chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient said the night of the injection - posterior of the site of the injection area was red, warm, swollen and itchy. She said she had supervisor look at it and was told it was a local reaction and to take BENADRYL for it. Patient said she didn't have any and wouldn't take it anyway since it makes her too sleepy. She called Infection prevention coordinator 4/25/14 (left msg re: reaction). I saw pt 4/28/14 at 1540. She said "it was good all weekend" area slightly bruised purple/yellow no swelling - denied itching or pain at site.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction
Clinical narrative: Patient said the night of the injection - posterior of the site of the injection area was red, warm, swollen and itchy. She said she had supervisor look at it and was told it was a local reaction and to take BENADRYL for it. Patient said she didn't have any and wouldn't take it anyway since it makes her too sleepy. She called Infection prevention coordinator 4/25/14 (left msg re: reaction). I saw pt 4/28/14 at 1540. She said "it was good all weekend" area slightly bruised purple/yellow no swelling - denied itching or pain at site.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling, Pyrexia, Throat tightness
Clinical narrative: Mother reported night after administration pt woke up feeling like her throat was closing and felt like she was having trouble breathing, had fever 100.8 and redness/swelling near injection site.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Convulsion, Muscle rigidity, Syncope
Clinical narrative: Fainted, seizure event happened 2-3 minutes past injection. Appeared rigid lasted 8-12 seconds child alert past event. Stated he had not had any liquid intake since breakfast, gave Gatorade in office. Child left office alert and responding appropriately.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Pruritus, Rash
Clinical narrative: Next day rash down arm to elbow burning itchy blisters lasted 1 month.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unknown age and gender patient. Medical history, drug reactions or allergies were not reported. On 28-APR-2014, the patient was inadvertently vaccinated with an expired ZOSTAVAX lot # J010447, expiry date: 22-APR-2014 subcutaneous (dose was not reported). Concomitant therapy was not reported. No adverse effects reported. It was reported that ZOSTAVAX was supported as per spreadsheet. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Rash, pain, and swelling on injected limb.  Pt given Benadryl by mother with symptoms improved.  Still pain in limb with significant decrease in rash.
Age: 1.76
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13, DTAP, HEPA, HIBV, PNC13
Symptoms: Injection site abscess, Ultrasound scan
Clinical narrative: Abscess left thigh.
Age: 1.76
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13, DTAP, HEPA, HIBV, PNC13
Symptoms: Cyst, Injection site abscess
Clinical narrative: Abscess left thigh.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Site where IPV was administered, lt upper arm, was slightly swollen, red and warm to touch.
Age: 23.0
Sex: F
Vaccine: HEPA, IPV, TYP, YF
Symptoms: Abdominal discomfort, Asthenia, Chills, Discomfort, Fatigue
Clinical narrative: I was immunized for yellow fever, polio, typhoid fever, and hepatitis A on 4/29 at 3:15 PM. Around 3:15 the next day I began to get sleepy. I went outside at 4PM and became very drowsy and slightly nauseous. By 5PM I was so exhausted I had to sleep, but I was having heart palpitations. I slept for almost 2 hours, and still woke up drowsy. I got a fever with chills and sweats for another hour or two, which was relieved by Advil. My upper abdomen (hypogastric region) started burning on 4/30 and is still burning today on 5/2- it is very uncomfortable and makes me feel slightly weak.
Age: 23.0
Sex: F
Vaccine: HEPA, IPV, TYP, YF
Symptoms: Hyperhidrosis, Nausea, Palpitations, Pyrexia, Somnolence
Clinical narrative: I was immunized for yellow fever, polio, typhoid fever, and hepatitis A on 4/29 at 3:15 PM. Around 3:15 the next day I began to get sleepy. I went outside at 4PM and became very drowsy and slightly nauseous. By 5PM I was so exhausted I had to sleep, but I was having heart palpitations. I slept for almost 2 hours, and still woke up drowsy. I got a fever with chills and sweats for another hour or two, which was relieved by Advil. My upper abdomen (hypogastric region) started burning on 4/30 and is still burning today on 5/2- it is very uncomfortable and makes me feel slightly weak.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown demographics. No information about medical history concurrent conditions and concomitant medications was reported. The nurse reported that on an unknown date an unspecified number of patients were administered with doses of VARIVAX (Merck) (therapy dates, strength, route not reported) that were improperly stored since an unspecified date in June 2012. No adverse events were reported. The outcome of the events reported is unknown. Additional information has been requested.
