chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Face injury, Fall, Hyperventilation, Loss of consciousness, Syncope
Clinical narrative: Within seconds of receiving vaccine pt leaned forward, fainting, and fell of table appearing to hit face. Regained consciousness within seconds. Began to hyperventilate. Transferred to ER via ambulance.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Joint range of motion decreased, Local swelling, Skin warm
Clinical narrative: (L) arm hot to touch, chills. Swollen (L) shoulder. Pain with decreased (L) shoulder and decreased ROM. No fever, pruritus head, upper trunk body, arms, thighs without lesions. Seen 10/14/14/.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt has significant swelling and redness in her right arm between her shoulder and elbow. She reported itching and soreness as well.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site discomfort
Clinical narrative: Started with some discomfort on the injection site after the injection then the next morning there was a purplish blue color mark around the injection site. Four days later the mark was about 6 inches long and 4 inches wide from the injection site to 2 inches above elbow.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Pain, Swelling
Clinical narrative: Pt had reaction to FLUZONE HIGH DOSE and PNEUMOVAX 23 shot. Pt experienced soreness, swelling and site that was warm to the touch.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient complained pain/soreness in arm and fever. Patient was contacted next day, and informed us that she is feeling better but still on pain/fever.
Age: 70.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: None. Dose was given IM instead of SQ.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local swelling, Pain in extremity
Clinical narrative: Site where given-warm, red and swollen-under L arm swollen- (axilla). Entire left arm is sore.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Bruse line circle 2 inch in diameter around area where injection given. Appeared day after and getting better to day looked like blood vessels leaked under skin.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUN4, IPV, MMR, VARCEL
Symptoms: Fatigue, Malaise, Pyrexia
Clinical narrative: DTaP/IPV/MMR/VARIVAX/FLUMIST given on 10/14. Fevers began 10/8, lasted 3-4 days associated with malaise and fatigue. No sick contacts, no URI/cough. Normal exam 10/15/14.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None Noted
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Received influenza vac 10/6/14 - 10/7/14 AM noticed redness at injection site - redness increased after that - 5x6 area redness upon presentation - no other symptoms - has been icing and taking ibuprofen - no unusual pain to arm (L).
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Discomfort, Feeling abnormal, Headache
Clinical narrative: I received FLUVIRIN on 10/6/14 and was feeling well at time, no symptoms. Woke up during night of 10/7/14 with bad headache. Felt bad 10/7, 10/8 and still feeling bad 10/9/14. Symptoms include chills, diarrhea, general body discomfort, headache and congestion. I am reporting this because I've been getting flu shot for over 10 years without any side effects. This year was different for me. I am 59 years old male in good general health.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Respiratory tract congestion
Clinical narrative: I received FLUVIRIN on 10/6/14 and was feeling well at time, no symptoms. Woke up during night of 10/7/14 with bad headache. Felt bad 10/7, 10/8 and still feeling bad 10/9/14. Symptoms include chills, diarrhea, general body discomfort, headache and congestion. I am reporting this because I've been getting flu shot for over 10 years without any side effects. This year was different for me. I am 59 years old male in good general health.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None noted
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Nervousness, Pruritus
Clinical narrative: Pt received a Flu shot approx 10:20 at campus flu clinic at the law school. She returned to the room where shots were given at approx 10:55 with c/o "funny breating". She laid on the couch B/P 114/76 after 76 over.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Hyperhidrosis, Pain
Clinical narrative: About 16-24 hrs after receiving the flu vaccine, patient reports experiencing the sweats, fatigue, and generalized body aches for approximately 36 hours.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Infection, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling right upper arm. Treated for infection.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Headache x 14 Starting day of vaccine
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Tenderness
Clinical narrative: Swollen and tender left arm.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Inappropriate schedule of drug administration, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: 2nd dose of PNEUMOVAX 23 given at 11 months instead of 5 yrs, Patient reported fever, cold symptoms, aches and pains which she said was brought on by second shot given way before, she also got a FLU vaccine same day.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: Swollen Supraclavicular lymph nodes on L side; same side FLU shot administered
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Nausea, Tremor
Clinical narrative: Within 10 minutes after vaccination began to get flushed, nauseated, body shakes symptoms resolved after 15 minutes
Age: 75.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthenia, Chills, Incontinence, Pain in extremity, Somnolence
Clinical narrative: Sudden onset of pain in R upper arm, severe shaking, severe chills, rare incontinency, fainting (totally rare)  Began drinking fluids in excess. Weak and sleepy next day.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Syncope, Thirst, Tremor
Clinical narrative: Sudden onset of pain in R upper arm, severe shaking, severe chills, rare incontinency, fainting (totally rare)  Began drinking fluids in excess. Weak and sleepy next day.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hypersensitivity, Mobility decreased, Pain, Pyrexia, Swelling
Clinical narrative: Major allergic reaction 6 hours after PNEUMOVAX 23 val 0.5 MLX 10CC right arm totally disables. Forward movement 10% max. Major pain, swelling, little fever as of this writing its been 48 hrs with movement of my arm about 65%. Not happy off to see my Dr. Dr. at pharmacist had me on Excedrin and Benadryl, Ice pak.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Vaccination complication
Clinical narrative: Allergic reaction to FLU shot symptoms did not develop until 4-5 days after shot.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient Complained that arm was still very sore 2 weeks after vaccination.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site anaesthesia, Injection site reaction, Paraesthesia
Clinical narrative: Pataient reports numbness and tingling at the injections site
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Patient indicated that her arm was very sore 2 weeks after receiving vaccine. Arm was weak.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Hypersomnia, Injection site erythema, Injection site pain, Pain
Clinical narrative: Pain and red patch 4-5 inches in diameter over shoulder injected with PNEUMOVAX (R). Patient aches all over and is sleeping more than usual. Patient states she is tired.
