. At the time of the report the outcome was unknown. Patient seek medical attention. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 2 year old male patient. On 14-JAN-2014, the patient was vaccinated with the first 0.5ml dose of VAQTA (lot # not reported) intramuscularly and on 19-JUN-2014, the patient received the second 0.5 ml dose of VAQTA (lot # not reported) intramuscularly. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist refers to eight unspecified patients of unknown age and gender with medical history of exposure to shingles. On an unknown date the patients were vaccinated with ZOSTAVAX, vial, 1 injection, subcutaneous, (lot number, expiration date and dosage were not reported). Concomitant therapy was not reported. The pharmacist informed that on an unknown date the patients that were previously exposed to shingles, had a more pronounced injection site reaction to ZOSTAVAX. There was not treatment given for the adverse event and the patient did not seek medical attention. The outcome of the event was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Rash pruritic
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 60 year old female patient with drug reaction/allergies Ibuprofen, iodine, sulfa drugs, gastroesophageal reflux disease (GERD, asthma and depression. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, frequency, strength, lot number, expiration date and route were not reported). Concomitant therapies included SEREVENT, SINGLULAIR, FLONASE, nortriptyline, albuterol, RANITIDINE, BENADRYL, aluminium hydroxide, GAVISCON ANTACID TABLETS, VITAMIN D (UNSPECIFIED) and minerals (Unspecified), CENTRUM. the pharmacist reported that an unspecified date in the past, a patient developed a large, itchy rash and shortness of breath after receiving M-M-R II. The outcome was reported as recovered on an unknown date. Patient seek medical attention. Additional information has been requested. These case is one (1) of two (2) reports from the same source. (MARRS 1407USA006059 and 1407USA006768)
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Convulsion, Dizziness, Syncope, Tremor
Clinical narrative: Within 5 minutes after administration of all listed vaccines patient reported feeling "light-headed". Pt sat down in a chair and within 1 minute the patient had fainted et began to shake as if having a small seizure. Episode lasted approximately 20 seconds et pt woke up. After having pt lay down for 10-15 minutes she had fully recovered.
Age: 1.04
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site rash
Clinical narrative: Rash around left arm injection site for MMR and VZV.
Age: 0.85
Sex: F
Vaccine: HEPA
Symptoms: Culture urine negative, Decreased appetite, Diarrhoea, Drug administered to patient of inappropriate age, Pyrexia
Clinical narrative: 10 month old received Hep A 7/9/14 inadvertently. Had fever, loss of appetite, emesis, diarrhea the next day seen in Emergency 7/14/14, urine culture negative fever 103.2 degrees seen in doctor's office 7/15/14 follow up.
Age: 0.85
Sex: F
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: 10 month old received Hep A 7/9/14 inadvertently. Had fever, loss of appetite, emesis, diarrhea the next day seen in Emergency 7/14/14, urine culture negative fever 103.2 degrees seen in doctor's office 7/15/14 follow up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, PNC13, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Right SQ vaccine injection, swelling, warm to touch, area measured 50 x 30 cm on right arm. Pt had been given MMR vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Shot around 430pm. Pain in hand around 8pm. 1130AM next day -aching in hand (left) but pain is less than night before.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness 2 x 3" size in area of injection.
