chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a public health, healthcare professional refers to unspecified patients of unknown age and gender. On an unknown date the unspecified patients might had vaccinated with improperly stored M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 53F for 12 hours and M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 54F for five hours. No adverse effects reported. Follow up information has been received from an office manager concerning a patient. On 03-SEP-2013 the patient was vaccinated with improperly stored M-M-R II (H020257, exp. 08-NOV-2014), which were exposed to 53F for 12 hours (date excursion ended 22-JUL-2013). This is one of several reports received from the same source (linked MARRS#: 1311USA007619, MARRS1311USA011609, MARRS1311USA011610, MARRS1311USA011611, MARRS1311USA011613, MARRS1311USA011614, MARRS1311USA011615, MARRS1311USA011616, MARRS1311USA011617, MARRS1311USA011618, MARRS1311USA011619). Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a public health, healthcare professional refers to unspecified patients of unknown age and gender. On an unknown date the unspecified patients might had vaccinated with improperly stored M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 53F for 12 hours and M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 54F for five hours. No adverse effects reported. Follow up information has been received from an office manager concerning a patient. On 08-AUG-2013 the patient was vaccinated with improperly stored M-M-R II (H018181, exp. 05-OCT-2014), which were exposed to 53F for 12 hours (date excursion ended 22-JUL-2013). This is one of several reports received from the same source (linked MARRS#: 1311USA007619, 1311USA011609, 1311USA011611, 1311USA011612, 1311USA011613, 1311USA011614, 1311USA011615, 1311USA011616, 1311USA011617, 1311USA011618, 1311USA011619). Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a public health, healthcare professional refers to unspecified patients of unknown age and gender. On an unknown date the unspecified patients might had vaccinated with improperly stored M-M-R II (lot #, dose, frequency and route unspecified), which were exposed to 53F for 12 hours and M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 54F for five hours. No adverse effects reported. Follow up information has been received from an office manager concerning a patient. On 05-AUG-2013 the patient was vaccinated with improperly stored M-M-R II (H018181 ,exp. 05-OCT-2014), which were exposed to 53F for 12 hours (date excursion ended 22-JUL-2013). This is one of several reports received from the same source (linked MARRS#: 1311USA007619, 1311USA011610, 1311USA011611, 1311USA011612, 1311USA011613, 1311USA011614, 1311USA011615, 1311USA011616, 1311USA011617, 1311USA011618, 1311USA011619).
Age: 1.19
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a nurse via field representative refers to a 3 year old female patient mentioned as healthy young lady, immunocompetent, with no health issues. The patient is the grandchild of the nurse. On 02-JAN-2012, the patient was vaccinated with VARIVAX (Merck) dose 1 at the physician's office. Dose and route were not reported. Lot number was 671126/1062AA and expiry date 05-JUL-2013. From an unknown date in November 2013 approximately (reported as currently), the patient was being treated for chicken pox diagnosed on 19-NOV-2013 (reported in followup call as yesterday), and at doctor's appointment on 20-NOV-2013 (reported as today in follow up call). The pox had started to blister. The outcome of chicken pox was not resolved. The child's physician's contact information was provided, but not mentioned if medical attention was sought. Nurse stated that she thought it was unique that both children had chicken pox reported one day apart that were administered in January 2012, in different facilities. Both children had small, multiples of chicken pox. No treatment was prescribed. This is 2 of 2 reports from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure decreased, Fall, Head injury, Headache, Syncope
Clinical narrative: The patient was given FLUVIRIN vaccine (0.5mL) into his right deltoid. The patient was okay after administration, but soon after, slid from a sitting position, off the chair and fell, hitting the floor head-first. He was conscious and was able to speak, but explained his head hurt from the fall, 911 was called and the ambulance arrived within a few minutes. He was taken to the hospital for further evaluation since his blood pressure was dropping. His ear had a drop of blood on it, but paramedic explained it was due to a superficial scrape from hitting the floor. Mother explained that her son does not have a seizure diagnosis, but a similar incident occurred one time, years ago at the dentist. She feels like his "fainting" is due to "white coat syndrome" or being afraid of needles.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a public health, healthcare professional refers to unspecified patients of unknown age and gender. On an unknown date the unspecified patients might had vaccinated with improperly stored M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 53F for 12 hours and M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 54F for five hours. No adverse effects reported. Follow up information has been received from an office manager concerning a patient. On 14-NOV-2013 the patient was vaccinated with improperly stored M-M-R II (J003791, exp. 28-MAR-2015), which were exposed to 53F for 12 hours (date excursion ended 22-JUL-2013). This is one of several reports received from the same source (linked MARRS#: 1311USA007619, 1311USA011609, 1311USA011610, 1311USA011611, 1311USA011612, 1311USA011613, 1311USA011615, 1311USA011616, 1311USA011617, 1311USA011618, 1311USA011619). Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a public health, healthcare professional refers to unspecified patients of unknown age and gender. On an unknown date the unspecified patients might had vaccinated with improperly stored M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 53F for 12 hours and M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 54F for five hours. No adverse effects reported. Follow up information has been received from an office manager concerning a patient. On 23-OCT-2013 the patient was vaccinated with improperly stored M-M- R II (J003791, exp. 28-MAR-2015), which were exposed to 53F for 12 hours (date excursion ended 22-JUL-2013). This is one of several reports received from the same source (linked MARRS#: 1311USA007619, 1311USA011609, 1311USA011610, 1311USA011611, 1311USA011612, 1311USA011614, 1311USA011615, 1311USA011616, 1311USA011617, 1311USA011618, 1311USA011619). Additional information is not expected.
