chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 25 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in an 11-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; unknown lot number received on 23 January 2012, lot number C4026AA received on 06 March 2012 and lot number C4275AA received on 06 June 2012 (routes and sites of administration not reported). The subject developed cough on 03 October 2012, approximately 4 months after the last dose. Paroxysmal coughing (without a whoop) began on 09 October 2012 and cold-like symptoms developed on 17 October 2012. The subject also experienced posttussive vomiting, sleep disturbance, and apnea (dates not reported). Laboratory testing included positive PCR on 09 October 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin starting on 09 October 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 23 October 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 20 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 25 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in an 11-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; unknown lot number received on 23 January 2012, lot number C4026AA received on 06 March 2012 and lot number C4275AA received on 06 June 2012 (routes and sites of administration not reported). The subject developed cough on 03 October 2012, approximately 4 months after the last dose. Paroxysmal coughing (without a whoop) began on 09 October 2012 and cold-like symptoms developed on 17 October 2012. The subject also experienced posttussive vomiting, sleep disturbance, and apnea (dates not reported). Laboratory testing included positive PCR on 09 October 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin starting on 09 October 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 23 October 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 20 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.94
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 25 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3591AA received on 14 April 2010, lot number C3805AA received on 12 May 2011 and lot number C3967AB received on 13 January 2012 (routes and sites of administration not reported). The subject developed a cough on 19 September 2012, approximately 8 months after the last dose. Paroxysmal coughing began on 22 September 2012. The subject also experienced cold-like symptoms and posttussive vomiting (dates not reported). Laboratory testing included positive PCR on 24 September 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 24 September 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 04 October 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 25 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.94
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting
Clinical narrative: Initial report received on 25 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3591AA received on 14 April 2010, lot number C3805AA received on 12 May 2011 and lot number C3967AB received on 13 January 2012 (routes and sites of administration not reported). The subject developed a cough on 19 September 2012, approximately 8 months after the last dose. Paroxysmal coughing began on 22 September 2012. The subject also experienced cold-like symptoms and posttussive vomiting (dates not reported). Laboratory testing included positive PCR on 24 September 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 24 September 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 04 October 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 25 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 7.0
Sex: U
Vaccine: FLU3
Symptoms: Influenza, Influenza A virus test positive, Polymerase chain reaction, Vaccination failure
Clinical narrative: Initial report received from a healthcare professional on 01 June 2012, who provided information on this case of one unidentified patient out of a cluster of 10 unidentified patients (previously reported as approximately nine unidentified patients), in case number 2012-05660. Information on the remaining nine patients is captured in case numbers: 2012-05660, 2012-06067, 2012-06068, 2012-06069, 2012-06070, 2012-06072, 2012-06073. The reporter for this case is also the same reporter as case numbers 2012-05658 (six elderly patients) and 2012-05659 (two adolescent patients). The reporter stated, of the cases reported as vaccine failure, one unidentified patient received an injection of FLUZONE, sanofi pasteur Inc., lot number reported as U4118A (incomplete lot number) (route, site and date of administration were not reported). An unspecified amount of time later, the patient tested PCR positive for influenza A/H3 at the state laboratory, since January. The patient's outcome was not reported. There was no additional individual patient information available. Follow-up information received from a health care professional on 25 October 2012. The patient was identified as a 7-year-old child (gender not provided) who had received vaccination with FLUZONE (lot number confirmed as U4118AA) and subsequently had a Rapid Flu test through the state health department that was positive for influenza A subtype H3N2 on 17 April 2012 (172 days p-v). Influenza was confirmed. The patient had been seen in the physician's office after vaccination for unspecified reasons, but had not been seen for complaint of influenza. Vaccine failure was reported. Outcome was recovered (date unspecified). Documents held by sender: None.
Age: 2.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Initial information received from a healthcare professional on 24 August 2012. A 02-year-old female patient whose medical history and concomitant drugs were unknown; had received an intramuscular injection (dose 4) of DAPTACEL (lot number C4127AA) in the right deltoid on 28 August 2012. The patient also received Varicella vaccine (manufacturer unknown, lot number, route and site of administration were not reported) on 28 August 2012. On 29 August 2012 i.e. one day post vaccination, the patient developed redness, swelling and hotness at injection site. The size was 5 cm by 3 cm. Laboratory details and corrective treatment were not reported. The patient's outcome was unknown. Follow-up information was received 26 October 2012 from a health care professional. Based upon new information received, it was determined this case now meets seriousness criteria and has been upgraded from nonserious to serious. The patient had no significant past medical history and no illness at the time of vaccination. On 29 August 2012, the patient was examined by their physician and the right shoulder of their arm was slightly tender with a 3cm round area with a 2cm induration area in the middle. Temperature was 99.8. The patient received oral KEFLEX 200 mg tid for ten days as treatment for possible cellulitis and the patient's arm improved within 24 hours. Laboratory and diagnostic testing was not performed. At the time of the report, the reporter stated the patient had returned to their usual state of good health and had recovered (date of recovery not reported). Documents held by sender: None.
