chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site induration, Injection site rash, Panniculitis
Clinical narrative: Days post vaccination 9cm round indurated felt non tender rash at MMR injection site. Panniculitis.
Age: 13.0
Sex: F
Vaccine: FLUN3, HEPA, VARCEL
Symptoms: Urticaria
Clinical narrative: Pt. broke in hives on 10-8-09 after getting vaccines on 10-6-09.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea
Clinical narrative: Mom stated that pt had diarrhea the next day. Dad said he also had diarrhea, but didn't get the flu vaccine.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle twitching, Pain, Paraesthesia
Clinical narrative: About 5 days after vaccination index finger on that arm c/forefinger began to tingle with pins and needles feeling. Now has aching in + up of arm and forearm and muscle twitching has this constant feeling.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia facial, Visual impairment
Clinical narrative: Pt claims saw floaters at time of injection. Pt was asked to stay for 15 min. Pt called back 30 minutes later and stated he was experiencing numbness of face, forehead and cheek. Directed pt to ER. At ER pt was given BENADRYL and PEPCID.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Patient had rash all over body 2 days after receiving influenza injection. Went ER 2 days later (4 days post-injection) - Received hydrocortisone cr and BENADRYL at ER.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal blistering, Swollen tongue
Clinical narrative: Tongue swelled 32 hrs after injection. Blister in mouth 32 hrs after injection. As of 10/14/09 7:00 PM tongue still swollen - Patient taking BENADRYL.
Age: 23.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Body temperature increased, Heart rate increased, Hypertension, Injection site erythema
Clinical narrative: Red at site.- T high 102 degrees, Heart rate high 140- 160 - BP high 146/94 - TYLENOL ES tabs 2 po - SV started, BENADRYL 50 mg QV sent to ER
Age: 23.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Blood pressure increased, Body temperature increased, Cellulitis, Chills, Electrocardiogram ST segment depression
Clinical narrative: Red at site.- T high 102 degrees, Heart rate high 140- 160 - BP high 146/94 - TYLENOL ES tabs 2 po - SV started, BENADRYL 50 mg QV sent to ER
Age: 23.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Electrocardiogram abnormal, Heart rate increased, Injection site erythema
Clinical narrative: Red at site.- T high 102 degrees, Heart rate high 140- 160 - BP high 146/94 - TYLENOL ES tabs 2 po - SV started, BENADRYL 50 mg QV sent to ER
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash vesicular
Clinical narrative: Within 10 days of administering VARIVAX vaccine, patient developed focal areas of itchy vesicular crusty lesions
Sex: U
Vaccine: PPV
Symptoms: Chills, Induration, Lethargy, Oropharyngeal pain, Pyrexia
Clinical narrative: Given PNEUMOVAX 12 Oct, sore throat night - next day fever, induration, chills and lethargy. No other vaccines given this year.
Age: 8.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Rash
Clinical narrative: Raised area 30 mm X 15 mm occurred 12 hours after shot given.
Age: 8.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Local swelling
Clinical narrative: Raised area 30 mm X 15 mm occurred 12 hours after shot given.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypokinesia, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Appox. 4 PM pain started from (L) shoulder radiating down arm. She has swelling and redness. 10/14/09 8:00 (L) extremity swelling from shoulder to just above elbow. Area hard and painful. Decreased ROM - KEFLEX 750 bid X 5day. BENADDRYL q 4 hrs prn.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Swelling
Clinical narrative: Appox. 4 PM pain started from (L) shoulder radiating down arm. She has swelling and redness. 10/14/09 8:00 (L) extremity swelling from shoulder to just above elbow. Area hard and painful. Decreased ROM - KEFLEX 750 bid X 5day. BENADDRYL q 4 hrs prn.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness
Clinical narrative: Dizzy, weak.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Dry throat, Rash papular
Clinical narrative: Dry throat - First night (10-609) - Rash w/Bumps - Started day two -mildly - Full blown by noon - day 3
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL, DTAPIPV, HEPA, MMR, VARCEL, DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 4-year-old male subject who was vaccinated with DTaP+IVP (Glaxosmithkline) for prophylaxis. There was no concomitant medications or relevant medical history. The subject had not experienced adverse events following previous vaccinations. Concurrent vaccination included HEP A inactivated (Glaxosmithkline) given on 24 July 2009; MMR (non-gsk) given on 24 July 2009; VARICELLA (non-gsk) (Merck) given on 24 July 2009. On 24 July 2009 at 8:20 the subject received 1st dose of DTaP+IPV (.5 ml, unknown route, left arm). On 25 July 2009,, 1 day after vaccination with DTaP+IPV, the subject experienced swelling at injection site, injection site hot to touch and injection site tenderness. At the time of reporting the events were resolved. This case is associated to a product complaint. The healthcare professional reported that 3 vials of DTaP+IPV may be effective which caused the adverse events over the past 5 weeks. There are 22 singe units left (2 full packages of 10 plus 2 single vials) and the physician in charge ordered that they not be given to other patients. There were 3 different patients involved (see case IDS A0799437A and A0799441A for more details). Follow-up information from the QA department was received on 06 August 2009. Based on the fact that no precise technical problem was reported, no technical investigation was performed accordingly. The complaint was considered as not verified.