Age: 74.0
Sex: M
Vaccine: VARZOS, FLU3, FLU3
Symptoms: CSF test abnormal, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: About 1-2 weeks after receiving flu shot began to develop paresthesias and weakness. Diagnosed with Guillain Barre by neurologist.
Age: 74.0
Sex: M
Vaccine: VARZOS, FLU3, FLU3
Symptoms: CSF protein increased, Guillain-Barre syndrome
Clinical narrative: About 1-2 weeks after receiving flu shot began to develop paresthesias and weakness. Diagnosed with Guillain Barre by neurologist.
Age: 74.0
Sex: M
Vaccine: VARZOS, FLU3, FLU3
Symptoms: Asthenia, CSF test abnormal, Guillain-Barre syndrome, Paraesthesia
Clinical narrative: About 1-2 weeks after receiving flu shot began to develop paresthesias and weakness. Diagnosed with Guillain Barre by neurologist.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dyspnoea, Erythema, Eye inflammation, Eye oedema
Clinical narrative: Received flu vaccination at 8:30 am; at approximately 11:30 am eyes became inflamed and edematous bilaterally; by 1:00 pm, began experiencing labored breathing, shortness of breath; seen in occupational medicine dept (I am an employee of a medical clinic), B/P 180/110, heart rate 120's, developed progressive respiratory distress, oxygen desaturation into the 70% range, O2 placed per nasal cannula initially, then 100% O2 by mask as condition continued to deteriorate, intravenous line placed, given Benadryl 25 mg and Solumedrol 125 mg IV, transported by ambulance to local hospital emergency room, paramedics repeated the Benadryl 25 mg IV.   After evaluation by ER physician, Famotidine 20 mg IV and Decadron 20 mg IV administered by ER staff.  Respiratory distress subsequently resolved over approximately 2 hours.  Eyes became less swollen and erythema subsided over the following 24 hours.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Oxygen saturation decreased, Respiratory distress
Clinical narrative: Received flu vaccination at 8:30 am; at approximately 11:30 am eyes became inflamed and edematous bilaterally; by 1:00 pm, began experiencing labored breathing, shortness of breath; seen in occupational medicine dept (I am an employee of a medical clinic), B/P 180/110, heart rate 120's, developed progressive respiratory distress, oxygen desaturation into the 70% range, O2 placed per nasal cannula initially, then 100% O2 by mask as condition continued to deteriorate, intravenous line placed, given Benadryl 25 mg and Solumedrol 125 mg IV, transported by ambulance to local hospital emergency room, paramedics repeated the Benadryl 25 mg IV.   After evaluation by ER physician, Famotidine 20 mg IV and Decadron 20 mg IV administered by ER staff.  Respiratory distress subsequently resolved over approximately 2 hours.  Eyes became less swollen and erythema subsided over the following 24 hours.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Drug hypersensitivity, Inappropriate schedule of drug administration, Stevens-Johnson syndrome
Clinical narrative: This spontaneous report was received from a registered nurse (RN) refers to 11 months male patient. Primary reporter called and stated that the patient had received the first dose of VARIVAX (Merck) (lot # unspecified) (dose, frequency, route unspecified) as chicken pox vaccine was administered on 15-MAY-2010, prior to the patient's first birthday, and the second dose of VARIVAX (Merck) (lot # unspecified) (dose, frequency, route unspecified) as chicken pox vaccine was administered on 08-AUG-2008. The patient had titers drawn on an unspecified date, and the titers came back as negative. The patient experienced allergic reaction to the sulfonamide antibiotic (unspecified manufacturer) on unspecified date. The patient suffered Stevens Johnson Syndrome as result of the allergic reaction to the sulfonamide based antibiotic on an unspecified date. Outcome of Stevens Johnson Syndrome was not reported. No treatment was given for the events. Action taken was reported as not discontinued. Upon internal review, the event Stevens Johnson Syndrome was considered to be medically significant. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: About 2 weeks after getting the ZOSTAVAX vaccine, the patient got shingles. The patient was prescribed some Mupirocin ointment.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Computerised tomogram head normal, Road traffic accident
Clinical narrative: Patient had MVA after leaving drs office ? of syncopal episode while driving. Timing not perfectly clear from ED report - seems to be 20 -40 minutes post vaccine administration. Pt had been fine - alert active jocular when left office and throughout procedure before leaving.
