chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: CSF culture, Guillain-Barre syndrome
Clinical narrative: Patient now presents with Guillain-Barre syndrome to Medical Center 1 week after flu vaccine. There is no other obvious source of infection, CSF cultures/tests are pending for viral/bacterial infections. The exact date and time of vaccination is unclear, but patient states roughly 1 week before symptoms started (which clearly started on 9/12/2013).
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site rash
Clinical narrative: Injection site red, nodule noted small bumps in area. Ice packs to area. Benadryl for itching at site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: 2 day post vac 3x6 cm rash warm rasied hwere Rx L arm.
Age: 44.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Diarrhoea, Ear pain, Headache, Pain
Clinical narrative: Adverse reactions severe body aches, including spine and neck, headache, ear pain, diarrhea. Symptoms increased. Today body aches are less.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Swollen left arm and tenderness around the immunization area. Also has a slight redness about 4 cm below the immunization area. Left arm pain. Treatmen: Naproxen DR 500mg B10x1 wk, Toradol injection adn Keflex (per ER visit).
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Dyskinesia, Pallor
Clinical narrative: Patient became pale was standing sat in chair - 3-4 jerks of arms lasted < 15 seconds. Patient able to lay on table. Felt improved within 5 minutes. Patient had not eaten all day.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Musculoskeletal stiffness, Neck pain
Clinical narrative: 9:30 AM 15 min after receiving flu injection c/o "warm feeling and stiffness" in (R) arm. Reports usually occurs after inject. but "lasting longer this time" c/o pain in neck. BP 138/74. Pulse 76 Reg. Denies SOB, swelling, itching. 9:45 - pain in neck subsiding client took own ibuprofen (OTC).
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Computerised tomogram head normal, Head injury, Headache, Syncope, Vomiting
Clinical narrative: Syncope -> head injury with HA and vomiting -> sent to ER for head CT (neg).
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Full blood count, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, pain, erythema, increased warmth at injection site. Dizziness, fever 102, myalgias.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Myalgia, Pyrexia
Clinical narrative: Swelling, pain, erythema, increased warmth at injection site. Dizziness, fever 102, myalgias.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Dyskinesia, Gaze palsy, Hypotonia, Immediate post-injection reaction, Moaning
Clinical narrative: Gave HPV, VAR in (R) arm. Immediately after giving Hep A in (L) del, patient became limp, (remained sitting up), eyes briefly rolled back, had a few general jerking motions, stood up, eyes open, moaned and was unresponsive. Lasted approx 30 seconds, possibly less. Then said "What happened?" Instructed to sit on the floor. VSS monitored. Mid level practitioner eval, EMS called. Not transported.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: Gave HPV, VAR in (R) arm. Immediately after giving Hep A in (L) del, patient became limp, (remained sitting up), eyes briefly rolled back, had a few general jerking motions, stood up, eyes open, moaned and was unresponsive. Lasted approx 30 seconds, possibly less. Then said "What happened?" Instructed to sit on the floor. VSS monitored. Mid level practitioner eval, EMS called. Not transported.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Injection site bruising, Injection site pain, Muscular weakness
Clinical narrative: 9/11/13 Pain at site of injection and weakness in arm. Bruising from injection site to elbow continuing through 9/16/13. 9/12/13 Diarrhea started and continued through 9/16/13.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 26.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Pyrexia, Rash, Scab
Clinical narrative: Student with 4 days fever - on day 2 of fever rash developed. Seen today with crusted over vesicles.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Blister, Cerebrovascular accident, Erythema, Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer (patient's daughter), refers to a 89 year old male patient with none pertinent medical history. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) (dose and route not reported). Concomitant therapy was not reported. The patient's daughter reported that her father experienced on an unknown date, about two years after being vaccinated with ZOSTAVAX, "shingles, big swollen blisters, a red line from the back of the head down the side of the face, nerve pain, tingling, weakness, and a stroke." The patient's daughter stated her father was "treated with a gel type substance (unspecified name, dosage/frequency, and manufacturer) for the shingles in the eye, and a prescription (unspecified name, dosage/frequency, and manufacturer) for nerve pain." The patient was also taking an unspecified blood pressure medication prescribed for prevention of a second stroke, not prescribed for high blood pressure (also reported as a concomitant therapy). The reporter stated, "she did not think her father's stroke was related to receiving ZOSTAVAX. At the time of the report the patient's outcome was recovering. Upon internal review the stroke was considered other important medical event. Additional information has been requested.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia, Ophthalmic herpes zoster, Paraesthesia
Clinical narrative: This spontaneous report as received from a consumer (patient's daughter), refers to a 89 year old male patient with none pertinent medical history. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) (dose and route not reported). Concomitant therapy was not reported. The patient's daughter reported that her father experienced on an unknown date, about two years after being vaccinated with ZOSTAVAX, "shingles, big swollen blisters, a red line from the back of the head down the side of the face, nerve pain, tingling, weakness, and a stroke." The patient's daughter stated her father was "treated with a gel type substance (unspecified name, dosage/frequency, and manufacturer) for the shingles in the eye, and a prescription (unspecified name, dosage/frequency, and manufacturer) for nerve pain." The patient was also taking an unspecified blood pressure medication prescribed for prevention of a second stroke, not prescribed for high blood pressure (also reported as a concomitant therapy). The reporter stated, "she did not think her father's stroke was related to receiving ZOSTAVAX. At the time of the report the patient's outcome was recovering. Upon internal review the stroke was considered other important medical event. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Ocular hyperaemia, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Very high fever, red eyes, runny nose, sore throat.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysstasia, Feeling abnormal, Gait disturbance, Hyperhidrosis
Clinical narrative: Sweating and dizzy, head felt weird. Unable to stand or walk straight. Color was green and felt nauseated. Tx: Laid down.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Skin discolouration
Clinical narrative: Sweating and dizzy, head felt weird. Unable to stand or walk straight. Color was green and felt nauseated. Tx: Laid down.
