chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pallor
Clinical narrative: Employee experienced light headedness, weakness in legs, pallor, stomach cramps, nausea, and diarrhea.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Dry skin, Pain, Pruritus, Rash
Clinical narrative: The patient is a 62 year old female who presents with a complaint of a skin rash. The onset of the rash has been acute and has been occurring in a persistent pattern for 1 day. The course has been constant. The rash is characterized as red, pustular and raised above the skin. The rash was first seen on the back. It spread to the upper extremity (right side). There has been associated itching and pain, while there has been no chills. Overall examination of the patient's skin reveals - Skin is warm and dry. Note: she has rash consistent with shingles on right upper back...three patchy areas of vesicles. FAMCLOVIR 500MG; LORTAB 5 5-500MG. Follow up if no improvement or if symptoms worsen.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pustular, Skin warm
Clinical narrative: The patient is a 62 year old female who presents with a complaint of a skin rash. The onset of the rash has been acute and has been occurring in a persistent pattern for 1 day. The course has been constant. The rash is characterized as red, pustular and raised above the skin. The rash was first seen on the back. It spread to the upper extremity (right side). There has been associated itching and pain, while there has been no chills. Overall examination of the patient's skin reveals - Skin is warm and dry. Note: she has rash consistent with shingles on right upper back...three patchy areas of vesicles. FAMCLOVIR 500MG; LORTAB 5 5-500MG. Follow up if no improvement or if symptoms worsen.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Local swelling
Clinical narrative: Local swelling
Age: 35.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Cough, Ear pain, Oedema peripheral, Pain in extremity
Clinical narrative: Mild swelling and pain Left hand and bilateral feet. no rash. c/o cough and earache given Z-pk.  Follow-up information received January 15, 2010. Dr did not administer injection. As noted pt. received at POD given by Dept of Health.  Patient received H1N1 at POD given by Dept of Health. Came to our office with adverse reaction.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Akinesia, Bradyphrenia, Ear disorder, Eye disorder, Hyperacusis
Clinical narrative: At approx 5:00 AM on 01/06/10 employee awakened feeling "motionless"/did not want to move; difficult to raise her head off bed.  Took shower, laid back down and was late for work.  All day it was a struggle to keep her eyes open and perform normal lab functions where she works.  Felt very irritable with co-workers. Felt like she "could not tolerate anything."  Felt like noises were abnormally loud; felt like her body was "shutting down."  It was a "struggle to even think." Finished work; went home and slept for approx 1 hr; 45 min, then stayed in chair & watched TV for couple of hrs; then went to bed and to sleep.  Next day, called in sick; told dept she had a rxn from flu shot.  This day (01/07/10) her body felt "kind of paralyzed"; body did not want to move nor eyes to open.  She did not want to get up; but was to get out of bed to go to bathroom.  Felt "out of it."  Felt like she was having slower reactions, like answering her parents when they were on the phone. Thinking very slowly also.  About 3 PM that afternoon, could tell she was feeling better.  (Had slept at least until 12 noon).  On Friday, Jan 8, she could tell that "everthing in her body was tingling" (legs and body tingling); she felt "like she was coming out of it."  She worked all day without problems; was happy to be back to work.  She called Employee Health; she also called her Primary MD and talked to the nurse practitioner and asked her to put this reaction to flu shot in her medical file.  Over last weekend she still felt "sluggish".  Today, Jan 12---no problems at all.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Hypokinesia, Impaired work ability, Irritability, Mental impairment, Paraesthesia
Clinical narrative: At approx 5:00 AM on 01/06/10 employee awakened feeling "motionless"/did not want to move; difficult to raise her head off bed.  Took shower, laid back down and was late for work.  All day it was a struggle to keep her eyes open and perform normal lab functions where she works.  Felt very irritable with co-workers. Felt like she "could not tolerate anything."  Felt like noises were abnormally loud; felt like her body was "shutting down."  It was a "struggle to even think." Finished work; went home and slept for approx 1 hr; 45 min, then stayed in chair & watched TV for couple of hrs; then went to bed and to sleep.  Next day, called in sick; told dept she had a rxn from flu shot.  This day (01/07/10) her body felt "kind of paralyzed"; body did not want to move nor eyes to open.  She did not want to get up; but was to get out of bed to go to bathroom.  Felt "out of it."  Felt like she was having slower reactions, like answering her parents when they were on the phone. Thinking very slowly also.  About 3 PM that afternoon, could tell she was feeling better.  (Had slept at least until 12 noon).  On Friday, Jan 8, she could tell that "everthing in her body was tingling" (legs and body tingling); she felt "like she was coming out of it."  She worked all day without problems; was happy to be back to work.  She called Employee Health; she also called her Primary MD and talked to the nurse practitioner and asked her to put this reaction to flu shot in her medical file.  Over last weekend she still felt "sluggish".  Today, Jan 12---no problems at all.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Paralysis, Sluggishness, Vaccination complication
Clinical narrative: At approx 5:00 AM on 01/06/10 employee awakened feeling "motionless"/did not want to move; difficult to raise her head off bed.  Took shower, laid back down and was late for work.  All day it was a struggle to keep her eyes open and perform normal lab functions where she works.  Felt very irritable with co-workers. Felt like she "could not tolerate anything."  Felt like noises were abnormally loud; felt like her body was "shutting down."  It was a "struggle to even think." Finished work; went home and slept for approx 1 hr; 45 min, then stayed in chair & watched TV for couple of hrs; then went to bed and to sleep.  Next day, called in sick; told dept she had a rxn from flu shot.  This day (01/07/10) her body felt "kind of paralyzed"; body did not want to move nor eyes to open.  She did not want to get up; but was to get out of bed to go to bathroom.  Felt "out of it."  Felt like she was having slower reactions, like answering her parents when they were on the phone. Thinking very slowly also.  About 3 PM that afternoon, could tell she was feeling better.  (Had slept at least until 12 noon).  On Friday, Jan 8, she could tell that "everthing in her body was tingling" (legs and body tingling); she felt "like she was coming out of it."  She worked all day without problems; was happy to be back to work.  She called Employee Health; she also called her Primary MD and talked to the nurse practitioner and asked her to put this reaction to flu shot in her medical file.  Over last weekend she still felt "sluggish".  Today, Jan 12---no problems at all.
