chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Pain in extremity, Sensation of heaviness
Clinical narrative: Information has been received from a Registered Nurse concerning a 54 year old female patient with no pertinent medical history and no drug reactions or allergies who on 27-SEP-2011 was vaccinated IM with a dose of PNEUMOVAX 23 (lot number: 670187/0895AA, expiration date 12-NOV-2012), 0.5 ml into the right arm. The registered nurse did not known if this was the first time this patient received PNEUMOVAX 23. Concomitant vaccine included FLUVIRIN into the left arm. The patient experienced severe right arm pain for 4 days after receiving PNEUMOVAX 23, and reported to the registered nurse that her arm felt like "dead weight". Also, it was reported that the patient was unable to "go to work". No lab test was performed. The patient sought medical attention by a phone call. At time of the report, the patient was recovering. Severe right arm pain and her arm felt like "dead weight" were considered to be disabling by the Registered Nurse. The nurse requested a lot check. A lot check for lot 670187/0895AA was requested. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR, IPV, MMR, PNC
Symptoms: Type 1 diabetes mellitus
Clinical narrative: Information has been received from a physician concerning an approximately 4 year old male patient who on 09-AUG-2007 was vaccinated with the first dose of MMR II (Lot number 656033/0280U, Exp. Date: 02-FEB-2009) and on 05-MAY-2010 received the second dose of MMR II (Lot number 664655/0640Y, Exp. Date: May-2011). The physician reported that "few months" after the second dose was given (approximately August 2010), the patient was diagnosed with insulin dependent diabetes. The patient was hospitalized at the time of the diagnosis. Insulin was given as a treatment for the experience. At the time of the report, the patient was still insulin dependant diabetic. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR, IPV, MMR, PNC
Symptoms: Albumin urine present, Blood glucose decreased, Blood glucose increased, Diabetes mellitus inadequate control, Ear infection
Clinical narrative: Information has been received from a physician concerning an approximately 4 year old male patient who on 09-AUG-2007 was vaccinated with the first dose of MMR II (Lot number 656033/0280U, Exp. Date: 02-FEB-2009) and on 05-MAY-2010 received the second dose of MMR II (Lot number 664655/0640Y, Exp. Date: May-2011). The physician reported that "few months" after the second dose was given (approximately August 2010), the patient was diagnosed with insulin dependent diabetes. The patient was hospitalized at the time of the diagnosis. Insulin was given as a treatment for the experience. At the time of the report, the patient was still insulin dependant diabetic. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR, IPV, MMR, PNC
Symptoms: Glucose urine absent, Glycosylated haemoglobin, Protein urine present, Urine ketone body absent
Clinical narrative: Information has been received from a physician concerning an approximately 4 year old male patient who on 09-AUG-2007 was vaccinated with the first dose of MMR II (Lot number 656033/0280U, Exp. Date: 02-FEB-2009) and on 05-MAY-2010 received the second dose of MMR II (Lot number 664655/0640Y, Exp. Date: May-2011). The physician reported that "few months" after the second dose was given (approximately August 2010), the patient was diagnosed with insulin dependent diabetes. The patient was hospitalized at the time of the diagnosis. Insulin was given as a treatment for the experience. At the time of the report, the patient was still insulin dependant diabetic. This is one of several reports from the same source. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Biopsy skin abnormal, Blister, Dermatitis atopic, Dermatitis contact, Eczema
Clinical narrative: A review of the medical records and interview noted that pt received AVA # 1 in Nov 2000 and # 2 and # 3 during deployment in Jan 2001. He reported that it was shortly after AVA # 3 the he began to notice small patches of pruritic blisters that started on his hands, then on other areas of his body to include arms, feet and thighs. He denied any prior hx of skin issues. The lesion would appear intermittently, last a couple of wks and then resolve. He reported that they do not always reoccur in the same places and has no known precipitated factors. He has multiple visits to include an allergy consult in Aug 2001 and was assessed as having a contact dermatitis. Due to problems controlling his symptoms with various creams and a round of steroids he underwent a civilian dermatology evaluation in Jun 2004. He had skin testing for trees, grasses, molds, and animals. Testing noted strong positives to the majority of trees, grasses and weeds, with neg results to molds and animals. He was assessed as having a chronic urticarial/vesicular dermatitis of undetermined etiology, and an autoimmune process was ruled out. He continued to have reoccurrences of rash without relief from antihistamines and topical steroids. In Jan 07 he was evaluated by a military dermatologist and underwent a skin biopsy which revealed spongiotic dermatitis with focal overlying parakeratosis. He was assessed and treated for atopic eczematous dermatitis. Despite treatment with creams and moisturizers, he continues to have problems with his skin.
