chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Mother reported today at another child's office visit that pt experienced swelling and a hard lump, tender to touch, redness, & heat to touch at injection site and painful walking x 3 days after immunization. Ibuprofen and cold packs & rest treated symptoms.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site warmth, Pain
Clinical narrative: Mother reported today at another child's office visit that pt experienced swelling and a hard lump, tender to touch, redness, & heat to touch at injection site and painful walking x 3 days after immunization. Ibuprofen and cold packs & rest treated symptoms.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Arthropathy, Asthenia, Immediate post-injection reaction, Lymphadenopathy, Oedema peripheral
Clinical narrative: Immediately following the vaccine he had severe arm swelling x 3 days, which resolved and was followed by reactive lymph nodes in the axilla x 3 days. This was followed by weakness and buckling of the knees (bilaterally). This is improving but it fluctuates up and down. No numbness, tingling, or incontinence. No treatment given.
Age: 27.0
Sex: M
Vaccine: HEPA, IPV, TYP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR
Symptoms: Injection site erythema
Clinical narrative: 3 cc red area on left deltoid.
Age: 5.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site red, swollen, painful to touch, itchy, hot to touch. Prescribed cephalexin 250 mg - 1 tsp BID.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt received ZOSTAVAX on Tues, 5/3/11. He noticed a shingles-like rash on his (L) butt cheek on Fri, 5/6/11. On Mon 5/9/11 he saw his Dr. who diagnosed the rash as shingles & gave him an rx for 7-day course of valacyclovir.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness & swelling 3in around injection site.
Age: 0.91
Sex: M
Vaccine: PNC13
Symptoms: Diarrhoea, Pyrexia, Rash
Clinical narrative: Rash, diarrhea, fever.
Age: 4.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Vaccine error, the patient was given a Tdap instead of the Dtap that was due & ordered. CDC states because it is 5th dose it counts and no other action is needed.
Age: 49.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Diplopia, Fatigue, Hypoaesthesia, Nervous system disorder
Clinical narrative: Case number PHHY2011US40066 is a combined initial and follow-up spontaneous report received from a consumer (patient) respectively on 10 May 2011 and 11 May 2011. This report concerns a 50 old male patient. He had a medical history of arthritis and had no vaccination history with INFLUENZA vaccine. He was vaccinated with S-OIV FLUVIRIN (batch number: unknown) intramuscularly on 02 Jan 2010. Two weeks after vaccination the patient presented with lot of fatigue and weakness ("had no energy"). He also had numbness ("very little feeling") in his hands and feet, double vision which all seemed like a neurological problem. However, a final diagnosis was not made. He was treated with medications (unspecified names) which did not help. The outcome was not reported. The events were reported as severe.
Sex: M
Vaccine: FLU3
Symptoms: Biopsy skin abnormal, Erythema multiforme, Generalised erythema, Pruritus generalised, Pyrexia
Clinical narrative: Case number PHHY2011AR39627 is an initial spontaneous report received from a physician on 10 May 2011. This report concerns a male patient with unknown medical history. He was vaccinated with FLUVIRIN 2010/2011 (batch number: unknown) five days prior to the report (exact date not reported). The patient presented with 24 hours of fever and generalized pruritic erythematous reaction on unspecified date. A skin biopsy performed revealed erythema polymorphe. The outcome, seriousness and causality were not reported for the event erythema polymorphe.
Age: 77.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Diagnosed with Guillain-Barré syndrome 11 days after administration of flu vaccine in Oct 2009. Was in rehab facility for approximately 3 months.  Further details unavailable to this writer.
Age: 1.03
Sex: M
Vaccine: DTAP, HEP, MMR
Symptoms: Lethargy, Pyrexia, Reaction to previous exposure to any vaccine, Vomiting
Clinical narrative: High fever, vomiting, lethargic. Going on 12 days. Last shot round it lasted a month.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Heart rate increased, Injection site mass, Injection site rash, Injection site swelling
Clinical narrative: Elevated heart rate for 2-3 hours 6:00 PM day of injection. Swelling, lump and rash at injection site from 5/12/2011 for 5 days. 95% cleared up by 5/21/2011. Mild to moderate Joint pain increase to present.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: Elevated heart rate for 2-3 hours 6:00 PM day of injection. Swelling, lump and rash at injection site from 5/12/2011 for 5 days. 95% cleared up by 5/21/2011. Mild to moderate Joint pain increase to present.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Heart rate increased, Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Elevated heart rate for 2-3 hours 6:00 PM day of injection. Swelling, lump and rash at injection site from 5/12/2011 for 5 days. 95% cleared up by 5/21/2011. Mild to moderate Joint pain increase to present.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin swelling, Skin warm
Clinical narrative: Patient called me (the pharmacist) Sat 10 am (about 24 hours post injection) complaining of skin that was hot to the touch, swollen and the swelling was continuing to spread.  She was concerned.  She has a history of one bad reaction to tetanus vaccine that required medical care several years ago, she mentioned the same really big swelling during our consult on Friday.  On Friday we discussed her history and since it was a different vaccine and she had no problems with influenza or Pneumovax, she elected to get the Zostavax.  I suggested she circle the current swelling zone in permanent marker and then find a ride to urgent care to get checked out.  As of right now, no shortness of breath reported.
