chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: FLUX, PPV, VARZOS
Symptoms: Blister, Pain in extremity, Paraesthesia, Rash erythematous, Spinal pain
Clinical narrative: This spontaneous report was received from a 62 year old female patient. The patient's pertinent medical history was unknown. The patient had no known drug reactions/allergies. On 06-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiration date were not provided). Other suspect therapies included PCV (manufacturer unknown) (dose, route, lot number and expiration date were not provided) and influenza virus vaccine (manufacturer unknown) (dose, route, lot number and expiration date were not provided). Concomitant therapies included valacyclovir hydrochloride and ointment. It was reported that the next day after vaccination, on 07-SEP-2013, the patient got the tingling red spots Sat night, the next day after another patch. The patient did get the rash as well as the blistering. The pain was at the base of the spine and went around the right side upper leg. The patient after received the three vaccines on the same date, was told by her pharmacist that it would be fine. The patient received treatment for the events (therapy unspecified). No laboratory diagnostic tests were performed. The patient sought unspecified medical attention. At the time of the report, the patient's outcome and relatedness between the events and suspect therapies were not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site erythema, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with none drug reaction/allergies. On approximately 17-SEP-2013, about a week ago, the patient was vaccinated with a dose of ZOSTAVAX dose, route and lot # not reported. In September 2013 the patient experienced an injection site reaction that was red and 3 to 4 inches in diameter. The pharmacist stated that the patient reported that she started to feel tingling around her mid back, which within 24  hours became a unilateral tingling and burning on the patient's left side. The patient had not developed a rash at this time. The patient had not yet seen her physician. There was none treatment given and no lab diagnostics studies were performed. The outcome of adverse events was unknown. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: Ringing in one ear, continuous.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Eye pruritus, Eye swelling, Ocular hyperaemia, Pyrexia
Clinical narrative: My eyes became extremely itchy, red and swollen - they are still red and itchy today (9/25/2013).  I also developed a fever of 102.5 around 11:00 PM that evening as well.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient initially reported her left hand going numb while in class and being unable to effectively complete tasks requiring dexterity in the fingers. She said that this went on for a few days, but not only gets tingling in her fingers in the left hand when she crosses her arms or puts any kind of pressure on the nerves in her arm.  The injection that we administered was in the left arm.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Muscle aches primarily in lower and upper back and shoulders; fever; headache; fatigue.  Symptoms cleared around 10:00 AM on 09/25/2013.
Age: 11.0
Sex: U
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Headache, Injection site pain
Clinical narrative: Headache, soreness at site, dizziness. Dizziness begun within 10 mins, lasted a few days. Headache started about 4 h, lasted 1 wk.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Injection site pain, erythema.  Fever onset overnight.  Already hospitalized for methotrexate overdose.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Lymph node pain, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Gland in throat swelling. Pt came to clinic 2 days later and had golf ball size left cervial lymphnode. Tender. No lab work done. Pt had sore throat, chills, joint pain.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Patient reports ongoing dizziness and lightheadedness, beginning in the afternoon after vaccine administration.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Inflammation, Mobility decreased, Musculoskeletal stiffness, Pain, Vaccination site nodule
Clinical narrative: Reported large nodule in arm at vaccination site; nodule increased in size and effected the left side of the neck and shoulder.  Reported inability to lift arm and turn neck; pain; inflammation; stiffness.  Flu shot recieved at work as part of staff vaccination program and it was reported as an on the job injury.
Age: 69.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Activities of daily living impaired, Aphagia, Arthralgia, Asthenia, Back pain
Clinical narrative: Started with chills and progressed to severe body, muscle and joint pain, headache, pain in my neck and back.  I was very weak and broke out in a sweat about 2:00 AM.  I was in bed all day Saturday and most of Sunday with pain. My flesh hurt all the way to the bone. The site of the injection was swollen, red and feverish until today, Wednesday. I could not eat for several days.
Age: 69.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Headache, Hyperhidrosis, Injection site erythema, Injection site swelling
Clinical narrative: Started with chills and progressed to severe body, muscle and joint pain, headache, pain in my neck and back.  I was very weak and broke out in a sweat about 2:00 AM.  I was in bed all day Saturday and most of Sunday with pain. My flesh hurt all the way to the bone. The site of the injection was swollen, red and feverish until today, Wednesday. I could not eat for several days.
Age: 69.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site warmth, Myalgia, Neck pain, Pain
Clinical narrative: Started with chills and progressed to severe body, muscle and joint pain, headache, pain in my neck and back.  I was very weak and broke out in a sweat about 2:00 AM.  I was in bed all day Saturday and most of Sunday with pain. My flesh hurt all the way to the bone. The site of the injection was swollen, red and feverish until today, Wednesday. I could not eat for several days.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Nausea
Clinical narrative: Nausea.
