chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Joint swelling
Clinical narrative: This spontaneous report as received from a consumer refers to herself who was a 47 year old female patient, as part of marketing research program. Patient's relevant medical history included type 1 diabetes. On an unspecified date in October 2009 the patient was vaccinated with PNEUMOVAX23 (strength, formulation, lot#, dose, route and duration were unspecified). Concomitant therapy might included flu shot received at the same time. On an unspecified date in October 2009, after receiving shot, the patient experienced tennis-ball sac swelling on elbow and flu-like symptoms. Patient was treated with BENADRYL. The outcome of events was reported as recovered/resolved in 2009, "about 3 days after onset". Action taken was reported as "none". Reporter considered the events as non-serious and considered the events as related to the suspect therapy. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Daughter called pharmacy 10/18 to ask if mom's reaction was common->she's experiencing a sore, red hard lump (size of 1/2 dollar) at injection site. It's warm to the touch. Soreness started today (3 days post-immun.) radiating up to shoulder and neck. Told pt to see her PCP or MD.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: Daughter called pharmacy 10/18 to ask if mom's reaction was common->she's experiencing a sore, red hard lump (size of 1/2 dollar) at injection site. It's warm to the touch. Soreness started today (3 days post-immun.) radiating up to shoulder and neck. Told pt to see her PCP or MD.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Autoimmune disorder, Haemorrhage, Inflammation, Joint range of motion decreased, Mobility decreased
Clinical narrative: Extreme pain in left arm.  Unable to lift arm. Went to Primary care physician and had x-rays, went to and still under care of orthopedic surgeon.  Have had ultrasound, physical therapy, ultrasound therapy, tens therapy, trigger point massage therapy.  Still have pain and 70 degree range of motion. Vaccine caused negative autoimmune response.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle injury, Pain in extremity, Rotator cuff syndrome, Scar, Ultrasound joint
Clinical narrative: Extreme pain in left arm.  Unable to lift arm. Went to Primary care physician and had x-rays, went to and still under care of orthopedic surgeon.  Have had ultrasound, physical therapy, ultrasound therapy, tens therapy, trigger point massage therapy.  Still have pain and 70 degree range of motion. Vaccine caused negative autoimmune response.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Extreme pain in left arm.  Unable to lift arm. Went to Primary care physician and had x-rays, went to and still under care of orthopedic surgeon.  Have had ultrasound, physical therapy, ultrasound therapy, tens therapy, trigger point massage therapy.  Still have pain and 70 degree range of motion. Vaccine caused negative autoimmune response.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Agitation, Cellulitis, Chills, Feeling cold, Headache
Clinical narrative: This spontaneous report as received from a 68 years old female patient. Patient had sulfites and nitrates drug allergy. On 14-MAR-2014, the patient was vaccinated with PNEUMOVAX 23, lot (not specified), expiry date (2015), dose 2, 0.5 ml (milliliter), injection. Concomitant therapies included EPIPEN emergencies, PULMICORT 180MCG (microgram), PROAIR uses as needed, and SYNTHROID. The patient reported that the evening that she had been revaccinated with PNEUMOVAX 23 was when she started to have adverse reactions (adverse event onset date was also reported as on 14-MAR-2014). She stated that the evening the injection site had swelled up like a bullseye/beat red thing, she had cold chills, it was painful, and she could not lift her arm. The next day, the patients arm had become swollen. The patient went to an urgent care where she was diagnosed with cellulitis and was put on an antibiotic called CIPRO 5mg twice a day. Patient sought medical attention. Lab diagnostics studies were not performed. The patient did not know why she had this reaction when the first time she received with PNEUMOVAX 23 (on an unspecified date) she was fine. She thought maybe because the first time she was given the with PNEUMOVAX 23 it was from a single dose vial. The second vaccination the patient was given a dose from the multi-vial with PNEUMOVAX 23. The outcome of cellulitis was reported as resolving. No product quality compliant was involved. Causality was not provided. No further adverse event information was reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Malaise, Mobility decreased
