chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 06-APR-2016, the patient was vaccinated with an expired dose of M-M-R II (lot # K000737 and expiration date 16-JAN-2016, an albumin status therapy type, dose and route of administration were not reported. Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. On the same day, the patient received an improperly stored dose of RECOMBIVAX HB (captured in MARRS# 1607USA005367). Additional information is not expected as no contact details were reported.
Age: 0.08
Sex: U
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 6 week old patient. The patient's current conditions, medical history and concomitant medications were not provided. On 11-MAY-2016 (on patient's date of birth), the patient was vaccinated with first dose of RECOMBIVAX HB. On 14-JUN-2016, the patient was vaccinated with second dose of RECOMBIVAX HB. On 28-JUN-2016, the patient was then inadvertently given a third dose of RECOMBIVAX HB (inappropriate schedule of vaccine administered). The patient inadvertently received an extra dose of vaccine, because the patient's mother had not given the physician the patient's complete vaccination history. No symptoms were reported (no adverse event). Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 0.08
Sex: U
Vaccine: HEP, HEP
Symptoms: Blood culture negative, C-reactive protein increased, CSF culture negative, CSF test normal, Culture urine negative
Clinical narrative: This spontaneous report was received from a physician and refers to a 6 week old patient. The patient's current conditions, medical history and concomitant medications were not provided. On 11-MAY-2016 (on patient's date of birth), the patient was vaccinated with first dose of RECOMBIVAX HB. On 14-JUN-2016, the patient was vaccinated with second dose of RECOMBIVAX HB. On 28-JUN-2016, the patient was then inadvertently given a third dose of RECOMBIVAX HB (inappropriate schedule of vaccine administered). The patient inadvertently received an extra dose of vaccine, because the patient's mother had not given the physician the patient's complete vaccination history. No symptoms were reported (no adverse event). Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 0.08
Sex: U
Vaccine: HEP, HEP
Symptoms: Enterovirus test negative, Herpes simplex test negative, Polymerase chain reaction, Rash, Rash erythematous
Clinical narrative: This spontaneous report was received from a physician and refers to a 6 week old patient. The patient's current conditions, medical history and concomitant medications were not provided. On 11-MAY-2016 (on patient's date of birth), the patient was vaccinated with first dose of RECOMBIVAX HB. On 14-JUN-2016, the patient was vaccinated with second dose of RECOMBIVAX HB. On 28-JUN-2016, the patient was then inadvertently given a third dose of RECOMBIVAX HB (inappropriate schedule of vaccine administered). The patient inadvertently received an extra dose of vaccine, because the patient's mother had not given the physician the patient's complete vaccination history. No symptoms were reported (no adverse event). Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 0.08
Sex: U
Vaccine: HEP, HEP
Symptoms: Rash macular, White blood cell count normal
Clinical narrative: This spontaneous report was received from a physician and refers to a 6 week old patient. The patient's current conditions, medical history and concomitant medications were not provided. On 11-MAY-2016 (on patient's date of birth), the patient was vaccinated with first dose of RECOMBIVAX HB. On 14-JUN-2016, the patient was vaccinated with second dose of RECOMBIVAX HB. On 28-JUN-2016, the patient was then inadvertently given a third dose of RECOMBIVAX HB (inappropriate schedule of vaccine administered). The patient inadvertently received an extra dose of vaccine, because the patient's mother had not given the physician the patient's complete vaccination history. No symptoms were reported (no adverse event). Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 12-JUL-2016, the patient was vaccinated with an expired dose of PROQUAD 0.5 ml, once, subcutaneously, lot # K022447, expiration date 13-MAY-2016 (anatomical location was not provided). No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Drug administered at inappropriate site, Erythema, Injection site inflammation, Injection site pain
Clinical narrative: Initial unsolicited misuse report received from a nurse on 19 March 2016. This case involves a patient who was vaccinated with a 0.1 ml dose of Fluzone QIV intradermally at the left forearm instead of TUBERCULIN PPD(M) 5 TU (Tubersol) on 18 March 2016. It was reported that on 18 March 2016 same day after vaccination patient had raised wheal at site on day of administration and the next day the wheal was raised, red, and warm to the touch. It was a case of wrong vaccine administered, Drug use via unapproved administration route and vaccine underdose. The patient was not recovered from the events. Follow-up information received from a nurse on 26-MAY-2016. This case involves a male patient (age not reported). On 18 March 2016, patient was administered with 0.1 ml of FLUZONE QIV (batch number UI440AB, expiry date 30-Jun-2016) via subcutaneous (SQ) route in left forearm. Patient's illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Adverse event following prior vaccination in patient and in brother or sister was reported as unknown. Any