chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Lumbar puncture normal, Muscle twitching, Nuclear magnetic resonance imaging abnormal, Partial seizures, Status epilepticus
Clinical narrative: On 4/1 and 3/31 T 102+. On 4/2/14 T 103+ and one arm twitching, witnessed by EMS and ER. Given ATIVAN/fosphenytoin and observed. Recurrence focal and generalized sz with (+) EEG findings until put on phenobarbital. All viral and bacterial cultures (-), HSV negative. MRI - diffuse changes c/w seizures. Dx Complex Febrile Sz - focal status epilepticus.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Viral test negative
Clinical narrative: On 4/1 and 3/31 T 102+. On 4/2/14 T 103+ and one arm twitching, witnessed by EMS and ER. Given ATIVAN/fosphenytoin and observed. Recurrence focal and generalized sz with (+) EEG findings until put on phenobarbital. All viral and bacterial cultures (-), HSV negative. MRI - diffuse changes c/w seizures. Dx Complex Febrile Sz - focal status epilepticus.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Electrocardiogram normal, Fluid retention, Joint swelling, Laboratory test
Clinical narrative: Pt describes swelling in ankles, shortness of breath and fluid retention. Physician prescribed furosemide 60mg for 3 days then 20mg daily. Ordered more diagnostic tests.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Injection site erythema, Injection site induration, Injection site reaction, Local swelling
Clinical narrative: Pt arm was swollen from armpit to elbow and developed a large blister. Had low grade fever. Went to urgent care with fever and MD worried about necrotic tissue fever is now gone and pt swelling is down. Just has a red hard scaly area at the injection site. MD told me this may take a month to go away. Still has small red circle at injection site but much better.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Skin exfoliation
Clinical narrative: Pt arm was swollen from armpit to elbow and developed a large blister. Had low grade fever. Went to urgent care with fever and MD worried about necrotic tissue fever is now gone and pt swelling is down. Just has a red hard scaly area at the injection site. MD told me this may take a month to go away. Still has small red circle at injection site but much better.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site vesicles, Malaise
Clinical narrative: Pt arm was swollen from armpit to elbow and developed a large blister. Had low grade fever. Went to urgent care with fever and MD worried about necrotic tissue fever is now gone and pt swelling is down. Just has a red hard scaly area at the injection site. MD told me this may take a month to go away. Still has small red circle at injection site but much better.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: Big red spot, hot in the area of the vaccine site, bumpy.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Vaccine was given subcutaneously, not intramuscularly. Pt prefer IM.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, C-reactive protein, Local swelling, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Pt has Tdap on 3/21/14 per general ACIP recommendations. On 3/29/14, pt. started to ache in her knees. By 3/31 her leg was throbbing - was seen by dr. MRI done. Found small Baker's cyst - Later that day her neck was stiff and by that evening she could hardly move. By 4/1/14 every joint hurt. (L) foot swollen. In 2012 after salmonella dx, pt developed Reiter's syndrome. This recent incident was worse.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain in extremity, Red blood cell sedimentation rate increased, Synovial cyst
Clinical narrative: Pt has Tdap on 3/21/14 per general ACIP recommendations. On 3/29/14, pt. started to ache in her knees. By 3/31 her leg was throbbing - was seen by dr. MRI done. Found small Baker's cyst - Later that day her neck was stiff and by that evening she could hardly move. By 4/1/14 every joint hurt. (L) foot swollen. In 2012 after salmonella dx, pt developed Reiter's syndrome. This recent incident was worse.
Age: 85.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left upper arm redness, swelling, tenderness began 1 day following vaccine admin.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Pt c/o rash, swelling, and pain at site of injection. (L) deltoid.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Feeling hot
Clinical narrative: Patient began feeling hot and weak a couple minutes after vaccine was administered. EMS were called and while we waited her blood pressure was checked. It was 106/85.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Influenza like illness, Injection site swelling, Pain
Clinical narrative: Received pneumococcal polysaccharide vaccine age 65 and over: Site of injection swollen down to 2" above elbow for 5 days plus body aches and pain (Flu like symptoms).
