chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Injection site erythema, Injection site swelling, Vomiting
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of throwing up in a 61-year-old female subject who was vaccinated with influenza vaccine unspecified (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included systemic lupus erythematosus. Co-suspect medication included BELIMUMAB solution at 120 mg every 28 days. The subject started BELIMUMAB on 30 July 2013 and her most recent infusion was 11 October 2013. On 11 October 2013 the subject received a dose of influenza vaccine unspecified (unknown, unknown arm) and an infusion of BELIMUMAB. In 12 October 2013, 1 day after vaccination with influenza vaccine unspecified and her most recent infusion of BELIMUMAB, the subject experienced throwing up, feeling weak, dizziness, injection site redness and injection site swollen. The subject reported that she received her BELIMUMAB infusion and influenza vaccine unspecified on 11 October 2013 and became "ill throwing up and feeling weak and dizzy all weekend". The subject stated that "the arm where she received the flu vaccine became bright red and swollen." At the time of reporting the outcome of the events was unspecified. Follow-up information received from the consumer (subject) on 04 November 2013. The subject reported that she never went to her physician for "this experience". She denied authorization to contact her physician.
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: Choking sensation, Chronic obstructive pulmonary disease, Drug ineffective, Emphysema, Fall
Clinical narrative: This case was reported by a consumer and described the occurrence of cough with brown phlegm in a male patient who received VENTOLIN hfa-cfc free inhaler for COPD with pulmonary emphysema. A physician or other health care professional has not verified this report. The patient's past medical history included heart attack, high blood pressure, hospitalization, lung disorder, lung pain, problem breathing, recurrent pneumonia, renal pain, rheumatoid arthritis and staphylococcal infection. Concurrent medical conditions included finger osteoarthritis and osteoarthritis of hip. Co-suspect medication included ADVAIR 250/50 mcg. Concurrent medications included lisinopril, prednisone, aspirin and ibuprofen. On 2009 the patient started salbutamol sulphate (inhaled) 2 puffs four times a day as needed and then was recently switched to at 2 puff(s) twice per day. At an unknown time after starting salbutamol sulphate, the patient experienced cough with brown phlegm described as "brown cottage cheese phlegm"), choking sensation, lack of efficacy, and possible dispensing error when he said the previous prescription was 1-2 puff every four hours as need and this inhaler said 2 puffs twice a day. At the time of reporting, the events were worse. The patient was a poor historian and could not remember dates. The patient reported that his most recent VENTOLIN inhaler has instructions to take 2 inhalations in the morning and at night, and that he believes that this was a pharmacy mistake. The patient was previously taking VENTOLIN 1-2 puffs every 4 hours as needed, and has continued to use VENTOLIN as needed. He said that he uses VENTOLIN when he was coughing so that he can cough up phlegm. He said if he takes VENTOLIN while he was not coughing he feels like he was choking . Additional information received in 18 October 2013 from the consumer (patient). Co-suspect medication included influenza vaccine unspecified. In September 2013, the currently 81-year-old male patient received the influenza vaccine unspecified (details unknown). Less than months later (in September 2013 or October 2013), the subject experienced runny nose. At the time of reporting, the runny nose was unresolved. No further detail was provided. Follow-up information was received on 19 December 2013 from the patient via a program. Treatment with fluticasone propionate+salmeterol xinafoate was started on 14 December 2011 for chronic obstructive pulmonary disease and emphysema. On an unknown date, the patient went to the hospital for a twisted foot and fell on his hip. The patient stated he had arthritis and it seemed to flare up. The patient stated he did not think it had anything to do with fluticasone propionate+salmeterol xinafoate or salbutamol sulphate. It was not reported whether the patient was hospitalized. The action taken with fluticasone propionate+salmeterol xinafoate and salbutamol sulphate was not provided. At the time of reporting, the outcome of foot twisted, fell on hip and arthritis flare was unknown.
