chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cerebral haemorrhage, Exercise tolerance decreased, Fatigue, Headache, Injection site erythema
Clinical narrative: This spontaneous report as received via a letter from a 87 year old female consumer refers to herself. Patient's concurrent conditions included: abnormal blood pressure and underactive thyroid. On 29-APR-2013 the patient was vaccinated with ZOSTAVAX (dose, route and lot number not reporter). Concomitant therapies included levothyroxine, ramipril, diltiazem, aspirin, caltrate 400-D and calcium and vitamin D. The patient reported that on 30-APR-2013 she found her arm had an area approximately 3-inch wide and 1-inch deep (also reported as 1.5 inch deep) at the injection side. She added that the area was warm, had a reddish hue, had a rash and she pain and sensitivity at this place. On 02-MAY-2013 the patient visited the clinic and was seen by the physician who told her that the injection site was infected. The patient was prescribed hydrocortisone cream to help the infection. In 2013 (also reported as by this time) the patient experienced a pain deep in her legs and the back of head on the left side, she stated that it was extremely painful and she tried to treat it by walking (the movement relieved the situation but only during the time she was walking). On 15-MAY-2013 the patient visited another physician who thought the patient might have restless legs. The patient was given instructions and information to help restless legs. The physician also performed lab diagnostics studies on 15-MAY-2013: blood work, iron binding capacity unsaturated (UIBC), iron binding capacity total (TIBC), %sat, magnesium, vitamin B12, folate and the tests came back fine. On 31-MAY-2013 the patient discussed the lab diagnostic test results with the first physician and she was prescribed doxycycline as a cautionary measure for a tick fever that patient might have. On an unspecified date, in approximately May 2013 the patient became extremely nauseous, she had dry heaves up until noon, every time she drank water or tried to eat. She complained that could no longer performed her exercises because it was exhausting and painful. In July 2013 the patient experienced a brain bleed and she lost her vision and then it came back. She reported that she had also atrial fibrillation (started on an unspecified date) in which her heart goes in and out off. The patient reported that at the time of the letter the injection site was slowly diminishing, the redness was pale and area was smaller. It was also no longer painful when rubbed. The patient's outcome was not reported. The reporter considered restless legs, retching, injection site infection, nausea, injection site pain, injection site warmth, injection site redness, injection site rash, fatigue and pain to be related to the therapy with ZOSTAVAX. Upon internal review brain bleed was considered to be medically significant. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site hypersensitivity, Injection site infection, Injection site pain, Injection site rash, Injection site reaction
Clinical narrative: This spontaneous report as received via a letter from a 87 year old female consumer refers to herself. Patient's concurrent conditions included: abnormal blood pressure and underactive thyroid. On 29-APR-2013 the patient was vaccinated with ZOSTAVAX (dose, route and lot number not reporter). Concomitant therapies included levothyroxine, ramipril, diltiazem, aspirin, caltrate 400-D and calcium and vitamin D. The patient reported that on 30-APR-2013 she found her arm had an area approximately 3-inch wide and 1-inch deep (also reported as 1.5 inch deep) at the injection side. She added that the area was warm, had a reddish hue, had a rash and she pain and sensitivity at this place. On 02-MAY-2013 the patient visited the clinic and was seen by the physician who told her that the injection site was infected. The patient was prescribed hydrocortisone cream to help the infection. In 2013 (also reported as by this time) the patient experienced a pain deep in her legs and the back of head on the left side, she stated that it was extremely painful and she tried to treat it by walking (the movement relieved the situation but only during the time she was walking). On 15-MAY-2013 the patient visited another physician who thought the patient might have restless legs. The patient was given instructions and information to help restless legs. The physician also performed lab diagnostics studies on 15-MAY-2013: blood work, iron binding capacity unsaturated (UIBC), iron binding capacity total (TIBC), %sat, magnesium, vitamin B12, folate and the tests came back fine. On 31-MAY-2013 the patient discussed the lab diagnostic test results with the first physician and she was prescribed doxycycline as a cautionary measure for a tick fever that patient might have. On an unspecified date, in approximately May 2013 the patient became extremely nauseous, she had dry heaves up until noon, every time she drank water or tried to eat. She complained that could no longer performed her exercises because it was exhausting and painful. In July 2013 the patient experienced a brain bleed and she lost her vision and then it came back. She reported that she had also atrial fibrillation (started on an unspecified date) in which her heart goes in and out off. The patient reported that at the time of the letter the injection site was slowly diminishing, the redness was pale and area was smaller. It was also no longer painful when rubbed. The patient's outcome was not reported. The reporter considered restless legs, retching, injection site infection, nausea, injection site pain, injection site warmth, injection site redness, injection site rash, fatigue and pain to be related to the therapy with ZOSTAVAX. Upon internal review brain bleed was considered to be medically significant. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Iron binding capacity total normal, Iron binding capacity unsaturated, Nausea, Pain in extremity
