chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. No information regarding their concomitant medications, pertinent medical history, drug reactions or allergies was provided. On an unknown date, patients were vaccinated with ZOSTAVAX vial 19400 plaque-forming units (PFU) (lot#, expiration date, dose, were not provided), concomitantly with PNEUMOVAX 23 (lot#, expiration date, dose, frequency: unknown). No adverse events were reported. Additional information is not expected, as the reporter did not wish further contact.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to three patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On 22-SEP-2016, the patients were vaccinated with three doses of improperly stored dose of VAQTA (lot # M017982, expiration date 13-SEP-2017, dose and route were not reported). No adverse effects were reported. This is one of the several reports received from the same reporter.  Additional information is not expected as there is no contact consent to follow up.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients stated the HPV vaccine series GARDASIL and finished the series with GARDASIL 9 (inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 22-SEP-2016, the patient was vaccinated with one improperly stored dose of GARDASIL 9 (lot # M011117, expiration date 07-DEC-2017, dose and route were not reported). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information is not expected as there is no contact consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Physician Assistant (P.A), concerning an unspecified patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unspecified date in 2016, the patient was vaccinated with an unspecified expired dose of ZOSTAVAX via subcutaneous route (expiration date of 23-APR-2016) (strength, dose, anatomical location and lot number were not reported). No adverse effects were provided. Concomitant medications were not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, refers to the 14 patients of unknown age and gender. No information on the patients' concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of (wistar ra 27-3) M-M-R II (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. No information on patient's pertinent medical history or drug reactions or allergies was provided. On unknown dates, multiple unspecified patients were administered improperly stored doses of GARDASIL 9 (lot # L043213, expiry date 28-AUG-2017, lot# M007764, expiry date 30-JAN-2015, lot # M004116, expiry date 12-OCT-2017 (doses and routes were unspecified) that underwent temperature excursions in 49 Fahrenheit degree for 227 hours. Data logger was involved. There were no previous excursions and temperature was back in range. No adverse effects were reported. This is the one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. No information on patient's pertinent medical history or drug reactions or allergies was provided. On unknown dates, multiple unspecified patients were administered improperly stored doses of M-M-R II (Lot # L047133 Expiry date: 24-NOV-2017) (doses and route were unspecified) that underwent temperature excursion in 49 Fahrenheit degree for 227 hours. Data logger was involved. There were no previous excursions and temperature was back in range. No adverse effects were reported. This is the one of the several reports from the same reporter. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt receive BOOSTRIX instead of FLUARIX at Flu clinic. Pt to F/U with MD.
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt receive BOOSTRIX at a flu clinic instead of FLUARIX.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt receive BOOSTRIX instead of FLUARIX at clinic for flu vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-OCT-2016, the patient was vaccinated with ZOSTAVAX, lot # reported as M035146, expiration date: 26-JUL-2017, intramuscularly rather than subcutaneously (strength, dose number, and anatomical location of administration were unknown). No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt receive BOOSTRIX instead of FLUARIX at Flu clinic.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain, Skin warm
Clinical narrative: Soreness w/in 1-2 hrs of vaccine administration. About 24 hours after administration patient noticed swelling and redness that extended from deltoid to bicep and red area was warm to the touch. Pt seen by PCP approximately 48 hours after administration. Probable cellulitis diagnosed and antibiotics started. Pt continued to self-treat w/BENADRYL. Swelling completely resolved w/in 3 days, soreness w/in 5 days. Swelling and redness had started to improve before antibiotic administration.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: At site of injection, burning, itchy, hot to touch.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site pain, Road traffic accident
Clinical narrative: Pt reported "severe muscle pain" at injection site first. Then dizzy/lightheaded. Resulted in car accident on 10/5/16.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Local swelling
Clinical narrative: 3x5 inch area on arm-swollen, pink, hard. Her PCP said it was not cellulitis- but should be reported.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Redness, warmth, swelling up left arm the day after injection.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Pallor, Pyrexia
Clinical narrative: Patient turn pale and experience dizziness fever minutes after vaccination.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Pruritus, Rash macular, Urticaria
Clinical narrative: 1-1/2 hr after receiving HPV9-felt very itchy w/blotchy hive-like welts on arms, legs, torso. Resolved w/BENADRYL.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Rash erythematous, Skin warm
Clinical narrative: Red rash in injected arm, pain/soreness warm to touch (rash area).
