chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that on 31-JUL-2014 the patient received (Oka-Merck PROQUAD INJ, 0.5 ml, once, subcutaneously (lot number not provided), to "catch up schedule". It was reported that therapy was not discontinued. No adverse effects were noted. Additional information has been requested.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Skin warm, Swelling
Clinical narrative: Pt states that she has always experienced bruising and swelling after flu shot but that this time she experienced more bruising, swelling, and redness than previous times. Redness extends from injection site to right above her elbow, and area is warm to the touch.
Age: 5.0
Sex: U
Vaccine: HEPA
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 5 year old patient of unknown gender. On 29-AUG-2014 the patient was vaccinated with a dose of VAQTA (dose: 0.5 ml, intramuscularly, lot # 672226/1441AA) which expired on 09-AUG-2014. No adverse effects reported. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Blepharospasm, Pyrexia, Tremor
Clinical narrative: Fever of 102, eye twitching and leg tremoring.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker refers to an unspecified number of patients of unknown age and gender. Between July and August 2014 the patients were vaccinated with an improperly stored dose of GARDASIL Lot # K004204, expiration date: 12-JAN-2017 (dose and route of administration was not reported). No adverse effects were reported. It was reported that sterile water diluent (Lot # J015953, expiration date: 30-SEP-2016, Lot # K01010820, expiration date: 13-MAY-2017 and lot # K006954, expiration date: 28-FEB-2017) were exposed to 83F for 12 hours and to 28F for 36 hours. No adverse effects were reported. This is one of several reports received 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 an health care worker refers to an unspecified number of patients of unknown age and gender. Between July and August 2014 the patients were vaccinated with an improperly stored dose of VARIVAX (Merck), Lot # K002929, expiration date: 26-FEB-2016 and Lot # reported as K003409 and expiration date: 06-MAR-2016 (dose and route of administration were not reported). The vaccine was exposed to 17F for 12 hours. It was also reported that sterile water diluent (Lot # J015953, expiration date: 30-SEP-2016, Lot # K01010820, expiration date: 13-MAY-2017 and lot # K006954, expiration date: 28-FEB-2017) were exposed to 83F for 12 hours and to 28F for 36 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Erythema, Induration, Mass, Pruritus
Clinical narrative: Hard lump, red, swollen, itchy. Upset stomach. Symptoms peaked on 9/7/14.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Hard lump, red, swollen, itchy. Upset stomach. Symptoms peaked on 9/7/14.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker refers to an unspecified number of patients of unknown age and gender. Between July and August 2014 the patients were vaccinated with an improperly stored dose of ROTATEQ orally, Lot # reported as K005273, expiration date: 23-FEB-2016 (dose was not reported). No adverse effects were reported. It was reported that sterile water diluent (Lot # J015953, expiration date: 30-SEP-2016, Lot # K01010820, expiration date: 13-MAY-2017 and lot # K006954, expiration date: 28-FEB-2017) were exposed to 83F for 12 hours and to 28F for 36 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV2
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. No pertinent medical history or drug reactions/allergies were provided. Pharmacist reported that the unspecified patient received GARDASIL INJ (dose, route and lot number not provided) for his first dose and CERVARIX as the second dose in the Human Papillomavirus (HPV) vaccination schedule (dates not specified). No adverse effect was reported. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: FLUN4
Symptoms: HIV infection
Clinical narrative: Pt. denied having any known chronic health or medical problems. Pt. was asked specifically if he was being treated for HIV and stated "no". FLUMIST was given. Pt. later reported "I have HIV".
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Intussusception
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of intussusception in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of ROTARIX (oral). At an unspecified time after vaccination with ROTARIX, the subject experienced intussusception. Per the reporter, the subject required medical attention and that "it has been taken care of". This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unknown. The physician inquired on 7 February 2014 or 10 February 2014 if the subject should receive another ROTARIX dose.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC, RV1
Symptoms: Incorrect route of drug administration, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline), PEDIARIX, ENGERIX B and (non-gsk) PREVNAR. On an unspecified date the subject received unspecified dose of ROTARIX (intramuscular, right thigh), unspecified dose of PEDIARIX (unknown), unspecified dose of ENGERIX B (unknown), unspecified dose of PREVNAR (unknown). At the time of vaccination with ROTARIX the subject experienced drug administered via inappropriate route. The nurse inadvertently administered ROTARIX intramuscularly in the right leg. At the time of vaccination with ENGERIX B the subject experienced overdose. Within hours of vaccination with ENGERIX B, PEDIARIX, PREVNAR and ROTARIX, the subject experienced fever that lasted for one night. At the time of reporting the fever was resolved.
