chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Asthenia, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Pt report unable to lift arm past a certain point. Dull pain in left arm. Has been taking Ibuprofen 200mg - Reports weakness. Dull aching pain that stays the same. Trouble putting on clothes.
Age: 82.0
Sex: U
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on extremities only- alot better today
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Asthma, Chest pain, Condition aggravated, Dyspnoea, Swelling face
Clinical narrative: Chest pain, swelling face, SOB, on wheezing - Tx prednisone 50 mg until wheezing resolve (Hx of asthma) VENTOLIN inh.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Chest pain, swelling face, SOB, on wheezing - Tx prednisone 50 mg until wheezing resolve (Hx of asthma) VENTOLIN inh.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Middle insomnia, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Since administration of flu vaccine, right arm has ached a lot. (Bicep area) pain wakes me up at NOC; must take Ibuprofen freq. Difficulty using right arm.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Urticaria started on trunk the afternoon after vaccine administered. Patient came to Dr. (PCP) after urticaria continued x 4 days.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Lacrimation increased, Nasal congestion, Respiratory tract congestion
Clinical narrative: Patient reported that within 3 hours of receiving the vaccine, he became short of breath and had chest congestion (with watery eyes and nasal congestion).
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: (L) arm back of elbow, red, hot and tender 10cm x 8.5 cm. Tx: Dicloxacillin 500mg PO TID x 7 days
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left upper arm was red, swollen, and tender, pt. went to dermatologist and got prescription for MEDROL dose pak.
Age: 57.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, raised, hot, swollen area at injection site.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cough, Diarrhoea, Oropharyngeal pain, Tremor
Clinical narrative: 10/2 shot at 7:15 pm - 9:00 - severe sore throat and cough. 10:00 - vomiting, diarrhea and severe shaking. 2:30 am - finally subsided. 10/3 weakness.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: 10/2 shot at 7:15 pm - 9:00 - severe sore throat and cough. 10:00 - vomiting, diarrhea and severe shaking. 2:30 am - finally subsided. 10/3 weakness.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac stress test, Chest pain, Computerised tomogram head, Confusional state, Dizziness
Clinical narrative: C/O sharp pain in (L) arm that went up to head approx 1/2 hr later c/o dizziness, chest pain, slight confusion - BP 150/70 - went to ER. CT scan, stress test complete - symptoms subsided.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain in extremity
Clinical narrative: C/O sharp pain in (L) arm that went up to head approx 1/2 hr later c/o dizziness, chest pain, slight confusion - BP 150/70 - went to ER. CT scan, stress test complete - symptoms subsided.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Feeling hot, Swelling
Clinical narrative: Redness, swelling, hotness to LUE. Placed on clindamyacin for cellulitus. Problem resolved.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Pyrexia, Urticaria
Clinical narrative: Fever, hives, itchy on front/back torso, between legs (thighs), on hands and arms - front/back, on feet on bottom of feet.
Age: 24.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: FLUZONE HD was administered. Pt did not have adverse events on follow up 10/10/14 AM.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia, Sensation of heaviness
Clinical narrative: At 1545 - pt. called down from other building to say his "(L) hand felt heavy and that his (L) arm felt number and tingly". Denied pain, SOB, dizzy, denied rash. Had stated he had full ROM without difficulty other than numb/tingly. CDC was called. No allergic reaction -> by 1655 pt voice he "was fine".