Age: 36.0
Sex: M
Vaccine: FLUN4, HPV4
Symptoms: No adverse event
Clinical narrative: PT had no signs or symptoms.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient developed hives all over his body. Patient contacted his physician and was advised to take 2 tabs Benadryl OTC. After 2 doses of Benadryl the hives have resolved. Patient has had INFLUENZA vaccine previously with no problems.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Erythema, Induration, Local swelling, Nodule
Clinical narrative: Hard knot/Redness shoulder to elbow by 7pm. Fever/chills/swelling upper arm/pain when trying to lift arm first 2 days/ knot moved down arm/itchy hot. Dr. suggested  Benadryl. Symptoms letting up day 5
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pruritus, Pyrexia, Skin warm
Clinical narrative: Hard knot/Redness shoulder to elbow by 7pm. Fever/chills/swelling upper arm/pain when trying to lift arm first 2 days/ knot moved down arm/itchy hot. Dr. suggested  Benadryl. Symptoms letting up day 5
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Injection site erythema, Ocular hyperaemia, Pain, Pyrexia
Clinical narrative: 3 hrs after injection eyes began with red and itching. Redness to injections. Fever 101.6 began about 6pm. Body aches until Monday 10/6/14. Fever until 10/5/14
Sex: U
Vaccine: PPV
Symptoms: Erythema, Inappropriate schedule of drug administration, Local swelling, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. In 2013 (reported as: one year ago) the patient was vaccinated with PNEUMOVAX 23 (dose 1; route, dosage and lot number unknown) for prevention. In October 2014 the patient inadvertently received a second dose of PNEUMOVAX 23 (dose 2, lot # K009809 EXP 16-MAY-2015; route and dosage unknown) for prevention. By the third day post second injection, patient reported to pharmacist that their arm hurt due swelling and redness. The outcome of the events was reported as resolved (unknown date). Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as receivfed from a physician assistant refers to a 12 year old female patient. On 24-JUL-2014, the patient was vaccinated with a 0.5 ml dose of GARDASIL (lot # not reported) intramuscularly. The physician assistant reported that on 26-JUL-2014, the patient experienced small bumps at the injection site. The pyatient was treated with BENADRYL and the bumps resolved on 02-AUG-2014. Additional information is not expected. There is not permission to contact the physician.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to an unspecified patients of unknown age and gender. 02-AUG-2014, doses of RECOMBIVAX HB were exposed to an unsupported temperature excursion of -1C for "5 to 16 hours". On an unspecified dates since 02-AUG-2014, RECOMBIVAX HB (lot # J012567; expiration date: 30-JAN-2016) (dose and route were not reported) were administered to unspecified patients. No adverse effect has been observed or reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Decreased activity, Erythema, Fatigue, Gait disturbance, Local swelling
Clinical narrative: Swollen and red right arm. Tired. Decreased activity. "Too tired to walk". Referred to PCP.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Fall, Loss of consciousness
Clinical narrative: Patient was given ADACEL in (R) delt. When patient went to leave she walked out of the exam room and to the front office where she fell had LOC for about 30 secs. When she came to she was alert and oriented. We sent to ER to evaluate head.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Injection site pain, Nausea, Pyrexia
Clinical narrative: Night of HPV #3, pt felt dizzy, queasy, low gd fever 99.9, very painful site of injection.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Local swelling
Clinical narrative: This spontaneous report was received from a 55 year old female patient reporting on herself. No medical history or concurrent conditions were reported. On 10-OCT-2014, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous in the arm (lot # reported as 1225925-03015). Concomitant therapies were reported as unspecified medications. On 10-OCT-2014, the patient reported that her arm was red and started swelling up after she was administered with ZOSTAVAX. The patient also stated that she had a bump at the injection site. On 14-OCT-2014, the swelling started to go down some, but now (approximately in October 2014), the injection site was itching. The patient stated that the ZOSTAVAX was applied on a pharmacy. Treatment was suggested (ice on the injection site), no labs diagnostic studies were performed and the patient sought medical attention (went back to pharmacy where shot was given). At the time of the report, the outcome of redness, itching and the bump at the vaccination site was not recovered. The outcome of swelling at the vaccination site was recovering. The causal relationship between the events and ZOSTAVAX was unknown. Lot number 1225925-03015 is an invalid lot number for ZOSTAVAX. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt presented with injection site reaction 10/15/14 (Given 10/13/14) Red, swollen, painful site Approx 5" x 2" and possible beginning of blisters.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to female patient, currently patient was 83 year old. No medical history and current conditions reported. On an unknown date (in the past) the patient was vaccinated with ZOSTAVAX (dose, frequency and route unknown) for unknown indication. No concomitant medications reported. On an unknown date, the patient experienced swelling around the injection site. The outcome of patient experienced swelling around the injection site was unknown. The causality was unknown. This report is linked to 1410USA006971 (same reporter). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. The reporter reported that an expired dose of ZOSTAVAX (Lot# unspecified, expired on 14-SEP-2014) was inadvertently administered to an unspecified patient on 03-OCT-2014 (dose, frequency and route unspecified). This was supported. No adverse effects reported. Outcome of the event was not reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: (L) lateral arm - 4.5 in x 5.5 in red, hot, itching. BENADRYL, ZYRTEC, KEFLEX.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Round, raised, red itchy injection site reaction. Patient advised to take BENADRYL and apply a cold compress.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 06-OCT-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 0.5 mL, lot # J004332, expiration date: 26-SEP-2014, subcutaneous. No adverse effects were reported. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 59 year old male patient. Patient's concurrent condition included allergy to niacin (flushing). On 04-OCT-2014 the patient was vaccinated with ZOSTAVAX (lot # K006438; expiration date: 05-AUG-2015) 0.65 ml, subcutaneous. On 13-OCT-2014, the patient experienced "intense itching all over his body". The reporter stated that the patient did not have any rash or any visible changes in his skin. No treatment was given at this time. No lab diagnostics studies were performed. On an unknown date, the patient sought medical attention by a call to pharmacy. The outcome of "intense itching all over his body" was reported as not recovered/not resolved. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swelling around most of upper deltoid where vaccine was administered.
Age: 1.58
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Abnormal behaviour, Crying, Pyrexia, Unresponsive to stimuli
Clinical narrative: Mother narrates persistent elevated fever to 105+, 3 hrs. continuous crying after vaccines administered. Mother also describes "wierd" behavior, not responding to her name and rolling around on the ground within hours after vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 06-OCT-2014 the patient was vaccinated with an expired dose of ZOSTAVAX, 0.65 ml, once in the right deltoid region (lot # and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: IPV, MMRV, MNQ
Symptoms: Screaming
Clinical narrative: 9/2/14 Pt's mother reported she heard screaming in her head. Pt seen by PCP and psych.
Age: 1.32
Sex: M
Vaccine: DTAP, HIBV, MMRV
Symptoms: Rash
Clinical narrative: Rash.
Age: 1.32
Sex: F
Vaccine: DTAP, HIBV, MMRV
Symptoms: Rash
Clinical narrative: Rash.
Age: 4.0
Sex: M
Vaccine: HEP
Symptoms: Inflammation
Clinical narrative: Hep B site 4 cm-oval inflammatory response-warm. No streaking. No drainage. No fever. Other 2 Iz sites were WNL.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Chest discomfort, Cough, Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt here, c/o pain to (L) upper arm, decreased mobility, pain at arm pit itching last night with cough and chest tightness last night after receiving pneumococcal vaccine polyvalent (PNEUMOVAX 23) in (L) arm 10/2/14. Pt c/o enlarged, painful lymph nodes (L) under arm. Pt reports had influenza vaccine 1 month before this date. No HA; Afebrile at 97.5 today. Decreased mobility to (L) arm. Pt exhibited decreased mobility (L)(L) arm; no enlarged lymph nodes palpated upon exam.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Lymph node pain, Lymphadenopathy, Pruritus
Clinical narrative: Pt here, c/o pain to (L) upper arm, decreased mobility, pain at arm pit itching last night with cough and chest tightness last night after receiving pneumococcal vaccine polyvalent (PNEUMOVAX 23) in (L) arm 10/2/14. Pt c/o enlarged, painful lymph nodes (L) under arm. Pt reports had influenza vaccine 1 month before this date. No HA; Afebrile at 97.5 today. Decreased mobility to (L) arm. Pt exhibited decreased mobility (L)(L) arm; no enlarged lymph nodes palpated upon exam.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. On 22-AUG-2014 the patient was inadvertently vaccinated with an expired dose of MMR II (dose was not reported, subcutaneously, HSA; lot # H014977, expiration date 09-AUG-2014). The MMR II was supported. No adverse effects were reported. No PQC (product quality complaint) was involved. This is the one of two reports received from the same reporter. Additional information has been requested.
