chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dermatitis allergic, Fatigue, Influenza virus test, Oedema peripheral
Clinical narrative: Weakness, fatigue started that night.  Generalized allergic/viral type rash started with high fever the next morning. Also complained of hand/feet swelling, hives. Pt seen in UC with 102 fever (2hrs after taking 400mg of ibuprofen).
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Rash generalised, Urticaria, Viral rash
Clinical narrative: Weakness, fatigue started that night.  Generalized allergic/viral type rash started with high fever the next morning. Also complained of hand/feet swelling, hives. Pt seen in UC with 102 fever (2hrs after taking 400mg of ibuprofen).
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Following Pneumovax 23 INJ 25MCG/05 ML injection, sudden fever, R. upper arm swelling and pain; injection site 9 x 7 cm; went to physician next day 11/30/2011 diagnosed with "cellulitis"; prescribed 1 week course of antibiotics.
Age: 29.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site induration, Injection site swelling, Injection site warmth, Sensation of heaviness
Clinical narrative: Arm felt heavy, site swollen, harden and warm to touch on the vaccinated area.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Skin tightness, Urticaria
Clinical narrative: Patient presented with hives and tightness on both hands. No difficulty breathing, no itching anywhere else on body.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Eczema, Rash
Clinical narrative: Rash, eczema. Finally was given hydrocortisone around age two. Child still suffers from eczema.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Injection site pain, Injection site swelling
Clinical narrative: Received MENACTRA (R) arm & ADACEL (L) arm on 11/17/11. On 11/18/11 went ER painful, swollen (R) arm at site of MENACTRA. No fever. Tx for cellulitis (R) arm with clindamycin 300mg tid x 10 days.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Injection site erythema
Clinical narrative: Pt returned two days later with redness around site. Pt was going out of town, warned pt that redness is possible, but if worsens could be infection. She went in to MD & was given antibiotic to treat infection. Pt has improved.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Blood pressure increased, Burning sensation, Erythema, Full blood count
Clinical narrative: Was seen by Dr. at clinic 12/2/11. Started w/ hive-like rash night of 11/29/11. Took BENADRYL that night. Saw Dr. on 11/30/11 and gave PREDNISONE 50mg to take today for 6 days. On 12/1/11 - rash covering body and itching and burning. Joints very swollen and painful. Extreme body pain. BP elevated, HP up. Dx. w/ serum sickness. 12/2 Rash mostly cleared. Face bright red. Continues w/ joint pain and body hurts.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Heart rate increased, Joint swelling, Pain, Pruritus, Rash generalised
Clinical narrative: Was seen by Dr. at clinic 12/2/11. Started w/ hive-like rash night of 11/29/11. Took BENADRYL that night. Saw Dr. on 11/30/11 and gave PREDNISONE 50mg to take today for 6 days. On 12/1/11 - rash covering body and itching and burning. Joints very swollen and painful. Extreme body pain. BP elevated, HP up. Dx. w/ serum sickness. 12/2 Rash mostly cleared. Face bright red. Continues w/ joint pain and body hurts.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Red blood cell sedimentation rate, Serum sickness, Urticaria
Clinical narrative: Was seen by Dr. at clinic 12/2/11. Started w/ hive-like rash night of 11/29/11. Took BENADRYL that night. Saw Dr. on 11/30/11 and gave PREDNISONE 50mg to take today for 6 days. On 12/1/11 - rash covering body and itching and burning. Joints very swollen and painful. Extreme body pain. BP elevated, HP up. Dx. w/ serum sickness. 12/2 Rash mostly cleared. Face bright red. Continues w/ joint pain and body hurts.
Age: 54.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Started as a sore arm in early evening. By midnight was in severe pain & unable to move arm. Put off going to doctor, but did not improve. Went to PCP on 11/11/11 and put on steroids & 1 week later given another Rx for another week of steroids.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Soft tissue mass, Surgery, Synovial cyst
Clinical narrative: Patient has shoulder pain with a small tissue mass consistent with ganglionic cyst. The patient had the mass surgically removed on 11/3/11.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: 4 hours after injection patient experienced headache, nausea, vomiting, fever and bronchial soreness.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dyskinesia
Clinical narrative: Pt took Flu shot at local drug store - 45 min to 1 hour later - had sudden onset of chills, weakness and jerking - (patient waited in store for required 20 minutes).
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 12.0
Sex: M
Vaccine: FLUN3, HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Tenderness
Clinical narrative: Redness next a.m., no fever, tender.
Age: 30.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain
Clinical narrative: Burning and soreness at injection site. Soreness lasting over 30 days.
