chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Flushing, Injection site pain, Lip swelling, Localised oedema, Oedema
Clinical narrative: This spontaneous report as received from a physician refers to an 11 year old male patient. The patient's pertinent medical history included chronic constipation, Pervasive developmental disorder (PDD) (autistic spectrum disorder), developmental delays and cochlear implants usage due to difficulty in hearing. The patient had no drug reaction/allergies. The physician reported that the patient was vaccinated with the first dose of M-M-R II and VARIVAX (Merck), when he was an infant (dose, strength, vaccination site, route unspecified). On 08-SEP-2015, the patient was vaccinated with second dose of VARIVAX (Merck) and M-M-R II in the left deltoid (strength, route, dose unspecified). Concomitant therapies included MIRALAX. After 2-3 minutes of administration of the vaccines, the patient began to feel itchy and was flushed in the cheeks and ear. Then the patient was administered with 25mg diphenhydramine. Then 7-8 minutes later, the patients lips began to swell and hives appeared scattered on his back. The patient was under observation and after 5 additional minutes, the patient developed edema of his torso and the hives continued to the torso, the patient was then administered epinephrine. The patient was observed for another half an hour, with vital signs being stable, was sent home with a prescription of prednisone. The physician reported that the patient was seen again on 09-SEP-2015 in the office for a recheck up. Although the patient complained about pain near the injection site with epinephrine, all the symptoms were resolved. Product quality complaint (PQC) was not reported. The relatedness between the events and VARIVAX (Merck) was not reported. The reporting physician considered the events to be related to M-M-R II. Upon internal review, the events were considered serious due to other medically significant events. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to an 11 year old male patient. The patient's pertinent medical history included chronic constipation, Pervasive developmental disorder (PDD) (autistic spectrum disorder), developmental delays and cochlear implants usage due to difficulty in hearing. The patient had no drug reaction/allergies. The physician reported that the patient was vaccinated with the first dose of M-M-R II and VARIVAX (Merck), when he was an infant (dose, strength, vaccination site, route unspecified). On 08-SEP-2015, the patient was vaccinated with second dose of VARIVAX (Merck) and M-M-R II in the left deltoid (strength, route, dose unspecified). Concomitant therapies included MIRALAX. After 2-3 minutes of administration of the vaccines, the patient began to feel itchy and was flushed in the cheeks and ear. Then the patient was administered with 25mg diphenhydramine. Then 7-8 minutes later, the patients lips began to swell and hives appeared scattered on his back. The patient was under observation and after 5 additional minutes, the patient developed edema of his torso and the hives continued to the torso, the patient was then administered epinephrine. The patient was observed for another half an hour, with vital signs being stable, was sent home with a prescription of prednisone. The physician reported that the patient was seen again on 09-SEP-2015 in the office for a recheck up. Although the patient complained about pain near the injection site with epinephrine, all the symptoms were resolved. Product quality complaint (PQC) was not reported. The relatedness between the events and VARIVAX (Merck) was not reported. The reporting physician considered the events to be related to M-M-R II. Upon internal review, the events were considered serious due to other medically significant events. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Body temperature increased, Cellulitis, Peripheral swelling
Clinical narrative: Seen ER 9/13. (R) arm swelling s/p KINRIX vaccine on 9/11/15. Seen in our office 9/14 for follow up ER dx with cellulitis. Temp 100 on cephalexin. Area improved.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray, Chills, Electrocardiogram, Full blood count, Heart rate increased
Clinical narrative: High fever 102.5. Chills body ache. Nausea, vomiting. Went to ER. High heart rate.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: High fever 102.5. Chills body ache. Nausea, vomiting. Went to ER. High heart rate.
Age: 1.19
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Rash morbilliform
Clinical narrative: Rash, resembles measles.
Age: 61.0
Sex: F
Vaccine: FLUC3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Experienced pain at the left deltoid injection site while vaccine was administered, then severe L shoulder pain later in the day that severely limited mobility of the LUE for ~1 week. The pain & difficulty with UE mobility gradually decreased over time, then resolved.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: Immediately after adm injection of HPV child fainted. Child did not respond for seconds, his face was pale; BP 109/68; P 70. Observed pt and child was able to respond to questions. Oriented to person and place.
Age: 80.0
Sex: M
Vaccine: PNC13
Symptoms: Chest X-ray normal, Dizziness, Fatigue
Clinical narrative: Dizziness, fatigue.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Influenza like illness, Pyrexia
Clinical narrative: FLU-LIKE SYMPTOMS; FEVER/CHILLS/PERSPIRATION.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Peripheral swelling
Clinical narrative: Swelling of entire upper arm, lasted 3 days.
