chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an patient of unknown age and gender. On an unknown date in 2014 (also reported as since 24-JUN-2014), was vaccinated with (Oka/Merck) VARIVAX, subcutaneous (lot # K002927 expiration date not reported), dose and route not reported which went out of temperature range multiple times. These excursions were supported. No adverse effects were reported. Outcome of the events were not reported. Causality was not reported. This case has been linked to 1408USA009333, 1408USA013366, and 1408USA013367 as same reporter link. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Biceps below injection site red, swollen and sore. Patient took TYLENOL and BENADRYL.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Culture urine, Full blood count, Metabolic function test, Ultrasound abdomen, Ultrasound skull
Clinical narrative: Persistent vomiting 1-2 times per day.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Urine analysis, Vomiting, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Persistent vomiting 1-2 times per day.
Age: 0.22
Sex: M
Vaccine: DTAPIPVHIB, PPV, DTAPIPVHIB, PNC13
Symptoms: Crying, Diet refusal, Eating disorder, Insomnia, Screaming
Clinical narrative: Non Stop High piteched screaming, stiff body, refused to eat or sleep and crying lasted for 5 hours non stop when he was sleeping every 3 hours at that time.  His whole sleep schedule was thrown off after that and he had more trouble sleeping and eating than usual.
Age: 0.22
Sex: M
Vaccine: DTAPIPVHIB, PPV, DTAPIPVHIB, PNC13
Symptoms: Crying, Decreased appetite, Insomnia, Musculoskeletal stiffness, Screaming
Clinical narrative: Non Stop High piteched screaming, stiff body, refused to eat or sleep and crying lasted for 5 hours non stop when he was sleeping every 3 hours at that time.  His whole sleep schedule was thrown off after that and he had more trouble sleeping and eating than usual.
Age: 17.0
Sex: F
Vaccine: MEN, VARCEL
Symptoms: Fatigue, Injection site erythema, Injection site inflammation, Injection site swelling, Injection site vesicles
Clinical narrative: Upper right arm (site where vaccine was given) turned dark red, began to swell, developed erythema and inflammation, and developed shingles-type vesicular lesions at injection site. Fever of 101 noted with fatigue and generalized achiness.  Treated at urgent care center - given Kenalog injection, started on Prednisone for allergic reaction, ice applied to site, ibuprofen given, rest and fluids ordered.
Age: 17.0
Sex: F
Vaccine: MEN, VARCEL
Symptoms: Pain, Pyrexia
Clinical narrative: Upper right arm (site where vaccine was given) turned dark red, began to swell, developed erythema and inflammation, and developed shingles-type vesicular lesions at injection site. Fever of 101 noted with fatigue and generalized achiness.  Treated at urgent care center - given Kenalog injection, started on Prednisone for allergic reaction, ice applied to site, ibuprofen given, rest and fluids ordered.
Age: 12.0
Sex: M
Vaccine: HEPA, MEN, TDAP, UNK
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Site of shot was hard and swollen. Area was very red and hot. Drew a line around border of swelling and was about the size of a quarter. At noon on 8/23/2014 area was checked again and had some more swelling. Marked another border line around the swelling. Had ice pack applied to area for 15 mins. Appeared to have some decrease in swelling. Checked again at 9pm and saw no change. At noon on 8/24/2014 site was checked again. Swelling had increased again and was found to be 3 inches in diameter. Site was extremely hot, red and hard. Administered 200mg ibuprofen and 25mg of Benadryl. Checked for fever and was at 100.2 orally. Had ice applied for 15 mins. Rechecked at 3:30 PM and found swelling had decreased and fever had come down to 99.2. Continued to monitor. Appeared to be getting better still at 9 PM.
Age: 68.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Inflammation, Local swelling, Pain in extremity
Clinical narrative: Swelling, inflammation and pain on arm (right arm).
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hyperaesthesia, Limb discomfort, Local swelling
Clinical narrative: Raised, red area sensitive to touch surrounded by erythematous skin; discomfort in arm.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash erythematous, Rash pruritic
Clinical narrative: Red itchy spots, blister like.
