chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, FLUX, HEP, FLU3, HEP
Symptoms: Lymphadenopathy, Metabolic function test normal, Mononucleosis heterophile test negative, Nausea, Oropharyngeal pain
Clinical narrative: 2/1/12 initial vaccination. Back pain, fever over next several days. Abscesses formed at day 5. Light-headed, shortness of breath over last 5 days. Still being treated for symptoms. Wednesday Feb 1: Initial vaccination 9:00am (L) arm ache 2 hours later, nauseous, lightheaded, fever/chills over night. Thursday Feb 2: Shaky, OK in morning, elevated temp, take BENADRYL, back pain starting-mild. Friday Feb 3: (L) arm lymph nodes swollen. Back pain intensifying. Elevated temp. Saturday Feb 4: Intense back pain, fever, pain radiates to extremities. Sunday Feb 5: Excruciating pain over body, hurts to move. Elevated temp 102. Lymph nodes in neck swollen, difficulty swallowing, dizziness upon standing. Monday Feb 6: See doctor. White spots appear in back of throat, hard to swallow. Lymph nodes swollen. Strep negative. Back pain easing, fever. Tuesday Feb 7: Throat swelling, more spots. Painful, unable to swallow, difficulty breathing. Take BENADRYL, fever. Wednesday Feb 8: See doctor. Strep test negative (x2). CBC, CMP, blood cultures drawn. Symptoms same as day before. IV antibiotics given. Thursday Feb 9: Temp, throat pain. Taking prescribed antibiotics. Take methylprednisone - have allergic reaction to steroid. Friday Feb 10: See doctor. Some lab results back, all negative or normal. No bacterial infection seen. Still in some pain, throat swollen, painful, difficult to breathe. Take BENADRYL. Saturday/Sunday Feb 11, 12: Lightheaded, short of breath, feel like could pass out any time. Monday Feb 13: See doctor. Admitted to facility for fluids (IV) and IV antibiotics. Lightheaded, short of breath, orthostatic vitals positive. Diagnosis: Severe dehydration. Tuesday Feb 14: Lightheaded, SOB, symptoms not changed. Drinking fluids as ordered. Wednesday Feb 15: Attempt to return to work. Still lightheaded, orthostatic vitals checked; positive. Given 1L fluids IV. CBC, CMP lab draws. Diagnosis: possible kidney function impaired.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, FLUX, HEP, FLU3, HEP
Symptoms: Pain, Pain in extremity, Pharyngeal oedema, Pyrexia, Streptococcus test negative
Clinical narrative: 2/1/12 initial vaccination. Back pain, fever over next several days. Abscesses formed at day 5. Light-headed, shortness of breath over last 5 days. Still being treated for symptoms. Wednesday Feb 1: Initial vaccination 9:00am (L) arm ache 2 hours later, nauseous, lightheaded, fever/chills over night. Thursday Feb 2: Shaky, OK in morning, elevated temp, take BENADRYL, back pain starting-mild. Friday Feb 3: (L) arm lymph nodes swollen. Back pain intensifying. Elevated temp. Saturday Feb 4: Intense back pain, fever, pain radiates to extremities. Sunday Feb 5: Excruciating pain over body, hurts to move. Elevated temp 102. Lymph nodes in neck swollen, difficulty swallowing, dizziness upon standing. Monday Feb 6: See doctor. White spots appear in back of throat, hard to swallow. Lymph nodes swollen. Strep negative. Back pain easing, fever. Tuesday Feb 7: Throat swelling, more spots. Painful, unable to swallow, difficulty breathing. Take BENADRYL, fever. Wednesday Feb 8: See doctor. Strep test negative (x2). CBC, CMP, blood cultures drawn. Symptoms same as day before. IV antibiotics given. Thursday Feb 9: Temp, throat pain. Taking prescribed antibiotics. Take methylprednisone - have allergic reaction to steroid. Friday Feb 10: See doctor. Some lab results back, all negative or normal. No bacterial infection seen. Still in some pain, throat swollen, painful, difficult to breathe. Take BENADRYL. Saturday/Sunday Feb 11, 12: Lightheaded, short of breath, feel like could pass out any time. Monday Feb 13: See doctor. Admitted to facility for fluids (IV) and IV antibiotics. Lightheaded, short of breath, orthostatic vitals positive. Diagnosis: Severe dehydration. Tuesday Feb 14: Lightheaded, SOB, symptoms not changed. Drinking fluids as ordered. Wednesday Feb 15: Attempt to return to work. Still lightheaded, orthostatic vitals checked; positive. Given 1L fluids IV. CBC, CMP lab draws. Diagnosis: possible kidney function impaired.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, FLUX, HEP, FLU3, HEP
Symptoms: Throat irritation, Tremor
Clinical narrative: 2/1/12 initial vaccination. Back pain, fever over next several days. Abscesses formed at day 5. Light-headed, shortness of breath over last 5 days. Still being treated for symptoms. Wednesday Feb 1: Initial vaccination 9:00am (L) arm ache 2 hours later, nauseous, lightheaded, fever/chills over night. Thursday Feb 2: Shaky, OK in morning, elevated temp, take BENADRYL, back pain starting-mild. Friday Feb 3: (L) arm lymph nodes swollen. Back pain intensifying. Elevated temp. Saturday Feb 4: Intense back pain, fever, pain radiates to extremities. Sunday Feb 5: Excruciating pain over body, hurts to move. Elevated temp 102. Lymph nodes in neck swollen, difficulty swallowing, dizziness upon standing. Monday Feb 6: See doctor. White spots appear in back of throat, hard to swallow. Lymph nodes swollen. Strep negative. Back pain easing, fever. Tuesday Feb 7: Throat swelling, more spots. Painful, unable to swallow, difficulty breathing. Take BENADRYL, fever. Wednesday Feb 8: See doctor. Strep test negative (x2). CBC, CMP, blood cultures drawn. Symptoms same as day before. IV antibiotics