chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified amount of patients of unknown age and gender. On an unknown date these unspecified amount of patients were vaccinated with M-M-R II (lot#, dose, route not provided) that underwent a temperature excursion. Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient with no drug reactions or allergies. On 16-AUG-2014, the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot # J009827, expiration date 10-AUG-2014) 0.5 ml, intramuscular in the left upper arm. The next day, on 17-AUG-2014 the patient contacted pharmacist complaining of pain on the left arm near the injection site. There was no treatment given for adverse event. Laboratory tests were not performed. The outcome of pain on the left arm near the injection site was unknown. The relatedness between adverse event with PNEUMOVAX23 was not reported. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 16-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX lot # H013181, 0.5 ml, subcutaneous. No concomitant medication was reported. On 16-AUG-2014, the patient experienced patient was inadvertently administered a dose of (Oka/Merck) VARIVAX that had expired on 05-JUL-2014. No adverse event was reported. Product quality complaint was not reported. The outcome of events was unknown. 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 nurse refers to unspecified amount of patients of unknown age and gender. On an unknown date these unspecified amount of patient were vaccinated with GARDASIL (lot#, dose, route not reported) that underwent a temperature excursion. Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, MMR, VARCEL
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: Went in to check out patient, saw a swollen weal where MMR was given. Notified provider. Provider ordered .5 ml of Childrens BENADRYL and we put allergy itch relief cream on . Observed patient for 15 more min's. Advised. Left.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Injection site rash, Rash
Clinical narrative: Rash with pimples on right side of body ie leg, stomach, shoulder, head, eye. Symptoms began four hours after vaccine and continued for about 10 days- symptoms were mild- Rash at injection site.
Age: 35.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus generalised
Clinical narrative: Received MMR vaccine on 8/18/2014 at 2PM. Patient noticed localized swelling, redness, and itching at injection site at 8:30 PM on 8/18/14. Patient also started itching  "all over" at 8:30 PM. Symptoms completely subsided by 8/20/14.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: arm slowly become more sore, red, hot at injection site.  by 8:00 pm went to bed exhausted; not an ounce of energy.  took a half of a hydrocodone.  next day intense pain, swelling down to elbow.  called Dr and- I cannot take advil because of ulcer from fosamax- he recommended steroid, which we had in house, 16 milligrams.  then 1/2 steroid at noon, then 1/2 this morning.  The steroid has helped, but the pain has been severe.  unable to raise arm and it hurts to lower hand. sleeping with pillow under arm  I am beginning to feel better but arm still red, swollen, painful, and am very tired.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Mobility decreased
Clinical narrative: arm slowly become more sore, red, hot at injection site.  by 8:00 pm went to bed exhausted; not an ounce of energy.  took a half of a hydrocodone.  next day intense pain, swelling down to elbow.  called Dr and- I cannot take advil because of ulcer from fosamax- he recommended steroid, which we had in house, 16 milligrams.  then 1/2 steroid at noon, then 1/2 this morning.  The steroid has helped, but the pain has been severe.  unable to raise arm and it hurts to lower hand. sleeping with pillow under arm  I am beginning to feel better but arm still red, swollen, painful, and am very tired.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Patient received vaccinations and started to cry. As the patient was crying she began to feel dizzy. I laid patient down on exam table. Patient laid there for 5 minutes. She began to feel better she stated. BP 99/66 laying down. Patient sat up BP 108/71. Patient stood up and felt good to walk. BP 111/56. Followed patient to car and informed mother if patient feels dizzy again lay her down. If she doesn't get better take her to ER.
Sex: F
Vaccine: TDAP
Symptoms: Polymyalgia rheumatica, Rheumatoid arthritis
Clinical narrative: This case was reported by a consumer and described the occurrence of polymyalgia rheumatica in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included type 1 diabetes. Concurrent medications included HUMALOG, LANTUS, LASIX and COUMADIN. In June 2014, the subject received an unspecified dose of BOOSTRIX (administration site and route unknown, batch number not provided). At an unspecified time after vaccination with BOOSTRIX, the subject experienced polymyalgia rheumatica arthritis. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the events was unspecified.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. On 01-MAY-2014, the patient was vaccinated with GARDASIL (dose and route of administration were not provided)(reported lot # was illegible, expiration date: 28-SEP-2014) dose 1 in the left deltoid. The GARDASIL was out of range temperature. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chest X-ray, Dyspnoea, Headache, Pyrexia
Clinical narrative: Fever, headache, joint pain, shortness of breath.