Age: 2.0
Sex: M
Vaccine: FLUN4, HEPA, VARZOS, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt given 0.5ml SC of Zostavax vaccine instead of Varicella vaccine. No immediate adverse effect was noted.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Chills, Eye discharge, Night sweats, Oropharyngeal pain
Clinical narrative: Pt. stated that five hours after receiving flu shot he was sitting outside and noticed that his eyes were filled with yellow mucus, and his throat was itchy, sore and tight.  His chest also felt tight.  Took Benadryl and Motrin with good results, but woke up with chills and sweats in the middle of the night.  Felt improved the next day. Referred to PCP.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Throat irritation, Throat tightness
Clinical narrative: Pt. stated that five hours after receiving flu shot he was sitting outside and noticed that his eyes were filled with yellow mucus, and his throat was itchy, sore and tight.  His chest also felt tight.  Took Benadryl and Motrin with good results, but woke up with chills and sweats in the middle of the night.  Felt improved the next day. Referred to PCP.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Body temperature increased, Cold sweat, Fatigue, Feeling hot
Clinical narrative: Weakness in legs (hard to walk); exhaustion; broke out into a sweat (hot, very clammy to the touch); aching (arms, legs, back); temperature of 100.3; headache.  Called on-call nurse and decided to get checked out at the ER.  Vitals were checked by a nurse but left before seeing a physician due to hours of waiting time.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Gait disturbance, Headache, Hyperhidrosis, Muscular weakness, Pain in extremity
Clinical narrative: Weakness in legs (hard to walk); exhaustion; broke out into a sweat (hot, very clammy to the touch); aching (arms, legs, back); temperature of 100.3; headache.  Called on-call nurse and decided to get checked out at the ER.  Vitals were checked by a nurse but left before seeing a physician due to hours of waiting time.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Malaise, Oropharyngeal pain, Pain, Productive cough
Clinical narrative: Scratchy throat, 9/22 cutting sore throat with cough, Monday 9/23 low grade fever 100.8 sinus pain yellow mucous with cough, malaise, aches. Wednesday same symptoms slightly better. Cough continues, nose continues. Contacted MD if by Friday no improvement will need to see them.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Sinus headache, Throat irritation
Clinical narrative: Scratchy throat, 9/22 cutting sore throat with cough, Monday 9/23 low grade fever 100.8 sinus pain yellow mucous with cough, malaise, aches. Wednesday same symptoms slightly better. Cough continues, nose continues. Contacted MD if by Friday no improvement will need to see them.
Age: 17.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: PT WAS GIVEN ZOSTER VACCINE INSTEAD OF VARICELLA. NO REACTIONS WERE REPORTED BY PATIENT, AFTER VACCINE WAS ADMINISTERED.
Age: 1.07
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Immediate post-injection reaction, Induration, Injection site erythema, Injection site pain, Mass
Clinical narrative: Fever began at 7:00pm, started at 100.8 and crept up and down all night. Pain at injection site began immediately following vaccination, redness extending from site began at 12 hour mark and continued spreading. Hard lump formed by 24 hour mark. Redness still increasing at 48 hour mark, fever persists and congestion in nose and chest began.
Age: 1.07
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Nasal congestion, Pyrexia, Respiratory tract congestion
Clinical narrative: Fever began at 7:00pm, started at 100.8 and crept up and down all night. Pain at injection site began immediately following vaccination, redness extending from site began at 12 hour mark and continued spreading. Hard lump formed by 24 hour mark. Redness still increasing at 48 hour mark, fever persists and congestion in nose and chest began.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Erythema, Fatigue, Injection site pruritus
Clinical narrative: 9/19/13 Approx 9:30 a little itching at site, none since 9/19/13 10 PM - legs hurting terrible, 12MN-7AM hurting middle of lower back downward, legs, lower back, hips. Terrible pain. Could not move. Fever 100.5. Took 2 ES Tylenol-fever broke. 9/20/13 Feels really beat 8:30 AM-going home to rest-may see doctor. Had red, puffy area between L thumb and forefinger. No sign of a bite. No problem at site of injection.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: 9/19/13 Approx 9:30 a little itching at site, none since 9/19/13 10 PM - legs hurting terrible, 12MN-7AM hurting middle of lower back downward, legs, lower back, hips. Terrible pain. Could not move. Fever 100.5. Took 2 ES Tylenol-fever broke. 9/20/13 Feels really beat 8:30 AM-going home to rest-may see doctor. Had red, puffy area between L thumb and forefinger. No sign of a bite. No problem at site of injection.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Injected limb mobility decreased
Clinical narrative: On 9-25-13 pt stopped by pharmacy, stated she had severe joint pain and unable to raise her arms in both arms after receiving FLUZONE HD and PNEUMOVAX took Aleve OTC for pain. Still experiencing some effects in her left arm. Pt did not seek medical treatment. States shoulder joints still hurt can not lift arm all way.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Cellulitis - Keflex, Motrin
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Started one day later - neck/right arm stiffness/couldn't move - in bed - 9/24 - started to affect his left arm - gets reg flu shot yearly - no reaction.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Eyelid oedema, Feeling abnormal, Injection site rash, Wheezing
Clinical narrative: Pt is an employee. Five minutes after she got her Fluarix inj. she started to have rash on the injection site then funny feeling. Started to cough then went to clinic she started to wheeze with eyelids became swollen. Dr. was notified treated with 50 mg IM Benadryl and x1 dose of Albuterol inhalation.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Pain, Swelling
Clinical narrative: Patient states immediately after receiving vaccine developed swelling and pain. No treatment done.
