chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Condition aggravated, Injection site rash, Latex allergy, Pharyngeal oedema, Swollen tongue
Clinical narrative: Case number PHEH2011US06094, is an initial spontaneous report from a pharmacist on 05 Oct 2011: This report refers to 23-year-old female patient. She had been previously vaccinated with influenza vaccine (unknown manufacturer) without any reaction. She became allergic to latex, as she had reaction to latex gloves after she gave birth last year in Sep 2010. She received FLUVIRIN (batch number 11020501), 0.5 ml, intramuscularly into her left deltoid on 05 Oct 2011. The patient asked the pharmacist if the flu shot was latex free, and it was confirmed from the manufacturer that FLUVIRIN was latex free. It was also reported that the pharmacist used latex free gloves, syringes and needle. About 30 minutes later the patient had latex allergy, with rash around the site of injection, tongue swollen for 45 minutes and her throat closed off. She was given a shot of BENADRYL and the events got subsided. At the time of this report the patient was doing well. Follow up information received from the pharmacist on 11 Oct 2011: Updated medical history and event description.
Age: 23.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Condition aggravated, Injection site rash, Latex allergy, Swollen tongue, Throat tightness
Clinical narrative: Case number PHEH2011US06094, is an initial spontaneous report from a pharmacist on 05 Oct 2011: This report refers to 23-year-old female patient. She had been previously vaccinated with influenza vaccine (unknown manufacturer) without any reaction. She became allergic to latex, as she had reaction to latex gloves after she gave birth last year in Sep 2010. She received FLUVIRIN (batch number 11020501), 0.5 ml, intramuscularly into her left deltoid on 05 Oct 2011. The patient asked the pharmacist if the flu shot was latex free, and it was confirmed from the manufacturer that FLUVIRIN was latex free. It was also reported that the pharmacist used latex free gloves, syringes and needle. About 30 minutes later the patient had latex allergy, with rash around the site of injection, tongue swollen for 45 minutes and her throat closed off. She was given a shot of BENADRYL and the events got subsided. At the time of this report the patient was doing well. Follow up information received from the pharmacist on 11 Oct 2011: Updated medical history and event description.
Age: 31.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Increased soreness leading to extreme weakness in upper extremities, no strength increased fatigue. Went to ER and admitted to ICU for r/o GBS. Tx - IV fluids, Immunoglobulin (IG), MSO4. Reaction to IG with increased HR and creatinine. Transferred to civilian ICU d/t kidneys. Military physicians dx GBS.
Age: 31.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Adverse reaction, Asthenia, Blood creatinine increased, Fatigue, Guillain-Barre syndrome
Clinical narrative: Increased soreness leading to extreme weakness in upper extremities, no strength increased fatigue. Went to ER and admitted to ICU for r/o GBS. Tx - IV fluids, Immunoglobulin (IG), MSO4. Reaction to IG with increased HR and creatinine. Transferred to civilian ICU d/t kidneys. Military physicians dx GBS.
Age: 31.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Heart rate increased, Immunoglobulin therapy, Intensive care, Muscular weakness, Pain in extremity
Clinical narrative: Increased soreness leading to extreme weakness in upper extremities, no strength increased fatigue. Went to ER and admitted to ICU for r/o GBS. Tx - IV fluids, Immunoglobulin (IG), MSO4. Reaction to IG with increased HR and creatinine. Transferred to civilian ICU d/t kidneys. Military physicians dx GBS.
Age: 31.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Renal disorder
Clinical narrative: Increased soreness leading to extreme weakness in upper extremities, no strength increased fatigue. Went to ER and admitted to ICU for r/o GBS. Tx - IV fluids, Immunoglobulin (IG), MSO4. Reaction to IG with increased HR and creatinine. Transferred to civilian ICU d/t kidneys. Military physicians dx GBS.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness postural, Fatigue, Headache, Pain, Paraesthesia
Clinical narrative: Overall weakness, aching muscles, fatigue (always tired), trouble concentrating, occasional stabbing pain in various areas (upper back, arm), headaches, slight dizziness, knees are weak, pain in joints. Symptoms are on-going.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Asthenia, Back pain, Blood test normal, Chest X-ray normal
Clinical narrative: Overall weakness, aching muscles, fatigue (always tired), trouble concentrating, occasional stabbing pain in various areas (upper back, arm), headaches, slight dizziness, knees are weak, pain in joints. Symptoms are on-going.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Disturbance in attention, Dizziness, Electrocardiogram normal, Fatigue, Headache
Clinical narrative: Overall weakness, aching muscles, fatigue (always tired), trouble concentrating, occasional stabbing pain in various areas (upper back, arm), headaches, slight dizziness, knees are weak, pain in joints. Symptoms are on-going.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Influenza virus test negative, Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: Overall weakness, aching muscles, fatigue (always tired), trouble concentrating, occasional stabbing pain in various areas (upper back, arm), headaches, slight dizziness, knees are weak, pain in joints. Symptoms are on-going.