Age: 17.0
Sex: F
Vaccine: FLUN4, HEPA, HPV4, VARCEL
Symptoms: Chest X-ray normal, Dyspnoea, Electrocardiogram normal, Local reaction, Palpitations
Clinical narrative: Pt. had localized reaction. Stated they felt heart racing and trouble breathing. Sent to ER. Gave Benadryl OTC for localized reaction, where Varicella vaccine was given. Reaction occurred 24 hours after administration.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Softball sized red area on left arm resulting in significant pain and inflammation resulting in decreased mobility.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Condition aggravated, Cough, Gait disturbance, Joint swelling
Clinical narrative: I noticed aching in my joints the evening that I received the flu shot. The swelling and pain in my joints grew worse each day until on 9/14 at 10:20 AM, I went to the Urgent Care facility. I had a fever of 101, could barely walk and could not put weight on my hands. The pain was extreme. I was given a Demerol shot and prescribed Benadryl and Tylenol. Today, 9/16, the swelling and pain have decreased so that I can move around but it is still very swollen and painful. Last night I had a fever of 99.9 but I don't have one now.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Urine analysis normal, Weight bearing difficulty
Clinical narrative: I noticed aching in my joints the evening that I received the flu shot. The swelling and pain in my joints grew worse each day until on 9/14 at 10:20 AM, I went to the Urgent Care facility. I had a fever of 101, could barely walk and could not put weight on my hands. The pain was extreme. I was given a Demerol shot and prescribed Benadryl and Tylenol. Today, 9/16, the swelling and pain have decreased so that I can move around but it is still very swollen and painful. Last night I had a fever of 99.9 but I don't have one now.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Bed rest, Chills, Decreased appetite, Dizziness, Headache
Clinical narrative: CHILLS, FREQUENT URINATION, SLEEPLESSNESS: 1 TO 4 AM; THEN EXTREME SWEATING (WITHOUT FEVER) AND DIZZINESS/VERTIGO: 4 TO 6 AM. BOTH TREATED WITH BEDREST. 6 AM TO NOON, HEADACHE, MALAISE AND LOSS OF APPETITE. TYLENOL AND BEDREST.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Insomnia, Malaise, Pollakiuria, Vertigo
Clinical narrative: CHILLS, FREQUENT URINATION, SLEEPLESSNESS: 1 TO 4 AM; THEN EXTREME SWEATING (WITHOUT FEVER) AND DIZZINESS/VERTIGO: 4 TO 6 AM. BOTH TREATED WITH BEDREST. 6 AM TO NOON, HEADACHE, MALAISE AND LOSS OF APPETITE. TYLENOL AND BEDREST.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Fine rash, no urticaria.
Age: 38.0
Sex: F
Vaccine: FLU3, HEPA, TDAP, TYP
Symptoms: Pruritus, Rash
Clinical narrative: Pimple-like rash with extreme itching, resolved next day, reappeared after next dose, extending to chest, back.
Age: 45.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Arthralgia, Chest discomfort, Cough, Eye pruritus, Fatigue
Clinical narrative: Fatigue, sore throat, light coughing, chest heaviness, swollen lower lip, itchy eyes, muscle aches in leg joints.