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL, DTAPIPV, HEPA, MMR, VARCEL, DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 4-year-old male subject who was vaccinated with DTaP+IVP (Glaxosmithkline) for prophylaxis. There was no concomitant medications or relevant medical history. The subject had not experienced adverse events following previous vaccinations. Concurrent vaccination included HEP A inactivated (Glaxosmithkline) given on 24 July 2009; MMR (non-gsk) given on 24 July 2009; VARICELLA (non-gsk) (Merck) given on 24 July 2009. On 24 July 2009 at 8:20 the subject received 1st dose of DTaP+IPV (.5 ml, unknown route, left arm). On 25 July 2009,, 1 day after vaccination with DTaP+IPV, the subject experienced swelling at injection site, injection site hot to touch and injection site tenderness. At the time of reporting the events were resolved. This case is associated to a product complaint. The healthcare professional reported that 3 vials of DTaP+IPV may be effective which caused the adverse events over the past 5 weeks. There are 22 singe units left (2 full packages of 10 plus 2 single vials) and the physician in charge ordered that they not be given to other patients. There were 3 different patients involved (see case IDS A0799437A and A0799441A for more details). Follow-up information from the QA department was received on 06 August 2009. Based on the fact that no precise technical problem was reported, no technical investigation was performed accordingly. The complaint was considered as not verified.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL, DTAPIPV, HEPA, MMR, VARCEL, DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 4-year-old male subject who was vaccinated with DTaP+IVP (Glaxosmithkline) for prophylaxis. There was no concomitant medications or relevant medical history. The subject had not experienced adverse events following previous vaccinations. Concurrent vaccination included HEP A inactivated (Glaxosmithkline) given on 24 July 2009; MMR (non-gsk) given on 24 July 2009; VARICELLA (non-gsk) (Merck) given on 24 July 2009. On 24 July 2009 at 8:20 the subject received 1st dose of DTaP+IPV (.5 ml, unknown route, left arm). On 25 July 2009,, 1 day after vaccination with DTaP+IPV, the subject experienced swelling at injection site, injection site hot to touch and injection site tenderness. At the time of reporting the events were resolved. This case is associated to a product complaint. The healthcare professional reported that 3 vials of DTaP+IPV may be effective which caused the adverse events over the past 5 weeks. There are 22 singe units left (2 full packages of 10 plus 2 single vials) and the physician in charge ordered that they not be given to other patients. There were 3 different patients involved (see case IDS A0799437A and A0799441A for more details). Follow-up information from the QA department was received on 06 August 2009. Based on the fact that no precise technical problem was reported, no technical investigation was performed accordingly. The complaint was considered as not verified.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Local reaction, No reaction on previous exposure to drug
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 5-year-old male subject who was vaccinated with combined DTaP+IPV (Glaxosmithkline) for prophylaxis. There was no relevant medical history. The subject had not experienced adverse events following previous vaccinations. Concurrent vaccination included MMR (non-gsk) (Merck; right arm) given on 20 July 2009; VARICELLA (non-gsk) (Merck; right arm) given on 20 July 2009. Previous medications included Allergy medication (Allergy shot) given on 10 July 2009. On 20 July 2009 the subject received a dose of DTap+IPV (.5cc, unknown route, left arm) as the 5th dose in the DTaP series, and 4th in the POLIO series. The lot numbers was reported as ACZ0B115AA. On 20 July 2009, less than one day after vaccination with DTap+IPV, the subject experienced swelling at injection site, injection site redness, and later on an injection site rash. The healthcare professional reported that the subject experienced a 7 centimeter local reaction at the injection site in his left arm only. The swelling and redness occurred the same day of vaccination but the rash developed later. At the time of reporting, the rash had spread to the subject's elbow. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with DTaP+IPV. Follow-up information was received from the reporting nurse on 07 August 2009. DTaP+IPV was given intramuscularly. The events resolved with sequelae on an unknown date. There were no relevant laboratory tests, investigations or procedures. The subject received allergy shots (dust, mold). The subject had no alcohol or tobacco use. The nurse reported that there was no further information available.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 5-year-old male subject who was vaccinated with combined DTaP+IPV (Glaxosmithkline) for prophylaxis. There was no relevant medical history. The subject had not experienced adverse events following previous vaccinations. Concurrent vaccination included MMR (non-gsk) (Merck; right arm) given on 20 July 2009; VARICELLA (non-gsk) (Merck; right arm) given on 20 July 2009. Previous medications included Allergy medication (Allergy shot) given on 10 July 2009. On 20 July 2009 the subject received a dose of DTap+IPV (.5cc, unknown route, left arm) as the 5th dose in the DTaP series, and 4th in the POLIO series. The lot numbers was reported as ACZ0B115AA. On 20 July 2009, less than one day after vaccination with DTap+IPV, the subject experienced swelling at injection site, injection site redness, and later on an injection site rash. The healthcare professional reported that the subject experienced a 7 centimeter local reaction at the injection site in his left arm only. The swelling and redness occurred the same day of vaccination but the rash developed later. At the time of reporting, the rash had spread to the subject's elbow. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with DTaP+IPV. Follow-up information was received from the reporting nurse on 07 August 2009. DTaP+IPV was given intramuscularly. The events resolved with sequelae on an unknown date. There were no relevant laboratory tests, investigations or procedures. The subject received allergy shots (dust, mold). The subject had no alcohol or tobacco use. The nurse reported that there was no further information available.