other vaccination within four weeks prior to date of vaccination was reported as unknown. It was reported that the patient continued to have inflammation and tenderness over the site of the injection. Patient also experienced cellulitis of the left arm. On an unspecified date (2 days later), the patient had positive PPD test (10 mm) on right forearm On an unspecified date (2 days later), the patient received the corrective treatment for cellulitis with Keflex 500 mg, one per oral, daily for 10 days. It was reported that the on an unspecified date (after 4 days), the patient recovered from the event raised wheal at site (swelling) and for event cellulitis of left forearm the outcome was not reported. List of documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Skin warm, Tuberculin test positive, Underdose, Urticaria, Wrong drug administered
Clinical narrative: Initial unsolicited misuse report received from a nurse on 19 March 2016. This case involves a patient who was vaccinated with a 0.1 ml dose of Fluzone QIV intradermally at the left forearm instead of TUBERCULIN PPD(M) 5 TU (Tubersol) on 18 March 2016. It was reported that on 18 March 2016 same day after vaccination patient had raised wheal at site on day of administration and the next day the wheal was raised, red, and warm to the touch. It was a case of wrong vaccine administered, Drug use via unapproved administration route and vaccine underdose. The patient was not recovered from the events. Follow-up information received from a nurse on 26-MAY-2016. This case involves a male patient (age not reported). On 18 March 2016, patient was administered with 0.1 ml of FLUZONE QIV (batch number UI440AB, expiry date 30-Jun-2016) via subcutaneous (SQ) route in left forearm. Patient's illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Adverse event following prior vaccination in patient and in brother or sister was reported as unknown. Any other vaccination within four weeks prior to date of vaccination was reported as unknown. It was reported that the patient continued to have inflammation and tenderness over the site of the injection. Patient also experienced cellulitis of the left arm. On an unspecified date (2 days later), the patient had positive PPD test (10 mm) on right forearm On an unspecified date (2 days later), the patient received the corrective treatment for cellulitis with Keflex 500 mg, one per oral, daily for 10 days. It was reported that the on an unspecified date (after 4 days), the patient recovered from the event raised wheal at site (swelling) and for event cellulitis of left forearm the outcome was not reported. List of documents held by sender: none.
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Eye movement disorder
Clinical narrative: Initial unsolicited report received from a Physician on 29 June 2016. This case involves a male patient (age was not reported) who was vaccinated with a dose of MENACTRA (batch number- U5180AA, expiry date, site and route of administration was not reported) and ADACEL (batch number- U5316AA, expiry date, site and route of administration was not reported) on an unspecified date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unspecified date, same day following the vaccination, the patient had experienced eyes rolled back. Laboratory investigations and corrective treatment were not reported. The patient outcome was reported as unknown. List of documents held by sender: none.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Full body itching rash.
Age: 36.0
Sex: F
Vaccine: ANTH, JEV, SMALL, TYP
Symptoms: Arthralgia, C-reactive protein increased, Complement factor, Joint swelling, Musculoskeletal stiffness
Clinical narrative: Neck pain, significant neck stiffness, joint pain in knees, ankles, feet and hands. Joint swelling, most notable in PIPs of hands and MTPs of feet.
Age: 36.0
Sex: F
Vaccine: ANTH, JEV, SMALL, TYP
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Neck pain, significant neck stiffness, joint pain in knees, ankles, feet and hands. Joint swelling, most notable in PIPs of hands and MTPs of feet.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Disseminated varicella zoster vaccine virus infection, Rash, Varicella virus test positive
Clinical narrative: Disseminated varicella zoster virus diagnosed in a 9-year old 2-dose varicella vaccine recipient. Painful rash in bilateral dermatomes. History of malignancy and chemotherapy treatment. Treated with IV acyclovir. No complications.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site bruising, Pyrexia, Skin warm, Tenderness
Clinical narrative: By evening noticed bruise at needle site puncture. Bruise more pronounced by the morning. Area of redness about 2 1/2 inches wide, tender, warm. Took ibuprofen and used ice pack and helped a little. Had very slight fever (below 100).
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. The patient was not sure if she was vaccinated with a dose of MMR II. Date, dose, route, frequency, lot number and expiration date were not provided. No other suspect or concomitant therapy was reported. On an unspecified date the patient had titers drawn as part of employment testing, and titers for MMR II were negative (Viral test negative). The outcome of the event was unknown. The causality between the therapy with MMR II and the event was unknown. Additional information is not expected since there is no contact information.
