chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Lobar pneumonia, Myalgia, Nausea, Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 17 December 2014 and follow-up information was received on 19 December 2014. A 77-years-old male patient, whose concomitant medications were not reported, had received a dose of FLUZONE QUADRIVALENT (Dose number, Batch number, expiry date, route and site of vaccination were not reported), on 16 December 2014. The patient had LASIX allergy and asthma as medical history. On 16 December 2014, after vaccination the patient had shivers, chills, myalgia, nausea and fever of body temperature 103F within the next few hours. By 9 pm he was disoriented and confused. He was taken to ER and diagnosed with Right Lower Lobe Pneumonia. On admission the patient's body temperature was about 101 and his blood lactic acid was elevated. He had no shortness of breath, bronchospasm, or any injection-site reaction. The patient had started on an antibiotic in the emergency room. The allergist consulted on the case who stated there was not IgG response to vaccine. Chest X-ray did not show definitive infiltrates. By 5 am on 17 Dec 2014, he was back to baseline with respect to his mental status and on the same day the patient was expected to be discharged from the hospital on an oral antibiotic. Illness at the time of vaccination, birth defects and medical conditions were unknown. At the time of this report, the outcome of the adverse events was not recovered. List of documents held by sender: none.
Age: 36.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Monocyte count increased, Unevaluable event
Clinical narrative: None stated.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Rash generalised
Clinical narrative: Reddening of cheeks, progressively worsened.  By 8AM on 12/29 the rash had spread all over the body.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site discolouration, Injection site pain, Weight bearing difficulty
Clinical narrative: Soreness and discoloration around injection site developed shortly after the injection.  Over the next day, soreness and discoloration spread from shoulder joint to half way down upper arm. Within several hours of injection, developed difficulty in lifting or preforming weight bearing activities with arm and restricted mobility of shoulder. Discoloration has diminished, but soreness and limited motion remain. Some ease of pain is received with Tylenol.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Staphylococcal infection
Clinical narrative: Rash on left elbow, bilateral groin, and inner thighs.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a multiple anonymous patients of unknown age. On an unknown date the patients were vaccinated with ROTATEQ (dose was not reported, route of administration defaulted to oral). On an unknown date the patients have been administered oral, ROTATEQ post supported excursion. No adverse effects noted by any patients. This is one of several reports from the same source. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Angioedema, Injection site nodule, Injection site pain, Pruritus, Swelling
Clinical narrative: On December 1, 2014 I had a routine physical exam at Doctors office. Doctor stated that because of my age; I was due for a tetanus shot. I have had a regular tetanus shot before years ago without any adverse reactions or side effects. I was not told by the doctor that I was getting a combination of Tetanus Toxoid, TDAP. I assumed it was a regular tetanus injection. But after the ADACEL I had pain a large nodule at the site and severe pruritus. The pruritus progress to through my body. Then large nodules and huge angioedemas began to surface and my extremities swelled. At that point I went to the hospital. They swellings were so large that a Doppler was done to see if a clot had formed. The swelling looked so bad that they looked infected. The attending put me on KEFLEX, BACTRIM and BENADRYL; none of them helped. Therefore I went to the doctor's office explained what happened and medication prescribed. When she seen the large swellings she wanted to do a Doppler also. I told her the hospital already did a Doppler on another swelling and it was negative for a clot. She diagnosed it as a reaction to ADACEL vaccine. Since BENADRYL wasn't working she ordered a prescription antihistamine, MEDROL Dosepak. I have two days left of medications. However, the intense itching has returned and the nodules are manifesting again. My problem started 1/12/2014 and 12/20/2014 I am still dealing with it. This is a bad vaccine. It should not be give to people over 50. Because anyone that has a reaction with this vaccine has have no way of knowing what part of the vaccine they are reacting to; the Pertussis and Diphtheria. Also, based on the testimonies of others it is not safe to mix these diseases; then overwhelm the immune system with this injection.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination complication