Sex: U
Vaccine: RV5, DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Haematochezia
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, the patient was vaccinated with the first and second dose of ROTATEQ (dose, route, lot number and expiration date were not provided). On an unknown date, after receiving the second dose of ROTATEQ the patient experienced blood in the stool. Outcome of blood in the stool was unknown at the time of the report. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5, DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Culture stool, Differential white blood cell count, Discomfort, Escherichia test, Full blood count
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, the patient was vaccinated with the first and second dose of ROTATEQ (dose, route, lot number and expiration date were not provided). On an unknown date, after receiving the second dose of ROTATEQ the patient experienced blood in the stool. Outcome of blood in the stool was unknown at the time of the report. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5, DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Haematochezia, Irritability, Occult blood, Red blood cell sedimentation rate
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, the patient was vaccinated with the first and second dose of ROTATEQ (dose, route, lot number and expiration date were not provided). On an unknown date, after receiving the second dose of ROTATEQ the patient experienced blood in the stool. Outcome of blood in the stool was unknown at the time of the report. No additional information was provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: This spontaneous report was received from a male consumer of unknown age regarding himself. Approximately in 2009 (also reported as "4-5 years ago") the patient was vaccinated with ZOSTAVAX 1 shot, injection. In 2012 (also reported as "2 years ago") the patient developed shingles and he currently still had post herpetic neuralgia (PHN). The outcome of he developed shingles was unknown. The outcome of he currently still had post herpetic neuralgia (PHN) was not recovered. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: 7 x 8 cm erythema at site of injection.
Age: 50.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Feeling abnormal, Injection site rash, Pyrexia, Rash
Clinical narrative: Imm. given 4/24/14 at 930am - pt. developed chills, fever that evening, feeling poorly. Called 4/26/14 - and seen at office w/ rash (R) upper arm extended to back and right flank.
Age: 71.0
Sex: M
Vaccine: TDAP
Symptoms: Cough, Diarrhoea, Epistaxis, Throat irritation
Clinical narrative: Tickle in throat and severe coughing for 1/2 to 1 minute. Diarrhea. Nosebleed, went to ER for treatment, 4-26-14.
Age: 0.16
Sex: M
Vaccine: DTAP
Symptoms: Crying, Electrocardiogram normal, Heart rate decreased, Immediate post-injection reaction, Pallor
Clinical narrative: Pt given DTAP, immediately cried after then became pale and dropped heart rate 130-140 down to 80's - episode lasted 3-4 minutes - pt placed on O2 2 liters PSO2 and sent to ER via ambulance. EKG NL. Pt kept overnight x 24 hrs then discharged home.
Age: 57.0
Sex: F
Vaccine: TYP, YF
Symptoms: Rash, Rash erythematous
Clinical narrative: Pt returned to the pharmacy on 4/28/14 b/c a red, circular, growth/rash appeared on her arm. Pt states she felt fine and she wasn't even sure when it happened but she felt it on her arm today (4/28/14). Pt has no fever or other symptoms beside spot on arm.
Age: 28.0
Sex: F
Vaccine: JEV1
Symptoms: Dysgeusia
Clinical narrative: Pt reported a metallic in the mouth.
Age: 66.0
Sex: F
Vaccine: HEP, PPV, TDAP
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Woke up 5/2/14 with "hives from waist to chin". States she took ibuprofen for arm pain and after prompting states she "reacted like this once before to ibuprofen with codeine". Recommended she call her physician.
Age: 0.16
Sex: M
Vaccine: HEP, PNC13, RV5, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: None adverse events. Tdap was accidentally given instead of PENTACEL.
Age: 0.56
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Chest X-ray normal, Culture urine negative, Full blood count normal, Metabolic function test normal, Pyrexia
Clinical narrative: Patient received routine vaccinations morning 4/25/14. Approximately ten hrs later developed fever to 105 and had ten minute tonic seizure.