Sex: U
Vaccine: RV1
Symptoms: Regurgitation
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of regurgitation in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of ROTARIX (oral). At an unspecified time after vaccination with ROTARIX, the subject experienced regurgitation. At the time of reporting the outcome of the events was unspecified.
Sex: U
Vaccine: RV1
Symptoms: Rotavirus infection, Vaccination failure
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of rotavirus infection in an unknown number of subject of unspecified age and gender who was vaccinated with ROTARIX (lyophilized formulation, GlaxoSmithKline). On an unspecified date (s) the subjects received 1st dose and 2nd dose of ROTARIX lyophilized formulation (oral). At an unspecified time after vaccination with ROTARIX lyophilized formulation the subjects experienced rotavirus infection and vaccination failure. The reporter stated that "6 to 12 patients were given the ROTARIX vaccine and experienced lack of efficacy and were having break through cases." No additional information was available at the time of reporting. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events were unspecified. Follow up was received from a nurse on 7 October 2013. The nurse stated that her practice needs additional subject details to identify the subject. No details were made available to GSK therefore no additional details provided.
Sex: U
Vaccine: RV1
Symptoms: Rotavirus infection, Vaccination failure
Clinical narrative: This case was reported by a physician and described the occurrence of vaccination failure in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date(s) the subject received 1st dose and 2nd dose of ROTARIX (oral). At an unspecified time after vaccination with ROTARIX, the subject experienced rotavirus infection and vaccination failure. At the time of reporting, there were no additional details available. This case was assessed as medically serious by GSK. The physician considered the events to be possibly related to ROTARIX vaccine. At the time of reporting the outcome of the events were unspecified. Follow up was received from a nurse on 7 October 2013. The nurse stated that her practice needs additional subject details to identify the subject. No details were made available to GSK therefore no additional details provided.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from nurse refers to a female patient of unknown age without drug reactions and allergies. On an unknown date the patient was vaccinated with VARIVAX (Merck) (dose, lot # and route of administration. On an unknown date (same day that the patient was vaccinated) she experienced localized injection site reaction at the site of VARIVAX (Merck) injection. The outcome of the event was reported as recovered/resolved on unknown date. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 0 month old male patient. On 22-JUN-2014 at 10:40 am (same date that the patient was born) the patient was vaccinated improperly stored dose of RECOMBIVAX HB intramuscular, dose 1, Lot # J012520, Expiration date: 30-JAN-2016 (dose was not reported). No adverse symptoms reported. It was reported that the vaccine storage temperature dropped to 0-1 degrees (units not reported) for 18 different episodes according to minimum/maximum. All recorded temperatures were within 2-8 degrees (units were not reported). Additional information is not expected due to all follow ups requested to complete the case were received.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Weight bearing difficulty
Clinical narrative: W/in 24 hrs. of adm. (L) thigh swollen, erythematous from injection site to knee. Refused to weight bear. Pt evaluated at urgent care. Returned to office on 9/10/14 - swelling decreased and was walking.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactoid reaction, Dyspnoea, Pharyngeal oedema
Clinical narrative: Pt experienced anaphylaxis type rxn on 9/8/14 including difficulty breathing and reported throat swelling which was relieved by administration of epinephrine.