Age: 1.13
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Pt developed varicella 4 weeks after receiving the initial vaccine, per CDC consult, VAERS need to be filed as varicella reaction is usually noted 2-3 weeks after receiving the varicella vaccine. Varicella VIS 3/13/08.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Activities of daily living impaired, Dysstasia, Mass, Pain, Pruritus
Clinical narrative: Swelling began and continued throughout the night.  Flu like symptoms the next day.  Could not work.  Swelling continued for 5 days reaching from the armpit to below the elbow.  Fever.  Extreme itching.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Pyrexia
Clinical narrative: Swelling began and continued throughout the night.  Flu like symptoms the next day.  Could not work.  Swelling continued for 5 days reaching from the armpit to below the elbow.  Fever.  Extreme itching.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Activities of daily living impaired, Influenza like illness, Local swelling, Pruritus, Pyrexia
Clinical narrative: Swelling began and continued throughout the night.  Flu like symptoms the next day.  Could not work.  Swelling continued for 5 days reaching from the armpit to below the elbow.  Fever.  Extreme itching.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Swelling
Clinical narrative: Swelling began and continued throughout the night.  Flu like symptoms the next day.  Could not work.  Swelling continued for 5 days reaching from the armpit to below the elbow.  Fever.  Extreme itching.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The pharmacist reported that on 10-JUL-2014 the patient was administered a dose of VARIVAX (Merck) (lot #J013734 and expiration date 30-OCT-2015, dose, route not reported) that was stored improperly. Concomitant medications were not provided. No adverse effects were reported.  Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unknown number of patients. It was reported that the patients were administered (Oka/MERCK) VARIVAX of unknown strength and dose (Lot # and Expiry date not reported), since June 2014 that had been improperly stored. No adverse events reported. Also no product quality complain was reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site warmth, Local swelling
Clinical narrative: Left arm swelling injection site was hard, hot, red redness radiating down arm.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to about 6 patients of unknown age (gender unknown). On an unknown date, about 6 patients were vaccinated with (Oka/Merck) VARIVAX, subcutaneous (strength, dose, frequency unknown). Patient were vaccinated with (Oka/Merck) VARIVAX which was improperly exposed to 10F for 3 days and to 5-9.6F for 360 hours. No known adverse effects. Follow up information has been received from nurse. Nurse stated that an unspecified number of patients received doses (unspecified in series) of (Oka/Merck) VARIVAX exposed to 16 F for 120 hours. Nurse stated that the affected lots were lot #J009990; expiration date: 13-AUG-2015 (also reported as 12-AUG-2015) and lot # J012210; expiration date: 28-AUg-2015. No adverse effects reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 5 year old male patient. The patient's medical history was not reported. On 11-JUL-2014 the patient was vaccinated with VARIVAX and was also administered a dose PROQUAD. M-M-R II was the vaccine prescribed not PROQUAD. No adverse effects were reported. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 73 year old male patient with no chronic medication conditions that would have predisposed him to pneumococcal disease. On 20-JUN-201 the patient was vaccinated in error with a second dose of PNEUMOVAX 23 (dose, route and lot# not reported). On 28-MAR-2014 the patient was vaccinated with the first dose of PNEUMOVAX 23 (dose, route, lot # not reported). At the time of report, no adverse event were known. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 71 year old male patient. No relevant medical history of the patient was reported. On 10-JUL-2014, the patient was vaccinated with an expired dose of MMR II (lot # 0184AE, 18-JAN-2014), first dose (strength and site of administration were unknown). There was no concomitant medications reported. The patient experienced no adverse effect. There was no product quality complaint involved. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 11-JUL-2014 the patient was vaccinated with an expired MMR II (Lot # reported as H012132, Expiration date reported as 25-JUL-2014 (dose and route were unknown). It was reported that this information was supported. No adverse events reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site. Pt advised to take BENADRYL and use HC 1% cream on rash, also, keep red area cool.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 year old female patient. On 12-JUN-2014, 1 day before her 16th birthday, she was vaccinated with a dose of VAQTA 50/1.0 U/ml (an adult dose was inadvertently administered: 1 ml intramuscularly; lot# and expiration date not provided). No adverse effects were reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Disorientation, Retinal detachment, Vision blurred
Clinical narrative: This spontaneous report as received from a physician refers to a 20 years old female patient. The patient did not have pertinent medical history and no drug reactions/allergies. In October 2013 (date unspecified) the patient was vaccinated with first dose of GARDASIL (dose, route, lot # not reported). On 07-JUN-2014 or 08-JUN-2014 the patient was vaccinated with second dose of GARDASIL (dose, route, lot # not reported). There was no concomitant medication. On the morning 05-JUL-2014 the patient woke up with blurred vision in both eyes. She ignored it for the day because she assumed it was her contacts that were causing the issue. On 06-JUL-2014 she awoke with worsening vision and went to unspecified hospital for Emergency Room visit, but they were not helpful. She saw a doctor on 08-JUL-2014 and was diagnosed with Exuda Retinal Detachment in both right and left eyes. The patient was treated with prednisone (manufacturer unknown) 60mg daily. The patient stated she had some improvement but is not fully recovered and the condition is disorienting. No lab diagnostic studies were performed. The relatedness between Exuda Retinal Detachment and GARDASIL was not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Disorientation, Impaired driving ability, Retinal detachment, Vision blurred