Age: 44.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, TDAP, TYP
Symptoms: Abulia, Computerised tomogram normal, Fatigue, Feeling abnormal, Headache
Clinical narrative: 2006 - indecisiveness, not feeling "regular". 2007 - tiredness, extreme sensitivity. 2008 - physical symptoms in arms. 2009 - diagnosed w/ paralysis, severe headaches. 2011 - diagnosed w/ MS after brain MRI. 2013 - reconfirmed MS after brain and spinal MRI's.
Age: 44.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, TDAP, TYP
Symptoms: Hyperaesthesia, Lumbar puncture normal, Multiple sclerosis, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: 2006 - indecisiveness, not feeling "regular". 2007 - tiredness, extreme sensitivity. 2008 - physical symptoms in arms. 2009 - diagnosed w/ paralysis, severe headaches. 2011 - diagnosed w/ MS after brain MRI. 2013 - reconfirmed MS after brain and spinal MRI's.
Age: 44.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, TDAP, TYP
Symptoms: Nuclear magnetic resonance imaging spinal abnormal, Paralysis
Clinical narrative: 2006 - indecisiveness, not feeling "regular". 2007 - tiredness, extreme sensitivity. 2008 - physical symptoms in arms. 2009 - diagnosed w/ paralysis, severe headaches. 2011 - diagnosed w/ MS after brain MRI. 2013 - reconfirmed MS after brain and spinal MRI's.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Echocardiogram, Electrocardiogram abnormal, Pericardial effusion, Pleural effusion
Clinical narrative: 3 week history of fevers, chest pain - pleuritic and a pericardial effusion - all following a flu shot. Cardiology consultation noted. (Etiology very possible immunization reaction).
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, Tachycardia
Clinical narrative: 3 week history of fevers, chest pain - pleuritic and a pericardial effusion - all following a flu shot. Cardiology consultation noted. (Etiology very possible immunization reaction).
Age: 29.0
Sex: M
Vaccine: FLUN4, HEPA, TDAP
Symptoms: Autoimmune disorder, Lichen planus, Rash generalised
Clinical narrative: Rash on arms, wrists, legs, ankles, feet. Diagnosed as Lichen Planus, Auto Immune Deficiency. Started shortly after my vaccinations while at work. PLAQUENIL prescribed for treatment.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Contusion, Erythema, Rash, Swelling
Clinical narrative: This spontaneous report as received from a registered nurse via a field representative refers to a 65 year old female patient. On 19-NOV-2013 the patient was vaccinated with ZOSTAVAX (dose, route and lot# not reported) and PNEUMOVAX23 (dose, route and lot# not reported) at the same time, on the same date, both injections in the right arm. After receiving these two vaccines, on an unknown date in November 2013, the patient developed swelling, redness, rash and bruising. The patient was using unspecified antibiotics (name, dose, frequency, and manufacture unknown) as treatment for this adverse event. The patient sought unspecified medical attention. At the time of reporting, the patient's outcome was recovering. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site reaction, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an adult female patient of unknown age. On an unknown date, the patient was vaccinated with the first dose of VARIVAX (lot # and expiration date not reported), 0.5 ml, subcutaneous because the patient had no immunity to varicella. On an unknown date, the patient developed redness and 2 small chickenpox lesions near the injections site. This occurred 10 days after vaccination. The patient recovered 2 days after onset of symptoms. Patient had not received any treatment for her symptoms. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to an unspecified number of patients of unknown age and gender. On unknown dated the patients were vaccinated with ZOSTAVAX, vial (route, strength, lot number an expiration date not provided). On unknown dates the patients experienced rash. The patients sought unspecified medical attention. The outcome of rash was unknown. The relatedness between vaccination with ZOSTAVAX and rash was not reported. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 76 year old female patient with none drug reactions or allergies. The patient's medical history included shingles which damaged eyesight and hemorrhoids. On 19-NOV-2013 the patient was vaccinated with the dose of ZOSTAVAX (lot number: J011212, expiration date 29-AUG-2014), injections (route and strength not provided). Concomitant therapies included hydrocortisone suppositories. On 20-NOV-2013 the patient experienced red rash around injection site the size of a silver dollar. On 22-NOV-2013 the patient called the pharmacist and reported that "now" the whole back of her (same arm as ZOSTAVAX was administered) was red but not blistery. The patient sought medical attention and called physician. None treatment was given for adverse event. No lab diagnostics studies were performed. The pharmacist noted that the patient will be seeing her primary care physician at the day of report. The outcome of whole back of her arm was red and red rash around injections site was reported as not recovered/not resolved. The relatedness between vaccination with ZOSTAVAX and whole back of her arm was red and red rash around injections site was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a practice manager (other health professional) refers to multiple patients of unknown age. The practice manager reported to the field representative that multiple unspecified patients have been re-vaccine with PNEUMOVAX (lot/batch #, route and indication unknown) "every 5 years" regardless of their age. It was reported that the patients have potentially been given more than a single re-vaccination of PNEUMOVAX23. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: This spontaneous report was received from a female patient of unknown age. Current conditions of the patient included DEMEROL allergy, Neosporin allergy (derma manifestation), penicillin allergy and sulfa drugs allergy. The medical history included multiple cases of shingles since 2003. Approximately on an unknown date in 2006 (reported as 2006 or 2007), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant therapy included ATARAX (50 milligrams) (manufacturer unspecified). Approximately on an unknown date in 2006 (reported as between four and six months following the vaccination in 2006 or 2007), the patient broke out in another case of shingles. She reported that she had experienced between five and seven outbreaks of shingles between her first case and the case she was experiencing at the time of report. Since on an unknown date, she also suffers greatly from post-herpetic syndrome, experiencing pain from prior cases of shingles. The blisters, which had first occurred only on one side of her body seemed to be extending around her waist at the time of report. She described the pain as a biting mosquito-like sensation. She added that, because there was nothing stating that a prior case of shingles was a contraindication to receiving ZOTAVAX, the physician felt that it may or may not help her, but would probably not hurt her. It was unspecified if the patient sought any medical attention. The patient was treated with VALTREX (1 gram, three times daily for seven days). It was unspecified if any lab tests were performed. The patient was not recovered from the events at the time of report. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Flushing, Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Pt c/o IM site became very hot flush to face rash and redness at IM site size of baseball pt describes rush feeling not feeling well sl blurred vision denied SOB B/P 120/80 HR 78 remains talking no SE of anaphylaxis applied cool compress to site IM inc increased fluids observed 15 min symptoms slowly dissipated.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Vision blurred
Clinical narrative: Pt c/o IM site became very hot flush to face rash and redness at IM site size of baseball pt describes rush feeling not feeling well sl blurred vision denied SOB B/P 120/80 HR 78 remains talking no SE of anaphylaxis applied cool compress to site IM inc increased fluids observed 15 min symptoms slowly dissipated.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. On an unknown date (in 2013), the patient was vaccinated with the third dose of RECOMBIVAX HB (dose, route and lot # were not provided). No other co-suspects were reported. Pharmacist reported that the patient might have experienced titers on the threshold of not responding to RECOMBIVAX HB after completing series within the last six months. Patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 30-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, (lot # and expiration date not reported), subcutaneous for immunization. The pharmacist reported that after receiving ZOSTAVAX, the patient was experiencing recurring "nerve" pain, every few hours, in the arm that ZOSTAVAX was administered on an unspecified date in 2013. The patient also experienced this pain in her arm when she was putting on her coat. The outcome of the events was reported as not recovered. The patient sought medical attention by coming back into the pharmacy. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Abasia, Dizziness, Feeling hot, Herpes zoster, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. No information on medical history and concomitant information was provided. On an unknown date the patient was vaccinated with one standard dose of ZOSTAVAX for prevention of shingles (dose, dose number and route of administration unknown). On an unknown date the patient became very dizzy, but could walk on her own. Additional symptoms were an overall extreme body warmth and "tingly sensation". The administrating Pharmacist "called 911". The outcome of became very dizzy, tingling sensation and overall extreme body warmth is unknown. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to her friends of unknown age. On an unknown date her friends were vaccinated with ZOSTAVAX (lot#, expiration date, dose and route not reported). The pharmacist stated that "her friends experienced redness and swelling" after receiving ZOSTAVAX on an unknown date. The outcome of the events was unknown. It was unspecified if the patients had sought medical attention. Additional information is not expected