Age: 66.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Fatigue, Throat tightness
Clinical narrative: Patient felt a little fatigue, felt like her throat closing. Patient contacted md and was advised to take Benadryl. Patient felt a little better.
Age: 9.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Cyanosis, Dizziness, Headache, Hyperhidrosis
Clinical narrative: h/a, blurry vision, very pale, blue lips, dizzy. Sweating, weak. EMS called and arrived (with parents)
Age: 9.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pallor, Vision blurred
Clinical narrative: h/a, blurry vision, very pale, blue lips, dizzy. Sweating, weak. EMS called and arrived (with parents)
Age: 74.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Itchiness and hives at injection site, staying localized to small area.
Age: 45.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Cough, Dizziness, Fatigue, Lacrimation increased, Laryngitis
Clinical narrative: Watery eyes and nasal congestion to start.  Three days later progressed to dizziness, fatigue, cough, laryngitis and sneezing.
Age: 45.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Nasal congestion, Sneezing
Clinical narrative: Watery eyes and nasal congestion to start.  Three days later progressed to dizziness, fatigue, cough, laryngitis and sneezing.
Age: 1.46
Sex: F
Vaccine: DTAPHEPBIP, FLUX, MMR, VARCEL
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Fever up to 104 for 4 days (until 1/10/10 at 8pm) and one episode of shaking (likely chills).
Age: 1.03
Sex: M
Vaccine: MMR, PNC
Symptoms: Urticaria
Clinical narrative: Dessimated urticaria developed approximately 24 hours after administration of MMR#1 and Prevnar #4.Continued presentation of hives over 3 days until seen by Dr. on 01/11/10.
Age: 47.0
Sex: M
Vaccine: FLU(H1N1), FLU3, PPV
Symptoms: Fatigue, Injection site swelling, Local swelling, Testicular disorder
Clinical narrative: Severe fatigue and local swelling extending up deltoid into neck.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blood culture, Full blood count, Pallor, Pyrexia, Rash
Clinical narrative: Pt received #1 MMR on 12/30/2009. Pt developed fever to >104 F on the night of 01/06/2010, rash started on 01/07/2010. Generalized erythematous maculopapular blanching eruption involving palms and soles. CBC, BCx Supportive Care provided.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: Pt received #1 MMR on 12/30/2009. Pt developed fever to >104 F on the night of 01/06/2010, rash started on 01/07/2010. Generalized erythematous maculopapular blanching eruption involving palms and soles. CBC, BCx Supportive Care provided.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site scab
Clinical narrative: Scab at injection site "like a smallpox scab", with redness
Age: 74.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Dizziness, Heart rate increased, Palpitations, Vision blurred
Clinical narrative: Blurred vision, weakness, dizziness, lightheaded, rapidly pounding heart - felt in chest, upper arms and shoulders. Lasted 20 min and pulse was 120 10 min after cessation. 20 min after cessation I felt perfectly normal.
Age: 7.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Fall, Head injury, Malaise, Syncope
Clinical narrative: Said she didn't feel good, then fainted, falling out of her chair. Hit her head on chair in front of her as she fell to floor.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site rash, Rash papular, Syncope
Clinical narrative: Developed papular rashes on the L upper at the site of where vaccination then spread to the body and back. Given BENADRYL. Pt fainted a day after the vaccination. ORAPRED was also given.
Age: 56.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blood cortisol, Blood electrolytes, Blood pressure increased, Blood thyroid stimulating hormone, Full blood count
Clinical narrative: - headache and tinnitus started 2 days after H1N1 vaccination, increased blood pressure since then as well. - headache resolved, BP still elevated and still has tinnitus
Age: 56.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Headache, Liver function test, Renal function test normal, Tinnitus
Clinical narrative: - headache and tinnitus started 2 days after H1N1 vaccination, increased blood pressure since then as well. - headache resolved, BP still elevated and still has tinnitus
Age: 46.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Cough, Dyspnoea, Influenza serology, Pain, Pyrexia
Clinical narrative: ? failed vaccine response developed fever, shortness of breath, aches, cough 1/2 and 1/4/10 - seen in ED 1/5/10 positive H1N1.