Age: 24.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Arthralgia, Chills, Fatigue, Incontinence, Pyrexia
Clinical narrative: Woke up with high fever, extreme joint pain, incontinence, body chills, extreme exhaustion.  After finally figuring out she was given pertussis, she hadn't been told that was in the vaccine, we called the Dr. who checked her vitals and recommended rest and the use of an allergy medicine.
Age: 24.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Asthenia, Emotional disorder, Myalgia, Restlessness, Urinary incontinence
Clinical narrative: Woke up with high fever, extreme joint pain, incontinence, body chills, extreme exhaustion.  After finally figuring out she was given pertussis, she hadn't been told that was in the vaccine, we called the Dr. who checked her vitals and recommended rest and the use of an allergy medicine.
Age: 0.11
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Apnoea, Apparent life threatening event, Gaze palsy, Resuscitation, Tardive dyskinesia
Clinical narrative: H/O ALTE with apnea, both eyes rolled back & lip smacking (possible seizure). Required CPR x 2. Exam are benign. Admitted for investigation.
Age: 1.3
Sex: F
Vaccine: DTP, HIBV, VARCEL
Symptoms: Blood immunoglobulin G, Contusion, Full blood count, Idiopathic thrombocytopenic purpura, Platelet count decreased
Clinical narrative: ITP within 2 wks of vaccines. She started to display bruising and it increased. Was taken to ER and dx ITP. Was prev. vaccinated with DPT/HIB - new vaccine - Varicella.
Age: 1.3
Sex: F
Vaccine: DTP, HIBV, VARCEL
Symptoms: X-ray
Clinical narrative: ITP within 2 wks of vaccines. She started to display bruising and it increased. Was taken to ER and dx ITP. Was prev. vaccinated with DPT/HIB - new vaccine - Varicella.
Age: 55.0
Sex: F
Vaccine: DT, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Pt received Tetanus & ZOSTAVAX on 5/16. Noticed pain & erythema 2 days later at site of ZOSTAVAX & warmth & itching. Erythema spreading. No fever. Dx cellulitis. Area marked. Given KEFLEX 500mg BID x 7 days. CLARITIN or BENADRYL for itching. F/U in 4 days. Sooner if worsening.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Pt received vaccine 5/17/11 - developed cellulitis 5/21/11 at site of injection & further down arm. Received ROCEPHIN & AUGMENTIN to treat in ED.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Hypoaesthesia, Injection site pain, Paraesthesia, Sensation of pressure
Clinical narrative: Bad headache and pressure in back of neck, along with extreme soreness at injection site and numbness/tingling to fingers on same side.
Age: 1.2
Sex: M
Vaccine: MMR
Symptoms: Auricular swelling, Pyrexia, Rash
Clinical narrative: fever, rash, then swelling in front of right ear
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Myalgia, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Report received from a pharmacist on 20-SEP-2010 (received via Merck WAES: 1009USA04047). An 82 year old female patient received one dose of AFLURIA (batch number: M50907, expiry date: 30-JUN-2011, route of administration: not specified) in the left arm on 17-SEP-2010. The patient has a medical history of diabetes. Concomitant medications included ZETIA, AMARYL, NORVASC, CALTRATE 600mg Plus Vitamin D, baby aspirin, vitamin D, magnesium, vitamin B-12, fiber tablets and BYETTA. Dose/ route of administration and indications of concomitant medication not specified. On 17-SEP-2010, the day of vaccination with the suspect drug AFLURIA, the patient developed a fever of 102.5F, swelling of left arm, soreness, muscle aches, flu-like symptoms and kept sleeping. The patient sought medical attention. The patient's outcome was recovered on 19-SEP-2010. The case was reported as non-serious. The reporter did not provide a causality assessment in relation to the suspect drug, AFLURIA. The company considered events possible in relation to the suspect drug, AFLURIA. Follow up provided 21-OCT-2010 from a pharmacist. The patient received AFLURIA in the left deltoid on 17-SEP-2010 at approximately 6:50pm. The patient had previously had 1 dose of AFLURIA. The patient recovered from swelling of left arm, soreness, muscle aches, flu-like symptoms on the 18-SEP-2010, approximately 8 hours after the AFLURIA vaccination, and not on the 19-SEP-2010 as first reported. No further information provided. Information derived from this AE report does not change the current safety profile of the product. Follow up received 03-NOV-2010. The adverse event onset was reported as "later that evening". No further information provided. Information derived from this AE report does not change the current safety profile of the product. Follow up received on 28-DEC-2010. The patient stated that she has diabetes, but she did not indicate the type of medications she was taking. The time of event onset was unknown. The patient's temperature was measured via oral route. It was unknown if acetaminophen or other antipyretics were administered, however the patient did not receive any other treatment for the events. The patient did not require consultation with a doctor, review in a hospital emergency department or admission to hospital. The febrile symptoms lasted 2 days. The patient received seasonal influenza vaccine injection in the past and tolerated previous vaccination. The patient had not received any other recent immunisations. It was unknown if the patient received the H1N1 vaccine. Information derived from this AE report does not change the current safety profile of the product.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Report received from a nurse via distributor (Merck Ref: 1010USA01787) on 14-OCT-2010. A 48 year-old female patient received 0.5ml/once AFLURIA (batch: unknown) intramuscularly on 13-OCT-2010. The patient's medical history and concomitant medications were unknown. On 14-OCT-2010, 2 days after AFLURIA was started, the patient developed numbness around her mouth and forehead. The patient sought medical attention. The event outcome was not recovered at the time reporting. No further information was provided. The company considered events possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product.
