chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site warmth, Product quality issue
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 4-year-old male patient who received KINRIX (batch number KB75Z, expiry date 20th March 2017). This case was associated with a product complaint. On 1st June 2015, the patient received KINRIX (intramuscular) .5 ml. On 1st June 2015, less than a day after receiving KINRIX, the patient experienced injection site erythema and injection site warmth. On an unknown date, the patient experienced product complaint. On an unknown date, the outcome of the injection site erythema, injection site warmth and product complaint were unknown. The reporter considered the injection site erythema and injection site warmth to be possibly related to KINRIX. It was unknown if the reporter considered the product complaint to be related to KINRIX. Additional information received: There were also 2 other patients who experienced the same side effects. Nurse had 7 more prefilled syringes left on the box and she preferred to have a different box to replace the one she already had as she is concerned about using the remaining prefilled syringes. Nurse is sending the product back to the company. Company is replacing product for the physician's office.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site warmth, Product quality issue
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 5-year-old female patient who received KINRIX (batch number KB75Z, expiry date 20th March 2017). This case was associated with a product complaint. On 2nd June 2015, the patient received KINRIX (intramuscular) .5 ml. On 2nd June 2015, less than a day after receiving KINRIX, the patient experienced injection site erythema and injection site warmth. On an unknown date, the patient experienced product complaint. On an unknown date, the outcome of the injection site erythema, injection site warmth and product complaint were unknown. It was unknown if the reporter considered the injection site erythema injection site warmth and product complaint to be related to KINRIX. Additional information received: There were also 2 other patients who experienced the same side effects. Nurse had 7 more prefilled syringes left on the box and she preferred to have a different box to replace the one she already had as she is concerned about using the remaining prefilled syringes. Nurse is sending the product back to the company. Company is replacing product for the physician's office.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Dysarthria, Hypoaesthesia oral, Mouth swelling, Paraesthesia oral
Clinical narrative: 66 year old male reported to have an anaphylactic reaction to the zoster vaccine on 6/5/12. He has no prior history of a reaction to vaccinations. The vaccine was administer subcutaneously in the deltoid (records do not specify which) and within a minute of administration, the patient complained of numbness and tingling of the left side of the mouth. He was observed to have swelling of the mouth, slurred speech, and tongue thickening. Patient denied difficulty breathing or swallowing. Nurses called 911 immediately and he was brought to the closest ED. Patient was given IV steroids, ranitidine, and diphenhydramine and symptoms resolved with some residual soreness in the teeth. Medications to treat anaphylaxis given at ED therefore doses not specified.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Tongue disorder, Toothache
Clinical narrative: 66 year old male reported to have an anaphylactic reaction to the zoster vaccine on 6/5/12. He has no prior history of a reaction to vaccinations. The vaccine was administer subcutaneously in the deltoid (records do not specify which) and within a minute of administration, the patient complained of numbness and tingling of the left side of the mouth. He was observed to have swelling of the mouth, slurred speech, and tongue thickening. Patient denied difficulty breathing or swallowing. Nurses called 911 immediately and he was brought to the closest ED. Patient was given IV steroids, ranitidine, and diphenhydramine and symptoms resolved with some residual soreness in the teeth. Medications to treat anaphylaxis given at ED therefore doses not specified.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Acute kidney injury, Arthralgia, Myalgia, Neck pain, Oedema peripheral
Clinical narrative: Myalgia. skin rash, acute renal failure & BLE edema. Acetaminophen.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: Myalgia. skin rash, acute renal failure & BLE edema. Acetaminophen.
Age: 34.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Pyrexia, Rash, Swelling
Clinical narrative: Fever, rash and rigors, swelling.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash and urticarial pruritus. Ranitidine 150 mg bid, methylprednisolone, fluocinolone.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Nausea, Rash, Vomiting
Clinical narrative: Myalgia, skin rash and nausea vomiting. Dicloxacillin 500 mg bid x 10 days.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Flushing, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Nausea, vomiting and diaphoretic, flushed, little lightheaded.
Age: 70.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Rash
Clinical narrative: Rash.
Age: 24.0
Sex: F
Vaccine: HPV4, PPV
Symptoms: Pain in extremity, Swelling
Clinical narrative: Left arm pain 7/10, swelling.  Amoxicillin, acetaminophen.