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient (the reporter's mother) of unknown age. On an unknown date, the patient was vaccinated with an expired dose of PNEUMOVAX23 (dose, dose number, route of administration, lot/batch number, expiration date and indication were not reported). No adverse event symptoms were reported. No product quality complaint was reported. Additional information is not expected as the reporter declined to provide any contact information.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No medical history, concomitant medication and current conditions were reported. The reporter stated that the patient received the first dose of GARDASIL on 28-AUG-2012, and the second dose on 06-NOV-2012 (Dose, Lot number and expiration date were not reported both doses). It was reported that the patient was on the office to receive the third dose of GARDASIL on 19-AUG-2014. No adverse event was reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site mass
Clinical narrative: Raised lump > 50 cent size, round and hard on Rt thigh 3 inches above knee and 1-2 inches away from vaccine sites. No redness but tender. Afebrile. Mother used warm moist clothes to area and gave ibuprofen.
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 age and gender. On an unknown dates the patients received doses of (Oka/Merck) VARIVAX (dose, route of administration, lot# and expiration dates not reported), that were exposed to temperatures outside of the proper storage range. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. On an unknown dates the patients received doses of (Oka/Merck) PROQUAD (dose, route of administration, lot# and expiration dates not reported), that were exposed to temperatures outside of the proper storage range. No adverse effects reported. This is one of several reports from the same source. 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 healthcare worker refers to 4 patients of unknown ages and genders. On an unknown dates the patients were vaccinated with MMR II albumin status unknown (route, dose number and dosage unknown; lot # J003791 EXP 28-MAR-2015). It was reported that the vaccine was given to 4 patients after the vaccines were exposed to temperatures outside of recommended condition. No adverse events were reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Lt arm swollen and red at injection site. Seen by MD - to Tx with ADVIL and ice.
Age: 49.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Local swelling, Pain in extremity, Torticollis
Clinical narrative: Date of immunization patient had no problems. The next day patient c/o: soreness, swelling, numbness down (Rt) arm. She had a massage on 08/09/14. Patient was worse and went to urgent care. The urgent care provider diagnosed Torticollis and was prescribed anti-inflammatory and muscle relaxers. Pt reports Icing and Emu oil for treatment.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: We received a call the day after injection on 8/27. Pt's injection site became very swollen and painful. Pt tried BENADRYL and IBU without relief.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Immediate post-injection reaction, Injection site erythema, Injection site vesicles, Local swelling
Clinical narrative: I received the shingles vaccine & my arm immediately developed a large itchy red swollen patch encircling my arm and an even redder patch with blisters at the injection site. I'm also experiencing some pain-like soreness.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus
Clinical narrative: I received the shingles vaccine & my arm immediately developed a large itchy red swollen patch encircling my arm and an even redder patch with blisters at the injection site. I'm also experiencing some pain-like soreness.
Age: 1.31
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Seizure like phenomena
Clinical narrative: Patient presented to office with seizure like activity. Patient treated by DNP was treated for symptoms for 20 minutes while waiting for ambulance. Administered O2 in office and transported to ED. Subsequently sent to another hospital.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: The patient reported a rash at the injection site.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Rash
Clinical narrative: Developed rash on torso, neck and extremeties.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling, White blood cell count normal
Clinical narrative: Redness, swelling, pruritis and rash to R upper extremity (site of vaccination) persisting now 4 days.  Treatment received from local Urgent Care for presumed cellulitis (oral antibx) then further hospitalization on 8/27-28 for unresolved and worsening presumed cellulitis (IV antibx x 1 day). No fevers or chills noted or evidence of cellulitis upon hospital Infectious Disease consultation.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Skin depigmentation
Clinical narrative: Autoimmune/Skin depigmentation.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Approximately 19cm x 8cm red area on the left upper back of the arm, warm to touch. Treated with Benadryl and Steroid.
