chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: 5/31/17 - Patient feels soreness in upper arm. 6/1/17 - Patient developed fever. Upper arm became red, swollen, and tender to the touch. Patient seen doctor who suspected cellulitis. Was prescribed Cephalexin 500mg. 6/5/17 - Patient recovered (never took the antibiotics).
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: 5/31/17 - Patient feels soreness in upper arm. 6/1/17 - Patient developed fever. Upper arm became red, swollen, and tender to the touch. Patient seen doctor who suspected cellulitis. Was prescribed Cephalexin 500mg. 6/5/17 - Patient recovered (never took the antibiotics).
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right deltoid red, hot and swollen.
Age: 10.0
Sex: F
Vaccine: HEP, HPV4, IPV, MMRV, TDAP
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site of MMRV. Redness developed the day after the vaccine 2.5 cm x 3.75 cm.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, FLU4, MMRV, PNC13
Symptoms: Injection site erythema
Clinical narrative: Redness at the injection site of MMRV (LUA). 6 cm x 3 cm.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Diarrhoea, Rash, Somnolence
Clinical narrative: Rash, chills, diarrhea, drowsiness, achy joints; started evening of injection, rash spreading 1 week later; treated with BENADRYL.
Age: 1.5
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient given expired dose of MMR. No reaction for patient.
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Insomnia, Malaise, Nausea, Pain
Clinical narrative: Feels sick, chills, achy, sore all over, nausea, insomnia.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Screaming
Clinical narrative: For 2 hrs after PEDIARIX (DaPT/HEP B/IPV)- she had uncontrolled screaming for 2 plus hours. Over past 6 days, has periods of screaming-20-30 min per episode -2-3x/day. No fever, no leg swelling. Acts fine in between.
Age: 2.0
Sex: F
Vaccine: HEPAB
Symptoms: Depressed level of consciousness, Dizziness, Headache, Pregnancy test negative, Somnolence
Clinical narrative: Pt. seen on 6/6/17 for C/O inj. on 6/3/17. Pt. stated C/O grogginess/cloudiness hours after receiving inj. Pt. B/P 143/89. Pt. also stated C/O headache dizziness one possible fainting on 6/6/17 at 13:30 and believes it is R/T inj. No Tx performed. F/U with HCP.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Rash macular, Vaccination complication
Clinical narrative: Patient got an odd red blotch on 'bicep' area, was inflamed, went to MD, thought it was just a reaction to vaccine, cleared up in 48 degrees.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pyrexia, Urticaria
Clinical narrative: Patient reports erythema and fever, swelling, induration at site and generalized hives and Patient reports that signs and symptoms appeared the evening of vaccination date and resolved within 2 days without treatment.
Age: 21.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Head injury, Hyperhidrosis, Syncope
Clinical narrative: Hep. A (HAVRIX) and HPV9 (GARDASIL 9 - Merck) administered at 1:10 pm. Pt. out to waiting area. Fainted at 1:15 pm and came to awareness within seconds. Bumped head on (L) side. Given apple juice and crackers. Diaphoretic, but A and O x3. BP:.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Diarrhoea, Pyrexia, Respiration abnormal, Vomiting
Clinical narrative: Fever. Abnormal breathing. Vomiting. Diarrhea.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Decreased appetite, Dizziness, Fatigue, Headache, Pyrexia
Clinical narrative: Fever on set w 24 hrs. after vaccine, Tmax 104F. Associated symptoms of headache, decreased appetite, fatigue, dizziness. Duration approximately 5 days, relieved with MOTRIN and/or TYLENOL. No rash, no reaction at injection site.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Injection site discolouration, Mobility decreased, Neck pain
Clinical narrative: Pt said after the vaccine she had neck and back pain. The area where the shot was given appeared blue black circle the size of a quarter. She said cannot turn to the right due to the pain.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Erythema, Fatigue, Headache, Nausea
Clinical narrative: Headache, constant nausea, redness and swelling to area, body aches/chills/fatigue disrupted sleep. Moderate reaction. Advised to manage symptoms with Ibuprofen and call back if fever/joint swelling/warmth occurs.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Sleep disorder, Swelling
Clinical narrative: Headache, constant nausea, redness and swelling to area, body aches/chills/fatigue disrupted sleep. Moderate reaction. Advised to manage symptoms with Ibuprofen and call back if fever/joint swelling/warmth occurs.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Mobility decreased, Sleep disorder
Clinical narrative: Patient reported left arm soreness at sight of injection that has been ongoing w/o resolution. Patient seen physician. Has trouble exercising and cannot sleep on his left side due to soreness.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain
Clinical narrative: Patient reported left arm soreness at sight of injection that has been ongoing w/o resolution. Patient seen physician. Has trouble exercising and cannot sleep on his left side due to soreness.