Age: 30.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Burning and soreness at injection site. Soreness lasting over 30 days.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Head discomfort, Hypoaesthesia, Paraesthesia, Quality of life decreased
Clinical narrative: Case number PHEH2011US02085 is an initial spontaneous report received from a consumer 18 Aug 2011 with a follow-up received from the consumer on 22 Nov 2011: This report refers to a 58-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 111808P1) on 15 Oct 2010. On the same day, four to five hours after vaccination, she began to experience heaviness on the left side of her head and face "like it was full of water". Her left side started to vibrate and it went into her inner right leg. The shot was administered on her left side and it somehow attacked her central nervous system. She said it felt like hot lava was poured in side of her. She had to sleep sitting up in a chair. She saw a neurologist and he couldn't do anything for her. She now had a new doctor who was trying to help. She was not taking any other concomitant medications. The patient said this experience made it horrible for her to live this way. The vibration she was feeling had not stopped from the time she received the shot. She also had problems with periodic numbness and tingling on the left side of her body. No further information was provided. Follow-up received from the consumer on 22 Nov 2011: Updated events and outcome.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Sensation of heaviness, Sleep disorder, Vibratory sense increased
Clinical narrative: Case number PHEH2011US02085 is an initial spontaneous report received from a consumer 18 Aug 2011 with a follow-up received from the consumer on 22 Nov 2011: This report refers to a 58-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 111808P1) on 15 Oct 2010. On the same day, four to five hours after vaccination, she began to experience heaviness on the left side of her head and face "like it was full of water". Her left side started to vibrate and it went into her inner right leg. The shot was administered on her left side and it somehow attacked her central nervous system. She said it felt like hot lava was poured in side of her. She had to sleep sitting up in a chair. She saw a neurologist and he couldn't do anything for her. She now had a new doctor who was trying to help. She was not taking any other concomitant medications. The patient said this experience made it horrible for her to live this way. The vibration she was feeling had not stopped from the time she received the shot. She also had problems with periodic numbness and tingling on the left side of her body. No further information was provided. Follow-up received from the consumer on 22 Nov 2011: Updated events and outcome.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Rash associated with shingles meds given Lidocaine Gel 2%, Acyclovir 200mg.
Age: 1.0
Sex: F
Vaccine: DTAP, HEP, HEPA, IPV, MMR, PNC
Symptoms: Anion gap normal, Blood culture negative, Blood glucose increased, Blood sodium normal, Body temperature increased
Clinical narrative: Received routine first Hep A and MMR, with fourth PCV7, Hep B, IPV and DTaP immunizations at 1 year of age. Mom reported child exposed to another child who had cold like symptoms with fever, runny nose, and cough, etc week before and within 48 hours of 2/11/2009 vaccinations. Mom reported child okay all day experiencing soreness to bilateral thighs which she treated with age appropriate TYLENOL about 8 pm. By midnight mom advised child was "fussy" (cried, seemed to be in pain, no fever) so she retreated with TYLENOL. Approximately 5-630 AM on 2/12/2009 mom awoke with child "convulsing" describing her daughters eyes were starring ahead and her whole body jerking. Mom called 911 with grandmother placing child on side rubbing back. Mom currently remembers seizure lasted 10-15 minutes before rescue arrived with child sleepy and lethargic; however ER documentation document seizure at home lasted 3 minutes. While in the emergency department child has a second 2-3 minute seizure (treated with VERSED) with temperature of 102.2F (38.9C) (treated with TYLENOL and 2 hr later MOTRIN) with pulse of 133, respirations 36 and oxygen saturations of 97% room air. A sepsis workup including lumbar puncture was completed with admission to rule out meningitis.
Age: 1.0
Sex: F
Vaccine: DTAP, HEP, HEPA, IPV, MMR, PNC
Symptoms: CSF glucose normal, CSF protein normal, CSF white blood cell count negative, Carbon dioxide decreased, Chest X-ray normal
Clinical narrative: Received routine first Hep A and MMR, with fourth PCV7, Hep B, IPV and DTaP immunizations at 1 year of age. Mom reported child exposed to another child who had cold like symptoms with fever, runny nose, and cough, etc week before and within 48 hours of 2/11/2009 vaccinations. Mom reported child okay all day experiencing soreness to bilateral thighs which she treated with age appropriate TYLENOL about 8 pm. By midnight mom advised child was "fussy" (cried, seemed to be in pain, no fever) so she retreated with TYLENOL. Approximately 5-630 AM on 2/12/2009 mom awoke with child "convulsing" describing her daughters eyes were starring ahead and her whole body jerking. Mom called 911 with grandmother placing child on side rubbing back. Mom currently remembers seizure lasted 10-15 minutes before rescue arrived with child sleepy and lethargic; however ER documentation document seizure at home lasted 3 minutes. While in the emergency department child has a second 2-3 minute seizure (treated with VERSED) with temperature of 102.2F (38.9C) (treated with TYLENOL and 2 hr later MOTRIN) with pulse of 133, respirations 36 and oxygen saturations of 97% room air. A sepsis workup including lumbar puncture was completed with admission to rule out meningitis.