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Pain continued to left arm after receiving vaccine 5 weeks ago. Informed pt to see physician.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Patient reported on 10-17-14 on phone as having fine itchy rash on whole body. Took BENADRYL for rash and itch. Symptoms were seen 3 days after getting vaccines.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site bruising, Injection site warmth
Clinical narrative: Bruising on (left) upper arm to elbow - lasting 2-3 days warm to touch for 2-3 days. Completely recovered.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain to (Lt) deltoid that has continued for 5 weeks. Informed to see physician.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Electrocardiogram, Immediate post-injection reaction, Muscle tightness
Clinical narrative: Pt was given flu shot in (R) deltoid, and immediately his muscles became tense and he felt he could barely breathe, he denies any seizure activity. He has had previous flu shots without any problems. Pt taken to Emergency Room. VS = BP 132/100 - P=132 - R=20 - T=99; HT=70"; WT=222; O2 sat=98%.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt. c/o (Lt) arm pain a couple of weeks after injection administered. Informed pt to see Dr. Pt. placed on anti-inflammatories.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Hiccups, Rash
Clinical narrative: Rash around neck. Hiccups started 24 hours post-INJ.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Rash on torso; red; itchy.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Cough, Influenza, Influenza A virus test positive, Pyrexia
Clinical narrative: FLU MIST 10-14. 10-19 symptoms of flu, fever, cough. 10-21 (+) flu test influenza A.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Eyelid oedema, Eyelids pruritus, Injection site erythema, Injection site swelling
Clinical narrative: Slight redness at injection site. Swelling at injection site about the size of a lemon. Itchiness and puffiness underneath eyes. Vaccine administered 10/21/14 to right arm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Pruritus, Rash papular, Rash pustular
Clinical narrative: Papular rash esp. on trunk, one small pastule on hand. Onset of rash 10/22/14, while playing outside. Itches.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Shoulder pain / arm stiffness.
Age: 1.82
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose increased, Injection site erythema, Injection site swelling, White blood cell count normal
Clinical narrative: 48 hrs after left thigh swelling and erythema, no fever. Taken to ER given KEFLEX, BENADRYL and ibuprofen.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Redness and erythema at injection site.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Redness and erythema at injection site.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Redness and erythema at injeciton site.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Injection site swelling, Pain
Clinical narrative: Local erythema, swelling at site, chills, body aches. Symptoms 24 hours.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia, Laboratory test abnormal, Pain in extremity, Rotator cuff syndrome
Clinical narrative: An hour after vaccine patient states arm started hurting. Then it went numb. Patient went to ER thinking she had a heart attack. After relevant tests they decided she actually tore her rotator cuff. Unknown if any follow up tests were actually done.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Injection given on 10-14-14 reaction of rash reported on 10-16-14. See attached.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site mass, Pain in extremity, Vaccination complication
Clinical narrative: Patient received ZOSTAVAX at approx 5:15 PM on Sunday, October 19th, 2014. Vaccine was given in back of right upper arm with 5/8" needle SQ. Upon removing needle from arm, pt had bleeding running down arm. I was able to stop the bleeding quickly and placed band aid over injection site. A black and blue bruise formed around injection site (no larger than the band aid). Patient was given ice and remained in store for additional 20 minutes. After the 20 minutes, there were no signs of trouble breathing, temperature, or anaphylaxis. The bruising did not grow any larger. The patient stated she was ok and was going home. I told her to ice at home and if anything changes to contact her physician. Overnight, the bruising spread up her arm, a lump formed and arm became very sore. The patient saw her physician on Monday, where it was determined this was an adverse reaction to the vaccine. I spoke to her physician who said it had noting to do with my injection technique, but her body reaction to the vaccine. The patient was prescribed an antibiotic and is following up with doctor on Friday Oct 24th. I spoke with the patient today (October 22nd) and she stated the lump is shrinking and bruising is starting to improve.
Age: 34.0
Sex: F
Vaccine: HEP, HEPA, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a 34 year old female patient refers to herself. The patient became pregnant with last menstrual period (LMP) of 12-SEP-2014 and estimated due date (EDD) of 19-JUN-2015. On 09-OCT-2014 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, RECOMBIVAX HB, and VAQTA (lot #, strength, dose, frequency and route unspecified). The patient stated that she discovered she was pregnant on 10-OCT-2014 a day after she received the three vaccines. Initial exposure to (Oka/Merck) VARIVAX was at 4 weeks. The pregnancy outcome was outcome pending. The outcome of the event was unknown. Additional information is not expected as there was no contact details.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Burning sensation, Dizziness, Fatigue, Headache