Clinical narrative: This spontaneous report as received from a 68 years old female patient. Patient had sulfites and nitrates drug allergy. On 14-MAR-2014, the patient was vaccinated with PNEUMOVAX 23, lot (not specified), expiry date (2015), dose 2, 0.5 ml (milliliter), injection. Concomitant therapies included EPIPEN emergencies, PULMICORT 180MCG (microgram), PROAIR uses as needed, and SYNTHROID. The patient reported that the evening that she had been revaccinated with PNEUMOVAX 23 was when she started to have adverse reactions (adverse event onset date was also reported as on 14-MAR-2014). She stated that the evening the injection site had swelled up like a bullseye/beat red thing, she had cold chills, it was painful, and she could not lift her arm. The next day, the patients arm had become swollen. The patient went to an urgent care where she was diagnosed with cellulitis and was put on an antibiotic called CIPRO 5mg twice a day. Patient sought medical attention. Lab diagnostics studies were not performed. The patient did not know why she had this reaction when the first time she received with PNEUMOVAX 23 (on an unspecified date) she was fine. She thought maybe because the first time she was given the with PNEUMOVAX 23 it was from a single dose vial. The second vaccination the patient was given a dose from the multi-vial with PNEUMOVAX 23. The outcome of cellulitis was reported as resolving. No product quality compliant was involved. Causality was not provided. No further adverse event information was reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Chills, Feeling cold, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a 68 years old female patient. Patient had sulfites and nitrates drug allergy. On 14-MAR-2014, the patient was vaccinated with PNEUMOVAX 23, lot (not specified), expiry date (2015), dose 2, 0.5 ml (milliliter), injection. Concomitant therapies included EPIPEN emergencies, PULMICORT 180MCG (microgram), PROAIR uses as needed, and SYNTHROID. The patient reported that the evening that she had been revaccinated with PNEUMOVAX 23 was when she started to have adverse reactions (adverse event onset date was also reported as on 14-MAR-2014). She stated that the evening the injection site had swelled up like a bullseye/beat red thing, she had cold chills, it was painful, and she could not lift her arm. The next day, the patients arm had become swollen. The patient went to an urgent care where she was diagnosed with cellulitis and was put on an antibiotic called CIPRO 5mg twice a day. Patient sought medical attention. Lab diagnostics studies were not performed. The patient did not know why she had this reaction when the first time she received with PNEUMOVAX 23 (on an unspecified date) she was fine. She thought maybe because the first time she was given the with PNEUMOVAX 23 it was from a single dose vial. The second vaccination the patient was given a dose from the multi-vial with PNEUMOVAX 23. The outcome of cellulitis was reported as resolving. No product quality compliant was involved. Causality was not provided. No further adverse event information was reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Local swelling, Mobility decreased, Pain
Clinical narrative: This spontaneous report as received from a 68 years old female patient. Patient had sulfites and nitrates drug allergy. On 14-MAR-2014, the patient was vaccinated with PNEUMOVAX 23, lot (not specified), expiry date (2015), dose 2, 0.5 ml (milliliter), injection. Concomitant therapies included EPIPEN emergencies, PULMICORT 180MCG (microgram), PROAIR uses as needed, and SYNTHROID. The patient reported that the evening that she had been revaccinated with PNEUMOVAX 23 was when she started to have adverse reactions (adverse event onset date was also reported as on 14-MAR-2014). She stated that the evening the injection site had swelled up like a bullseye/beat red thing, she had cold chills, it was painful, and she could not lift her arm. The next day, the patients arm had become swollen. The patient went to an urgent care where she was diagnosed with cellulitis and was put on an antibiotic called CIPRO 5mg twice a day. Patient sought medical attention. Lab diagnostics studies were not performed. The patient did not know why she had this reaction when the first time she received with PNEUMOVAX 23 (on an unspecified date) she was fine. She thought maybe because the first time she was given the with PNEUMOVAX 23 it was from a single dose vial. The second vaccination the patient was given a dose from the multi-vial with PNEUMOVAX 23. The outcome of cellulitis was reported as resolving. No product quality compliant was involved. Causality was not provided. No further adverse event information was reported. Additional information has been requested.
Sex: U
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Dizziness, Respiratory arrest, Unresponsive to stimuli, Vomiting
Clinical narrative: This spontaneous report was received from a pharmacist (who was not the administering pharmacist), regarding a patient of unknown age and gender with no drug reactions or allergies and no pertinent medical history. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) (dose and route not reported). No other suspect therapies were reported. Concomitant therapies included T-DAP. The pharmacist reported that the patient went into anaphylactic shock and stopped breathing when administered concomitantly with ZOSTAVAX and T-DAP. It was reported that the patient was given an EPIPEN as treatment and began breathing again. The patient was transported on an unknown date to an unspecified hospital but it was unspecified if the patient was admitted. The outcome for anaphylactic shock was unknown, the outcome for stopped breathing was recovered since the patient began breathing again. Upon internal review anaphylactic shock and stopped breathing were considered medically significant events. Additional information has been requested.