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Scab
Clinical narrative: This spontaneous report was received from a 84 year old female patient reporting on herself. In approximately 2008, the patient was vaccinated with ZOSTAVAX (dose, strength and lot number were not provided). Concomitant therapies reported as 2 blood pressure medications (medication names unspecified). In approximately January 2013, reported as one year ago in January, the patient experienced shingles. Patient stated that she felt some pain for about a week. After a week of experiencing pain her daughter could see blisters across her shoulder; though her daughter informed her that the blisters had already began to crust. Patient stated that the pain she experienced was not a lot of pain and that the whole experience lasted for only a few weeks, she felt that it was a mild case of shingles. Patient stated that 5 months later, her physician could see the spots on her shoulder still from where the blisters had been. Lab diagnostic studies were not performed. Patient sought medical attention. At the time of the report, the outcome of the events was recovered. The causal relationship between the event and ZOSTAVAX was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Information was received from a claims administrator for a pharmacy concerning a female who was vaccinated with ZOSTAVAX. On 29-MAR-2014, she sustained an allergic reaction. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a patient of unknown age and gender. No medical history or concurrent conditions reported. On 13-NOV-2013, the patient was vaccinated with the first dose of GARDASIL, intramuscular injection, dose: 0 .5 ml (Lot number and strength not provided). On 13-DEC-2013, patient was vaccinated with the second dose and on 15-JAN-2014 was vaccinated with the third dose. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from an anonymous reporter (demographics unknown) concerning a female patient of unknown age. The reporter stated he/she knew someone who on an unknown date received a dose of MMR II (Lot # not reported) (dose and route not reported). Concomitant medications were not reported. On an unknown date the female patient experienced many unspecified adverse reactions. The patient's outcome was unknown. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Retching
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patient of unknown demographics. The patients current conditions or medical history were not reported. On an unknown date, the patient received the first dose of ROTATEQ suspension 2 (dose, route, lot number and expiration date were not reported). On an unknown date, after receiving the first dose of ROTATEQ the patient. Outcome of ** was unknown at the time of the report. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from medical assistant, concerning to a patient of unknown age and gender, the patient's pertinent medical history, dug reactions/allergies were not provided. On unknown date, sometime in the past, the patient was vaccinated inadvertently with a dose of PROQUAD (Merck) (total dose, route and lot number were not provided), instead of a dose of VARIVAX (Merck) (total dose, route and lot number were not provided). This is one of several reports received from the same source. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from medical assistant, concerning to an 8 year old patient (gender not provided). The patient's pertinent medical history, drug reactions/allergies were not provided. On 11-APR-2014, the patient was vaccinated inadvertently with a dose of PROQUAD (Merck) (total dose, route and lot number were not provided), instead of a dose of VARIVAX (Merck) (total dose, route and lot number were not provided). No symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a physician assistant via a company representative refers to a 73 year old female patient. None pertinent medical history, drug reactions or allergies reported. On approximately 2000, reported as "12 to 14 years ago", the patient was vaccinated with ZOSTAVAX (dose and lot # were not reported) for prevention of shingles as part of a "shingles prevention study". The reporter was not sure if the patient received ZOSTAVAX "unblinded". Concomitant therapy included unspecified cholesterol medication and unspecified hormone replacement. On 08-APR-2014, the patient experienced significant case of shingles with significant rash with grouped vesicles on the left flank to midline. On 11-APR-2014, the patient was seen at physician's office. The patient was prescribed VALTREX. The outcome of significant case of shingles was unknown. Causality was not reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. On 03-APR-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # J010396, 0.5 ml, IM) for vaccination. On an unknown date in April 2014 the patient experienced pain at the injection site. The patient was called the office for medical attention and was suggested to use ice compresses and ibuprofen. None lab was performed. The outcome of the adverse event was unknown. This is one of the two reports from the same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: No therapeutic response, Seroconversion test negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 23 year old female patient with none pertinent medical history or drug reaction allergies. In 1992 the patient received the first dose of M-M-R II (Lot # not reported) (dose and route not reported) and in 1996 the patient received the second dose of M-M-R II (Lot # not reported) (dose and route not reported). There was no concomitant therapy. On 04-APR-2014 antibody titer was drawn and the patient failed to seroconvert. The patient will be vaccinated with another dose of M-M-R II. No treatment was given for the adverse event. The outcome of client failed to seroconvert and no therapeutic response was unknown. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site swelling, Pain
Clinical narrative: Received ZOSTAVAX inj single dose vial 10pk. Site of injection swollen down to 2" above elbow and body aches and pains (Flu like symptoms) that lasted 5-6 days.