Clinical narrative: This spontaneous report as received via a letter from a 87 year old female consumer refers to herself. Patient's concurrent conditions included: abnormal blood pressure and underactive thyroid. On 29-APR-2013 the patient was vaccinated with ZOSTAVAX (dose, route and lot number not reporter). Concomitant therapies included levothyroxine, ramipril, diltiazem, aspirin, caltrate 400-D and calcium and vitamin D. The patient reported that on 30-APR-2013 she found her arm had an area approximately 3-inch wide and 1-inch deep (also reported as 1.5 inch deep) at the injection side. She added that the area was warm, had a reddish hue, had a rash and she pain and sensitivity at this place. On 02-MAY-2013 the patient visited the clinic and was seen by the physician who told her that the injection site was infected. The patient was prescribed hydrocortisone cream to help the infection. In 2013 (also reported as by this time) the patient experienced a pain deep in her legs and the back of head on the left side, she stated that it was extremely painful and she tried to treat it by walking (the movement relieved the situation but only during the time she was walking). On 15-MAY-2013 the patient visited another physician who thought the patient might have restless legs. The patient was given instructions and information to help restless legs. The physician also performed lab diagnostics studies on 15-MAY-2013: blood work, iron binding capacity unsaturated (UIBC), iron binding capacity total (TIBC), %sat, magnesium, vitamin B12, folate and the tests came back fine. On 31-MAY-2013 the patient discussed the lab diagnostic test results with the first physician and she was prescribed doxycycline as a cautionary measure for a tick fever that patient might have. On an unspecified date, in approximately May 2013 the patient became extremely nauseous, she had dry heaves up until noon, every time she drank water or tried to eat. She complained that could no longer performed her exercises because it was exhausting and painful. In July 2013 the patient experienced a brain bleed and she lost her vision and then it came back. She reported that she had also atrial fibrillation (started on an unspecified date) in which her heart goes in and out off. The patient reported that at the time of the letter the injection site was slowly diminishing, the redness was pale and area was smaller. It was also no longer painful when rubbed. The patient's outcome was not reported. The reporter considered restless legs, retching, injection site infection, nausea, injection site pain, injection site warmth, injection site redness, injection site rash, fatigue and pain to be related to the therapy with ZOSTAVAX. Upon internal review brain bleed was considered to be medically significant. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Restless legs syndrome, Retching, Vitamin B12 normal
Clinical narrative: This spontaneous report as received via a letter from a 87 year old female consumer refers to herself. Patient's concurrent conditions included: abnormal blood pressure and underactive thyroid. On 29-APR-2013 the patient was vaccinated with ZOSTAVAX (dose, route and lot number not reporter). Concomitant therapies included levothyroxine, ramipril, diltiazem, aspirin, caltrate 400-D and calcium and vitamin D. The patient reported that on 30-APR-2013 she found her arm had an area approximately 3-inch wide and 1-inch deep (also reported as 1.5 inch deep) at the injection side. She added that the area was warm, had a reddish hue, had a rash and she pain and sensitivity at this place. On 02-MAY-2013 the patient visited the clinic and was seen by the physician who told her that the injection site was infected. The patient was prescribed hydrocortisone cream to help the infection. In 2013 (also reported as by this time) the patient experienced a pain deep in her legs and the back of head on the left side, she stated that it was extremely painful and she tried to treat it by walking (the movement relieved the situation but only during the time she was walking). On 15-MAY-2013 the patient visited another physician who thought the patient might have restless legs. The patient was given instructions and information to help restless legs. The physician also performed lab diagnostics studies on 15-MAY-2013: blood work, iron binding capacity unsaturated (UIBC), iron binding capacity total (TIBC), %sat, magnesium, vitamin B12, folate and the tests came back fine. On 31-MAY-2013 the patient discussed the lab diagnostic test results with the first physician and she was prescribed doxycycline as a cautionary measure for a tick fever that patient might have. On an unspecified date, in approximately May 2013 the patient became extremely nauseous, she had dry heaves up until noon, every time she drank water or tried to eat. She complained that could no longer performed her exercises because it was exhausting and painful. In July 2013 the patient experienced a brain bleed and she lost her vision and then it came back. She reported that she had also atrial fibrillation (started on an unspecified date) in which her heart goes in and out off. The patient reported that at the time of the letter the injection site was slowly diminishing, the redness was pale and area was smaller. It was also no longer painful when rubbed. The patient's outcome was not reported. The reporter considered restless legs, retching, injection site infection, nausea, injection site pain, injection site warmth, injection site redness, injection site rash, fatigue and pain to be related to the therapy with ZOSTAVAX. Upon internal review brain bleed was considered to be medically significant. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site cellulitis, Myalgia
Clinical narrative: This spontaneous report as received from a nurse refers to a 46 year old female patient. The patient's history condition included got hives when she take Penicillin and had an anaphylactic reaction when she takes RELAFEN. On 10-JUN-2013 the patient was vaccinated with VARIVAX (Merck) (lot # H018796, expiration date 2s4-OCT-2014) Once, 0.5 ml, subcutaneously. There was no concomitant therapy. On 12-JUN-2013, the patient experienced cellulitis at the injection site and myalgia. The patient sought medical attention by seeing an unspecified physician in the office on 13-JUN-2013 and the physician prescribed sulfamethoxazole, BACTRIM and MOTRIN. No lab test was done. At the time of the report, the events outcome was not recovered. This is one of several reports received from the same source (1306USA006664 and 1306USA007540). Additional information is not expected.
