chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site discolouration, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid, warm to touch, discoloration and swelling began yesterday 4/23/13. Advised ice and BENADRYL.
Age: 1.03
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Chest X-ray normal, Convulsion, Febrile convulsion, Pharyngeal disorder
Clinical narrative: Febrile seizure 9 days after MMR. Generalized seizure lasting 5-10 minutes. Temp 103.4. Seen in ER had sores in throat. Faint red macular rash on trunk.
Age: 1.03
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Rash macular
Clinical narrative: Febrile seizure 9 days after MMR. Generalized seizure lasting 5-10 minutes. Temp 103.4. Seen in ER had sores in throat. Faint red macular rash on trunk.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain at injection site and swelling approx. 1 wk after receiving injection. No evidence of cellulitis.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Injection site pain, Mobility decreased, Myalgia, Pain
Clinical narrative: Inj. 4-16-13. 4-17-13 - soreness. 4-20-13 - shoulder/muscle pain (L) limited movement. 4-23-13 - no chg - instructed to see private physician - was seen afternoon of 4-23-13. 4-23-13 Tx: Exercise steroid pack. 4-24-13: Called above client decreased pain increased movement - to return to work either Friday 4/26 or Monday 4/29 - pt to call physician if any changes.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site reaction, Irritability, Musculoskeletal stiffness, Oedema peripheral, Skin disorder
Clinical narrative: Swollen and stiff leg x 4 days after vaccines, very fussy - still has extra skin fold on (L) upper thigh. Possible DDH. Referred to orthopedics due to extra skin fold.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Ultrasound scan normal, X-ray normal
Clinical narrative: Swollen and stiff leg x 4 days after vaccines, very fussy - still has extra skin fold on (L) upper thigh. Possible DDH. Referred to orthopedics due to extra skin fold.
Age: 5.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 50.0
Sex: F
Vaccine: YF
Symptoms: Decreased appetite, Injection site swelling, Injection site warmth, Malaise, Rash
Clinical narrative: 4/18/ Felt ill, no appetite, site swollen approximately half dollar size, warm to touch, no fever or redness, shot given 4/16 evening. 4/19/13 Feeling better, still decreased appetite did take 1 BENADRYL evening before. 4/22/13 No redness, no warmth but now little bumps on arm. No other c/os, states fine.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Patient c/o left upper arm redness and swelling. Patient c/o itching. Mother medicated w/ BENADRYL and ibuprofen, doesn't seem to have improve since yesterday.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Immediate post-injection reaction, Injection site rash
Clinical narrative: Immediately rash broke out around the vaccine site. BENADRYL 1 tsp administered for reaction. Monitored for observation discharged after 15 min successful observation by P.A.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, PNC13
Symptoms: Condition aggravated, Convulsion, Endotracheal intubation, Intensive care, Status epilepticus
Clinical narrative: Unclear if related to vaccines as 5 days post-vaccine & poorly controlled seizure disorder. Pt with increased seizures, presented to ED in status epilepticus, admitted to PICU, intubated during stay, 10 days in hospital.
Age: 1.96
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Muscle twitching
Clinical narrative: Neck twitching, muscle twitching.
Age: 14.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Diarrhoea, Erythema, Inflammation, Nausea
Clinical narrative: Arm was swollen and red.  Patient had chills, fever, nausea, vomiting, diarrhea.  Admitted to hospital and received steroids and antibiotics for severe inflammatory reaction.
Age: 14.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pyrexia, Vomiting
Clinical narrative: Arm was swollen and red.  Patient had chills, fever, nausea, vomiting, diarrhea.  Admitted to hospital and received steroids and antibiotics for severe inflammatory reaction.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site swelling, Injection site warmth, Nausea, Pain
Clinical narrative: Fever x 3 days 101 degrees. Bodyaches, nausea and swelling and warmth 4 " across at injection site.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Fever x 3 days 101 degrees. Bodyaches, nausea and swelling and warmth 4 " across at injection site.
Age: 7.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right deltoid hot to touch, swollen and tender.
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Vaccine administered, patient fainted sitting in chair.  Nurse able to support patient and use ice pack to help with recovery.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood culture, C-reactive protein, Chest X-ray, Decreased appetite, Dyspnoea
Clinical narrative: Pt had fever of 102, was shaking, vomiting, decreased appetite and having a hard time breathing.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Full blood count, Metabolic function test, Pyrexia, Red blood cell sedimentation rate, Tremor
Clinical narrative: Pt had fever of 102, was shaking, vomiting, decreased appetite and having a hard time breathing.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Urine analysis, Vomiting
Clinical narrative: Pt had fever of 102, was shaking, vomiting, decreased appetite and having a hard time breathing.
Age: 27.0
Sex: F
Vaccine: ANTH
Symptoms: Skin reaction
Clinical narrative: Skin reaction, was referred to a dermatologist.