given. Thursday Feb 9: Temp, throat pain. Taking prescribed antibiotics. Take methylprednisone - have allergic reaction to steroid. Friday Feb 10: See doctor. Some lab results back, all negative or normal. No bacterial infection seen. Still in some pain, throat swollen, painful, difficult to breathe. Take BENADRYL. Saturday/Sunday Feb 11, 12: Lightheaded, short of breath, feel like could pass out any time. Monday Feb 13: See doctor. Admitted to facility for fluids (IV) and IV antibiotics. Lightheaded, short of breath, orthostatic vitals positive. Diagnosis: Severe dehydration. Tuesday Feb 14: Lightheaded, SOB, symptoms not changed. Drinking fluids as ordered. Wednesday Feb 15: Attempt to return to work. Still lightheaded, orthostatic vitals checked; positive. Given 1L fluids IV. CBC, CMP lab draws. Diagnosis: possible kidney function impaired.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PPV, VARCEL
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Significant swelling at the site of one injection and a fever that reached 102.4 degrees.  Fever responded to Tylenol and the swelling slowly started going down.  Doctor said to administer Tylenol as needed for fever and make sure the swelling doesn't continue to increase.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Decreased activity, Hypotonic-hyporesponsive episode, Pallor
Clinical narrative: 4 hrs after vaccines administered (PENTACEL, PREVNAR 13, Hep B, Rotavirus) infants became pale "gray", less active for about an hour. No vomiting no loss of consciousness. Nursed well. No fever no cyanosis no abnl movements. Sounds like hypotonic hyporesonsive episode.
Age: 0.18
Sex: M
Vaccine: RV5
Symptoms: Gastric occult blood positive, Haematemesis, Laboratory test, Occult blood negative, Upper gastrointestinal haemorrhage
Clinical narrative: Information has been received from a nurse practitioner (N.P.) and a registered nurse (R.N.) concerning a 9 week old patient with no concurrent conditions, no known drug allergies and no pertinent medical history who on 03-FEB-2012, was vaccinated with a first dose of ROTATEQ, 2 ml, P.O. (lot number 669825/1347AA) which was given as part of the 2 month vaccination series. Concomitant vaccine included PENTACEL. There were no other concomitant medications. It was reported that within a week of getting ROTATEQ, the baby had "coffee ground emesis". The reporter stated that the exact date of adverse experience was unknown. Patient's family called the office on 05-FEB-2012, to report the event. Patient was admitted to hospital at that time. The baby was diagnosed with an upper gastrointestinal bleed. It was unknown if the event was disabling or life threatening. It was reported that the therapy with ROTATEQ was not reintroduced. The nurse practitioner reported, that the baby's stool tested negative for blood but the vomit tested positive for blood. There were also some other unspecified laboratory studies performed. At the time of the report, the baby's outcome was unknown. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Differential white blood cell count, Full blood count, Local swelling
Clinical narrative: Swelling in neck which increased to golf ball size. Within a week period. Pt given Amoxicillin 200mg tid x 7days & blood work. Pt to f/u w/ us Tue. Sooner if any other problems.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Fall, Pallor
Clinical narrative: Patient became pale & fell to floor at check out counter of MD's office. No loss of consciousness. Approx 3-5 minutes after receiving vaccines.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Erythematous and tender with mild edema - to (R) upper arm. This is arm that vaccine was administered in.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Left arm sore beginning at 630pm. More sore with movement. Most intense pain at site of injection with pain radiating to entire upper arm. Considering ibuprofen, ice, heat.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV
Symptoms: Erythema, Induration, Injection site erythema, Injection site haematoma, Injection site pain
Clinical narrative: Swelling & redness in arm Saturday (had sl. bruise Friday after shot) with c/o pain, sl. temp, c/o itch Saturday night. Redness & induration spread Sunday and today. Treatment TYLENOL, ADVIL, ice & BENADRYL x1 Sunday.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV
Symptoms: Injection site swelling, Pruritus, Pyrexia
Clinical narrative: Swelling & redness in arm Saturday (had sl. bruise Friday after shot) with c/o pain, sl. temp, c/o itch Saturday night. Redness & induration spread Sunday and today. Treatment TYLENOL, ADVIL, ice & BENADRYL x1 Sunday.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Alanine aminotransferase increased, Blood alkaline phosphatase increased, C-reactive protein increased, Hypoaesthesia, Musculoskeletal pain
Clinical narrative: Diffuse generalized pain aching. Worse (R) arm & shoulder. (R) hand feels numb started 3 - 4 days after receiving the flu shot. Seen on 11/15 & again on 11/17.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Pain in extremity, Red blood cell sedimentation rate increased, Troponin normal
Clinical narrative: Diffuse generalized pain aching. Worse (R) arm & shoulder. (R) hand feels numb started 3 - 4 days after receiving the flu shot. Seen on 11/15 & again on 11/17.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm (site of MENACTRA) showed redness, warmth, tenderness, swelling - 2-2-12. Right upper arm (site of Tdap) - minimal chgs.