Clinical narrative: On December 1, 2014 I had a routine physical exam at Doctors office. Doctor stated that because of my age; I was due for a tetanus shot. I have had a regular tetanus shot before years ago without any adverse reactions or side effects. I was not told by the doctor that I was getting a combination of Tetanus Toxoid, TDAP. I assumed it was a regular tetanus injection. But after the ADACEL I had pain a large nodule at the site and severe pruritus. The pruritus progress to through my body. Then large nodules and huge angioedemas began to surface and my extremities swelled. At that point I went to the hospital. They swellings were so large that a Doppler was done to see if a clot had formed. The swelling looked so bad that they looked infected. The attending put me on KEFLEX, BACTRIM and BENADRYL; none of them helped. Therefore I went to the doctor's office explained what happened and medication prescribed. When she seen the large swellings she wanted to do a Doppler also. I told her the hospital already did a Doppler on another swelling and it was negative for a clot. She diagnosed it as a reaction to ADACEL vaccine. Since BENADRYL wasn't working she ordered a prescription antihistamine, MEDROL Dosepak. I have two days left of medications. However, the intense itching has returned and the nodules are manifesting again. My problem started 1/12/2014 and 12/20/2014 I am still dealing with it. This is a bad vaccine. It should not be give to people over 50. Because anyone that has a reaction with this vaccine has have no way of knowing what part of the vaccine they are reacting to; the Pertussis and Diphtheria. Also, based on the testimonies of others it is not safe to mix these diseases; then overwhelm the immune system with this injection.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Widespread shingles-like rash and redness, burning and itching, on both arms up to shoulders.  I have had shingles in the past (a few months before shot) but never in this area.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Pain, Pruritus
Clinical narrative: Widespread shingles-like rash and redness, burning and itching, on both arms up to shoulders.  I have had shingles in the past (a few months before shot) but never in this area.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Lymphadenopathy, Peripheral swelling, Vaccination complication
Clinical narrative: She started swelling in the deltoid, supraclavicular and axilla, likely lymph swelling.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Local reaction
Clinical narrative: Local injection site reaction w/ erythema, induration and pruritus approximately 25 cm in (L) thigh.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old male patient with penicillin allergy. On 30-NOV-2014 the patient was vaccinated with 0.65 ml ZOSTAVAX (lot # J014809, exp 20-FEB-2015) subcutaneous in an unspecified arm. On 01-DEC-2014, the patient developed a rash on that also developed into bubble-like lesions on 02-DEC-2014. The patient reported this rash via telephone and this was not assessed by the pharmacist. No treatment given to the events. No lab diagnostics studies performed. The patient did not seek medical attention. The outcome of the events was unknown. No PQC (Production Quality Control) involved. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Stomatitis
Clinical narrative: Sore inside left cheek, mouth, 2 day after shot, called ENT, went to ENT, for check up sore had gone.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. Current conditions and medical history was not reported. On 22-SEP-2012, the patient was vaccinated with first dose of GARDASIL injection, 0.5 milliliter (ml) intramuscular. Concomitant medications were not reported. On 18-JAN-2014, the patient received second dose of GARDASIL. The patient has not received dose number three yet. No adverse experience reported. Outcome of the events was not reported. Product quality complaint was not reported. No further information provided. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal pain, Periarthritis
Clinical narrative: Extreme left shoulder pain, frozen shoulder.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 21-DEC-2014 the patient was vaccinated with ZOSTAVAX 0.65ml, subcutaneous, lot # H012523, expiry date: 09-OCT-2013. On 21-DEC-2014 the patient received an expired dose of ZOSTAVAX. No adverse effect was reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 24 year old female patient. The reporter stated that the patient received her first dose of GARDASIL inj (lot# and expiration date not provided) (dose not reported) on 03-DEC-2007 and her second dose on 18-JUN-2008. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to an adult patient of unspecified age and gender. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with the first dose of VARIVAX (Merck) (dose, route of administration, anatomical location, lot# and exp. date were not provided). On an unknown date, the patient was vaccinated with the second dose of VARIVAX (Merck) (dose, route of administration, anatomical location, lot# and exp. date were not provided) No concomitant therapies were reported. On an unspecified date, in December 2014 (reported as "now"), the patient had no titers when lab work was done. The reporting physician queried if the patient  should receive a third dose of VARIVAX (Merck) (then had the titers retested 6-8 weeks post vaccination) and asked how the patient should be treated clinically. The outcome of the event was unknown. The relatedness between vaccination with VARIVAX (Merck) and the event was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 22-DEC-2014 the patient was vaccinated with an expired dose of RECOMBIVAX HB 0.5 ml, intramuscular, lot# 0384AE, expiry date: 02-NOV-2014). No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report as received from a representatives refers to a female patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot # K009809, EXP date 16-MAY-2015)(dose, frequency was unknown) in the left arm. The patient experienced strong pain on her left arm and was not able to raise it. The patient had search medical attention. The action taken and outcome of the event was unknown. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a multiple anonymous patients of unknown age. On an unknown date the patients were vaccinated with RECOMBIVAX HB (dose and route of administration were not provided). On an unknown date the patients have been administered RECOMBIVAX HB post supported excursion. No adverse effects noted by any patients. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a multiple anonymous patients of unknown age. On an unknown date the patients were vaccinated with GARDASIL, 0.5 ml, intramuscularly. On an unknown date the patients have been administered GARDASIL post supported excursion. No adverse effects noted by any patients. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager/medical assistant refers to an unknown number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies were reported. Since 03-DEC-2014 doses of PNEUMOVAX 23, which underwent supported temperature excursions, have been administered to unknown number of patients (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects were reported. No concomitant therapies were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager/medical assistant refers to an unknown number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies were reported. Since 03-DEC-2014 doses of GARDASIL, which underwent supported temperature excursions, have been administered to unknown number of patients for vaccination (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects were reproted. No concomitant therapies were reported. This is one of several reports received from the same reproter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager/medical assistant refers to an unknown number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies were reported. Since 03-DEC-2014 doses of PEDVAXHIB, which underwent supported temperature excursions, have been administered to unknown number of patients (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects were reported. No concomitant therapies were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager/medical assistant refers to an unknown number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies were reported. Since 03-DEC-2014 doses of RECOMBIVAX HB, which underwent supported temperature excursions, have been administered to unknown number of patients (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects were reported. No concomitant therapies were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Diarrhoea, Fatigue, Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Red, itchy hive at site of varicella vaccine. Pink color about 3 inches in diameter and red center about 1 inch in diameter. Area is gradually getting larger. Diarrhea, tired, achy. No treatment yet.
Age: 31.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Pain
Clinical narrative: Red, itchy hive at site of varicella vaccine. Pink color about 3 inches in diameter and red center about 1 inch in diameter. Area is gradually getting larger. Diarrhea, tired, achy. No treatment yet.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Crying, Delusion, Fear, Pyrexia
Clinical narrative: Delusions, fever, crying and scared something was going to happen to her. Went to ER on 12/23/2014, back to ER on 12/24/2014 and physican office same day.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site oedema, Local swelling, Muscular weakness
Clinical narrative: Patient was experiencing localized swelling and redness; moderate to severe in intensity. Patient reports some weakness in affected arm and edematous area has relocated from the deltoid area (site of injection) to back side of the arm. Visibly edematous and red upon inspection. Currently taking Benadryl and Naprosyn as instructed by an allergist; patient reports that symptoms have improved but not resolved in entirety.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Myalgia
Clinical narrative: Joint and muscle ache.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Injection site joint pain, Injection site reaction, Mobility decreased, Muscle spasms
Clinical narrative: Numb arm, severe pain, couldn't lift the arm by itself had to assist with the other arm. Couldn't allow the arm to touch my body or anything else. Had to wedge a pillow between my body and my arm for comfort. No treatment was given. Was told that it would go away by itself in a day on two. Still have issues with sharp pain in shoulder joint and muscle spasms in the muscle where shot was given.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Numb arm, severe pain, couldn't lift the arm by itself had to assist with the other arm. Couldn't allow the arm to touch my body or anything else. Had to wedge a pillow between my body and my arm for comfort. No treatment was given. Was told that it would go away by itself in a day on two. Still have issues with sharp pain in shoulder joint and muscle spasms in the muscle where shot was given.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient developed rash approximately 2 weeks after vaccine on upper part of body.