Age: 41.0
Sex: F
Vaccine: YF
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient received YF vaccine Sept 11th and noted onset several hours late of hives and itchy. Seen 9/18/2013 in f/u due hx continuous itching.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Nausea, Throat tightness
Clinical narrative: Pt received Flu vaccine 9/24/13 at 11:45 AM return to office at 4 PM. C/O weakness, nausea, throat closing.
Age: 0.18
Sex: F
Vaccine: DTAP, HIBV, RV5
Symptoms: Culture stool, Diarrhoea, Faeces discoloured, Haematochezia, Occult blood positive
Clinical narrative: Diarrhea: green and mucous filled. Mon 9/16/2013:  Blood in stool. Blood in stool and green, mucous in stools lasted throughout week.  Still having issue at time of reporting.
Age: 11.0
Sex: M
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: Feeling hot, Pruritus, Rash, Rash generalised
Clinical narrative: Per pt's mother: approx. 20 mins after vaccine administration, pt complained of feeling warm and itchy, and had rash on back and armpits, gave Benadryl, oatmeal bath, hydrocortisone topically, next a.m. rash was head-to-toe "including scalp and private area," took to ER, prescribed prednisone and Atarax.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Burning sensation, Pruritus
Clinical narrative: Itching and burning on left side of stomach with blister forming.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Grip strength decreased, Hypoaesthesia, Injection site pain
Clinical narrative: States left arm deltoid region extremely painful. Started day of injection and continues on - now 5 days post injection.  Patient states numbness in hand.  Has decreased grip in left hand.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site pruritus, Rash
Clinical narrative: Patient called pharmacy on 9/25/13 to report that she had a rash from the zoster vaccine injection that has lasted for 6 days. She further stated that she experienced itching at the injection site for 1.5 days and then the rash developed sometime after. She reports that she did not noticed when it appeared. The patient's PCP was notified of the adverse reaction on 9/25/13.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Blood creatine phosphokinase, Blood thyroid stimulating hormone, Chest pain, Culture urine, Fibrin D dimer
Clinical narrative: Started getting headach and low-grade Fever. At about 3:30 I started getting a stabbing pain in my right lung under my breast whenever I took a deep breath. I attempted to wait it out and went to my primary care physician on 9/19/13 to find out more. Due to my breathing being shallow to avoid pain, I fainted and had to go to the ER. ER Doctor diagnosed me with Pleurisy.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Full blood count, Headache, Hypopnoea, Metabolic function test, Pleurisy
Clinical narrative: Started getting headach and low-grade Fever. At about 3:30 I started getting a stabbing pain in my right lung under my breast whenever I took a deep breath. I attempted to wait it out and went to my primary care physician on 9/19/13 to find out more. Due to my breathing being shallow to avoid pain, I fainted and had to go to the ER. ER Doctor diagnosed me with Pleurisy.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Pregnancy test urine, Pyrexia, Syncope, Troponin, Urine analysis
Clinical narrative: Started getting headach and low-grade Fever. At about 3:30 I started getting a stabbing pain in my right lung under my breast whenever I took a deep breath. I attempted to wait it out and went to my primary care physician on 9/19/13 to find out more. Due to my breathing being shallow to avoid pain, I fainted and had to go to the ER. ER Doctor diagnosed me with Pleurisy.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: X-ray therapy to lung
Clinical narrative: Started getting headach and low-grade Fever. At about 3:30 I started getting a stabbing pain in my right lung under my breast whenever I took a deep breath. I attempted to wait it out and went to my primary care physician on 9/19/13 to find out more. Due to my breathing being shallow to avoid pain, I fainted and had to go to the ER. ER Doctor diagnosed me with Pleurisy.
Age: 21.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Injection site pain, Injection site swelling
Clinical narrative: Patient returned to clinic at 2:20pm said that he had woke up with a headache, had soreness and swelling at injection site that morning. Examined by physician, no fever or swelling noted.  Still c/o of soreness. Advised to take NSAID, rest, ice.  Return to clinic if not resolved in a few days or if more symtoms present.
