chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site pain, Loss of consciousness, Pallor, Syncope
Clinical narrative: Fainted. Was on exam table so allowed to lay back onto exam table as became pale. Regained consciousness within 15 seconds. Cool cloth to head. After 15 minutes sat up drank juice. Sat for 15 minutes no other issues. PC to mother 5-16-14 & client doing well only soreness at injection sites.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Rash macular
Clinical narrative: Mom noticed are to thigh getting red blotches first then spread.
Age: 1.28
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Hypoxia, Slow response to stimuli, Unresponsive to stimuli, Vomiting
Clinical narrative: Patient received her 15 month shots and seemed fine. When her mother strapped her in car seat she vomited, seemed unresponsive. She rushed her back into the clinic. She was 88% hypoxic -> responded to O2 and minimally responsive. She didn't improve over a period of about 10 minutes; we transported via EMS en route she returned to baseline, about 30 min after the start of the episode.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a unspecified number of patients of unknown demographics. No information about medical history, concurrent conditions and concomitant medications were reported. The healthcare worker reported that ROTATEQ dose 2 ml, route oral that was exposed to 0C for 30 minutes on 12-FEB-2014 had been administered to an unspecified amount of patients. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the cases 1405USA007978, 1405USA007982, 1405USA007990, 1405USA008052 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a unspecified number of patients of unknown demographics. No information about medical history, concurrent conditions and concomitant medications were reported. The healthcare worker reported that VAQTA dose 0.5 ml, route intramuscular that was exposed to 0C for 30 minutes on 12-FEB-2014 had been administered to an unspecified amount of patients. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the case 1405USA007203, 1405USA007982, 1405USA007990, 1405USA008052 via same reporter link. 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 health care worker refers to a unspecified number of patients of unknown demographics. No information about medical history, concurrent conditions and concomitant medications were reported. The healthcare worker reported that RECOMBIVAX HB dose 0.5 ml, route intramuscular that was exposed to 0C for 30 minutes on 12-FEB-2014 had been administered to an unspecified amount of patients. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the case 1405USA007203, 1405USA007978, 1405USA007990, 1405USA008052 via same reporter link. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Vaccine positive rechallenge
Clinical narrative: This spontaneous report as received from an office manager (via company representative) refers to her daughter of unknown age. In May 2004 (reported as 10 years ago) the patient was vaccinated with a dose of VARIVAX (dose, lot # and route not reported) for prevention of chickenpox. Office manager stated her daughter received VARIVAX and had an adverse experience with it (approximately in 2004). The patient "broke out in a large area around the injection site". The patient has had the same adverse experience with other unspecified vaccines. It was unknown what those other vaccines were. On an unknown date the patient recovered. Relatedness between the therapy and the event was not reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a consumer refers to a around 66 year old male patient. The patient's pertinent medical history and concurrent conditions were unspecified. Approximately on 29-APR-2014 (reported as about two weeks ago) the patient was tired immediately after receiving the ZOSTAVAX. Lab diagnostic studies performed were none. The outcome of headache and was tired immediately after receiving the ZOSTAVAX was reported as recovered/resolved (Reported as recovered within a day or two). The causality was not reported. The patient did not sought the medical attention. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL, DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Eye swelling, Productive cough, Rhinorrhoea, Trichomoniasis, Wheezing
Clinical narrative: Almost immediately started with profuse drainage from nose and wet cough.  Cough began to progress in severity with stridor and wheezing.  Eyes noted to have some swelling.  Benadryl 5 ml given po immediately and patient sent to the ER.  ER notified patient coming.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL, DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Eye swelling, Productive cough, Rhinorrhoea, Stridor, Urticaria
Clinical narrative: Almost immediately started with profuse drainage from nose and wet cough.  Cough began to progress in severity with stridor and wheezing.  Eyes noted to have some swelling.  Benadryl 5 ml given po immediately and patient sent to the ER.  ER notified patient coming.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL, DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Wheezing
Clinical narrative: Almost immediately started with profuse drainage from nose and wet cough.  Cough began to progress in severity with stridor and wheezing.  Eyes noted to have some swelling.  Benadryl 5 ml given po immediately and patient sent to the ER.  ER notified patient coming.
