chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: This case was reported by a pharmacist and described the occurrence of lightheadedness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 1 October 2013 the subject received a dose of FLULAVAL (unknown details). On 1  October 2013, less than one day after vaccination with FLULAVAL, the subject experienced lightheadedness. Limited information was provided. At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in an unknown number of subjects of unspecified age and gender who were vaccinated with FLULAVAL (GlaxoSmithKline). In 2013 the subject received a dose of FLULAVAL (unknown details). In 2013, within months of vaccination with FLULAVAL, the subjects experienced injection site redness. The healthcare professional reported that "one patient had nausea, and many patients with redness at the site." The healthcare professional had previously reported nausea in 2 other cases (see cases A1043170A and A1043122A for details). At the time of reporting the outcome of the event was unspecified.
Sex: M
Vaccine: FLU3
Symptoms: International normalised ratio increased
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of international normalized ratio increased in "about 5" male subjects of unspecified age who were vaccinated with FLULAVAL. Concurrent medications included warfarin. The nurse documented that reactions experienced with previous flu shots as "last year was Sanofi." It was unclear from the report what this statement meant. On an unspecified date (s) the subject's received a dose of FLULAVAL (.5 ml, unknown details). The nurse documented the following as dates of administration for FLULAVAL: 1 October 2013, 3 October 2013 and August 2013. In 2013, at an unspecified time after vaccination with FLULAVAL, the subjects experienced international normalized ration increased. At the time of reporting the event was unresolved. The nurse reported another case with FLULAVAL. See case A1045977A for details on the other case.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of injection site soreness in a 48-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 1 October 2012 at 13:00 the subject received a dose of FLULAVAL (.5 ml, unknown route, right arm). On 1 October 2012, immediately after vaccination with FLULAVAL, the subject experienced injection site soreness, arm swelled at injection site and erythema of arm at injection site. The nurse stated that the subject "experienced a swollen red arm at the injection site that was the size of a dollar piece and very sore." The subject was treated with Ice pack. On 2 October 2012, the events were resolved within 24 hours. The healthcare professional (nurse) considered the events were probably related to vaccination with FLULAVAL.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pruritus, Underdose, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of intramuscular formulation administered by other route in an adult between 60 and 69 years old of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 7 October 2013 at 14:30 the subject received a dose of FLULAVAL (.1 dose, intradermal, unknown arm) and experienced intramuscular formulation administered by other route, wrong vaccine administered, and underdose. The FLULAVAL is indicated as a 0.5ml dose to be administered intramuscularly; however this subject received 0.1 dose (underdose) "in the forearm" (intramuscular formulation administered by other route). The nurse reported that "she accidentally have" "a 0.1 dose of FLULAVAL as a PPD in the forearm, instead of intramuscularly." The nurse refused to provide any additional details at the time of the report. On 7 October 2013, on the same day as vaccination with FLULAVAL, the subject experienced injection site pruritus (described as "severe") and injection site redness. At the time of reporting the events were improved. The nurse reported 2 other cases with FLULAVAL. See cases A1045209A and A1045207A for details on the other cases. Follow up was received from nurse on 1 November 2013. The nurse reported that this case had been reported to a Regulatory agency; however, a reference number was not provided. The nurse documented that on 7 October 2013 at 14:00 (previously 14:30), a female subject between 60 - 69 years old (previously an adult of unknown gender) received a primary dose of FLULAVAL and experienced "marked pruritis for 10 minutes" (injection site pruritis). The nurse did not consider the events serious. The events were not life threatening, did not involve severe or permanent disability; did not involve hospitalization, did not involve congenital defect, and did not jeopardize the subject or required intervention. The subject was evaluated by a physician within 15 minutes of the vaccination. On 10 October 2013, the nursing report documented that there were no adverse reactions at that date; however, the specific date of resolution was not reported. The nurse also provided follow up for the other 2 cases of A1045207A and A1045209A.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Apgar score normal, Exposure during pregnancy, Influenza like illness
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 35-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline) during pregnancy. The subject's medical history included no previous pregnancies. The subject was not using contraception. On 9 October 2012 the subject received a dose of FLULAVAL (.5 ml, intramuscular, right deltoid) and experienced vaccine exposure during the first trimester of pregnancy. The gestational age at the time of vaccination was reported as "about 3 weeks." The date of last menstrual period was not reported. The estimated date of delivery was reported as the "beginning of June 2013." At the time of reporting, the pregnancy was ongoing. The subject did not experience any adverse events from receiving the vaccine FLULAVAL. Follow up was received from the nurse reporter on 26 March 2013. The nurse documented for this conception, the method of conception was normal and no in-vitro fertilization was used. This pregnancy was with one fetus. Concurrent medications included Calcium with vitamin D, VITAFOL ONE, Ferrous fumarate and PPD. The date of last menstrual period was reported as 20 August 2012 and the estimated date of delivery was reported as 4 June 2013. At the time of reporting, the subject was at 7 and a half months pregnant and there had been no problems. Follow up was received from the consumer (subject) on 17 September 2013. The information received was not medically confirmed. The subject documented that the