Age: 59.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: IM vaccine was given SubQ - Large, quarter sized, red bump appeared within an hour after vaccine was given to back of upper, left arm.  Today is 8 days later, bright redness has disappeared but the LUMP is still the same size. I was given a Tdap and a Hepatitis A vaccine on 8/20/14; The nurse told me Tdap was given in left arm and Hep A in the right, however she documented this information backwards.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Crying, Discomfort, Disturbance in attention, Fatigue, Vomiting
Clinical narrative: When we came home from the doctor, I fed her lunch and put her down for a nap. Then she woke up crying and threw up five times over the course of two hours. After that, I tried giving her some water, but she threw up a sixth time. She seemed tired, uncomfortable, and unfocused. After three hours, she suddenly seemed completely back to normal and was able to hold down clear fluids and eventually food.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Decreased appetite, Injection site discolouration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient is a 4  y.o. 11  m.o. male who presents with left thigh redness and swelling after getting the DTAP/Polio vaccine on 8/21/14. The area is warm to touch. He is not complaining of pain. Mom noticed the swelling on 8/22/14. She has given him ibuprofen once. She has been putting ice on it around the clock. No fever. Bactroban given.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Patient is a 4  y.o. 11  m.o. male who presents with left thigh redness and swelling after getting the DTAP/Polio vaccine on 8/21/14. The area is warm to touch. He is not complaining of pain. Mom noticed the swelling on 8/22/14. She has given him ibuprofen once. She has been putting ice on it around the clock. No fever. Bactroban given.
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Asthenia, Headache, Oropharyngeal pain, Pain, Pruritus
Clinical narrative: MOTHER STATES PATIENT HAD A HEADACHE, THROAT PAIN, PAIN, ITCHING, STOMACH WEAKNESS. PATIENT CAME TO ER AFTER LEAVING THE CLINIC.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right upper arm was red and swollen.
Age: 10.0
Sex: M
Vaccine: DTAPH
Symptoms: Amnesia, Confusional state, Mood altered
Clinical narrative: My son became very confused after the vaccine.  His memory deteriorated rapidly and he became very moody.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Bleeding upon withdrawal of needle, soreness at injection site, soreness of injected left arm, stiffness of injected left arm.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Insomnia, Pyrexia, Rash erythematous, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Started to get fever and red dots on his torso.  Continued to worsen over the next few days.  Had runny nose and sounded congested.  Cleared up by 8/26/14. Having trouble sleeping.
Age: 0.55
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Insomnia, Irritability, Nasal congestion, Pyrexia
Clinical narrative: High fever, nasal congestion, extreme fussiness, difficulty sleeping, loss of appetite.  Infant Advil administered.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Mobility decreased, Myalgia, Pyrexia
Clinical narrative: Severe muscle pain, swelling at injection site, redness at injection site, fever, reduced mobility in arm.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hyperhidrosis, Injection site pain, Malaise, Pain
Clinical narrative: PT COMPLAINED OF FEELING SICK, SWEATING, ACHES, AND PAIN AT INJECTION SITE.
Age: 62.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Local swelling
Clinical narrative: Swelling around his neck.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Hyperhidrosis, Myalgia, Pain in extremity
Clinical narrative: Pt experienced muscle aches, extreme sweating episodes, and weakness/pain in fingers/vaccination arm on day of vaccination. Approximately 4 hours later, went to MD for A.E. MD said wait 48 hours. Pt came in next day feeling 70% better.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a nurse practitioner referred to a 53 year old female patient. No drug reactions/allergies. On 19-AUG-2014 the patient was vaccinated with a dose of ZOSTAVAX (Lot# unspecified), strength 19400 PFU, 0.65 ml, subcutaneous. Concomitant therapies included CELEXA, loratadine (manufacturer unknown), amoxicillin, SYNTHROID and FOSAMAX. The patient reported to the nurse practitioner that the injection site was red, sore and was swollen on unspecified dates in August 2014. The nurse practitioner stated that the swelling and redness was "almost resolved" without treatment. No treatment was given for all the events. The patient had sought medical attention-office visit. No lab diagnostics studies were performed. The patient's present status was recovering. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Injection site reaction, Rash papular
Clinical narrative: 10 days after vaccination, patient developed pre-vesicular erythematous papula's at site of vaccination right upper thigh and low grade temp 99.