Age: 31.0
Sex: F
Vaccine: TYP
Symptoms: Dizziness, Erythema, Feeling hot, Palpitations
Clinical narrative: On 12-22-14 by 4 PM felt lightheaded, racing heart. Felt like she had a fever at 4 PM because she was hot. Took TYLENOL, went to bed at 7:30 PM. 12-23 - felt better. Also redness (hivelike) to left arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Injection site reaction approximately 2"-3" (raised area, redness, itching) occurred about 24 hrs post injection. At about 96 hours post-injection area was red and approximately half-dollar sized.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Erythema, Malaise, Nausea
Clinical narrative: Evening of 12-24-14 feeling sick , body chills, aching then hot diarrhea, nauseated, no vomiting. Noted arm is tender, red and swollen around area of infection. No itching. Taking BENADRYL and TYLENOL. Type 2 diabetic. No appetite. Able to control blood sugar. Had flu shot in Oct.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Swelling, Tenderness
Clinical narrative: Evening of 12-24-14 feeling sick , body chills, aching then hot diarrhea, nauseated, no vomiting. Noted arm is tender, red and swollen around area of infection. No itching. Taking BENADRYL and TYLENOL. Type 2 diabetic. No appetite. Able to control blood sugar. Had flu shot in Oct.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Pruritus, Skin warm, Tenderness, Urticaria
Clinical narrative: Burning and itchy, tender, hot up (R) neck (urticaria); lasted until 12/21 AM. This AM - resolving.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Shot pain with ER visit.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Complex regional pain syndrome, Injection site pain, Mobility decreased
Clinical narrative: Burning at injection site. Loss of movement in arm, left. Dr diagnosis of Reflex Sympathetic Dystrophy (RSD). Referred to pain mgmt dr for nere block, dr, not certain of long term damage.
Age: 33.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Induration, Pain, Pain in extremity
Clinical narrative: Awakened am after vaccine admin with left arm pain and chills. On 12/16/14 presented to clinic with (L) arm pain, very painful to move arm, induration significant (L) arm circumference = 37 cm. (R) arm circumference = 34 cm.
Age: 11.0
Sex: M
Vaccine: FLUN4, HEPA, MNQ, TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Swollen upper right arm, redness down to elbow, soreness. Began one day after administration. Also experienced headache and malaise.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Rash
Clinical narrative: After injection, there was swelling and pain/soreness at the injection site. Later, she developed a rash up and down both arms.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Rash
Clinical narrative: Bumps on forehead.  Noticed bumps on scalp day after flu shot.  10/25/2014 went to Urgent Care and diagnosed with shingles.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: Neck pain on 2nd day, severe shoulder pain that has persisted for 7 days.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Blood culture negative, Blood gases normal, Encephalopathy, Enterococcus test positive, Full blood count normal
Clinical narrative: Patient became listless, hypotonic, somnolent, minimally responsive (encephalopathy).
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Hyporesponsive to stimuli, Hypotonia, Listless, Somnolence, Urine analysis normal
Clinical narrative: Patient became listless, hypotonic, somnolent, minimally responsive (encephalopathy).
Age: 47.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Injection site cellulitis, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Left arm at injection site was red, warm to touch, inflamed and very painful as well as fever, and chills. Within 3 days, the redness, swelling and heat had spread to below the elbow however the fever and chills went away. Spoke with doctor's office on 12/6/2014 and were told it was just a reaction, he should be fine however by 12/07/2014 it was worse, then on 12/08/2014 spoke directly to the doctor who wanted to see him right away, he was then told he had cellulitis and placed on Keflex.  After approx. 1 1/2 weeks the arm was returning to normal.