Age: 0.49
Sex: F
Vaccine: HIBV, PNC13, TDAP
Symptoms: Body temperature increased, Chills, Convulsion, Cyanosis, Pallor
Clinical narrative: Child developed rigors and/or seizures accompanied by period of deep pallor/cyanosis although perceived by mother to be moving extremities and having heat beat; on arrival to Emergency Dept she was 104.7 degrees with a pulse >200 beats/min.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a unspecified number of patients of unknown demographics. No information about medical history, concurrent conditions and concomitant medications were reported. The healthcare worker reported that GARDASIL dose 0.5 ml, route intramuscular that was exposed to 0C for 30 minutes on 12-FEB-2014 had been administered to an unspecified amount of patients. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the cases 1405USA007203, 1405USA007978, 1405USA007982, 1405USA008052 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a unspecified number of patients of unknown demographics. No information about medical history, concurrent conditions and concomitant medications were reported. The healthcare worker reported that PEDVAXHIB dose 0.5 ml, route intramuscular that was exposed to 0C for 30 minutes on 12-FEB-2014 had been administered to an unspecified amount of patients. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the cases 1405USA007203, 1405USA007978, 1405USA007982, 1405USA007990 via same reporter link. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 year old patient of unknown gender. On 02-MAY-2014 the patient was vaccinated with PROQUAD (Merck), subcutaneous injection (dosing regimen unspecified). Patient's concomitant medication was not reported. On 02-MAY-2014, medication error reported that a 14 year old patient was inadvertently administered PROQUAD (Merck). No adverse effects reported. There was no product quality complaint (PQC) involved. The outcome of medication error that 14 year old patient was inadvertently administered PROQUAD (Merck) was unknown. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Musculoskeletal stiffness, Pain
Clinical narrative: Approximately 4 hours after receiving injection, patient reports experiencing extreme body aches and fatigue.  The following day had some neck stiffness.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Bronchitis, Chest pain, Dyspnoea, Electrocardiogram normal, Headache
Clinical narrative: Initial information was received on 12 May 2014 from an investigator participating in a trial. A 20-year-old male subject, with no relevant medical history, received the following vaccines on 22 April 2014: ACAM2000 (lot number, route and site of administration not reported); typhoid vaccine (manufacturer, lot number, route and site of administration not reported); and anthrax vaccine (other manufacturer, lot number, route and site of administration not reported). One day post-vaccination, on 23 April 2014, he developed chest pain and shortness of breath, headache, and fever. He was seen in the emergency room and diagnosed with bronchitis. On 01 May 2014, ECG and troponin I levels were normal (troponin <0.10 ng/mL). Treatment included MUCINEX, beginning 26 April 2014. The event was considered to be possible myopericarditis, was moderate, and was still ongoing at the time of the report. The investigator considered the event to be possibly related to study vaccine. Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Pyrexia, Troponin I normal
Clinical narrative: Initial information was received on 12 May 2014 from an investigator participating in a trial. A 20-year-old male subject, with no relevant medical history, received the following vaccines on 22 April 2014: ACAM2000 (lot number, route and site of administration not reported); typhoid vaccine (manufacturer, lot number, route and site of administration not reported); and anthrax vaccine (other manufacturer, lot number, route and site of administration not reported). One day post-vaccination, on 23 April 2014, he developed chest pain and shortness of breath, headache, and fever. He was seen in the emergency room and diagnosed with bronchitis. On 01 May 2014, ECG and troponin I levels were normal (troponin <0.10 ng/mL). Treatment included MUCINEX, beginning 26 April 2014. The event was considered to be possible myopericarditis, was moderate, and was still ongoing at the time of the report. The investigator considered the event to be possibly related to study vaccine. Documents held by sender: None.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Chills, Emotional disorder, Erythema, Headache
Clinical narrative: Emotional ill, intense pain, chilly, suffering the itchiness, temperature is high, awful headache, rashes, red, swollen blistered and sleepless night. My primary doctor prescribed the antibiotic medicine for my slight wound then shingles vaccine shot.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Laboratory test, Pain, Pruritus, Pyrexia
Clinical narrative: Emotional ill, intense pain, chilly, suffering the itchiness, temperature is high, awful headache, rashes, red, swollen blistered and sleepless night. My primary doctor prescribed the antibiotic medicine for my slight wound then shingles vaccine shot.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Swelling, Wound
Clinical narrative: Emotional ill, intense pain, chilly, suffering the itchiness, temperature is high, awful headache, rashes, red, swollen blistered and sleepless night. My primary doctor prescribed the antibiotic medicine for my slight wound then shingles vaccine shot.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Staring
Clinical narrative: Glazed over stare 7 to 19 days 5 days after vaccination.