Age: 27.0
Sex: M
Vaccine: FLU3, HEPA, TYP
Symptoms: Muscular weakness, Pain, Pain in extremity
Clinical narrative: (R) arm and hand weakness, pain. Pain resolved in (R) arm and hand on 9/11/14 but was severe with injection. (R) leg posterior lower leg knee to foot shooting sharp pain for 4 days. No improvement.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced local bruising at site of injection, which was still present on 09/11/14. Patient also experienced swelling, tenderness, redness, and warmth in the lower region of her upper arm that began about 3 inches below injection site that was approximately 3-4 inches in diameter. Symptoms last about 7 days.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender with dialysis. Patient's drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with the first dose of RECOMBIVAX HB, (40 microgram dialysis formulation) (lot #, expiration date, and route not provided). It was reported that on an unspecified date, the patient received ENGERIX-B (Lot #, expiration date and route not provided) for a second dose. No adverse symptoms reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a consumer refers to a 60 years old wife. On 07-AUG-2014 the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, route, lot#, expiration date and frequency were unknown) in the upper right arm for vaccination. On an unknown date in August 2014 (post ZOSTAVAX vaccination) the patient experienced red circle at the injection site and pain. The outcome of pain and red circle at the injection site was reported as recovered/resolved on an unknown date in August 2014. This is one of several reports from the same reporter. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to an unspecified patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, route, strength not reported). The pharmacist reported that an unspecified patient called into the pharmacy to report that they developed redness at the injection site after receiving ZOSTAVAX. The outcome of the event was unknown. Additional information is not expected since the reporter didn't want to be contacted.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Anticoagulation drug level above therapeutic, Injection site discolouration, Injection site pruritus
Clinical narrative: Pt admits 1 hour after vaccination, she started to have itching around the injection site. Later on that night she started to have blue/purple skin around injection site and spread. She write one day and on Saturday went to see doctor. She admits Dr. run tests and told her that her blood coumadin levels were high. Patient admits Dr. told her it will go away in a couple of days, and that everything is normal.
Sex: U
Vaccine: VARCEL
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. On an unknown date the patients were vaccinated with improperly stored dosed of VARIVAX (Merck). (strength, route, lot number and expiration date not reported). No adverse effects reported. This is one of two reports received from the same reporter (1409USA003408). Additional information has been requested.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date the patient was inadvertently administered a dose of PROQUAD (lot#, strength, dosage and route unknown) and a dose of MMR II (lot#, strength, dosage and route unknown) during the same office visit. No adverse effects reported. The outcome of the events was unknown. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Two hours after FLUZONE HD administered, felt feverish approximately equal to 100 degrees F, chills, pain at injection site, very sore arm - unable to move arm around. Got shot around 3 PM, symptoms subsided around 10-11 PM. Next day felt weak but able to move arm around. Acute event. Pt took an anti-inflammatory for pain sore arm. Symptoms resolved.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Two hours after FLUZONE HD administered, felt feverish approximately equal to 100 degrees F, chills, pain at injection site, very sore arm - unable to move arm around. Got shot around 3 PM, symptoms subsided around 10-11 PM. Next day felt weak but able to move arm around. Acute event. Pt took an anti-inflammatory for pain sore arm. Symptoms resolved.
Age: 0.32
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Eyelid oedema, Pyrexia, Rash generalised
Clinical narrative: Rash all over body. Eyes swelling shut, fever, seen at emergency room and prescribed prednisone.
Sex: U
Vaccine: MMRV
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. On an unknown date the patients were vaccinated with improperly stored (Oka-Merck) PROQUAD (strength, route, lot number and expiration date not reported). No adverse effects reported. This is one of two reports received from the same reported (1409USA005622). Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient had a syncopal episode following administration of vaccines. Mother stated this has happened in the past after vaccines were given today.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Muscular weakness, Pain, Paraesthesia
Clinical narrative: Intermittent pain at left arm IM site traveled throughout (L) arm and (L) shoulder with on/off left arm weakness and/or limited range of motion x6 months. Plus, a one-time event of tingling sensation into left hand digits 1 and 2.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: The patient received the PNEUMOVAX vaccine on 9/09/14 referred by her doctor. The next day 9/10/14 she presented at the pharmacy with her arm red, it was warm. The doctor was called to explain the situation and she said she had cases to work on and it wasn't till 9/11/14 that the doctor medicated him with DURICEF 500; DESOWEN lotion; Sulindac 200mg.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Discomfort, Injection site urticaria, Rash, Urticaria
Clinical narrative: Pt got 3rd Hep B injection 1.0 mL IM (R) deltoid on 9/4/14 AM. She states she woke up at 4 AM 9/5/14 uncomfortable with a rash. Pt called the clinic and was advised to come into the clinic. Pt arrived at 1600. At that time face, nose and cheeks had hives. (R) arm from injection site to hand had multiple hives. She had hives on chest, neck, back, both arms and legs. No hives on palms.
Age: 73.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Cough, Fatigue, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Tetanus and pneumonia vaccines given 8/18/14 achy, coughing, fatigue, swelling of (R) upper arm with induration, pain and tenderness. (+) fever - Pneumonia 23.