Age: 21.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Hypersensitivity, Parakeratosis, Pruritus, Rash, Seasonal allergy
Clinical narrative: A review of the medical records and interview noted that pt received AVA # 1 in Nov 2000 and # 2 and # 3 during deployment in Jan 2001. He reported that it was shortly after AVA # 3 the he began to notice small patches of pruritic blisters that started on his hands, then on other areas of his body to include arms, feet and thighs. He denied any prior hx of skin issues. The lesion would appear intermittently, last a couple of wks and then resolve. He reported that they do not always reoccur in the same places and has no known precipitated factors. He has multiple visits to include an allergy consult in Aug 2001 and was assessed as having a contact dermatitis. Due to problems controlling his symptoms with various creams and a round of steroids he underwent a civilian dermatology evaluation in Jun 2004. He had skin testing for trees, grasses, molds, and animals. Testing noted strong positives to the majority of trees, grasses and weeds, with neg results to molds and animals. He was assessed as having a chronic urticarial/vesicular dermatitis of undetermined etiology, and an autoimmune process was ruled out. He continued to have reoccurrences of rash without relief from antihistamines and topical steroids. In Jan 07 he was evaluated by a military dermatologist and underwent a skin biopsy which revealed spongiotic dermatitis with focal overlying parakeratosis. He was assessed and treated for atopic eczematous dermatitis. Despite treatment with creams and moisturizers, he continues to have problems with his skin.
Age: 21.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Skin disorder, Skin lesion, Skin oedema, Skin test positive, Urticaria chronic
Clinical narrative: A review of the medical records and interview noted that pt received AVA # 1 in Nov 2000 and # 2 and # 3 during deployment in Jan 2001. He reported that it was shortly after AVA # 3 the he began to notice small patches of pruritic blisters that started on his hands, then on other areas of his body to include arms, feet and thighs. He denied any prior hx of skin issues. The lesion would appear intermittently, last a couple of wks and then resolve. He reported that they do not always reoccur in the same places and has no known precipitated factors. He has multiple visits to include an allergy consult in Aug 2001 and was assessed as having a contact dermatitis. Due to problems controlling his symptoms with various creams and a round of steroids he underwent a civilian dermatology evaluation in Jun 2004. He had skin testing for trees, grasses, molds, and animals. Testing noted strong positives to the majority of trees, grasses and weeds, with neg results to molds and animals. He was assessed as having a chronic urticarial/vesicular dermatitis of undetermined etiology, and an autoimmune process was ruled out. He continued to have reoccurrences of rash without relief from antihistamines and topical steroids. In Jan 07 he was evaluated by a military dermatologist and underwent a skin biopsy which revealed spongiotic dermatitis with focal overlying parakeratosis. He was assessed and treated for atopic eczematous dermatitis. Despite treatment with creams and moisturizers, he continues to have problems with his skin.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a father regarding his 13 year old daughter who on an unspecified date was vaccinated with a first dose of GARDASIL (dose, route and lot # not reported). The patient's father stated that his daughter had a seizure in the car that lasted for seven or eight seconds. There was no treatment given for the events. There were no laboratories performed. The patient did no seek medical attention. At the time of the report, the patient's outcome was unknown. Upon internal review, seizure was considered to be an other important medical event. No further information is available.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Blood HIV RNA, Blood heavy metal normal, Blood test normal, Borrelia test negative
Clinical narrative: Information has been received from a physician concerning a 19 year old male patient with no pertinent medical history and no drug reactions or allergies who on 13-JUN-2011 was vaccinated IM with the first dose of GARDASIL (lot number: 668554/0306AA, expiration date: 10-MAY-2013). There was no concomitant medication. The patient had been suffering some unusual events since having his first dose of GARDASIL immunization. It was reported that on 25-JUL-2011, the patient began experienced headaches, nausea, muscle aches and body aches. The patient was a competitive golfer and an athlete. Since 25-JUL-2011, the patient had had to drop out of some tournaments and had times even had trouble walking because of the pain. In approximately July of 2011, numerous tests had been done including blood test for "every organism imaginable" including syphilis, HIV, HFV, Lymes disease and various other organism. He had been tested for heavy metal poisoning. All blood test were normal. The patient had a spinal tap on 05-AUG-2011 and his CFS was normal. The patient spent one night in the hospital for this procedure. He had also had an MRI which was normal. At this time the diagnosis was fibromyalgia. The patient was being treated with doxycycline and gabapentin. The patient sought medical attention by an office visit. Therapy with GARDASIL was discontinued and no reintroduced. Fibromyalgia and trouble walking because of the pain were considered to be disabling by the physician. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: CSF test normal, Fibromyalgia, Gait disturbance, HIV test negative, Headache