Age: 0.19
Sex: M
Vaccine: DPP, IPV, RVX
Symptoms: Antibody test negative, Drug ineffective, Ear infection
Clinical narrative: Previous HIB vaccination and boosters did not have proper effect.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Haematemesis, Nausea, Urinary tract infection, Vomiting
Clinical narrative: Nausea & Vomiting of stomach contents and bright red blood, multiple times prior to seeking treatment in ER. Treated with Zofran 4mg every 8 hours as needed for nausea. Also diagnosed with UTI and treated with an antibiotic.
Age: 21.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Rash generalised
Clinical narrative: Rash all over body.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: AREA AROUND INJECTION SITE BECAME VERY RED, SWOLLEN AND HOT TO THE TOUCH. THE AREA BEGAN TO SPREAD FROM THE SITE TO THE ELBOW. TREATED WITH KEFLEX, ATARAX AND TRIAMCINOLONE.
Age: 0.6
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 6 month old patient of unknown gender. On 12-MAY-2014 the patient was vaccinated with a dose of PROQUAD (Merck), subcutaneously. It was reported that the patient received the PROQUAD (Merck) in error. No known adverse effects reported. No further information was provided. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Crying, Emotional distress
Clinical narrative: Unconsolable after receiving vaccines. Returned home, took a nap and awoke crying. Called health unit, which is when she was referred to MD or ER for concerns. 5/16/14 attempted phone f/u. 5/17/14.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer and the patient's daughter, refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On 12-MAY-2014, the patient was vaccinated with ZOSTAVAX 1 time vaccine. Lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The consumer reported that the patient received ZOSTAVAX and at the time of this report had shingles (on 13-MAY-2014). The outcome of shingles was unknown. Treatment was not specified. The patient sought medical attention. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, PPV, TD
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from a company representative via a registered nurse who was informed by the patient's mother refers to an 11 years old female patient. On 30-APR-2014 the patient was vaccinated with a first dose of GARDASIL (in the left arm, dose, route and strength not reported, lot# J014219, expiry 05-OCT-2015). Other suspect therapy included PNEUMOVAX 23 given in the right arm  (strength, dose, route, lot/batch number and indication not reported) given on 30-APR-2014 (on the same date). Concomitantly with GARDASIL and PNEUMOVAX 23 the VACCIN TH was administered on 30-APR-2014 (on the same date) in the right arm. On 30-APR-2014 (on teh same date) in the right arm. On 30-APR-2014 the patient experienced chills, nausea and high fever after receiving the first dose of GARDASIL. The patient did not take any medication for the treatment of the events. The patient sought medical attention on an unknown date in 2014 by calling the physician's office. The outcome of the events was unknown. The relatedness between the events and GARDSAIL and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a other healthcare worker refers to a 60 year old patient. On 07-MAY-2014, the patient was vaccinated with expired ZOSTAVAX lot # J002692 (expiry: 30-APR-2014), 0.65 ml, right deltoid subcutaneous. The reporter stated that the dose ZOSTAVAX had not been exposed to any temperature excursions. The patient did not reported or demonstrated any adverse effects. No additional information was provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Expired drug administered, No adverse event
Clinical narrative: No reaction has occurred. Vaccine was outdated 4/18/14.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Developed significant redness, warmth and swelling from injection site to left deltoid extending to shoulder and elbow with small patch of vesicles below injection site. Treated with antihistamines.