Age: 18.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Headache, Injection site pain, Nausea
Clinical narrative: Pt reports headache, nausea, pain at site of injection. Saw in health services 9/14/15. Nausea and headache has resolved. Provided with 600mg ibuprofen for that day; 400 mg for next day if pain continued.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient had a red, warm spot on her arm where it was given.
Age: 12.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Rash generalised, Rash pruritic, Urticaria
Clinical narrative: Welts/rash that itched broke out on patient's skin, beginning on both arms and progressing to rest of body.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Injection site swelling
Clinical narrative: The injection site swelled within hours of adminstration. Her face turned red and hot as well.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose increased, Erythema, Skin warm
Clinical narrative: Approximately 2 inch red circle, warm to touch that lasted about 3 days. Patient reports spike in blood sugars (190-210) over normal blood sugar (100-130) for approximately 3 days but have since returned to normal. Patient reports having had similar reactions in past but this years was more pronounced and lasted longer.
Sex: F
Vaccine: HPV4
Symptoms: Chronic fatigue syndrome, Influenza
Clinical narrative: This spontaneous report was received from an adult Nurse Practitioner who is the office manager via company representative regarding a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (confirmed as not GARDASIL 9) dose 1, (lot# not provided). Concomitant medications were not reported. On an unspecified date a couple of years ago in 2013, the patient experienced chronic fatigue syndrome and was hospitalized after the first dose of GARDASIL. It was reported that the treatment provider suspected that the patient had developed influenza. It was reported that the patient's parent felt that the events were attributed to the GARDASIL. The patient received no further doses of the GARDASIL. It was reported that the patient sought medical attention and treatment (unspecified) for the events. The outcome of chronic fatigue syndrome and influenza were not reported. The reporter did not provide causality assessment. Additional information is not expected as the reporter did not wish further contact.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Bronchitis, Cardiac disorder, Dizziness, Hypotension
Clinical narrative: She developed bronchitis and pneumonia, heart irregularities within 5 days of injection-she was put on lots of medications and has gotten down to current therapy of amlodipine 2.5mg and amiodarone 100mg daily, ELIQUIS 2.5 mg bid-has frequent episodes of low blood pressure, dizziness, weakness.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: She developed bronchitis and pneumonia, heart irregularities within 5 days of injection-she was put on lots of medications and has gotten down to current therapy of amlodipine 2.5mg and amiodarone 100mg daily, ELIQUIS 2.5 mg bid-has frequent episodes of low blood pressure, dizziness, weakness.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Immediate post-injection reaction, Injection site pain, Insomnia, Pain
Clinical narrative: Stated immediately experienced pain left upper arm after receiving flu vaccine. Describes throbbing & burning. Difficulty sleeping. Seen on occ Health Rx: FLEXERIL & tramadol for pain.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Blood glucose normal, Blood test, Cardiac disorder, Condition aggravated
Clinical narrative: Nauseous, light headed, jaw pain, neck back pain. BP taken in his office (L) arm manually 118/82 P up 87. Glucose take by PT/meter 118 pt hx of diabetes. PCP conversation w/TL on 9/3/15, nurse believes pt was having a cardiac and/or diabetic episode.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Diabetes mellitus, Dizziness, Electrocardiogram, Nausea, Neck pain
Clinical narrative: Nauseous, light headed, jaw pain, neck back pain. BP taken in his office (L) arm manually 118/82 P up 87. Glucose take by PT/meter 118 pt hx of diabetes. PCP conversation w/TL on 9/3/15, nurse believes pt was having a cardiac and/or diabetic episode.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in jaw
Clinical narrative: Nauseous, light headed, jaw pain, neck back pain. BP taken in his office (L) arm manually 118/82 P up 87. Glucose take by PT/meter 118 pt hx of diabetes. PCP conversation w/TL on 9/3/15, nurse believes pt was having a cardiac and/or diabetic episode.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Muscle tightness
Clinical narrative: Approx. 7 hours after injection, pt. developed symptoms of headache. chills, tight muscles.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Crying, Gait disturbance, Pain in extremity, Pallor, Pyrexia
Clinical narrative: Patient lost color on his face, starting crying and was shaking so much. He had a high fever for 3 days, vomiting large amounts. Patient slept for most of the day for about 2 days. Patient would not walk for 2 day his legs were hurting him.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Somnolence, Tremor, Vomiting
Clinical narrative: Patient lost color on his face, starting crying and was shaking so much. He had a high fever for 3 days, vomiting large amounts. Patient slept for most of the day for about 2 days. Patient would not walk for 2 day his legs were hurting him.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, warm and swelling arm where today was given.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site phlebitis, Skin warm
Clinical narrative: PATIENT ARM IS RED AND HOT. PATIENT WENT TO DR. DR STATES PT HAS PHLEBITIS AT INJECTION SITE.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site irritation
Clinical narrative: 3X6 irritation on right upper arm onset post tetanus shot. Will use Benadryl prn. This per MD.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Chills, Culture urine negative, Full blood count normal, Haematuria, Metabolic function test normal