Age: 46.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Asthenia, Back pain, Dysphagia, Dyspnoea, Guillain-Barre syndrome
Clinical narrative: Pt is a 46 y.o. female who was admitted to the hospital, on 12/20/12 with complaints of back pain, neck pain, generalized weakness, and numbness of her hands and feet. She additional reported mild difficulty swallowing and some shortness of breath. She had received the influenza vaccine approximately one week prior to the onset of symptoms -which was approximately 4 days prior to this admission-. Unable to determine where influenza vaccination occurred. She had recently been seen in clinic and received prescriptions for acetaminophen with codeine and cyclobenzaprine for her back pain. She was also taking ibuprofen prn. Her muscle weakness progressed and she was seen by neurology who diagnosed her with Guillain Barre Syndrome. She received IVIG 0.4 g/kg iv daily x 5 days. She went into respiratory failure and required mechanical ventilation and eventually tracheostomy. A second 3 day course of IVIG was administered. She had a long hospital course with pneumonia and metabolic encephalopathy/delirium/hallucinations thought to be due to medications. She gradually showed some slight improvement in muscle strength. She was transferred to a long term acute care facility on 1/15/13 to continue with rehabilitation. -Submitted to VAERS 7/2/13-.
Age: 46.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Hypoaesthesia, Mechanical ventilation, Neck pain, Respiratory failure, Tracheostomy
Clinical narrative: Pt is a 46 y.o. female who was admitted to the hospital, on 12/20/12 with complaints of back pain, neck pain, generalized weakness, and numbness of her hands and feet. She additional reported mild difficulty swallowing and some shortness of breath. She had received the influenza vaccine approximately one week prior to the onset of symptoms -which was approximately 4 days prior to this admission-. Unable to determine where influenza vaccination occurred. She had recently been seen in clinic and received prescriptions for acetaminophen with codeine and cyclobenzaprine for her back pain. She was also taking ibuprofen prn. Her muscle weakness progressed and she was seen by neurology who diagnosed her with Guillain Barre Syndrome. She received IVIG 0.4 g/kg iv daily x 5 days. She went into respiratory failure and required mechanical ventilation and eventually tracheostomy. A second 3 day course of IVIG was administered. She had a long hospital course with pneumonia and metabolic encephalopathy/delirium/hallucinations thought to be due to medications. She gradually showed some slight improvement in muscle strength. She was transferred to a long term acute care facility on 1/15/13 to continue with rehabilitation. -Submitted to VAERS 7/2/13-.
Age: 46.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Asthenia, Back pain, Delirium, Dysphagia, Dyspnoea
Clinical narrative: Pt is a 46 y.o. female who was admitted to the hospital, on 12/20/12 with complaints of back pain, neck pain, generalized weakness, and numbness of her hands and feet. She additional reported mild difficulty swallowing and some shortness of breath. She had received the influenza vaccine approximately one week prior to the onset of symptoms -which was approximately 4 days prior to this admission-. Unable to determine where influenza vaccination occurred. She had recently been seen in clinic and received prescriptions for acetaminophen with codeine and cyclobenzaprine for her back pain. She was also taking ibuprofen prn. Her muscle weakness progressed and she was seen by neurology who diagnosed her with Guillain Barre Syndrome. She received IVIG 0.4 g/kg iv daily x 5 days. She went into respiratory failure and required mechanical ventilation and eventually tracheostomy. A second 3 day course of IVIG was administered. She had a long hospital course with pneumonia and metabolic encephalopathy/delirium/hallucinations thought to be due to medications. She gradually showed some slight improvement in muscle strength. She was transferred to a long term acute care facility on 1/15/13 to continue with rehabilitation. -Submitted to VAERS 7/2/13-.