Age: 1.42
Sex: F
Vaccine: DTAP
Symptoms: Injection site urticaria, Rash generalised, Rash maculo-papular, Rash pruritic
Clinical narrative: 17 month old child broke out into weal rash at vaccine site. Also fine maculopapular itchy rash on her body. Extremities. Mom noticed 24 hrs later.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Fatigue, Headache, Insomnia, Myalgia, Nausea
Clinical narrative: Patient developed fatigue on evening of 6/9/17. During the day on 6/10/17 had myalgias, fatigue, nausea and difficulty sleeping on the night of 6/10. Called on call physician 6/11 instructed to hydrate, limit exercised. Had headache 6/11. Symptoms improved.
Age: 51.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness around injection site, approximately 3 inches in diameter. Patient also described pain near area.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling, Somnolence
Clinical narrative: Pt went home and was extremely drowsy. Arm was red and swollen. Pt. went to Primary care doctor and was diagnosed with cellulitis and was given an antibiotic.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Pain, Pruritus, Rash
Clinical narrative: Patient experienced blisters, itchy areas, and a rash which developed around his ankles starting 2 weeks after receiving ZOSTAVAX. The rash spread to the upper arm and lower legs. Patient was still experiencing the rash as of 1/30/2017. The rash goes away when steroids are used for a COPD exacerbation, and then returns when the course of therapy is completed. Skin rash, rash, urticaria pruritus and blisters, swelling, pain, burning sensation. Fludrocortisone 0.1 mg every day, triamcinolone apply sparingly to AA on shin, clobetasol AAA bid to extremities, torso.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Patient experienced blisters, itchy areas, and a rash which developed around his ankles starting 2 weeks after receiving ZOSTAVAX. The rash spread to the upper arm and lower legs. Patient was still experiencing the rash as of 1/30/2017. The rash goes away when steroids are used for a COPD exacerbation, and then returns when the course of therapy is completed. Skin rash, rash, urticaria pruritus and blisters, swelling, pain, burning sensation. Fludrocortisone 0.1 mg every day, triamcinolone apply sparingly to AA on shin, clobetasol AAA bid to extremities, torso.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Angioedema, Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling
Clinical narrative: Patient called on 11/28/12 to report she had a skin reaction to the PNEUMOVAX vaccine given to her on 11/23/12 - she developed swelling and a red hard knot at the injection site. Patient is currently on chemotherapy and immunosuppressants and believes the reaction was probably due to that. Angioedema and red hard knot at injection site.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Skin reaction
Clinical narrative: Patient called on 11/28/12 to report she had a skin reaction to the PNEUMOVAX vaccine given to her on 11/23/12 - she developed swelling and a red hard knot at the injection site. Patient is currently on chemotherapy and immunosuppressants and believes the reaction was probably due to that. Angioedema and red hard knot at injection site.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema multiforme, Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: The evening of injection pt noted a small hard red area in the area of the shot. This continued to expand for 3 days. At time of MD notification it was quite large red indurated and tender to palpation. The area was about the size, in diameter, of an orange. Erythema multiform and edema at injection site. Diphenhydramine 25 mg hs, Loratadine 10 mg every day, cephalexin 500 mg QID.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction
Clinical narrative: The evening of injection pt noted a small hard red area in the area of the shot. This continued to expand for 3 days. At time of MD notification it was quite large red indurated and tender to palpation. The area was about the size, in diameter, of an orange. Erythema multiform and edema at injection site. Diphenhydramine 25 mg hs, Loratadine 10 mg every day, cephalexin 500 mg QID.
Age: 50.0
Sex: M
Vaccine: HEPAB
Symptoms: Chills, Diarrhoea, Nausea, Pain, Pyrexia
Clinical narrative: Stomach flu was also circulating at the time. Unknown if symptoms were due to vaccine administration or flu. Fever, diarrhea, nausea, vomiting and body aches, chills.