Sex: U
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Anaphylactic shock, Respiratory arrest
Clinical narrative: This spontaneous report was received from a pharmacist (who was not the administering pharmacist), regarding a patient of unknown age and gender with no drug reactions or allergies and no pertinent medical history. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) (dose and route not reported). No other suspect therapies were reported. Concomitant therapies included T-DAP. The pharmacist reported that the patient went into anaphylactic shock and stopped breathing when administered concomitantly with ZOSTAVAX and T-DAP. It was reported that the patient was given an EPIPEN as treatment and began breathing again. The patient was transported on an unknown date to an unspecified hospital but it was unspecified if the patient was admitted. The outcome for anaphylactic shock was unknown, the outcome for stopped breathing was recovered since the patient began breathing again. Upon internal review anaphylactic shock and stopped breathing were considered medically significant events. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old male patient. Patients relevant medical history and past drug history were unknown. The patient was to receive ZOSTAVAX Lot number J013451, Expiry date: 24-JAN-2015, 0.65mL, once, in his left arm, on 29-MAR-2014. No concomitant medication reported. On 29-MAR-2014, the pharmacist was giving the ZOSTAVAX to the patient and was almost done when the plunger would not go in anymore, like it was stuck. The pharmacist pulled the needle back out a little bit and some of the ZOSTAVAX squirted out around the needle at the injection site. The pharmacist stated that, it was unknown how much of the intended 0.65mL dose of ZOSTAVAX patient received and there was 0.1mL left as well in the syringe. He has had no relevant laboratory testing performed. As of 29-MAR-2014, it was unknown if the patient would continue to receive ZOSTAVAX. But the plan was to repeat the injection after speaking to the patient's physician and the outcome of not receiving a full dose of ZOSTAVAX was unknown. Causality was not reported. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old male patient. Patients relevant medical history and past drug history were unknown. The patient was to receive ZOSTAVAX Lot number J013451, Expiry date: 24-JAN-2015, 0.65mL, once, in his left arm, on 29-MAR-2014. No concomitant medication reported. On 29-MAR-2014, the pharmacist was giving the ZOSTAVAX to the patient and was almost done when the plunger would not go in anymore, like it was stuck. The pharmacist pulled the needle back out a little bit and some of the ZOSTAVAX squirted out around the needle at the injection site. The pharmacist stated that, it was unknown how much of the intended 0.65mL dose of ZOSTAVAX patient received and there was 0.1mL left as well in the syringe. He has had no relevant laboratory testing performed. As of 29-MAR-2014, it was unknown if the patient would continue to receive ZOSTAVAX. But the plan was to repeat the injection after speaking to the patient's physician and the outcome of not receiving a full dose of ZOSTAVAX was unknown. Causality was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from a physician assistant refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL with unknown strength, dose, route and lot number. The physician assistant reported an unspecified patient (the daughter of a friend) experienced a seizure after receiving GARDASIL. It was unknown if the patient sought medical attention. At the time of reporting, the outcome of event was not reported. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test, Lung neoplasm malignant, Rash, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 78 year old male patient. The patient's medical history and drug allergies were not reported. On 26-SEP-2013 the patient was vaccinated with ZOSTAVAX (dose, frequency, route, lot# and expired date were not reported). Concomitant therapy was not reported. On an unknown date the patient developed shingles after receiving ZOSTAVAX. She reported that the shingles appeared as a "disseminated rash" on the patient's back "resembling chickenpox". She stated that the patient was hospitalized on an unspecified date due to the shingles at an unspecified hospital. She also stated that the patient had unspecified labs drawn while in the hospital and that the patient was diagnosed with lung cancer on an unspecified date and given an unspecified treatment. The outcome of the adverse event was not reported. Upon internal review, lung cancer was considered to be medically significant. This is one of several reports from the same source. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 83 year old female patient. No medical history was provided. In September 2012 the patient was vaccinated with PNEUMOVAX23. This may have been a booster dose of PNEUMOVAX23. The patient had previously been hospitalized at an unspecified facility on unspecified dates. The pharmacist also states that "the patient cannot tolerate the (unspecified) flu vaccine," but that the patient is "otherwise healthy." The pharmacist stated that she was unsure whether the patient did receive more than one dose of PNEUMOVAX23 and if the patient was hospitalized after receiving a dose of PNEUMOVAX23 before September 2012. The outcome was reported as recovered. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site rash, Rash papular, Vaccination site reaction
Clinical narrative: PATIENT RECEIVED VACCINES ON 3/19/14 THEN TWO DAYS (3/21/14) LATER PRESENTED TO OFFICE C/O OF  PAPULAR RASH AT VACCINE SITES- BOTH THIGHS.  PARENTS WERE ADVISED TO USE EUCERIN CREAM TO AFFECTED AREA.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Swelling, Tenderness
Clinical narrative: Soreness of the area, swelling and tenderness, slight fever.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Condition aggravated, Culture, Eczema, Rash erythematous, Rash pruritic
Clinical narrative: 3 hours later after DTAP vaccine he started having rash on his arms, the next day it spread to his neck and trunk, it kept spreading and forming patches until his whole body was covered with red itchy oozing red patches.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Staphylococcal infection, Vaccination complication
Clinical narrative: 3 hours later after DTAP vaccine he started having rash on his arms, the next day it spread to his neck and trunk, it kept spreading and forming patches until his whole body was covered with red itchy oozing red patches.