Age: 2.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site warmth
Clinical narrative: Initial information received from a healthcare professional on 24 August 2012. A 02-year-old female patient whose medical history and concomitant drugs were unknown; had received an intramuscular injection (dose 4) of DAPTACEL (lot number C4127AA) in the right deltoid on 28 August 2012. The patient also received Varicella vaccine (manufacturer unknown, lot number, route and site of administration were not reported) on 28 August 2012. On 29 August 2012 i.e. one day post vaccination, the patient developed redness, swelling and hotness at injection site. The size was 5 cm by 3 cm. Laboratory details and corrective treatment were not reported. The patient's outcome was unknown. Follow-up information was received 26 October 2012 from a health care professional. Based upon new information received, it was determined this case now meets seriousness criteria and has been upgraded from nonserious to serious. The patient had no significant past medical history and no illness at the time of vaccination. On 29 August 2012, the patient was examined by their physician and the right shoulder of their arm was slightly tender with a 3cm round area with a 2cm induration area in the middle. Temperature was 99.8. The patient received oral KEFLEX 200 mg tid for ten days as treatment for possible cellulitis and the patient's arm improved within 24 hours. Laboratory and diagnostic testing was not performed. At the time of the report, the reporter stated the patient had returned to their usual state of good health and had recovered (date of recovery not reported). Documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Blood glucose increased
Clinical narrative: Initial report was received from a consumer on 24 October 2012. A child (age not reported) received an injection of FLUZONE (Lot number, route, site, and date of vaccination was not reported) and a week later experienced elevated blood sugars. No further information was provided. The patient's outcome was unknown. Documents held by sender: None.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Cellulitis, Chills, Cold sweat, Injection site erythema, Injection site pruritus
Clinical narrative: Cold sweats, chills, red, itchy, swollen arm from injection site down to elbow, weakness in arm, shooting pains down into fingers, fever.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site swelling, Muscular weakness, Pain, Pyrexia
Clinical narrative: Cold sweats, chills, red, itchy, swollen arm from injection site down to elbow, weakness in arm, shooting pains down into fingers, fever.
Age: 12.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site inflammation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Increased swelling, pain, inflammation, and hotness of left upper arm (injection site), nausea, and eventually involvement of left elbow and shoulder---skin resembled orange-peel texture---requiring ER visit at 4:00 AM om 08/31/2012 for dx and tx of cellulitis. Prescriptions for prednisone and cephalexin eventually relieved symptoms after a week.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Skin disorder
Clinical narrative: Increased swelling, pain, inflammation, and hotness of left upper arm (injection site), nausea, and eventually involvement of left elbow and shoulder---skin resembled orange-peel texture---requiring ER visit at 4:00 AM om 08/31/2012 for dx and tx of cellulitis. Prescriptions for prednisone and cephalexin eventually relieved symptoms after a week.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Flushing, Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: UPPPER RIGHT-ARM: REDNESS SPREAD-OUT 7"x5" BELOW THE INJECTION SITE, SWELLING, SKIN FLUSH AND HOT TO THE TOUCH, MULTIPLE NICKLE AND DIME SIZED HIVES ON SHOULDERS AND ON THE BACK OF THE UPPER RIGHT ARM.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Urticaria
Clinical narrative: UPPPER RIGHT-ARM: REDNESS SPREAD-OUT 7"x5" BELOW THE INJECTION SITE, SWELLING, SKIN FLUSH AND HOT TO THE TOUCH, MULTIPLE NICKLE AND DIME SIZED HIVES ON SHOULDERS AND ON THE BACK OF THE UPPER RIGHT ARM.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Lip swelling, Oedema mouth, Swelling face, Swollen tongue
Clinical narrative: Facial swelling around eyes, mouth, upper lip and under tongue.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Child had approx 3 inch circle of redness and swelling around the injection site with tenderness, Ice applied to area and given 25mg po of Benadryl.