Age: 23.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Exposure during pregnancy, Mycobacterium tuberculosis complex test positive, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from Registered Nurse refers to a 23 year old female patient with no drug reaction. The patient was no medical history. On 27-FEB-2013 the patient was vaccinated with VARIVAX (Merck), 05 ml/once, subcutaneous (Lot# J005869 and unspecified expiration date) and a dose of M-M-R II (Lot # H015833 and expiration date was on 24-AUG-2014). Concomitant medication included prenatal vitamins. The patient was seen in office today on 04-APR-2014, due to "a positive tuberculosis (TB) blood test". During the office visit, the nurse stated the patient "had a positive pregnancy test". The nurse stated the patient was 10 weeks pregnant. The patient became pregnant with LMP of 24-JAN-2014 and EDD of 31-OCT-2014. Initial exposure to VARIVAX (Merck) was at 5 week(s). The pregnancy outcome was outcome pending. The patient did not treat events. The outcome of events was unknown. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 68 year old male patient. On 14-APR-2014, the patient was vaccinated with a 0.5 ml expired dose of PNEUMOVAX 23 (Lot # H016295, expiration date 02-NOV-2013) intramuscularly. No adverse effects were reported. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Sensation of heaviness
Clinical narrative: This spontaneous report as received from a medical assistant refers to a male patient of unknown age. On 02-APR-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # J010396, 0.5 ml, IM). On an unknown date in April 2014 the patient experienced pain at the injection site and legs feel like he was walking through 3 feet of snow. The patient was called the office for medical attention and was suggested to use ice compresses and ibuprofen. None lab was performed. The outcome of the adverse events was unknown. This is one of the two reports from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Fatigue, Pain
Clinical narrative: This spontaneous report as received from a mother refers to a 15 year old female patient. On an unknown date the patient was vaccinated with GARDASIL (lot number not reported). On an unknown date after the first dose of the vaccine, the patient experienced unexplained pain and fatigue. After the second dose, the pain (disability) and fatigue (disability) worsened to the point patient could not attend school. It was reported at first the family did not suspect the vaccine. Doctors couldn't explain her reaction either. However, when the family mapped out her absences from school, they realized they started and intensified in the days after receiving the vaccine. The reporter stated that there's a big difference between correlation and causation and she understand that. But it seemed very clear at that point. Doctors told  reporter that reactions to the vaccine do happen. The family filed a report with the FDA's Vaccine Adverse Event Reaction System (VAERS). The outcome of unexplained pain, fatigue, the pain (disability) and fatigue (disability) worsened to the point patient could not attend school was unknown. The reporter considered the events to be related to GARDASIL. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin lesion
Clinical narrative: This spontaneous report as received from a nurse refers to a 64 year old female patient with drug reactions/allergies to morphine and with no pertinent medical history. On 20-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J006828, expiration date 14-SEP-2014), dose not reported, subcutaneous. Concomitant therapies included TYLENOL, losartan potassium (manufacturer unknown), ibuprofen, fish oil, simvastatin (manufacturer unknown), ubidecarenone, calcium (unspecified) and multivitamin. On 24-NOV-2013, the patient experienced shingles after received ZOSTAVAX. No Lab diagnostics studies was performed. The treatments of famciclovir and hydrocodone were given to the event. The outcome of the event was reported as not recovered. The patient had sought medical attention by office visit. Follow up information had been received from the nurse refers to a 64 year old female patient. On 20-NOV-2013 at 04:23 PM the patient was vaccinated with the first dose of ZOSTAVAX (lot # J006828, expiration date 14-SEP-2014) subcutaneously in the left upper arm. On 23-NOV-2013, the patient experienced eruption of skin lesion, left chest and mid back, total 3 lesions. The patient had required emergency room/doctor visit for medical attention. The event was required medical/surgical intervention which was considered as medically significant event. The outcome of eruption of skin lesion, left chest and mid back, total 3 lesions was unknown. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: SMALL
Symptoms: Rash maculo-papular, Rash pruritic
Clinical narrative: Patient developed pruritic maculo/papular rash on torso and extremties, including palms of hands and soles of feet.
Age: 0.54
Sex: M
Vaccine: 6VAX-F, PPV, RVX
Symptoms: Injection site rash
Clinical narrative: Rash on all injection sites lasted 2 months.
Age: 76.0
Sex: F
Vaccine: FLUX, VARZOS, FLUX, VARZOS
Symptoms: Abasia, Chills, Erythema, Feeling of body temperature change, Neuropathy peripheral
Clinical narrative: This consumer report (initial receipt 05-Apr-2014) concerns a 76 year old female patient who had a medical history of spina bifida, diabetes, neuropathy and a stent in the heart which was due to 80% block in the aorta. Concomitant medications included gabapentin and duloxetine. The patient previously had used clopidogrel. On an unspecified date in Aug-2013, the patient received the influenza virus vaccine (manufacturer and batch number not reported) one injection. On the same day, the patient received ZOSTAVAX (batch number not specified) one injection. On the 24-Mar-2014, the patient developed hot and cold chills, red patches on her right leg from the knee to the groin and could not walk due to the pain. The pain progressively got worse. The patient thought it was shingles. On an unknown date, the patient saw two different doctors who told her that it was not shingles but neuropathy. The patient was diagnosed with neuropathy. In Mar-2014, the patient went for an X-ray and she had no broken bones. Outcome was not recovered. Reporter comments: The reporter stated she will not have ZOSTAVAX again and it was unknown whether she would get the flu shot again. The reporter assessed the case as potentially non-serious.