Age: 1.39
Sex: M
Vaccine: DTAPIPVHIB, FLU3, MMR, DTAPIPVHIB, FLU3, MMR
Symptoms: Balance disorder, Crying, Gait disturbance, Pyrexia
Clinical narrative: Mother states that pt started running a fever and crying unconsolable for long periods of time, then he would nap about 45 minutes at a time and this lasted through the evening.  Tylenol was given every 4 hours.  When child woke up next morning, he could not keep his balance when he tried to walk.  This lasted about 1 hour.  Mother took child to PMD.
Age: 1.39
Sex: M
Vaccine: DTAPIPVHIB, FLU3, MMR, DTAPIPVHIB, FLU3, MMR
Symptoms: Balance disorder, Crying, Pyrexia
Clinical narrative: Mother states that pt started running a fever and crying unconsolable for long periods of time, then he would nap about 45 minutes at a time and this lasted through the evening.  Tylenol was given every 4 hours.  When child woke up next morning, he could not keep his balance when he tried to walk.  This lasted about 1 hour.  Mother took child to PMD.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Hypotonic-hyporesponsive episode, Somnolence
Clinical narrative: Initial report was received 14 October 2011 from a health care professional. A two-month-old female patient had received an injection of PENTACEL, lot number C4027AA, and ROTATEQ (manufacturer Merck), lot number 0203AA, and PREVNAR (Manufacturer Unknown, lot number not reported) and on the evening of vaccination (also reported as 06 October 2011), the patient experienced a hypotonic hyporesponsive episode. The patient was hospitalized for one day. On Monday 10 October 2011, the patient had a check up with her pediatrician and was completely recovered. The patient's pediatrician believed the hypotonic hyporesponsive episode was due to PENTACEL as he had read an article indicating that this type of event occurred more often in patients who received PENTACEL. Documents held by sender: None.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Hypotonic-hyporesponsive episode
Clinical narrative: Initial report was received 14 October 2011 from a health care professional. A two-month-old female patient had received an injection of PENTACEL, lot number C4027AA, and ROTATEQ (manufacturer Merck), lot number 0203AA, and PREVNAR (Manufacturer Unknown, lot number not reported) and on the evening of vaccination (also reported as 06 October 2011), the patient experienced a hypotonic hyporesponsive episode. The patient was hospitalized for one day. On Monday 10 October 2011, the patient had a check up with her pediatrician and was completely recovered. The patient's pediatrician believed the hypotonic hyporesponsive episode was due to PENTACEL as he had read an article indicating that this type of event occurred more often in patients who received PENTACEL. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives on legs, face, stomach- Benadryl and Calamine.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Influenza like illness, Pyrexia, Syringe issue
Clinical narrative: I experienced unusual fatigue and other flu-like symptoms. Though no fever measured, I felt feverish alternating with chills. This went on for about 3 days. I have experienced similar reaction to past flu shots, but not with this intensity and duration. (Previous episodes resolved after a night's sleep.) Reaction was possibly linked to fact that first shot was a leaky syringe - much fluid sprayed out rather than went into arm - so pharmacy tech gave me a second full dose.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: CSF protein increased, Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Syndrome.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blister, Injection site erythema, Injection site reaction, Pallor
Clinical narrative: Erythematous patches, positive blanching, in (R) deltoid area with multiple large bullae, extends from lateral acromion to distal humerus.
Age: 59.0
Sex: F
Vaccine: FLU3, HIBV, PPV
Symptoms: Chills, Injection site erythema, Myalgia, Pyrexia, Tremor
Clinical narrative: Shaking, chills. Fever to 104. Myalgias. Red, angry arm distal to injection site.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Cough, Ear discomfort, Headache, Malaise
Clinical narrative: Several hours after injection, started feeling like coming down with something (a little scratchy throat). For the 2 wks since, have been dealing with achy joints on and off, H/A early on, congestion, runny nose. 2 weeks later, still have dry non-productive cough, stuffy ears. Felt fine prior to vaccine.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Respiratory tract congestion, Rhinorrhoea, Throat irritation
Clinical narrative: Several hours after injection, started feeling like coming down with something (a little scratchy throat). For the 2 wks since, have been dealing with achy joints on and off, H/A early on, congestion, runny nose. 2 weeks later, still have dry non-productive cough, stuffy ears. Felt fine prior to vaccine.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Visual impairment
Clinical narrative: After the shot for rest of day had a dark shadow in my vision in the right eye. Cleared up by the next day.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Redness, soreness, itching. Noticed on Friday - vaccinated on Wednesday called pharmacist  - advised ice & BENADRYL.