Age: 60.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain, Pruritus, Rash
Clinical narrative: Patient has extensive severe rash on trunk, arms, legs. Itching and Pain phamacist recommended 2 Benadryl at 4-6 hr interval. Also apply Benadryl lotion to affected area. This reaction unknown to patient having received vaccine for numerous previous years. He received vaccine without preservative and in previous years was with preservative.
Age: 60.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: No reaction on previous exposure to drug, Rash generalised
Clinical narrative: Patient has extensive severe rash on trunk, arms, legs. Itching and Pain phamacist recommended 2 Benadryl at 4-6 hr interval. Also apply Benadryl lotion to affected area. This reaction unknown to patient having received vaccine for numerous previous years. He received vaccine without preservative and in previous years was with preservative.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: States 3 days after vaccine, she developed hives, severe pruritis, needed IM kenalog and po Benadryl, given by PMD
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Activities of daily living impaired, Back pain, Chest pain, Muscle spasms
Clinical narrative: Pain in chest area and middle back as evening progressed pain spead into sides and abdomin area.Had muscle spasms. hurt so bad couldn't lay daown or sit.could not apply presure to any midrif area. I took a couple of doses of Advil and about 10:00 pm I finally was able to rest.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Pain in chest area and middle back as evening progressed pain spead into sides and abdomin area.Had muscle spasms. hurt so bad couldn't lay daown or sit.could not apply presure to any midrif area. I took a couple of doses of Advil and about 10:00 pm I finally was able to rest.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Epistaxis
Clinical narrative: Mother reports that child was playing in playground 3 hours after vaccine (mist) was given.  Child reported to have blood on face and arms.  After cleaning, found blood coming from nose.  Child did not report injury to nose.  Was not in pain.  Mother unsure how much child bled or for how long.  She relates that the bloody nose was from the Flu Mist.  Unsure whether dose was split between nostrils or given in one dose to one nostril.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Lymphadenopathy, Malaise, Musculoskeletal pain, Neck pain
Clinical narrative: On 10/08 patient developed pain on right side of neck.  This was followed by swollen lymph nodes in the same area that appeared red.  10/14 left side of neck had swollen red appearing lymph nodes with no pain.  Denies sore throat, ear pain, fever.  She also had malaise but thought it may be due to her menstrual cycles since that is usual.  She also reported on 10/8 bone pain in left shoulder same time as the beginning of the swollen lymph nodes.  She has not seen her physician yet, but will call for an appointment today.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Headache, Rash
Clinical narrative: Dizziness and headache for 15 minutes after receiving the vaccination Rash medial to the vaccination site
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: extreme dizziness
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle fatigue, Pain
Clinical narrative: 10-14-09 @ 09:30 - received inoculation right deltoid; 10-14-09 @ 17:00 - began aching to right lower arm with some muscle fatigue of right arm.  10-15-09 @ 06:00 - awoke with aching/muscle fatigue right arm, right side to right leg - no weakness.  No erythema or bruising.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Noted lump 9/28/09 Red and warm . Not feeling bad - Arm hurt. Redness and warmth upper arm was given sample XYZAL 5mg one daily. Symptoms resolved.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot, Lip swelling
Clinical narrative: 45min past influenza vaccine was admin - Pt began to feel lips swell, hot and dizzy.
