chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pulmonary congestion, Serum sickness
Clinical narrative: This consumer report (initial receipt 05-Mar-2014) was received via a pharmaceutical company and concerns a male patient who was aged between 60 and 69 years. Medical history included acid reflux, allergy to animals, citrus, dairy, iodine, peanuts, walnuts and shellfish; osteoporosis (diagnosed in Oct-2010). Concomitant medications included metformin hydrochloride, vitamin D, multivitamins and esomeprazole. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not provided) and pneumococcal virus vaccine (manufacturer and batch number not provided). On an unspecified date, within months of vaccination with the influenza vaccine and pneumonia vaccine, the patient developed serum sickness and lung congestion. On the 15-Nov-2013, the patient commenced fluticasone propionate/salmeterol xinafoate inhaler 500/50mcg to be taken one puff twice daily for the lung congestion which was secondary to the serum sickness. The patient was concerned to take the steroid inhaler therefore reduced the dose on the 24-Nov-2013 to 250/50mcg, one puff before bedtime when he felt a build-up of phlegm on his chest and would start to cough. The fluticasone propionate/salmeterol xinafoate inhaler allowed him to sleep, as he was not sleeping well, and was pleased with the medication. On approximately 23-Dec-2013, the patient received a blood test which showed his blood sugar numbers increased to 5.8 during treatment with fluticasone propionate/salmeterol xinafoate inhaler. Late Dec-2013, the patient was diagnosed with diabetes but his doctor said he was right on the edge of having diabetes. Outcome was reported as not recovered for serum sickness, lung congestion, mucus in chest, cough, diabetes, increased blood sugar. The patient had recovered from the poor quality sleep.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Dementia Alzheimer's type, Mental status changes
Clinical narrative: This spontaneous report as received from a physician, who is patient's son also refers to a 85 year old male patient. There was no pertinent medical history reported. No drug reaction or allergy was reported. On 30-DEC-2013 the patient was vaccinated with ZOSTAVAX (lot number and dose not reported). Concomitant therapies included CADUET. In January 2014 (reported as approximately 2-4 weeks after receiving ZOSTAVAX), the patient experienced acute exacerbation of Alzheimer's disease (hospitalization, disability and life threatening) and mental status changes (hospitalization, disability and life threatening). The patient sought medical attention for the events. Treatment was not given for the events. The patient was hospitalized for 5 days. The outcome of events was reported as not recovered. The causality of the suspect product with the event was not reported. Product quality complaint was not reported. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a now 4 months year old male patient of unknown age with allergic to dairy (possible). There was no pertinent medical history. On 08-JAN-2014 the patient was vaccinated with first dose of oral ROTATEQ, dose not reported. There was no concomitant medication. On an unknown date in 2014 the patient experienced diarrhea. No lab diagnostics studies performed. The outcome of diarrhea was reported as not recovered. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Crying, Fatigue, Feeling cold, Musculoskeletal stiffness
Clinical narrative: Patient presents 1.5 hours after receiving vaccine earlier from clinic. C/o pain in (L) arm extending up into neck "arm getting stiff" excruciating pain with movement. Crying fatigue "feels cold, nausea, abd pain."
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient presents 1.5 hours after receiving vaccine earlier from clinic. C/o pain in (L) arm extending up into neck "arm getting stiff" excruciating pain with movement. Crying fatigue "feels cold, nausea, abd pain."