Age: 47.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Left arm at injection site was red, warm to touch, inflamed and very painful as well as fever, and chills. Within 3 days, the redness, swelling and heat had spread to below the elbow however the fever and chills went away. Spoke with doctor's office on 12/6/2014 and were told it was just a reaction, he should be fine however by 12/07/2014 it was worse, then on 12/08/2014 spoke directly to the doctor who wanted to see him right away, he was then told he had cellulitis and placed on Keflex.  After approx. 1 1/2 weeks the arm was returning to normal.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Burning, itching, swelling and redness around the site of injection.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Injection site pain, Middle insomnia, Pain
Clinical narrative: It has now been 2 months since my flu shot and I am still experiencing pain in my right deltoid area, not getting worse but not getting better.  It hurts when I abduct my arm to the horizontal position and internally or externally rotate my shoulder.  The pain wakes me up at night, makes it difficult to lift things with the affected arm, and it hurts to raise my arm above my head/put on clothing.  The pain radiates to my right clavicle.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Fatigue, Memory impairment, Rash
Clinical narrative: Fatigue, joint pain, easily tire, skin rashes, bad short term memory.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Myalgia, Nausea
Clinical narrative: Developed a persistent low grade fever 12/26-12/27, treated with ibuprofen; nausea 12/27-12/28, not treated; muscle pain at injection site 12/26-12/28. Redness and itching at muscle site 12/29-?.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Developed a persistent low grade fever 12/26-12/27, treated with ibuprofen; nausea 12/27-12/28, not treated; muscle pain at injection site 12/26-12/28. Redness and itching at muscle site 12/29-?.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Epstein-Barr virus antibody positive, Headache, Injection site erythema, Injection site pain
Clinical narrative: Initial report received from a non-healthcare professional on 19 December 2014. A 7-years-old male patient, whose had no medical history and concomitant medications were not reported, had received a dose of FLUZONE (Dose number, Batch number, expiry date, route and site of vaccination were not reported), in November 2014 on an unspecified date. On an unspecified date, in November 2014 stated at first had redness and soreness at injection site which lasted for over one and half weeks. Then patient developed severe headache, spine ache, and abdominal pain. Stated patient has seen his pediatrician and has had consult with infectious diseases MD. At the time of this report the patient continues to have headaches, spinal ache, and abdominal pain. The patient had an elevated IGG for antibodies for Epstein Barr but did not have an active infection. The patient had "mild cold" at the time of vaccination. Pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. The patient required ER visit. At the time of this report, the outcome of the adverse events was not recovered. The case was considered as serious due to important medical event elevated IgG antibodies for Epstein Barr, spine ache, abdominal pain and severe headache. List of documents held by sender: none.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Spinal pain
Clinical narrative: Initial report received from a non-healthcare professional on 19 December 2014. A 7-years-old male patient, whose had no medical history and concomitant medications were not reported, had received a dose of FLUZONE (Dose number, Batch number, expiry date, route and site of vaccination were not reported), in November 2014 on an unspecified date. On an unspecified date, in November 2014 stated at first had redness and soreness at injection site which lasted for over one and half weeks. Then patient developed severe headache, spine ache, and abdominal pain. Stated patient has seen his pediatrician and has had consult with infectious diseases MD. At the time of this report the patient continues to have headaches, spinal ache, and abdominal pain. The patient had an elevated IGG for antibodies for Epstein Barr but did not have an active infection. The patient had "mild cold" at the time of vaccination. Pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. The patient required ER visit. At the time of this report, the outcome of the adverse events was not recovered. The case was considered as serious due to important medical event elevated IgG antibodies for Epstein Barr, spine ache, abdominal pain and severe headache. List of documents held by sender: none.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Blood blister
Clinical narrative: Blood blister under left nares 5 days. Used ABREVVA. Eventually dried up.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Nuclear magnetic resonance imaging
Clinical narrative: Flu shot administered at approximately 9:30 AM, Oct 30, 2013. By 8:00PM that evening I couldn't lift my right arm.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Rash erythematous, Skin warm
Clinical narrative: Case number PHEH2014US020145, is an initial spontaneous report received from a nurse on 03 Oct 2014, with a follow up report received from the nurse on 16 Dec 2014. This report refers to a 26 year old female patient. Past vaccinations (unspecified) were well tolerated. The patient was vaccinated with the initial application of FLUVIRIN (batch number: 14512P) intramuscularly at a dose of 0.5 ml on 01 Oct 2014. On an unknown date (on the same date of vaccination or on the next day after vaccination), the patient's injection site was very hot to the touch and had redness and soreness at the injection site. Further on an unknown date, the patient experienced red hot raised rash which lasted for 3 to 4 days. The patient was hospitalized. The outcome of the events was complete recovery. Causality of the events was not reported. Follow up report received from the nurse on 16 Dec 2014: Updated patient demographics (26 year old female), vaccination history, added events (rash erythematous and skin warm), changed outcome (complete recovery) and seriousness (hospitalization).
