chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a registered nurse, for HPV vaccine, a Pregnancy Registered product, concerning a 21 year old female patient with allergic to CECLOR and with a history of seizures who was vaccinated IM with the first 0.5ml dose and the second dose of HPV vaccine (lot# 671463/1359AA) on 19-JAN-2012 and 16-MAR-2012, respectively. Concomitant therapy included KEPPRA, LAMICTAL and folic acid. Nurse reported that on 07-FEB-2012, the patient was seen at the obstetrics (OB) office, and it was determined that the patient was 9 weeks pregnant. Nurse reported that the patient received the second dose of HPV vaccine on 16-MAR-2012, while the patient was 14 weeks pregnant. Last menstrual period (LMP) was approximately on 06-DEC-2011 and estimated delivery date (EDD) was on 11-SEP-2012. Nurse reported that the patient was not experiencing any adverse effects. Nurse reported that the patient received the HPV vaccine at the patient's primary care office, not the OB office. Prenatal care was given for the event. Lab diagnostics studies performed included blood work (results unspecified). The patient sought unspecified medical attention. Follow up information has been received from the registered nurse concerning a 21 year female with allergic to CECLOR and with epilepsy and obesity and with a history of seizures who was vaccinated IM with the first 0.5ml dose and the second dose of HPV vaccine (lot# of dose 1: 668261/1397AA; lot# of dose 2: 671463/1359AA) on 19-JAN-2012 and 16-MAR-2012, respectively. Last menstrual period (LMP) was approximately on 09-JAN-2012 and estimated delivery date (EDD) was on 15-OCT-2012. The patient was placed on PNV for pregnancy. The patient had 2 previous pregnancies. The number of full term deliveries was one. There were no infant complications in previous pregnancies and no birth defect in previous pregnancy. Follow-up information has been received and reported that all telephone attempts to obtain follow-up information have been unsuccessful. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse via company representative refers to a patient of unknown age and gender. In 2013 (date unspecified) the patient was vaccinated with a dose of PNEUMOVAX 23, injection (strength, dose, route, lot number and expiration date not provided). The nurse reported that the patient had adverse reactions (type of reaction unspecified) with in the last couple of weeks (in 2013, date unspecified) following vaccination with PNEUMOVAX 23. The outcome of adverse event was not reported. The relatedness between vaccination with PNEUMOVAX 23 and adverse reactions was not reported. The adverse event had been provided to the Vaccine Adverse Event Reporting System (VAERS). This is one of two reports from the same source (#1312USA004888). Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Arthralgia, Blood test normal, Inflammatory marker increased
Clinical narrative: Received TWINRIX A and B on 30 Oct. and 6 Nov. at your office. Mild joint and muscle pain started 5 days after first shot and progressed to  severe joint pain in shoulders, knees, elbows within a few days of second shot. Called office on 15 Nov. Nurse had not heard of such reaction and could not provide help. Pain became debilitating while I was out of country. Visited my primary care doctor day after return, 25 Nov. A 5 day course of prednisone gave some relief but severe pain gradually returned after course ended. Doctor put me on stronger longer second prednisone course after 2nd visit to his office on 4 Dec. which also provided relief. Tapering down prednisone now and joint pain is coming back. Extensive blood tests show all normal except inflammation markers which are all way above normal. I have gone from active athletic to almost not being able to function. I am calling GlaxoSmithKline to report adverse reaction Monday. Maybe they have some answers. Any information you can provide to help would be greatly appreciated as well.
Sex: M
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report as received from a consumer (also reported as mother of the patient) refers to a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot number and expiry date not reported) (dosing regimen and frequency unknown) for an unknown indications. No concomitant medications were reported. On an unknown date the patient received first two shots of GARDASIL but never received the 3rd shot of GARDASIL. The patient experienced no adverse event. No product quality issue was reported. Additional information has been requested.
Age: 0.54
Sex: F
Vaccine: DTAP, HEP, IPV, RVX
Symptoms: Vomiting
Clinical narrative: Vomited 3 times over the course of 2-3 hours.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 12/16/2013-. Swelling, redness, and warmth to all of arm injection was given in. Antihistime and ibuprofen given. 12/17/2013- Swelling, redness, warmth, and pain at still at site of injection.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Local swelling, Skin warm
Clinical narrative: 12/16/2013-. Swelling, redness, and warmth to all of arm injection was given in. Antihistime and ibuprofen given. 12/17/2013- Swelling, redness, warmth, and pain at still at site of injection.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Scar
Clinical narrative: Rash/large raised bumps on legs and upper arms.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Pain and soreness in arm where shot was administered. Pain lasted for 24 hours. It was also hard to lift my arm in certain directions or sleep in it.
