chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.92
Sex: F
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Postictal state, Pyrexia, Skin warm
Clinical narrative: Generalized tonic/clonic seizure and fever (febrile seizure) T102. Seizure while in bed "felt warm" per mom - lasted approximately 2 minutes. 30-60 min post-ictal phase transfer to ER via ambulance, blood work and fld and urine cultures
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Arm pain - unable to use. No complaints from 1st dose given 07/07/16.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt. received an injection in her LT arm. The area quarter size sore, red yesterday. She applied ice. Now the whole LT arm red, warm to touch and very sore. The redness size is now orange.
Age: 19.0
Sex: M
Vaccine: HEPA, HPV9, MENB
Symptoms: Nausea, Weight decreased
Clinical narrative: Patient complained of nausea for 3 days after vaccine was given. Had weight loss as well, no local reaction on arms, no rash, no other significant symptoms.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Rash generalised, Urticaria
Clinical narrative: Developed urticaria rash over entire body about 1 hour post vaccination. Resolved with one dose of BENADRYL.
Age: 17.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Myalgia, Pain in extremity, Tenderness, Tendon pain
Clinical narrative: Developed (L) arm pain approximately 12 hours after vaccine administered. At 2 day exam - no inflammation heat or swelling. (+) muscle and tendon tenderness. Pain remains after 3 days.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, pain, redness at injection site 24 hours after administration.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus generalised, Skin ulcer
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 year old female patient. The patient had no known drug reactions or allergies. On 11-JUL-2016, the patient was vaccinated with a dose of ZOSTAVAX lot # L037790, expiration date 30-DEC-2016 subcutaneous. Concomitant therapies included warfarin and gabapentin. On 13-JUL-2016, 2 days after ZOSTAVAX administration, the patient developed blisters and sores all over her body which itched really badly. The pharmacist reported that the patient was seen on an unspecified date by a physician who prescribed prednisone (manufacturer unknown) 5 mg in a dose pack and hydroxyzine hydrochloride (manufacturer unknown) 25 mg for the itching. The pharmacist stated that the patient reported that everything was ok the first day she took prednisone (manufacturer unknown) and then, everything got really worse. After this, the patient went to a different physician who discontinued the prednisone (manufacturer unknown) and increased the hydroxyzine hydrochloride (manufacturer unknown) to 50 mg. At the time of the report, the patient continued to have the blisters and sore and they were still itching "really badly". The pharmacist did not assess the relationship of the events to ZOSTAVAX. The varicella zoster virus identification program pack was sent to the pharmacist. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On unspecified date (reported as "when he was 6 months of age, 6 years old and 12 years old"), and on an unspecified date in July 2016, the patient was vaccinated with the first, second, third and fourth doses of M-M-R II (lot number, expiration date, strength, dose, frequency and route unknown) (drug use for unapproved schedule and unapproved dose administered). The pharmacist did not know why the patient received so many doses of M-M-R II and stated that the patient now wanted to receive another dose. No adverse events were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a physician refers to a multiple patients of unknown ages and genders. Pertinent medical history, concurrent conditions and drug reactions or allergies were not reported. On an unknown dates the patients were vaccinated with improperly stored GARDASIL 9 lot # M003659, expiration date 20-SEPT-2017, (Dose, route and anatomical location were not provided). Other suspect product involved was sterile diluent (MERCK sterile diluent) lot # L041683 Expiration date 19-MAY-2018 and Lot # M002421 Expiration date 22-JUL-2018. Temperature: Lowest 25 Fahrenheit degrees (4 cycles) below. Time frame: 1 week. Previous: No. Digital data logger was involved. No product quality complain was involved. No other concomitant medication was reported. This is one of five reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Diplegia
Clinical narrative: This is a spontaneous report from a non-contactable consumer reporting on behalf of her mother via a sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration, on an unspecified date, at single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced paralysis of the legs on an unspecified date with unknown outcome.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: Information has been received from the authors of the published literature article. The authors enrolled participants from 12 of the original 15 communities in the 1981 immunogenicity study with a documented response to the primary plasma-derived hepatitis B vaccine series. Among the study participants at 30 years, they had 3 main groups: Group 2, persons who did not receive a booster dose at 22 years (because their 22-year anti-HBs level was greater than or equal to 10 mlU/mL); and group 3, persons (with anti-HBs level less than 10 mlU/mL) who received a booster dose of vaccine at 22 years. An anti-HBs level greater than or equal to 10 mlU/mL was considered protective. Study participants with anti-HBs levels less than 10 mlU/mL were offered an intramuscular booster dose of 10 ug of RECOMBIVAX HB given to assess immune response to an antigenic challenge. The authors attempted to determine the concentration of anti-HBs 30 days after the boost (median interval between booster and follow-up blood collection, 33 days). A positive booster dose response was defined as anti-HBs levels greater than or equal to 10 mlU/mL at 30 days after the boost. Among the 435 study participants, group 2: 129 who did not receive a booster vaccine dose at 22 years (owing to anti-HBs levels greater than or equal to 10 mlU/mL). In group 2, among the 36 persons tested 30 days after the booster dose, 33 (92%) responded with anti-HBs levels greater than or equal to 10 mlU/mL; the GMC was 419.8 mlU/mL. This case refers of the less 3 patients who after received a booster dose of RECOMBIVAX HB did not respond with anti-HBs levels greater than or equal to 10 mlU/mL. Among participants in group 2 with an anti-HBs level less than 10 mlU/mL at 30 years, those with a higher pre-boost anti-HBs level were more likely to demonstrate a booster response (antiHBs greater than or equal to 10 mlU/mL) than those with lower pre-boost anti-HBs levels. This suggests that even if the anti-HBs level at 30 years has waned to less than 10 mlU/mL, the close the level is to 10 mlU/mL, the higher the probability that the boost will succeed. This is one of two reports from the same literature source (linked to MARRS # 1608USA006505). Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Urticaria, Vomiting projectile