conception was not by normal method; however, also documented that in-vitro fertilization was not received. Concurrent medications included: prenatal vitamin, insulin LANTUS (from "20 weeks until delivery"), and insulin HUMALOG (from "20 weeks until delivery"). Concurrent medical conditions included: gestational diabetes from "20 weeks until delivery." The consumer did not consider this event to be serious. On an unknown date, after an unknown number of weeks gestation, the subject gave birth to a female live infant with no apparent congenital anomaly. The delivery method and infant weight were not reported. The consumer did not consider events in the infant to be serious; however, there were no events reported. Follow up was received from a healthcare professional on 18 October 2013. The healthcare professional reported that in October 2012, 3 weeks after vaccination (at approximately 6 weeks gestation) with FLULAVAL, the subject experienced flu like symptoms. The outcome was reported as improved and possibly related to FLULAVAL per the reporter. The healthcare professional did not consider the events to be serious. On 6 June 2013, after 40 weeks gestation, the subject gave birth to a full-term female live infant with no congenital anomaly. The infant as delivered by normal vaginal delivery and weighed 3.5 kilograms and was 19 inches long. The APGAR score at 1 minute and 5 minutes were 10.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pruritus, Underdose, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of intramuscular formulation administered by other route in an adult subject between 48 and 52 years of age of unknown gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 7 October 2013 at 14:30 the subject received a dose of FLULAVAL (.1 dose, intradermal, unknown arm) and experienced intramuscular formulation administered by other route, wrong vaccine administered, and underdose. The FLULAVAL is indicated as a 0.5ml dose to be administered intramuscularly; however this subject received 0.1 dose (underdose) "in the forearm". The nurse reported that "she accidentally gave" "a 0.1 dose of FLULAVAL as a PPD in the forearm, instead of intramuscularly." The nurse refused to provide any additional details. The nurse reported 2 other cases with FLULAVAL. See cases A1045209A and A1045210A for details on the other cases. Follow up received from nurse on 1 November 2013. The nurse reported that this case had been reported to Regulatory agency; however, a reference number was not provided. The nurse documented that on 7 October 2013 at 14:00 (previously 14:30), a female subject between 60-69 years old (previously an adult between 48 and 52 years of age of unknown gender) received a primary dose of FLULAVAL and experienced "marked pruritis for 10 minutes" and injection site redness (not previously reported). The nurse did not consider the events serious. The events were not life threatening, did not involve severe or permanent disability, did not involve hospitalization, did not involve congenital defect, and did not jeopardize the subject or required intervention. The subject was evaluated by a physician within 15 minutes of the vaccination. On 10 October 2013, the nursing report documented that there were no adverse reactions at that date; however, the specific date of resolution was not reported. The nurse also provided follow up for the other 2 cases of A1045210A and A1045209A.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Lacrimation increased, Rhinorrhoea
Clinical narrative: This case was reported by a healthcare professional (nurse, subject) and described the occurrence of sore arm (injection site) in a 61-year-old female subject who was vaccinated with FLULAVAL TETRA (GlaxoSmithKline). The subject's medical history included gallbladder attack and gallbladder exeresis. Concurrent medications included Vitamin D, Calcium salt (Calcium) and Oestradiol (Estradiol patch). On 31 October 2013 the subject received 1st dose of FLULAVAL TETRA 2013-2014 (unknown details, left arm). The subject reported that she was required to receive the vaccination as part of her employment. She also reported that she "would have to use a face mask with her interactions with patients in the hospital." On 31 October 2013, within "a few hours" of vaccination with FLULAVAL TETRA 2013-2014, the subject experienced sore arm (injection site), injection site reaction (difficulty in moving arm). The subject reported that she could "barely life her arm." On 31 October 2013, within the same day as vaccination with FLULAVAL TETRA 2013-2014, the subject experienced chest tightness and headache. In 2013, within weeks of vaccination with FLULAVAL TETRA 2013-2014, the subject experienced runny nose, watering eyes and decreased in thinking of words to say. The subject reported that she had "some difficulty with saying words and speaking, due to her not being able to think about what she wants to say". At the time of reporting the events of sore arm (injection site), injection site reaction (difficulty in moving arm), and decreased in thinking of words to say were resolved on an unknown date. The reporter documented that the chest tightness had improved. The reporter stated that events of runny nose, watering eyes, and headache were not resolved at the time of reporting. The healthcare professional considered the events of sore arm (injection site), injection site reaction (difficulty in moving arm), and chest tightness were probably related to vaccination with FLULAVAL TETRA. The nurse did not document causality with the other events. Follow-up information was received on 09 December 2013 via healthcare professional (nurse), who is also the subject. The subject had not received FLULAVAL TETRA previously. The subject reported the events occurred on 31 October 2013 and are unresolved (different from initial report). The reporter did not consider the events to be serious. She did not attribute the events to medical history/concurrent illness, lack of efficacy or suspected transmission of infectious agent via medicinal product. Follow-up information received on 08 January 2014 via physician who reported the events started shortly after the subject received the flu shot and have since resolved. The physician did not attribute the events to medical history/concurrent illness. The physician reported the subject "came to see me one and half after the vaccine was given at her work. She doesn't want to receive flu shot again. Her symptoms had resolved by time she presented to me." At the time of the report no other information was provided.