Age: 0.56
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Tonic convulsion
Clinical narrative: Patient received routine vaccinations morning 4/25/14. Approximately ten hrs later developed fever to 105 and had ten minute tonic seizure.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Local swelling, Tenderness
Clinical narrative: Received Tdap, MENACTRA, HPV on 4-30-14 (Wed). Thurs (L) arm swollen, red, tender; seen in ER; told by ER Dr. should not have received MENACTRA - too young. Follow up in HC - encouraged to take Ibuprofen, ice and BENADRYL for comfort. Education provided around Tdap and MENACTRA.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Aura, Computerised tomogram, Eye pain, Full blood count, Headache
Clinical narrative: Pt complained of pain in left arm after injection. On 4-30-14 pt advises that late in the evening on 4-29-14 she began to have a headache: On 4-30-14 she describes the worst HA she has ever had with vomiting, and Aura, muscle fatigue, neck stiffness, eye pain with movement, evaluation by physician, evaluation by neurology, Pt taken to ER CT, spinal tap, Admit to floor, Pt currently receiving IV steroids, IV fluids, IV ABX.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lumbar puncture, Metabolic function test, Muscle fatigue, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Pt complained of pain in left arm after injection. On 4-30-14 pt advises that late in the evening on 4-29-14 she began to have a headache: On 4-30-14 she describes the worst HA she has ever had with vomiting, and Aura, muscle fatigue, neck stiffness, eye pain with movement, evaluation by physician, evaluation by neurology, Pt taken to ER CT, spinal tap, Admit to floor, Pt currently receiving IV steroids, IV fluids, IV ABX.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vomiting
Clinical narrative: Pt complained of pain in left arm after injection. On 4-30-14 pt advises that late in the evening on 4-29-14 she began to have a headache: On 4-30-14 she describes the worst HA she has ever had with vomiting, and Aura, muscle fatigue, neck stiffness, eye pain with movement, evaluation by physician, evaluation by neurology, Pt taken to ER CT, spinal tap, Admit to floor, Pt currently receiving IV steroids, IV fluids, IV ABX.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site reaction, Lumbar puncture, Meningitis
Clinical narrative: Pt complained of pain in left arm after injection. On 4-30-14 pt advises that late in the evening on 4-29-14 she began to have a headache: On 4-30-14 she describes the worst HA she has ever had with vomiting, and Aura, muscle fatigue, neck stiffness, eye pain with movement, evaluation by physician, evaluation by neurology, Pt taken to ER CT, spinal tap, Admit to floor, Pt currently receiving IV steroids, IV fluids, IV ABX.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. The physician reported that the patient received a second dose of ZOSTAVAX. The first dose of ZOSTAVAX was received on 09-DEC-2009 and the second dose was received 03-DEC-2013. The Field Representative stated that the patient is experiencing no adverse reactions from the second dose of ZOSTAVAX. The patient's outcome was unknown. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: Paresthesia to the left arm and lower left leg.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Vaccine to left UE 4/30/14. (L) UE redness, swelling and tenderness on 5/1/14; and by 5/2/14 only red, no swelling or tenderness.
Age: 22.0
Sex: M
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Diffuse rash.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Lymphocyte count decreased, Neck pain, Neutrophil count decreased, Pain in extremity, Urticaria
Clinical narrative: Hives, pain in arm 4-6 hr after injection, pain radiating up to neck, no distinct calor.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count normal
Clinical narrative: Hives, pain in arm 4-6 hr after injection, pain radiating up to neck, no distinct calor.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Bruising to the left thigh, redness, swelling and pain below immunization site. It involved almost entire medial surface of thigh.  Right thigh:  blister formed 1 1/2 inch medial to immunization site.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Chills, Headache, Injection site pain, Nausea, Palpitations
Clinical narrative: Nausea, fever 100.4, HA, chills, racing heart rate, injection sites sore.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Pyrexia
Clinical narrative: Nausea, fever 100.4, HA, chills, racing heart rate, injection sites sore.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: HPV Vaccine dose #3 given five weeks too soon.
Age: 2.0
Sex: M
Vaccine: IPV
Symptoms: Injection site swelling, Pruritus, Rash
Clinical narrative: Extreamly swollen thigh with a bump where vaccination was administered.  Over a month and a half still has a rash and has not gone away, swelling is still visible  but minor. Ichy at times.
Age: 34.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Acute hepatic failure, Anaemia, Blood test abnormal, Colitis, Colonoscopy abnormal
Clinical narrative: Heartburn began one hour after shot. I never get heartburn. Followed by nausea and vomiting as well as diarrhea that night. Nausea, vomiting and diarrhea worsened over next several days. I became unable to stomach even water. Went to emergency room on several occasions over next couple weeks, got IVs of fluids for dehydration. Only able to drink water and Gatorade- no food - after a day. Began vomiting and stooling blood and intestinal tissue. Back to emergency room. Vomiting or having diarrhea every half hour for three weeks. Finally went to a normal doctor at a health clinic, who immediately recognized I was jaundiced and ordered blood tests.  I had acute liver failure, kidney failure, hemoglobin counts of 6.9, and was told to go straight to the hospital. Stayed two days at hospital where I got IVs and two blood transfusions. Got partial colonoscopy which found colitis. Slowly allowed to eat again. Was told that if I hadn't had a stronger and hardier immune system (I'm very health conscious), then I would have died. Doctors had no idea what caused it. Kept saying the vaccines I had were dead vaccines. (Had yellow fever and hepatitis A vaccines that day. I just recently read that yellow fever vaccine can have this rare side effect, so I now know this is what caused it).