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: Increased upper airway secretion, Ligament sprain, Productive cough, Rhinorrhoea
Clinical narrative: This case was reported by a consumer and described the occurrence of cough with brown phlegm in a male patient who received VENTOLIN hfa-cfc free inhaler for COPD with pulmonary emphysema. A physician or other health care professional has not verified this report. The patient's past medical history included heart attack, high blood pressure, hospitalization, lung disorder, lung pain, problem breathing, recurrent pneumonia, renal pain, rheumatoid arthritis and staphylococcal infection. Concurrent medical conditions included finger osteoarthritis and osteoarthritis of hip. Co-suspect medication included ADVAIR 250/50 mcg. Concurrent medications included lisinopril, prednisone, aspirin and ibuprofen. On 2009 the patient started salbutamol sulphate (inhaled) 2 puffs four times a day as needed and then was recently switched to at 2 puff(s) twice per day. At an unknown time after starting salbutamol sulphate, the patient experienced cough with brown phlegm described as "brown cottage cheese phlegm"), choking sensation, lack of efficacy, and possible dispensing error when he said the previous prescription was 1-2 puff every four hours as need and this inhaler said 2 puffs twice a day. At the time of reporting, the events were worse. The patient was a poor historian and could not remember dates. The patient reported that his most recent VENTOLIN inhaler has instructions to take 2 inhalations in the morning and at night, and that he believes that this was a pharmacy mistake. The patient was previously taking VENTOLIN 1-2 puffs every 4 hours as needed, and has continued to use VENTOLIN as needed. He said that he uses VENTOLIN when he was coughing so that he can cough up phlegm. He said if he takes VENTOLIN while he was not coughing he feels like he was choking . Additional information received in 18 October 2013 from the consumer (patient). Co-suspect medication included influenza vaccine unspecified. In September 2013, the currently 81-year-old male patient received the influenza vaccine unspecified (details unknown). Less than months later (in September 2013 or October 2013), the subject experienced runny nose. At the time of reporting, the runny nose was unresolved. No further detail was provided. Follow-up information was received on 19 December 2013 from the patient via a program. Treatment with fluticasone propionate+salmeterol xinafoate was started on 14 December 2011 for chronic obstructive pulmonary disease and emphysema. On an unknown date, the patient went to the hospital for a twisted foot and fell on his hip. The patient stated he had arthritis and it seemed to flare up. The patient stated he did not think it had anything to do with fluticasone propionate+salmeterol xinafoate or salbutamol sulphate. It was not reported whether the patient was hospitalized. The action taken with fluticasone propionate+salmeterol xinafoate and salbutamol sulphate was not provided. At the time of reporting, the outcome of foot twisted, fell on hip and arthritis flare was unknown.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Asthenia, Cardiac function test normal, Dizziness, Electrocardiogram ambulatory normal
Clinical narrative: This case was reported by a healthcare professional (subject and nurse) and described the occurrence of lip swelling in a 38-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medications included lisinopril, chlorothiazide, ZOLOFT and ADDERALL. On 27 September 2013 the subject received a dose of influenza vaccine unspecified (.5 ml, unknown route, right arm). On 30 September 2013, 3 days after vaccination with influenza vaccine unspecified, the subject experienced lip swelling, swelling of eyes, swelling of hands and feet, swelling of face. These symptoms occurred when she woke up on 30 September 2013. The subject sought medical care at an emergency room and was treated with BENADRYL and an unknown intravenous treatment. The subject did not stay in the emergency room overnight. On 10 October 2013, 13 days after vaccination with FLUARIX, the subject had a sudden onset of heart rate high, felt like about to pass out. The subject sought medical attention from the emergency room. "She had a 24 hour Holter monitor; she was monitored and all cardiac testing came back negative." On 12 October 2013, 15 days after vaccination with FLUARIX, the subject "woke up again with the same symptoms as of 10 October 2013 and she had to go again to the emergency room" and also experienced a feeling of doom (described as a "feeling of impending doom"). In 2013, within the same month of vaccination with FLUARIX, the subject also experienced feeling weak and feeling tired. At the time of reporting the outcome of the events of lip swelling, swelling of eyes, swelling of hands and feet, swelling of face, heart rate high, felt like about to pass out, and feeling of doom were resolved. The subject reported still feeling weak and tired at the time of reporting.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Fatigue, Heart rate increased, Lip swelling, Local swelling