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Myalgia, Neck pain, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative refers to a 26 year old female patient. Medical history included other unspecified medical problems. The patient was not pregnant. On an unknown date, the patient was vaccinated with a first dose of GARDASIL (Lot number, expiry date, route and dose were not reported). On an unknown date, the patient developed muscle pain, fever, joint pain and neck pain. The patient sought medical attention for the same (saw the doctor). The outcome of developed muscle pain, fever, joint pain and neck pain was reported as recovering/resolving. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Patient lost conscious x 7. Pt laid down during vaccine and waited 15 minutes after given, walked to checkout and lost conscious, laid on floor legs elevated. Sat back up, water given, pt lost conscious again, laid on floor, legs elevated, soda and food given.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. On an unknown date in February 2014 the patients were vaccinated with ROTATEQ (lot number and frequency unknown) (dosing regimen and frequency unknown) which had been improperly stored. No concomitant medications were reported. No adverse events were reported. The action taken with ROTATEQ was unknown. No product quality issue was reported. this case is related to case 1403USA007409 and 1403USA008198 via same reporter link. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 27-FEB-2014 the patient, who was younger than 50 years old was vaccinated subcutaneously with ZOSTAVAX (dose, lot # and expiration date were not reported). No adverse effect reported. The patient was on therapy with AVONEX for an unspecified amount of time for multiple sclerosis and was immunosuppressed at the time of the ZOSTAVAX administration. The patient was seen a neurologist to be evaluated, prior to receiving ZOSTAVAX. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Flushing, Local swelling, Skin warm, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 years old female patient. On 08-MAR-2014 the patient was vaccinated with ZOSTAVAX (route of administration, dose, lot # and expiration date not reported). In March 2014, after vaccination the patient experienced swollen, welted arm that was flushed and hot. The pharmacist stated that the patient's arm did not appear as shingles. The patient planned to see a physician. The pharmacist advised the patient to consider ice to the location (date unspecified in March 2014). The patient sought medical attention by contacted pharmacy in March 2014. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a female patient of unknown age. On an unknown date, sometimes ago, the patient was vaccinated with ZOSTAVAX (19400 PFU) (dose, route and frequency were not reported). On an unknown date, the patient experienced rash. It was reported that the patient did not develop rash immediately after vaccination with ZOSTAVAX (19400 PFU). The physician reported that on an unknown date, the rash was painful. The patient sought medical attention and visited the office. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 0.53
Sex: F
Vaccine: HIBV, PNC13, RV5
Symptoms: Blood culture, Haematology test, Laboratory test, Synovitis, Ultrasound joint
Clinical narrative: Patient developed transient synovitis. She was admitted to the hospital for treatment. Sent home with Rx for ZANTAC and instructions to take ibuprofen prn.
Age: 0.53
Sex: F
Vaccine: HIBV, PNC13, RV5
Symptoms: X-ray
Clinical narrative: Patient developed transient synovitis. She was admitted to the hospital for treatment. Sent home with Rx for ZANTAC and instructions to take ibuprofen prn.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients. In 2014 an unspecified number of patients received improperly stored COMVAX (lot #, expiration date and dose unspecified). No symptoms reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. On an unknown date in February 2014 the patients were vaccinated with RECOMBIVAX HB (lot number and frequency unknown) (dosing regimen and frequency unknown) which had been improperly stored. No concomitant medications were reported. No adverse events were reported. The action taken with RECOMBIVAX HB was unknown. No product quality issue was reported. This case is related to case 1403USA008198 and 1403USA008197 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. On an unknown date in February 2014 the patients were vaccinated with GARDASIL (lot number and frequency unknown) (dosing regimen and frequency unknown) which had been improperly stored. No concomitant medications were reported. No adverse events were reported. The action taken with GARDASIL was unknown. No product quality issue was reported. This case is related to case 1403USA007409 and 1403USA008197 via same reporter link. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with opioid and penicillin allergy. In March 2011 (reported as about three years ago), the patient was vaccinated with a dose of PNEUMOVAX 23 injection (lot number and expiration date not provided) (route, strength and dose not provided). On an unknown date the patient developed hives post vaccination. The patient sought unspecified medical attention. For treatment an BENADRYL orally was given. The outcome of hives post vaccination was reported as recovered/resolved. The relatedness between vaccination with PNEUMOVAX 23 and hives was not reported. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients. In 2014 an unspecified number of patients received improperly stored VAQTA (lot #, expiration date and dose unspecified). No symptoms reported. This is one of several reports received from same source. Additional information has been requested.
Age: 1.51
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Aphasia, Communication disorder, Cough, Muscle twitching
Clinical narrative: Child developed symptoms of viral illness fever cough etc.  Within a month following vaccination child began doing what I can only describe as a twitch.  He also began ignoring people, and demonstrated other changes such as loss of language, and reduced desire to communicate verbally.