Age: 9.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Myalgia, Oropharyngeal pain, Pyrexia, Rhinorrhoea, Tenderness
Clinical narrative: 9 y/o female with sx of fever (felt warm), muscle pains, runny nose & sore throat, tenderness following Vaccine adm x 2d.
Age: 46.0
Sex: F
Vaccine: HEPAB
Symptoms: Induration, Injection site erythema, Injection site swelling, Pain in extremity, Pruritus
Clinical narrative: Next day redness and swollen area about 1.5 inch around injection site; itchy and tissue about 2 inches below site become hard and painful. Today tissue is still "some what hard and painful" but resolving.
Age: 55.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Diarrhoea, Feeling cold, Hot flush, Vomiting
Clinical narrative: Vaccinated on 01/06/2010. Symptoms began on 01/07/2010 and were vomiting, diarrhea and hot and cold flashes. Diarrhea and hot and cold flashes still present today, 01/12/2010.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Injected limb mobility decreased, Injection site anaesthesia, Injection site pain, Pain in extremity
Clinical narrative: Mother called today states pain in arm. c/o pain in arm where needle given. As per mother, movement of arm less no Hx of loss of sensation upon questioning mother stated that he had some numbness in area where needle was given.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU(H1N1), FLU3, HEP, HEPA, MMR, VARCEL
Symptoms: Ocular hyperaemia
Clinical narrative: Area around eyes started getting red.
Age: 22.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: C/O Severe Right arm pain.  States cannot raise Right arm. Has pain radiating from shoulder to elbow with attempt to raise arm
Age: 77.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Injection site pain
Clinical narrative: Patient reports he thinks we hit a nerve. Affected arm went limp. Now aches from shoulder to elbow. Has lost strength in that arm. Reported all of the above to local health dept. 01/12/10.
Age: 78.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Blood pressure increased
Clinical narrative: Blood pressure elevation of about 33 points, systolic (130 to 163) over a period of about 10 days
Age: 0.39
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV1
Symptoms: Urticaria
Clinical narrative: Appearance of whelps on face and scalp. then covering her back.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Oedema peripheral, Skin discolouration
Clinical narrative: Arm turned a "dark plum" color, swollen, unable to lift the arm.  Advised to take patient to the doctor.
Age: 26.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Facial palsy
Clinical narrative: Bell's Palsy affecting the right side of the face.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Oral pruritus, Paraesthesia, Swelling
Clinical narrative: 2 minutes after injection began to itch around mouth, tingling in L. arm Localized swelling
Age: 72.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Erythema, Hypoaesthesia, Oedema peripheral, Rash macular
Clinical narrative: Pt had increased edema in left leg 4 to 5 inches, numbness and red blotches. He called his doctor and will be in contact with him to keep an eye on situation.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Activated partial thromboplastin time, Contusion, Fibrin D dimer, Full blood count, International normalised ratio
Clinical narrative: Petechia all over body, bruises all over legs
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Petechiae, Platelet count decreased
Clinical narrative: Petechia all over body, bruises all over legs
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Injection site reaction, Injection site urticaria, Rash erythematous
Clinical narrative: Hives and erythemaous rash at injection site.  Patient given 1 dose of Benadryl, and hives resolved.
Age: 40.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Cough, Fatigue, Influenza like illness, Nasal congestion, Pain
Clinical narrative: Flu-like symptoms emerged 24 hrs after vaccination. Fever 100F, runny nose, light cough. 48 hours later (01/12/2010) - stuffed nose, body aches, light cough, fatigue.
Age: 40.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Flu-like symptoms emerged 24 hrs after vaccination. Fever 100F, runny nose, light cough. 48 hours later (01/12/2010) - stuffed nose, body aches, light cough, fatigue.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Oedema peripheral, Pain in extremity
Clinical narrative: Pneumococcal vaccination given by RN in left deltoid. Arm became swollen, achy and developed redness as well as a round hardened area several hours after injection. Reaction was not immediate and did not appear to be systemic in nature. Area however did increase in size but remained localized to left upper arm. Patient was given Methylpredinisolone 40mg IM x1 dose and Benadryl 25mg oral x1 dose at first complaint of soreness and redness by patient at 1:26 and 1:29 on 01/07/2010.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache
Clinical narrative: Day after vaccine I felt very tired, then the next day 01/08/2010 I awoke with a headache that continued to get worse throughout the day. I took ibuprofen 400mg, twice during the day then 2 Exedrin migraine in early evening then the pain excelled and I took a very old Vicoden that made me fall asleep. Mild headache the following day that went away after 400mgs of Ibuprofen. I felt normal thereafter.
Age: 2.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Pyrexia
Clinical narrative: Fever 102.0 F
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: According to mother, mom called office stated that she walked into baby room he was unresponsive, she called EMS and baby was taken to local ER where he was pronounced dead. Have not spoken to mother, she called office and spoke with nurse.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Pt received VARIVAX vaccine (2nd dose) on 11-6-2009: according to the pt's mother "she swelled up @ injection site 3 hours later. Pt was taken to the MD who prescribed warm compress & pt to stay away from VARIVAX vaccine.