Clinical narrative: Patient has nausea, chills x 48 hours after vaccines. Then the morning of 9/12, patient developed gross hematuria.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Nausea, Pregnancy test negative, Red blood cells urine positive, Ultrasound kidney normal, Ultrasound pelvis normal
Clinical narrative: Patient has nausea, chills x 48 hours after vaccines. Then the morning of 9/12, patient developed gross hematuria.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness postural, Headache
Clinical narrative: 8-26-15 0 when discussing completing the series, patient and mother stated she had headaches and dizziness on standing x months after the vaccine.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: Arm Pain, Leg, Muscle, Joint Pain.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site erythema
Clinical narrative: Red area surrounding site of vaccination.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Cellulitis, Injection site swelling
Clinical narrative: Patient had swelling at injection site. First informed patient to use cold compresses at injection site. Patient was also informed to go to ER/Urgent care of swelling increased in area or temperature developed. Patient returned next day area of swelling increased and patient was instructed to go to urgent care.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site swelling, Injection site erythema, Injection site pruritus
Clinical narrative: SUNDAY NIGHT PATIENT BEGAN FEELING SOME ITCHING AND SWELLING AROUND ADMINISTRATION SITE. THE MORNING OF 9/14 PATIENT NOTICED RED AREA WITH SWELLING AROUND IT. PATIENT CALLED DOCTOR ON 9/14 EARLY AFTERNOON, WAS ADVISED TO DRAW RED CIRCLE AROUND SPOT. THE SPOT HAS DECREASED IN REDNESS BUT HAS SWOLLEN FURTHER AROUND THE AREA. PATIENT HAS TAKEN ZYRTEC BUT NO OTHER MEDICATIONS.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Injected limb mobility decreased, Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: Reported to clinic on Tues 9/15/15 with c/o reddened area above vaccination site (given 9/12/15).  Inability to move arm on 09/13 and had 2.5"x5" area over site that was bright yellow and c/o headache 4/10 pain scale.  On 9/14 area progressed to raised reddened area and headache continued.  Now area raised and red, warm to the touch and has headache 2/10 pain.  ROM for left arm has increased, but still mildly sore.  Denies n/v/d, no CP or SOB, denies neck pain, denies n/t to distal extremity.  Taking 800 mg Motrin PO daily since Sunday 9/13.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: Reported to clinic on Tues 9/15/15 with c/o reddened area above vaccination site (given 9/12/15).  Inability to move arm on 09/13 and had 2.5"x5" area over site that was bright yellow and c/o headache 4/10 pain scale.  On 9/14 area progressed to raised reddened area and headache continued.  Now area raised and red, warm to the touch and has headache 2/10 pain.  ROM for left arm has increased, but still mildly sore.  Denies n/v/d, no CP or SOB, denies neck pain, denies n/t to distal extremity.  Taking 800 mg Motrin PO daily since Sunday 9/13.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Severe shoulder pain (7 or 8 out of 10); unable to move arm without severe pain.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Eye swelling, Headache, Ocular hyperaemia, Pain
Clinical narrative: Cough, headache, extremely itchy, red, swollen eyes, upper body aches for 2 days.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Cough, headache, extremely itchy, red, swollen eyes, upper body aches for 2 days.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Pain in extremity, Swelling face, Throat tightness
Clinical narrative: Patient stopped by the pharmacy the day after she got her flushot to say she had an allergic reaction to the flushot. Patient said her arm starting hurting about an hour after the vaccine so she took some otc pain med, and about 2 hours after her face started to swell and she felt like her throat was closing. Patient states she took some Benadryl then and now most of the swelling has subsided.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Blood test, Cognitive disorder, Computerised tomogram, Dizziness, Dyspnoea
Clinical narrative: Heart Palpitations, labored breathing, night sweats, night mares, tingling/numbness in extremities, extreme lethargy, ringing in ears, dizziness, throat constriction, cognition problems, trouble speaking. Caused 2 visits to E.R.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Lethargy, Night sweats, Nightmare, Nuclear magnetic resonance imaging
Clinical narrative: Heart Palpitations, labored breathing, night sweats, night mares, tingling/numbness in extremities, extreme lethargy, ringing in ears, dizziness, throat constriction, cognition problems, trouble speaking. Caused 2 visits to E.R.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Palpitations, Paraesthesia, Speech disorder, Throat tightness, Tinnitus
Clinical narrative: Heart Palpitations, labored breathing, night sweats, night mares, tingling/numbness in extremities, extreme lethargy, ringing in ears, dizziness, throat constriction, cognition problems, trouble speaking. Caused 2 visits to E.R.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in 4th and 5th digit starting after vaccine was administered in 2014. Symptoms are still present.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: After vaccination pt described arm as becoming swollen from (R) shoulder to elbow, becoming very warm to touch w/ softball size nodule at injection site. As of 9/15/15, swelling was reduced, but still had softball size bruise at injection site.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Nausea, Vomiting
Clinical narrative: Nausea/vomiting, hot/red/swelling around injection site noted approx. 14 hours after administration. Given ZOFRAN ODT and cefadroxil antibiotic.