Clinical narrative: This spontaneous report as received from a 62 year old female patient who refers to herself. On 02-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAZ (dose, route of administration, lot number and expiration date not reported) Concomitant therapies included SYNTHROID and amlodipine. Pertinent medical history and drug reactions/allergies were reported as none. On 02-OCT-2014, right after receiving ZOSTAVAX the patient experienced an instant headache which started from the back of her head and up just about 4 inches. She also had fever for four days. The consumer's arm had an "8 inch red burn" going down where the shot went down. It was hot to the touch. The patient was tired with fatigue and experienced some dizziness. The patient reported also she was unable to function properly and slept in bed for about "day and a half". She noticed also bump that was located to her hair that gave her an "itchy and burning" sensation.  There was none lab diagnostics studies performed. There was no treatment given for adverse events. It was also reported that the patient put BENADRYL on the injection site and took naproxen. The outcome of adverse event (except headache) was recovering on the therapy. The patient did not seek medical attention. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersomnia, Injection site erythema, Injection site pain, Injection site warmth, Pruritus
Clinical narrative: This spontaneous report as received from a 62 year old female patient who refers to herself. On 02-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAZ (dose, route of administration, lot number and expiration date not reported) Concomitant therapies included SYNTHROID and amlodipine. Pertinent medical history and drug reactions/allergies were reported as none. On 02-OCT-2014, right after receiving ZOSTAVAX the patient experienced an instant headache which started from the back of her head and up just about 4 inches. She also had fever for four days. The consumer's arm had an "8 inch red burn" going down where the shot went down. It was hot to the touch. The patient was tired with fatigue and experienced some dizziness. The patient reported also she was unable to function properly and slept in bed for about "day and a half". She noticed also bump that was located to her hair that gave her an "itchy and burning" sensation.  There was none lab diagnostics studies performed. There was no treatment given for adverse events. It was also reported that the patient put BENADRYL on the injection site and took naproxen. The outcome of adverse event (except headache) was recovering on the therapy. The patient did not seek medical attention. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: This spontaneous report as received from a 62 year old female patient who refers to herself. On 02-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAZ (dose, route of administration, lot number and expiration date not reported) Concomitant therapies included SYNTHROID and amlodipine. Pertinent medical history and drug reactions/allergies were reported as none. On 02-OCT-2014, right after receiving ZOSTAVAX the patient experienced an instant headache which started from the back of her head and up just about 4 inches. She also had fever for four days. The consumer's arm had an "8 inch red burn" going down where the shot went down. It was hot to the touch. The patient was tired with fatigue and experienced some dizziness. The patient reported also she was unable to function properly and slept in bed for about "day and a half". She noticed also bump that was located to her hair that gave her an "itchy and burning" sensation.  There was none lab diagnostics studies performed. There was no treatment given for adverse events. It was also reported that the patient put BENADRYL on the injection site and took naproxen. The outcome of adverse event (except headache) was recovering on the therapy. The patient did not seek medical attention. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Feeling hot, Pruritus, Urticaria
Clinical narrative: 21 cm x 23 cm redness and urticarial redness and warmth and pruritis.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient got shingles, he went to Dr and confirmed shingles.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: Iching, swelling, pain (6/10)
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number os patients of unknown age. On an unknown date the patients were vaccinated with (Oka/Merck) VARIVAX (lot # not reported), 0.5 ml, subcutaneously. It was reported that an unknown number of patients have received doses of (Oka/Merck) VARIVAX that were exposed to temperatures above 5 degrees F but below `9 degrees F for a total time of 9 hours above 5 degrees F. No adverse effect reported. The vaccines were not administered at the time of the 09-OCT-2014 call. Later it was reported that improperly stored vaccines administered was made known on 21-OCT-2014.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date a few years ago the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry date, dose, frequency and route were unspecified. On an unknown date recently the patient developed shingles. The outcome of shingles was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, itching at injection site. 9.5 cm area with 2 cm central area slightly bympy warm to touch. No fever.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Upper thigh local reaction. Redness/swelling.
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a bachelor of science in nursing (BSN) refers to an unspecified number of patients of unknown gender and 1 year of age or less. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that the patients had been vaccinated with LIQUID PEDVAXHIB INJ on unspecified dates 3 times within their first year (dose, route and lot number not provided) and had not received any booster doses of the vaccine after 12 months of age. No adverse symptoms reported. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 72 year old male patient. The patient who received his first dose of RECOMBIVAX HB (route and lot # not provided)on 05-SEP-2014, was scheduled to receive his second dose of RECOMBIVAX HB on 05-OCT-2014, however, the patient represented to the pharmacy today on 15-OCT-2014, to receive the second dose RECOMBIVAX HB. The pharmacy stated that he intended to administer the second dose of RECOMBIVAX HB (route and lot # not provided) when the call was disconnected. He stated that the patient had not reported or demonstrated any adverse effects. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Oedema, Pruritus
Clinical narrative: PCV 13 vaccination to (R) arm pt c/o arm red/itchy, mild edema.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: 7 cm x 6 cm reddened area toward left axilla.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Headache, Nausea, Swelling
Clinical narrative: Patient noticed extreme warmth and redness on the evening of his injection. Swelling started the-next day and continued x 4 days. Also experienced nausea and headache x 1 1/2 days.