Age: 11.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Headache, Seizure like phenomena, Syncope
Clinical narrative: Patient recieved a finger stick for a POC Cholesterol and then a Tdap and HPV shot, patient yelled immediately that his head hurt and proceeded to faint in almost a seizure like way. We got him on the table and he started to feel better, he was given juice and crackers and the MD came in and checked him and his heart and rate.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: After injection patient reports red, warm, painful area at injection site. Warmth in area increased over the next three days, as did the size of the red area (approx 2 inches).  Patient attempted to use ice/cold water to relieve warmth, and also tried Benadryl oral with no relief.  Patient reported seeing nurse at doctor's office 04/29/13 and was advised that this reaction was within normal for injection.  Patient reports that symptoms have improved dramatically since they started last week.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody, Ear pain, Fatigue, Full blood count, Hypoaesthesia
Clinical narrative: EE experienced numbness and tingling of left leg. EE states after receiving the flu shot she became ill several days later with a sinus infection, ear ache and fatigue. She was treated in an urgent care clinic and given antibiotics. She states she had good response to the medication however the following weekend (11/11) left leg heaviness, foot numbness and decrease sensation to left foot. She then followed up with her (11/15/13) PCP who prescribed a steroid. On f/u visit (week later) she showed no significant improvement so labs were ordered. Because of previous elevated ANA she is being followed by a Rheumatologist who then referred her to a neurologist for evaluation. NCS was performed to r/o MS along with other exams to r/o autoimmune diseases. EE continues with neurologist follow-up but has improved. Dx. Inflammatory Myelitis T3 secondary to flu vaccine.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Metabolic function test, Myelitis, Nerve conduction studies, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: EE experienced numbness and tingling of left leg. EE states after receiving the flu shot she became ill several days later with a sinus infection, ear ache and fatigue. She was treated in an urgent care clinic and given antibiotics. She states she had good response to the medication however the following weekend (11/11) left leg heaviness, foot numbness and decrease sensation to left foot. She then followed up with her (11/15/13) PCP who prescribed a steroid. On f/u visit (week later) she showed no significant improvement so labs were ordered. Because of previous elevated ANA she is being followed by a Rheumatologist who then referred her to a neurologist for evaluation. NCS was performed to r/o MS along with other exams to r/o autoimmune diseases. EE continues with neurologist follow-up but has improved. Dx. Inflammatory Myelitis T3 secondary to flu vaccine.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Sensation of heaviness, Sinusitis
Clinical narrative: EE experienced numbness and tingling of left leg. EE states after receiving the flu shot she became ill several days later with a sinus infection, ear ache and fatigue. She was treated in an urgent care clinic and given antibiotics. She states she had good response to the medication however the following weekend (11/11) left leg heaviness, foot numbness and decrease sensation to left foot. She then followed up with her (11/15/13) PCP who prescribed a steroid. On f/u visit (week later) she showed no significant improvement so labs were ordered. Because of previous elevated ANA she is being followed by a Rheumatologist who then referred her to a neurologist for evaluation. NCS was performed to r/o MS along with other exams to r/o autoimmune diseases. EE continues with neurologist follow-up but has improved. Dx. Inflammatory Myelitis T3 secondary to flu vaccine.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Axillary mass, Chills, Condition aggravated, Influenza like illness
Clinical narrative: EE states he received flu shot on 11/28/11 and presents to clinic 3 days s/p injection and states that he has a lump in left axillary. He states that he had flu-like symptoms with malaise and chills the day after shot. Last flu shot was 10 years ago and he did develop flu-like symptoms but no swelling or erythema. On subsequent follow up he states left should and neck pain with muscle weakness and pain. EE has history of bilateral shoulder surgery but was completely asymptomatic until 7 days after injection. EE referred to Ortho and completed a battery of exams, including MRI, PT and injection to left shoulder. EE referred to neuroDx joint pain possible error in placement of injection, possible inflammatory reaction to joint capsule or tendon/bursae (9/7/2012). EE referred back to Ortho(3/20/13) Dx-- Arthralgia left shoulder, temporary aggravation of pre-existing impingement syndrome.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Muscular weakness, Musculoskeletal pain, Myalgia, Neck pain
Clinical narrative: EE states he received flu shot on 11/28/11 and presents to clinic 3 days s/p injection and states that he has a lump in left axillary. He states that he had flu-like symptoms with malaise and chills the day after shot. Last flu shot was 10 years ago and he did develop flu-like symptoms but no swelling or erythema. On subsequent follow up he states left should and neck pain with muscle weakness and pain. EE has history of bilateral shoulder surgery but was completely asymptomatic until 7 days after injection. EE referred to Ortho and completed a battery of exams, including MRI, PT and injection to left shoulder. EE referred to neuroDx joint pain possible error in placement of injection, possible inflammatory reaction to joint capsule or tendon/bursae (9/7/2012). EE referred back to Ortho(3/20/13) Dx-- Arthralgia left shoulder, temporary aggravation of pre-existing impingement syndrome.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Rotator cuff syndrome
Clinical narrative: EE states he received flu shot on 11/28/11 and presents to clinic 3 days s/p injection and states that he has a lump in left axillary. He states that he had flu-like symptoms with malaise and chills the day after shot. Last flu shot was 10 years ago and he did develop flu-like symptoms but no swelling or erythema. On subsequent follow up he states left should and neck pain with muscle weakness and pain. EE has history of bilateral shoulder surgery but was completely asymptomatic until 7 days after injection. EE referred to Ortho and completed a battery of exams, including MRI, PT and injection to left shoulder. EE referred to neuroDx joint pain possible error in placement of injection, possible inflammatory reaction to joint capsule or tendon/bursae (9/7/2012). EE referred back to Ortho(3/20/13) Dx-- Arthralgia left shoulder, temporary aggravation of pre-existing impingement syndrome.