Age: 73.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Tetanus and pneumonia vaccines given 8/18/14 achy, coughing, fatigue, swelling of (R) upper arm with induration, pain and tenderness. (+) fever - Pneumonia 23.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Received Tdap left arm and PPD R forearm on 8/23/14 at 4PM. 5 hours later B/L upper arm pain. Left arm pain resolved by 8/26/14. R upper arm pain persisted, associated with progressive pain and inability to raise right upper arm. Pt. received previous Tdap 3/24/09/.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Induration, Tenderness
Clinical narrative: A few hours after receiving an IM hepatitis B vaccination (#3), redness, tenderness and induration occurred. The symptoms were at their worst after 36 hours and improved over the next 12 hours. At that time, there was 6 x 8 cm of induration.
Age: 20.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Headache, Hypoaesthesia, Influenza like illness, Injection site erythema
Clinical narrative: Headache (0930 AM 8/13/14) Ibuprofen, TYLENOL. Temperature elevation (102 degrees) (1200 8/13/14 - 8/16/14). "Flu" like symptoms, malaise, body aches (8/13 - 8/18/14). Right hand numbness 8/15/14 (prednisone). Injection site (left deltoid) red, hot, swollen (8/15/14). Resolved symptoms 8/23/14.
Age: 20.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Malaise, Pain
Clinical narrative: Headache (0930 AM 8/13/14) Ibuprofen, TYLENOL. Temperature elevation (102 degrees) (1200 8/13/14 - 8/16/14). "Flu" like symptoms, malaise, body aches (8/13 - 8/18/14). Right hand numbness 8/15/14 (prednisone). Injection site (left deltoid) red, hot, swollen (8/15/14). Resolved symptoms 8/23/14.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site swelling
Clinical narrative: Pt developed a bump on her left thigh after receiving immunization.
Age: 48.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Insomnia, Musculoskeletal pain, Neck pain
Clinical narrative: Extreme pain up into her neck and shoulder couldn't sleep all night. Has to elevate arm above head for any relief. No swelling or redness. Feels it is more than normal reaction. Took ibuprofen I suggested ice. Pain level of 10.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Patient arm swelled up where shot administered IM. Told her to keep an eye on it. Looks like it might bruised. Told her to call MD and watch for worsening. Compress and BENADRYL if needed.
Age: 31.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site urticaria, Pyrexia
Clinical narrative: Fever 102 and large welt on arm at injection site 6 cm diameter. No tx.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site induration, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Pt. received the Pneumovax Vaccine at 1500 on 9/10/14 by 1900 on 9/10/14 patient's left arm was painful, reddened, swollen and warm to touch. Also her entire left bicep was firm. Cold packs applied, arm elevated and PRN BENADRYL PO 25mg every 4 hours given.
Age: 61.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling
Clinical narrative: (R) arm appeared red and a little swollen (showed me inside of arm).
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling on the same arm where the vaccine was administered, but on the opposite end or underside. Advised patient to take ibuprofen 200mg to take 1-2 tabs 3 times a day as needed.
Age: 45.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Band neutrophil percentage increased, Chest X-ray normal, Loss of consciousness, Pneumonia, Pyrexia
Clinical narrative: Patient received influenza and pneumococcal vaccine on 9/9/14. Yesterday, 9/10/14, patient had a fever of 102 and then passed out this morning after having a BM. Patient's wife called 911. Pt went to ER and diagnosed with pneumonia.