Age: 86.0
Sex: U
Vaccine: TDAP
Symptoms: Antibody test, Clostridium test negative, Corynebacterium test negative
Clinical narrative: Initial unsolicited report received from the literature on 01 June 2016. This case is linked to cases 2016SA108584, 2016SA108560, and 2016SA108575 (same literature). The following is verbatim from the article: Background. Many adult immunization schedules recommend that tetanus and diphtheria vaccination be performed every 10 years. In light of current epidemiological trends of disease incidence and rates of vaccine-associated adverse events, the 10-year revaccination schedule has come into question. Methods. We performed cross-sectional analysis of serum antibody titers in 546 adult subjects stratified by age or sex. All serological results were converted to international units after calibration with international serum standards. Results. Approximately 97 percent of the population was seropositive to tetanus and diphtheria as defined by a protective serum antibody titer of .0.01 IU/mL. Mean antibody titers were 3.6 and 0.35 IU/mL against tetanus and diphtheria, respectively. Antibody responses to tetanus declined with an estimated half-life of 14 years (95 percent confidence interval, 11.17 years), whereas antibody responses to diphtheria were more long-lived and declined with an estimated half-life of 27 years (18.51 years). Mathematical models combining antibody magnitude and duration predict that 95 percent of the population will remain protected against tetanus and diphtheria for 30 years without requiring further booster vaccination. Conclusions. These studies demonstrate that durable levels of protective antitoxin immunity exist in the majority of vaccinated individuals. Together, this suggests that it may no longer be necessary to administer booster vaccinations every 10 years and that the current adult vaccination schedule for tetanus and diphtheria should be revisited. This case involves an 86-year old patient (gender not reported) who was vaccinated with a dose of TDAP (lot number, expiry date, dose, dose series, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unknown date, unspecified timeframe after vaccination, the patient lacked immunity to both toxins (diphtheria and Tetanus). A serum antibody titers was performed (results not provided). Other laboratory data and corrective treatment was not reported. The outcome of the event was not reported. Documents held by sender: none.
Age: 1.03
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Unknown tried to contact parent twice with no answer.
Age: 26.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a health professional referring to a 26 year old patient of unknown gender. Information about the patient's medical history and concurrent conditions was not provided. On an unknown date, while being 26 years old, the patient was vaccinated with a dose of PROQUAD (administration route, lot number and expiration date were not provided). No concomitant therapies were reported, neither was any adverse event. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Syncope
Clinical narrative: Patient fainted after receiving vaccination for HPV. Mother was with patient. Patient fell on floor lying with back and head down. Patient states she has no pain to back of head or neck and able to state her name and date and place where she's at. No change in Level of consciousness. No complaints of dizziness or vomiting. No bump, swelling, or bruising noted to back of head and neck. Assisted patient to room and checked VS. Pt was stable/asymptomatic when leaving the office with no complaint of dizziness, N/V. PT on exam neurologically intact. Evaluated by PAC.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Musculoskeletal pain
Clinical narrative: REDNESS AND SWELLING OF INJECTION SITE. PAIN IN UPPER SHOULDER - LEFT SIDE.
Age: 41.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Joint range of motion decreased, Musculoskeletal discomfort, Musculoskeletal pain, Pain, Sleep disorder
Clinical narrative: Increasing shoulder pain with movement. Limited range of motion. Progressed to where I could not raise my arm above shoulder level. Has improved with medication to the point of chronic discomfort, however I am unable to sleep on that side and still do not have full range of motion.
Age: 41.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Discomfort, Joint range of motion decreased, Musculoskeletal pain, Pain, Sleep disorder
Clinical narrative: Increasing shoulder pain with movement. Limited range of motion. Progressed to where I could not raise my arm above shoulder level. Has improved with medication to the point of chronic discomfort, however I am unable to sleep on that side and still do not have full range of motion.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Asthenia, Dizziness, Tremor
Clinical narrative: Dizzy, weak, shaky for just over an hour.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Urticarial-type rash noted to upper chest extending up towards anterior neck and upper back that is erythemic and itchy. 5.5in x 3in. area of erythema/swelling/warmth to left bicep area with mild tenderness to touch.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticarial-type rash noted to upper chest extending up towards anterior neck and upper back that is erythemic and itchy. 5.5in x 3in. area of erythema/swelling/warmth to left bicep area with mild tenderness to touch.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: A bit below the injection site, developed a deep ache, followed by swelling and redness. Over the course of the evening I watched the redness and swelling actually crawl down my arm to my elbow. The whole of my upper arm was hot, swollen, red and tender by bedtime. Following day (yesterday) I went back to the Drs. office and he prescribed Cephalexin antibiotic, 500mg 4X daily for a Dx of Cellulitis. Also cold compresses and Ibuprofen for discomfort. Today, my arm is swollen beyond the elbow, halfway down my forearm. It is still tender, painful at times, red, hot and swollen. I got light headed this morning when I went out I felt lightheaded and have been feeling "weak" all day.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: A bit below the injection site, developed a deep ache, followed by swelling and redness. Over the course of the evening I watched the redness and swelling actually crawl down my arm to my elbow. The whole of my upper arm was hot, swollen, red and tender by bedtime. Following day (yesterday) I went back to the Drs. office and he prescribed Cephalexin antibiotic, 500mg 4X daily for a Dx of Cellulitis. Also cold compresses and Ibuprofen for discomfort. Today, my arm is swollen beyond the elbow, halfway down my forearm. It is still tender, painful at times, red, hot and swollen. I got light headed this morning when I went out I felt lightheaded and have been feeling "weak" all day.