Age: 46.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Guillain-Barre syndrome, Hallucination, Hypoaesthesia, Immunoglobulin therapy, Mechanical ventilation
Clinical narrative: Pt is a 46 y.o. female who was admitted to the hospital, on 12/20/12 with complaints of back pain, neck pain, generalized weakness, and numbness of her hands and feet. She additional reported mild difficulty swallowing and some shortness of breath. She had received the influenza vaccine approximately one week prior to the onset of symptoms -which was approximately 4 days prior to this admission-. Unable to determine where influenza vaccination occurred. She had recently been seen in clinic and received prescriptions for acetaminophen with codeine and cyclobenzaprine for her back pain. She was also taking ibuprofen prn. Her muscle weakness progressed and she was seen by neurology who diagnosed her with Guillain Barre Syndrome. She received IVIG 0.4 g/kg iv daily x 5 days. She went into respiratory failure and required mechanical ventilation and eventually tracheostomy. A second 3 day course of IVIG was administered. She had a long hospital course with pneumonia and metabolic encephalopathy/delirium/hallucinations thought to be due to medications. She gradually showed some slight improvement in muscle strength. She was transferred to a long term acute care facility on 1/15/13 to continue with rehabilitation. -Submitted to VAERS 7/2/13-.
Age: 46.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Metabolic encephalopathy, Muscular weakness, Neck pain, Pneumonia, Respiratory failure
Clinical narrative: Pt is a 46 y.o. female who was admitted to the hospital, on 12/20/12 with complaints of back pain, neck pain, generalized weakness, and numbness of her hands and feet. She additional reported mild difficulty swallowing and some shortness of breath. She had received the influenza vaccine approximately one week prior to the onset of symptoms -which was approximately 4 days prior to this admission-. Unable to determine where influenza vaccination occurred. She had recently been seen in clinic and received prescriptions for acetaminophen with codeine and cyclobenzaprine for her back pain. She was also taking ibuprofen prn. Her muscle weakness progressed and she was seen by neurology who diagnosed her with Guillain Barre Syndrome. She received IVIG 0.4 g/kg iv daily x 5 days. She went into respiratory failure and required mechanical ventilation and eventually tracheostomy. A second 3 day course of IVIG was administered. She had a long hospital course with pneumonia and metabolic encephalopathy/delirium/hallucinations thought to be due to medications. She gradually showed some slight improvement in muscle strength. She was transferred to a long term acute care facility on 1/15/13 to continue with rehabilitation. -Submitted to VAERS 7/2/13-.
Age: 46.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Tracheostomy
Clinical narrative: Pt is a 46 y.o. female who was admitted to the hospital, on 12/20/12 with complaints of back pain, neck pain, generalized weakness, and numbness of her hands and feet. She additional reported mild difficulty swallowing and some shortness of breath. She had received the influenza vaccine approximately one week prior to the onset of symptoms -which was approximately 4 days prior to this admission-. Unable to determine where influenza vaccination occurred. She had recently been seen in clinic and received prescriptions for acetaminophen with codeine and cyclobenzaprine for her back pain. She was also taking ibuprofen prn. Her muscle weakness progressed and she was seen by neurology who diagnosed her with Guillain Barre Syndrome. She received IVIG 0.4 g/kg iv daily x 5 days. She went into respiratory failure and required mechanical ventilation and eventually tracheostomy. A second 3 day course of IVIG was administered. She had a long hospital course with pneumonia and metabolic encephalopathy/delirium/hallucinations thought to be due to medications. She gradually showed some slight improvement in muscle strength. She was transferred to a long term acute care facility on 1/15/13 to continue with rehabilitation. -Submitted to VAERS 7/2/13-.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Inflammation, Injection site pain, Injection site pruritus, Injection site swelling, Oedema peripheral
Clinical narrative: The injection site started burning and stinging. The next morning I woke up to a very swollen arm. It was swollen to about the size of a tennis ball around the injection site. The swollen part of my arm was very sore, itchy and and also felt stingy.  It was treated with Coconut and lavender oil. Also pineapple juiced for inflammation. I am breastfeeding so other medications were not an option.
Age: 5.0
Sex: F
Vaccine: DTP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: She has a spot about the size of a baseball around the injection site that is red, swollen, hard, and hot to the touch.