Age: 1.96
Sex: F
Vaccine: FLU3
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Patient started with a fever the afternoon after the vaccine was given and had a febrile seizure which she was seen in the ER for.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: 24hrs after getting flu shot, pt developed a rash over her entire body except face, hands, and feet. Rash was not itchy, but face did itch. Rash was pinpoint, non-raised in size, except the inner thighs had pencil eraser, raised bumps. No breathing issues. Pt was placed on Prednisone X 3 QAM, Benadryl QPM.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Pain in extremity
Clinical narrative: Vaccine 10/10/13. Seen by me 11/6/13 c/o leg pain, numbness, x 6 days. Diagnosed with Guillain-Barre 11/11/13. Treated IVIG.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Blood immunoglobulin E, Erythema, Injection site pain, Local swelling
Clinical narrative: Seen employee health office 12/10/13 (L) deltoid tender. Small amt redness and swelling upper forearm - afebrile - improving when seen.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Pain in extremity
Clinical narrative: Pt. called 12/5 complained of soreness/pain of left arm and she has been taking DILAUDID and apply lidocaine patch over the painful area. She was seen in the ER 12/8 and doctor diagnosed her w/ cellulitis and was treated w/ clindamycin and DILAUDID.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysphagia, Dyspnoea, Eye discharge, Nausea
Clinical narrative: Vaccine given at 1226, approximately 15 min later felt a bit lightheaded. By 330pm, difficulty breathing/swallowing - 5pm took 25mg BENADRYL - (430pm eyes began to drain) approx 6pm nauseated. Achy took 800mg ibuprofen at 7pm to urgent care 8pm. Given eye drops and TAMIFLU. Pt was febrile. Pt with no symptoms prior to vaccine.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Vaccine given at 1226, approximately 15 min later felt a bit lightheaded. By 330pm, difficulty breathing/swallowing - 5pm took 25mg BENADRYL - (430pm eyes began to drain) approx 6pm nauseated. Achy took 800mg ibuprofen at 7pm to urgent care 8pm. Given eye drops and TAMIFLU. Pt was febrile. Pt with no symptoms prior to vaccine.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Fatigue, Flushing, Headache, Muscular weakness
Clinical narrative: Symptoms flushing, palpitations, headache, "burning" both arms, weakness bilateral arms. Dx - fatigue, myalgia, paresthesia s/p influenza vaccine. Resolved after 3 weeks no further influenza vaccines per PCP.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Palpitations, Paraesthesia
Clinical narrative: Symptoms flushing, palpitations, headache, "burning" both arms, weakness bilateral arms. Dx - fatigue, myalgia, paresthesia s/p influenza vaccine. Resolved after 3 weeks no further influenza vaccines per PCP.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site extravasation, Injection site swelling
Clinical narrative: Right deltoid red, swollen and leaking. Starting the evening of 12-9-13 after administration. Relieved with TYLENOL. Started on antibiotics by PCP.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: About 48 hours after receiving vaccine client states site became red, swollen and itchy. Sore to the touch. Seen in HD office 12/5/13. RN notes skin red, swollen. Area of reaction covers back of arm around site. Recommended seeing MD. Antibiotics prescribed.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Blood immunoglobulin E normal, Muscular weakness, Oedema peripheral
Clinical narrative: Office visits x 2 - PCP and another office. C/O bilateral foot and leg edema, joint pain and leg weakness within 24 hours after influenza vaccine.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Pruritus
Clinical narrative: Transferred to emergency dept with chest tightness, itching, resp 24-28 - acute shortness breath and pruritus Rx with BENADRYL and prednisone released from ED.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Injection site nodule
Clinical narrative: Mom reports child has pea-size "knot" on (Lt) leg at injection site. Denies redness or warmth to touch. Afebrile. Mom states it was first noticed sometime last week, but she doesn't recall when.