Age: 23.0
Sex: F
Vaccine: FLU3, TYP, YF
Symptoms: Injection site pruritus, Injection site rash, Injection site urticaria, Wheezing
Clinical narrative: Approximately 1 hr following immunizations-patient reported to medical with raised hive like rash on (R) upper arm-large bumps about 6-7 in number with c/o itching-(L) arm 2 raised hive like bumps with itching-slight wheeze LLL-no facial edema-no SOB-Epi 0.3mg administered via EPIPEN.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient given vaccine at CPE on 9/10/15, reports onset of full body hives on 9/11/-9/14/15.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Dizziness, Nausea, Pruritus, Rash erythematous
Clinical narrative: Nausea and dizzy @ 7:00pm 9/14/15. Raised red rash the size of a quarter and tennis ball with itching and burning @ 1:00pm on 9/15/2015.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram, Cough, Head injury, Malaise, Syncope
Clinical narrative: Patient got sick at work at 5pm, so several hours after the vaccine was given. His daughter states he was coughing and then he fainted.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Patient got sick at work at 5pm, so several hours after the vaccine was given. His daughter states he was coughing and then he fainted.
Age: 20.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ
Symptoms: Incorrect dose administered
Clinical narrative: Pediatric dose given to adult. Have patient return for additional dose.
Age: 38.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Pruritus generalised
Clinical narrative: Itching all over the body.
Age: 38.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Injection site irritation, Pruritus generalised
Clinical narrative: Itching all over the body.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Lymphadenopathy, Oropharyngeal pain, Streptococcus test positive
Clinical narrative: Horrible sore throat......enlarged lymph nodes....DIAGNOSED POSITIVE STREP...7 days of penicillin v 1500 mg/day.....  Question: might it have been diphtheria instead?
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, headache, muscle aches, fatigue.
Age: 29.0
Sex: M
Vaccine: JEV1
Symptoms: Headache, Malaise, Musculoskeletal stiffness
Clinical narrative: Severe headache, malaise, and neck stiffness starting about 1 day after vaccine and lasting 3 days.  Symptomatic treatment with ibuprofen OTC.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Syncope
Clinical narrative: Patient got faint after getting immunization and fainted. He got up after a few seconds.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: Patient presented to ER complaining of a rash that started the day after he had received a Fluzone HD and a Pneumovax-23 immunization in the left arm. The rash was encircling the deltoid area and was erythematous & hot. May have had a fever.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Burning sensation, International normalised ratio normal, Papule, Petechiae, Platelet count normal
Clinical narrative: Patient developed flesh colored papules on the bilateral hands, petechiae on the bilateral hands, and a burning sensation to the hands and feet.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Red blood cell count normal, White blood cell count increased
Clinical narrative: Patient developed flesh colored papules on the bilateral hands, petechiae on the bilateral hands, and a burning sensation to the hands and feet.
Age: 20.0
Sex: F
Vaccine: RAB, TYP, YF
Symptoms: Arthralgia, Decreased appetite, Dysmenorrhoea, Fatigue, Gingival bleeding
Clinical narrative: Fever up to 104, night sweats, malaise, fatigue, joint pain, mild gum bleeding after brushing teeth, decreased appetite, sore throat, mild global headache, and mild menstral cramps with increased bleeding.
Age: 20.0
Sex: F
Vaccine: RAB, TYP, YF
Symptoms: Headache, Malaise, Menorrhagia, Night sweats, Oropharyngeal pain
Clinical narrative: Fever up to 104, night sweats, malaise, fatigue, joint pain, mild gum bleeding after brushing teeth, decreased appetite, sore throat, mild global headache, and mild menstral cramps with increased bleeding.
