chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, PER, RVX
Symptoms: Incorrect dose administered, Pain, Screaming
Clinical narrative: My son was given the rotavirus vaccine at his 8 week check up.  It is unclear how much of it he even swallowed, as he spit out large amounts and the nurse had a difficult time getting him to take it.  He was crying quite a bit during the administration resisting it.  About 30 min. after the dose he nursed just fine and then fell asleep for several hours. He awoke screaming in pain...certainly not just your typical "I'm hungry,  tired, or want to be held cry".  My baby is typically a very mellow baby, so this was especially concerning to us.  Patient screamed for several hours...he would not nurse or take his pacifier.  He stopped for approximately 3-4 min increments about every hour and then the screaming started again.  His fists were tightly clenched and his toes flexed as he cried.  His belly was very, very tight and I could tell that he was having a lot of abdominal pain.  After approx 3 hours of crying I placed him in a very warm bath and massaged his belly.  This seemed to calm him down a little and he had a small bowel movement, which seemed to relax his tight belly as well.   He ate after that as well.  For the rest of the evening, the screamed continued but did become less in duration and frequency.  Through the night, he would scream about 10 min and then have an enormous bowel movement.....intense diarrhea.  The diarrhea was gone by late the next morning and the screaming and stomach pain stopped as well.   Ironically, my now three year old daughter demonstrated the EXACT same reaction after and course of events after her 8 week dose.  For this reason, we decided NOT to give her the 4 and 6 month doses.
Age: 3.0
Sex: F
Vaccine: FLUN3, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site vesicles, Injection site warmth
Clinical narrative: 18 x 10cm area of redness, induration; warm to touch; itchy; slightly painful - able to walk. Small cluster of vesicles around injection site 10 day course of Cephalexin; Ibuprofen warm compress.
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Fatigue, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: Combined initial reports were received from health care professional via the call center on 28 Jan 2011 and from the consumer on 31 Jan 2011: This poly-medicated patient had a medical history of fibromyalgia and rheumatoid arthritis. The patient had a vaccination history of influenza INN, tick-borne encephalitis INN and hepatitis A and B INN. All vaccinations had always been well tolerated. The patient was vaccinated with a first dose of RABIPUR (batch no. 48011A) on 15 Dec 2010, second dose on 22 Dec 2010 (batch no. 48011A) and the third dose (batch no. 48011A) on 12 Jan 2011. Approximately 1.5 hours after the first dose on 15 Dec 2010, the patient developed dizziness which was persisting including the next day and then completely recovered. Approximately 3 hours after the second dose on 22 Dec 2010, the patient developed dizziness which persisted including next day and then completely resolved. From 23 Dec 2010, the patient felt exhausted and tired. On 25 Dec 2010, the patient displayed in the evening a migraine like attack and numbness and prickle in the ring finger and index finger in both hands. The symptoms were more pronounced in the right hand. On 31 Dec 2010, the patient had completely recovered. On 05 Jan 2011 and 06 Jan 2011, the patient again displayed a migraine like attack (headache) which completely resolved. One to two hours after third vaccination on 12 Jan 2011, the patient again displayed migraine-like attack with headache and dizziness. These symptoms lasted until 24 Jan 2011. From 25 Jan 2011 to 27 Jan 2011, the patient displayed headache and exhaustedness. The final outcome of the events was reported as recovered.
Sex: F
Vaccine: RAB
Symptoms: Vaccine positive rechallenge
Clinical narrative: Combined initial reports were received from health care professional via the call center on 28 Jan 2011 and from the consumer on 31 Jan 2011: This poly-medicated patient had a medical history of fibromyalgia and rheumatoid arthritis. The patient had a vaccination history of influenza INN, tick-borne encephalitis INN and hepatitis A and B INN. All vaccinations had always been well tolerated. The patient was vaccinated with a first dose of RABIPUR (batch no. 48011A) on 15 Dec 2010, second dose on 22 Dec 2010 (batch no. 48011A) and the third dose (batch no. 48011A) on 12 Jan 2011. Approximately 1.5 hours after the first dose on 15 Dec 2010, the patient developed dizziness which was persisting including the next day and then completely recovered. Approximately 3 hours after the second dose on 22 Dec 2010, the patient developed dizziness which persisted including next day and then completely resolved. From 23 Dec 2010, the patient felt exhausted and tired. On 25 Dec 2010, the patient displayed in the evening a migraine like attack and numbness and prickle in the ring finger and index finger in both hands. The symptoms were more pronounced in the right hand. On 31 Dec 2010, the patient had completely recovered. On 05 Jan 2011 and 06 Jan 2011, the patient again displayed a migraine like attack (headache) which completely resolved. One to two hours after third vaccination on 12 Jan 2011, the patient again displayed migraine-like attack with headache and dizziness. These symptoms lasted until 24 Jan 2011. From 25 Jan 2011 to 27 Jan 2011, the patient displayed headache and exhaustedness. The final outcome of the events was reported as recovered.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Bacterial infection, Muscle rupture, Pain in extremity, Pyrexia
Clinical narrative: A serious spontaneous report of tear in his thigh muscle and bacterial infection has been received from a non-health professional concerning a nine-year-old male, subsequent to FLUMIST. The patient received FLUMIST last season and had no adverse events. Concomitant medications were not reported. The patient received FLUMIST on 15-Nov-2010. The patient started getting a fever and leg cramps on Thursday 18-Nov-2010. The patient's leg cramps were really leg pain. The pain became more severe, he continued to have fever and on 23-Nov-2010, the subject was taken to the hospital urgent care. He was diagnosed with a "tear in his thigh muscle" and had a bacterial infection. He was admitted that day and was treated with intravenous antibiotics. He was discharged on 26-Nov-2010. A home health nurse visited the patient at home and administered IV antibiotics. His fever resolved and the leg pain resolved. The hospital physicians reported that the events were not related to FLUMIST. The outcome of tear in his thigh muscle and bacterial infection was resolved. Additional information was received on 04-Jan-2011 and incorporated in the narrative: adverse events changed to 'tear in his thigh muscle' and 'bacterial infection', outcome of the events and medical history. case has been upgraded to be a 15-Day case due to hospitalization and unlabeled events.