Age: 76.0
Sex: F
Vaccine: FLUX, VARZOS, FLUX, VARZOS
Symptoms: Pain, X-ray normal
Clinical narrative: This consumer report (initial receipt 05-Apr-2014) concerns a 76 year old female patient who had a medical history of spina bifida, diabetes, neuropathy and a stent in the heart which was due to 80% block in the aorta. Concomitant medications included gabapentin and duloxetine. The patient previously had used clopidogrel. On an unspecified date in Aug-2013, the patient received the influenza virus vaccine (manufacturer and batch number not reported) one injection. On the same day, the patient received ZOSTAVAX (batch number not specified) one injection. On the 24-Mar-2014, the patient developed hot and cold chills, red patches on her right leg from the knee to the groin and could not walk due to the pain. The pain progressively got worse. The patient thought it was shingles. On an unknown date, the patient saw two different doctors who told her that it was not shingles but neuropathy. The patient was diagnosed with neuropathy. In Mar-2014, the patient went for an X-ray and she had no broken bones. Outcome was not recovered. Reporter comments: The reporter stated she will not have ZOSTAVAX again and it was unknown whether she would get the flu shot again. The reporter assessed the case as potentially non-serious.
Age: 76.0
Sex: F
Vaccine: FLUX, VARZOS, FLUX, VARZOS
Symptoms: Abasia, Chills, Erythema, Feeling cold, Feeling hot
Clinical narrative: This consumer report (initial receipt 05-Apr-2014) concerns a 76 year old female patient who had a medical history of spina bifida, diabetes, neuropathy and a stent in the heart which was due to 80% block in the aorta. Concomitant medications included gabapentin and duloxetine. The patient previously had used clopidogrel. On an unspecified date in Aug-2013, the patient received the influenza virus vaccine (manufacturer and batch number not reported) one injection. On the same day, the patient received ZOSTAVAX (batch number not specified) one injection. On the 24-Mar-2014, the patient developed hot and cold chills, red patches on her right leg from the knee to the groin and could not walk due to the pain. The pain progressively got worse. The patient thought it was shingles. On an unknown date, the patient saw two different doctors who told her that it was not shingles but neuropathy. The patient was diagnosed with neuropathy. In Mar-2014, the patient went for an X-ray and she had no broken bones. Outcome was not recovered. Reporter comments: The reporter stated she will not have ZOSTAVAX again and it was unknown whether she would get the flu shot again. The reporter assessed the case as potentially non-serious.
Age: 76.0
Sex: F
Vaccine: FLUX, VARZOS, FLUX, VARZOS
Symptoms: Neuropathy peripheral, Pain, X-ray normal
Clinical narrative: This consumer report (initial receipt 05-Apr-2014) concerns a 76 year old female patient who had a medical history of spina bifida, diabetes, neuropathy and a stent in the heart which was due to 80% block in the aorta. Concomitant medications included gabapentin and duloxetine. The patient previously had used clopidogrel. On an unspecified date in Aug-2013, the patient received the influenza virus vaccine (manufacturer and batch number not reported) one injection. On the same day, the patient received ZOSTAVAX (batch number not specified) one injection. On the 24-Mar-2014, the patient developed hot and cold chills, red patches on her right leg from the knee to the groin and could not walk due to the pain. The pain progressively got worse. The patient thought it was shingles. On an unknown date, the patient saw two different doctors who told her that it was not shingles but neuropathy. The patient was diagnosed with neuropathy. In Mar-2014, the patient went for an X-ray and she had no broken bones. Outcome was not recovered. Reporter comments: The reporter stated she will not have ZOSTAVAX again and it was unknown whether she would get the flu shot again. The reporter assessed the case as potentially non-serious.
Age: 76.0
Sex: F
Vaccine: FLUX, VARZOS, FLUX, VARZOS
Symptoms: Abasia, Chills, Erythema, Feeling of body temperature change, Neuropathy peripheral
Clinical narrative: This spontaneous report as received from an unknown person refers to a 76 year old female patient with diabetes. The patient's medical history included neuropathy, spina bifida and stent in heart due to 80% block in aorta. The patient's relevant past drug history includes PLAVIX. On AUG-2013 the patient was vaccinated with one dose of ZOSTAVAX (No lot numbers or expiration dates were reported) injection, dose unknown on an unknown date in August 2013. Other suspect therapies included a dose of influenza virus vaccine (manufacturer unknown) (reported as flu shot) injection, dose unknown on the same day in Aug2013. Concomitant therapies included CYMBALTA and gabapentin. On 24-MAR-2014 the patient started to get hot and cold chills, red patches on her right leg from knee to groin and could not walk due to the pain. She states it is progressively getting worse in pain. The patient thought it was shingles. On unknown dates she saw 2 different doctors who told her it was not shingles but neuropathy. On an unknown date in March 2014 she was sent for an X-ray and she had no broken bones. As of 05-APR-2014 she would never have the ZOSTAVAX again, it was unknown if she would get the flu shot again. She continued to have hot and cold chills, red patches on her right leg from knee to groin and cannot walk due to the pain, and was progressively getting worse in pain. The doctors had diagnosed it as neuropathy and not the shingles. The outcome of neuropathy was unknown. Additional information is not expected.