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Rash
Clinical narrative: 21 yr F, veterinary student, received her pre-rabies vaccine; series of (3). Developed a rash - systemic on 8-2-14 trunk/back, arms and legs x 1 1/2 weeks, still has rash presently.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Several hours after injection, patient noted rash, pain, redness, warm and swollen upper left arm. Patient seen in follow-up 8/13, 8/14, and 8/15 and 8/18/14. Treatment: 5 day course of clindamycin, probiotics. Resolved.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Erythema, Local swelling, Skin warm
Clinical narrative: Red hot swollen arm - cellulitis being treated.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Pain, Swelling
Clinical narrative: Red hot swollen arm - cellulitis being treated.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Headache, Injection site bruising, Nausea, Pain
Clinical narrative: Entire body aches, pains, nausea, vomiting, roaring headaches, fever, exhaustion, bruising on injection sites.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Entire body aches, pains, nausea, vomiting, roaring headaches, fever, exhaustion, bruising on injection sites.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Malaise, Nausea, Pain, Pyrexia
Clinical narrative: Felt very sick with body aches. Low temperature and had nausea, as well as general weakness.
Age: 1.09
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 13 month old patient. On 28-MAY-2014 the patient was vaccinated w ith (Oka/Merck) VARIVAX lot # J012377 expiration date 03-OCT-2015 dose and route not reported) and M-M-R II (lot # J013315, expiration date 18-OCT-2015, dose and route not reported) which were stored improperly. There was no adverse affect reported. This is one of several reports received from the same source. Additonal information is not expected.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 year old patient. On 07-MAY-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # J002319. expiration date 22-FEB-2014, dose and route not reported) and M-M-R II (Lot # J003785, expiration date 28-MAR-2015, dose and route not reported) which were stored improperly. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 year old patient. On 07-MAY-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # J009164, expiration date 07-AUG-2014, dose and route not reported) and M-M-R II (lot # J003785, expiration date 28-MAR-2015, dose and route not reported) which were stored improperly. There was no adverse effect reported. This is one of several reports from the same source. Additional information is not expected.
Age: 1.39
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 16 month old patient. On 15-MAY-2014 the patient was vaccinated with M-M-R II (lot # J013315, expiration date 18-OCT-2015, dose and route not reported) which was stored improperly. On 10-JUL-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # J014229, expiration date 08-NOV-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a female pharmacist of unknown age refers to herself who was not pregnant.  The pharmacist reported that "one year ago" in August 2013, while she was preparing ZOSTAVAX (lot #, dose, route not reported) for administration to a patient, the pharmacist was accidentally sprayed with medication.  No adverse effects were reported. PQC was filled. No medical attention was sought.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient with no medical history and drug reactions/allergies. On 31-JUL-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot # J014810, expiration date 21-FEB-2015) 0.65 ml once, subcutaneous for recommended age. Concomitant therapies included gabapentin, estradiol and losartan potassium (+) hydrochlorothiazide (manufacturer unknown). On 02-AUG-2014, the patient called the pharmacy to report that she was experiencing warmth, redness and itching at the injection site. The patient was seen in the pharmacy on 04-AUG-2014 and "the patient's arm was still red and warm it had extended down to her elbow not just at the injection site; it was a larger reaction that the pharmacist usually saw with ZOSTAVAX". The pharmacist stated the patient reported that she self treated with hydrocortisone cream. When asked the patient's present status, the pharmacist stated that he/she knew the reaction was there on 04-AUG-2014 but did not know how the patient was doing on 05-AUG-2014. Lab diagnostics studies were not performed. The outcomes of the adverse event was unknown. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 year old patient. On 24-JUN-2014 the patient was vaccinated with M-M-R II (lot # J011332, expiration date 13-SEP-2015, dose and route not reported) which were stored improperly. There was no adverse effect reported. This is one of several reports from the same source. Additional information is not expected.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 year old patient. On 27-MAY-2014 the patient was vaccinated with (Oka/Merck) VARVIAX (lot # J009728, expiration date 07-AUG-2014, dose and route not reported) and M-M-R II (lot # J003785, expiration date 27-MAY-2015, dose and route not reported) which were stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Physician concerning a 13 year old, Male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 18-Dec-2013. It was reported by Physician that eight patients were received expired FLUMIST QUADRIVALENT on 18-Dec-2013. The outcome of the event of received expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Health Professional concerning a patient, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). Concomitant Drug(s) Not Used. FLUMIST QUADRIVALENT started on an unknown date. The reporter stated the patient received FLUMIST by mistake 9 weeks pregnant. The outcome of the event of received FLUMIST by mistake 9 weeks pregnant is unknown. The report was considered to be non-serious by the reporter.