Age: 1.05
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile sz s/p receiving MMR on 11.6.13.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Bursitis, Pain
Clinical narrative: Received shot (FLUVIRIN) on 10/ and had pain and was told by his doctor he developed bursitis since he received shot between shoulder blade and lt tendon.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: On 11/27/13 approximately 11:25 AM, pt. came to consultation window and stated he rec'd a Flu shot and has pain in arm and radiates to his hand and has been this way since receipt of Flu shot on 11/9/13. Suggested warm compresses and Ibuprofen and to see MD if does not help or improve.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Limb discomfort, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Tendonitis
Clinical narrative: Received influenza vaccine to right arm severe pain to arm lasting for over 6 months continues painful and uncomfortable today.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Body temperature increased, Erythema, Induration, Malaise
Clinical narrative: Started running a T and felt very ill and weak. Arm turned red, hot, hard and painful past elbow. 1:30 AM T (102.7) taken w/ digital thermometer. I was ill for 4 days and slowly got better. I did have inflamed sinus on (L) at the time and post nasal drip. T that high unusual for me.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Started running a T and felt very ill and weak. Arm turned red, hot, hard and painful past elbow. 1:30 AM T (102.7) taken w/ digital thermometer. I was ill for 4 days and slowly got better. I did have inflamed sinus on (L) at the time and post nasal drip. T that high unusual for me.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling of the left arm for 2 weeks. Went to ER 11/14/13. Went to see MD 11/20/13.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration
Clinical narrative: Some area of increased induration and redness about 3-4 cm in diameter. Large surrounding area of mild erythema without tenderness about 10-15 cm in diameter.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Localized redness, swelling left upper arm - subcutaneous tissue mild tenderness area 4 x 3 inches.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash, Rash generalised
Clinical narrative: Rash on back, face, arms, abdomen and legs 2 days after flu shot.
Age: 37.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Pt reported a knot in her arm at injection site, was red and a little swollen. She made a complete recovery, did not seek medical attention.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Immediate post-injection reaction, Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: PREVNAR 13 was given in (L) leg - immediately after vaccine given the (L) leg turned red -> then purple, swelling at the site. Nl pulses. About 1 min later the leg was starting to look normal again.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Urticaria
Clinical narrative: Urticaria and joint pain since flu shot in 10/13. She was seen in our office after seeing doctor at clinic. Steroids Rx'd orally, IM, and also antihist. given.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient reported 12/10/2013 that since his flu shot on 11/1/13 his arm has been tender to touch at the injection site. There are no signs of swelling or inflammation, nor are there any lumps or abnormalities that can be felt under the skin.
Age: 6.0
Sex: M
Vaccine: FLUN4, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Nine days following varicella vaccine - developed a reddened, warm, tender, cellulitis over the injection site. Required treatment with OMNICEF (antibiotic).
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a 70 year old female consumer with arthritis and no drug reactions/allergies, refers to herself. In March 2013, the patient was vaccinated with ZOSTAVAX (lot number, dose and route not provided). No co-suspect therapies were reported. Concomitant therapies included EVISTA, diclofenac and SYNTHROID. The consumer stated that since the day following the shot with ZOSTAVAX, in March 2013, she was experiencing itching at the injection site. The patient also reported that the injection site was still swollen. At the time of the report, the patient had not recovered from the adverse events. The patient did not seek medical attention and did not receive any treatment. No lab diagnostics studies were performed. The causality was not provided. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Dizziness, headache, very tired for about 8 hours - chills - nausea.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: The shot was given on left arm. My arm became very red and extremely swollen. It hurt badly up to my finger tips. It lasted for 7 days.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Hypertensive crisis, Similar reaction on previous exposure to drug
Clinical narrative: Pt developed hypertensive crisis necessitating hospitalization about 2 weeks after getting the flu shot this year. Same thing happened last year!
Sex: U
Vaccine: FLU3, TDAP
Symptoms: Arthralgia, Borrelia test negative, Immunology test normal, Inflammation, Joint swelling
Clinical narrative: Received FLUZONE and ADACEL Tdap on 10/17/13. On 11/7 had severe neck pain. Following that, I have had migrating joint pain and swelling. Doctor tested for Lyme, inflammation, RA and autoimmune disease - all negative. Not getting better. Treatment is NSAIDs and they don't help.
Sex: U
Vaccine: FLU3, TDAP
Symptoms: Neck pain, Rheumatoid factor
Clinical narrative: Received FLUZONE and ADACEL Tdap on 10/17/13. On 11/7 had severe neck pain. Following that, I have had migrating joint pain and swelling. Doctor tested for Lyme, inflammation, RA and autoimmune disease - all negative. Not getting better. Treatment is NSAIDs and they don't help.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site rash
Clinical narrative: Patient came in 2 days after vaccination with a raised rash at site of injection approx. 2 inches in diameter. Patient described mild discomfort. Recommended oral BENADRYL and topical hydrocortisone.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Pain in arm. Limited range of motion. 12/7/13 arm still has dull pain and is stiff with limited range of motion.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erosion, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 15 cm x 14 cm area of erythema, warmth and generalized swelling of (R) lateral arm, superficial abrasion over mid arm from scratching.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Electroencephalogram normal
Clinical narrative: Pt stated she received flu shot on 11/2 and that she had seizure on the next day - 11/3. Went to ER, ran tests and did EEG. They didn't find anything, but has appt with neurologist. Not able to drive yet.
