chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV, PNC
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood immunoglobulin E increased, C-reactive protein normal, Eosinophil percentage decreased
Clinical narrative: Initial report collected from Case Reports in the literature in 11 January 2012 through the local affiliates under local reference number A201200014. The Case Report: Lesson from patient who had a moderate generalized reaction following vaccination - Predicting allergy and chronic EB virus infection. Objective: The patient had a generalized adverse reaction after he/she received vaccination at the hospital and he or she was hospitalized. It was revealed that he/she had allergic disposition. We would like to report the handling of child patient with allergic disposition, which is considered to be a risk factor for adverse reactions. Experience: In the hospital, we performed an allergy test on child patients who are suspected to have allergy disposition or who have worsened local reaction after several vaccinations. We recommended those with allergy disposition to take oral anti-allergic drugs before and after vaccination, and for those with high-risk patients, we perform a prick test (risks are lower than an intradermal test and a result can be obtained in 15 minutes), which is normally used to predict development of anaphylaxis. Case report: A child patient (gender and age not reported) with allergic disposition and no concomitant therapy had simultaneously received a subcutaneous dose of ACT-HIB (batch number unknown) and a dose of PREVENAR (Other manufacturer, batch number unknown) on 18 January 2011. On 19 January 2011, the patient had a fever of 38 degrees C and mild nasal discharge and was hospitalized for poor oral intake. Severe swelling was noted at both injection sites, which were associated with redness and induration. A blood test showed WBC of 12800 (Eo 0.5%), CRP 0.86 and AST/ALT 30/16. Fluid therapy and intravenous and external treatment with anti-allergic agents were started. The patient became afebrile on the next day, swelling at the injection sites and poor oral intake improved. When the patient was discharged on 21 January 2011, induration on both sites still remained. T-IgE was 71.7 IU/L, which was higher than the normal value for the patient's age. Discussion: It is said that if patients with history of severe hypersensitivity to mosquito bite do not receive appropriate treatment, chronic EB virus infection may cause death in about one third of them as they develop EBV related malignant lymphoma or hemophagocytic syndrome during the course of five to ten years. A serious generalized reaction has been reported to occur in the same mechanism when an additional vaccination is given for DPT vaccine, which requires multiple shots, and in also in these cases, EBV-infected cells were reactivated due to the vaccine which had been given previously and a serious generalized reaction occurred. This patient was found to have allergic disposition, and thus in future we will take anti-allergic measures when administering vaccination and ensure that adverse reactions are reduced.
Sex: U
Vaccine: HIBV, PNC
Symptoms: Hypophagia, Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: Initial report collected from Case Reports in the literature in 11 January 2012 through the local affiliates under local reference number A201200014. The Case Report: Lesson from patient who had a moderate generalized reaction following vaccination - Predicting allergy and chronic EB virus infection. Objective: The patient had a generalized adverse reaction after he/she received vaccination at the hospital and he or she was hospitalized. It was revealed that he/she had allergic disposition. We would like to report the handling of child patient with allergic disposition, which is considered to be a risk factor for adverse reactions. Experience: In the hospital, we performed an allergy test on child patients who are suspected to have allergy disposition or who have worsened local reaction after several vaccinations. We recommended those with allergy disposition to take oral anti-allergic drugs before and after vaccination, and for those with high-risk patients, we perform a prick test (risks are lower than an intradermal test and a result can be obtained in 15 minutes), which is normally used to predict development of anaphylaxis. Case report: A child patient (gender and age not reported) with allergic disposition and no concomitant therapy had simultaneously received a subcutaneous dose of ACT-HIB (batch number unknown) and a dose of PREVENAR (Other manufacturer, batch number unknown) on 18 January 2011. On 19 January 2011, the patient had a fever of 38 degrees C and mild nasal discharge and was hospitalized for poor oral intake. Severe swelling was noted at both injection sites, which were associated with redness and induration. A blood test showed WBC of 12800 (Eo 0.5%), CRP 0.86 and AST/ALT 30/16. Fluid therapy and intravenous and external treatment with anti-allergic agents were started. The patient became afebrile on the next day, swelling at the injection sites and poor oral intake improved. When the patient was discharged on 21 January 2011, induration on both sites still remained. T-IgE was 71.7 IU/L, which was higher than the normal value for the patient's age. Discussion: It is said that if patients with history of severe hypersensitivity to mosquito bite do not receive appropriate treatment, chronic EB virus infection may cause death in about one third of them as they develop EBV related malignant lymphoma or hemophagocytic syndrome during the course of five to ten years. A serious generalized reaction has been reported to occur in the same mechanism when an additional vaccination is given for DPT vaccine, which requires multiple shots, and in also in these cases, EBV-infected cells were reactivated due to the vaccine which had been given previously and a serious generalized reaction occurred. This patient was found to have allergic disposition, and thus in future we will take anti-allergic measures when administering vaccination and ensure that adverse reactions are reduced.
