chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Significant pain, redness, swelling at injection site; also experiences headache.
Age: 1.03
Sex: M
Vaccine: MEN, MMR
Symptoms: Balance disorder, Convulsion, Decreased appetite, Erythema, Eye pruritus
Clinical narrative: Seizure at 9:15pm on the same day of vaccine and the next day also 9:15pm having seizure, both of seizures were happened without fever. He lost appetite for few days, loss of balance, irritable, drowsy, itch eyes, redness on neck and chin.
Age: 1.03
Sex: M
Vaccine: MEN, MMR
Symptoms: Irritability, Somnolence
Clinical narrative: Seizure at 9:15pm on the same day of vaccine and the next day also 9:15pm having seizure, both of seizures were happened without fever. He lost appetite for few days, loss of balance, irritable, drowsy, itch eyes, redness on neck and chin.
Age: 42.0
Sex: M
Vaccine: YF
Symptoms: Blood pressure increased, Chest discomfort, Dizziness, Dyspnoea, Hyperhidrosis
Clinical narrative: Shortly after receiving yellow fever vaccine, patient complained of pruritis at injection site. Site was examined, gauze applied, patient reported pruritis stopped. Shortly thereafter, patient complained of sweatiness and lightheadedness, followed by report of constriction in chest causing some difficulty breathing, followed by tingling sensations moving around upper back/neck and left arm. BP elevated. EMS activated to bring patient to ER.
Age: 42.0
Sex: M
Vaccine: YF
Symptoms: Injection site pruritus, Paraesthesia
Clinical narrative: Shortly after receiving yellow fever vaccine, patient complained of pruritis at injection site. Site was examined, gauze applied, patient reported pruritis stopped. Shortly thereafter, patient complained of sweatiness and lightheadedness, followed by report of constriction in chest causing some difficulty breathing, followed by tingling sensations moving around upper back/neck and left arm. BP elevated. EMS activated to bring patient to ER.
Age: 5.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Child came into Health Center with note from mother saying that arm was hot. It is 11cm x 11cm hot and erythematous.
Age: 51.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Ear pruritus, Erythema, Eye pruritus, Feeling hot, Headache
Clinical narrative: Headache; raised rash - red 2" x 3+" - itching, hot; fever off and on since before sunup, aches. The arm which got the shingles vaccine has the large raised rash. Later developed pruritus in ears, eyes, throat.
Age: 51.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pruritus, Pyrexia, Rash, Throat irritation
Clinical narrative: Headache; raised rash - red 2" x 3+" - itching, hot; fever off and on since before sunup, aches. The arm which got the shingles vaccine has the large raised rash. Later developed pruritus in ears, eyes, throat.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 15 year old female patient. The patient had a history of menstrual at regular intervals, but she had only "spotted" in "June 2014" without experiencing her regular menstrual period. On 29-AUG-2014 the patient was vaccinated with first dose of GARDASIL injection, 120Y, lot # K004204, Expiration Date 12-JAN-2017 (dose, frequency and route unknown). The patient discovered she was pregnant after she received her first dose of GARDASIL. Prior to receiving the dose of GARDASIL, the patient had been unable to void in the clinic, so routine pregnancy screening was not able to completed prior to administration of the dose of GARDASIL. The patient's mother preferred for the patient to receive GARDASIL, so the dose was administered without pregnancy screening. The patient had a positive "home" urine pregnancy test on an unspecified date. The patient sought medical attention via consulting her pediatrician, who detected fetal heart tones by doppler (result not provided). The patient was estimated to be approximately 4 months pregnant, she was scheduled for an Ultrasound to determine the gestational age. The patient was not demonstrating any adverse effects, and she was offering any complaints. Outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Product packaging issue
Clinical narrative: This spontaneous report was received from a pharmacist. The pharmacist was reporting the packaging of the MMR II and the sterile diluent (manufacturer unknown) were similar and were the same color, which could potentially cause confusion between the products. The pharmacist stated no misadministration had occurred. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Asthenia, Erythema, Feeling hot, Pain, Pruritus
Clinical narrative: Weakness - redness - heat - itch - soreness - light tightness in throat.