Age: 54.0
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Encephalitis, Injection site rash, Pain, Paraesthesia, Paraesthesia oral
Clinical narrative: Information has been received from a 63 year old female consumer reporting on herself with intracranial hypertension, allergy to penicillin, sulpha, cephalexin and ciprofloxacin, who on 16-OCT-2011, was vaccinated with ZOSTAVAX (Merck) (lot number, route and dose not reported). Consumer reported that on 18-OCT-2011, a "big lump on her arm and it was hot after receiving the ZOSTAVAX (Merck)". It was spreading and doubled from the vaccination she had on Sunday (16-OCT-2011). On 18-OCT-2011, there was rash on her arm and at the injection site. She also had weird tingling sensations all over her body including her face and lips. She had body aches all over. "Consumer was concerned about encephalitis because she had intracranial hypertension or IH. She had a shunt but it was not working at the time of reporting". Patient did not receive any treatment for adverse reactions. The patient did not seek medical attention. At the time of reporting the patient had not recovered. Upon internal review "concerned about encephalitis" was considered to be other important medical event. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Shunt malfunction, Skin warm, Upper extremity mass
Clinical narrative: Information has been received from a 63 year old female consumer reporting on herself with intracranial hypertension, allergy to penicillin, sulpha, cephalexin and ciprofloxacin, who on 16-OCT-2011, was vaccinated with ZOSTAVAX (Merck) (lot number, route and dose not reported). Consumer reported that on 18-OCT-2011, a "big lump on her arm and it was hot after receiving the ZOSTAVAX (Merck)". It was spreading and doubled from the vaccination she had on Sunday (16-OCT-2011). On 18-OCT-2011, there was rash on her arm and at the injection site. She also had weird tingling sensations all over her body including her face and lips. She had body aches all over. "Consumer was concerned about encephalitis because she had intracranial hypertension or IH. She had a shunt but it was not working at the time of reporting". Patient did not receive any treatment for adverse reactions. The patient did not seek medical attention. At the time of reporting the patient had not recovered. Upon internal review "concerned about encephalitis" was considered to be other important medical event. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Antibody test positive, Haematology test, Herpes zoster, Immunology test, Rash
Clinical narrative: Information has been received from a physician concerning an adult patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number not provided). It was reported that at an unknown time frame after receiving ZOSTAVAX (Merck), the patient developed shingles. At the time of the report the patient's outcome was unknown. Follow-up information was received from the physician concerning the 64 year old male with a history of chickenpox at childhood and no recent exposure to chickenpox or herpes zoster who on 01-JUL-2011 was vaccinated subcutaneously into the right arm (also reported as into the left arm) with a dose of ZOSTAVAX (Merck) (lot number 02188AA (Lot number 02188AA is an invalid lot number for ZOSTAVAX (Merck)); dose not reported). Concomitant therapy included prednisone and methotrexate. The physician reported that on approximately 25-AUG-2011, the patient developed lesions on right wrist. On 02-SEP-2011, the patient was seen in the Dermatology unit with lesions on head, trunk and extremities. The patient's shingles was described as "disseminated". Direct fluorescent antibody (DFA) was positive. VZV antigen tests were performed on 02-SEP-2011 and 06-SEP-2011 (results not provided). The patient was treated with valacyclovir hydrochloride. ON 06-SEP-2011, the patient had a dermatology follow-up where he was found to have more lesions and was admitted to the hospital. From 06-SEP-2011 to 08-SEP-2011, the patient was treated with IV acyclovir. On 08-SEP-2011, 27 lesions were counted on face. It was reported that other than rash the patient was well. The patient's maximum temperature was 98 degrees and there was no pain. On 16-SEP-2011, the patient recovered. A specimen was not collected for PCR. It was reported that a photo was taken. This is one of several reports received from the same source. No further information is available.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin lesion, Varicella virus test, Viral test negative
Clinical narrative: Information has been received from a physician concerning an adult patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number not provided). It was reported that at an unknown time frame after receiving ZOSTAVAX (Merck), the patient developed shingles. At the time of the report the patient's outcome was unknown. Follow-up information was received from the physician concerning the 64 year old male with a history of chickenpox at childhood and no recent exposure to chickenpox or herpes zoster who on 01-JUL-2011 was vaccinated subcutaneously into the right arm (also reported as into the left arm) with a dose of ZOSTAVAX (Merck) (lot number 02188AA (Lot number 02188AA is an invalid lot number for ZOSTAVAX (Merck)); dose not reported). Concomitant therapy included prednisone and methotrexate. The physician reported that on approximately 25-AUG-2011, the patient developed lesions on right wrist. On 02-SEP-2011, the patient was seen in the Dermatology unit with lesions on head, trunk and extremities. The patient's shingles was described as "disseminated". Direct fluorescent antibody (DFA) was positive. VZV antigen tests were performed on 02-SEP-2011 and 06-SEP-2011 (results not provided). The patient was treated with valacyclovir hydrochloride. ON 06-SEP-2011, the patient had a dermatology follow-up where he was found to have more lesions and was admitted to the hospital. From 06-SEP-2011 to 08-SEP-2011, the patient was treated with IV acyclovir. On 08-SEP-2011, 27 lesions were counted on face. It was reported that other than rash the patient was well. The patient's maximum temperature was 98 degrees and there was no pain. On 16-SEP-2011, the patient recovered. A specimen was not collected for PCR. It was reported that a photo was taken. This is one of several reports received from the same source. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Childhood disintegrative disorder, Educational problem, Learning disorder, Reading disorder