Age: 0.84
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Inappropriate schedule of drug administration, No therapeutic response
Clinical narrative: This spontaneous report was received from a medical assistant concerning an approximately 10 months old (at the time of medication error) female patient with no drug reaction or allergies. The medical history of the patient included premature birth. On an unknown date, the patient was vaccinated with the first dose of RECOMBIVAX HB (lot number, expiry date, dose and route unspecified) when she was born, however, the unspecified hospital had no record of the vaccination. On 11-JAN-1999, the patient was vaccinated with the second dose of RECOMBIVAX HB (lot number and expiry date reported as 627176/1091H and 26-MAR-2001 respectively, dose unspecified), intramuscularly in the left thigh. On 11-OCT-1999, the patient was vaccinated with the third dose of of RECOMBIVAX HB (lot number, expiry date and dose unspecified), intramuscularly in the left thigh. Concomitant medication included iron supplements (unspecified). The patient had blood titers drawn for Hepatitis B surface antibodies on 28-JUN-2013. Approximately on an unknown date in July 2013 (reported as last week), the results were received and the Hepatitis B surface antibodies were low. The reporter stated that they read 8.6 when immunity should be 9.9 or greater. No treatment was provided. The outcome of the event was unknown. The relatedness for the event was unknown for RECOMBIVAX HB. Additional information is not expected.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a consumer, the father of the patient, refers to a 16 year old patient. Patient experienced fainting (unspecified date) after receiving with a first dose of GARDASIL (intramuscular, strength, formulation, lot#, dose/frequency and duration were unspecified) on an unknown date. The patient recovered quickly in the physician office. Additional information is not expected.
Age: 18.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Computerised tomogram abdomen normal, Erythema, Feeling hot, Inflammation, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Local erythema, warmth, fever to 104. Ended up with 5 day hospitalization. MRI showed "non-necrotic inj inflammation of deltoid and fascia". Rx'ed with oral antibiotics.
Age: 18.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Local erythema, warmth, fever to 104. Ended up with 5 day hospitalization. MRI showed "non-necrotic inj inflammation of deltoid and fascia". Rx'ed with oral antibiotics.
Age: 1.02
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 month old patient. On 28-JUN-2013 the patient was inadvertently vaccinated with a dose of RECOMBIVAX HB in error who was scheduled to receive VAQTA. No adverse event was reported. It was unknown if the patient sought medical attention. At the time of report, the status of patient was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.N.P.) refers to a patient of unknown age and gender. On 13-JUN-2013 the patient was vaccinated with a dose of RECOMBIVAX (lot # reported as h017304, exp. date 11-JUL-2015) (dose, route and site of administration not reported), which on an unknown date was exposed to minus 2 degrees centigrade for 19 hours. No adverse effects were reported. This was one of several reports received from the same source. Other linked reports are: MARRS # 1307USA006244, 1307USA006246, 1307USA006247, 1307USA006248, 1307USA006245, 1307USA006250 and 1306USA007793. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule
Clinical narrative: This spontaneous report was received from a pharmacist (who is also the patient) of unknown age regarding herself. On an unknown date, the pharmacist administered herself with a dose of ZOSTAVAX (lot #, expiry not reported), intramuscularly. On an unknown date, the patient developed a knot at the site where ZOSTAVAX was injected. The outcome of knot developed at the site where ZOSTAVAX was injected was unknown. No Varicella Zoster Virus Identification Program (VZVIP) packet faxed at this time. Additional information has been requested.
Sex: U
Vaccine: FLU3
Symptoms: Injection site anaesthesia, Injection site reaction, Paraesthesia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of numbness at the injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX (unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced numbness at the injection site and injection site tingling. At the time of reporting the outcome of the events were unspecified. The pharmacist reported during a FLUARIX administration, there were two complaints of numbness and tingling at the injection site. For the other case please see A0999336A.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.N.P.) refers to a patient of unknown age and gender. On 11-JUN-2013 the patient was vaccinated with a dose of RECOMBIVAX (lot # reported as H017304, exp. date 11-JUL-2015) (dose, route and site of administration not reported), which on an unknown date was exposed to minus 1 degrees centigrade for 19 hours. This was one of several reports received from the same source. Other linked reports are: MARRS # 1307USA006244, 1307USA006245, 1307USA006247, 1307USA006248, 1307USA006249, 1307USA006250 and 1306USA007793. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: MNQ, YF
Symptoms: Dizziness, Immediate post-injection reaction, Nausea