Age: 54.0
Sex: U
Vaccine: HEPAB
Symptoms: Dizziness, Thirst
Clinical narrative: After TWINRIX shot, pt felt dizzines, thirsty, which last 5-10 min. No treatment.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No information about medical history, concurrent conditions, drug reactions and allergies was specified. The pharmacist reported that on an unknown date, over 4 years ago an unspecified Pharmacy provided patient with ZOSTAVAX (lot#, dose, route not reported) to carry to Physician's office for administration. Patient states at that time the healthcare worker questioned whether it was too warm, but administered it anyway. No concomitant medications were reported. There was no stability check done at that time. Patient has not experienced any adverse effects. The patient did not seek medical attention. There was no product quality complaint. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with PNEUMOVAX 23 (lot # not reported) (dose and route unknown) on 25-AUG-2014 and 18-SEP-2014. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. "About 4 years ago", in approximately 2010, the patient was vaccinated with the first and second dose of GARDASIL (strength, dose, route and lot # not reported). On 03-OCT-2014 the patient was vaccinated with the third dose of GARDASIL (strength, dose, route and lot # not reported). No adverse effect reported. Additional information has been requested.
Age: 1.58
Sex: M
Vaccine: DTP, HIBV, DTAP, HIBV
Symptoms: Ear swelling, Erythema, Eyelid oedema, Rash erythematous, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hives in a 19-month-old male subject who was vaccinated with (GlaxoSmithKline) INFANRIX. Concurrent medical conditions included allergy to eggs and allergy to peanuts. Concurrent vaccination included influenza type B (non-GSK, Sanno; unknown route, injection site and batch number) given on 23 JULY 2014. On 23 JULY 2014, at 9:30 AM, the subject received 4th dose of INFANRIX (.5 ml, unknown route, left thigh). In the afternoon of 23 JULY 2014, less than one day after vaccination with INFANRIX, the subject experienced hives after waking up. The subject was treated with BENADRYL, On 24 JULY 2014, the event was resolved. The subject also received Hib Vaccine the same day which HCP did not feel eel is a co-suspect in the adverse reaction the subject experienced.   Follow up information received on 23 SEPTEMBER 2014: This case was reported by a nurse and described the occurrence of hives in a 19-month-old male patient who received INFANRIX (batch number 32PC3, expiry date 14th December 2015). Concomitant products included HAEMOPHILLIUS INFLUENZA B vaccine (non-GSK),  intramuscular, 0.5ml.  On 23rd JULY 2014, the patient received the 4th dose of INFANRIX (unknown route) .5ml.  On 23rd JULY 2014, less than a day after receiving INFANRIX, the patient experienced hives, skin rash and contact dermatitis. The patient was treated with BENADRYL (nos). On 24th JULY 2014, after 24 hours, the outcome of the hives, skin rash and contact dermatitis were recovered/resolved. It was unknown if the reporter considered the hives, skin rash and contact dermatitis to be related to INFANRIX.
Age: 1.58
Sex: M
Vaccine: DTP, HIBV, DTAP, HIBV
Symptoms: Dermatitis contact, Rash, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hives in a 19-month-old male subject who was vaccinated with (GlaxoSmithKline) INFANRIX. Concurrent medical conditions included allergy to eggs and allergy to peanuts. Concurrent vaccination included influenza type B (non-GSK, Sanno; unknown route, injection site and batch number) given on 23 JULY 2014. On 23 JULY 2014, at 9:30 AM, the subject received 4th dose of INFANRIX (.5 ml, unknown route, left thigh). In the afternoon of 23 JULY 2014, less than one day after vaccination with INFANRIX, the subject experienced hives after waking up. The subject was treated with BENADRYL, On 24 JULY 2014, the event was resolved. The subject also received Hib Vaccine the same day which HCP did not feel eel is a co-suspect in the adverse reaction the subject experienced.   Follow up information received on 23 SEPTEMBER 2014: This case was reported by a nurse and described the occurrence of hives in a 19-month-old male patient who received INFANRIX (batch number 32PC3, expiry date 14th December 2015). Concomitant products included HAEMOPHILLIUS INFLUENZA B vaccine (non-GSK),  intramuscular, 0.5ml.  On 23rd JULY 2014, the patient received the 4th dose of INFANRIX (unknown route) .5ml.  On 23rd JULY 2014, less than a day after receiving INFANRIX, the patient experienced hives, skin rash and contact dermatitis. The patient was treated with BENADRYL (nos). On 24th JULY 2014, after 24 hours, the outcome of the hives, skin rash and contact dermatitis were recovered/resolved. It was unknown if the reporter considered the hives, skin rash and contact dermatitis to be related to INFANRIX.