Age: 9.0
Sex: F
Vaccine: MNQ, PNC13, PPV
Symptoms: Cellulitis, Eosinophil count decreased, Full blood count normal, Injection site erythema, Injection site pain
Clinical narrative: The day after immunization given, tender erythematous wheals to injection sites. BENADRYL administered at clinic. Presented to ER with fever 102, given MOTRIN and discharged. Presented to another ER and admitted for fevers and Dx = cellulitis.
Age: 9.0
Sex: F
Vaccine: MNQ, PNC13, PPV
Symptoms: Injection site urticaria, Pyrexia, Urine analysis normal, White blood cell count normal
Clinical narrative: The day after immunization given, tender erythematous wheals to injection sites. BENADRYL administered at clinic. Presented to ER with fever 102, given MOTRIN and discharged. Presented to another ER and admitted for fevers and Dx = cellulitis.
Age: 43.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Malaise, Pain in extremity
Clinical narrative: Developed sore arm, redness increased, malaise for 48 hours. Decreased pain, but redness continues; after receiving TDAP & FLUZONE in (L) arm.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Contusion
Clinical narrative: Patient had painful bruise under the vaccinated arm.
Age: 27.0
Sex: M
Vaccine: FLU3, HEPA, IPV, TDAP, YF
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: (L) hand swelling, redness and itching since 7:00pm on 2/2/12. No fever, chills, SOB, tongue swelling or throat swelling. No apparent reaction at injection site either (L) or (R) arm. Per pt swelling and redness subsided within 48 hours. (2/9/12 back to normal).
Sex: U
Vaccine: PER
Symptoms: Pertussis
Clinical narrative: Initial report was received on 08 February 2012 from an electronic lay press article. It represents a cluster of two confirmed cases of pertussis following vaccination with a pertussis vaccine (manufacturer not reported). The second patient is captured in case number 2012-01547. A child in elementary school (age and gender not reported) received an injection of pertussis vaccine (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later, developed pertussis. The patient was reported as being immunized. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Culture throat negative, Headache, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 2-5-12 Awakened with painful back of (lt) side of neck, fever, headache. Had 2" reddened, warm indurated area at site KINRIX inj. on (rt) thigh.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Laboratory test normal, Neck pain, Pyrexia, Streptococcus test
Clinical narrative: 2-5-12 Awakened with painful back of (lt) side of neck, fever, headache. Had 2" reddened, warm indurated area at site KINRIX inj. on (rt) thigh.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy to vaccine, Dyspnoea, Eyelid oedema, Influenza like illness, Pain
Clinical narrative: Patient had flu shot yesterday. Stated she became short of breath in parking lot but that is not unusual for her when she walks as she is heavy and asthmatic. She then drove and went out to dinner and during dinner became more short of breath. When she arrived home she felt "achy" and had a runny nose thought she felt like she had the flu. At 1 AM she woke up and her eyes were swollen shut she went to the emergency room and was treated with IV steroids and she was told she was allergic to the flu shot and not have the flu shot anymore.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: Patient had flu shot yesterday. Stated she became short of breath in parking lot but that is not unusual for her when she walks as she is heavy and asthmatic. She then drove and went out to dinner and during dinner became more short of breath. When she arrived home she felt "achy" and had a runny nose thought she felt like she had the flu. At 1 AM she woke up and her eyes were swollen shut she went to the emergency room and was treated with IV steroids and she was told she was allergic to the flu shot and not have the flu shot anymore.
Age: 52.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Chills, Decreased appetite, Diarrhoea, Lethargy, Pyrexia
Clinical narrative: Patient called complaining of fever, severe chills and several bouts of diarrhea. He also complains of lethargy and loss of appetite.