Age: 41.0
Sex: M
Vaccine: DTAP
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain and redness and swelling at injection site. Some unspecified fever, body aches, fatigue and two days headache.
Age: 41.0
Sex: M
Vaccine: DTAP
Symptoms: Pain, Pyrexia
Clinical narrative: Pain and redness and swelling at injection site. Some unspecified fever, body aches, fatigue and two days headache.
Age: 3.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Diarrhoea, Injection site reaction, Lethargy, Pyrexia, Somnolence
Clinical narrative: On Friday, April 26th, started out slightly lethargic, but still had appetite. On Saturday, April 27th was quiet and lethargic, threw up three times starting at 12:00 AM Sunday, April 21st. Then had diarrhea Sunday and Monday, the 29nd. Threw up Tuesday, April 30th morning, 2:00 AM and again at 8:30 AM. He is sleeping a lot today. On Monday, April 29th administered Tylenol, had a 99.1 fever. I also noticed a about 5 welts around the injection site. I called Dr. this morning, April 30th who suggested a bland diet and to check him again if not better by the end of the week. He mentioned it could be unrelated to the vaccination and is rare to have a reaction like this occur later in the week, usually only a fever within first 24 hrs.
Age: 3.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Urticaria, Vomiting
Clinical narrative: On Friday, April 26th, started out slightly lethargic, but still had appetite. On Saturday, April 27th was quiet and lethargic, threw up three times starting at 12:00 AM Sunday, April 21st. Then had diarrhea Sunday and Monday, the 29nd. Threw up Tuesday, April 30th morning, 2:00 AM and again at 8:30 AM. He is sleeping a lot today. On Monday, April 29th administered Tylenol, had a 99.1 fever. I also noticed a about 5 welts around the injection site. I called Dr. this morning, April 30th who suggested a bland diet and to check him again if not better by the end of the week. He mentioned it could be unrelated to the vaccination and is rare to have a reaction like this occur later in the week, usually only a fever within first 24 hrs.
Age: 1.11
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: 1145: Patient developed a few hives on his face and one on his back 15 minutes after administration of the following vaccines: PCV 13, Hep A, MMR, Varicella. No wheezing or difficulty breathing. Dr. notified and assessed patient; patient observed for another 15 minutes. 1210: Hives resolved. No further signs of allergic reaction noted. Dr. assessed patient and discussed signs and symptoms of an allergic reaction and when to call clinic or bring patient to ER with mother. Patient discharged home with mother. 4/30/2013: RN called parents to follow up today. No answer. Left message requesting call back.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma, Viral infection
Clinical narrative: Patient now carries virus and has over ten plantar warts on both feet.
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site pain, Malaise, Myalgia, Night sweats
Clinical narrative: Arm pain at injection site; F/C/night sweats; malaise; mylagias.
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Arm pain at injection site; F/C/night sweats; malaise; mylagias.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Abasia, Injection site pain, Weight bearing difficulty
Clinical narrative: Severe pain in leg that received vaccine when touched or standing, unable to put any weight on leg. Symptom lasted 24 hrs. Treated with Motrin for pain around 10:00PM 04/29/2013. After treatment patient still unable to walk until hours later.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Focal redness, swelling and itching improved after 10 min with below treatment. Ice pack applied to area. 5mL's of BENADRYL given.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Asthenia, Bundle branch block right, Electrocardiogram abnormal, Hyperhidrosis, Hypotension
Clinical narrative: Fainting episode - x 5 minutes after inj. Pale, hypotension. (Sweating, weakness).