Clinical narrative: A consumer obtained the information from a website concerning a female student patient who was an honor roll student in the seventh grade, failing in the eighth grade and starting high school in a special education class in diapers who on an unspecified date was vaccinated with a dose of GARDASIL (lot number, dose and route not provided). On an unspecified date, the patient was reading at a fifth grade level with maybe the comprehension of fourth grader. She was kicked out of school that year in just the third week. At the time of this report, the patient's outcome was unknown. Upon internal review "she was reading at a fifth grade level with maybe the comprehension of fourth grader and she was kicked out of school" were considered to be disabling. No further information is available.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema multiforme
Clinical narrative: Initial report was received 12 October 2011 from a health care professional in a country. A 4-year-old male patient had received DTAP (manufacturer unknown, lot number, route, site and date of administration not reported) six years ago, and an unspecified amount of time later, the patient developed erythema multiforme. Outcome was not reported. At the time of this report, the patient was 10 years of age. No additional information was provided at the time of the report. The patient experienced a similar subsequent event which has been captures in case number 2011-09949. Documents held by sender: None.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Headache, Influenza like illness, Paraesthesia, Paraesthesia oral
Clinical narrative: Initial report was received 13 October 2011 from a health care professional. A 40-year-old female patient who had a history of left temporal pain, tinnitus, and facial tingling and paraesthesia in 2010 following an Influenza vaccination, had received an intramuscular left deltoid injection of FLUZONE No Preservative 2011-2012, lot number UT447AA on 06 October 2011 and one day later, she developed a runny nose, itchy eyes, and flu-like symptoms. On 12 October 2011, six days after vaccination, she developed left temporal pain, increased ringing in her ears, and tingling and paraesthesia of the face and lower lip. The event required a doctor's visit; it was not reported if treatment was required. The patient had been taking TOPRAMAX concomitantly. According to the reporter, the patient's neurologist approved vaccination. Outcome was unknown. Documents held by sender: None.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea, Similar reaction on previous exposure to drug, Tinnitus
Clinical narrative: Initial report was received 13 October 2011 from a health care professional. A 40-year-old female patient who had a history of left temporal pain, tinnitus, and facial tingling and paraesthesia in 2010 following an Influenza vaccination, had received an intramuscular left deltoid injection of FLUZONE No Preservative 2011-2012, lot number UT447AA on 06 October 2011 and one day later, she developed a runny nose, itchy eyes, and flu-like symptoms. On 12 October 2011, six days after vaccination, she developed left temporal pain, increased ringing in her ears, and tingling and paraesthesia of the face and lower lip. The event required a doctor's visit; it was not reported if treatment was required. The patient had been taking TOPRAMAX concomitantly. According to the reporter, the patient's neurologist approved vaccination. Outcome was unknown. Documents held by sender: None.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Arthralgia, Dysphonia, Irritability, Laryngitis
Clinical narrative: Initial information received on 13 October 2011 from the patient, who is also a health care professional. A 53-year-old female patient received a first intramuscular dose of FLUZONE (manufacturer Sanofi Pasteur), lot number not reported, in the left deltoid on 19 September 2011. The specific formulation of the vaccine was not reported. Three days later, on 22 September 2011, the patient woke up and had a sore throat, hoarseness, and laryngitis. Eight days post-vaccination, on 27 September 2011, she had severe joint pain affecting the foot, ankle, wrist, knuckle, and shoulder. The pain was described as "like arthritis". She was unable to walk due to foot and ankle pain. By 28 September 2011 she was unable to make a fist or open and close her hands due to severe pain. She was seen in the emergency room that day and was treated with SOLU-MEDROL. She was "okay" for 36 hours before her symptoms returned. She was treated with a MEDROL dose pack. Her symptoms appeared to be cyclic. She would have no problems during the day, but would experience pain and inability to walk by evening. She continued to have symptoms, which were reported to be resolving at the time of this report. The patient has not recovered from the events. List of documents held by sender: none.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Oropharyngeal pain, Pain in extremity
Clinical narrative: Initial information received on 13 October 2011 from the patient, who is also a health care professional. A 53-year-old female patient received a first intramuscular dose of FLUZONE (manufacturer Sanofi Pasteur), lot number not reported, in the left deltoid on 19 September 2011. The specific formulation of the vaccine was not reported. Three days later, on 22 September 2011, the patient woke up and had a sore throat, hoarseness, and laryngitis. Eight days post-vaccination, on 27 September 2011, she had severe joint pain affecting the foot, ankle, wrist, knuckle, and shoulder. The pain was described as "like arthritis". She was unable to walk due to foot and ankle pain. By 28 September 2011 she was unable to make a fist or open and close her hands due to severe pain. She was seen in the emergency room that day and was treated with SOLU-MEDROL. She was "okay" for 36 hours before her symptoms returned. She was treated with a MEDROL dose pack. Her symptoms appeared to be cyclic. She would have no problems during the day, but would experience pain and inability to walk by evening. She continued to have symptoms, which were reported to be resolving at the time of this report. The patient has not recovered from the events. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Initial report was received on 17 October 2011 from a healthcare professional. A cluster of two pediatric patients had received FLUZONE (lot number, route, site and date of administration not reported) and unspecified amount of time later, experienced cellulitis. According to the report, the patient's had received the same lot number of "sanofi flu vaccine". No further information was available at the time of the report. The patient's outcomes were not reported. Documents held by sender: none.