Age: 8.0
Sex: M
Vaccine: FLUX, HIBV, PPV
Symptoms: Myositis, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Fever and severe leg pain at site of swelling, myositis on MRI.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dysarthria, Headache, Panic reaction, Throat tightness
Clinical narrative: Patient reported blurred vision, slurred speech, ligthheadedness and headache lasting for 2-3 hrs except headache which persists.  Additionally, noted throat feeling tight and panicky while brushing teeth this morning (9/25/2013) and she administered 2 puffs of her albuterol inhaler.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Vision blurred
Clinical narrative: Patient reported blurred vision, slurred speech, ligthheadedness and headache lasting for 2-3 hrs except headache which persists.  Additionally, noted throat feeling tight and panicky while brushing teeth this morning (9/25/2013) and she administered 2 puffs of her albuterol inhaler.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Diarrhoea, Erythema, Local swelling, Pain
Clinical narrative: Pt experienced pain, swelling of entire arm, fever of 102 F, redness of arm, diarrhea; physician diagnosed pt with cellulitis and prescribed Augmentin as treatment.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Pt experienced pain, swelling of entire arm, fever of 102 F, redness of arm, diarrhea; physician diagnosed pt with cellulitis and prescribed Augmentin as treatment.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Rash pruritic
Clinical narrative: Lightheaded, headache, itchy rash on back. All resolved after 1.5 days except rash which decreases with Benadryl cream application.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient reported itching, burning, redness, and pain at site of Zostavax injection.  Over the next few days it got worse, so she went to a Dr for evaluation.  Dr diagnosed the reaction as cellulitis and prescribed antibiotics.  Patient reported some relief over next two days.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash, Rash erythematous, Rash generalised
Clinical narrative: Rash in injection sites and red dots to face and body.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Hypotension, Loss of consciousness
Clinical narrative: Patient lost consciousness for approx. 10-15 seconds 1-2 minutes after receiving the immunization. She regained consciousness and I monitored her vital signs until EMTS arrived. She was given IV fluids, had a low BP of approx 80/50 and was taken to a local ER.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: I believe I am suffering from worsening side effects after receiving the shingles vaccine on 7/12/2010. I have referred me to a dermatologist whose name I cannot remember. I recall my children coming down with the chicken pox; however, I cannot recall ever having the chicken pox. I have been suffering with a worsening severe itching of my scalp (like it is on fire) ever since I received the vaccine. My daughter has said that the dermatomes affected were only in the C2 area but now have started occurring in the V1 area as well. My daughter is writing this information for me.  I have an appointment again with my dermatologist in a week. I cannot stand this itching any longer. The topical steroids I have been prescribed are unable to address the likelihood of what seems to be a viral response to the vaccination. I hope you can send this information to the appropriate person to help me. My daughter has contacted facility also, my endocrinologist and the pharmacist. Please, please help me. Thank you.
Age: 12.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Lethargy
Clinical narrative: Pt is a 12 y.o. male accompanied with mother. Mother states that pt. received vaccines on Monday 9/23/13 and since then pt has been nauseated and lethargic. Mother also states that (L) arm where pt received vaccine is red and swollen. Upon examination (L) arm very erythematous and warm to touch. Diagnosed with Cellulitis. Tx: KEFLEX 500mg.
Age: 12.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Nausea
Clinical narrative: Pt is a 12 y.o. male accompanied with mother. Mother states that pt. received vaccines on Monday 9/23/13 and since then pt has been nauseated and lethargic. Mother also states that (L) arm where pt received vaccine is red and swollen. Upon examination (L) arm very erythematous and warm to touch. Diagnosed with Cellulitis. Tx: KEFLEX 500mg.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Eye pruritus, Face oedema, Ocular hyperaemia
Clinical narrative: Redness to left eye, edema to face below left eye, child c/o itchy feeling in left eye, no treatment, mother given verbal instructions to watch for any increased edema or irritation, instructed to seek medical attention if further concerns develop, follow telephone contact, mother states that redness and edema and irritation to left eye are gone.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warm to touch to R arm started at injection site and spread to entire upper R arm.
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Abnormal dreams, Chills, Erythema, Injection site erythema, Pain
Clinical narrative: Started w/chills around 2000hrs then fever and body aches w/disturbing dreams and a large area (3X10 inches) of redness at the injection site radiating upwards towards the shoulder and continuing to this evening with the redness.  Still achy but no fever or chills.