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pallor, Syncope
Clinical narrative: Fainting episode - x 5 minutes after inj. Pale, hypotension. (Sweating, weakness).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Herpes zoster, Injection site reaction, Local swelling
Clinical narrative: Raised red area 2 1/2" x 2", 3 small shingle pox > right arm injection site. Hot and itchy and pain. Recovering. Treatment topical ZOVIRAX.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus
Clinical narrative: Raised red area 2 1/2" x 2", 3 small shingle pox > right arm injection site. Hot and itchy and pain. Recovering. Treatment topical ZOVIRAX.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Blindness, Blood test normal, Brain scan normal, Nuclear magnetic resonance imaging, Visual field tests abnormal
Clinical narrative: Hours after intramuscular tetanus shot, bilat visual loss was measured on a visual field. It was present a week later and now 5 weeks later, but shows improvement with time.
Age: 26.0
Sex: M
Vaccine: PNC13
Symptoms: Blood creatinine normal, Blood glucose normal, Chills, Dizziness, Full blood count normal
Clinical narrative: Patient developed headache, malaise, subjective fevers and chills, dizziness about 8 hours after receiving one dose of PREVNAR 13.
Age: 26.0
Sex: M
Vaccine: PNC13
Symptoms: Headache, Malaise, Pyrexia
Clinical narrative: Patient developed headache, malaise, subjective fevers and chills, dizziness about 8 hours after receiving one dose of PREVNAR 13.
Age: 52.0
Sex: F
Vaccine: HEPAB, PPV, TDAP
Symptoms: Bone pain, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Soreness; redness on arm where the vaccine was given. Injection site was swollen and patient stated that it was very painful. Patient had a headache, bone ache and a high temperature when she went to the hospital on 4-27-13.
Age: 52.0
Sex: F
Vaccine: HEPAB, PPV, TDAP
Symptoms: Pyrexia, Urine analysis
Clinical narrative: Soreness; redness on arm where the vaccine was given. Injection site was swollen and patient stated that it was very painful. Patient had a headache, bone ache and a high temperature when she went to the hospital on 4-27-13.
Age: 42.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Left arm very swollen for 5 days following injection; pain and itching in left arm.
Age: 38.0
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 27.0
Sex: M
Vaccine: HEPAB, PPV, TDAP
Symptoms: Blood test, Dizziness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swell, redness and pain on injection area. Client stated that he had a fever of 102 degrees. He also felt lightheaded and had to go to the ER on 4-27-13. Client was given TORADOL, BACTRIM DS and TYLENOL.
Age: 27.0
Sex: M
Vaccine: HEPAB, PPV, TDAP
Symptoms: Pyrexia, Urine analysis, White blood cell count increased
Clinical narrative: Swell, redness and pain on injection area. Client stated that he had a fever of 102 degrees. He also felt lightheaded and had to go to the ER on 4-27-13. Client was given TORADOL, BACTRIM DS and TYLENOL.
Age: 1.72
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP
Symptoms: Expired drug administered
Clinical narrative: Expired dose given.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Swelling, Urticaria
Clinical narrative: Patient developed hives and swelling, redness on (R) thigh within 5 minutes of receiving DTaP and IPV. Patient was given BENADRYL and kept in office for observation. Sent home after responding to BENADRYL.
Age: 1.32
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Chest X-ray abnormal, Ear infection, Febrile convulsion, Lung infiltration, Pneumonia
Clinical narrative: DTaP, HiB given 4/26/2013. High fever 4/27/13. Febrile seizure early AM 4/28/13. Diagnosed bilateral otitis, Pneumonia.
Age: 1.32
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Pyrexia, White blood cell count normal
Clinical narrative: DTaP, HiB given 4/26/2013. High fever 4/27/13. Febrile seizure early AM 4/28/13. Diagnosed bilateral otitis, Pneumonia.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Influenza like illness, Pyrexia, Tenderness
Clinical narrative: Pt. reported 'flu-like' sxs after PCV-13. Fever, chills, aches in joints and tenderness in (R) arm. Began 5-6 hrs after administered. Much better the following day.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Metal poisoning, Stress
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a 21 year old female patient. Approximately on an unknown date in April 2009 (reported as 4 years ago) the patient was vaccinated with dose 1, GARDASIL (lot # and expiration date not reported), intramuscularly (reported as standard route). The patient's father reported that since the beginning of college late in August 2012 his daughter has begun displaying symptoms of aluminum toxicity. Symptoms included increases stress and tiredness. The physician reported that the patient had written a ten-page report regarding the issue basing his information on two websites. The father claimed that his daughter had an allergy to cats which left her with a compromised immune system leading to the aluminum toxicity. He was requesting further tests to confirm his belief. The physician noted that no adverse symptoms had been reported until after patient began college. The outcome of the reported events were unknown. Patient sought an unspecified medical attention. Causality was not reported. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Fatigue, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: Headache, myalgias, sore throat, fatigue starting hours after injection. Supportive therapy, NSAID.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site urticaria
Clinical narrative: Localized large hive-like skin rash 11 x 20 on leg shot given, no angioedema.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy student concerning a patient of unknown gender and age. In January 2013 the patient was vaccinated with one dose of PNEUMOVAX23 (route and lot number not reported)) and was inadvertently administered a second dose of PNEUMOVAX23 (route and lot number not reported) in April 2013. No adverse effects were reported. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to an approximately 54-year-old female patient. On 25-APR-2013 the patient was vaccinated with 0.65 milliliter (ml) ZOSTAVAX (lot# J000493, expiration date 14-APR-2014), subcutaneously. Approximately on an unknown date in April 2013, the patient experienced swollen ankles. The outcome of swollen ankles was reported as not recovered/not resolved. Patient did not seek medical attention for the event. It was unspecified whether lab diagnostic studies were performed. Causality was not reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
