chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: F
Vaccine: DTAP, RVX
Symptoms: Opisthotonus, Pain, Streptococcus test, Vomiting
Clinical narrative: Started with refusing food the following day. By that night, diarrhea had started. The following day, she had 15 diarrhea diapers. This lasted for 8 days total, between 8 and 15 diapers a day. On the 6th and 7th day, she also began throwing up. Her appetite was greatly reduced throughout the duration, and she was refusing food more than half the time. By day 6 she was so sick that I was concerned she was dehydrated. She was also arching as though she was in a great deal of pain, and her bottom appeared to be infected. I brought her to the doctors office at that point, and she was seen by a physician who seemed to also believe this illness was a result of the vaccination.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Oropharyngeal pain, Pruritus, Throat irritation, Wheezing
Clinical narrative: Itchy throat and ears, sore throat, difficulty breathing, wheezing.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Local swelling, Skin irritation
Clinical narrative: Patient complained of burning sensation down the arm (left) the shot was given yesterday. Today it looks raised and patient complains of irritation. They were consulted to put ice on the area and take BENADRYL.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Tenderness
Clinical narrative: Very red face that is tender to patient. Applying lotion.
Age: 13.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Dizziness, Headache
Clinical narrative: Patient received vaccines in office. After patient complained of headache and dizziness. Cold compress and BP taken. 45 min post administration patient left office. Follow up 24 hrs later showed patient still with headache and dizziness.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea, Neck pain
Clinical narrative: Mom called office back stating after receiving vaccine, after they left from here which is approx with in 20 min experienced neck ache, headache, and vomiting (not vomited felt nauseous) was referred to ER, went to UC and there received steroid shot, BENADRYL and oral prednisone for 4 days.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Heart rate increased, Loss of consciousness, Muscle contracture, Pallor, Respiratory rate increased
Clinical narrative: Loss of consciousness (syncope) following Tdap vaccine administration. Pt experienced contractures and tremors increased heart rate, rapid respirations, pallor. Due to history of food allergies, pt given 5 ml Benadryl (wt= around 90 #) fluids po (around 16 oz) and 2L oxygen by facial mask over around 30 minutes. Discharged home oriented x 3, ambulating well.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope, Tremor
Clinical narrative: Loss of consciousness (syncope) following Tdap vaccine administration. Pt experienced contractures and tremors increased heart rate, rapid respirations, pallor. Due to history of food allergies, pt given 5 ml Benadryl (wt= around 90 #) fluids po (around 16 oz) and 2L oxygen by facial mask over around 30 minutes. Discharged home oriented x 3, ambulating well.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea
Clinical narrative: Diarrhea after 1 hr of getting flu shot she didn't eat anything from night before and she got the shot around 3:00pm. Around 5:00 pm she started diarrhea.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Syncope
Clinical narrative: Pt reports pain at injection site of pneumonia vaccine and syncopal episode evening of immunization.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: One day after vaccine pt presented with large red area on arm below site that was warm to touch.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: 9/19/13 swelling, redness, warm to touch, 48 hours after vaccine administered. Recommended cold compresses and ibuprofen and return for reassessment in 24 hours. Called mother 9/20/13 - swelling, redness and hot to touch "almost completely gone".
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash on the arm near the injection site, last up to 5 days or more.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: Itching at injection site x 4 hours. Home care treatment, Benadryl.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Inflammation, Local swelling, Malaise, Pain
Clinical narrative: Fever, malaise. Large-red-swollen painful-inflamed area upper arm 10cm x 10cm. Treatment: ice, BENADRYL, ADVIL.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever, malaise. Large-red-swollen painful-inflamed area upper arm 10cm x 10cm. Treatment: ice, BENADRYL, ADVIL.
Age: 16.0
Sex: M
Vaccine: FLUN4, HPV4
Symptoms: Loss of consciousness
Clinical narrative: Pt received GARDASIL sitting stood up and few seconds later passed out x 20 seconds. Sat up BP - 114/68. Placed in chair and then passed out again x 10 seconds. Laid down x 10 minutes and OK.