Sex: U
Vaccine: DTAPHEPBIP, DTAPIPV
Symptoms: Incorrect storage of drug
Clinical narrative: This case was reported by a other health professional via call center representatives and described the occurrence of incorrect storage of drug in a unk patient who received  KINRIX (batch number KJ924, expiry date 22nd October 2015). Co-suspect products included PEDIARIX (batch number L9L2K, expiry date June 2016) and (batch number 4M76D, expiry date October 2015) and PEDIARIX (batch number 4M78D, expiry date 9th October 2015). On an unknown date, the patient received KINRIX and PEDIARIX. On an unknown date, the dose was un unknown dose. On an unknown date, the patient received PEDIARIX. On an unknown date, an unknown time after receiving KINRIX, PEDIATRIX and PEDIARIX, the patient experienced incorrect storage of drug. ON an unknown date, the outcome of the incorrect storage of drug was unknown. It was unknown if the reporter considered the incorrect storage of drug to be related to KINRIX, PEDIARIX AND PEDIARIX.  Additional information received: Per HCP, KINRIX and PEDIARIX were exposed to -0.5 deg C then subsequently administered to several pediatric patients. HCP is currently accumulating a list of patients that were given the vaccines that were considered unstable due to colder temperature excursion. PEDIARIX lot # L0L2K ex 6/5/16. PEDIARIX lot # 4M76D exp 10/9/15, KINRIX KJ924 exp 10/22/15.
Sex: F
Vaccine: MMR
Symptoms: Incorrect dose administered, Mumps antibody test negative
Clinical narrative: This spontaneous report as received from female medical assistant of unknown age reporting of herself with no pertinent medical history and drug reactions or allergies. The reporter stated that she received two doses of M-M-R II as a child on unspecified dates. She stated that over the last ten years, she had received two additional doses of M-M-R II on unspecified dates. Concomitant medication were not reported. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, route and lot number were not reported). On an unknown date, the reported stated that "recently" she had titers drawn and her titers for mumps were negative. She stated that they were "under 90" (units not reported). No symptoms or disease reported. The reporter did not sought medical attention. The patient did not received a treatment. The outcome of her titers for mumps were negative was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to an unspecified number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date approximately in September 2041, reported as "the past week and a half", the patients were vaccinated with improperly stored ROTATEQ oral, (dose, lot number and expiration date not reported). No adverse effects were reported. Co-suspect and concomitant therapies were not reported. This is one of several reports from the same source. Additional information is not expected, since the reporter did not want to be contacted.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Mother reports redness blistering at area of varicella for 48 hours. No treatment given. Family did not notify provider until today, 5 weeks afterwards.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This spontaneous report as received from a consumer's wife refers to a 77 year old diabetic male patient. At the time of this report, the patient had no known allergies. On 24-JUN-2014 the patient was vaccinated with ZOSTAVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). Concomitant medications included an unspecified medication for diabetes. On an unspecified date in 2014, the patient developed a case of shingles. The reporter described the rash as vesicular, with three long vertical bands going across the patient's hip. The patient had no pain with this outbreak. On 10-OCT-2014, the patient was seen by his physician and was diagnosed with shingles. It was unspecified if treatment was given for the adverse event. Laboratory diagnostics studies performed were unspecified. The outcome of shingles was reported as not recovered/not resolved. The relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 2 inch x 1 inch swelling, redness around injection site.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Local swelling, Pruritus
Clinical narrative: Patients states that last night her arm was swollen, hard as a rock, and itchy, but t oday the swelling went down a bit and her arm is still itchy. She bought some loratidien and ibuprofen for the symptoms. She also applied ice.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a female consumer of unknown age refers to herself. Pertinent medical history was unknown. On an unknown date the patient was vaccinated with ZOSTAVAX (reported as unspecified smallpox vaccine) (dose, route of administration and lot number were unknown). Concomitant medications were not reported. On an unknown date the patient experienced unspecified reaction. The outcome of unspecified reaction was unknown. The causality was unknown. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown gender and age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number, lot/batch number, route and expiration date were not reported). On an unknown date, after receiving ZOSTAVAX, the patient experienced shingles. The outcome of shingles was unknown. The patient sought medical attention by visiting the office (date unspecified). The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to an adult patient of unknown age and gender. The reporter stated that on 25-SEP-2014 the patient was vaccinated with VARIVAX (Merck) (dose, lot number, route of administration and anatomical location were unknown) instead of ZOSTAVAX. Pertinent medical history and concomitant medications were unspecified by reporter. No symptoms reported. The outcome of the events was unknown. No other details were provided. Additional information has been requested.