Clinical narrative: This case was reported by a healthcare professional (subject and nurse) and described the occurrence of lip swelling in a 38-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medications included lisinopril, chlorothiazide, ZOLOFT and ADDERALL. On 27 September 2013 the subject received a dose of influenza vaccine unspecified (.5 ml, unknown route, right arm). On 30 September 2013, 3 days after vaccination with influenza vaccine unspecified, the subject experienced lip swelling, swelling of eyes, swelling of hands and feet, swelling of face. These symptoms occurred when she woke up on 30 September 2013. The subject sought medical care at an emergency room and was treated with BENADRYL and an unknown intravenous treatment. The subject did not stay in the emergency room overnight. On 10 October 2013, 13 days after vaccination with FLUARIX, the subject had a sudden onset of heart rate high, felt like about to pass out. The subject sought medical attention from the emergency room. "She had a 24 hour Holter monitor; she was monitored and all cardiac testing came back negative." On 12 October 2013, 15 days after vaccination with FLUARIX, the subject "woke up again with the same symptoms as of 10 October 2013 and she had to go again to the emergency room" and also experienced a feeling of doom (described as a "feeling of impending doom"). In 2013, within the same month of vaccination with FLUARIX, the subject also experienced feeling weak and feeling tired. At the time of reporting the outcome of the events of lip swelling, swelling of eyes, swelling of hands and feet, swelling of face, heart rate high, felt like about to pass out, and feeling of doom were resolved. The subject reported still feeling weak and tired at the time of reporting.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: This case was reported by a healthcare professional (subject and nurse) and described the occurrence of lip swelling in a 38-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medications included lisinopril, chlorothiazide, ZOLOFT and ADDERALL. On 27 September 2013 the subject received a dose of influenza vaccine unspecified (.5 ml, unknown route, right arm). On 30 September 2013, 3 days after vaccination with influenza vaccine unspecified, the subject experienced lip swelling, swelling of eyes, swelling of hands and feet, swelling of face. These symptoms occurred when she woke up on 30 September 2013. The subject sought medical care at an emergency room and was treated with BENADRYL and an unknown intravenous treatment. The subject did not stay in the emergency room overnight. On 10 October 2013, 13 days after vaccination with FLUARIX, the subject had a sudden onset of heart rate high, felt like about to pass out. The subject sought medical attention from the emergency room. "She had a 24 hour Holter monitor; she was monitored and all cardiac testing came back negative." On 12 October 2013, 15 days after vaccination with FLUARIX, the subject "woke up again with the same symptoms as of 10 October 2013 and she had to go again to the emergency room" and also experienced a feeling of doom (described as a "feeling of impending doom"). In 2013, within the same month of vaccination with FLUARIX, the subject also experienced feeling weak and feeling tired. At the time of reporting the outcome of the events of lip swelling, swelling of eyes, swelling of hands and feet, swelling of face, heart rate high, felt like about to pass out, and feeling of doom were resolved. The subject reported still feeling weak and tired at the time of reporting.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 23-JUL-2014 the patient was vaccinated with VAQTA (50/1.0 U/ML) (dose: 1.0 ml, route: intramuscular). Pertinent medical history and concomitant medications were not reported. The reporter stated that VAQTA was administered after being exposed to 48F for 30 minutes. No adverse effects reported. The outcome of the event was unknown. No further information reported. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Throat tightness
Clinical narrative: This case was reported by a physician and described the occurrence of throat tightness in a 54-year-old female subject who was vaccinated with influenza vaccine unspecified (manufacturer unspecified). On an unspecified date in 2009 the subject received a dose of influenza vaccine unspecified (details unknown). On an unspecified date in 2009, "a few hours" after vaccination with influenza vaccine unspecified, the subject experienced throat tightness. The subject went to the Emergency Room and received unspecified oral medications. At the time of reporting the event was resolved.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Extensive swelling of vaccinated limb, Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of extensive swelling of vaccinated limb in a 45-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 24 September 2013 the subject received 1st dose of FLUARIX (.5 ml, unknown route, right deltoid). On 24 September 2013, less than one day after vaccination with FLUARIX, the subject experienced extensive swelling of vaccinated limb, injection site redness, injection site pain and injection site warmth (described as fever on right arm). The nurse reported that the edema on the subject's right arm at the injection site was 4 inches by 3 inches in size (75 by 101.6 millimeters). The nurse reported that the injection site pain as "pain, achy." At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLUARIX. Follow-up information was received on 01 November 2013 via healthcare professional who reported the subject received FLUARIX via subcutaneous injection on 24 September 2013 and experienced an additional event of intramuscular formulation administered by other route. The healthcare professional did not attribute the events to medical history/ concurrent illness, lack of efficacy, erroneous administration or suspected transmission of an infectious agent via medicinal product, and considered the events not serious. On 1 October 2013, the extensive swelling of vaccinated limb, injection site redness, injection site pain and injection site warmth were resolved.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting, Weight decreased