Age: 0.15
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying
Clinical narrative: Uncontrollable crying since receiving 2 month immunizations; child able to sleep at night but cries throughout the daytime hours; did not do this before receiving immunizations.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Nausea
Clinical narrative: C/o redness, soreness in arm where injection was given at site of injection. Today presents with erythematous area around site of injection measuring 12.5cm x 11.5cm.  Area slightly warm to touch.  Pt also complaining of nausea since 3/28/14.
Age: 52.0
Sex: M
Vaccine: MMR
Symptoms: Ear pain, Headache, Musculoskeletal stiffness, Myalgia, Nasal congestion
Clinical narrative: Initially myalgias, progressed to fever to 104, photophobia, headache, neck stiffness, ear pain, nasal congestion, nausea, whole body rash- took one week for recovery.
Age: 52.0
Sex: M
Vaccine: MMR
Symptoms: Nausea, Photophobia, Pyrexia, Rash generalised
Clinical narrative: Initially myalgias, progressed to fever to 104, photophobia, headache, neck stiffness, ear pain, nasal congestion, nausea, whole body rash- took one week for recovery.
Age: 1.03
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: High fever 106 degrees F at home that evening.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Local swelling, Pharyngeal oedema, Pyrexia
Clinical narrative: MOM CALLED 11:30 04/01/2014 STATING CHILD HAD ALLERGIC REACTION BETWEEN 1 OR 2 HOURS AFTER HAVING THE VACCINE. Patient arm swelled up, high fever of 102.7, swollen throat. Mom gave 2 Motrin right away and made the child lay down for a few hours contacted a friend who is a nurse and went to local ER last night they gave her something for fever last night. She has improved and is better. I suggested child to follow up if need asap.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Arm felt itchy at site of injection and when pt looked at it, she noticed redness and swelling. Seen in office and arm showed erythema 10cm x 10.5cm and induration 4cm x 6cm.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Blood alkaline phosphatase increased, Body temperature increased, C-reactive protein increased, Eosinophil count increased, Feeling cold
Clinical narrative: Initial case received from a health care professional (physician's assistant) on 26 March 2014. A 33-year-old male patient, with a history of left shoulder surgery, received an intramuscular left deltoid injection of ADACEL (lot number U4837AA) on 11 March 2014. On unspecified time post vaccination, he began experiencing severe myalgia and malaise with body aches, headache, and muscle aches both lower extremities and elbows. On 21 March 2014 the patient reported feeling cold for two hours, followed by sweats and a temperature of 100 degrees Fahrenheit. The patient was evaluated by his physician on 24 March 2014. According to the reporter, the patient's symptoms were "severe to the point that the patient had to be seen in a wheelchair". Laboratory testing performed on an unspecified date were as follows: white blood count 18,000; sedimentation rate 121; C-reactive protein 30.5; increased alkaline phosphatase, liver enzymes, monocytes, neutrophils, and eosinophils. Hepatitis A, B, and C testing and liver ultrasound were negative. The patient was to be evaluated by a rheumatologist; results of the consultation were not reported. According to the reporter, the physician was "ruling out serum sickness versus infection". Outcome was unknown. Documents held by sender: None.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Hepatic enzyme increased, Hepatitis A antibody negative, Hepatitis B test negative, Hepatitis C test negative
Clinical narrative: Initial case received from a health care professional (physician's assistant) on 26 March 2014. A 33-year-old male patient, with a history of left shoulder surgery, received an intramuscular left deltoid injection of ADACEL (lot number U4837AA) on 11 March 2014. On unspecified time post vaccination, he began experiencing severe myalgia and malaise with body aches, headache, and muscle aches both lower extremities and elbows. On 21 March 2014 the patient reported feeling cold for two hours, followed by sweats and a temperature of 100 degrees Fahrenheit. The patient was evaluated by his physician on 24 March 2014. According to the reporter, the patient's symptoms were "severe to the point that the patient had to be seen in a wheelchair". Laboratory testing performed on an unspecified date were as follows: white blood count 18,000; sedimentation rate 121; C-reactive protein 30.5; increased alkaline phosphatase, liver enzymes, monocytes, neutrophils, and eosinophils. Hepatitis A, B, and C testing and liver ultrasound were negative. The patient was to be evaluated by a rheumatologist; results of the consultation were not reported. According to the reporter, the physician was "ruling out serum sickness versus infection". Outcome was unknown. Documents held by sender: None.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Hyperhidrosis, Infection, Malaise, Monocyte count increased, Myalgia