Age: 33.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Chest pain, Circumoral oedema, Electrocardiogram T wave inversion, Oropharyngeal pain, Pruritus
Clinical narrative: This is filed in follow-up to #414584. The pt is a 33yo who received a SPV (primary) in his left deltoid on 11/3/10 (with a take per pt history). On 11/13/10 the pt developed a maculopapular, pruritic rash on his hands (palms) which was treated with BENADRYL. On 11/14/10 the rash spread to his feet (soles), arms, chest, legs, neck and head. This was associated with a scratchy throat, generalized body aches and weakness. On PE the oral pharynx was erythematous but otherwise normal. The pt was admitted to the ward and IV steroids were started. On 11/16/10 the pt noted chest pressure (4-5/10) and "difficulty breathing" while supine. These symptoms improved when sitting up. The pt was started on ASA and INDOCIN. Cardiac exam was normal. Additionally, by 11/16/10 the rash was improving. The positional chest pressure and SOB were improved the next day and resolved completely by 11/19/10. Following this incident the pt described decreased cardio exercise tolerance ("feeling out of breath after walking normal distances"). He also stated that he had experienced episodes of his "heart racing" while at rest (pulse is greater than 100). Of note the pt stopped taking OTC fish oil, creatine powder and testosterone (Black Forge). The pt was evaluated at the Cardiology Clinic on 4/18/11 (see below for test results). The pt was cleared for full duty without restrictions on 4/25/11. On 4/28/11 the pt stated that his exercise tolerance had returned to baseline and that he had no further episodes of "racing" heart rate.
Age: 33.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Rash, Rash generalised
Clinical narrative: This is filed in follow-up to #414584. The pt is a 33yo who received a SPV (primary) in his left deltoid on 11/3/10 (with a take per pt history). On 11/13/10 the pt developed a maculopapular, pruritic rash on his hands (palms) which was treated with BENADRYL. On 11/14/10 the rash spread to his feet (soles), arms, chest, legs, neck and head. This was associated with a scratchy throat, generalized body aches and weakness. On PE the oral pharynx was erythematous but otherwise normal. The pt was admitted to the ward and IV steroids were started. On 11/16/10 the pt noted chest pressure (4-5/10) and "difficulty breathing" while supine. These symptoms improved when sitting up. The pt was started on ASA and INDOCIN. Cardiac exam was normal. Additionally, by 11/16/10 the rash was improving. The positional chest pressure and SOB were improved the next day and resolved completely by 11/19/10. Following this incident the pt described decreased cardio exercise tolerance ("feeling out of breath after walking normal distances"). He also stated that he had experienced episodes of his "heart racing" while at rest (pulse is greater than 100). Of note the pt stopped taking OTC fish oil, creatine powder and testosterone (Black Forge). The pt was evaluated at the Cardiology Clinic on 4/18/11 (see below for test results). The pt was cleared for full duty without restrictions on 4/25/11. On 4/28/11 the pt stated that his exercise tolerance had returned to baseline and that he had no further episodes of "racing" heart rate.
Age: 33.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Chest pain, Circumoral oedema, Electrocardiogram ST segment normal, Electrocardiogram T wave inversion, Oropharyngeal pain
Clinical narrative: This is filed in follow-up to #414584. The pt is a 33yo who received a SPV (primary) in his left deltoid on 11/3/10 (with a take per pt history). On 11/13/10 the pt developed a maculopapular, pruritic rash on his hands (palms) which was treated with BENADRYL. On 11/14/10 the rash spread to his feet (soles), arms, chest, legs, neck and head. This was associated with a scratchy throat, generalized body aches and weakness. On PE the oral pharynx was erythematous but otherwise normal. The pt was admitted to the ward and IV steroids were started. On 11/16/10 the pt noted chest pressure (4-5/10) and "difficulty breathing" while supine. These symptoms improved when sitting up. The pt was started on ASA and INDOCIN. Cardiac exam was normal. Additionally, by 11/16/10 the rash was improving. The positional chest pressure and SOB were improved the next day and resolved completely by 11/19/10. Following this incident the pt described decreased cardio exercise tolerance ("feeling out of breath after walking normal distances"). He also stated that he had experienced episodes of his "heart racing" while at rest (pulse is greater than 100). Of note the pt stopped taking OTC fish oil, creatine powder and testosterone (Black Forge). The pt was evaluated at the Cardiology Clinic on 4/18/11 (see below for test results). The pt was cleared for full duty without restrictions on 4/25/11. On 4/28/11 the pt stated that his exercise tolerance had returned to baseline and that he had no further episodes of "racing" heart rate.