Age: 0.35
Sex: M
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: FEVER 103 NOT CONTROLLED BY TYLENOL
Age: 21.0
Sex: F
Vaccine: TYP, YF, TYP, YF
Symptoms: Asthenia, Dizziness, Loss of consciousness, Pallor
Clinical narrative: After receiving vaccines client was checking out of the clinic. Client became pale and compained of weakness and dizziness. She was eased to a chair by staff and reportedly lost consciousness for approx 2 minutes. She was seen by the Clinic physician and cleared to go home.
Age: 21.0
Sex: F
Vaccine: TYP, YF, TYP, YF
Symptoms: Syncope, Urticaria
Clinical narrative: After receiving vaccines client was checking out of the clinic. Client became pale and compained of weakness and dizziness. She was eased to a chair by staff and reportedly lost consciousness for approx 2 minutes. She was seen by the Clinic physician and cleared to go home.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pt came in today and claimed her arm still hurt from the shot (movement limited). She claims the shot was given on the top shoulder blade. The shot was given in the deltoid muscle. She has seen her own doctor who said I should have used a shorter needle, he recommended pain pills for her, but she says she still has limited movement. Added note 2-5-11/Pt says arm still hurts.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Electromyogram, Hypoaesthesia, Laboratory test, Lumbar puncture
Clinical narrative: 6 wks after receiving the vaccine began having progressive weakness and numbness in legs and fingertips. Few days prior to admission to hosptial 1/26/2011 unable to walk.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging, Scan, X-ray
Clinical narrative: 6 wks after receiving the vaccine began having progressive weakness and numbness in legs and fingertips. Few days prior to admission to hosptial 1/26/2011 unable to walk.
Age: 1.11
Sex: M
Vaccine: FLU3, MMR, PNC13, VARCEL
Symptoms: Cough, Pyrexia, Rhinorrhoea
Clinical narrative: High fever (103-104), runny nose, cough, for 6 days. Suspected bronchiolitis but this was ruled out.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered
Clinical narrative: None. Pt. had vaccine MCV-4 administered on 1-5-11 at another facility according to vaccine record.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Rash macular
Clinical narrative: Multiple macular rash along his arms observed during clinic visit about 10-15 minutes after vaccine was given.  MD prescribed Benadryl and Medrol Dose pack for treatment.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Staphylococcal infection
Clinical narrative: Pt verbally reported that one week after recieving a Tdap she experienced redness, swelling and tenderness at the sight.  She stated there was NOT any drainage or any type of fluid filled mass. She stated she had NO fever.  She did have it examined by her OB/GYN while being seen for routine appt who dx MRSA and placed her on an Bactrim.  A culture was not obtained as "there was nothing to culture".
Age: 11.0
Sex: F
Vaccine: HEP, HPV4, IPV, MNQ
Symptoms: Dyskinesia, Loss of consciousness
Clinical narrative: Had jerking movements and passed out about one minute after receiving HPV, MCV, Hep B & IPV.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 4" x 2" reddened hot area (L) deltoid x 1 day.
Sex: F
Vaccine: MMR
Symptoms: Drug exposure during pregnancy, No adverse event, Ultrasound scan
Clinical narrative: No adverse reaction. At time of visit pt. was unaware that she was pregnant.
Age: 1.32
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Immediate post-injection reaction, Rash erythematous
Clinical narrative: Immediately developed red bumps on forehead.
Age: 1.02
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Ataxia, Balance disorder, Blood test normal, Fall
Clinical narrative: Mother states child received vaccines Wednesday evening. Thursday morning around 1:00am, she noticed child was "off-balance" when walking. The next day, Friday, she noticed child was even more "off-balance," and fell backward when looking up. On Sunday, 11/21/2010, she took the child to the Emergency Room, as child did not have a physician. Mother states the ER physician diagnosed the child with "Severe Ataxia," and said it was probably from the varicella vaccine the child had received. Mother states ER physician told her it may take a while for symptoms to go away, and if no improvement she should take the child to a neurologist. Mother states after about 6 weeks the child had completely recovered. She states she did not take him to any additional physicians.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Fatigue
Clinical narrative: Fatigue and joint pains.