Age: 45.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Urine analysis normal, White blood cell count increased
Clinical narrative: Patient received influenza and pneumococcal vaccine on 9/9/14. Yesterday, 9/10/14, patient had a fever of 102 and then passed out this morning after having a BM. Patient's wife called 911. Pt went to ER and diagnosed with pneumonia.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site irritation, Lip swelling, Oral discomfort
Clinical narrative: Patient complained of swelling lip, burning in mouth (said it felt like he was drinking hot sauce), irritation at injection site.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Very sore arm several days receiving Tdap that required ER visit with resulting antibiotic and anti-inflammatory treatment.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: The next day there was a large, round, red, inflamed area at injection site. It was the size of a tennis ball and warm to the touch.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Arachnoid cyst, Asthenia, Back pain, Balance disorder
Clinical narrative: Daily headaches, back pain (whole back from top of neck to bottom of the tailbone), dizzy, dry mouth, vision problems, blurred vision, dry eyes, stomach aches, nausea, sore arms and legs, unbalanced feeling, very tired, bouts of hyper ness, fast talking, weak, forgetful, seeing colors, spots, neck pain.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dry eye, Dry mouth, Electrocardiogram normal, Electroencephalogram abnormal
Clinical narrative: Daily headaches, back pain (whole back from top of neck to bottom of the tailbone), dizzy, dry mouth, vision problems, blurred vision, dry eyes, stomach aches, nausea, sore arms and legs, unbalanced feeling, very tired, bouts of hyper ness, fast talking, weak, forgetful, seeing colors, spots, neck pain.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Memory impairment, Nausea, Neck pain
Clinical narrative: Daily headaches, back pain (whole back from top of neck to bottom of the tailbone), dizzy, dry mouth, vision problems, blurred vision, dry eyes, stomach aches, nausea, sore arms and legs, unbalanced feeling, very tired, bouts of hyper ness, fast talking, weak, forgetful, seeing colors, spots, neck pain.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal normal, Pain in extremity, Psychomotor hyperactivity, Renal cyst
Clinical narrative: Daily headaches, back pain (whole back from top of neck to bottom of the tailbone), dizzy, dry mouth, vision problems, blurred vision, dry eyes, stomach aches, nausea, sore arms and legs, unbalanced feeling, very tired, bouts of hyper ness, fast talking, weak, forgetful, seeing colors, spots, neck pain.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Seizure like phenomena, Speech disorder, Spinal X-ray normal, Ultrasound bladder normal, Ultrasound kidney abnormal
Clinical narrative: Daily headaches, back pain (whole back from top of neck to bottom of the tailbone), dizzy, dry mouth, vision problems, blurred vision, dry eyes, stomach aches, nausea, sore arms and legs, unbalanced feeling, very tired, bouts of hyper ness, fast talking, weak, forgetful, seeing colors, spots, neck pain.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Vision blurred, Visual impairment
Clinical narrative: Daily headaches, back pain (whole back from top of neck to bottom of the tailbone), dizzy, dry mouth, vision problems, blurred vision, dry eyes, stomach aches, nausea, sore arms and legs, unbalanced feeling, very tired, bouts of hyper ness, fast talking, weak, forgetful, seeing colors, spots, neck pain.
Age: 70.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dyspepsia, Gastrooesophageal reflux disease, Urticaria pressure
Clinical narrative: Received FLUZONE HIGH DOSE 0.5ml vaccine on 9-3-2014 at Pharmacy. Started showing symptoms of allergic reaction on 9-4-2014. Unable to determine any other reason or exposure to any other unusual material that may have caused the reaction. It should be noted that the reaction manifests as hives and is known as pressure urticaria. I have experienced this reaction before after industrial exposure to isocyanates used in urethane. The symptoms of that allergic reaction lasted approximately 7-8 years before gradually disappearing. I have been relatively symptom free for the last 5-6 years until now. I have regularly received flu vaccines and did receive the high dose vaccine last year for the first time. Symptoms include hives and swelling in any area that pressure is placed upon--ie hands where rail of aluminum ladder pressed on hands while carrying or tissue on buttocks where sitting on hard surfaces. Additionally have indigestion and acid reflux that haven't been present since last allergic event. Currently am taking antihistamines but will seek additional medical treatment if needed in a few days if symptoms don't subside.
Age: 70.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Urticaria
Clinical narrative: Received FLUZONE HIGH DOSE 0.5ml vaccine on 9-3-2014 at Pharmacy. Started showing symptoms of allergic reaction on 9-4-2014. Unable to determine any other reason or exposure to any other unusual material that may have caused the reaction. It should be noted that the reaction manifests as hives and is known as pressure urticaria. I have experienced this reaction before after industrial exposure to isocyanates used in urethane. The symptoms of that allergic reaction lasted approximately 7-8 years before gradually disappearing. I have been relatively symptom free for the last 5-6 years until now. I have regularly received flu vaccines and did receive the high dose vaccine last year for the first time. Symptoms include hives and swelling in any area that pressure is placed upon--ie hands where rail of aluminum ladder pressed on hands while carrying or tissue on buttocks where sitting on hard surfaces. Additionally have indigestion and acid reflux that haven't been present since last allergic event. Currently am taking antihistamines but will seek additional medical treatment if needed in a few days if symptoms don't subside.