Age: 0.03
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Induration, Rash erythematous, Skin warm
Clinical narrative: Erythematous induration +- 15 cm in diameter with warmth.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia facial, Lymph node pain, Lymphadenopathy, Oedema peripheral, Pharyngeal hypoaesthesia
Clinical narrative: Left arm localized swelling the size of a grapefruit. Swollen lymph nodes in armpit very tender. Numbness in left side of throat and ear. Improving
Age: 18.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ, TDAP
Symptoms: Gaze palsy, Hypotonia, Immediate post-injection reaction, Musculoskeletal stiffness, Syncope
Clinical narrative: Immediately after administration all the above vaccine she became limp then stiff - eyes rolled up - fainted - helped to the floor within a minute she recovered fully - vitals signs normal. No treatment given - paramedics came - no medications given - stable.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Anion gap normal, Autoimmune thyroiditis, Basophil count decreased, Blood thyroid stimulating hormone increased, Body temperature
Clinical narrative: Information has been received from a physician concerning a 13 year old female who in 2008 was vaccinated with GARDASIL. The patient completed the series of GARDASIL in 2008 and was recently diagnosed with Autoimmune Thyroiditis (2009). The patient sought her pediatrician. At the time of the reporting, the patient had not recovered from the event. Follow up information received on 06-OCT-2009 from a physician via medical records indicated that the patient was female student, with no medical history, known allergies or illness at the time of vaccination. The patient's family history included hypothyroidism and polycystic ovary syndrome (mother), aniridia (brother) and hypothyroidism (paternal grandmother). On 26-NOV-2008 the patient was vaccinated with a third dose of GARDASIL (lot # 650557/0072X), intramuscularly into the left arm. Secondary suspect vaccination given on the same day included a third dose of FLUZONE, (lot # U2760AA), intramuscularly into the right arm. The patient presented with her mother in the physician's office on 19-MAY-2009, complaining of feeling tired, muscle aches and requiring long naps. She has been experiencing these symptoms for the last couple of months (end of school year). The myalgias were generalized and most pronounced in her knees, hips and shoulders. TYLENOL helps some. She has been sleeping well-getting 8 hours of sleep without significant interruption. She generally feels well rested in the morning. She has not been short of breath and she denies fever, chills, night sweats, nausea, vomiting. She started her menstrual periods last July and they have been irregular. Her mother noticed that the fatigue and body aches were more pronounced just prior to her most recent menstruation. She had no urinary problems and she denied increase thirst. She grew approximately 2 inches in height in the past year. The physical exam was within normal limits. The patient developed hypothyroidism diagnosed on 19-MAY-2009 with symptoms beginning in March 2009 (approximate). The patient had a complete blood cell count, comprehensive metabolic panel and serum thyroid-stimulating hormone test drawn. All were normal except for serum thyroid-stimulating hormone test of 12.060 UIU/ml (high), normal 0.400-5.100, done on 19-MAY-2009. Patient's mother was notified and instructed to make an appointment with a child endocrinologist to evaluate hypothyroidism. The patient was not in any thyroid medication. On 30-JUL-2009, the patient was evaluated for hypothyroidism. There was no goiter. The patient's mother reported that the symptoms have somewhat improved despite no treatment. Patient scheduled for additional blood tests to evaluate need for her to start taking Levothyroxine. The reporting physician considered the hypothyroidism to be an other important medical event. No further information is available.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Eosinophil count normal, Fatigue, Hypothyroidism, Lymphocyte count normal, Menstruation irregular
Clinical narrative: Information has been received from a physician concerning a 13 year old female who in 2008 was vaccinated with GARDASIL. The patient completed the series of GARDASIL in 2008 and was recently diagnosed with Autoimmune Thyroiditis (2009). The patient sought her pediatrician. At the time of the reporting, the patient had not recovered from the event. Follow up information received on 06-OCT-2009 from a physician via medical records indicated that the patient was female student, with no medical history, known allergies or illness at the time of vaccination. The patient's family history included hypothyroidism and polycystic ovary syndrome (mother), aniridia (brother) and hypothyroidism (paternal grandmother). On 26-NOV-2008 the patient was vaccinated with a third dose of GARDASIL (lot # 650557/0072X), intramuscularly into the left arm. Secondary suspect vaccination given on the same day included a third dose of FLUZONE, (lot # U2760AA), intramuscularly into the right arm. The patient presented with her mother in the physician's office on 19-MAY-2009, complaining of feeling tired, muscle aches and requiring long naps. She has been experiencing these symptoms for the last couple of months (end of school year). The myalgias were generalized and most pronounced in her knees, hips and shoulders. TYLENOL helps some. She has been sleeping well-getting 8 hours of sleep without significant interruption. She generally feels well rested in the morning. She has not been short of breath and she denies fever, chills, night sweats, nausea, vomiting. She started her menstrual periods last July and they have been irregular. Her mother noticed that the fatigue and body aches were more pronounced just prior to her most recent menstruation. She had no urinary problems and she denied increase thirst. She grew approximately 2 inches in height in the past year. The physical exam was within normal limits. The patient developed hypothyroidism diagnosed on 19-MAY-2009 with symptoms beginning in March 2009 (approximate). The patient had a complete blood cell count, comprehensive metabolic panel and serum thyroid-stimulating hormone test drawn. All were normal except for serum thyroid-stimulating hormone test of 12.060 UIU/ml (high), normal 0.400-5.100, done on 19-MAY-2009. Patient's mother was notified and instructed to make an appointment with a child endocrinologist to evaluate hypothyroidism. The patient was not in any thyroid medication. On 30-JUL-2009, the patient was evaluated for hypothyroidism. There was no goiter. The patient's mother reported that the symptoms have somewhat improved despite no treatment. Patient scheduled for additional blood tests to evaluate need for her to start taking Levothyroxine. The reporting physician considered the hypothyroidism to be an other important medical event. No further information is available.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Monocyte count increased, Myalgia, Neutrophil count decreased, Respiratory rate