Age: 82.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Throat tightness
Clinical narrative: Weakness - redness - heat - itch - soreness - light tightness in throat.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient received ZOSTAVAX vaccination and 2 days later came in with redness and swelling at the injection site.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Lump/swelling/redness/warm at injection site/mild headache (asted 2-3 days). Still have lump.
Age: 14.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Induration, Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling, at injection site 5AM Induration, possibly infected - placed on Keflex.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever, body aches, headaches approximately 24 hrs after administration of vaccine.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Redness and swelling 1st with pruritus. Onset mild pain day 3 post administration no fever or chills; no wheezing or dysphagia.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt developed an erythematous, slightly raised, warm area, 7x11 cm, at injection site. Treated with BENADRYL PO and ice.
Age: 78.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Local swelling
Clinical narrative: Given in upper left arm. Swelling and redness in mid upper arm. Still red, but much better. Took BENADRYL and applied ice pack per doctor's instructions.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Anti-islet cell antibody positive, Glucose urine, Pollakiuria, Thirst, Type 1 diabetes mellitus
Clinical narrative: Sudden onset of blurry vision, frequent thirst and urination, waited 5 days to call the doctor he then had me come in and ran glucose urine test, diagnosed with type 1 diabetes due to the positive results of auto antibodies.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Vision blurred
Clinical narrative: Sudden onset of blurry vision, frequent thirst and urination, waited 5 days to call the doctor he then had me come in and ran glucose urine test, diagnosed with type 1 diabetes due to the positive results of auto antibodies.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker refers to unknown number of patients of unknown demographics. No relevant medical history of the patients were reported. On unknown dates the patients were vaccinated with COMVAX (strength, dose, route of administration, lot number and expiry dates were not reported). No concomitant medications were reported. It was reported that unknown number of patients received improperly stored COMVAX on unknown dates. All vaccines were supported with in-house stability data. No adverse symptoms were reported. There was no product quality complaint involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker refers to unknown number of patients of unknown demographics. No relevant medical history of the patients were reported. On unknown dates the patients were vaccinated with VAQTA 25/0.5 (units unspecified) (dose, route of administration, lot number and expiry dates were not reported). No concomitant medications were reported. It was reported that unknown number of patients received improperly stored VAQTA on unknown dates. All vaccines were supported with in-house stability data. No adverse symptoms were reported. There was no product quality complaint involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a approximately 10 patients of unknown age and gender. Since 08-AUG-2014 the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (dose, route of administration and indication were not reported). The temperature excursion for (Oka/Merck) VARIVAX was found to be supported excursion with in-house stability data. No adverse effect reported. 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 nurse refers to 8 patients of unknown age and gender. The nurse states that 8 patients were vaccinated with improperly stored (oka-merck) PROQUAD (lot#, expiry date, dose and route not reported) from 12-JUL-2014 till "today" (05-SEP-2014). No adverse effects reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker refers to unknown number of patients of unknown demographics. No relevant medical history of the patients were reported. On unknown dates the patients were vaccinated with GARDASIL (strength, dose, route of administration, lot number and expiry dates were not reported). No concomitant medications were reported. It was reported that unknown number of patients received improperly stored GARDASIL on unknown dates. All vaccines were supported with in-house stability data. No adverse symptoms were reported. There was no product quality complaint involved. The outcome was unknown. 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 nurse refers to two patients of unknown age. ON 28-AUG-2014 the patients were vaccinated expired doses of M-M-R II (HSA, lot # H014647, expiration date 03-AUG-2014) (dose, route unspecified). No symptoms reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker refers to unknown number of patients of unknown demographics. No relevant medical history of the patients were reported. On unknown dates the patients were vaccinated with ROTATEQ, oral (dose, route of administration, lot number and expiry dates were not reported). No concomitant medications were reported. It was reported that unknown number of patients received improperly stored ROTATEQ on unknown dates. All vaccines were supported with in-house stability data. No adverse symptoms were reported. There was no product quality complaint involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Eye movement disorder, Musculoskeletal stiffness
Clinical narrative: See attached clinic note. Cried inconsolably, body stiffened, eyes rolled back: had 6 of these episodes - Did go to ER - Was cleared.