Age: 1.48
Sex: M
Vaccine: YF
Symptoms: Ear infection, Lethargy, Pyrexia, Viral infection
Clinical narrative: Fever, lethargy, possible seizure. Also found to have ear infection, and viral infection.  Treated with one dose of ceftriaxone (I believe) and Augmentin.
Age: 30.0
Sex: M
Vaccine: YF
Symptoms: Vaccination site rash
Clinical narrative: Rash over site of vaccination, 3cm in circumference
Age: 0.21
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Onset of fever PM 2-4-11, 103.4, fever resolved 2-6-5-2011.  Onset of watery stools 2-5-11.  Office visit 2-8-11, well hydrated, negative provider assessment.
Age: 20.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Cellulitis, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Pt had a HA after shot, then on Sunday 2/6 she developed redness and swelling at site of shot.  By 2/7 when she presented to clinic, red swollen area was approximately 12 cm x 7 cm. pt was treated with Bactrim. When she returned to clinic for recheck on 2/9, cellulitis had resolved.
Age: 1.28
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Local reaction on left thigh.
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: wrong dose administered
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Contusion, Idiopathic thrombocytopenic purpura, Injection site haematoma, Injection site reaction, Platelet count decreased
Clinical narrative: Dark purple bruising starting on his arms. Noticed red splotches on arms, legs and back which turned to bruises overnight. Diagnosed with ITP related to MMR. Course of prednisone.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash macular, Skin discolouration
Clinical narrative: Dark purple bruising starting on his arms. Noticed red splotches on arms, legs and back which turned to bruises overnight. Diagnosed with ITP related to MMR. Course of prednisone.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture negative, C-reactive protein increased, Cellulitis, Electrocardiogram normal, Erythema
Clinical narrative: A 67-yo female received a Pneumovax injection 0.5ml IM in the left deltoid and 2 days later presented to the Emergency Department with complaints of erythema, warmth, edema, and pain in the left upper extremity.  The symptoms were moving down the extremity and were not relieved with Benadryl.  The patient had a history of hyperlipidemia, osteoarthritis of the knee, and osteopenia and was seen in the Geriatric Clinic on 20 Jan 2011 where she received the Pneumovax injection.  Concomitant medications included Actonel 150mg monthly, aspirin 81mg daily, Niaspan 500mg daily, Vytorin 10/80mg daily, and Zolpidem 10mg at bedtime as needed for sleep.  The patient also reported taking alpha lipoic acid tablets, Citracal+D, CoQ10, fish oil 1200mg, glucosamine chondroitin complex, vitamin B complex, and vitamin C.  On 22 Jan 2011 when presenting to the Emergency Department, the patient's blood pressure was 157/84, heart rate 84, respirations 18, temperature 36.8ºC, and pulse oximetry 98% on room air.  The patient reported pain of 7 on a scale of 0 to 10.  The patient was diagnosed with cellulitis and was admitted to the hospital on 23 Jan 2011.  History and physical showed "swelling, redness, and tenderness in the upper left limb extending to the wrist with marked pain, associated tenderness".  There was no fever or chills. On 23 Jan 2011, a duplex of the left upper extremity showed no evidence of deep venous thrombosis, CBC was normal, EKG normal, and blood culture was negative.  C-Reactive protein was high at 5.9 (normal <0.6mg/dL).  The patient was treated with IV clindamycin with significant improvement. On 24 Jan 2011 the CBC was normal.  The patient was discharged home on oral clindamycin 300mg every six hours for 6 days.  On 31 Jan 2011 the patient was seen in the Geriatric Clinic for follow-up.  She was still having some paresthesia along the inner proximal left arm and minimal pain when lifting objects.  The swelling had subsided and there was some residual mild pink discoloration.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count normal, Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: A 67-yo female received a Pneumovax injection 0.5ml IM in the left deltoid and 2 days later presented to the Emergency Department with complaints of erythema, warmth, edema, and pain in the left upper extremity.  The symptoms were moving down the extremity and were not relieved with Benadryl.  The patient had a history of hyperlipidemia, osteoarthritis of the knee, and osteopenia and was seen in the Geriatric Clinic on 20 Jan 2011 where she received the Pneumovax injection.  Concomitant medications included Actonel 150mg monthly, aspirin 81mg daily, Niaspan 500mg daily, Vytorin 10/80mg daily, and Zolpidem 10mg at bedtime as needed for sleep.  The patient also reported taking alpha lipoic acid tablets, Citracal+D, CoQ10, fish oil 1200mg, glucosamine chondroitin complex, vitamin B complex, and vitamin C.  On 22 Jan 2011 when presenting to the Emergency Department, the patient's blood pressure was 157/84, heart rate 84, respirations 18, temperature 36.8ºC, and pulse oximetry 98% on room air.  The patient reported pain of 7 on a scale of 0 to 10.  The patient was diagnosed with cellulitis and was admitted to the hospital on 23 Jan 2011.  History and physical showed "swelling, redness, and tenderness in the upper left limb extending to the wrist with marked pain, associated tenderness".  There was no fever or chills. On 23 Jan 2011, a duplex of the left upper extremity showed no evidence of deep venous thrombosis, CBC was normal, EKG normal, and blood culture was negative.  C-Reactive protein was high at 5.9 (normal <0.6mg/dL).  The patient was treated with IV clindamycin with significant improvement. On 24 Jan 2011 the CBC was normal.  The patient was discharged home on oral clindamycin 300mg every six hours for 6 days.  On 31 Jan 2011 the patient was seen in the Geriatric Clinic for follow-up.  She was still having some paresthesia along the inner proximal left arm and minimal pain when lifting objects.  The swelling had subsided and there was some residual mild pink discoloration.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain, Pain in extremity, Paraesthesia, Sinus rhythm