Age: 4.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old. Male subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 16-Dec-2013. The patient was administered expired FLUMIST which was started on 16-dec-2013. The outcome of the event of ADMINISTRATION OF EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Age: 4.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old. Male subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 16-Dec-2013. The patient was administered expired FLUMIST which was started on 16-dec-2013. The outcome of the event of ADMINISTRATION OF EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Age: 4.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A report hs been received from a Health Professional concerning a 4 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 16-dec-2013. It was reported that expired FLUMIST has been administered which started on 16-Dec-2013. The report was considered to be non-serious.
Age: 4.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report hs been received from a Health Professional concerning a 4 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 16-dec-2013. It was reported that expired FLUMIST has been administered which started on 16-Dec-2013. The report was considered to be non-serious.
Age: 4.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST(Intranasal) started on an unknown date. Reporter reported that she ADMINISTRATION OF EXPIRED FLUMIST which started on 16-Dec-2013. The outcome of the event of ADMINISTRATION OF EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Age: 4.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST(Intranasal) started on an unknown date. Reporter reported that she ADMINISTRATION OF EXPIRED FLUMIST which started on 16-Dec-2013. The outcome of the event of ADMINISTRATION OF EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Age: 3.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a 3 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) was started on 16-Dec-2013. The reporter mentioned that patient was administered expired FLUMIST on 16-Dec-2013. The outcome of the event of ADMINISTRATION OF EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Age: 3.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 3 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) was started on 16-Dec-2013. The reporter mentioned that patient was administered expired FLUMIST on 16-Dec-2013. The outcome of the event of ADMINISTRATION OF EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Age: 14.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a 14 year old, male subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 16-Dec-2013. The reporter mentioned that patient was administered of expired FLUMIST on 16-Dec-2013. The outcome of the event of ADMINISTRATION OF EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Age: 14.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 14 year old, male subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 16-Dec-2013. The reporter mentioned that patient was administered of expired FLUMIST on 16-Dec-2013. The outcome of the event of ADMINISTRATION OF EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Age: 4.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, Male subject, who had been receiving FLUMIST, (intranasal). FLUMIST started on an unknown date. Reporter reported that administration of expired FLUMIST which started on 16-Dec-2013. The outcome of the event of administration of expired FLUMIST is unknown. The report was considered to be non-serious.
Age: 4.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, Male subject, who had been receiving FLUMIST, (intranasal). FLUMIST started on an unknown date. Reporter reported that administration of expired FLUMIST which started on 16-Dec-2013. The outcome of the event of administration of expired FLUMIST is unknown. The report was considered to be non-serious.
Age: 3.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A report has been received from a health professional concerning a patient, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on an unknown date. It was reported that the patient had administration of expired FLUMIST QUADRIVALENT on 16-Dec-2013. The outcome of the event of administration of expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 31-Dec-2013 from health professional: Start date added for the FLUMIST and event administration of expired FLUMIST QUADRIVALENT. Suspect drug details like lot number and expiration date added. New reporter added as patient and other reporter's details added. Patient's details updated.
Age: 3.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a health professional concerning a patient, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on an unknown date. It was reported that the patient had administration of expired FLUMIST QUADRIVALENT on 16-Dec-2013. The outcome of the event of administration of expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 31-Dec-2013 from health professional: Start date added for the FLUMIST and event administration of expired FLUMIST QUADRIVALENT. Suspect drug details like lot number and expiration date added. New reporter added as patient and other reporter's details added. Patient's details updated.