Age: 51.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Nausea
Clinical narrative: 9/3/14 Took 1st tab - no adverse effect. 9/5/14 Took 2nd tab - no adverse effect. 9/7/14 - hives on forearms only- BENADRYL/Cortisone topical. Took 3rd dose. 9/9/14 - Took 4th dose - rash spreading on arms. 9/10/14 - chills, diarrhea, nausea, headache - rash turns to hives. 9/11/14 - headache, dizziness, achy joints, diarrhea, continued hives - supportive care, Ibuprofen, BRAT diet. Offered Rx for nausea - declined. Using ginger tabs.
Age: 51.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Rash, Urticaria
Clinical narrative: 9/3/14 Took 1st tab - no adverse effect. 9/5/14 Took 2nd tab - no adverse effect. 9/7/14 - hives on forearms only- BENADRYL/Cortisone topical. Took 3rd dose. 9/9/14 - Took 4th dose - rash spreading on arms. 9/10/14 - chills, diarrhea, nausea, headache - rash turns to hives. 9/11/14 - headache, dizziness, achy joints, diarrhea, continued hives - supportive care, Ibuprofen, BRAT diet. Offered Rx for nausea - declined. Using ginger tabs.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker refers to unknown number of patients of unknown demographics. No relevant medical history of the patients were reported. On unknown dates the patients were vaccinated with RECOMBIVAX HB (strength, dose, route of administration, lot number and expiry dates were not reported). No concomitant medications were reported. It was reported that unknown number of patients received improperly stored RECOMIBVAX HB on unknown dates. All vaccines were supported with in-house stability data. No adverse symptoms were reported. There was no product quality complaint involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site pain, Wrong drug administered
Clinical narrative: Zostavax accidentally administered instead of varicella.  Patient's mother indicated that patient experienced soreness at administration site that evening.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Feeling hot, Headache, Myalgia
Clinical narrative: Fever, arthralgias, myalgias, headache, rash, redness, swelling, heat, tenderness.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Rash, Swelling, Tenderness
Clinical narrative: Fever, arthralgias, myalgias, headache, rash, redness, swelling, heat, tenderness.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Rash pruritic
Clinical narrative: Itchy raised bumps noticed on face starting at chin and nasolabial fold. Continued over next 24 hours to include cheeks and jawline -- more on left side than right. OTC hydrocortisone cream applied for itchiness.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Syncope
Clinical narrative: After being given the Hep A vaccine, the client was seated for approximately 10 minutes. He got up and walked over to where the nurse was administering vaccines to his older brother and suddenly fainted into the nurse's lap. We layed him down and he immediately woke up. His BP 100/80 Pulse 80/regular and respirations 18 nonlabored. His color was normal, skin cool and dry. He remained in our clinic for 45 minutes. He said he was still a little dizzy so we advised the mother to keep him home from school for today.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Injection site erythema
Clinical narrative: Patient had an erythematous area on the right deltoid where MCV 4 was placed.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TD, VARCEL
Symptoms: Blood test normal, Computerised tomogram normal, Convulsion, Electrocardiogram normal, Electroencephalogram normal
Clinical narrative: Pt had a seizure on 8/5/14 and was taken to ER via ambulance, treated and released. She became unresponsive, tonic/clonic movements while talking w/friends.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TD, VARCEL
Symptoms: Nuclear magnetic resonance imaging normal, Tonic clonic movements, Unresponsive to stimuli
Clinical narrative: Pt had a seizure on 8/5/14 and was taken to ER via ambulance, treated and released. She became unresponsive, tonic/clonic movements while talking w/friends.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site swelling, Local reaction
Clinical narrative: Local reaction. Swelling reaction to inj. site.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Patient came in on 9/11 complaining of fever and pain on iste of ZOSTAVAX injection administered on 9/9/14. Stated has has been using ALEVE for fever but is uncured. Contacted PCP and referred patient.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Patient received PNEUMOVAX vaccine during office visit on 7/17/2014 and then developed pain and swelling around the injection site. On 7/20/2014, patient called her physician complaining of persistent fever, redness and swelling around the injection site. The physician advised the patient go to ER. Patient was admitted to the hospital for cellulitis of upper arm, SIRS and abnormal liver function tests (patient does not have history of alcohol abuse or hepatitis). The patient was treated with IV antibiotics (vancomycin, levofloxacin) and IV fluids.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Liver function test abnormal, Pyrexia, Systemic inflammatory response syndrome, White blood cell count increased