Sex: U
Vaccine: PER
Symptoms: Pertussis
Clinical narrative: Initial report was received on 08 February 2012 from an electronic lay press article. It represents a cluster of two confirmed cases of pertussis following vaccination with a pertussis vaccine (manufacturer not reported). The second patient is captured in case number 2012-01546. A child in elementary school (age and gender not reported) received an injection of pertussis vaccine (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later, developed pertussis. The patient was reported to be immunized. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (L) upper arm (site of Dtap injection) is swollen, red, and warm to touch (painful); covering about 25% of upper arm.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Arthritis bacterial, Drug administered at inappropriate site, Injection site abscess, Product quality issue, Wrong technique in drug usage process
Clinical narrative: This case was reported by a healthcare professional and by a healthcare professional via a sales representative and described the occurrence of septic shoulder in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 5 February 2012 at 14:30 or 15:00 the subject received a dose of BOOSTRIX (.5 ml, shoulder injection site) and experienced wrong injection technique. One of the reporting healthcare professionals believed that injection technique played a role in the events. He reported that the vaccine may have been administered too closed to the shoulder joint. On 12 February 2012, 7 days after vaccination with BOOSTRIX, the subject experienced septic shoulder ("developed sepsis in the shoulder joint of the arm in which the vaccine was administered") and in February 2012, the subject experienced abscess at injection site on shoulder. The subject presented to the emergency room "last night" (12 February 2012) and was hospitalized overnight. The subject was scheduled for surgery to remove abscess. This case was associated with a pharmaceutical product complaint. One of the healthcare professionals reported that the vaccine lot had been used with no other complaints since December 2011 and the he was 99 percent sure there was not a problem with the vaccine, but was waiting on the vaccine culture results. Another healthcare professional reported via the sales representative that facility put a temporary hold on this lot of vaccine and was having the lot cultured because they think there maybe something wrong with the product. The subject was hospitalised and the healthcare professionals considered the events were disabling and clinically significant (or requiring intervention). At the time of reporting the events were unresolved.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Shot (HIB) given on 2/3/2012. Foster mother reports red area around site on 2/14/12. Dx: cellulitis tx: KEFLEX on 2/16/12.
Age: 91.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Right arm swelling and pain increasing in intensity from 1 day post vaccine adm. Seen by NP from clinic.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Arthralgia, Asthenia, Chills, Cough
Clinical narrative: Within an hour of vaccination, swelling of arm, warmth, and pain that radiated from injection site; took 2 Acetaminophen, iced injection site. Within two hours of vacc., onset of chills, fatigue, and nausea; went to bed. Slept hard for four hours, woke with 100 deg fever, neck- and headache, weakness, pain increase in arm, which had swollen and hardened. Took 400 mg Ibuprofen, hot tea, returned to bed. Slept hard. Following morning, continued all symptoms, added severe joint pain. Fever to 102.2 on Sunday. Continued cycling acetaminophen/ ibuprofen / icing injection site. Monday A.M. could not get out of bed without help. Phoned doctor to report symptoms. Advised to continue as I was going with rest/ med / ice, and avoid pertussis vaccine in future. Tuesday much the same as Sun & Mon, but no further nausea. Wed, was strong enough to get out of bed, headache and joint pain mostly gone, swelling in arm subsided from size of grapefruit to about regular orange, but with hoarseness in throat, slight wheezing; Wed eve took 2 Benadryl for swollen throat, wheezing. Thurs fever back to 101, severely swollen throat, wheezing, beginning of cough. Determined to visit doctor Friday if no improvement. Arm less swollen Thurs eve (about size of Clementine only, could tolerate touch). Friday AM, woke with still swollen throat, cough, mild wheezing, 100 deg fever, arm only golfball swelling. Will see doctor for assessment/ further recommendation.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Dysphonia, Fatigue, Headache, Induration, Injection site pain
Clinical narrative: Within an hour of vaccination, swelling of arm, warmth, and pain that radiated from injection site; took 2 Acetaminophen, iced injection site. Within two hours of vacc., onset of chills, fatigue, and nausea; went to bed. Slept hard for four hours, woke with 100 deg fever, neck- and headache, weakness, pain increase in arm, which had swollen and hardened. Took 400 mg Ibuprofen, hot tea, returned to bed. Slept hard. Following morning, continued all symptoms, added severe joint pain. Fever to 102.2 on Sunday. Continued cycling acetaminophen/ ibuprofen / icing injection site. Monday A.M. could not get out of bed without help. Phoned doctor to report symptoms. Advised to continue as I was going with rest/ med / ice, and avoid pertussis vaccine in future. Tuesday much the same as Sun & Mon, but no further nausea. Wed, was strong enough to get out of bed, headache and joint pain mostly gone, swelling in arm subsided from size of grapefruit to about regular orange, but with hoarseness in throat, slight wheezing; Wed eve took 2 Benadryl for swollen throat, wheezing. Thurs fever back to 101, severely swollen throat, wheezing, beginning of cough. Determined to visit doctor Friday if no improvement. Arm less swollen Thurs eve (about size of Clementine only, could tolerate touch). Friday AM, woke with still swollen throat, cough, mild wheezing, 100 deg fever, arm only golfball swelling. Will see doctor for assessment/ further recommendation.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Nausea, Neck pain, Oedema peripheral