Age: 33.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Pruritus, Rash, Rash generalised
Clinical narrative: This is filed in follow-up to #414584. The pt is a 33yo who received a SPV (primary) in his left deltoid on 11/3/10 (with a take per pt history). On 11/13/10 the pt developed a maculopapular, pruritic rash on his hands (palms) which was treated with BENADRYL. On 11/14/10 the rash spread to his feet (soles), arms, chest, legs, neck and head. This was associated with a scratchy throat, generalized body aches and weakness. On PE the oral pharynx was erythematous but otherwise normal. The pt was admitted to the ward and IV steroids were started. On 11/16/10 the pt noted chest pressure (4-5/10) and "difficulty breathing" while supine. These symptoms improved when sitting up. The pt was started on ASA and INDOCIN. Cardiac exam was normal. Additionally, by 11/16/10 the rash was improving. The positional chest pressure and SOB were improved the next day and resolved completely by 11/19/10. Following this incident the pt described decreased cardio exercise tolerance ("feeling out of breath after walking normal distances"). He also stated that he had experienced episodes of his "heart racing" while at rest (pulse is greater than 100). Of note the pt stopped taking OTC fish oil, creatine powder and testosterone (Black Forge). The pt was evaluated at the Cardiology Clinic on 4/18/11 (see below for test results). The pt was cleared for full duty without restrictions on 4/25/11. On 4/28/11 the pt stated that his exercise tolerance had returned to baseline and that he had no further episodes of "racing" heart rate.
Age: 33.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Asthenia, Cardiac stress test abnormal, Cardiovascular examination, Chest discomfort, Dyspnoea
Clinical narrative: This is filed in follow-up to #414584. The pt is a 33yo who received a SPV (primary) in his left deltoid on 11/3/10 (with a take per pt history). On 11/13/10 the pt developed a maculopapular, pruritic rash on his hands (palms) which was treated with BENADRYL. On 11/14/10 the rash spread to his feet (soles), arms, chest, legs, neck and head. This was associated with a scratchy throat, generalized body aches and weakness. On PE the oral pharynx was erythematous but otherwise normal. The pt was admitted to the ward and IV steroids were started. On 11/16/10 the pt noted chest pressure (4-5/10) and "difficulty breathing" while supine. These symptoms improved when sitting up. The pt was started on ASA and INDOCIN. Cardiac exam was normal. Additionally, by 11/16/10 the rash was improving. The positional chest pressure and SOB were improved the next day and resolved completely by 11/19/10. Following this incident the pt described decreased cardio exercise tolerance ("feeling out of breath after walking normal distances"). He also stated that he had experienced episodes of his "heart racing" while at rest (pulse is greater than 100). Of note the pt stopped taking OTC fish oil, creatine powder and testosterone (Black Forge). The pt was evaluated at the Cardiology Clinic on 4/18/11 (see below for test results). The pt was cleared for full duty without restrictions on 4/25/11. On 4/28/11 the pt stated that his exercise tolerance had returned to baseline and that he had no further episodes of "racing" heart rate.
Age: 33.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Echocardiogram normal, Ejection fraction normal, Electrocardiogram ST segment normal, Electrocardiogram T wave inversion, Electrocardiogram abnormal
Clinical narrative: This is filed in follow-up to #414584. The pt is a 33yo who received a SPV (primary) in his left deltoid on 11/3/10 (with a take per pt history). On 11/13/10 the pt developed a maculopapular, pruritic rash on his hands (palms) which was treated with BENADRYL. On 11/14/10 the rash spread to his feet (soles), arms, chest, legs, neck and head. This was associated with a scratchy throat, generalized body aches and weakness. On PE the oral pharynx was erythematous but otherwise normal. The pt was admitted to the ward and IV steroids were started. On 11/16/10 the pt noted chest pressure (4-5/10) and "difficulty breathing" while supine. These symptoms improved when sitting up. The pt was started on ASA and INDOCIN. Cardiac exam was normal. Additionally, by 11/16/10 the rash was improving. The positional chest pressure and SOB were improved the next day and resolved completely by 11/19/10. Following this incident the pt described decreased cardio exercise tolerance ("feeling out of breath after walking normal distances"). He also stated that he had experienced episodes of his "heart racing" while at rest (pulse is greater than 100). Of note the pt stopped taking OTC fish oil, creatine powder and testosterone (Black Forge). The pt was evaluated at the Cardiology Clinic on 4/18/11 (see below for test results). The pt was cleared for full duty without restrictions on 4/25/11. On 4/28/11 the pt stated that his exercise tolerance had returned to baseline and that he had no further episodes of "racing" heart rate.