Age: 20.0
Sex: F
Vaccine: RAB, TYP, YF
Symptoms: Pyrexia
Clinical narrative: Fever up to 104, night sweats, malaise, fatigue, joint pain, mild gum bleeding after brushing teeth, decreased appetite, sore throat, mild global headache, and mild menstral cramps with increased bleeding.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Malaise, Nausea, Pain, Pyrexia
Clinical narrative: 45 minutes post injection pt presented feeling unwell progressing to  nausea/vomiting/diarrhea plus aches and fever of 102.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: 45 minutes post injection pt presented feeling unwell progressing to  nausea/vomiting/diarrhea plus aches and fever of 102.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Urticaria
Clinical narrative: Hives on legs and back started on Friday and resolved on Sunday.  Patient did not feel sick.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hypoaesthesia, Paraesthesia
Clinical narrative: RIGHT AFTER THE FLU SHOT GIVEN PATIENT STARTED TO FEEL DIZZY. PATIENT ALSO REPORTS ARMS AND FACE TINGLING AND NUMB. PATIENT WAS MONITOR IN OBSERVATION FOR ABOUT A HOUR BY APRN. PATIENT VS WERE STABLE.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Myelitis transverse, Paralysis
Clinical narrative: Post vaccine complete transverse myelitis. Pt is paralyzed from the breast down.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Balance disorder, Chills, Dizziness, Fatigue, Heart rate increased
Clinical narrative: Fever between 103-105 degrees F for 5 days, extreme exhaustion, muscle weakness, pain head to toe, dizziness, heartbeat racing, sweating profusely, chills, very off balance. This is day 6, still dizzy, off balance, fever down to 100.8deg F. Took Tylenol whenever awake, to no avail.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Hyperhidrosis, Muscular weakness, Pain, Pyrexia
Clinical narrative: Fever between 103-105 degrees F for 5 days, extreme exhaustion, muscle weakness, pain head to toe, dizziness, heartbeat racing, sweating profusely, chills, very off balance. This is day 6, still dizzy, off balance, fever down to 100.8deg F. Took Tylenol whenever awake, to no avail.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient described injection site reaction of swollen bump that he experienced after receiving the shot. Patient decided to call pharmacy at 09/15/2015 around 4:45pm describing bump is still there. Advise patient to apply a cold compress to the site for approximately 15 minutes if soreness and swelling of injection site. Also recommend analgesic (i.e. NSAID/APAP) if no contraindications to it for pain. Also, to seek medical attention if it gets worse.
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Rash macular, Rash pruritic
Clinical narrative: Itchy rash on chest, neck, arms. Blotchy red skin.  Advised diphenhydramine, which patient took. At 8:45 AM the next day, all symptoms had resolved.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Asthenia, Decreased immune responsiveness, Epstein-Barr virus test, Fatigue
Clinical narrative: Pre-Gardasil: Daughter had lots of energy & exceptional immune system (rarely ill, could be around sick people and not catch illness). Very active. After Gardasil: It took a while after the last shot in the series for the issue to take hold and for her parents to notice. Parents at first push it off as a growth spurt. Fatigue to such a level falls asleep in car before and after school--on way to and fro. Lacks stamina she had in past for exercise and sports, no longer enjoys taking part in cross country team.  Low energy.  Eats tremendous amounts, but doesn't gain weight.  Daughter gets sick very easily (catches colds, flu, etc...  Parents can be exposed to same illnesses and do not come down with it.  Before Gardasil, parents more likely to become ill than daughter).  Parents taking daughter in to Drs. about concerns in 2012-2015 (last Gardasil shot in late 2011).  Fainting incident at school.   Very low Vitamin D levels.  Later, blood tests show low white cell count, Epstein Barr, mild neutropena, mono.  Daughter gets ill very easily and is ill often. Chronic fatigue persists.  Daughter no longer goes out for cross country, changes life to accommodate fatigue and compromised immune system.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Human herpes virus 6 serology, Immunodeficiency, Mononucleosis heterophile test, Neutropenia, Neutrophil count decreased
Clinical narrative: Pre-Gardasil: Daughter had lots of energy & exceptional immune system (rarely ill, could be around sick people and not catch illness). Very active. After Gardasil: It took a while after the last shot in the series for the issue to take hold and for her parents to notice. Parents at first push it off as a growth spurt. Fatigue to such a level falls asleep in car before and after school--on way to and fro. Lacks stamina she had in past for exercise and sports, no longer enjoys taking part in cross country team.  Low energy.  Eats tremendous amounts, but doesn't gain weight.  Daughter gets sick very easily (catches colds, flu, etc...  Parents can be exposed to same illnesses and do not come down with it.  Before Gardasil, parents more likely to become ill than daughter).  Parents taking daughter in to Drs. about concerns in 2012-2015 (last Gardasil shot in late 2011).  Fainting incident at school.   Very low Vitamin D levels.  Later, blood tests show low white cell count, Epstein Barr, mild neutropena, mono.  Daughter gets ill very easily and is ill often. Chronic fatigue persists.  Daughter no longer goes out for cross country, changes life to accommodate fatigue and compromised immune system.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Somnolence, Syncope, Vitamin D decreased, Weight gain poor, White blood cell count decreased