Age: 1.0
Sex: F
Vaccine: DTAP, HEP, HEPA, IPV, MMR, PNC
Symptoms: Convulsion, Crying, Dyskinesia, Gram stain, Gram stain negative
Clinical narrative: Received routine first Hep A and MMR, with fourth PCV7, Hep B, IPV and DTaP immunizations at 1 year of age. Mom reported child exposed to another child who had cold like symptoms with fever, runny nose, and cough, etc week before and within 48 hours of 2/11/2009 vaccinations. Mom reported child okay all day experiencing soreness to bilateral thighs which she treated with age appropriate TYLENOL about 8 pm. By midnight mom advised child was "fussy" (cried, seemed to be in pain, no fever) so she retreated with TYLENOL. Approximately 5-630 AM on 2/12/2009 mom awoke with child "convulsing" describing her daughters eyes were starring ahead and her whole body jerking. Mom called 911 with grandmother placing child on side rubbing back. Mom currently remembers seizure lasted 10-15 minutes before rescue arrived with child sleepy and lethargic; however ER documentation document seizure at home lasted 3 minutes. While in the emergency department child has a second 2-3 minute seizure (treated with VERSED) with temperature of 102.2F (38.9C) (treated with TYLENOL and 2 hr later MOTRIN) with pulse of 133, respirations 36 and oxygen saturations of 97% room air. A sepsis workup including lumbar puncture was completed with admission to rule out meningitis.
Age: 1.0
Sex: F
Vaccine: DTAP, HEP, HEPA, IPV, MMR, PNC
Symptoms: Injection site pain, Irritability, Laboratory test, Lethargy, Lumbar puncture normal
Clinical narrative: Received routine first Hep A and MMR, with fourth PCV7, Hep B, IPV and DTaP immunizations at 1 year of age. Mom reported child exposed to another child who had cold like symptoms with fever, runny nose, and cough, etc week before and within 48 hours of 2/11/2009 vaccinations. Mom reported child okay all day experiencing soreness to bilateral thighs which she treated with age appropriate TYLENOL about 8 pm. By midnight mom advised child was "fussy" (cried, seemed to be in pain, no fever) so she retreated with TYLENOL. Approximately 5-630 AM on 2/12/2009 mom awoke with child "convulsing" describing her daughters eyes were starring ahead and her whole body jerking. Mom called 911 with grandmother placing child on side rubbing back. Mom currently remembers seizure lasted 10-15 minutes before rescue arrived with child sleepy and lethargic; however ER documentation document seizure at home lasted 3 minutes. While in the emergency department child has a second 2-3 minute seizure (treated with VERSED) with temperature of 102.2F (38.9C) (treated with TYLENOL and 2 hr later MOTRIN) with pulse of 133, respirations 36 and oxygen saturations of 97% room air. A sepsis workup including lumbar puncture was completed with admission to rule out meningitis.
Age: 1.0
Sex: F
Vaccine: DTAP, HEP, HEPA, IPV, MMR, PNC
Symptoms: Lymphocyte percentage decreased, Monocyte count increased, Neutrophil percentage increased, Red blood cells CSF positive, Somnolence
Clinical narrative: Received routine first Hep A and MMR, with fourth PCV7, Hep B, IPV and DTaP immunizations at 1 year of age. Mom reported child exposed to another child who had cold like symptoms with fever, runny nose, and cough, etc week before and within 48 hours of 2/11/2009 vaccinations. Mom reported child okay all day experiencing soreness to bilateral thighs which she treated with age appropriate TYLENOL about 8 pm. By midnight mom advised child was "fussy" (cried, seemed to be in pain, no fever) so she retreated with TYLENOL. Approximately 5-630 AM on 2/12/2009 mom awoke with child "convulsing" describing her daughters eyes were starring ahead and her whole body jerking. Mom called 911 with grandmother placing child on side rubbing back. Mom currently remembers seizure lasted 10-15 minutes before rescue arrived with child sleepy and lethargic; however ER documentation document seizure at home lasted 3 minutes. While in the emergency department child has a second 2-3 minute seizure (treated with VERSED) with temperature of 102.2F (38.9C) (treated with TYLENOL and 2 hr later MOTRIN) with pulse of 133, respirations 36 and oxygen saturations of 97% room air. A sepsis workup including lumbar puncture was completed with admission to rule out meningitis.
Age: 1.0
Sex: F
Vaccine: DTAP, HEP, HEPA, IPV, MMR, PNC
Symptoms: Staring, Urine analysis normal, White blood cell count increased
Clinical narrative: Received routine first Hep A and MMR, with fourth PCV7, Hep B, IPV and DTaP immunizations at 1 year of age. Mom reported child exposed to another child who had cold like symptoms with fever, runny nose, and cough, etc week before and within 48 hours of 2/11/2009 vaccinations. Mom reported child okay all day experiencing soreness to bilateral thighs which she treated with age appropriate TYLENOL about 8 pm. By midnight mom advised child was "fussy" (cried, seemed to be in pain, no fever) so she retreated with TYLENOL. Approximately 5-630 AM on 2/12/2009 mom awoke with child "convulsing" describing her daughters eyes were starring ahead and her whole body jerking. Mom called 911 with grandmother placing child on side rubbing back. Mom currently remembers seizure lasted 10-15 minutes before rescue arrived with child sleepy and lethargic; however ER documentation document seizure at home lasted 3 minutes. While in the emergency department child has a second 2-3 minute seizure (treated with VERSED) with temperature of 102.2F (38.9C) (treated with TYLENOL and 2 hr later MOTRIN) with pulse of 133, respirations 36 and oxygen saturations of 97% room air. A sepsis workup including lumbar puncture was completed with admission to rule out meningitis.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Mobility decreased, Neck pain, Pain in extremity
Clinical narrative: Pt not able to lift arm c/o pain radiating into neck and into back. Tx: NSAIDS, ice, rest.