Sex: U
Vaccine: FLU3
Symptoms: Flushing, Nausea, Syncope
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of nausea in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2013 the subject received a dose of FLULAVAL (unknown details). In 2013, within months of vaccination with FLULAVAL, the subject experienced nausea, syncope and flushing. At the time of reporting the outcome of the events were unspecified. The healthcare professional reported another case with FLULAVAL. See case A1043170A for details on the other case.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Generalised erythema, Hyperaesthesia, Pruritus generalised, Rash generalised, Rash vesicular
Clinical narrative: This case was reported by a consumer and described the occurrence of erythema in a 63-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included Blood pressure medication (Unknown blood pressure "medication for an extra heartbeat/blood pressure"), Vitamin and Diuretic (Medication for fluid retention described as "medication for edema"). On 27 or 28 November 2012 during mid-morning, probably 11:30 the subject received a dose of FLULAVAL (unknown route, left arm). On 28 or 29 November 2012, 1 day after vaccination with FLULAVAL, the subject experienced erythema ("redness all over body"), itching, skin feels like it's burning, sensitivity to water, skin swelling, body rash and chicken pox like rash on feet. The subject stated that the day after she received FLULAVAL, "she experienced redness and itching all over body, burns skin when she takes a shower, and it looks like someone hit her with a stick since her sin raises up a quarter of an inch." She stated that she can "only tolerate a shower every other day now instead of every day, because her skin gets itchy and red like she has been burnt." The subject reports daily itching of the skin and a "rash redness all over her body." She noted that her "feet look like she has chicken pox." She stated that "she is itching so bad that she wants to die" and stated "that she has been in hell." The subject was treated with unknown (Cream). Then she contacted her physician who prescribed her "a large dose of" BENADRYL "which did not help". "She was then placed on a tapering dose of steroids which did not help." At the time of reporting the events were unresolved.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Skin burning sensation, Skin swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of erythema in a 63-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included Blood pressure medication (Unknown blood pressure "medication for an extra heartbeat/blood pressure"), Vitamin and Diuretic (Medication for fluid retention described as "medication for edema"). On 27 or 28 November 2012 during mid-morning, probably 11:30 the subject received a dose of FLULAVAL (unknown route, left arm). On 28 or 29 November 2012, 1 day after vaccination with FLULAVAL, the subject experienced erythema ("redness all over body"), itching, skin feels like it's burning, sensitivity to water, skin swelling, body rash and chicken pox like rash on feet. The subject stated that the day after she received FLULAVAL, "she experienced redness and itching all over body, burns skin when she takes a shower, and it looks like someone hit her with a stick since her sin raises up a quarter of an inch." She stated that she can "only tolerate a shower every other day now instead of every day, because her skin gets itchy and red like she has been burnt." The subject reports daily itching of the skin and a "rash redness all over her body." She noted that her "feet look like she has chicken pox." She stated that "she is itching so bad that she wants to die" and stated "that she has been in hell." The subject was treated with unknown (Cream). Then she contacted her physician who prescribed her "a large dose of" BENADRYL "which did not help". "She was then placed on a tapering dose of steroids which did not help." At the time of reporting the events were unresolved.
Age: 47.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Chronic, sharp pain on left arm where shot was administered, pain remains in arm from day after shot to present.
Age: 47.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Chronic, sharp pain on left arm where shot was administered, pain remains in arm from day after shot to present.