Age: 2.0
Sex: M
Vaccine: DTPHEP
Symptoms: Pyrexia
Clinical narrative: High fever at 104 degree Fahrenheit.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Excessive eye blinking, Eye movement disorder, Fall, Gait disturbance
Clinical narrative: Patient was given an HPV vaccination at 4:22 PM, approximately 1-2 minutes later after exiting the treatment room, patient's eyes started fluttering and roll and and patient started stumbling and falling to the ground, patient was then helped to the ground. Immediately upon reaching the ground, patient's state started returning to normal and patient tried to sit up. Patient was instructed to remain on his back and his legs were elevated at this time. A code blue was called and a code team responded. Patient was evaluated by code team and a set of vital signs was taken. Patient was not recommended to go to emergency room. Approximately 7-10 minutes after event started, patient was placed in a wheelchair and given a can of soda. Patient was then monitored for another 25 minutes and approximately 35 minutes after event, patient was released and departed hospital with his parents.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Eye movement disorder, Febrile convulsion, Pneumonia aspiration, Pyrexia, Respiratory depression
Clinical narrative: This is a young 1-year-old female, who presented to emergency room with persistent febrile seizures. The patient received a few doses of ATIVAN. Had some respiratory distress due to the depression of the respiratory system and for that reason, she. During the process, the patient has an aspiration pneumonia and the respiratory distress increased in the emergency room. After stabilization in the emergency room, the patient was transferred to us. Basically this patient has been with intermittent fever for the last 2 days. The last fever the family says that it was 104. The patient started having some abnormal movements in the eye and the seizure lasted for at least 1 hour.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Respiratory distress
Clinical narrative: This is a young 1-year-old female, who presented to emergency room with persistent febrile seizures. The patient received a few doses of ATIVAN. Had some respiratory distress due to the depression of the respiratory system and for that reason, she. During the process, the patient has an aspiration pneumonia and the respiratory distress increased in the emergency room. After stabilization in the emergency room, the patient was transferred to us. Basically this patient has been with intermittent fever for the last 2 days. The last fever the family says that it was 104. The patient started having some abnormal movements in the eye and the seizure lasted for at least 1 hour.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness to left shoulder and upper arm, warm to touch. Patient noticed the redness yesterday morning, and stated this morning she noticed it had moved farther down towards her elbow.
Age: 1.04
Sex: F
Vaccine: DPP, HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Pallor, Pyrexia, Rash macular
Clinical narrative: Low-grade fever (101F or less) that persisted for 48 hours, resolved, the patient developed a diffuse macular blanching rash c/w known MMR potential side effect.
Age: 0.19
Sex: M
Vaccine: DTAP
Symptoms: Decreased appetite, Injection site pain, Lethargy, Pyrexia, Screaming
Clinical narrative: Child became lethargic a few hours after the shot, then later that evening developed a fever and had no interest in nursing. 24 hours later he started screaming and would not stop for 12 hours. Took to ER.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site warmth, Pain, Pain in extremity
Clinical narrative: Pt presented to clinic with left arm pain, rated a 5/10 at rest and can go up to a 10/10 upon movement. Able to raise arm slowly. Pt able to make left hand into a fist and twist wrist without pain. From pt's left bicep muscle to deltoid muscle was visibly red and warm to touch.  In comparison to right arm, minimal swelling. Had fever previous night, but it went away. Afebrile in office. Pt denied being itchy, SOB/WOB, or the inability to use his left arm. Dx cellulitis following pneumococcal vaccine in L deltoid.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Pt presented to clinic with left arm pain, rated a 5/10 at rest and can go up to a 10/10 upon movement. Able to raise arm slowly. Pt able to make left hand into a fist and twist wrist without pain. From pt's left bicep muscle to deltoid muscle was visibly red and warm to touch.  In comparison to right arm, minimal swelling. Had fever previous night, but it went away. Afebrile in office. Pt denied being itchy, SOB/WOB, or the inability to use his left arm. Dx cellulitis following pneumococcal vaccine in L deltoid.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Initial unsolicited report received from a nurse on 8 June 2015. This case is linked to 2015SA081386 and 2015SA081396. (Same vaccine, same lot number). A 51-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of ADACEL (batch number- C4712AA, route of administration, site of administration were not reported) on 3 June 2015. On 5 June 2015; 2 days after vaccination, the patient experienced red hot injection site reaction and which was diagnosed with cellulitis. The patient required emergency room/doctor visit. Laboratory investigations were not reported. The patient was treated with KEFLEX and MOTRIN. At the time of this report the patient was recovered from the events. Upon medical review, the case was considered as serious due to important medical event: vaccination site cellulitis. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Foetal exposure during pregnancy, Renal failure neonatal
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) on 9 June 2015. This case is linked with mother case (2015SA082748). A patient (age 0 day) received a dose of FLUZONE (batch number and site of administration not reported) during foetal life via transplacental route on an unspecified date in the year 2012. It was reported that mother had received FLUZONE intramuscularly in the year 2012 during pregnancy and her last menstrual period was not reported. Information related to medical history and concomitant medications in mother was not provided. On an unspecified date, patient was born with kidney failure. Laboratory investigations and corrective treatments were not reported. The gestation period at exposure, gestation period at onset of event and pregnancy exposure timing was not reported. At the time of this report the outcome of the event was unknown. Upon medical review, the case was considered as serious due to important medical event: Kidney failure. Documents held by sender: none.