Clinical narrative: Information has been received from a physician concerning a 13 year old female who in 2008 was vaccinated with GARDASIL. The patient completed the series of GARDASIL in 2008 and was recently diagnosed with Autoimmune Thyroiditis (2009). The patient sought her pediatrician. At the time of the reporting, the patient had not recovered from the event. Follow up information received on 06-OCT-2009 from a physician via medical records indicated that the patient was female student, with no medical history, known allergies or illness at the time of vaccination. The patient's family history included hypothyroidism and polycystic ovary syndrome (mother), aniridia (brother) and hypothyroidism (paternal grandmother). On 26-NOV-2008 the patient was vaccinated with a third dose of GARDASIL (lot # 650557/0072X), intramuscularly into the left arm. Secondary suspect vaccination given on the same day included a third dose of FLUZONE, (lot # U2760AA), intramuscularly into the right arm. The patient presented with her mother in the physician's office on 19-MAY-2009, complaining of feeling tired, muscle aches and requiring long naps. She has been experiencing these symptoms for the last couple of months (end of school year). The myalgias were generalized and most pronounced in her knees, hips and shoulders. TYLENOL helps some. She has been sleeping well-getting 8 hours of sleep without significant interruption. She generally feels well rested in the morning. She has not been short of breath and she denies fever, chills, night sweats, nausea, vomiting. She started her menstrual periods last July and they have been irregular. Her mother noticed that the fatigue and body aches were more pronounced just prior to her most recent menstruation. She had no urinary problems and she denied increase thirst. She grew approximately 2 inches in height in the past year. The physical exam was within normal limits. The patient developed hypothyroidism diagnosed on 19-MAY-2009 with symptoms beginning in March 2009 (approximate). The patient had a complete blood cell count, comprehensive metabolic panel and serum thyroid-stimulating hormone test drawn. All were normal except for serum thyroid-stimulating hormone test of 12.060 UIU/ml (high), normal 0.400-5.100, done on 19-MAY-2009. Patient's mother was notified and instructed to make an appointment with a child endocrinologist to evaluate hypothyroidism. The patient was not in any thyroid medication. On 30-JUL-2009, the patient was evaluated for hypothyroidism. There was no goiter. The patient's mother reported that the symptoms have somewhat improved despite no treatment. Patient scheduled for additional blood tests to evaluate need for her to start taking Levothyroxine. The reporting physician considered the hypothyroidism to be an other important medical event. No further information is available.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Anion gap normal, Arthralgia, Autoimmune thyroiditis, Basophil percentage decreased, Blood thyroid stimulating hormone increased
Clinical narrative: Information has been received from a physician concerning a 13 year old female who in 2008 was vaccinated with GARDASIL. The patient completed the series of GARDASIL in 2008 and was recently diagnosed with Autoimmune Thyroiditis (2009). The patient sought her pediatrician. At the time of the reporting, the patient had not recovered from the event. Follow up information received on 06-OCT-2009 from a physician via medical records indicated that the patient was female student, with no medical history, known allergies or illness at the time of vaccination. The patient's family history included hypothyroidism and polycystic ovary syndrome (mother), aniridia (brother) and hypothyroidism (paternal grandmother). On 26-NOV-2008 the patient was vaccinated with a third dose of GARDASIL (lot # 650557/0072X), intramuscularly into the left arm. Secondary suspect vaccination given on the same day included a third dose of FLUZONE, (lot # U2760AA), intramuscularly into the right arm. The patient presented with her mother in the physician's office on 19-MAY-2009, complaining of feeling tired, muscle aches and requiring long naps. She has been experiencing these symptoms for the last couple of months (end of school year). The myalgias were generalized and most pronounced in her knees, hips and shoulders. TYLENOL helps some. She has been sleeping well-getting 8 hours of sleep without significant interruption. She generally feels well rested in the morning. She has not been short of breath and she denies fever, chills, night sweats, nausea, vomiting. She started her menstrual periods last July and they have been irregular. Her mother noticed that the fatigue and body aches were more pronounced just prior to her most recent menstruation. She had no urinary problems and she denied increase thirst. She grew approximately 2 inches in height in the past year. The physical exam was within normal limits. The patient developed hypothyroidism diagnosed on 19-MAY-2009 with symptoms beginning in March 2009 (approximate). The patient had a complete blood cell count, comprehensive metabolic panel and serum thyroid-stimulating hormone test drawn. All were normal except for serum thyroid-stimulating hormone test of 12.060 UIU/ml (high), normal 0.400-5.100, done on 19-MAY-2009. Patient's mother was notified and instructed to make an appointment with a child endocrinologist to evaluate hypothyroidism. The patient was not in any thyroid medication. On 30-JUL-2009, the patient was evaluated for hypothyroidism. There was no goiter. The patient's mother reported that the symptoms have somewhat improved despite no treatment. Patient scheduled for additional blood tests to evaluate need for her to start taking Levothyroxine. The reporting physician considered the hypothyroidism to be an other important medical event. No further information is available.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Eosinophil count normal, Fatigue, Hypersomnia, Hypothyroidism, Lymphocyte count normal