Age: 59.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Musculoskeletal stiffness, Vision blurred
Clinical narrative: C/O stiff neck, blurred vision started about 3 days after. Vision cleared <24 hrs. Neck stiff about 48 hrs.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Erythema of eyelid, Flushing, Lip swelling, Oropharyngeal pain
Clinical narrative: On 5/07/14 vaccine given at 11:40 AM (BENADRYL was given at 11:30 AM) 11:50 AM coughing and flushed skin, wheezing on auscultation. -> Sore throat redness to (L) eyelid. Albuterol neb unsuccessful. Epi 1:1000 0.2 cc SC at 12:15 PM. Prednisolone 22.5mg PO at 12:25 PM. And Rxd Prednisolone 22.5 mg BID x22. Woke 5:30 AM 5/8/14 with swollen tongue, lips and (L) side of face. Resolved with BENADRYL and Prednisolone.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Swelling face, Swollen tongue, Wheezing
Clinical narrative: On 5/07/14 vaccine given at 11:40 AM (BENADRYL was given at 11:30 AM) 11:50 AM coughing and flushed skin, wheezing on auscultation. -> Sore throat redness to (L) eyelid. Albuterol neb unsuccessful. Epi 1:1000 0.2 cc SC at 12:15 PM. Prednisolone 22.5mg PO at 12:25 PM. And Rxd Prednisolone 22.5 mg BID x22. Woke 5:30 AM 5/8/14 with swollen tongue, lips and (L) side of face. Resolved with BENADRYL and Prednisolone.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Rash papular
Clinical narrative: Pt received MMRV on 4/30/14 on 5/7/14 developed large mildly erythematous papules scattered on face, neck and arms.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Body temperature increased, Chills, Headache, Injected limb mobility decreased
Clinical narrative: Onset morning following. Myalgias, severe HA, mild nausea, arthralgia, temp to 105, chills. No GI sx, no new rash. (L) upper arm: hot, red, very swollen, limited ROM, tender to touch.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Onset morning following. Myalgias, severe HA, mild nausea, arthralgia, temp to 105, chills. No GI sx, no new rash. (L) upper arm: hot, red, very swollen, limited ROM, tender to touch.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea
Clinical narrative: Onset morning following. Myalgias, severe HA, mild nausea, arthralgia, temp to 105, chills. No GI sx, no new rash. (L) upper arm: hot, red, very swollen, limited ROM, tender to touch.
Age: 0.44
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 60.0
Sex: M
Vaccine: TD
Symptoms: Dizziness
Clinical narrative: Dizziness with movement.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Haematochezia, Intussusception
Clinical narrative: Pt. mom states bloody stool, uncontrollable crying.
Age: 71.0
Sex: M
Vaccine: PER, TD
Symptoms: Oropharyngeal pain, Pharyngeal oedema, Throat tightness
Clinical narrative: Sore throat, throat swelling, and perceived airway tightness and swelling.
Age: 1.12
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Febrile convulsion, Grand mal convulsion
Clinical narrative: Tonic clonic seizure x2 mins. No fever present. Hx of 2 febrile seizures one 11/2013 and second on 1/2014.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU3, HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: SWOLLEN INJECTION SITE WITH REDNESS. ORAL ANTIHISTAMINE PRESCRIBED.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Mother had called Pediatricians office the day after immunizations to report reaction that patient had red, hot swelling, and itching of deltoid region on left arm, later in day swelling extended to around arm region. Told by peds office to take Benadryl & cool packs.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus, Injection site swelling, Pruritus generalised, Rash generalised
Clinical narrative: INJECTION SITE BECAME SWOLLEN AND ITCHY, BROKE OUT IN RAISED RASH OVER BODY AND ITCHING SPREAD OVER BODY.  PATIENT DID NOT KNOW HOW LONG RASH LASTED.  NO RASH NOTED AT NEXT VISIT, 05/15/2014.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Demyelination, Dyspnoea, Electromyogram abnormal, Gait disturbance
Clinical narrative: 52 y/o M no PMH presents to ED w/ 24 hours progressive numbness/weakness 1 week after receiving flu shot. Unable to raise arms above head, difficulty walking, loss of fine motor skills. Also reports shortness of breath. Testing so far remains inconclusive, though evidence of acquired demyelinating process. IVIG x5 days. Remains in ICU.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Intensive care, Lumbar puncture normal, Mobility decreased
Clinical narrative: 52 y/o M no PMH presents to ED w/ 24 hours progressive numbness/weakness 1 week after receiving flu shot. Unable to raise arms above head, difficulty walking, loss of fine motor skills. Also reports shortness of breath. Testing so far remains inconclusive, though evidence of acquired demyelinating process. IVIG x5 days. Remains in ICU.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Motor dysfunction
Clinical narrative: 52 y/o M no PMH presents to ED w/ 24 hours progressive numbness/weakness 1 week after receiving flu shot. Unable to raise arms above head, difficulty walking, loss of fine motor skills. Also reports shortness of breath. Testing so far remains inconclusive, though evidence of acquired demyelinating process. IVIG x5 days. Remains in ICU.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Fatigue, Guillain-Barre syndrome, Headache