Age: 16.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Bradycardia, Dizziness, Dyskinesia, Loss of consciousness
Clinical narrative: 1 minute after admin. of vaccine pt. was sitting and passed out with jerking x 1 minute. Awoke - BP 116/72. Sat up after 3 minutes - passed out again x 30 sec with jerking, O2 86% - O2 started on x 10 minutes. Sat up and felt llightheaded. Down with O2 x 10 minutes then Ok. BP 110/66, HR48-64.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue, Throat tightness
Clinical narrative: Pt. felt like tongue was swelling and throat was closing. Was taken to ER via EMS. ER Dr notes patient airway with no distress with no swelling. Pt. administered 60mg Prednisone PO and 25mg BENADRYL PO then prescribed 40mg Prednisone dly x 4 days and 25mg BENADRYL x 3 days every 8 hours. Total episode lasted 4-5 hours.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Headache, Local swelling, Nausea, Neck pain
Clinical narrative: Shots given at 10: AM at 8:00 PM - Neck and arm was hurting, neck had several red areas and that were extremely painful and swollen, arm was red from shoulder to almost elbow. Aches and headache. Went next day to urgent care they told me to go to emergency room. Fever started at 101 next two day from 102-103. Dr said extreme reaction to vaccination. Lasted total of 4 days. Also nausea and vomiting.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Shots given at 10: AM at 8:00 PM - Neck and arm was hurting, neck had several red areas and that were extremely painful and swollen, arm was red from shoulder to almost elbow. Aches and headache. Went next day to urgent care they told me to go to emergency room. Fever started at 101 next two day from 102-103. Dr said extreme reaction to vaccination. Lasted total of 4 days. Also nausea and vomiting.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local swelling, Pruritus, Skin discolouration, Urticaria
Clinical narrative: Swollen arm - red - hives - pain. I still have discoloration since 9-4-13 the day I had the vaccine - still itches.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red and swollen injection site, lt deltoid.
Age: 26.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Myalgia
Clinical narrative: Swelling at injection site and axillary area. Muscle pain. Diphenhydramine, Hydrocodone/APAP 5/325, Cyclobenzaprine.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site induration, Injection site urticaria
Clinical narrative: Vaccine is giving sub-q and patient is getting a welt (hard).
Age: 83.0
Sex: U
Vaccine: FLU3
Symptoms: Tremor, Vomiting
Clinical narrative: Vomiting and uncontrollable shaking.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Redness at area of injection and a bump. It was at Zostavax site. Looked like local reaction. Patient said she had talked with her physician and he recommended cold compress. Talked with MD office they said common local reaction.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Pain in arm and hives.
Age: 1.52
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: Pt with fever 102(+) -> 104.3 wi 24 hours of vaccines. Mom very upset at "catch up" immunization given. I sent pt to ER for eval.
Age: 77.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient came to pharmacy with wife for a FLUZONE HD vaccine, and was given BOOSTRIX vaccine in error. No treatment necessary or adverse effects noted by patient.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: Patient presented to pharmacy with husband for a BOOSTRIX shot and was given a FLUZONE HD vaccine in error. No treatment necessary or adverse effects noted by patient.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dizziness, Hypoaesthesia
Clinical narrative: Numbness in fingers, dizziness, elevated blood pressure, over a period of an hour. Treatment included eating, drinking fluids and rest.
Age: 1.7
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Fall, Gait disturbance, Injection site erythema, Injection site swelling
Clinical narrative: Shots in left leg, leg swollen and red. Limping, falling a lot otherwise a good walker.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Local reaction, Rash papular
Clinical narrative: Flu vaccine on 9.26.13. Developed local injection rash -  papulovesicular - hx of egg allergies.
Sex: U
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, route and lot # not reported). On an unknown date the patient experienced adverse event. The outcome of adverse event was unknown. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: Injected and felt burning immed in shoulder. HA in 30 min took 4 Advil. Feels LH, weak, nausea. No SOB, no tightening in chest. No prev rxn to vaccine. VS Rx adm (prior) Pepcid, Benadryl.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Injected and felt burning immed in shoulder. HA in 30 min took 4 Advil. Feels LH, weak, nausea. No SOB, no tightening in chest. No prev rxn to vaccine. VS Rx adm (prior) Pepcid, Benadryl.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash macular, Rash pruritic, Vaccination complication
Clinical narrative: On 8-30-13 (12 days after my shingles shot) I developed red splotchy spots on my face and it was itchy. It was much worse the following day so I went to see Dr. He put me on Rx of Acyclovir and Metronidazole lotion Rx. He felt it was a reaction to the vaccine.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: 24 hours post vaccines, pt had pronounced redness from elbow to shoulder with slight swelling. Pt had mild and worsening pain in shoulder with nausea. Got prednisone inj. at urgent care and resolved within 10 min.