Age: 76.0
Sex: F
Vaccine: FLUX, VARZOS, FLUX, VARZOS
Symptoms: Pain, X-ray normal
Clinical narrative: This spontaneous report as received from an unknown person refers to a 76 year old female patient with diabetes. The patient's medical history included neuropathy, spina bifida and stent in heart due to 80% block in aorta. The patient's relevant past drug history includes PLAVIX. On AUG-2013 the patient was vaccinated with one dose of ZOSTAVAX (No lot numbers or expiration dates were reported) injection, dose unknown on an unknown date in August 2013. Other suspect therapies included a dose of influenza virus vaccine (manufacturer unknown) (reported as flu shot) injection, dose unknown on the same day in Aug2013. Concomitant therapies included CYMBALTA and gabapentin. On 24-MAR-2014 the patient started to get hot and cold chills, red patches on her right leg from knee to groin and could not walk due to the pain. She states it is progressively getting worse in pain. The patient thought it was shingles. On unknown dates she saw 2 different doctors who told her it was not shingles but neuropathy. On an unknown date in March 2014 she was sent for an X-ray and she had no broken bones. As of 05-APR-2014 she would never have the ZOSTAVAX again, it was unknown if she would get the flu shot again. She continued to have hot and cold chills, red patches on her right leg from knee to groin and cannot walk due to the pain, and was progressively getting worse in pain. The doctors had diagnosed it as neuropathy and not the shingles. The outcome of neuropathy was unknown. Additional information is not expected.
Age: 76.0
Sex: F
Vaccine: FLUX, VARZOS, FLUX, VARZOS
Symptoms: Abasia, Chills, Erythema, Feeling cold, Feeling hot
Clinical narrative: This spontaneous report as received from an unknown person refers to a 76 year old female patient with diabetes. The patient's medical history included neuropathy, spina bifida and stent in heart due to 80% block in aorta. The patient's relevant past drug history includes PLAVIX. On AUG-2013 the patient was vaccinated with one dose of ZOSTAVAX (No lot numbers or expiration dates were reported) injection, dose unknown on an unknown date in August 2013. Other suspect therapies included a dose of influenza virus vaccine (manufacturer unknown) (reported as flu shot) injection, dose unknown on the same day in Aug2013. Concomitant therapies included CYMBALTA and gabapentin. On 24-MAR-2014 the patient started to get hot and cold chills, red patches on her right leg from knee to groin and could not walk due to the pain. She states it is progressively getting worse in pain. The patient thought it was shingles. On unknown dates she saw 2 different doctors who told her it was not shingles but neuropathy. On an unknown date in March 2014 she was sent for an X-ray and she had no broken bones. As of 05-APR-2014 she would never have the ZOSTAVAX again, it was unknown if she would get the flu shot again. She continued to have hot and cold chills, red patches on her right leg from knee to groin and cannot walk due to the pain, and was progressively getting worse in pain. The doctors had diagnosed it as neuropathy and not the shingles. The outcome of neuropathy was unknown. Additional information is not expected.
Age: 76.0
Sex: F
Vaccine: FLUX, VARZOS, FLUX, VARZOS
Symptoms: Neuropathy peripheral, Pain, X-ray normal
Clinical narrative: This spontaneous report as received from an unknown person refers to a 76 year old female patient with diabetes. The patient's medical history included neuropathy, spina bifida and stent in heart due to 80% block in aorta. The patient's relevant past drug history includes PLAVIX. On AUG-2013 the patient was vaccinated with one dose of ZOSTAVAX (No lot numbers or expiration dates were reported) injection, dose unknown on an unknown date in August 2013. Other suspect therapies included a dose of influenza virus vaccine (manufacturer unknown) (reported as flu shot) injection, dose unknown on the same day in Aug2013. Concomitant therapies included CYMBALTA and gabapentin. On 24-MAR-2014 the patient started to get hot and cold chills, red patches on her right leg from knee to groin and could not walk due to the pain. She states it is progressively getting worse in pain. The patient thought it was shingles. On unknown dates she saw 2 different doctors who told her it was not shingles but neuropathy. On an unknown date in March 2014 she was sent for an X-ray and she had no broken bones. As of 05-APR-2014 she would never have the ZOSTAVAX again, it was unknown if she would get the flu shot again. She continued to have hot and cold chills, red patches on her right leg from knee to groin and cannot walk due to the pain, and was progressively getting worse in pain. The doctors had diagnosed it as neuropathy and not the shingles. The outcome of neuropathy was unknown. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Local swelling, Pruritus
Clinical narrative: Pt's arm got very red, swollen, and itchy radiating out from vaccine site. It was larger than a softball. She saw MD.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site swelling
Clinical narrative: Pt's arm got very red, swollen, and itchy radiating out from vaccine site. It was larger than a softball. She saw MD.