Clinical narrative: Initial report received from a healthcare professional on 10 June 2013. A 22-year-old female patient whose concomitant medications were not reported, had received a subcutaneous dose of YF VAX vaccine (batch number - UH596AA, dose number-not reported) in left triceps and an intramuscular dose of MENACTRA vaccine (batch number-U4428AA, dose number-not reported) in right deltoid, both on 07 June 2013. The patient's pre-existing physician diagnosed allergies, birth defects and medical conditions include PMH Turner's syndrome. As per the reporter, the patient had no acute illness at time of vaccination. On 07 June 2013, the patient experienced a sense of light headedness and queasiness immediately post vaccination which resolved within 15 minutes. The corrective treatments were not reported and laboratory investigations were not done. On an unspecified date, the patient recovered from the events. Documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site soreness in an adult female subject who was vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Approximately in 2007 the subject received unspecified dose of Influenza vaccine (unknown). In 2007, at an unspecified time after vaccination with Influenza vaccine, the subject experienced injection site soreness. At the time of reporting the outcome of the injection site soreness was unspecified. At the time of the report no other details were provided. The subject reported an adverse event with ENGERIX B; please see case A0977003A.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Discomfort, Feeling abnormal, Malaise
Clinical narrative: This case was reported by a consumer and described the occurrence of not feeling well in a 43-year-old female subject who was vaccinated with Flu vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On 23 October 2003 the subjects received 1st dose of Flu vaccine (unknown, left arm). On 23 October 2003, less than one day after vaccination with Flu vaccine, the subject experienced not feeling well, discomfort and something was wrong [feels something is wrong unsure what]. The subject reported she had "ambulance treatment at the clinic where administered, they observed her; no Epinephrine shot was administered." The subject consulted her healthcare provider regarding the events. On 23 October 2003, the not feeling well, discomfort and something was wrong were resolved.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Diplopia, Dizziness
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of dizziness in a 50-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 18 September 2012 at 14:45 the subject received dose of FLUARIX (details unknown, left deltoid). On 18 September 2012, 45 minutes after vaccination with FLUARIX, the subject experienced dizziness and double vision. The healthcare provider reported that FLUARIX was given to the subject on 18 September 2012 at 2:45 PM at her work and 45 minutes later, the subject experienced double vision and dizziness. The subject went to her doctor's office to get treated for the double vision and the dizziness. The healthcare provider stated the subject has received flu vaccines in the past and has not experienced any type of reactions previously. No further information was provided. At the time of reporting the outcome of the events was unspecified.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site cellulitis, 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 injection site cellulitis in a 64-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included anxiety, arthritis and seasonal allergy. Concurrent medications included LEXAPRO, ALLEGRA and FLONASE. It was reported that the subject had not previously received any flu shots and there were no known adverse events following previous vaccinations. On 12 September 2012, the subject received dose of FLUARIX (.5 ml, details unknown, left deltoid). No other vaccines were administered on this same date. On 13 September 2012, 1 day after vaccination with FLUARIX, the subject experienced left shoulder warm, hot and painful above the injection site, "previous vaccination site was red" and bruise injection site. On 14 September 2012, 2 days after vaccination with FLUARIX, the subject experienced injection site cellulitis. This case was assessed as medically serious by GSK. The subject's primary care physician diagnosed her with cellulitis and prescribed antibiotics and ZYRTEC to treat it. The subject required medical attention at the doctor's office. The left shoulder warm, hot and painful above the injection site, "previous vaccination site was red", and injection site cellulitis resolved on 17 September 2012. At the time of reporting the bruise injection site was improved.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Headache, Meningitis viral, Urticaria
Clinical narrative: Initial case received on 02 July 2013 from a healthcare provider (physician). On 24 June 2013, an 11 year old male patient was administered a first dose of MENACTRA Lot # U4594AB intramuscularly into the right deltoid, a first dose of ADACEL, C4365AA intramuscularly into the left deltoid and a first dose of GARDASIL, Manufacturer Merck, batch number H021861 intramuscularly into the left deltoid. The patient has a history of allergy to cats. It was reported that the patient was not ill at the time of vaccination. On 25 June 2013, the patient experienced hives which would not resolve with BENADRYL and went to the emergency room. The patient was seen by a physician on 01 July 2013. The child was diagnosed with viral meningitis on an unspecified date. The patient had headache complaints on an unspecified date and was treated ADVIL, dose and dates not reported. The patient was followed up by neurology, details not provided. The patient outcome was not reported. Documents held by sender: None.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Local swelling, Pain in extremity
Clinical narrative: Patient called on 7-11-13 complaining of arm pain and swelling. The swelling per patient went 2/3 down her arm, some redness around injection site. Patient to come in for us to measure. Said swelling was on the inside and outside of he arm.