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, HIBV, PPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: He was hospitalized at Medical Center due to vaccine at 2 months.
Age: 2.0
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Delusion, Pyrexia, Tremor
Clinical narrative: Pt ran fever but mom stated that thermometer was broken during the night. States was delusional and trembling.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history was not reported. On 16-JUN-2015 the patient was vaccinated with an expired dose of ZOSTAVAX (lot# 007208, exp 20-SEP-2014) via an unknown route and dose. No concomitant medication was reported. No adverse symptoms reported. Outcome, action taken and causality were not provided. No product quality issue (PQC) was involved. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Rash erythematous, Rash generalised, Urticaria
Clinical narrative: approx 5 minutes after vaccine developed an erythematous rash entire body; hive like on upper chest and back
Age: 1.32
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Generalised tonic-clonic seizure, Pharyngitis, Pyrexia
Clinical narrative: Seizure, grand mal. 3 episodes 7 pm: 7 minutes 6/18/2015 1 am: 4 minutes 6:30 am: 2 minutes
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: CSF virus no organisms observed, Injected limb mobility decreased, Mobility decreased, Polymerase chain reaction, Pyrexia
Clinical narrative: Pt. had fever as high as 101, on 5/20, 5/21.  Days later, he was noted to not move his right hand and right leg.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Varicella virus test positive
Clinical narrative: Pt. had fever as high as 101, on 5/20, 5/21.  Days later, he was noted to not move his right hand and right leg.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Anxiety, Crying, Dizziness, Nausea
Clinical narrative: Dizziness, nausea, anxiety, uncontrollable crying beginning 1 hour following vaccine.
Age: 13.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Vaccination site dermatitis
Clinical narrative: Localized dermatitis at site of varicella vaccine - most likely due to vigorous cutaneous immune response to live vaccine. Has been ongoing x1 year. Onset delayed by one week after vaccine administered. Decided against therapy at this time, anticipate it will fully resolve.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site swelling
Clinical narrative: Swelling (L) upper arm. No tenderness, no redness.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: Pt reported feeling pain in injection site & tingling sensation in fingers of injection site hand. Pharmacist on duty advised pt to see dr. Pt saw ER physician who prescribed 3 medications for rxn.
Age: 81.0
Sex: M
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Influenza like illness
Clinical narrative: Patient said they became sick with flu-like symptoms and couldn't leave their bed.
Age: 83.0
Sex: M
Vaccine: PNC13
Symptoms: Chest X-ray, Malaise, Pneumonia
Clinical narrative: Had yearly check-up. Fine-no problems. Got PREVNAR shot. 2 wk. later sick. Thought nothing to be concerned about. Kept getting sicker. Dr. diagnosed pneumonia 6-4-15.