Age: 0.6
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Autism, Crying, Speech disorder developmental
Clinical narrative: Initial report was received on 17 October 2011 from a consumer in a country who is also the patient's parent. A male patient who was seven months-old at the time of vaccination had received IPV (manufacturer, lot number, route, site and date of administration not reported), DTAP (manufacturer, lot number, route, site and date of administration not reported), MMR vaccine (manufacturer, lot number, route, site and date of administration not reported) and hepatitis vaccine (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later the parent stated he "cried all day, was just crying all the time", he did not speak until he was two years-old and he was diagnosed with autism. The parent reported that the patient had received two vaccines in each leg. Treatments were not reported. No further information was available at the time of vaccination. The patient's outcome was not recovered. Documents held by sender: none.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Adverse event
Clinical narrative: Initial report was received 14 October 2011 from a health care professional which involved a cluster of two patients. This case captures one patient. The other patient has been captured in case number 2011-10152. An elderly female patient had received an injection of FLUZONE HIGH DOSE, lot number UT457AA and an unspecified amount of time later, the patient went to the emergency room (also reported as hospitalized). The adverse event experienced by the patient was not specified. No additional information was provided at the time of the report. Outcome was not reported. Documents held by sender: None.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Pt fainted after flu shot BP 104/57. Pt regained full consciousness. Evaluated by 911 crew. Pt left with father.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Back pain, Cough, Erythema, Fatigue
Clinical narrative: Redness, pain with movement, back & hip pain, fatigue, hot, cold, headache, cough.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling of body temperature change, Headache, Pain
Clinical narrative: Redness, pain with movement, back & hip pain, fatigue, hot, cold, headache, cough.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Injection site (R)U arm 2 x 3 inch - reddened, raised, hard, itchy, burning - seen 10/18/11 - now 1 x 2 inch - discolored, small lump, no burning, positive tenderness & didn't feel well 10/13/11 PM.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Malaise
Clinical narrative: Injection site (R)U arm 2 x 3 inch - reddened, raised, hard, itchy, burning - seen 10/18/11 - now 1 x 2 inch - discolored, small lump, no burning, positive tenderness & didn't feel well 10/13/11 PM.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: (L) lower thigh with redness\induration measures 20 cm warm to touch under injection site by 3cm no other visible open wounds. AMOXIL, warm compress.
Age: 22.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Contusion, Haematoma, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Clt. seen in clinic, received Tdap & TWINRIX vaccine on 10-11-11 called & reported pain, tingling, numbness on 10-19-11. Advised on use of cold & hot compresses; ibuprofen & BENADRYL and moving arm. Saw MD on 10-20-11 & was told had large hematoma pressing on nerve - to continue hot compresses, exercising arm & pain meds. Bruise occurred 1 wk after injection, still painful.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Chest pain, Musculoskeletal pain, Myalgia, Neck pain
Clinical narrative: Extreme muscle soreness on Right arm w/in min of rec. Pain spread to shoulder, neck, chest, back by mid-afternoon. Resolved after 9 days.
Age: 0.6
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Patient received 6mo immunizations on 10/18/2011. That evening, experienced fever to 104-105 degrees F and simple febrile seizure lasting about 10 minutes.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site rash
Clinical narrative: Patient received a high dose Flu vaccine on 10/18/11. She returned to the pharmacy on 10/20/11 to show the pharmacist that she had a rash in the same area. (Allergic reaction).
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Large red spot. Swollen and feverish.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Skin warm
Clinical narrative: Bruising warm to touch. Bruise site: 7 " wide 2" high.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Oropharyngeal pain, Sensation of foreign body
Clinical narrative: Arm swelling & redness. Sore throat - pt describes it as "golf balls in throat".
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain
Clinical narrative: Pt woke up with left knee pain during the night. The pain is on the side of the knee and it hurts when moves, not swollen. Does not hurt when touched.