Clinical narrative: This spontaneous report as received from a physician refers to a 20 years old female patient. The patient did not have pertinent medical history and no drug reactions/allergies. In October 2013 (date unspecified) the patient was vaccinated with first dose of GARDASIL (dose, route, lot # not reported). On 07-JUN-2014 or 08-JUN-2014 the patient was vaccinated with second dose of GARDASIL (dose, route, lot # not reported). There was no concomitant medication. On the morning 05-JUL-2014 the patient woke up with blurred vision in both eyes. She ignored it for the day because she assumed it was her contacts that were causing the issue. On 06-JUL-2014 she awoke with worsening vision and went to unspecified hospital for Emergency Room visit, but they were not helpful. She saw a doctor on 08-JUL-2014 and was diagnosed with Exuda Retinal Detachment in both right and left eyes. The patient was treated with prednisone (manufacturer unknown) 60mg daily. The patient stated she had some improvement but is not fully recovered and the condition is disorienting. No lab diagnostic studies were performed. The relatedness between Exuda Retinal Detachment and GARDASIL was not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vogt-Koyanagi-Harada syndrome
Clinical narrative: This spontaneous report as received from a physician refers to a 20 years old female patient. The patient did not have pertinent medical history and no drug reactions/allergies. In October 2013 (date unspecified) the patient was vaccinated with first dose of GARDASIL (dose, route, lot # not reported). On 07-JUN-2014 or 08-JUN-2014 the patient was vaccinated with second dose of GARDASIL (dose, route, lot # not reported). There was no concomitant medication. On the morning 05-JUL-2014 the patient woke up with blurred vision in both eyes. She ignored it for the day because she assumed it was her contacts that were causing the issue. On 06-JUL-2014 she awoke with worsening vision and went to unspecified hospital for Emergency Room visit, but they were not helpful. She saw a doctor on 08-JUL-2014 and was diagnosed with Exuda Retinal Detachment in both right and left eyes. The patient was treated with prednisone (manufacturer unknown) 60mg daily. The patient stated she had some improvement but is not fully recovered and the condition is disorienting. No lab diagnostic studies were performed. The relatedness between Exuda Retinal Detachment and GARDASIL was not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: This spontaneous report was received from a nurse refers to a 20 year old female patient without drug reactions, allergies and medical history. In 2005 the patient was vaccinated with VARIVAX (Merck) 0.5mL, dose 1, subcutaneously. On 14-JUL-2014 the patient was vaccinated with VARIVAX (Merck) 0.5mL, dose 2, intramuscular. There was no concomitant medication. On 14-JUL-2014 the patient experienced brief stinging sensation at the injection site after administration of her second dose of VARIVAX (Merck). The patient sought medical attention and did not receive any treatment for the adverse event. There were not laboratory diagnostics performed. The outcome of brief stinging sensation at the injection site was reported as recovered/resolved on 14-JUL-2014. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, Incomplete course of vaccination
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a 6 month old female patient. Medical history was not reported. On an unknown date the patient was vaccinated with the first dose of ROTATEQ oral, (lot number, expiration date and dosage were not reported). Concomitant therapy was not reported. The medical assistant informed that on an unknown date the patient received only one dose of ROTATEQ. The medical assistant asked if there was anything wrong with that or if was it contraindicated after any certain point. The medical assistant informed that the patient should have started at 2 months but she missed those immunizations so they wanted to give at least one dose. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Seizure activity about 30 seconds after the vaccine was given and the seizure activity lasted for about 30 seconds.
Age: 21.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Pain in jaw, Trismus
Clinical narrative: Began feeling pain bilaterally in jaws 07/11/2014.  Persisted through out weekend.  On 7/14/2014 woke up with difficulty opening jaw.  Had not taken any pain relievers or anti-inflammatory. Reported to health dept. Health Dept consulted with CDC info line.  States no current literature indicating this is side effect of vaccine received.  Recommended pain reliever/ anti-inflammatory.  If persists to follow up with MD.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Feeling of body temperature change, Headache, Nausea, Vomiting
Clinical narrative: Rec'd Tdap 7/12/14 at 11:35 am. 7/13 - Awake at 04:30 am c/o HA, hot/cold, T 100.4, nausea, vomiting x 4.
Age: 14.0
Sex: M
Vaccine: MEN
Symptoms: Borrelia test, Fatigue, Headache, Hypoaesthesia, Nausea
Clinical narrative: I woke up with: 102 Fever, fatigue, numb/tingling arm, headache, nausea. Doctor gave prescription for antibiotics and ibuprofen.
Age: 14.0
Sex: M
Vaccine: MEN
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: I woke up with: 102 Fever, fatigue, numb/tingling arm, headache, nausea. Doctor gave prescription for antibiotics and ibuprofen.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever of 103 rectally after shots.