Clinical narrative: Within an hour of vaccination, swelling of arm, warmth, and pain that radiated from injection site; took 2 Acetaminophen, iced injection site. Within two hours of vacc., onset of chills, fatigue, and nausea; went to bed. Slept hard for four hours, woke with 100 deg fever, neck- and headache, weakness, pain increase in arm, which had swollen and hardened. Took 400 mg Ibuprofen, hot tea, returned to bed. Slept hard. Following morning, continued all symptoms, added severe joint pain. Fever to 102.2 on Sunday. Continued cycling acetaminophen/ ibuprofen / icing injection site. Monday A.M. could not get out of bed without help. Phoned doctor to report symptoms. Advised to continue as I was going with rest/ med / ice, and avoid pertussis vaccine in future. Tuesday much the same as Sun & Mon, but no further nausea. Wed, was strong enough to get out of bed, headache and joint pain mostly gone, swelling in arm subsided from size of grapefruit to about regular orange, but with hoarseness in throat, slight wheezing; Wed eve took 2 Benadryl for swollen throat, wheezing. Thurs fever back to 101, severely swollen throat, wheezing, beginning of cough. Determined to visit doctor Friday if no improvement. Arm less swollen Thurs eve (about size of Clementine only, could tolerate touch). Friday AM, woke with still swollen throat, cough, mild wheezing, 100 deg fever, arm only golfball swelling. Will see doctor for assessment/ further recommendation.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pharyngeal oedema, Pyrexia, Wheezing
Clinical narrative: Within an hour of vaccination, swelling of arm, warmth, and pain that radiated from injection site; took 2 Acetaminophen, iced injection site. Within two hours of vacc., onset of chills, fatigue, and nausea; went to bed. Slept hard for four hours, woke with 100 deg fever, neck- and headache, weakness, pain increase in arm, which had swollen and hardened. Took 400 mg Ibuprofen, hot tea, returned to bed. Slept hard. Following morning, continued all symptoms, added severe joint pain. Fever to 102.2 on Sunday. Continued cycling acetaminophen/ ibuprofen / icing injection site. Monday A.M. could not get out of bed without help. Phoned doctor to report symptoms. Advised to continue as I was going with rest/ med / ice, and avoid pertussis vaccine in future. Tuesday much the same as Sun & Mon, but no further nausea. Wed, was strong enough to get out of bed, headache and joint pain mostly gone, swelling in arm subsided from size of grapefruit to about regular orange, but with hoarseness in throat, slight wheezing; Wed eve took 2 Benadryl for swollen throat, wheezing. Thurs fever back to 101, severely swollen throat, wheezing, beginning of cough. Determined to visit doctor Friday if no improvement. Arm less swollen Thurs eve (about size of Clementine only, could tolerate touch). Friday AM, woke with still swollen throat, cough, mild wheezing, 100 deg fever, arm only golfball swelling. Will see doctor for assessment/ further recommendation.
Age: 18.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site reaction, Injection site warmth, Tension
Clinical narrative: Pt received varicella vaccine and returns to office with tension and warmth where she received the vaccine.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Myalgia, Swelling
Clinical narrative: Swelling, erythema- large lcoal reaction, myalgias.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site vesicles, Injection site warmth, Rash
Clinical narrative: Multiple small red blisters on her left arm from the shoulder to her elbow. Mom voice that it was warm at touch and itching. No fever present. Parent did not bring her to the clinic to be check they gave her Benadryl for a week orally and topic (cream) the rash last little over a week.
Age: 1.28
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: 1.5 CM CONFLUENT RED PATCH RIGHT LAT. THIGH WHERE CHICKEN POX VACCINE WAS ADMINISTERED WITH LOW GRADE FEVER.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, redness, swelling for the first 2-3 days, then hot to the touch at the injection site 5 days after injection given.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Anxiety, Blindness transient, Dysphagia, Dyspnoea, Electrocardiogram normal
Clinical narrative: This case was reported by a consumer and described the occurrence of shooting pains in a 50-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included fractured neck which resulted in paralysis of one lung. Concurrent medical conditions included exercise induced asthma, high blood pressure and muscle spasm. Concurrent medications included PROZAC, anti-viral medication, clonidine, ibuprofen, FENTANYL and tizanidine. In October 2011 the subject received a dose of FLULAVAL in the right arm (2 inches above his elbow in the side of his right arm). Within 24 hours of vaccination with FLULAVAL, the subject experienced shooting pains, fever (in his arm) and red skin. He described the pain as severe pain that felt like electrical shocks (electric shock sensation in arm). These events were described as worse at the time of reporting.  The subject also reported that he developed systemic problems such as intermittent blindness, prostate problem, migraines, worsened breathing and swallowing difficulty. The subject stated that every day he "feels like he is dying" and it was getting worse. The subject was very anxious over his symptoms and was not sure if FLULAVAL was the cause of his worsening condition. It was reported that an MRI and EKG performed on unspecified dates revealed normal results. The subject additionally reported that following previous flu shots, he developed pain after the injections. No further details were provided.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Feeling abnormal, Migraine, Nuclear magnetic resonance imaging normal, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of shooting pains in a 50-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included fractured neck which resulted in paralysis of one lung. Concurrent medical conditions included exercise induced asthma, high blood pressure and muscle spasm. Concurrent medications included PROZAC, anti-viral medication, clonidine, ibuprofen, FENTANYL and tizanidine. In October 2011 the subject received a dose of FLULAVAL in the right arm (2 inches above his elbow in the side of his right arm). Within 24 hours of vaccination with FLULAVAL, the subject experienced shooting pains, fever (in his arm) and red skin. He described the pain as severe pain that felt like electrical shocks (electric shock sensation in arm). These events were described as worse at the time of reporting.  The subject also reported that he developed systemic problems such as intermittent blindness, prostate problem, migraines, worsened breathing and swallowing difficulty. The subject stated that every day he "feels like he is dying" and it was getting worse. The subject was very anxious over his symptoms and was not sure if FLULAVAL was the cause of his worsening condition. It was reported that an MRI and EKG performed on unspecified dates revealed normal results. The subject additionally reported that following previous flu shots, he developed pain after the injections. No further details were provided.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Prostatic disorder, Skin warm