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Started w/chills around 2000hrs then fever and body aches w/disturbing dreams and a large area (3X10 inches) of redness at the injection site radiating upwards towards the shoulder and continuing to this evening with the redness.  Still achy but no fever or chills.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Blood test, Gait disturbance, Joint stiffness, Joint swelling
Clinical narrative: Knee joint pain and stiffness, difficulty walking and climbing stairs. Some swelling in the knees.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test, X-ray
Clinical narrative: Knee joint pain and stiffness, difficulty walking and climbing stairs. Some swelling in the knees.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site pain, Injection site warmth, Mass
Clinical narrative: Huge red area with a bump felt underneath. Pain and warm to the touch all within the injection site.
Sex: F
Vaccine: FLU3, MMR
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting which started 5-6 hours after vaccine administration.
Age: 51.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Arthralgia, Diarrhoea, Myalgia, Pyrexia
Clinical narrative: Pt had #1 vaccine Hep B did not report adverse Rxn. Came for vaccine #2 Hep B denied previous issue and #2 given. She returned for #3 and states she had symptoms after #2 vaccine and #1 vaccine (both Hep B). She states she thought that sx after #1 was related to a virus at which sx were same after #2 she correlated it to vaccine. Sx: Fever, diarrhea, myalgia, joint pain.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Local swelling, Pyrexia
Clinical narrative: Swelling to (R) lower leg/foot, high temp, antibiotic Thursday - overnight at hospital - Friday ER visit.
Age: 1.03
Sex: F
Vaccine: DTAP, HEPA, MMR, PNC13, VARCEL
Symptoms: Convulsion, Pyrexia, Rash generalised, Rash morbilliform, Respiratory arrest
Clinical narrative: Fever up to 105.2 - had seizure. Measle like rash all over body. Post seizure child stopped breathing and ambulance called.
Age: 1.02
Sex: F
Vaccine: DTAP, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash generalised, Rash morbilliform
Clinical narrative: Fever of 102.5 with measle like rash all over body - went to PCP.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Oedema mouth
Clinical narrative: Upper left side  lip and mouth swelled when awakened next AM - took her regimen of Claritin (AM) and Zyrtec and Zantac (PM) and it cleared - has had angioedema in past from penicillin, black cohosh. Under allergists care and possibly may have had past reaction from flu shot but can't put a definite yes to this - forgot about it . Confirmed allergies were only penicillin.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Breast tenderness, Chest discomfort, Feeling hot
Clinical narrative: Given flu vaccine 4 PM at 10 PM pt reports feeling chest tightness and warm, tenderness at L breast implant site and L axilla. Took Advil and ASA with some relief. Today st afebrile with continued breast implant site tenderness.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Choking, Cough, Dysphagia, Dyspnoea, Throat irritation
Clinical narrative: Administered at approx 1415. 1500 small tickle in back of throat by 1700 it was difficult to swallow and I was unable to take a deep breath without choking/coughing. Felt like someone was holding my throat whenever I swallowed.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure immeasurable, Dizziness, Dyskinesia, Feeling abnormal, Loss of consciousness
Clinical narrative: Pt began complaining of dizziness and "feeling funny" within 30 seconds of receiving vaccine; body jerked back and pt appeared to lose consciousness for about 10-20 seconds followed by nausea; pt regained consciousness at this point and still complained mainly of nausea; tried to keep pt calm, fanned pt and attempted to get BP reading without success; 911 was called after pt jerked back at beginning of episode and they took over care.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Pt began complaining of dizziness and "feeling funny" within 30 seconds of receiving vaccine; body jerked back and pt appeared to lose consciousness for about 10-20 seconds followed by nausea; pt regained consciousness at this point and still complained mainly of nausea; tried to keep pt calm, fanned pt and attempted to get BP reading without success; 911 was called after pt jerked back at beginning of episode and they took over care.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling, Oral herpes, Pyrexia, Swollen tongue
Clinical narrative: High fever 103.5 on 9/7/13 lips, tongue were swollen received fever blisters on upper and lower lip - symptoms lasted until 9/11/13. Fever only lasted 1 day. Pt received Prednisone and Benadryl from urgent care.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Skin warm, Tenderness
Clinical narrative: Pt arm was swollen, warm, and tender to touch. Pt had to got to ER and got a steroid shot and BENADRYL.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature decreased, Bronchitis, Flushing, Headache, Malaise
Clinical narrative: -Got Immun. (flu) on 9/20. On Saturday 9/21 felt very ill - shaking, headaches, body aches, felt flushed. Still doesn't feel well. - Took temp Wed 9/25 - 91.1 degrees F - Lives with brother who currently has bronchitis.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Tremor
Clinical narrative: -Got Immun. (flu) on 9/20. On Saturday 9/21 felt very ill - shaking, headaches, body aches, felt flushed. Still doesn't feel well. - Took temp Wed 9/25 - 91.1 degrees F - Lives with brother who currently has bronchitis.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Diplopia, Dysphagia, Headache, Intensive care, Laboratory test