Clinical narrative: Initial case received from a health care professional (physician's assistant) on 26 March 2014. A 33-year-old male patient, with a history of left shoulder surgery, received an intramuscular left deltoid injection of ADACEL (lot number U4837AA) on 11 March 2014. On unspecified time post vaccination, he began experiencing severe myalgia and malaise with body aches, headache, and muscle aches both lower extremities and elbows. On 21 March 2014 the patient reported feeling cold for two hours, followed by sweats and a temperature of 100 degrees Fahrenheit. The patient was evaluated by his physician on 24 March 2014. According to the reporter, the patient's symptoms were "severe to the point that the patient had to be seen in a wheelchair". Laboratory testing performed on an unspecified date were as follows: white blood count 18,000; sedimentation rate 121; C-reactive protein 30.5; increased alkaline phosphatase, liver enzymes, monocytes, neutrophils, and eosinophils. Hepatitis A, B, and C testing and liver ultrasound were negative. The patient was to be evaluated by a rheumatologist; results of the consultation were not reported. According to the reporter, the physician was "ruling out serum sickness versus infection". Outcome was unknown. Documents held by sender: None.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Neutrophil count increased, Pain, Red blood cell sedimentation rate increased, Serum sickness, Ultrasound liver normal
Clinical narrative: Initial case received from a health care professional (physician's assistant) on 26 March 2014. A 33-year-old male patient, with a history of left shoulder surgery, received an intramuscular left deltoid injection of ADACEL (lot number U4837AA) on 11 March 2014. On unspecified time post vaccination, he began experiencing severe myalgia and malaise with body aches, headache, and muscle aches both lower extremities and elbows. On 21 March 2014 the patient reported feeling cold for two hours, followed by sweats and a temperature of 100 degrees Fahrenheit. The patient was evaluated by his physician on 24 March 2014. According to the reporter, the patient's symptoms were "severe to the point that the patient had to be seen in a wheelchair". Laboratory testing performed on an unspecified date were as follows: white blood count 18,000; sedimentation rate 121; C-reactive protein 30.5; increased alkaline phosphatase, liver enzymes, monocytes, neutrophils, and eosinophils. Hepatitis A, B, and C testing and liver ultrasound were negative. The patient was to be evaluated by a rheumatologist; results of the consultation were not reported. According to the reporter, the physician was "ruling out serum sickness versus infection". Outcome was unknown. Documents held by sender: None.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Wheelchair user, White blood cell count increased
Clinical narrative: Initial case received from a health care professional (physician's assistant) on 26 March 2014. A 33-year-old male patient, with a history of left shoulder surgery, received an intramuscular left deltoid injection of ADACEL (lot number U4837AA) on 11 March 2014. On unspecified time post vaccination, he began experiencing severe myalgia and malaise with body aches, headache, and muscle aches both lower extremities and elbows. On 21 March 2014 the patient reported feeling cold for two hours, followed by sweats and a temperature of 100 degrees Fahrenheit. The patient was evaluated by his physician on 24 March 2014. According to the reporter, the patient's symptoms were "severe to the point that the patient had to be seen in a wheelchair". Laboratory testing performed on an unspecified date were as follows: white blood count 18,000; sedimentation rate 121; C-reactive protein 30.5; increased alkaline phosphatase, liver enzymes, monocytes, neutrophils, and eosinophils. Hepatitis A, B, and C testing and liver ultrasound were negative. The patient was to be evaluated by a rheumatologist; results of the consultation were not reported. According to the reporter, the physician was "ruling out serum sickness versus infection". Outcome was unknown. Documents held by sender: None.
Sex: F
Vaccine: PPV
Symptoms: Cough, Pneumonia, Pyrexia, Wheezing
Clinical narrative: This spontaneous report as received from a female patient of unknown age concerning herself via Pfizer (other company number 2014073846). 10 years ago, in approximately March 2004 the patient was vaccinated with PNEUMOVAX 23 (lot number, dose, route and strength were not reported). Then the patient received a booster vaccine (manufacturer unknown) 2 years ago in approximately March 2012. Diagnosed with pneumonia this last week (in March 2014). The patient experienced cough, fever, wheezing. The patient was asked that why would she get pneumonia when she received the pneumonia vaccine. The outcome and action taken were not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to two unspecified patients. The patients' medical history and drug allergies were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX (dose, frequency, route, lot# and expired date were not reported). Concomitant therapy was not reported. On an unknown date the patients developed shingles after receiving ZOSTAVAX. The outcome of the adverse event was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Rash morbilliform
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a female patient of unknown age. On 14-FEB-2014 the patient was vaccinated with a dose of M-M-R II (lot # J007156) (1 viral, injection). On 24-FEB-2014, the patient developed measles like rash after receiving M-M-R II. The patient sought medical attention by seeing physician. There was no treatment given. The outcome of the event was unknown. Additional information has been requested.