Age: 17.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 17 year old, female patient. The patient's medical history, concurrent medications were not reported. On 27-Jan-2014 the patient received FLUMIST (Intranasal), but the vaccine was expired on 20-Jan-2014. At the time of reporting, the outcome of the event of inadvertently gave expired FLUMIST was unknown. The report was considered to be non-serious by the reporter.
Age: 62.0
Sex: F
Vaccine: YF, YF
Symptoms: Back pain, Hypoaesthesia, Lumbar puncture, Musculoskeletal pain, Myelitis transverse
Clinical narrative: Patient presented with progressive numbness and paresthesia with associated weakness involving lower left extremity.  Also, with decreased sensation and balance.
Age: 62.0
Sex: F
Vaccine: YF, YF
Symptoms: Nuclear magnetic resonance imaging spinal abnormal, Pain in extremity
Clinical narrative: Patient presented with progressive numbness and paresthesia with associated weakness involving lower left extremity.  Also, with decreased sensation and balance.
Age: 62.0
Sex: F
Vaccine: YF, YF
Symptoms: Balance disorder, Hypoaesthesia, Muscular weakness, Paraesthesia, Sensory disturbance
Clinical narrative: Patient presented with progressive numbness and paresthesia with associated weakness involving lower left extremity.  Also, with decreased sensation and balance.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Inappropriate schedule of drug administration, Malaise
Clinical narrative: Fatigue, generally not feeling well.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Malaise
Clinical narrative: Fatigue, generally not feeling well.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, VARCEL
Symptoms: Rash maculo-papular, Skin lesion
Clinical narrative: Macular/papular rash with approximately 8 lesions.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Erythema, Induration, Laboratory test, Skin warm
Clinical narrative: L entire buttocks warm and red, R buttocks w/ quarter sized firm induration. Cellulitis? Fat necrosis? Granuloma?
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Biopsy lung, Bronchoscopy, Computerised tomogram thorax, Echocardiogram, Intensive care
Clinical narrative: Fevers 103-104 with Tylenol and ibuprofen 3 days later respiratory distress which lead to respiratory failure to awaiting lung transplant.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pyrexia, Respiratory distress, Respiratory failure
Clinical narrative: Fevers 103-104 with Tylenol and ibuprofen 3 days later respiratory distress which lead to respiratory failure to awaiting lung transplant.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Paraesthesia, Radiculitis brachial
Clinical narrative: Acute left shoulder pain, left arm tingling. Brachial neuritis.
Age: 21.0
Sex: M
Vaccine: HPV4
Symptoms: Culture, Emotional distress, Herpes zoster, Injection site vesicles
Clinical narrative: This spontaneous report as received from the mother refers to her 21 year old son with no pertinent medical history or drug reactions/allergies. On 17-JUL-2014 the patient was vaccinated with a dose of GARDASIL (dose, route and lot# not reported). There was no concomitant therapy included. On 17-AUG-2014, after one month, the patient developed 3 blisters with fluids at the injection site. Patient was upset and went to emergency room. And the patient was told by physician that blisters looked like shingles, so culture was obtained for that. One culture for unspecified criteria and a specific culture to test for shingles were performed. Patient sought medical attention by visiting emergency room and valacyclovir was given as treatment. It was reported that the patient was admitted to a hospital on an unknown date. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Death
Clinical narrative: Information was received from a physician via a company representative regarding unspecified patients (demographics or details of patients not provided). The physician stated that an unspecified pediatrician sent an email with an article from an unspecified pediatric or infectious disease journal that stated that there have been deaths associated with GARDASIL. No further information is expected.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Eye inflammation, Laryngitis, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: An hour after immunization, experienced increasing congestion, sore throat; over the following few days increased congestion and coughing, laryngitis, inflamed eyes (looked like conjunctivitis).