Clinical narrative: Information has been received from a physician concerning a 19 year old male patient with no pertinent medical history and no drug reactions or allergies who on 13-JUN-2011 was vaccinated IM with the first dose of GARDASIL (lot number: 668554/0306AA, expiration date: 10-MAY-2013). There was no concomitant medication. The patient had been suffering some unusual events since having his first dose of GARDASIL immunization. It was reported that on 25-JUL-2011, the patient began experienced headaches, nausea, muscle aches and body aches. The patient was a competitive golfer and an athlete. Since 25-JUL-2011, the patient had had to drop out of some tournaments and had times even had trouble walking because of the pain. In approximately July of 2011, numerous tests had been done including blood test for "every organism imaginable" including syphilis, HIV, HFV, Lymes disease and various other organism. He had been tested for heavy metal poisoning. All blood test were normal. The patient had a spinal tap on 05-AUG-2011 and his CFS was normal. The patient spent one night in the hospital for this procedure. He had also had an MRI which was normal. At this time the diagnosis was fibromyalgia. The patient was being treated with doxycycline and gabapentin. The patient sought medical attention by an office visit. Therapy with GARDASIL was discontinued and no reintroduced. Fibromyalgia and trouble walking because of the pain were considered to be disabling by the physician. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Human papilloma virus test negative, Lumbar puncture normal, Myalgia, Nausea, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a physician concerning a 19 year old male patient with no pertinent medical history and no drug reactions or allergies who on 13-JUN-2011 was vaccinated IM with the first dose of GARDASIL (lot number: 668554/0306AA, expiration date: 10-MAY-2013). There was no concomitant medication. The patient had been suffering some unusual events since having his first dose of GARDASIL immunization. It was reported that on 25-JUL-2011, the patient began experienced headaches, nausea, muscle aches and body aches. The patient was a competitive golfer and an athlete. Since 25-JUL-2011, the patient had had to drop out of some tournaments and had times even had trouble walking because of the pain. In approximately July of 2011, numerous tests had been done including blood test for "every organism imaginable" including syphilis, HIV, HFV, Lymes disease and various other organism. He had been tested for heavy metal poisoning. All blood test were normal. The patient had a spinal tap on 05-AUG-2011 and his CFS was normal. The patient spent one night in the hospital for this procedure. He had also had an MRI which was normal. At this time the diagnosis was fibromyalgia. The patient was being treated with doxycycline and gabapentin. The patient sought medical attention by an office visit. Therapy with GARDASIL was discontinued and no reintroduced. Fibromyalgia and trouble walking because of the pain were considered to be disabling by the physician. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Pain, Treponema test negative
Clinical narrative: Information has been received from a physician concerning a 19 year old male patient with no pertinent medical history and no drug reactions or allergies who on 13-JUN-2011 was vaccinated IM with the first dose of GARDASIL (lot number: 668554/0306AA, expiration date: 10-MAY-2013). There was no concomitant medication. The patient had been suffering some unusual events since having his first dose of GARDASIL immunization. It was reported that on 25-JUL-2011, the patient began experienced headaches, nausea, muscle aches and body aches. The patient was a competitive golfer and an athlete. Since 25-JUL-2011, the patient had had to drop out of some tournaments and had times even had trouble walking because of the pain. In approximately July of 2011, numerous tests had been done including blood test for "every organism imaginable" including syphilis, HIV, HFV, Lymes disease and various other organism. He had been tested for heavy metal poisoning. All blood test were normal. The patient had a spinal tap on 05-AUG-2011 and his CFS was normal. The patient spent one night in the hospital for this procedure. He had also had an MRI which was normal. At this time the diagnosis was fibromyalgia. The patient was being treated with doxycycline and gabapentin. The patient sought medical attention by an office visit. Therapy with GARDASIL was discontinued and no reintroduced. Fibromyalgia and trouble walking because of the pain were considered to be disabling by the physician. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Contusion, Erythema, Local swelling, Pruritus
Clinical narrative: Received flu shot in my (L) arm. Toward back of arm. Later that afternoon noticed a bruise and redness and swelling about 3 inches down my arm and 2 inches wide. Went to the Drs. about my arm on 10/11/11. Dr. told me to put cortisone cream on the site for itching, take some BENADRYL and use a warm soak. That night put warm corn bag on my arm the pocket went down by the next morning redness went away a couple of days later.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Fatigue, Nervousness, Sensation of heaviness, Skin warm
Clinical narrative: Swelling and redness to left shoulder. Feeling tired and nervous, arms felt heavy and warm.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Swelling
Clinical narrative: Swelling and redness to left shoulder. Feeling tired and nervous, arms felt heavy and warm.
Age: 26.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL, TYP
Symptoms: Anxiety, Erythema, Eschar, Headache, Injection site pain
Clinical narrative: Patient concerned about enlarged lymph nodes, headache, tenderness & itching of the site as well as worry over appearance of the site. Erythema measured 3 cm x 3 cm  & eschar 1.5 cm x 0.75 cm. Tender surrounding deltoid without drainage building or streaking.