Clinical narrative: Mom fed baby breastmilk and burped baby. During administration baby projectile vomited and broke out in hives.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: Information has been received from the authors of the published literature article. The authors enrolled participants from 12 of the original 15 communities in the 1981 immunogenicity study with a documented response to the primary plasma-derived hepatitis B vaccine series. Among the study participants at 30 years, they had 3 main groups: Group 1 comprised persons who did not participate in the 22-year study and therefore had no blood drawn at that time. An anti-HBs level >=10mIU/mL was considered protective. Study participants with anti-HBs levels<10mIU/mL were offered an intramuscular booster dose of 10 ug of RECOMBIVAX HB given to assess immune response to an antigenic challenge. The authors attempted to determine the concentration of anti-HBs 30 days after the boost (median interval between booster and follow-up blood collection, 33 days). A positive booster dose response was defined as anti-HBs levels >=10mIU/mL at 30 days after the boost. Among the 435 study participants, group 1: Comprised 243 persons who did not participate in the 22-year study and therefore had no blood drawn at that time. In group 1, among 118 eligible participants, 96 (81%) who had anti-HBs level <10 mIU/ml received a booster dose of RECOMBIVAX HB. The median age of the 85 persons from whom serum was obtained after the booster dose was 40 years; 47 (55%) were male. Among these 85 persons tested 30 days after the booster dose, 75 (88%) responded with anti-HBs level >=10mIU/mL; the GMC was 150.4 mIU/mL. Among the 243 group 1 participants, 125 (51%; 95% confidence interval, 47%-55%) had evidence of long-term protection from hepatitis B vaccination (defined by anti-HBs levels >=10 mIU/mL). Among the remaining 118 persons with anti-HBs levels <10 mIU/mL, 75 of 85 available participants (88%) who received a booster dose responded with anti-HBs levels >=10 mIU/mL. This case refers of the less 10 patients who after received a booster dose of RECOMBIVAX HB did not respond with anti-HBs levels >=10 mIU/mL. Among participants in group 1 with an anti-HBs level <10mIU/mL at 30 years, those with a higher pre-booster anti-HBs level were more likely to demonstrate a booster response (antiHBs>=10mIU/mL) than those with lower pre-boost anti-HBs levels. This suggests that even if the anti-HBs level at 30 years has waned to <10mIU/mL, the closer the level is to 10 mIU/mL, the higher the probability that the boost will succeed. This is one of two reports from the same literature source (linked to MARRS # 1608USA006624). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a physician refers to a multiple patients of unknown ages and genders. Pertinent medical history, concurrent conditions and drug reactions or allergies were not reported. On an unknown dates the patients were vaccinated with improperly stored VAQTA Adult, Lot # M005885, expiration date 26-MAY-2017, and Pediatric/Adolescent, Lot # K026529, expiration date 02-JUN-2017 (Dose, route and anatomical location were not provided). Other suspect product involved was sterile diluent (Merck Sterile Diluent) lot # L041683 Expiration date 19-MAY-2018 and Lot # M002421 Expiration date 22-JUL-2018. Temperature: Lowest 25 Fahrenheit degrees (4 cycles) below. Time frame: 1 week. Previous: No. Digital data logger was involved. No product quality complain was involved. No other concomitant medication was reported. This is one of five reports received from the same reporter. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: An initial spontaneous report was received on 11-JUL-2016 from a registered nurse who reported a 28 year old female patient with adverse event while on therapy GARDASIL 9. The nurse reported that another nurse from her facility administered GARDASIL 9 intramuscularly to the patient on 08-JUL-2016. The patient later discovered she was pregnant via a pregnancy test. She was reported to be 9 weeks pregnant. It was reported that the patient sought medical attention. The patient was advised to go directly to the emergency room if there were any incidents of cramping and /or bleeding. To date no such symptoms were reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Right upper arm with 8 X 10 CM area of erythema, induration, warm, tender.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Muscle rigidity, Unresponsive to stimuli, Vomiting
Clinical narrative: Immediately after completion of vaccine administration, pt became rigid and unresponsive for aproximately 2-3 minutes per administering LPN and pt's mother.  Immediately following rigidity, patient vomited.  After vomiting, patient became alert and oriented x 3.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Contusion, Erythema, Oedema, Skin tightness, Skin warm
Clinical narrative: The evening after having vaccines, pt's arm had some bruising. Wednesday pt was brought into the office with 4x4cm circular area of erythema, warmth, edema, nontender, and tight but no distinct induration.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, RVX
Symptoms: Sleep apnoea syndrome
Clinical narrative: 2 episodes of sleep apnea at 2 and 4am.  Breathing alarm sounded after 20 seconds of no breathing.  No false alarms or previous episodes prior to yesterday.