Age: 68.0
Sex: M
Vaccine: HEPA
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: About 50 hrs after vaccination, pt got fever 102 deg with aches and chills. Also a severe headache. On 2/20 fever was 101 deg and taking Tylenol. On 2/21 at 11 am, pt called us to report and states he has no fever today, but still taking Tylenol and still has aches.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Tardive dyskinesia
Clinical narrative: This case was reported by a healthcare professional (pharmacy student, 4th year) and described the occurrence of tardive dyskinesia in a 64-year-old female subject who was vaccinated with FLULAVAL TETRA (GlaxoSmithKline). On an unspecified date in 2013 the subject received unspecified dose of FLULAVAL TETRA (unknown). The pharmacy student was unsure which flu vaccine was administered, but based on lot number review the provided lot number of "35GY3" corresponded to FLULAVAL TETRA. In 2013, within months of vaccination with FLULAVAL TETRA, the subject experienced tardive dyskinesia. The pharmacy student did not have much information at the time of the report. At the time of reporting the outcome of the event was unspecified.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Rhinorrhoea
Clinical narrative: This case was reported by a consumer and described the occurrence of sniffles in a 14-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included sinus problems intermittent. On 15 January 2013 the subject received a dose of FLULAVAL (.5 ml, unknown route, right arm) and experienced inappropriate age at vaccine administration. The subject was younger than the indicated age for FLULAVAL. On 15 January 2013, 1 day after vaccination with FLULAVAL, the subject experienced sniffles. At the time of reporting the events were unresolved.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date ("within the last 2 weeks" prior to 11 January 2013) the subject received a dose of FLULAVAL (unknown details). On an unspecified date, within the last 2 weeks after vaccination with FLULAVAL, the subject experienced injection site redness and swelling injection site. The events were described as "significant redness and swelling at the injection site. "Last year", on an unspecified date the subject received a dose of FLULAVAL (unknown details). On an unspecified date after vaccination with FLULAVAL, the subject experienced injection site redness and swelling injection site. The events were described as "significant redness and swelling at the injection site. At the time of reporting the outcome of the events were both vaccinations were unspecified.
Age: 62.0
Sex: M
Vaccine: PNC13
Symptoms: Dizziness
Clinical narrative: Patient came into pharmacy about 3 days after getting PREVNAR 13 vaccine said he's been feeling dizzy/lightheaded since he got vaccine.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Feeding disorder neonatal, Irritability, Opisthotonus, Pyrexia
Clinical narrative: 1/17/13 3 days nasal congestion; fever 99.9; restlessness; vomited due to congestion; decreased urination; hard to nurse; very fussy, calmed by car ride. 1/17/13 tried albuterol, antipyretic, benzocaine in hear to provide comfort and promote rehydration. 1/18/13 fever gone, wet diapers normalized, still very fussy, falling asleep, legs "would start moving and 'rubbing together' and pt. would wake up". 1/18/13 visit - cries when put down, resume normal nursing, hip abduction 80 degrees (<90 degrees), neuro - arched back when ear examined otherwise no neurologic abnormalities, PE essentially normal, gained 0.1 lb., advised ER parents declined, after nap less fussy. 1/28/13 no further contact since 1/18, visit for cough (irritability improved 2 days after 1/18), wheezed - prescribed albuterol, all prior sx had resolved before this new illness.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Respiratory tract congestion, Restlessness, Urine output decreased, Vomiting, Wheezing
Clinical narrative: 1/17/13 3 days nasal congestion; fever 99.9; restlessness; vomited due to congestion; decreased urination; hard to nurse; very fussy, calmed by car ride. 1/17/13 tried albuterol, antipyretic, benzocaine in hear to provide comfort and promote rehydration. 1/18/13 fever gone, wet diapers normalized, still very fussy, falling asleep, legs "would start moving and 'rubbing together' and pt. would wake up". 1/18/13 visit - cries when put down, resume normal nursing, hip abduction 80 degrees (<90 degrees), neuro - arched back when ear examined otherwise no neurologic abnormalities, PE essentially normal, gained 0.1 lb., advised ER parents declined, after nap less fussy. 1/28/13 no further contact since 1/18, visit for cough (irritability improved 2 days after 1/18), wheezed - prescribed albuterol, all prior sx had resolved before this new illness.
Age: 60.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Dizziness, Muscular weakness, Pain in extremity, Syncope, Tenderness
Clinical narrative: Patient presented to ER afternoon of 2/19/14 c/o bad (L) arm pain. Needed medication. C/o syncope and dizziness. Admitted for observation. Significant tenderness and weakness in arm. Patient has hx of leukemia.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: 2/20/14 AM - woke up with dizziness and nausea.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Patient received vaccine on 02/03/2014 at public health. Presented to clinic to see FNP on 02/05/2014. Diagnosis was outlined urticarial L upper arm. Was booster injection.
Age: 12.0
Sex: M
Vaccine: HEPA, MMR, MNQ, TDAP
Symptoms: Feeling abnormal, Joint swelling, Lip swelling, Local swelling, Rash pruritic
Clinical narrative: Approximately 3 days after the vaccines he developed an itchy rash on his back, hands and feet.   They do not recall what the rash looked like.  Mom says during the middle of the night he complained of his heart feeling weird.  Mom says he developed swelling of his elbows, followed by hands, then knees and then feet.  There are unsure how quickly the swelling developed (8 to 12 hours between joint involvement).  The hands remained swollen for several days. The other joints did not remain swollen.  He had pain with walking for about 2 days.  He was taken to the ED and given steroids and antihistamines.  Mom does not recall if it helped significantly.  He also had lip swelling at some point during the course.  They do not recall how long his lips were swollen - maybe 6 to 8 hours.