Age: 45.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Lip swelling, Myalgia, Oropharyngeal pain
Clinical narrative: Fatigue, sore throat, light coughing, chest heaviness, swollen lower lip, itchy eyes, muscle aches in leg joints.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: Fever/chills two days.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Cyanosis, Feeling hot, Pain, Rash, Skin discolouration
Clinical narrative: Pain, swelling, rash, black & blue, very hot. Started to go away on 9/16/2013. Have not had problems in the past, this was a double shot.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Swelling
Clinical narrative: Pain, swelling, rash, black & blue, very hot. Started to go away on 9/16/2013. Have not had problems in the past, this was a double shot.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Loss of consciousness, Pyrexia
Clinical narrative: I had a fever of 101.6 for all of the night. At 5:00 AM I passed out in the bathroom and felt awful. After sleeping a few more hours I began to feel better. I have never had a reaction to a flu shot before, and have been getting them for around 20 years. I took acetaminophen for the fever.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Musculoskeletal stiffness, Pain, Skin warm
Clinical narrative: Large area of redness and swelling, like a band around the outside of her arm, felt warm to the touch but no bumps. Also felt leg stiffness and slight pain.
Age: 20.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site rash
Clinical narrative: Bumpy rash on upper arm where shot was delivered. Not itchy.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: 3 red welts at injection site & around (round in nature), hot to touch, & slightly painful. Use Benadryl, hydrocortisone cream, and ice to site.
Age: 25.0
Sex: M
Vaccine: SMALL, YF
Symptoms: Activities of daily living impaired, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Pt experienced fever, body aches, extreme fatigue, headaches.   Missed 1 day off of work and caused to him to go home early on 2nd day.  Had sx's for 3 days.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Crying, Screaming, Staring
Clinical narrative: Three scary days of prolonged periods of high pitched screaming, staring at the ceiling, and inconsolability. I wasn't going to report this, but then I figured if no one reports adverse reactions, what good is that?
Age: 73.0
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Dizziness, Faecal incontinence, Muscle contractions involuntary, Pyrexia
Clinical narrative: Very high fever, dizziness, loss of bowel and bladder control, loss of muscle control, diarrhea.
Age: 73.0
Sex: M
Vaccine: FLUX
Symptoms: Urinary incontinence
Clinical narrative: Very high fever, dizziness, loss of bowel and bladder control, loss of muscle control, diarrhea.
Age: 10.0
Sex: F
Vaccine: HEP, HEPA, IPV, TDAP, VARCEL
Symptoms: Bacterial test negative, Full blood count normal, Herpes simplex serology negative, Polymerase chain reaction, Pyrexia
Clinical narrative: Severe vesicular rash, fever involving several dermatomes (R) leg upper anterior lateral posterior perineum - also lesions on lower abd, few on chest.
Age: 10.0
Sex: F
Vaccine: HEP, HEPA, IPV, TDAP, VARCEL
Symptoms: Rash vesicular, Skin lesion, Tuberculin test negative, Varicella virus test positive, Viral test negative
Clinical narrative: Severe vesicular rash, fever involving several dermatomes (R) leg upper anterior lateral posterior perineum - also lesions on lower abd, few on chest.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Eye discharge, Lacrimation increased, Ocular hyperaemia
Clinical narrative: Pt presented with blood shot eyes, watering and discharge. No rash at injection site. Pt has 2 new medications.
Sex: U
Vaccine: HPV4
Symptoms: Aphasia, Convulsion, Encephalitis autoimmune
Clinical narrative: This spontaneous report as received from a consumer refers to her cousin of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot #, expiration, dose, route unspecified). On an unknown date the patient developed "MDMA anti-receptor encephalitis" after receiving GARDASIL. As a result, the patient lost the ability to speak and began having seizures. The events outcome was unknown. Upon internal review, the event of "MDMA anti-receptor encephalitis" was considered as medically significant. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Ear swelling, Erythema
Clinical narrative: Redness on cheek, swelling of both ears of vaccines were given. Immediately administered 0.15 mL of epinephrine. Watched pt for 10 mins. until redness and swelling went down.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUN4, MMRV
Symptoms: Culture negative, Pyrexia, Streptococcus test negative
Clinical narrative: Prolonged fever x5 days.
Age: 31.0
Sex: F
Vaccine: MMR, TD, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Localized reaction, raised, itchy, tender, erythematous, round mass surrounding injection site. 5cm x 5cm.
Age: 31.0
Sex: F
Vaccine: MMR, TD, VARCEL
Symptoms: Local reaction
Clinical narrative: Localized reaction, raised, itchy, tender, erythematous, round mass surrounding injection site. 5cm x 5cm.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Local swelling
Clinical narrative: Pain/soreness back of left arm started 9-10-13. Felt pain in same location at time of injection. Soreness at site of injection lasted 1-2 days. No redness/warmth. Feels a bump to side of vaccination site. Client is very concerned.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No medical history or drug reactions/allergies were reported. The nurse reported that on 28-NOV-2012, the patient received PREVNAR (Lot#, dose and route not provided) and then, on 27-DEC-2012, the patient received PNEUMOVAX23 (lot#, dose and route not provided); less than the 8 minimal interval. No adverse effect were reported. Additional information has been requested.