Age: 1.49
Sex: F
Vaccine: MMR
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from licensed practical nurse refers to a currently 19 year old female patient with no drug reactions/allergies. The patient's pertinent medical history included menorrhagia. At the age of 18 months old, approximately in August 1996, the patient was vaccinated with M-M-R II INJ, (dose, route and lot number not provided). Concomitant therapy included GILDESS FE (reported as GILDESS). On an unknown date, after receiving M-M-R II, the patient developed "multiple" seizures. The patient sought medical attention by an unspecified way. At the time of the report, the outcome of the event was unknown. Upon internal review, the event "The patient developed multiple seizures" was considered as medically significant. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Fever starting at 99 and going up to 102 by 2 am. Fever of 101 continuing next day 08/24/2014.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Sycopal episode after vaccines administered.
Age: 80.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Developed hives on left forearm.  Later, on back, back of legs, thighs.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Swelling
Clinical narrative: Swollen, size of golf ball, and painful.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Pruritus, Skin warm, Somnolence, Swelling
Clinical narrative: Swollen, approximately 1.5 inch diameter, hot to touch, itchy. Child "super sleepy" in the morning. Swollen area iced and child given Benadryl - per mom both helped relieve symptoms but symptoms returned. Recommended patient go to Urgent Care.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Nausea, Syncope
Clinical narrative: Syncopal episode lasting a few seconds.  She was sitting in her moms lap so she didn't fall to the floor.  Once she came to, she placed her head between her legs for a few minutes.  She was given water to drink and a cool compress for her head.  She also felt as if she was going to vomit.  She was monitored for about 20 minutes before leaving the office.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Limb discomfort, Pain, Scar
Clinical narrative: 24 hours post Pneumovax 23 injection, patient c/o discomfort in arm. Established scar near injection site was first to turn red. Over 12 hours on 8/24/14 and 8/25/14, patient c/o increasing pain/redness. Treated with Benadryl 25 mg PO (1 dose given 8/24/14 at 21:30 and 1 dose given 8/25/14 at 04:00).
Age: 0.57
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Inflammation, Injection site nodule, Insomnia, Pyrexia, Rhinorrhoea
Clinical narrative: Mom c/o "knots on legs" after receiving immunizations last Friday. Mom states child has slept less, and had a slight fever for 2 days. Mother gave infants APAP and Motrin for relief. Denies increased fussiness, denies reduced appetite, denies any previous reactions to vaccinations, denies redness or warmth to the area, denies any indication that the area is tender to the infant. Fever was as high as 100.4 Saturday and has since resolved, no fever Sunday nor today.
Age: 0.57
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Swelling
Clinical narrative: Mom c/o "knots on legs" after receiving immunizations last Friday. Mom states child has slept less, and had a slight fever for 2 days. Mother gave infants APAP and Motrin for relief. Denies increased fussiness, denies reduced appetite, denies any previous reactions to vaccinations, denies redness or warmth to the area, denies any indication that the area is tender to the infant. Fever was as high as 100.4 Saturday and has since resolved, no fever Sunday nor today.
Age: 5.0
Sex: M
Vaccine: DTPIPV, HEPA, MMRV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Right swollen and tender thigh.
Age: 36.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Dizziness, Erythema, Injection site pain, Local swelling
Clinical narrative: Pneumonia shot soreness at inj. site after given, extremely painful right arm had some dizziness, weakness and nausea, red raised noticed it yesterday.