Age: 15.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Cellulitis
Clinical narrative: Cellulitis, treated w/antibiotics.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Pain, Pruritus, Urticaria
Clinical narrative: Large local (6 cm of wheal and flare) that occurred 2 days after vaccination. Associated pain & pruritus.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised, Vomiting
Clinical narrative: Fever (102.8) x 8 d. after imm., vomiting x 1 on day 9 after imm., rash over body (face to legs) & fever on 11/30/11. No tx; to rtn. to PCP - PRN.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Pain, Paraesthesia
Clinical narrative: When pt came in received flu shot 11/2/11 said the shot was fairly painful thought it was a little high since then arms had tingling and numb that evening but had improved/when lifting arm still sore. Saw her doctor yesterday 11/30/11 during her moms appt. Doctor to come back in, in a few weeks if not better.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Local erythematous reaction adjacent to injection site but not involving.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Local reaction, Vaccination complication
Clinical narrative: Local reaction to PNEUMOCOCCAL vaccine.
Age: 0.1
Sex: U
Vaccine: HEP, HIBV, IPV, PPV
Symptoms: Crying
Clinical narrative: Case number PHHY2011US85595 is an initial literature report received on 04 Sep 2011. The authors present a case of adverse event in a neonate after immunizations. This report refers to a one month old neonate of unknown gender. This healthy neonate was vaccinated with Hib vaccine (manufacturer and batch number: unknown, therefore conservatively taken as VAXEMHIB), IPV vaccine (manufacturer and batch number: unknown, therefore conservatively taken as IPV VIRELON), HepB vaccine (manufacture and batch number: unknown), DTaP vaccine (other manufacturer) and PCV-7 vaccine (manufacture and batch number: unknown). Less than one day after vaccination, this neonate presented with inconsolable crying. The causality was assessed as possible by the reporter. No further information about the outcome of the event was available.
Age: 1.0
Sex: U
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Cerebellar ataxia
Clinical narrative: Case number PHHY2011US85547 is an initial literature report received on 04 Sep 2011. The authors present a case of cerebellar ataxia following immunizations in an infant. This report refers to a one and a half year old infant of unknown gender (table 3). This healthy infant was vaccinated with Hib vaccine (manufacturer and batch number: unknown, therefore conservatively taken as VAXEMHIB INN), MMR (manufacturer and batch number: unknown), varicella (manufacturer and batch number: unknown) and DTaP (other manufacturer) on an undetermined date. Nine days after vaccination, this infant developed cerebellar ataxia. The causality was assessed as probable by the reporter. No further information about the outcome of the event was available.
Age: 0.3
Sex: U
Vaccine: DTAP, HEPA, HIBV, IPV, PPV, RVX
Symptoms: Fontanelle bulging, Irritability
Clinical narrative: Case number PHHY2011US85561 is an initial literature report received on 04 Sep 2011. The authors present a case of bulging fontanelle following immunizations in a neonate. This report refers to a three month old neonate of unknown gender (table 3). This healthy neonate was vaccinated with Hib (manufacturer and batch number: unknown, therefore conservatively taken as VAXEMHIB INN), IPV (manufacturer and batch number: unknown, therefore conservatively taken as IPV VIRELON INN), HepB (manufacture and batch number: unknown), PCV-7 (manufacturer and batch number: unknown), DTaP (other manufacturer) and rotavirus (manufacture and batch number: unknown) on an undetermined date. Less than a day after vaccination, this neonate experienced bulging fontanelle and was fussy. The causality was assessed as possible by the reporter. No further information about the outcome of the event was available.
Age: 0.5
Sex: U
Vaccine: DTAP, HIBV, PPV
Symptoms: Myelitis transverse, Neonatal disorder
Clinical narrative: Case number PHHY2011US85588 is an initial literature report received on 04 Sep 2011. The authors present a case of transverse myelitis in a neonate. This case refers to a six month old neonate of unknown gender (table 3). This healthy neonate was vaccinated with Hib (manufacturer and batch number: unknown, therefore conservatively taken as VAXEMHIB INN), DTaP (other manufacturer) and PCV-7 (manufacture and batch number: unknown) on an undetermined date. Fourteen days after vaccination, this neonate experienced transverse myelitis. The causality was assessed as possible by the reporter. No further information about the outcome of the event was available.