Age: 1.29
Sex: M
Vaccine: DTAP
Symptoms: Crying, Flushing, Immediate post-injection reaction, Injection site mass, Rash generalised
Clinical narrative: Immediately after receiving vaccination my son's cheeks became flushed, he broke out into a full body rash, a lump formed under his skin at the injection site, and he began crying intensely. The dr administered 12.5 mg of BENADRYL.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a consumer via poison and drug center (MFR#USIS-027832) referring to her daughter a 13 year old female patient. The patient's relevant medical history and past drug history were unknown. In 2014, one year ago, the patient started her first dose of GARDASIL (1 injection, once, route strength, lot# and expiration date were unknown). Concomitant medications were unknown. Since starting the first injection, the patient had had headaches daily. It was unknown if there was any relevant laboratory data. The patient never completed the series. As of the report time it was unknown if the patient would receive a GARDASIL again and she had daily headaches. The relationship of the event and GARDASIL was not reported. Additional information is not expected as the reporter refused any safety report information.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. On unknown dates the patients were vaccinated with VARIVAX (Merck) (strength, lot#, expiration date, dose and route were unknown) which was improperly stored. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug dose omission, Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 2 patients of unknown age and gender. On 03-JUN-2015 the two patients missed prescribed doses of unspecified frozen vaccine which may have been ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown) for an unknown indication due to improper storage. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with vaccine ZOSTAVAX was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with vaccine ZOSTAVAX was unknown. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Age: 1.76
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a 21 month old patient of unknown gender. No relevant medical history or concurrent conditions were reported. On 15-JUN-2015 the patient was vaccinated with 0.5ml dose of (Oka/Merck) VARIVAX (lot # K016132, expiration date 24-SEP-2016) which had been exposed to temperatures outside of the recommended range, subcutaneously. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with the unknown dose of (Oka/Merck) PROQUAD lot number and expiration ate not reported) with unknown therapy route. The reported stated that the administered doses were stored improperly. There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mobility decreased, Mumps antibody test negative, Pain in extremity, Rubella antibody negative
Clinical narrative: Information has been received from a licensed practical nurse referring to a 43 year old female patient with Attention Deficit Disorder (ADD), environmental allergies and penicillin allergy. Before the vaccine was administered, an antibody test was drawn to the patient on unspecified date: Measles result was 0.90 (unit not provided) which reporting nurse said was okay, Mumps result was 0.2690 (unit not provided) low and Rubella was non-reactive. On 15-SEP-2014, the patient was vaccinated with a dose of MMR II, 0.5 ml, subcutaneous in the left arm (lot # K001230, expiration date 27-JAN-2016, dose number unknown). Concomitant therapies included alprazolam, dextroamphetamine, CYMBALTA, loratadine (manufacturer unknown) and zolpidem (manufacturer unknown). On 15-SEP-2014, almost immediately post vaccination, the patient developed soreness and achiness in her legs and arms and was unable to move her arms or legs. This occurred in both arms and both legs. No treatment was given to the patient and she never contacted the office with these symptoms. The events lasted for about 2 weeks and she recovered on approximately 29-SEP-2014. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness and swelling to Lt. deltoid. Mother notes sx started after shots were given. Sx have gotten a little better. Rx for PRELONE 15mg/5ml and BENADRYL.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: Patient was admitted to the hospital and diagnosed with pneumonia.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Allergy to vaccine, Injection site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Mother mentions that after the MENACTRA, Tdap (ADACEL), and Varicella the patient had pain, redness and was warm to touch in the vaccination area.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Parent noticed yesterday. Warm itchy red and swollen 3 x 1 inch (L) arm.
Sex: M
Vaccine: HEP
Symptoms: Anxiety, Autism, Crying, Developmental delay, Emotional distress
Clinical narrative: He is diagnosed with autism. Cried for first two years of his life. Nothing would console him. Many sensory issues. Anxiety, overwhelmed, caused horrible meltdowns. 7 years old and still isn't potty trained with bowel movements. Shows he must be struggling with a guy issue caused from vaccinations.
Sex: M
Vaccine: HEP
Symptoms: Sensory disturbance
Clinical narrative: He is diagnosed with autism. Cried for first two years of his life. Nothing would console him. Many sensory issues. Anxiety, overwhelmed, caused horrible meltdowns. 7 years old and still isn't potty trained with bowel movements. Shows he must be struggling with a guy issue caused from vaccinations.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Erythema, swelling, no treatment.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Clients leg was swollen, red, and hard. Mom called her private physician who advised ice, heat, and OTC pain relievers. Mother called health dept on afternoon of 6/17 to report and ask when/if child should have another vaccine. This is only child's second DTaP last one was in March 2014 and had been advised to return in one month for catch up schedule.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Local reaction
Clinical narrative: Patient had a localized reaction, redness and swelling knot at site. Patient is to apply cool compress and can take motrin if he is having pain. Typically go away in 5-7days. This is not the first time this have happened with our patients who receive the Menveo (meningococcal) vaccine.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling
Clinical narrative: Morning after vaccine given patient's thigh was swollen, red and had hard knot in area of injection. Was given Amoxicillin prescription on 6/12/15 for 7 day course.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Haematochezia, Mucous stools, Occult blood positive
Clinical narrative: ROTATEQ admin 1330. Mom called at 1700 saying there was blood in his stool. Seen in office that evening by MD. (+) Guaiac/mucus stool. Monitor at home.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 2 patients of unknown age and gender. On 03-JUN-2015 the two patients missed prescribed doses of unspecified frozen vaccine which may have been (Oka/Merck) PROQUAD (lot number and expiry date unknown)(dosing regimen and frequency unknown) for an unknown indication due to improper storage. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy unknown. The relatedness of the events to the therapy with (Oka/Merck) PROQUAD was unknown. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: TD
Symptoms: Body temperature increased, Malaise, Nausea, Vaccination site oedema, Vaccination site pain
Clinical narrative: Less than 24 hours following Td vaccination, our 15yo son developed significant pain an edema at the vaccination site and then developed nausea and temperature elevation of 100.3 with malaise and generally feeling ill.