Age: 34.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Dehydration, Diarrhoea, Dyspepsia, Haematemesis, Haematochezia
Clinical narrative: Heartburn began one hour after shot. I never get heartburn. Followed by nausea and vomiting as well as diarrhea that night. Nausea, vomiting and diarrhea worsened over next several days. I became unable to stomach even water. Went to emergency room on several occasions over next couple weeks, got IVs of fluids for dehydration. Only able to drink water and Gatorade- no food - after a day. Began vomiting and stooling blood and intestinal tissue. Back to emergency room. Vomiting or having diarrhea every half hour for three weeks. Finally went to a normal doctor at a health clinic, who immediately recognized I was jaundiced and ordered blood tests.  I had acute liver failure, kidney failure, hemoglobin counts of 6.9, and was told to go straight to the hospital. Stayed two days at hospital where I got IVs and two blood transfusions. Got partial colonoscopy which found colitis. Slowly allowed to eat again. Was told that if I hadn't had a stronger and hardier immune system (I'm very health conscious), then I would have died. Doctors had no idea what caused it. Kept saying the vaccines I had were dead vaccines. (Had yellow fever and hepatitis A vaccines that day. I just recently read that yellow fever vaccine can have this rare side effect, so I now know this is what caused it).
Age: 34.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Haemoglobin decreased, Hepatitis viral test negative, Jaundice, Nausea, Renal failure
Clinical narrative: Heartburn began one hour after shot. I never get heartburn. Followed by nausea and vomiting as well as diarrhea that night. Nausea, vomiting and diarrhea worsened over next several days. I became unable to stomach even water. Went to emergency room on several occasions over next couple weeks, got IVs of fluids for dehydration. Only able to drink water and Gatorade- no food - after a day. Began vomiting and stooling blood and intestinal tissue. Back to emergency room. Vomiting or having diarrhea every half hour for three weeks. Finally went to a normal doctor at a health clinic, who immediately recognized I was jaundiced and ordered blood tests.  I had acute liver failure, kidney failure, hemoglobin counts of 6.9, and was told to go straight to the hospital. Stayed two days at hospital where I got IVs and two blood transfusions. Got partial colonoscopy which found colitis. Slowly allowed to eat again. Was told that if I hadn't had a stronger and hardier immune system (I'm very health conscious), then I would have died. Doctors had no idea what caused it. Kept saying the vaccines I had were dead vaccines. (Had yellow fever and hepatitis A vaccines that day. I just recently read that yellow fever vaccine can have this rare side effect, so I now know this is what caused it).
Age: 34.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Transfusion, Vomiting
Clinical narrative: Heartburn began one hour after shot. I never get heartburn. Followed by nausea and vomiting as well as diarrhea that night. Nausea, vomiting and diarrhea worsened over next several days. I became unable to stomach even water. Went to emergency room on several occasions over next couple weeks, got IVs of fluids for dehydration. Only able to drink water and Gatorade- no food - after a day. Began vomiting and stooling blood and intestinal tissue. Back to emergency room. Vomiting or having diarrhea every half hour for three weeks. Finally went to a normal doctor at a health clinic, who immediately recognized I was jaundiced and ordered blood tests.  I had acute liver failure, kidney failure, hemoglobin counts of 6.9, and was told to go straight to the hospital. Stayed two days at hospital where I got IVs and two blood transfusions. Got partial colonoscopy which found colitis. Slowly allowed to eat again. Was told that if I hadn't had a stronger and hardier immune system (I'm very health conscious), then I would have died. Doctors had no idea what caused it. Kept saying the vaccines I had were dead vaccines. (Had yellow fever and hepatitis A vaccines that day. I just recently read that yellow fever vaccine can have this rare side effect, so I now know this is what caused it).
Age: 1.62
Sex: M
Vaccine: MMR
Symptoms: Crying, Injection site rash, Injection site reaction, Urticaria
Clinical narrative: 1015 AM -> MMR given. 1020 -> Dime size welt with surrounding rash about 1" above injection site. 1030 -> 12.5 mg BENADRYL given IM as welt increased in size to quarter size. 1055 -> TYLENOL 160mg given orally as patient crying inconsolably. 1115 Pt. discharged as he relaxed and welt and rash lessened.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. No information provided regarding medical history and concurrent conditions. On an unknown date of December-2013 (reported as 5 months ago) the patient was vaccinated with ZOSTAVAX lot # J003360, expire date 21-JUN-2014, (route, frequency, dose number not reported). No concomitant medication reported. It was reported that the physician administered the ZOSTAVAX that reached 77 F for 30 minutes. No PQC. The ZOSTAVAX was not supported by this temperature and time frame. No adverse effect reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Rash
Clinical narrative: Pt. noted fine, non raised rash on abdomen and back on Saturday evening 4/19/14, denies itching, fever, joint pain or other sx., resolved spontaneously 4/21/14.