Age: 11.0
Sex: U
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Increased redness, swelling, itching, site tender to touch. Site right deltoid. lasting 2 days. Treatment medication prescribed, Diphenhydramine Hcl 25mg as needed every 6 to 8 hours. Ice pack applied.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 21-AUG-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot# K006921 is an invalid lot number for PNEUMOVAX 23)), Exp date 09-AUG-2014, (strength, dose, frequency and route unspecified). No adverse effect was reported. 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 other certified medical assistant refers to a patient of unknown age and gender. On 26-AUG-2014, the patient was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (lot # K004204, exp 12-JAN-2017) that underwent a temperature excursion. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a "college aged patient" of unknown gender. Information about concurrent medical conditions, concomitant medication and medical history was not provided. On 11-JUN-2014 the "college aged patient" was accidentally vaccinated with 0.5ml dose of PROQUAD (Merck) (injection, lot# and frequency were not provided) subcutaneously instead of ZOSTAVAX. No adverse effects reported. Additional information has been requested.
Age: 0.41
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Irritability
Clinical narrative: Pt became very fussy and unconsolable at 45 min intervals for over 24 hrs.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The medical assistant reported that the unspecified patient received the first and second dose of GARDASIL inj (doses, lot numbers and routes not provided) on unspecified dates in 2011, and was in the office on 25-AUG-2014, to receive the third dose of GARDASIL. No adverse effects reported. Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pyrexia, Skin warm
Clinical narrative: Arm was red, swollen, and warm. Pt. had a fever.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to injection site right deltoid region.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, RV5
Symptoms: Diarrhoea, Faeces discoloured
Clinical narrative: Received ROTATEQ later that evening developed diarrhea charcoal in color.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site anaesthesia, Loss of consciousness, Syncope
Clinical narrative: Patient developed numbness in (R) upper arm after injection given. He did have a syncopal episode. He waited in the clinic for 30 min; after 15 minutes he passed out. LOC for a few seconds after he recovered (15 min) he still complained of arm numbness. This has happened x2 both injections of GARDASIL caused same reaction.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients of an unknown age and gender. Medical history was not reported. On an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX (lot number, expiration date, dosage and route were not reported). Concomitant therapy was not reported. The medical assistant reported that on an unknown date the (Oka/Merck) VARIVAX was exposed to 10 defrost cycles per month for 5 minutes each time, with highest temperature of 10F. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact with the physician.
Age: 0.4
Sex: M
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old male patient. No pertinent medical hisotry or drug reactions/allergies were provided. The nurse reported that, on 27-AUG-2014, a baby received a dose of PNEUMOVAX 23, 0.5 ml, intramuscular, at too young an age. No adverse effects were reported. Additional information is not expected because there was no consent to follow up.
Age: 13.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Patient developed chicken pox from varicella vaccine the evening after having varicella vaccine.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Vomiting