Age: 19.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Pain in extremity
Clinical narrative: Had vaccines Gardasil and Trumenba. Complained of severe pain to right arm. Injection sight of Trumenba.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Severe pain with movement of arm, significant swelling "as big as a softball", redness, fever, and vomiting.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Severe pain with movement of arm, significant swelling "as big as a softball", redness, fever, and vomiting.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling, Urticaria
Clinical narrative: Patient states that she had swelling, soreness, tingling to fingers and forearms, in both arms and hives to back, both arms and thighs approximately one day after receiving MCV4 vaccine.
Age: 15.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient under the age of 19yo was given the adult dose of Vaqta.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Had no reaction, but was given the varicella injection twice.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient under the age of 19yo was given adult dose of VAQTA.
Age: 21.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Dyspnoea, Loss of consciousness, Rash
Clinical narrative: Patient mother called and reported that patient is in the ER with a reaction after receiving the vaccines reports"patient is breaking out, Difficulties breathing, and passing out.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Rash
Clinical narrative: Approximate time, not exact. Parent states R deltoid at site of meningitis vaccine became red, swollen, and he developed itching on both arms, some rash on both arms? No respiratory difficulty, no vomiting or other reaction.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PPV, TDAP, VARCEL
Symptoms: Crying, Groin pain, Irritability, Lymphadenopathy
Clinical narrative: Swollen lymph nodes on both sides of groin.  Pain so bad she thrashes and kicks her legs out, crying fussy all the time now.  Its been over a month since her shots been seen 2 times.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles rash broke out on neck.  Saw doctor on 08/11/2016, and was given Acyclovir 800mg five times a day (number 35).
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Child woke up with erythema and swelling, "4 inches down his arm" per his father.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Fall, Loss of consciousness
Clinical narrative: Pt received flu inj. Felt dizzy. Sat down. Unconscious. Fell to floor. Conscious again. Layed down until paramedics arrived. Pt fine after 15 minutes.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Patient reports to this nurse fatigue, inability to lift left arm (injected arm), swollen lymph to left axilla, severe abdominal pain, diarrhea, dizziness, chills, fever 100.3 and moderate headache. Patient states that she took Alka Seltzer and improving improving today.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injected limb mobility decreased, Lymphadenopathy, Pyrexia
Clinical narrative: Patient reports to this nurse fatigue, inability to lift left arm (injected arm), swollen lymph to left axilla, severe abdominal pain, diarrhea, dizziness, chills, fever 100.3 and moderate headache. Patient states that she took Alka Seltzer and improving improving today.
Age: 9.0
Sex: M
Vaccine: TDAP
Symptoms: Hyperhidrosis, Pallor, Posture abnormal
Clinical narrative: Few seconds after given vaccine to patient, he started slumping down, with pale and sweaty face. Oxygen was administered, V/S take B/P 110/62, pulse 62, resp 20. Patient became alert and oriented X 4, but mother insisted that paramedic will called because of the paleness and sweaty appearance the patient. Paramedic was called and the patient was taken to Hospital for further evaluation.
Age: 5.0
Sex: F
Vaccine: IPV, MMRV
Symptoms: Erythema, Hypersensitivity, Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Redness and warmth over left thigh (site of injection), prompted ER visit. Diagnosed there with cellulitis vs allergic reaction and given Benadryl - wound margins marked. Mom reports erythema spread beyond marked margins and pt scratching at area. Started on Cephalexin x 10 days, warm compresses, Zyrtec and Benadryl prn.