Clinical narrative: This spontaneous report as received from a nurse via field employee refers to a 11 year old female patient. The reporter stated that a patient received her first dose of GARDASIL (0.5 ml, route unspecified) on 06-APR-2014 (also reported as date therapy started: 09-APR-2014) and had been experiencing vomiting since. The reporter also stated that the patient had lost 14 pounds due to the vomiting. The reporter also reported that the patient received her second dose of GARDASIL on 11-JUN-2014 and continues to experience vomiting after that dose, as well. The patient sought medical attention and visited office (details unspecified). The outcome of the events was reported as not recovered/not resolved. The causality was unknown. No further AE information provided. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Hypersomnia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of increased sleeping time in a 30-month-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 24 September 2013 the subject received 1st dose of FLUARIX (.5 ml, unknown details) and experienced inappropriate age at vaccine administration. The subject was younger than the indicated age for FLUARIX. On 24 September 2013, less than one day after vaccination with FLUARIX, the subject experienced increased sleeping time. Per the reporter, the subject "slept for 4 hours after the injection during naptime." The subject "usually only sleeps 1 hour during naptime." At the time of reporting the outcome of the event was unspecified. No additional details were provided by the pharmacist.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The reporter stated that the patient received his first dose of GARDASIL (0.5  ml, intramuscular (reported as IM) on 22-APR-2014, received his dose 2 of GARDASIL on 22-MAY-2014 and received dose 3 on 24-JUN-2014. Pertinent medical history and concomitant medications were not reported. No adverse effects reported. The outcome of the events was unknown. No further information was available. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Chronic obstructive pulmonary disease, Dyspnoea
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of difficulty breathing in a 66-year-old female subject who was vaccinated with influenza vaccine (unspecified) (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to formaldehyde. The subject experienced second-hand smoke exposure. Concurrent medications included trazodone and XANAX. In October 2010 the subject received a dose of influenza vaccine (unspecified) (unknown details, left arm). In October 2010, less than one day ("within 24 hours") after vaccination with influenza vaccine (unspecified), the subject experienced difficulty breathing. The subject was told the difficulty breathing "may have happened due to the vaccine having formaldehyde." In September 2012, the subject was diagnosed with chronic obstructive pulmonary disease. The subject "was not sure if this was related to the flu vaccine but she said it might be." At the time of reporting the event of difficulty breathing was resolved. Per the subject, the "difficulty breathing only lasted for less than one day." The subject reported that chronic obstructive pulmonary disorder were unresolved. The subject did consult a healthcare professional regarding the event(s); however, she reported that medical attention was not required. The subject reported 2 other cases with influenza vaccine (unspecified). See cases A1044321A and A1044322A for details on the other cases.
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient on unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (subcutaneously, dose was not reported, Lot # and expiration date were not provided). On the following day (date unspecified) the patient experienced diarrhoea and vomiting. The outcome of vomiting and diarrhoea was reported as recovered/resolved (date unspecified). The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: FLUX
Symptoms: Condition aggravated, Dyspnoea
Clinical narrative: This case was reported by a consumer (daughter of subject) and described the occurrence of shortness of breath in a female subject of unspecified age who was vaccinated with influenza vaccine (unspecified) (manufacturer unspecified). A physician or other health care professional has not verified this report. Medical conditions included "pre-existing" shortness of breath. The reporter stated that the subject was a "heart patient with pre-existing shortness of breath." In 2010 the subject received a dose of influenza vaccine (unspecified) (unknown details). In 2010, at an unspecified time after vaccination with influenza vaccine (unspecified), the subject experienced shortness of breath. The reporter mentioned that her mother "received a flu vaccine in 2010 and felt short of breath after the shot." No other details were mentioned. At the time of reporting the outcome of the event was unspecified. The subject reported 2 other cases with influenza vaccine (unspecified). See cases A1044320A and A1044322A for details on the other cases.