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 70 year old consumer (height: 5'1 inch, weight: 128lbs) refers to himself. In November 2009 (4 years ago) the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose and route not reported) for prevention of shingles. The patient reported that in November 2013 "now", he thought he had gotten the shingles. The patient had not seen his doctor yet and he was almost sure it was. The outcome of the event was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with none drug reactions or allergies. On 20-NOV-2013 the patient was vaccinated with the dose of ZOSTAVAX (lot # J007854, expiration date 28-SEP-2013) 0.65 ml injection, subcutaneously. Concomitant therapies included Celexa, vitamin D (unspecified), Synthroid, Reglan, Cymbalta, metoprolol, simvastatin (manufacturer unknown), Lamictal, Cozaar. In November 2013 the patient experienced swelling in the arm where the patient received ZOSTAVAX. The patient sought medical attention and called the pharmacy. No treatment was given for adverse event. None lab diagnostics studies were performed. The outcome of swelling in the arm was reported as not recovered/not resolved. The relatedness between vaccination with ZOSTAVAX and swelling in the arm was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. On 26-NOV-2013 the patient was vaccinated with an expired dose of oral ROTATEQ (lot # H011443, expiry date 15-NOV-2015) (dose was unknown). No adverse effects reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient with nonsteroidal anti-inflammatory drug (also reported as NSAID) allergy, penicillin allergy and Sulfa allergy. On 22-NOV-2013 the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # J007207, expiration date 20-SEP-2014), subcutaneous for prevention of shingles. Concomitant therapies included estrogens (unspecified), omeprazole (manufacturer unknown) and Zocor. On 22-NOV-2013, the patient experienced a 50 cent  sized, dark red circle surrounded by a three inch, light red, outer circle at the injection site, which felt hot, after patient received ZOSTAVAX. The circle had not increased in size in the past 24 hours. The patient saw the pharmacist. Ice packs to injection site was given for treatment. The events outcome was unknown. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site warmth, Pyrexia
Clinical narrative: For 3 days pt says she had a 3 inch red, hot, and firm area around injection site, dull headache, and low grade fever (fever for only 24 hours).
Age: 19.0
Sex: M
Vaccine: HPV2
Symptoms: Lip swelling, Rash generalised, Swelling face
Clinical narrative: Swelling to face and lips and body rash - pt took BENADRYL.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vertigo
Clinical narrative: AM after flu vaccine - client had severe vertigo and nausea x 2 days duration.
Age: 2.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Pruritus, Rash
Clinical narrative: Mom reported rash that developed 1 day following injection. She did not bring her back for evaluation so no exam was done. No fever or GI symptoms. (+) pruritus.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, Redness, itching at injection site. Antihistamines for treatment.
Age: 14.0
Sex: M
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Diarrhoea, Disturbance in attention, Injection site swelling, Malaise, Nausea
Clinical narrative: Got adol vaccines, Tdap, HPV #2, Ckpox #2 - c/o just not feeling well day later, nausea, slight diarrhea; swelling at site of injection, itching all over - c/o just not being able to concentrate. Got ibuprofen et BENADRYL started taking Wed - Th saw dr Th 11/21/13 - Dr feels rx to HPV. Informed to me receive 3rd dose.
Age: 14.0
Sex: M
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Pruritus generalised
Clinical narrative: Got adol vaccines, Tdap, HPV #2, Ckpox #2 - c/o just not feeling well day later, nausea, slight diarrhea; swelling at site of injection, itching all over - c/o just not being able to concentrate. Got ibuprofen et BENADRYL started taking Wed - Th saw dr Th 11/21/13 - Dr feels rx to HPV. Informed to me receive 3rd dose.
Age: 66.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Hypersensitivity, Hypoaesthesia, Infection, Injection site anaesthesia
Clinical narrative: Received Hepatitis B vaccine on 11/22/13 at 14:00. Started having symptoms in L arm at 15:00. Progressed from pain at injection to redness, swelling and numbness down arm past elbow. Eval at local ED. Allergic reaction vs infection. Benadryl and course of Keflex given. Symptoms lessened in 24 hr and gone completely by 11/25/13.
Age: 66.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local swelling
Clinical narrative: Received Hepatitis B vaccine on 11/22/13 at 14:00. Started having symptoms in L arm at 15:00. Progressed from pain at injection to redness, swelling and numbness down arm past elbow. Eval at local ED. Allergic reaction vs infection. Benadryl and course of Keflex given. Symptoms lessened in 24 hr and gone completely by 11/25/13.
Sex: M
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to a patient of unknown age and unknown gender. No information on medical history and concomitant medication was provided. On 15-NOV-2013 the patient as vaccinated with MMR II (lot # 0705AA, expiration date 05-NOV-2013), intramuscular for an unknown indication. This was the only dose of MMR II this patient has ever been administered. On 15-NOV-2013, the patient was administered an expired dose of MMR II. No adverse effect was reported. The outcome of was administered an expired dose of MMR II is unknown. Additional information is not expected.