Age: 5.0
Sex: F
Vaccine: IPV, MMRV
Symptoms: Scratch
Clinical narrative: Redness and warmth over left thigh (site of injection), prompted ER visit. Diagnosed there with cellulitis vs allergic reaction and given Benadryl - wound margins marked. Mom reports erythema spread beyond marked margins and pt scratching at area. Started on Cephalexin x 10 days, warm compresses, Zyrtec and Benadryl prn.
Age: 38.0
Sex: F
Vaccine: MMR, TD, VARCEL
Symptoms: Dizziness, Electrocardiogram, Eye movement disorder, Hypotension, Loss of consciousness
Clinical narrative: PATIENT HAD SYNCOPE EPISODE UPON COMPLETION OF THIRD VACCINATION. PATIENT NEEDED Td, VARICELLA AND MMR COMPLETED FOR IMMIGRATION PROCESS. ADMINISTERED Td FIRST INTO RIGHT DELTOID THEN VARIVAX SECOND INTO RIGHT POSTERIOR SQ TISSUE THEN ADMINISTERED M-M-R II THIRD INTO LEFT POSTERIOR SQ TISSUE. UPON FINISHING INJECTION WHEN SYRINGE WAS TO AUTO RETRACT, PATIENT STATED SHE FELT FAINT AND STARTED TO LEAN TOWARDS HER RIGHT ONTO THE BENCH WE HAVE IN THE IMMUNIZATION ROOM. I GUIDED HER SLOWLY ONTO THE BENCH AND WHILE KEEPING ONE ARM ON HER SO SHE DIDN'T ROLL OFF THE BENCH, REACHED TO OPEN THE IMMUNIZATION DOOR TO HAVE MY TECHNICIAN CALL 9-1-1. PATIENT WAS UNCONSCIOUS FOR ABOUT TEN SECONDS AFTER WHICH TIME SHE STARTED TO HAVE INVOLUNTARY RAPID EYE MOVEMENTS WITH EYES OPENING THEN CRISS CROSSING. UPON STARTING TO AWAKEN, PATIENT BEGAN SPEAKING IN DIFFERENT LANGUAGE THEN ABOUT TEN SECONDS LATER SAT UP AS IF NOTHING HAPPENED. PARAMEDICS ARRIVED ON SCENE AND MEASURED BLOOD PRESSURE AND HOOKED UP A HEART MONITOR. BLOOD PRESSURE WAS LOW AT 80 PALP AND PULSE AT 46. PATIENT WAS TRANSPORTED TO HOSPITAL FOR EVALUATION.
Age: 38.0
Sex: F
Vaccine: MMR, TD, VARCEL
Symptoms: Strabismus, Syncope
Clinical narrative: PATIENT HAD SYNCOPE EPISODE UPON COMPLETION OF THIRD VACCINATION. PATIENT NEEDED Td, VARICELLA AND MMR COMPLETED FOR IMMIGRATION PROCESS. ADMINISTERED Td FIRST INTO RIGHT DELTOID THEN VARIVAX SECOND INTO RIGHT POSTERIOR SQ TISSUE THEN ADMINISTERED M-M-R II THIRD INTO LEFT POSTERIOR SQ TISSUE. UPON FINISHING INJECTION WHEN SYRINGE WAS TO AUTO RETRACT, PATIENT STATED SHE FELT FAINT AND STARTED TO LEAN TOWARDS HER RIGHT ONTO THE BENCH WE HAVE IN THE IMMUNIZATION ROOM. I GUIDED HER SLOWLY ONTO THE BENCH AND WHILE KEEPING ONE ARM ON HER SO SHE DIDN'T ROLL OFF THE BENCH, REACHED TO OPEN THE IMMUNIZATION DOOR TO HAVE MY TECHNICIAN CALL 9-1-1. PATIENT WAS UNCONSCIOUS FOR ABOUT TEN SECONDS AFTER WHICH TIME SHE STARTED TO HAVE INVOLUNTARY RAPID EYE MOVEMENTS WITH EYES OPENING THEN CRISS CROSSING. UPON STARTING TO AWAKEN, PATIENT BEGAN SPEAKING IN DIFFERENT LANGUAGE THEN ABOUT TEN SECONDS LATER SAT UP AS IF NOTHING HAPPENED. PARAMEDICS ARRIVED ON SCENE AND MEASURED BLOOD PRESSURE AND HOOKED UP A HEART MONITOR. BLOOD PRESSURE WAS LOW AT 80 PALP AND PULSE AT 46. PATIENT WAS TRANSPORTED TO HOSPITAL FOR EVALUATION.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Chills, nausea, dizziness, redness and swelling at site of injection.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: The next day the injection site became inflamed and erythematous, was the size of a half dollar and continued to increase in size.  On 8/13/16 the site was the size of an orange.  She did not experience any signs of anaphylaxis and no difficulty breathing.  Patient is a nurse and is familiar with appropriate steps to take: cold compress, Benadryl, etc.