Clinical narrative: Pre-Gardasil: Daughter had lots of energy & exceptional immune system (rarely ill, could be around sick people and not catch illness). Very active. After Gardasil: It took a while after the last shot in the series for the issue to take hold and for her parents to notice. Parents at first push it off as a growth spurt. Fatigue to such a level falls asleep in car before and after school--on way to and fro. Lacks stamina she had in past for exercise and sports, no longer enjoys taking part in cross country team.  Low energy.  Eats tremendous amounts, but doesn't gain weight.  Daughter gets sick very easily (catches colds, flu, etc...  Parents can be exposed to same illnesses and do not come down with it.  Before Gardasil, parents more likely to become ill than daughter).  Parents taking daughter in to Drs. about concerns in 2012-2015 (last Gardasil shot in late 2011).  Fainting incident at school.   Very low Vitamin D levels.  Later, blood tests show low white cell count, Epstein Barr, mild neutropena, mono.  Daughter gets ill very easily and is ill often. Chronic fatigue persists.  Daughter no longer goes out for cross country, changes life to accommodate fatigue and compromised immune system.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Cough, Lower respiratory tract infection, Pruritus, Rhinorrhoea
Clinical narrative: The patient had: running nose, itching, chest cold, cough, increase blood pressure, according to the patient's daughter. Symptoms start 2 hours after vaccination.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site bruising, Injection site haematoma, Injection site pain, Injection site swelling
Clinical narrative: One to two days after getting the PREVNAR-13 shot, patient developed moderate to severe bruising, swelling, pain, and hematoma approximately 1 to 1.5 inches around the injection site on right arm.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pain, Pyrexia
Clinical narrative: Pt received FLUZONE vaccine. She stated she had a fever, body aches and SOB. She took an ADVIL and called back 2 hours later that she feels better.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Infection, Injection site discomfort, Injection site erythema
Clinical narrative: Patient had discomfort at injection site and went to urgent care where it was determined patient had infection. Treated with antibiotics. Site was red when presented to the pharmacist.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of adverse reaction in a 63-year-old female patient who received FLUARIX TETRA QIV. On an unknown date, the patient received FLUARIX TETRA at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX TETRA, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to FLUARIX TETRA. Additional details were received as follows: The patient experienced a bad reaction while using FLUARIX quadrivalent (season unspecified). No further information was available.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Exposure during pregnancy, Injection site pain
Clinical narrative: This is a prospective pregnancy case. This 32-year-old female subject was enrolled in a study. The subject received Flu Seasonal QIV Dresden .5 ml on 4th September 2015. On 4th September 2015, an unknown time after receiving Flu Seasonal QIV Dresden, the subject developed wrong injection technique (Non-serious). Additional event(s) included injection site pain in September 2015 and vaccine exposure during pregnancy. The outcome of wrong injection technique was unknown. The outcome(s) of the additional event(s) included injection site pain (unknown) and vaccine exposure during pregnancy (unknown). The pregnancy was ongoing. It was unknown if the investigator considered the injection site pain to be related to Flu Seasonal QIV Dresden. Additional details were received as follows: The patient received FLUARIX QIV higher in the upper arm leading to wrong injection technique. In September 2015, less than a week after receiving FLUARIX QIV, the patient had more pain than usual at the injection site. The reporter was asking if the patient could be revaccinated. The reporter did not have any patient details, product details and patient's medical history.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Joint swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to an approximately 68 year old male patient. The concurrent condition of the patient included gout and allergy to penicillin. No medical history was reported. On 09-SEP-2015, the patient was vaccinated with ZOSTAVAX (lot # L013546, Exp. 17-JUL-2016, 19400 PFU, dose not provided, subcutaneously). Concomitant therapies included allopurinol. On 10-SEP-2015, the patient developed elbow tenderness and swelling. The patient sought medical attention and contacted pharmacist. The patient was treated with BENADRYL and TYLENOL. The outcome of the event was reported as not recovered. The causality assessment was not reported. No product quality issue was involved. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Joint swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to an approximately 68 year old male patient. The concurrent condition of the patient included gout and allergy to penicillin. No medical history was reported. On 09-SEP-2015, the patient was vaccinated with ZOSTAVAX (lot # L013546, Exp. 17-JUL-2016, 19400 PFU, dose not provided, subcutaneously). Concomitant therapies included allopurinol. On 10-SEP-2015, the patient developed elbow tenderness and swelling. The patient sought medical attention and contacted pharmacist. The patient was treated with BENADRYL and TYLENOL. The outcome of the event was reported as not recovered. The causality assessment was not reported. No product quality issue was involved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Blood glucose normal, Syncope