Age: 26.0
Sex: M
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Lymphadenopathy
Clinical narrative: This case was reported by a physician and described the occurrence of increased lymph node size in a subject of unspecified age and gender who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of FLUARIX QUADRIVALENT (.5 ml, intramuscular, unknown deltoid and batch number). In September 2014, at an unspecified time after vaccination with FLUARIX QUADRIVALENT, the subject experienced increased lymph node size and increased lymph node tenderness in the axillary area. It was unknown if the events were localized to the arm of vaccination. At the time of reporting, the outcome of the events was unspecified. This is one of the 3 cases reported by the same reporter for the same vaccine and same events. Follow-up information received on 25 September 2014: This case was reported by a physician and described the occurrence of enlargement of lymph nodes in a 26-year-old male patient who received FLUARIX QUADRIVALENT (batch number LM55C, expiry date 23rd June 2015). The patient was immunized for EMT training requirement. The patient also was given a TBD test. Concomitant products included BOOSTRIX. On 16th September 2014, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 18th September 2014, 2 days after receiving FLUARIX QUADRIVALENT and BOOSTRIX, the patient experienced enlargement of lymph nodes (2cm) and lymph node tenderness, on the right axillary. On an unknown date, the outcome of the enlargement of lymph nodes and lymph node tenderness were unknown. The reporter considered the enlargement of lymph nodes and lymph node tenderness to be probably related to FLUARIX QUADRIVALENT.
Age: 26.0
Sex: M
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: This case was reported by a physician and described the occurrence of increased lymph node size in a subject of unspecified age and gender who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of FLUARIX QUADRIVALENT (.5 ml, intramuscular, unknown deltoid and batch number). In September 2014, at an unspecified time after vaccination with FLUARIX QUADRIVALENT, the subject experienced increased lymph node size and increased lymph node tenderness in the axillary area. It was unknown if the events were localized to the arm of vaccination. At the time of reporting, the outcome of the events was unspecified. This is one of the 3 cases reported by the same reporter for the same vaccine and same events. Follow-up information received on 25 September 2014: This case was reported by a physician and described the occurrence of enlargement of lymph nodes in a 26-year-old male patient who received FLUARIX QUADRIVALENT (batch number LM55C, expiry date 23rd June 2015). The patient was immunized for EMT training requirement. The patient also was given a TBD test. Concomitant products included BOOSTRIX. On 16th September 2014, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 18th September 2014, 2 days after receiving FLUARIX QUADRIVALENT and BOOSTRIX, the patient experienced enlargement of lymph nodes (2cm) and lymph node tenderness, on the right axillary. On an unknown date, the outcome of the enlargement of lymph nodes and lymph node tenderness were unknown. The reporter considered the enlargement of lymph nodes and lymph node tenderness to be probably related to FLUARIX QUADRIVALENT.
Age: 25.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Lymphadenopathy
Clinical narrative: This case was reported by a physician and described the occurrence of increased lymph node size in a subject of unspecified age and gender who was vaccinated with FLUARIX, (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of FLUARIX (.5 ml, intramuscular, unknown deltoid and batch number). In September 2014, at an unspecified time after vaccination with FLUARIX, the subject experienced increased lymph node size and increased lymph node tenderness in the axillary area. It was unknown if the events were localized to the arm of vaccination. At the time of reporting, the outcome of the events was unspecified. This is one of the 3 cases reported by the same reporter for the same vaccine and same events. Follow-up information received on 25 September 2014: This case was reported by a physician and described the occurrence of pea sized supra clavicular nodule in a 25-year-old male patient who received FLUARIX (batch number LM55C, expiry date 23rd June 2015). The patient also received a TBD test on the same day; no other vaccines were given. On 12th September 2014, the patient received FLUARIX (intramuscular) .5 ml. On 13th September 2014, 1 days after receiving FLUARIX, the patient experienced a 1 cm pea sized supra clavicular nodule. On an unknown date, the outcome of the pea sized supra clavicular nodule was unknown. The reporter considered the pea sized supra clavicular nodule to be probably related to FLUARIX.