Sex: M
Vaccine: FLUX
Symptoms: Condition aggravated, Fatigue, Influenza like illness
Clinical narrative: This case was reported by a consumer (subject's wife) and described the occurrence of flu-like feeling in a male subject of unspecified age who was vaccinated with influenza vaccine (unspecified), (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included feeling drained and flu-like feeling. The reporter stated that the subject's flu-like feeling and feeling drained were pre-existing; however, this was not clear from the report. In 2010 the subject received a dose of influenza vaccine (unspecified) (unknown details). In 2010, at an unspecified time after vaccination with influenza vaccine (unspecified), the subject experienced flu-like feeling and feeling drained. At the time of reporting the outcome of the events were unspecified. The subject reported 2 other cases with influenza vaccine (unspecified). See cases A1044320A and A1044321A for details on the other cases.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Allergy to vaccine, Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza in a 58-year-old female subject who was vaccinated with influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date, "about 20 years ago", the subject received a dose of influenza vaccine (details unknown). Less than a year after vaccination with influenza vaccine "about 20 years ago", the subject experienced influenza, possible allergy and vaccination failure. The subject stated that she "got severe flu after getting a flu shot about 20 years ago." According to the subject, her physician stated she "must be allergic to the base of the flu", but did not specifically say she has an allergy to egg. The subject did not recall the name of the flu vaccine. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Age: 1.06
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: Information has been received from the healthcare worker who reported that on 23-APR-2014, a 12 month old patient of unspecified gender was vaccinated with a single dose (was exposed to 47 F for 4 hours) reported as 0.5 (units not provided) of M-M-R II/(lot # J003790, expiration date: 28-MAR-2015) (dose number and route were not provided). The is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: This case was reported by a pharmacist and described the occurrence of influenza in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In 2013, "over the last 30 days," the subjects received a dose of FLUARIX (unknown details). In 2013, "over the last 30 days," less than one month after vaccination with FLUARIX, the subjects experienced influenza. The pharmacist reported that "several" subjects "who were vaccinated with FLUARIX over the last 30 days (different days) came down with flu." At the time of reporting the outcome of the event was unspecified.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Injection site discolouration, Injection site pain, Injection site pruritus, Laboratory test normal
Clinical narrative: This prospective pregnancy case was reported by a consumer (subject) and described the occurrence of injection site pain in a 41-year-old female subject who was vaccinated with FLUARIX quadrivalent (GlaxoSmithKline) during pregnancy. A physician or other health care professional has not verified this report. The subject had no previous pregnancies. The subject was not using contraception and the conception was normal. There was no evidence of defect from prenatal testing. There was no maternal and paternal history which may have an impact on the outcome of this pregnancy. On 16 September 2013 the subject received a dose of FLUARIX quadrivalent (.5 ml, unknown route, left arm) and experienced vaccine exposure during pregnancy the 3rd trimester of pregnancy. The gestational age at the time of vaccination was calculated to be 36 weeks. The date of last menstrual period was not reported. The estimated date of delivery was reported as 10 October 2013 per the subject. At the time of reporting, the pregnancy was ongoing. On 16 September 2013, less than one day after vaccination with FLUARIX quadrivalent, the subject experienced injection site pain. On 23 September 2013, 7 days after vaccination with FLUARIX quadrivalent, the subject experienced injection site discoloration (described as "a ring formed around injection site and was discolored") and injection site pruritus (described as "the ring and discoloration were associated with itching"). It was unclear from the report whether the ring formed on 23 September 2013 or 27 September 2013. At the time of reporting the event of injection site pain was resolved. At the time of reporting, the events of injection site discoloration and injection site pruritus were unresolved per the reporter. 31 January 2014 - No further information was provided; patient lost to follow-up.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Prenatal screening test
Clinical narrative: This prospective pregnancy case was reported by a consumer (subject) and described the occurrence of injection site pain in a 41-year-old female subject who was vaccinated with FLUARIX quadrivalent (GlaxoSmithKline) during pregnancy. A physician or other health care professional has not verified this report. The subject had no previous pregnancies. The subject was not using contraception and the conception was normal. There was no evidence of defect from prenatal testing. There was no maternal and paternal history which may have an impact on the outcome of this pregnancy. On 16 September 2013 the subject received a dose of FLUARIX quadrivalent (.5 ml, unknown route, left arm) and experienced vaccine exposure during pregnancy the 3rd trimester of pregnancy. The gestational age at the time of vaccination was calculated to be 36 weeks. The date of last menstrual period was not reported. The estimated date of delivery was reported as 10 October 2013 per the subject. At the time of reporting, the pregnancy was ongoing. On 16 September 2013, less than one day after vaccination with FLUARIX quadrivalent, the subject experienced injection site pain. On 23 September 2013, 7 days after vaccination with FLUARIX quadrivalent, the subject experienced injection site discoloration (described as "a ring formed around injection site and was discolored") and injection site pruritus (described as "the ring and discoloration were associated with itching"). It was unclear from the report whether the ring formed on 23 September 2013 or 27 September 2013. At the time of reporting the event of injection site pain was resolved. At the time of reporting, the events of injection site discoloration and injection site pruritus were unresolved per the reporter. 31 January 2014 - No further information was provided; patient lost to follow-up.