Age: 10.0
Sex: M
Vaccine: DT
Symptoms: Condition aggravated, Drug administered to patient of inappropriate age, Erythema multiforme, Similar reaction on previous exposure to drug
Clinical narrative: Initial report was received 12 October 2011 from a health care professional which involved a case of misuse/medication error (inappropriate age at time of vaccine administration). A 10-year-old male patient had received an injection of DT ADS PED USP (lot number, route, site and date of administration not reported) and an unspecified amount of time later, the patient developed diffuse erythema multiforme. The patient had previously experienced the same event after receiving a DTAP vaccination (manufacturer unknown) six years prior. No additional information was provided at the time of the report. Outcome was not reported. This patient experienced another event which has been captured in case number 2011-09950. Documents held by sender: None.
Age: 7.0
Sex: U
Vaccine: PER
Symptoms: Pertussis
Clinical narrative: Initial information received on 13 October 2011 from a company representative who provided a link to an online news article (lay press). Information in this article was provided by county health officials. A seven-year-old who was up-to-date with immunizations was diagnosed with pertussis. No specific product information or laboratory confirmation of the diagnosis was provided. No additional information available. List of documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Rash radiating from injection site. Pt was told to take antihistamine & see PCP. Pt stated would take medication & see PCP if rash progress or saw any other symptoms.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Rash
Clinical narrative: Injection given for influenza approx 1:15 pm. Pt presents to nurse @ 2:15 pm. Rash on neck & upper chest. Denies itching or dysnpea. "Feels hot around neck". Pt took BENADRYL 25 mg PO.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash macular
Clinical narrative: Given INFLUENZA injection at approx 12:30 pm. Present to nurse at 2 pm with slight splotchy rash on (L) neck. Denies SOB & itching, BP 162/82. Pulse 84 RR 18. Advised to contact PMD stat. Patient left. Advised to leave with adult.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Night of vaccination pt had fever starting at 101 then progressed to 103. She also experienced body aches and sore throat. Symptoms lasted until AM.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient called stating injection site was red, hard & hot. She went to ER & was given antibiotic & steroids, which interacted w/other rx's so she did not take. She went to he primary MD in the morning & was prescribed antibiotic, pain med & fluconazole for (R) arm.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Paraesthesia
Clinical narrative: Dizziness, tightness in chest, labored breathing, tingling & numbness in hands & arms 2-3 hours post injection. Administered EPIPEN one time 11:17 am.
Age: 46.0
Sex: F
Vaccine: FLUX, TYP
Symptoms: Eyelid oedema, Injection site swelling, Lip swelling, Local swelling, Oedema mouth
Clinical narrative: Patient reports waking approx 11 hours after vaccination w/swelling of lower lip, around eyes, some inside mouth, neck & top of (L) arm. Denied difficulty breathing. Self treated w/OTC BENADRYL x 4 over the next 12 hours. Symptoms resolved afternoon of 10/20/11.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patch of redness developed near site of injection - also area warm to touch.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Bone pain, Chills, Diarrhoea
Clinical narrative: Patient complains of stomach upset, diarrhea, and "bone pain" & chills.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Laboratory test, Pain in jaw
Clinical narrative: 2-13-08 I took shingles shot. Feb 15, 08 both jaws had sudden pain, as if I had been kicked in the face. I have been to Drs. and Dentists to rule out cause. I believe cause is vaccine. Have been to specialists in area & through other facility. Other sets of tests answered what caused it.  Every week-10 days I have 1 1/2 days when I have difficulty in getting food/water to go on down. I'm still on 2 clonazepam .5 and 6 gabapentin 400. I tried skipping a gabapentin, but that didn't work, the sore jaws came again. Symptoms for the most part, don't re-occur as long as I am on clonazepam & gabapentin. I do have symptoms if I am late taking or don't take them at all. It will soon be 4 yrs (Feb), and I'm hoping yet that it will leave my body so I don't have to take pills.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Pain in extremity, Rash, Skin infection
Clinical narrative: Skin infection - pain on arm, armpit - rash around shoulder.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Pt called on 9/30/11 stating after receiving flu vaccine on 9/20/11, she had body aches throughout body. States she has arthritis but she doesn't know if its the vaccine or her current disease state causing the pain.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Arm swelled severely, hot to touch, and painful. Pt went to her doctor and received a cortisone short which cleared up her symptoms. Pt recovered and is now in good health.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Injection site swelling, Urticaria
Clinical narrative: Swelling/lump at injection site. Hives across arms and back. BENADRYL.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Erythema, Pruritus, Rash erythematous
Clinical narrative: Pt received FLUMIST within hour, face started to itch. 4p - face red. 5p (6) red spots on face - next hour red spots began to expand and multiply to 20 - 30 spots - as large as hand. Dr's office called - liq BENADRYL given. Most spots gone by 9 pm. Pt has receive FLUMIST in past - no problems.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: (R) arm erythema, edema & pain within 12 hrs after vaccine, followed by fever to 101.5 & chills lasting 3 days. Improvement of arm redness & swelling after 4 days without treatment.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Atrial fibrillation, Chills, Condition aggravated, Hypertension, Pyrexia
Clinical narrative: Within about 3hs had reaction (light fever, chills, wheezing, developing into tachycardia). Rxn started 3hrs after vaccine progressed over 1/2 - 1 hr, high blood pressure (189/100+). Gave IV CARDIZEM, breathing treatment, prednisone.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Tachycardia, Wheezing
Clinical narrative: Within about 3hs had reaction (light fever, chills, wheezing, developing into tachycardia). Rxn started 3hrs after vaccine progressed over 1/2 - 1 hr, high blood pressure (189/100+). Gave IV CARDIZEM, breathing treatment, prednisone.