Age: 1.51
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Viral infection
Clinical narrative: Child developed symptoms of viral illness fever cough etc.  Within a month following vaccination child began doing what I can only describe as a twitch.  He also began ignoring people, and demonstrated other changes such as loss of language, and reduced desire to communicate verbally.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Fatigue, Influenza, Laboratory test
Clinical narrative: 10 minutes after receiving the shot I felt dizzy and nauseated. About an hour later I was very fatigued. By the next day I had a pain in my right arm. I went back to the pharmacist that administrated the injection he told me to take some Tylenol and it would pass. It did not pass it became progressively worse.  Several days later I had a strange blister rash all over my body and the pain in my arm became more intense.  I went back to the pharmacist again and he told me to contact VAERS. Over the course of the next several months (up until December) my arm was extremely painful. I had to go to the emergency room several times but they could not find the reason for the pain. All they did was run tests and give me pain medication. I kept telling them all of this started after the flu shot. I had to sleep sitting up because anything that touched my arm intensified the pain was absolutely debilitated from the pain in my arm. By December, I had a full blown case of the flu that took about 3 weeks to run its course. Once the flu ran its course all of the pain in my arm subsided; it almost felt as if I had every imaginable symptom of the flu, each in its own time but it lasted for until January.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle strain, Nausea, Pain in extremity, Rash generalised, Rash vesicular
Clinical narrative: 10 minutes after receiving the shot I felt dizzy and nauseated. About an hour later I was very fatigued. By the next day I had a pain in my right arm. I went back to the pharmacist that administrated the injection he told me to take some Tylenol and it would pass. It did not pass it became progressively worse.  Several days later I had a strange blister rash all over my body and the pain in my arm became more intense.  I went back to the pharmacist again and he told me to contact VAERS. Over the course of the next several months (up until December) my arm was extremely painful. I had to go to the emergency room several times but they could not find the reason for the pain. All they did was run tests and give me pain medication. I kept telling them all of this started after the flu shot. I had to sleep sitting up because anything that touched my arm intensified the pain was absolutely debilitated from the pain in my arm. By December, I had a full blown case of the flu that took about 3 weeks to run its course. Once the flu ran its course all of the pain in my arm subsided; it almost felt as if I had every imaginable symptom of the flu, each in its own time but it lasted for until January.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: 10 minutes after receiving the shot I felt dizzy and nauseated. About an hour later I was very fatigued. By the next day I had a pain in my right arm. I went back to the pharmacist that administrated the injection he told me to take some Tylenol and it would pass. It did not pass it became progressively worse.  Several days later I had a strange blister rash all over my body and the pain in my arm became more intense.  I went back to the pharmacist again and he told me to contact VAERS. Over the course of the next several months (up until December) my arm was extremely painful. I had to go to the emergency room several times but they could not find the reason for the pain. All they did was run tests and give me pain medication. I kept telling them all of this started after the flu shot. I had to sleep sitting up because anything that touched my arm intensified the pain was absolutely debilitated from the pain in my arm. By December, I had a full blown case of the flu that took about 3 weeks to run its course. Once the flu ran its course all of the pain in my arm subsided; it almost felt as if I had every imaginable symptom of the flu, each in its own time but it lasted for until January.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hyperaesthesia, Neck pain, Rash
Clinical narrative: This spontaneous report as received from a consumer refers to a 76 year old female patient with high blood pressure, thyroid problems and penicillin allergy. The patient had shingles on an unspecified date years ago. In 2009 patient was vaccinated with ZOSTAVAX (1 dose, subcutaneous), because she thought it would prevent the shingles from happening again. Concomitant therapies included SYNTHROID and doxycycline (manufacturer unknown). On 07-MAR-2014 the patient experienced a case of shingles. She developed pain on her neck but did not have blisters. Her skin became sensitive and developed a rash on her neck. She was then prescribed NEURONTIN and VALTREX (dosage/frequencies unknown) and she feels much better now. The outcome of a case of shingles was reported as recovering. The patient sought medical attention by seeing her doctor; no lab diagnostic studies were performed. Additional information is not expected.