Age: 37.0
Sex: F
Vaccine: MNQ
Symptoms: Head injury, Induration, Pain in extremity, Pyrexia, Syncope
Clinical narrative: FEVER STARTED FIRST (101), THEN "FAINTED" 04/16/14 AT 08:00 A.M., FOR BRIEF PERIOD, "HIT HEAD AGAINST WALL" PER HUSBAND, RECOVERED QUICKLY. STILL HAS FEVER 04/17/14, 99.9 AT 11:00 A.M. PER HUSBAND. MAIN COMPLAINT IS ARM IS HARD AND SORE, DOES NOT WANT TO TOUCH IT. HAS BEEN TAKING TYLENOL.
Age: 1.03
Sex: M
Vaccine: FLU3, HEP, HIBV, IPV, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site urticaria, Urticaria
Clinical narrative: Immediately after vaccines given (MMR, Varicella, influenza to right leg) (HIB, HEP B, IPV to left leg) child developed hives to right leg and face. Child taken to treatment room and Benadryl 12.5mg administered, child observed for one hour and hives then resolved.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site streaking
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a female patient of unknown age who was being hospitalized since an unspecified date for pancreatitis. The patient did not have drug reactions/allergies. On 11-APR-2014, the patient was vaccinated with PNEUMOVAX 23 (lot # J010332, lot number 14-JAN-2015) (dose and route were not reported) during the hospitalization in her upper arm. Concomitant medical history was not reported. In approximately April 2014, the patient experienced a streak going down the arm in which she was administered PNEUMOVAX 23. The patient was diagnosed with cellulitis. It was unspecified by pharmacy technician whether hospitalization was prolonged by cellulitis. The outcome of the event was unknown. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 31 year old patient. Pertinent medical history and drug reactions/allergies were not reported. On 14-APR-2014, the patient was vaccinated with a expired VARIVAX (lot # H006462, expiration date of 08-MAR-2014) 0.5ml, subcutaneous for citizenship. No adverse effects reported. Concomitant therapy was not reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Immediate post-injection reaction, Presyncope
Clinical narrative: Near syncopal episode immediately after the immunization. Back to normal w/i 15 min after immunization.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a other Nurse Practitioner refers to a patient of unknown age. On 11-APR-2013 the patient was inadvertently vaccinated with MMR II expired vaccine (lot # 0183AE exp date: 18-JAN-2014), 0.5 ml, subcutaneous. No adverse effects reported. The patient outcome was unknown. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 38 year old female patient. On 04-APR-2014, the patient was vaccinated with a dose of PROQUAD (Merck), subcutaneous (lot # and expiration date were not provided). Other suspect therapies also administered on 04-APR-2014, included VARIVAX (Merck) (route, lot # and expiration date were not provided). On 04-APR-2014, when the patient was 38 years old, she received PROQUAD (Merck) and VARIVAX (Merck) in error. There were no known adverse effects. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 60 year old male patient. Pertinent medical history was not reported. Concomitant therapy was not reported. In 2014, the patient was vaccinated with ZOSTAVAX (lot number, dose and route were not reported) for vaccination. Concomitant therapy was not reported. In 2014, the patient developed a sore arm, post vaccination with ZOSTAVAX. The soreness occurred at the injection site a few days after administration of the ZOSTAVAX (unspecified which arm). The soreness went away. The patient did not seek medical attention. Lab diagnostic studies were not reported. The outcome of the event was reported as recovered (2014). Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a consumer regarding her daughter, a female patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with GARDASIL. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The reported stated that her daughter received dose two of GARDASIL about two to three years after the first dose. No adverse events reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperacusis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 12 year old female patient. On an unknown date, the patient was vaccinated with the third dose of GARDASIL (route, lot #, expiration date were not provided). On approximately February 2014, the patient experienced hypersensitivity to sound. No treatment was given to the patient. It was unknown if the patient sought medical attention. The pharmacist stated they believed the issue started right after the third dose but it did not become apparent until about two months ago. The outcome of hypersensitivity to sound was reported as not recovered/not resolved. Additional information is not expected.