Clinical narrative: A 67-yo female received a Pneumovax injection 0.5ml IM in the left deltoid and 2 days later presented to the Emergency Department with complaints of erythema, warmth, edema, and pain in the left upper extremity.  The symptoms were moving down the extremity and were not relieved with Benadryl.  The patient had a history of hyperlipidemia, osteoarthritis of the knee, and osteopenia and was seen in the Geriatric Clinic on 20 Jan 2011 where she received the Pneumovax injection.  Concomitant medications included Actonel 150mg monthly, aspirin 81mg daily, Niaspan 500mg daily, Vytorin 10/80mg daily, and Zolpidem 10mg at bedtime as needed for sleep.  The patient also reported taking alpha lipoic acid tablets, Citracal+D, CoQ10, fish oil 1200mg, glucosamine chondroitin complex, vitamin B complex, and vitamin C.  On 22 Jan 2011 when presenting to the Emergency Department, the patient's blood pressure was 157/84, heart rate 84, respirations 18, temperature 36.8ºC, and pulse oximetry 98% on room air.  The patient reported pain of 7 on a scale of 0 to 10.  The patient was diagnosed with cellulitis and was admitted to the hospital on 23 Jan 2011.  History and physical showed "swelling, redness, and tenderness in the upper left limb extending to the wrist with marked pain, associated tenderness".  There was no fever or chills. On 23 Jan 2011, a duplex of the left upper extremity showed no evidence of deep venous thrombosis, CBC was normal, EKG normal, and blood culture was negative.  C-Reactive protein was high at 5.9 (normal <0.6mg/dL).  The patient was treated with IV clindamycin with significant improvement. On 24 Jan 2011 the CBC was normal.  The patient was discharged home on oral clindamycin 300mg every six hours for 6 days.  On 31 Jan 2011 the patient was seen in the Geriatric Clinic for follow-up.  She was still having some paresthesia along the inner proximal left arm and minimal pain when lifting objects.  The swelling had subsided and there was some residual mild pink discoloration.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Tenderness, Ultrasound scan normal
Clinical narrative: A 67-yo female received a Pneumovax injection 0.5ml IM in the left deltoid and 2 days later presented to the Emergency Department with complaints of erythema, warmth, edema, and pain in the left upper extremity.  The symptoms were moving down the extremity and were not relieved with Benadryl.  The patient had a history of hyperlipidemia, osteoarthritis of the knee, and osteopenia and was seen in the Geriatric Clinic on 20 Jan 2011 where she received the Pneumovax injection.  Concomitant medications included Actonel 150mg monthly, aspirin 81mg daily, Niaspan 500mg daily, Vytorin 10/80mg daily, and Zolpidem 10mg at bedtime as needed for sleep.  The patient also reported taking alpha lipoic acid tablets, Citracal+D, CoQ10, fish oil 1200mg, glucosamine chondroitin complex, vitamin B complex, and vitamin C.  On 22 Jan 2011 when presenting to the Emergency Department, the patient's blood pressure was 157/84, heart rate 84, respirations 18, temperature 36.8ºC, and pulse oximetry 98% on room air.  The patient reported pain of 7 on a scale of 0 to 10.  The patient was diagnosed with cellulitis and was admitted to the hospital on 23 Jan 2011.  History and physical showed "swelling, redness, and tenderness in the upper left limb extending to the wrist with marked pain, associated tenderness".  There was no fever or chills. On 23 Jan 2011, a duplex of the left upper extremity showed no evidence of deep venous thrombosis, CBC was normal, EKG normal, and blood culture was negative.  C-Reactive protein was high at 5.9 (normal <0.6mg/dL).  The patient was treated with IV clindamycin with significant improvement. On 24 Jan 2011 the CBC was normal.  The patient was discharged home on oral clindamycin 300mg every six hours for 6 days.  On 31 Jan 2011 the patient was seen in the Geriatric Clinic for follow-up.  She was still having some paresthesia along the inner proximal left arm and minimal pain when lifting objects.  The swelling had subsided and there was some residual mild pink discoloration.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Crying, Vomiting
Clinical narrative: He had no symptoms when he went to bed at 7PM, started crying at 8PM where I found that he vomited and after a bath he vomited 2 more times. No temperature.
Age: 1.05
Sex: F
Vaccine: FLUX, MMR
Symptoms: Dermatitis diaper, Diarrhoea, Fungal infection, Rash
Clinical narrative: Slight skin rash on legs, runny stools. Diarrhea Still occurring 6 days later, very little improvement. Diaper rash turned into a yeast infection which required prescription ointment.
Age: 36.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Induration/swelling redness & tenderness around the injection site. Increased warmth over the area of redness occurred day after injection to now (last 3 days). Will try TYLENOL, NSAID & ice.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site haematoma, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Vaccine administered on 2-6-11, pt came back to pharmacy today with a softball sized red raised area over the administration site with bruising on the bottom. Patient states it is itchy & hard spot.