Age: 1.27
Sex: M
Vaccine: DTPPHIB, HEPA, MMRV, PNC
Symptoms: Diarrhoea, Pyrexia, Rash, Vomiting
Clinical narrative: Fever up to 103.8, rash, vomiting diarrhea, sudden onset, all voiced by mother of child. ER record shows fever 99.5ax no resp distress.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: Patient arrived for Hepatitis A #2. Patient was well. Given immunization. Five minutes later fainted while standing up. Given juice, crackers, BP taken.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Bacterial test positive, Cerebrovascular accident, Chest pain, Dysarthria, Facial pain
Clinical narrative: On the seventh day after I received my shot, I was extremely sick. By day ten I went into the emergency room with symptoms of mild stroke like symptoms, chest pains, slurred speech, jaw and face pain. Urine showed bacteria and a PH of 5.   No treatments or additional tests were given or brought up, so I did my own research and resresorted to doing an enema detox with coffee, clay bath detoxing and chlorophyll treatments to remove  excess toxins out of my body. I had to apply onion poutices behind my ear and chest area to remove the painful chest infections that resulted from the shot.  Since then my PH has gone back up and the flue/like after symptoms have gone. But I am still struggling with building up my immunity and dealing with long term removal of toxins released. I continue to do weekly detoxing with clay and chlorophyll treatments.  I had an lowered dose of Levelthyroxine for Hypothyroidism in November, which I have been treated for with generally positive results since 2006.  The emergency doctor and my doctor; dismissed the idea that the shot caused a sever reaction.   I have had gum issues, over sensitivity issues to products and food since receiving the shot. I do not ever recommend getting any mercury/based shots if you have amalgam fillings and a weakened immunity system or any antibiotic treatments prior to taking any shots.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Gingival disorder, Hypersensitivity, Influenza like illness, Pain in jaw, pH urine decreased
Clinical narrative: On the seventh day after I received my shot, I was extremely sick. By day ten I went into the emergency room with symptoms of mild stroke like symptoms, chest pains, slurred speech, jaw and face pain. Urine showed bacteria and a PH of 5.   No treatments or additional tests were given or brought up, so I did my own research and resresorted to doing an enema detox with coffee, clay bath detoxing and chlorophyll treatments to remove  excess toxins out of my body. I had to apply onion poutices behind my ear and chest area to remove the painful chest infections that resulted from the shot.  Since then my PH has gone back up and the flue/like after symptoms have gone. But I am still struggling with building up my immunity and dealing with long term removal of toxins released. I continue to do weekly detoxing with clay and chlorophyll treatments.  I had an lowered dose of Levelthyroxine for Hypothyroidism in November, which I have been treated for with generally positive results since 2006.  The emergency doctor and my doctor; dismissed the idea that the shot caused a sever reaction.   I have had gum issues, over sensitivity issues to products and food since receiving the shot. I do not ever recommend getting any mercury/based shots if you have amalgam fillings and a weakened immunity system or any antibiotic treatments prior to taking any shots.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyskinesia, Injection site mass, Tremor
Clinical narrative: Developed large egg shaped bump where injection was. Upon standing up, legs shook & trembled jerkingly and felt like they were going to give way, arms trembled and shook uncontrollably. This lasted about 2 weeks then stopped.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyskinesia, Injection site swelling, Tremor
Clinical narrative: Developed large egg shaped bump where injection was. Upon standing up, legs shook & trembled jerkingly and felt like they were going to give way, arms trembled and shook uncontrollably. This lasted about 2 weeks then stopped.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Dyspnoea
Clinical narrative: PT experienced shortness of breath around 10 mins after receiving the Anthrax vaccine.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Chest discomfort, Decreased appetite, Dizziness, Fatigue, Nausea
Clinical narrative: After being in hot tub, developed chest tightness, dizziness, fatigue, and decreased appetite. Shortly after developed fever (103). Developed nausea and emesis (x10) around 3:00 AM on 02/18/2014. Treated with Advil and small sips of fluids at home. Came to urgent care at 9:52 AM on 02/18/2014 and was feeling well.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Pyrexia, Vomiting
Clinical narrative: After being in hot tub, developed chest tightness, dizziness, fatigue, and decreased appetite. Shortly after developed fever (103). Developed nausea and emesis (x10) around 3:00 AM on 02/18/2014. Treated with Advil and small sips of fluids at home. Came to urgent care at 9:52 AM on 02/18/2014 and was feeling well.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV4, MNQ, TDAP
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea and vomiting accompanied by a slight fever.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling
Clinical narrative: Fingers swelled up in arm that vaccine was administered in.
Age: 69.0
Sex: F
Vaccine: VARCEL
Symptoms: Lipoatrophy
Clinical narrative: Development of an indentation in her left buttock following varicella (shingles) vaccination. Described as lipoatrophy.
Age: 0.24
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Fever of 101.5 degrees.  Two events of diarrhea and 1 episode of vomiting.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chest X-ray normal, Chills, Fatigue, Full blood count normal
Clinical narrative: I began to develop a large welt at the site of injection shortly after the Pneumovax. Then, later that evening, I had a headache, myalgias and fatigue. I awoke the following morning with shaking chills and a fever. This evolved into a high fever of nearly 107 untouched by antipyretics, and requiring an ER visit. The local reaction also progressed, and developed into a cellulitis over nearly my entire arm. I continued to have high fevers in the 103-106 range for three days following despite dual antibiotic use, and was nearly hospitalized by my physician. Fever, headache, myalgias, shaking chills, and severe pain in the arm with the local reaction all lasted for several days.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site urticaria, Local reaction, Metabolic function test normal, Myalgia
Clinical narrative: I began to develop a large welt at the site of injection shortly after the Pneumovax. Then, later that evening, I had a headache, myalgias and fatigue. I awoke the following morning with shaking chills and a fever. This evolved into a high fever of nearly 107 untouched by antipyretics, and requiring an ER visit. The local reaction also progressed, and developed into a cellulitis over nearly my entire arm. I continued to have high fevers in the 103-106 range for three days following despite dual antibiotic use, and was nearly hospitalized by my physician. Fever, headache, myalgias, shaking chills, and severe pain in the arm with the local reaction all lasted for several days.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Neutrophil count increased, Pyrexia, Tremor, Urine analysis normal
Clinical narrative: I began to develop a large welt at the site of injection shortly after the Pneumovax. Then, later that evening, I had a headache, myalgias and fatigue. I awoke the following morning with shaking chills and a fever. This evolved into a high fever of nearly 107 untouched by antipyretics, and requiring an ER visit. The local reaction also progressed, and developed into a cellulitis over nearly my entire arm. I continued to have high fevers in the 103-106 range for three days following despite dual antibiotic use, and was nearly hospitalized by my physician. Fever, headache, myalgias, shaking chills, and severe pain in the arm with the local reaction all lasted for several days.
Age: 37.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Chills, Dizziness, Dyspnoea, Fatigue
Clinical narrative: FIRST HIVES HEAVY ITCHING SECOND DIZZINESS AND WEAKNESS THIRD NAUSEA FOURTH DIFFICULTY BREATHING FIFTH FEVER SIXTH COLD SHAKES OR SHIVERING SEVENTH PALE SKIN LOSS OF BLOOD IN THE FACE EIGHTH FEELING OF FAINTING NINTH EXTREME EXHAUSTION
Age: 37.0
Sex: M
Vaccine: FLUX
Symptoms: Feeling cold, Haemorrhage, Nausea, Pallor, Pruritus
Clinical narrative: FIRST HIVES HEAVY ITCHING SECOND DIZZINESS AND WEAKNESS THIRD NAUSEA FOURTH DIFFICULTY BREATHING FIFTH FEVER SIXTH COLD SHAKES OR SHIVERING SEVENTH PALE SKIN LOSS OF BLOOD IN THE FACE EIGHTH FEELING OF FAINTING NINTH EXTREME EXHAUSTION
Age: 37.0
Sex: M
Vaccine: FLUX
Symptoms: Tremor, Urticaria
Clinical narrative: FIRST HIVES HEAVY ITCHING SECOND DIZZINESS AND WEAKNESS THIRD NAUSEA FOURTH DIFFICULTY BREATHING FIFTH FEVER SIXTH COLD SHAKES OR SHIVERING SEVENTH PALE SKIN LOSS OF BLOOD IN THE FACE EIGHTH FEELING OF FAINTING NINTH EXTREME EXHAUSTION
Sex: U
Vaccine: FLU3
Symptoms: Flushing, Nausea, Syncope
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of nausea in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2013 the subject received a dose of FLULAVAL (unknown details). In 2013, within months of vaccination with FLULAVAL, the subject experienced nausea, syncope and flushing. At the time of reporting the outcome of the events were unspecified. The healthcare professional reported another case with FLULAVAL. See case A1043122A for details on the other case.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Injection site pain
Clinical narrative: This prospective pregnancy case was reported by a consumer and described the occurrence of sore arm (injection site) in a 30-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline) during pregnancy. A physician or other health care professional has not verified this report. The current pregnancy was by normal conception and the subject was not using contraception. There was no evidence of a defect on prenatal testing. There was no maternal or paternal history which may have an impact on the outcome of the pregnancy. The subject had no concomitant medications. On 11 September 2013 the subject received a dose of FLULAVAL (unknown, left arm) and experienced vaccine exposure during the second trimester of pregnancy. The gestational age was calculated as 22 5/7 weeks at the time of vaccination. The date of last menstrual period was 05 April 2013 and the estimated delivery date was 10 January 2014. On 11 September 2013, less than one day after vaccination with FLULAVAL, the subject experienced sore arm (injection site). At the time of reporting the event was resolved. The subject considered the event related to the vaccination. At the time of the report, the pregnancy was ongoing.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Nausea
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of headache in a 50-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject's medical history included migraine. On 29 January 2013 at 17:00 the subject received a 0.5 ml dose of FLULAVAL (unknown details). On 29 January 2013, 3 hours after vaccination with FLULAVAL 2012-13, the subject experienced headache and nausea. The reporter described the headache and nausea as severe without vomiting. No diarrhea was reported per the reporter. The nurse stated that the subject contemplated going to the hospital but did not. On 30 January 2013, the events were resolved. The nurse stated that the subject reported being "75 percent" better by the next morning. The nurse stated that all events had resolved by noon the next day, 30 January 2013.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary mass, Injection site pain, Mammogram
Clinical narrative: Lump under left arm size of lima bean. Patient still sore at site of injection. The lump has gone away.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Dyspnoea, Lethargy, Syncope
Clinical narrative: Patient became lethargic with shortness of breath (vasovagal syncope). Patient put in semifowlers position and 2L of O2. Patient placed in dark room while vitals monitored (stable). D/c in stable condition.