Age: 25.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Laboratory test, Lymph node pain, Lymphadenopathy, Nodule
Clinical narrative: This case was reported by a physician and described the occurrence of increased lymph node size in a subject of unspecified age and gender who was vaccinated with FLUARIX, (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of FLUARIX (.5 ml, intramuscular, unknown deltoid and batch number). In September 2014, at an unspecified time after vaccination with FLUARIX, the subject experienced increased lymph node size and increased lymph node tenderness in the axillary area. It was unknown if the events were localized to the arm of vaccination. At the time of reporting, the outcome of the events was unspecified. This is one of the 3 cases reported by the same reporter for the same vaccine and same events. Follow-up information received on 25 September 2014: This case was reported by a physician and described the occurrence of pea sized supra clavicular nodule in a 25-year-old male patient who received FLUARIX (batch number LM55C, expiry date 23rd June 2015). The patient also received a TBD test on the same day; no other vaccines were given. On 12th September 2014, the patient received FLUARIX (intramuscular) .5 ml. On 13th September 2014, 1 days after receiving FLUARIX, the patient experienced a 1 cm pea sized supra clavicular nodule. On an unknown date, the outcome of the pea sized supra clavicular nodule was unknown. The reporter considered the pea sized supra clavicular nodule to be probably related to FLUARIX.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information about medical history, drug reactions and allergies was specified. The medical assistant reported that on 19-SEP-2014 the patient was inadvertently administered a dose of ZOSTAVAX (lot# J011212, dose not reported) subcutaneously, that had expired on 29-AUG-2014. No concomitant medications were reported. No adverse effects reported. Follow up information as received from medical assistant refers to a 79 years old retired male patient. Patient's concurrent conditions included: atrial fibrillation (A-fib), hypertension (HTN), parkinsonism and diabetes mellitus type II (DMII). On 19-SEP-2014 at approximately 10:00 AM the patient was inadvertently administered a first dose of ZOSTAVAX (lot# J011212, dose not reported) subcutaneously in the left deltoid, that had expired on 29-AUG-2014. There was none illness at time of vaccination. On 25-SEP-2014 the patient died due to stroke. Patient's death was reported to be not related to ZOSTAVAX injection. Upon internal review the event of stroke was considered to be medically significant. Additional information is not expected, because all follow up information has been obtained.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cerebrovascular accident, Death, Expired drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information about medical history, drug reactions and allergies was specified. The medical assistant reported that on 19-SEP-2014 the patient was inadvertently administered a dose of ZOSTAVAX (lot# J011212, dose not reported) subcutaneously, that had expired on 29-AUG-2014. No concomitant medications were reported. No adverse effects reported. Follow up information as received from medical assistant refers to a 79 years old retired male patient. Patient's concurrent conditions included: atrial fibrillation (A-fib), hypertension (HTN), parkinsonism and diabetes mellitus type II (DMII). On 19-SEP-2014 at approximately 10:00 AM the patient was inadvertently administered a first dose of ZOSTAVAX (lot# J011212, dose not reported) subcutaneously in the left deltoid, that had expired on 29-AUG-2014. There was none illness at time of vaccination. On 25-SEP-2014 the patient died due to stroke. Patient's death was reported to be not related to ZOSTAVAX injection. Upon internal review the event of stroke was considered to be medically significant. Additional information is not expected, because all follow up information has been obtained.
Age: 1.56
Sex: M
Vaccine: HIBV, DTAP, HIBV, PNC13
Symptoms: Injection site cellulitis, Injection site nodule
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of viral infection in a 18-month-old male subject who was vaccinated with INFANRIX, (GlaxoSmithKline), HIB (non-GSK) and PREVENAR (non-GSK). The subject had no concomitant medication or relevant medical history. On 11 September 2014 at 09:49, the subject received unspecified dose of INFANRIX (.5 ml, other route, left thigh). On the same day the subject received the 3rd dose of HIB (Non-GSK) (unknown route and injection site) and 4th dose of PREVENAR (unknown route and injection site). On 11 September 2014, less than one day after vaccination with HIB (Non-GSK), INFANRIX and PREVENAR, the subject was febrile and had a local injection site reaction. His both thighs swelled up and developed a small knot on the upper left outer thigh (injection site swelling and nodule). On 13 September 2014, when the subject visited the emergency room his body temperature was of 39.44 Deg. C. The physician diagnosed the subject as having the Staph infection. On 16 September 2014, the subject was brought in for a follow up appointment. At that time the subject's body temperature was 36.72 Deg. C and all his blood work came back negative. The doctor was now treating the subject for a viral infection. The subject was treated with unknown (Unspecified). At the time of reporting the events were improved. The outcome of fever was resolved. Follow-up information received on 08 October 2014 from the physician: The patient's details were provided (weight, height). Patient's previous vaccinations with HIB (Non-GSK), INFANRIX and PREVENAR went uncomplicated. The patient received the diagnosis of injection site cellulitis. At the time of reporting the events were improved. Some of the VAERS field were completed.