Age: 52.0
Sex: F
Vaccine: RAB
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: She has received her third rabies vaccine and has developed pain and stiffness in her shoulder and neck on the side of administration now down her back into sacro iliac area, thought she had a fever early on but not now. She is slowly improving and will continue to treat symptoms, rx for naprosyn 500 mg bid and percocet prn, will rtc if sx persist.
Age: 1.41
Sex: M
Vaccine: MMRV
Symptoms: Rash generalised
Clinical narrative: Imm on 3/26/14, rash began 3/27/14 used topicals. 4/1/14 rash worsened, to ER on 4/1, given BENADRYL in ER, rash subsided. 4/3 rash returned, whole body rash. Pt to take BENADRYL 12.5 mg Q 6 hr x 1d and then continue Q 8-12 hrs if rash responds, then as needed. F/U if symptoms worsen.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Exposure during pregnancy, Pregnancy test positive, Viral titre
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse practitioner states that a female patient was tested for varicella titers because patient works in healthcare. Nurse practitioner states results of varicella titers were negative ("not showing immunity") so patient was vaccinated with VARIVAX (Merck) subcutaneous 0.5 ml once (LOT # reported as H020673 EXP DATE November 2014) on 24-MAR-2014. Nurse practitioner states at the time of VARIVAX (Merck) vaccination, an unspecified pregnancy test was completed and results were negative. Nurse practitioner states patient was seen in office on 11-APR-2014 reported as today for a follow up visit and an unspecified pregnancy test was completed with positive results. Nurse practitioner states patient was near 5 weeks gestation which means at vaccination, she would have been near 3 weeks gestation. The patient became pregnant with an estimated LMP of 17-FEB-2014 and an estimated EDD of 24-NOV-2014. The patient sought medical attention, she did not receive any treatment and the patient was reported as doing well. The pregnancy outcome was pending. Additional information has been requested.
Age: 0.19
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site rash, Injection site swelling, Rash papular
Clinical narrative: Patient was seen on 4/16/14, 8 days after the injections. Mother noticed rashes on both thighs 3 days after vaccines. Rashes were said to be papular with swelling at site of reaction. On exam, there were sparsely distributed non erythematous papular rash on both thighs anterolaterally.
Age: 1.02
Sex: F
Vaccine: FLU3, MMRV
Symptoms: Blood immunoglobulin G normal, Blood immunoglobulin M, Herpes zoster, Papule, Scab
Clinical narrative: This spontaneous report as received from a physician refers to a 1 year old female patient with no pertinent medical history and no drug reactions/allergies. On 24-FEB-2014, the patient was vaccinated with the first dose of PROQUAD (lot # J010597; expiration date 28-FEB-2015) (route not provided). Concomitant therapies included the second dose of FLUZONE, administered on 24-FEB-2014, separate site. No co-suspect therapies were reported. On 27-MAR-2014, the patient developed shingles following vaccination with PROQUAD. The physician reported that the patient developed shingles like rash that followed a dermatome on the upper left back. The physician reported that when she saw the rash it was described as crusted papules. The outcome of the event was reported as recovering/resolving. A physician was contacted. The patient received treatment with cephalexin and mupirocin ointment. A lab diagnostic test was performed for Varicella-Zoster Virus Antibodies, IgG and IgM on 03-APR-2014, and the result was negative antibodies detected to IgG and IgM. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: FLU3, MMRV
Symptoms: Varicella virus test negative
Clinical narrative: This spontaneous report as received from a physician refers to a 1 year old female patient with no pertinent medical history and no drug reactions/allergies. On 24-FEB-2014, the patient was vaccinated with the first dose of PROQUAD (lot # J010597; expiration date 28-FEB-2015) (route not provided). Concomitant therapies included the second dose of FLUZONE, administered on 24-FEB-2014, separate site. No co-suspect therapies were reported. On 27-MAR-2014, the patient developed shingles following vaccination with PROQUAD. The physician reported that the patient developed shingles like rash that followed a dermatome on the upper left back. The physician reported that when she saw the rash it was described as crusted papules. The outcome of the event was reported as recovering/resolving. A physician was contacted. The patient received treatment with cephalexin and mupirocin ointment. A lab diagnostic test was performed for Varicella-Zoster Virus Antibodies, IgG and IgM on 03-APR-2014, and the result was negative antibodies detected to IgG and IgM. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site warmth, Scab
Clinical narrative: 24 hours after getting vaccine, she noticed her arm was red, round, firm, hot to touch at injection site. No radiation, all local. She went to ER where she was treated with 10 days of BACTRIM DS and 3 days of prednisone 20mg bid. At follow up 4/15/14 - area is scabbed over.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This spontaneous report as received from a health care worker refers to a 17 year old female patient with drug allergy to cephalosporins (manufacturer unknown), penicillins manufacturer unknown) and sulfa drugs (manufacturer). The patient's pertinent medical  history as none. On 04-FEB-2014, the patient was vaccinated with GARDASIL (route: Intramuscularly) for treatment of human papillomavirus (HPV). On 10-APR-2014 the patient was vaccinated with second dose of GARDASIL (Intramuscularly in the left arm) (lot # H020901, Expiry date: 05-JUL-2015). No concomitant therapies were reported. On 12-APR-2014, the patient developed numbness and tingling in the right arm and down to her right leg. No lab diagnostic tests were done. The outcome of developed numbness and tingling after received a second dose of GARDASIL was reported as not recovered/not resolved. The patient sought medical attention by visiting the office of the reporting health care worker. additional information has been requested.