Age: 1.59
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash generalised, Rash papular
Clinical narrative: Erythematous papular rash all over the body including scalp. Fever 102 F. Treated with Acetaminophen and Benadryl elixir.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: After administration the patient developed swelling and redness at the site behind the left arm. The patient was given Benadryl and an ice pack.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Rash all over body.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Discomfort, Fatigue, Muscle twitching, Myalgia
Clinical narrative: Muscle aches began throughout body.  Extreme fatigue.  Discomfort with some muscle or nerve twitching in neck and face.  Muscle aches in abdomen to upper thighs moderate.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Amnesia, Asthenia, Blood test, Blood urine present, Decreased appetite
Clinical narrative: Weakness, lethargy, loss of appetite, inability to concentrate, some memory loss, dizziness, blood in urine, fainting spells and lightheaded symptoms.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Disturbance in attention, Dizziness, Lethargy, Syncope, Urine analysis
Clinical narrative: Weakness, lethargy, loss of appetite, inability to concentrate, some memory loss, dizziness, blood in urine, fainting spells and lightheaded symptoms.
Age: 0.44
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV
Symptoms: Basophil percentage increased, Bronchial hyperreactivity, Chest X-ray abnormal, Fontanelle bulging, Haematocrit normal
Clinical narrative: Bulging fontanelle.
Age: 0.44
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV
Symptoms: Haemoglobin normal, Lymphocyte percentage increased, Monocyte percentage, Neutrophil percentage decreased, Platelet count normal
Clinical narrative: Bulging fontanelle.
Age: 0.44
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV
Symptoms: Urine analysis normal, Viral infection, White blood cell count increased
Clinical narrative: Bulging fontanelle.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Glossodynia, Lip blister, Lip exfoliation, Lip pain, Lip swelling
Clinical narrative: My lips started burning and itching. They then became swollen and painful. The tonsils on the back of my tongue hurts. On Sunday (9/14), my outer and inner lips had purple and red blisters. Today, 9/15, the skin is peeling off my lips. My inner checks and tongue hurt and feel a little swollen. My lips hurt very bad.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema mouth, Oral discomfort, Oral pain, Pruritus, Swollen tongue
Clinical narrative: My lips started burning and itching. They then became swollen and painful. The tonsils on the back of my tongue hurts. On Sunday (9/14), my outer and inner lips had purple and red blisters. Today, 9/15, the skin is peeling off my lips. My inner checks and tongue hurt and feel a little swollen. My lips hurt very bad.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Tonsillar disorder
Clinical narrative: My lips started burning and itching. They then became swollen and painful. The tonsils on the back of my tongue hurts. On Sunday (9/14), my outer and inner lips had purple and red blisters. Today, 9/15, the skin is peeling off my lips. My inner checks and tongue hurt and feel a little swollen. My lips hurt very bad.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Anxiety, Arthritis, Coronary artery disease, Depression, Fatigue
Clinical narrative: High Blood Pressure. Anxiety. Depression. Hypothyroid condition. Fatigue. Easy to catch colds. Arthritis. Coronary artery disease. Was administered 6 Anthrax shots over scheduled time period from 1998 through 1999. Bioport manufactured. Including contaminated lots. Prior to these vaccinations I had no significant illnesses or problems.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Hypertension, Hypothyroidism, Infection susceptibility increased, Product contamination
Clinical narrative: High Blood Pressure. Anxiety. Depression. Hypothyroid condition. Fatigue. Easy to catch colds. Arthritis. Coronary artery disease. Was administered 6 Anthrax shots over scheduled time period from 1998 through 1999. Bioport manufactured. Including contaminated lots. Prior to these vaccinations I had no significant illnesses or problems.
Age: 65.0
Sex: F
Vaccine: DTPHIB, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Site of injection felt like burning, area very red, hot and hard.  Prescribed antibiotics, redness continued to grow to 2 1/2" x 4 1/2" area, remained red, hot and hard for 4 days.
Age: 1.91
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Emotional distress, Fatigue
Clinical narrative: Child had such a huge meltdown the night he got the shot - it was a cross between a really bad night terror and what I thought was a seizure. I could not calm him down for over an hour. Happened about 5-7 times since, plus he has been extremely tired, he is just not himself.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Injection site urticaria
Clinical narrative: Gave HPV (GARDASIL). About 10 minutes later 1/2 to 1 in below injection site (L) deltoid - hive started - grew larger to about size of 4x4. 3 PM BENADRYL 25mg administered as directed by Dr. Checked 330 PM - hives subsiding and fading.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Discomfort, Erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Rec'd vaccination PPV 23 9/10/13 at 3:05 pm, 4 hours later noticed mild pain and swelling around vaccination area progressed to his left axilla area erythema 80x60 mm then seen 9/12/13 to 160mm x 110mm. Given ice and TYLENOL for discomfort. No s/s discomfort, no wheezing, SOB, no lymphadenopathy, no chest tightness, no abdominal pain.