Age: 1.05
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: Information has been received from the healthcare worker who reported that on 21-APR-2014, a 12 month old patient of unspecified gender was vaccinated with a single dose (was exposed to 47 F for 4 hours) reported as 0.5 (units not provided) of M-M-R II (lot # J003790, expiration date: 28-MAR-2015) (dose number and route were not provided). The case is one of several reports received from the same reporter. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Ill-defined disorder, Injection site pain, Injection site warmth, Local swelling
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of swelling of arm at vaccination site in a 49-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 25 September 2013 the subject received a dose of FLUARIX (.5 ml, injection, unknown details). On the morning of 27 September 2013, 2 days after vaccination with FLUARIX, the subject experienced swelling of arm at vaccination site, injection site pain and injection site warmth. In 2013, within a week of vaccination with FLUARIX, the subject experienced ill defined disorder. The nurse reported that the subject woke up 2 days after the vaccination and found her hand and part of her arm swollen (swelling of arm at vaccination site). The nurse reported that the subject's "wrist hurt" (injection site pain) and "she could feel a knot there" (swelling of arm at vaccination site). There was some warmness at the injection site but "most of the symptoms were in lower arm." The subject sought medical attention from her chiropractor because "she felt something might be out of alignment but she felt it was caused by the vaccination" (ill defined disorder). At the time of reporting the events were improved. Per the nurse, the subject's symptoms were improving but her hand was still swollen and she could still feel the lump in her wrist. The healthcare professional considered the events were probably related to vaccination with FLUARIX.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Nodule, Vaccination site swelling
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of swelling of arm at vaccination site in a 49-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 25 September 2013 the subject received a dose of FLUARIX (.5 ml, injection, unknown details). On the morning of 27 September 2013, 2 days after vaccination with FLUARIX, the subject experienced swelling of arm at vaccination site, injection site pain and injection site warmth. In 2013, within a week of vaccination with FLUARIX, the subject experienced ill defined disorder. The nurse reported that the subject woke up 2 days after the vaccination and found her hand and part of her arm swollen (swelling of arm at vaccination site). The nurse reported that the subject's "wrist hurt" (injection site pain) and "she could feel a knot there" (swelling of arm at vaccination site). There was some warmness at the injection site but "most of the symptoms were in lower arm." The subject sought medical attention from her chiropractor because "she felt something might be out of alignment but she felt it was caused by the vaccination" (ill defined disorder). At the time of reporting the events were improved. Per the nurse, the subject's symptoms were improving but her hand was still swollen and she could still feel the lump in her wrist. The healthcare professional considered the events were probably related to vaccination with FLUARIX.
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of hives on arm and leg in a child female subject who was vaccinated with FLUARIX (GlaxoSmithKline). In 2013, the subject received 1st dose of FLUARIX (unknown details). In 2013, within months of vaccination with FLUARIX, the subject experienced hives on arm and leg and rash arms legs. The reporter documented that the subject experienced "hives and rashes on arms and legs bilaterally." The nurse documented that the immunization series was discontinued. At the time of reporting the outcome of the events were unspecified.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Pain in extremity, Wheezing
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 15 year old female patient with exercise induced asthma. On 13-JUN-2014 the patient was vaccinated with a dose of GARDASIL (dose, route, lot number not reported) in the right arm. Other suspect therapy included Hepatitis A vaccine, inactivated (manufacturer unknown) (dose, route, lot number not reported), vaccinated also in the right arm on 13-JUN-2014. It was reported that the patient experienced severe arm pain after receiving a dose of GARDASIL in her right arm (on 13-JUN-2014). The pain started as soreness on the day of the injection (on 13-JUN-2014), but 44 hours after the immunization, the pain became severe. It was also stated that the patient experienced some "slight wheezing" (on 13-JUN-2014) which the reporter did not believe was related to GARDASIL. There was no lab diagnostic studies performed. Treatment of the events included ibuprofen. Outcomes of the events were reported as recovered on 17-JUN-2014. The patient sought medical attention by a phone call to an office. There was no hospitalization or prolonged reported. The relatedness between the severe arm pain and GARDASIL and Hepatitis A vaccine, inactivated (manufacturer unknown) was not reported. The relatedness between "slight wheezing" and Hepatitis A vaccine, inactivated (manufacturer unknown) was not reported. Additional information has been requested.
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 a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX (unknown season) (unknown details). At an unspecified time after vaccination with FLUARIX (unknown season), the subject experienced injection site redness. The healthcare professional refused to provide details because "they did not want to have to report twice." At the time of reporting the outcome of the event was unspecified.