Age: 1.2
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a Nurse refers to a 14 month old patient. The nurse reported that on 28-MAR-2014, the patient was supposed to receive TDAP and was inadvertently vaccinated a dose of GARDASIL (0.5 ml intramuscular). No adverse effects were reported. No further information provided. 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 healthcare worker refers to an unspecified number of patients of unknown age and gender. It was reported that 20-30 doses of VARIVAX (Merck) that were exposed to temperatures outside of the range in the prescribing information have been administered (dates of administration, lot/batch numbers and expiration dates not reported). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. Pharmacist reported that unspecified patient, physician's office asked for stability of ZOSTAVAX (lot # J011335, expiration date 13-DEC-2014) exposed to 70F for total 40 minutes, in order to administer to patient. Unspecified patient might be receiving the improperly stored ZOSTAVAX (lot # J011335, expiration date 13-DEC-2014) on 19-MAR-2014. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient now in her 20's. The patient's current conditions or medical history were not reported. On an unspecified date, in the last year, the patient was vaccinated as adolescent with all 3 doses of GARDASIL (dose, route, lot number and expiration date were not reported). On an unspecified date, the patient was diagnosed with high risk HPV (human papilloma virus). The patient cleared the HPV without requiring treatment. The high risk HPV serotype was not determined. The patient went to the doctor's office for medical attention. Pap with HPV DNA testing were performed on an unspecified date, HPV serotype was not determined. This one of several reports from the same source. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Expired drug administered, Nausea, Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 80 year old female patient with Alzheimer's disease, drug reactions or allergies to iodine and nonsteroidal anti-inflammatory drugs. On 21-MAR-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # H010661, expiry date 02-FEB-2014, 0.5 ml, intramuscularly. Other suspect therapies included a dose of ZOSTAVAX (dose, route and lot number not reported) also administered on 21-MAR-2014. In approximately March 2014 the patient experienced nausea and vomiting. It was reported that the patient sought medical attention: her daughter called to pharmacy. The outcome of nausea and vomiting was unknown. Relatedness between nausea, vomiting and the therapies was unknown. This report is linked to MARRS # 1403USA013260 (Same reporter link). Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On 21-MAR-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # H010661, expiry date 02-FEB-2014, (dose and route not reported). The patient experienced no adverse event. This report is linked to MARRS # 1403USA012633 (Same reporter link). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 18-MAR-2014, the patient was vaccinated with a dose of PNEUMOVAX23, batch # J002646, lot # H013039, with an expiration date of 12-MAR-2014 (dose and route not reported). No adverse effect was reported. Additional information has been requested.
Age: 1.21
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Pt. vaccinated VARVAXI 3/17/14. Started with rash approx. 3/24/14 - seen 3/31/14 - rash verified by MD. Suspected post-vaccine chicken po.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 25-MAR-2014 the patient was vaccinated with M-M-R II (lot # 0412AE; expiration date 27-FEB-2014). On 25-MAR-2014 the patient was administered a dose of expired M-M-R II. No adverse effect reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Convulsion
Clinical narrative: Seizure (poss. febrile seizure as per ED visit on 3/29 - about 24 h. post immunization).