Age: 36.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Pain in extremity
Clinical narrative: Pneumonia shot soreness at inj. site after given, extremely painful right arm had some dizziness, weakness and nausea, red raised noticed it yesterday.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patient. On 19-AUG-2014, the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX, (lot#, expiration date unspecified), subcutaneous that underwent a temperature excursion. No adverse effect reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Exposure during pregnancy, Laboratory test, No adverse event, Ultrasound antenatal screen
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 17 year old female patient. The patient had no pertinent medical history or no known drug reactions/allergies. On 30-MAY-2014 the patient was vaccinated with her third dose of GARDASIL (lot # J012212, expiration date 18-FEB-2016, dose 0.5 ml, intramuscularly in the right deltoid ). No concomitant medications were provided. The patient had ultrasound on 24-JUL-2014 and it was found that client was 30 weeks and 3 days pregnant. Blood work and other lab tests were completed and the results were unspecified. The nurse stated the patient was not experiencing any adverse effects. The Last Menstrual Period (LMP) was estimated on 23-DEC-2013 (also reported on 03-APR-2014). The Estimated date of delivery (EDD) was estimated on 29-SEP-2014. No treatment was given. The patient did not seek medical attention. The outcome of the pregnancy was unknown. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Hyperhidrosis
Clinical narrative: This spontaneous report  as received from a healthcare worker refers to a male patient of unknown age with penicillin allergy, LORABID allergy and OMNICEF allergy. No pertinent medical history was reported. On 22-AUG-2013 the patient was vaccinated with GARDASIL (lot # was reported as J006736, expiration date February 2016), intramuscular. No concomitant medication included. On an unknown date the patient experienced sweating, after receiving GARDASIL. The patient sought medical attention via office visit on an unspecified date. No treatment was given. No lab diagnostic studies performed. Therapy was reported as continued. The event outcome was reported as recovered. It was also reported adverse event reappeared after Reintroduction. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Fatigue, Gastrooesophageal reflux disease, Immediate post-injection reaction, Migraine
Clinical narrative: This spontaneous report was received from a consumer refers to her daughter, a 12 year old female patient. On unknown dates by November 2013 the patient was vaccinated with GARDASIL dose 1, dose 2, dose 3 respectively (dose, route and lot# not reported). On unknown dates, in addition to injection site reactions immediately after receiving the vaccine (her "arm really sore"), the patient was "tired" and had "stomach ache and nausea". In December 2013, the patient started to have "migraines and gastroesophageal reflux". Migraines reoccurred on 16-JAN-2014 and 24-JAN-2014. The patient saw neurologist to seek medical attention but no medication administered. The outcome of the events was not recovered. Causality was not reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain in extremity
Clinical narrative: This spontaneous report was received from a consumer refers to her daughter, a 12 year old female patient. On unknown dates by November 2013 the patient was vaccinated with GARDASIL dose 1, dose 2, dose 3 respectively (dose, route and lot# not reported). On unknown dates, in addition to injection site reactions immediately after receiving the vaccine (her "arm really sore"), the patient was "tired" and had "stomach ache and nausea". In December 2013, the patient started to have "migraines and gastroesophageal reflux". Migraines reoccurred on 16-JAN-2014 and 24-JAN-2014. The patient saw neurologist to seek medical attention but no medication administered. The outcome of the events was not recovered. Causality was not reported. Additional information has been requested.
Age: 0.36
Sex: M
Vaccine: 6VAX-F, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 month old male patient. On 18-AUG-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, 0.5 ml subcutaneous, in the same thigh, right or left not specified, lot # J012773, expiration date 09-OCT-2015. Other suspect therapy administered also on 18-AUG-2014 included MMR II, 0.5 ml, lot # J003790, expiration date 28-MAR-2015 (dose and routed were not provided). Concomitantly, on 18-AUG-2014, it was administered Hib vaccine (unspecified carrier), DT, hepatitis B virus vaccine (unspecified), pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown, dose, route, lot #, expiration date were not provided). On 18-AUG-2014, the patient was mistakenly administered (Oka/Merck) VARIVAX and MMR II. No adverse effect was reported. It was unknown if the patient sought medical attention. The patient's status was reported as recovering. 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 registered nurse refers to an unspecified patient of unknown age and gender. The concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored PROQUAD, (dose, route, lot number were not reported). No adverse effects were reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pyrexia
Clinical narrative: Redness and swelling on left arm and fever.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pyrexia
Clinical narrative: Arm red down to about the elbow. Also a little swollen. Had a fever over night.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Papule, Rash maculo-papular, Rash maculovesicular, Skin discolouration
Clinical narrative: Macular papular and macular vesicular area on face 3-4 mm in size, 1 macular papular on the center of his back approximately 4 min in size, diaper area with a pink 2-3 mm papules along waistline and groin.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: About 40 hrs after immunization, right deltoid became erythematous, swollen, warm but bot pruritic or painful. No decreased range of motion. Pt was seen 8/20. No treatment. Rash resolved within 48 hours.