Clinical narrative: This case was reported by a consumer and described the occurrence of shooting pains in a 50-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included fractured neck which resulted in paralysis of one lung. Concurrent medical conditions included exercise induced asthma, high blood pressure and muscle spasm. Concurrent medications included PROZAC, anti-viral medication, clonidine, ibuprofen, FENTANYL and tizanidine. In October 2011 the subject received a dose of FLULAVAL in the right arm (2 inches above his elbow in the side of his right arm). Within 24 hours of vaccination with FLULAVAL, the subject experienced shooting pains, fever (in his arm) and red skin. He described the pain as severe pain that felt like electrical shocks (electric shock sensation in arm). These events were described as worse at the time of reporting.  The subject also reported that he developed systemic problems such as intermittent blindness, prostate problem, migraines, worsened breathing and swallowing difficulty. The subject stated that every day he "feels like he is dying" and it was getting worse. The subject was very anxious over his symptoms and was not sure if FLULAVAL was the cause of his worsening condition. It was reported that an MRI and EKG performed on unspecified dates revealed normal results. The subject additionally reported that following previous flu shots, he developed pain after the injections. No further details were provided.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Pt complained of red circle under her arm, some itching. Pharmacist advised her to take BENADRYL to help relieve itching.
Age: 0.8
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPV, HIBV
Symptoms: Abnormal behaviour, Injection site swelling, Pyrexia
Clinical narrative: Pediarix and Twinrix given at same time. No effects noted at that time. 2/15/12 PM, 2/16/12 AM telephone calls - slight fever, no redness, swelling noted on leg; no fussiness, change in behavior in baby. 2/17/12 AM no fever, no symptoms.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Dizziness, Headache, Hypoaesthesia, Hypoaesthesia oral, Nausea
Clinical narrative: Symptons began with a severe headach and progressed to nausea, dizziness and numbness in the mouth and nose area.  I called the pediatrician and they sent me to ER.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Computerised tomogram head, Cytogenetic analysis, Electrocardiogram, Endocrine test, Feeding disorder of infancy or early childhood
Clinical narrative: Lethargy, poor feeding with decreased po intake, and respiratory insufficiency resulting in prolonged ICU hospitalization with mechanical ventilation.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Hypophagia, Intensive care, Laboratory test, Lethargy, Lumbar puncture
Clinical narrative: Lethargy, poor feeding with decreased po intake, and respiratory insufficiency resulting in prolonged ICU hospitalization with mechanical ventilation.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Mechanical ventilation, Metabolic function test, Nuclear magnetic resonance imaging brain, Respiratory failure
Clinical narrative: Lethargy, poor feeding with decreased po intake, and respiratory insufficiency resulting in prolonged ICU hospitalization with mechanical ventilation.
Age: 19.0
Sex: M
Vaccine: FLUX
Symptoms: Adverse reaction, Arteriosclerosis, Computerised tomogram, Convulsion, Electrocardiogram
Clinical narrative: Seizures; black-outs; neurotrophy; arteriosclerosis; GERD.
Age: 19.0
Sex: M
Vaccine: FLUX
Symptoms: Gastrooesophageal reflux disease, Loss of consciousness
Clinical narrative: Seizures; black-outs; neurotrophy; arteriosclerosis; GERD.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site warmth, Mobility decreased
Clinical narrative: Cellulitis- injection site warm, red, positive induration spreading.  Low grade temp. Difficulty moving arm. ABX started.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: Cellulitis- injection site warm, red, positive induration spreading.  Low grade temp. Difficulty moving arm. ABX started.
Age: 26.0
Sex: M
Vaccine: YF
Symptoms: Pruritus, Rash
Clinical narrative: Pruritus, rash; better with Benadryl.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Bacterial infection, Cellulitis, Erythema, Pain, Skin discolouration
Clinical narrative: Localized cellulitic response: 5 cm area of raised erythema, warmth & pain w/ 2 cm halo.  Enlarging 8 days after vaccination.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Skin warm
Clinical narrative: Localized cellulitic response: 5 cm area of raised erythema, warmth & pain w/ 2 cm halo.  Enlarging 8 days after vaccination.
Sex: M
Vaccine: FLUX, MMR, PNC
Symptoms: Autism, Brain injury
Clinical narrative: Case number PHHY2012CA011067 is an initial spontaneous report received from a consumer (patient's father) via pharmaceutical company (reference number: 2012014508) on 06 Feb 2012: This report refers to a neonate (less than 1 year) male patient. There was no relevant medical history and no family history. He was vaccinated with a dose of seasonal influenza vaccine (manufacturer and batch number: unknown) along with PREVNAR vaccine (other manufacturer, batch number: 343285) and MMR (other manufacturer, batch number: unknown) on 19 Oct 2004. On an unknown date, he became autistic and suffered brain damage. The action taken with PREVNAR was post-therapy and the the outcome of the events was unknown. No further information was provided.