Age: 1.17
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13, VARCEL
Symptoms: Laboratory test abnormal, Pyrexia
Clinical narrative: P.C. from mom - reports was given immunizations yesterday has been running fever ever since. Comes down with TYLENOL or ibuprofen but goes back up.
Age: 43.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Pt. had immunization on 2/17/14 - came into clinic on 2/19/14 with c/o redness to (Rt) arm. Has area of redness - 12cm x 15cm irregular shape - warm to touch. Area was marked and pt. to be re-evaluated 2/20/14.
Age: 4.0
Sex: M
Vaccine: IPV, MMRV, TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: After administering DTaP and IPV to left deltoid, and IPV to left upper arm patient complained of itching, hives presented, RN administered 7ml BENADRYL per orders from MD. Patient was monitored for approx. 30 minutes.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Crying, Irritability, Muscle twitching
Clinical narrative: Patient's mother returned a couple hours after immunization stating patient was "twitchy" and "fussy", "crying". Patient was taken to back office, RN administered BENADRYL as ordered by MD. Patient was monitored for approximately 1 hour during which he calmed, and went to sleep in mother's arms.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Developed red itchy raised welts on feet, face beginning a few hours after vaccine. Still occurring intermittently now 3 days later, possibly related to vaccination.
Age: 1.01
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site nodule, Pain, Pyrexia
Clinical narrative: Fever, knot on left arm from injection site (left deltoid) to elbow, unable to move without pain.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient's caregiver called to express concern about the site of ZOSTAVAX injection. Specifically, per caregiver, the injection site is still pink but fading since November 1, 2012. Patient is contacted and confirmed, she is fine. Patient experienced soreness at the time of receiving the shot. Patient currently experiences neither pain nor any other side (adverse) effects even though the light pink discoloration is still presented. This STARS event is written up per Immunization Department's suggestion. This report is not a result of patient's complaint. Patient has an appointment to see her PCP about a separate issue. Per patient, she will ask MD about this skin discoloration and will let us know. Therefore, she does not want us to contact MD directly.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Per mom - red swollen hot to touch.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt. came in on 2/11/14 - said her arm was still very sore from flu shot given on 1/23/14. She said there was no swelling, rash or redness but her arm still hurts to move. Pt was told to let us know if she was still experiencing pain after a few more days. 2/14/14 pt returned said she took a muscle relaxant and her arm was feeling much better.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Swelling, redness, induration over central right upper arm proximally.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a 69 year old pharmacist regarding himself. Pharmacist reported that on unknown date in 2013, he administered himself with ZOSTAVAX, dose (unknown), frequency (unknown), subcutaneous, in the abdomen, for unknown indication. No concomitants were reported. On an unknown date, the patients whole abdomen became red. The outcome of was reported as recovered. Causality assessment was not provided. Oharmacist declined to answer any additional information questions about him. No further information was provided. This report is linked to 1402USA006892, 1402USA007824 and 1402USA007826 by the same reporter link. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Angioedema, Eyelid oedema, Local swelling, Pruritus, Rash
Clinical narrative: Per review of patient's chart: Patient reported adverse events to PCP two days after vaccine was given. Refused to go to emergency room until 1/8/14 after symptoms worsened. Diphenhydramine 50 MG QID.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Per review of patient's chart: Patient reported adverse events to PCP two days after vaccine was given. Refused to go to emergency room until 1/8/14 after symptoms worsened. Diphenhydramine 50 MG QID.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Pain in arm where injection was given.  Pain felt for about two days, then went away, then came back.  Pain enough to affect range of motion and hurts to raise arm and to dress.  It's an ongoing ache.  Aleve helped to reduce pain but it has not gone away. Will need to see my primary physician about it.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Dizziness, Migraine, Vision blurred