Sex: U
Vaccine: FLU3
Symptoms: Influenza like illness
Clinical narrative: Initial report was received from a consumer on 24 October 2012. This case involved a cluster of four unidentified patients who experienced adverse events following FLUZONE, lot number UH721AB. Four unidentified patients had received intramuscular injections of FLUZONE, lot number UH721AB, within the last month and had reactions. They all got sick like the flu. One patient was hospitalized and diagnosed with toxic encephalopathy. The patients' outcomes were unknown. Documents held by sender: None.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Facial pain, Herpes zoster, Neck pain, Pain of skin, Pruritus
Clinical narrative: Initial case received from a consumer on 25 October 2012. A female patient age 77 received a dose of FLUZONE, Lot # reported as UH319AD, (to be confirmed) intramuscularly in the left side, site to be confirmed on 13 September 2012. The patient had a history of penicillin allergy, reported as PCN, diabetes, hypertension reported as HTN, high cholesterol and a history of shingles. Concomitant medications and lab results were not reported. On 15 September 2012, the patient experienced a hurting itch on face and in hair with small bumps and it spread to the side of her neck. The patient was seen by an allergist on 18 September 2012 and was diagnosed with shingles. The patient was prescribed prednisone and an unspecified shingles medicine. No further details were available at the time of this report. The patient outcome was not reported. Documents held by sender: None.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Initial case received from a consumer on 25 October 2012. A female patient age 77 received a dose of FLUZONE, Lot # reported as UH319AD, (to be confirmed) intramuscularly in the left side, site to be confirmed on 13 September 2012. The patient had a history of penicillin allergy, reported as PCN, diabetes, hypertension reported as HTN, high cholesterol and a history of shingles. Concomitant medications and lab results were not reported. On 15 September 2012, the patient experienced a hurting itch on face and in hair with small bumps and it spread to the side of her neck. The patient was seen by an allergist on 18 September 2012 and was diagnosed with shingles. The patient was prescribed prednisone and an unspecified shingles medicine. No further details were available at the time of this report. The patient outcome was not reported. Documents held by sender: None.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Anaemia haemolytic autoimmune, Blood count, Blood test, Dehydration, Hypertension
Clinical narrative: Autoimmune hemolytic anemia, jaundice, syncope vaso-vagal, dehydration, hypertension, DM type I, uncontrolled secondary to steroid treatment, blood transfusion.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Jaundice, Syncope, Transfusion, Type 1 diabetes mellitus
Clinical narrative: Autoimmune hemolytic anemia, jaundice, syncope vaso-vagal, dehydration, hypertension, DM type I, uncontrolled secondary to steroid treatment, blood transfusion.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Feeling cold, Injection site haematoma, Injection site reaction, Musculoskeletal pain
Clinical narrative: Started with a sore arm and very sore shoulder blade on the side of the shot.  In the evening I had a fever:  wore two bathrobes and two pairs of socks and still couldn't get warm in bed: took Benadryl early morning to get some sleep.  Upon waking, my urine was very strong and I was slightly dizzy.  I started feeling better about 12:30 on Saturday.  I only drank water on Friday and more lemon water on Saturday to help flush my system.  Friday evening I was getting a bruise where the shot was given and got some welts around my arm from the place of the shot.  My arm was and is still very sore to touch.  The bruise is getting bigger today, Monday, but the welts are getting less; and the arm is still sore.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Urine odour abnormal, Urticaria
Clinical narrative: Started with a sore arm and very sore shoulder blade on the side of the shot.  In the evening I had a fever:  wore two bathrobes and two pairs of socks and still couldn't get warm in bed: took Benadryl early morning to get some sleep.  Upon waking, my urine was very strong and I was slightly dizzy.  I started feeling better about 12:30 on Saturday.  I only drank water on Friday and more lemon water on Saturday to help flush my system.  Friday evening I was getting a bruise where the shot was given and got some welts around my arm from the place of the shot.  My arm was and is still very sore to touch.  The bruise is getting bigger today, Monday, but the welts are getting less; and the arm is still sore.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia, Temperature difference of extremities
Clinical narrative: Numbness on left arm, tingling down to fingers. Feels like electricity running down to fingers. Lt hand feels cooler than right hand.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: High fever.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Headache, Nausea, Pain
Clinical narrative: Severe headache, aches, chills, nausea, dizziness, sudden onset.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Headache
Clinical narrative: Severe headache when moving the head around and up/down.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Dry throat, Headache, Oropharyngeal pain, Pain, Pharyngeal disorder
Clinical narrative: Sore throat with raised bright yellow patches scattered on back of throat. This lasted until 11/03/2012 6:00 PM; 11/04/2012 body aches all day then at 3:27 AM of 11/05/2012 one of the worst headaches commenced. Vomited multiple times. Took an Imitrex 100 mg with a Zofran 4 mg to rule out migraine. 11/05/2012 by 9:30 AM left arm (shot arm) is very "heavy" and hurts to move fingers.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Sensation of heaviness, Vomiting
Clinical narrative: Sore throat with raised bright yellow patches scattered on back of throat. This lasted until 11/03/2012 6:00 PM; 11/04/2012 body aches all day then at 3:27 AM of 11/05/2012 one of the worst headaches commenced. Vomited multiple times. Took an Imitrex 100 mg with a Zofran 4 mg to rule out migraine. 11/05/2012 by 9:30 AM left arm (shot arm) is very "heavy" and hurts to move fingers.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Eczema, Injection site erythema, Irritability
Clinical narrative: Mother called to report 2 small areas of redness at injection site on right thigh. Raised, looks like 'eczema' rash. Not fluid filled. Baby was 'fussy' over the weekend but mother did not report any fevers. No other rashes or signs of reaction other than on right thigh. No treatment taken other than watchful waiting.