Age: 10.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling Rt deltoid (+) tenderness. Ice and MOTRIN recommended.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Dizziness, Erythema, Fatigue, Local swelling
Clinical narrative: Stiff, swollen, red arm - treated with BENADRYL. Vomiting, chest tightness. Dizziness, fatigue. Fever 101 degrees - treated w/ TYLENOL. Body aches.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Pain, Pyrexia, Vomiting
Clinical narrative: Stiff, swollen, red arm - treated with BENADRYL. Vomiting, chest tightness. Dizziness, fatigue. Fever 101 degrees - treated w/ TYLENOL. Body aches.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Dizziness, Erythema, Local swelling, Poor quality sleep, Tenderness
Clinical narrative: Patient received Flu and PNEUMOVAX on 11/21/2013. That evening she didn't sleep well, was dizzy, (L) arm became red, swollen and very tender under arm, shoulder and down to elbow.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Decreased appetite, Discomfort, Disorientation, Dizziness, Feeling abnormal
Clinical narrative: Patient received Flu and PNEUMOVAX on 11/21/2013. That evening she didn't sleep well, was dizzy, (L) arm became red, swollen and very tender under arm, shoulder and down to elbow.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Impaired driving ability, Induration, Lip exfoliation, Local swelling, Mobility decreased
Clinical narrative: Patient received Flu and PNEUMOVAX on 11/21/2013. That evening she didn't sleep well, was dizzy, (L) arm became red, swollen and very tender under arm, shoulder and down to elbow.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Nausea, Pyrexia, Weight decreased
Clinical narrative: Patient received Flu and PNEUMOVAX on 11/21/2013. That evening she didn't sleep well, was dizzy, (L) arm became red, swollen and very tender under arm, shoulder and down to elbow.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Nausea, Visual impairment, Vomiting
Clinical narrative: This spontaneous report as received from a nurse practitioner via a field employee regarding a 12 year old female patient. On 18-NOV-2013 the patient was vaccinated with GARDASIL (Lot#J009098, Expiry: 04-DEC-2015) dose 1, intramuscularly. On 19-NOV-2013, the patient presented to the clinic with, black outs, black spots in her peripheral vision, nausea, and vomiting. The patient sought medical attention-office visits. It was unspecified if any treatment was rendered. The outcome of the events black outs, vomiting, nausea and black spots in her peripheral vision was unknown. Upon internal review the event black outs was considered to be medically significant. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Burning sensation, Dyspnoea, Erythema, Induration, Pain in extremity
Clinical narrative: (L) arm pain, burning, indurated, red with streaks shortness of breath, wheeze, palpitation.
Age: 40.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Palpitations, Spirometry, Wheezing
Clinical narrative: (L) arm pain, burning, indurated, red with streaks shortness of breath, wheeze, palpitation.
Age: 40.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest X-ray normal, Local reaction, Paraesthesia, Wheezing
Clinical narrative: (L) arm pain, burning, indurated, red with streaks shortness of breath, wheeze, palpitation.
Age: 5.0
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Mom reports "baseball size, red" area on left upper limb; states pt. c/o itching and mild pain at site.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (R) deltoid area with slightly raised 4 cm x 2.5 cm erythematous area no warmth.
Sex: M
Vaccine: ADEN_4_7, FLUN3, HEPAB, IPV, MMR, MNQ, TDAP
Symptoms: Anaphylactic reaction, Anaphylactic shock
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. The Adenovirus vaccine was given 14-Sep-2012. A male between the ages of 19-24 years old who experienced Other Anaphylactic Shock, NEC (Serious, since 17-Mar-2012, until 17-Mar-2012) while enrolled in a Teva study. The event on 17-Mar-2012- treatment outpatient visit, medication and non drug treatment- outcome resolved- seriousness disability/incapacity- severity not assessed. Treatment provided: EPIPEN 0.3 mg injection started 22-Sep-2012 and last dose 09-Nov-2012; and Prednisone 5 mg oral started 22-Sep-2012 and last dose 04-Oct-2012. "Hospital Rx'd patient for anaphylaxis 8 days after vaccine- only information." At the time of the report the outcome of the AEs were: Other Anaphylactic Shock, NEC : Unknown. The medical history of the patient was not specified. The patient's concomitant medication included Influenza Vaccine (Nasal, since 14-Sep-2012, until 14-Sep-2012); IPV (since 14-Sep-2012, until 14-Sep-2012); MMR (since 14-Sep-2012, until 14-Sep-2012); Hepatitis A Vaccine w/Hepatitis B Vaccine (unknown; since 14-Sep-2012, until 14-Sep-2012; since 22-Oct-2012, until 22-Oct-2012); Diphtheria-Tetanus-Pertussis Vaccine (unknown; since 14-Sep-2012, until 14-Sep-2012); Meningococcal Vaccine (unknown; since 14-Sep-2012, until 14-Sep-2012). The patient's past medication were unspecified. Action taken with suspect drugs: Adenovirus Vaccine - Not applicable. Lab tests were not reported. This case was considered serious based on the following criteria: (Other Serious (Important Medical Events)). The medical monitor states this case is not related to Adenovirus vaccine.