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 a patient of unknown age and gender. On 25-AUG-2014 the patient was vaccinated with VARIVAX (Merck) (dose, units, route of administration, anatomical location were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Computerised tomogram, Herpes zoster
Clinical narrative: This spontaneous report as received from 74 year old female patient with high blood pressure and none drug reactions or allergies. The patient's medical history included atrial fibrillation. On an unknown date the patient was vaccinated with ZOSTAVAX therapy route reported as: injection (dose, units, route of administration, anatomical location, lot number were not reported). Concomitant therapies included MULTAQ. The reporter stated that she had experienced shingles twice after receiving ZOSTAVAX. The first outbreak was on 02-MAR-2014 and the second outbreak was in October 2014 (exact date not reported). The patient was treated with an unspecified medications and both times she experienced a shingles. On an unknown date CAT (computerized tomography) scan and blood test were performed (results and units not reported). The patient sought medical attention via visiting an unspecified office on an unspecified date. The outcome of events was reported as not recovered. The relatedness between events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient with drug reactions/allergies to codeine. The patient did not  have pertient medical history. On 13-OCT-2014 the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneous (lot#K009198 and expiry date: 27-SEP-2014). There was no concomtiant medication. On 15-OCT-2014 the patient developed swelling and redness at the injection site, which spread to ther "upper arm". The patient was seen by physician and was prescribed  sulfamethoxazole, BACTRIM DS to treat a diagnosis of cellulitis (on 15-OCT-2014). The was no lab diagnostics stuides perforomed. The patient did not recover from cellulitis and swelling and redness at the injection site. Relatedness between the events and ZOSTAVAX was not specified. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: Pt has a red burning rash progressing down her arm from site of injection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: This spontaneous report as received from a 60 year old female patient referring herself. The patient's drug allergies and pertinent medical history was none. On 27-AUG-2014 the patient was vaccinated with ZOSTAVAX (dose/frequency: Unspecified). Concomitant therapies included LOPRESSOR, LIPITOR and LOVAZA. On 08-SEP-2014, the patient developed chicken pox. The patient sought medical attention, the patient reported the event to her physician and the patient was treated with calamine, camphor, CALDRYL lotion. Lab diagnostics performed were none. The outcome chicken pox was reported as recovered on an unknown date in 2014. The causality of the chicken pox was not reported. No product complaint was reported for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist (pharmacy district manager) refers to a patient of unknown age. The patient's medical history was not reported. On an unknown date the patient was inadvertently vaccinated with a second dose of ZOSTAVAX. No symptoms reported. No product complaint was reported for ZOSTAVAX. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: MMR, UNK
Symptoms: Injection site erythema, Injection site inflammation, Injection site urticaria
Clinical narrative: Hive at site within 5 min. Patient stayed in clinic for another 15 min  hive receding on own. Mom refused BENADRYL as she left it was improving on own and stated she would adm at home if needed.
Age: 1.1
Sex: F
Vaccine: MMR, UNK
Symptoms: Injection site urticaria
Clinical narrative: Hive at site within 5 min. Patient stayed in clinic for another 15 min  hive receding on own. Mom refused BENADRYL as she left it was improving on own and stated she would adm at home if needed.
Age: 66.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Infection, Injected limb mobility decreased
Clinical narrative: Arm swelling (causing disfigurement), pain, inability to move arm. Pt says he was hospitalized for several weeks and has been doing physical therapy ever since, TX unknown and Dx unknown to us.