Age: 70.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dyspepsia, Gastrooesophageal reflux disease, Hypersensitivity, Swelling, Urticaria
Clinical narrative: Received FLUZONE HIGH DOSE 0.5ml vaccine on 9-3-2014 at Pharmacy. Started showing symptoms of allergic reaction on 9-4-2014. Unable to determine any other reason or exposure to any other unusual material that may have caused the reaction. It should be noted that the reaction manifests as hives and is known as pressure urticaria. I have experienced this reaction before after industrial exposure to isocyanates used in urethane. The symptoms of that allergic reaction lasted approximately 7-8 years before gradually disappearing. I have been relatively symptom free for the last 5-6 years until now. I have regularly received flu vaccines and did receive the high dose vaccine last year for the first time. Symptoms include hives and swelling in any area that pressure is placed upon--ie hands where rail of aluminum ladder pressed on hands while carrying or tissue on buttocks where sitting on hard surfaces. Additionally have indigestion and acid reflux that haven't been present since last allergic event. Currently am taking antihistamines but will seek additional medical treatment if needed in a few days if symptoms don't subside.
Age: 48.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Patient reported passing out 1 day after Tdap administration.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old female patient with sulfa allergy and hypothyroidism. On 28-AUG-2014 the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # K003601, expiration date 19-MAR-2015), subcutaneous. Concomitant therapies included levothyroxine sodium (manufacturer unknown). On 29-AUG-2014, the patient experienced a large, raised, red, painful rash on her left arm at the injection site after receiving ZOSTAVAX. The patient came back to the pharmacy regarding this issue and also saw an unspecified physician for evaluation and treatment of her rash. The patient received KEFLEX, doxycycline and prednisone (manufacturer unknown) for treatment. No lab diagnostics studies performed. The outcome of a large, raised, red, painful rash on her left arm at the injection site was unknown. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old female patient with sulfa allergy and hypothyroidism. On 28-AUG-2014 the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # K003601, expiration date 19-MAR-2015), subcutaneous. Concomitant therapies included levothyroxine sodium (manufacturer unknown). On 29-AUG-2014, the patient experienced a large, raised, red, painful rash on her left arm at the injection site after receiving ZOSTAVAX. The patient came back to the pharmacy regarding this issue and also saw an unspecified physician for evaluation and treatment of her rash. The patient received KEFLEX, doxycycline and prednisone (manufacturer unknown) for treatment. No lab diagnostics studies performed. The outcome of a large, raised, red, painful rash on her left arm at the injection site was unknown. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Headache, Nausea, Oropharyngeal pain, Sleep disorder
Clinical narrative: Headache within several hours, followed by more generalized pain and lethargy. No fever.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Headache, Lethargy, Pain
Clinical narrative: Headache within several hours, followed by more generalized pain and lethargy. No fever.
Age: 54.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS, FLUX, VARZOS
Symptoms: Back pain, Condition aggravated, Injection site cellulitis
Clinical narrative: Patient called today at approximately 5:45 pm 8/29/14 from another state as she is traveling. She said she got bad infection around injection site where ZOSTAVAX was given and got antibiotic order from MD (cephalexin) per pt on phone. Faxed info to both doctors: family and MD on protocol (8/29/14).
Age: 54.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS, FLUX, VARZOS
Symptoms: Injection site infection
Clinical narrative: Patient called today at approximately 5:45 pm 8/29/14 from another state as she is traveling. She said she got bad infection around injection site where ZOSTAVAX was given and got antibiotic order from MD (cephalexin) per pt on phone. Faxed info to both doctors: family and MD on protocol (8/29/14).
Age: 31.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Muscle rigidity, Nausea, Pupil fixed, Snoring, Syncope
Clinical narrative: This spontaneous report was received from a nurse practitioner via company representative and refers to a 31 year old male patient. The patient's mother has history of fainting when getting shots. On 19-AUG-2014 the patient was vaccinated with VARIVAX (Merck) (dose number unknown), subcutaneous (vaccines required for college), M-M-R II (dose number unknown) subcutaneously and Tdap intramuscularly. On 19-AUG-2014, after therapy with VARIVAX (Merck) and Tdap the patient became nauseous. Then he was given M-M-R II and the patient fainted. He had fixed pupils and was rigid with straight arms and hands curved back. He was awake and snoring and might have had a seizure. The patient was made to wait an hour and half before leaving, his parents were called to get him as he was not permitted to drive. There was no treatment rendered for the events. The outcome of the events were unknown. The causality was unknown. The patient sought medical attention. Additional information has been requested.