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Rash erythematous, Skin warm
Clinical narrative: Case number PHEH2014US020147, is an initial spontaneous report from the nurse received on 03 Oct 2014, with a follow up received from nurse on 16 Dec 2014. This report refers to a 48-year-old female patient. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14512P) at a dose of 0.5 ml intramuscularly on 01 Oct 2014. On an unknown date (on the same date of vaccination or on the next day after vaccination) in Oct 2014, the patient's injection site was very hot to the touch and had redness and soreness at the injection site. Further, the patient experienced red hot rash lasting for three to four days. The patient was hospitalized. The reporter stated that no long term reactions were noted in the patient. The outcome of the event red hot rash was complete recovery; outcome of the other events was unknown. The seriousness and causality of the events were not reported. Follow up received from nurse on 16 Dec 2014: updated patient demographics (patient age and gender), new event (red hot rash) and other clinically relevant information in the narrative. Following an internal review for the date received on 16 Dec 2014 a significant correction was performed: Seriousness criteria hospitalization was added.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dizziness, Face injury, Haemorrhage
Clinical narrative: Aprox. 15 hrs. after receiving the vaccine, I very suddenly began feeling very dizzy, then nauseous, as I was gong to lay down, but fainted before I could. When I blacked out, I fell flat on my face and cut my lower lip open bit my tooth cutting through the skin. I lay there bleeding until my husband found me, helped me up and applied a compress to my lip. I felt very weakened, shakey and ill and had the chills, after first feeling feverish, this went on for about 3 hours.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Lip injury, Loss of consciousness, Malaise, Nausea, Nervousness
Clinical narrative: Aprox. 15 hrs. after receiving the vaccine, I very suddenly began feeling very dizzy, then nauseous, as I was gong to lay down, but fainted before I could. When I blacked out, I fell flat on my face and cut my lower lip open bit my tooth cutting through the skin. I lay there bleeding until my husband found me, helped me up and applied a compress to my lip. I felt very weakened, shakey and ill and had the chills, after first feeling feverish, this went on for about 3 hours.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Syncope
Clinical narrative: Aprox. 15 hrs. after receiving the vaccine, I very suddenly began feeling very dizzy, then nauseous, as I was gong to lay down, but fainted before I could. When I blacked out, I fell flat on my face and cut my lower lip open bit my tooth cutting through the skin. I lay there bleeding until my husband found me, helped me up and applied a compress to my lip. I felt very weakened, shakey and ill and had the chills, after first feeling feverish, this went on for about 3 hours.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Case number PHEH2014US025343 is an initial spontaneous report received from a consumer on 15 Dec 2014. This report refers to a 56 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 11 Dec 2014. On same day post vaccination, she experienced swelling on the left side of the face. It was reported that there was no swelling in any other part of the body and there was no associated neurological damage. Consumer explained that the swelling has significantly reduced. The outcome of the event was reported as condition improving. Reporter did not assess the seriousness of the event but the seriousness of the event (facial swelling) was upgraded as medically significant based on the information available in source document. The causality of the event was not reported.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Headache, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: On December 14, 2014  the Flu and PNEUMOVAX shot were administered on the same arm (Left).  The same day the arm became swollen, and turned red and warm.  Patient had fever and a headache.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Rash erythematous, Skin warm
Clinical narrative: Case number PHEH2014US020138, is an initial spontaneous report received from a nurse on 03 Oct 2014, with a follow up report received from the nurse on 16 Dec 2014. This report refers to a 23 year old female patient. Past vaccinations (unspecified) were well tolerated. The patient was vaccinated with the initial application of FLUVIRIN (batch number: 14512P) intramuscularly at a dose of 0.5 ml on 01 Oct 2014. On an unknown date (on the same date of vaccination or on the next day after vaccination), the patient's injection site was very hot to touch and had redness and soreness at the injection site. Further on an unknown date, the patient experienced red hot raised rash which lasted for 3 to 4 days. The patient was hospitalized. The outcome of the events was complete recovery. Causality of the events was not reported. Follow up report received from the nurse on 16 Dec 2014: Updated patient demographics (23 year old female), vaccination history, added events (rash erythematous and skin warm), changed outcome (complete recovery) and seriousness (hospitalization).