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 20 year old female patient. On 24-JUL-2009, the patient was vaccinated with first dose of 0.5 ml GARDASIL, (lot number, expiry date was not reported and route was intramuscular). On 29-APR-2013, the patient was vaccinated with second dose of 0.5 ml GARDASIL, (lot number, expiry date was not reported and route was intramuscular). Concomitant medications were not reported. No adverse effect was reported. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to an approximately 35-year-old female patient. On 25-APR-2013 the patient was vaccinated with dose 2, 0.5 milliliter (ml) M-M-R II (lot # H011889, expiration date 25-JUN-20134) subcutaneously which was improperly stored. The M-M-R II was exposed to 48 Farenheit (F) for 9 hours and had a previous excursion at 48F for 16.5 hours. On 31-JAN-2013, patient was vaccinated with dose 1, M-M-R II (lot#, expiration date and route not reported) at an unspecified facility. No adverse effect reported. Nurse was unaware if any additional patients received improperly stored M-M-R II. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pustular, Rash vesicular
Clinical narrative: This spontaneous report as received from a nurse refers to a 62 year old female patient with no pertinent medical history and no allergies reported. On 01-APR-2013 the patient was vaccinated with ZOSTAVAX 19400PFU (lot # J000435 and exp date 10-APR-2014). No other co suspects were reported. No concomitant therapy was reported. The nurse reported that on 20-APR-2013, the patient developed "scattered pustules across the body that look like chicken pox". The patient sought medical attention at office visit. Treatment was not given for the event. Lab diagnostics were not performed. The outcome of developed "scattered pustules across the body that look like chicken pox" was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 24-APR-2013 the patient was vaccinated with ZOSTAVAX (lot # and exp date 03-APR-2013) (dose, route and anatomical location unspecified). The pharmacist reported that patient was vaccinated with ZOSTAVAX which had expired on 03-APR-2013. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. The physician reported that she received an email from an unspecified colleague that a patient experienced a severe headache for 3 years after she was vaccinated with GARDASIL (dose, route and lot not reported). The outcome of a severe headache for 3 days after receiving GARDASIL was unknown. The relatedness between the event and GARDASIL was not reported. Additional information is not expected.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report as received from a health care professional refers to a 56 year old female patient with diabetes mellitus (DM), (DM) neuropathy and tinea pedis and no adverse events following prior vaccination. On 08-APR-2013 at 10:00am the patient was vaccinated with a first dose of PNEUMOVAX23 (lot # H015749 exp date 08-JUN-2014) first dose, intramuscular in the right deltoid (dose unspecified). Concomitant therapies included NEURONTIN, clotrimazole, metformin, benazepril, and aspirin. On 08-APR-2013 in the afternoon the patient experienced headache (H/A), generalized swelling and tenderness of site in the right deltoid, objective fever, chills, pruritic rash on right deltoid and upper chest, pain in site. On an unknown date (H/A), generalized swelling and tenderness of site in the right deltoid, objective fever, chills, pain in site had improved, but pruritic rash on right deltoid and upper chest did not improve unchanged. The patient required a doctor's visit and was instructed to take TYLENOL per needed (PRN), steroid taper and emergency room (ER) precautions. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Rash pruritic
Clinical narrative: This spontaneous report as received from a health care professional refers to a 56 year old female patient with diabetes mellitus (DM), (DM) neuropathy and tinea pedis and no adverse events following prior vaccination. On 08-APR-2013 at 10:00am the patient was vaccinated with a first dose of PNEUMOVAX23 (lot # H015749 exp date 08-JUN-2014) first dose, intramuscular in the right deltoid (dose unspecified). Concomitant therapies included NEURONTIN, clotrimazole, metformin, benazepril, and aspirin. On 08-APR-2013 in the afternoon the patient experienced headache (H/A), generalized swelling and tenderness of site in the right deltoid, objective fever, chills, pruritic rash on right deltoid and upper chest, pain in site. On an unknown date (H/A), generalized swelling and tenderness of site in the right deltoid, objective fever, chills, pain in site had improved, but pruritic rash on right deltoid and upper chest did not improve unchanged. The patient required a doctor's visit and was instructed to take TYLENOL per needed (PRN), steroid taper and emergency room (ER) precautions. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. In September 2011, the patient was vaccinated with GARDASIL dose 1. On 21-FEB-2013 the patient was vaccinated with GARDASIL dose 2. On 22-APR-2013 the patient was vaccinated with GARDASIL dose 3. The patient was not experiencing any known symptoms. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a healthcare worker via a company representative refers to a female patient of unknown age. Approximately on an unknown date in March 2013 (reported as within the last month) the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported). Approximately on an unknown date in March 2013 (reported as within the last month and came in the next day) the patient experienced rash on the arm by the injection site. The nurse stated that they put her on CLARITIN and she was fine at the time of this report. The outcome of the event was reported as recovering/resolving. Causality was not reported. The patient sought medical attention by returning to the physician's office. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a female (who is her sister) of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL, (lot number, expiry date and route was not reported). Concomitant medications were not reported. The patient was in the physicians office and was late for her third dose of GARDASIL, which was scheduled to be administered in december 2012. No adverse event was reported. Additional information is not expected.