Clinical narrative: Information has been received from a physician concerning a 13 year old female who in 2008 was vaccinated with GARDASIL. The patient completed the series of GARDASIL in 2008 and was recently diagnosed with Autoimmune Thyroiditis (2009). The patient sought her pediatrician. At the time of the reporting, the patient had not recovered from the event. Follow up information received on 06-OCT-2009 from a physician via medical records indicated that the patient was female student, with no medical history, known allergies or illness at the time of vaccination. The patient's family history included hypothyroidism and polycystic ovary syndrome (mother), aniridia (brother) and hypothyroidism (paternal grandmother). On 26-NOV-2008 the patient was vaccinated with a third dose of GARDASIL (lot # 650557/0072X), intramuscularly into the left arm. Secondary suspect vaccination given on the same day included a third dose of FLUZONE, (lot # U2760AA), intramuscularly into the right arm. The patient presented with her mother in the physician's office on 19-MAY-2009, complaining of feeling tired, muscle aches and requiring long naps. She has been experiencing these symptoms for the last couple of months (end of school year). The myalgias were generalized and most pronounced in her knees, hips and shoulders. TYLENOL helps some. She has been sleeping well-getting 8 hours of sleep without significant interruption. She generally feels well rested in the morning. She has not been short of breath and she denies fever, chills, night sweats, nausea, vomiting. She started her menstrual periods last July and they have been irregular. Her mother noticed that the fatigue and body aches were more pronounced just prior to her most recent menstruation. She had no urinary problems and she denied increase thirst. She grew approximately 2 inches in height in the past year. The physical exam was within normal limits. The patient developed hypothyroidism diagnosed on 19-MAY-2009 with symptoms beginning in March 2009 (approximate). The patient had a complete blood cell count, comprehensive metabolic panel and serum thyroid-stimulating hormone test drawn. All were normal except for serum thyroid-stimulating hormone test of 12.060 UIU/ml (high), normal 0.400-5.100, done on 19-MAY-2009. Patient's mother was notified and instructed to make an appointment with a child endocrinologist to evaluate hypothyroidism. The patient was not in any thyroid medication. On 30-JUL-2009, the patient was evaluated for hypothyroidism. There was no goiter. The patient's mother reported that the symptoms have somewhat improved despite no treatment. Patient scheduled for additional blood tests to evaluate need for her to start taking Levothyroxine. The reporting physician considered the hypothyroidism to be an other important medical event. No further information is available.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Menstruation irregular, Monocyte percentage increased, Myalgia, Neutrophil percentage decreased, Pain
Clinical narrative: Information has been received from a physician concerning a 13 year old female who in 2008 was vaccinated with GARDASIL. The patient completed the series of GARDASIL in 2008 and was recently diagnosed with Autoimmune Thyroiditis (2009). The patient sought her pediatrician. At the time of the reporting, the patient had not recovered from the event. Follow up information received on 06-OCT-2009 from a physician via medical records indicated that the patient was female student, with no medical history, known allergies or illness at the time of vaccination. The patient's family history included hypothyroidism and polycystic ovary syndrome (mother), aniridia (brother) and hypothyroidism (paternal grandmother). On 26-NOV-2008 the patient was vaccinated with a third dose of GARDASIL (lot # 650557/0072X), intramuscularly into the left arm. Secondary suspect vaccination given on the same day included a third dose of FLUZONE, (lot # U2760AA), intramuscularly into the right arm. The patient presented with her mother in the physician's office on 19-MAY-2009, complaining of feeling tired, muscle aches and requiring long naps. She has been experiencing these symptoms for the last couple of months (end of school year). The myalgias were generalized and most pronounced in her knees, hips and shoulders. TYLENOL helps some. She has been sleeping well-getting 8 hours of sleep without significant interruption. She generally feels well rested in the morning. She has not been short of breath and she denies fever, chills, night sweats, nausea, vomiting. She started her menstrual periods last July and they have been irregular. Her mother noticed that the fatigue and body aches were more pronounced just prior to her most recent menstruation. She had no urinary problems and she denied increase thirst. She grew approximately 2 inches in height in the past year. The physical exam was within normal limits. The patient developed hypothyroidism diagnosed on 19-MAY-2009 with symptoms beginning in March 2009 (approximate). The patient had a complete blood cell count, comprehensive metabolic panel and serum thyroid-stimulating hormone test drawn. All were normal except for serum thyroid-stimulating hormone test of 12.060 UIU/ml (high), normal 0.400-5.100, done on 19-MAY-2009. Patient's mother was notified and instructed to make an appointment with a child endocrinologist to evaluate hypothyroidism. The patient was not in any thyroid medication. On 30-JUL-2009, the patient was evaluated for hypothyroidism. There was no goiter. The patient's mother reported that the symptoms have somewhat improved despite no treatment. Patient scheduled for additional blood tests to evaluate need for her to start taking Levothyroxine. The reporting physician considered the hypothyroidism to be an other important medical event. No further information is available.