Clinical narrative: This spontaneous report as received from a physician refers to a 61 year old female patient with Igg deficiency. The patient had no pertinent medical history or drug reactions/allergies. On 13-SEP-2013 the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). Concomitant medications were not reported. The physician reported about a case of possible encephalitis after administration of ZOSTAVAX. On 18-SEP-2013, the patient developed diplopia. On 19-SEP-2013, the diplopia worsened and the patient had difficulty swallowing. She was admitted to the Hospital on 19-SEP-2013. She was transferred to the Intensive Care Unit (ICU) on 20-SEP-2013. Two Magnetic resonance imaging (MRI) of the brain have been normal. A provisional diagnosis of Myasthenia Gravis was made and the patient was started on plasma exchange. Since admission to the ICU, the patient has developed a neuropathic occipital headache radiating down her spine. The physician states that at the moment of the report, the patient was undergoing testing for possible encephalitis. Upon internal review Myasthenia Gravis was considered to be medically significant. Reporter considered the events caused significant disability or incapacity, and life threatening. The outcome of myasthenia gravis, neuropathic occipital headache radiating down her spine and plasma exchange was reported as not recovered/not resolved. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Myasthenia gravis, Nuclear magnetic resonance imaging brain normal, Plasmapheresis, Spinal pain
Clinical narrative: This spontaneous report as received from a physician refers to a 61 year old female patient with Igg deficiency. The patient had no pertinent medical history or drug reactions/allergies. On 13-SEP-2013 the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). Concomitant medications were not reported. The physician reported about a case of possible encephalitis after administration of ZOSTAVAX. On 18-SEP-2013, the patient developed diplopia. On 19-SEP-2013, the diplopia worsened and the patient had difficulty swallowing. She was admitted to the Hospital on 19-SEP-2013. She was transferred to the Intensive Care Unit (ICU) on 20-SEP-2013. Two Magnetic resonance imaging (MRI) of the brain have been normal. A provisional diagnosis of Myasthenia Gravis was made and the patient was started on plasma exchange. Since admission to the ICU, the patient has developed a neuropathic occipital headache radiating down her spine. The physician states that at the moment of the report, the patient was undergoing testing for possible encephalitis. Upon internal review Myasthenia Gravis was considered to be medically significant. Reporter considered the events caused significant disability or incapacity, and life threatening. The outcome of myasthenia gravis, neuropathic occipital headache radiating down her spine and plasma exchange was reported as not recovered/not resolved. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Influenza like illness, Oropharyngeal pain, Paraesthesia, Pruritus
Clinical narrative: Next day - achy back. Two days later - tingly, itchy face. Slight flu-like sx - runny nose, sore throat.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rhinorrhoea
Clinical narrative: Next day - achy back. Two days later - tingly, itchy face. Slight flu-like sx - runny nose, sore throat.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Pt received Fluzone vaccine 9/23/13 at 9 PM - 9/23/13 AM noted pain and bruising. 9/25/13 - redness to site and slight swelling at injection site.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Swelling at injection site immediately following vaccination.
Age: 45.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain and swelling at injection site and warm to touch. Left arm following PNEUMOVAX vaccination.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: Sore arm - red line running from immunization site around arm up to armpit.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Back pain, Erythema, Hyperhidrosis, Pain in extremity
Clinical narrative: After administering Flu and Pneumonia vaccines, within the couple of minutes, patient felt severe pain on his back and both legs with redness and sweat on his face with no breathing problems. After calling 911 and short evaluation from EMT personnel, after 10-15 minutes he said that he feels much better and he can walk without the pain. No treatment was given to hm and he refused to go to the hospital.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pyrexia, Rash generalised
Clinical narrative: Severe headache and fever for 1-2 days. All over body rash (small raised dots). Was visible on hands, arms, belly, legs. Patient used hydroxyzine and triamcinolone cream.
Age: 35.0
Sex: F
Vaccine: FLU3, HEP, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Swelling (L) upper arm.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: Patient stopped by pharmacy 2 days after receiving shot with a red raised rash around the injection site. Rash does not itch, but patient stated it burned and referred the patient to see her PCP.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: 09/20/13: Client reports rash appeared on legs at 9:00 PM and progressed to arms and trunk of body. Rash was itchy and red and progressively worsened by Saturday 9/21/13 AM.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Pain, Rash, Swelling
Clinical narrative: Rash, swelling, warmth, pain.