Age: 18.0
Sex: M
Vaccine: MNQ, TD, TYP, VARCEL
Symptoms: Abdominal discomfort, Abdominal pain upper, Nausea, White blood cell count normal
Clinical narrative: 8-19-14 clt stated taking oral typhoid on 8-12-14. That evening clt experienced slight stomach upset. With 2nd dose clt stated he had more stomach cramping and nausea. With 3rd dose clt stated he had severe cramping and nausea. Went to the ER. Had bloodwork done which was within normal limits. Clt took 4th dose and stated he did better with last dose - only slight stomach upset. Comparable to the first dose. Clt says he felt fine today no Sx. Advised clt to take injectable typhoid in future if needed.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nursery refers to unknown number of patients of unknown age. On an unknown date unknown number of patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot number, dose, frequency, route, indication were not reported). No concomitant medications were reported. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified time amount of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, those patients were vaccinated with doses of LIQUID PEDVAXHIB injection (lot number, dose and route were not reported) that underwent a temperature excursion. The physician reported that the refrigerator temperature had been 57.16 degrees Fahrenheit. The time frame period was from April 2014 to June 2014. Concomitant therapies were not reported. No adverse effect was reported. The physician enquired if patients whom received an improperly stored vaccine, on an unspecified date in 2014, should be re-vaccinated. This is one of several reports from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Eye swelling, Lacrimation increased, Rash, Throat irritation
Clinical narrative: 345pm parent left message: daughter's eyes swollen/draining (teary), throat itches, rash on neck/back. Took several tries to get hold of parent - instructed to go to local emergency room now. Tx'ed at hosp. with prednisone/BENADRYL.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site rash
Clinical narrative: 12 x 7 cm erythematous edematous rash at site of KINRIX.
Age: 1.11
Sex: M
Vaccine: HEPA
Symptoms: Rash papular
Clinical narrative: Pt. developed generalized papular rashes on 8/10/14, 2 days after receiving Hep A vaccine. No fever. No lethargy. No vomiting. No difficulty breathing. Appetite normal.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, TDAP
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Day after vaccination (R) arm red, swollen, painful.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a unspecified number of patients. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with ROTATEQ. Dose, route, lot number and expiration date were not reported. On an unknown date an unspecified number of patients received improperly stored ROTATEQ. No adverse symptoms reported. Follow up information was received on 21-AUG-2014. The reported stated that had heard nothing concerning any incorrect storage of vaccines at the facility. This is one of several reports from the same source. Additional information is not expected (cancelled all scheduled correspondence).
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a unspecified number of patients. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with VAQTA. Dose, route, lot number and expiration date were not reported. On an unknown date an unspecified number of patients received improperly stored VAQTA. No adverse symptoms reported. Follow up information was received on 21-AUG-2014. The reported stated that had heard nothing concerning any incorrect storage of vaccines at the facility. This is one of several reports from the same source. Additional information is not expected (cancelled all scheduled correspondance).
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 age and gender. No pertinent medical history or drug reactions/allergies were provided. The reporter stated that, since 08-JUL-2014 (exact dates not provided) RECOMBIVAX HB was administered to patients after improper storage (dose, route, lot number and expiration date not reported). No adverse effects were noted.  This case is linked to case MARRS#1407USA004179, 1408USA013887 and 1408USA013888 (same reporter link). Additional information is not expected because the reporter declined any further contact regarding this report.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site pain, Nausea, Vomiting
Clinical narrative: Vomiting, nausea, arm pain at injection site, tired.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema multiforme, Pruritus, Pyrexia, Rash, Urticaria
Clinical narrative: Fever, rash, eryrthema multiforme and urticaria, pruritus.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Mass, Pain, Swelling
Clinical narrative: Swelling, redness, soreness, lump.