Age: 50.0
Sex: M
Vaccine: HEPAB
Symptoms: Vomiting
Clinical narrative: Stomach flu was also circulating at the time. Unknown if symptoms were due to vaccine administration or flu. Fever, diarrhea, nausea, vomiting and body aches, chills.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity, Ultrasound scan normal
Clinical narrative: 4/10/17 Patient received PREVNAR 13 at office. 5/26/17 Seen in office for pain right arm. 6/2/17 Ultrasound negative.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Peripheral swelling
Clinical narrative: (R) arm swelling, onset 12 hrs. post injection. Associated with pain.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information was received on 05-JUN-2017 from an licensed practical nurse who was reporting on a male patient of unknown age. No medical history or concomitant medications were reported. The nurse reported that the patient had started hydrocortisone (manufacturer unknown) tablet therapy on an unknown date in the past. On 26-MAY-2017, the patient received a dose a dose of ZOSTAVAX (lot, expiration, dose and site not reported). No adverse effects were reported. All information reported was reconfirmed with the reporter. No other information was reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: No adverse event
Clinical narrative: Information was received on 05-JUN-2017 from an licensed practical nurse who was reporting on a male patient of unknown age. No medical history or concomitant medications were reported. The nurse reported that the patient had started hydrocortisone (manufacturer unknown) tablet therapy on an unknown date in the past. On 26-MAY-2017, the patient received a dose a dose of ZOSTAVAX (lot, expiration, dose and site not reported). No adverse effects were reported. All information reported was reconfirmed with the reporter. No other information was reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: Information was received on 05-JUN-2017 from an licensed practical nurse who was reporting on a male patient of unknown age. No medical history or concomitant medications were reported. The nurse reported that the patient had started hydrocortisone (manufacturer unknown) tablet therapy on an unknown date in the past. On 26-MAY-2017, the patient received a dose a dose of ZOSTAVAX (lot, expiration, dose and site not reported). No adverse effects were reported. All information reported was reconfirmed with the reporter. No other information was reported. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis, Injection site swelling
Clinical narrative: This spontaneous report as received from a Medical assistant refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 09-MAY-2017 the patient was vaccinated with PNEUMOVAX 23 lot #M043424; expiration date: 04-AUG-2018 intramuscular for prophylaxis (dose was not provided). On an unspecified date in 2017, the patient called with red lump and red wheal that progressed to cellulitis. Medical assistant reported that the patient also had diabetes, and was admitted to a hospital from 12-MAY-2017 to 15-MAY-2017 for unspecified treatment of cellulitis. The patient was due for a follow-up appointment "within 2 weeks". No labs were performed. On an unspecified in 2017 date the patient recovered from the events. The relatedness with PNEUMOVAX 23 was not reported. Upon internal review the events cellulitis and diabetes were considered to be medically significant. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis, Diabetes mellitus, Erythema, Mass, Urticaria
Clinical narrative: This spontaneous report as received from a Medical assistant refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 09-MAY-2017 the patient was vaccinated with PNEUMOVAX 23 lot #M043424; expiration date: 04-AUG-2018 intramuscular for prophylaxis (dose was not provided). On an unspecified date in 2017, the patient called with red lump and red wheal that progressed to cellulitis. Medical assistant reported that the patient also had diabetes, and was admitted to a hospital from 12-MAY-2017 to 15-MAY-2017 for unspecified treatment of cellulitis. The patient was due for a follow-up appointment "within 2 weeks". No labs were performed. On an unspecified in 2017 date the patient recovered from the events. The relatedness with PNEUMOVAX 23 was not reported. Upon internal review the events cellulitis and diabetes were considered to be medically significant. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Pyrexia, Urinary tract infection
Clinical narrative: 9 days after ZOSTAVAX patient was treated for UTI (urinary tract infection) - MACROBID for 7 days - Pyridium for 3 days.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urinary tract infection
Clinical narrative: 9 days after ZOSTAVAX patient was treated for UTI (urinary tract infection) - MACROBID for 7 days - Pyridium for 3 days.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Abasia, C-reactive protein, Computerised tomogram, Computerised tomogram head, Dysgeusia