Age: 48.0
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Asthenia, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient returned to the health center at 3:00 PM complaining of weakness, numbness of right arm with paraesthesia of right digits.
Age: 0.31
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying
Clinical narrative: Uncontrollable crying for 6 hours.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with VAQTA (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. The nurse reported that the VAQTA administered, reached a temperature outside the prescribing information. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous report as received from a healthcare student refers to a currently 65 year old male patient. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (route, lot # and expiration date were not provided). On an unknown date, a couple of years ago, the patient experienced an anaphylactic reaction. It was unknown if the patient sought medical attention. The outcome of the anaphylactic reaction was unknown. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with RECOMBIVAX HB (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. The nurse reported that the RECOMBIVAX HB administered, reached a temperature outside the prescribing information. No adverse effects reported. This is one of several reports from the same source. 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 Registered Nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with M-M-R II (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. The nurse reported that the M-M-R II administered, reached a temperature outside the prescribing information. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unknown number of patients (demographics not provided). On an unknown date unknown number of doses of VAQTA that were exposed to a supported temperature excursion were administered to patients after the temperature excursion. Doses, sites and routes of injection, lot# and expiration dates were not reported. No adverse effect was 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 Registered Nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with ROTATEQ (dose, lot number and expiration date not reported) oral. There was no concomitant medication reported. The nurse reported that the ROTATEQ administered, reached a temperature outside the prescribing information. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Wrong vaccine given - no adverse reaction.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash generalised, Rash pruritic
Clinical narrative: High fever of 104.7 while on ibuprofen.  High fever lasted from 7/12/14 through 7/14/14.  Then mild fever of 101-102.5 continued (while on ibuprofen).  A whole body red itchy rash started on  7/14/14 and lasted until 7/16/14.  Patient still has mild fever and slight rash as of 7/16/14.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Decreased appetite, Disorientation, Dyspnoea, Fatigue, Headache
Clinical narrative: Light itchy rash around left armpit; mild itchy rash around thighs, groin, hips; light, non-itching rash on chest and arms; fever of almost 103; extreme fatigue; no appetite; headache; some difficulty breathing; disoriented: thought an entire day had passed when only a couple of hours; hard, bright red mound 2" x 3" around injection site; very dark bruise around injection site.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema, Pyrexia, Rash
Clinical narrative: Light itchy rash around left armpit; mild itchy rash around thighs, groin, hips; light, non-itching rash on chest and arms; fever of almost 103; extreme fatigue; no appetite; headache; some difficulty breathing; disoriented: thought an entire day had passed when only a couple of hours; hard, bright red mound 2" x 3" around injection site; very dark bruise around injection site.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Rash pruritic
Clinical narrative: Light itchy rash around left armpit; mild itchy rash around thighs, groin, hips; light, non-itching rash on chest and arms; fever of almost 103; extreme fatigue; no appetite; headache; some difficulty breathing; disoriented: thought an entire day had passed when only a couple of hours; hard, bright red mound 2" x 3" around injection site; very dark bruise around injection site.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Tinnitus
Clinical narrative: Patient stated he had ringing in his right ear and noted onset around 11:45 AM.  RN assessed and monitored patient noting no signs of distress such as hives, breathing difficulty or swelling of his face or throat.  BP 116/72, respiration 20 and pulse rate 60.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture negative, Chest X-ray normal, Headache, Injection site erythema, Injection site pain
Clinical narrative: Fever, myalgias, headache. Erythema and significant tenderness at Pneumovax injection site.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Lumbar puncture normal, Myalgia, Pyrexia, Urine analysis normal, White blood cell count increased
Clinical narrative: Fever, myalgias, headache. Erythema and significant tenderness at Pneumovax injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Redness, swelling of right upper arm at site of vaccination.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Erythema, Induration, Injection site erythema
Clinical narrative: Several hours after Zostavax administration, patient developed pain, redness, swelling and itching at vaccine administration site.  That night she developed chills and temperature of 101.4.  Two days later with increased swelling (measured today at 11 X 10 cm area of induration, warmth, and erythema), temperature 99.2 F oral, and continued chills.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Skin warm, Vaccination site pain, Vaccination site swelling
Clinical narrative: Several hours after Zostavax administration, patient developed pain, redness, swelling and itching at vaccine administration site.  That night she developed chills and temperature of 101.4.  Two days later with increased swelling (measured today at 11 X 10 cm area of induration, warmth, and erythema), temperature 99.2 F oral, and continued chills.