Clinical narrative: Patient received PNEUMOVAX vaccine during office visit on 7/17/2014 and then developed pain and swelling around the injection site. On 7/20/2014, patient called her physician complaining of persistent fever, redness and swelling around the injection site. The physician advised the patient go to ER. Patient was admitted to the hospital for cellulitis of upper arm, SIRS and abnormal liver function tests (patient does not have history of alcohol abuse or hepatitis). The patient was treated with IV antibiotics (vancomycin, levofloxacin) and IV fluids.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Abscess rupture, Injection site abscess, Injection site haemorrhage, Injection site hypersensitivity, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site abscess in a 24-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 22 August 2014, the subject received a dose of BOOSTRIX (route unknown, right arm). On 24 August 2014, 2 days after vaccination with BOOSTRIX, the subject experienced bump at injection site which growed and turned into injection site abscess. This was considered as an allergic reaction. This case was assessed as medically serious by GSK. The subject was treated with Antibiotic. On 5 September 2014, the abscess ruptured and it bleed. At the time of reporting, allergic reaction was unresolved. The healthcare professional considered the allergic reaction was probably related to vaccination with BOOSTRIX.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: 90 x 80cm of redness around injection site. Warm to touch. Patient states painful and stiff.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash on neck/chest area.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, MMRV
Symptoms: Erythema, Local swelling, Pain, Pruritus, Skin warm
Clinical narrative: (R) arm muscle area appear red, swollen. C/O soreness, itchiness, hot to touch, afebrile, ok appetite, or drinking, no fevers, no S.O.B.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Tremor
Clinical narrative: Teeth chattering and shaking all over 4 hours later.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Chills, Injection site pain, Pain
Clinical narrative: Pt. received vaccinations 9-5-14 approx 1 PM. Severe pain onset evening, chills, temp 101 degrees. Severe pain in LUA at injection sites. Pain relieved, full shoulder arm motion observed 9-8-14. Pt seen by me 9-8-14 about 9:30 A.M. Recommended no further vaccines until allergy testing completed.
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Urticaria.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Diarrhoea, Mobility decreased
Clinical narrative: Patient called pharmacy 9-1-14. States she was unable to lift arm for 2 days after receiving the vaccine. Had diarrhea and felt weak for two days.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass, Pain in extremity
Clinical narrative: Arms hurt. Said there is a lump at injection site. 9/5/14 pea size lump still there. Is lessening.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: Patient broke out in a rash after receiving the flu and pneumonia vaccines on 9/5/14. Pt reported rash to pharmacy and MD today. Rash is worsening. Patient was told to take BENADRYL and MD prescribed hydroxyzine and MEDROL.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives on bend of arms, left wrist, right forearm, under chin on right side of neck and right ear.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Pt experienced 2nd seizure 4 days after 2nd GARDASIL vaccine. Pt also taken to ER. Awaiting ER report.
Age: 12.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: Diarrhoea, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Patient returned today, 9/12/14 for recheck of arm after vaccines given 9/10/14. On 9/11, (R) upper arm became red, swollen, warm, and very tender. Low grade fever and diarrhea. Mild improvement today. On exam, low grade temp. RUE from mid to shoulder very erythematous, tender, skin tight with 2 small blisters. Area marked, tx with cephalexin 500mg BID, BENADRYL PRN, MOTRIN PRN.
Age: 12.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: Injection site vesicles, Injection site warmth, Pyrexia, Skin tightness
Clinical narrative: Patient returned today, 9/12/14 for recheck of arm after vaccines given 9/10/14. On 9/11, (R) upper arm became red, swollen, warm, and very tender. Low grade fever and diarrhea. Mild improvement today. On exam, low grade temp. RUE from mid to shoulder very erythematous, tender, skin tight with 2 small blisters. Area marked, tx with cephalexin 500mg BID, BENADRYL PRN, MOTRIN PRN.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Rash macular, Tenderness
Clinical narrative: Mild muscle pain, tenderness. Red blotchy area near deltoid and to underside of arm.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: ARM THAT VACCINE WAS GIVEN IN IS NUMB.