Age: 33.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Exercise tolerance decreased, Pain, Palpitations, Pharyngeal erythema, Radioisotope scan
Clinical narrative: This is filed in follow-up to #414584. The pt is a 33yo who received a SPV (primary) in his left deltoid on 11/3/10 (with a take per pt history). On 11/13/10 the pt developed a maculopapular, pruritic rash on his hands (palms) which was treated with BENADRYL. On 11/14/10 the rash spread to his feet (soles), arms, chest, legs, neck and head. This was associated with a scratchy throat, generalized body aches and weakness. On PE the oral pharynx was erythematous but otherwise normal. The pt was admitted to the ward and IV steroids were started. On 11/16/10 the pt noted chest pressure (4-5/10) and "difficulty breathing" while supine. These symptoms improved when sitting up. The pt was started on ASA and INDOCIN. Cardiac exam was normal. Additionally, by 11/16/10 the rash was improving. The positional chest pressure and SOB were improved the next day and resolved completely by 11/19/10. Following this incident the pt described decreased cardio exercise tolerance ("feeling out of breath after walking normal distances"). He also stated that he had experienced episodes of his "heart racing" while at rest (pulse is greater than 100). Of note the pt stopped taking OTC fish oil, creatine powder and testosterone (Black Forge). The pt was evaluated at the Cardiology Clinic on 4/18/11 (see below for test results). The pt was cleared for full duty without restrictions on 4/25/11. On 4/28/11 the pt stated that his exercise tolerance had returned to baseline and that he had no further episodes of "racing" heart rate.
Age: 33.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Rash, Rash generalised, Rash maculo-papular, Rash pruritic, Single photon emission computerised tomogram normal
Clinical narrative: This is filed in follow-up to #414584. The pt is a 33yo who received a SPV (primary) in his left deltoid on 11/3/10 (with a take per pt history). On 11/13/10 the pt developed a maculopapular, pruritic rash on his hands (palms) which was treated with BENADRYL. On 11/14/10 the rash spread to his feet (soles), arms, chest, legs, neck and head. This was associated with a scratchy throat, generalized body aches and weakness. On PE the oral pharynx was erythematous but otherwise normal. The pt was admitted to the ward and IV steroids were started. On 11/16/10 the pt noted chest pressure (4-5/10) and "difficulty breathing" while supine. These symptoms improved when sitting up. The pt was started on ASA and INDOCIN. Cardiac exam was normal. Additionally, by 11/16/10 the rash was improving. The positional chest pressure and SOB were improved the next day and resolved completely by 11/19/10. Following this incident the pt described decreased cardio exercise tolerance ("feeling out of breath after walking normal distances"). He also stated that he had experienced episodes of his "heart racing" while at rest (pulse is greater than 100). Of note the pt stopped taking OTC fish oil, creatine powder and testosterone (Black Forge). The pt was evaluated at the Cardiology Clinic on 4/18/11 (see below for test results). The pt was cleared for full duty without restrictions on 4/25/11. On 4/28/11 the pt stated that his exercise tolerance had returned to baseline and that he had no further episodes of "racing" heart rate.
Age: 33.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Sinus rhythm, Supraventricular extrasystoles, Throat irritation, Troponin normal, Ventricular extrasystoles
Clinical narrative: This is filed in follow-up to #414584. The pt is a 33yo who received a SPV (primary) in his left deltoid on 11/3/10 (with a take per pt history). On 11/13/10 the pt developed a maculopapular, pruritic rash on his hands (palms) which was treated with BENADRYL. On 11/14/10 the rash spread to his feet (soles), arms, chest, legs, neck and head. This was associated with a scratchy throat, generalized body aches and weakness. On PE the oral pharynx was erythematous but otherwise normal. The pt was admitted to the ward and IV steroids were started. On 11/16/10 the pt noted chest pressure (4-5/10) and "difficulty breathing" while supine. These symptoms improved when sitting up. The pt was started on ASA and INDOCIN. Cardiac exam was normal. Additionally, by 11/16/10 the rash was improving. The positional chest pressure and SOB were improved the next day and resolved completely by 11/19/10. Following this incident the pt described decreased cardio exercise tolerance ("feeling out of breath after walking normal distances"). He also stated that he had experienced episodes of his "heart racing" while at rest (pulse is greater than 100). Of note the pt stopped taking OTC fish oil, creatine powder and testosterone (Black Forge). The pt was evaluated at the Cardiology Clinic on 4/18/11 (see below for test results). The pt was cleared for full duty without restrictions on 4/25/11. On 4/28/11 the pt stated that his exercise tolerance had returned to baseline and that he had no further episodes of "racing" heart rate.