Age: 12.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Syncope
Clinical narrative: Patient fainted approximately five minutes after HPV vaccine administration, vitals taken, patient given O2 via NC, alert & aware. No permanent injury. Cleared by MD.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Pain & induration (6cm x 4cm) on upper left thigh. Started shortly after injection & increased in size pt was seen in clinic 3 days after vaccine administered and was given PEDIAPRED, BENADRYL & sulfamethoxazole-trimethoprim.
Age: 1.8
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site discolouration
Clinical narrative: Given MMR and VARIVAX in (R) thigh 3/30/11. A month or so later, pigment started going away in (R) thigh, leg and top of foot! It has not come back still!!
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Paraesthesia, Pharyngeal oedema, Swelling face
Clinical narrative: Shortness of breath, tingling sensation, swelling to face & throat.
Age: 17.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Severe headache. Fever 102.7. Chills.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Raised red rash approx 2 1/2 in x 1 in at site of injection. According to patient it burns.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Severe joint pain.
Age: 21.0
Sex: M
Vaccine: FLU3, HPV4, PPV
Symptoms: Abdominal pain upper, Chest pain, Dizziness, Dyspnoea, Musculoskeletal stiffness
Clinical narrative: Vaccines given at approx 9-10 am. That same evening around 7-8 pm c/o stiffness (entire body), chest pain, SOB, stomach hurting, light headed. Called poison control & told to go to ER. States her "shots for pain & to calm him down & meds to counter act affects of vaccine ".
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Rash
Clinical narrative: Developed rash on lower legs in the evening after receiving the vaccine c/o burning. Rash on hands developed next day.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site swelling, Pain, Skin warm
Clinical narrative: Developed a 3" by one inch height raised area surrounding pinpoint needle entry. Developed on 10/15/11 about 24 hrs. after injection. The area was red, warm and sore to touch. She notified her PMD who advised her to go to a walk in clinic. Dr gave her 10 days AUGMENTIN.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Local reaction
Clinical narrative: Large local reaction 12 x 13 cm. Red tender arm at site of shot.
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Axillary mass, Borrelia test negative, Influenza like illness, Lymphadenopathy
Clinical narrative: Got flu shot in left arm on 10/13/11. Next day had flu like symptoms that continued throughout the weekend. Monday morning noticed significant lump under left armpit. Went to see PA Monday afternoon. She said it was my lymph node. Put on anti-biotics and it went down, but is still present.
Age: 57.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Flushing, Hyperhidrosis, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Approximately five minutes after injection, pt complained of itching at inj site, back, and arms. Inj site swelled to approx. one inch in diameter; she also developed flushing and sweats. Counteracted w/oral antihistamine and injected BENADRYL; blood pressure in normal range before she left.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Dysphagia, Dyspnoea, Increased upper airway secretion, Urticaria
Clinical narrative: 10/18 received Tdap - within one hour hives, S.O.B, trouble swallowing. Hives left within 2 hours. Still feel like phlegm in back of throat. Did not seek treatment. SPO2 99% 129/83 - 80.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Excoriation, Laceration, Lip injury, Syncope
Clinical narrative: Fainted - serapes on side of face, abrasions on left forehead, under left eye, corner of left nare & neck. Cut on bridge of nose & inside of upper lip.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Ear pain, Eye disorder, Eyelid oedema, Nasopharyngitis, Ocular hyperaemia
Clinical narrative: Patient developed blurred vision Rt eye. His eyelid became swollen and eye very red. He has severe pain. On 10/15/11 ophthalmologist stated he had virus. We mention Flu shot. She couldn't give an answer. Presently eye problem/now cold and pain Rt ear.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Ophthalmological examination, Pain, Viral infection, Vision blurred
Clinical narrative: Patient developed blurred vision Rt eye. His eyelid became swollen and eye very red. He has severe pain. On 10/15/11 ophthalmologist stated he had virus. We mention Flu shot. She couldn't give an answer. Presently eye problem/now cold and pain Rt ear.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site pruritus, Pain in extremity
Clinical narrative: Developed severe pain at injection site with influenza vaccination, later itching & now with (L) shoulder, deltoid, arm pain persisting = 5 weeks later.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Left arm: swollen, red, achy.