Age: 14.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Blood test normal, Chest X-ray normal, Computerised tomogram head, Computerised tomogram normal, Convulsion
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female who on 08-OCT-2009 was vaccinated with her second 0.5mL dose of GARDASIL (route and lot number not reported). Concomitant therapy included FLUMIST. IT was reported that half an hour later, on 08-OCT-2009, the patient experienced passed out, hit her head and had a seizure. The patient was taken to the emergency room and was released. The physician felt it was important to note that the patient had not eaten prior to vaccination. The patient recovered from hit her head, passed out and seizure on the same day. Follow up information was received from a registered nurse concerning the 14 year old female patient with no pertinent medical history reported and no known drug allergies who on 08-OCT-2009 was vaccinated with her second dose of GARDASIL (lot number 663451/0216Y) and concomitantly with a dose of FLUMIST (lot number 500711P). The registered nurse reported that the patient left the office and was in a restaurant when she "passed out and stiffened" on 08-OCT-2009. The patient was taken to the ER where a CT of the head, EKG, chest X-ray and blood work were performed (all normal). No treatment was needed. It was noted that the patient received the first dose of GARDASIL (route not reported, lot number 664780/0904Y, valid for ROTATEQ) on 16-JUL-2009. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Electrocardiogram normal, Head injury, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female who on 08-OCT-2009 was vaccinated with her second 0.5mL dose of GARDASIL (route and lot number not reported). Concomitant therapy included FLUMIST. IT was reported that half an hour later, on 08-OCT-2009, the patient experienced passed out, hit her head and had a seizure. The patient was taken to the emergency room and was released. The physician felt it was important to note that the patient had not eaten prior to vaccination. The patient recovered from hit her head, passed out and seizure on the same day. Follow up information was received from a registered nurse concerning the 14 year old female patient with no pertinent medical history reported and no known drug allergies who on 08-OCT-2009 was vaccinated with her second dose of GARDASIL (lot number 663451/0216Y) and concomitantly with a dose of FLUMIST (lot number 500711P). The registered nurse reported that the patient left the office and was in a restaurant when she "passed out and stiffened" on 08-OCT-2009. The patient was taken to the ER where a CT of the head, EKG, chest X-ray and blood work were performed (all normal). No treatment was needed. It was noted that the patient received the first dose of GARDASIL (route not reported, lot number 664780/0904Y, valid for ROTATEQ) on 16-JUL-2009. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Abdominal pain upper, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a healthcare worker concerning a 42 year old female patient who on 06-OCT-2009 was vaccinated with a dose of PNEUMOVAX (lot # 663012/1163X). It was not known at the time of reporting if this was the first time that the patient had received PNEUMOVAX 23. On the same day the patient developed severe swelling and redness of her arm at the injection site, fever and stomach pain. The swelling was first noted to be the size of an orange and was the size of a grapefruit at the time of reporting. The patient was first admitted to one hospital and then transferred on 08-OCT-2009 to another hospital. The patient was being treated with an unspecified intravenous antibiotic. At the time of reporting, the patient had not recovered. A lot number check for 663012/1163X is requested and initiated. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Pyrexia, Rash, Red blood cell sedimentation rate increased, Vaccination complication
Clinical narrative: Information has been received from a healthcare worker concerning a 42 year old female patient who on 06-OCT-2009 was vaccinated with a dose of PNEUMOVAX (lot # 663012/1163X). It was not known at the time of reporting if this was the first time that the patient had received PNEUMOVAX 23. On the same day the patient developed severe swelling and redness of her arm at the injection site, fever and stomach pain. The swelling was first noted to be the size of an orange and was the size of a grapefruit at the time of reporting. The patient was first admitted to one hospital and then transferred on 08-OCT-2009 to another hospital. The patient was being treated with an unspecified intravenous antibiotic. At the time of reporting, the patient had not recovered. A lot number check for 663012/1163X is requested and initiated. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV, PPV
Symptoms: White blood cell count increased
Clinical narrative: Information has been received from a healthcare worker concerning a 42 year old female patient who on 06-OCT-2009 was vaccinated with a dose of PNEUMOVAX (lot # 663012/1163X). It was not known at the time of reporting if this was the first time that the patient had received PNEUMOVAX 23. On the same day the patient developed severe swelling and redness of her arm at the injection site, fever and stomach pain. The swelling was first noted to be the size of an orange and was the size of a grapefruit at the time of reporting. The patient was first admitted to one hospital and then transferred on 08-OCT-2009 to another hospital. The patient was being treated with an unspecified intravenous antibiotic. At the time of reporting, the patient had not recovered. A lot number check for 663012/1163X is requested and initiated. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Cough, Eye pain, Pain, Pyrexia
Clinical narrative: 9 hrs post injection, fever 103 for day and half, sore eyes, cough & body ache.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Eye pain, Pain, Pyrexia
Clinical narrative: 5 hours post injection fever 103 degrees persisting for 2 days, sore eyes and body aches wit.h dry cough. Still fever at time of report.