Sex: U
Vaccine: HIBV, PNC
Symptoms: Rhinorrhoea, Vaccination complication, White blood cell count increased
Clinical narrative: Initial report collected from Case Reports in the literature in 11 January 2012 through the local affiliates under local reference number A201200014. The Case Report: Lesson from patient who had a moderate generalized reaction following vaccination - Predicting allergy and chronic EB virus infection. Objective: The patient had a generalized adverse reaction after he/she received vaccination at the hospital and he or she was hospitalized. It was revealed that he/she had allergic disposition. We would like to report the handling of child patient with allergic disposition, which is considered to be a risk factor for adverse reactions. Experience: In the hospital, we performed an allergy test on child patients who are suspected to have allergy disposition or who have worsened local reaction after several vaccinations. We recommended those with allergy disposition to take oral anti-allergic drugs before and after vaccination, and for those with high-risk patients, we perform a prick test (risks are lower than an intradermal test and a result can be obtained in 15 minutes), which is normally used to predict development of anaphylaxis. Case report: A child patient (gender and age not reported) with allergic disposition and no concomitant therapy had simultaneously received a subcutaneous dose of ACT-HIB (batch number unknown) and a dose of PREVENAR (Other manufacturer, batch number unknown) on 18 January 2011. On 19 January 2011, the patient had a fever of 38 degrees C and mild nasal discharge and was hospitalized for poor oral intake. Severe swelling was noted at both injection sites, which were associated with redness and induration. A blood test showed WBC of 12800 (Eo 0.5%), CRP 0.86 and AST/ALT 30/16. Fluid therapy and intravenous and external treatment with anti-allergic agents were started. The patient became afebrile on the next day, swelling at the injection sites and poor oral intake improved. When the patient was discharged on 21 January 2011, induration on both sites still remained. T-IgE was 71.7 IU/L, which was higher than the normal value for the patient's age. Discussion: It is said that if patients with history of severe hypersensitivity to mosquito bite do not receive appropriate treatment, chronic EB virus infection may cause death in about one third of them as they develop EBV related malignant lymphoma or hemophagocytic syndrome during the course of five to ten years. A serious generalized reaction has been reported to occur in the same mechanism when an additional vaccination is given for DPT vaccine, which requires multiple shots, and in also in these cases, EBV-infected cells were reactivated due to the vaccine which had been given previously and a serious generalized reaction occurred. This patient was found to have allergic disposition, and thus in future we will take anti-allergic measures when administering vaccination and ensure that adverse reactions are reduced.
Age: 68.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Aphasia, Asthenia, Borrelia test negative, Diplopia, Dysphagia
Clinical narrative: Nausea, loss of speech, diplopia, upper body weakness, dysphagia.
Age: 68.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Lumbar puncture normal, Monocyte count increased, Nausea, Nuclear magnetic resonance imaging brain normal, Troponin normal
Clinical narrative: Nausea, loss of speech, diplopia, upper body weakness, dysphagia.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Feeling abnormal, Head injury, Loss of consciousness, Swelling
Clinical narrative: Patient received vaccine and was asked to wait for twenty minutes (in the waiting room) and be checked before leaving.  She went out to the waiting room and went up to the front desk to schedule her next dose. She felt "not right", then she said "everything went black". She fell to the floor and hit the back of her head on the lobby door.  She immediately regained consciousness and was assisted into a wheelchair, taken to the bed in the observation room.  Blood pressure was 136/74, pulse 76.  She was given Gatorade to sip. Dr. examined the back of her head. Patient rested and sipped three boxes of Gatorade until about 11:30AM.  Then she was assisted to sitting up in bed. Given ibuprofen 600 mg for the bump on her head and an ice pack to apply.  Discharged feeling "fine" at 12:15PM.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Sx were noticed by pt in the AM and shown to the school nurse. In the afternoon left upper arm showed a redness (4"x2") pain, swelling and itching. Sx persisted throughout the weekend with some numbness of the arm described by the patient.
Age: 40.0
Sex: F
Vaccine: DTAP
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Severe extensive redness, pain, swelling at the injection site. I have had chills and fever of 101.
Age: 1.26
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Red raised spots on abdomen almost 1 mo. after receiving vaccine, itchy. Relieved by BENADRYL, rash resolved.