Age: 63.0
Sex: M
Vaccine: HEPAB
Symptoms: Rash
Clinical narrative: Patient has developed rash on the upper body.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, Injection site reaction
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to unspecified number of patients. On an unknown date, the patients were vaccinated with a dose of ZOSTAVAX (route and lot # not reported). The pharmacist reported that the patients experienced less injection site adverse reactions when the sterile diluent was stored in the refrigerator versus at room temperature. The outcome of injection site adverse reactions was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a female patient of unknown age who was as inpatient for an unspecified reason at the hospital. On 11-APR-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # J010332, expiry date: 14-JAN-2015) in her upper arm for an indication reported as 'age appropriate'. On 11-APR-2014 the patient experienced cellulitis. It was unspecified by the pharmacy technician if hospitalisation was prolonged by cellulitis. The outcome of the event was unknown. The relatedness between the PNEUMOVAX 23 and the event was unknown. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Dyspnoea, Pruritus, Urticaria
Clinical narrative: 0735 developed hives, itching; 0800 progressed to shortness of breath; employee walked to emergency room for treatment.
Age: 28.0
Sex: F
Vaccine: TTOX
Symptoms: Nasal congestion, Nasopharyngitis, Pain, Respiratory tract congestion
Clinical narrative: Cold like symptoms, full body achiness, chest congestion and nasal congestion.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Blood glucose normal, Blood pressure increased, Dyspnoea, Feeling cold, Feeling hot
Clinical narrative: Nausea, Hot, Cold, sweating, elevated BP, difficulty breathing.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Hyperhidrosis, Nausea
Clinical narrative: Nausea, Hot, Cold, sweating, elevated BP, difficulty breathing.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Contusion, Discomfort, Erythema, Pruritus, Skin warm
Clinical narrative: Began local redness about 1/2 dollar size. Then after 1 day possibly after scratching increased to 4.5 x 2.5 in redness/warmth with discomfort. No fever, some bruising.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus generalised
Clinical narrative: Patient developed pruritus over body. Patient prescribed ATARAX and prednisone resulting subsequent shingle outbreak. Patient required 2 rounds of prednisone.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: Small red splotches scattered on both arms, both legs, tops of feet, and stomach. No itching, burning or pain associated with splotches. No other symptoms reported.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Diarrhoea, Pyrexia, Rash generalised, Rash maculo-papular
Clinical narrative: Fever, maculo-papular skin rashes (all over) 5 days after receiving MMR, VARIVAX vaccines and diarrhea. ADVIL given.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site urticaria
Clinical narrative: Hives at injection site.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Aspergillus infection, Malaise
Clinical narrative: This spontaneous report was received from a consumer (patient mother) refers to a male patient of unknown age. The patient was allergic to tetracycline. On an unknown date in April 2008 (also reported as 5 or 6 years ago) the patient was vaccinated with ZOSTAVAX (dose, route and frequency were not reported). Concomitant medication included some kind of antibiotic. On an unknown date, the patient experienced aspergillus, which is a fungal infection in the lungs. The reporter also stated that she was not known how long after receiving the vaccination his symptoms started. The reporter stated her son was very ill and has sought medical attention several times, and has an upcoming appointment with a specialist. The outcome of the event was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a male patient of unknown age. No information about medical history concurrent conditions and concomitant medications was reported. The reporter stated that the patient received of RECOMBIVAX HB (dose strength, route, indication was not reported) first dose on 19-JUN-2013 and the second dose on 18-JUL-2013 but missed the 3rd dose when scheduled. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Age: 1.27
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR
Symptoms: Macule, Measles post vaccine, Mouth haemorrhage, Pharyngeal erythema, Pharyngeal exudate
Clinical narrative: DX: Vaccine induced measles - moderate fever > 101 starting, 4/11/14 and lasting 3 days. Multiple purple/violet macules noted ranging in size from 1-3 mm on face, trunk,  and upper/lower extremities bilaterally . Examination of the oropharynx showed petechial hemorrhages on the soft and hard palate. 1+ enlargement and erythema of both tonsils. Exudate also noted on both tonsils.