Sex: M
Vaccine: RV1
Symptoms: Infantile spitting up, Oral administration complication
Clinical narrative: This case was reported by a nurse and described the occurrence of spitting in an infant male subject who was vaccinated with ROTARIX (lyophilized formulation, GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of ROTARIX lyophilized formulation (oral). During vaccination with ROTARIX lyophilized formulation, the subject consumed only about a quarter of the vaccine although the total dose of 1 mL was administered and spit otu the rest of the vaccine which led to an underdose. At the time of reporting the outcome of the event was unspecified.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: DAD STATES PATIENT DEVELOPED RASH AROUND NECK AND MOUTH APPROXIMATELY 7-8 HOURS AFTER RECEIVING SHOT.  HE ISSUED BENADRYL. PATIENT HAS HAD REOCCURING RASH ALL WEEK BUT IT IS SUBSIDING AND GETTING SMALLER.  BENADRYL HAS BEEN GIVEN ABOUT 2-3 TIMES THIS WEEK.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity, White blood cell count increased
Clinical narrative: Severe pain right arm, inability to move right arm.  Pt presented to the ER last night and to the clinic this am.
Age: 24.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Arm was red, warm, swollen, hurt. No SOB/wheezing/systemic rash.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No current condition was reported. No historical drug was reported. On 04-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 lot # J009827, 0.5 ml, intramuscular. No concomitant medication was reported. Pharmacist reported that the patient received expired dose of PNEUMOVAX 23 (lot #J009827, exp. Date 10-AUG-2014) on 04-SEP-2014. No adverse effect was reported. No further information was provided. No PQC involved. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant refers to a 18 year old patient. On 24-JUL-2014 at 10:00 AM the patient was vaccinated with the first dose of GARDASIL (dose and route not reported, lot # J013324, expired date: 12-FEB-2016) in the right deltoid that was improperly stored. There was no illness at time of vaccination or pre-existing allergies, birth defects, medical conditions. There was no adverse event following prior vaccination. Medical assistant confirmed that GARDASIL was administered according to the dose and route recommended in the prescribing information. N adverse effects were reported. No product quality complaint (PQC) was reported. This is one of several reports from the same source. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Chest X-ray normal, Computerised tomogram normal, Headache, Hyperhidrosis
Clinical narrative: Pt developed severe lower back pain several minutes after receiving a pneumococcal polyvalent 23 vaccine lot# J009833, exp: 1/25/15, NDC 0006-4943-01.  Back pain radiated up to her head.  Pt started sweating & was starting to pass out before being revived with ammonia inhalants.  MD applied oxygen & cold compress before pt was transported to ER for evaluation.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Loss of consciousness
Clinical narrative: Pt developed severe lower back pain several minutes after receiving a pneumococcal polyvalent 23 vaccine lot# J009833, exp: 1/25/15, NDC 0006-4943-01.  Back pain radiated up to her head.  Pt started sweating & was starting to pass out before being revived with ammonia inhalants.  MD applied oxygen & cold compress before pt was transported to ER for evaluation.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Cough, Oropharyngeal pain, Paranasal sinus hypersecretion
Clinical narrative: Started as mild sore throat then advanced next day into considerable sinus drainage that in turn resulted in significant coughing. Temperature normal days one, two and three then rose to 100.1. Tylenol two doses reduced and by day four temperature gone and other symptoms gone. If this was sinus infection or cold it is one of the strangest I have had in my 73 years.  Can only assume it was result of the Quad flu shot I received.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pruritus, Injection site rash, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to approximately 68 year old female patient. Current condition was not reported. The patient's medical history included shingles. On 31-AUG-2014, the patient was vaccinated with ZOSTAVAX lot # J014810, expiration date 21-FEB-2015, (dose, strength and route was not reported). Concomitant therapies included levothyroxine sodium, omeprazole, metoprolol, glipizide, lisinopril, SINGULAIR, pravastatin sodium, alendronate sodium (+) cholecalciferol, vitamin d (unspecified), nystatin, LASIX, fexofenadine hydrochloride, ALLEGRA-D, gastrointestinal preparations (unspecified) and aspirin. Approximately in 2014, as reported patient received ZOSTAVAX on 31-AUG-2014, immediately began to experience an itchy rash at the injection site following the administration. The patient then also experienced an itchy rash on her forehead that consisted of only 2 bumps. The outcome of itchy rash on forehead, an itchy rash at injection site and itchy rash on her forehead that consisted of only 2 bumps was reported as not resolved. No treatment was given for adverse event. No PQC was involved. Patient sought medical attention. Causality was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist via patient's wife refers to a male patient of unknown age. Current condition was not reported. Historical medication was not reported. On 31-AUG-2014 the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported). No concomitant medication was reported. Approximately in 2014, as reported patient received ZOSTAVAX on 31-AUG-2014, immediately began to experience an itchy rash at the injection site following the administration. It was reported that the itchy rash did not spread anywhere else on body. The outcome of an itchy rash at injection site was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Guillain-Barre syndrome, Intensive care, Muscular weakness, VIIth nerve paralysis