Age: 20.0
Sex: F
Vaccine: HEP, HEP, VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Small swollen welt at injection site. Throughout the day, the welt got bigger. Became tender, sore, and itchy. 10cm x 5.5cm large.
Age: 20.0
Sex: F
Vaccine: HEP, HEP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: Small swollen welt at injection site. Throughout the day, the welt got bigger. Became tender, sore, and itchy. 10cm x 5.5cm large.
Age: 20.0
Sex: F
Vaccine: HEP, HEP, VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Redness and swelling at site of injection. Rt. arm. (varicella site). 10cmx5.5cm right posterior arm, erythema. Cetirizine HCL 10 mg. Mild TTP.
Age: 20.0
Sex: F
Vaccine: HEP, HEP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: Redness and swelling at site of injection. Rt. arm. (varicella site). 10cmx5.5cm right posterior arm, erythema. Cetirizine HCL 10 mg. Mild TTP.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Red, swollen, hot to touch at site of injection started about 24 hours after injection. Still red, swollen, hot to touch 48 hours later. Also experiencing body aches, headache, nausea, and itchy throat for past 48 hours.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Throat irritation
Clinical narrative: Red, swollen, hot to touch at site of injection started about 24 hours after injection. Still red, swollen, hot to touch 48 hours later. Also experiencing body aches, headache, nausea, and itchy throat for past 48 hours.
Age: 26.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Several red circles in the area around the injection site.  Some swelling and itching.  Patient also reported warmth in the area.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Condition aggravated, Multiple sclerosis relapse
Clinical narrative: This solicited report has been received from a physician concerning to an 48 years old female patient with multiple sclerosis. Information about medical history and concomitant medication were not provided. On an unspecified date, the patient was vaccinated with PNEUMOVAX  23 (concentration, dose, lot number and expiration date were not reported). On an unknown date, the patient experienced multiple sclerosis relapse and was hospitalized. The outcome of multiple sclerosis relapse was unknown. The causality between the therapy with PNEUMOVAX  23 and the event was reported as related. Upon internal review, the event multiple sclerosis relapse was considered to be medically significant. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HPVX, MENB
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Patient was sitting down at the time. He fainted and fell forward and hit his head.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Got shot then felt light headed drank water then passed for 30 sec then woke up and drank more water and waited to stand. No medications given by EMS.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, Herpes zoster
Clinical narrative: Information has been received from a Registered pharmacist (R.Ph.) concerning a currently 71 year old female patient. The patient's pertinent medical history was not reported; however, her concurrent conditions included rheumatoid arthritis. There were no drug allergies/drug reactions. On unknown date in 2011, the patient was vaccinated with an unspecified dose of ZOSTAVAX, via subcutaneous route, (strength, dose, anatomical location, lot number and expiration date were not reported). Secondary suspect therapy included ENBREL. Concomitant medications included MOBIC, folic acid (manufacturer unknown), PRILOSEC and methotrexate (manufacturer unknown). It was reported that the patient received ZOSTAVAX while on therapy with ENBREL and as a result, the patient experienced multiple outbreaks of shingles "on and off for the past 5 years", approximately since 2011; at the time of the report, reported as currently, she had an outbreak of shingles. The patient sought medical attention by visiting the physician, and received treatment that included VALTREX. At the time of reporting, the patient had not recovered from the adverse event. No product quality complaint was involved. The relatedness between the outbreak of shingles and therapy with ZOSTAVAX was not reported. The reporter considered the outbreak of shingles as a significant disability/incapacity event. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Blood glucose, Blood magnesium, Chest X-ray, Computerised tomogram head, Drug screen
Clinical narrative: Pt "blacked out" while driving home after immunization and hit tree.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Electrocardiogram, Fibrin D dimer, Full blood count, Loss of consciousness, Metabolic function test
Clinical narrative: Pt "blacked out" while driving home after immunization and hit tree.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Road traffic accident, Troponin
Clinical narrative: Pt "blacked out" while driving home after immunization and hit tree.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster oticus, Pruritus