Age: 1.05
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Scab
Clinical narrative: This spontaneous report as received from a physician refers to a 12 month old female patient. The patient had no pertinent medical history and no drug allergy. On 13-SEP-2013 the patient was vaccinated with VARIVAX (Merck) (lot# reported as J003542325). There was no concomitant therapy. On 16-SEP-2013, the patient developed a few varicella like lesions on the buttocks, thigh and pubic region. Physician stated that when he saw the patient on 19-SEP-2013, he noted that the lesions are beginning to crust over. No treatment was given. No lab test was done. The outcome of event was reproted as not recovered/not resolved. Patient sought medical attention via office visit. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from an unknown age male consumer refers to himself. On an unknown date the patient might be vaccinated with a dose of ZOSTAVAX (lot #< expiration date, dose, route, indication not reported) but wasn't sure. On an unknown date the patient experienced shingles but wasn't sure and the patient did not clarify whether his "shingles" occurred before or after he might have possible received ZOSTAVAX. The outcome of the event was unknown. Additional information is not expected.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to 7 unspecified patients of unknown age and gender. The nurse reported that between 27-AUG-2013 and 06-SEP-2013, the patients received unspecified doses (in schedule) of GARDASIL (lot # H021861, expiry: 09-OCT-2015) 0.5 ml, intramuscularly. Nurse stated that the GARDASIL doses were exposed to 31F maximum for total of 1.5 hours cumulatively on 27-AUG-2013. No adverse effects reported. Follow up information has been received from the registered nurse, who stated that after reviewing office records, 4 patients (previously reported as 7 patients) had received the vaccinations. The patient identifiers were given and dates of birth. The patient concerning his report was 12 years old. This case is related with MARRS 1309USA003768, 1309USA012207, 1309USA012208. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to a 7 unspecified patients of unknown age and gender. The nurse reported that between 27-AUG-2013 and 06-SEP-2013, the patients received unspecified doses (in schedule) of GARDASIL (lot # H021861, expiry: 09-OCT-2015) 0.5 ml, intramuscularly. Nurse stated that the GARDASIL doses were exposed to 31F maximum for total of 1.5 hours cumulatively on 27-AUG-2013. No adverse effects reported. Follow up information has been received from the registered nurse, who stated that after reviewing office records, 4 patients (previously reported as 7 patients) had received the vaccinations. The patient identifiers were given and dates of birth. The patient had 15 years old. This case is related with MARRS 1309USA003768, 1309USA012208, 1309USA012209. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to 7 unspecified patients of unknown age and gender. The nurse reported that between 27-AUG-2013 and 06-SEP-2013, the patients received unspecified doses (in schedule) of GARDASIL (lot # H021861,expiry:09-OCT-2015) 0.5 ml, intramuscularly. Nurse stated that the GARDASIL doses were exposed to 31F maximum for total of 1.5 hours cumulatively on 27-AUG-2013. No adverse effects reported. Follow up information has been received from the registered nurse, who stated that after reviewing office records, 4 patients (previously reported as 7 patients) had received the vaccinations. The patient identifiers were given and dates of birth. The patient concerning his report was currently 14 years old. This case is related with MARRS 1309USA003768, 1309USA012207, 1309USA012209. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a administering pharmacist via field representative refers to an unknown age female patient. Pertinent medical history, drug reactions or allergies were not reported. In September 2013, "ess than two weeks ago", the patient was vaccinated with ZOSTAVAX (concentration, dose and lot number were not provided). Concomitant medications was not reported. On an unspecified day in September 2013, also reported as "shortly after receiving ZOSTAVAX" and "less than two weeks ago", the patient experienced an injection site reaction. The patient displayed a large swollen lump "the size of a golf ball", along with redness, tenderness and a red-hot feeling. The reporting pharmacist advised the patient to visit her family physician if the reaction did not improve. It was unspecified if the patient sought medical attention. At the time of this report, the patient's present status was unknown. The casual relationship between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Feeling hot, Injection site reaction, Swelling, Tenderness
Clinical narrative: This spontaneous report as received from a administering pharmacist via field representative refers to an unknown age female patient. Pertinent medical history, drug reactions or allergies were not reported. In September 2013, "ess than two weeks ago", the patient was vaccinated with ZOSTAVAX (concentration, dose and lot number were not provided). Concomitant medications was not reported. On an unspecified day in September 2013, also reported as "shortly after receiving ZOSTAVAX" and "less than two weeks ago", the patient experienced an injection site reaction. The patient displayed a large swollen lump "the size of a golf ball", along with redness, tenderness and a red-hot feeling. The reporting pharmacist advised the patient to visit her family physician if the reaction did not improve. It was unspecified if the patient sought medical attention. At the time of this report, the patient's present status was unknown. The casual relationship between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram head, Fall, Head injury, Syncope