Age: 6.0
Sex: M
Vaccine: PNC13
Symptoms: Body temperature increased, Injection site pain, Injection site swelling
Clinical narrative: Temp. 105 large swelling and pain at site (deltoid). Rx - prednisolone (2mg/kg).
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Pertinent medical history and drug reactions/allergies were not reported. On 22-APR-2014, the patient was vaccinated with an expired PNEUMOVAX 23 25/0.5 (lot # H014653, expiration date 19-APR-2014) 0.5 ml in the left deltoid (route was not reported). No adverse effects noted to patient. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and genders. Medical history and drug reactions/allergies were not reported. On an unknown date, the multiple unspecified patients were vaccinated with improperly stored M-M-R II (lot, dose, frequency and route not reported). Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source (1405USA001550 and 1405USA001551). Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a  Doctor of pharmacy refers to a patient of unknown age. On 30-APR-2014, the patient was vaccinated with improperly stored 0.65 ml dose of ZOSTAVAX (Lot # not reported) subcutaneously. The pharmacist stated that the ZOSTAVAX reached a high temperature of 12 F and was out of range from 02-APR-2014 to 08-APR-2014 for a total of about 96 hours. No adverse effect was reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site pain, Pruritus, Rash vesicular
Clinical narrative: This spontaneous report as received from a 61 year old female consumer concerning herself. The patient had no pertinent medical history and no drug allergies. On approximately 22-APR-2014 (reported as around two weeks ago), the patient was vaccinated with ZOSTAVAX, (lot number and expiration date), dose route and anatomical location unspecified, one single shot. Concomitant therapies included ZOLOFT, atorvastatin, doxofylline and DULERA. On approximately 22-APR-2014 (reported as around two weeks ago), after injection the site was sore and discolored, the patient developed an unspecified itchy, lumpy area on her neck that "looks like chicken pox" and it was also reported that she continued to have pain and discoloration at the site of vaccination. The patient sought medical attention (visited pharmacist) and no treatment was given for the events, lab diagnostics studies were not performed. The outcome of the site was sore and discolored itchy, lumpy area on her neck that "looks like chicken pox" and pain and discoloration at the site of vaccination was reported as not recovered/not resolved. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and genders. Medical history and drug reactions/allergies were not reported. On an unknown date, the multiple unspecified patients were vaccinated with improperly stored VARIVAX (Merck) (lot, dose, frequency and route not reported), Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source (1405USA000349 and 1405USA001551). Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous reports as received from an office manager refers to unspecified patients of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On 22-APR-2014, the patients were vaccinated with improperly stored PNEUMOVAX23, reported lot# J013555 expiry date: 02-MAY-2015 (dose was not reported) that had been received outside recommended shipping duration. No adverse effects reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Blister, Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: 11 cm x 11 cm area of erythema and edema to left upper arm tender, warm, firm to touch, small vesicle to edge of lesion with serous fluid - no distinct abscess or discharge.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site warmth, Skin lesion
Clinical narrative: 11 cm x 11 cm area of erythema and edema to left upper arm tender, warm, firm to touch, small vesicle to edge of lesion with serous fluid - no distinct abscess or discharge.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and genders. Medical history and drug reactions/allergies were not reported. On an unknown date, the multiple unspecified patients were vaccinated with improperly stored PROQUAD (lot, dose, frequency and route not reported). Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source (1405USA000349 and 1405USA001550). Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Local swelling, Migraine
Clinical narrative: Approximately 1 hour after injection, site became ache, swelling, hot, and patient had migraine. Pt took BENADRYL. Arm swollen from back of down to elbow for several days. Swelling is coming down per patient.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site beginning the day after administration.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Eyelid oedema, Injection site erythema, Injection site swelling
Clinical narrative: Vaccine ok per RMA. Slight eyelid swelling noted 5/1/14 but very obvious eyelid swelling, redness above cheek bones and localized swelling and redness of (R) thigh.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth, Pallor
Clinical narrative: MMR injection given 4/28/14. Parent called clinic on 4/30/14 reporting that injection site was red, tender and warm to touch. Red area was larger than previous day. Patient was seen in clinic 5/1/14 by P.A. Patient also examined by Dr who agrees likely a reaction to MMR. Given the quick spread overnight, will treat for cellulitis (about 5 x 4, mild self blanching around injection site warm, erythematous, no firmness - treated with amoxicillin 960 mg by mouth 2 times daily x 10 days.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Vaccination complication