Clinical narrative: Light-headed, G.S, threw up. Placed in Trendelenburg position, ice pack, continued monitoring, reassessed and released. Emesis done.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients of an unknown age and gender. Medical history was not reported. On an unknown date the patient was vaccinated with PROQUAD (Merck) (lot number, expiration date, dosage and route were not reported). Concomitant therapy was not reported. The medical assistant reported that on an unknown date the PROQUAD (Merck) was exposed to 10 defrost cycles per months for 5 minutes each time, with highest temperature of 10F. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact with the physician.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Crying, Ear swelling, Erythema, Injection site erythema, Local swelling
Clinical narrative: Redness to legs and arms and feet, pt was breathing fast. Face was swollen and red, white around mouth, and crying a lot. 1:15 pm pulse ox 95% RA. 1:20 pm Epi (R) thigh 0.125mg. 1:25 pm Methylprednisolone 20mg IM (L) thigh. 1:25 pm BENADRYL 12.5mg po. 1:30 pm Erythema decreased. Respirations unlabored. Vitals: pulse 93 POX 97% RA. Pt. crying. Redness to legs and feet decreasing at 1:25 pm. Pt breathing strongly. Rash to back seems to be going away. 99% 139 heart rate. Pt's (R) arm seems more irritated than (L) arm. Sleeping. 1:40 pm Pt now snoring and breathing very strong. Pt's face still swollen, red and ears as well. 95% 122 heart rate. (R) arm is now getting better almost all the red and swollen is off. Pt breathing through his mouth due to stuffy nose. 1:47 pm Pt not snoring anymore, pt seems much calmer, breathing better. Face, ears, feet still red. Nipples and around nipples are popping out/as per someone seems okay. 1:50 pm Rash to body getting smaller. Face still swollen and red, ears as well. 97% 121. 2:10 Pt still asleep, ears still red and swollen. 100% 122 heart rate.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Mouth breathing, Nasal congestion, Rash, Respiratory rate increased, Skin irritation
Clinical narrative: Redness to legs and arms and feet, pt was breathing fast. Face was swollen and red, white around mouth, and crying a lot. 1:15 pm pulse ox 95% RA. 1:20 pm Epi (R) thigh 0.125mg. 1:25 pm Methylprednisolone 20mg IM (L) thigh. 1:25 pm BENADRYL 12.5mg po. 1:30 pm Erythema decreased. Respirations unlabored. Vitals: pulse 93 POX 97% RA. Pt. crying. Redness to legs and feet decreasing at 1:25 pm. Pt breathing strongly. Rash to back seems to be going away. 99% 139 heart rate. Pt's (R) arm seems more irritated than (L) arm. Sleeping. 1:40 pm Pt now snoring and breathing very strong. Pt's face still swollen, red and ears as well. 95% 122 heart rate. (R) arm is now getting better almost all the red and swollen is off. Pt breathing through his mouth due to stuffy nose. 1:47 pm Pt not snoring anymore, pt seems much calmer, breathing better. Face, ears, feet still red. Nipples and around nipples are popping out/as per someone seems okay. 1:50 pm Rash to body getting smaller. Face still swollen and red, ears as well. 97% 121. 2:10 Pt still asleep, ears still red and swollen. 100% 122 heart rate.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Snoring, Swelling face
Clinical narrative: Redness to legs and arms and feet, pt was breathing fast. Face was swollen and red, white around mouth, and crying a lot. 1:15 pm pulse ox 95% RA. 1:20 pm Epi (R) thigh 0.125mg. 1:25 pm Methylprednisolone 20mg IM (L) thigh. 1:25 pm BENADRYL 12.5mg po. 1:30 pm Erythema decreased. Respirations unlabored. Vitals: pulse 93 POX 97% RA. Pt. crying. Redness to legs and feet decreasing at 1:25 pm. Pt breathing strongly. Rash to back seems to be going away. 99% 139 heart rate. Pt's (R) arm seems more irritated than (L) arm. Sleeping. 1:40 pm Pt now snoring and breathing very strong. Pt's face still swollen, red and ears as well. 95% 122 heart rate. (R) arm is now getting better almost all the red and swollen is off. Pt breathing through his mouth due to stuffy nose. 1:47 pm Pt not snoring anymore, pt seems much calmer, breathing better. Face, ears, feet still red. Nipples and around nipples are popping out/as per someone seems okay. 1:50 pm Rash to body getting smaller. Face still swollen and red, ears as well. 97% 121. 2:10 Pt still asleep, ears still red and swollen. 100% 122 heart rate.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEP, MMRV
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Swelling and itching to injection site.