Age: 42.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blood test, Laboratory test, Muscle twitching, Myalgia, Nerve conduction studies
Clinical narrative: Muscle tremors, muscle twitches, tingling all over, ringing in ear, muscle aches
Age: 42.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Paraesthesia, Tinnitus, Tremor
Clinical narrative: Muscle tremors, muscle twitches, tingling all over, ringing in ear, muscle aches
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Rash
Clinical narrative: Pt developed painful irritated rash 12/13/09. New areas with tingling. Seen by PCP 12/17/09. Treated with acyclovir 800 mg 5/d x 7 days
Age: 36.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Erythema, Oedema, Pain, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 36 year old female patient with hypothyroidism and a history of splenectomy and no allergies who on an unspecified date in approximately 2005 (5 years ago) was vaccinated with a first dose of PNEUMOVAX (lot# not reported). On 04-JAN-2010 the patient was vaccinated intramuscularly with a second 0.5ml dose of PNEUMOVAX (lot# 664864/1365Y) into the right deltoid. Concomitant therapy included SYNTHROID. On 04-JAN-2010 the patient developed warmth and swelling at the injection site several hours after receiving her second dose of PNEUMOVAX. The patient was recommended to apply warm compresses to the affected area. On 05-JAN-2010 the patient contacted the office to report nausea and increase in the injection site symptoms. The patient was examined in the office and was prescribed BENADRYL injection and MOTRIN. On 06-JAN-2010 the patient was seen in office again with vomiting and increased induration of the injection site reaction. The patient was prescribed KEFLEX, DEPOMEDROL and PHENERGAN. On 06-JAN-2010, at the night, the patient was admitted to hospital due to severe widespread body aching and muscle pain. "The pain was so severe the patient can't move". The patient was found to have a white blood cell count elevated to over 50000. The patient was being treated with unspecified antibiotics and morphine. On 07-JAN-2010 the white blood cell count had decreased to 39000. At the time of this report, the patient had not recovered. The patient's conditions were considered to be immediately life-threatening, significantly disabling and other important medical events by the reporter. A lot check has been initialized. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Information has been received from a physician concerning a 36 year old female patient with hypothyroidism and a history of splenectomy and no allergies who on an unspecified date in approximately 2005 (5 years ago) was vaccinated with a first dose of PNEUMOVAX (lot# not reported). On 04-JAN-2010 the patient was vaccinated intramuscularly with a second 0.5ml dose of PNEUMOVAX (lot# 664864/1365Y) into the right deltoid. Concomitant therapy included SYNTHROID. On 04-JAN-2010 the patient developed warmth and swelling at the injection site several hours after receiving her second dose of PNEUMOVAX. The patient was recommended to apply warm compresses to the affected area. On 05-JAN-2010 the patient contacted the office to report nausea and increase in the injection site symptoms. The patient was examined in the office and was prescribed BENADRYL injection and MOTRIN. On 06-JAN-2010 the patient was seen in office again with vomiting and increased induration of the injection site reaction. The patient was prescribed KEFLEX, DEPOMEDROL and PHENERGAN. On 06-JAN-2010, at the night, the patient was admitted to hospital due to severe widespread body aching and muscle pain. "The pain was so severe the patient can't move". The patient was found to have a white blood cell count elevated to over 50000. The patient was being treated with unspecified antibiotics and morphine. On 07-JAN-2010 the white blood cell count had decreased to 39000. At the time of this report, the patient had not recovered. The patient's conditions were considered to be immediately life-threatening, significantly disabling and other important medical events by the reporter. A lot check has been initialized. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Apparent life threatening event, Injection site induration, Injection site swelling, Injection site warmth, Mobility decreased
Clinical narrative: Information has been received from a physician concerning a 36 year old female patient with hypothyroidism and a history of splenectomy and no allergies who on an unspecified date in approximately 2005 (5 years ago) was vaccinated with a first dose of PNEUMOVAX (lot# not reported). On 04-JAN-2010 the patient was vaccinated intramuscularly with a second 0.5ml dose of PNEUMOVAX (lot# 664864/1365Y) into the right deltoid. Concomitant therapy included SYNTHROID. On 04-JAN-2010 the patient developed warmth and swelling at the injection site several hours after receiving her second dose of PNEUMOVAX. The patient was recommended to apply warm compresses to the affected area. On 05-JAN-2010 the patient contacted the office to report nausea and increase in the injection site symptoms. The patient was examined in the office and was prescribed BENADRYL injection and MOTRIN. On 06-JAN-2010 the patient was seen in office again with vomiting and increased induration of the injection site reaction. The patient was prescribed KEFLEX, DEPOMEDROL and PHENERGAN. On 06-JAN-2010, at the night, the patient was admitted to hospital due to severe widespread body aching and muscle pain. "The pain was so severe the patient can't move". The patient was found to have a white blood cell count elevated to over 50000. The patient was being treated with unspecified antibiotics and morphine. On 07-JAN-2010 the white blood cell count had decreased to 39000. At the time of this report, the patient had not recovered. The patient's conditions were considered to be immediately life-threatening, significantly disabling and other important medical events by the reporter. A lot check has been initialized. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Movement disorder, Myalgia, Nausea, Pain, Vomiting