Clinical narrative: 2 weeks PTA had flu shot and developed fever/chills, resolved w/ medication. 1-2 weeks PTA developed fatigue and headaches. 5 days PTA awoke with numbness in fingers and toes. Presented w/ worsening neuropathy and weakness. Admitted and diagnosed w/ Guillain Barre. Pt pain managed w/ medication and treated w/ 5 days IVIG. Improved substantially and discharged.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture, Neuropathy peripheral, Pyrexia
Clinical narrative: 2 weeks PTA had flu shot and developed fever/chills, resolved w/ medication. 1-2 weeks PTA developed fatigue and headaches. 5 days PTA awoke with numbness in fingers and toes. Presented w/ worsening neuropathy and weakness. Admitted and diagnosed w/ Guillain Barre. Pt pain managed w/ medication and treated w/ 5 days IVIG. Improved substantially and discharged.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Constipation, Convulsion, Headache, Urinary tract infection
Clinical narrative: This spontaneous report as received from a physician refers to a 14 year old female patient. On an unknown date when she was 12 years old the patient was vaccinated with GARDASIL dose 1 and dose 2 (dose, route, lot number and expiration date was not provided) with no issues. On an unknown date the patient was vaccinated with GARDASIL dose 3 (dose, route, lot number and expiration date was not provided). On an unknown date, after receiving the third dose of GARDASIL when the patient turn 14 years of age she experienced headache, chronic constipation, severe abdominal pain, urinary tract infection. Also reported that the patient experienced several seizures and was hospitalized. At the time of the report, the outcome of the events was not recovered/not resolved. The patient sought medical attention. Upon internal reviewed several seizures were considered medically significant. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HEPA, IPV, MMRV, MNQ, TDAP
Symptoms: Blood pressure decreased, Dizziness, Heart rate decreased, Oxygen saturation decreased, Posture abnormal
Clinical narrative: Pt. became faint, B/P dropped to 80/32, O2 sats 68, pulse 37. Client was to receive 5 injections. He was very nervous. Talked with client and provided instruction. Three shots were administered into his left arm and two shots in the right arm. Client proceeded to act faint and the nurses attempted to arouse the client. The client did open his eyes and a cool pack was placed behind the client's neck and a glass of water was given to the client. He drank the water and then gave us the cup. His head went back and his eyes were closed. Continued to try to talk with client and he was not responding. Asked his mother if he had ever done this before and she replied with a yes. The questions on the questionnaire that was reviewed by the nurse state no previous reactions to vaccines and no allergies. An interpreter was called on the mother's phone and the nurse talked with the interpreter. The client is extremely scared of needles and blood. The last time it took 40 minutes for the client to come around. Again, attempts were made to arouse the client. An oximeter was applied to his finger. O2 sats were in the 90's on room air. Pulse was in the 60's. B/P was taken at 80/32. O2 sat continued to drop into the 80's and then the 70's. One nurse continued to try to arouse the client while the other nurse administered 0.5cc of epinephrine IM. Ambulance and Medical Director was called. O2 sats did come up into the low 90's. The client was placed safely onto the floor. O2 sats continued to run in the low 90's. The ambulance crew arrived and the client was transported to the hospital.
Age: 13.0
Sex: M
Vaccine: HEPA, IPV, MMRV, MNQ, TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Pt. became faint, B/P dropped to 80/32, O2 sats 68, pulse 37. Client was to receive 5 injections. He was very nervous. Talked with client and provided instruction. Three shots were administered into his left arm and two shots in the right arm. Client proceeded to act faint and the nurses attempted to arouse the client. The client did open his eyes and a cool pack was placed behind the client's neck and a glass of water was given to the client. He drank the water and then gave us the cup. His head went back and his eyes were closed. Continued to try to talk with client and he was not responding. Asked his mother if he had ever done this before and she replied with a yes. The questions on the questionnaire that was reviewed by the nurse state no previous reactions to vaccines and no allergies. An interpreter was called on the mother's phone and the nurse talked with the interpreter. The client is extremely scared of needles and blood. The last time it took 40 minutes for the client to come around. Again, attempts were made to arouse the client. An oximeter was applied to his finger. O2 sats were in the 90's on room air. Pulse was in the 60's. B/P was taken at 80/32. O2 sat continued to drop into the 80's and then the 70's. One nurse continued to try to arouse the client while the other nurse administered 0.5cc of epinephrine IM. Ambulance and Medical Director was called. O2 sats did come up into the low 90's. The client was placed safely onto the floor. O2 sats continued to run in the low 90's. The ambulance crew arrived and the client was transported to the hospital.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient has an orange size elevation at the injection site. Pt reports pain and itching at the site. The swelling is red and hard.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red swelling around the injection site. Dr. marked around the swelling the swelling was more than the area marked next day. Dr. prescribed her BACTRIM. Area is hot.