Age: 12.0
Sex: F
Vaccine: DTAP, HEPA, HPV4, MNQ, VARCEL
Symptoms: Antinuclear antibody, Differential white blood cell count, Fall, Full blood count, Metabolic function test
Clinical narrative: Guillain Barre complex after vaccines of Tdap, Hep A, GARDASIL, Varicella, MENACTRA on 1/3/11; falls started on 1/5/11 - total of seven to date.
Age: 12.0
Sex: F
Vaccine: DTAP, HEPA, HPV4, MNQ, VARCEL
Symptoms: Neurological examination, Nuclear magnetic resonance imaging brain, Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: Guillain Barre complex after vaccines of Tdap, Hep A, GARDASIL, Varicella, MENACTRA on 1/3/11; falls started on 1/5/11 - total of seven to date.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Local redness, itching, swelling at injection site.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness & swelling at shot site warm to the touch. Treated w/KEFLEX 250mg/5ml 2 tsp PO three times per day x 10 days.
Age: 20.0
Sex: F
Vaccine: SMALL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This is a follow-up to a previously submitted VAERS report 397107-1. No adverse event - vaccinee received SPV while pregnant. Delivered healthy baby boy; birth weight - 3050 gm.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Death, Meningococcal infection
Clinical narrative: 10/18 fever & vomiting.  10/19 body aches & slurred speech.  Taken to hospital by ambulance. Blood & CSF cultures positive for Neisseria meningitidis serogroup C.  Had septic shock, DIC, respiratory failure, renal failure, & Waterhouse-Friderichsens syndrome.  10/20 2:35 AM Pronounced dead.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Blood culture positive, CSF culture positive, Death, Disseminated intravascular coagulation, Dysarthria
Clinical narrative: 10/18 fever & vomiting.  10/19 body aches & slurred speech.  Taken to hospital by ambulance. Blood & CSF cultures positive for Neisseria meningitidis serogroup C.  Had septic shock, DIC, respiratory failure, renal failure, & Waterhouse-Friderichsens syndrome.  10/20 2:35 AM Pronounced dead.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Meningococcal infection, Neisseria test positive, Pain, Pyrexia, Renal failure
Clinical narrative: 10/18 fever & vomiting.  10/19 body aches & slurred speech.  Taken to hospital by ambulance. Blood & CSF cultures positive for Neisseria meningitidis serogroup C.  Had septic shock, DIC, respiratory failure, renal failure, & Waterhouse-Friderichsens syndrome.  10/20 2:35 AM Pronounced dead.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Respiratory failure, Septic shock, Vomiting, Waterhouse-Friderichsen syndrome
Clinical narrative: 10/18 fever & vomiting.  10/19 body aches & slurred speech.  Taken to hospital by ambulance. Blood & CSF cultures positive for Neisseria meningitidis serogroup C.  Had septic shock, DIC, respiratory failure, renal failure, & Waterhouse-Friderichsens syndrome.  10/20 2:35 AM Pronounced dead.
Age: 26.0
Sex: M
Vaccine: FLU3, HEPAB, MNQ, TDAP, FLU3, HEPAB, MNQ, TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Pruritus, hives.
Age: 0.17
Sex: M
Vaccine: HEP, HIBV, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Burning sensation, Crying, Unresponsive to stimuli
Clinical narrative: Initial case received from a nurse on 31 January 2011.  An 8-week old male infant received first doses of the following vaccines at 6:20 pm on 25 January 2011:  PENTACEL (lot number C3657AA); ENGERIX-B (GlaxoSmithKline, lot number AHBVB805BA); PREVNAR 13 (Wyeth, lot number 915186); and ROTATEQ (Merck, lot number 08692Z).  Approximately 25 minutes post-vaccination, at 6:47 pm, the patient returned to the clinic unresponsive to stimuli and "blueing around the lips".  A pulse oximetry measurement was 82%.  He was administered oxygen via a nasal mask at 100%, and at approximately 6:51 pm the patient was noted to be pink and crying, with pulse oximetry reading 98% and heart rate in the 150's.  He was dispatched to the emergency department by his physician.  The patient had no medical history, was not taking any medications, and was not ill at the time of vaccination.  His birth weight was 7 pounds 12 ounces, and he had no siblings.  No diagnostic testing was performed, and the patient subsequently recovered at an unspecified time.  Documents held by sender: None.