Age: 26.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Pt states the site started swelling and a bruise was formed. Around 6 pm pt states the site felt like it was pulsating. Today 13July some redness, swelling, and a little tender to the touch.
Age: 26.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Pain
Clinical narrative: Pt states the site started swelling and a bruise was formed. Around 6 pm pt states the site felt like it was pulsating. Today 13July some redness, swelling, and a little tender to the touch.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report concerning a 66 years old female patient with arthritis was received from the patient herself. Medical history was not reported, however, the patient stated that she had no allergies. On an unknown date in 2010, the patient was vaccinated with ZOSTAVAX (strength, dose, route, frequency, lot and expiration date were not provided). Concomitant medications include an unspecified diabetes medicine. On an unknown date in 2014, the patient experienced shingles rash, but she stated that she did not have any pain. The patient did not sought medical attention. Additionally, no laboratory diagnostic studies were performed and no treatment for the adverse event was given. No product quality complain was involved. At the time of reporting, the outcome of herpes zoster was reported as recovered on an unknown date (also reported as the adverse event did not improved). The reporter did not consider the event of herpes zoster life threatening or medically significant. The causality between the event of herpes zoster and ZOSTAVAX was not assessed. Additional information is not expected as the reporter did not consent for follow-up attempts.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Febrile with 102.5. Severe pain to L arm (at vaccination site). Unable to abduct arm laterally or anteriorly. Fatigue, chills, body aches.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Febrile with 102.5. Severe pain to L arm (at vaccination site). Unable to abduct arm laterally or anteriorly. Fatigue, chills, body aches.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Patient experienced dizziness and nausea 5-10 minutes after vaccination.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Syncope
Clinical narrative: Client fainted, client was monitored for an additional 20 minutes.  Client had not eaten today. Client was given juice and crackers. Client said he had a history of fainting with medical procedures. Client left clinic with his Grandmother.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Asthenia, Concussion, Face injury, Fall, Syncope
Clinical narrative: About 3 to 5  minutes after receiving the HPV #1 and Trumenba # 1 immunizations patient fainted while still in a sitting position on the exam table. She landed face down on the carpet. She rolled to her side then back. She responded after a few minutes, but was weak for a few minutes. Patient eventually was able to stand then walk. She left the office, accompanied by her mother. She was rechecked by the doctor on 6-23-16 and 6-27-16.
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Crying, Diet refusal, Discomfort, Irritability, Pyrexia
Clinical narrative: Inconsolable crying began 7/10/16 at 6:30am upon wake up. Was extremely fussy all day 7/10 and 7/11, going in and out of inconsolable crying sometimes crying for 1-2 hours at a time. Not able to be soothed by anything. Beyond fussiness, extreme discomfort was perceived. Refusal to eat, drink, or breastfeed for the majority of 7/10 and morning of 7/11. Visited doctor on 7/11/16 who diagnosed "fussiness due to shots". Began taking more fluids afternoon of 7/11. On 7/12 began running low grade fever and refusal to eat returned. This has continued through 7/13.
Age: 0.23
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: According to mother, hives developed 3 hours after vaccination.  Hives worsened the next day.  Patients mother called to report symptoms on 7/13/16.  Mother was advised to take child to urgent care.