Clinical narrative: Information has been received from a physician concerning a 36 year old female patient with hypothyroidism and a history of splenectomy and no allergies who on an unspecified date in approximately 2005 (5 years ago) was vaccinated with a first dose of PNEUMOVAX (lot# not reported). On 04-JAN-2010 the patient was vaccinated intramuscularly with a second 0.5ml dose of PNEUMOVAX (lot# 664864/1365Y) into the right deltoid. Concomitant therapy included SYNTHROID. On 04-JAN-2010 the patient developed warmth and swelling at the injection site several hours after receiving her second dose of PNEUMOVAX. The patient was recommended to apply warm compresses to the affected area. On 05-JAN-2010 the patient contacted the office to report nausea and increase in the injection site symptoms. The patient was examined in the office and was prescribed BENADRYL injection and MOTRIN. On 06-JAN-2010 the patient was seen in office again with vomiting and increased induration of the injection site reaction. The patient was prescribed KEFLEX, DEPOMEDROL and PHENERGAN. On 06-JAN-2010, at the night, the patient was admitted to hospital due to severe widespread body aching and muscle pain. "The pain was so severe the patient can't move". The patient was found to have a white blood cell count elevated to over 50000. The patient was being treated with unspecified antibiotics and morphine. On 07-JAN-2010 the white blood cell count had decreased to 39000. At the time of this report, the patient had not recovered. The patient's conditions were considered to be immediately life-threatening, significantly disabling and other important medical events by the reporter. A lot check has been initialized. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: PPV, PPV
Symptoms: White blood cell count increased
Clinical narrative: Information has been received from a physician concerning a 36 year old female patient with hypothyroidism and a history of splenectomy and no allergies who on an unspecified date in approximately 2005 (5 years ago) was vaccinated with a first dose of PNEUMOVAX (lot# not reported). On 04-JAN-2010 the patient was vaccinated intramuscularly with a second 0.5ml dose of PNEUMOVAX (lot# 664864/1365Y) into the right deltoid. Concomitant therapy included SYNTHROID. On 04-JAN-2010 the patient developed warmth and swelling at the injection site several hours after receiving her second dose of PNEUMOVAX. The patient was recommended to apply warm compresses to the affected area. On 05-JAN-2010 the patient contacted the office to report nausea and increase in the injection site symptoms. The patient was examined in the office and was prescribed BENADRYL injection and MOTRIN. On 06-JAN-2010 the patient was seen in office again with vomiting and increased induration of the injection site reaction. The patient was prescribed KEFLEX, DEPOMEDROL and PHENERGAN. On 06-JAN-2010, at the night, the patient was admitted to hospital due to severe widespread body aching and muscle pain. "The pain was so severe the patient can't move". The patient was found to have a white blood cell count elevated to over 50000. The patient was being treated with unspecified antibiotics and morphine. On 07-JAN-2010 the white blood cell count had decreased to 39000. At the time of this report, the patient had not recovered. The patient's conditions were considered to be immediately life-threatening, significantly disabling and other important medical events by the reporter. A lot check has been initialized. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Feeling hot, Nausea, Sensation of heaviness, Tinnitus, Tremor
Clinical narrative: Half way through my shower that morning, I suddenly felt nauseous, then felt extremely heavy and hot and the world started to get black. I was sure I was going to pass out (I never have before), so I managed to make it out of the shower and sat/laid down for a few minutes until I could stand again and go to a chair. For the next 10 minutes after the beginning of the event, my body was shaky and my ears were buzzing. I have never had anything like this happen to me in my life and am a healthy person.  I sought no treatment, as it had completely subsided in 15 or 20 minutes and did not recur.
Age: 7.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting, Diarrhea
Age: 49.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient states she woke up at 3 am in 1-8-10 itching and noticed hives on buttocks and some on the hands in the web spaces. No airway or respiratory symptoms. Given BENADRYL 25 mg PO and advised to take Q 6 hrs PRN.
Age: 4.0
Sex: F
Vaccine: FLU(H1N1), FLUN3
Clinical narrative: received the below shots on 12/11/09 and developed Henoch-Schonleion purpura on 12/21/09
Age: 31.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Muscle spasms, Muscle twitching
Clinical narrative: Approximately 24hrs. after vaccine I developed muscle twitching and muscle spasms. This has lasted since the vaccine for approximately 1- 1/2 months now.
Age: 31.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Alpha 1 globulin normal, Alpha 2 globulin normal, Beta globulin decreased, Blood albumin increased, Blood folate normal
Clinical narrative: Approximately 24hrs. after vaccine I developed muscle twitching and muscle spasms. This has lasted since the vaccine for approximately 1- 1/2 months now.
Age: 31.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Blood iron decreased, Borrelia burgdorferi serology negative
Clinical narrative: Approximately 24hrs. after vaccine I developed muscle twitching and muscle spasms. This has lasted since the vaccine for approximately 1- 1/2 months now.
Age: 31.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Electromyogram normal, Glycosylated haemoglobin normal, Immunoglobulins increased, Iron binding capacity total increased, Muscle spasms
Clinical narrative: Approximately 24hrs. after vaccine I developed muscle twitching and muscle spasms. This has lasted since the vaccine for approximately 1- 1/2 months now.
Age: 31.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Muscle twitching, Nerve conduction studies normal, Nuclear magnetic resonance imaging brain normal, Paraesthesia, Protein total normal
Clinical narrative: Approximately 24hrs. after vaccine I developed muscle twitching and muscle spasms. This has lasted since the vaccine for approximately 1- 1/2 months now.