Clinical narrative: EMPLOYEE STATES THAT SHE WAS FEELING LIGHT HEADED WITH A SLIGHT MIGRAINE, COLD, BLURRED VISION, CHILLS, DIZZINESS. TEMPERATURE WAS 98.4 F BP 152/91 PULSE 87. SYMPTOMS PERSISTED FOR ABOUT 60 MINS. LEGS WERE ELEVATED, NO BREATHING PROBLEMS NOTED, EMPLOYEE WAS IN SUPINE POSITION ON EXAM TABLE IN OFFICE. EMPLOYEE STARTED TO FEEL BETTER AFTER 60 MINS.  VITALS AT 09:45 AM WERE BP 138/64 PULSE 71 TEMPERATURE 98.6.  EMPLOYEE STATED THAT SHE STILL HAD A SLIGHT MIGRAINE BUT SHE FELT BETTER. EMPLOYEE STATED THAT SHE HAD SLIGHT MIGRAINES OCCASIONALLY OVER THE PAST FEW WEEKS. EMPLOYEE RETURNED BACK TO WORK IN PRODUCTION, STATING SHE FELT FINE. AT 10:30 AM EMPLOYEE RETURNED TO  OFFICE STATING THAT SHE IS STILL HAVING A MIGRAINE AND BEING LIGHTHEADED. 10:35 AM VITALS BP 138/87 PULSE 64, TEMPERATURE 98.4 F.  EMPLOYEE LAID IN SUPINE POSITION ON EXAM TABLE. EMPLOYEE HAD STAFF MEMBER CALL HER BOYFRIEND TO COME PICK HER UP. EMPLOYEE REMAINED IN OFFICE UNTIL BOYFRIEND PICKED HER UP AT 12:30 PM.  VITALS AT TIME OF RELEASE WAS BP 122/85 PULSE 63.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Blood test, Computerised tomogram, Convulsion, Intensive care, Laboratory test
Clinical narrative: Fever, seizure that would not stop on its own, had to use drugs and sedation to stop seizure after over an hour. Resulted in paramedic transport to emergency room, admission to PICU, on ventilator for 3 days, still in PICU today 2.22.2104.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Mechanical ventilation, Nuclear magnetic resonance imaging, Pyrexia, Sedation
Clinical narrative: Fever, seizure that would not stop on its own, had to use drugs and sedation to stop seizure after over an hour. Resulted in paramedic transport to emergency room, admission to PICU, on ventilator for 3 days, still in PICU today 2.22.2104.
Age: 75.0
Sex: M
Vaccine: ANTH
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat. Do you realize this stupid computer will not accept am or pm but requires AM or PM or else it rejects the entry. You people are not serious people.
Age: 15.0
Sex: M
Vaccine: PPV
Symptoms: Adenosine deaminase normal, Alpha-1 anti-trypsin normal, B-lymphocyte count, CD4 lymphocytes decreased, CD8 lymphocytes decreased
Clinical narrative: This literature marketed report as received from health professional refers to a 15 year old male patient. Patient's current condition reported as chronic mucocutaneous candidiasis (CMC) and type 1 diabetes. On an unknown date, at the age of 13, the patient was presented with recurrent sinusitis and mucocutaneous fungal infections. There was no history of pneumonia or serious bacterial infections. On an unknown date, daily DIFLUCAN was given with dramatic improvement in his skin and oral candidiasis. On an unknown date, the patient was vaccinated with PCV 23 (manufacturer unspecified) injection, booster dose (dose and route of administration unspecified). On an unknown date, at the age of 15, he was admitted to the pediatric intensive care unit with respiratory insufficiency due to pneumonia (hospitalization) complicated by pleural effusion requiring chest tube decompression. On an unknown date, the patient was discharged. On an unknown date, he was readmitted shortly after discharge for refractory pneumonia (hospitalization) and positive enterovirus PCR. On an unknown date: Autoimmune regulator (AIRE) gene and quantitative immunoglobulins were normal. Polysaccharide response was poor despite repeat boosting with PCV 23 (manufacturer unspecified). On an unknown date, Tetanus and diphtheria titers were protective. Stool alpha anti-trypsin and neutrophil oxidative burst were normal. Lymphocyte enumeration was persistently abnormal and mitogen stimulation shows reduced T-cell proliferation. HIV PCR was negative. Adenosine deaminase and purine nucleoside phosphorylase were normal. Toll-Like Receptor assay (TLR assay) showed absent toll like receptor 3 (TLR3) function but normal toll like receptor 1-8 (TLR1-8) function. Further evaluation confirmed a heterozygous L412F mutation of toll like receptor 3 (TLR3) and a heterozygous mutation in the DNA-binding domain of signal transducer and activator of transcription (STAT 1). Conclusion the combination of toll like receptor (TLR) and signal transducer and activator of transcription (STAT) gene mutations may produce a severe form of chronic mucocutaneous candidiasis (CMC). The patient was clinically stable until age 15 and both immunoglobulin replacement and bone marrow transplant (BMT) are treatment considerations. The outcome of events pneumonia and refractory pneumonia was unknown. The reporters assessment for the events pneumonia and refractory pneumonia with the PCV 23 (manufacturer unspecified) was unknown. Additional information has been requested.