Age: 10.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Feeling hot, Induration, Local swelling, Skin warm
Clinical narrative: (R) triceps are with diffuse area of warmth, erythema and swelling-induration 4x5cm. Pink and warm 10x 11cm.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Pain in (R) arm, with red streaks that wrap around arm to armpit.
Age: 1.03
Sex: M
Vaccine: FLU3, PNC13, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Varicella like rash (10 days) after VZV I/Z.
Age: 49.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Severe body aches, chills, fever, diarrhea, pain and swelling in joints. Headache, fatigue.
Age: 49.0
Sex: F
Vaccine: UNK
Symptoms: Joint swelling, Pain, Pyrexia
Clinical narrative: Severe body aches, chills, fever, diarrhea, pain and swelling in joints. Headache, fatigue.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Rash macular
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of approximately 67 year old with congestive heart failure, diverticulosis, hiatal hernia, hemorrhoids, hyperlipidemia, malaise, fatigue, valvular disease, chronic obstructive pulmonary disease and hypertension. On an unspecified date in the past, the patient received a dose of PNEUMOVAX23 and did not have any adverse reactions. Drug reaction and allergies were reported as none. On 02-DEC-2013, the patient was vaccinated with PNEUMOVAX23 (lot # J010332, expiration date 14-JAN-2013, dose 2, 0.5 ml, intramuscular). Concomitant therapies included COUMADIN, NEXIUM, atorvastatin, amlodipine, PROAIR, vitamin D, hydrochlorothiazide (manufacturer unknown), loratadine (manufacturer unknown), ULTRACET, BUSPAR, ZANAFLEX, LINZESS, amikacin, FOSAMAX and NORCO. In December 2013, the patient experienced redness, blotching and a rash around the injection site and extending down her arm. Patient sought medical attention, she saw a physician. Lab diagnostics studies were not performed. No treatment was given for the events. The outcome of the events was reported as not recovered. Additional information has been requested.
Age: 0.22
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Injection site haematoma
Clinical narrative: Bilateral subcutaneous hematomas on thighs.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Pt receive Flu shot (Quad) on 11/5. Next day, on 12/11/13 in the morning saw a 2" round red puffy area at injection site. Hard when pressed in middle, itched a bit, warm. On 12/12 area had grown to a 4" circle. Stopped by pharmacist for feedback but went to the doctor. Also doctor recommended cortisone cream for itchiness. On 12/13 are larger and middle of it darker and hard.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Pt receive Flu shot (Quad) on 11/5. Next day, on 12/11/13 in the morning saw a 2" round red puffy area at injection site. Hard when pressed in middle, itched a bit, warm. On 12/12 area had grown to a 4" circle. Stopped by pharmacist for feedback but went to the doctor. Also doctor recommended cortisone cream for itchiness. On 12/13 are larger and middle of it darker and hard.
Age: 19.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: Pt is a 19 yo M with a documented allergy to PERTUSSIS VACCINES (Other Reaction: SCREAMING FOR 2; severity: medium; since 6/20/2012). On 12/16/13, pt presented to clinic for annual exam. During visit, pt was ordered Tdap vaccine. The allergy was noted & discussed with the pt. Based on the pt's report that this was not a substantial concern, the decision was made to administer the Tdap vaccine. 0.5 mL was given IM in left deltoid (Mfg: GSK, Lot #2RY59, Exp: 3/13/2016; NDC #58160-842-52). Pt denied any adverse effects after injection & was discharged home in stable condition. On 12/17, pt awoke w/ nausea & vomiting x 1. Pt's mother called clinic & reported symptoms. MD charted "It is possible that his symptoms this morning are related to the pertussis vaccine given yesterday but it is difficult to know for sure. I spoke with both [pt] & his mother at length & apologized for the concerns that have arisen based on his symptoms. The symptoms are improving through the day & he is doing better, but I acknowledged that further clarification of the concerns surrounding the pertussis vaccine should have been taken." On 12/17/2013, pt's allergy profile was updated to include PERTUSSIS VACCINES (OTHER REACTION-CONCERN FOR ALLERGIC SYMPTOMS - MUST NOT RECEIVE ANY PERTUSSIS VACCINE; severity: medium).