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Pt received high dose FLUZONE shot on 11-22. Pt came to pharmacy on 11-24 stating the day after the shot she developed redness and bruising around injection site. Also it ached like sore muscle.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None stated.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Patient states he "broke out" with itchy, red hives about an hour after receiving flu vaccine. Patient came back to pharmacy 2 days later and did present with rash. Suggested he try oral BENADRYL and contact PCP.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Client received flu vaccination on 11/20/13. Left deltoid was swollen and red starting Thursday morning. Care at home caused no relief and client sought treatment from urgent care on 11/22/13. Client given cephalexin 500mg TID x 10 days for cellulitis.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Flu injection given. 5 minutes later pt. passed out. Pt was moved to exam table with elevated legs and observed for 15 minutes. Pt. exam by Dr. was normal. Pt. walked to parent vehicle without any problem.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Induration, Injection site vesicles, Pyrexia
Clinical narrative: Large red area with induration 40mm x 40mm. Blistering noted at center of injection site. Pt c/o fever of 99.0-100.2 2 days after the injection and headache. Used MOTRIN q 8 hours and ice to area.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Pain, Pyrexia, Tremor
Clinical narrative: Vomiting, shivers, shaking, fever, pain, weakness.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Vomiting, shivers, shaking, fever, pain, weakness.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Cyanosis, Loss of consciousness, Pallor, Respiratory arrest
Clinical narrative: Paleness, loss of consciousness turned blue, appeared no breathing in doctors office; 3 -5 minutes length no treatment by MD; Slowly resumed to normal.
Age: 1.11
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Rash erythematous, Swelling face
Clinical narrative: Father states 2 days post vaccine administration child had swelling on R side of face lasting 3-4 days. Also stated red rash on face, neck, trunk lasting 1 wk. Given Tylenol, not seen by physician or at ER.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Rash, Respiratory rate increased, Throat irritation
Clinical narrative: Rash, trouble breathing - increased respiratory rate, throat "felt funny".
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Injection site cellulitis, Local swelling, Pruritus
Clinical narrative: Client c/o swelling on (L) arm and itching internally on arm. C/O arm feeling heavy - PHN notes raised area of erythema 6 1/4 in x 6 1/4 in with area of darker redness with "blisterlike" appearance 60 x 30 mm. Area is warm to touch. Client states she iced arm off and on yesterday.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Sensation of heaviness, Skin warm
Clinical narrative: Client c/o swelling on (L) arm and itching internally on arm. C/O arm feeling heavy - PHN notes raised area of erythema 6 1/4 in x 6 1/4 in with area of darker redness with "blisterlike" appearance 60 x 30 mm. Area is warm to touch. Client states she iced arm off and on yesterday.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Lip swelling, Orbital oedema, Swelling face
Clinical narrative: Orbital edema. Swelling of face and lips. No wheezing.
Age: 69.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt appeared w/redness, soreness and hot area where shot was administered. Also a little swollen w/a small knot.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Chest X-ray normal, Chest discomfort
Clinical narrative: Multiple symptoms
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Decreased appetite, Diarrhoea, Dizziness, Dysgeusia
Clinical narrative: Multiple symptoms
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dysphonia, Electrocardiogram normal, Fatigue, Feeling abnormal, Gastrointestinal pain
Clinical narrative: Multiple symptoms
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Hyperhidrosis, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Multiple symptoms
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Laboratory test normal, Lip swelling
Clinical narrative: Multiple symptoms
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Nasal congestion, Nausea, Pain, Paraesthesia oral, Productive cough
Clinical narrative: Multiple symptoms
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Skin warm, Somnolence, Urticaria
Clinical narrative: Multiple symptoms
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Malaise, Rash erythematous, Skin exfoliation, Swelling face
Clinical narrative: Swollen lips, tongue, and face. Hives from top of head to bottoms of feet. Looked like sunburn, skin on arms, shoulders and feet and palm of hands all peeled off three Dr. visit and put on steroids for 2 weeks. Very, very sick. Symptoms have lasted over 4 weeks.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Swollen lips, tongue, and face. Hives from top of head to bottoms of feet. Looked like sunburn, skin on arms, shoulders and feet and palm of hands all peeled off three Dr. visit and put on steroids for 2 weeks. Very, very sick. Symptoms have lasted over 4 weeks.