Age: 62.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Dizziness, Dyspnoea, Flushing, Immediate post-injection reaction
Clinical narrative: PATIENT WAS GIVEN PNEUMOVAX 23 FIRST, IMMEDIATELY AFTER GIVING THE SECOND SHOT WHICH WAS BOOSTRIX, PATIENT FELT DIZZY, LIGHTHEADED AND EXPERIENCED FLUSHING AND SHORTNESS OF BREATH. WE OFFERED HER BENADRYL AND EPIPEN INJECTION AND TO CALL 911. SHE REFUSED AND REJECTED THE OFFERS. A FEW MINUTES LATER, SHE SAID SHE FELT BETTER. AFTER WAITING NEAR THE PHARMACY FOR 30 MINUTES, SHE SAID SHE WAS FEELING BETTER AND SAID SHE WAS ABLE TO GO HOME.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient received Zostavax injection in her right arm on 7/9/16. On 7/12/16 she came into the pharmacy because the injection site where she received Zostavax had become slightly swollen, red, itchy and warm but did not hurt. She stated that she had been putting hydrocortisone on it and was feeling relief from that. She stated she would return to the pharmacy if symptoms progressed. Today 7/13/16 I called her to check in and she said that her symptoms had greatly reduced today after icing and hydrocortisone cream so she was relieved about that. She was not concerned nor upset and said that she did not need or want us to contact her prescriber about this.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Formication, Pruritus
Clinical narrative: Patient was very anxious about receiving the injection and reported her skin "was crawling and itching" when I followed up with her 15 min after administration.  She didn't know if it was "nerves" or a reaction to the injection. I gave her 20mg of cetirizine (she stated benedryl allergy)and she took 150mg of ranitidine she had just purchased. The patient reported the symptoms had mostly resolved 15 min after taking the two histamine blocking medications.  When I followed-up an hour later the symptoms had completely resolved.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Patient reported pain and soreness in left arm, with it spreading to her leg and shoulders/neck. She said it was painful and it kept hurting until the next day 7/13/16. She came in to the pharmacy to be evaluated and there was  2-3 inches area of redness/puffiness about 1-2 inches below the injection site. Arm skin and injection site was normal otherwise, besides the red/swollen area.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hyperhidrosis, Injection site erythema, Injection site mass, Malaise
Clinical narrative: Patient reports they experienced nausea, dizziness and sweating, described it as feeling "sick". She felt like she couldn't see well, "things were a blur". On 7/12/16 she felt sleepy, dizzy and nauseous. Around noon of 7/12/16 she noticed a lump growing around her injection site at the back of her arm. She describes it as red and a lump the size of a quarter.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Somnolence, Vision blurred
Clinical narrative: Patient reports they experienced nausea, dizziness and sweating, described it as feeling "sick". She felt like she couldn't see well, "things were a blur". On 7/12/16 she felt sleepy, dizzy and nauseous. Around noon of 7/12/16 she noticed a lump growing around her injection site at the back of her arm. She describes it as red and a lump the size of a quarter.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pain, Swelling
Clinical narrative: Started with pain and soreness. The swelling began to spread and was told to see the MD.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Nasopharyngitis
Clinical narrative: Bad cold like sym.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Cellulitis, Ultrasound scan
Clinical narrative: Cellulitis alleged. Follow-up with PCP.
Age: 1.26
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Pyrexia, Seizure
Clinical narrative: High fevers, seizures.
Age: 0.22
Sex: M
Vaccine: RV5
Symptoms: Abdominal pain, Intussusception, Irritability, Ultrasound abdomen abnormal, X-ray abnormal
Clinical narrative: On 6/4/16 presented to ER with abdominal pain, fussiness. Xray and ultrasound done showing intussusception. Then transferred to another hospital for surgery and recovery.
Age: 77.0
Sex: M
Vaccine: VARCEL
Symptoms: Disability, Genital swelling, Herpes zoster, Urinary retention
Clinical narrative: This spontaneous report as received from a physician refers to an 80 year old male patient with high cholesterol. The patient had no pertinent medical history or drug reactions/allergies. On 29-NOV-2012, the patient was vaccinated with a dose of VARIVAX (Merck), subcutaneously, lot # reported as 0834AA and expiry date on 02-JUN-2013. Concomitant therapy included unknown "statin" for high cholesterol. It was reported that ten days ago, on 28-JUN-2016, the patient developed a case of shingles on his genital area. The patient was so swollen in that area, that the patient was unable to urinate which the physician felt was causing significant disability or incapacity to the patient. The reporter also stated that patient sought medical attention by being seen at unknown urgent care and was then seen at the physician's office on 27-JUN-2016. During the doctor's visit, the patient was administered a dose of DECADRON and a dose of DEPO MEDROL intramuscularly, as treatment for the swelling and the shingles outbreak. The patient was also prescribed acyclovir cream and unknown dose of famciclovir oral as treatment for the swelling and the shingles outbreak. At the reporting time, the patient had not recovered from the events. No laboratory studies were performed. The causal relationship between the events and suspect therapy was not provided. The reporter considered the event of urinary retention to be disability/incapacity. Upon internal review, the event of urinary retention was considered to be medically significant. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Injection site urticaria
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 18-year-old female patient who received BEXSERO. Concomitant products included BEXSERO. On 24th June 2016, the patient received the 2nd dose of BEXSERO. On an unknown date, less than a month after receiving BEXSERO, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site pain and injection site urticaria. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site pain and injection site urticaria were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site pain and injection site urticaria to be related to BEXSERO. Additional information was provided as follows: On 26th May 2016, the patient received 1st dose of BEXSERO with no reaction. No other vaccines were administered during this office visit. The 2nd dose of BEXSERO was administered on left deltoid. After administration, a red wheal was noted at the injection site which was 4 inches in diameter and slightly raised (extensive swelling of vaccination limb). No further information was reported regarding the event.