Clinical narrative: MMR injection given 4/28/14. Parent called clinic on 4/30/14 reporting that injection site was red, tender and warm to touch. Red area was larger than previous day. Patient was seen in clinic 5/1/14 by P.A. Patient also examined by Dr who agrees likely a reaction to MMR. Given the quick spread overnight, will treat for cellulitis (about 5 x 4, mild self blanching around injection site warm, erythematous, no firmness - treated with amoxicillin 960 mg by mouth 2 times daily x 10 days.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from clinical medical assistant refers to a patient of unknown age and gender. On 04-APR-2014 the patient was vaccinated with one dose of PNEUMOVAX 23, (lot number and expiration date unknown), 0.5 ml, intramuscularly and on 29-APR-2014 a second dose of PNEUMOVAX 23 was accidentally administered instead of ZOSTAVAX. No adverse effects were reported. It was also reported that ZOSTAVAX has not been administered to the patient yet. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood test normal, Fatigue, Headache, Myalgia
Clinical narrative: Persistent fever, weakness, muscle pain, fatigue, headache, nausea, leg pain, paleness.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain in extremity, Pallor, Pyrexia
Clinical narrative: Persistent fever, weakness, muscle pain, fatigue, headache, nausea, leg pain, paleness.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Autoimmune disorder, Fatigue, Fibromyalgia, Insomnia, Muscle twitching
Clinical narrative: Chronic Fatigue, Fibromyalgia, PAIN! Everywhere, all the time. Insomnia. Twitching, Autoimmune like issues. These started around the time of my first dose and after my last one......it never stopped.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Pain
Clinical narrative: Chronic Fatigue, Fibromyalgia, PAIN! Everywhere, all the time. Insomnia. Twitching, Autoimmune like issues. These started around the time of my first dose and after my last one......it never stopped.
Age: 34.0
Sex: F
Vaccine: SMALL
Symptoms: Erythema, Joint range of motion decreased, Swelling
Clinical narrative: Extreme swelling and redness, limited ROM to arm.
Age: 56.0
Sex: M
Vaccine: HEP
Symptoms: Feeling abnormal, Hypertension, Laboratory test normal, Malaise, Myalgia
Clinical narrative: High blood pressure, low grade fever, torturous muscle pains like bricks fell on whole body, general malaise, and a feeling as if you are about to die.
Age: 56.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: High blood pressure, low grade fever, torturous muscle pains like bricks fell on whole body, general malaise, and a feeling as if you are about to die.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Pain, Pruritus, Rash erythematous, Swelling
Clinical narrative: Swelling with a red rash and pain and itching, area 5 square inches.
Age: 1.61
Sex: M
Vaccine: HEPA
Symptoms: Rash papular
Clinical narrative: Papular rash. Mom took 4 digital photos of the rash, it's very impressive. I'd be glad to send them for your review.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Unsure on onset time, but pt got the slight raised, red rash that can occur in 1 of every 3 people that receive Zostavax injections.
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Burning sensation, Injection site pain, Nausea
Clinical narrative: Pt receceived Hep B vaccine in L arm around 10:00 AM with no reactions. Pt stated 4-5 hours later he had a burning sensation in upper L arm that radiated to fingers with complaint of nausea. No vomiting, syncope, or external reactions noted.
Age: 27.0
Sex: F
Vaccine: TYP
Symptoms: Swollen tongue
Clinical narrative: Swollen tongue.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: RASH AND PRURITUS OVER INJECTION SITE, TREATED WITH BENADRYL.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Abasia, Cellulitis, Culture, Drug administered at inappropriate site
Clinical narrative: This spontaneous report as received from a physician refers to a 3 year old male patient. The patient had no known pertinent medical history. On 29-APR-2014 ("yesterday"), the patient was vaccinated with a dose of PNEUMOVAX 23 in the left lateral thigh to prepare for a cochlear implant surgery that was scheduled for "next month" (lot #, expiration date, strength, dose and route not reported). There was no concomitant medication. The physician reported that when the patient woke up this morning (on 30-APR-2014), he wasn't able to walk, and his mother brought him to the emergency room (ER). The patient was diagnosed with "cellulitis attributed to PNEUMOVAX 23 injection", and was admitted (the AE onset date was also reported as 02-APR-2014). The physician stated that he was treating the patient in the hospital, and that the patient had not yet been discharged. The physician stated that there was no drainage from the injection site, and the patient was taking clindamycin and BENADRYL. No labs had been performed and the injection site had not been cultured. The physician stated that he was unsure if the patient received PNEUMOVAX 23 or PREVNAR 13, but he believed that the patient received PNEUMOVAX 23. The outcome of the events was not recovered. The reporter considered the event "cellulitis" to be related to PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from a pharmacy technician who reported that RECOMBIVAX HB was improperly stored and exposed to 71F for unknown timeframes prior to the birth of unspecified patients. No adverse effects were reported. No further information was provided. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Herpes zoster, Injection site discolouration, Injection site pain, Injection site rash
Clinical narrative: Rash, pain, swelling, purple at injection site; Body chills, fever, malaise; Herpes outbreak; Terrible nausea, weight loss.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Malaise, Nausea, Pyrexia, Weight decreased
Clinical narrative: Rash, pain, swelling, purple at injection site; Body chills, fever, malaise; Herpes outbreak; Terrible nausea, weight loss.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Pyrexia, Skin warm, Swelling
Clinical narrative: Itching, swelling, fever, warmth to feel, soreness.