Age: 66.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Deformity, Local swelling, Movement disorder, Pain in extremity
Clinical narrative: Arm swelling (causing disfigurement), pain, inability to move arm. Pt says he was hospitalized for several weeks and has been doing physical therapy ever since, TX unknown and Dx unknown to us.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 15 year old male patient. On 20-AUG-2014 the patient was vaccinated with the first dose of GARDASIL (dose, route, lot # not reported). In 2014, exact date not specified, the patient "passed out" after receiving his first dose of GARDASIL. The outcome of the event of "passed out" was unknown. Relatedness between the event and GARDASIL was not specified. Upon internal review the event of "passed out" was considered as medically significant. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 15 year old male patient. On 20-AUG-2014 the patient was vaccinated with the first dose of GARDASIL (dose, route, lot # not reported). In 2014, exact date not specified, the patient "passed out" after receiving his first dose of GARDASIL. The outcome of the event of "passed out" was unknown. Relatedness between the event and GARDASIL was not specified. Upon internal review the event of "passed out" was considered as medically significant. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Expired drug administered
Clinical narrative: Expired vaccine given 9-4-14 (PNEUMOVAX 23). Revaccinated 10-10-14
Age: 69.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Expired drug administered
Clinical narrative: Expired vaccine given 9-5-14 (PNEUMOVAX 23).
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Back pain, Muscle spasms, Muscular weakness, Pain in extremity
Clinical narrative: High 103 temperature, high blood pressure 220/?, vomiting, diarrhea, severe right thigh muscle spasms along with lower back and groin pain.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Back pain, Blood test, Computerised tomogram, Culture, Diarrhoea
Clinical narrative: High 103 temperature, high blood pressure 220/?, vomiting, diarrhea, severe right thigh muscle spasms along with lower back and groin pain.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Groin pain, Hypertension, Muscle spasms, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: High 103 temperature, high blood pressure 220/?, vomiting, diarrhea, severe right thigh muscle spasms along with lower back and groin pain.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vomiting, X-ray
Clinical narrative: High 103 temperature, high blood pressure 220/?, vomiting, diarrhea, severe right thigh muscle spasms along with lower back and groin pain.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site reaction, Musculoskeletal discomfort, Musculoskeletal pain, Myalgia
Clinical narrative: Patient complained about pain near left shoulder and it hurts to move her shoulder. Denies swelling/other reactions.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain
Clinical narrative: Patient complained about pain near left shoulder and it hurts to move her shoulder. Denies swelling/other reactions.
Age: 18.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MEN, HPV4
Symptoms: Amnesia, Chills, Dizziness, Headache, Lactation disorder
Clinical narrative: This spontaneous report was received from mother refers to her 18 year old female daughter (who is the patient). No medical history reported. On 07-JUL-2014, the patient was vaccinated with GARDASIL (dose and dose number unknown), (lot number not reported). Concomitant medication includes meningitis vaccine (manufacturer unknown) administered to the patient on the same day as GARDASIL. On an unknown date in 2014, the patient experienced a rash after being vaccinated with GARDASIL. The rash was located on her shin and chest. About a week later she noticed additional reactions to the vaccine. The patient also experienced leakage from her breast. When the leakage dried, everything looks kind of yellow. The patient experienced nausea and chills. One minute the patient would feel hot and then she gets cold. The patient has bad headaches and experienced forgetfulness. The mother stated that her daughter had told her that sometimes she just feels horrible. Before the vaccination the patient was a runner and now she felt it's harder to run. She mentioned that the patient's bones felt achy. The patient had undergone unspecified tests on 07-OCT-2014. The patient was administered hydrocortisone cream (manufacturer unknown) as well as hydrocortisone injection (also reported as hydrocortisone shots) as treatment for the events. The outcome of the events were reported as not recovered. The causality for the events was unknown. The patient sought medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MEN, HPV4
Symptoms: Nausea, Pruritus, Rash