Age: 7.0
Sex: M
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a field employee. The physician stated he was attempting to administer an influenza vaccine (manufacturer unknown) which had a similar cap color as GARDASIL, 0.5 mg, intramuscular (lot # not reported) and inadvertently administered GARDASIL to an unspecified 7.5 year old patient "a couple of weeks ago". No adverse effect reported. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date and route not reported). On an unknown date the patient experienced itching and warm lump around the ZOSTAVAX injection site. The outcome of the reported events were unknown. Causality was not reported. Additional information is not expected.
Age: 49.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Back pain, Blood culture negative, Chest pain, Electrocardiogram, Pyrexia
Clinical narrative: This serious medically confirmed report (initial receipt: 23-Apr-2013) concerns a 49-year-old male patient, who had a medical history of diabetes, former smoker, hypertension and hyperlipidaemia. Concomitant medications included aspirin, bivalirudin, unfractionated heparin, clopidogrel, hydrochlorothiazide, oxycodone hydrochloride; acetaminophen combination, fosinopril sodium, simvastatin and gabapentin. On 16-Feb-2012 at 08:57 the patient was enrolled to a clinical study (non CSL clinical study) and underwent a percutaneous coronary intervention (PCI). Prior to randomisation the patient received aspirin 81 mg, unfractionated heparin and bivalirudin. On 16-Feb-2012 at 10:54 an angiography revealed one vessel with greater than 50 % stenosis. At 11:17 the patient received a loading dose of 4 capsules of clopidogrel (study medication). At 11:20 the patient received a 10.3 mL bolus of clopidogrel (study medication) followed by an 82.2 mL/hr infusion of clopidogrel (study medication) from 11:21 to 13:30. At 11:20 the patient began to undergo a PCI via a radial catheter access site during which time the right coronary artery (RCA) was treated with three non-drug eluting stents (total length of 71). The patient received bivalirudin pre/during procedure. The PCI concluded at 12:19. The patient received 4 capsules of clopidogrel (study medication) post infusion at 13:30. Post procedure, the patient was given clopidogrel 75 mg. At discharge he received aspirin and clopidogrel 75 mg. On 17-Feb-2012 at 09:22 the patient received an influenza virus immunisation (brand name, manufacturer and lot number was not reported) at a dose of 45 ug once intramuscularly. At the same time, he also received pneumococcal 23 immunisation at a dose of 25 ug once intramuscularly. The patient was discharged from the hospital on 17-Feb-2012 at 10:55. On 17-Feb-2012 at 18:59 the patient returned to the hospital via the emergency room with complaints of back pain, chest pain and a fever of 103 F (Fahrenheit). He was admitted to the hospital and diagnosed with possible drug fever at 21:05. Blood cultures obtained on 17-Feb-2012 were negative. An electrocardiogram (EKG) was obtained, however the results were not provided. Treatment included intravenous (IV) vancomycin and IV LEVAQUIN. On 20-Feb-2012 the patient was discharged home with oral LEVAQUIN (five days of treatment). The events resolved on 20-Feb-2012 at 11:18. Reporter's comment: The Investigator considered the event of 'possible drug fever' to be possible related to clopidogrel (study medication), influenza virus immunisation and pneumococcal 23 immunisation.
Age: 27.0
Sex: F
Vaccine: HEPA
Symptoms: Anti-cyclic citrullinated peptide antibody negative, Antinuclear antibody positive, Arthralgia, Arthritis, Arthritis reactive
Clinical narrative: Initially bilateral wrist pain, swelling and decreased range of motion.  Progressed over next 6 months prompting further evaluation and diagnosed with tenosynovitis in wrists b/l.  Continued to progress over following year affecting knees, elbows, ankles, shoulders, fingers and feet.  Diagnosed with presumptive Unspecified Connective Tissue Disease.  Treated with PO NSAIDS, steroids, steroid injections in wrists b/l, braces, hand OT, PT all with transient relief.  Vaccination is suspected to have triggered autoimmune response (UCTD vs seronegative RA) vs reactive arthritis.