Sex: F
Vaccine: FLUX
Symptoms: Cough, Malaise, Musculoskeletal chest pain
Clinical narrative: This case was reported by a consumer via Communispace "Our Voice" and described the occurrence of sick in a female subject of unspecified age who was vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Co-suspect medication included ADVAIR. On an unknown date, the patient started ADVAIR, unknown dosing. On an unspecified date in 2012 the subject received unspecified dose of Influenza vaccine (unknown). At an unknown time after starting Fluticasone propionate+salmeterol xinofoate, and less than one year after vaccination with Influenza vaccine, the subject experienced sick, possible flu virus, possible bronchial infection, sore ribs and cough. The subject reported "I got my shot quite some time ago but know that it is not 100 percent effective. For the last month I've been sick. Don't know if it's the flu or just some form of bronchial infection but it has certainly taken its toll. Been to the doctor twice, ribs are sore from coughing etc., but I know this too shall pass. Got some new medication hoping it's effective. Otherwise, I try to stay away from anyone who seems visibly sick, wash my hands often and am getting plenty of rest and drinking lots of fluids". At the time of reporting the sick, possible flu virus, possible bronchial infection, sore ribs and cough were unresolved.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Vaccination complication
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of anaphylactic reaction to vaccine in a 38-year-old female subject who was vaccinated with influenza vaccine (manufacturer unspecified). Concurrent medical conditions included allergy to eggs. On an unspecified date in 2005 the subject received unspecified dose of influenza vaccine (unknown). At an unspecified time in 2005, after vaccination with influenza vaccine, the subject experienced anaphylactic reaction to vaccine. The subject had an anaphylactic reaction in approximately 2005 following flu shot. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the anaphylaxis was unspecified. The healthcare professional refused to provide complete contact information. The subject had an adverse event with FLUARIX 2011-2012 vaccine, please see A1005612A.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Food allergy
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of peanut allergy in a 64-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 1 November 2012 the subject received a dose of FLUARIX (unknown details). In November 2012, less than one month after vaccination with FLUARIX, the subject experienced peanut allergy. The subject stated he "received the flu vaccine and developed a peanut allergy." The subject stated that the immunization series was not discontinued. At the time of reporting the event was unresolved.
Sex: U
Vaccine: FLU3
Symptoms: Injection site anaesthesia, Injection site reaction, Paraesthesia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of numbness at the injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX (unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced numbness at the injection site and injection site tingling. At the time of reporting the outcome of the events were unspecified. The pharmacist reported during a FLUARIX administration, there were two complaints of numbness and tingling at the injection site. For the other case please see A0999335A.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, In vitro fertilisation, Pain in extremity
Clinical narrative: This prospective pregnancy case was reported by a consumer and described the occurrence of arm pain in a 37-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report during pregnancy. The subject's medical history included one previous pregnancy that resulted in a normal birth complicated by gestational diabetes. Concurrent medications included Prenatal vitamin, Calcium + D and Fish oil. On 8 October 2012 the subject received unspecified dose of FLUARIX (unknown, left arm). Her last menstrual period was on 25 September 2012 and estimated date of delivery was 02 July 2013. This pregnancy was by in vitro fertilization. At the time of the report, no testing has been performed. The subject was exposed to FLUARIX at two weeks gestation, during the first trimester. On 8 October 2012, at the time of vaccination with FLUARIX, the subject experienced vaccine exposure during pregnancy. On 8 October 2012, 3 hours after vaccination with FLUARIX, the subject experienced arm pain. By mid day on 09 October 2012, the arm pain resolved. The outcome of the pregnancy was unknown. The subject considered the arm pain related to vaccination with FLUARIX.
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Fatigue, Influenza like illness, Injection site pain, Malaise
Clinical narrative: This case was reported by a healthcare professional (physician therapist, subject) and described the occurrence of injection site soreness in a male subject of unspecified age who was vaccinated with influenza virus vaccine (manufacturer unspecified). The subject's medical history included anaphylaxis. The subject had an "anaphylactic response to anything related to penicillin (i.e. amoxicillin) in which he lost consciousness and went into atrial fibrillation for several hours." In 2002 (approximately 10 years ago), 2003 and 2004 the subject received a dose each year of influenza vaccine (unknown details). In 2002, approximately 10 years ago, less than one day after vaccination with influenza vaccine (unknown arm), the subject experienced injection site soreness. The subject described his experience as "a mild injection site reaction in which his arm was sore after receiving the flu vaccine." "The next two years, he got sick each time after receiving the flu vaccine." The injection site soreness resolved 2 days after receiving the vaccination. The subject reports that he did consult his health care provider regarding the event. In approximately 2003, the next day following a flu shot, the subject reports that he was sick, fever, weakness, tiredness and pain. The subject reports that he "felt feverish, weak, tired and achy and believes these events were systemic in nature." The subject reported that these symptoms resolved 2 to 3 days after receiving the vaccination. The subject reports that he did consult his health care provider regarding the event. In approximately 2004, the next day following a flu shot, the subject reports that was sick, fever, weakness, tiredness and pain. The subject reports that he "felt feverish, weak, tired and achy and believes these events were systemic in nature." The subject reported that these symptoms resolved 2 to 3 days after receiving the vaccination. The subject reports that he did consult his health care provider regarding the event. The subject stated that "he decided not to receive the flu vaccine anymore because each year the symptoms worsened. This year his company is requiring him to receive a flu vaccine and he is considering receiving it again." At the time to this reporting, all adverse events had resolved. Follow up was received from the healthcare provider (patient) on 20 November 2012. The reporter added that he received a dose of influenza vaccine (unknown details) on an unknown date. Approximately 5-6 years ago after vaccination with "flu-vaccine" the subject experienced flu-like symptoms. The flu-like symptoms were resolved 3 days later. The reporter stated that the flu-like symptoms were not serious. The reporter also stated that he had no adverse events following previous vaccinations.