Clinical narrative: Patient received MENACTRA on 9-10-15 at around 12:45. Patient left office and Mom reported syncopal event in vehicle. Patient was brought in office - evaluated and let her go home.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Haematochezia
Clinical narrative: Within 36 hrs of receiving vaccines, the baby began crying inconsolably and passed bloody bowel movements. Symptoms lasted <24 hrs.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count normal, Pain in extremity, Pyrexia, Urine analysis normal
Clinical narrative: (L) arm pain, fever.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fall
Clinical narrative: After vaccine patient was laughing and less than one minutes she fell on the floor said she was dizzy. Sat down took BP and waited 10 mins. and recovered.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Pyrexia, Varicella
Clinical narrative: Received VARIVAX on 9/4/15. Seen in our office 9/14/15 with 3 day hx low grade fever and 2 day hx of multiple vesicles on body. Dx with varicella.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site cellulitis, Injection site reaction
Clinical narrative: Patient developed localized shingles at injection site, along with a cellulitis infection.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a 62 year old female patient with phenobarbital allergy and none pertinent medical history. On 03-SEP-2015 the patient was vaccinated with ZOSTAVAX, subcutaneously (strength, dose and lot# were unknown) for vaccination. Concomitant therapies included ALLEGRA. On 04-SEP-2015, next morning the patient noticed that she had an injection site reaction. The injection site was bright red in color, extended about 3 inches and developed a rash. The rash extended from her shoulder to her elbow which became inflamed, including itching and pain (the pain lasted for five days). BENADRYL and CORTIZONE cream twice daily were given to treat the events. None lab diagnostics studies were performed. The patient reported this adverse reaction to her physician. The outcome of the events was reported as recovering/resolving. The causality was not reported. Additional information is not expected as there was no reporter's contacted information.
Age: 59.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Dizziness, Headache, Lymphadenopathy, Nausea, Pain
Clinical narrative: Patient seen by a M.D. was told symptoms such as swelling of her gland, pain, dizziness, h/a, n/v where associated with receiving MMR vaccine.
Age: 59.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Vomiting
Clinical narrative: Patient seen by a M.D. was told symptoms such as swelling of her gland, pain, dizziness, h/a, n/v where associated with receiving MMR vaccine.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Oropharyngeal pain
Clinical narrative: Patient received Tdap on 9-9-15 next day had silver dollar size swelling, redness and warmth at site. Now achy, sore throat, T 97.5 - erythema 18 x 12 cm, very warm to touch. Treated with prednisone and cephalexin.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Skin warm
Clinical narrative: Patient received Tdap on 9-9-15 next day had silver dollar size swelling, redness and warmth at site. Now achy, sore throat, T 97.5 - erythema 18 x 12 cm, very warm to touch. Treated with prednisone and cephalexin.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or concurrent condition reported. On 28-AUG-2015 the patients were administered an unspecified number of improperly stored doses of VARIVAX (Merck) (lot # L016123, expiration date 06-MAY-2017) (dose and route were not reported). There was no concomitant medication reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or concurrent condition reported. On 28-AUG-2015 the patients were administered an unspecified number of improperly stored doses of (Oka/Merck) VARIVAX (lot # L016123, expiration date 06-MAY-2017) (dose and route were not reported). There was no concomitant medication reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from Nurse refers to a patient of unknown age and gender. On 25-AUG-2015 the patient was vaccinated with PROQUAD (Merck) (dose, route, frequency and lot # unspecified). Nurse reported PROQUAD (Merck) which expired on 18-AUG-2015 which was inadvertently administered to a patient on 25-AUG-2015. No adverse effects reported. No additional information to report. Additional information has been requested.
Age: 1.6
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Erythema, Induration, Injection site vesicles, Tenderness
Clinical narrative: 2.5 x 2.5 cm induration, tender, erythema 10 d after injection approximately 5-6 small vesicales (L) thigh.
Age: 45.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Inejction site of MENACTRA local redness, swelling, pruritus approx 5 cm in circumference. No drainage.