Age: 0.26
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: No sign or symptoms. Normal physical exam.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a female patient of unknown age. On an unknown date, the patient received the first and second doses of GARDASIL (dose, route, indication and lot number were not provided). On an unknown date, reported as "only 9 weeks after her second dose", the patient was inadvertently administered the third dose of GARDASIL (dose, route, indication and lot number were not provided). NO concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: This spontaneous report was received from a female consumer of unknown age referring herself. Pertinent medical history or allergies were not reported. On an unknown date (reported as: a while ago) the patient was vaccinated with ZOSTAVAX. Concentration, duration and route of administration were not reported. Concomitant medications were not reported. The patient stated that on an unknown date the patient had ZOSTAVAX and "now" she suffers Fromm neuropathy and was treated with LYRICA. She also said that her elderly father has nerve pain as a result of shingles (he did not received the vaccine) and has taken LYRICA, but it didn't control the nerve pain. The patient's father also took several unspecified creams, but these have not relieved his nerve pain. The outcome of neuropathy was unknown. The reporter did not established any relationship between ZOSTAVAX and neuropathy. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning to a patient of unknown age and gender. Medical history and drug reactions or allergies were not reported. On 11-SEP-2013, the patient was vaccinated with PNEUMOVAX23 lot # 6720747/1502AA, expiration date 19-MAY-2013 intramuscular (dose not reported). Concomitant therapy was not reported. On 11-SEP-2013, the patient was administered an expired dose of PNEUMOVAX23 and no adverse effect was reported. At the time of report, the patient's outcome was unknown. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old male patient with allergy to penicillin. On 17-SEP-2013 the patient was vaccinated with PNEUMOVAX23 (lot # J004332, exp date 26-SEP-2014), (0.5 ml dose, intramuscular). Also the patient reported getting an unspecified pneumonia vaccine seven years ago also. Concomitant therapy was not reported. On 17-SEP-2013 the patient experienced pain in arm that went over his shoulder and down his back. The patient had not seen physician or taken any treatment for the pain. Laboratory diagnostic studies were not performed. At the time of the report the patient's outcome was not recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker regarding a patient of unknown age and gender. The patient's medical history, drug reactions or allergies were not provided. On 13-SEP-2013, the patient was vaccinated with an expired 0.5 ml, subcutaneous dose of VARIVAX (Merck) (Lot number 1244AA, expiration date 01-AUG-2013). No adverse effect reported. This is one of several reports from the same source (MARRS #1309USA007339). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker regarding a patient of unknown age and gender. The patient's medical history, drug reactions or allergies were not provided. On 13-SEP-2013, the patient was vaccinated with an expired 0.5 ml, subcutaneous dose of VARIVAX (Merck) (lot number 1244AA, expiration date 01-AUG-2013). No adverse effect reported. This is one of several reports from the same source (MARRS #1309USA012898). Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Disorientation, Dizziness, Palpitations
Clinical narrative: Symptoms: Seizure, dizziness, fainted (2 mins. approx.). After effects: Headaches (for a few days) and a palpitation. Treatment: I-V, CT scan, X-ray, blood and urine test.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Blood test, Computerised tomogram, Convulsion, Dizziness, Headache
Clinical narrative: Symptoms: Seizure, dizziness, fainted (2 mins. approx.). After effects: Headaches (for a few days) and a palpitation. Treatment: I-V, CT scan, X-ray, blood and urine test.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Palpitations, Syncope, Urine analysis, X-ray
Clinical narrative: Symptoms: Seizure, dizziness, fainted (2 mins. approx.). After effects: Headaches (for a few days) and a palpitation. Treatment: I-V, CT scan, X-ray, blood and urine test.
Age: 75.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Local swelling, Pruritus, Urticaria
Clinical narrative: About 8 hours later I got hives. The hives were on both jaws and throat area. Also above my lip - additional lesions appeared on my hands - I felt itchy allover I used BENADRYL as suggested by pharmacy.
Age: 75.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pruritus generalised, Skin lesion, Urticaria
Clinical narrative: About 8 hours later I got hives. The hives were on both jaws and throat area. Also above my lip - additional lesions appeared on my hands - I felt itchy allover I used BENADRYL as suggested by pharmacy.
Age: 1.03
Sex: M
Vaccine: MMR, MMR
Symptoms: Pyrexia, Rash morbilliform, Rhinorrhoea
Clinical narrative: Measles like illness with fever. Runny nose and rash. 2 or with me and eval at ER.