Sex: U
Vaccine: PNC13
Symptoms: Arthralgia, Body temperature increased, Bone pain, Chills, Erythema
Clinical narrative: Fri eve 6-4-15 approx. 1800 I developed the following. Increased temp (103 F), chills, bone crushing pain to all joints. Large goose egg area to (L) upper arm. Redness, tender to touch, warm, itching, painful. Occurred after being injected with PREVNAR.
Sex: U
Vaccine: PNC13
Symptoms: Injection site swelling, Pain, Pruritus, Skin warm
Clinical narrative: Fri eve 6-4-15 approx. 1800 I developed the following. Increased temp (103 F), chills, bone crushing pain to all joints. Large goose egg area to (L) upper arm. Redness, tender to touch, warm, itching, painful. Occurred after being injected with PREVNAR.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood culture negative, Blood glucose increased, Chest X-ray normal, Culture urine negative, Decreased appetite
Clinical narrative: Fever up to 103 within hour, lethargy, reduced feeding.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Lethargy, Pyrexia, White blood cell count normal
Clinical narrative: Fever up to 103 within hour, lethargy, reduced feeding.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site induration, Injection site inflammation
Clinical narrative: L arm:  3.5 cm x 3 cm area of inflamed skin with mild induration to L lower deltoid area; 4.5 cm x 3 cm ovular area of inflamed skin with induration to L SC area, no pustules and no fluctuance. Localized, inflammatory reaction to vaccines.  Low suspicion for cellulitic process at this time. Areas outlined and discussed concerning si/sx with mom. Advised children's Benadryl, cool compress.  Needs f/u in office if sxs worsen.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: Itching at injection site.
Age: 12.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Arthralgia, Joint swelling, Joint warmth, Pain in extremity
Clinical narrative: Client was given HPV & MCV4 vaccinations at 10:30 am at PHO, 1 hour later began to have intermittent dull pain in her wrists and ankles, the pain moved up her legs into her knees and in the upper extremities it moved into her hands/fingers and up into her elbows. Returned to PHO at 1 PM to inform of above, wrists and ankles appeared swollen and felt warm to touch. Client had not experienced any fainting or lightheadedness. CDC and State DOH Epi dept contacted for guidance.  Client referred to PCP for evaluation. M.D. from PCP clinic called RN at PHO with update on client's condition. M.D. sent client home at 2:30 pm with instructions to take Ibuprofen prn and return to clinic if pain or swelling increases.
Age: 16.0
Sex: F
Vaccine: HEP, HEPA, HPV4, MEN, VARCEL
Symptoms: Syncope
Clinical narrative: Patient fainted
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Exposure during pregnancy, Lymphadenopathy, Pain in extremity
Clinical narrative: Left sided supraclavicular lymph node swelling x 2, joint pain in hands bilaterally, thumb pain, left thigh pain.
Age: 0.35
Sex: M
Vaccine: DTAPIPV, HEP, HIBV, RVX
Symptoms: Crying, Injection site erythema, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Bright pink hives roughly the size of quarters appeared after about five minutes. Both thighs were pink, somewhat swollen, and warm to the touch in roughly five inch circles around the injection sites. The baby was crying uncontrollably for roughly an hour following the vaccinations. Later that night, the baby cried/screamed for several hours and was inconsolable. The baby received Tylenol during this time but it did not appear to help. The following evening, the baby had a temperature of 102.5 after not having any Tylenol for roughly 5 hours. After receiving more Tylenol, the temperature dropped to about 100. The baby had a fever for roughly three days following the vaccinations and was treated with Tylenol to prevent it rising. The baby acted generally sick and sleepy during this time.