Age: 33.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Patient reported swollen, hot, painful injection site reaction also tenderness, swelling, and pain face and arms two days following administration. Doctor diagnosed it local adverse reaction.
Age: 33.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling, Pain in extremity, Swelling face
Clinical narrative: Patient reported swollen, hot, painful injection site reaction also tenderness, swelling, and pain face and arms two days following administration. Doctor diagnosed it local adverse reaction.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Swelling
Clinical narrative: Itchy, swollen rash running from her chest up to her eyes; occurred 12 days after vaccination, but patient insists nothing else has changed that could have caused it. Was treated successfully w/prednisone.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site reaction, Injection site urticaria, Urticaria
Clinical narrative: Patient was given MMR vaccine sub Q in right leg. While at the checkout window mom noticed red welts and hives around the injection site. Placed patient in an exam room, examined by Dr. Patient was given 1 tsp of BENADRYL, waited for 30 mins. Patient reassessed by Dr. Discharged home.
Age: 0.17
Sex: F
Vaccine: DTAP, RV5
Symptoms: Diarrhoea, Haematochezia, Rectal prolapse
Clinical narrative: Watery diarrhea beginning several hours after administration. 10 or more watery stools per day, 2 early on containing blood streaks. Now on day 7, just put on PEDIALYTE and started probiotic. (+) rectal prolapse developed on day 4.
Age: 0.18
Sex: M
Vaccine: DTAP, RV5, DTAP, RV5
Symptoms: Diarrhoea, Faecal volume increased
Clinical narrative: Watery diarrhea beginning several hours after administration, large volume of watery stools 2-3 times a day, continuing through today. No ill contacts. No fever, emesis or other symptoms. Exclusively breast fed.
Age: 0.18
Sex: M
Vaccine: DTAP, RV5, DTAP, RV5
Symptoms: Diarrhoea
Clinical narrative: Watery diarrhea beginning several hours after administration, large volume of watery stools 2-3 times a day, continuing through today. No ill contacts. No fever, emesis or other symptoms. Exclusively breast fed.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Alopecia, Antinuclear antibody, Blood glucose, Blood thyroid stimulating hormone, Serum ferritin
Clinical narrative: Initial alopecia after varicella in May 2009. Continued for months - seen dermatology in 8/2009. Gave HPV - series - #1 8-23-13 - alopecia - restarted by #2 dose 11-21-13 pt losing eyebrows and lashes too 3rd dose - held.
Age: 5.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt was given TDAP rather than DTAP in error. Parent notified. Pt brought in and given DTAP as directed.
Age: 1.05
Sex: F
Vaccine: PNC
Symptoms: Herpes zoster, Varicella virus test positive
Clinical narrative: Shingles
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pain, Papule, Pruritus, Rash
Clinical narrative: Rash, erythematous papules, pain, itchiness lasting 4 weeks post shot.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: Arm red the size of a tea saucer, hard and itches.