Age: 0.27
Sex: F
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, Urticaria
Clinical narrative: Patient was given the MMR vaccine at the age of 3 months without authorization from any doctor and without any concern from the nurse administering the shot. Hives have been prevalent since the shot, which may have also been from the PCV shot which was given 4 days earlier. No obvious other signs have been apparent.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pallor, Visual impairment
Clinical narrative: Pallor, dizzy, patient felt like everything was going black. Treatment was to lay flat and elevate legs.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Patient had injection site reaction that appeared the day after vaccination. Symptoms inlude itch, swelling, redness, and hardening of the skin.  Size of the area increased to a diameter of about 2.5 to 3 inches.  Symptoms persisted for almost a week. Patient self-treated with hydrocortisone cream and cold-compress.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Hives, raised all over body. Multiple Dr. visits.
Age: 47.0
Sex: M
Vaccine: SMALL
Symptoms: Herpes virus infection, Pruritus, Rash pustular
Clinical narrative: Military mobilization received small pox vaccine for overseas deployment.  Pustules below the belt line and just above genitals and on buttocks with itching and sensitivity appeared a few weeks later.  Went on sick call a few weeks after symptoms and diagnosis was unknown but given Ketoconazole topical solution to relieve symptoms.  Reappears every 2-3 months, saw my healthcare provider at home around July 2013 and he diagnosed as herpes and prescribed Valacyclovir HCL1.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Pain, Vaccination site pain
Clinical narrative: Started with usual post immunization soreness at vaccine site, but got progressively worse. By 9 months after the vaccine, I had lost significant range of motion in my upper arm and shoulder, as well as developed sharp shooting pains during certain arm movements.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Electromyogram, Immunoglobulin therapy, Musculoskeletal pain, Neck pain, Neurological examination
Clinical narrative: Severe pain right neck, shoulder radiating to upper arm and scapula. Persistent for several hours and recurring for several days. Immunoglobulin infusion therapy - 15 infusions. Prednisone therapy - 60 mg daily for 2 months and then tapered. Paralysis is permanent.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Paralysis
Clinical narrative: Severe pain right neck, shoulder radiating to upper arm and scapula. Persistent for several hours and recurring for several days. Immunoglobulin infusion therapy - 15 infusions. Prednisone therapy - 60 mg daily for 2 months and then tapered. Paralysis is permanent.
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash on body related to MMR vaccine (most likely).
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Pruritus
Clinical narrative: Injection site erythema/induration 4 cm; pruritus. Treated with anti-inflammatories; ice pack; topical and oral BENADRYL.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Local reaction
Clinical narrative: Localized reaction to vaccine.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia, Vomiting
Clinical narrative: Developed sudden onset of fever 104 with vomiting approx. 4 hrs after vaccine - Hepatitis A.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Chest pain, Headache, Pyrexia, Vomiting
Clinical narrative: Thursday night she had headache and vomiting. She had fever of 101 on Saturday. On Sunday she had chest pain. On Monday she was better and did not have any symptoms.
Age: 71.0
Sex: M
Vaccine: MMR, PPV, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Skin warm
Clinical narrative: Gradual onset of pain, redness, swelling of (L) upper arm approximately 4 hours after IM deltoid injection. Skin warm to touch. Proximal distal - 8" - circumference 7".
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle swelling
Clinical narrative: Patient reports swelling/bulging of muscle in (L) arm which vaccine was administered. Saw MD thinking it was blood clot. MD did not have any findings
Age: 2.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 year old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies were not provided. It was reported that the patient received doses of RECOMBIVAX HB 5/0.5 microgram/mL, on 11-JUL-2012 for first dose, second dose on 27-SEP-2012, third dose on 25-OCT-2013, and fourth dose on 11-JUL-2014 (route: intramuscular, lot # and expiration date not provided for any dose). The patient had not demonstrated any adverse effects. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain, X-ray
Clinical narrative: 2 hrs after vaccination severe shoulder pain, various cortisone shot etc. Pain and range of motion difficulties to present day.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, the patients were administered a dose of RECOMBIVAX HB (dose, route, lot number and expiration date not reported) that was exposed to a temperature outside the prescribing information. The temperature excursions were not reported. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to unknown number of patients of unknown age and gender. On unknown date (between November 2013 and July 2013), the patients were vaccinated with (oka/MERCK) VARIVAX (dose, route and lot # were not reported) that had been improperly stored. No adverse effects reported. This is one of 6 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with PROQUAD (lot#, dose and route not reported) that was stored improperly. No adverse effects reported. Additional information is not expected (reporter refused additional contact).