Age: 1.02
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: Information has been received form the healthcare worker who reported that on 16-APR-2014, a 12 month old patient of unspecified gender was vaccinated with a single dose (was exposed to 47 D for 4 hours) reported as 0,5 (units not provided) of M-M-R II (HSA) (lot # J003790, expiration date: 28-MAR-2015) (dose number and route were not provided). The case is one of several reports received from the same reporter.  Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Heart rate increased, Palpitations, Photophobia
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of rapid heart rate in a 37-year-old female subject who was vaccinated with FLUARIX (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included reflux (nos). Concurrent medications included NEXIUM. On 8 October 2013 at 08:45 the subject received 1st dose of influenza vaccine unspecified (unknown details). On 8 October 2013, "within 5 minutes" after vaccination with influenza vaccine unspecified, the subject experienced rapid heart rate, heart palpitation, and dizziness. On 8 October 2013, 6 hours after vaccination with influenza vaccine unspecified, the subject experienced photophobia. At the time of reporting the event of heart palpitations was unresolved. At the time of reporting, the events of rapid heart rate, dizziness and photophobia had resolved.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of sore arm (injection site) in a 63-year-old female subject who was vaccinated with influenza vaccine unspecified (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included acid reflux, diabetes, high blood pressure and high cholesterol. Concurrent medications included metoprolol, triamterene + hydrochlorothiazide, aspirin, amlodipine, pravastatin, pantoprazole and insulin. On 8 October 2013 at 15:30 the subject received 1st dose of influenza vaccine unspecified (unknown details, right arm). On 9 October 2013, 1 day after vaccination with influenza vaccine unspecified, the subject experienced sore arm (injection site). The subject sought medication attention at her doctor's office. The subject planned to "continue follow up with her physician on an unknown date." At the time of reporting the event was unresolved.
Age: 1.06
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: Information has been received from the healthcare worker who reported that on 07-MAY-2014, a 12 month old patient of unspecified gender was vaccinated with a single dose (was exposed to 47 F for 4 hours) reported as 0.5 (units not provided) of M-M-R II (lot # J003790, expiration date: 28-MAR-2015) (dose number and route were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of joint pain all over body in a 50-year-old male subject who was vaccinated with influenza vaccine unspecified (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included anxiety. Concurrent medications included XANAX. On 9 October 2013 at 18:30 the subject received 1st dose of influenza vaccine unspecified (unknown details). On 10 October 2013, less than one day after vaccination with influenza vaccine unspecified, described as "mid-day", the subject experienced joint pain all over body. The subject reported that he "began aching in every joint in his body." At the time of reporting the event was unresolved.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Pruritus, Rash erythematous, Rash vesicular
Clinical narrative: 2x3in red rash with 6-8 white "chicken pox" like spots. Rash last 5 days with intense itchiness.
Age: 18.0
Sex: F
Vaccine: MNQ, TYP
Symptoms: Dizziness, Loss of consciousness, Muscle rigidity, Pallor, Seizure like phenomena
Clinical narrative: Patient received two vaccines.  She was at the front discussing billing after she received them and felt dizzy.  She was brought a wheelchair to sit in and given a glass of water.  After this she became very pale, lost consciousness, had seizure like activity (shaking, muscle rigidity and loss of bladder control).  This lasted for about 30 seconds, then she was very drowsy.  Emergency Medical Services were called.