Clinical narrative: This spontaneous report referring a 71 years old female patient, was received from a pharmacist (also the patient's husband) and the patient. The patient's medical history and concurrent conditions were not reported. In 2007, the patient was vaccinated with ZOSTAVAX 19400 PFU injection (dose, lot number, expiration date, route and anatomical location of administration were not reported). The patient had no concomitant therapies. On approximately 01-AUG-2016 (reported as "1 week ago today/last Monday") the patient started feeling itchy and developed shingles (herpes zoster). On approximately 03-AUG-2016 (reports as "by Wednesday"), a spot appeared in the middle of her chest, then a cluster on the top of her right shoulder, then on the right side of her skull into her right ear, then it spread to the side of her jaw on the right side, afterwards a mirror image appeared on her left side of her face into her left ear (herpes zoster oticus). The right side of her shoulder was the worst area. The patient sought medical attention with a physician and on 06-AUG-2016 (reported as "on Saturday") was prescribed with valacyclovir, 1 gram, orally, three times per day as treatment. No laboratory diagnostics were performed. On 07-AUG-2016 (reported as "by Sunday"), she had an area 4 inches long under her left breast and the left shoulder area was drying up, but still had classic signs and continued to have outbreak areas. She felt no pain, only itching at all sites. The patient was requesting that her physician be provided with a courtesy supply of ZOSTAVAX (two doses) one for herself and one for her husband to prevent shingles from reoccurring in the future. No product quality complaint was involved. At the time of reporting, the outcome of the events was reported as not recovered. The causal relationship between the events and ZOSTAVAX was not reported. Upon internal review, the herpes zoster oticus was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a Licensed practitioner nurse concerning to a 15 year old female patient with chronic myeloid leukemia and not known allergies. On an unknown date the patient was vaccinated with dose one of GARDASIL 9 (dose, lot number and indication not reported) without any reaction. on 18-SEP-2015, the patient was vaccinated with dose 2 of GARDASIL 9 (Lot number not reported), intramuscular for human papilloma virus immunization. Concomitant therapies included SPRYCEL. On 18-SEP-2015, the patient experienced injection site erythema. The patient did not report any additional symptoms. No treatment was given nor lab diagnostics tests were performed. No cancer, congenital anomality, death, disability, life threatening nor overdose were reported. The outcome of injection site erythema was unknown. The relations between injection site erythema and therapy with GARDASIL 9 was not reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Rash
Clinical narrative: This spontaneous report concerning a female patient of unknown age was received from a pharmacist. The reporter stated that the patient had no allergies or drug reactions. No concurrent conditions and medical history were reported. On 03-JUN-2016, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, lot and expiration date were not reported) by subcutaneous route. There were no concomitant medications reported. On an unknown date in 2016, the patient experienced a rash under her throat and over her chest (rash) after receiving the ZOSTAVAX. In addition, the reporter stated that patient still had a purplish discoloration at the site of injection. No laboratory diagnostic studies were performed and no treatment for the adverse event was given. The patient sought medical attention by reporting her adverse event to her pharmacist. No product quality complain was involved. At the time of reporting, the action taken and the outcome of injection site discolouration and rash were unknown. The causality between the events of injection site discolouration and rash were not medically significant or life threatening. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: A spontaneous report was received on 12-JUL-2016 from a healthcare worker regarding a female patient (age not reported). On 12-JUL-2016 the patient was inadvertently administered an expired dose of PNEUMOVAX 23 (lot # L007720, expiration 07-JUL-2016). No adverse effect was reported. No further details were provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an 81 year male patient with heart disease. The patient's medical history and drug reactions or allergies were unknown by the reporter. On an unknown date, "4 or 5 years ago", the patient was vaccinated with ZOSTAVAX (dose, route, anatomical location, lot number and expiration date were not provided). The patient's concomitant medications were unknown by the reporter. On an unknown date the patient developed a "severe case of Herpes zoster after receiving ZOSTAVAX". The physician also reported that the Herpes zoster caused post Herpetic neuralgia. No product quality complaint was involved. The outcome of the Herpes zoster and post Herpetic neuralgia was reported as not recovered/not resolved. The causality between the events and the therapy with ZOSTAVAX was unknown. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: This spontaneous report has been received from a physician (who is also the patient's mother) referring to her son a 14 year old male patient. Information regarding medical history, concurrent conditions, drug reaction and allergies was not provided. On 29-JUL-2016, the patient was vaccinated with 2 doses of GARDASIL 9, intramuscular (dose, anatomical location, lot# and expiration date were not provided). It was reported that the 2 doses were administered at the same day at the pediatrician's office. There was no concomitant medication reported. It was also reported that the patient had a low grade of fever. At the time of the reporting, the outcome of low grade of fever was reported as recovered (unspecified date in 2016). The relatedness between the fever and GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions or allergies were not provided. In January 2016, reported as "six months ago", the patient was vaccinated with a dose of ZOSTAVAX (Route, anatomical location, lot number and expiration date were unknown). No other suspect or concomitant medication were reported. The pharmacist reported that in 2016, the patient was seen by an unknown physician and the provider feels the patient "now has a case of Shingles" (herpes zoster).