Age: 0.17
Sex: M
Vaccine: HEP, HIBV, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Cyanosis, Unresponsive to stimuli
Clinical narrative: Initial case received from a nurse on 31 January 2011.  An 8-week old male infant received first doses of the following vaccines at 6:20 pm on 25 January 2011:  PENTACEL (lot number C3657AA); ENGERIX-B (GlaxoSmithKline, lot number AHBVB805BA); PREVNAR 13 (Wyeth, lot number 915186); and ROTATEQ (Merck, lot number 08692Z).  Approximately 25 minutes post-vaccination, at 6:47 pm, the patient returned to the clinic unresponsive to stimuli and "blueing around the lips".  A pulse oximetry measurement was 82%.  He was administered oxygen via a nasal mask at 100%, and at approximately 6:51 pm the patient was noted to be pink and crying, with pulse oximetry reading 98% and heart rate in the 150's.  He was dispatched to the emergency department by his physician.  The patient had no medical history, was not taking any medications, and was not ill at the time of vaccination.  His birth weight was 7 pounds 12 ounces, and he had no siblings.  No diagnostic testing was performed, and the patient subsequently recovered at an unspecified time.  Documents held by sender: None.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Flushing, Hypertension, Immediate post-injection reaction, Malaise
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning a 62 year old male patient who on 01-FEB-2011 was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (Oka/Merck) (Lot#669190/1455Z, expiration date: 29-JAN-2012). Pharmacist reported that after being vaccinated with a dose of ZOSTAVAX (Oka/Merck), the patient immediately felt flushed and "like something was surging through his body". Patient called EMS (Emergency Medical Service) to seek for medical attention and receive treatment for the events, and was hospitalized. Pharmacist considered this to be an other important medical event. Pharmacist requested a lot check. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Flushing, Immediate post-injection reaction
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning a 62 year old male patient who on 01-FEB-2011 was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (Oka/Merck) (Lot#669190/1455Z, expiration date: 29-JAN-2012). Pharmacist reported that after being vaccinated with a dose of ZOSTAVAX (Oka/Merck), the patient immediately felt flushed and "like something was surging through his body". Patient called EMS (Emergency Medical Service) to seek for medical attention and receive treatment for the events, and was hospitalized. Pharmacist considered this to be an other important medical event. Pharmacist requested a lot check. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cold sweat, Dizziness, Dizziness postural, Dysgeusia, Hyperhidrosis
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 67 year old male patient, who on 01-FEB-2011 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # 669190/1455Z EXP 29-JAN-2012). Concomitant therapy included AVAPRO and pravastatin Na. The pharmacist reported that the patient received ZOSTAVAX (Merck) on 01-FEB-2011, immediately felt dizzy, light headed, hands sweaty, shaky and medicine like taste in mouth and was hospitalized. At the time of the report, the patient was recovering. The pharmacist requested a lot check. A lot check has been initiated. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Tremor
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 67 year old male patient, who on 01-FEB-2011 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # 669190/1455Z EXP 29-JAN-2012). Concomitant therapy included AVAPRO and pravastatin Na. The pharmacist reported that the patient received ZOSTAVAX (Merck) on 01-FEB-2011, immediately felt dizzy, light headed, hands sweaty, shaky and medicine like taste in mouth and was hospitalized. At the time of the report, the patient was recovering. The pharmacist requested a lot check. A lot check has been initiated. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Dysgeusia, Hyperhidrosis, Immediate post-injection reaction, Tremor
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 67 year old male patient, who on 01-FEB-2011 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # 669190/1455Z EXP 29-JAN-2012). Concomitant therapy included AVAPRO and pravastatin Na. The pharmacist reported that the patient received ZOSTAVAX (Merck) on 01-FEB-2011, immediately felt dizzy, light headed, hands sweaty, shaky and medicine like taste in mouth and was hospitalized. At the time of the report, the patient was recovering. The pharmacist requested a lot check. A lot check has been initiated. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: Experiencing soreness and pain in arm that hasn't decreased since getting vaccination on 12/4/10. She has had to visit her primary MD and chiropractor to try and treat it with no success. First complaint on 12/20/10 and second complaint on 1/28/11.
Age: 56.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Pain in extremity
Clinical narrative: Experiencing soreness and pain in arm that hasn't decreased since getting vaccination on 12/4/10. She has had to visit her primary MD and chiropractor to try and treat it with no success. First complaint on 12/20/10 and second complaint on 1/28/11.