Age: 27.0
Sex: F
Vaccine: HEPA
Symptoms: Autoimmune disorder, Biopsy tendon abnormal, C-reactive protein normal, Cell marker, Fibrosis tendinous
Clinical narrative: Initially bilateral wrist pain, swelling and decreased range of motion.  Progressed over next 6 months prompting further evaluation and diagnosed with tenosynovitis in wrists b/l.  Continued to progress over following year affecting knees, elbows, ankles, shoulders, fingers and feet.  Diagnosed with presumptive Unspecified Connective Tissue Disease.  Treated with PO NSAIDS, steroids, steroid injections in wrists b/l, braces, hand OT, PT all with transient relief.  Vaccination is suspected to have triggered autoimmune response (UCTD vs seronegative RA) vs reactive arthritis.
Age: 27.0
Sex: F
Vaccine: HEPA
Symptoms: Joint range of motion decreased, Joint swelling, Laboratory test normal, Nuclear magnetic resonance imaging abnormal, Red blood cell sedimentation rate normal
Clinical narrative: Initially bilateral wrist pain, swelling and decreased range of motion.  Progressed over next 6 months prompting further evaluation and diagnosed with tenosynovitis in wrists b/l.  Continued to progress over following year affecting knees, elbows, ankles, shoulders, fingers and feet.  Diagnosed with presumptive Unspecified Connective Tissue Disease.  Treated with PO NSAIDS, steroids, steroid injections in wrists b/l, braces, hand OT, PT all with transient relief.  Vaccination is suspected to have triggered autoimmune response (UCTD vs seronegative RA) vs reactive arthritis.
Age: 27.0
Sex: F
Vaccine: HEPA
Symptoms: Rheumatoid arthritis, Rheumatoid factor negative, Scan with contrast abnormal, Tenosynovitis, Ultrasound joint
Clinical narrative: Initially bilateral wrist pain, swelling and decreased range of motion.  Progressed over next 6 months prompting further evaluation and diagnosed with tenosynovitis in wrists b/l.  Continued to progress over following year affecting knees, elbows, ankles, shoulders, fingers and feet.  Diagnosed with presumptive Unspecified Connective Tissue Disease.  Treated with PO NSAIDS, steroids, steroid injections in wrists b/l, braces, hand OT, PT all with transient relief.  Vaccination is suspected to have triggered autoimmune response (UCTD vs seronegative RA) vs reactive arthritis.
Age: 27.0
Sex: F
Vaccine: HEPA
Symptoms: Ultrasound scan abnormal, Undifferentiated connective tissue disease, Vaccination complication, X-ray limb normal
Clinical narrative: Initially bilateral wrist pain, swelling and decreased range of motion.  Progressed over next 6 months prompting further evaluation and diagnosed with tenosynovitis in wrists b/l.  Continued to progress over following year affecting knees, elbows, ankles, shoulders, fingers and feet.  Diagnosed with presumptive Unspecified Connective Tissue Disease.  Treated with PO NSAIDS, steroids, steroid injections in wrists b/l, braces, hand OT, PT all with transient relief.  Vaccination is suspected to have triggered autoimmune response (UCTD vs seronegative RA) vs reactive arthritis.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to a patient of unknown age. On 19-JUN-2007, the patient was vaccinated with GARDASIL (lot # not reported) (strength and total daily dose not reported). On 07-SEP-2010, the patient was vaccinated with another dose of GARDASIL (lot # not reported) (strength and total daily dose not reported). No adverse effect was reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was inadvertently given VARIVAX instead of ZOSTAVAX. No adverse events were reported. Patient and Dr were notified. I also contacted Merck.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, X-ray limb normal
Clinical narrative: Within hours after receiving 2nd HPV, developed diffuse arm pain, from shoulder to wrist, involving entire arm. Later that evening with right leg pain (no injection in leg) aching in leg.
Age: 39.0
Sex: U
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed redness, swelling, pain, warmth at immunization site. Does not recall if shot was given IM or SQ. Did not treat and symptoms resolved within 2 weeks.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Redness & swelling to left arm for 1-2 day.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a female patient of unknown age. On 26-APR-2013 the patient was vaccinated with GARDASIL dose 3, 0.5 ml. The patient received her second dose of GARDASIL two years ago and was in the office to receive her third dose. No adverse effects reported. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Extensive erythema and edema (L) deltoid --> elbow.