Age: 26.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL, TYP
Symptoms: Injection site pruritus, Lymphadenopathy
Clinical narrative: Patient concerned about enlarged lymph nodes, headache, tenderness & itching of the site as well as worry over appearance of the site. Erythema measured 3 cm x 3 cm  & eschar 1.5 cm x 0.75 cm. Tender surrounding deltoid without drainage building or streaking.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC13, RV5
Symptoms: Cyanosis, Respiratory distress, Sleep apnoea syndrome, Vaccine positive rechallenge
Clinical narrative: This is a spontaneous report from a contactable office manager. This reporter reported similar events in the same patient after the first dose of PREVNAR 13. This is the second of two reports. A 4-month-old male patient received the second dose of PREVNAR 13 on 12SEP2011. Additional suspect vaccines administered on 12Sep2011 included a dose of HEPATITIS B VACCINE, a dose of ROTATEQ and a dose of PENTACEL. Past vaccine history included the first dose of PREVNAR 13 administered on 11Jul2011 (at the age of 2 months) with similar events of respiratory distress, sleep apnea and cyanosis. Relevant medical history included premature, born at 27 weeks. Concomitant medication was not provided. On 12Sep2011 the patient experienced the same reactions as after the first dose: respiratory distress and apnea that was responsive to stimulation and was significant enough to turn the patient blue. The outcome of the events was unknown. The patient was referred to pulmonary for urgent appointment and further appointments will be considered. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13.
Age: 0.2
Sex: M
Vaccine: PNC13
Symptoms: Cyanosis, Respiratory disorder, Sleep apnoea syndrome
Clinical narrative: This is a spontaneous report from a contactable office manager. This reporter reported similar events in the same patient after the second dose of PREVNAR 13. This is the first of two reports. A 2-month-old male patient received the first dose of PREVNAR 13 during his 2 month check up in the hospital on 11Jul2011. Relevant medical history included premature, born at 27 weeks. Concomitant medications were not reported. On an unspecified date after receiving the vaccine, the patient experienced severe respiratory problems, sleep apnea and then he turned blue. The outcome of the event was unknown. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Hypoaesthesia, Vertigo
Clinical narrative: Dizziness with room spinning, facial numbness from cheekbones to top of head, head pressure in middle of head.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Extreme fatigue, generalized pain, feverish without fever and chills that lasted about 24 hours. Has not occurred previously, but pt received co-administered pneumococcal + influenza while on Hep C treatment.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Oral herpes, Paraesthesia oral, Pyrexia
Clinical narrative: Within 24 hours pt developed lip tingling and within 72 hours developed multiple herpes lesions on lips. No sore throat. Low-grade fever, no other symptoms. Lesions resolved in 7-10 days. 1 year earlier 924 Sept 2009), pt developed nausea, vomiting and diarrhea within 24 hours of vaccination. Low-grade fever, no respiratory symptoms. No sore throat. Did require ED visit. Lasted 3-5 days.
Age: 62.0
Sex: F
Vaccine: HEP, MMR, TD, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Pt c/o fever and body aches, pt taking Tylenol/Ibuprofen. Redness, swelling and tenderness to injection site.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Eye pain, Malaise
Clinical narrative: Uncontrolled chills x 3 hrs even after acetaminophen. Body joint pain, eye pain and general malaise x 18 hrs.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Pt stated injection painful and soreness right after vaccine was given. Arm joint/soreness started the same evening especially when pt moved arm up and certain ways. Mobility limited. Stated may have flared up bursitis? Pain and soreness has been consistent to this day. Advised pt to contact their physican.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Paraesthesia, Sensation of heaviness, Swelling
Clinical narrative: Am of 10/15/11 emp felt nauseous Rt. leg with tingling and prickling along with rt. arm. Feel swollen. On 10/17/111 attempted to walk stairs at work and legs buckled and felt heavy.
Age: 44.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Chills, Headache, Pain
Clinical narrative: Severe, debilitating whole body aches, uncontrollable chills, headache....chills and headache lasted for 7 hours, body aches lasted 20 hours but became less severe with time.....took Tylenol every 4 hours.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Dyspnoea, Injection site pain, Pain
Clinical narrative: General aching, rib pain. Referred to her Dr. for follow up. Then 10/14/11 called in to complain of worsening symptoms of back ache, can't breathe, gasping for air at times. L arm hurting where the flu shot was given. Referred to her physician again to follow up.
Age: 40.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: At first just mild but by 09/23/2011 I could not lift my arm lateral of my body. Pain level was 9. I contacted pharmacy and 13 days later I went to doctor and received a cortisone shot. Pain level went down to 2 within 6 hours. I still feel pain in arm. Level 2 to 3 all the time.