Age: 45.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Inejction site of MENACTRA local redness, swelling, pruritus approx 5 cm in circumference. No drainage.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reactions/allergies reported. On unknown dates, the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (lot # L003775 with expired date 04-FEB-2017, lot# L013827 with expired date 21-APR-2017, lot# L017145 with expired date 13-MAY-2017, lot# L017997 with expired date 19-MAY-2017, dose and route were unknown). No concomitant medication was reported. The nurse could not tell how many of each lot number of this vaccine had been administered. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected since the reporter refused to be contacted.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Administered ZOSTAVAX on 9/10/15 at 3:15pm. Patient did not complain at the time. She called on 9/12 and said she experienced burning and itching and swollen area at the injection site. RPh on duty told patient to apply ice and hydrocortisone cream to the area.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Insomnia, Pain, Peripheral swelling, Skin warm
Clinical narrative: 2 hours tender, sore, pink.  4 - through the night, swelling very red could not sleep increase - thought normal - 1st day painful while riding, very red - took ADVIL - arm swelled nearly 2x and hot - weekend - went to Dr. Monday - cephalexin capsules - 10 days - ok.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, Tenderness
Clinical narrative: 2 hours tender, sore, pink.  4 - through the night, swelling very red could not sleep increase - thought normal - 1st day painful while riding, very red - took ADVIL - arm swelled nearly 2x and hot - weekend - went to Dr. Monday - cephalexin capsules - 10 days - ok.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD (Merck) (lot # L004297 with expired date 17-AUG-2016, lot # L009209 with expired date 17-SEP-2016, lot# L009207 with expired date 17-SEP-2016, lot # L023113 with expired date 24-DEC-2016, dose and route were unknown). No concomitant medication was reported. The reporter could not tell how many of each lot number of the vaccine had been administered. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected since the reporter refused to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown date, the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # L017997 with expired date 04-FEB-2017, lot# L013827 with expired date 21-APR-2017, lot# L017145 with expired date 13-MAY-2017, lot# L17997 with expired date 19-MAY-2017, dose and route were unknown. No concomitant medication was reported. The nurse could not tell how many of each lot number of this vaccine had been administered. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected since the reporter refused to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD (Merck) (lot # L005297 with expired date 17-AUG-2016, lot# L009209 with expired date 17-SEP-2016, lot# L009207 with expired date 17-SEP-2016, lot# L023113 with expired date 24-DEC-2016, dose and route were unknown). No concomitant medication was reported. The reporter could not tell how many of each lot number of the vaccine had been administered. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected since the reporter refused to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician via a company representative referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL (dose, strength and route were not known). On an unknown date, after receiving the vaccine the patient fainted. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt tolerated shot well at time of injection, but after 5 days then pt had notable swelling, redness and pain at site with warmth. No fever. Pt has been taking TYLENOL and drinking fluids. Reaction was delayed c/o nausea and weakness. Denies SOB, vomit or fever.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea
Clinical narrative: Pt tolerated shot well at time of injection, but after 5 days then pt had notable swelling, redness and pain at site with warmth. No fever. Pt has been taking TYLENOL and drinking fluids. Reaction was delayed c/o nausea and weakness. Denies SOB, vomit or fever.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Cough, Pain in jaw
Clinical narrative: Information has been received from a 73 year old female physician referring to herself. The patient's pertinent medical history included chickenpox, asthma, stroke (happened 1 year ago), hypertension, mitral valve prolapse, depression, osteopenia, low vitamin-d, psoriasis and skin cancers. The patient's drug reactions/allergies included SULFA, BACTRIM, CIPRO, COMPAZINE and VALIUM. The patient was also lactose sensitive and latex allergy. On 06-AUG-2015 the patient was vaccinated with a dose of ZOSTAVAX (1 injection, dose, route, lot no and expiration date were unknown) in the left upper arm for prevent shingles. Concomitant therapies included PROAIR and "About 15 other unspecified medications". On 10-AUG-2015 the patient began to have some joint pain that "felt like arthritic joint pain" and within the last couple of days stated she had developed a cough, exact onset date unspecified (on an unknown date in August 2015). The patient reported that the arthritic joint pain felt like it ran from her knee to her jaw. She also reported that she had "taken TYLENOL 500mg two times, saw her Chiropractor for the joint pain and also had to use her PROALR inhaler, 2 puffs, for her cough," on unspecified dates. She then reported that her "knee is feeling better, her respiratory symptoms are getting better after using her inhaler, and her jaw pain has improved since she has taken TYLENOL 500mg two times." None lab diagnostics studies were performed. The patient sought medical attention by calling to the primary physician and pharmacy. The outcome of the events was reported as recovering. The patient also reported that when the patient took penicillin or KEFLEX she broke out in an unspecified rash. Additional information has been requested.