Age: 0.71
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (Medical Assistant) refers to an 8 month old patient. On 22-APR-2014 (at the reporting day) the patient was vaccinated with the first dose of ROTATEQ, 2 ml, (lot #, expiration date and dose unspecified). No adverse effect reported. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Chills, Culture, Diarrhoea, Exposure during pregnancy, Pain
Clinical narrative: Got med 4:15 pm - at 900pm - lightheaded, dizzy, chills. 0600 - Horrible diarrhea then to labor and delivery.
Age: 31.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Pyrexia, Tachycardia, Tachycardia foetal, White blood cell count normal
Clinical narrative: Got med 4:15 pm - at 900pm - lightheaded, dizzy, chills. 0600 - Horrible diarrhea then to labor and delivery.
Age: 31.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Chills, Diarrhoea, Dizziness, Exposure during pregnancy
Clinical narrative: Got med 4:15 pm - at 900pm - lightheaded, dizzy, chills. 0600 - Horrible diarrhea then to labor and delivery.
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Coma, Convulsion, Endotracheal intubation, Intensive care, Laboratory test normal
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified patient. On an unknown date the patient was vaccinated with GARDASIL (dose, route, indication and lot # not reported). On an unknown date the patient experienced atypical seizures (reported as "same issue"). The physician stated "no one is blaming the GARDASIL for this; but, she had a Dr. friend (unspecified) in which the physician had the same issue with an unspecified patient. The outcome of atypical seizures was unknown. Upon internal review, atypical seizures were considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified patient. On an unknown date the patient was vaccinated with GARDASIL (dose, route, indication and lot # not reported). On an unknown date the patient experienced atypical seizures (reported as "same issue"). The physician stated "no one is blaming the GARDASIL for this; but, she had a Dr. friend (unspecified) in which the physician had the same issue with an unspecified patient. The outcome of atypical seizures was unknown. Upon internal review, atypical seizures were considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient's medical history was not provided. On 29-APR-2014, the patient was vaccinated with ZOSTAVAX (lot # J001010, Expiry date: 24-APR-2014). Concomitant medications were not reported. The patient received expired ZOSTAVAX on 29-APR-2014. Pharmacist reported the ZOSTAVAX in question had not had any previous temperature excursions. The outcome of received expired ZOSTAVAX and patient had not reported any adverse symptoms was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient's medical history was not provided. On 29-APR-2014, the patient was vaccinated with ZOSTAVAX (lot # J001010, Expiry date: 24-APR-2014). Concomitant medications were not reported. The patient received expired ZOSTAVAX on 29-APR-2014. Pharmacist reported the ZOSTAVAX in question had not had any previous temperature excursions. The outcome of received expired ZOSTAVAX and patient had not reported any adverse symptoms was unknown. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Hypotonia, Muscular weakness, Pain
Clinical narrative: This spontaneous report as received from a healthcare student refers to a 54 year old male patient with no drug reactions or allergies. On 29-APR-2014, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot # reported as 5011799, expiration date 09-FEB-2015) (lot # 5011799 is an invalid lot number for PNEUMOVAX 23) intramuscularly in the left arm. Concomitant therapies included BOOSTRIX, ZOLOFT, PROAIR, simvastatin (manufacturer unknown) and XOPENEX. It was reported that on 29-APR-2014 the patient received a second dose of BOOSTRIX was in the opposite arm of the PNEUMOVAX 23. The student reported that on 29-APR-2014, 2 hours after vaccination, the patient went to hospital emergency room due to developing excruciating pain in his upper left arm. The patient was not admitted to the hospital and was sent home with prescriptions for oxycodone and TYLENOL. The student stated that when the patient went to pick up his prescriptions at the pharmacy on 30-APR-2014, she noted that his left arm was limp. The outcome of left arm was limp and excruciating pain in his upper left arm was reported as not recovered/not resolved. The Health care student considered left arm was limp to be significant disabling. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Hypotonia, Pain in extremity