Age: 16.0
Sex: M
Vaccine: HIBV, MNQ, PPV, PPV
Symptoms: Body temperature increased, Computerised tomogram abnormal, Injection site oedema, Injection site pain, Malaise
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 16 year old male patient. The patient's medical history included splenic laceration. On 14-AUG-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # J009723, expiration date 30-JAN-2015, intramuscular injection (dose and dose number were not reported). There was no concomitant medication. On 16-AUG-2014, the patient experienced cellulitis on an unspecified area of the body. On the same day the patient was admitted to the hospital and given 1 dose of clindamycin and 1 dose of vancomycin. Later that day (16-AUG-2014), the patient had itching which the pharmacist believed was a possible allergic reaction to the vancomycin. Later the same day (16-AUG-2014), the patient started on ZOSYN which he was taking till 19-AUG-2014. On 19-AUG-2014, the patient was discharged from the hospital and sent home with AUGMENTIN. In an approximately August 2014, the complete blood count (CBC), chemistry panel (reported as chem panel) and blood culture were performed, no results were reported. The outcome of cellulitis and itching was unknown. The relatedness between the adverse events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HIBV, MNQ, PPV, PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 16 year old male patient. The patient's medical history included splenic laceration. On 14-AUG-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # J009723, expiration date 30-JAN-2015, intramuscular injection (dose and dose number were not reported). There was no concomitant medication. On 16-AUG-2014, the patient experienced cellulitis on an unspecified area of the body. On the same day the patient was admitted to the hospital and given 1 dose of clindamycin and 1 dose of vancomycin. Later that day (16-AUG-2014), the patient had itching which the pharmacist believed was a possible allergic reaction to the vancomycin. Later the same day (16-AUG-2014), the patient started on ZOSYN which he was taking till 19-AUG-2014. On 19-AUG-2014, the patient was discharged from the hospital and sent home with AUGMENTIN. In an approximately August 2014, the complete blood count (CBC), chemistry panel (reported as chem panel) and blood culture were performed, no results were reported. The outcome of cellulitis and itching was unknown. The relatedness between the adverse events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HIBV, MNQ, PPV, PPV
Symptoms: Blood culture, Cellulitis, Full blood count, Laboratory test, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 16 year old male patient. The patient's medical history included splenic laceration. On 14-AUG-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # J009723, expiration date 30-JAN-2015, intramuscular injection (dose and dose number were not reported). There was no concomitant medication. On 16-AUG-2014, the patient experienced cellulitis on an unspecified area of the body. On the same day the patient was admitted to the hospital and given 1 dose of clindamycin and 1 dose of vancomycin. Later that day (16-AUG-2014), the patient had itching which the pharmacist believed was a possible allergic reaction to the vancomycin. Later the same day (16-AUG-2014), the patient started on ZOSYN which he was taking till 19-AUG-2014. On 19-AUG-2014, the patient was discharged from the hospital and sent home with AUGMENTIN. In an approximately August 2014, the complete blood count (CBC), chemistry panel (reported as chem panel) and blood culture were performed, no results were reported. The outcome of cellulitis and itching was unknown. The relatedness between the adverse events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Rash
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to a 61 year old female patient. There was no pertinent medical history, drug reactions or allergies reported. On 11-AUG-2014, the patient was vaccinated with a dose ZOSTAVAX lot# J014810, expiration date: 21-FEB-2015 (dose, dose number and route of administration not reported). There were no concomitant medications reported. On an approximately 14-AUG-2014(also reported as yesterday), the patient experienced swelling, redness and blistery rash that was present near the ZOSTAVAX injection site. It was reported that the first time the patient came in on 14-AUG-2014 (reported as yesterday), the swelling, redness and rash was only about an inch in diameter around the injection site and the second time the patient came in to the pharmacy on 14-AUG-2014 (reported as yesterday), the swelling, redness and rash was present around the patient's entire arm. The patient was directed to seek medical attention from an unspecified physician (it was reported that the patient sought medical attention). There was no treatment given for the event. No laboratory diagnostics studies were performed. It was reported that the patient sought medical attention. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to a 61 year old female patient. There was no pertinent medical history, drug reactions or allergies reported. On 11-AUG-2014, the patient was vaccinated with a dose ZOSTAVAX lot# J014810, expiration date: 21-FEB-2015 (dose, dose number and route of administration not reported). There were no concomitant medications reported. On an approximately 14-AUG-2014(also reported as yesterday), the patient experienced swelling, redness and blistery rash that was present near the ZOSTAVAX injection site. It was reported that the first time the patient came in on 14-AUG-2014 (reported as yesterday), the swelling, redness and rash was only about an inch in diameter around the injection site and the second time the patient came in to the pharmacy on 14-AUG-2014 (reported as yesterday), the swelling, redness and rash was present around the patient's entire arm. The patient was directed to seek medical attention from an unspecified physician (it was reported that the patient sought medical attention). There was no treatment given for the event. No laboratory diagnostics studies were performed. It was reported that the patient sought medical attention. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Asthenia, Asthma, Back pain, Chest pain, Cough