Age: 39.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: This case was reported by a physician and described the occurrence of pain in a 39-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included cephalosporin allergy. Previous and/or concurrent vaccination included influenza virus vaccine; GlaxoSmithKline; unknown given on 19 October 2010. The influenza vaccine was reported as FLULAVAL, however, the lot number that was reported corresponded to FLUARIX. There were no concurrent medications. The subject had not experienced any adverse events following previous vaccinations, with the exception of having pain after the 2nd dose of TWINRIX. On an unspecified date, the subject received 2nd dose of TWINRIX (details unknown) and experienced pain. No other information was provided. The outcome of this event was unspecified. On 19 October 2010, at approximately 10:50 AM, the subject received 3rd dose of TWINRIX (1 ml, unknown, left arm). On 19 October 2010, at time of vaccination (10:50 AM) with TWINRIX, the subject experienced pain and injection site reaction. On 20 October 2010, less than one day after vaccination with TWINRIX, she experienced swelling injection site, injection site pruritus and injection site redness. The subject was treated with BENADRYL, antihistamine, ice pack and heat application. At the time of reporting, the events that occurred after the 3rd dose of TWINRIX were improved. The physician considered the events that occurred after the 3rd dose of TWINRIX were probably related to vaccination with TWINRIX. At the time of TWINRIX injection (3rd dose), the subject experienced pain and achiness. The subject was given an ice pack at the time of the vaccination. The reporter notes that the next morning, she experienced a golf ball sized swelling at the site of the injection. There was itching as well. The subject took BENADRYL and an antihistamine and applied heat. The events did not require medical attention. At the time of the report, the symptoms improved. Follow-up information was received on 22 November 2010 via healthcare professional who reported the events experienced by the subject resolved on 22 October 2010. At the time of the report, no other information was provided.
Age: 29.0
Sex: F
Vaccine: HEPAB
Symptoms: Dysgeusia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of metallic taste in month in a 29-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Previous vaccination included 1st dose of TWINRIX GlaxoSmithKline given on 15 November 2010. Concurrent vaccination given on an unspecified date included TYPHIM (manufacturer unspecified) given in 2010 (within the last couple of days of reporting). There were no concurrent medications. On 22 November 2010 the subject received 2nd dose of TWINRIX (according to the accelerated dosing schedule before traveling). On 22 November 2010, 5 seconds after vaccination with TWINRIX, the subject experienced a metallic taste in her mouth. The metallic taste resolved within 5 seconds. The nurse practitioner kept the subject in the office for at least 15 minutes and she did no have any other problems. Her condition did not meet serious criteria.
Sex: U
Vaccine: HEPAB
Symptoms: Nausea, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of nausea in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received TWINRIX, and then went on a vacation and upon return from vacation the subject had nausea and vomiting. It was unclear if the subject just got sick, contracted Hepatitis A, Hepatitis B or adverse event from the vaccination. At the time of the report no other information was provided. At the time of reporting the outcome of nausea, vomiting, possible hepatitis A and possible hepatitis B were unspecified.
Age: 42.0
Sex: M
Vaccine: HEPAB, IPV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site haematoma, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site swelling in a 42-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included IPOL (non-gsk); non-GSK manufacturer; unknown; unknown given on 21 January 2011. Concurrent medications included (Non-GSK) Yellow fever. On 21 January 2011 the subject received 1st dose of TWINRIX (1 ml, unknown, left arm). On 21 January 2011, immediately after vaccination with TWINRIX, the subject experienced injection site swelling, injection site redness, and injection site pain; the size was described as a fourth to half a dollar size. Intervention to prevent further swelling was performed at the physician's office and included application of ice. On an unspecified date in January 2011, three days after vaccination with TWINRIX, the subject reported having pain and a little bruising at injection site. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with Ice pack. At the time of reporting the outcome of the injection site swelling, injection site redness, pain and bruising at injection were unspecified. This is the first of two cases reported by the healthcare professional; for the second case see A0910940A. Follow-up information was received on 16 February 2011 via healthcare professional who reported as of 24 January 2011 the injection site swelling and injection site redness injection site pain and bruising at injection site had improved. The immunization series was not delayed or discontinued.
Age: 46.0
Sex: M
Vaccine: HEPAB
Symptoms: Hepatitis B antibody negative, Seroconversion test negative
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of low seroconversion to combination Hep A/Hep B vaccine in a 46-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). On 11 November 2010, 11 June 2010 and 11 May 2010 the subject received 3rd dose, 2nd dose and 1st dose of TWINRIX to complete the three dose series. Titers were drawn on 11 December 2010 and were found to be negative. The subject experienced low seroconversion to combination Hep A/Hep B vaccine. No additional details were provided. The nurse did not have the lot numbers for the vaccines administered. It was reported that the subject may have received a hepatitis series in the past (2007). Titers drawn in April 2010 prior to TWINRIX administration were negative.
Age: 55.0
Sex: M
Vaccine: HEPAB
Symptoms: Blood glucose abnormal, Blood glucose increased
Clinical narrative: This case was reported by another manufacturer Merck and described the occurrence of abnormal blood glucose level in a 55-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline) for prophylaxis and treatment for Hepatitis C. Concurrent medical conditions included diabetes and hepatitis C. On unspecified dates the subject received unspecified dose of TWINRIX (unknown). At an unspecified time after the vaccination with TWINRIX, the subject experienced abnormal blood glucose level. "While taking TWINRIX the [subject's] blood sugar level went to 240. He is a diabetic and had been receiving his injections one month apart at an unspecified dose". At the time of reporting the outcome of the abnormal blood glucose level was unspecified. No further information was provided.
Sex: F
Vaccine: HEPAB
Symptoms: Headache, Malaise
Clinical narrative: This case was reported by a consumer and described the occurrence of headache in an adult female subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 2 April 2011 the subject received unspecified dose of TWINRIX (unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced headache and not feeling well. At the time of reporting the events were unresolved. Follow-up information received via the consumer on 12 April 2011 indicated that the event resolved. The consumer reported that she was not seen by her physician regarding the events. She will not be receiving further doses of TWINRIX. No additional information expected.