Age: 31.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Spinal X-ray, Spinal X-ray normal, Transferrin saturation decreased, Vitamin B12 normal
Clinical narrative: Approximately 24hrs. after vaccine I developed muscle twitching and muscle spasms. This has lasted since the vaccine for approximately 1- 1/2 months now.
Age: 23.0
Sex: M
Vaccine: ANTH, FLUX(H1N1), YF
Symptoms: Cellulitis, Induration, Pruritus, Skin warm, Swelling
Clinical narrative: Itching, swelling, skin warmth - No systemic symptoms 9cm x 5cm patch on R tricep - Warm and indurated. Dx: Cellulitis Tx: SEPTRA DS 1 tablet by mouth every 12 hrs for 7 days.
Age: 11.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Cardiac enzymes, Computerised tomogram, Convulsion, Dyskinesia
Clinical narrative: On 01/03/2010 patient was observed to slump in church then jerk her head back and arch her back, identified as seizure by pastor-no in continue-no post-ictal state. In the past patient has had approximately 6 vasovaginal syncope and mear syncope.
Age: 1.28
Sex: M
Vaccine: FLU(H1N1), MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever 103-105 x 2 days.
Age: 84.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Atrial fibrillation, Electrocardiogram abnormal, Flatulence, Headache, Myocardial ischaemia
Clinical narrative: Patient developed a headache, nausea & gas pains within an hour of the shot. Symptoms became more general and patient was found to be in atrial fibrillation and an ischemic cardiac event on the day of the shot is suspected.
Age: 84.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Nausea
Clinical narrative: Patient developed a headache, nausea & gas pains within an hour of the shot. Symptoms became more general and patient was found to be in atrial fibrillation and an ischemic cardiac event on the day of the shot is suspected.
Age: 28.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Blood creatine phosphokinase increased, Hypoaesthesia, Musculoskeletal stiffness, Rhabdomyolysis
Clinical narrative: C/o muscle stiffness, leg numbness - (Rhabdomyolysis/elevated CPK).
Age: 28.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Drug exposure during pregnancy, Intra-uterine death
Clinical narrative: I gave birth to a stillborn two weeks after receiving the H1N1 vaccine. I was 25 weeks pregnant and there were no birth defects.
Age: 62.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pruritus, Rash, Rash vesicular, Urticaria
Clinical narrative: Skin Rash, Rash, Urticaria Pruritis, VESICULAR RASH. Tx: DIPHENHYDRAMINE, HYDROCORTISONE, PREDNISONE  Follow up information received - Patient's date of birth 04/28/47, manufacturer: Novartis, vaccine lot number 102132P1, IM, left deltoid, doses.
Age: 37.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Blister
Clinical narrative: Oral blisters treatment VALTREX.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLUN(H1N1), MMR, VARCEL
Symptoms: Gait disturbance
Clinical narrative: Pt had vaccines 1/5/10 (MMR, VZV, KINRIX & H1N1). Next day she had abnormal gait hard to walk per parents, she is now much better but her parents say her walk is still abnormal.
Age: 56.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Rash
Clinical narrative: Patient called next day to say she had a rash on her arm after receiving the H1N1 vaccine.
Age: 38.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Anxiety, Tachycardia
Clinical narrative: 5 minutes after receiving flumist patient became anxious and tachycardic. 110/64 - 72 - 18 after 5 minutes. Recovered quickly. Left clinic with husband.
Sex: U
Vaccine: DTIPV, HEP, RAB, TYP
Symptoms: Abortion induced, Drug exposure during pregnancy, Foetal disorder
Clinical narrative: On 13 JUL 2007 we received from the regulatory agency the following information: A 32-year-old female patient was vaccinated with RABVERT (manufacturer and date of vaccination unknown). Further suspect vaccinations (same day?) Included ENGERIX B vaccine, REVAXIS and Typhoid. Patient was likely to be conceiving just at the time of the second dose of vaccines. The fetus has Down's syndrome and a cardiac abnormality. Patient has had a termination of pregnancy. After internal discussion on 24 JUL 2007 we decided to create an additional case for the fetus. (see case MA2007-0753). We received a follow-up information from the regulatory agency on 06 AUG 2007 without new information. (#GB-MHRA-ADR-20139770 and MHRA no. ADR2019770-001). This case was previously recorded as MA2007-0753. Follow up health authority report received on 09 Dec 2009: The mother (see case PHHY2007GB01352) was likely to be conceiving, just at the time of the second dose of the vaccine. The Foetus had Down's Syndrome and cardiac abnormality. No other information was provided.
Age: 55.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site pain, Paraesthesia, Rash, Rash macular
Clinical narrative: 1/12 Pt received vaccinations 1:30pm in Rt upper arm and reported 1hr later that 10 mins after receiving vaccination she had tingling of Rt hand and pain with Rt arm between shoulder & elbow.  1/13 at 11:00 spoke with patient on phone. Reports - pain & tingling resided at about 9pm 1/12 and then she noted hive-like splotches on face & body. Took Benadryl & they are going away. Awaiting return phone call from her MD.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Incorrect dose administered
Clinical narrative: Inadvertently gave 0.5cc H1N1 in left deltoid and right deltoid. Patient area 1 to 1 1/2 hr. No adverse reaction noted during this time.