Age: 74.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Dyspnoea, Erythema, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Patient received ZOSTAVAX on 09.11.2013 in (R) arm and 2013/2014 influenza vaccine in (L) arm. On 09.12.13, patient woke up with site reaction on (R) arm at origin of ZOSTAVAX. Red double ring around injection site and painful as well as difficulty breathing. Presents on 9.15.13 at pharmacy with arm red and swollen.
Age: 74.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Local swelling
Clinical narrative: Patient received ZOSTAVAX on 09.11.2013 in (R) arm and 2013/2014 influenza vaccine in (L) arm. On 09.12.13, patient woke up with site reaction on (R) arm at origin of ZOSTAVAX. Red double ring around injection site and painful as well as difficulty breathing. Presents on 9.15.13 at pharmacy with arm red and swollen.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Ear pain, Heart rate increased, Oropharyngeal pain
Clinical narrative: SOB/wheezing; ear throbbing/sore throat; increase heart rate; chills; inflammation of salivary glands.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Parotid gland inflammation, Wheezing
Clinical narrative: SOB/wheezing; ear throbbing/sore throat; increase heart rate; chills; inflammation of salivary glands.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Dyskinesia, Syncope
Clinical narrative: Patient fainted after shot at 09:00, when laid back on bed started clenching fists for less than a minute and stopped. TX: Patient laid on back with feet elevated on pillow vs checked continuously.
Age: 40.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Lip swelling, Local swelling, Tenderness
Clinical narrative: Patient states on Sat 9-14-13 (RA) swollen, red, tender then upper lip was swollen but no respiratory problems, hives or temperature. Patient stated he took 2 doses of BENADRYL in 12 hours and 1 dose of ZYRTEC. Symptoms were resolved by 10pm on 9/14/13. As of today 9/16/13 (RA) slightly red, swollen.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient reported (12 days post vaccine) still experiencing mild to moderate pain in the arm of vaccination. No swelling or redness reported. No other symptoms reported.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Full blood count, Immediate post-injection reaction, Injection site erythema, Injection site nodule, Injection site reaction
Clinical narrative: Pt has a knot come up right after injection under skin. Now red whelp measures 6 mm x 20 mm. Also red surrounding red whelp. Varicella.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Urticaria
Clinical narrative: Pt has a knot come up right after injection under skin. Now red whelp measures 6 mm x 20 mm. Also red surrounding red whelp. Varicella.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dizziness, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: Headache immediately, spike in blood pressure, dizziness, swelling and pain at injection site after 10 minutes.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Headache immediately, spike in blood pressure, dizziness, swelling and pain at injection site after 10 minutes.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Bronchospasm
Clinical narrative: Pt. received shot. Pt. called 9-1-13 and spoke to RPh on duty and reported bronchospasm = 6 hr after shot. Had to get Rx for albuterol inhaler. Currently doing fine. Pt. has hx of pneumonia. No other symptoms reported.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a Nurse Practitioner refers to a 26 year old pre-diabetic female patient with hyperthyroidism, mild asthma and no drug reactions/allergies. The patient's medical history included chickenpox as child. On 04-SEP-2013 the patient was vaccinated with a dose of VARIVAX lot # J003361, expiring 29-MAR-2015, subcutaneous (dose not reported). Concomitant therapies included Propylthiouracil. The patient was 5 weeks pregnant when received VARIVAX. No adverse event was reported. The patient's LMP was approximately of 31-JUL-2013 and EDD of 07-May-2014. No treatment was given. No lab diagnostic tests were performed. The patient sought medical attention by an office visit. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse reported a patient was administered the first dose of RECOMBIVAX HB (1 ml, intramuscular, lot # and exp date were not reported) in December 2011 and was in the office on 05-SEP-2013, to receive the second dose of RECOMBIVAX HB (1 ml, intramuscular, lot # and exp date were not reported). No adverse effects reported. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Accidental exposure to product, Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received a physician and from an office administrator refers to a 26 year old female patient with no pertinent medical history. On 06-SEP-2013 the patient was inadvertently vaccinated with her first dose of GARDASIL (lot # J002641, expiration date 10-DEC-2015, 0.5ml, intramuscularly). There was no concomitant medication. The patient became pregnant with LMP of 11-JAN-2013 and EDD of 18-OCT-2013. Initial exposure to GARDASIL was at 34 week(s). No lab diagnostics studies performed. The patient did not seek medical attention. The pregnancy outcome was outcome pending. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer of unknown age and gender, as part of a marketing research program conducted, regarding on himself/herself. In November, the patient was vaccinated with a dose of zoster vaccine live (manufacturer unknown) (route, dose and lot # not reported). On 09-SEP-2013, "2 days ago", the patient experienced shingles despite past vaccination. The outcome of had shingles despite past vaccination was unknown. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with no pertinent medical history or drug allergies. On 09-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot # J002692, expiry date: 30-APR-2014) 0.65 ml once subcutaneously. There was no concomitant medication. On an unknown date the patient developed a rash after vaccination. Patient called the pharmacy on 12-SEP-2013, and stated there is a rash on her back the size of a "quarter of half dollar". The outcome of the event was reported as not recovered. No treatment was given. No lab test was performed. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning a patient of unknown gender and age. On 21-SEP-2012 the patient was vaccinated with the first dose of GARDASIL. On 14-JUN-2013, the patient was vaccinated with the second dose of GARDASIL. The nurse reported that the patient was in the office on 12-SEP-2013 to receive the third dose of GARDASIL. No adverse symptoms were reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: This spontaneous report as received from a physician, via company representative, refers to a 70 year old female report. On approximately 30-AUG-2013 (reported as one week ago), the patient was vaccinated with ZOSTAVAX (dose, route and lot umber were not reported). Concomitant medications were not reported. The physician reported that the patient developed blisters on her feet and lower legs, about one week after being vaccinated with ZOSTAVAX, on approximately 06-SEP-2013. The patient was treated with a cream (unspecified). The outcome of blisters on her feet and lower legs was reported as recovering/resolving. Patient had a office visit on an unknown date. The relationship between ZOSTAVAX and the blisters was not reported. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL dose 2 (dose, route and lot number not provided). On an unknown date, after receiving the 2nd dose of GARDASIL, the patient developed a rash on her legs and arms. The patient was given BENADRYL dosage (manufacture and dose unspecified) as treatment of the adverse event. The outcome of rash on her legs and arms was unknown. The causal relationship was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Erythema, Face oedema, Headache
Clinical narrative: This spontaneous report was received from a 66 year old female consumer refers to herself. No concomitant medication and pertinent medical history were reported. Drug reactions/allergies to penicillin and sulfa drugs, unspecified reaction to "a smallpox vaccine booster dose sometime in the 1960's". On 23-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # unspecified) subcutaneous injection at her right arm. After vaccination, she first developed a bad headache. The next day, on 24-AUG-2013 she developed a lump on her arm at the injection site and began to get very achy with a lot of joint and muscle pain that was mostly on her right side (her injection site). She reported pain also in her hips and back. She first spoke with an unspecified pharmacist about her reaction. On 25-AUG-2013, she had "facial edema" and her face "felt tight",. She saw an unspecified doctor on 26-AUG-2013, and the  doctor told her to continue treatment with ice and BENADRYL. The patient could not confirm whether or not the redness on her skin was a rash, but she stated that the redness was itchy and "a little like a rash". No lab diagnostics studies were performed. At the time of report, the outcome of the events was recovering. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Myalgia, Pain, Pruritus, Skin tightness
Clinical narrative: This spontaneous report was received from a 66 year old female consumer refers to herself. No concomitant medication and pertinent medical history were reported. Drug reactions/allergies to penicillin and sulfa drugs, unspecified reaction to "a smallpox vaccine booster dose sometime in the 1960's". On 23-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # unspecified) subcutaneous injection at her right arm. After vaccination, she first developed a bad headache. The next day, on 24-AUG-2013 she developed a lump on her arm at the injection site and began to get very achy with a lot of joint and muscle pain that was mostly on her right side (her injection site). She reported pain also in her hips and back. She first spoke with an unspecified pharmacist about her reaction. On 25-AUG-2013, she had "facial edema" and her face "felt tight",. She saw an unspecified doctor on 26-AUG-2013, and the  doctor told her to continue treatment with ice and BENADRYL. The patient could not confirm whether or not the redness on her skin was a rash, but she stated that the redness was itchy and "a little like a rash". No lab diagnostics studies were performed. At the time of report, the outcome of the events was recovering. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Vertigo
Clinical narrative: This spontaneous report was received from a consumer refers to his father of unknown age. On an unspecified date, the patient received a dose of ZOSTAVAX (lot# unspecified), (dose, route and location unspecified). The son reported that his father developed vertigo and uneasy feelings after being administered ZOSTAVAX. At the time of report, the outcome of vertigo and uneasy was unknown. Additional information is not expected.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report was received from a treating registered nurse via a company representative concerning a 52 year old male patient. on an unknown date (reported as recently), the patient was vaccinated with the second dose of PNEUMOVAX 23 (lot number, expiry date, dose and route unspecified) (date of administration of first dose was not given). No concomitant therapy was reported. On an unknown date, the patient experienced injection site reaction and cellulitis after the vaccination of second dose. The patient sought medical attention (doctor appointment). He was treated with unspecified antibiotics. It was unspecified if any lab tests were performed. The outcome of injection site reaction and cellulitis was unknown. The relatedness for injection site reaction and cellulitis was unknown for PNEUMOVAX23. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report was received from an 84 year old female patient with hypertrophic cardiomyopathy and codeine allergy. On an unknown date of 4 to 5 years ago, the patient was vaccinated with a dose of ZOSTAVAX (dose and lot # not reported). Concomitant therapies included losartan potassium (manufacturer unknown), metformin, TOPROL XL Tablets, and vitamins (unspecified) (all with unspecified manufacturer and dose). At the beginning of July 2013, the patient developed a rash on the right side of her breast extending under the arm and around to her back. The patient stated a few weeks later the pain accompanied the rash and she went to a walk-in clinic where she was diagnosed with "Shingles" and prescribed prednisone and NEURONTIN (manufacturer and dose not specified). No laboratory test was performed. The patient telephoned physician's office. The outcome of shingles was reported as not recovered. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: MMRV
Symptoms: Exposure during pregnancy, Menstruation delayed, Pregnancy test positive
Clinical narrative: This spontaneous report was received from the medical assistant and refers to an approximately 40 years old female patient. On 02-JUN-2006 the patient was vaccinated with PROQUAD (Merck). No concomitant medications were reported. On 22-OCT-2008 the patient was seen as a regular patient. The patient came into the office because she did not have her period in one month. The patient had a pregnancy test on 22-OCT-2008 which was positive. The patient had 1 child already. The patient's outcome and the relatedness between the event and the vaccination with PROQUAD (Merck) was not reported. This case is linked with MARRS # 0606USA04467 (Same Patient Link). Additional information is not expected.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood albumin decreased, Chest X-ray normal, Dehydration, Electrocardiogram normal, Feeding disorder neonatal
Clinical narrative: Patient woke up around 7 and was inconsolably crying and seemed quiet unhappy and uncomfortable.  She had a fever of 103 F. and when she wasn't crying she was looking uncomfortable and tired/quiet and "blank".  She also had a rash which was around her nose and mouth and a little around her eyes, it was red and seemed to be a sheet of read around those areas.  We gave her Tylenol as told to by the doctor and then went to the doctor around 11 AM (first we could get).  There they tested her for all sorts of viruses and took some blood to check for bacteria and then treated her with an antibiotic to be sure to cover their bases.  We continued with the fever reducers and monitoring her over the weekend as well as going back in Saturday for another intramuscular antibiotic dose.  She did not really improve and began to refuse the breast and the bottle.  We had to force feed her milk and Pedialyte just to get her to barely pee every 6 hours. When we went to the doctor's on Monday they sent us to the E.R. because she was "puny" and very dehydrated.  There she was further tested and observed and given fluids.  Her IV had to be put in by the "air care" team because of her dehydration.  She had a spinal tap because they were concerned about meningitis.  She was then admitted to the hospital and that evening her rash spread more and became more spot-like.  She also began to swell all over her whole body.  They gave her Benadryl, Tylenol, a new antibiotic because they worried the rash was allergic.  The rash was confirmed as not allergic and not viral later on.  I believe it was an autoimmune type of reaction within her whole body (meaning all her symptoms).  She also received a medication to reduce swelling because she had gone up a whole diaper size as a result of it (I cannot remember the name).  After a couple days her rash cleared and her swelling started to go down. Her fever remained hardly changed until they decided her immune system had been overwhelmed and to treat her with IV IG.  They had to treat her twice before they could rid her of the fevers she was having for this whole time.  She lost a few pounds in this process and I had to pump to keep my breast milk supply up.  This is my first baby and I am going to be scarred for life.  She did go home and has been doing well, but I will never ever forget this.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Livedo reticularis, Lumbar puncture normal, Neutrophil count decreased, Pyrexia
Clinical narrative: Patient woke up around 7 and was inconsolably crying and seemed quiet unhappy and uncomfortable.  She had a fever of 103 F. and when she wasn't crying she was looking uncomfortable and tired/quiet and "blank".  She also had a rash which was around her nose and mouth and a little around her eyes, it was red and seemed to be a sheet of read around those areas.  We gave her Tylenol as told to by the doctor and then went to the doctor around 11 AM (first we could get).  There they tested her for all sorts of viruses and took some blood to check for bacteria and then treated her with an antibiotic to be sure to cover their bases.  We continued with the fever reducers and monitoring her over the weekend as well as going back in Saturday for another intramuscular antibiotic dose.  She did not really improve and began to refuse the breast and the bottle.  We had to force feed her milk and Pedialyte just to get her to barely pee every 6 hours. When we went to the doctor's on Monday they sent us to the E.R. because she was "puny" and very dehydrated.  There she was further tested and observed and given fluids.  Her IV had to be put in by the "air care" team because of her dehydration.  She had a spinal tap because they were concerned about meningitis.  She was then admitted to the hospital and that evening her rash spread more and became more spot-like.  She also began to swell all over her whole body.  