Sex: U
Vaccine: FLU3, PNC13, TDAP
Symptoms: Arthralgia, Headache
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of headache in a adult patient who received dTpa vaccine. Co-suspect products included Influenza vaccine and PREVENAR 13. On an unknown date, the patient received dTpa vaccine at an unknown dose, Influenza vaccine at an unknown dose and PREVENAR 13 at an unknown dose. On an unknown date, an unknown time after receiving dTpa vaccine and Influenza vaccine, the patient experienced headache and joint pain. On an unknown date, the outcome of the headache and joint pain were unknown. It was unknown if the reporter considered the headache and joint pain to be related to dTpa vaccine and Influenza vaccine. Additional details were provided as follows: The patient's age at vaccination was not reported. This patient had been vaccinated with Influenza and Tdap vaccines as well as PREVENAR 13 at the same time. The reporter informed that, one adult patient came complaining from headache and joint pain after receiving the PREVENAR 13. She wanted to know how long this side effect will last and if there was any further complication expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to five unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, between 28-JUN-2016 and 05-JUL-2016, the patients were vaccinated with improperly stored M-M-R II (recombinant human albumin (rHA); lot # L028273 with expiry date 28-JUL-2017; dose and frequency were not reported) subcutaneously. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to five patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, between 28-JUN-2016 and 05-JUL-2016, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L042266 with expiry date 27-OCT-2017; dose and frequency were not reported), subcutaneously. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Back pain, Diarrhoea, Local swelling, Nausea
Clinical narrative: 7/8/16: Date Tdap given. 7/9/16: Reported "stomach ache" around 10 AM. Reported pain has been constant and still reported mild pain on 7/12/16. Also reported nausea and diarrhea. 7/9/16: Itching of neck and collar bones bilaterally. Resolved 7/12/16. 7/9/16: Jaw and neck swelling. Still reported mild neck swelling 7/12/16. 7/9/16: Reported low grade fever but never took temperature. Resolved 7/11/16. 7/10/16: Sore throat with sores in back of throat at 8:00 AM. Resolved 7/11/16. 7/10/16: Left arm pain and swelling. Swelling resolved that evening but still reported arm pain (improving) on 7/12/16. 7/11/16: Upper back pain that was present (improving) 7/12/16. Reported taking Ibuprofen on 7/10/16 for her symptoms.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Oropharyngeal pain, Pain, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: 7/8/16: Date Tdap given. 7/9/16: Reported "stomach ache" around 10 AM. Reported pain has been constant and still reported mild pain on 7/12/16. Also reported nausea and diarrhea. 7/9/16: Itching of neck and collar bones bilaterally. Resolved 7/12/16. 7/9/16: Jaw and neck swelling. Still reported mild neck swelling 7/12/16. 7/9/16: Reported low grade fever but never took temperature. Resolved 7/11/16. 7/10/16: Sore throat with sores in back of throat at 8:00 AM. Resolved 7/11/16. 7/10/16: Left arm pain and swelling. Swelling resolved that evening but still reported arm pain (improving) on 7/12/16. 7/11/16: Upper back pain that was present (improving) 7/12/16. Reported taking Ibuprofen on 7/10/16 for her symptoms.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Stomatitis, Swelling face
Clinical narrative: 7/8/16: Date Tdap given. 7/9/16: Reported "stomach ache" around 10 AM. Reported pain has been constant and still reported mild pain on 7/12/16. Also reported nausea and diarrhea. 7/9/16: Itching of neck and collar bones bilaterally. Resolved 7/12/16. 7/9/16: Jaw and neck swelling. Still reported mild neck swelling 7/12/16. 7/9/16: Reported low grade fever but never took temperature. Resolved 7/11/16. 7/10/16: Sore throat with sores in back of throat at 8:00 AM. Resolved 7/11/16. 7/10/16: Left arm pain and swelling. Swelling resolved that evening but still reported arm pain (improving) on 7/12/16. 7/11/16: Upper back pain that was present (improving) 7/12/16. Reported taking Ibuprofen on 7/10/16 for her symptoms.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On unspecified dates on 1999 the patient was vaccinated with two doses of RECOMBIVAX HB. Doses, routes, frequency, lots numbers and expiration dates were not provided. No other suspect or concomitant therapy was reported. The pharmacist stated that the patient would like to receive a third dose now. No adverse symptoms were reported. Additional information is not expected since there is no contact information.