Age: 36.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Erythema, Rash pruritic, Swelling
Clinical narrative: Pt received H1N1 inhaled on 1/6/10 with no reaction. On 1/8/10 itchy rash erupted on face, hands, feet, & body. Pt took BENADRYL at home with decreasing of redness & swelling which reduced after dose wore off. To clinic 1/12 rxd with Prednisone & hydroxyzine.
Age: 67.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Condition aggravated, Diverticulitis, Dyspnoea, Guillain-Barre syndrome
Clinical narrative: Physician diagnosed Guillain Barre Syndrome. Onset 12/27/09 with weakness, tingling and numbness in fingers and toes-progressively worse extending up arms and legs that day. Take by squad to ER 12/28/09 in a.m. Progressively worse. Developed dyspnea-transferred to med central hosp 12/30/09-on ventilator. Also received seasonal flu vaccine on 12/23 at hospital while hospitalized for Diverticulitis.
Age: 67.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Physician diagnosed Guillain Barre Syndrome. Onset 12/27/09 with weakness, tingling and numbness in fingers and toes-progressively worse extending up arms and legs that day. Take by squad to ER 12/28/09 in a.m. Progressively worse. Developed dyspnea-transferred to med central hosp 12/30/09-on ventilator. Also received seasonal flu vaccine on 12/23 at hospital while hospitalized for Diverticulitis.
Age: 0.62
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Injection site papule, Injection site swelling
Clinical narrative: Mother stated that 3 hours after vaccine, she noticed a red spot with raised bumps approximately 1 1/2 inches across at injection site. Reaction began to fade 2 hours after that. No treatment was rendered.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram, Muscle contractions involuntary, Vaccination complication
Clinical narrative: Benign fasciculations with neg. EMG. Constant since 10 days after receiving seasonal flu vaccine. No muscle weakness norm CPK
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Diarrhoea, Haematochezia
Clinical narrative: Diarrhea after blood in stool @ 8pm after vaccines were given at 10:30 am same day on 1-11-10.
Age: 35.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site pain
Clinical narrative: Client reports mild to moderate aching pain at R deltoid, site of H1N1 vaccination. Pain onset on 11/14/09 and continuous for 6 weeks. No redness, swelling, induration, ulceration, excoriation, or scarring observed.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Cold compress therapy, Injection site discolouration, Injection site erythema
Clinical narrative: 48h post immunization the 11cm x 13cm area around vaccination site was pink, recommended cool compresses and monitor.
Age: 69.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Myalgia, Neuralgia, X-ray
Clinical narrative: Patient states the day of the injection her arm started to feel funny within one to two hours. She finally went to the MD on 01/08/10 with complaints of nerve and muscle pain of the neck, arm and shoulder. MD did a shoulder X-ray. Pt. was prescribed MEDROL dose pk, DILAUDID 2 mg and nerflex 100 mg to deal with side effect of the injection from over a week ago.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: ADACEL given 12-15-09 in L shoulder IM by physician. Pt c/o of pain @ injection site @ least 2 wks out but it had diminished somewhat. Worse in early am but rc ROM dissipated in severity during day. ("shooting pain down arm initially").
Age: 82.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Fatigue, Headache
Clinical narrative: 4-5 days after shot patient had extreme fatigue for three days, a frontal headache and no temperature. The fatigue caused her to stay in bed for one full day.
Age: 41.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Feeling hot, Oedema peripheral, Pruritus
Clinical narrative: Approx. 72 hours after vaccine left arm became hot, swollen, itchy.
Age: 56.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Client had an itching sensation 10 to 15 after receiving the vaccine. Later that night a red raised rash appeared on her chest and back that lasted 24 hours.
Age: 4.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Activated partial thromboplastin time prolonged, Alanine aminotransferase normal, Ammonia normal, Anion gap normal, Aspartate aminotransferase normal
Clinical narrative: Patient transported to ED for evaluation by EMS. Patient was at the PCP's office where she received dose # 2 of H1N1 Influenza. Approximately 15 minutes after the immunization was administered (IM in the left thigh), the patient was seated in the back seat of the car. Mother noted that the patient's face was stiffened and "contorted", her eyes were opened - but fixed straight ahead. She was not responding to verbal or physical stimulation. She was breathing well on her own. Either removed her from the car, noting her body was not rigid or stiff, but she was not responsive. EMS arrived, IV access was established, and the patient was given 25 mg of IV BENADRYL for concern for dystonic reaction. EMS noted that the patient's jaw was firmly clenched and they were unable to open the patient's mouth. There was no tonic clonic activity. Within a minute of BENADRYL administration, the facial contortion resolved. The patient was then crying, confused, and did not seem to react to her parents appropriately. There was no LOC or deterioration in cardio-respiratory status per EMS. No rash. Patient was otherwise well. No fever, runny nose, no history of allergic reactions or anaphylaxis. Patient has had H1N1 Influenza # 1 6 weeks ago without issues and there has been no previous reaction to vaccinations. Re-evaluation after nap (2 hours): Marked improvement in mental status with return with baseline mental. Patient subjectively feels much better. No further deterioration in neurologic or cardio-respiratory status in ED. Consultation with Neurology. Unclear if this was dystonic reaction vs. seizure. Likely a reaction to vaccination. Patient to follow-up as an outpatient for consultation and EEG. Would defer future Influenza vaccination. Consultation with PCP. PCP's office will file adverse reaction with VAERS (as they have vaccine maker and lot number information).