Age: 16.0
Sex: U
Vaccine: VARCEL
Symptoms: Blister, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 16 year old patient of unknown gender. Pertinent medical history and drug reactions or allergies were not specified. On unknown dates, the patient had either 1 or 2 doses of VARIVAX administered (frequency, route, anatomical location, lot numbers and indication were not reported). Concomitant medications were not specified. On an unknown date, at least 2 years later (after the vaccination) the patient developed zoster-like vesicles on the foot. The outcome of zoster-like vesicles on the foot was reported as recovered on an unspecified date. The relatedness between the zoster-like vesicles on the foot and VARIVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers unspecified number of patients of unknown gender and age. On an unspecified date in February 2014 until 13-MAY-2014, the patients were vaccinated with doses of LIQUID PEDVAXHIB (doses, route and lot # not reported) that were improperly stored. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers unspecified number of patients of unknown gender and age. On an unspecified date in February 2014 until 13-MAY-2014, the patients were vaccinated with doses of GARDASIL (doses, route and lot # not reported) that were improperly stored. No adverse events were reported. This is one of several reports received from the same source.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers unspecified number of patients of unknown gender and age. On an unspecified date in February 2014 until 13-MAY-2014, the patients were vaccinated with doses of VARIVAX (doses, route and lot # not reported) that were improperly stored. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
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 gender and age. On an unknown date, the patients were vaccinated with a dose of (Oka/Merck) VARIVAX (lot # reported as J006108, expiration date 17-MAY-2015) (dose not reported) that was improperly stored. The nurse stated that (Oka/Merck) VARIVAX had excursions of 7 F for 8 days and to 22 F for 5 days. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
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 gender and age. On an unknown date, the patients were vaccinated with a 0.5 ml dose of GARDASIL (dose and lot # not reported) intramuscularly that was improperly stored. The nurse stated that GARDASIL had multiple excursions (48 F for 2 days, 34 F for 16 hours, 34 F for 2 days, 49 F for 1 day, 34 F for 8 hours, 47 F for 4 days 34 F for 2 days. No adverse effects were reported. This is one of serveral reports received from the same source. Additional information has been requested.
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 gender and age. On an unknown date, the patients were vaccinated with a dose of LIQUID PEDVAXHIB (dose and lot # not reported) that was improperly stored. The nurse stated that LIQUID PEDVAXHIB had multiple excursions (48 F for 2 days, 34 F for 16 hours, 34 F for 2 days, 49 F for 1 day, 34 F for 8 hours, 47 F for 4 days, 34 F for 2 days). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
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 gender and age. On an unknown date, the patients were vaccinated with a dose of PROQUAD (Merck) (lot # J011330, expiration date 13-MAR-2015, lot # K000711, expiration date 16-JUL-2015 and lot # reported as J014236 expiration date 07-MAY-2015) (dose not reported) that were improperly stored. The nurse stated that PROQUAD (Merck) had excursions of 7 F for 8 days and to 22 F for 5 days. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Aura, Computerised tomogram, Eye pain, Full blood count, Headache
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. Pertinent medical history and drug reactions or allergies were not specified. On an unknown date, the patient was vaccinated with a second dose of GARDASIL (dose, frequency, route, lot number and indication were not specified). Concomitant medications were not specified. On an unknown date, the patient experienced an injection site reaction that was quite pronounced. The patient was admitted to a Medical Center for a suspected case of meningitis (date not specified). The length of stay at the Medical Center was unspecified. It was also not specified when the patient had received the first dose of GARDASIL. The patient was given unspecified steroids as the treatment for the events. Laboratory diagnostic studies performed included spinal tap (date and result not specified). The patient sought medical attention, was seen by the physician. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. Upon internal review meningitis was considered medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lumbar puncture, Metabolic function test, Muscle fatigue, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. Pertinent medical history and drug reactions or allergies were not specified. On an unknown date, the patient was vaccinated with a second dose of GARDASIL (dose, frequency, route, lot number and indication were not specified). Concomitant medications were not specified. On an unknown date, the patient experienced an injection site reaction that was quite pronounced. The patient was admitted to a Medical Center for a suspected case of meningitis (date not specified). The length of stay at the Medical Center was unspecified. It was also not specified when the patient had received the first dose of GARDASIL. The patient was given unspecified steroids as the treatment for the events. Laboratory diagnostic studies performed included spinal tap (date and result not specified). The patient sought medical attention, was seen by the physician. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. Upon internal review meningitis was considered medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. Pertinent medical history and drug reactions or allergies were not specified. On an unknown date, the patient was vaccinated with a second dose of GARDASIL (dose, frequency, route, lot number and indication were not specified). Concomitant medications were not specified. On an unknown date, the patient experienced an injection site reaction that was quite pronounced. The patient was admitted to a Medical Center for a suspected case of meningitis (date not specified). The length of stay at the Medical Center was unspecified. It was also not specified when the patient had received the first dose of GARDASIL. The patient was given unspecified steroids as the treatment for the events. Laboratory diagnostic studies performed included spinal tap (date and result not specified). The patient sought medical attention, was seen by the physician. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. Upon internal review meningitis was considered medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site reaction, Lumbar puncture, Meningitis
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. Pertinent medical history and drug reactions or allergies were not specified. On an unknown date, the patient was vaccinated with a second dose of GARDASIL (dose, frequency, route, lot number and indication were not specified). Concomitant medications were not specified. On an unknown date, the patient experienced an injection site reaction that was quite pronounced. The patient was admitted to a Medical Center for a suspected case of meningitis (date not specified). The length of stay at the Medical Center was unspecified. It was also not specified when the patient had received the first dose of GARDASIL. The patient was given unspecified steroids as the treatment for the events. Laboratory diagnostic studies performed included spinal tap (date and result not specified). The patient sought medical attention, was seen by the physician. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. Upon internal review meningitis was considered medically significant. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: Itching, red splotchy rash around injection site with pink rash surrounding, warm to touch, swollen.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Rash macular
Clinical narrative: Itching, red splotchy rash around injection site with pink rash surrounding, warm to touch, swollen.