Age: 38.0
Sex: F
Vaccine: HIBV, MNQ, PPV, TDAP
Symptoms: Chills, Erythema, Nausea, Pyrexia
Clinical narrative: Fever to 106 degrees F with local redness (nausea chills).
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Headache, Immediate post-injection reaction, Tonic clonic movements, Tremor
Clinical narrative: GARDASIL injection was given. Pt immediately had a sudden onset of headache & tonic-clonic shaking of head and arms lasting 3-5 seconds. Pt was assisted to exam table. Observed for 40 minutes, she was given juice, crackers 2 tabs ALEVE, TYLENOL 325 mg 2 tabs, she was discharged to home with a severe headache which lasted 2 days.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: - Reddish bumps (rash) around area of administration, appeared 3 days after (10/17/11) according to mother - hardly visible. - mother felt no treatment necessary - dr was informed 10/18/11.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling abnormal, Feeling hot, Mobility decreased
Clinical narrative: The evening after vaccine given pt experienced chills & shivering, the got very hot. The next day she did not feel good & stayed in bed all day.
Age: 1.01
Sex: M
Vaccine: FLU3, HEPA, PNC13, VARCEL
Symptoms: Injection site inflammation
Clinical narrative: 10 days after vaccine given, pt presented with local inflammatory reaction at site.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Cold sweat, Dizziness, Headache, Nausea
Clinical narrative: Severe headache, nausea, clammy skin, dizziness.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Rash, Urticaria
Clinical narrative: Swollen lips, hives and rash.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Paraesthesia
Clinical narrative: Limited mobility in left arm with tenderness at injection site.  Numbness with tingling to finger tips.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea
Clinical narrative: Severe Diarrhea from 8:00 pm until about 2:00 am.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Broke out on abdomen, few arms and legs.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Full blood count, Injection site erythema, Injection site pain, White blood cell count
Clinical narrative: Left arm is very red and burning from the shoulder down to the elbow.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Malaise, Nausea, Pain
Clinical narrative: Severe chills, body aches, weak, nauseous, all over sick feeling. Probably had a fever though I didn't take my temperature. I took Advil and the symptoms lessened but didn't go away completely. Had to miss a day of work because I still felt ill in the morning.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Eye pruritus, Eyelid oedema, Feeling hot, Rash
Clinical narrative: Itchy puffy eyes, facial skin hot red itchy, granular, progressing to rash on face eyebrows, cheeks, neck, and chest over a period of time from 10/13/2011 until 10/24/2011 when rash began to fade and itching somewhat subside.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Rash, Skin warm
Clinical narrative: From left shoulder to elbow very red, swollen and hot arm. Temp 100 degrees lasting until 10/23/2011. Following day, developed rash (similar to roseola) from top of legs to top of feet.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Anaemia, Back pain, Chills, Headache, Influenza like illness
Clinical narrative: Started with severe backache, in 3 days progressed to severe headaches, and major flu like symtoms, high fever, severe chills and tremors,and body aches. High white platelets jumped to 638,000, then to 900,000, and became amemic. Have been sent to hematologist on 22nd. Waiting for results-appt on Nov 1st.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Platelet count increased, Pyrexia, Tremor
Clinical narrative: Started with severe backache, in 3 days progressed to severe headaches, and major flu like symtoms, high fever, severe chills and tremors,and body aches. High white platelets jumped to 638,000, then to 900,000, and became amemic. Have been sent to hematologist on 22nd. Waiting for results-appt on Nov 1st.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Right arm- swollen and spreading outward, hot to touch, and painful- itching also.
Age: 1.26
Sex: M
Vaccine: PER, PNC13
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Vomiting and Diarrhea. Followed by a Fever. All symptoms lasted 6 days.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling cold, Hyperhidrosis
Clinical narrative: I had uncontrollable chills for two hours without relief.  I was SOOOO cold and could not get warm no matter what. 3 hours later I was sweating like crazy.  I have never felt worse in my life.
Age: 10.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Balance disorder, Hypoaesthesia
Clinical narrative: Noticed my childs limbs were numb and balance off a little while walking.
Age: 1.14
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Raised welt at (R) thigh immediately following admin. of MMR vaccine. Also, localized redness at site of VZV vaccine (L) thigh (2.5 cm). (Redness on (R) thigh about 4 cm).
Age: 33.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Activities of daily living impaired, Injection site pain, Local swelling, Mobility decreased, Pain in extremity
Clinical narrative: Pain in L arm, unable to lift arm to put on shirt, pain is localized at the injection site, (upper deltoid muscle) possible hyperventilation after injection. Came into center 10.07.2011 md saw a localized swelling. Pt returned on 10.18.2011, no swelling but continues to be unable to left arm, unless helped.