Age: 1.03
Sex: M
Vaccine: MMR, MMR
Symptoms: Measles, Pyrexia, Rash, Rhinorrhoea, Viral test
Clinical narrative: Measles like illness with fever. Runny nose and rash. 2 or with me and eval at ER.
Age: 35.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Anxiety, Dizziness, Flushing, Immediate post-injection reaction, Pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of allergic reaction in a 35-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 19 September 2013 at 13:00 the subject received 1st dose of ENGERIX B (unknown, left arm). On 19 September 2013, immediately after vaccination with ENGERIX B, the subject experienced allergic reaction and dizziness/lightheaded; and about 1 hour after vaccination with ENGERIX B, the subject experienced anxiety, flushing, rash on neck and shoulders and pruritus all over body. The healthcare professional indicated that the subject felt lightheaded and dizzy immediately after the vaccination. About an hour later, the subject began to feel anxious, flushed and developed a rash around her neck and shoulders, and began to itch all over body. The healthcare professional described the allergic reaction as lightheadedness, dizzy, anxious, flushed, rash and itching. The subject's symptoms resolved after seeking treatment in the emergency room (ER). The subject was treated with BENADRYL and prednisone in the ER and "shortly thereafter the symptoms resolved." According to the healthcare professional, the subject did not experience any respiratory problems. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). The length of stay in the hospital was not provided. At the time of reporting the events were resolved. The vaccination course with ENGERIX B was discontinued.
Age: 35.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of allergic reaction in a 35-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 19 September 2013 at 13:00 the subject received 1st dose of ENGERIX B (unknown, left arm). On 19 September 2013, immediately after vaccination with ENGERIX B, the subject experienced allergic reaction and dizziness/lightheaded; and about 1 hour after vaccination with ENGERIX B, the subject experienced anxiety, flushing, rash on neck and shoulders and pruritus all over body. The healthcare professional indicated that the subject felt lightheaded and dizzy immediately after the vaccination. About an hour later, the subject began to feel anxious, flushed and developed a rash around her neck and shoulders, and began to itch all over body. The healthcare professional described the allergic reaction as lightheadedness, dizzy, anxious, flushed, rash and itching. The subject's symptoms resolved after seeking treatment in the emergency room (ER). The subject was treated with BENADRYL and prednisone in the ER and "shortly thereafter the symptoms resolved." According to the healthcare professional, the subject did not experience any respiratory problems. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). The length of stay in the hospital was not provided. At the time of reporting the events were resolved. The vaccination course with ENGERIX B was discontinued.
Age: 35.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Anxiety, Dizziness, Flushing, Hypersensitivity, Immediate post-injection reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of allergic reaction in a 35-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 19 September 2013 at 13:00 the subject received 1st dose of ENGERIX B (unknown, left arm). On 19 September 2013, immediately after vaccination with ENGERIX B, the subject experienced allergic reaction and dizziness/lightheaded; and about 1 hour after vaccination with ENGERIX B, the subject experienced anxiety, flushing, rash on neck and shoulders and pruritus all over body. The healthcare professional indicated that the subject felt lightheaded and dizzy immediately after the vaccination. About an hour later, the subject began to feel anxious, flushed and developed a rash around her neck and shoulders, and began to itch all over body. The healthcare professional described the allergic reaction as lightheadedness, dizzy, anxious, flushed, rash and itching. The subject's symptoms resolved after seeking treatment in the emergency room (ER). The subject was treated with BENADRYL and prednisone in the ER and "shortly thereafter the symptoms resolved." According to the healthcare professional, the subject did not experience any respiratory problems. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). The length of stay in the hospital was not provided. At the time of reporting the events were resolved. The vaccination course with ENGERIX B was discontinued.