Age: 87.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Pain at injection site. Limitation of arm movement.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Rash, Rash erythematous
Clinical narrative: 2-3 HOURS AFTER VACCINATION, RED BUMPS APPEARED ON TORSO.  INSTRUCTED PATIENT TO TAKE CHILD TO MD.  3/14/14  NURSE CONTACTED PARENT. PARENT STATED RASH CLEARED.  NO MEDS GIVEN.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash erythematous, Urticaria
Clinical narrative: Hives, red raised bumps very itchy. Medrol Dose pack prescribed by physician.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients. In 2014 an unspecified number of patients received improperly stored PEDVAXHIB (lot #, expiration date and dose unspecified). No symptoms reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients. In 2014 an unspecified number of patients received improperly stored ROTATEQ (lot #, expiration date and dose unspecified). No symptoms reported. This is one of several reports received from same source. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 90 year old female patient. On 13-MAR-2014 (reported as today), the patient received expired dose of PNEUMOVAX 23 injection 25 / 0.5 Y, (lot number H012650, expiry date 27-FEB-2014), dose and route of administration were unspecified. Concomitant therapy was unspecified. The pharmacist did not know if this dose of PNEUMOVAX 23 was the patients first dose. It was reported that the patient has not reported or demonstrated any adverse effects. The dose of PNEUMOVAX 23 was administered as part of a long term care facility admission protocol. No product quality compliant was involved. No further information was provided. Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: MMR given at 2 months of age.
Age: 70.0
Sex: F
Vaccine: TYP
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Pain upon lifting arm/resistance, decreased range of motion of shoulder in arm administer. Tried OTC pain relievers.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Borrelia test, Electromyogram, Full blood count, Inflammation
Clinical narrative: Rec'd flu shot in left upper arm on 2/20/14 - pain in arm - waited 6 wks to be seen in ER Nov 2013 - given prednisone and naproxen (arm painful and inflamed) started seeing Employee Health Dr in Dec 2013 - started PT therapy 12/31/13 - severe pain in left shoulder down through elbow and stiffness/limited mobility.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Rec'd flu shot in left upper arm on 2/20/14 - pain in arm - waited 6 wks to be seen in ER Nov 2013 - given prednisone and naproxen (arm painful and inflamed) started seeing Employee Health Dr in Dec 2013 - started PT therapy 12/31/13 - severe pain in left shoulder down through elbow and stiffness/limited mobility.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Red blood cell sedimentation rate, X-ray limb
Clinical narrative: Rec'd flu shot in left upper arm on 2/20/14 - pain in arm - waited 6 wks to be seen in ER Nov 2013 - given prednisone and naproxen (arm painful and inflamed) started seeing Employee Health Dr in Dec 2013 - started PT therapy 12/31/13 - severe pain in left shoulder down through elbow and stiffness/limited mobility.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Incorrect dose administered
Clinical narrative: Pt was given a 4th dose of GARDASIL in error.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Skin warm
Clinical narrative: Per mother patient has swelling at site of injection. Hot to the touch, no fever, no rash. Patient has not been given medicine for pain. Advised to give MOTRIN and contact primary physician if no sign of recovery.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Blood follicle stimulating hormone increased, Blood oestrogen decreased, Cytogenetic analysis normal, Infertility female, Premature menopause
Clinical narrative: Premature ovarian failure - unable to have children. Didn't realize until off of birth control and trying to conceive. Genetics testing was done and there was nothing to attribute to how else I would have got this.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Local swelling, Rash, Rash generalised, Rash macular, Rash papular
Clinical narrative: Diffuse generalized macular, papular rash. After 23 hours swelling in left arm and tender. Local rash.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Tenderness
Clinical narrative: Diffuse generalized macular, papular rash. After 23 hours swelling in left arm and tender. Local rash.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling, Pyrexia
Clinical narrative: High fever 2 days - PM 10/24/13 104.2. Pain swelling and red rash at site of injection. TX - TYLENOL 10/26/13 lower fever 99.6 to 102 for 4 days. Rash burning tissues and moving around arm 28 days post injection tissue still burns and skin itches.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Rash erythematous
Clinical narrative: High fever 2 days - PM 10/24/13 104.2. Pain swelling and red rash at site of injection. TX - TYLENOL 10/26/13 lower fever 99.6 to 102 for 4 days. Rash burning tissues and moving around arm 28 days post injection tissue still burns and skin itches.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Arthralgia, Decreased appetite, Injection site erythema, Injection site swelling
Clinical narrative: Starting 2 hours after vaccination: modest local reaction at injection site (red, swollen). Myalgias, arthralgias, decreased appetite, abdominal cramps.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Local reaction, Myalgia
Clinical narrative: Starting 2 hours after vaccination: modest local reaction at injection site (red, swollen). Myalgias, arthralgias, decreased appetite, abdominal cramps.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Large local reaction at site of injection began about 24 hours after injection - no treatment needed.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Acoustic stimulation tests normal, Tinnitus
Clinical narrative: Acute tinnitus starting in the right ear within seconds of receiving the injection in my right arm. Within 1 week it moved to both ears.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site swelling, Pallor, Skin discolouration, Skin warm
Clinical narrative: Pt received vaccines on 3/10/14 and by the next day arm was swollen from shoulder to elbow on the right side. Skin blanched red and white. Warm to touch.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site pain
Clinical narrative: Patient complained of large red, irritated area around injection site. Also describes it as burning.