Clinical narrative: Two weeks of daily migraines preceded, onset (Oct 19th) of progressive weakness starting in lower extremities. Systemic tingling sensation. Next day had altered taste and unilateral tongue numbness. Weakness continued to progress affecting upper extremities and core with fatigue, heat intolerance and pain in lower extremities. Eventually there was loss of continence as well. Patient was diagnosed with Guillain Barre, was hospitalized and treated with plasmapheresis and IVIG. A second hospitalization was required when symptoms recurred after three weeks of inpatient therapy. Another inpatient therapy stay was required after the second hospitalization to recover ability to use arms, legs, hands, regain control of toileting, relearn to walk and recover from the floor. Patient is still recovering.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Electromyogram, Fatigue, Full blood count, Guillain-Barre syndrome, Hypoaesthesia oral
Clinical narrative: Two weeks of daily migraines preceded, onset (Oct 19th) of progressive weakness starting in lower extremities. Systemic tingling sensation. Next day had altered taste and unilateral tongue numbness. Weakness continued to progress affecting upper extremities and core with fatigue, heat intolerance and pain in lower extremities. Eventually there was loss of continence as well. Patient was diagnosed with Guillain Barre, was hospitalized and treated with plasmapheresis and IVIG. A second hospitalization was required when symptoms recurred after three weeks of inpatient therapy. Another inpatient therapy stay was required after the second hospitalization to recover ability to use arms, legs, hands, regain control of toileting, relearn to walk and recover from the floor. Patient is still recovering.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Immunoglobulin therapy, Incontinence, Lumbar puncture, Metabolic function test, Migraine
Clinical narrative: Two weeks of daily migraines preceded, onset (Oct 19th) of progressive weakness starting in lower extremities. Systemic tingling sensation. Next day had altered taste and unilateral tongue numbness. Weakness continued to progress affecting upper extremities and core with fatigue, heat intolerance and pain in lower extremities. Eventually there was loss of continence as well. Patient was diagnosed with Guillain Barre, was hospitalized and treated with plasmapheresis and IVIG. A second hospitalization was required when symptoms recurred after three weeks of inpatient therapy. Another inpatient therapy stay was required after the second hospitalization to recover ability to use arms, legs, hands, regain control of toileting, relearn to walk and recover from the floor. Patient is still recovering.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Pain in extremity, Paraesthesia, Plasmapheresis, Temperature intolerance
Clinical narrative: Two weeks of daily migraines preceded, onset (Oct 19th) of progressive weakness starting in lower extremities. Systemic tingling sensation. Next day had altered taste and unilateral tongue numbness. Weakness continued to progress affecting upper extremities and core with fatigue, heat intolerance and pain in lower extremities. Eventually there was loss of continence as well. Patient was diagnosed with Guillain Barre, was hospitalized and treated with plasmapheresis and IVIG. A second hospitalization was required when symptoms recurred after three weeks of inpatient therapy. Another inpatient therapy stay was required after the second hospitalization to recover ability to use arms, legs, hands, regain control of toileting, relearn to walk and recover from the floor. Patient is still recovering.
Age: 25.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Tuberculin test negative, Urticaria
Clinical narrative: Itchy hives.
Age: 59.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site raised slightly and turned into a small bump. Area just below site pink and warm, abnormal shape, slightly raised. Better the next morning.
Age: 0.75
Sex: F
Vaccine: HIBV
Symptoms: Blood bicarbonate normal, Blood electrolytes normal, Chest X-ray normal, Diarrhoea, Escherichia test positive
Clinical narrative: Vomiting and diarrhea; no fever. She was seen in ER and treated and released. Symptoms resolved by 6/4/2017; developed fever 6/6/2017, diagnosed with pyelonephritis 6/9/2017, treated.
Age: 0.75
Sex: F
Vaccine: HIBV
Symptoms: Pyelonephritis, Pyrexia, Vomiting, White blood cell count increased
Clinical narrative: Vomiting and diarrhea; no fever. She was seen in ER and treated and released. Symptoms resolved by 6/4/2017; developed fever 6/6/2017, diagnosed with pyelonephritis 6/9/2017, treated.
Age: 20.0
Sex: F
Vaccine: MMR, MNQ
Symptoms: Loss of consciousness, Seizure like phenomena, Syncope
Clinical narrative: After receiving MENACTRA and MMR vaccines patient grew faint, demonstrated seizure like activity, and loss of consciousness. EMS called. Patient did regain consciousness and was oriented prior to EMS arrival. Patient taken to emergency room for further evaluation and treatment.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On an unknown dates, the patients were vaccinated with the third dose of RECOMBIVAX HB injection (strength, dose schedule, route, lot# and expiration date were not provided) for prophylaxis, outside of the recommended time frame. No adverse effect were reported. Additional information has been requested.