Age: 35.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Pruritus generalised, Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of allergic reaction in a 35-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 19 September 2013 at 13:00 the subject received 1st dose of ENGERIX B (unknown, left arm). On 19 September 2013, immediately after vaccination with ENGERIX B, the subject experienced allergic reaction and dizziness/lightheaded; and about 1 hour after vaccination with ENGERIX B, the subject experienced anxiety, flushing, rash on neck and shoulders and pruritus all over body. The healthcare professional indicated that the subject felt lightheaded and dizzy immediately after the vaccination. About an hour later, the subject began to feel anxious, flushed and developed a rash around her neck and shoulders, and began to itch all over body. The healthcare professional described the allergic reaction as lightheadedness, dizzy, anxious, flushed, rash and itching. The subject's symptoms resolved after seeking treatment in the emergency room (ER). The subject was treated with BENADRYL and prednisone in the ER and "shortly thereafter the symptoms resolved." According to the healthcare professional, the subject did not experience any respiratory problems. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). The length of stay in the hospital was not provided. At the time of reporting the events were resolved. The vaccination course with ENGERIX B was discontinued.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site urticaria, Pruritus, Urticaria
Clinical narrative: Rash started on arm of vaccination, spread to other arm and legs and face.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rash
Clinical narrative: Rash started on arm of vaccination, spread to other arm and legs and face.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Pruritus generalised, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling tender to touch and itching on vaccine site. Also really itchy all over body.
Age: 27.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Blood creatine phosphokinase normal, Chills, Cyanosis, Injection site discolouration, Injection site erythema
Clinical narrative: Received Pneumovax and flu shot (injectable) on 9/20/2013 morning. That evening started to develop generalized body aches, chills, and low grade fever. Continued for 3 days. On 9/23/2013 started to have pain in the right upper arm (both vaccines were given in this arm). Pain worsened, started to notice swelling in the upper portion of arm above elbow and three distinct reddish circles on the inner aspect of the arm just above elbow. The reddish circles seemed to grow over time. Came to clinic 9/24 for evaluation. At that time right arm was warm to the touch and swollen from approx shoulder to elbow. Very tender to touch this entire portion of the arm. Had three separate reddish maculopapular lesions approximately quarter sized on anterior surface of arm just proximal to the antecubital fossa. No signs of cellulitis. CK checked given degree of pain/muscle tenderness and was normal. Given Benadryl for potential hives + ibuprofen/Tylenol for pain + icing of the arm. Gradually improving per RN check on pt 9/25 and 9/26. Still with mild rash and now new bluish area on the upper arm near elbow (has not come for further evaluation). Fevers have resolved, pain slowly improving.
Age: 27.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Received Pneumovax and flu shot (injectable) on 9/20/2013 morning. That evening started to develop generalized body aches, chills, and low grade fever. Continued for 3 days. On 9/23/2013 started to have pain in the right upper arm (both vaccines were given in this arm). Pain worsened, started to notice swelling in the upper portion of arm above elbow and three distinct reddish circles on the inner aspect of the arm just above elbow. The reddish circles seemed to grow over time. Came to clinic 9/24 for evaluation. At that time right arm was warm to the touch and swollen from approx shoulder to elbow. Very tender to touch this entire portion of the arm. Had three separate reddish maculopapular lesions approximately quarter sized on anterior surface of arm just proximal to the antecubital fossa. No signs of cellulitis. CK checked given degree of pain/muscle tenderness and was normal. Given Benadryl for potential hives + ibuprofen/Tylenol for pain + icing of the arm. Gradually improving per RN check on pt 9/25 and 9/26. Still with mild rash and now new bluish area on the upper arm near elbow (has not come for further evaluation). Fevers have resolved, pain slowly improving.
Age: 27.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: Received Pneumovax and flu shot (injectable) on 9/20/2013 morning. That evening started to develop generalized body aches, chills, and low grade fever. Continued for 3 days. On 9/23/2013 started to have pain in the right upper arm (both vaccines were given in this arm). Pain worsened, started to notice swelling in the upper portion of arm above elbow and three distinct reddish circles on the inner aspect of the arm just above elbow. The reddish circles seemed to grow over time. Came to clinic 9/24 for evaluation. At that time right arm was warm to the touch and swollen from approx shoulder to elbow. Very tender to touch this entire portion of the arm. Had three separate reddish maculopapular lesions approximately quarter sized on anterior surface of arm just proximal to the antecubital fossa. No signs of cellulitis. CK checked given degree of pain/muscle tenderness and was normal. Given Benadryl for potential hives + ibuprofen/Tylenol for pain + icing of the arm. Gradually improving per RN check on pt 9/25 and 9/26. Still with mild rash and now new bluish area on the upper arm near elbow (has not come for further evaluation). Fevers have resolved, pain slowly improving.