Age: 1.25
Sex: M
Vaccine: HIBV, IPV, VARCEL
Symptoms: Body temperature increased, Crying, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: HIB vaccine given IM to (R) deltoid on 3/10/14. Next AM temp of 100 and crying. T Max on 3/11/14 103.9, vaccine sites were a little red per Mom. On 3/12/14, seen in office and (R) deltoid hard, mild warmth, temp 99.9.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Blindness, Dyskinesia, Fatigue, Loss of consciousness, Pallor
Clinical narrative: Vaccine given with sterile technique. About 1 min post-injection, pt attempted to stand up from chair, pt not coherent. Ran to patient who made a jerking motion, then after a few sec - was able to respond, but not making sense. Very pale. Co-worker came into room. We assisted patient to the bed and placed in supine position. Pt stated "I can't see, are my eyes open." Within 30 sec, pt was answering appropriately, vision returned. Vitals taken and normal. Complete return to condition prior to incident. Total time of black-out, loss of vision about 1.5 min. Monitored for 45 min post-reaction. Notified mother. Notified FNP. Mother picked up patient. Made f/u care call 1.5 hrs later, patient doing well, just "tired".
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 10 March 2014. A 26-year-old male subject, with no reported medical history, received an injection of ACAM2000 (lot not reported) on 15 January 2014. On 28 January 2014, i.e. 13 days post-vaccination, the subject was diagnosed with other and unspecified acute myocarditis. The highest recorded Troponin I on 27 January 2014 was 0.56 ng/mL. Additional diagnostic testing on 27 January 2014 included ECG, which was reported as abnormal, and echocardiogram, reported as normal. MRI of the brain, spinal cord, and heart, and lumbar puncture were not performed. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Redness site of vaccine. Rx for cellulitis.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer concerning a patient of unknown age and gender (consumer's friend). No medical history reported. On an unspecified date, the patient had an active case of wild-type shingles. It was reported that while the shingles was still in the active phase, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, strength, lot and expiration date not provided). The consumer reported that her friend's shingles symptoms seemed to get worse. At the time of the report, the outcome of the event was unknown. The causal relationship between ZOSTAVAX and the event was unknown. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: "Very severe headaches that night and the next day."
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Feeling hot, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swollen, hot, painful injection site: pruritic (itchy).
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 15 year old female patient. On 30-OCT-2009, the patient was vaccinated with first dose of GARDASIL (dose, route of administration and Lot number not reported). On 07-SEP-2010 the patient was vaccinated with second dose of GARDASIL (dose, route of administration and Lot number not reported). On 02-NOV-2010, the patient was vaccinated with third dose of GARDASIL (dose, route of administration and Lot number not reported). No adverse effect was reported. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Malaise, Rash
Clinical narrative: Pt came into pharmacy on 3-18-14 to report that 3 days after receiving ZOSTAVAX vaccine she was so sick she couldn't get out of bed. Later she had a cough for which she bought OTC med. On 3-16-14 she developed a rash on face.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dyspnoea, Nausea, Rash, Vomiting
Clinical narrative: Rash, nausea, vomiting, gasping for air.