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a physician refers to a multiple patients of unknown ages and genders. Pertinent medical history, concurrent conditions and drug reactions or allergies were not reported. On an unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB Lot # K023310, Expiration Date 15-APR-2017, and Pediatric/Adolescent Lot #L001456, Expiration Date 22-OCT-2016 (Dose, route and anatomical location were not provided). Other suspect product involved was sterile diluent lot # L041683 Expiration date 19-MAY-2018 and Lot # M002421 Expiration date 22-JUL-2018. Temperature: Lowest 25 Fahrenheit degrees (4 cycles) below. Time frame: 1 week. Previous: No. Digital data logger was involved. No product quality complain was involved. No other concomitant medication was reported. This is one of five reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Nurse, referring to an unknown number of patients of unknown age and gender. No pertinent medical histories, concurrent conditions and concomitant therapies were reported. On 04-AUG-2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB. Dose, route, lot #, indication and anatomical location were not reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a physician refers to a multiple patients of unknown ages and genders. Pertinent medical history, concurrent conditions and drug reactions or allergies were not reported. On an unknown dates the patients were vaccinated with improperly stored ROTATEQ lot # L013206, expiration date 29-JAN-2017, (Dose, route and anatomical location were not provided). Other suspect product involved was sterile diluent lot # L041683 Expiration date 19-MAY-2018 and Lot # M002421 Expiration date 22-JUL-2018. Temperature: Lowest 25 Fahrenheit degrees (4 cycles) below. Time frame: 1 week. Previous: No. Digital data logger was involved. No product quality complain was involved. No other concomitant medication was reported. This is one of five reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a Nurse, referring to an unknown number of patients of unknown age and gender. No pertinent medical histories, concurrent conditions and concomitant therapies were reported. On 04-AUG-2016, the patients were vaccinated with improperly stored doses of M-M-R II. Dose, route, lot # indication and anatomical location were not reported. A product quality complaint was not involved. This is one of several reports received from the same reporter.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: Shortly after vaccine given, patient c/o dizziness, light headedness and being "hot". Patient was diaphoretic and nervous before shot. Cool compress applied. Mother in room. Patient observed x 20 minutes with no further issues. Denied issues upon leaving. Declined H2O.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Fatigue, Hyperhidrosis, Loss of consciousness, Nausea
Clinical narrative: Shortly after vaccines given, patient became pale, diaphoretic and passes out. Ammonia inhalant used and patient aroused. A and O. C/o nausea, dizzy, lightheaded. Cool compress applied. Mother present. Patient observed x 20 minutes without further issues. Denied issues upon leaving. States, "I am just tired". Did drink water.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Pallor
Clinical narrative: Shortly after vaccines given, patient became pale, diaphoretic and passes out. Ammonia inhalant used and patient aroused. A and O. C/o nausea, dizzy, lightheaded. Cool compress applied. Mother present. Patient observed x 20 minutes without further issues. Denied issues upon leaving. States, "I am just tired". Did drink water.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Discomfort, Injected limb mobility decreased, Limb discomfort, Mobility decreased, Pain in extremity
Clinical narrative: Extreme swelling and pain of left arm with a feeling of heaviness and inability to move arm. The following day, her entire body felt heavy and hard to move. No fever. No rash. By the 3rd day after the vaccine she started to improve and after a few more days was better. Pt reported reaction on 8/12/16.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Peripheral swelling
Clinical narrative: Extreme swelling and pain of left arm with a feeling of heaviness and inability to move arm. The following day, her entire body felt heavy and hard to move. No fever. No rash. By the 3rd day after the vaccine she started to improve and after a few more days was better. Pt reported reaction on 8/12/16.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Body temperature, Injection site erythema, Injection site swelling, Vomiting
Clinical narrative: Clients guardian called on 8/3/16 reporting (R) leg was swollen had a temp of 101.0 and was vomiting. 8/4/16 temp 99.5 (R) leg near inj. site red, swelling had gone down then increased. After phone call came to office measured about 7 in diameter reddened area, reported on 8/3/16 had vomited 3 times.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Tdap administered IM into (L) deltoid. Less than 12 hrs. after vaccination admin. Pt C/O discomfort, swelling, redness and heat at injection site. C/O similar SX when received Dtap at age 4.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Arm (L) upper - Red, swollen, painful, hot to touch, itching. Temp 99.0, malaise. Prednisone burst 20mg x 3days x3; 3 days x2 3days x1 Hydroxyzine 25mg one every 8 hours.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site warmth, Malaise
Clinical narrative: Arm (L) upper - Red, swollen, painful, hot to touch, itching. Temp 99.0, malaise. Prednisone burst 20mg x 3days x3; 3 days x2 3days x1 Hydroxyzine 25mg one every 8 hours.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: Erythema induration rash at site of injection. No vesicles.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Extensive swelling of vaccinated limb, Injection site pain
Clinical narrative: Patient had extensive swelling from injection site down to fingers and severe pain up thru shoulder.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Flushing, Nausea, Syncope
Clinical narrative: Nausea, flush, weakness. She did not pass out. Mild course of syncope. She also only had banana to eat. Maybe heat and blood sugar also caused her to have symptoms.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Patient received ZOSTAVAX on 8-8-16 in left upper arm subcutaneously. He presented to the pharmacy on 8-11-16 and was concerned about the injection site. It was a raised, firm 2-3" in diameter area (very red) that was itchy. 2 Pharmacists confirmed a local allergic reaction.