Sex: M
Vaccine: FLUX, MMR, PNC
Symptoms: Autism, Brain injury
Clinical narrative: Case number PHHY2012CA011066 is an initial spontaneous report received from a consumer (patient's father) via pharmaceutical company (reference number: 2012014501) on 06 Feb 2012: This report refers to a neonate (less than 1 year) male patient. There was no relevant medical history and no family history. He was vaccinated with a dose of seasonal influenza vaccine (manufacturer and batch number: unknown) along with PREVNAR (other manufacturer, batch number: 343285) and MMR (other manufacturer, batch number: unknown) on 19 Oct 2004. On an unknown date, autism was diagnosed after these injections, and he suffered brain damage. The reporter felt there should be a warning about administering other vaccines at the same time as he report that apparently his son had too much aluminum adjuvant upon receipt of these vaccine together because the maximum aluminum adjuvant dose was 1.25 mg. The reporter further stated that his son went over that amount of aluminum and his body could not handle it. The outcome of the events was unknown. No further information was provided.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Hypoaesthesia
Clinical narrative: Numbness in arm - then hand then elevated BP EMT phoned & pt taken to hospital for observation.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Vaccine administered on 2/15/12 to (L) arm. Redness to site, warm to touch, tenderness with palpation.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site streaking, Injection site swelling
Clinical narrative: PM or 2-15-12 (L) deltoid painful. 2-16-12 PM (L) deltoid very red, swollen & red streaks radiating to (L) armpit, (L) deltoid painful.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: PM or 2-15-12 (L) deltoid painful. 2-16-12 PM (L) deltoid very red, swollen & red streaks radiating to (L) armpit, (L) deltoid painful.
Age: 3.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site vesicles
Clinical narrative: Injection site reaction left thigh where Varicella #2 given 7cm x 8cm area of erythema with a few clear vesicles. Injection site reaction from DTaP 6cm x 5cm area of round erythema. Treated with ibuprofen.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Malaise, Mass, Pain, Skin warm
Clinical narrative: 6.5cm x 8cm swollen area, painful - hard knot under skin; warm to touch. C/O general malaise, temp of 98 degrees, oral. Was feeling some better, less achy by Friday PM.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: 6.5cm x 8cm swollen area, painful - hard knot under skin; warm to touch. C/O general malaise, temp of 98 degrees, oral. Was feeling some better, less achy by Friday PM.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Injection site erythema, Injection site swelling, Pruritus, Skin warm
Clinical narrative: 2-17-12 Client return for reading of TB skin test with mother. Mother reported that he had a reaction from the "chicken pox" vaccine. Child's left arm at the varicella injection site was red and raised 3 1/2" x 3 1/2", in the center a heart like shape appeared a darker red. Mother reported the evening after the vaccine his arm appeared to have a blister and was warm to touch. Child reports that it is not painful and "it itches".
Age: 33.0
Sex: M
Vaccine: FLU3, MMR, PPV, TDAP
Symptoms: Body temperature increased, Erythema, Induration, Vaccination complication
Clinical narrative: Note of nurse 1-6-12 "Pt came into have PPD read- neg. Stated got a reaction from the pneumococcal vaccine. His (Rt) arm got very red & hard. He ran a T of 103. He went to ER. He was given some medication & discharged. T at hospital 98.1. Both arms still red." Accompanied by wife.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Chills, Headache, Malaise, Pain in extremity
Clinical narrative: 2-3-12 Received Tdap - that night had HA, arm soreness (no redness), chills, fever, malaise. 2-4-12 Same s/l as above - in bed all day. 2-5-12 malaise, arm soreness. 2-7-12 malaise, arm soreness. 2-8-12 malaise (reported  to HD), arm soreness. 2-9-12 arm soreness. 2-10-12 arm soreness.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: 2-3-12 Received Tdap - that night had HA, arm soreness (no redness), chills, fever, malaise. 2-4-12 Same s/l as above - in bed all day. 2-5-12 malaise, arm soreness. 2-7-12 malaise, arm soreness. 2-8-12 malaise (reported  to HD), arm soreness. 2-9-12 arm soreness. 2-10-12 arm soreness.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient had/has severe arm/shoulder pain. Had flu shot 10/28/11 and now has to go to physical therapy on arm. Only has 50% use of her arm.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, PNC13
Symptoms: Irritability, Muscle rigidity, Pyrexia, Similar reaction on previous exposure to drug
Clinical narrative: High fevers up to 104 degrees F, muscle rigidity & fussiness. These sxs occurred x6 (each time vaccines were administered with no other acute illness).
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest X-ray normal, Chest pain, Dizziness, Electrocardiogram, Electrocardiogram ST segment elevation
Clinical narrative: Patient presented with 2 day history of left sided chest pain, described as constant moderately severe pain, worse with deep inspiration, improved by nothing. Doees not radiate. No associated SOB. Does endorse lightheadedness. Additionally reports diffuse myalgias the past two days.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Myalgia, Painful respiration, Troponin increased
Clinical narrative: Patient presented with 2 day history of left sided chest pain, described as constant moderately severe pain, worse with deep inspiration, improved by nothing. Doees not radiate. No associated SOB. Does endorse lightheadedness. Additionally reports diffuse myalgias the past two days.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Laboratory test abnormal, Painful respiration
Clinical narrative: Patient presented with 2 day history of left sided chest pain, described as constant moderately severe pain, worse with deep inspiration, improved by nothing. Doees not radiate. No associated SOB. Does endorse lightheadedness. Additionally reports diffuse myalgias the past two days.