Age: 1.26
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Blood culture, Condition aggravated, Culture urine, Differential white blood cell count, Febrile convulsion
Clinical narrative: Child had febrile seizure.
Age: 1.26
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Full blood count, Urine analysis, Viral test
Clinical narrative: Child had febrile seizure.
Age: 7.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Rash
Clinical narrative: When pt's mother was contacted we found out pt had a rash reaction to the shot on chest and face and needed treatment.
Age: 7.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Drug administered to patient of inappropriate age, Rash
Clinical narrative: When pt's mother was contacted we found out pt had a rash reaction to the shot on chest and face and needed treatment.
Age: 48.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Vaccination site bruising, Vaccination site induration
Clinical narrative: 3/15/2014: patient experienced itchiness, hardening, and redness around vaccination site (approx. 2 in diameter) 3/16/2014: AM- redness, inflammation, and itchiness spread from vaccination site to surrounding tissue (approx 4 in diameter). PM- redness, inflammation, hardening continues to spread to 6 in diameter. 3/17/14- AM symptoms spread to entire upper left arm. Tissue is hardened and swollen and emitting heat. Very uncomfortable for patient and tender to touch. Vaccination site is bruised. Member noted a similar but smaller reaction during previous vaccination April 2010.
Age: 48.0
Sex: M
Vaccine: ANTH
Symptoms: Vaccination site inflammation, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 3/15/2014: patient experienced itchiness, hardening, and redness around vaccination site (approx. 2 in diameter) 3/16/2014: AM- redness, inflammation, and itchiness spread from vaccination site to surrounding tissue (approx 4 in diameter). PM- redness, inflammation, hardening continues to spread to 6 in diameter. 3/17/14- AM symptoms spread to entire upper left arm. Tissue is hardened and swollen and emitting heat. Very uncomfortable for patient and tender to touch. Vaccination site is bruised. Member noted a similar but smaller reaction during previous vaccination April 2010.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Injection site pain, Pain, Ultrasound scan
Clinical narrative: Acute pain when given. Took ibuprofen & heat/cold. Prednisone then PT. Ultrasound. Dr. noted shot was misplaced PT started Jan. 1, 2014. 4 months for recovery.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Narcolepsy, Nasopharyngitis, Sleep study
Clinical narrative: Had  cold, followed by extreme fatigue in the weeks following the vaccine. Diagnosed with narcolepsy.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Erythema, Rash, Swelling face
Clinical narrative: Face started swelling and turning red and developed rash over abdomen. Took child to ER and was given steroids. Took child to her doctor the next day and symptoms were completely resolved.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Barium enema, Diarrhoea, Enema administration, Intussusception, Vomiting
Clinical narrative: ROTATEQ vaccine given 2/18/14. On 2/21/14, patient developed vomiting and diarrhea. On 2/22/14, patient diagnosed with intussusception and pt advised surgical correction at hospital.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site mass, Injection site warmth
Clinical narrative: INJECTION SITE INFLAMED AND HOT WITH LARGE LUMP.  TREATED AT PHYSICIANS OFFICE IN THE EVENING. GIVING CEFTRIAXONE INJECTION IN OFFICE AND KEFLEX 500 TID X7 DAYS ON 3/18/14.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Rash on chest and under right breast. Very painful. Rash came after 2 days of vaccination (roughly).
Age: 0.45
Sex: F
Vaccine: DTAPIPV, HEP, HIBV, PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.31
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: C-reactive protein, Crying, Full blood count, Irritability, Pain
Clinical narrative: Mom called 3/7/14. High fever after vaccines. 3/6/14 fever started at 9 or 10 o'clock, 103-104. Cranky fussy -cries when moved picked up in clinic. 3/7/14 fever 102.8 crying sent to hospital for labs and x-rays.