Age: 13.0
Sex: F
Vaccine: FLUN3
Symptoms: Convulsion
Clinical narrative: Student in class for 30 mins. Had seizure in classroom. After vaccine received became aware of recent history of prior seizures.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site vesicles, Pyrexia
Clinical narrative: Fever and chills during the night on 11/03/2012 and blisters at the site of injection with redness on 11/5/2012.  Physician prescribed Valtrex 1gram 3 times daily for 7 days beginning in the afternoon on 11/5/2012.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting and Diarrhea.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Pruritus, Urticaria
Clinical narrative: Face and arm became itchy, a few hours later hives developed. Hives increased in frequency after soccer practice, hand and feet were swollen and hives on soles of her feet.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: HIVES.
Age: 0.51
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood pressure decreased, Blood test, Cardiac monitoring, Chest X-ray, Chills
Clinical narrative: Felt cold, chills, pain @ site of injection (could not lift arm), fever spiked, uncontrollable shaking, drop of blood pressure.  Husband called 911.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling cold, Injected limb mobility decreased, Injection site pain, Pyrexia, Tremor
Clinical narrative: Felt cold, chills, pain @ site of injection (could not lift arm), fever spiked, uncontrollable shaking, drop of blood pressure.  Husband called 911.
Age: 64.0
Sex: F
Vaccine: DPP
Symptoms: Burning sensation, Tinnitus
Clinical narrative: Extremely loud ringing noise in my left ear!! Burning sensation down both arms and both legs and burning sensation in my upper back, also. This lasted for about an hour.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Nodule, Oedema peripheral, Pain in extremity
Clinical narrative: Patient reports arm is still swollen and painful with a knot after almost 3 weeks.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Electromyogram, Hypoaesthesia, Immunoglobulin therapy, Paraesthesia
Clinical narrative: Numbness hands and feet, tingling. EMG 05/15/2012. Neurology Consult 05/16/2012. IVIG x 5 days. Outpatient.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Lethargy
Clinical narrative: At injection site- Large (approx 4 inches across at the widest point) raised, red, hot, painful area. This worsened over the course of 3 days, then gradually diminished, and was completely gone by 5. On trunk and extremities- rash consisting of small raised, red bumps. This worsened over the course of 1 day, then gradually resolved, resolved by day 3. Low grade fever, lethargy, and cold symptoms appeared 1 day after injection, resolved by day 4.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Nasopharyngitis, Pyrexia, Rash, Rash erythematous
Clinical narrative: At injection site- Large (approx 4 inches across at the widest point) raised, red, hot, painful area. This worsened over the course of 3 days, then gradually diminished, and was completely gone by 5. On trunk and extremities- rash consisting of small raised, red bumps. This worsened over the course of 1 day, then gradually resolved, resolved by day 3. Low grade fever, lethargy, and cold symptoms appeared 1 day after injection, resolved by day 4.