Age: 0.35
Sex: M
Vaccine: DTAPIPV, HEP, HIBV, RVX
Symptoms: Pyrexia, Screaming, Somnolence, Urticaria
Clinical narrative: Bright pink hives roughly the size of quarters appeared after about five minutes. Both thighs were pink, somewhat swollen, and warm to the touch in roughly five inch circles around the injection sites. The baby was crying uncontrollably for roughly an hour following the vaccinations. Later that night, the baby cried/screamed for several hours and was inconsolable. The baby received Tylenol during this time but it did not appear to help. The following evening, the baby had a temperature of 102.5 after not having any Tylenol for roughly 5 hours. After receiving more Tylenol, the temperature dropped to about 100. The baby had a fever for roughly three days following the vaccinations and was treated with Tylenol to prevent it rising. The baby acted generally sick and sleepy during this time.
Age: 11.0
Sex: M
Vaccine: HPVX, MEN, TDAP
Symptoms: Computerised tomogram head normal, Dyskinesia, Fall, Feeling abnormal, Nausea
Clinical narrative: Minutes after first HPV vaccine:  My healthy 11 yr old son, fell to the floor, jerked for a second and was in a fog for the entire day/evening.  He had very severe nausea.  He had a CAT-scan because we thought he may have had a concussion.  It was horrific.
Age: 11.0
Sex: M
Vaccine: HPVX, MEN, TDAP
Symptoms: Postictal state, Syncope, Vomiting
Clinical narrative: Minutes after first HPV vaccine:  My healthy 11 yr old son, fell to the floor, jerked for a second and was in a fog for the entire day/evening.  He had very severe nausea.  He had a CAT-scan because we thought he may have had a concussion.  It was horrific.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Allergy test, Urticaria
Clinical narrative: Hives about 3 hrs after vaccine. Treated with oral antihistamine with resolution.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV9, HEPA
Symptoms: Asthenia, Eye movement disorder, Fall, Tremor
Clinical narrative: Minutes after HPV and hepatitis vaccines were given, my son's eyes rolled back in his head he fell off exam table and right side of his body was shaking as well as his head. I yelled for nurse. He came to quickly and they had him relax, drink Sprite and then he seemed ok but a little weak.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV9, HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Minutes after HPV and hepatitis vaccines were given, my son's eyes rolled back in his head he fell off exam table and right side of his body was shaking as well as his head. I yelled for nurse. He came to quickly and they had him relax, drink Sprite and then he seemed ok but a little weak.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Agitation, Condition aggravated, Cytogenetic analysis abnormal, Eczema, Methylenetetrahydrofolate reductase gene mutation
Clinical narrative: Fever, severe agitation, eczema flareup.  Every day since (almost 3 years) symptoms continued to get worse.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever, severe agitation, eczema flareup.  Every day since (almost 3 years) symptoms continued to get worse.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Hot flush, Injection site vesicles, Nausea, Pruritus, Vomiting
Clinical narrative: The Patient is a 21 year old male. Patient complains of 2 additional smallpox vaccination blisters that occurred after initial vaccination. Patient states vomiting the day prior and feeling of generalized hot flashes, nausea. Patient denies difficulty breathing. Patient states he was covering the site adequately and as instructed. Patient states moderate itching. Patient vaccination date was 09JUN2015. Patient blisters located on left arm with two being on the deltoid and one additional in the antecubital space.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: No adverse events.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated subcutaneously with the unknown dose of VARIVAX (Merck) (lot number and expiration date not reported). The reporter stated that the administered doses were stored improperly. There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Joint swelling, Mobility decreased, Pain in extremity, Peripheral swelling, Skin discolouration
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of ankle swelling in a 48-year-old male patient who received BOOSTRIX (batch number 5MG55, expiry date 15th October 2016). Concurrent medical conditions included gastroesophageal reflux disease, dysuria and sleep apnea syndrome. Concomitant products included LASIX and NEXIUM. On 1st June 2015, the patient received BOOSTRIX .5 ml. On 2nd June 2015, 1 days after receiving BOOSTRIX, the patient experienced ankle swelling, swelling of legs, skin coloring, mobility decreased and leg pain. On an unknown date, the outcome of the ankle swelling, swelling of legs, skin coloring, mobility decreased and leg pain were not recovered/not resolved. It was unknown if the reporter considered the ankle swelling, swelling of legs, skin coloring, mobility decreased and leg pain to be related to BOOSTRIX. Additional information received: Patient lower leg was "bluish" in color and he has decreased mobility and movement in his left ankle. On Friday 5 June, he went back to see his Primary care MD (where he got the vaccination) to be examined by them. To date, it has not resolved. No further information was given.