Clinical narrative: Pt developed syncopal episode following administration of GARDASIL - pt was sent via EMR to emergency dept for close monitoring - pt d'c after few hours - pt readmitted later that afternoon with complaints of chest and back pain and cough - pt later transferred to another facility x 2 days for evaluation.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Dizziness, Dyspnoea, Electrocardiogram normal, Syncope, Viral infection
Clinical narrative: Pt developed syncopal episode following administration of GARDASIL - pt was sent via EMR to emergency dept for close monitoring - pt d'c after few hours - pt readmitted later that afternoon with complaints of chest and back pain and cough - pt later transferred to another facility x 2 days for evaluation.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Back pain, Chest X-ray, Chest pain, Cough, Laboratory test
Clinical narrative: Pt developed syncopal episode following administration of GARDASIL - pt was sent via EMR to emergency dept for close monitoring - pt d'c after few hours - pt readmitted later that afternoon with complaints of chest and back pain and cough - pt later transferred to another facility x 2 days for evaluation.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Pt developed syncopal episode following administration of GARDASIL - pt was sent via EMR to emergency dept for close monitoring - pt d'c after few hours - pt readmitted later that afternoon with complaints of chest and back pain and cough - pt later transferred to another facility x 2 days for evaluation.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Constipation, Crying, Flatulence, Hypersomnia, Lethargy
Clinical narrative: Baby girl was inconsolable with high pitched cry 2 hours after her vaccinations. Then for the next 5 days she was very lethargic and slept about 18-20 hours a day (very unusual for her). She did not have bowel movements for 4 days (never happened before). Called pediatrician's office 3 times, nurses said all this was normal. Mom used "The Windy" twice to help relieve gas and constipation. After that, baby was able to have normal bowel movements on day 4.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: SEVERE EMESIS ALL NIGHT REQUIRING IV MEDICATION'S AND FLUIDS TO BE ADMINISTERED IN EMERGENCY DEPARTMENT.
Age: 1.15
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Polymerase chain reaction, Rash
Clinical narrative: Rash, PCR positive.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Blood test, Colitis, Computerised tomogram, Rectal haemorrhage
Clinical narrative: This spontaneous report as received from a consumer refers to his 76 year old female mother with diabetes, high blood pressure and a history of colon cancer. On approximately 11-AUG-2014 ("about two weeks ago") the patient was vaccinated with PNEUMOVAX 23 (lot # reported as K004282, expiration date 22-MAR-2015), which is an invalid lot# for PNEUMOVAX 23 (dose, route unspecified). Unspecified concomitant medications were taken. On an unspecified date in August 2014, the patient experienced weakness, blurred vision and she fainted one day after receiving the PNEUMOVAX 23 vaccination on approximately 12-AUG-2014. The patient was seen at Hospital Emergency room and then released and returned to her home. About one week after receiving the PNEUMOVAX 23 injection, on approximately 18-AUG-2014, she experienced rectal bleeding and was taken to the hospital on 22-AUG-2014 and admitted and diagnosed with colitis. The patient was prescribed IV antibiotics (details not specified) and was released on 26-AUG-2014. The patient underwent Computerised tomogram (CAT scan) and blood work without results provided. The events outcome was unknown. No product quality complaint (PQC) was reported. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Syncope, Vision blurred
Clinical narrative: This spontaneous report as received from a consumer refers to his 76 year old female mother with diabetes, high blood pressure and a history of colon cancer. On approximately 11-AUG-2014 ("about two weeks ago") the patient was vaccinated with PNEUMOVAX 23 (lot # reported as K004282, expiration date 22-MAR-2015), which is an invalid lot# for PNEUMOVAX 23 (dose, route unspecified). Unspecified concomitant medications were taken. On an unspecified date in August 2014, the patient experienced weakness, blurred vision and she fainted one day after receiving the PNEUMOVAX 23 vaccination on approximately 12-AUG-2014. The patient was seen at Hospital Emergency room and then released and returned to her home. About one week after receiving the PNEUMOVAX 23 injection, on approximately 18-AUG-2014, she experienced rectal bleeding and was taken to the hospital on 22-AUG-2014 and admitted and diagnosed with colitis. The patient was prescribed IV antibiotics (details not specified) and was released on 26-AUG-2014. The patient underwent Computerised tomogram (CAT scan) and blood work without results provided. The events outcome was unknown. No product quality complaint (PQC) was reported. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pruritus, Urticaria
Clinical narrative: Patient had urticaria at both arm pits and itching at the injection site.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: The mother of the child stated that the onset of the symptoms started at least 24 hours after the vaccinaion. The child developed flat, pink spots that do not itch (per the child) on her face, and arms. The mother stated that the child had a fever, but she never took her temperature. The injection site was red, swollen, and warm to the touch. Upon visual inspection by the nurses here at the County Health Department, no spots were found on the child's chest or back.