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle atrophy
Clinical narrative: "Dent in arm" - muscle atrophy.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen red area ranging from elbow to injection site, hot to the touch. Lasted 4 days.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 1ST FLU SHOT IN 19 YEARS. LEFT ARM SITE REACTION: 70 MM CIRCULAR, HOT AREA, WITH CENTRAL HARDNESS FELT, ERYTHEMATOUS. Pt. denied HA, SOB, wheezing, urticaria, chest/sinus congestion.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Febrile convulsion, Muscle twitching, Pyrexia
Clinical narrative: 2 days after recieiving MMR and Hep A Vaccine, my daughter had a fever ranging from 101.5 thru 102. It would not lower with Motrin or Tylenol. Upon placing my daughter to sleep, her arms and legs began to twitch off and on for one hour. Appeared to be a febrile seizure.
Age: 33.0
Sex: M
Vaccine: FLUN4
Symptoms: Asthenia, Dizziness, Headache, Myalgia, Respiratory tract congestion
Clinical narrative: Lightheadedness, weakness, runny nose, congestion, HA, muscle aches. States, "almost did not go to work following day- but at work" reporting symptoms.
Age: 33.0
Sex: M
Vaccine: FLUN4
Symptoms: Rhinorrhoea
Clinical narrative: Lightheadedness, weakness, runny nose, congestion, HA, muscle aches. States, "almost did not go to work following day- but at work" reporting symptoms.
Age: 23.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Arm is red swollen and warm to touch.
Age: 49.0
Sex: F
Vaccine: TD
Symptoms: Injected limb mobility decreased, Muscle contusion, Pain, Pain in extremity
Clinical narrative: Soreness to arm and when I move it in certain ways feels like someone is stabbing me with ice pick. Has progressed to the point the cannot lift arm over shoulder height.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Neuralgia, Pain in extremity
Clinical narrative: Patient complains of nerve pain at injection site down to whole arm, presented about 1 month after vaccination.  Informed patient to go see PCP as soon as possible.  Contacted PCP to inform him to follow up with patient.
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: Asthenia, Dizziness, Dyspnoea, Urticaria
Clinical narrative: Shortness of breath, dizziness, weakness and small wheals (urticaria) on thigh and hip area.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Fever, chills ,vomiting.
Age: 57.0
Sex: M
Vaccine: UNK
Symptoms: Back pain, Gait disturbance, Mobility decreased, Muscular weakness
Clinical narrative: Pain started on right side of lower back. By the second day after receiving shot, I could not walk without excruciating pain. Pain then walked down the front of my right leg. Saw doctor twice over it, trip to ER, and was placed in physical therapy and pain is still continuing. Pain is causing my right leg to give out/ buckle underneath of me with every step I take. This has drastically changed my life and my mobility. I can barely walk.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: Patient complaints of difficulty breathing, dizziness, and feeling of knot in chest.
Age: 1.01
Sex: F
Vaccine: FLU4, PNC13, VARCEL
Symptoms: Computerised tomogram head, Convulsion, Depressed level of consciousness, Drug screen, Electroencephalogram
Clinical narrative: Child became lethargic 12/12/13 in afternoon - had seizure - was unable to arouse baby - went to ER - transferred to another hospital by ambulance. Remained unable to arouse baby for total of 13 hours. Discharged 12/14/13.
Age: 1.01
Sex: F
Vaccine: FLU4, PNC13, VARCEL
Symptoms: Full blood count, Lethargy, Metabolic function test
Clinical narrative: Child became lethargic 12/12/13 in afternoon - had seizure - was unable to arouse baby - went to ER - transferred to another hospital by ambulance. Remained unable to arouse baby for total of 13 hours. Discharged 12/14/13.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Full blood count normal, Metabolic function test normal, Monocyte count normal, Petechiae, Platelet count decreased
Clinical narrative: Petechial rash and itching on trunk started w/in 2 hours of vaccine - on trunk only. Platelets low normal.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash, Red blood cell sedimentation rate normal
Clinical narrative: Petechial rash and itching on trunk started w/in 2 hours of vaccine - on trunk only. Platelets low normal.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: Pain and edema at injection site.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fall, Malaise, Syncope
Clinical narrative: Very sick. Fainting and falling on floor twice.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Rash papular
Clinical narrative: Itchy papular rash at injection site, developed 2 days after injection. Given triamcinolone cream for treatment.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain, Skin warm, Swelling
Clinical narrative: Received pneumonia vaccine 12-12-13 to (L) arm. Pain, swelling and redness started night of 12-13-13. Cannot lift arm or sleep due to pain and swelling. Area 4 x 6 inchs, redness and swelling to tricep muscle. Pt comes 3 days s/p pneumonia vaccine left tricept the lesion 10 cm diameter. Swelling began 1 day PRA. Area is tender to touch. No exudate. Skin is warm. Cellulitis 2nd to vaccination.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness, Vaccination complication
Clinical narrative: Received pneumonia vaccine 12-12-13 to (L) arm. Pain, swelling and redness started night of 12-13-13. Cannot lift arm or sleep due to pain and swelling. Area 4 x 6 inchs, redness and swelling to tricep muscle. Pt comes 3 days s/p pneumonia vaccine left tricept the lesion 10 cm diameter. Swelling began 1 day PRA. Area is tender to touch. No exudate. Skin is warm. Cellulitis 2nd to vaccination.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Vomiting
Clinical narrative: Following MENACTRA #2, pt developed severe headache within 20 minutes and then 6 hours of protracted vomiting 8-10 episodes. Then symptoms abruptly resolved.