Age: 27.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Blood creatine phosphokinase, Chills, Pain, Pyrexia, Rash
Clinical narrative: Received Pneumovax and flu shot (injectable) on 9/20/2013 morning. That evening started to develop generalized body aches, chills, and low grade fever. Continued for 3 days. On 9/23/2013 started to have pain in the right upper arm (both vaccines were given in this arm). Pain worsened, started to notice swelling in the upper portion of arm above elbow and three distinct reddish circles on the inner aspect of the arm just above elbow. The reddish circles seemed to grow over time. Came to clinic 9/24 for evaluation. At that time right arm was warm to the touch and swollen from approx shoulder to elbow. Very tender to touch this entire portion of the arm. Had three separate reddish maculopapular lesions approximately quarter sized on anterior surface of arm just proximal to the antecubital fossa. No signs of cellulitis. CK checked given degree of pain/muscle tenderness and was normal. Given Benadryl for potential hives + ibuprofen/Tylenol for pain + icing of the arm. Gradually improving per RN check on pt 9/25 and 9/26. Still with mild rash and now new bluish area on the upper arm near elbow (has not come for further evaluation). Fevers have resolved, pain slowly improving.
Age: 27.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Tenderness
Clinical narrative: Received Pneumovax and flu shot (injectable) on 9/20/2013 morning. That evening started to develop generalized body aches, chills, and low grade fever. Continued for 3 days. On 9/23/2013 started to have pain in the right upper arm (both vaccines were given in this arm). Pain worsened, started to notice swelling in the upper portion of arm above elbow and three distinct reddish circles on the inner aspect of the arm just above elbow. The reddish circles seemed to grow over time. Came to clinic 9/24 for evaluation. At that time right arm was warm to the touch and swollen from approx shoulder to elbow. Very tender to touch this entire portion of the arm. Had three separate reddish maculopapular lesions approximately quarter sized on anterior surface of arm just proximal to the antecubital fossa. No signs of cellulitis. CK checked given degree of pain/muscle tenderness and was normal. Given Benadryl for potential hives + ibuprofen/Tylenol for pain + icing of the arm. Gradually improving per RN check on pt 9/25 and 9/26. Still with mild rash and now new bluish area on the upper arm near elbow (has not come for further evaluation). Fevers have resolved, pain slowly improving.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Computerised tomogram, Diarrhoea, Nausea, Pyrexia
Clinical narrative: Severe stomach pain and nausea low grade fever watery stool.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Severe chills, fever, malaise beyond any previous flu vaccination; recovered in three days.
Age: 0.45
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration
Clinical narrative: Fluzone .25mg was given to this patient who is 5 months and 11 days old.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Swollen with a diameter of about 2", raised about 1/4". Right below the injected site. Swollen area appears like a bruise. No itching, no pressure, not hot to the touch. Subside with ice application.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count normal, Induration, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: Low grade fever, pain/redness at injection site of flu shot. Myalgias, induration of 2cm.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Low grade fever, pain/redness at injection site of flu shot. Myalgias, induration of 2cm.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Induration, Pruritus, Skin warm, Tenderness
Clinical narrative: Vaccine was administered at approx 6 pm on 9/16/13. Upon awakening at 7 AM on 9/17/13 he noticed an area of induration that measured 3" x 2". The area was reddened and warm to touch. He stated that there was some itchiness and slight tenderness on palpitation. No other sx reported.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: Injection site erythema starting with 24 hrs of vaccination increasing in size over 4 days to 8.5 x 9 cm with tenderness and fixed nodule at injection site. Erythema is hot to the touch. Started BACTRIM DS on day 4. Resolved by day 8.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Paraesthesia
Clinical narrative: Patient felt lightheaded, tightness in chest, tingling down left arm.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Hypoacusis, Nausea, Sensory loss, Vision blurred
Clinical narrative: This spontaneous report as received from patient's grandmother refers to her grandson who was a 16 year old male patient. Patient received his first dose of injection of GARDASIL (strength, formulation, Lot#, route and duration were unspecified) last month (August 2013) and before getting 2nd injection of GARDASIL (strength, formulation, Lot#, route and duration were unspecified) today (23-SEP-2013) he felt nauseated, however he went through physical activity at school without eating then was taken in to get injection and was feeling nauseated. He could not feel his legs and could barely hear and vision was blurry after receiving the 2nd injection of GARDASIL. Patient did not seek medical attention. Therapy was continued. No treatment was given for the events. The outcome was unknown. Upon internal review, barely hear was considered as other medical significant event. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray normal, Chest discomfort, Conjunctivitis, Cough, Dyspnoea
Clinical narrative: Vaccine given at 3 PM. 2 hrs later she developed chest constriction / SOB / myalgias / cough and bilateral conjunctivitis. Went to ED. Chest X-ray -> NL. Symptoms resolved with MOTRIN.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Vaccine given at 3 PM. 2 hrs later she developed chest constriction / SOB / myalgias / cough and bilateral conjunctivitis. Went to ED. Chest X-ray -> NL. Symptoms resolved with MOTRIN.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Injection site pruritus, Skin warm
Clinical narrative: Pt rec'd her vaccine at public clinic at 515pm on 9/17. She noted that site was mildly itchy at bedtime. At 6am when she was getting into shower she noticed an area of induration approx 3" x 2" that was reddened and warm to touch. She reported to the school nurse who contacted me. I spoke directly to patient today. Area of induration remains unchanged.