They gave her Benadryl, Tylenol, a new antibiotic because they worried the rash was allergic.  The rash was confirmed as not allergic and not viral later on.  I believe it was an autoimmune type of reaction within her whole body (meaning all her symptoms).  She also received a medication to reduce swelling because she had gone up a whole diaper size as a result of it (I cannot remember the name).  After a couple days her rash cleared and her swelling started to go down. Her fever remained hardly changed until they decided her immune system had been overwhelmed and to treat her with IV IG.  They had to treat her twice before they could rid her of the fevers she was having for this whole time.  She lost a few pounds in this process and I had to pump to keep my breast milk supply up.  This is my first baby and I am going to be scarred for life.  She did go home and has been doing well, but I will never ever forget this.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash erythematous, Streptococcus test negative, Ultrasound scan normal, White blood cell count increased
Clinical narrative: Patient woke up around 7 and was inconsolably crying and seemed quiet unhappy and uncomfortable.  She had a fever of 103 F. and when she wasn't crying she was looking uncomfortable and tired/quiet and "blank".  She also had a rash which was around her nose and mouth and a little around her eyes, it was red and seemed to be a sheet of read around those areas.  We gave her Tylenol as told to by the doctor and then went to the doctor around 11 AM (first we could get).  There they tested her for all sorts of viruses and took some blood to check for bacteria and then treated her with an antibiotic to be sure to cover their bases.  We continued with the fever reducers and monitoring her over the weekend as well as going back in Saturday for another intramuscular antibiotic dose.  She did not really improve and began to refuse the breast and the bottle.  We had to force feed her milk and Pedialyte just to get her to barely pee every 6 hours. When we went to the doctor's on Monday they sent us to the E.R. because she was "puny" and very dehydrated.  There she was further tested and observed and given fluids.  Her IV had to be put in by the "air care" team because of her dehydration.  She had a spinal tap because they were concerned about meningitis.  She was then admitted to the hospital and that evening her rash spread more and became more spot-like.  She also began to swell all over her whole body.  They gave her Benadryl, Tylenol, a new antibiotic because they worried the rash was allergic.  The rash was confirmed as not allergic and not viral later on.  I believe it was an autoimmune type of reaction within her whole body (meaning all her symptoms).  She also received a medication to reduce swelling because she had gone up a whole diaper size as a result of it (I cannot remember the name).  After a couple days her rash cleared and her swelling started to go down. Her fever remained hardly changed until they decided her immune system had been overwhelmed and to treat her with IV IG.  They had to treat her twice before they could rid her of the fevers she was having for this whole time.  She lost a few pounds in this process and I had to pump to keep my breast milk supply up.  This is my first baby and I am going to be scarred for life.  She did go home and has been doing well, but I will never ever forget this.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abnormal behaviour, Bacterial test, Crying, Dehydration, Depressed mood
Clinical narrative: Patient woke up around 7 and was inconsolably crying and seemed quiet unhappy and uncomfortable.  She had a fever of 103 F. and when she wasn't crying she was looking uncomfortable and tired/quiet and "blank".  She also had a rash which was around her nose and mouth and a little around her eyes, it was red and seemed to be a sheet of read around those areas.  We gave her Tylenol as told to by the doctor and then went to the doctor around 11 AM (first we could get).  There they tested her for all sorts of viruses and took some blood to check for bacteria and then treated her with an antibiotic to be sure to cover their bases.  We continued with the fever reducers and monitoring her over the weekend as well as going back in Saturday for another intramuscular antibiotic dose.  She did not really improve and began to refuse the breast and the bottle.  We had to force feed her milk and Pedialyte just to get her to barely pee every 6 hours. When we went to the doctor's on Monday they sent us to the E.R. because she was "puny" and very dehydrated.  There she was further tested and observed and given fluids.  Her IV had to be put in by the "air care" team because of her dehydration.  She had a spinal tap because they were concerned about meningitis.  She was then admitted to the hospital and that evening her rash spread more and became more spot-like.  She also began to swell all over her whole body.  They gave her Benadryl, Tylenol, a new antibiotic because they worried the rash was allergic.  The rash was confirmed as not allergic and not viral later on.  I believe it was an autoimmune type of reaction within her whole body (meaning all her symptoms).  She also received a medication to reduce swelling because she had gone up a whole diaper size as a result of it (I cannot remember the name).  After a couple days her rash cleared and her swelling started to go down. Her fever remained hardly changed until they decided her immune system had been overwhelmed and to treat her with IV IG.  They had to treat her twice before they could rid her of the fevers she was having for this whole time.  She lost a few pounds in this process and I had to pump to keep my breast milk supply up.  This is my first baby and I am going to be scarred for life.  She did go home and has been doing well, but I will never ever forget this.