Age: 1.36
Sex: M
Vaccine: DTAP
Symptoms: Rash, Swelling face, Urticaria
Clinical narrative: Rash followed by swelling of the face and welt like rash all ovewr face, body and trunk.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Injection site warmth, Limb discomfort, Skin warm
Clinical narrative: After vaccination, patient started to leave but returned because her arm was feeling hot. MD assessed. The area on the lower right deltoid to just above the elbow was raised approximately1"-1" circle and slightly erythematous and warm to touch. Warmth was also present. Pt placed in exam room and ice applied to site. Pt afebrile. After 10 minutes, pt felt fine other than arm discomfort. Pt monitored for another 10 minutes and then was discharged with ice pack and instructions on seeking medical attention and to take Tylenol for pain prn.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Rash erythematous
Clinical narrative: Severe erythematous rapidly progressive rash spreading distally down right arm past elbow. Self-resolved after 3 days.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Hypoaesthesia, Oedema peripheral, Pain, Vaccination complication
Clinical narrative: Patient felt arm got swollen and started experiencing pain.  She went to emergency clinic when pain continued. Was told that it was probably a reaction to vaccine and for her to take ibuprofen and put warm compression.  Patient says as of 11/5/2012 pain continues and she is now she is feeling numbness in 3 of her fingers and that her back hurts.  Says Ibuprofen does not relieve pain.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Abdominal pain, Crying, Discomfort, Erythema, Grunting
Clinical narrative: Patient discomfort started when mom was changing his diaper. Patient started to cry uncontrollably and crunch up into fetal position but on his side. Mom tried to help patient straighten up and he kept crying in pain with grunting and turning red. Then an hour later of being curled up and crying, mom feed him soon after patient vomited. Two hours later of crying and being curled up on his right side he was feed once again then vomited. This event happen 1 other time. When mother called doctor she said this was not related to vaccine.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Vomiting
Clinical narrative: Patient discomfort started when mom was changing his diaper. Patient started to cry uncontrollably and crunch up into fetal position but on his side. Mom tried to help patient straighten up and he kept crying in pain with grunting and turning red. Then an hour later of being curled up and crying, mom feed him soon after patient vomited. Two hours later of crying and being curled up on his right side he was feed once again then vomited. This event happen 1 other time. When mother called doctor she said this was not related to vaccine.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Chill 1 hour later severe chills 3 to 4 hrs later. Muscle ache and head ache following day with lesser chilling.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Anger, Depressed mood, Ecchymosis, Erythema
Clinical narrative: This spontaneous report as received from a physician refers to a 64 years old female patient. The patient was vaccinated with a dose of PNEUMOVAX 23 (Lot number reported as H013581, expiration date unspecified) 0.5 ml in her left arm (route not reported) on 25-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. At an unspecified time interval, in October 2012, the patient developed redness, swelling, pain and patchy ecchymosis on her left arm. The physician stated that the patient went to an unspecified emergency department and received unspecified antibiotics intravenously. The physician did not specify if the patient was hospitalized, but she said that the patient was very unhappy and that her condition on her left arm was limiting her daily functioning. The physician also stated that the patient's condition did not improve in response to the intravenous antibiotics and that the patient was in her practice and was very angry. The relatedness for the events was not reported for PNEUMOVAX 23. Redness, swelling, pain and patchy ecchymosis on her left arm, unhappy, condition on left arm limiting her daily functioning and angry were considered to be disabling by the reporting physician. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: This spontaneous report as received from a physician refers to a 64 years old female patient. The patient was vaccinated with a dose of PNEUMOVAX 23 (Lot number reported as H013581, expiration date unspecified) 0.5 ml in her left arm (route not reported) on 25-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. At an unspecified time interval, in October 2012, the patient developed redness, swelling, pain and patchy ecchymosis on her left arm. The physician stated that the patient went to an unspecified emergency department and received unspecified antibiotics intravenously. The physician did not specify if the patient was hospitalized, but she said that the patient was very unhappy and that her condition on her left arm was limiting her daily functioning. The physician also stated that the patient's condition did not improve in response to the intravenous antibiotics and that the patient was in her practice and was very angry. The relatedness for the events was not reported for PNEUMOVAX 23. Redness, swelling, pain and patchy ecchymosis on her left arm, unhappy, condition on left arm limiting her daily functioning and angry were considered to be disabling by the reporting physician. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Cardiac monitoring, Pruritus, Rash, Throat tightness