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abnormal behaviour, Activities of daily living impaired, Breath sounds abnormal, Chest X-ray abnormal, Chills
Clinical narrative: In the afternoon while talking to a friend, realize that there were behavioral type changes. Went to bed early at 6:30pm and awoke with paralysis, excruciating pain, headache and hallucinations. At one point of delirium maybe had high temperature. Had paralysis throughout body and was in and out of consciousness. This ordeal lasted about 3-4 hours. At 11pm was able to walk to get a drink of water and wash cloth for face. Was rubber legged. Considered calling 911 but did not because door was locked and dog was already quite upset. Symptoms began to subside just had fever and chills. Slept all day long to recover. Due to bladder infection doctor prescribed BACTRIM and was taking it. A cough started on Tuesday and got worse by Wednesday. Did not feel good all week long by the end of the week muscle spasms started. On Saturday had cramps in right leg, dizziness and lightheadedness so called ambulance to be taken to ER. BP was 135/70. Dr. at hospital ran chest x-ray, EKG, urine test. He confirmed that there was still a bladder infection but also heard rattling in lungs so diagnosed as pneumonia. By this day had almost finished 7 day treatment of BACTRIM--only had 1 day dose left. Doctor prescribed Levofloxacin 500mg to help with the bladder infection and pneumonia. Regularly patient is very active and intellectual - speaks multiple languages, rides horse and has high mental acuity -- but the week after the vaccine had to think doing things in steps to perform daily activities. Had to think through thoughts to be coherent. Now she feels better, relieved that her skills are coming back even her sense of humor. Called her doctor to let them know what happened.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Condition aggravated, Consciousness fluctuating, Cough, Cystitis, Delirium
Clinical narrative: In the afternoon while talking to a friend, realize that there were behavioral type changes. Went to bed early at 6:30pm and awoke with paralysis, excruciating pain, headache and hallucinations. At one point of delirium maybe had high temperature. Had paralysis throughout body and was in and out of consciousness. This ordeal lasted about 3-4 hours. At 11pm was able to walk to get a drink of water and wash cloth for face. Was rubber legged. Considered calling 911 but did not because door was locked and dog was already quite upset. Symptoms began to subside just had fever and chills. Slept all day long to recover. Due to bladder infection doctor prescribed BACTRIM and was taking it. A cough started on Tuesday and got worse by Wednesday. Did not feel good all week long by the end of the week muscle spasms started. On Saturday had cramps in right leg, dizziness and lightheadedness so called ambulance to be taken to ER. BP was 135/70. Dr. at hospital ran chest x-ray, EKG, urine test. He confirmed that there was still a bladder infection but also heard rattling in lungs so diagnosed as pneumonia. By this day had almost finished 7 day treatment of BACTRIM--only had 1 day dose left. Doctor prescribed Levofloxacin 500mg to help with the bladder infection and pneumonia. Regularly patient is very active and intellectual - speaks multiple languages, rides horse and has high mental acuity -- but the week after the vaccine had to think doing things in steps to perform daily activities. Had to think through thoughts to be coherent. Now she feels better, relieved that her skills are coming back even her sense of humor. Called her doctor to let them know what happened.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Electrocardiogram, Feeling abnormal, Hallucination, Headache
Clinical narrative: In the afternoon while talking to a friend, realize that there were behavioral type changes. Went to bed early at 6:30pm and awoke with paralysis, excruciating pain, headache and hallucinations. At one point of delirium maybe had high temperature. Had paralysis throughout body and was in and out of consciousness. This ordeal lasted about 3-4 hours. At 11pm was able to walk to get a drink of water and wash cloth for face. Was rubber legged. Considered calling 911 but did not because door was locked and dog was already quite upset. Symptoms began to subside just had fever and chills. Slept all day long to recover. Due to bladder infection doctor prescribed BACTRIM and was taking it. A cough started on Tuesday and got worse by Wednesday. Did not feel good all week long by the end of the week muscle spasms started. On Saturday had cramps in right leg, dizziness and lightheadedness so called ambulance to be taken to ER. BP was 135/70. Dr. at hospital ran chest x-ray, EKG, urine test. He confirmed that there was still a bladder infection but also heard rattling in lungs so diagnosed as pneumonia. By this day had almost finished 7 day treatment of BACTRIM--only had 1 day dose left. Doctor prescribed Levofloxacin 500mg to help with the bladder infection and pneumonia. Regularly patient is very active and intellectual - speaks multiple languages, rides horse and has high mental acuity -- but the week after the vaccine had to think doing things in steps to perform daily activities. Had to think through thoughts to be coherent. Now she feels better, relieved that her skills are coming back even her sense of humor. Called her doctor to let them know what happened.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Incoherent, Muscle spasms, Muscular weakness, Pain, Paralysis