Age: 44.0
Sex: M
Vaccine: DTP
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: Burning, tingling sensation on surface of extremities (hands, legs, feet). Reported to Dr., same day. The next day was seen with Dr.  No action.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Mild fever and chills.  General muscle ache lasting one day.
Age: 29.0
Sex: F
Vaccine: HEPAB, IPV, MMR
Symptoms: Asthenia, Body temperature increased, Fatigue, Headache, Musculoskeletal pain
Clinical narrative: I started getting a sore throat around 5pm. My neck was painful to turn. By the end of the night, my throat hurt, my temperature was elevated, headache and I had neck pain that shot down into my shoulders. I felt weak and tired for the next 3 days with accompanied sore throat, headache and neck pain. Treated with ibuprofen otc and a heating pad.
Age: 29.0
Sex: F
Vaccine: HEPAB, IPV, MMR
Symptoms: Neck pain, Oropharyngeal pain
Clinical narrative: I started getting a sore throat around 5pm. My neck was painful to turn. By the end of the night, my throat hurt, my temperature was elevated, headache and I had neck pain that shot down into my shoulders. I felt weak and tired for the next 3 days with accompanied sore throat, headache and neck pain. Treated with ibuprofen otc and a heating pad.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pyrexia, Rash
Clinical narrative: Patient reports getting shingles within 3 days of vaccine. Severe pain, fever, rash.
Age: 40.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: Back pain, Computerised tomogram, Fatigue, Full blood count, Headache
Clinical narrative: Severe tingling in back arms, legs neck with pain in head and back with nasuea and fatigue. Went to ER and ambulatory car three time for these symptoms.
Age: 40.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: Nausea, Paraesthesia
Clinical narrative: Severe tingling in back arms, legs neck with pain in head and back with nasuea and fatigue. Went to ER and ambulatory car three time for these symptoms.
Age: 2.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Pyrexia
Clinical narrative: Fever of 102.3, given Acetaminophen.  6:00 AM Fever of 103.2 given Ibuprofen.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: Redness, swelling, hot and itchy.  Tylenol and cool compress.  Dr prescribed antibiotics if redness area increases.
Age: 1.5
Sex: F
Vaccine: MMR
Symptoms: Brain injury, Grand mal convulsion, Pyrexia
Clinical narrative: Grand Mal Convulsions, 105 degree fever, resulted in permanent severe brain damage.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Guillain-Barre syndrome, Influenza, Nausea
Clinical narrative: After flu shot flu symptoms and strange weakness starting on 10/11/2010.  Flu symptoms except for nausea and weakness went away within 3-4 days.  Nausea eventually went away.  Weakness pronounced on 110/14/2010.  Went to the Dr. and then to the emergency room on 10/15/2010.  Diagnosed and treated for Guillain Barre.
Sex: F
Vaccine: FLU3
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Approximately 44hrs after vaccination hives near site of injection, arm, neck, trunk were noticed. BENADRYL was administered.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Oedema peripheral, Vaccination complication
Clinical narrative: Rxn varicella vaccine to (R) arm. Erythema, swollen, indurated 10 cm; local cold packs and anti-histamines suggested per dr.
Age: 30.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2011US94960 is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS Ref: 433690) website on 27 Oct 2011 with a follow up received from the quality assurance department (quality reference number: 132275) on 08 Feb 2012. This report refers to a 30 year old female patient. The patient had a medical history of allergies and low immune system. Concomitant medications included SINGULAIR, ZYRTEC and OMNICEF. She was vaccinated with MENVEO (batch number: A10051) in the left arm and PNEUMOVAX 23 (manufactured by Merck and Co, batch number: 0595AA) in the right arm on 25 Aug 2011. The patient had swollen arm at the injection site which was very warm and sore to the touch and also had redness at the injection site (left or right arm not reported) on 26 Aug 2011. The patient visited 2 doctors who confirmed that the patient had a 7x8 cm cellulitis. The patient recovered on unspecified date. Based on the batch review report it was stated that the concerned MENVEO batch A10051 was manufactured in accordance with the approved internal procedures and is in compliance with the agency requirements. Follow up information received from the quality assurance department on 08 Feb 2012: Updated batch review report.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Lymphadenopathy, Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fatigue in a 24-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included mononucleosis. Concurrent medications included SINGULAIR. On the afternoon of 8 September 2011 the subject received a dose of FLULAVAL at 0.5 ml in the left deltoid. On 11 September 2011, 3 days after vaccination with FLULAVAL, the subject experienced fatigue, swollen lymph node and rash. The subject was seen in the emergency room. but was not admitted to the hospital. Fatigue was unresolved at the time of reporting, swollen lymph node was improved and the rash was resolved (date not provided. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL.