chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: ANTH, YF
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: 21 y/o female who on the morning of 5 NOV 2011, around 1030, received AVA (2) vaccine in her left upper arm and Yellow Fever vaccine in her right upper arm during week-end drill. By noon on Saturday, she felt "out of it mentally" and was dizzy and clammy and had a headache. She denies rashes, facial swelling, nasal symptoms, throat tightness or itching, difficulty swallowing or breathing, chest tightness, and cough. No significant local vaccination site reactions. Within 2 hours of symptom onset, she drove to her mother's house. When she got there, she laid on the couch and noticed that her feet and hands were tingling - "felt like they fell asleep". She felt "twice as bad" as she did in OCT. She experienced vomiting and diarrhea within 2 1/2 hours of arrival at her mother's house. She experienced sweating alternating with chills. Her headache was not associated with nausea and visual changes, but she did experience photosensitivity. No nuchal rigidity. Headache pain was different from other headaches she experienced with regard to intensity and character. Patient felt dizzy and confused. She slept for 5 hours and when she awoke, she still felt weak, tired and confused. She slept through the night and the next morning she woke up feeling feverish and dizzy with a headache and nausea and vomiting, but the confusion was gone. Her mother took her to be seen at the local ER, but the wait was so long, they left without being seen. By noon, she was starting to feel a little better; the nausea and vomiting were resolved and she was able to lunch. She continued to have a headache, so she rested in a dark room that afternoon and evening. The tingling of her extremities had resolved before bedtime Sunday night. When patient awoke on Monday morning, she was feeling better but, still running a low grade fever. She rested on Monday. She returned to work on Tuesday, although she still felt tired and weak. By Wednesday, she felt back to normal. Patient reports feeling well prior to and days prior to above vaccine receipt. She denies any other possible exposures around time of above vaccine receipt. She denies allergies to medications, foods, latex, and insect stings. She was not taking any routine medications at the time of vaccine receipt. She denies any other previous vaccine reactions except for self limited flu-like symptoms, usually following flu vaccine. Denies significant medical history.
Age: 22.0
Sex: M
Vaccine: ANTH, YF
Symptoms: Nausea, Paraesthesia, Photosensitivity reaction, Pyrexia, Vomiting
Clinical narrative: 21 y/o female who on the morning of 5 NOV 2011, around 1030, received AVA (2) vaccine in her left upper arm and Yellow Fever vaccine in her right upper arm during week-end drill. By noon on Saturday, she felt "out of it mentally" and was dizzy and clammy and had a headache. She denies rashes, facial swelling, nasal symptoms, throat tightness or itching, difficulty swallowing or breathing, chest tightness, and cough. No significant local vaccination site reactions. Within 2 hours of symptom onset, she drove to her mother's house. When she got there, she laid on the couch and noticed that her feet and hands were tingling - "felt like they fell asleep". She felt "twice as bad" as she did in OCT. She experienced vomiting and diarrhea within 2 1/2 hours of arrival at her mother's house. She experienced sweating alternating with chills. Her headache was not associated with nausea and visual changes, but she did experience photosensitivity. No nuchal rigidity. Headache pain was different from other headaches she experienced with regard to intensity and character. Patient felt dizzy and confused. She slept for 5 hours and when she awoke, she still felt weak, tired and confused. She slept through the night and the next morning she woke up feeling feverish and dizzy with a headache and nausea and vomiting, but the confusion was gone. Her mother took her to be seen at the local ER, but the wait was so long, they left without being seen. By noon, she was starting to feel a little better; the nausea and vomiting were resolved and she was able to lunch. She continued to have a headache, so she rested in a dark room that afternoon and evening. The tingling of her extremities had resolved before bedtime Sunday night. When patient awoke on Monday morning, she was feeling better but, still running a low grade fever. She rested on Monday. She returned to work on Tuesday, although she still felt tired and weak. By Wednesday, she felt back to normal. Patient reports feeling well prior to and days prior to above vaccine receipt. She denies any other possible exposures around time of above vaccine receipt. She denies allergies to medications, foods, latex, and insect stings. She was not taking any routine medications at the time of vaccine receipt. She denies any other previous vaccine reactions except for self limited flu-like symptoms, usually following flu vaccine. Denies significant medical history.
Sex: U
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: 3 days of fever to 103. Measles like rash.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Rash papular, Rash vesicular
Clinical narrative: Scattered eryth. pap/vesc lesions, trunk.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Death
Clinical narrative: Patient passed away the day after his well exam. Vaccines were not indicated as a reason for death.
Age: 1.22
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Child developed erythematous rash trunk & back & low grade fever day after vaccines.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Dark circles under eyes, Decreased appetite, Pallor, Pyrexia
Clinical narrative: HIGH FEVER NOW GOING ON FOUR DAYS, (102-104.6 DEGREES)IBUPROFEN AND TYLENOL BRING FEVER DOWN FOR A SHORT TIME. HAS NO APPETITE. IS WEAK, IF SHE MOVES AROUND HER TEMPERATURE GOES HIGHER.  HER FACE IS OF PALE COLOR, DARK BELOW HER EYES.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Blood pressure increased, Erythema, Hyperhidrosis, Injection site pain, Injection site swelling
Clinical narrative: Reports diaphoresis, swelling and pain of the left arm (injection site), redness of the left arm. New blood pressure elevation noted in office during examination of left arm redness on 03/19/2012.
Age: 68.0
Sex: M
Vaccine: TDAP
Symptoms: Cough, Diarrhoea, Injection site erythema, Injection site rash, Sneezing
Clinical narrative: Bump at Tdap injection site on right arm, hot red circle about 3 inches around, lasted 3 days, then diarrhea, then sneezing and constant cough.
Age: 0.73
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Child developed intermittent fever approx. 24 hours after vaccine administration. Presented to ER on 3/17 with fever 105.3. Received acetaminophen and discharged home. Treated with alternate acetaminophen and Motrin. Child afebrile 3/18/2012.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Herpes simplex, Polymerase chain reaction, Post vaccination autoinoculation, Skin lesion, Varicella virus test negative
Clinical narrative: Four lesions consistent with inadvertent inoculation developed over the next few days after vaccination. Three on shoulder/back, one on L chest. On day eleven he developed upper lip lesion which proved to be HSV 1 on PCR testing.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Oral herpes, Polymerase chain reaction, Post vaccination autoinoculation, Simplex virus test positive, Skin lesion
Clinical narrative: Four lesions consistent with inadvertent inoculation developed over the next few days after vaccination. Three on shoulder/back, one on L chest. On day eleven he developed upper lip lesion which proved to be HSV 1 on PCR testing.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Varicella virus test negative
Clinical narrative: Four lesions consistent with inadvertent inoculation developed over the next few days after vaccination. Three on shoulder/back, one on L chest. On day eleven he developed upper lip lesion which proved to be HSV 1 on PCR testing.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13, VARCEL
Symptoms: Cough, Malaise, Otitis media, Pyrexia, Rhinorrhoea
Clinical narrative: 61 eruptions of chickenpox; vomited; cough; nose; fever 102 degrees. Sick since 3-16-12. Dx: Varicella, (L) OM.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13, VARCEL
Symptoms: Varicella post vaccine, Vomiting
Clinical narrative: 61 eruptions of chickenpox; vomited; cough; nose; fever 102 degrees. Sick since 3-16-12. Dx: Varicella, (L) OM.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity, Oedema peripheral, Swelling face
Clinical narrative: ENGERIX B given IM at approx 14:00 pm on 3/19/12. Reports swelling in Rt arm, hand & face started approx. 1030 pm.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, VIIth nerve paralysis
Clinical narrative: Patient received vaccine ZOSTAVAX on 10/1/11. Patient came in Fri Mar. 16, 2012 informed me that Feb. 20th developed shingles in her mouth and now has Bells Palsy. She was treated with valacyclovir and prednisone.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Maternal exposure during pregnancy, Streptococcus test positive
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N.) for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female patient, with pollen allergy, who on 19-OCT-2009 (also reported as 16-OCT-2009), was vaccinated with the first dose of GARDASIL (Lot #, expiration date, dose and route not reported), and then, on 29-MAR-2011, received the second dose of GARDASIL (Lot # 666987/1016Z) (Expiration date, dose and route not reported). The Licensed Practical Nurse reported that the patient received two doses of GARDASIL and became pregnant. On 18-APR-2011 the patient visited another clinic "partners", and was found to be pregnant. Exact date of pregnancy was unspecified at the time of the report. The patient did not receive any treatment for the event. The patient's last menstrual period was on 03-FEB-2011. Expected date of delivery was approximately in 10 November 2011. Follow up information has been received via telephone call from a nursing supervisor concerning the patient who on 15-NOV-2011 at 40 weeks gestation gave birth via C-section to a healthy baby girl weighing 8 lbs, 15 oz. The baby had an APGAR score of 8/9. The nursing supervisor did not have any information exactly why the C-section was performed; however she stated the patient was positive for vaginal group B streptococcus. There were no complications reported with the pregnancy or delivery. Upon internal review C-section was considered to be an other important medical event. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Benign tumour excision, Herpes zoster, Mass, Pain, Rash
Clinical narrative: Information has been received from a registered nurse concerning her 65 year old male husband with chronic dermatitis on the legs, a lot of medical history but mostly broken bones, sleep apnoea, rapid eye movements (REM) sleep disorder and no drug reactions or allergies, who at the end of 2010 or beginning of 2011, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number not reported). Concomitant therapy included clonazepam, clobetasol propionate and triamcinolone. The nurse mentioned that her husband received ZOSTAVAX (Merck) and approximately in June 2011 (in the summer 2011), experienced "lumps with pain and skin rash that was on his head and neck". The husband was in significant pain. The physician (who did not gave the patient ZOSTAVAX (Merck)) diagnosed and treated her husband the patient for shingles. The patient was treated with a new antiviral; the nurse could not remember the name. Sometime in the summer 2011, the patient recovered from shingles; the nurse stated that it took 3-4 weeks to go away (approximately in July 2011). No laboratory tests were performed. The patient sought medical attention by an office visit. Follow up information has been received from a healthcare worker who reported that the patient was placed on VALTREX 1000 mg therapy, three times a day for 7 days, for the shingles. In addition the physician stated in his notes that he felt that the shingles were caused by the stress of the surgical removal (on an unspecified date) of a benign tumor that was located below jaw line on the right. It was diagnosed by other physician. At the time of the report, the patient's outcome for benign neoplasm was not reported. Upon internal review, benign neoplasm was determined to be an other important medical event. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Stress
Clinical narrative: Information has been received from a registered nurse concerning her 65 year old male husband with chronic dermatitis on the legs, a lot of medical history but mostly broken bones, sleep apnoea, rapid eye movements (REM) sleep disorder and no drug reactions or allergies, who at the end of 2010 or beginning of 2011, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number not reported). Concomitant therapy included clonazepam, clobetasol propionate and triamcinolone. The nurse mentioned that her husband received ZOSTAVAX (Merck) and approximately in June 2011 (in the summer 2011), experienced "lumps with pain and skin rash that was on his head and neck". The husband was in significant pain. The physician (who did not gave the patient ZOSTAVAX (Merck)) diagnosed and treated her husband the patient for shingles. The patient was treated with a new antiviral; the nurse could not remember the name. Sometime in the summer 2011, the patient recovered from shingles; the nurse stated that it took 3-4 weeks to go away (approximately in July 2011). No laboratory tests were performed. The patient sought medical attention by an office visit. Follow up information has been received from a healthcare worker who reported that the patient was placed on VALTREX 1000 mg therapy, three times a day for 7 days, for the shingles. In addition the physician stated in his notes that he felt that the shingles were caused by the stress of the surgical removal (on an unspecified date) of a benign tumor that was located below jaw line on the right. It was diagnosed by other physician. At the time of the report, the patient's outcome for benign neoplasm was not reported. Upon internal review, benign neoplasm was determined to be an other important medical event. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Headache, Nausea, Pain, Vomiting
Clinical narrative: H/A, N/V, fatigue, "body aches". No fever.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Culture throat positive, Erythema multiforme, Oedema, Rash, Streptococcus test positive
Clinical narrative: Developed hives approximately 3-4 hours after Hep A given. Resolved with BENADRYL. Seen in office 3/14 to evaluate. Hives continued to recur. Rapid Strep (+) however throat c/s (-) strep. Recheck in office 3/15 & Dx erythema multiforme by Dr, as well as hives. DECADRON 12 mg orally given. To take ZYRTEC q am, BENADRYL q pm & recheck in 2 days. Also on 3 days of ORAPRED -> pt improving with decreased rash & decreased edema 3/19.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Developed hives approximately 3-4 hours after Hep A given. Resolved with BENADRYL. Seen in office 3/14 to evaluate. Hives continued to recur. Rapid Strep (+) however throat c/s (-) strep. Recheck in office 3/15 & Dx erythema multiforme by Dr, as well as hives. DECADRON 12 mg orally given. To take ZYRTEC q am, BENADRYL q pm & recheck in 2 days. Also on 3 days of ORAPRED -> pt improving with decreased rash & decreased edema 3/19.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Rash vesicular
Clinical narrative: Localized vesicular rash, itchy at injection site. BENADRYL & ZOVIRAX cream.
Age: 23.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Dysuria, Orthopoxvirus test positive, Pain, Paraesthesia, Pruritus
Clinical narrative: 23 y/o female who had intimate contact with primary vaccinee (vaccination date of 2/22/12) on 2/26, 2/29, 3/3 and 3/8. During at least one of these encounters the vaccination site dressing came dislodged/off. On 3/11/12 she developed fever, body aches, and vaginal pruritis. On 3/12/12 the pt developed itchy lesions of her thigh and vulva. The pt scratched all of lesions and irritated areas. Additionally, she applied TEMOVATE cream to her vaginal area. She developed a lesion on her back on 3/13/12. Lesion to thigh and vulva tested positive for orthopox virus (per LRN) 3/15/12. Pt used tampons to manage menses 3/12-3/15. Pt was treated with VIG on 3/17/12. Symptoms: Dysuria, Disturbance of skin sensation.
Age: 23.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Pyrexia, Skin irritation, Skin lesion, Vulval disorder, Vulvovaginal pruritus
Clinical narrative: 23 y/o female who had intimate contact with primary vaccinee (vaccination date of 2/22/12) on 2/26, 2/29, 3/3 and 3/8. During at least one of these encounters the vaccination site dressing came dislodged/off. On 3/11/12 she developed fever, body aches, and vaginal pruritis. On 3/12/12 the pt developed itchy lesions of her thigh and vulva. The pt scratched all of lesions and irritated areas. Additionally, she applied TEMOVATE cream to her vaginal area. She developed a lesion on her back on 3/13/12. Lesion to thigh and vulva tested positive for orthopox virus (per LRN) 3/15/12. Pt used tampons to manage menses 3/12-3/15. Pt was treated with VIG on 3/17/12. Symptoms: Dysuria, Disturbance of skin sensation.
Age: 23.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Dysuria, Immunoglobulin therapy, Orthopoxvirus test positive, Pain, Paraesthesia
Clinical narrative: 23 y/o female who had intimate contact with primary vaccinee (vaccination date of 2/22/12) on 2/26, 2/29, 3/3 and 3/8. During at least one of these encounters the vaccination site dressing came dislodged/off. On 3/11/12 she developed fever, body aches, and vaginal pruritis. On 3/12/12 the pt developed itchy lesions of her thigh and vulva. The pt scratched all of lesions and irritated areas. Additionally, she applied TEMOVATE cream to her vaginal area. She developed a lesion on her back on 3/13/12. Lesion to thigh and vulva tested positive for orthopox virus (per LRN) 3/15/12. Pt used tampons to manage menses 3/12-3/15. Pt was treated with VIG on 3/17/12. Symptoms: Dysuria, Disturbance of skin sensation.
Age: 23.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Pruritus, Pyrexia, Secondary transmission, Skin irritation, Skin lesion
Clinical narrative: 23 y/o female who had intimate contact with primary vaccinee (vaccination date of 2/22/12) on 2/26, 2/29, 3/3 and 3/8. During at least one of these encounters the vaccination site dressing came dislodged/off. On 3/11/12 she developed fever, body aches, and vaginal pruritis. On 3/12/12 the pt developed itchy lesions of her thigh and vulva. The pt scratched all of lesions and irritated areas. Additionally, she applied TEMOVATE cream to her vaginal area. She developed a lesion on her back on 3/13/12. Lesion to thigh and vulva tested positive for orthopox virus (per LRN) 3/15/12. Pt used tampons to manage menses 3/12-3/15. Pt was treated with VIG on 3/17/12. Symptoms: Dysuria, Disturbance of skin sensation.
Age: 23.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Vulval disorder, Vulvovaginal pruritus
Clinical narrative: 23 y/o female who had intimate contact with primary vaccinee (vaccination date of 2/22/12) on 2/26, 2/29, 3/3 and 3/8. During at least one of these encounters the vaccination site dressing came dislodged/off. On 3/11/12 she developed fever, body aches, and vaginal pruritis. On 3/12/12 the pt developed itchy lesions of her thigh and vulva. The pt scratched all of lesions and irritated areas. Additionally, she applied TEMOVATE cream to her vaginal area. She developed a lesion on her back on 3/13/12. Lesion to thigh and vulva tested positive for orthopox virus (per LRN) 3/15/12. Pt used tampons to manage menses 3/12-3/15. Pt was treated with VIG on 3/17/12. Symptoms: Dysuria, Disturbance of skin sensation.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Skin necrosis, Stomatitis, Vaccine positive rechallenge, Vaginal lesion
Clinical narrative: Necrotic vaginal/clitoral lesions and mouth sores.
Age: 19.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, TD
Symptoms: Dyspnoea, Pruritus, Throat tightness
Clinical narrative: TIGHTNESS IN HIS THROAT WITH DIFFICULTY BREATHING AND FULL BODY PRURITIS.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Dysphemia, Pyrexia, Speech disorder
Clinical narrative: Fever at 102.0, gave her a Tylenol reducer took fever to 99.0. Bad Stuttering started with 36 hours. Punctuation and diminished and length of sentences and declined. Not as sharp as she always has been.
Age: 65.0
Sex: M
Vaccine: HEP
Symptoms: Computerised tomogram, Erythema, Swelling
Clinical narrative: Redness and swelling. Diphenhydramine recommended to pt OTC and take as directed on packaging, per Dr.
Age: 0.15
Sex: F
Vaccine: HEP, PNC13, RV1
Symptoms: Electroencephalogram normal, Neurological examination, Tremor, Unresponsive to stimuli
Clinical narrative: Pt seen by me in office (11/02/2011) for abnormal shaking movement episodes with nonresponsiveness, mother with video of episode. Pt episodes became more frequent and pt hospitalized, seen by neuro and EEG done. No seizure activity on EEG. Pt seen by me in office for well child visit and infant recieved Pentacel, no rxn noted. Pt return 02/28/2012 for vaccinations recieved Prevnar. Pt brought to office by mother 03/14/2012 for abnormal muscle jerky episodes with nonresponiveness.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness with induration to (L) thigh where immunization admin. on 3-6-12.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Swelling of arm (left).
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash generalised
Clinical narrative: Rash starting on chest - by morning 17/03, all over the body. BENADRYL prescribed afternoon 17 Mar to relieve itching.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Aphagia, Fatigue, Musculoskeletal stiffness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fatigue in a 24-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 21 February 2012 the subject received 1st dose of ENGERIX B at 1 cc in the left arm. On 21 February 2012, 1 to 2 hours after vaccination with ENGERIX B, the subject experienced fatigue, musculoskeletal stiffness (neck and shoulder stiffness) and was unable to eat. This event was considered medically significant via GlaxoSmithKline. The physician's assistant reported that the patient's symptoms improved on 24 February 2012 and then resolved on 1 March 2012.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Adverse drug reaction, Urticaria, Viral rash
Clinical narrative: See attached biopsy report for reference. The differential diagnosis includes urticaria, or some forms of drug reaction or viral exanthem.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Alpha 1 foetoprotein, Anaemia, Blood glucose increased, Glucose tolerance test, Maternal exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a consumer (also the subject) and described the occurrence of vaccine exposure during pregnancy in a 41-year-old female subject who was vaccinated with Influenza vaccine (manufacturer unspecified) during pregnancy. A physician or other health care professional has not verified this report. Concurrent medications included Prenatal vitamin. On 23 November 2011 at 18:30 the subject received a dose of Influenza vaccine (manufacturer unknown, unknown route, right arm) and experienced vaccine exposure during the second trimester of her pregnancy. The estimated delivery date was 5 May 2012. Gestational age at the time of vaccination and date of last menstrual period were not provided. Follow up received from the subject on 09 February 2012. The subject provided authorization to contact her physician. She reported the lot number indicating that she had received FLUARIX. She also noted that she had no reaction to the vaccination. Follow up received from the subject's physician on 13 March 2012. Concurrent medical conditions included advanced maternal age and declined amniocentesis. Sickle trait with father of the baby (FOB) same and declined amniocentesis, PPD skin test positive and chest x-ray negative indicating latent tuberculosis infection (LTBI), varicella non-immune and suboptimal cardiac imaging with multiple ultrasounds. The subject's physician reported that the pregnancy was by normal contraception and no in-vitro fertilization was used. The subject is pregnant with one fetus. The date of the last menstrual period was 20 July 2011. The gestational age at the time of the FLUARIX was 16 weeks. The subject received the FLUARIX 0.5 ml dose by intramuscular injection. On 21 December 2011, the subject received Tdap from an unknown manufacturer 0.5 ml dose by intramuscular injection. The gestational age at the time of the Tdap was 21 weeks. The vaccine exposure during pregnancy with Tdap was also during the second trimester. On an unknown date, less than a year after vaccination with FLUARIX and Tdap, the subject experienced abnormal quad screen indicating increased risk for open neural tube defect (ONTD) and declined amniocentesis, elevated glucose loading test (GLT) with glucose tolerance test (GTT) pending and anemia minor. However, the physician also noted, the subject had not experienced any adverse events.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Prenatal screening test abnormal
Clinical narrative: This prospective pregnancy case was reported by a consumer (also the subject) and described the occurrence of vaccine exposure during pregnancy in a 41-year-old female subject who was vaccinated with Influenza vaccine (manufacturer unspecified) during pregnancy. A physician or other health care professional has not verified this report. Concurrent medications included Prenatal vitamin. On 23 November 2011 at 18:30 the subject received a dose of Influenza vaccine (manufacturer unknown, unknown route, right arm) and experienced vaccine exposure during the second trimester of her pregnancy. The estimated delivery date was 5 May 2012. Gestational age at the time of vaccination and date of last menstrual period were not provided. Follow up received from the subject on 09 February 2012. The subject provided authorization to contact her physician. She reported the lot number indicating that she had received FLUARIX. She also noted that she had no reaction to the vaccination. Follow up received from the subject's physician on 13 March 2012. Concurrent medical conditions included advanced maternal age and declined amniocentesis. Sickle trait with father of the baby (FOB) same and declined amniocentesis, PPD skin test positive and chest x-ray negative indicating latent tuberculosis infection (LTBI), varicella non-immune and suboptimal cardiac imaging with multiple ultrasounds. The subject's physician reported that the pregnancy was by normal contraception and no in-vitro fertilization was used. The subject is pregnant with one fetus. The date of the last menstrual period was 20 July 2011. The gestational age at the time of the FLUARIX was 16 weeks. The subject received the FLUARIX 0.5 ml dose by intramuscular injection. On 21 December 2011, the subject received Tdap from an unknown manufacturer 0.5 ml dose by intramuscular injection. The gestational age at the time of the Tdap was 21 weeks. The vaccine exposure during pregnancy with Tdap was also during the second trimester. On an unknown date, less than a year after vaccination with FLUARIX and Tdap, the subject experienced abnormal quad screen indicating increased risk for open neural tube defect (ONTD) and declined amniocentesis, elevated glucose loading test (GLT) with glucose tolerance test (GTT) pending and anemia minor. However, the physician also noted, the subject had not experienced any adverse events.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Hives and itching at administration site.
Age: 28.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Convulsion, Dizziness, Gaze palsy, Loss of consciousness
Clinical narrative: Ddizziness, light headedness, then passed out.  Administering nurse said that my eyes rolled back into my head and I started involuntary convulsions for a "few seconds".  I came to and did not have any recollection of the convulsions and/or seizures, but did recall passing out and waking up.
Age: 0.42
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Allergy test positive, Culture negative, Diarrhoea, Eczema, Food allergy
Clinical narrative: Diarrhea for 2 weeks with weight loss, blood in stool, eczema on face, neck & head. Blood immunology testing on 3/7/12 revealing egg & peanut allergy. With avoidance he is symptom free.
Age: 0.42
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Haematochezia, Urine analysis normal, Weight decreased
Clinical narrative: Diarrhea for 2 weeks with weight loss, blood in stool, eczema on face, neck & head. Blood immunology testing on 3/7/12 revealing egg & peanut allergy. With avoidance he is symptom free.
Age: 67.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Diarrhoea, Flank pain, Headache, Pruritus genital
Clinical narrative: Diarrhea, H/A, weakness, flank pain, genital itching.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: Increased mucus production. Pt has never had this problem before but claims after flu shot she has had a marked increase in mucus production.
Age: 71.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema
Clinical narrative: Red area, 2 inch circumference on lateral aspect and 4 inches down from shoulder.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Encephalitis, Fatigue, Headache, Pollakiuria, Pyrexia
Clinical narrative: Headache, constant urination, severe fatigue, arms and legs began to feel very heavy. Fever.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Quadriparesis, Sensation of heaviness
Clinical narrative: Headache, constant urination, severe fatigue, arms and legs began to feel very heavy. Fever.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash vesicular
Clinical narrative: Painful vesicular rash involving the right lower abdominal area, extending to the back and upper gluteal area. Possible Shingles. On 3/9/12 started on Valtrex 1gm po tid x7d, given involvement of 3 dermatomal levels away from injection site.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash, Rash morbilliform
Clinical narrative: Child first got a low grade fever for about 1 day, followed by a rash (measles-like spots) that began on his face and eventually spread down his neck and torso. Dr. seemed unconcerned by the side-effect and we are currently monitoring the rash.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site mass
Clinical narrative: Firm lump on left arm.
Age: 53.0
Sex: M
Vaccine: PNC13
Symptoms: Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Fatigue and mild headache, mild dizziness and nausea.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Discomfort, Pruritus, Urticaria
Clinical narrative: Patient received vaccines on 3/12/2012. Mom called the following morning to report hives. Doctor recommended BENADRYL for itching and TYLENOL for discomfort. Told to call if symptoms worsened.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMR
Symptoms: Erythema, Pain in extremity, Skin induration
Clinical narrative: Left shoulder injection 3/16/12, arm redness and pain developed on 3/17/12 area reddened and indurated 8 x 5 cm.
Age: 61.0
Sex: M
Vaccine: PNC13
Symptoms: Diarrhoea, Fatigue, Malaise, Nausea, Pain
Clinical narrative: Nausea, diarrhea, vomiting, severe body aches, "the worse I have ever felt in my life", fatigue.
Age: 61.0
Sex: M
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: Nausea, diarrhea, vomiting, severe body aches, "the worse I have ever felt in my life", fatigue.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Paraesthesia
Clinical narrative: PNEUMOVAX given 2/27/12. Two days later noted tingling in both hands. By 3/3/12 noted intermittent tingling arms, hands, legs, feet & face. Comes & goes but present on a daily basis - changes all the time. Bad headache x 5 days after the shot - resolved.
Age: 0.47
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Skin candida
Clinical narrative: Dx: Candida rash of groin.
Age: 0.66
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives around injection site of (R) thigh abt 4 in square, chest 2-2 1/2 size hives and stomach, quarter size hives. Pt advised to take BENADRYL.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: (L) arm marked swelling & erythema, - no significant pain.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, IPV
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Urticaria all over the body, site of vaccines, no swelling or redness, but hives came on 1 hr after vaccine. No respiratory problems.
Age: 0.59
Sex: M
Vaccine: PNC13
Symptoms: Injection site rash, Rash, Rash erythematous, Rash papular
Clinical narrative: Rash on legs and torso. Red/bumpy per doc - outer surface (R) thigh with eryth - papular rash.
Age: 60.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Electrocardiogram ambulatory, Ventricular extrasystoles
Clinical narrative: Initial report was received on 08 March 2012 from a health care professional. A 60 year old male patient with no past medical history and no illness at the time of vaccination had received on 29 February 2012 a first dose intramuscular left deltoid injection of ADACEL, lot number C4023AA and approximately 30 hours post vaccination on 01 March 2012, experienced occasional premature ventricular contractions (PVC's) when the patient was skiing at 7000 feet in the cold. The patient was reported to have a Holter monitor with results pending. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Warm, tender, swollen red rash on left upper arm, mild fever w/ chills.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous
Clinical narrative: Warm, tender, swollen red rash on left upper arm, mild fever w/ chills.
Age: 0.61
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Local reaction
Clinical narrative: 24 hours after vaccine given, parents noted localized reaction to (B) legs, progressing to torso, medial (B) arms & legs. Came in for evaluation.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Myalgia, Neck pain, Tremor
Clinical narrative: Received GARDASIL #1 vaccine on Mon. 3-12-12. Patient began on following Tues. night with hand tremors at rest which con't into Wed. & Thurs. No tremors today on Fri. March 16th. Patient also complains of sore neck & back muscles. No treatment.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Maternal exposure during pregnancy
Clinical narrative: Information has been received from a medical assistant for GARDASIL, a Pregnancy registry product, concerning a 10 year old female who on 07-MAY-2010 was vaccinated with a dose of GARDASIL (lot no. 662529/0299Z, expir. 30-MAY-2011) 0.5 ml IM while pregnant. Subsequently the patient delivered a child in November or December 2010. There was no available information on the present medical status of either the mother or the child. Follow up information received from the medical assistant regarding the patient pregnancy outcome. She reported that the patient gave birth to a live healthy infant with no congenital anomalies. When asked, she had no other information regarding the delivery/pregnancy statistics to report on the newborn or the patient. She reported that the 12 year old (also reported as 10 years old when vaccine exposure) patient gave birth via C-section due to her age and that the mother gave the child up for adoption. At the time of this report, patient's status was unknown. Upon internal review, "patient gave birth via C-section due to her age" was determined to be an other important medical event. Additional information is not expected.
Age: 42.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Drug administration error, Lymphadenopathy
Clinical narrative: DURING VACCINATION, ADMINISTRATOR SEEMED RUSHED. PUSHING PRE-SCREENING PAPERWORK IN ORDER TO BEGIN VACCINE PROCESS. ADMINISTRATOR DID NOT CLEAN AREA WITH ALCOHOL PRIOR TO ADMINISTERING TYPHOID, ANTHRAX BOOSTER, AND SMALLPOX. WAS BRIEFED THAT SMALLPOX VACCINE WOULD CONSIST OF 15 SMALL PRICKS, BUT SEVERAL OTHERS WERE ADMINISTERED. " WITHIN SEVERAL DAYS, SWOLLEN GLANDS UNDER SMALLPOX ARMPIT WITH ACHY FEELING AND STREAKING. SYMPTOMS PROGRESSIVELY WORSENED OVER TIME. SAW MEDICAL PERSONNEL FOR STREAKING AND WAS SENT TO ER. WAS ADMINISTERED VANCOMYCIN (2 GRAMS) VIA IV WITH PERSCRIPTION FOR CLINDAMYCIN 150 MG 2 CAPSULES EVERY 6 HOURS. (# 56 CAPSULES) MAINTAINING FOLLOW UP WITH MEDICAL DOCTORS EVERY 2-3 DAY IN ORDER TO MONITOR SITE AND TREATMENT PLAN.
Age: 42.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Axillary pain, Drug administration error, Erythema, Lymphadenopathy
Clinical narrative: DURING VACCINATION, ADMINISTRATOR SEEMED RUSHED. PUSHING PRE-SCREENING PAPERWORK IN ORDER TO BEGIN VACCINE PROCESS. ADMINISTRATOR DID NOT CLEAN AREA WITH ALCOHOL PRIOR TO ADMINISTERING TYPHOID, ANTHRAX BOOSTER, AND SMALLPOX. WAS BRIEFED THAT SMALLPOX VACCINE WOULD CONSIST OF 15 SMALL PRICKS, BUT SEVERAL OTHERS WERE ADMINISTERED. " WITHIN SEVERAL DAYS, SWOLLEN GLANDS UNDER SMALLPOX ARMPIT WITH ACHY FEELING AND STREAKING. SYMPTOMS PROGRESSIVELY WORSENED OVER TIME. SAW MEDICAL PERSONNEL FOR STREAKING AND WAS SENT TO ER. WAS ADMINISTERED VANCOMYCIN (2 GRAMS) VIA IV WITH PERSCRIPTION FOR CLINDAMYCIN 150 MG 2 CAPSULES EVERY 6 HOURS. (# 56 CAPSULES) MAINTAINING FOLLOW UP WITH MEDICAL DOCTORS EVERY 2-3 DAY IN ORDER TO MONITOR SITE AND TREATMENT PLAN.
Age: 49.0
Sex: F
Vaccine: HEPA, IPV
Symptoms: Decreased appetite, Pain, Pyrexia
Clinical narrative: Body Aches, loss of appetite, fever of 102.0 F. Body aches better and fever reduced to 100.0 F by Tuesday 3/20/2012.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling, Pain
Clinical narrative: I am not sure when the unset occurred only know that is when I noticed my sons leg while giving him a bath. He complained of pain but I thought it was just sore because of the shot. Where he recieved the shot is blotchy and red, and it had a large hard swelling region around it. I took him back to the clinic and they recommended I report the reaction and to come back if symptoms get worse.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Rash macular
Clinical narrative: I am not sure when the unset occurred only know that is when I noticed my sons leg while giving him a bath. He complained of pain but I thought it was just sore because of the shot. Where he recieved the shot is blotchy and red, and it had a large hard swelling region around it. I took him back to the clinic and they recommended I report the reaction and to come back if symptoms get worse.
Age: 0.75
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Nine month old infant seen for well child visit given RotaTeq which exceeded the maximum age of 8 months.
Age: 12.0
Sex: M
Vaccine: DTAP, MUR, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: My son was given a duplicate injection of a vaccine which was already given previous in the same year.  The two medical offices did not share information from previous records.
Age: 0.35
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood albumin decreased, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Onset of fever; fever never went away.
Age: 0.35
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Laboratory test, Lymphocyte count increased, Neutrophil count normal, Platelet count normal, Pyrexia
Clinical narrative: Onset of fever; fever never went away.
Age: 0.35
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Red blood cell count decreased, White blood cell count increased
Clinical narrative: Onset of fever; fever never went away.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Asthma, Condition aggravated, Malaise, Nasopharyngitis, Viral infection
Clinical narrative: I just wanted you to know that I've gotten the flu shot for 7 years and I haven't gotten pneumonia or bronchitis since.  I've been relatively healthy and I've been able to get over colds fairly quickly.  Since the H1N1 has been added to the flu shot I've experienced colds that take a month to break, asthma related problems for 3-4 months, and generally more susceptible to other viruses and illnesses.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling in Right upper arm area since she received the immunization. Instructed to use Benadryl and cold packs. Follow up if symptoms worsen.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Patient reports that she noticed redness and swelling in mirror on 3/20/12.  She is taking cetirizine 10 mg for seasonal allergies, and states that it looks better today (probably due to the cetirizine).  She showed the reaction to me (her pharmacist) and I recommended that she continue taking cetirizine 10 mg and to also take acetaminophen or ibuprofen for swelling and pain.  I also instructed her to contact her physician if it does not continue to improve over the next 3 days.
Age: 28.0
Sex: F
Vaccine: FLU3, MMR, TDAP, VARCEL
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: (L) arm - red and warm to the touch. Levofloxacin 500 mg 1 QD x 7 days. Dx: Cellulitis.
Age: 1.1
Sex: M
Vaccine: PNC13
Symptoms: Blood culture positive, Blood immunoglobulin G increased, CSF culture positive, Chest X-ray normal, Meningitis pneumococcal
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 13-month-old male patient received the fourth dose of PREVNAR 13 in the thigh on an unknown date in 2012. Relevant medical history, family history, drug allergy history and concomitant medication were none. Past vaccine history includes: the first dose of PREVNAR 13 administered on 31Jan2011 at the age of 2 months (Lot #914514, expiration date: 29Feb2012), the second dose of PREVNAR 13 administered on 31Mar2011 at the age of 4 months (Lot #914972, expiration date: 31Mar2012) and the third dose of PREVNAR 13 administered on 01Jun2011 at the age of 6 months (Lot #915371, expiration date: 31May2012). On 17Jan2012 the patient experienced pneumococcal meningitis and pneumococcal sepsis and was hospitalized. Relevant laboratory data on (17Jan2012) was as follows: Blood culture positive for Streptococcus pneumoniae (Pneumococcal serotype: 29, 35, 42); CSF culture positive for Streptococcus pneumonia (Pneumococcal serotype: 29, 35, 42) and chest x-ray: normal. Laboratory data on (18Jan2012) was as follows: Pneumococcal IgG serotypes 1: 0.5; Pneumococcal IgG serotypes 3: less than 0.3; Pneumococcal IgG serotypes 4: less than 0.3; Pneumococcal IgG serotypes 5: 0.7; Pneumococcal IgG serotypes 8: less than 0.3; Pneumococcal IgG serotypes 9: (N) less than 0.3; Pneumococcal IgG serotypes 12: (f) less than 0.3; Pneumococcal IgG serotypes 14: 2.5; Pneumococcal IgG serotypes 19: (f) 0.7; Pneumococcal IgG serotypes 23: (f) 0.7; Pneumococcal IgG serotypes 26: (6B) 0.5; Pneumococcal IgG serotypes 51: (7F) 1.7; Pneumococcal IgG serotypes 56: (18C) 0.4 and Pneumococcal IgG serotypes 68: (av) 0.5. The patient recovered from the event on an unknown date in 2012. Follow-up (12Mar2012): New information reported from the contactable physician includes: patient demographics, product details, past vaccine history and lab data. Follow-up attempts completed. No further information expected.
Age: 1.1
Sex: M
Vaccine: PNC13
Symptoms: Pneumococcal sepsis, Streptococcus test positive
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 13-month-old male patient received the fourth dose of PREVNAR 13 in the thigh on an unknown date in 2012. Relevant medical history, family history, drug allergy history and concomitant medication were none. Past vaccine history includes: the first dose of PREVNAR 13 administered on 31Jan2011 at the age of 2 months (Lot #914514, expiration date: 29Feb2012), the second dose of PREVNAR 13 administered on 31Mar2011 at the age of 4 months (Lot #914972, expiration date: 31Mar2012) and the third dose of PREVNAR 13 administered on 01Jun2011 at the age of 6 months (Lot #915371, expiration date: 31May2012). On 17Jan2012 the patient experienced pneumococcal meningitis and pneumococcal sepsis and was hospitalized. Relevant laboratory data on (17Jan2012) was as follows: Blood culture positive for Streptococcus pneumoniae (Pneumococcal serotype: 29, 35, 42); CSF culture positive for Streptococcus pneumonia (Pneumococcal serotype: 29, 35, 42) and chest x-ray: normal. Laboratory data on (18Jan2012) was as follows: Pneumococcal IgG serotypes 1: 0.5; Pneumococcal IgG serotypes 3: less than 0.3; Pneumococcal IgG serotypes 4: less than 0.3; Pneumococcal IgG serotypes 5: 0.7; Pneumococcal IgG serotypes 8: less than 0.3; Pneumococcal IgG serotypes 9: (N) less than 0.3; Pneumococcal IgG serotypes 12: (f) less than 0.3; Pneumococcal IgG serotypes 14: 2.5; Pneumococcal IgG serotypes 19: (f) 0.7; Pneumococcal IgG serotypes 23: (f) 0.7; Pneumococcal IgG serotypes 26: (6B) 0.5; Pneumococcal IgG serotypes 51: (7F) 1.7; Pneumococcal IgG serotypes 56: (18C) 0.4 and Pneumococcal IgG serotypes 68: (av) 0.5. The patient recovered from the event on an unknown date in 2012. Follow-up (12Mar2012): New information reported from the contactable physician includes: patient demographics, product details, past vaccine history and lab data. Follow-up attempts completed. No further information expected.
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Blood creatinine increased, Delirium, Eye swelling, Feeling abnormal, Nausea
Clinical narrative: Initial report was received from another manufacturer who received the report from a consumer, who was also the patient, on 12 March 2012 under reference number S2012US01089. A 47-year-old male patient had received an injection of FLUZONE (lot number, route and site not reported) on 18 October 2011 and an unspecified amount of time later developed rash, eye swelling, nausea and vomiting (N&V), delirious, irrational, heart raced and "felt like he was going to die." The patient went to the emergency room (ER) and was treated. Laboratory results included creatinine 2.7 and blood pressure (BP) 182-190. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Palpitations, Rash, Thinking abnormal, Vomiting
Clinical narrative: Initial report was received from another manufacturer who received the report from a consumer, who was also the patient, on 12 March 2012 under reference number S2012US01089. A 47-year-old male patient had received an injection of FLUZONE (lot number, route and site not reported) on 18 October 2011 and an unspecified amount of time later developed rash, eye swelling, nausea and vomiting (N&V), delirious, irrational, heart raced and "felt like he was going to die." The patient went to the emergency room (ER) and was treated. Laboratory results included creatinine 2.7 and blood pressure (BP) 182-190. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Diarrhoea, Haematochezia, X-ray
Clinical narrative: Bloody stools / diarrhea shortly past immns.