Clinical narrative: In the afternoon while talking to a friend, realize that there were behavioral type changes. Went to bed early at 6:30pm and awoke with paralysis, excruciating pain, headache and hallucinations. At one point of delirium maybe had high temperature. Had paralysis throughout body and was in and out of consciousness. This ordeal lasted about 3-4 hours. At 11pm was able to walk to get a drink of water and wash cloth for face. Was rubber legged. Considered calling 911 but did not because door was locked and dog was already quite upset. Symptoms began to subside just had fever and chills. Slept all day long to recover. Due to bladder infection doctor prescribed BACTRIM and was taking it. A cough started on Tuesday and got worse by Wednesday. Did not feel good all week long by the end of the week muscle spasms started. On Saturday had cramps in right leg, dizziness and lightheadedness so called ambulance to be taken to ER. BP was 135/70. Dr. at hospital ran chest x-ray, EKG, urine test. He confirmed that there was still a bladder infection but also heard rattling in lungs so diagnosed as pneumonia. By this day had almost finished 7 day treatment of BACTRIM--only had 1 day dose left. Doctor prescribed Levofloxacin 500mg to help with the bladder infection and pneumonia. Regularly patient is very active and intellectual - speaks multiple languages, rides horse and has high mental acuity -- but the week after the vaccine had to think doing things in steps to perform daily activities. Had to think through thoughts to be coherent. Now she feels better, relieved that her skills are coming back even her sense of humor. Called her doctor to let them know what happened.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pneumonia, Pyrexia, Somnolence, Urine analysis abnormal
Clinical narrative: In the afternoon while talking to a friend, realize that there were behavioral type changes. Went to bed early at 6:30pm and awoke with paralysis, excruciating pain, headache and hallucinations. At one point of delirium maybe had high temperature. Had paralysis throughout body and was in and out of consciousness. This ordeal lasted about 3-4 hours. At 11pm was able to walk to get a drink of water and wash cloth for face. Was rubber legged. Considered calling 911 but did not because door was locked and dog was already quite upset. Symptoms began to subside just had fever and chills. Slept all day long to recover. Due to bladder infection doctor prescribed BACTRIM and was taking it. A cough started on Tuesday and got worse by Wednesday. Did not feel good all week long by the end of the week muscle spasms started. On Saturday had cramps in right leg, dizziness and lightheadedness so called ambulance to be taken to ER. BP was 135/70. Dr. at hospital ran chest x-ray, EKG, urine test. He confirmed that there was still a bladder infection but also heard rattling in lungs so diagnosed as pneumonia. By this day had almost finished 7 day treatment of BACTRIM--only had 1 day dose left. Doctor prescribed Levofloxacin 500mg to help with the bladder infection and pneumonia. Regularly patient is very active and intellectual - speaks multiple languages, rides horse and has high mental acuity -- but the week after the vaccine had to think doing things in steps to perform daily activities. Had to think through thoughts to be coherent. Now she feels better, relieved that her skills are coming back even her sense of humor. Called her doctor to let them know what happened.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pallor, Rash
Clinical narrative: 7x7 cm raised, red, warm area on (L) thigh. Rash blanches.
Age: 1.02
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Clonus, Convulsion, Muscle twitching, Pyrexia
Clinical narrative: First seizure occurred 3-27, called paramedics who took him to the ER. Seizure way not focal, clonic movements lasted approximately 5 mins. Fever 103.8 ER gave TYLENOL and d/c'd patient. 3-28 - twitching - non-focal ? approximately 10 mins. Went to ER temp 102.8 mom had been alternating MOTRIN and TYLENOL.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Arthralgia, Asthenia, Chills, Contusion
Clinical narrative: Right leg, ankle, foot injury and other symptoms. Starting 01.11.2014 Sat, my first adverse reactions were: strong persistent headache, right leg/ankle/foot with pain, swelling, numbness and tingling of same area. Toe area was black and blue - right foot. Starting 01.13.2014 Mon. my lower right leg and foot had the chills. I had a persistent strong headache that lasted the whole week, my vision became painful when I tried to read anything, mild fever, mild bruising, pain, redness/sunburn-like skin of my right foot, numbness, swelling of my right foot and ankles and legs, right foot had gone through some muscle weakness, my right foot-my skin became dry, rough, leathery, and weighed extra heavy while bottom of foot sagged from it's extra weight. My right lower leg and ankle is bent, crooked (moved to one side), and out of joint. I can't walk without assistance (a walker). I experience fatigue, sleep more, lack strength which limits the amount of work that I can do each day. On some days, my feet are very sensitive to any floor surface that I walk on so I may end up taking TYLENOL or aspirin for pain. Frequently, I skip meals because it's too painful/difficult to walk. The pain is not primarily coming from a tingling foot. Mostly, when I's sitting or standing, my right foot will not lay flat on the floor. My arch to my heel wants to stand off the ground. Sometimes, my upper left leg and hip will start hurting because of how much the left side of my body has to support the rest of me. On 01.16.2014 Thu. is when I first got up off my bed to start walking and start my day. I started taking a few short steps passing two lazy boy chairs and near the second chair my right ankle gave way two times within five minutes causing me to slide onto the floor along side the chair and then I had a hard time getting into the chair. The second time I fell my right ankle made a squishy sound. On 01.13.2014 Mon. is when I took my mom to and from a dr's appt., and before we got home we stopped at our local grocery store. My foot was swollen and hurting and as I proceeded to pass (heading to the store) our car, my ankle locked up in intense pain and I had to hop back to the car. I had to do the same thing when we went home (hop). The only shoes I've been able to wear was house shoes. I've had to go from crawling all over the house to using a walker every where I go. I rarely drive a car (now). It's just too hard and scary now. I can only go shop in stores that have the  handicap scooters. My mom pain for my flu shot and a walker for me. I live with her and she supports me. I have no income and no medical insurance. The medical clinic that I'll be going to is a low cost charity clinic. My first dr's visit is on: 04.22.2014 Tue.