Age: 51.0
Sex: F
Vaccine: TD, TD
Symptoms: Injection site nodule, Injection site oedema, Injection site pain, Nuclear magnetic resonance imaging normal, Oedema peripheral
Clinical narrative: Initial report was received 12 May 2011 from a consumer, who is also the patient. A 51-year-old female patient who had a history of situational BP, had received an intramuscular left arm injection of an unspecified Tetanus vaccine (manufacturer sanofi pasteur; lot number not reported) in November 2009 and on the evening of vaccination, she experienced a 5 x 5 inch area of swelling at the left deltoid with red, raised bumps that were itchy at times. She also experienced numbness in her left arm with shooting pain from her left shoulder to her fingers and was unable to utilized her arm. Her fingers were described as sore, achy and tender and her middle finger was slightly swollen. The pain has started to move to her underarm and breast area. Pain was described as constant, and worsened with movement. The patient has been evaluated at the facility where she was vaccinated, but she was not sure what kind of Tetanus vaccine (Tetanus Toxoid, DECAVAC, or ADACEL) she received. The patient was also evaluated at the emergency room where she was prescribed hydrocodone and MOTRIN. She had no concurrent illness at the time of vaccination and she had not experienced any adverse events following prior vaccinations. Concomitant medications consisted of Amoxicillin and HCTZ. According to the reporter, the redness had subsided some, but the swelling had not gone down. Outcome was not recovered. Documents held by sender: None.
Age: 51.0
Sex: F
Vaccine: TD, TD
Symptoms: Pain in extremity, Red blood cell sedimentation rate increased, Ultrasound scan normal
Clinical narrative: Initial report was received 12 May 2011 from a consumer, who is also the patient. A 51-year-old female patient who had a history of situational BP, had received an intramuscular left arm injection of an unspecified Tetanus vaccine (manufacturer sanofi pasteur; lot number not reported) in November 2009 and on the evening of vaccination, she experienced a 5 x 5 inch area of swelling at the left deltoid with red, raised bumps that were itchy at times. She also experienced numbness in her left arm with shooting pain from her left shoulder to her fingers and was unable to utilized her arm. Her fingers were described as sore, achy and tender and her middle finger was slightly swollen. The pain has started to move to her underarm and breast area. Pain was described as constant, and worsened with movement. The patient has been evaluated at the facility where she was vaccinated, but she was not sure what kind of Tetanus vaccine (Tetanus Toxoid, DECAVAC, or ADACEL) she received. The patient was also evaluated at the emergency room where she was prescribed hydrocodone and MOTRIN. She had no concurrent illness at the time of vaccination and she had not experienced any adverse events following prior vaccinations. Concomitant medications consisted of Amoxicillin and HCTZ. According to the reporter, the redness had subsided some, but the swelling had not gone down. Outcome was not recovered. Documents held by sender: None.
Age: 51.0
Sex: F
Vaccine: TD, TD
Symptoms: Axillary pain, Breast pain, Hypoaesthesia, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Initial report was received 12 May 2011 from a consumer, who is also the patient. A 51-year-old female patient who had a history of situational BP, had received an intramuscular left arm injection of an unspecified Tetanus vaccine (manufacturer sanofi pasteur; lot number not reported) in November 2009 and on the evening of vaccination, she experienced a 5 x 5 inch area of swelling at the left deltoid with red, raised bumps that were itchy at times. She also experienced numbness in her left arm with shooting pain from her left shoulder to her fingers and was unable to utilized her arm. Her fingers were described as sore, achy and tender and her middle finger was slightly swollen. The pain has started to move to her underarm and breast area. Pain was described as constant, and worsened with movement. The patient has been evaluated at the facility where she was vaccinated, but she was not sure what kind of Tetanus vaccine (Tetanus Toxoid, DECAVAC, or ADACEL) she received. The patient was also evaluated at the emergency room where she was prescribed hydrocodone and MOTRIN. She had no concurrent illness at the time of vaccination and she had not experienced any adverse events following prior vaccinations. Concomitant medications consisted of Amoxicillin and HCTZ. According to the reporter, the redness had subsided some, but the swelling had not gone down. Outcome was not recovered. Documents held by sender: None.
Age: 51.0
Sex: F
Vaccine: TD, TD
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling, Oedema peripheral
Clinical narrative: Initial report was received 12 May 2011 from a consumer, who is also the patient. A 51-year-old female patient who had a history of situational BP, had received an intramuscular left arm injection of an unspecified Tetanus vaccine (manufacturer sanofi pasteur; lot number not reported) in November 2009 and on the evening of vaccination, she experienced a 5 x 5 inch area of swelling at the left deltoid with red, raised bumps that were itchy at times. She also experienced numbness in her left arm with shooting pain from her left shoulder to her fingers and was unable to utilized her arm. Her fingers were described as sore, achy and tender and her middle finger was slightly swollen. The pain has started to move to her underarm and breast area. Pain was described as constant, and worsened with movement. The patient has been evaluated at the facility where she was vaccinated, but she was not sure what kind of Tetanus vaccine (Tetanus Toxoid, DECAVAC, or ADACEL) she received. The patient was also evaluated at the emergency room where she was prescribed hydrocodone and MOTRIN. She had no concurrent illness at the time of vaccination and she had not experienced any adverse events following prior vaccinations. Concomitant medications consisted of Amoxicillin and HCTZ. According to the reporter, the redness had subsided some, but the swelling had not gone down. Outcome was not recovered. Documents held by sender: None.