Age: 14.0
Sex: U
Vaccine: TDAP
Symptoms: Asthenia, Pallor, Syncope
Clinical narrative: Pt. received a BOOSTRIX vaccine at our pharmacy. After administration pt. had an event of syncope. His face turned pale and fainted for a second. He woke up right away but appeared weak. Pt. remained seated for 20 minutes and recovered.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Fatigue, Malaise, Pyrexia
Clinical narrative: Extreme fatigue, followed in AM by 102° temp and chills. This did not resolve until 08/4/2016 followed by several days of fatigue.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Body temperature increased, Chills, Fatigue
Clinical narrative: Extreme fatigue, followed in AM by 102° temp and chills. This did not resolve until 08/4/2016 followed by several days of fatigue.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Heart rate increased
Clinical narrative: Increased Heart Rate.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: Terrible pain, high fever, shaking.
Age: 11.0
Sex: M
Vaccine: DTAP, HPVX, MEN
Symptoms: Erythema, Musculoskeletal stiffness, Pain, Pruritus, Skin warm
Clinical narrative: Redness, hot spot, itching, stiffness, sore. Area about 4 inches. IBP given. 4 days later symptoms still persist.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash, Rash generalised
Clinical narrative: Rash all over face and body.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Fainted.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Patient noticed warm sensation and upon inspection was very swollen and red.  Not particularly painful or irritated.  Warm and somewhat swollen.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Facial paralysis, Guillain-Barre syndrome, Infection, Laboratory test, Lumbar puncture abnormal
Clinical narrative: Left-sided facial nerve palsy with bilateral paresthesias that progressed from 8/4-8/10. MRI and LP support diagnosis of Guillain-Barre. Symptoms followed an acute mono-like illness that started on 7/29. Testing to diagnose preceding infection still pending.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Malaise, Nuclear magnetic resonance imaging abnormal, Paraesthesia
Clinical narrative: Left-sided facial nerve palsy with bilateral paresthesias that progressed from 8/4-8/10. MRI and LP support diagnosis of Guillain-Barre. Symptoms followed an acute mono-like illness that started on 7/29. Testing to diagnose preceding infection still pending.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Pain, redness, hard lump, warmth at injection site still going on at day 2.
Age: 65.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Cough
Clinical narrative: States she has a cough that started after receiving the vaccine.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Fatigue, Headache, Mobility decreased, Myalgia
Clinical narrative: Adverse symptoms: Extremely sore shoulder muscle that made it difficult to move; fatigue; headache; joint aches (began morning of 8/13/2016); nausea (only at 10pm on 8/12/2016).  All other symptoms are persisting until the current time (3:15 PM on 8/13/16).  Treatment: Advil (ineffective)
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Nausea
Clinical narrative: Adverse symptoms: Extremely sore shoulder muscle that made it difficult to move; fatigue; headache; joint aches (began morning of 8/13/2016); nausea (only at 10pm on 8/12/2016).  All other symptoms are persisting until the current time (3:15 PM on 8/13/16).  Treatment: Advil (ineffective)
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain, Swelling
Clinical narrative: Patient did not provide an exact/accurate timeline but stated she had some pain and swelling starting the day of the administration of the vaccination which progressed up until the date of this report. I recommended the patient see her doctor/provider for assessment and informed her that swelling and pain at the injection site is farely common with the Zostavax but it would be wise to still inform her provider of the swelling and pain. Patient plans on informing her provider on Monday since the providers office is closed this weekend.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Gingival bleeding
Clinical narrative: Since onset, the problem has been gradually worsening. Affected locations: Entire body, started on face neck and chest, has spread to entire body. Associated symptoms include sore throat, malaise, fatigue, non-blanching rash, fever, and myalgias. Negative for cough, congestion, shortness of breath, vomiting, nail changes, joint pain, facial edema, painful lesions, rhinorrhea, headache, and diarrhea. Symptoms are relieved by OTC analgesics/fever reducers. Associated symptoms include chills, arthalgia (2 days ago for a few days), and fever (tactile, felt chilled). Negative for ear pain (Reports she got dizzy for a few minutes on Friday (2 days ago) right top gums hurts, reports bleeding when she brushes her teeth. Right side of throat started hurting this morning). Risk factors include Negative for sick contacts. PMH significant for Negative for tuberculosis, cancer, immunocompromised, renal insufficiency, liver disease, and HIV.