Age: 18.0
Sex: F
Vaccine: MNQ, TYP
Symptoms: Somnolence, Tremor, Urinary incontinence
Clinical narrative: Patient received two vaccines.  She was at the front discussing billing after she received them and felt dizzy.  She was brought a wheelchair to sit in and given a glass of water.  After this she became very pale, lost consciousness, had seizure like activity (shaking, muscle rigidity and loss of bladder control).  This lasted for about 30 seconds, then she was very drowsy.  Emergency Medical Services were called.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Pallor, Presyncope, Pyrexia, Rash generalised
Clinical narrative: Tightness in throat, pale appearing, near-syncope sensation then development of generalized rash. Also low grade fever and headache.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Throat tightness
Clinical narrative: Tightness in throat, pale appearing, near-syncope sensation then development of generalized rash. Also low grade fever and headache.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, PNC13
Symptoms: Abasia, Abnormal behaviour, Decreased appetite, Dysarthria, Dysstasia
Clinical narrative: 7:00 PM began low appetite and fussiness, expression of soreness and fatigue; woke at 6:00 AM 06/26/2014 with soreness, and by 8:00 AM was resistant to walking; by 1:00 PM stated she was unable to walk, and urinated self while unable to hold it or maneuver to toilet; 4:00 PM arrived ER (on instruction of on-call physician), and exhibited palsy-like loss of control over body from waist-down; unable to take even a step, even with support (but was able to stand with assistance); hip x-rays clear but was admitted for observation around 7:00 PM due in part to family history of vaccine reactions/proximity of home to hospital; treated with ibuprofen, fever all sub-100, "loopy" and slurred speech; discharged from hospital able to take a few shaky steps at a time, but without full muscle control.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, PNC13
Symptoms: Fatigue, Gait disturbance, Irritability, Laboratory test normal, Pain
Clinical narrative: 7:00 PM began low appetite and fussiness, expression of soreness and fatigue; woke at 6:00 AM 06/26/2014 with soreness, and by 8:00 AM was resistant to walking; by 1:00 PM stated she was unable to walk, and urinated self while unable to hold it or maneuver to toilet; 4:00 PM arrived ER (on instruction of on-call physician), and exhibited palsy-like loss of control over body from waist-down; unable to take even a step, even with support (but was able to stand with assistance); hip x-rays clear but was admitted for observation around 7:00 PM due in part to family history of vaccine reactions/proximity of home to hospital; treated with ibuprofen, fever all sub-100, "loopy" and slurred speech; discharged from hospital able to take a few shaky steps at a time, but without full muscle control.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, PNC13
Symptoms: Paralysis, Pyrexia, Tremor, Urinary incontinence, White blood cell count normal
Clinical narrative: 7:00 PM began low appetite and fussiness, expression of soreness and fatigue; woke at 6:00 AM 06/26/2014 with soreness, and by 8:00 AM was resistant to walking; by 1:00 PM stated she was unable to walk, and urinated self while unable to hold it or maneuver to toilet; 4:00 PM arrived ER (on instruction of on-call physician), and exhibited palsy-like loss of control over body from waist-down; unable to take even a step, even with support (but was able to stand with assistance); hip x-rays clear but was admitted for observation around 7:00 PM due in part to family history of vaccine reactions/proximity of home to hospital; treated with ibuprofen, fever all sub-100, "loopy" and slurred speech; discharged from hospital able to take a few shaky steps at a time, but without full muscle control.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, PNC13
Symptoms: X-ray of pelvis and hip normal
Clinical narrative: 7:00 PM began low appetite and fussiness, expression of soreness and fatigue; woke at 6:00 AM 06/26/2014 with soreness, and by 8:00 AM was resistant to walking; by 1:00 PM stated she was unable to walk, and urinated self while unable to hold it or maneuver to toilet; 4:00 PM arrived ER (on instruction of on-call physician), and exhibited palsy-like loss of control over body from waist-down; unable to take even a step, even with support (but was able to stand with assistance); hip x-rays clear but was admitted for observation around 7:00 PM due in part to family history of vaccine reactions/proximity of home to hospital; treated with ibuprofen, fever all sub-100, "loopy" and slurred speech; discharged from hospital able to take a few shaky steps at a time, but without full muscle control.
Age: 1.04
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: Information has been received from the healthcare worker who reported that on 05-MAY-2014, the a 12 month old patient of unspecified gender was vaccinated with a single dose (was exposed to 47 F for 4 hours) reported as 0,5 (units not provided) of MMR II (lot # J003790, expiration date: 28-MAR-2015) (dose number and route were not provided). The case is one of several reports received from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Baseball size knot has appeared at the injection site.  Knot is red in appearance.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: PATIENT FELT DIZZY AND LOSS CONSCIOUSNESS FOR A SECOND THEN REGAIN CONSCIOUSNESS.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unknown number of patient of unknown age and gender. On an unknown date unknown number of patients were vaccinated with unspecified number of improperly stored doses of GARDASIL (dose, route, lot # not reported). GARDASIL was exposed to a low temperature of 0 C, this excursion was supported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unknown number of patients of unknown age and gender. On an unknown date unknown number of patients were vaccinated with unspecified number of improperly stored doses of (Oka/Merck) VARIVAX 0,5 ml subcutaneous (lot # not reported). VARIVAX (Oka/Merck) was exposed to temperature as high as -8.2 C. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Local reaction
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a patient of unknown age with no pertinent medical history. On an unknown date the patient was vaccinated with VAQTA (0.5ml/1 shot, frequency, lot # and expiration date were unknown) intramuscular. On an unknown date the patient developed a local reaction after receiving VAQTA. The patient sought unspecified medical attention. No lab diagnostics studies were performed. The outcome of the event was unknown. Additional information has been requested.