Age: 1.5
Sex: M
Vaccine: DTAP, FLU3, MMR
Symptoms: Convulsion
Clinical narrative: Brief seizure, self limited, about 24 hours after vaccines given.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reports onset of injection site redness, swelling, itchiness and soreness onsetting approximately 24 hours after immunization received. Patient reports area of redness/swelling size of half dollar. Advised patient to call physician and gooly ice for discomfort.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a physician for HPV rL 1 6 11 16 18, concerning a 25 year old female with tobacco user and a history of asthma and a history of 1 pregnancy and 1 live birth. No miscarriage, no elective terminations and no birth defected in previous pregnancy who on 01-SEP-2011 was vaccinated with the first dose of HPV rL 1 6 11 16 18, (lot# 666595/0992Z, expiry date in 14-OCT-2012). On 28-OCT-2011 the patient experienced newly diagnosed pregnancy. Patient's LMP was in August 2011 and EDD would be approximately in May 2012. At the time of the report, it was unspecified if the patient had sought medical attention. Follow up information has been received regarding pregnancy outcome information. The physician and other healthcare professional were no longer at the office and they had no additional information to provide. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to unspecified patients of unknown age and gender. On unspecified dates, the patients were vaccinated with GARDASIL (lot number, concentration and dose were not reported) that was improperly stored. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, dose and route were not reported) to prevent shingles. Concomitant therapy was not reported. On an unknown date, the patient developed redness at the injection site after receiving ZOSTAVAX and the redness did not go away after a week. The patient sought medical attention by contacting pharmacist. Relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Accidental exposure to product, No adverse event, Product quality issue, Syringe issue
Clinical narrative: This spontaneous report as received from an office manager refers to a female nurse of unknown age. An unknown date the nurse was preparing doses of GARDASIL (20 mcg-40 mcg-40 mcg-20 mcg/0.5 ml) to be administered and the product leaked and got on her skin. No adverse effects were reported. A product quality complaint was filled to document that two GARDASIL pre filled syringes cracked. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, drug reaction or allergies were not reported. On an unknown date, the patients were vaccinated with MMR II (dose and lot number were not reported). Concomitant therapy was not reported. On an unknown date, the patients may have received improperly stored MMR II. No adverse event was reported. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to unspecified patients of unknown age and gender. On unspecified dates, the patients were vaccinated with VAQTA 50/1.0 u/ml (lot number and dose were not reported) that was improperly stored. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to unspecified patients of unknown age and gender. On unspecified dates, the patient were vaccinated with RECOMBIVAX HB (lot number, concentration and dose were not reported) that was improperly stored. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Acidosis, Amylase normal, C-reactive protein normal, Dehydration
Clinical narrative: Case number PHHY2013US127756, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 499873) website on 11 Nov 2013, with the follow-up received from Quality Assurance Department (reference number: 263986) on 06 Dec 2013. This report refers to an 11-year-old female patient. Historical drugs included penicillin and ZITHROMAX and had allergies with them. She was vaccinated with MENVEO (batch number: M11081 and expiry date: Apr 2014) intramuscularly in the left arm on 09 Aug 2013. On the same date, she also received GARDASIL (batch number: H021608) and BOOSTRIX (batch number: AC52B100CA) both intramuscularly in the right arm. On 10 Aug 2013, after vaccination she experienced abdominal pain, vomiting with increased eosinophil count. No other symptoms. Extensive work up done and complete blood count differentiation showed eosinophil increased, C-reactive protein normal, CMP normal and amylase lipase normal and urine analysis showed ketones. The patient progressed to dehydration and was admitted on an unknown date. She was mildly acidotic and no diagnosis could be made. The outcome of the events was reported as recovered as of 15 Aug 2013. The seriousness (of events other than dehydration and acidotic) and causality of the events were not reported. Based on the investigation performed, the QA department stated that, the MENVEO (batch number: M11081) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 263986) on 06 Dec 2013: Updated batch review report.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Differential white blood cell count abnormal, Eosinophil count increased, Full blood count abnormal, Lipase normal, Metabolic function test normal