Age: 4.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Basophil percentage, Blood albumin normal, Blood alkaline phosphatase increased, Blood amylase increased, Blood bilirubin normal
Clinical narrative: Patient transported to ED for evaluation by EMS. Patient was at the PCP's office where she received dose # 2 of H1N1 Influenza. Approximately 15 minutes after the immunization was administered (IM in the left thigh), the patient was seated in the back seat of the car. Mother noted that the patient's face was stiffened and "contorted", her eyes were opened - but fixed straight ahead. She was not responding to verbal or physical stimulation. She was breathing well on her own. Either removed her from the car, noting her body was not rigid or stiff, but she was not responsive. EMS arrived, IV access was established, and the patient was given 25 mg of IV BENADRYL for concern for dystonic reaction. EMS noted that the patient's jaw was firmly clenched and they were unable to open the patient's mouth. There was no tonic clonic activity. Within a minute of BENADRYL administration, the facial contortion resolved. The patient was then crying, confused, and did not seem to react to her parents appropriately. There was no LOC or deterioration in cardio-respiratory status per EMS. No rash. Patient was otherwise well. No fever, runny nose, no history of allergic reactions or anaphylaxis. Patient has had H1N1 Influenza # 1 6 weeks ago without issues and there has been no previous reaction to vaccinations. Re-evaluation after nap (2 hours): Marked improvement in mental status with return with baseline mental. Patient subjectively feels much better. No further deterioration in neurologic or cardio-respiratory status in ED. Consultation with Neurology. Unclear if this was dystonic reaction vs. seizure. Likely a reaction to vaccination. Patient to follow-up as an outpatient for consultation and EEG. Would defer future Influenza vaccination. Consultation with PCP. PCP's office will file adverse reaction with VAERS (as they have vaccine maker and lot number information).
Age: 4.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose increased, Blood magnesium increased
Clinical narrative: Patient transported to ED for evaluation by EMS. Patient was at the PCP's office where she received dose # 2 of H1N1 Influenza. Approximately 15 minutes after the immunization was administered (IM in the left thigh), the patient was seated in the back seat of the car. Mother noted that the patient's face was stiffened and "contorted", her eyes were opened - but fixed straight ahead. She was not responding to verbal or physical stimulation. She was breathing well on her own. Either removed her from the car, noting her body was not rigid or stiff, but she was not responsive. EMS arrived, IV access was established, and the patient was given 25 mg of IV BENADRYL for concern for dystonic reaction. EMS noted that the patient's jaw was firmly clenched and they were unable to open the patient's mouth. There was no tonic clonic activity. Within a minute of BENADRYL administration, the facial contortion resolved. The patient was then crying, confused, and did not seem to react to her parents appropriately. There was no LOC or deterioration in cardio-respiratory status per EMS. No rash. Patient was otherwise well. No fever, runny nose, no history of allergic reactions or anaphylaxis. Patient has had H1N1 Influenza # 1 6 weeks ago without issues and there has been no previous reaction to vaccinations. Re-evaluation after nap (2 hours): Marked improvement in mental status with return with baseline mental. Patient subjectively feels much better. No further deterioration in neurologic or cardio-respiratory status in ED. Consultation with Neurology. Unclear if this was dystonic reaction vs. seizure. Likely a reaction to vaccination. Patient to follow-up as an outpatient for consultation and EEG. Would defer future Influenza vaccination. Consultation with PCP. PCP's office will file adverse reaction with VAERS (as they have vaccine maker and lot number information).
Age: 4.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blood phosphorus, Blood potassium normal, Blood sodium normal, Blood urea normal, Carbon dioxide normal
Clinical narrative: Patient transported to ED for evaluation by EMS. Patient was at the PCP's office where she received dose # 2 of H1N1 Influenza. Approximately 15 minutes after the immunization was administered (IM in the left thigh), the patient was seated in the back seat of the car. Mother noted that the patient's face was stiffened and "contorted", her eyes were opened - but fixed straight ahead. She was not responding to verbal or physical stimulation. She was breathing well on her own. Either removed her from the car, noting her body was not rigid or stiff, but she was not responsive. EMS arrived, IV access was established, and the patient was given 25 mg of IV BENADRYL for concern for dystonic reaction. EMS noted that the patient's jaw was firmly clenched and they were unable to open the patient's mouth. There was no tonic clonic activity. Within a minute of BENADRYL administration, the facial contortion resolved. The patient was then crying, confused, and did not seem to react to her parents appropriately. There was no LOC or deterioration in cardio-respiratory status per EMS. No rash. Patient was otherwise well. No fever, runny nose, no history of allergic reactions or anaphylaxis. Patient has had H1N1 Influenza # 1 6 weeks ago without issues and there has been no previous reaction to vaccinations. Re-evaluation after nap (2 hours): Marked improvement in mental status with return with baseline mental. Patient subjectively feels much better. No further deterioration in neurologic or cardio-respiratory status in ED. Consultation with Neurology. Unclear if this was dystonic reaction vs. seizure. Likely a reaction to vaccination. Patient to follow-up as an outpatient for consultation and EEG. Would defer future Influenza vaccination. Consultation with PCP. PCP's office will file adverse reaction with VAERS (as they have vaccine maker and lot number information).