Sex: U
Vaccine: TD
Symptoms: Arthralgia, Fluid retention
Clinical narrative: Knee pain and fluid.
Age: 36.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Headache, Heart rate increased, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Client c/o nausea immediately following the shot, headache 2 1/2 hrs after and dizziness 3 1/2 hrs after, felt fast heart rate which lasted for 15 mins, numbness (L) breast, had on 3 pillows last night. Did not take any meds. Is still c/o slight dizziness today. Patient recovering still c/o slight nausea and dizziness.
Age: 36.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Nausea
Clinical narrative: Client c/o nausea immediately following the shot, headache 2 1/2 hrs after and dizziness 3 1/2 hrs after, felt fast heart rate which lasted for 15 mins, numbness (L) breast, had on 3 pillows last night. Did not take any meds. Is still c/o slight dizziness today. Patient recovering still c/o slight nausea and dizziness.
Age: 36.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Cough, Pruritus generalised
Clinical narrative: Five minutes after receiving injectable H1N1 vaccine, developed dry cough & generalized itching.
Age: 49.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Headache, Hyperhidrosis, Immunisation reaction, Influenza like illness
Clinical narrative: I had an extreme reaction with sever Flu like symptoms - light/sound sensitive, front headach, total body achs sore - high Fever, chills, sweating on 2nd day.
Age: 49.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Phonophobia, Photophobia, Pyrexia
Clinical narrative: I had an extreme reaction with sever Flu like symptoms - light/sound sensitive, front headach, total body achs sore - high Fever, chills, sweating on 2nd day.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Pt reported swelling, fiery red rash, itching and soreness peri-injection site approx 48 hours after receiving injection. Pt states she took BENADRYL at time reported - rash resolving.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Pruritus, Rash
Clinical narrative: See attached documentation.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: (1) Pt. claims arm is still sore about 2 weeks after injection.
Age: 34.0
Sex: F
Vaccine: TTOX
Symptoms: Back pain, Chills, Epistaxis, Headache, Injection site erythema
Clinical narrative: Severe headache, nose bleed, chills/low grade fever, swelling & redness site of injection, severe back ache.
Age: 34.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Severe headache, nose bleed, chills/low grade fever, swelling & redness site of injection, severe back ache.
Age: 53.0
Sex: F
Vaccine: HEP, HEPA, TYP, YF
Symptoms: Injection site erythema
Clinical narrative: Erythema where administered 5X3.2 cm. (R) arm.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Eye pruritus, Eye swelling, Vision blurred
Clinical narrative: Blurred vision and itching to L eye began at 5:00 pm; L eye swollen in A.M. of 10/15/09 Ms. Converse took Benadryl PO on evening of 10/14/09
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Heart rate increased, Pruritus
Clinical narrative: Adverse Event: Weakness, a fast heart beat, dizzines, itching arms & chest Treatment:  Benadryl 2 Tablets @ 4:00PM 10/13/09 & 1 Tablet 10/14 10/15/09 all symtems gone
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Headache, Influenza serology negative, Pyrexia
Clinical narrative: Received a fluzone vaccine in the am of 10/12/2009. That evening developed a fever of 103, headache and back pain. Came to office 10/13/2009 flu test was negative with no signs of illness.
Age: 43.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Asthma, Condition aggravated, Headache, Immediate post-injection reaction
Clinical narrative: Had slight headache right after receiving nasal mist for h1n1. It lasted for about 3 hours.  Had a asthma attack at 10:30 pm and used Maxair inhalar to stop episode.
Age: 1.08
Sex: M
Vaccine: HEPA, PNC, VARCEL
Symptoms: Gianotti-Crosti syndrome, Oedema, Rash, Rash papular, Skin lesion
Clinical narrative: rash.  ? if started ~6/8/09.  came into office to be seen on 6/15/09 with edematous papules, esp on forearms and thighs.  macular lesions of lower back and buttocks.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Injection site pain, Swollen tongue
Clinical narrative: The evening of the shot she had pain at injection site.  The following morning, had difficulty breathing, and tongue swelling.
Age: 25.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal pain upper, Blindness unilateral, Keratoconus, Photophobia, Vision blurred
Clinical narrative: developed very severe stomach aches (went to emergency room) and shortly following that severe keratoconus (blindness) in my right eye, from which i've been suffering ever since.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza like illness, Lethargy, Pain, Pyrexia
Clinical narrative: Developed signs and symptoms of the flu 6 hours after receiving the flumist. He had fever 101, body aches and lethargy.