Age: 24.0
Sex: M
Vaccine: FLUC3
Symptoms: Rash pruritic, Swelling
Clinical narrative: Swelling and rash w/itching.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Drug administration error, Insomnia, Pain
Clinical narrative: About 4 hrs after pneumonia shot (arm and shoulder) became increasingly painful and achy. I took a pain pill at 6 pm and went to bed. I never take pain pills. I was up at midnight and took another one! This continued for three days and nights very strong. It started to let up just a little after that. I did not sleep for night pain for a full week and went back to dr. and she gave me more pain pills. It has been five weeks now and I still cannot (without pain) do certain things. When nurse gave me the shot she stood next to me as I sat on exam table. I looked like she was vertical not horizontal.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Pain, Pain in extremity, Ultrasound scan
Clinical narrative: PNEUMOVAX given 11-11-13 in left arm. Arm slightly sore initial 5 days. On 6th day pain increased to severe and extended into elbow. If pt. holds arm still he has no pain, but with certain movements. Pain is severe.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Middle insomnia, Pruritus
Clinical narrative: Itching sensation in hands at least 2 times per day - no relief when occurs. Can feel it coming on. Also in feet. No pain. Wakes her up during night. Symptoms started with couple days of vaccination.
Age: 27.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Dysuria, Gallbladder disorder
Clinical narrative: Patient reports difficulty urinating and a feeling of pressure on his bladder.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Herpes zoster, Inappropriate schedule of drug administration, Local swelling, Urinary tract infection
Clinical narrative: This spontaneous report was received from a pharmacist regarding his wife a 60 year old female patient with breast cancer. The patient's medical history included right side mastectomy on 17-OCT-2013. On 18-OCT-2013 (also reported as 19-OCT-2013), the patient was vaccinated with PNEUMOVAX23 (lot number, concentration and dose were not reported). Concomitant therapies were not reported. The reported believed that the PNEUMOVAX23 lowered patient's resistance. On 18-OCT-2013, within hours her arm began to swell. The swelling in her arm resolved within 5 days, however, she since had developed a Urinary Tract infection and the day of the report the patient was on her way to see her physician with complaint of Shingles, which developed approximately on 12-OCT-2013 (reported as 2 days ago). The reporter stated that his wife believed that she had received PNEUMOVAX23, "a few months earlier" and would confirm with her physician. Patient received treatment with Keflex initially prescribed for arm swelling and changed out to Ciprofloxacin when urinary tract infection developed. The outcome of the arm began to swell was reported as recovered. The outcome of the others events were unknown. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Audiogram abnormal, Deafness unilateral, Vertigo
Clinical narrative: Left ear profound hearing loss and vertigo starting the morning after the flu vaccine.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Right arm injection site reaction, erythema, edema, induration, tenderness and warthm worsen with spread to upper forearm.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Right arm injection site reaction, erythema, edema, induration, tenderness and warthm worsen with spread to upper forearm.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 11/18/13 diagnosed with cellulitis (redness, swelling, tenderness) to L arm where immunization was received.  Placed on Augmentin x 10 days.  F/u 11/20/13 showed improvement of symptoms.
Age: 1.01
Sex: M
Vaccine: FLU3, HEPA, MMRV
Symptoms: Complex partial seizures, Febrile convulsion
Clinical narrative: Febrile complex seizure lasting <10 min per parents.
Age: 74.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site bruising, Injection site discolouration
Clinical narrative: The injection site looks like a yellowing bruise. It is the size of a silver dollar.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3
Symptoms: Blister
Clinical narrative: Blisters on arm.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised, Rash macular
Clinical narrative: 10/29/13 Pt phined the office and stated she thinks she has a rash down her arm as a reslt of the flu injection given 10/22/13. Dr. notified and orders given to pt to take Benadryl during the night and Claritin during the day. If no improvement by 10/31/13 Pt. instructed to call the clinic and she will be seen. 11/15/13 a slight rash "all over and is wondering if it is from the flu shot 11/22/13 Phone call made to CDC re: if pts rash may poss be from the influenza vaccine given on 10/22/13. Pt. reported initial rash to arm injection was given, on 10/29/13, however pt states that rash actually started within about 4 days after the injection. CDC stated that it would probably be a good idea to report this to VAERS (vaccine adverse event reporting system) for tracking purposes, as there were 300 million of these vaccines given and any data that may be associated with an adverse event within 42 days of the vaccine should be reported. Pt. notified and aware that I will be filing this report and was in agreement with doing so. DCO will also be notified of such action. When I spoke with pt. today, she states that the rash seems to be subsiding. (when I saw her last Friday it was a very fine scattered macular generalized non-puritic rash.)   12/2/2013 Phoned patient and she states rash is almost completely gone.