Age: 1.31
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Pyrexia, Red blood cell sedimentation rate, X-ray of pelvis and hip
Clinical narrative: Mom called 3/7/14. High fever after vaccines. 3/6/14 fever started at 9 or 10 o'clock, 103-104. Cranky fussy -cries when moved picked up in clinic. 3/7/14 fever 102.8 crying sent to hospital for labs and x-rays.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Left arm red and swollen. Given MOTRIN and warm compresses. Mother also gave BENADRYL. Fever 103 - Given office appt - Mother canceled took to hosp.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Convulsion, Gaze palsy, Posture abnormal
Clinical narrative: Pt. had about 30 second seizure with arms bent, hands clenched, eyes rolled back, that started approx. 1 minute after vaccine was given. Father states he had same reaction 1/18/14 with first Hep B given. Prior to vaccine pt Father only stated pt "passed out last time". But after further discussion - symptoms were the same.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site of (L) deltoid; (R) deltoid normal. Treatment ice, ibuprofen monitor f/u if worsening.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Right upper outer arm with pink/red swollen area the size of a softball. Slightly tender to the touch. No fever and no treatment ordered.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Injection site and area around tricep to elbow red, warm wheal, no induration, swelling, painful started ibuprofen 200mg 2 tab Q 6 hours prn, BENADRYL 25mg 1 tab Q 4 to 6 hours prn. Follow up as needed.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site swelling, Pruritus, Rash
Clinical narrative: Within a couple of hours patient had a headache and swelling at the injection site. The following day a rash developed on her torso with itching.
Age: 72.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site bruising, Injection site induration, Injection site urticaria, Joint range of motion decreased
Clinical narrative: Pt got severe bruising around site of injection (+) hard welt at injection site. It decreased range of movement x 2 days. Now improving. It is on right arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Local swelling, Pruritus, Rash vesicular
Clinical narrative: Red swollen induration with chicken pox-like rash; itching.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 17-FEB-2014, the patient was vaccinated with PNEUMOVAX 23 25/0.5, Lot # H010661; Expiration date: 14-FEB-2014 (dose and route was not reported). Pharmacist reported that a patient picked up PNEUMOVAX 23 from the pharmacy and transported it to the physician's office for administration. Pharmacist stated that the PNEUMOVAX 23 was not expired when the patient picked up the vaccine, however, it was expired by the time the physician administered it to the patient. Pharmacist stated that the PNEUMOVAX 23 did not have any known temperature excursions. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a female patient (age not reported) who in November (reported as "Noember") 2013 was vaccinated with dose one of GARDASIL (route and site not reported) for disease prevention. On 13-MAR-2014 the patient received the second dose of GARDASIL. No adverse effects noted to patient. The patient did not seek for medical attention. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of unspecified patients of unknown ages and genders. On unknown dates the patients were vaccinated with doses of RECOMBIVAX HB (reported as RECOMBIVAX) (lot #, expiry date, dose, route and indication unknown) that were exposed to supported temperature excursions. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a pharmacy technician who stated that on 10-MAR-2014 or 11-MAR-2014 (reported as "on Monday or Tuesday") a box of ROTATEQ was "dropped off and left out". She said that the box sat at 72 F for at least 72 hours. On an unknown date a patient (age and gender not reported) received a dose of ROTATEQ (indication not reported), but the reporter stated that "it wasn't the one left out". However, her information was not specific enough to eliminate possibility that the recipient received one of the exposed ROTATEQ. No actual adverse event involved. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Headache, Hypoaesthesia
Clinical narrative: This spontaneous report as received from a nurse via a company representative  refers to a 27 year old female patient. The patient's current conditions or medical history were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (dose, route, lot number and expiration date were not provided). On an unknown date, the patient was vaccinated with the second dose of GARDASIL (dose, route, lot number and expiration date were not provided). On unknown date, the patient was vaccinated with the third dose of GARDASIL (dose, route, lot number and expiration date were not provided). On an unknown date in 2014, reported as within the last few days, after the patient had received all three GARDASIL injections she had an adverse experience, the patient had first gone to an unspecified urgent care within the last few days and complained of chest pains, numbness in an unspecified part of her body and a headache. Then on 05-MAR-2014, reported as yesterday, the patient went into the clinic to be prescribed treatment for her adverse experience because the urgent care could not identify what was wrong with the patient. At the time of the report outcome of chest pain, numbness and headache was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of unspecified patients of unknown ages and genders. On unknown dates the patients were vaccinated with doses of ROTATEQ (lot #, expiry date, dose, route and indication unknown) that were exposed to supported temperature excursions. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of unspecified patients of unknown ages and genders. On unknown dates the patients were vaccinated with doses of GARDASIL (lot #, expiry date, route and indication unknown) that were exposed to supported temperature excursions. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of unspecified patients of unknown ages and genders. On unknown dates the patients were vaccinated with doses of VAQTA (lot #, expiry date, dose, route and indication unknown) that were exposed to supported temperature excursions. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via company representative who reported 3 individuals (unknown gender and age) who in approximately 2014 (reported as over the past 3 months) received a dose of ZOSTAVAX (Lot #, exp date, dose and route not reported). Concomitant therapy was not reported. In approximately 2014, the patients were subsequently diagnosed, per unspecified physician, with shingles. It was unknown if the patients sought medical attention. The patient's outcome for shingles was unknown. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Case number PHHY2012US111308 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number 467102) received on 04 Dec 2012, with the follow-up received from Quality Assurance Department (reference number: 210308) on 18 Mar 2014: This report refers to a 51-year-old male patient. The patient's medical history included seizure disorder related to traumatic brain injury which was stable with medication. The patient was vaccinated with FLUVIRIN (batch number 1204201) intramuscularly in left arm on 01 Sep 2012. On 03 Sep 2012 two days after vaccination the patient had a seizure. The outcome of the event was reported as not recovered. The seriousness and causality assessment of the event was unknown. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 1204201) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 210308) on 18 Mar 2014: Updated batch review report.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Dyspnoea, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Case number PHHY2014US012789, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 514781) website on 03 Feb 2014 and a follow up received from Quality Assurance Department (QA, reference number: 279894) on 07 Mar 2014. This report refers to a 16-year-old male patient. Past medical history included tree pollen allergies. No concomitant medication was reported. He was vaccinated with FLUVIRIN (batch number: 1309301) intramuscularly in the left arm on 01 Nov 2013. On the same day immediately after vaccination, he experienced dizziness, sweating, paleness, weakness, nausea, shakiness, and labored breathing. The symptoms lasted for four hours. Treatment was rendered with BENADRYL. The final outcome of the events was complete recovery. The seriousness and causality of the events were not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1309301) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (QA, reference number: 279894) on 07 Mar 2014: Updated batch review report.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Pallor, Tremor
Clinical narrative: Case number PHHY2014US012789, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 514781) website on 03 Feb 2014 and a follow up received from Quality Assurance Department (QA, reference number: 279894) on 07 Mar 2014. This report refers to a 16-year-old male patient. Past medical history included tree pollen allergies. No concomitant medication was reported. He was vaccinated with FLUVIRIN (batch number: 1309301) intramuscularly in the left arm on 01 Nov 2013. On the same day immediately after vaccination, he experienced dizziness, sweating, paleness, weakness, nausea, shakiness, and labored breathing. The symptoms lasted for four hours. Treatment was rendered with BENADRYL. The final outcome of the events was complete recovery. The seriousness and causality of the events were not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1309301) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (QA, reference number: 279894) on 07 Mar 2014: Updated batch review report.
Age: 38.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Musculoskeletal pain, Neck pain, Neuralgic amyotrophy, Neurological examination, Robust take following exposure to vaccinia virus
Clinical narrative: This case was received on 13 March 2014 via a third party query tool search on the VAERS database, under reference number 516338. A 38-year-old male patient received the following vaccinations on 04 April 2013: ACAM2000 (lot number VV04003A); Typhoid Vi Polysaccharide vaccine (lot number G1124), and BIOTHRAX (Emergent, lot number FAV310). The patient had a history of neck sprain (2010) and Lyme disease (2007); he had no current illness at the time of vaccination, and no other medications or laboratory data was reported. On 10 April 2013, i.e. six days post-vaccination, the patient developed acute onset neck and shoulder pain. On 13 April 2013 he was seen in the emergency room, where he was treated for "robust take of SPV site". On 13 May 2013 he was seen by a neurologist and diagnosed with neuralgic amyotrophy. Recovery was unknown. Documents held by sender: None.