Sex: U
Vaccine: HEPAB
Symptoms: Hepatitis A antibody negative
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis A antibody negative in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (details unknown). At an unknown time after vaccination with TWINRIX, the subject experienced hepatitis A antibody negative. The subject's titres were drawn and revealed no titres for hepatitis A. No further information was provided.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Body temperature increased, Cough, Injection site warmth, Malaise
Clinical narrative: ONE HALF HOUR AFTER VACCINE felt warmth at injection site and had a low grade temp. Upon 12 hours following body aches, malaise, sore throat, cough and asthma symptoms such as wheezing and now going into third day post vaccine.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Wheezing
Clinical narrative: ONE HALF HOUR AFTER VACCINE felt warmth at injection site and had a low grade temp. Upon 12 hours following body aches, malaise, sore throat, cough and asthma symptoms such as wheezing and now going into third day post vaccine.
Age: 22.0
Sex: F
Vaccine: ANTH, YF
Symptoms: Chest discomfort, Disturbance in attention, Dizziness, Fatigue, Headache
Clinical narrative: Dizziness, racing heart, headache, trouble concentrating, fatigue, vomiting, tingly feeling in fingers and toes, pressure in chest.
Age: 22.0
Sex: F
Vaccine: ANTH, YF
Symptoms: Palpitations, Paraesthesia, Vomiting
Clinical narrative: Dizziness, racing heart, headache, trouble concentrating, fatigue, vomiting, tingly feeling in fingers and toes, pressure in chest.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Dermatitis bullous, Petechiae, Platelet count decreased, Platelet transfusion
Clinical narrative: Petechial, bullae reaction rapidly progressing. Found to have platelet count non detectable with normal platelet count 172,000 two weeks before. Hospitalized. Treated with platelets, steroids, etc.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram head, Headache, Laboratory test, Musculoskeletal stiffness
Clinical narrative: Started with pain and stiffness left side of neck, same side shot was given, became severe on 11/10/2011 spread to entire neck and head and had to go to after hour clinic and emergency room.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Spinal X-ray
Clinical narrative: Started with pain and stiffness left side of neck, same side shot was given, became severe on 11/10/2011 spread to entire neck and head and had to go to after hour clinic and emergency room.
Age: 4.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: Her thigh where the flu vaccine was administered began to swell to an abnormal size.  The welt was roughly 5-6" in diamater, taking up her entire thigh from hip to knee.  It was surrounded by a red ring, was extremely hot to the touch, extremely hard, and extremely uncomfortable for my daughter.
Age: 4.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site warmth, Urticaria
Clinical narrative: Her thigh where the flu vaccine was administered began to swell to an abnormal size.  The welt was roughly 5-6" in diamater, taking up her entire thigh from hip to knee.  It was surrounded by a red ring, was extremely hot to the touch, extremely hard, and extremely uncomfortable for my daughter.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Poor quality sleep
Clinical narrative: A few days after the flu shot in my left shoulder, I had extremely limited arm movement. I was unable to lift my arm up to be parallel with the rest of my body. I cannot put any weight on affected arm because of pain or lift anything heavy. I am unable to sleep on side with affected arm because I wake up at night from pain and then my shoulder is extremely sore. I am unable to move arm in a certain manner with tasks such as taking off shirts or putting on socks. The pain has lasted for 3.5 weeks until I saw my doctor on November 11, 2011. Before then I was applying warm compresses, which did not improve the pain, so I switched to cold compresses which also did not help. I took ibuprofen which did not help. Then I decided to take Tylenol which helped a little. My physician prescribed me a 15-day course of Prednisone which helped and the pain subsided completely. I finished course at the beginning of this week (11/27/11) and noticed onset of pain again in left shoulder yesterday (12/02/11). Today I was unable to lift grocery bags. Pain is localized in the shoulder.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On 11/30/11, noticed swelling, soreness and redness. On 12/01/11 swelling, soreness and redness continued, with additional "fevered" feel at the injection site. Site looked like a large "knot" with increased redness and soreness.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Dyspnoea, Fear, Hypersensitivity, Injected limb mobility decreased
Clinical narrative: Started with a rash and itching, but by evening, I was in SEVERE pain 10/10...I had a lump bigger than the size of a soft ball where the shot was given, my whole arm and fingers were swollen, my neck and jaw were stiff, I couldn't move my left arm or shoulder at all, my tongue felt swollen, I started coughing in the ER waiting room, and couldn't stop and couldn't breathe out and could barely breathe in, I had to use my inhaler 4x...I had already taken 50mg of liquid Benadryl as well...I was very scared that I was about to die!
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Joint stiffness, Musculoskeletal stiffness, Oedema peripheral, Pain
Clinical narrative: Started with a rash and itching, but by evening, I was in SEVERE pain 10/10...I had a lump bigger than the size of a soft ball where the shot was given, my whole arm and fingers were swollen, my neck and jaw were stiff, I couldn't move my left arm or shoulder at all, my tongue felt swollen, I started coughing in the ER waiting room, and couldn't stop and couldn't breathe out and could barely breathe in, I had to use my inhaler 4x...I had already taken 50mg of liquid Benadryl as well...I was very scared that I was about to die!