Sex: M
Vaccine: MMRV
Symptoms: Incorrect dose administered, No adverse event, Syringe issue
Clinical narrative: Information was received on 07-JUN-2017 from a nurse who reported that on 05-JUN-2017 a four year old male patient was administered PROQUAD (lot# reported as M044719, expiration 07-MAY-2018; dose not reported) subcutaneous, reconstituted with sterile water diluent, and patient received less than recommended dose due to syringe leaking. No adverse reactions reported. No further information provided.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-JUN-2017, the patient was inadvertently vaccinated with an expired dose of GARDASIL injection, lot number M014929, expiration date: 27-MAY-2017 (strength, dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Seroconversion test negative
Clinical narrative: Information has been received from a registered nurse (RN) reporting on a 15 year old female patient. The patient's concurrent conditions included Crohn's disease, GERD (gastroesophageal reflux disease) and asthma. The patient was lactose intolerant. The RN stated that the patient was on several unspecified medications.  In July 2001, September 2001 and July 2002, the patient received the first, second and third dose respectively of RECOMBIVAX HB for prophylaxis (dose, strength, route of administration, lot number and expiration date were not reported). On 24-MAY-2017, the patient received a laboratory testing where it was found that the patient did not seroconvert to Hepatitis B. The RN reported that the patient received an unspecified treatment for the event. The outcome of hepatitis b surface antibody negative and the causal relationship between the event and therapy with RECOMBIVAX HB were not reported. It was also reported that the patient experienced and adverse event after vaccination with VARIVAX (MARRS# 1706USA001206). Additional information has been requested.; Sender's Comments: US-009507513-1706USA001206:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates since 05-JUN-2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, frequency and route were not reported) lot # N003702 with expiration date of 08-NOV-2019, lot # N002914 with expiration date of 04-NOV-2019 and lot # N002202 with expiration date of 04-NOV-2019, that were reconstituted with diluent MRK (injection; lot # and expiration date were not reported), for prophylaxis. The temperature of the RECOMBIVAX HB was between 9°C and 25°C for a time frame of 2 hours and 2 minutes. No previous temperature excursion occurred and data logger was involved. No adverse effects were reported. This is one of four reports received from the same source.  Additional information has been requested.; Sender's Comments:  US-009507513-1706USA006312: US-009507513-1706USA006313: US-009507513-1706USA006314:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an unspecified reporter concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an expired dose of VAQTA as prophylaxis (strength, dose, route, lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a 16-year-old patient of unknown gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 04-JUN-2017, the patient was vaccinated with an expired dose of GARDASIL (lot # M014929 and expiration date 27-MAY-2017) for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacy technician regarding a female patient of unknown age. The patient's current condition, medical history and concomitant medications were not reported. The patient's drug reaction/allergies were unknown by the reporter. On 02-JUN-2017, the patient was vaccinated with ZOSTAVAX (strength and dose were not reported) (lot/batch # M037656, Expiry date: 29-NOV-2017) (strength and dose were not reported) after reconstituting with sterile water diluent (MERCK STERILE DILUENT) (expiration date and lot/batch # were not reported), subcutaneously in her right upper extremity for vaccination. On 03-JUN-2017, the patient's reported that her arm hurt. The patient was directed by pharmacy to put ice on the area and to take ADVIL. On 04-JUN-2017, the patient was advised by different pharmacy who directed her to take BENADRYL. It was reported that on 06-MAY-2017, the patient saw her family physician and the physician told her that "she had a really bad infection and if she hadn't come in then she would have lost her arm". Patient was then prescribed an unspecified antibiotic and unspecified steroid. On 08-JUN-2017, the patient reported that the patient's right upper extremity appeared "swollen". Information regarding lab diagnostics studies performed were unknown by the reporter. There was no product quality issue (PQC) involved. The outcome of the events were reported as not recovered. The causality assessment was not provided by the reporter. Upon internal review the event bad infection was considered medically significant. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative concerning a 50 year old female patient. The patient's concurrent conditions included diabetes. Other pertinent medical history, drug reactions/allergies or concomitant medications were unknown by the reporter. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 for diabetes and age (Strength, dose, route, lot # and expiration date were not reported).  On an unknown date, the patient experienced "a really bad reaction, the patient's arm swelled up" (peripheral swelling). No treatment was given for the event. It was unknown if laboratories diagnostics studies were performed to the patient or if she did seek medical attention. The outcome of peripheral swelling was unknown.    The reporter did not provide the causality between peripheral swelling and PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant and  refers to a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On 09-JUN-2017, the patient was vaccinated with an unspecified dose of VAQTA intramuscular for prophylaxis (lot # M031695 with an expiration date of 26-MAY-2017) (dose and anatomical location were not reported). Other suspect and concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates since 05-JUN-2017, the patients were vaccinated with improperly stored doses of VAQTA (dose, frequency and route were not reported) lot # N005274 with expiration date of 03-APR-2018, that were reconstituted with diluent MRK (injection; lot # and expiration date were not reported), for prophylaxis. The temperature of the VAQTA was between 9 °C and 25 °C for a time frame of 2 hours and 2 minutes. No previous temperature excursion occurred and data logger was involved. No adverse effects were reported. This is one of four reports received from the same source.  Additional information has been requested.; Sender's Comments:  US-009507513-1706USA004409: US-009507513-1706USA006312: US-009507513-1706USA006313:
Sex: F
Vaccine: MENB
Symptoms: Anaphylactic reaction, Rash, Urticaria
Clinical narrative: This is a spontaneous report from a contactable medical assistant, who reported about her niece,  communicated to a Pfizer sales representative. A female patient of an unspecified age and ethnicity received TRUMENBA at 0,5ml single dose for immunization on an unknown date, via an unspecified route. Relevant medical history and concomitant medications were unknown. The patient had an anaphylactic reaction of hives and very bad rash. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. A male patient of an unspecified age and race/ethnicity received TRUMENBA at single dose and meningococcal quadrivalent conjugate vaccine, both via an unspecified route of administration in the same arm on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced significant swelling and redness in his arm with outcome of unknown.