Age: 43.0
Sex: M
Vaccine: ANTH, FLUX, HEP, SMALL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Rash erythematous, Skin warm
Clinical narrative: Case number PHEH2014US020150, is an initial spontaneous report from the nurse received on 03 Oct 2014, with a follow up received from nurse on 16 Dec 2014. This report refers to a 52-year-old female patient. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14512P) at a dose of 0.5 ml intramuscularly on 01 Oct 2014. On an unknown date (on the same date of vaccination or on the next day after vaccination) in Oct 2014, the patient's injection site was very hot to the touch and had redness and soreness at the injection site. Further, the patient experienced red hot rash lasting for three to four days. The patient was hospitalized. The reporter stated that no long term reactions were noted in the patient. The outcome of the event red hot rash was complete recovery; outcome of the other events was unknown. The seriousness and causality of the events were not reported. Follow up received from nurse on 16 Dec 2014: updated patient demographics (patient age and gender), new event (red hot rash) and other clinically relevant information in the narrative. Following an internal review for the date received on 16 Dec 2014 a significant correction was performed: Seriousness criteria hospitalization was added.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPVHIB, PNC13, RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reaction mother stated via phone call.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Rash erythematous, Skin warm
Clinical narrative: Case number PHEH2014US020153 is an initial spontaneous report from the nurse received on 03 Oct 2014 with a follow up received from nurse on 16 Dec 2014. This report refers to a 39-year-old female patient. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14512P) at a dose of 0.5 ml intramuscularly on 01 Oct 2014. On an unknown date (on the same date of vaccination or on the next day after vaccination) in Oct 2014, the patient's injection site was very hot to the touch and had redness and soreness at the injection site. Further, the patient experienced red hot rash lasting for three to four days. The patient was hospitalized. The reporter stated that no long term reactions were noted in the patient. The outcome of the event red hot rash was complete recovery; outcome of the other events was unknown. The seriousness and causality of the events were not reported. Follow up received from nurse on 16 Dec 2014: updated patient demographics (patient age and gender), new event (red hot rash) seriousness criteria hospitalization and other clinically relevant information in the narrative.
Age: 44.0
Sex: F
Vaccine: FLUC3
Symptoms: Chills, Fatigue, Headache, Migraine, Myalgia
Clinical narrative: Case number PHEh2014US021405, is an initial spontaneous report received from a nurse on 23 Oct 2014, with a follow up report received from the nurse on 15 Dec 2014. This report refers to a 44 years old female patient. Her medical history and concomitant medication were not reported. Her past vaccinations were well tolerated (no further details). She was vaccinated with the initial application of FLUCELVAX (batch number: unknown) intramuscularly at a dose of 0.5 ml in right deltoid on 02 Oct 2014. On 04 Oct 2014 (2 days after vaccination), she experienced intense headache which triggered migraines for 3 days. She also experienced fever, chills, muscle ache and fatigue that lasted for 4 days. The outcome of headache and migraine was reported as complete recovery after 3 days of onset and outcome for rest of the events was complete recovery on 08 Oct 2014. These events were reported as serious (permanent disability). Causality of these events was not reported. Follow up report received from the nurse on 15 Dec 2014: Updated patient demographics (height and weight), vaccination site, added new event (headache), updated outcome details and seriousness (serious).
Age: 44.0
Sex: F
Vaccine: FLUC3
Symptoms: Pyrexia
Clinical narrative: Case number PHEh2014US021405, is an initial spontaneous report received from a nurse on 23 Oct 2014, with a follow up report received from the nurse on 15 Dec 2014. This report refers to a 44 years old female patient. Her medical history and concomitant medication were not reported. Her past vaccinations were well tolerated (no further details). She was vaccinated with the initial application of FLUCELVAX (batch number: unknown) intramuscularly at a dose of 0.5 ml in right deltoid on 02 Oct 2014. On 04 Oct 2014 (2 days after vaccination), she experienced intense headache which triggered migraines for 3 days. She also experienced fever, chills, muscle ache and fatigue that lasted for 4 days. The outcome of headache and migraine was reported as complete recovery after 3 days of onset and outcome for rest of the events was complete recovery on 08 Oct 2014. These events were reported as serious (permanent disability). Causality of these events was not reported. Follow up report received from the nurse on 15 Dec 2014: Updated patient demographics (height and weight), vaccination site, added new event (headache), updated outcome details and seriousness (serious).