Age: 40.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Ligament pain, Mobility decreased, Neuralgia, Pain in extremity, Tendon pain
Clinical narrative: At first just mild but by 09/23/2011 I could not lift my arm lateral of my body. Pain level was 9. I contacted pharmacy and 13 days later I went to doctor and received a cortisone shot. Pain level went down to 2 within 6 hours. I still feel pain in arm. Level 2 to 3 all the time.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Oedema peripheral, Pain
Clinical narrative: Swelling of arm, throbbing pain, can not move arm even 4 days later, after shot.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 05 October 2011 from the investigator under the reference number M5A16. A case of pertussis disease in a four-year-old female subject was identified by the investigator based on review of data from the surveillance system database. The subject's vaccine history included 4 doses of DAPTACEL; lot number C2657AA received on 04 September 2007 and 29 October 2007, lot number C2607AA received on 03 January 2008, and lot number C2956AA received on 29 December 2008 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 24 August 2011, approximately 31 months after the last dose. On 12 September 2011, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 12 September 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 12 September 2011 for five days. The subject was not hospitalized. At the time of final contact on 15 September 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 23 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Document held by sender: None.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 05 October 2011 from the investigator under the reference number M5A16. A case of pertussis disease in a four-year-old female subject was identified by the investigator based on review of data from the surveillance system database. The subject's vaccine history included 4 doses of DAPTACEL; lot number C2657AA received on 04 September 2007 and 29 October 2007, lot number C2607AA received on 03 January 2008, and lot number C2956AA received on 29 December 2008 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 24 August 2011, approximately 31 months after the last dose. On 12 September 2011, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 12 September 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 12 September 2011 for five days. The subject was not hospitalized. At the time of final contact on 15 September 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 23 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Document held by sender: None.
Age: 0.52
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC
Symptoms: Chills, Dyskinesia, Myoclonus, Tremor
Clinical narrative: Initial report was received from a health care professional on 05 October 2011. A six month-old female patient had received the following vaccines on 27 September 2011 an intramuscular left thigh injection of PENTACEL, lot number C3951AA; an intramuscular left thigh injection of FLUZONE, lot number UT4119AA and a right thigh injection of PREVNAR, lot number F13779 (route of administration not reported). On 29 September 2011, the patient experienced shaking, shivering, monoclonic jerks of extremities and head jerking. The symptoms lasted for "moments" at a time and reoccurred through the day over a 12 hour period and then resolved. The patient was afebrile and not fussy. No further information was available at the time of the report. The outcome was reported as recovered. Documents held by sender: none.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chest pain, Limb discomfort, Muscle twitching, Musculoskeletal pain
Clinical narrative: C/o left arm discomfort & weakness with pain in the (L) scapula & chest. Also c/o twitching to left side of race. To see PCP.
Age: 28.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Redness and warm to the touch since 10/15/11. Staying the same reaction.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dizziness, Pyrexia
Clinical narrative: Light headed, weak, chills, temp 101, soreness in arm, took ADVIL to eliminate fever 200 mg. Went away as quickly as it came on, gone by afternoon. Now she is doing well.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Confusional state, Dizziness, Feeling cold, Mental disorder, Ocular hyperaemia
Clinical narrative: Approximately 30 minutes after receiving vaccine patient's eyes became red (appeared as if she had been crying). She complained of being dizzy and cold. No trouble breathing. Referred to instore clinic - vitals: BP: 98/60, HR: 55, regular, O2 sat 96% on room air, BS. 103 clear breath sounds. Increasing confusion paramedics arrived due to acutely altered mental state given BENADRYL at hospital.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Approximately 30 minutes after receiving vaccine patient's eyes became red (appeared as if she had been crying). She complained of being dizzy and cold. No trouble breathing. Referred to instore clinic - vitals: BP: 98/60, HR: 55, regular, O2 sat 96% on room air, BS. 103 clear breath sounds. Increasing confusion paramedics arrived due to acutely altered mental state given BENADRYL at hospital.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Erythema, Immediate post-injection reaction, Respiratory distress
Clinical narrative: Immediate reaction after flu vaccination 2 cm round area of erythema. Tx with BENADRYL 50 mg PO & ice 1 hour later c/o chest tightness & resp distress neb with XOPONEX 0.63 mg kept for 6 hour of observation. All sx resolved.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Patient reports severe swelling, redness and pain (one day after administration of flu and pneumo) in left upper arm. Left deltoid was injection site of pneumo and flu. Pt c/o itching day 3. Tx: ice/MOTRIN.
Age: 1.01
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Rash all over, low grade fever, started same day vaccine given, no treatment.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Rash erythematous
Clinical narrative: After receiving injection of preservative free single dose Inactivated Influenza vaccine the patient experienced onset of flushing, erythema rash, ? hives on face & upper chest. Symptoms onset approx 10 minutes after vaccination.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Syncope
Clinical narrative: Pt states that she received the high dose FLUZONE vaccine on 9/22 around noon. At 2AM on 9/23, pt states she woke to profuse sweating and then fainted. Pt states she had no further problems and has recovered fully.