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report received from a Medical Assistant refers to a 4 year old patient. On 25-JUN-2014 the patient was vaccinated with PORQUAD (lot# K004418, expiration date 25-SEP-2015, dose not reported) subcutaneous. There was no concomitant medication reported. The Medical Assistant reported that the PROQUAD administered to the patient was improperly stored, it was exposed to 18F for two hours. No adverse effects were reported. This is one of two reports from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 4 year old patient. On 25-JUN-2014 the patient was vaccinated with (Oka-Merck) PROQUAD (lot # K004418, expiration date 25-SEP-2015, dose not reported) subcutaneous. There was no concomitant medication reported. The Medical Assistant reported that the (Oka-Merck) PROQUAD administered to the patient was improperly stored, it was exposed to 18F for two hours. No adverse effects were reported. This is one of two reports from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, IPV, MMR, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Cellulitis of upper right arm/deltoid area. Area red, raised, warm. Skin marked w/ marker. Treatment included warm compresses TID, TYLENOL and clindamycin on 6/25/14.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to unknown number of patients of unknown age and gender. On unknown date (between November 2013 and July 2013), the patients were vaccinated with PNEUMOVAX 23 (dose, route and lot # were not reported) that had been improperly stored. No adverse effects reported. This is one of 6 reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nursing student refers to a female patient of unknown age. The patient's medical history included allergy to latex. On 25-JUN-2014 the patient was vaccinated with a dose of ZOSTAVAX (Lot # and exp. date not reported) (0.65 ml, subcutaneous). Concomitant therapies were not reported. In approximately 2014 ("reported as now the patient had shingles") the patient experienced shingles. The patient sought unspecified medical attention and received Acyclovir and an unspecified pain medication for the treatment of shingles. The outcome of shingles was reported as not recovered. Additional information is not expected, since the nursing student does not want to be contacted, and she needed to get permission from her supervisor to give additional information.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to unknown number of patients of unknown age and gender. On unknown date (between November 2013 and July 2013), the patents were vaccinated with RECOMBIVAX HB (dose, route and lot # were not reported) that had been improperly stored. No adverse effects reported. This is one of 6 reports received from the same reporter. Additional information has been requested.
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 unknown number of patients of unknown age and gender. On unknown date (between November 2013 and July 2013), the patients were vaccinated with GARDASIL (dose, route and lot# were not reported) that had been improperly stored. No adverse effects reported. This is one of 6 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, the patients were administered a dose of GARDASIL (dose, route, lot number and expiration date not reported) that was exposed to a temperature outside the prescribing information. The temperature excursions were not reported. No adverse effects reported. This is one of several reports from the same reporter. 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 medical assistant refers to an unspecified number of patients of unknown demographics. The patients current conditions or medical history were not reported. On an unknown date, the patients were administered a dose of MMR II (dose, route, lot number and expiration date not reported) that was exposed to a temperature outside the prescribing information. The temperature excursions were not reported. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a male consumer of unknown age referring to himself. None drug reactions, allergies or pertinent medical history were reported. On an unknown date the patient was vaccinated with GARDASIL, dose 3, (route, lot number and expiration date were unspecified). No concomitant therapies were reported. The patient stated that he received his last dose (dose 3) of GARDASIL about 1 year after the second dose. No adverse event reported. The outcome of received his last dose about 1 year after the second dose was unknown. Additional information is not expected because no reporter details were provided.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified patient of unknown demographics. The patient's current conditions or medical history were not reported. On 14-JUL-2014, the physician reported that the patient was in her office to receive their third dose of GARDASIL (dose, route, lot number and expiration date not reported). The patient should had received that dose two months ago on an unspecified date (approximately in May 2014). No adverse effects reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Oedema, Skin warm
Clinical narrative: Mild edema and erythema, warm to the touch.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to unknown number of patients of unknown age and gender. On unknown date (between November 2013 and July 2013), the patients were vaccinated with ZOSTAVAX (dose, route and lot # were not reported) that had been improperly stored. No adverse effects reported. This is one of 6 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to unknown number of patients of unknown age and gender. On unknown date (between November 2013 and July 2014), the patients were vaccinated with MMR II (dose, route and lot # were not reported) that had been improperly stored. No adverse effects reported. This is one of 6 reports received from the same reporter. Additional information has been requested.