Age: 1.51
Sex: F
Vaccine: HEPA
Symptoms: Injection site swelling, Peripheral swelling, Pyrexia, Rash, Swelling face
Clinical narrative: This case was reported by a medical representative via call center representative and described the occurrence of hives in a 18-month-old female patient who received HAVRIX pediatric. On 8th May 2015, the patient received the 1st dose of HAVRIX pediatric. On 9th May 2015, 1 days after receiving HAVRIX pediatric, the patient experienced hives, fever, swelling arm and rash. On 10th May 2015, the patient experienced facial swelling. The patient was treated with ZYRTEC and Steroids. On 13th May 2015, the outcome of the hives, fever, swelling arm, rash and facial swelling were recovered/resolved. It was unknown if the reporter considered the hives, fever, swelling arm, rash and facial swelling to be related to HAVRIX pediatric. Additional information provided: The initial reproter, a Medical assistant to the treating physician, reported that a patient was given the 1st dose of HAVRIX on 08 May 2015. On 9 May 2015, the patient experienced rash, fever, swelling of arms and hives. The patient was treated with steroids. On 10 May 2015, the swelling worsened, having spread to her face so she went to the emergencies. The patient was treated with steroids and ZYRTEC and symptoms resolved on 13 May 2015.
Age: 1.51
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: This case was reported by a medical representative via call center representative and described the occurrence of hives in a 18-month-old female patient who received HAVRIX pediatric. On 8th May 2015, the patient received the 1st dose of HAVRIX pediatric. On 9th May 2015, 1 days after receiving HAVRIX pediatric, the patient experienced hives, fever, swelling arm and rash. On 10th May 2015, the patient experienced facial swelling. The patient was treated with ZYRTEC and Steroids. On 13th May 2015, the outcome of the hives, fever, swelling arm, rash and facial swelling were recovered/resolved. It was unknown if the reporter considered the hives, fever, swelling arm, rash and facial swelling to be related to HAVRIX pediatric. Additional information provided: The initial reproter, a Medical assistant to the treating physician, reported that a patient was given the 1st dose of HAVRIX on 08 May 2015. On 9 May 2015, the patient experienced rash, fever, swelling of arms and hives. The patient was treated with steroids. On 10 May 2015, the swelling worsened, having spread to her face so she went to the emergencies. The patient was treated with steroids and ZYRTEC and symptoms resolved on 13 May 2015.
Age: 1.29
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site swelling
Clinical narrative: Right leg swollen on upper part. Provider will send Rx for ibuprofen and BENADRYL. Patient advised to put a warm wash cloth on area.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site reaction, Rash pruritic
Clinical narrative: Golf ball sized round red area surrounding the injection site. Visible needle puncture site-size of a pen ink dot bruising 4 inch itchy rash/redness beginning from edge of raised area traveling down the arm.  No spreading since 6/16/15 (afternoon) & 6/18/15- no spreading-> itchiness today, no swelling just redness & bruising at site of injection. Refer patient to see doctor but pt doesn't want to.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Chest X-ray abnormal, Malaise, Pneumonia, Pyrexia, Vomiting
Clinical narrative: Had well teen exam on 6/1/15 & received MMR on 6/11/15 developed pneumonia (seen in clinic) w/presenting malaise, fever, vomiting. Persistent fever 6/17/15 & seen in ER w/worsening pneumonia. No rash.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Local reaction, Peripheral swelling, Pruritus
Clinical narrative: Pt's arm was red & swollen. Pt states it was also itchy and that he had been scratching it. Pt received MENACTRA & Tdap on (L) arm. Dr looked at it and stated it was a local reaction. No treatment given.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: 4 hours after injection, the patient was unable to move her arm. It started in her fingertips. Eventually entire arm in pain. No redness or swelling.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: On 6/15/15 2 inches redness, warmest & swelling at site of injection in the back pt the arm. On 6/16/15 pt. stated she has 3 spots on her arm. The next day, she noticed it became round. No itchiness & no other symptoms, spreading. Refer to the doctor but she refuse. She said it is not spreading. Asked patient to cover her rash as a precaution.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Symptoms-extreme swelling at injection site, redness. Patient sought treatment at hospital ER.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Application site swelling, Injection site erythema, Pain in extremity
Clinical narrative: Symptoms-extreme swelling at injection site, redness. Patient sought treatment at hospital ER.