Age: 1.26
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Computerised tomogram normal, Condition aggravated, Convulsion, Cystogram, Electroencephalogram normal
Clinical narrative: 45 min seizure, discharged on KEPPRA.
Age: 1.26
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Laboratory test normal, Ultrasound kidney normal
Clinical narrative: 45 min seizure, discharged on KEPPRA.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Pt. complains of soreness, redness and "hives-like" bumps around injection site, (L) arm, since yesterday (9/27/11). Pt. received injection on 9/26/11. Pt. advised to contact primary care provider.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus generalised
Clinical narrative: Felt overall itching sensation (pruritus) but no rash evident.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site erythema, Pruritus
Clinical narrative: Pt. (L) arm above elbow with 7cm x 7cm redness patchy, not raised. No pain. Minimal bruising, minimal itch. No swelling, no fever, no chills.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Angioedema, Eye discharge, Eye pruritus, Lacrimation increased, Pharyngeal oedema
Clinical narrative: Runny and itchy eyes which progressed to palm and sole itching, an urticarial rash, eyelid angioedema and subjective swelling in the back of her throat.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Skin test, Skin test negative, Urticaria
Clinical narrative: Runny and itchy eyes which progressed to palm and sole itching, an urticarial rash, eyelid angioedema and subjective swelling in the back of her throat.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Condition aggravated, Encephalomyelitis, Meningeal disorder, Musculoskeletal stiffness
Clinical narrative: Neurological Lyme symptoms returned with a vengeance. Encephalomyelitis; extremely stiff, painful neck; Bilateral facial palsy; Meningial burning and pain; vasculitis in brain worsened; blurry vision returned.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Neurological symptom, Pain, VIIth nerve paralysis, Vasculitis cerebral
Clinical narrative: Neurological Lyme symptoms returned with a vengeance. Encephalomyelitis; extremely stiff, painful neck; Bilateral facial palsy; Meningial burning and pain; vasculitis in brain worsened; blurry vision returned.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Neurological Lyme symptoms returned with a vengeance. Encephalomyelitis; extremely stiff, painful neck; Bilateral facial palsy; Meningial burning and pain; vasculitis in brain worsened; blurry vision returned.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Fatigue, Hypersomnia, Mobility decreased
Clinical narrative: Extreme fatigue - unable to function at all on 10/8/11. Still extreme fatigue on 10/9/11; however could function somewhat. Went to work on 10/10/11; however was extremely tired. Much better on 10/11/11. 10/8 and 10/9 - slept most of the time.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Nerve compression, Oedema peripheral, Pain in extremity, Paraesthesia
Clinical narrative: Tdap vaccine administered on 10-5-11. Patient began to experience swelling that evening. When clinic contacted on 10-7-11, patient experiencing soreness/severe swelling encompassing entire forearm. Also tingling in fingers due to compression of nerves, pt advised MOTRIN (2) 4x's a day for next several days.
Age: 48.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Injection site erythema, Nodule
Clinical narrative: Slight redness on injection site. Approx dime size nodule.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Back pain, Full blood count normal, Injection site pain, Laboratory test normal, Pain in extremity
Clinical narrative: High fever 101.8-102. Soreness at vaccine site. Achy pain in arms & back.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia, Streptococcus test negative
Clinical narrative: High fever 101.8-102. Soreness at vaccine site. Achy pain in arms & back.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Headache, Pain, Pain in extremity, Paraesthesia
Clinical narrative: 9/25 - h/a,  9/27 - fever to 101 degrees, 9/28 - tingling/pain of hands/torso; morbilliform rash; 10/3 - vesicles on lower lip.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash morbilliform, White blood cell count decreased
Clinical narrative: 9/25 - h/a,  9/27 - fever to 101 degrees, 9/28 - tingling/pain of hands/torso; morbilliform rash; 10/3 - vesicles on lower lip.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma, Injection site pain, Injection site reaction, Injection site swelling, Livedo reticularis
Clinical narrative: 10/7/11 1345 employee c/o left deltoid swelling, mottled & tenderness. States it "appears bruised". Advised she ice area & take ibuprofen prn & return to Occ Med clinic Monday 10/10/11 appears IM given in mid-deltoid area.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injection site swelling, Injection site warmth, Tenderness
Clinical narrative: TIV given 10-6-11 in Rt. deltoid IM around 0900AM. By afternoon, employee c/o tenderness. Next day 10/7 1350, site was examined. IM appeared to be given toward posterior side of deltoid area, warm & swollen. Appears to be improper site.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Arthralgia, Asthenia, Chills, Feeling abnormal
Clinical narrative: 5 hrs later had chills, shaking, could not walk, pain in left leg severe, pains in joints fever 101 degrees, weak, not able to walk. Wanted to go to hospital felt so bad. Vomited, headache, next day and slept all day. We didn't know it after shot that got for over 65 yrs old. Monday rec'd it, Wednesday felt better.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Hypersomnia, Pain in extremity, Pyrexia, Tremor
Clinical narrative: 5 hrs later had chills, shaking, could not walk, pain in left leg severe, pains in joints fever 101 degrees, weak, not able to walk. Wanted to go to hospital felt so bad. Vomited, headache, next day and slept all day. We didn't know it after shot that got for over 65 yrs old. Monday rec'd it, Wednesday felt better.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: 5 hrs later had chills, shaking, could not walk, pain in left leg severe, pains in joints fever 101 degrees, weak, not able to walk. Wanted to go to hospital felt so bad. Vomited, headache, next day and slept all day. We didn't know it after shot that got for over 65 yrs old. Monday rec'd it, Wednesday felt better.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Hives arms & face. Tx = BENADRYL 25mg Q6h prn.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, TDAP, VARCEL
Symptoms: Asthenia, Chest pain
Clinical narrative: Patient's mother called within 15 min of departure stating child c/o sudden onset of chest pain describe as sharp in character. Denies SOB. Mother states child "looks weak". Advised to report to E.R. immediately.