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to an 18 years old female patient with heart murmur (cardiac murmur). The patient's medical history was not reported. On an unknown date in 2016, reported as "no more than six weeks", the patient became pregnant (the dates of last menstrual period and estimated date of delivery were unknown); on 22-JUN-2016, the patient went for an annual checkup and was vaccinated with GARDASIL (lot, expiration date and strength were not provided) dose 1, intramuscular (exposure during pregnancy). There were no concomitant medications. The reporter stated that the patient self-administered, on unspecified dates, six pregnancy test with conflicting results. On 05-JUL-2016, the patient sought medical attention and reported a lack of a menstrual cycle for the past six weeks. On that day, a blood pregnancy test was performed to the patient and the pregnancy was confirmed. No adverse events were reported. No product quality complain was involved. At the time of reporting, the pregnancy outcome was pending and the fetal outcome was unknown. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Dizziness, Heart rate decreased, Somnolence
Clinical narrative: Dizziness, drowsiness, decreased BP 75/S slow pulse. Please rule: Pt needle/shot phobia. Was very nervous. Does experience panic attacks. Was in sun all day w/o food.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of unspecified patients. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # K021444 expiration date 17-SEP-2016 and lot # L026598 expiration date 26-JUN-2017). No adverse effects reported. This report is for data logger. The vaccines were exposed to the following exposures: 1.6 degree centigrade for 1 hour 48 minutes (rounds to 2 degree centigrade). 1.4 degree centigrade for 4 hours and 40 minutes. 1.5 degree centigrade for 1 hour 17 minutes (rounds to 2 degree centigrade). Previous excursions included: 1.7 degree centigrade for 25 minutes (rounds to 2 degree centigrade). 1.4 degree centigrade for 2 hours and 32 minutes. 1.4 degree centigrade for 3 hours and 36 minutes. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of unspecified patients. On unknown dates the patients were vaccinated with improperly stored VAQTA lot # K012457 (lot # M011116 expiration date 17-JUN-2017 and lot # K012457 expiration date 04-JUN-2017). No adverse effects reported. This report is for data logger. The vaccines were exposed to the following exposures: 1.6 degree centigrade for 1 hour 48 minutes (rounds to 2 degree centigrade). 1.4 degree centigrade for 4 hours and 40 minutes. 1.5 degree centigrade for 1 hour 17 minutes (rounds to 2 degree centigrade). Previous excursions included: 1.7 degree centigrade for 25 minutes (rounds to 2 degree centigrade). 1.4 degree centigrade for 2 hours and 32 minutes. 1.4 degree centigrade for 3 hours and 36 minutes. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of unspecified patients. On unknown dates the patients were vaccinated with improperly stored VARIVAX (lot # L004651 expiration date 11-FEB-2017 and lot # L035127 expiration date 14-SEP-2017). The vaccines were exposed to -11.6 degree centigrade for 1 hour and 50 minutes. Previous excursion included: -11.7 degree centigrade for 1 hour and 56 minutes. No adverse effects reported. This report is for data logger. 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 medical assistant refers to unspecified number of unspecified patients. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (lot# K019305 expiration date 15-JUL-2016 and lot # L033693 expiration date 31-MAY-2016). No adverse effects reported. The vaccines were exposed to the following exposures: 1.6 degree centigrade for 1 hour 48 minutes (rounds to 2 degree centigrade); 1.4 degree centigrade for 4 hours and 40 minutes; 1.5 degree centigrade for 1 hour 17 minutes (rounds to 2 degree centigrade). Previous excursions included: 1.7 degree centigrade for 25 minutes (rounds to 2degree centigrade; 1.4degree centigrade for 2 hours and 32 minutes; 1.4degree centigrade for 3 hours and 36 minutes. Additional information had been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a 61 years old female patient. The patient's pertinent medical history and drug reactions/allergies were unknown. On 22-JUN-2016, the patient was vaccinated with ZOSTAVAX (lot # and expiry date were not reported, 1 shot), subcutaneously for prevention of shingles. Concomitant therapies were unknown. The next day, on 23-JUN-2016, the patient experienced a slight fever, and a reddish mark smaller than palm size around the injection site. On the same day, the patient returned to the pharmacy and reported the events. The patient went to her physician and he stated that it was nothing serious. No treatment was given for the adverse events. The mark went away the next day (24-JUN-2016) and the patient had recovered from slight fever on an unspecified date in 2016. The causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Paraesthesia, Visual impairment
Clinical narrative: Approx. 12 hours after injection pt C/O visual disturbance, Facial and (R) arm parasthesia with headache. Went to sleep - all symptoms were resolved in the morning except for 3-4/10 throbbing headache.