Sex: U
Vaccine: MENB
Symptoms: Erythema, Headache, Pain in extremity, Pyrexia, Swelling
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for 4 adolescent patients. This is the 2nd of 4 reports. An adolescent patient of an unspecified ethnicity and gender received TRUMENBA (Lot# F26962), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced headache, redness, pain radiating down arm to hand, fever of 103 and swelling all on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 103. Sender's Comments: Linked Report(s): US-PFIZER INC-2017256820 Same reporter/drug/event, different patient.
Sex: U
Vaccine: MENB
Symptoms: Erythema, Headache, Pain in extremity, Pyrexia, Swelling
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for 4 adolescent patients. This is the 3rd of 4 reports. An adolescent patient of an unspecified ethnicity and gender received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced headache, redness, pain radiating down arm to hand, fever of 103 and swelling all on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 103. Sender's Comments: Linked Report(s): US-PFIZER INC-2017256820 Same reporter/drug/event, different patient.
Sex: U
Vaccine: MENB
Symptoms: Erythema, Headache, Pain in extremity, Pyrexia, Swelling
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for 4 adolescent patients. This is the 4th of 4 reports. An adolescent patient of an unspecified ethnicity and gender received TRUMENBA (Lot# F26962), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced headache, redness, pain radiating down arm to hand, fever of 103 and swelling all on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 103. Sender's Comments: Linked Report(s): US-PFIZER INC-2017256820 Same reporter/drug/event, different patient.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Diarrhoea, Ultrasound abdomen normal, X-ray normal
Clinical narrative: Diarrhea 2d after Rotavirus, abdominal pain, possible intussusception. Sent to ER.
Age: 12.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Abdominal pain, Chest pain, Dizziness, Dyspnoea, Headache
Clinical narrative: Within about 20 minutes of vaccination, pt developed chest/abdominal pain, dizziness, malaise, headache, DIB. Pulse OX 98 and exam was normal. Resolved on its own in about an hour.
Age: 12.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Malaise
Clinical narrative: Within about 20 minutes of vaccination, pt developed chest/abdominal pain, dizziness, malaise, headache, DIB. Pulse OX 98 and exam was normal. Resolved on its own in about an hour.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt reported temp 100.4 overnight and tenderness at site.  Upon assessment--Erythema and warmth noted at injection site. No edema, eccymosis, or pain upon palpation. Vital signs WNL.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Abnormal behaviour, Blood culture, Blood urine present, Chest X-ray, Culture throat
Clinical narrative: Patient received Hepatitis A on 6/5/17, on 6/7/17 patient came hoe from daycare clingy & with fever up to 39.3C. Fever continued for 6 days.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Culture urine negative, Full blood count, Pyrexia, Urine ketone body present, White blood cell count increased
Clinical narrative: Patient received Hepatitis A on 6/5/17, on 6/7/17 patient came hoe from daycare clingy & with fever up to 39.3C. Fever continued for 6 days.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: White blood cells urine positive
Clinical narrative: Patient received Hepatitis A on 6/5/17, on 6/7/17 patient came hoe from daycare clingy & with fever up to 39.3C. Fever continued for 6 days.