Age: 1.16
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Rashes all over body 1/19/2012. Seen by MD Dr. 1/20/2012 1600.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Flu shot - left arm.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised, Rash pruritic, Urticaria
Clinical narrative: Itchy rash over body diagnosed as allergic urticaria.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain, swelling at injection site approximately 6cm x 10cm in size.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Diarrhoea haemorrhagic
Clinical narrative: Diarrhea after vaccine, 3rd-7th day up to 16 x per day, bloody on 4th day streaks/mucousy, remained hydrated.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, redness, swelling & fever to (R) delt. Pt scheduled follow up 01/13/12 - no showed unable to reach by phone - letter mailed 1/16/12.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Cellulitis, Dizziness, Erythema, Fatigue, Hypersensitivity
Clinical narrative: (No anaphylactic symptoms). Received HPV & MCV4 vaccines in (L) deltoid. Next morning woke up & whole (L) upper arm swollen, pt felt fatigued & dizzy, nauseous, hand numb. Arm progressively swollen & red. Seen in ED that evening, given ibuprofen, BENADRYL & ZOFRAN & started on clindamycin for cellulitis. Afebrile; arm swelling decreased, arm itchy. Clindamycin stopped by Pediatrician 1/12/12 - suspect large local reaction (allergic) to vaccine.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Hypoaesthesia, Injection site swelling, Local reaction, Nausea, Oedema peripheral
Clinical narrative: (No anaphylactic symptoms). Received HPV & MCV4 vaccines in (L) deltoid. Next morning woke up & whole (L) upper arm swollen, pt felt fatigued & dizzy, nauseous, hand numb. Arm progressively swollen & red. Seen in ED that evening, given ibuprofen, BENADRYL & ZOFRAN & started on clindamycin for cellulitis. Afebrile; arm swelling decreased, arm itchy. Clindamycin stopped by Pediatrician 1/12/12 - suspect large local reaction (allergic) to vaccine.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pruritus
Clinical narrative: (No anaphylactic symptoms). Received HPV & MCV4 vaccines in (L) deltoid. Next morning woke up & whole (L) upper arm swollen, pt felt fatigued & dizzy, nauseous, hand numb. Arm progressively swollen & red. Seen in ED that evening, given ibuprofen, BENADRYL & ZOFRAN & started on clindamycin for cellulitis. Afebrile; arm swelling decreased, arm itchy. Clindamycin stopped by Pediatrician 1/12/12 - suspect large local reaction (allergic) to vaccine.
Age: 19.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Induration, Pain in extremity
Clinical narrative: Patient had large reddened area on upper arm that was described as painful and hardened area. On all nurse referred pt. out to ER when red area went 1" past line of demarcation. Student on antibiotics.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction
Clinical narrative: Injected Tdap at deltoid with reaction.
Age: 29.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: (R) upper arm w/firm , tender warm area w/surrounding erythema (about walnut sized) - treated with AUGMENTIN/MEDROL.
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Gait disturbance, Hypoaesthesia, Hypoaesthesia oral, Presyncope
Clinical narrative: This case was reported by a healthcare professional (also the subject) and described the occurrence of numbness of upper and lower lips in a 23-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included possibly allergic to thimerosal. On an unspecified date in 1988 the subject received 1st dose of ENGERIX B (unknown, unknown arm). On an unspecified date, less than one month after vaccination with ENGERIX B, the subject experienced numbness of upper and lower lips. The event resolved after 24 to 48 hours. The healthcare professional did not assess this event to be serious. On an unspecified date in 1988, one month after 1st dose of ENGERIX B, the subject received 2nd dose of ENGERIX B (details unknown). On an unspecified date in 1988, at an unknown time after 2nd dose of ENGERIX B, the subject experienced a rush over his head of numbness, was presyncopal, was dizzy, had a hard time walking and had to crawl to other staff. The subject was monitored and released by the staff where he received the vaccination. He was not hospitalized overnight and no further treatment was recommended. The healthcare professional considered the events following 2nd dose of ENGERIX B as disabling. On an unspecified date, the events resolved. The vaccination series with ENGERIX B was discontinued. It was reported that the staff would not provide the subject the 3rd dose of ENGERIX B. The healthcare professional considered the events were probably related to vaccinations with ENGERIX B and stated that the events may have been related to the thimerosal in ENGERIX B at that time as he had a reaction to contact lens solution with thimerosal ingredient.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Erythema
Clinical narrative: Pt called 1/13/12 to report bilateral arm erythema and temp of 101 degrees one day after ADACEL immunization.
Age: 6.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Asthenia, Chest pain, Headache, Injection site haematoma, Injection site mass
Clinical narrative: Large rash around site of injection, extreme nausea, chest pains, headaches, lump in throat, weakness, fever, achy, bruising large lump (welt) at injection site.
Age: 6.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Injection site rash, Injection site urticaria, Nausea, Pain, Pyrexia
Clinical narrative: Large rash around site of injection, extreme nausea, chest pains, headaches, lump in throat, weakness, fever, achy, bruising large lump (welt) at injection site.
Age: 6.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Sensation of foreign body
Clinical narrative: Large rash around site of injection, extreme nausea, chest pains, headaches, lump in throat, weakness, fever, achy, bruising large lump (welt) at injection site.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Intussusception, Ultrasound scan abnormal
Clinical narrative: Intussusception.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Swelling, redness, pain extending over entire upper arm.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Pruritus, Skin induration
Clinical narrative: Distal to injection (influenza site) site is red/hot/itchy and hard to touch - baseball size per mother.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Mobility decreased, Muscular weakness, Myalgia
Clinical narrative: Immediate pain on injection. Deltoid soreness advanced to severe pain and limited movement due to pain at left upper arm. Profuse muscle pains for 3 days post vaccine. On going intermittent muscle weakness with mod-severe pain to left upper arm - injection site as well.
Age: 26.0
Sex: F
Vaccine: PPV, TD
Symptoms: Cellulitis, Chills, Erythema, Headache, Nausea
Clinical narrative: Per patient on 11/10/11 she woke up with chills, fever, body aches. Headaches and nausea. Arm pain and swelling, redness, rash. Admitted to hospital for cellulitis on 11/18/11 and D/C on 11/21/11 IV antibiotics.
Age: 26.0
Sex: F
Vaccine: PPV, TD
Symptoms: Oedema peripheral, Pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: Per patient on 11/10/11 she woke up with chills, fever, body aches. Headaches and nausea. Arm pain and swelling, redness, rash. Admitted to hospital for cellulitis on 11/18/11 and D/C on 11/21/11 IV antibiotics.
Age: 26.0
Sex: F
Vaccine: PPV, TD
Symptoms: White blood cell count increased
Clinical narrative: Per patient on 11/10/11 she woke up with chills, fever, body aches. Headaches and nausea. Arm pain and swelling, redness, rash. Admitted to hospital for cellulitis on 11/18/11 and D/C on 11/21/11 IV antibiotics.
Age: 68.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Culture, Haematoma, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Pt reports soreness in left deltoid after vaccines 1/17/12 which subsided then on Saturday 1/21 began with redness, itchiness, swelling & warmth. On 1/22 went to ER redness was 4x5 cm. Was started on Doxycycline was discharged & then returned back to ER & was admitted waiting cultures. Denies fever.
Age: 68.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Pt reports soreness in left deltoid after vaccines 1/17/12 which subsided then on Saturday 1/21 began with redness, itchiness, swelling & warmth. On 1/22 went to ER redness was 4x5 cm. Was started on Doxycycline was discharged & then returned back to ER & was admitted waiting cultures. Denies fever.
Age: 28.0
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Red, inflamed right arm (covering from shoulder to elbow) outside only.
Age: 1.03
Sex: M
Vaccine: FLU3, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash, Vaccination complication, Varicella post vaccine
Clinical narrative: See by PCP on 12/29/11 for rash that started on 12/24/11. Dx vaccine associated varicella infection started from legs to body.
Age: 56.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Pain, Pollakiuria, Pyrexia
Clinical narrative: Felt achy, fever 102.4 urinated more oftren then normal (urine was checked at physical the day of vaccine-which was normal). Also had headache.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Culture negative, Dysstasia, Ear infection, Fatigue
Clinical narrative: Pt got the Hep A shot on Jan 19, 2012 in the morning. Low grade temperature (99.6) started on Jan 20, 2012 in the morning shortly after pt woke up. Fever has worsensed since then, rarely dropping below 100 degrees. Sunday, temperature spiked to 103.1 and pt was very weak and shaky and could not even stand up straight. Have been alternating ibprofen and acetaminophen since Friday as well as giving her lukewarm baths. Pt was very lethargic and tired all weekend. She woke up this morning (1/23/2012) and was running a temp of 101.3, wheezing, and small rash on arm. Called the dr and took her in. Flu swab came back negative and then Dr. said she might have a little ear infection and prescribed penicillin. Pt has not been pulling on ears at all nor has she been acting like she has an ear infection at all. She has not been sick for the last 15 months except for when she got the Prevnar shot last month and was sick for a week.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Influenza virus test negative, Lethargy, Pyrexia, Rash, Tremor
Clinical narrative: Pt got the Hep A shot on Jan 19, 2012 in the morning. Low grade temperature (99.6) started on Jan 20, 2012 in the morning shortly after pt woke up. Fever has worsensed since then, rarely dropping below 100 degrees. Sunday, temperature spiked to 103.1 and pt was very weak and shaky and could not even stand up straight. Have been alternating ibprofen and acetaminophen since Friday as well as giving her lukewarm baths. Pt was very lethargic and tired all weekend. She woke up this morning (1/23/2012) and was running a temp of 101.3, wheezing, and small rash on arm. Called the dr and took her in. Flu swab came back negative and then Dr. said she might have a little ear infection and prescribed penicillin. Pt has not been pulling on ears at all nor has she been acting like she has an ear infection at all. She has not been sick for the last 15 months except for when she got the Prevnar shot last month and was sick for a week.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Wheezing
Clinical narrative: Pt got the Hep A shot on Jan 19, 2012 in the morning. Low grade temperature (99.6) started on Jan 20, 2012 in the morning shortly after pt woke up. Fever has worsensed since then, rarely dropping below 100 degrees. Sunday, temperature spiked to 103.1 and pt was very weak and shaky and could not even stand up straight. Have been alternating ibprofen and acetaminophen since Friday as well as giving her lukewarm baths. Pt was very lethargic and tired all weekend. She woke up this morning (1/23/2012) and was running a temp of 101.3, wheezing, and small rash on arm. Called the dr and took her in. Flu swab came back negative and then Dr. said she might have a little ear infection and prescribed penicillin. Pt has not been pulling on ears at all nor has she been acting like she has an ear infection at all. She has not been sick for the last 15 months except for when she got the Prevnar shot last month and was sick for a week.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Paraesthesia
Clinical narrative: Approximately 2 seconds after the shot was administered, I felt tingling in my face and heat. The heat then began radiating down both arms, sides, legs. The heat then became increasingly more intense. It felt similar to the way it feels when dye is injected for contrasting in a CAT scan but more intense. Severe.
Age: 0.34
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Bacterial test negative, Crying, Culture stool negative, Haematochezia, Mucous stools
Clinical narrative: 3hrs after vaccine pt had bright red blood and mucus in stool. Up to 10-14 stools on days 1-3, then 5 stools with mucus, then 2-3 stools with mucus for 3days. 1hr of crying in the middle of the night after vaccine, went to ER.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Body temperature increased, Disorientation, Incoherent, Influenza like illness, Irritability
Clinical narrative: Flu-like symptoms with vomiting, lethargy, temperature of 103, stuffy head, runny nose, irratibility, crankiness and changed personality. Disorientation and loss of coherent thought/speech for several minutes.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Lethargy, Mental impairment, Personality change, Rhinorrhoea, Sinus congestion
Clinical narrative: Flu-like symptoms with vomiting, lethargy, temperature of 103, stuffy head, runny nose, irratibility, crankiness and changed personality. Disorientation and loss of coherent thought/speech for several minutes.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Speech disorder, Vomiting
Clinical narrative: Flu-like symptoms with vomiting, lethargy, temperature of 103, stuffy head, runny nose, irratibility, crankiness and changed personality. Disorientation and loss of coherent thought/speech for several minutes.
Age: 0.2
Sex: F
Vaccine: DTAP, RVX, DTAP, RV5
Symptoms: Abdominal pain, Crying, Diarrhoea, Fatigue, Hypophagia
Clinical narrative: She was very tired slept most of the day (01/20/2012) and does not usually doesn't sleep that much. Very colicky 01/21/2012 cried unless she was asleep could not be soothed would did not eat very much. Seemed a little better 01/22/2012. Same senerio as 01/21/2012 happened again on 1/23/2012 cried for 5 hours befor having very painful runny diarrhea then slept. Also still on 1/23/2012 has hard bump at injection site.
Age: 0.2
Sex: F
Vaccine: DTAP, RVX, DTAP, RV5
Symptoms: Injection site induration, Injection site mass, Painful defaecation, Somnolence
Clinical narrative: She was very tired slept most of the day (01/20/2012) and does not usually doesn't sleep that much. Very colicky 01/21/2012 cried unless she was asleep could not be soothed would did not eat very much. Seemed a little better 01/22/2012. Same senerio as 01/21/2012 happened again on 1/23/2012 cried for 5 hours befor having very painful runny diarrhea then slept. Also still on 1/23/2012 has hard bump at injection site.
Age: 0.2
Sex: F
Vaccine: DTAP, RVX, DTAP, RV5
Symptoms: Abdominal pain, Abdominal pain upper, Crying, Diarrhoea
Clinical narrative: She was very tired slept most of the day (01/20/2012) and does not usually doesn't sleep that much. Very colicky 01/21/2012 cried unless she was asleep could not be soothed would did not eat very much. Seemed a little better 01/22/2012. Same senerio as 01/21/2012 happened again on 1/23/2012 cried for 5 hours befor having very painful runny diarrhea then slept. Also still on 1/23/2012 has hard bump at injection site.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever for 3 days and I am filling this report on day 3 and no signs of fever stopping. Fever of 102.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Blister, Erythema, Varicella post vaccine
Clinical narrative: Seen in office on 1/21/12 bil legs abd with numerous vesicles on erythematous base in different stages. Dx chicken pox. No previous/known chicken pox exposures.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Malaise, Myalgia
Clinical narrative: About 12 hours after injection, pt. began to feel chills, malaise, and myalgia. Approximately 24 hours after symptoms began, pt. stopped feeling symptoms. No body temperature was taken. Pt. took 1000mg of acetaminophen one time.
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash vesicular
Clinical narrative: 2 day hx of vesicular rash on right flank began on back and spread in a dermatomal distribution along (R) side. Mother has history of shingles. Most recent outbreak one week ago. No exposure to children with chicken pox.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient developed cellulitis.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Pain in extremity
Clinical narrative: Patient reported experiencing right arm soreness ever since she got her flu shot. Per patient, doctor said she might develop tendonitis. Patient suspected that the pharmacist who administered the vaccine might have injected a little high up on the deltoid area but she admitted she had been carrying her twins which might have worsen the symptom.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Nasal congestion, Pyrexia, Sinus congestion
Clinical narrative: Patient complains of head/nasal congestion, fever > 100 degrees, cold sweats.
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash on chest, abdomen, neck, back - 1st noted on 12/19/11. Saw N/P on 12/19/11. N/P wasn't sure rash was vaccine related.
Age: 1.49
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Patient developed subjective fever and redness on vaccine site (4 1/4 in x 3 1/2 in) for the first two day. Instructed to apply ice and BENADRYL po.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Felt sharp pain upon vaccine receipt. For 3 wks. can only lift arm to 45 degrees. Ibup/heat recommended. Also to follow-up with provider if continues.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Fatigue, Influenza, Pain, Pyrexia
Clinical narrative: Pt c/o feeling achy, fever, cough & fatigue. Thinks she has the "flu" from the from the flu shot. Is on steroids for rheumatoid arthritis.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Erythema, Lymphadenopathy
Clinical narrative: - Swelling in right axillary lymph nodes 5 days after vaccine. - Redness and pain in right axilla same day as vaccine.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: One day following vaccine, c/o sore throat, achy, fever (103 degrees) was ordered a Z-PAK by her doctor.
Age: 23.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Open wound, Oropharyngeal blistering, Stevens-Johnson syndrome
Clinical narrative: On 19Jan2012, mother called to report patient had developed Steven Johnson Syndrome in hospital. Developed blisters in mouth. Then started on antibiotics for finger wound.
Age: 23.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Oral mucosal blistering, Stevens-Johnson syndrome, Wound
Clinical narrative: On 19Jan2012, mother called to report patient had developed Steven Johnson Syndrome in hospital. Developed blisters in mouth. Then started on antibiotics for finger wound.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspepsia, Headache, Nausea
Clinical narrative: For 2 days, experienced headache & indigestion with nausea after vaccine. Took TYLENOL with relief.
Age: 1.52
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Erythema multiforme, Injection site erythema
Clinical narrative: Erythema spread from site down the leg. Erythema multiforme, on buttocks, face & legs. Topical steroid & BENADRYL.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness around injection site, painful and hot. Large area as big as palm of hand. Pt said MD diagnosed her w/cellulitis.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative, Incorrect dose administered, No therapeutic response
Clinical narrative: This case was reported by a physician and described the occurrence of not responding to therapy in a 19-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Previous vaccination included three doses of ENGERIX B (GlaxoSmithKline) given on unspecified dates. On an unspecified date the subject received 4th dose of ENGERIX B at 1 ml in the left arm. This was considered to be a maladministration (asymptomatic/extra dose given). The subject received a full three dose series "before", but now tested to have no antibodies (not responding to therapy), so the physician gave a "booster" dose of ENGERIX B. No adverse events were reported. Follow-up information was received on 05 July 2011. The 4th dose of ENGERIX B was given intramuscularly. There were no further details or events reported.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a physician, via a GSK representative, and described the occurrence of not responding to therapy in a child subject of unspecified age and gender who was vaccinated with hepatitis B (manufacturer unspecified). On unspecified dates, as an infant, the subject received 1st dose, 2nd dose and 3rd dose of hepatitis B vaccine (details unknown). At an unknown time after vaccination with hepatitis B vaccine, the subject experienced not responding to therapy ("no immunity/no protection"). The physician reported that four subject's, all children from the same family, were vaccinated with her hepatitis B vaccine series (unknown manufacturer) as infants, and as the children are not older (unknown ages) two of the children have tested positive for hepatitis B, and two of the other children were tested as having no immunity/no protection. This is case 4 of 4 (see case IDs A0938693A, A0939314A, A0939315A for details of the other reports).