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Dizziness, Headache, Pyrexia, Viral infection
Clinical narrative: My 15 year old daughter received the first GARDASIL vaccine at about 1:30 pm on 12/9/14. By 5 pm she had a fever over 100 degrees and was dizzy, had trouble seeing and a severe headache. I had her eat some soup, take some MOTRIN and rest. At 5:30 am on 12/10, her fever had returned, and she still had a bad headache and only slight dizziness. I have kept her out of school for the day and am monitoring her symptoms. Upon calling her pediatrician's office, I was informed that they have never seen these side effects and she probably just has a virus that came on at the same time.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Visual impairment
Clinical narrative: My 15 year old daughter received the first GARDASIL vaccine at about 1:30 pm on 12/9/14. By 5 pm she had a fever over 100 degrees and was dizzy, had trouble seeing and a severe headache. I had her eat some soup, take some MOTRIN and rest. At 5:30 am on 12/10, her fever had returned, and she still had a bad headache and only slight dizziness. I have kept her out of school for the day and am monitoring her symptoms. Upon calling her pediatrician's office, I was informed that they have never seen these side effects and she probably just has a virus that came on at the same time.
Age: 49.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Varicella virus test negative
Clinical narrative: Developed 3 singular, isolated, red, raised "spots": (L) neck; (R) neck and (R) shoulder on 12/17/14.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chapped lips, Lip swelling
Clinical narrative: Chapped, swollen upper lip 2/3 in length, lasted 5 days. RPh suggested BENADRYL to decrease swelling. AFLURIA 2014-2015 syringe NDC 33332-0014-01.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Glossodynia, Headache, Injection site erythema, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Pt experienced headache, redness and soreness at injection site, possible yeast infection (vaginal). Burning sensation on side of tongue, neck stiffness.
Age: 68.0
Sex: U
Vaccine: FLUX, PPV
Symptoms: Chills, Decreased appetite, Erythema, Pain, Pyrexia
Clinical narrative: Fever, chills, no appetite, very pink. Rash from shoulder to elbow. Very sore. Took TYLENOL.
Age: 68.0
Sex: U
Vaccine: FLUX, PPV
Symptoms: Rash
Clinical narrative: Fever, chills, no appetite, very pink. Rash from shoulder to elbow. Very sore. Took TYLENOL.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Neck pain
Clinical narrative: Pt complained of neck pain that restricted mvmt. Lasted 36 hrs. Used ibuprofen and heat to tolerate pain. Recommended going to MD if not feeling better after first 12 hrs but he said pain started to dissipate.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Urticaria, Wheezing
Clinical narrative: One day after receiving GARDASIL vaccine, mom reported wheezing, hives, and shortness of breath. No ER visit required. Mom called 6 days after vaccine to report reaction.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Heat, redness and swelling at site of injection. Diarrhea and nausea.
Age: 1.0
Sex: F
Vaccine: FLU3, MMR, PNC13, VARCEL
Symptoms: Cellulitis, Erythema
Clinical narrative: Local cellulitis; Red; No induration; No warmth.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Pallor
Clinical narrative: Patient became weak and woozy. He lost color in his face. This lasted for fifteen minutes and he began to feel better. No treatment required.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: 3 days after receiving flu and pneumonia shots same arm, inch apart per pt request, redness/swollen/warm in left arm. Diagnosis: Cellulitis per Dr. Treatment: BACTRIAM and levofloxacin
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cystitis, Headache, Injection site discomfort, Muscle spasms
Clinical narrative: This spontaneous report as received from a consumer refers to a 69 year old male patient concerning himself with no pertinent medical history/concurrent conditions. On 13-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot number, route and expiration date were not reported). No concomitant medication reported. On 13-OCT-2014, the patient experienced headache, body aches and injection site discomfort. On 15-OCT-2014, about two days after receiving the injection, the patient experienced real bad chills, muscle cramps, body aches and shaked in a ball position for 30 seconds. On an unknown date in 2014, the patient developed a rash under his arm and a bladder infection. The patient also reported that he is now experiencing pain in the balls of his feet and when he "nods his head he gets a vibration of tingling feeling in the base of his neck that runs down to the base of his spine sometimes, and other times it runs down to his left leg and to his foot". The patient reported that after visiting the doctor for the adverse effects, his doctor told him that the shingles anti-virus is not in his system. The patient reported that the vaccine had failed. The outcome of headache, bladder infection, rash under arm, muscle cramps, shaking in a ball position for 30 seconds, chills real bad, body aches and injection site discomfort was reported as "eventually went away", recovered. The outcome of pain in the balls of his feet and when he "nods his head he gets a vibration of tingling feeling in the base of his neck that runs down to the base of his spine sometimes, and other times it runs down to his left leg and to his foot" was reported as not recovered. Additional information has been requested.