Clinical narrative: Pt had vasovagal reaction, passed out and hit her head on the floor.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram, Head injury, Loss of consciousness, Presyncope
Clinical narrative: Pt had vasovagal reaction, passed out and hit her head on the floor.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Blood prolactin normal, C-reactive protein increased, Erythema, Injection site cellulitis, Intensive care
Clinical narrative: Pt developed fever/chills 6-7 hrs post-vaccination. Was admitted to hospital later that night. Developed cellulitis in his entire upper (R) arm. Progressed to sepsis, pt admitted to ICU for 2-3 days, released from hospital around 9/19/13. This may have already been reported by the hospital.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Local swelling, Pyrexia, Septic shock
Clinical narrative: Pt developed fever/chills 6-7 hrs post-vaccination. Was admitted to hospital later that night. Developed cellulitis in his entire upper (R) arm. Progressed to sepsis, pt admitted to ICU for 2-3 days, released from hospital around 9/19/13. This may have already been reported by the hospital.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Chills, Injection site cellulitis, Intensive care, Pyrexia, Sepsis
Clinical narrative: Pt developed fever/chills 6-7 hrs post-vaccination. Was admitted to hospital later that night. Developed cellulitis in his entire upper (R) arm. Progressed to sepsis, pt admitted to ICU for 2-3 days, released from hospital around 9/19/13. This may have already been reported by the hospital.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Erythema, Local swelling, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 years male patient with none drug reaction. On 20-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot # J002865, exp 07-JUN-2014, 0.65 ml, subcutaneous). The pharmacist reported that the patient developed redness, swelling and warmth in an area about 3 inches by 2 inches around the injection site where ZOSTAVAX was administered. The patient took BENADRYL (manufacturer unknown) for a few days and then went to an unspecified physician on 23-SEP-2013 who diagnosed him with having "cellulitis" and prescribed an unspecified antibiotic (manufacturer unknown). The outcome of diagnosed him with having cellulitis was reported as recovering/resolving. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 years male patient with none drug reaction. On 20-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot # J002865, exp 07-JUN-2014, 0.65 ml, subcutaneous). The pharmacist reported that the patient developed redness, swelling and warmth in an area about 3 inches by 2 inches around the injection site where ZOSTAVAX was administered. The patient took BENADRYL (manufacturer unknown) for a few days and then went to an unspecified physician on 23-SEP-2013 who diagnosed him with having "cellulitis" and prescribed an unspecified antibiotic (manufacturer unknown). The outcome of diagnosed him with having cellulitis was reported as recovering/resolving. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Eye swelling, Lip swelling
Clinical narrative: Angioedema to face few hours after flu vaccine given.
Age: 17.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Angioedema
Clinical narrative: Angioedema to face few hours after flu vaccine given.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Crying, Erythema, Fatigue, Flushing
Clinical narrative: injection site pain, body aches, fatigue, fever of 104 by midnight, crying, chills, severe arm pain, complaints of shock like shooting pains in hands and feet, flushed red skin, nausea, pain on deep breath, sleeping for hours.  treated with ibuprofen 400 to 600 mg every 4-6 hours.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: injection site pain, body aches, fatigue, fever of 104 by midnight, crying, chills, severe arm pain, complaints of shock like shooting pains in hands and feet, flushed red skin, nausea, pain on deep breath, sleeping for hours.  treated with ibuprofen 400 to 600 mg every 4-6 hours.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Shock, Somnolence
Clinical narrative: injection site pain, body aches, fatigue, fever of 104 by midnight, crying, chills, severe arm pain, complaints of shock like shooting pains in hands and feet, flushed red skin, nausea, pain on deep breath, sleeping for hours.  treated with ibuprofen 400 to 600 mg every 4-6 hours.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: About 12 hours after receiving the vaccine, I developed a red, itchy, raised hive about 1 inch in diameter at the injection site.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Balance disorder, Chills, Dizziness, Hyperhidrosis, Injection site pain
Clinical narrative: First had mild nausea and pain at injection site. Nausea continued to worsen, injection site was swollen @ 8:00 pm. Began wrenching at 8:30 pm. With chills and body aches. By 9:30 pm could barely sit up due to extreme nausea and dizziness. Started going from sweats to chills every 15-30 minutes. Lay on bathroom floor until 11:00 pm. Able to get into bed and wretch into plastic bag for rest of the night. Woke up nauseous with body aches and unsteadiness.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site swelling, Nausea, Pain, Vomiting
Clinical narrative: First had mild nausea and pain at injection site. Nausea continued to worsen, injection site was swollen @ 8:00 pm. Began wrenching at 8:30 pm. With chills and body aches. By 9:30 pm could barely sit up due to extreme nausea and dizziness. Started going from sweats to chills every 15-30 minutes. Lay on bathroom floor until 11:00 pm. Able to get into bed and wretch into plastic bag for rest of the night. Woke up nauseous with body aches and unsteadiness.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Herpes zoster
Clinical narrative: Shingles blisters on right leg near the knee.  Sought medical help on 9/2/2013. Taking acyclovir.