Age: 51.0
Sex: F
Vaccine: TD, TD
Symptoms: Pain, Pain in extremity, Tenderness
Clinical narrative: Initial report was received 12 May 2011 from a consumer, who is also the patient. A 51-year-old female patient who had a history of situational BP, had received an intramuscular left arm injection of an unspecified Tetanus vaccine (manufacturer sanofi pasteur; lot number not reported) in November 2009 and on the evening of vaccination, she experienced a 5 x 5 inch area of swelling at the left deltoid with red, raised bumps that were itchy at times. She also experienced numbness in her left arm with shooting pain from her left shoulder to her fingers and was unable to utilized her arm. Her fingers were described as sore, achy and tender and her middle finger was slightly swollen. The pain has started to move to her underarm and breast area. Pain was described as constant, and worsened with movement. The patient has been evaluated at the facility where she was vaccinated, but she was not sure what kind of Tetanus vaccine (Tetanus Toxoid, DECAVAC, or ADACEL) she received. The patient was also evaluated at the emergency room where she was prescribed hydrocodone and MOTRIN. She had no concurrent illness at the time of vaccination and she had not experienced any adverse events following prior vaccinations. Concomitant medications consisted of Amoxicillin and HCTZ. According to the reporter, the redness had subsided some, but the swelling had not gone down. Outcome was not recovered. Documents held by sender: None.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Cough, Dysgeusia, Hyperhidrosis, Immediate post-injection reaction, Increased upper airway secretion
Clinical narrative: Initial report was received from a health care professional on 16 May 2011, who also reported it to VAERS (Temporary VAERS E-Report Number: E-53208). A 29 year-old female with allergies to penicillin and aloe had received a first dose intramuscular left arm injection of ADACEL, lot number C3518AA and immediately experienced injection site itching which spread until generalized, red splotches appeared on site arm, patient rapidly progressed to uncontrolled coughing, diaphoresis, metallic taste in her mouth, sore throat and phlegm in her throat. The patient's vital signs were monitored and she never became short of breath. Treatments included oral liquid BENADRYL and an intramuscular injection of DEPOMEDROL after no response from the BENADRYL. The symptoms recovered 15 min (minutes) following administration. Follow-up contact with patient three hours later revealed no return in symptoms and she was feeling fine. The patient had no reported illnesses at the time of vaccination and other medications were none. The patient's outcome was reported as recovered. Documents held by sender: none.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site pruritus, Oropharyngeal pain, Pruritus generalised, Rash macular
Clinical narrative: Initial report was received from a health care professional on 16 May 2011, who also reported it to VAERS (Temporary VAERS E-Report Number: E-53208). A 29 year-old female with allergies to penicillin and aloe had received a first dose intramuscular left arm injection of ADACEL, lot number C3518AA and immediately experienced injection site itching which spread until generalized, red splotches appeared on site arm, patient rapidly progressed to uncontrolled coughing, diaphoresis, metallic taste in her mouth, sore throat and phlegm in her throat. The patient's vital signs were monitored and she never became short of breath. Treatments included oral liquid BENADRYL and an intramuscular injection of DEPOMEDROL after no response from the BENADRYL. The symptoms recovered 15 min (minutes) following administration. Follow-up contact with patient three hours later revealed no return in symptoms and she was feeling fine. The patient had no reported illnesses at the time of vaccination and other medications were none. The patient's outcome was reported as recovered. Documents held by sender: none.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Oropharyngeal pain, Pruritus generalised
Clinical narrative: Initial report was received from a health care professional on 16 May 2011, who also reported it to VAERS (Temporary VAERS E-Report Number: E-53208). A 29 year-old female with allergies to penicillin and aloe had received a first dose intramuscular left arm injection of ADACEL, lot number C3518AA and immediately experienced injection site itching which spread until generalized, red splotches appeared on site arm, patient rapidly progressed to uncontrolled coughing, diaphoresis, metallic taste in her mouth, sore throat and phlegm in her throat. The patient's vital signs were monitored and she never became short of breath. Treatments included oral liquid BENADRYL and an intramuscular injection of DEPOMEDROL after no response from the BENADRYL. The symptoms recovered 15 min (minutes) following administration. Follow-up contact with patient three hours later revealed no return in symptoms and she was feeling fine. The patient had no reported illnesses at the time of vaccination and other medications were none. The patient's outcome was reported as recovered. Documents held by sender: none.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Rash macular
Clinical narrative: Initial report was received from a health care professional on 16 May 2011, who also reported it to VAERS (Temporary VAERS E-Report Number: E-53208). A 29 year-old female with allergies to penicillin and aloe had received a first dose intramuscular left arm injection of ADACEL, lot number C3518AA and immediately experienced injection site itching which spread until generalized, red splotches appeared on site arm, patient rapidly progressed to uncontrolled coughing, diaphoresis, metallic taste in her mouth, sore throat and phlegm in her throat. The patient's vital signs were monitored and she never became short of breath. Treatments included oral liquid BENADRYL and an intramuscular injection of DEPOMEDROL after no response from the BENADRYL. The symptoms recovered 15 min (minutes) following administration. Follow-up contact with patient three hours later revealed no return in symptoms and she was feeling fine. The patient had no reported illnesses at the time of vaccination and other medications were none. The patient's outcome was reported as recovered. Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: (L) arm had raised, warm, reddened area, 9 cm in diameter, pt was given Rx for KEFLEX 500mg 2 PO BID x 10 days.