Clinical narrative: This spontaneous report was received from mother refers to her 18 year old female daughter (who is the patient). No medical history reported. On 07-JUL-2014, the patient was vaccinated with GARDASIL (dose and dose number unknown), (lot number not reported). Concomitant medication includes meningitis vaccine (manufacturer unknown) administered to the patient on the same day as GARDASIL. On an unknown date in 2014, the patient experienced a rash after being vaccinated with GARDASIL. The rash was located on her shin and chest. About a week later she noticed additional reactions to the vaccine. The patient also experienced leakage from her breast. When the leakage dried, everything looks kind of yellow. The patient experienced nausea and chills. One minute the patient would feel hot and then she gets cold. The patient has bad headaches and experienced forgetfulness. The mother stated that her daughter had told her that sometimes she just feels horrible. Before the vaccination the patient was a runner and now she felt it's harder to run. She mentioned that the patient's bones felt achy. The patient had undergone unspecified tests on 07-OCT-2014. The patient was administered hydrocortisone cream (manufacturer unknown) as well as hydrocortisone injection (also reported as hydrocortisone shots) as treatment for the events. The outcome of the events were reported as not recovered. The causality for the events was unknown. The patient sought medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MEN, HPV4
Symptoms: Activities of daily living impaired, Bone pain, Breast discharge, Chills, Feeling abnormal
Clinical narrative: This spontaneous report was received from mother refers to her 18 year old female daughter (who is the patient). No medical history reported. On 07-JUL-2014, the patient was vaccinated with GARDASIL (dose and dose number unknown), (lot number not reported). Concomitant medication includes meningitis vaccine (manufacturer unknown) administered to the patient on the same day as GARDASIL. On an unknown date in 2014, the patient experienced a rash after being vaccinated with GARDASIL. The rash was located on her shin and chest. About a week later she noticed additional reactions to the vaccine. The patient also experienced leakage from her breast. When the leakage dried, everything looks kind of yellow. The patient experienced nausea and chills. One minute the patient would feel hot and then she gets cold. The patient has bad headaches and experienced forgetfulness. The mother stated that her daughter had told her that sometimes she just feels horrible. Before the vaccination the patient was a runner and now she felt it's harder to run. She mentioned that the patient's bones felt achy. The patient had undergone unspecified tests on 07-OCT-2014. The patient was administered hydrocortisone cream (manufacturer unknown) as well as hydrocortisone injection (also reported as hydrocortisone shots) as treatment for the events. The outcome of the events were reported as not recovered. The causality for the events was unknown. The patient sought medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MEN, HPV4
Symptoms: Feeling of body temperature change, Gait disturbance, Headache, Laboratory test, Memory impairment
Clinical narrative: This spontaneous report was received from mother refers to her 18 year old female daughter (who is the patient). No medical history reported. On 07-JUL-2014, the patient was vaccinated with GARDASIL (dose and dose number unknown), (lot number not reported). Concomitant medication includes meningitis vaccine (manufacturer unknown) administered to the patient on the same day as GARDASIL. On an unknown date in 2014, the patient experienced a rash after being vaccinated with GARDASIL. The rash was located on her shin and chest. About a week later she noticed additional reactions to the vaccine. The patient also experienced leakage from her breast. When the leakage dried, everything looks kind of yellow. The patient experienced nausea and chills. One minute the patient would feel hot and then she gets cold. The patient has bad headaches and experienced forgetfulness. The mother stated that her daughter had told her that sometimes she just feels horrible. Before the vaccination the patient was a runner and now she felt it's harder to run. She mentioned that the patient's bones felt achy. The patient had undergone unspecified tests on 07-OCT-2014. The patient was administered hydrocortisone cream (manufacturer unknown) as well as hydrocortisone injection (also reported as hydrocortisone shots) as treatment for the events. The outcome of the events were reported as not recovered. The causality for the events was unknown. The patient sought medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MEN, HPV4
Symptoms: Nausea, Rash
Clinical narrative: This spontaneous report was received from mother refers to her 18 year old female daughter (who is the patient). No medical history reported. On 07-JUL-2014, the patient was vaccinated with GARDASIL (dose and dose number unknown), (lot number not reported). Concomitant medication includes meningitis vaccine (manufacturer unknown) administered to the patient on the same day as GARDASIL. On an unknown date in 2014, the patient experienced a rash after being vaccinated with GARDASIL. The rash was located on her shin and chest. About a week later she noticed additional reactions to the vaccine. The patient also experienced leakage from her breast. When the leakage dried, everything looks kind of yellow. The patient experienced nausea and chills. One minute the patient would feel hot and then she gets cold. The patient has bad headaches and experienced forgetfulness. The mother stated that her daughter had told her that sometimes she just feels horrible. Before the vaccination the patient was a runner and now she felt it's harder to run. She mentioned that the patient's bones felt achy. The patient had undergone unspecified tests on 07-OCT-2014. The patient was administered hydrocortisone cream (manufacturer unknown) as well as hydrocortisone injection (also reported as hydrocortisone shots) as treatment for the events. The outcome of the events were reported as not recovered. The causality for the events was unknown. The patient sought medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MEN, HPV4