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of rash on skin in a 46-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medications included ZYRTEC as needed and VALIUM as needed. Concurrent medical conditions included sulfa allergy. On 22 September 2012 the subject received a dose of FLUARIX (.5 ml, unknown route, left arm). At 22:00 on 22 September 2012, hours after vaccination with FLUARIX, the subject experienced rash on skin, itching, throat tightness and anxiety. At 22:20 on 22 September 2012, the subject self treated with ZYRTEC-D. At 23:00, the subject presented to the emergency room. Relevant test results included oxygen saturation on room air was 95 percent. Cardiac monitoring was performed with results unknown. At the emergency department, the subject was treated with 50 mg of BENADRYL orally, 0.3mg of Epinephrine intramuscularly, and 60mg of oral prednisone. The subject was discharged at 0:47 on 23 September 2012 with instructions to take 60 mg of prednisone daily for 2 days and BENADRYL. The subject was "seen at an occupational health clinic on 27 September 2012 by which time the events had resolved." The healthcare professional (nurse practitioner) considered the events to be clinically significant. The nurse practitioner considered the events of rash on skin, itching and throat tightness probably related to vaccination with FLUARIX. The nurse practitioner considered the event of anxiety to be unrelated to vaccination with FLUARIX. At the time of reporting the events were resolved.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Alanine aminotransferase normal, Albumin globulin ratio, Anion gap, Aspartate aminotransferase normal, Basophil count normal
Clinical narrative: 55 y/o female Behavioral Health Registration Clerk ref by OCC HEALTH to Healthcare Center for determination of how to proceed with required employee 2012-13 Seasonal (IM) Influenza Vaccination, given ER Dx of Bell's Palsy (28OCT2011), two weeks s/p receipt of 2011-12 IM Split Virus Influenza Vaccine. Patient endorses preceding viral illness with fever blister on lip and non-productive cough x 7-10 days prior to onset of Bell's Palsy. She received her 2011 Seasonal (IM) Influenza vaccine, on 04OCT11 at the Flu Drive.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Basophil percentage decreased, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal
Clinical narrative: 55 y/o female Behavioral Health Registration Clerk ref by OCC HEALTH to Healthcare Center for determination of how to proceed with required employee 2012-13 Seasonal (IM) Influenza Vaccination, given ER Dx of Bell's Palsy (28OCT2011), two weeks s/p receipt of 2011-12 IM Split Virus Influenza Vaccine. Patient endorses preceding viral illness with fever blister on lip and non-productive cough x 7-10 days prior to onset of Bell's Palsy. She received her 2011 Seasonal (IM) Influenza vaccine, on 04OCT11 at the Flu Drive.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Blood chloride normal, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase normal, Blood creatinine increased, Blood glucose normal
Clinical narrative: 55 y/o female Behavioral Health Registration Clerk ref by OCC HEALTH to Healthcare Center for determination of how to proceed with required employee 2012-13 Seasonal (IM) Influenza Vaccination, given ER Dx of Bell's Palsy (28OCT2011), two weeks s/p receipt of 2011-12 IM Split Virus Influenza Vaccine. Patient endorses preceding viral illness with fever blister on lip and non-productive cough x 7-10 days prior to onset of Bell's Palsy. She received her 2011 Seasonal (IM) Influenza vaccine, on 04OCT11 at the Flu Drive.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea increased, Carbon dioxide increased, Computerised tomogram head normal
Clinical narrative: 55 y/o female Behavioral Health Registration Clerk ref by OCC HEALTH to Healthcare Center for determination of how to proceed with required employee 2012-13 Seasonal (IM) Influenza Vaccination, given ER Dx of Bell's Palsy (28OCT2011), two weeks s/p receipt of 2011-12 IM Split Virus Influenza Vaccine. Patient endorses preceding viral illness with fever blister on lip and non-productive cough x 7-10 days prior to onset of Bell's Palsy. She received her 2011 Seasonal (IM) Influenza vaccine, on 04OCT11 at the Flu Drive.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Differential white blood cell count, Eosinophil count normal, Eosinophil percentage, Eyelid oedema
Clinical narrative: 55 y/o female Behavioral Health Registration Clerk ref by OCC HEALTH to Healthcare Center for determination of how to proceed with required employee 2012-13 Seasonal (IM) Influenza Vaccination, given ER Dx of Bell's Palsy (28OCT2011), two weeks s/p receipt of 2011-12 IM Split Virus Influenza Vaccine. Patient endorses preceding viral illness with fever blister on lip and non-productive cough x 7-10 days prior to onset of Bell's Palsy. She received her 2011 Seasonal (IM) Influenza vaccine, on 04OCT11 at the Flu Drive.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Full blood count, Glomerular filtration rate, Haematocrit decreased, Haemoglobin normal, Hypoaesthesia
Clinical narrative: 55 y/o female Behavioral Health Registration Clerk ref by OCC HEALTH to Healthcare Center for determination of how to proceed with required employee 2012-13 Seasonal (IM) Influenza Vaccination, given ER Dx of Bell's Palsy (28OCT2011), two weeks s/p receipt of 2011-12 IM Split Virus Influenza Vaccine. Patient endorses preceding viral illness with fever blister on lip and non-productive cough x 7-10 days prior to onset of Bell's Palsy. She received her 2011 Seasonal (IM) Influenza vaccine, on 04OCT11 at the Flu Drive.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Lymphocyte count normal, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume normal
Clinical narrative: 55 y/o female Behavioral Health Registration Clerk ref by OCC HEALTH to Healthcare Center for determination of how to proceed with required employee 2012-13 Seasonal (IM) Influenza Vaccination, given ER Dx of Bell's Palsy (28OCT2011), two weeks s/p receipt of 2011-12 IM Split Virus Influenza Vaccine. Patient endorses preceding viral illness with fever blister on lip and non-productive cough x 7-10 days prior to onset of Bell's Palsy. She received her 2011 Seasonal (IM) Influenza vaccine, on 04OCT11 at the Flu Drive.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Mean platelet volume normal, Metabolic function test, Monocyte count normal, Monocyte percentage, Neutrophil count normal