Age: 62.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Burning sensation, Erythema, Pain, Pruritus
Clinical narrative: Burning, itching, pain, red round spot. Possible erythema.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (L) upper arm red & swollen approx 2 in in diameter.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: After the injection the patient spoke within 2-3 seconds her head was on the table them within 2-3 seconds she was speaking. Appeared to have fainted and came to within a matter of seconds applied cool compressed to face, neck and hands. Patient waited 15 min then walked around for about 10 min.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Patient received vaccination in back of store by pharmacy, waited a few minutes, then proceeded to leave with her father. Upon getting to the front of the store patient got lightheaded and fainted - her dad caught her and lowered her to the ground. Patient regained consciousness as store staff called 911. Dad and staff helped patient to sit up in a wheelchair and she got lightheaded again but did not lose consciousness. Ambulance arrived and took patient to the hospital for evaluation.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Rash around area of injection started 6/16 after receiving shot. Worsened in morning rash slightly red, pruritic, mildly painful.
Age: 50.0
Sex: U
Vaccine: TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Pt received Tdap-in (R) arm. Next day developed swelling & redness. At visit 9 days later, swelling resolved but still some erythema of upper arm.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at the injection site.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV4, HPV4
Symptoms: Balance disorder, Blood test, Chest pain, Computerised tomogram, Dizziness
Clinical narrative: This spontaneous report as received from a nurse in a physician's office via a company representative refers to a 13 year old female patient. No concurrent condition or medical history reported. On an unknown date in march 2015, the patient was vaccinated with second or third dose of GARDASIL, (lot number K001631 and expiry date 06-NOV-2016) intramuscularly. No concomitant medications were reported. On 12-MAR-2015, within two hours of receiving the GARDASIL the patient started shaking, repeating herself, had a chest discomfort and complained about being hot. The patient sought medical attention and was hospitalized overnight for those events. On an unknown date in 2015, the patient underwent a Computerized axial tomography (CAT scan), Blood work (details unspecified), drug screen and urine analysis the results of which were unknown. The action taken with the therapy with GARDASIL was not applicable. The outcome of the events was reported as recovered on an unknown date in 2015. The relatedness of the events to the therapy with GARDASIL was unknown. There was no product quality issue reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV4, HPV4
Symptoms: Electroencephalogram, Headache, Muscular weakness, Tremor, Urine analysis
Clinical narrative: This spontaneous report as received from a nurse in a physician's office via a company representative refers to a 13 year old female patient. No concurrent condition or medical history reported. On an unknown date in march 2015, the patient was vaccinated with second or third dose of GARDASIL, (lot number K001631 and expiry date 06-NOV-2016) intramuscularly. No concomitant medications were reported. On 12-MAR-2015, within two hours of receiving the GARDASIL the patient started shaking, repeating herself, had a chest discomfort and complained about being hot. The patient sought medical attention and was hospitalized overnight for those events. On an unknown date in 2015, the patient underwent a Computerized axial tomography (CAT scan), Blood work (details unspecified), drug screen and urine analysis the results of which were unknown. The action taken with the therapy with GARDASIL was not applicable. The outcome of the events was reported as recovered on an unknown date in 2015. The relatedness of the events to the therapy with GARDASIL was unknown. There was no product quality issue reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV4, HPV4
Symptoms: Blood test, Chest discomfort, Chills, Computerised tomogram, Drug screen
Clinical narrative: This spontaneous report as received from a nurse in a physician's office via a company representative refers to a 13 year old female patient. No concurrent condition or medical history reported. On an unknown date in march 2015, the patient was vaccinated with second or third dose of GARDASIL, (lot number K001631 and expiry date 06-NOV-2016) intramuscularly. No concomitant medications were reported. On 12-MAR-2015, within two hours of receiving the GARDASIL the patient started shaking, repeating herself, had a chest discomfort and complained about being hot. The patient sought medical attention and was hospitalized overnight for those events. On an unknown date in 2015, the patient underwent a Computerized axial tomography (CAT scan), Blood work (details unspecified), drug screen and urine analysis the results of which were unknown. The action taken with the therapy with GARDASIL was not applicable. The outcome of the events was reported as recovered on an unknown date in 2015. The relatedness of the events to the therapy with GARDASIL was unknown. There was no product quality issue reported. Additional information has been requested.