Clinical narrative: Patient had facial droop on 9-2-14 and went to ER and was treated for presumed Bell's Palsy. Patient returned to ER on 9-8-14 with facial droop and leg weakness and was admitted to ICU for GUILLAIN-BARRE syndrome. She was then transferred to hospital.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal discomfort
Clinical narrative: Discomfort that is worse in the morning in joint above where vaccine administered.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, Injection site pain
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 71 year old female patient. There was no pertinent medical history and no drug reaction/allergies reported. On 03-SEP-2014 the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # J004747, Expiration Date 20-JUL-2014. 0.5 ml, intramuscularly. No concomitant therapy reported. On 04-SEP-2014 (reported as next day), the patient's arm was a little sore at the injection site. No treatment was given. No lab diagnostic studies were performed. The patient didn't seek medical attention. The outcome of "her arm was a little sore" at the injection site was reported as recovered/resolved on an unspecified date in September 2014. The causality was unknown. 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 health care worker regarding four patients of unknown age and gender. The demographics were reported. On an unknown date, the four patients were vaccinated with GARDASIL (dose, frequency, product lot#, expiry date, route not reported) that were improperly stored. No adverse effects were reported. There was no product quality complaint involved. The outcome of the events was unknown. This is one of the 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 was received from a health care worker regarding four patients of unknown age and gender. The demographics were not reported. On an unknown date, the four patients were vaccinated with VAQTA (dose, frequency, product lot#, expiry date, route not reported) that were improperly stored. No adverse effects were reported. There was no product quality complaint involved. The outcome of the events was unkonwn. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The nurse reported that the patient received 4 dose of GARDASIL injection. On 15-FEB-2013 the patient was vaccinated with the first dose of GARDASIL (strength and lot# unknown) injection, 0.5 ml, intramuscular. On 09-APR-2013, 06-JUN-2014 and 09-AUG-2014 the patient was vaccinated with the second, third and fourth dose of GARDASIL (strength and lot# unknown) injection, 0.5 ml, intramuscularly. No adverse effect reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 13 year old male patient. The patient was vaccinated with his first dose of GARDASIL (lot#, expiration date, strength, dose and route not reported) on 10-MAY-2013, second dose on 11-JUL-2013, and the third dose on 30-AUG-2013. This occurred at another facility. No adverse events was reported. It was unspecified if the patient sought medical attention. Additional information is not expected since the reporter didn't want to be contacted.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 0 month old male patient. On 27-JUN-2014 at 13:11pm (same date that the patient was born) the patient was vaccinated improperly stored dose of RECOMBIVAX HB intramuscular, dose 1, Lot # J012520, Expiration date: 30-JAN-2016 (dose was not reported). No adverse symptoms reported. It was reported that the vaccine storage temperature dropped to 0-1 deg (units not reported) for 18 different episodes according to minimum/maximum. All recorded temperatures were within 2-8 deg (units were not reported). Additional information is not expected due to all follow ups requested to complete the case was received.
Age: 63.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Myalgia, Pain, Pyrexia
Clinical narrative: "Awful muscle pain/aches/chills/fever for 48 hr period".
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyskinesia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 11 year old female patient with nasal allergies. On 08-SEP-2014 the patient was vaccinated with GARDASIL (Lot # J010668 exp date: 29-APR-2016) dose 1, 0.5 ml, intramuscular. Concomitant therapies included (unspecified), tetanus toxoid and MENACTRA. The Nurse reported that on 08-SEP-2014, the patient received, toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and MENACTRA first, just prior to GARDASIL and did not experience any problem. Then on same date the patient received GARDASIL as third vaccine on this visit and right after receiving GARDASIL, patient complained of being lightheaded and so patient was asked to lie down on the examination bed. While patient was lying down, nurse reported that patient had a few jerky movement of her body. No additional information provided. The outcome of the patient had a few jerky movement of her body and patient complained of being lightheaded was unknown. The relatedness between adverse events and GARDASIL was unknown. Additional information has been requested.