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. On an unspecified date, the patient was vaccinated with VARIVAX, (lot#, expiration date, dose and route not reported). The patient experienced rash on an unknown date. The outcome of rash was reported as recovering. The patient had contacted the physician's office on an unspecified date. This is one of several reports from the same source. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test normal, Injection site discomfort, Injection site erythema, Injection site mass, Urine analysis normal
Clinical narrative: This spontaneous report as received from a patient's wife refers to a 66 years old male patient with asthma, high blood pressure. bladder dysfunction (patient's bladder did not empty by itself) and LEVAQUIN allergy. On 02-AUG-2014 the patient was vaccinated with ZOSTAVAX (injection, one time vaccine, lot # and expiry date were not reported). Concomitant therapy included unspecified blood pressure medication, daily sulfur medication to prevent bladder infection and unspecified asthma medication. ON 03-AUG-2014, the next day after getting a vaccine, the patient noticed that discomfort was gone but the lump remained, still pink at injection site, two inches around at site of injection. IT was reported that blood test and urine test were performed few weeks ago (in 2014), which came back fine. It was reported that no treatment was given to the patient. The patient did not seek medical attention. The relatedness between ZOSTAVAX, discomfort and lump still pink at injection site, two inches around at site of injection was not reported. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Seizure like phenomena
Clinical narrative: Pt experience very high fever, shivering - thought he was going to have seizure. Took 2 acetaminophen 500mg - symptoms resolved.
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: Product packaging issue
Clinical narrative: This spontaneous report as received from a medical assistant. The medical assistant reported that the packaging of the M-M-R II, (Oka/Merck) VARIVAX, and (Oka/Merck) PROQUAD was similar, and this could potentially cause confusion between the products. The medical assistant stated no misadministration has occurred. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 year old male patient with no drug reactions or allergies. On 18-FEB-2008 the patient was vaccinated with ZOSTAVAX (lot#, strength, dosage and route unknown). Concomitant therapies included Bystolic. On 11-JUN-2014, the patient was seen at an unspecified physician's office because "he didn't feel right". The unspecified physician diagnosed him with shingles and prescribed Valtrex. The pharmacist reported that patient also came into the pharmacy on 11-JUN-2014 to fill the Valtrex prescription and to report the adverse event. The pharmacist stated "he had a mild case of shingles". No lab diagnostics studies performed. The outcome of the events was reported as recovered on an unspecified date in 2014. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: This spontaneous report as received from a 63 years old female patient with sulfa drug allergy and computed tomography (CT) scan iodine allergy. The patient's medical history included colon cancer (5 years ago in 2009). On 02-AUG-2014, also reported as two weeks ago, the patient was vaccinated with the first dose (one time vaccine) ZOSTAVAX (injection, lot # and expiry date were not reported). There was no concomitant therapy. On  14-AUG-2014, reported as last night, the patient noticed in the mirror that she had pinkish color around injection site with pin paint bruise at center where the needed went in it was reported that blood test and urine test were performed 4 months ago as a part of follow up for her cancer (April 2014). It was reported that the patient did not seek medical attention. The outcome of pinkish color around injection site with pin point little bruise at center where the needed went in was not reported. The relatedness between ZOSTAVAX and pinkish color around injection site with pin point little bruise at center where the needle went in was not reported.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. On an unspecified date, the patient was vaccinated with (Oka/Merck) VARIVAX (lot #, expiry date, dose and route not reported. On an unknown date, the patient experienced cellulitis. The outcome of the event was reported as recovering. The patient had contacted the physician's office on unspecified date. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to patient of unknown age and gender. On an unspecified date, the patient was vaccinated with (Oka/Merck) VARIVAX, (lot #, expiry date, dose and route not reported). On an unknown date, the patient experienced rash and visited the emergency room, but was not admitted. The outcome of rash was reported as recovering. The patient had contacted the physician's office on an unspecified date. This is one of several reports from the same source. Additional information has been requested.