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Rash, Swollen tongue
Clinical narrative: Started with a rash and itching, but by evening, I was in SEVERE pain 10/10...I had a lump bigger than the size of a soft ball where the shot was given, my whole arm and fingers were swollen, my neck and jaw were stiff, I couldn't move my left arm or shoulder at all, my tongue felt swollen, I started coughing in the ER waiting room, and couldn't stop and couldn't breathe out and could barely breathe in, I had to use my inhaler 4x...I had already taken 50mg of liquid Benadryl as well...I was very scared that I was about to die!
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Epistaxis, Face injury, Fall, Lip injury, Syncope
Clinical narrative: 5 minutes after receiving flu vaccine pt fell from chair-unclear if syncope or pt just fell, landed face first, split upper lip and bleeding from both nares-sent to ER for further evaluation of nose.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Blood test, Ovulation disorder, Pregnancy test negative
Clinical narrative: After I got the first dose of the Gardasil injection in may I stopped getting my period. That last time I got it was April 21st, 2011. Then I didn't get it again until July 4th, 2011.  I went to the obgyn in June 2011 and all she did was take a pregnancy test that came out negative. I got the 2nd dose of the Gardasil vaccine on July 14th, 2011. After that I stopped getting my period again. I went to a different gynecologist in September 2011 performed different blood tests and who reviewed my hormone levels. She determined that I just kept ovulating developing cysts. She gave me a progesterone shot in order to provoke my period.  Eventually my period came back October 8, 2011.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Pronounced redness and swelling in arm next day. he was instructed to take BENADRYL and seek medical attention with doctor. He said swelling & redness has improved.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Fall, Fatigue
Clinical narrative: Within 5 minutes of shot, pt appeared dizzy, began to fall, lowered to ground by father at 11:15 am. 1122 am still dizzy. Continuing to monitor. 1128 am walked to bathroom with assistance. 1120 walked to family care with assistance, safely. Take water. Stated "I feel better. Just tired." Able to ambulate independently. Advised father to call MD or ED of any further concerns. Verbalized understanding (ED). 1315 spoke to someone she's fine ate soup. Denies recommended seek medical help for concerns or questions - verbalized ok.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot, Nausea
Clinical narrative: Patient stated she felt light headed, warm and nauseated. She requested that writer inject her with an EPI pen and that an ambulance be called. Patient was injected with EPI pen x 1.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Pruritus
Clinical narrative: A day after receiving vaccine, pt experienced intense itching and severe redness/rash at the site of injection. Pt came in and reported event on 12/2. Pt took a CLARITAN and was told to contact MD of rash grew larger/spread.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt received vaccine 10/25/11. Arm is still sore 11/30/11.
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Blepharospasm, Dizziness, Dyspnoea, Joint swelling
Clinical narrative: Got home - rash in shot arm, up arm up face. 7pm. Anaphylactic symptoms - Shortness of breath, neck swelling at shoulder. Dizzy, nausea. Called ambulance. Twitching eye, neck pain.
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Nausea, Neck pain, Rash
Clinical narrative: Got home - rash in shot arm, up arm up face. 7pm. Anaphylactic symptoms - Shortness of breath, neck swelling at shoulder. Dizzy, nausea. Called ambulance. Twitching eye, neck pain.
Age: 31.0
Sex: M
Vaccine: IPV, MMR, TDAP
Symptoms: Cold sweat, Dizziness, Electrocardiogram normal, Heart rate irregular, Pallor
Clinical narrative: Pt c/o lightheadedness, dizziness after vaccination. Pt sat down looked ashen. Pt laid down. Pulse taken 35, irregular. Pt became clammy. Legs raised provider called. Dr responded. Pt placed on O2 via NRB at 15 LPM. Subsequent vitals taken. BP 120/68 pulse 68. ECG taken. Patient seen by Dr. Patient walked from Dr office.
Age: 65.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Abasia, Dizziness, Lethargy, Nausea, Palpitations
Clinical narrative: I felt dizziness.  I could not walk for a few hours. I experienced heart palpitations, nausea and lethargy. It was a very bad experience. The dizziness lasted until noon.  The lethargy lasted for 48 hours. The nausea lasted two weeks.
Age: 1.0
Sex: M
Vaccine: FLUX, MEN, MMR, VARCEL
Symptoms: Decreased appetite, Pyrexia, Rash, Sleep disorder
Clinical narrative: Fever 11-28 until 11 12-1 highest was 11-29 evening 103.1 rectal.  Medicated with ibuprofen and Tylenol. 12-3 developed rash on chest and abdomen.  Child having sleep disturbances since vaccine given. Decreased appetite.
Age: 46.0
Sex: F
Vaccine: FLUX, TD
Symptoms: Cough, Dysphonia, Dyspnoea, Electrocardiogram, Headache
Clinical narrative: The first symptom was blurred vision. Around 2:00 I had difficulty breathing, hoarseness and a dry cough. An hour later I had swelling of the face and lips, headache and a racing pulse.