Age: 26.0
Sex: F
Vaccine: ANTH, FLUC3
Symptoms: Dyspnoea, Hyperhidrosis, Pyrexia, Rash, Urticaria
Clinical narrative: Urticaria, fever, rash, sweating, and shortness of breath.
Age: 43.0
Sex: M
Vaccine: FLUN4
Symptoms: Headache, Subarachnoid haemorrhage
Clinical narrative: He developed a headache about 2 hours after receiving the vaccine.  The headache became severe and he was taken to a nearby emergency room where he was diagnosed with a subarachnoid hemorrhage.  He was transferred to another hospital where he spent 10 days recovering.  No underlying etiology was found and he has no sequelae from the event.  He reported this to me yesterday when he came in for his daughter's well check.  I was unaware of this event until yesterday.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, pain and warmth at injection site.  Pt did state he worked out the day after the injection site.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Blood test, Computerised tomogram, Dizziness, Fatigue
Clinical narrative: Weakness, dizziness, fatigue, pain, numbness, tingling.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Nuclear magnetic resonance imaging, Pain, Paraesthesia, X-ray
Clinical narrative: Weakness, dizziness, fatigue, pain, numbness, tingling.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised, Streptococcus test negative, Vision blurred
Clinical narrative: High Fever for two days up to 103, Blurry Vision, Rash all over torso, back, neck, face-Generally acting out of control.
Age: 41.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Headache, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Initially sore arm, swelling of injection site.  Later in day headache, body-aches, joint pain, fever.
Age: 41.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Initially sore arm, swelling of injection site.  Later in day headache, body-aches, joint pain, fever.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Local swelling, Pain
Clinical narrative: Patient had severe pain (feel like broken ankle) and swollen left arm (twice normal size). Dr advised him to take BENADRYL on 5/16. Patient had less pain and swelling on 5/17.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Cellulitis, Erythema, Injection site swelling, Pruritus
Clinical narrative: Burning, itching, redness. Bump at site of injection. ER diagnosis: cellulitis.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Injection site erythema
Clinical narrative: This spontaneous report as received from nurse refers to a 12 month old male patient with no drug allergies and no pertinent medical history. On 07-MAY-2014 the patient was vaccinated with VARIVAX (Merck) (0.5 milliliter (ml), subcutaneous in the left thigh). On 07-MAY-2014, 5 minutes after the injection, the injection site turned a deep red and the physician drew a circle around it to help monitor any spreading. The nurse reported that the patient was administered BENADRYL and that thirty minutes later, the redness spread to the left buttock, then spread to the right buttock, the left thigh and up the lower back. The nurse reported that the patient "did not seem to be bothered by itching or pain". The nurse also stated that the physician administered 1 teaspoon of ORAPRED and the redness started to decrease. The causality was not reported. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Back pain, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 80 year old male patient. On 07-MAY-2014 the patient was vaccinated with ZOSTAVAX (lot # J007208, expiration date: 20-SEP-2014, strength and dose not reported), subcutaneously. Concomitant therapies included lisinopril (manufacturer unknown), PRILOSEC, ZOCOR and hydrochlorothiazide. On 07-MAY-2014, the patient experienced rash and pain in his back. The patient sought unspecified medical attention. On 13-MAY-2014, the patient came to the pharmacy to get a prescription filled for VALTREX for the rash that he stated he developed on the middle portion of his back after getting ZOSTAVAX. The patient was also treated with TYLENOL and codeine. Therapy with ZOSTAVAX was not reintroduced. The outcome of pain in his back and rash was reported as recovering/resolving. The reporter considered rash and pain in back to be significant disability. Additional information has been requested.