Clinical narrative: Case number PHHY2013US127756, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 499873) website on 11 Nov 2013, with the follow-up received from Quality Assurance Department (reference number: 263986) on 06 Dec 2013. This report refers to an 11-year-old female patient. Historical drugs included penicillin and ZITHROMAX and had allergies with them. She was vaccinated with MENVEO (batch number: M11081 and expiry date: Apr 2014) intramuscularly in the left arm on 09 Aug 2013. On the same date, she also received GARDASIL (batch number: H021608) and BOOSTRIX (batch number: AC52B100CA) both intramuscularly in the right arm. On 10 Aug 2013, after vaccination she experienced abdominal pain, vomiting with increased eosinophil count. No other symptoms. Extensive work up done and complete blood count differentiation showed eosinophil increased, C-reactive protein normal, CMP normal and amylase lipase normal and urine analysis showed ketones. The patient progressed to dehydration and was admitted on an unknown date. She was mildly acidotic and no diagnosis could be made. The outcome of the events was reported as recovered as of 15 Aug 2013. The seriousness (of events other than dehydration and acidotic) and causality of the events were not reported. Based on the investigation performed, the QA department stated that, the MENVEO (batch number: M11081) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 263986) on 06 Dec 2013: Updated batch review report.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Urine ketone body present, Vomiting
Clinical narrative: Case number PHHY2013US127756, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 499873) website on 11 Nov 2013, with the follow-up received from Quality Assurance Department (reference number: 263986) on 06 Dec 2013. This report refers to an 11-year-old female patient. Historical drugs included penicillin and ZITHROMAX and had allergies with them. She was vaccinated with MENVEO (batch number: M11081 and expiry date: Apr 2014) intramuscularly in the left arm on 09 Aug 2013. On the same date, she also received GARDASIL (batch number: H021608) and BOOSTRIX (batch number: AC52B100CA) both intramuscularly in the right arm. On 10 Aug 2013, after vaccination she experienced abdominal pain, vomiting with increased eosinophil count. No other symptoms. Extensive work up done and complete blood count differentiation showed eosinophil increased, C-reactive protein normal, CMP normal and amylase lipase normal and urine analysis showed ketones. The patient progressed to dehydration and was admitted on an unknown date. She was mildly acidotic and no diagnosis could be made. The outcome of the events was reported as recovered as of 15 Aug 2013. The seriousness (of events other than dehydration and acidotic) and causality of the events were not reported. Based on the investigation performed, the QA department stated that, the MENVEO (batch number: M11081) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 263986) on 06 Dec 2013: Updated batch review report.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Eosinophil count increased, Full blood count abnormal, Metabolic function test normal, Urine analysis abnormal, Urine ketone body present
Clinical narrative: Case number PHHY2013US127756, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 499873) website on 11 Nov 2013, with the follow-up received from Quality Assurance Department (reference number: 263986) on 06 Dec 2013. This report refers to an 11-year-old female patient. Historical drugs included penicillin and ZITHROMAX and had allergies with them. She was vaccinated with MENVEO (batch number: M11081 and expiry date: Apr 2014) intramuscularly in the left arm on 09 Aug 2013. On the same date, she also received GARDASIL (batch number: H021608) and BOOSTRIX (batch number: AC52B100CA) both intramuscularly in the right arm. On 10 Aug 2013, after vaccination she experienced abdominal pain, vomiting with increased eosinophil count. No other symptoms. Extensive work up done and complete blood count differentiation showed eosinophil increased, C-reactive protein normal, CMP normal and amylase lipase normal and urine analysis showed ketones. The patient progressed to dehydration and was admitted on an unknown date. She was mildly acidotic and no diagnosis could be made. The outcome of the events was reported as recovered as of 15 Aug 2013. The seriousness (of events other than dehydration and acidotic) and causality of the events were not reported. Based on the investigation performed, the QA department stated that, the MENVEO (batch number: M11081) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 263986) on 06 Dec 2013: Updated batch review report.