Age: 26.0
Sex: M
Vaccine: HEPA, MEN, TYP, YF
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Vaccines administered 9/8, onset 9/9 malaise, body ache, fever to 100.2.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Blood pressure increased, Dizziness, Heart rate increased, Hyperhidrosis, Paraesthesia
Clinical narrative: LIGHT HEADEDNESS, DIZZY, SWEATING, INCREASED BLOOD PRESSURE, INCREASED HEART RATE, TINGLING IN ARM THAT VAC. WAS GIVEN.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash generalised, Rash macular, Rash pruritic
Clinical narrative: Red, splotchy rash that itched intensely and spread all over body.  Reaction began about an hour after the flu shot was given.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Induration, Mass, Swelling
Clinical narrative: Swelling; redness; hard lump under skin.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling
Clinical narrative: Patient experienced redness and swelling in the arm vaccine was administered.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Lethargy, Local swelling, Somnolence
Clinical narrative: Localized swelling and itchiness at site. Drowsiness and lethargy.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Headache, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Injection sight swelling, redness, itching, burning, hot to touch. Bruising. Swelling area 3x4 inch on upper arm. Head ache and joint aches.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection sight swelling, redness, itching, burning, hot to touch. Bruising. Swelling area 3x4 inch on upper arm. Head ache and joint aches.
Age: 68.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site discomfort, Injection site swelling
Clinical narrative: Swelling with moderate discomfort involving upper left arm and shoulder region.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient noted discomfort, redness and warmth of his left arm (site of injection) about an hour after vaccine administration.  When awoke this am on 9/12/2014, complained of further discomfort and father noted arm to be swollen, warm and red extending near area from deltoid to forearm.  No treatment given at home prior to evaluation.  Patient seen on 9/12/14 at clinic visit for evaluation.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: Swelling at the site, then swelling progressed from shoulder to elbow, fever and pain.
Age: 1.71
Sex: M
Vaccine: DTAPHEPBIP, MMR
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, and swelling around the site of injection that developed into cellulitis.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Lip swelling, Swelling face
Clinical narrative: Swelling on both sides of jaw which progressed into the lip on left side of face.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising
Clinical narrative: Patient developed a bruise the took over her upper arm, starting at the site of injection.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Woke up with hives on entire body.
Age: 0.54
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Erythema, Eye swelling, Injection site erythema, Local swelling
Clinical narrative: Started with leg swelling within 2 hours, much worse next am, right eye swollen next am as well. Left leg erythematous area 4cm x 2.25cm, right leg erythematous area 4.5cm x 7cm. Left thigh 25.5cm, right thigh 26.5cm, left foot diameter 13.5cm, right foot diameter 13cm.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: On my way home I immediately began to feel strong knife pain on site and in shoulder. I came home and took 2 Ibuprofen which took the edge off.  It left me w/ no strength in my left arm and an ache that wouldn't stop. I waited to see if it would get better.  It is now 3 weeks. Some days it is only weak but other days I feel the pain in the immediate spot and pain in the upper arm w/ no strength. I am not able to lift my arm w/o help.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Blood pressure increased, Dizziness, Dyspnoea, Neck pain
Clinical narrative: PATIENT EXPERIENCE SYNCOPE.  SPECIFIC SYMPTOMS INCLUDE PAIN FROM NECK TO BACK, LIGHT HEADEDNESS, SHORTNESS OF BREATH, AND SPIKE OF BLOOD PRESSURE.  ACUTE REACTION SUBSIDED AND PATIENT WAS GIVEN DIPHENHYDRAMINE 25 MG WITH WATER.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Syncope, Vaccination complication
Clinical narrative: PATIENT EXPERIENCE SYNCOPE.  SPECIFIC SYMPTOMS INCLUDE PAIN FROM NECK TO BACK, LIGHT HEADEDNESS, SHORTNESS OF BREATH, AND SPIKE OF BLOOD PRESSURE.  ACUTE REACTION SUBSIDED AND PATIENT WAS GIVEN DIPHENHYDRAMINE 25 MG WITH WATER.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Blood test abnormal, Chills, Infection, Injection site erythema
Clinical narrative: Patient experienced chills the evening of vaccination. Felt weak. He was recovering from knee surgery 2 1/2 wks before. He mentioned the wound also felt more pain. Advised going to ER. Test showed he had infection in the blood, WBC increased also. Fever spiked to 103 2 days later. Red, swelling on injection site, also warmth to the touch. Pt. was admitted to hospital that nite.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth, Nuclear magnetic resonance imaging normal, Procedural pain, Pyrexia
Clinical narrative: Patient experienced chills the evening of vaccination. Felt weak. He was recovering from knee surgery 2 1/2 wks before. He mentioned the wound also felt more pain. Advised going to ER. Test showed he had infection in the blood, WBC increased also. Fever spiked to 103 2 days later. Red, swelling on injection site, also warmth to the touch. Pt. was admitted to hospital that nite.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: White blood cell count increased, Wound complication
Clinical narrative: Patient experienced chills the evening of vaccination. Felt weak. He was recovering from knee surgery 2 1/2 wks before. He mentioned the wound also felt more pain. Advised going to ER. Test showed he had infection in the blood, WBC increased also. Fever spiked to 103 2 days later. Red, swelling on injection site, also warmth to the touch. Pt. was admitted to hospital that nite.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site induration, Injection site pain, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: 2 days after administration patient developed worsening erythematous indurated painful rash approx 25 cm area extending down from injection site. Warm to touch. No systemic symptoms of fever. Placed on BACTRIM orally.