Age: 11.0
Sex: M
Vaccine: FLU3, HEPA, HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria, itching, diffuse, treated with BENADRYL by mother. Symptoms lasted approximately 5 hours.
Sex: U
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discomfort, Injection site erythema
Clinical narrative: Intermittent redness left deltoid -> elbow. Discomfort at injection site only. Referred by this nurse to PMP f/u telephone call 10/17/11: Redness resolved today, did not see PMP/oncologist. Encouraged her to speak with physician prior to next year's flu vaccine season regarding reaction.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Feeling cold, Headache, Hypersomnia
Clinical narrative: My husband got sick at 4 pm and I got sick at 8:30 PM. Had a fever 101 degrees, chills, shaking could not stop & couldn't get warm. Headache, slept all next day, pains in joints, felt better 10/5/11.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pyrexia, Tremor
Clinical narrative: My husband got sick at 4 pm and I got sick at 8:30 PM. Had a fever 101 degrees, chills, shaking could not stop & couldn't get warm. Headache, slept all next day, pains in joints, felt better 10/5/11.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Migraine, Vomiting
Clinical narrative: Migraine type headache, constant (better with Aspirin), loss of appetite, vomiting.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Fatigue
Clinical narrative: Case number PHEH2011US06145 is an initial spontaneous report received from a nurse on 06 Oct 2011. This case refers to a 58-year-old female patient. She was vaccinated with FLUVIRIN vaccine (batch number: 1102001) at a dose of 0.5ml intramuscularly on 30 Sep 2011. On 03 Oct 2011, she began to experience fatigue and difficulty in breathing. Subsequently, she was hospitalized. Final event outcome was not reported.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, HEP
Symptoms: Body temperature increased, Infantile spitting up, Injection site swelling, Retching
Clinical narrative: Pt had low grade temp evening of vaccine (L) leg swelling, dry heaving, spit up, mom gave TYLENOL & used ice packs. Temp was b/w 99.4-100.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, CSF protein increased, Guillain-Barre syndrome, Influenza like illness, Lumbar puncture abnormal
Clinical narrative: 12/10 - approximately 12/20 - Flu-like symptoms. 1/1/11 - Went to walk-in clinic, treated for cold/flu-like symptoms. 1/14-1/18 - Flu-like symptoms were not getting better, pain in back radiating to legs & feet. 1/18-1/23 Pain increasing in back & legs. 1/05 Admitted to Hosp. Diagnosed w/ Guillain-Barre Syn.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Nasopharyngitis, Pain in extremity
Clinical narrative: 12/10 - approximately 12/20 - Flu-like symptoms. 1/1/11 - Went to walk-in clinic, treated for cold/flu-like symptoms. 1/14-1/18 - Flu-like symptoms were not getting better, pain in back radiating to legs & feet. 1/18-1/23 Pain increasing in back & legs. 1/05 Admitted to Hosp. Diagnosed w/ Guillain-Barre Syn.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Headache, Malaise, Oropharyngeal pain
Clinical narrative: Patient went to bed not feeling well. He woke up at midnight with chills, sore throat, headache along with facial swelling.. He also says he was short of breath. Took 2 tablets BENADRYL and fell back to sleep. Woke up at 5 am with facial swelling that has decreased through the morning.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Patient went to bed not feeling well. He woke up at midnight with chills, sore throat, headache along with facial swelling.. He also says he was short of breath. Took 2 tablets BENADRYL and fell back to sleep. Woke up at 5 am with facial swelling that has decreased through the morning.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: Pt received PNEUMOVAX 23 10/13/11. Returned to office 4 days later complaining of pain in the area of injection. No redness, swelling or induration. Hurts mainly in the night and keeps him awake. Pt advised to use warm compresses and use ibuprofen & TYLENOL with codeine as needed for pain.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: (L) deltoid area - warm, tender to touch, red with a blanched ring around injection site, itchy.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pallor
Clinical narrative: (L) deltoid area - warm, tender to touch, red with a blanched ring around injection site, itchy.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Neck pain
Clinical narrative: Red & hard & hot to the touch. Pain on site (on right deltoid) up to (Rt) side of neck. Fever.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Red & hard & hot to the touch. Pain on site (on right deltoid) up to (Rt) side of neck. Fever.