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation, Injection site oedema, Injection site swelling, Injection site warmth, Skin reaction
Clinical narrative: This spontaneous report as received from a physician via company representative refers to physician's mother of unknown age. On an unknown date in September 2013 (reported as about a week ago) the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and lot# not reported). Concomitant therapy included unspecified blood pressure medication. On an unknown date in September 2013, the patient experienced localized reaction around the injection site from shoulder to the lower third of her arm. Symptoms included swelling, warmth, inflammation and edema. The patient sought unspecified medical attention. The outcome was reported as recovered/resolved (on an unknown date in September 2013) within 48 hours from onset date. Additional information has been requested.
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Cellulitis, Erythema, Feeling hot, Local swelling, Pain in extremity
Clinical narrative: Information has been received from a third party claims administrator regarding a case in litigation concerning a female consumer. At a pharmacy, on 07SEP13, the patient was vaccinated by injection with 3 vaccines, 2 in the left arm AFLURIA (lot # 08849211A) and PNEUMOVAX (lot # H020684) and the third one BOOSTRIX (lot # AC52B099BA) on the left hand. The patient sustained on her left arm, redness, swelling, pain and her arm felt hot and fever. The patient was admitted to the hospital and was hospitalized due to a cellulitis in left arm. Additional information has been requested.
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Information has been received from a third party claims administrator regarding a case in litigation concerning a female consumer. At a pharmacy, on 07SEP13, the patient was vaccinated by injection with 3 vaccines, 2 in the left arm AFLURIA (lot # 08849211A) and PNEUMOVAX (lot # H020684) and the third one BOOSTRIX (lot # AC52B099BA) on the left hand. The patient sustained on her left arm, redness, swelling, pain and her arm felt hot and fever. The patient was admitted to the hospital and was hospitalized due to a cellulitis in left arm. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation
Clinical narrative: Inflammation of arm.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Local reaction, Local swelling, Pain
Clinical narrative: Pt. rec'd PNEUMOVAX (L) deltoid on 9/19/13 and had just a local reaction with redness / soreness x 24 hrs. On 9/21 she developed a large swollen area down below (L) antecubital area to mid biceps - approx 10 cm area of cellulitis requiring BACTRIM.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site swelling, Ophthalmic herpes zoster, Oral herpes
Clinical narrative: Pt had a swollen "bar" at injection site, had fever blisters in nostrils, and got shingles in the eye.
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (R) arm swollen around injection site. Redness at injection site. Warm to touch.
Age: 0.33
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Abdominal X-ray, Barium enema, Haematochezia, Pyrexia, Ultrasound abdomen
Clinical narrative: Pt was not seen at PCP office. Hospital records indicate fever beginning 8/21/13 with vomiting x2 and bloody stools beginning 8/22/13.