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Panic attack, Tremor
Clinical narrative: She got 2 vaccines. Left pharmacy and came back 1/2 hour later - was shaking. Ambulance came and said she had panic attack. Her son came and took her home.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Aphonia, Chills, Fatigue, Pyrexia
Clinical narrative: Night after receiving vaccinations patient came down with a 100 degree F fever. She had fever and chills the next day and fatigue the following day. The third day out she lost her voice for one day.
Age: 25.0
Sex: F
Vaccine: FLUN4
Symptoms: Dizziness
Clinical narrative: Dizziness.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. ON an unknown date, the patients were vaccinated with ROTATEQ Route, lot # and expiration date were not provided). On an unknown date, the patients were administered ROTATEQ that had been improperly stored in the same temperature excursion as the M-M-R II previously reported. No adverse effects were reported. IT was unknown if the patient's sought medical attention. At the time of the report, the patient's status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On 02-SEP-2014, the patient was vaccinated with PNEUMOVAX23 lot # J009827, expiration date 10-AUG-2014 (dose, strength, frequency were not reported). Secondary and concomitant therapies were not reported. Pharmacist stated that patient was vaccinated, at an other store location, with expired PNEUMOVAX23 on 02-SEP-2014 (reported as yesterday). No adverse effects reported. Additional information is not expected because the pharmacist did not want to be contacted.
Age: 26.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient presented to health center for different reason and in conversation related that she had an episode of fever with vomiting at 2AM the following morning post immunization. No further reactions noted.
Age: 39.0
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: Very red, large area, hot to touch. Whole arm looks red. Couple days later it happened.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: After receiving Tdap and Tb skin test she said she broke out in a rash around neck and to/around eye (R) eye.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Pt received flu vaccine and then reported feeling dizzy at check out in front store to store associate. Pt was given a seat to sit in, was offered a call to 911 but denied it, had a cup of water and then left with husband. RPh called pt at home and she stated she was feeling fine.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Extreme redness and inflammation originating at the site of injection. Area is hot to touch and slightly painful.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. 09-SEP-2014 the patient was vaccinated with an improperly stored dose of ZOSTAVAX 0.65 ml, subcutaneous (lot # was not reported). It was reported that the vaccine was exposed to 40F for one hour. No adverse effects were reported. Additional information has been requested.
Age: 1.43
Sex: F
Vaccine: HIBV, MMR
Symptoms: Rash macular, Rash papular, Rash pruritic
Clinical narrative: Vaccine administered in (L) thigh 9/11/14. Mom reports erythematous, flat rash 5 hours later. This morning woke up with papular rash over right shoulder, scapula, flank. Scattered papules on abdomen and flank. Pruritic. No fever, irritability or change in appetite. No N/V/D.
Age: 10.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Type I hypersensitivity
Clinical narrative: Type 1 Histamine mediated reaction. No systemic reaction.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Local swelling
Clinical narrative: HPV vaccine given at 5:30 pm 9/10/14 - states she awoke 9/11/14 feeling that both hands were "swollen and on fire". Took BENADRYL 50 mg PO.