Sex: U
Vaccine: HIBV, HPV9, PPV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine coordinator concerning an unspecified patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient might have received one improperly stored dose of PNEUMOVAX23 lot numbers N003993, N004564, expiration dates 20-OCT-2018, 22-OCT-2018 respectively (dose and route were not reported), ROTATEQ orally, lot number M019691, expiration date 02-NOV-2017 (dose was not reported), GARDASIL 9 lot numbers M031557, M041990, expiration dates 07-APR-2019, 28-JUN-2019 respectively (dose and route was not reported) or LIQUID PEDVAXHIB lot numbers M020101, K016964, expiration dates 07-MAR-2019, 16-JUL-2017 respectively (dose and route were not reported) all for prophylaxis. The reporter was not sure about which of the vaccines was received for the patient. The temperature involve was -0.9 Celsius Degrees for 3 hours and 30 minutes. There was no temperature excursion, and a data logger was involved. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MENB
Symptoms: Erythema, Headache, Pain in extremity, Pyrexia, Swelling
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for 4 adolescent patients. This is the first of 4 reports. An adolescent patient of an unspecified race, ethnicity and gender received TRUMENBA (Lot# F26962), via an unspecified route of administration, on an unspecified date, at single dose, for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache, redness, pain radiating down arm to hand, fever of 103 F and swelling all on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2017256875 same reporter/drug/event, different patient; US-PFIZER INC-2017256876 same reporter/drug/event, different patient; US-PFIZER INC-2017256877 same reporter/drug/event, different patient.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Fatigue, Headache, Influenza virus test negative, Nausea, Pyrexia
Clinical narrative: Pt mother stated pt started to feel nauseated to his stomach and a headache. Later that evening started vomiting. That evening pt started to run a 103 fever, and pt felt fatigued. Nurse advised pt to go the Primary care physician or ER.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Streptococcus test negative, Vomiting
Clinical narrative: Pt mother stated pt started to feel nauseated to his stomach and a headache. Later that evening started vomiting. That evening pt started to run a 103 fever, and pt felt fatigued. Nurse advised pt to go the Primary care physician or ER.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, HEPA, HPVX, MEN
Symptoms: Headache, Syncope
Clinical narrative: Client given HPV9 vaccine to right deltoid. Was sitting at the time. Within 10 seconds fainted. Came to within 5-10 seconds. C/O head hurting after event.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, HEPA, HPVX, MEN
Symptoms: Concussion, Confusional state, Dizziness, Fall, Head injury
Clinical narrative: Client given HPV9 vaccine to right deltoid. Was sitting at the time. Within 10 seconds fainted. Came to within 5-10 seconds. C/O head hurting after event.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, HEPA, HPVX, MEN
Symptoms: Headache, Loss of consciousness, Neurological examination abnormal, Sensory loss, Syncope
Clinical narrative: Client given HPV9 vaccine to right deltoid. Was sitting at the time. Within 10 seconds fainted. Came to within 5-10 seconds. C/O head hurting after event.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, HEPA, HPVX, MEN
Symptoms: Tremor
Clinical narrative: Client given HPV9 vaccine to right deltoid. Was sitting at the time. Within 10 seconds fainted. Came to within 5-10 seconds. C/O head hurting after event.
Sex: U
Vaccine: MENB
Symptoms: Local reaction, Product quality issue
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of local reaction in a patient who received BEXSERO (batch number 1645401A, expiry date April 2018) and batch number 165401A, expiry date April 2018). This case was associated with a product complaint. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced local reaction and product complaint. On an unknown date, the outcome of the local reaction and product complaint were unknown. It was unknown if the reporter considered the local reaction to be related to BEXSERO. Additional details were reported as follows: The patient developed a local reaction after receiving a dose of BEXSERO. One of the reactions was severe enough, it required the patient to follow-up with an orthopaedic doctor. The healthcare provider was on a tight schedule and didn't have time to go through the adverse event details with the reporter. The physician said she would try and call back on Tuesday, 6th June 2017 with more details. This case is one of the 3 cases which were reported by the same reporter for the patients who received the same lot of BEXSERO. The batch number reported for BEXSERO could 165401A or 1645401A, clarification has been requested for the same. No further details were given.
Age: 11.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal discomfort, Headache, Malaise, Poor quality sleep
Clinical narrative: PATIENT'S MOTHER REPORTED BY PHONE PATIENT HAD STOMACH UPSET, HEADACHE, GENERAL MALAISE, NOT FEELING WELL, SLEPT POORLY. MOTHER GAVE IBUPROFEN LIQUID 3 TSP AT 07:30AM. AT 10:00AM MOTHER REPORTED PATIENT FEELS BETTER AND WENT TO THE  DAYCAMP.