Age: 29.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Exposure during pregnancy, Foetal disorder, Haemorrhage in pregnancy, Ultrasound antenatal screen abnormal
Clinical narrative: This serious medically-confirmed report (initial receipt: 19-Apr-2013) concerns a 29-year-old female pregnant patient. She had 1 previous pregnancy with full-term delivery and no birth defect. Her last menstrual period was 08-Dec-2012 and estimated delivery date was 14-Sep-2013. As of 18-Mar-2013, the patient was 13 weeks pregnant. On 17-Nov-2012 the patient received a flu vaccine (brand name, manufacturer and batch number were not reported) and dTap intramuscularly. On 10-Dec-2012 she received VARIVAX (batch number: 670988/0972AA) injection. On 06-Jan-2013 she also received Z-PAK and 2 other Abx (antibiotics) (category B). On 15-Mar-2013, the patient had an ultrasound scan (screening after vaccination) that showed ABN (abnormal) Rt (right) hand. On 19-Apr-2013 a detailed anatomy eval (evaluation) done via ultrasound revealed absent of radius (ABN Rt hand). The physician reported fetus right hand was not formed and had a malformed right forearm. The physician also reported there was a bleeding from the placenta. There was no maternal adverse event reported.
Age: 0.36
Sex: F
Vaccine: DTP
Symptoms: Hypotonia, Petit mal epilepsy
Clinical narrative: Initial case was received from a healthcare professional, who mentioned the event and provided no other information, (not medically confirmed) on 19 April 2013; and the consumer called immediately after to provide the following information. A female infant received dose three of an intramuscular injection of diphtheria, tetanus and pertussis vaccine, manufacturer and lot number unknown, (site and side not reported) on an unspecified day in March 1988. The patient stated her mother stated she went limp after the third vaccine in the baby series for tetanus, with no other symptoms, on an unspecified day in March 1988. The doctor called it a petit mal seizure at that time. The patient had no past medical history or allergies; and no illness at time of vaccination. No laboratory, diagnostic testing or treatments were reported. The patient's outcome was reported as recovered on an unspecified date. Documents held by sender: None.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Body temperature increased, Fatigue, Headache, Lip swelling
Clinical narrative: Patient reports onset of fatigue, headache swelling of lips, anxiety, and elevated temp - approx 6 hrs after receiving vaccine.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Patient called stating that her arm (left) swelled after vaccine was given. Swelling is gone now.
Age: 26.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Arthralgia, Rash
Clinical narrative: 13 days after receiving MMR vaccine pt developed rash on face and trunk front and back. Denies fever, chills. (L) hand ring finger with knuckle joint pain noted as well - treated with NSAIDS.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Muscular weakness, Myalgia, Pain
Clinical narrative: "Body aches", "joint ache" Myalgias, arthralgias, weakness to legs. No treatment.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Day after receiving shot patient started to get redness and some swelling around injection site.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Develop a full blown shingles.
Age: 26.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, itching, pain, heat at and around the injection site. The signs and symptoms increased over the next 5-6 days (6X10mm). One week later (7th day), the injection site is smaller, but still red and itchy.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Dizziness, Dysstasia, Headache, Injection site erythema
Clinical narrative: Fever 103, headache, lightheaded, weakness, difficulty standing.  Site of injection red, swollen and hot.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Fever 103, headache, lightheaded, weakness, difficulty standing.  Site of injection red, swollen and hot.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Chills, Dizziness, Headache, Injection site erythema, Injection site pain
Clinical narrative: Fever 103, headache, lightheaded, weakness, difficulty standing.  Site of injection red, swollen and hot.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Injection site swelling, Injection site warmth, Malaise, Pyrexia
Clinical narrative: Fever 103, headache, lightheaded, weakness, difficulty standing.  Site of injection red, swollen and hot.
Age: 15.0
Sex: F
Vaccine: TYP
Symptoms: Fall, Head injury, Muscle rigidity, Pallor, Syncope
Clinical narrative: Pt. seated while receiving vaccine, after pt. given vaccine, pt. got up sat in different chair. Pt. then stood up walked to desk area in clinic room, while standing and reading out loud, pt. suddenly fainted, falling backwards hitting back of head on floor. No bleeding noted, body became rigid momentarily, pale skin color noted. Pt. then became more alert, skin color improved. Pt. remained in clinic about 40 minutes after event, walked out with no difficulty.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy peripheral nerve, Blood test, Chronic inflammatory demyelinating polyradiculoneuropathy, Computerised tomogram, Guillain-Barre syndrome
Clinical narrative: Severe pain in legs, muscle loss and nerve damage in both legs. Guillain Barre syndrome, pathology results show presence of CIDP. Severe pain lasted 3-4 weeks.  Treated with IVIG and intravenous steroids.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Muscle atrophy, Nerve injury, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Severe pain in legs, muscle loss and nerve damage in both legs. Guillain Barre syndrome, pathology results show presence of CIDP. Severe pain lasted 3-4 weeks.  Treated with IVIG and intravenous steroids.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Positron emission tomogram, X-ray
Clinical narrative: Severe pain in legs, muscle loss and nerve damage in both legs. Guillain Barre syndrome, pathology results show presence of CIDP. Severe pain lasted 3-4 weeks.  Treated with IVIG and intravenous steroids.