Age: 0.23
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1, RV1, DTAP, HEP, HIBV, IPV, PPV, RV1
Symptoms: Intussusception, Surgery
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX, (GlaxoSmithKline). Previous and/or concurrent vaccination included HIB; manufacturer unspecified; unknown; unknown given in 2010; dtap; manufacturer unspecified ; unknown given in 2010; hepatitis B vaccine; manufacturer unspecified; unknown; unknown given in 2010; poliomyelitis inactivated (non-gsk); non-GSK manufacturer; unknown; unknown given in 2010; SYNFLORIX; manufacturer unspecified; unknown; unknown given in 2010. On 16 November 2010 and 7 October 2010 the subject received 2nd dose and 1st dose of ROTARIX (oral). On 30 December 2010, 44 days after vaccination with 2nd dose of ROTARIX, 84 days after vaccination with the 1st dose ROTARIX, the subject experienced intussusception. The sales representative stated that the physician reported the subject had a surgical procedure to repair the intussusception. The subject was hospitalised. At the time of reporting the intussusception was resolved. This is one of three cases reported by sales representative. For the other cases see A0911213A and A0911220A
Age: 0.23
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1, RV1, DTAP, HEP, HIBV, IPV, PPV, RV1
Symptoms: Abdominal X-ray, Barium enema abnormal, Enema administration, Intussusception, Laparotomy
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX, (GlaxoSmithKline). Previous and/or concurrent vaccination included HIB; manufacturer unspecified; unknown; unknown given in 2010; dtap; manufacturer unspecified ; unknown given in 2010; hepatitis B vaccine; manufacturer unspecified; unknown; unknown given in 2010; poliomyelitis inactivated (non-gsk); non-GSK manufacturer; unknown; unknown given in 2010; SYNFLORIX; manufacturer unspecified; unknown; unknown given in 2010. On 16 November 2010 and 7 October 2010 the subject received 2nd dose and 1st dose of ROTARIX (oral). On 30 December 2010, 44 days after vaccination with 2nd dose of ROTARIX, 84 days after vaccination with the 1st dose ROTARIX, the subject experienced intussusception. The sales representative stated that the physician reported the subject had a surgical procedure to repair the intussusception. The subject was hospitalised. At the time of reporting the intussusception was resolved. This is one of three cases reported by sales representative. For the other cases see A0911213A and A0911220A
Age: 0.23
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1, RV1, DTAP, HEP, HIBV, IPV, PPV, RV1
Symptoms: Small intestinal intussusception reduction, Ultrasound abdomen abnormal, X-ray abnormal
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX, (GlaxoSmithKline). Previous and/or concurrent vaccination included HIB; manufacturer unspecified; unknown; unknown given in 2010; dtap; manufacturer unspecified ; unknown given in 2010; hepatitis B vaccine; manufacturer unspecified; unknown; unknown given in 2010; poliomyelitis inactivated (non-gsk); non-GSK manufacturer; unknown; unknown given in 2010; SYNFLORIX; manufacturer unspecified; unknown; unknown given in 2010. On 16 November 2010 and 7 October 2010 the subject received 2nd dose and 1st dose of ROTARIX (oral). On 30 December 2010, 44 days after vaccination with 2nd dose of ROTARIX, 84 days after vaccination with the 1st dose ROTARIX, the subject experienced intussusception. The sales representative stated that the physician reported the subject had a surgical procedure to repair the intussusception. The subject was hospitalised. At the time of reporting the intussusception was resolved. This is one of three cases reported by sales representative. For the other cases see A0911213A and A0911220A
Age: 0.8
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, RV1
Symptoms: Barium enema, Intussusception
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of intussusception in a 10-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included Haemophilius influenza type b vaccine ;manufacturer unspecified;unknown;unknown given in 2010; diphtheria and tetanus toxoids and acellular pertussis vaccine ;manufacturer unspecified;unknown given in 2010; hepatitis B vaccine recombinant ;manufacturer unspecified;unknown;unknown given in 2010; poliomyelitis vaccine inactivated (non-gsk) ;non-GSK manufacturer;unknown;unknown given in 2010; ROTATEQ (non-gsk); non-GSK manufacturer; unknown given on 11 May 2010 and 31 August 2010; SYNFLORIX  ;manufacturer unspecified;unknown given in 2010. On an unspecified date the subject received 3rd dose of ROTARIX (oral) and experienced and wrong vaccine administered. The subject received ROTATEQ for the 1st and 2nd dose and ROTARIX for the 3rd dose. On 4 January 2011, at an unspecified time after vaccination with ROTARIX, the subject experienced intussusception. The sales representative stated that the physician reported the subject had a surgical procedure to repair the intussusception. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). At the time of reporting the intussusception was resolved. This is the second of three cases reported by the sales representative. For the other cases see A0911009A and A0911220A.
Age: 0.8
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, RV1
Symptoms: Intussusception, Surgery, Wrong drug administered
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of intussusception in a 10-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included Haemophilius influenza type b vaccine ;manufacturer unspecified;unknown;unknown given in 2010; diphtheria and tetanus toxoids and acellular pertussis vaccine ;manufacturer unspecified;unknown given in 2010; hepatitis B vaccine recombinant ;manufacturer unspecified;unknown;unknown given in 2010; poliomyelitis vaccine inactivated (non-gsk) ;non-GSK manufacturer;unknown;unknown given in 2010; ROTATEQ (non-gsk); non-GSK manufacturer; unknown given on 11 May 2010 and 31 August 2010; SYNFLORIX  ;manufacturer unspecified;unknown given in 2010. On an unspecified date the subject received 3rd dose of ROTARIX (oral) and experienced and wrong vaccine administered. The subject received ROTATEQ for the 1st and 2nd dose and ROTARIX for the 3rd dose. On 4 January 2011, at an unspecified time after vaccination with ROTARIX, the subject experienced intussusception. The sales representative stated that the physician reported the subject had a surgical procedure to repair the intussusception. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). At the time of reporting the intussusception was resolved. This is the second of three cases reported by the sales representative. For the other cases see A0911009A and A0911220A.
Age: 18.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, TDAP, FLU3, HEPA, MNQ, TDAP
Symptoms: Dyspnoea, Pruritus, Wheezing
Clinical narrative: Sudden onset of dyspnea, pruritis face, wheezing bilateral.
Age: 1.41
Sex: M
Vaccine: DTAP, PPV
Symptoms: Acoustic stimulation tests, Balance disorder, Gait disturbance, Hypoacusis, Injection site swelling
Clinical narrative: High Fever >105 degrees F, Drowsiness, swelling of injection site for a week, sensitivity to light, imbalance in walking, reduced responsiveness and hearing
Age: 1.41
Sex: M
Vaccine: DTAP, PPV
Symptoms: Photophobia, Pyrexia, Slow response to stimuli, Somnolence
Clinical narrative: High Fever >105 degrees F, Drowsiness, swelling of injection site for a week, sensitivity to light, imbalance in walking, reduced responsiveness and hearing
Age: 42.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Blister, Pruritus, Rash, Rash erythematous
Clinical narrative: Rashed started on bilateral hands/arms. Red colored bumps, blister looking, itchy. She took Benadryl in the evening.