Age: 11.0
Sex: M
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: POST VACCINE EVALUATION BY RN, MOTHER REPORTED BY PHONE ON 06/14/2017 THAT PATIENT HAD FEVER OF 102.1 AT 11:00 PM, GAVE IBUPROFEN LIQUID 3 TEASPOON AT 11:30 PM. RN ADVISED MOTHER TO DO COOLONG MEASURES,INCREASE FLUID INTAKE AND REST, TO GO TO ER IF SYMPTOMS WORSEN. AT 08:45 AM PATIENT FEELS BETTER, TEMPERATURE WAS 99.1. AT 10:00 AM MOTHER REPORTED PATIENT IS DOING FINE AND WENT TO DAYCAMP.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Local swelling, Pain
Clinical narrative: LOCALIZED SEVERE SWELLING GREATER THAN 3CM SEVERE PAIN AND CELLULITIS.
Age: 1.5
Sex: F
Vaccine: RAB
Symptoms: Body temperature increased
Clinical narrative: POST VACCINE FOLLOW UP BY RN, MOTHER REPORTED THAT PATIENT HAD TEMPERATURE OF 101.6 RECTALLY. TYLENOL 80mg SUPPOSITORY GIVEN BY MOTHER. RN INSTRUCTED MOTHER TO GIVE COOLING MEASURES, INCREASE HYDRATION, IF SYMPTOMS WORSEN TO BRING PATIENT TO ER.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Swelling
Clinical narrative: Red swelling.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies, or concomitant therapies were not reported. On 13-JUN-2017, the patient was vaccinated with an expired dose of VAQTA injection (dose was not reported) lot number M034896 and expiration date 26-MAY-2017 for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: HPV9, MEN
Symptoms: Feeling abnormal, Malaise, Pyrexia
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to an 18 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified date in June 2017, reported as last week, the patient received the first dose of GARDASIL 9 for immunisation along with meningococcal vaccine (unspecified) (dose, route, lot numbers and expiration dates of both therapies were not provided). On an unknown date in June 2017, the patient became sick with fever and "feeling really bad". He visited the physician's office but it was unknown if any lab diagnostic studies were performed. No treatment was given for the adverse events. At the time of the report, the outcome of the events was unknown. The causal relationship between the events and GARDASIL 9 and meningococcal vaccine (unspecified) was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies, or concomitant therapies were not reported. On 13-JUN-2017, the patient was vaccinated with an expired dose of M-M-R-II injection (dose and route of administration were not reported) lot number L019989 and expiration date 01-JUN-2017, for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV1
Symptoms: Accidental exposure to product, Device issue, Limb injury, Product quality issue
Clinical narrative: This case was reported by a nurse via call center rep and described the occurrence of finger injury in a vaccinating other healthcare professional who intended to vaccinate the patient with ROTARIX oral suspension. On an unknown date, the patient received ROTARIX oral suspension 1 ml. On an unknown date, immediately after receiving ROTARIX oral suspension, the patient experienced finger injury, inadvertent exposure to vaccine and pharmaceutical product complaint. On an unknown date, the outcome of the finger injury, inadvertent exposure to vaccine and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the finger injury to be related to ROTARIX oral suspension. Additional details were provided as follows: The age at vaccination is not applicable for this case. It was reported that, few of the staff have stated when they pop the top off of the vial with ROTARIX, the blue top comes off too causing a break in the vial glass and thus cutting the their fingers. It was reported that, this had happened three times so far. The staff has said that, occasionally when they push the liquid diluent into the vial, the transfer device pops off from the pressure and the vaccine sort of explodes, which led to inadvertent exposure to vaccine. The reporter wanted to know if this kind of scenarios were seen with other clinics and to see if their technique is wrong in some way. The patients were the other health care professionals.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Blood iron decreased, Chest X-ray normal, Cough, Haemoglobin decreased, Polymerase chain reaction
Clinical narrative: Rhinorrhea, cough and fever starting on 5/29; 6 days of high fevers including Tmax > 42 degrees Celsius on 6/3, seen in ED on that date, no evidence of other infectious source other than possible viral URI; self-resolved after this time and returning to normal self at time of reporting today ~1 week; parental concern for loss of some verbal expression/single words; regaining general verbal skills with resolution but not some specific words; also previously waving spontaneously to people and not now, but otherwise social engaged and will wave on command.