Age: 46.0
Sex: F
Vaccine: FLUX, TD
Symptoms: Lip swelling, Palpitations, Swelling face, Vision blurred
Clinical narrative: The first symptom was blurred vision. Around 2:00 I had difficulty breathing, hoarseness and a dry cough. An hour later I had swelling of the face and lips, headache and a racing pulse.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Musculoskeletal pain, Pain
Clinical narrative: Sore shoulder where flu shot was given that has persisted over a month later.  Pain in deltoid muscles, especially when raising arm or moving arm across chest.  Pain is strong when doing this.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Crying, Diarrhoea, Frequent bowel movements, Irritability, Painful defaecation
Clinical narrative: High Fever, Irritability, Crying. Cooled with a damp cloth and gave child Tylenol. She vomited a lot shortly afterward, then fever subsided and slept soundly until morning. She vomited a small amount at 7:15 AM but no fever. Child appeared normal in behavior rest of the day and since. However, stools immediately were very loose and frequent and sometimes painful for about 8 days. Other 2 children and both parents also received flu vaccine with no symptoms nor illness.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Vomiting
Clinical narrative: High Fever, Irritability, Crying. Cooled with a damp cloth and gave child Tylenol. She vomited a lot shortly afterward, then fever subsided and slept soundly until morning. She vomited a small amount at 7:15 AM but no fever. Child appeared normal in behavior rest of the day and since. However, stools immediately were very loose and frequent and sometimes painful for about 8 days. Other 2 children and both parents also received flu vaccine with no symptoms nor illness.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Dizziness, Dizziness postural, Palpitations
Clinical narrative: Pt stood up and felt dizzy & light headed. Felt anxious & felt heart racing. Sat patient back in chair told her to take some deep breaths. Took pulse & BP 66, 100/74. Waited 5 min took BP 96/70 (which she said was normal for her) took pulse 10 min later 60 bpm. Pt stated she has a history of anxiety & has not taken her medication. She felt she was just having some anxiety from the shot & from discussion of side effects. Pt stopped back 45 minutes later and she said she felt fine.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Maternal exposure during pregnancy, Musculoskeletal pain, Musculoskeletal stiffness, Pain
Clinical narrative: Initially there was typical soreness in the injection sight, but the soreness subsided and now I am experiencing shoulder stiffness and pain that wakes me up at night and causes pain when I lift my arm. It is painful to dress, shower, etc. in the shoulder where the shot was given. I have never had shoulder pain before this flu shot.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Poor quality sleep
Clinical narrative: Initially there was typical soreness in the injection sight, but the soreness subsided and now I am experiencing shoulder stiffness and pain that wakes me up at night and causes pain when I lift my arm. It is painful to dress, shower, etc. in the shoulder where the shot was given. I have never had shoulder pain before this flu shot.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Sustainted fever greater than 102* for 2 days, with a high of 103.2*; lower back stiffness; rash & raised skin and extreme tenderness at site of injection.
Sex: M
Vaccine: HEP
Symptoms: Body temperature increased, Developmental delay, Dyspnoea, Immediate post-injection reaction, Intensive care
Clinical narrative: Chest started to retract severely. Temperature spiked to 104. Gasping for air. Treatment was PCU for the next three days then sent home only to return to the hospital over five times in the next two weeks.  He stopped breathing, SIDS, when in the hospital on monitors.
Sex: M
Vaccine: HEP
Symptoms: Neonatal respiratory distress syndrome, Respiratory arrest, Sudden infant death syndrome
Clinical narrative: Chest started to retract severely. Temperature spiked to 104. Gasping for air. Treatment was PCU for the next three days then sent home only to return to the hospital over five times in the next two weeks.  He stopped breathing, SIDS, when in the hospital on monitors.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chills, Headache, Musculoskeletal pain, Pyrexia
Clinical narrative: Shaking Chills, aching from her head, back and shoulders, shivers. Feels like she had a fever, but did not take her temperature. Also a severe headache. Symptoms continued through most of the night until 2 am.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Shaking Chills, aching from her head, back and shoulders, shivers. Feels like she had a fever, but did not take her temperature. Also a severe headache. Symptoms continued through most of the night until 2 am.
Age: 37.0
Sex: M
Vaccine: ANTH, FLU3, HEP, MEN, TYP, YF
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: No Adverse Reaction.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Swelling on 10/1/11 alert to MD put on BENADRYL 150 mg/day (50 mg TID) x 1 week. MD indicated due to customer - should have used normal flu shot. Arm is ok as of 11/6/11.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: Dizziness, fast heart rate, shortness of breath. Went to ER but symptoms subsized completely, so did not stay to see MD.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Mass, Pain, Pruritus, Rash erythematous, Swelling
Clinical narrative: 3 inch diameter red spot, swelling, lump, itchiness, pain.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Rash
Clinical narrative: Received FLUMIST on 11-15-11, the evening of 11-15-11 mild rash appeared on chest, back, and arms. The rash was more moderate on elbows. MD ordered 11/16/11 BENADRYL x 1 and 11/16/11 ZYRTEC 5 mg QD until symptoms subsiding.