Age: 0.33
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Pt was not seen at PCP office. Hospital records indicate fever beginning 8/21/13 with vomiting x2 and bloody stools beginning 8/22/13.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood blister, Petechiae
Clinical narrative: Vaccine administered 9/24/13 - Pt reported blood blisters on tongue, gums, inside cheeks of mouth and petechia all over body on 9/25/13. 9/26/13 stated improving.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood blister, Oral mucosal blistering, Petechiae
Clinical narrative: Vaccine administered 9/24/13 - Pt reported blood blisters on tongue, gums, inside cheeks of mouth and petechia all over body on 9/25/13. 9/26/13 stated improving.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse, via company representative, refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported) for prevention of shingles. Concomitant medications were not reported. On an unknown date the patient experienced red circles and areas, and swelling around injection site. Nurse stated that the patient was prescribed Claritine. The outcome of swelling red circles and areas, and swelling around injection site was unknown. The relationship between the ZOSTAVAX and the events was not reported. This case is linked to case 1309USA013052 via same reporter link. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. On 16-SEP-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # J004747, expiration date 20-JUL-2014, dose unspecified) subcutaneous in the tricep muscle of left arm. Other suspect therapies included FLUVIRIN in the same arm. In September 2013 the patient experienced injection site reaction after vaccination with PNEUMOVAX23. It was unknown if this was the patient's first vaccination with PNEUMOVAX23. The patient was diagnosed with cellulitis. The patient sought medical attention via contacted physician. Unspecified antibiotic was given for treatment. The event outcome was reported as not recovered. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Pt given PNEUMOVAX on 9/16 - presented with injection site reaction. Pt diagnosed w/ cellulitis and started on KEFLEX on 9/19.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse, via company representative, refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported) for prevention of shingles. Concomitant medications were not reported. On an unknown date the patient experienced red circles and areas, and swelling around injection site. Nurse stated that the patient was prescribed Claritine. The outcome of swelling red circles and areas, and swelling around injection site was unknown. The relationship between the ZOSTAVAX and the events was not reported. This case is linked to case 1309USA000926 via same reporter link. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. The patient had a past history of shingles. The episode of the shingles occurred and resolved prior to the administration of ZOSTAVAX. The patient has no drug reactions/allergies. On 16-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot # J004266, exp 12-JUN-2014), subcutaneous, dose not provided. There was no concomitant medication. On 17-SEP-2013, the patient had a little redness and warmth at the injection site. On 18-SEP-2013 redness had expanded to the size of a baseball and the warmth continued. No treatment was given. No lab was performed. The patient called the reporting pharmacist. At time of report the patient was not recovered. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Rash
Clinical narrative: This spontaneous report as received from a pharmacist via other company refers to a male patient of unknown age. On an unknown date in 2011, the patient was vaccinated with the dose of PNEUMOVAX23 (dose, route of administration and lot number were not reported). On an unknown date, the patient experienced localised rash and swelling around the injection site after receiving PNEUMOVAX 23 in 2011. The outcome of swelling around the injections site and localised rash was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date the patient was vaccinated with RECOMBIVAX HB, intramuscular. Route, dose, dose number, frequency and lot number were not reported. The nurse reported that improperly stored RECOMBIVAX HB may have been administered to unspecified patients. RECOMBIVAX HB was exposed to temperatures of 31.5F for 4 hours and 31.5F for 1.5 hours. No adverse effects were reported. This case is linked to 1308USA014798, 1309USA013284 and 1309USA013285 (same reporter link). Additional information is expected.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician via company representative, refers to a 17 year old female patient. On 17-SEP-2013 was vaccinated with the dose of VARIVAX (dose, route of administration and lot number were not reported). In September 2013 the patient developed chicken pox after receiving VARIVAX. The patient sought medical attention via a physician visit. The patient was not treated for the event. The outcome of chicken pox was reported as not recovered/not resolved. The relatedness between the event and VARIVAX was not reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness 2" x 1 1/2", itching, and pain to touch at injection site. No systemic symptoms. Treat with oral BENADRYL, ice to site.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date the patient was vaccinated with PEDVAXHIB, intramuscular. Route, dose, dose number, frequency and lot number were not reported. The nurse reported that improperly stored PEDVAXHIB may have been administered to unspecified patients. PEDVAXHIB was exposed to temperatures of 31.5F for 4 hours and 31.5F for 1.5 hours. No adverse effects were reported. This case is linked to 1308USA014798, 1309USA013283 and 1309USA013284 (same reporter link). Additional information is expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical conisation, Loop electrosurgical excision procedure, Papilloma viral infection, Smear cervix normal
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter, a 21 year old female patient. Approximately in 2007 the patient was vaccinated with 3 dose of GARDASIL (lot#, expiration date, dose, route, indication not reported). Approximately in 2013 the patient was diagnosed with moderate HPV. Approximately in 2010 ("at 18"), the patient had a clean PAP smear and, had gone along with the change in direction of a 3 year later, it was at this level of invasion. The patient had been given a conization/Loop Electrosurgical Excision Procedure (LEEP). The outcome of the events was unknown. The consumer would wonder how many other girls were being infected, even though they had been given this vaccine. Additional information has been requested.