Age: 1.56
Sex: M
Vaccine: HIBV, DTAP, HIBV, PNC13
Symptoms: Blood test normal, Injection site cellulitis, Injection site nodule, Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of viral infection in a 18-month-old male subject who was vaccinated with INFANRIX, (GlaxoSmithKline), HIB (non-GSK) and PREVENAR (non-GSK). The subject had no concomitant medication or relevant medical history. On 11 September 2014 at 09:49, the subject received unspecified dose of INFANRIX (.5 ml, other route, left thigh). On the same day the subject received the 3rd dose of HIB (Non-GSK) (unknown route and injection site) and 4th dose of PREVENAR (unknown route and injection site). On 11 September 2014, less than one day after vaccination with HIB (Non-GSK), INFANRIX and PREVENAR, the subject was febrile and had a local injection site reaction. His both thighs swelled up and developed a small knot on the upper left outer thigh (injection site swelling and nodule). On 13 September 2014, when the subject visited the emergency room his body temperature was of 39.44 Deg. C. The physician diagnosed the subject as having the Staph infection. On 16 September 2014, the subject was brought in for a follow up appointment. At that time the subject's body temperature was 36.72 Deg. C and all his blood work came back negative. The doctor was now treating the subject for a viral infection. The subject was treated with unknown (Unspecified). At the time of reporting the events were improved. The outcome of fever was resolved. Follow-up information received on 08 October 2014 from the physician: The patient's details were provided (weight, height). Patient's previous vaccinations with HIB (Non-GSK), INFANRIX and PREVENAR went uncomplicated. The patient received the diagnosis of injection site cellulitis. At the time of reporting the events were improved. Some of the VAERS field were completed.
Age: 1.56
Sex: M
Vaccine: HIBV, DTAP, HIBV, PNC13
Symptoms: Pyrexia, Staphylococcal infection, Staphylococcus test negative, Viral infection
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of viral infection in a 18-month-old male subject who was vaccinated with INFANRIX, (GlaxoSmithKline), HIB (non-GSK) and PREVENAR (non-GSK). The subject had no concomitant medication or relevant medical history. On 11 September 2014 at 09:49, the subject received unspecified dose of INFANRIX (.5 ml, other route, left thigh). On the same day the subject received the 3rd dose of HIB (Non-GSK) (unknown route and injection site) and 4th dose of PREVENAR (unknown route and injection site). On 11 September 2014, less than one day after vaccination with HIB (Non-GSK), INFANRIX and PREVENAR, the subject was febrile and had a local injection site reaction. His both thighs swelled up and developed a small knot on the upper left outer thigh (injection site swelling and nodule). On 13 September 2014, when the subject visited the emergency room his body temperature was of 39.44 Deg. C. The physician diagnosed the subject as having the Staph infection. On 16 September 2014, the subject was brought in for a follow up appointment. At that time the subject's body temperature was 36.72 Deg. C and all his blood work came back negative. The doctor was now treating the subject for a viral infection. The subject was treated with unknown (Unspecified). At the time of reporting the events were improved. The outcome of fever was resolved. Follow-up information received on 08 October 2014 from the physician: The patient's details were provided (weight, height). Patient's previous vaccinations with HIB (Non-GSK), INFANRIX and PREVENAR went uncomplicated. The patient received the diagnosis of injection site cellulitis. At the time of reporting the events were improved. Some of the VAERS field were completed.