Clinical narrative: This spontaneous report as received from a healthcare student refers to a 54 year old male patient with no drug reactions or allergies. On 29-APR-2014, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot # reported as 5011799, expiration date 09-FEB-2015) (lot # 5011799 is an invalid lot number for PNEUMOVAX 23) intramuscularly in the left arm. Concomitant therapies included BOOSTRIX, ZOLOFT, PROAIR, simvastatin (manufacturer unknown) and XOPENEX. It was reported that on 29-APR-2014 the patient received a second dose of BOOSTRIX was in the opposite arm of the PNEUMOVAX 23. The student reported that on 29-APR-2014, 2 hours after vaccination, the patient went to hospital emergency room due to developing excruciating pain in his upper left arm. The patient was not admitted to the hospital and was sent home with prescriptions for oxycodone and TYLENOL. The student stated that when the patient went to pick up his prescriptions at the pharmacy on 30-APR-2014, she noted that his left arm was limp. The outcome of left arm was limp and excruciating pain in his upper left arm was reported as not recovered/not resolved. The Health care student considered left arm was limp to be significant disabling. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pruritus
Clinical narrative: SHOULDER AND ARM ERYTHEMA AND PRURITUS.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Pancreatitis
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with GARDASIL, intramuscular injection, "1 single shot". Dose, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The physician reported that "on an unspecified date the anonymous patient (demographics unknown) was hospitalized and diagnosed with having pancreatitis while using GARDASIL". The outcome of pancreatitis while using GARDASIL was unknown. Upon internal review the event pancreatitis was considered as an other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia, Burning sensation, Convulsion, Dizziness
Clinical narrative: Brain on fire. Headaches. Right side pain. Weak. Numb. Blurring vision. Seizures. Dizzy. Loss weight.  Body aches. Fever. Hip pain. Hurts to stand. Rash. Hard to breathe.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Dysstasia, Headache, Hypoaesthesia, Laboratory test
Clinical narrative: Brain on fire. Headaches. Right side pain. Weak. Numb. Blurring vision. Seizures. Dizzy. Loss weight.  Body aches. Fever. Hip pain. Hurts to stand. Rash. Hard to breathe.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Neurological examination, Pain, Pyrexia, Rash, Vision blurred
Clinical narrative: Brain on fire. Headaches. Right side pain. Weak. Numb. Blurring vision. Seizures. Dizzy. Loss weight.  Body aches. Fever. Hip pain. Hurts to stand. Rash. Hard to breathe.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Weight decreased
Clinical narrative: Brain on fire. Headaches. Right side pain. Weak. Numb. Blurring vision. Seizures. Dizzy. Loss weight.  Body aches. Fever. Hip pain. Hurts to stand. Rash. Hard to breathe.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Electrocardiogram PR interval, Electrocardiogram QT interval, Electrocardiogram normal, Painful respiration
Clinical narrative: A 25-year-old male subject, with no relevant medical history, developed chest pain 5 years after receiving an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported) on March 2009. On 18 April 2014, the subject developed pleuritic chest pain, associated with deep inspiration. He experienced 3 episodes of pleuritic chest pain. The severity of chest pain was reported as mild. No shortness of breath, no interference with his activities and no other symptoms associated with myopericarditis were noted. Electrocardiogram and rapid troponin test (<0.10 ng/mL) done on 22 April 2014 were normal. The subject had no pain at visit 2 but recurrence of the symptoms was reported. The subject did not take any medications to treat the SAE. No action was taken. The subject was referred for appropriate evaluation. The subject's outcome was reported as not recovered. The relationship was assessed as remote by the investigator. Documents held by sender: None.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Pleuritic pain, Troponin I increased
Clinical narrative: A 25-year-old male subject, with no relevant medical history, developed chest pain 5 years after receiving an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported) on March 2009. On 18 April 2014, the subject developed pleuritic chest pain, associated with deep inspiration. He experienced 3 episodes of pleuritic chest pain. The severity of chest pain was reported as mild. No shortness of breath, no interference with his activities and no other symptoms associated with myopericarditis were noted. Electrocardiogram and rapid troponin test (<0.10 ng/mL) done on 22 April 2014 were normal. The subject had no pain at visit 2 but recurrence of the symptoms was reported. The subject did not take any medications to treat the SAE. No action was taken. The subject was referred for appropriate evaluation. The subject's outcome was reported as not recovered. The relationship was assessed as remote by the investigator. Documents held by sender: None.
Age: 8.0
Sex: M
Vaccine: PPV, TD
Symptoms: Blood culture negative, C-reactive protein increased, Cellulitis, Erythema, Joint range of motion decreased
Clinical narrative: Redness to thigh, pain to thigh, unable to bend knee - pain started after vaccine given, redness and pain worsened until patient presented to ED on 5/4/14, elevated CRP and WBC, clindamycin started, improved on 5/5 and discharged home, cellulitis versus vaccine reaction.