Age: 22.0
Sex: U
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Injection site pain, Nausea
Clinical narrative: Pain at site and nausea.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Local reaction
Clinical narrative: Localized reaction: 5cm x 6cm no edema, erythema in circumscribed area.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site irritation, Injection site swelling, Injection site warmth
Clinical narrative: Patient complained of injection site irritation, swelling, and warm feeling.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Body rash and itching reported the day after vaccine administered. Reported on 9/12/14.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Rash, Vomiting
Clinical narrative: Rash appeared on stomach and complaining of nausea and vomiting. Told patient to go to ER.
Age: 4.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Vaccine given 9/10/14 - Dad called stating left leg was red/swollen with hives on both upper and lower extremities. Dad gave BENADRYL and this took away symptoms.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number patients of unknown age and gender. Since 02-SEP-2014, the patients were vaccinated with M-M-R II (HSA), subcutaneous, lot #K002036, expiration date 10-FEB-2016. Since 02-SEP-2014, the patients had been administered M-M-R II (HSA) which was improperly stored. This temperature excursion was not supported. No adverse effects were reported. It was unknown if the patient's sought medical attention. At the time of the report, the patient's status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: C/O swelling, pain, redness and warm to (L) deltoid and patient was given BENADRYL and advised to use cool compress and take Ibuprofen.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with VAQTA (route, lot # and expiration date were not provided). On an unknown date, the patients were administered VAQTA that had been improperly stored in the same temperature excursion as the M-M-R II previously reported. No adverse effects were reported. IT was unknown if the patient's sought medical attention. At the time of the report, the patients status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Nodule, Pain, Swelling
Clinical narrative: Red, swollen, pain and knot. Tennis ball size red circle.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Injection site swelling. Patient was given BACTRIM 400-80mg one twice daily for 3 days on 9-9-14.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Expired drug administered
Clinical narrative: On 9/11/14 patient was given a MENACTRA vaccine. After she received the dose, it was noted to have expired on 9/4/14.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt had pain in arm and difficulty moving arm.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site rash, Mobility decreased, Pain in extremity
Clinical narrative: Pt had pain in arm and difficulty moving arm.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Local swelling, Mobility decreased, Pain in extremity
Clinical narrative: Pt had pain in arm, swelling, and difficulty moving arm.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt had pain in arm, swelling, and difficulty moving arm.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Movement disorder, Muscle spasms
Clinical narrative: Patient's mom called saying she is having muscle spasms and having difficulty walking/moving.
Age: 24.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site rash, Injection site warmth, Pain in extremity
Clinical narrative: Spreading rash starting about 1 to 2 inches below injection site. Pt states rash is warm and arm hurts and rash is spreading down arm toward elbow.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 09-SEP-2014 the patient was vaccinated with RECOMBIVAX HB thimerosal status unknown (intramuscular; dosage, dose number, lot number unknown; Expiry reported as 08-SEP-2014). It was reported that on 09-SEP-2014 a dose of RECOMBIVAX HB which expired on 08-SEP-2014 was inadvertently administered to a patient. This was supported. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 0 month old male patient. On 14-JUN-2014 at 14:45 PM (same date tha thte patient was born) the patient was vaccinated improperly stored dose of RECOMBIVAX HB intramuscular, dose 1, Lot # J012520, Expiration date: 30-JAN-2015 (dose was not reported). No adverse symptoms reported.  It ws reported that the vaccine storage temperature dropped to 0-1 degrees (units not reported) for 18 different episodes according to minimum/maximum. All recorded temperatures were within 2-8 degrees (units were not reported). This is one of several reports received from the same reporter. Additional information is not expected due to all follow ups requested to complete the case were received.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with RECOMBIVAX HB (route, lot # and expiration date were not provided). On an unknown date, the patients were administered RECOMBIVAX HB that had been improperly stored in the same temperature excursion as the M-M-R II previously reported. No adverse effects were reported. It was unknown if the patient's sought medical attention. At the time of the report, the patients status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient of unknown age. No pertinent medical history and drug allergies reported. On an unknown date in February 2014 the patient was vaccinated with a dose of ZOSTAVAX, 19400 PFU subcutaneous (dose unspecified). No other concomitant therapies reported. On an unknown date in 2014 the patient developed redness, swelling and bleeding at injection site. The patient sought medical attention. The pharmacist reported that the patient's arm continued to bleed at the injection site until an unspecified date in June 2014, until he was seen at an unspecified dermatologist, where the area was cauterized. The pharmacist inquired if this has ever happened to any patient before and had inquired why this has happened. Lab diagnostic test were unspecified. The pharmacist reported that the patient came back recently and reported that injection site had stopped bleeding after cauterization. The outcome of the events redness, swelling at the injection site was reported as recovering and the outcome of bleeding at injection site was reported as recovered in 2014. Causality was not reported. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 0 month old male patient. On 14-JUN-2014 at 14:18 PM (same date that the patient was born) the patient was vaccinated improperly stored does of RECOMBIVAX HB intramuscular, dose 1, Lot # J012520, Expiration date: 30-JAN-2016 (dose was not reported). No adverse symptoms reported. It was reported that the vaccine storage temperature dropped to 0-1 degree (units not reported) for 18 different episodes according to minimum/maximum. All recorded temperatures were within 2-8 degrees (units were not reported). This is one of several reports received from the same reporter. Additional information is not expected due to all follow ups requested to complete the case were received.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash generalised, Retching
Clinical narrative: Body rash, itching and dry heaves the day following vaccine administration (9/4/14). Reported here by pt on (9/12/14).