Age: 0.04
Sex: M
Vaccine: VARCEL, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site swelling
Clinical narrative: Subcutaneous, non tender spongy area of swelling at previous varicella spot.
Age: 0.04
Sex: M
Vaccine: VARCEL, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Irritability, Vomiting
Clinical narrative: Subcutaneous, non tender spongy area of swelling at previous varicella spot.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Fall, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Patient received vaccine left exam room was standing at checkout window when fainted and fell backwards. Patient became very pale and diaphoretic and related to this and trauma cet transported to hospital.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Electrocardiogram normal, Erythema, Swelling
Clinical narrative: Patient called and reported redness, swelling, and shortness of breath today. Instructed to go to the ER for evaluation and tx. Seen in ER, discharged at 13:48 on 7/13/16.
Age: 25.0
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: 7/6/16 - 5pm - 1st dose - Felt dizzy but not much. 7/8/16 at 1pm - 2nd dose - headache after 2 hrs; last eaten at 10am, nausea. 7/10/16 at 10am - empty, stomach - ate 12pm - HA at 12pm, fever 99.9 (3pm) - took ADVIL 600 mg at 3:30pm felt fine, 7pm felt tired; fever returned, achy, HA, and diarrhea. 7/11/16 - 3rd dose HA and felt worse.
Age: 25.0
Sex: F
Vaccine: TYP
Symptoms: Pain, Pyrexia
Clinical narrative: 7/6/16 - 5pm - 1st dose - Felt dizzy but not much. 7/8/16 at 1pm - 2nd dose - headache after 2 hrs; last eaten at 10am, nausea. 7/10/16 at 10am - empty, stomach - ate 12pm - HA at 12pm, fever 99.9 (3pm) - took ADVIL 600 mg at 3:30pm felt fine, 7pm felt tired; fever returned, achy, HA, and diarrhea. 7/11/16 - 3rd dose HA and felt worse.
Age: 60.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Activities of daily living impaired, Antinuclear antibody negative, Arthralgia, Red blood cell sedimentation rate increased
Clinical narrative: Systemic joint pain for 2 months. I must take minimum of 400 mg MOTRIN every 6 hours to walk or bend. I cannot even put socks on until NSAIDS begin to work.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Abnormal behaviour, Body temperature increased, Diarrhoea
Clinical narrative: Mom states 48 hours after DTaP, hib and PREVNAR bad temp up to 102, refused to get out of bed for 3P, ate only 1/2 meal/day for 2 weeks. Mom states 1st step therapists thinks he's "out of it". Had 2 loose stools/day.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Right deltoid, red swollen, at 5cm in diameter. (Local reaction only).
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Herpes zoster, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received ZOSTAVAX on 7-12-16 after having shingles 3 weeks ago. Patient was complaining of swelling, redness and pain at site of injection, diarrhea, no fever.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Swelling and redness on right arm.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Irritability
Clinical narrative: Rec'd. routine 4 mo Imm. and WCE in office 07/06/16. S/S present approximately 1 week - frequent, intermittent fussiness; waking approximately 20 min after HS. Afebrile; no S/S illness. OTC TYELENOL "not helping" per Mom. AXID dose increased from 1.6 ml BID - to - 2 ml BID on 7/16/16 with no A. Tx Rec = TYLENOL HS x 1 wk.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified group of about 30 patients of unknown age and genders. Information about the patients' medical history and concurrent conditions was not provided. On unknown dates, starting on 01-APR-2016, the patients were vaccinated with, improperly exposed 34F for 475 hours, doses of RECOMBIVAX HB lot # L039660, expiration date: 04-FEB-2018, intramuscular. There were no known adverse effects at the time of this report. Additional information has been requested.