Clinical narrative: 55 y/o female Behavioral Health Registration Clerk ref by OCC HEALTH to Healthcare Center for determination of how to proceed with required employee 2012-13 Seasonal (IM) Influenza Vaccination, given ER Dx of Bell's Palsy (28OCT2011), two weeks s/p receipt of 2011-12 IM Split Virus Influenza Vaccine. Patient endorses preceding viral illness with fever blister on lip and non-productive cough x 7-10 days prior to onset of Bell's Palsy. She received her 2011 Seasonal (IM) Influenza vaccine, on 04OCT11 at the Flu Drive.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Neutrophil percentage, Oral herpes, Platelet count normal, Protein total normal, Red blood cell count decreased
Clinical narrative: 55 y/o female Behavioral Health Registration Clerk ref by OCC HEALTH to Healthcare Center for determination of how to proceed with required employee 2012-13 Seasonal (IM) Influenza Vaccination, given ER Dx of Bell's Palsy (28OCT2011), two weeks s/p receipt of 2011-12 IM Split Virus Influenza Vaccine. Patient endorses preceding viral illness with fever blister on lip and non-productive cough x 7-10 days prior to onset of Bell's Palsy. She received her 2011 Seasonal (IM) Influenza vaccine, on 04OCT11 at the Flu Drive.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Red cell distribution width normal, Troponin T, Troponin normal, VIIth nerve paralysis, Viral upper respiratory tract infection
Clinical narrative: 55 y/o female Behavioral Health Registration Clerk ref by OCC HEALTH to Healthcare Center for determination of how to proceed with required employee 2012-13 Seasonal (IM) Influenza Vaccination, given ER Dx of Bell's Palsy (28OCT2011), two weeks s/p receipt of 2011-12 IM Split Virus Influenza Vaccine. Patient endorses preceding viral illness with fever blister on lip and non-productive cough x 7-10 days prior to onset of Bell's Palsy. She received her 2011 Seasonal (IM) Influenza vaccine, on 04OCT11 at the Flu Drive.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: White blood cell count normal
Clinical narrative: 55 y/o female Behavioral Health Registration Clerk ref by OCC HEALTH to Healthcare Center for determination of how to proceed with required employee 2012-13 Seasonal (IM) Influenza Vaccination, given ER Dx of Bell's Palsy (28OCT2011), two weeks s/p receipt of 2011-12 IM Split Virus Influenza Vaccine. Patient endorses preceding viral illness with fever blister on lip and non-productive cough x 7-10 days prior to onset of Bell's Palsy. She received her 2011 Seasonal (IM) Influenza vaccine, on 04OCT11 at the Flu Drive.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Chills, Headache, Malaise
Clinical narrative: 26 y/o male sent to HC on walk-in basis by occupational health. No official consult placed in system. Pt walks into HC at 3:15PM (10 OCT12) c/o "fever, chills, muscle aches & pains in knees and lower back, nausea and HA at 27.5 hours s/p receipt of AFLURIA IM, placed in Rt deltoid around noon on yesterday (09 OCT 12). He denies any difficulty swallowing or breathing, angio or periorbital edema, lip swelling, thickening of tongue, wheezing or hives in the first 3 hours s/p receipt of the vaccine. No other vaccines administered at the same time, other than PPD, which is non-contributory. No other vaccines received in the previous 30 days. Denies prior viral or GI illness in the past 30 days.  Felt fine until bedtime last evening around 9-10PM, when low grade fever of 99.6F and chills began, accompanied by general malaise, HA, nausea (no V or D), muscle/joint aches- bilateral knees (no redness, swelling or warmth of knees or other joints) and lower back ache. Went to bed. Sx have continued throughout the day today. Pt has not taken any OTC ibuprofen or TYLENOL. Denies personal hx of RA, lupus or arthritis. No eczema, asthma, psoriasis, sickle cell or G6PD deficiency. Denies numbness or tingling in feet or extremities. Denies mental confusion or blurred vision. Pt states he feels this way every time he gets the flu shot.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Nausea, Pyrexia, Vaccine positive rechallenge
Clinical narrative: 26 y/o male sent to HC on walk-in basis by occupational health. No official consult placed in system. Pt walks into HC at 3:15PM (10 OCT12) c/o "fever, chills, muscle aches & pains in knees and lower back, nausea and HA at 27.5 hours s/p receipt of AFLURIA IM, placed in Rt deltoid around noon on yesterday (09 OCT 12). He denies any difficulty swallowing or breathing, angio or periorbital edema, lip swelling, thickening of tongue, wheezing or hives in the first 3 hours s/p receipt of the vaccine. No other vaccines administered at the same time, other than PPD, which is non-contributory. No other vaccines received in the previous 30 days. Denies prior viral or GI illness in the past 30 days.  Felt fine until bedtime last evening around 9-10PM, when low grade fever of 99.6F and chills began, accompanied by general malaise, HA, nausea (no V or D), muscle/joint aches- bilateral knees (no redness, swelling or warmth of knees or other joints) and lower back ache. Went to bed. Sx have continued throughout the day today. Pt has not taken any OTC ibuprofen or TYLENOL. Denies personal hx of RA, lupus or arthritis. No eczema, asthma, psoriasis, sickle cell or G6PD deficiency. Denies numbness or tingling in feet or extremities. Denies mental confusion or blurred vision. Pt states he feels this way every time he gets the flu shot.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Speech disorder
Clinical narrative: Shot administered at 2:30pm - patient complained of itching at site. Patient alert & speaking, gave patient 50mg. BENADRYL. Returned at 4:20pm - having trouble speaking - gave EPIPEN 0.3mg. Called EMS.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Rash, Rash erythematous
Clinical narrative: Diffuse red rash, flat, does not itch, mostly on trunk and upper arms. No fever, no cough, but body aches. Does feel more fatigued than normal. (Hx flu like symptoms in 1970's after flu vaccines.)