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Case number PHHY2013US127756, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 499873) website on 11 Nov 2013, with the follow-up received from Quality Assurance Department (reference number: 263986) on 06 Dec 2013. This report refers to an 11-year-old female patient. Historical drugs included penicillin and ZITHROMAX and had allergies with them. She was vaccinated with MENVEO (batch number: M11081 and expiry date: Apr 2014) intramuscularly in the left arm on 09 Aug 2013. On the same date, she also received GARDASIL (batch number: H021608) and BOOSTRIX (batch number: AC52B100CA) both intramuscularly in the right arm. On 10 Aug 2013, after vaccination she experienced abdominal pain, vomiting with increased eosinophil count. No other symptoms. Extensive work up done and complete blood count differentiation showed eosinophil increased, C-reactive protein normal, CMP normal and amylase lipase normal and urine analysis showed ketones. The patient progressed to dehydration and was admitted on an unknown date. She was mildly acidotic and no diagnosis could be made. The outcome of the events was reported as recovered as of 15 Aug 2013. The seriousness (of events other than dehydration and acidotic) and causality of the events were not reported. Based on the investigation performed, the QA department stated that, the MENVEO (batch number: M11081) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 263986) on 06 Dec 2013: Updated batch review report.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Rash erythematous
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 66 year old male patient with none drug reactions/allergies. The patient's medical history included dermatitis. On 14-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J002868, expiration date 14-JUN-2014) (dose not reported) subcutaneous in the left arm. Concomitant therapies included tamsulosin hydrochloride and nystatin. Approximately in August 2013 the patient developed a swollen injection site after vaccination. The site was also painful and warm to touch. The patient sought medical attention, he contacted with doctor's office. As the treatment TYLENOL was given. On 21-AUG-2013, reported as "about one week after vaccination" the patient recovered. Relatedness between therapy and adverse events were not reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 66 year old male patient with none drug reactions/allergies. The patient's medical history included dermatitis. On 14-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J002868, expiration date 14-JUN-2014) (dose not reported) subcutaneous in the left arm. Concomitant therapies included tamsulosin hydrochloride and nystatin. Approximately in August 2013 the patient developed a swollen injection site after vaccination. The site was also painful and warm to touch. The patient sought medical attention, he contacted with doctor's office. As the treatment TYLENOL was given. On 21-AUG-2013, reported as "about one week after vaccination" the patient recovered. Relatedness between therapy and adverse events were not reported. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PNC13, PNC13, TDAP
Symptoms: Blister, Purpura, Rash generalised, Rash maculo-papular
Clinical narrative: Patient received BOOSTRIX and PREVNAR 13 vaccines at office visit (different syringes/sites). 24-36 hrs a generalized maculopapular and blistering rash developed on face, scalp, trunk and extremities. Maculopapular rash with blistering/blood blisters to both feet. Mild itching to maculopapular rash palms and dorsal surface hands bilat. with mild itching. Rash to face was papular with crusting and dry skin. Maculopapular to scalp and back, arms. Lesions evolved over next 3-5 days.
Age: 73.0
Sex: M
Vaccine: PNC13, PNC13, TDAP
Symptoms: Blood blister, Dry skin, Pruritus, Rash generalised, Rash maculo-papular
Clinical narrative: Patient received BOOSTRIX and PREVNAR 13 vaccines at office visit (different syringes/sites). 24-36 hrs a generalized maculopapular and blistering rash developed on face, scalp, trunk and extremities. Maculopapular rash with blistering/blood blisters to both feet. Mild itching to maculopapular rash palms and dorsal surface hands bilat. with mild itching. Rash to face was papular with crusting and dry skin. Maculopapular to scalp and back, arms. Lesions evolved over next 3-5 days.
Age: 73.0
Sex: M
Vaccine: PNC13, PNC13, TDAP
Symptoms: Rash vesicular, Scab, Skin lesion
Clinical narrative: Patient received BOOSTRIX and PREVNAR 13 vaccines at office visit (different syringes/sites). 24-36 hrs a generalized maculopapular and blistering rash developed on face, scalp, trunk and extremities. Maculopapular rash with blistering/blood blisters to both feet. Mild itching to maculopapular rash palms and dorsal surface hands bilat. with mild itching. Rash to face was papular with crusting and dry skin. Maculopapular to scalp and back, arms. Lesions evolved over next 3-5 days.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patient received shingles vaccination, developed redness, swelling and pain.