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapeutic response decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a male subject of unspecified age who was vaccinated with hepatitis B vaccine (manufacturer unspecified). On unspecified dates the subject received 3rd dose, 2nd dose and 1st dose of hepatitis B vaccine (unknown) to complete the series. The subject's hepatitis B titer was tested later on an unspecified date and found to be low. The subject received a booster dose of hepatitis B vaccine from his physician, was tested again, and titers were still found to be low. No additional details were provided.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of therapy non-responder in an unspecified number of adult subjects of unspecified gender who was vaccinated with ENGERIX B (GlaxoSmithKline). From 01 January 2009 to 01 June 2009, an unspecified number of a group of approximately 32 adult subjects received an unspecified pediatric dose of ENGERIX B (.5 ml, unknown) (Please see case A0931532A for the report of vaccine underdose). On 01 June 2009, the mistake was discovered. Some subjects had seroconversion (therapy non-responder-for the subjects that did not seroconvert). All subjects received ENGERIX B on the correct schedule.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, No therapeutic response, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 16-year-old female subject who was vaccinated with hepatitis B (manufacturer unspecified). On 12 June 1995, 28 August 1995 and 27 December 1995 the subject received 1st dose, 2nd dose and 3rd dose of hepatitis B (unknown route, unknown deltoid). On 20 July 2011, approximately 16 years after vaccination with hepatitis B, the subject experienced not responding to therapy. On 20 July 2011 the subjects titers were drawn and were 0.1 (units not provided). At the time of reporting the subject had restarted hepatitis B vaccination series and received the 1st dose (vaccine unspecified) on 18 August 2011. This case involves a pharmaceutical product complaint. The healthcare professional reported that she had seen an increase in non-responders to vaccination with ENGERIX B and was concerned about the vaccine. It was noted that all the vaccines are monitored by several methods for temperature excursions. The healthcare professional reported 7 cases of not responding to therapy following hepatitis B vaccination. This is case 7 of 7 (see case IDs A0947199A, A0947239A-A0947243A for details of the other reports). Follow-up received from the reporting healthcare professional on 18 October 2011: On 20 September 2011, the subject's hepatitis B surface antibody was less than 0.1 mIU/mL (immunity was noted by the healthcare professional as greater than 0.99).
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Alopecia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hair loss in a 40-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 20 July 2011 at 15:45 the subject received 3rd dose of ENGERIX B (1 ml, unknown route, left arm). On an unspecified date in 2011, approximately 1 month after vaccination with ENGERIX B, the subject experienced hair loss. The subject was treated with unspecified medications under dermatologist care. At the time of reporting the event was worse.
Sex: U
Vaccine: HEP
Symptoms: Crying, Wrong technique in drug usage process
Clinical narrative: This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of increased crying in an unknown number of child subjects of unspecified gender who were vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent vaccination included dtpa-polio-hib (non-gsk); non-GSK manufacturer given on an unspecified date. On an unspecified date the subjects received unspecified dose of ENGERIX B (details unknown), which had not been shaken prior to administration (inappropriate preparation of medication). At an unspecified time after vaccination with ENGERIX B, the subjects experienced increased crying. At the time of reporting the outcome of the event was unspecified. The healthcare professional reported that they had not been shaking ENGERIX B prior to administration and had noticed that this seemed to result in "more crying" after administration to a number (unspecified) of pediatric subjects.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, No therapeutic response, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a female subject of unspecified age who was vaccinated with Hep B (manufacturer unspecified) and ENGERIX B (GlaxoSmithKline). Concurrent vaccination included tdap vaccine (non-gsk); non-GSK manufacturer given on 21 January 2010. On 24 July 1992, 25 August 1992 and 28 January 1993 the subject received 1st dose, 2nd dose and 3rd dose of Hep B (1ml, unknown route, unknown deltoid). On an unknown date the subject experienced not responding to therapy. The subject's titers were drawn and were negative. On 12 July 2007, 21 August 2007 and 21 January 2010 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (1 ml, unknown route, unknown deltoid). On 3 March 2010, 41 days after 3rd vaccination with ENGERIX B, 2 years after 2nd vaccination with ENGERIX B, 3 years after 1st vaccination with ENGERIX B, 17 years after 3rd vaccination with Hep B, 18 years after 2nd and 1st vaccination with Hep B, the subject experienced not responding to therapy. The subject's titers were drawn on 3 March 2010 and were 0.2 (units not provided). The subject received a booster dose (or 4th) dose of ENGERIX B on 5 March 2010 (1mL, unknown route, unknown deltoid). Repeat titer was drawn on 10 August 2011, 17 months after the booster dose of ENGERIX B and the subject experienced not responding to therapy. The titer was less than 0.1 (units not specified). This case involves a pharmaceutical product complaint. The healthcare professional reported that she had seen an increase in non-responders to vaccination with ENGERIX B and was concerned about the vaccine. It was noted that all the vaccines are monitored by several methods for temperature excursions. The healthcare professional reported 7 cases of not responding to therapy following Hep B vaccination. This is case 4 of 7 (see case IDs A0947199A, A0947239A, A0947240A, A0947242A-A0947244A for details of the other reports). Follow-up received from the reporting healthcare professional on 18 October 2011: On 03 March 2010, the subject's hepatitis B surface antibody was 0.26 mIU/mL (immunity was noted by the healthcare professional as greater than 0.99). On 08 August 2011, the subject's hepatitis B surface antibody was 0.53 mIU/mL. All doses of Hep B and ENGERIX B were administered intramuscularly. All doses of Hep B and the 1st and 4th doses of ENGERIX B were administered in the left deltoid. The 2nd and 3rd doses of ENGERIX B were administered in the right deltoid.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Balance disorder, Gait disturbance, Palpitations, Swelling, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hives on neck in a 41-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline), FLULAVAL. The subject's medical history included two c-sections and removal of gallbladder. Concurrent medications included Multivitamins (Vitamins). On 3 August 2011 at 16:00 the subject received 1st dose of ENGERIX B (1 ml, unknown route, left arm). One to two hours after vaccination with ENGERIX B, the subject experienced hives on the front of her neck. No other events were noted. After the next vaccination with ENGERIX B the event recurred. On 5 October 2011 at 10:00 the subject received 2nd dose of ENGERIX B (1 ml, unknown route, right arm). On 5 October 2011 the subject also received a dose of FLULAVAL (details unknown). It was not specified whether the 2nd of ENGERIX B was administered at the same time as FLULAVAL. On 5 October 2011, 1 to 2 hours after vaccination with ENGERIX B, and less than one day after vaccination with FLULAVAL, the subject experienced hives. On 6 October 2011, reported as 1 to 2 days after vaccination with FLULAVAL and ENGERIX B, the subject experienced heart palpitations, swelling of scalp (left side) and instability ("unsteadiness"). At the time of reporting the hives were resolved and the other events were unresolved. The healthcare professional considered the events were probably related to vaccination with ENGERIX B and FLULAVAL. Follow-up information was received from the healthcare professional on 08 November 2011: all vaccines were administered intramuscularly. FLULAVAL was given as 0.5cc dose in the left arm. Biopsy was not performed. The events resolved on an unspecified date.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, No therapeutic response, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 44-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 01 December 2010, 05 January 2011 and 07 June 2011 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (1 ml, unknown route, unknown deltoid). On 21 July 2011, 44 days after the 3rd vaccination with ENGERIX B, 6 months after the 2nd vaccination with ENGERIX B, and 8 months after the 1st vaccination with ENGERIX B, the subject experienced not responding to therapy. The subjects titers were drawn on 21 July 2011 and were less than 0.1 (units not provided). At the time of reporting the subject had not been restarted on vaccination series for hepatitis B. This case involves a pharmaceutical product complaint. The healthcare professional reported that she had seen an increase in non-responders to vaccination with ENGERIX B and was concerned about the vaccine. It was noted that all the vaccines are monitored by several methods for temperature excursions. The healthcare professional reported 7 cases of not responding to therapy following hepatitis B vaccination. This is case 2 of 7 (see case IDs A0947199A, A0947240A-A0947244A for details of the other reports). Follow-up received from the reporting healthcare professional on 18 October 2011: All doses of ENGERIX B were administered intramuscularly. Dose 1 was given in the right deltoid, and doses 2 and 3 were given in the left deltoid. On 20 July 2011, the subject's hepatitis B surface antibody was less than 0.1 mIU/mL (immunity was noted by the healthcare professional as greater than 0.99). The healthcare professional reported that the ENGERIX B series would be repeated and the 1st dose of the 2nd series was administered on 30 September 2011.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, No therapeutic response, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 44-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 19 November 2010, 20 December 2010 and 20 May 2011 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (1 ml, unknown route, unknown deltoid). On 22 July 2011, 63 days after the 3rd vaccination with ENGERIX B, 7 months after the 2nd vaccination with ENGERIX B, and 8 months after the 1st vaccination with ENGERIX B, the subject experienced not responding to therapy. The subjects titers were drawn on 22 July 2011 and were less than 0.1 (units not provided). At the time of reporting the subject had not been restarted on vaccination series for hepatitis B. This case involves a pharmaceutical product complaint. The healthcare professional reported that she had seen an increase in non-responders to vaccination with ENGERIX B and was concerned about the vaccine. It was noted that all the vaccines are monitored by several methods for temperature excursions. The healthcare professional reported 7 cases of not responding to therapy following hepatitis B vaccination. This is case 3 of 7 (see case IDs A0947199A, A0947239A, A0947241A-A0947244A for details of the other reports). Follow-up received from the reporting healthcare professional on 18 October 2011: On 21 July 2011, the subject's hepatitis B surface antibody was less than 0.1 mIU/mL (immunity was noted by the healthcare professional as greater than 0.99). All 6 doses of ENGERIX B were administered intramuscularly in the left deltoid. The healthcare professional reported that the ENGERIX B series would be repeated and the 1st dose of the 2nd series was administered on 06 October 2011.