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Swelling face, Urticaria, Vomiting
Clinical narrative: Immediate urticaria beginning on left arm and progressing to total body. Facial swelling and emesis sent to ER required epi.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Lip swelling, Movement disorder
Clinical narrative: Swollen lips, chills, unable to move/lift arm. Pt didn't seek medical attention.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Neck pain, Pain in extremity
Clinical narrative: Pt complained of pain radiating down arm, neck and back. No redness or heat coming off injection site. A week later the pain came back. First complaint was on 10/19 (day after injection). Then on 10/22 pain disappeared then resurfaced on 10/26.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure decreased, Chills
Clinical narrative: Pt received shot - called back in 20 min to say he was having violent shivering & felt that his B.P. was dropping. He did not want to contact PCP, so I did call his MD & notify them. Pt's phone number not working next day.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site swelling, Local reaction
Clinical narrative: Swelling around injection site. Seen at after hour treatment center and diagnosed with cellulitis. Seen in office 11-5-12, appears to be local reaction to vaccine and is resolved today.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Lg raised > 10 cm erythematous warmth to palpation tender area.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Decreased appetite, Myalgia, Nausea, Pyrexia
Clinical narrative: Severe myalgia, fever, intractable nausea, anorexia.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Pt. c/o nausea and vomiting the following day for 24-48 hours. Since resolved.
Age: 1.93
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Pt. had nausea and vomiting the following day for 24-48 hours. Since resolved.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Rash erythematous, Rash papular
Clinical narrative: Red, painful & itchy bumps with white heads - on rt. side buttock (underneath) - very painful. I can't take pain meds. I hallucinate.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Flu vaccine administered 10/19 in (L) deltoid. On Sunday 10/23 patient notice a red, raised pimple-like bump near site of vaccination. Put NEOSPORIN on it and got better. Patient came to pharmacy where administered on 11/3/12 to show RPh a dime size, red, scaly patch of skin near administration site.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Aphagia, Asthenia, Chills, Colitis
Clinical narrative: States 10/2/12 about 500pm not feeling well, began to run low grade fever (99.7-99.8) had chills, weak, no appetite, could not eat, diarrhea. Went to doctor 10/3/12 diagnosed with colitis. Says 7 days in bed able to return to full duty 10/16/12.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Diarrhoea, Malaise, Pyrexia
Clinical narrative: States 10/2/12 about 500pm not feeling well, began to run low grade fever (99.7-99.8) had chills, weak, no appetite, could not eat, diarrhea. Went to doctor 10/3/12 diagnosed with colitis. Says 7 days in bed able to return to full duty 10/16/12.
Age: 1.04
Sex: F
Vaccine: FLU3, MMRV, PNC, VARCEL, MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Double dose of varicella given (PROQUAD & VARIVAX). No adverse reactions within 2 days of vaccination. Parents told to call for rash, fever or other symptoms. Parents have not called with signs, symptoms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Blister, Rash papular
Clinical narrative: 4 yo male with scattered, erythematous papules & vesicles on trunk.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient diagnosed with shingles following ZOSTAVAX administration. Primary doctor gave diagnosis on 11/5/12.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (R) thigh red, warm to touch, swollen, low grade temp.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Rash generalised
Clinical narrative: Cellulitis (L) arm and generalized rash patient given antibiotic - KEFLEX 500mg 1 QID x 7 days.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient experienced a syncopal episode 20 minutes post immunization.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Patient's mother signed the consent form & requested that patient be vaccinated at the school based clinic. Patient received the influenza vaccine on 10-26-12. Mother called & reported that patient had received the flu vaccine a wk. prior during P.E. & she forgot to notify us to let us know.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased
Clinical narrative: Patient reports that she is unable to extend her (L) arm ever since she had her influenza vaccine on 10-26-12. She has a history of torn rotator cuff.