Age: 19.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Computerised tomogram head normal, Feeling abnormal, Headache
Clinical narrative: Pt had BOOSTERIX and MENVEO vaccines on 8/1/14. Pt developed headache after and felt like he was in fog. Headache was across frontal region. Ibuprofen did not help symptoms - Had Tetanus 5 yrs ago with no symptoms. CT head - Normal.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Redness, swelling around injection site next morning 1" wide x 2 1/2". Hives, bumps inside red area - 11:00 AM 8/14/14 - 4" x 4 1/2". Itching, burning - 11:00 AM 8/14/14. Prednisone 20mg taken 8/15/14 in AM, 8/15/14 in PM and ice. CLARITIN 10mg taken 8/15/14 in AM.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: Redness, swelling around injection site next morning 1" wide x 2 1/2". Hives, bumps inside red area - 11:00 AM 8/14/14 - 4" x 4 1/2". Itching, burning - 11:00 AM 8/14/14. Prednisone 20mg taken 8/15/14 in AM, 8/15/14 in PM and ice. CLARITIN 10mg taken 8/15/14 in AM.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Penile swelling, Rash, Rash pruritic
Clinical narrative: Patient states about 2 hours after his immunizations he developed a pruritic rash on his penis. Next day, rash on face with itching and penis seemed swollen. Treated with BENADRYL at home. Seen today at our office. Sent home on prednisone. No S.O.B., no tongue swelling, no swallowing problem.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site warmth
Clinical narrative: Cellulitis to (L) arm at injection site, 4 inches in diameter, warm to touch, occured within hours of injection, treated with prednisone.
Age: 1.36
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of the left thigh. Left thigh circumference 35 cm. Red area 15 cm x 12 cm.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Urticaria rash lasting 2 days. Rx OTC antihistamines.
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. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with RECOMBIVAX HB. Dose, route, lot number and expiration date were not reported. On an unknown date an unspecified number of patients received improperly stored RECOMBIVAX HB. No adverse symptoms reported.   Follow up information was received on 21-AUG-2014. The reporter stated that had heard nothing concerning any incorrect storage of vaccines at the facility. This is one of several reports from the same source. Additional information is not expected (canceled all scheduled correspondence).
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unknown number of patients of unknown age. On an unknown date unkown number of patients were vaccinated with improperly stored PROQUAD (Merck) (lot number, dose, frequency, route, indication were not reported). No concomitant medications were reported. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to at least 3 patients of unknown age and gender. On 20-AUG-2014 and 21-AUG-2014, at least 3 patients were vaccinated with expired doses of M-M-R II lot # H014978, expiry date 09-AUG-2014, subcutaneous (dose not reported). No known adverse effects were reported. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 29 year old female patient. Current conditions and other relevant medical history were not reported. On an unknown date the patient was vaccinated with GARDASIL (intramuscular injection, lot # J013324, expiration date: 12-FEB-2016, strength, route, dose number, anatomical location not reported). Concomitant therapies were not reported. The reproter stated that on an unknown date she administered a dose of GARDASIL to a 29 year old female patient. No adverse effects reported. No further details were provided. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site irritation, Injection site warmth
Clinical narrative: Redness, irritation, warm to touch around injection site. Slightly worse each day. Red, warm area about 2 inches in diameter. Noticed after second round of vaccinations 2 days after yellow fever vaccination (Hep A and Hep B IM on right arm; Typhoid IM on left arm near yellow fever site).
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, HPV4, HEPA, HPV4
Symptoms: Blood glucose, Electrocardiogram, Electroencephalogram, Metabolic function test, Tonic convulsion
Clinical narrative: Seizure- tonic lasting 30 sec.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, HPV4, HEPA, HPV4
Symptoms: Convulsion, Headache, Muscular weakness
Clinical narrative: Seizure- tonic lasting 30 sec.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, HPV4, HEPA, HPV4
Symptoms: Blood electrolytes normal, Blood glucose normal, Convulsion, Disorientation, Electrocardiogram normal
Clinical narrative: Seizure- tonic lasting 30 sec.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, HPV4, HEPA, HPV4
Symptoms: Electroencephalogram abnormal, Loss of consciousness, Muscular weakness, Somnolence, Tonic convulsion
Clinical narrative: Seizure- tonic lasting 30 sec.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, HPV4, HEPA, HPV4
Symptoms: Tremor
Clinical narrative: Seizure- tonic lasting 30 sec.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspepsia, Injection site anaesthesia, Injection site pain, Nausea
Clinical narrative: Severe dizziness, nauseous, stomach burning sensation, numbness in left arm where shot was given still sore after 5 days and still having dizziness.