Sex: M
Vaccine: FLUX
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a healthcare professional (physician therapist, subject) and described the occurrence of injection site soreness in a male subject of unspecified age who was vaccinated with influenza virus vaccine (manufacturer unspecified). The subject's medical history included anaphylaxis. The subject had an "anaphylactic response to anything related to penicillin (i.e. amoxicillin) in which he lost consciousness and went into atrial fibrillation for several hours." In 2002 (approximately 10 years ago), 2003 and 2004 the subject received a dose each year of influenza vaccine (unknown details). In 2002, approximately 10 years ago, less than one day after vaccination with influenza vaccine (unknown arm), the subject experienced injection site soreness. The subject described his experience as "a mild injection site reaction in which his arm was sore after receiving the flu vaccine." "The next two years, he got sick each time after receiving the flu vaccine." The injection site soreness resolved 2 days after receiving the vaccination. The subject reports that he did consult his health care provider regarding the event. In approximately 2003, the next day following a flu shot, the subject reports that he was sick, fever, weakness, tiredness and pain. The subject reports that he "felt feverish, weak, tired and achy and believes these events were systemic in nature." The subject reported that these symptoms resolved 2 to 3 days after receiving the vaccination. The subject reports that he did consult his health care provider regarding the event. In approximately 2004, the next day following a flu shot, the subject reports that was sick, fever, weakness, tiredness and pain. The subject reports that he "felt feverish, weak, tired and achy and believes these events were systemic in nature." The subject reported that these symptoms resolved 2 to 3 days after receiving the vaccination. The subject reports that he did consult his health care provider regarding the event. The subject stated that "he decided not to receive the flu vaccine anymore because each year the symptoms worsened. This year his company is requiring him to receive a flu vaccine and he is considering receiving it again." At the time to this reporting, all adverse events had resolved. Follow up was received from the healthcare provider (patient) on 20 November 2012. The reporter added that he received a dose of influenza vaccine (unknown details) on an unknown date. Approximately 5-6 years ago after vaccination with "flu-vaccine" the subject experienced flu-like symptoms. The flu-like symptoms were resolved 3 days later. The reporter stated that the flu-like symptoms were not serious. The reporter also stated that he had no adverse events following previous vaccinations.
Sex: F
Vaccine: FLUX
Symptoms: Allergy test positive, Eczema, Erythema, Hypersensitivity, Pruritus
Clinical narrative: This case was reported by a consumer (subject and GSK employee) and described the occurrence of itching of arm area in an adult female subject who was vaccinated with influenza vaccine. A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to molds. The subject stated no medical history of allergies (environmental or otherwise). The subject stated she had no medical history of eczema. On 7 November 2012 the subject received a dose of influenza vaccine (unknown details). On 8 November 2012, 1 day after vaccination with influenza vaccine, the subject experienced itching of arm area ("small, itchy" "area of skin under my left armpit"), and red areas on skin. The subject stated that, on 8 November 2012, she noticed "a small, itchy, red area of skin under my left armpit, about the size of a silver dollar." On 13 November 2012, the subject experienced rash all over body, red welts, and skin irritation. The subject stated that "the rash spread all over my body, with red welts, and severe itching and irritation." The "symptoms were minimally controlled with antihistamines." On 15 November 2012, the subject sought medical attention from a physician at an urgent care facility who determined that she experienced "an allergic reaction to the flu shot." The subject was treated "with a shot of prednisone and began an oral prednisone taper." On an unknown date in 2012, the subject "subsequently saw an allergist who performed allergy skin testing." The results of the allergy skin testing were negative for everything but positive for mold. The subject stated that the allergist told the subject she had suffered "an eczema flare." The subject, however, stated no medical history of allergies (environmental or otherwise). The subject stated she had no medical history of eczema. In November 2012, the subject stated the itching resolved "shortly after beginning prednisone." In 2012, the rash resolved. "The rash was visible for about 14 to 21 days" after 15 November 2012. The outcome of the red areas on skin, red welts, skin irritation, allergic reaction, and eczema flare was not reported.