Age: 0.03
Sex: M
Vaccine: HEPA, MMR, PPV
Symptoms: Rash, Rhinorrhoea, Vomiting
Clinical narrative: Vomiting, runny nose, rash on stomach
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a Licensed Visiting Nurse (L.V.N.) for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female with no medical history or drug allergies who on 23-FEB-2010 was vaccinated intramuscularly with a dose of GARDASIL (lot# 663558/0819Y). Concomitant therapy included TYLENOL. On 23-FEB-2010 the patient came into the office to get some lab exams and a pregnancy test. GARDASIL was ordered and given before the pregnancy result returned positive (about 7 weeks pregnancy). No adverse event occurred. It was unspecified if the patient sought medical attention. Follow-up information has been received from the L.V.N. via a voice mail reporting the patient had an "elective termination" on an unspecified date. Upon internal review, an "elective termination" was determined to be an other important medical event. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed shingles 3 days later.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Erythema, Swelling
Clinical narrative: None stated.
Age: 5.0
Sex: F
Vaccine: DTAP, FLU3, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Received DTAP on 2/2/11. Was seen 2/4/11 with c/o "hard, red & swollen area" where shot given. Physician assessment indicated moderately erythematous skin, mildly indurated under left deltoid injection site. No open lesions/drainage treatment - area marked to observe, cold compresses recheck prn.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site reaction, Vaccination complication
Clinical narrative: Received 5yr vaccine on 2/2/11. Mom called with c/o "significant" vaccine reaction. Seen on 2/3/11 and diagnosed with probable vaccine reaction but due to the significance of reaction started on KEFLEX. Area also marked to monitor for spread. Rec BENADRYL & warm compresses.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Vaccination complication
Clinical narrative: Received vaccines on 2/2/11. Came in for PPD reading & (L) shoulder was noticeably swollen from shoulder to mid forearm no redness not hard to touch. Seen by MD & diagnosed as vaccine reaction treatment BENADRYL.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Asthenia, Circulatory collapse, Contusion, Erythema nodosum
Clinical narrative: Weakness, edema, unable to walk, loss of circulation, bruising,
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema
Clinical narrative: Weakness, edema, unable to walk, loss of circulation, bruising,
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 5 x10 cm area surrounding injection site of swelling, itching & redness around perimeter. No fever or systemic reactions. No treatment given. Advised pt may take BENADRYL. She has been using hydrocortisone cream at home.
Age: 6.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Edema with induration, heat to left thigh 8.5 x 12.5 cm no pus, fever, chills, wheezes etc.
Age: 0.62
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13
Symptoms: Rash erythematous, Rash generalised, Rash pruritic, Urticaria
Clinical narrative: Seen for vaccines on 2/3/11. Returned to office on 2/6 with c/o intermittent rash on entire body, raise red itchy. Dx with hives ? due to vaccines. Had rec'd PCV13; PENTACEL in past w/o reaction. This was 1st flu vaccine.
Age: 1.2
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: L thigh was reddened and swollen
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Acute pulmonary oedema, Acute respiratory failure, Chronic obstructive pulmonary disease, Condition aggravated, Contraindication to vaccination
Clinical narrative: Initial literature report received on 31 Jan 2011: This article described about adverse events associated with pandemic influenza vaccines and comparison of the results of a follow-up study with those coming from spontaneous reporting. This patient had medical history of chronic obstructive pulmonary disease (COPD), diabetes and peripheral ischemia. Concomitant medication included triflusal and pentoxifylline. He was vaccinated with seasonal influenza virus vaccine (manufacturer and batch number unknown) on an unspecified date. He experienced acute pulmonary oedema, COPD exacerbation, acute respiratory failure and hypertensive crisis and hence it was reported that Influenza A vaccine was contraindicated in this patient. Outcome of the event was not reported. Two years later, he was vaccinated with S-OIV FOCETRIA (batch number unknown) on an unspecified date and experienced similar reaction (see case PHHY2011ES07993).
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Hypertensive crisis
Clinical narrative: Initial literature report received on 31 Jan 2011: This article described about adverse events associated with pandemic influenza vaccines and comparison of the results of a follow-up study with those coming from spontaneous reporting. This patient had medical history of chronic obstructive pulmonary disease (COPD), diabetes and peripheral ischemia. Concomitant medication included triflusal and pentoxifylline. He was vaccinated with seasonal influenza virus vaccine (manufacturer and batch number unknown) on an unspecified date. He experienced acute pulmonary oedema, COPD exacerbation, acute respiratory failure and hypertensive crisis and hence it was reported that Influenza A vaccine was contraindicated in this patient. Outcome of the event was not reported. Two years later, he was vaccinated with S-OIV FOCETRIA (batch number unknown) on an unspecified date and experienced similar reaction (see case PHHY2011ES07993).