Age: 39.0
Sex: F
Vaccine: FLUC3
Symptoms: Dyspnoea, Pruritus, Swelling, Urticaria
Clinical narrative: HIVES; WELTS ON FACE, ARMS TRUNK, LEGS, ELBOWS, KNEE, FEET, TOES; ITCHING, SWELLING; SHORTNESS OF BREATH.  FIVE DAYS; MOSTLY AT NIGHT TO LATE MORNING.  BENADRYL
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Injection site joint movement impairment, Injection site pain, Joint range of motion decreased, Musculoskeletal stiffness
Clinical narrative: Shooting pain down right arm. Right shoulder and upper arm stiffness and pain, decreased ROM, numbness and tingling.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Shooting pain down right arm. Right shoulder and upper arm stiffness and pain, decreased ROM, numbness and tingling.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Pallor
Clinical narrative: Patient became pale and c/o feeling hot at 2100, 5 min after flu vaccine was given.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Biopsy skin abnormal, Blood thyroid stimulating hormone increased, Fatigue
Clinical narrative: Hep B vaccine dose 04/29/2013 10:47 AM 1-weakness, fatigue. Hep B vaccine 05/30/2013 01:47 dose 2 within days I Rt. Shoulder, arm and wrist pain as well as Rt. Leg pain. Hep B vaccine 12/18/2013 09:20AM within 30 (01/2014) days I developed mushy lumps on my scalp that broke down into ulcers...like a cold sore. As of today 10/16/2014 I still have Right Shoulder and Arm pain requiring Steriod inj. My scalp requires Clobetasol Propionate Topical Solution, USP, 0.05% W/W to control scalp ulcers...they never go a way.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Glomerular filtration rate increased, Inflammation, Injection site pain, Mass, Pain in extremity
Clinical narrative: Hep B vaccine dose 04/29/2013 10:47 AM 1-weakness, fatigue. Hep B vaccine 05/30/2013 01:47 dose 2 within days I Rt. Shoulder, arm and wrist pain as well as Rt. Leg pain. Hep B vaccine 12/18/2013 09:20AM within 30 (01/2014) days I developed mushy lumps on my scalp that broke down into ulcers...like a cold sore. As of today 10/16/2014 I still have Right Shoulder and Arm pain requiring Steriod inj. My scalp requires Clobetasol Propionate Topical Solution, USP, 0.05% W/W to control scalp ulcers...they never go a way.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Skin ulcer
Clinical narrative: Hep B vaccine dose 04/29/2013 10:47 AM 1-weakness, fatigue. Hep B vaccine 05/30/2013 01:47 dose 2 within days I Rt. Shoulder, arm and wrist pain as well as Rt. Leg pain. Hep B vaccine 12/18/2013 09:20AM within 30 (01/2014) days I developed mushy lumps on my scalp that broke down into ulcers...like a cold sore. As of today 10/16/2014 I still have Right Shoulder and Arm pain requiring Steriod inj. My scalp requires Clobetasol Propionate Topical Solution, USP, 0.05% W/W to control scalp ulcers...they never go a way.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Borrelia test negative, Full blood count normal, Gait disturbance, Impaired driving ability
Clinical narrative: Site of injection remained swollen and sore until 10/6/14. Once injection site cleared there was an onset of complete body muscle soreness. Affected ability to walk, open doors, drive and lift items greater than 1 pound. Symptoms completely resolved on 10/14/14.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Site of injection remained swollen and sore until 10/6/14. Once injection site cleared there was an onset of complete body muscle soreness. Affected ability to walk, open doors, drive and lift items greater than 1 pound. Symptoms completely resolved on 10/14/14.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash on face arms and chest. No treatment given.
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hypersensitivity, Rash, Rash pruritic
Clinical narrative: This case was reported by a pharmacist and described the occurrence of allergic reaction in a female patient who received FLUARIX QUADRIVALENT (batch number 2KJ3T, expiry date 25th June 2015). Previously administered products included influenza vaccine with an associated reaction of no adverse event. Concurrent medical conditions included sulfonamide allergy and specific allergy (drug). On 26th September 2014, the patient received FLUARIX QUADRIVALENT .5 ml. On 26th September 2014, several hours after receiving FLUARIX QUADRIVALENT, the patient experienced allergic reaction (serious criteria clinically significant/intervention required), pruritic rash on neck and face (serious criteria clinically significant/intervention required), labored breathing (serious criteria clinically significant/intervention required) and possible allergy to vaccine (serious criteria clinically significant/intervention required). The patient was treated with prednisolone. On an unknown date, the outcome of the allergic reaction, pruritic rash on neck and face, labored breathing and possible allergy to vaccine were recovering/resolving. The reporter considered the allergic reaction, pruritic rash on neck and face, labored breathing and possible allergy to vaccine to be probably related to FLUARIX QUADRIVALENT.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Gastrointestinal sounds abnormal, Haematochezia, Intussusception
Clinical narrative: This case was reported by a other health professional and described the occurrence of intussusception in a 8-month-old male patient who received ROTARIX (batch number A41CB393A, expiry date 5th October 2016). Concomitant products included ROTARIX, PEDIARIX, PREVENAR and HIB. On 4th June 2014 11:30, the patient received the 2nd dose of ROTARIX (oral). On 1st October 2014, 119 days after receiving ROTARIX, the patient experienced intussusception (serious criteria hospitalization, GSK medically significant, life threatening and clinically significant/intervention required), bloody stool (serious criteria GSK medically significant) and absent bowel sounds. On an unknown date, the outcome of the intussusception, bloody stool and absent bowel sounds were not recovered/not resolved. It was unknown if the reporter considered the intussusception, bloody stool and absent bowel sounds to be related to ROTARIX. Additional information was provided. The patient had no known allergy, no relevant medical history and no reaction to previous vaccinations. The patient had no current medication. At the time of reporting, the patient was hospitalized, the events were worsened and the patient was possibly having surgery.