Symptoms: Breast discharge
Clinical narrative: This spontaneous report was received from mother refers to her 18 year old female daughter (who is the patient). No medical history reported. On 07-JUL-2014, the patient was vaccinated with GARDASIL (dose and dose number unknown), (lot number not reported). Concomitant medication includes meningitis vaccine (manufacturer unknown) administered to the patient on the same day as GARDASIL. On an unknown date in 2014, the patient experienced a rash after being vaccinated with GARDASIL. The rash was located on her shin and chest. About a week later she noticed additional reactions to the vaccine. The patient also experienced leakage from her breast. When the leakage dried, everything looks kind of yellow. The patient experienced nausea and chills. One minute the patient would feel hot and then she gets cold. The patient has bad headaches and experienced forgetfulness. The mother stated that her daughter had told her that sometimes she just feels horrible. Before the vaccination the patient was a runner and now she felt it's harder to run. She mentioned that the patient's bones felt achy. The patient had undergone unspecified tests on 07-OCT-2014. The patient was administered hydrocortisone cream (manufacturer unknown) as well as hydrocortisone injection (also reported as hydrocortisone shots) as treatment for the events. The outcome of the events were reported as not recovered. The causality for the events was unknown. The patient sought medical attention. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Bacterial infection, Cellulitis, Chest discomfort, Erythema, Local swelling
Clinical narrative: Called pt with no response.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Pain, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Called pt with no response.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Unevaluable event
Clinical narrative: Called pt with no response.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Called pt with no response.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: CSF lymphocyte count increased, CSF protein increased, CSF white blood cell count increased, Meningitis aseptic
Clinical narrative: On October 21, 2014 the pharmacy was called and informed by hospital that this patient was treated at their facility for aseptic meningitis. The infection prevention specialist inform the pharmacy that the treating physician noted in the chart that the cause of the aseptic meningitis was the flu shot she received at pharmacy.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Meningitis aseptic
Clinical narrative: On October 21, 2014 the pharmacy was called and informed by hospital that this patient was treated at their facility for aseptic meningitis. The infection prevention specialist inform the pharmacy that the treating physician noted in the chart that the cause of the aseptic meningitis was the flu shot she received at pharmacy.
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Pyrexia
Clinical narrative: Chills followed by low grade fever. Anti-inflammatories taken.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: I noticed my daughter was scratching her arm near the bandaid covering her injection site.  Upon closer inspection I realized that my daughter's arm was red nearly from shoulder to elbow, with the area closest to the injection point being very hot, hard, and swollen.
Age: 4.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives that come and go all over body. Started in the evening just a few hours after Flumist. Itching that comes and goes with hives. Doctor prescribed Zantac, steroid, and told to give Benadryl or Zyrtec. Hives are still occurring as of 10/23/1014.
Age: 25.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Dehydration, Full blood count, Headache, Injection site erythema, Injection site reaction
Clinical narrative: Severe swelling and pain in arm, high fever 103+, immediate dehydration, leg and body cramping, severe body pain, large red welt at injection side, severe headache, blurry vision.
Age: 25.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Local swelling, Muscle spasms, Pain, Pain in extremity, Pyrexia
Clinical narrative: Severe swelling and pain in arm, high fever 103+, immediate dehydration, leg and body cramping, severe body pain, large red welt at injection side, severe headache, blurry vision.
Age: 25.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Urticaria, Vision blurred
Clinical narrative: Severe swelling and pain in arm, high fever 103+, immediate dehydration, leg and body cramping, severe body pain, large red welt at injection side, severe headache, blurry vision.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram, Death, Dizziness, Fall
Clinical narrative: Patient told me that she had not felt well since she got the high dose flu shot last week.  She was light headed and experienced syncope.  As result of syncope she fell and hit the back of her head and fractured her left hip.  Hip surgery ensued and was successfully performed.  Upon release from hospital she was moved to a rehabilitation facility where she died the next morning.  Patient attributed the syncope to the administration of the flu shot.