Age: 30.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Myalgia, Swelling, Vaccination site pain, Vaccination site swelling
Clinical narrative: 22MAY11 Swelling at vaccine site (left deltoid) and tenderness. No fever, chills. Robaxin 500mg tab taken for muscle pain. 23MAY11 Increased swelling and erythema, 7cm diameter noted. Clindamycin 300mg every 6 hours initiated.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Swelling and itching to left deltoid area
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Intensive care, Myelitis transverse, Nuclear magnetic resonance imaging spinal cord abnormal
Clinical narrative: Transverse myelitis. Currently in PICU.
Age: 67.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Borrelia test negative, Chest X-ray normal, Cough, Pyrexia, White blood cell count normal
Clinical narrative: Pt. had fever and diarrhea 1 week prior to vaccine which resolved. Pt. afebrile at time of vaccines. Rec'd vaccines 5/16/11 - On May 19 had fever 103 degrees, very slight cough - no other symptoms. Went to ER 5/20. Labs WNL, Chest x-ray WNL - admitted to hospital.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Cellulitis, Feeling hot, Flatulence, Nausea
Clinical narrative: Nausea and cellulitis onset next day, warmth & fluctuance 2 days later, warmth & nausea persisted.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site haematoma, Injection site oedema, Injection site warmth
Clinical narrative: Right thigh with injection site (PCV13) surrounded by 1 cm bruise with additional 2 in. area of erythema/warmth/edema. No tenderness.
Age: 2.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Erythematous, raised rash surrounding PCV13 injection site on (R) thigh. Swelling approximately 2in x 2in. Mild tenderness. No fever.
Age: 3.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: 2in x 1 1/2in. erythematous raised rash surrounding injection site. No pain, mild tenderness. Placed on BENADRYL q 6 hours x 24 hours then q 6 hours prn. (R) thigh - PCV 13.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 4.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Culture wound, Injection site pustule, Vaccination site cellulitis
Clinical narrative: Cellulitis developed around vaccine site. Positive fluid filled pustules at margin of cellulitis. Culture sent.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Rash
Clinical narrative: Swollen arm left down to forearm, leg left spot - ice pack. Better now.
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Vomiting
Clinical narrative: Mother states that after 1 hour of the vaccine administration, patient vomited twice and had temperature of 39.7.
Age: 1.03
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Macule
Clinical narrative: Sparse red macules (B) upper extremities & lower extremities.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Fontanelle bulging, Insomnia, Pyrexia, Vaccination complication
Clinical narrative: Approximately 20 hours after receiving DTaP, HIB, IPV, PCV, and ROTATEQ parents noticed pt's head swelling. Pt diagnosed with fontanel swelling d/t vaccine administration. Slight fever - Tmax 100.4. Some insomnia.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Swelling, erythema, induration noted 24 hrs after injection. KEFLEX 500mg BID, TAC ointment 0.1%.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Rash
Clinical narrative: Child broke out in rash on head, neck and RT leg, with some redness and swelling at injection site.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Rash erythematous, Rash pruritic, Rash pustular
Clinical narrative: Red, itchy bumps on upper extremities which spread to trunk.
Age: 1.01
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Injection site urticaria, Rash generalised
Clinical narrative: Child has welty rash at vaccine site.  After about two hours the rash spread to whole body.
Age: 68.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Erythema
Clinical narrative: Reddened area appeared just below injection site approximately 2" long x 1/2" wide.  No itching, pain, or swelling.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Tenderness
Clinical narrative: Pt noted a 3" long by 1.5" wide oval rash on her left arm near the injection site.  She notes it was slightly tender 0.5/10 on the pain scale.  As of today 5/23, it is barely noticeable and just a little sore.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Pain, Pyrexia, Swelling
Clinical narrative: swelling, soreness, redness, fever, dizziness
Age: 15.0
Sex: M
Vaccine: HEP, HEPA, VARCEL
Symptoms: Retching, Syncope
Clinical narrative: SYNCOPE LASTING 2 MINUTES FOLLOWED BY GAG REFLEX.  NO VOMITING. NO DIFFICULTY BREATHING.  NO RASH.  RESTED 20 MIN AND HOME WITH DAD.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Mobility decreased
Clinical narrative: This consumer spontaneous report (initial receipt: 13-MAY-2011) concerns a 70-year old female patient, who had a medical history of allergy to egg whites. She experienced 'anxiety attacks' when she took hydrochlorothiazide. On an unknown date, the patient received a flu vaccine 'when it first came out' (brand name unspecified). The patient reported that immediately after she received the vaccine she was unable to move her arm for three months. She sought medical attention. The patient had recovered from the event and regained full use of her arm. Rechallenge was not performed. The reporter considered event serious (significant disability or incapacity) as she could not move her arm for 3 months.