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash generalised, Rash vesicular
Clinical narrative: Red spots (looks like chicken pox) started popping up all over and continued to pop up every hour. He has spots all over his body on 9/12/14 except for his face and legs. Mostly the spots cover his trunk and arms, but some spots are on his neck and buttocks and groin area. They don't itch are unaccompanied with a fever. After a spot has been there for a while it is surrounded by a spreading red circle (and no it does not look like ringworm).
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Nausea, Pain
Clinical narrative: Body aches, dizziness, nausea, fatigue.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Dizziness, Loss of consciousness, Respiratory arrest
Clinical narrative: PT became light headed, lost consciousness, stopped breathing briefly and began to seize for less than 10 seconds.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Agitation, Chills, Pyrexia, Sensory disturbance
Clinical narrative: Began to feel slightly agitated, similar to an Epinepherine response.  This lasted about 20 minutes and then was replaced with a slightly dull sensation over my body.  That disappeared after about 45 minutes.  At approximately 5 PM, I began to get a fever and started shivering.  Before I went to bed, I took three aspirin.  Temperature that night went to about 101 F.  Temperature broke during the night, but returned the next day.  At about 1:00 PM, it was about 99 F and lasted for 90 minutes.  By 36 hours after the vaccination, I had returned to normal.  I have never had a reaction to the regular vaccine and this is the first time I have received the High Dose.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient had shot around 2:00 pm then presented with a rash on arm around 6:00 pm the same day.
Age: 62.0
Sex: F
Vaccine: FLUC3
Symptoms: Rash morbilliform
Clinical narrative: Patient had the vaccine on 09/09/14 and stated on 09/12/14 that she developed a rash that looks like measles, and German measles that she had in the past. And she also stated that it was somewhat fading (???) as we were speaking.
Age: 1.34
Sex: F
Vaccine: MMR
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Erythemic area of induration approx. 4 inches across about 6 inches tangential from injection site with initial redness, pain, swelling. Eythema has persisted over 4 days with no decrease in size but has lightened in color. Initial somnolence, lethargy, overall feeling of weakness which has dissipated. Pt will take oral diphenhydramine and outline the area. Will seek medical treatment if area doesn't improve over 24 hours. Will discuss with PCP before receiving next dose of PPSV23.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Lethargy, Somnolence
Clinical narrative: Erythemic area of induration approx. 4 inches across about 6 inches tangential from injection site with initial redness, pain, swelling. Eythema has persisted over 4 days with no decrease in size but has lightened in color. Initial somnolence, lethargy, overall feeling of weakness which has dissipated. Pt will take oral diphenhydramine and outline the area. Will seek medical treatment if area doesn't improve over 24 hours. Will discuss with PCP before receiving next dose of PPSV23.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Area of injection became indurated with erythema.  The area is about 3 inches in diameter.  The are is warm to touch.  There is no bruising or hematoma present.
Age: 80.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: LEFT ARM PAIN. I CAN ONLY LIFT MY LEFT ARM A SMALL AMOUNT WITH OUT A LOT OF PAIN.