Age: 0.47
Sex: F
Vaccine: RV5
Symptoms: Cold sweat, Lethargy, Vomiting
Clinical narrative: Day after vaccine given, pt had 5 episodes of vomiting. Mom reported she felt cold, clammy and somewhat lethargic.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient called to report right arm pain after injection & continuing for last 2 weeks. Pain comes & goes.
Age: 75.0
Sex: M
Vaccine: FLUX
Symptoms: Decreased appetite, Dizziness, Fatigue, Laceration, Pain
Clinical narrative: He got the senior flu shot 9/22/11, had general aches, fever about 3 hrs later. Next am - still felt tired, poor appetite, felt dizzy after reaching up to get something out of cupboard before eating, had syncope. On only OTC vitamins, etc. Minor cut to head.
Age: 75.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia, Syncope
Clinical narrative: He got the senior flu shot 9/22/11, had general aches, fever about 3 hrs later. Next am - still felt tired, poor appetite, felt dizzy after reaching up to get something out of cupboard before eating, had syncope. On only OTC vitamins, etc. Minor cut to head.
Age: 71.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthma, Cough, Feeling abnormal, Headache, Musculoskeletal chest pain
Clinical narrative: On Monday Sept. 19 I had my annual flu shot, and the "mild problems" - aches, headache, fever, and a dry wheezing cough - that "usually" last two days continued beyond that point. By the fourth day the aches and headaches were gone but the fever and cough continued. The cough is best described as a dry wheezing asthmatic cough that came in uncontrollable bursts. I have never had asthma. I have had bronchitis and pneumonia but never a dry wheezing cough like this unaccompanied by any congestion in my chest. The coughing left my ribs sore and with a feeling that my brain had been rattling against my skull. The fever was in the 101 to 103 degree range and like the cough persisted without abatement for 10 days. I managed the fever with ADVIL. On th 11th day I went to the doctor who confirmed that I did not have bronchitis or pneumonia but was unable to identify the cause of the persistent cough and fever. I was prescribed a 5-day course of antibiotics and a cough suppressant. By the fourth day the fever ended. The cough has gradually gotten better, but as of today, October 13, still persists in a mild form.
Age: 71.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain, Pyrexia, Wheezing
Clinical narrative: On Monday Sept. 19 I had my annual flu shot, and the "mild problems" - aches, headache, fever, and a dry wheezing cough - that "usually" last two days continued beyond that point. By the fourth day the aches and headaches were gone but the fever and cough continued. The cough is best described as a dry wheezing asthmatic cough that came in uncontrollable bursts. I have never had asthma. I have had bronchitis and pneumonia but never a dry wheezing cough like this unaccompanied by any congestion in my chest. The coughing left my ribs sore and with a feeling that my brain had been rattling against my skull. The fever was in the 101 to 103 degree range and like the cough persisted without abatement for 10 days. I managed the fever with ADVIL. On th 11th day I went to the doctor who confirmed that I did not have bronchitis or pneumonia but was unable to identify the cause of the persistent cough and fever. I was prescribed a 5-day course of antibiotics and a cough suppressant. By the fourth day the fever ended. The cough has gradually gotten better, but as of today, October 13, still persists in a mild form.
Age: 71.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Cough, Head discomfort, Headache, Musculoskeletal chest pain, Pain
Clinical narrative: On Monday Sept. 19 I had my annual flu shot, and the "mild problems" - aches, headache, fever, and a dry wheezing cough - that "usually" last two days continued beyond that point. By the fourth day the aches and headaches were gone but the fever and cough continued. The cough is best described as a dry wheezing asthmatic cough that came in uncontrollable bursts. I have never had asthma. I have had bronchitis and pneumonia but never a dry wheezing cough like this unaccompanied by any congestion in my chest. The coughing left my ribs sore and with a feeling that my brain had been rattling against my skull. The fever was in the 101 to 103 degree range and like the cough persisted without abatement for 10 days. I managed the fever with ADVIL. On th 11th day I went to the doctor who confirmed that I did not have bronchitis or pneumonia but was unable to identify the cause of the persistent cough and fever. I was prescribed a 5-day course of antibiotics and a cough suppressant. By the fourth day the fever ended. The cough has gradually gotten better, but as of today, October 13, still persists in a mild form.