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 25-SEP-2016, the patient was vaccinated with an expired dose of ZOSTAVAX, 0.65 ml, lot # L021610, expiry date 10-SEP-2016 (route, anatomical site of injection and frequency were not reported). Information regarding concomitant medications was not reported. No adverse effects were reported. No product quality complain (PQC) was involved. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Erythema, Injection site dryness, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Redness, itching, bumps on arm administered. On 10/03/2016 patient received a FLUZONE intradermal flu shot in her right upper arm and Tdap (ADACEL) injection in her right upper arm. Subsequent patient states she developed a erythematous itchy dry rash in the area of the injection. Patient also states she had a separate rash mostly on her upper extremities she feels is consistent with poison ivy. This rash has subsequently resolved but the rash of her upper arm where the injections were given has persisted. She feels that she was exposed to poison ivy from her husband who was out hunting. Patient denies any other associated symptoms, such as fevers chills nausea vomiting diarrhea or constipation. Patient is use several different topical Ivy dry and over-the-counter cream and lotions on this area for symptomatic relief this has not improved the rash. The location of the rash has been continuous and he continues to have the same appearance to her. SKIN: Details: On the patient's right upper arm the patient has a diffuse erythematous fine prior rash. Appears to be some very fine areas of telangiectasias in the rash and the overall size of the rash is approximately 15-18 cm. The rash is not palpable. There is no tenderness or point tenderness noted in the injection site. There are no surrounding areas of vesicles or open draining areas. There is some secondary signs of excoriation from her scratching at it. There is no signs of increased warmth or infection.
Age: 22.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Redness, itching, bumps on arm administered. On 10/03/2016 patient received a FLUZONE intradermal flu shot in her right upper arm and Tdap (ADACEL) injection in her right upper arm. Subsequent patient states she developed a erythematous itchy dry rash in the area of the injection. Patient also states she had a separate rash mostly on her upper extremities she feels is consistent with poison ivy. This rash has subsequently resolved but the rash of her upper arm where the injections were given has persisted. She feels that she was exposed to poison ivy from her husband who was out hunting. Patient denies any other associated symptoms, such as fevers chills nausea vomiting diarrhea or constipation. Patient is use several different topical Ivy dry and over-the-counter cream and lotions on this area for symptomatic relief this has not improved the rash. The location of the rash has been continuous and he continues to have the same appearance to her. SKIN: Details: On the patient's right upper arm the patient has a diffuse erythematous fine prior rash. Appears to be some very fine areas of telangiectasias in the rash and the overall size of the rash is approximately 15-18 cm. The rash is not palpable. There is no tenderness or point tenderness noted in the injection site. There are no surrounding areas of vesicles or open draining areas. There is some secondary signs of excoriation from her scratching at it. There is no signs of increased warmth or infection.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 2015, about a year ago, the patient was vaccinated with a dose of ZOSTAVAX (lot # and expiry date were not reported). Other co-suspect or concomitant medications were not reported. On an unknown date, the patient had a quarter size red itchy area at the injection site, after receiving ZOSTAVAX that lasted for one week. The outcome of injection site erythema and injection site pruritus was unknown. No causal relationship was provided. Additional information is not expected; as permission to obtain follow up information was specified.
Sex: F
Vaccine: PPV
Symptoms: General symptom
Clinical narrative: This solicited report was received from a 60 year old female patient, as part of a market research, referring to herself. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23 (strength, dosage schedule, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant medications were not provided. On an unknown date, the patient stated that "the vaccines caused the disease". The outcome of general symptoms was unknown at the time of reporting. The patient considered general symptom to be related to PNEUMOVAX 23. Additional information is not expected, because the reporter contact details were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 82 year old female patient with allergy to penicillin. On 22-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously, lot number L031273, expiration date 19-NOV-2016, (dose and anatomical location were not reported). The patient's concomitant therapies included valsartan. On an unknown date in 2016, the patient experienced "injection site rash." No treatment was given and no laboratory diagnostics were performed for the event. At the time of reporting, the outcome of the injection site rash was unknown. The relatedness between the event and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Scab
Clinical narrative: I was trying to protect myself from getting the shingles. My insurance offered a free ZOSTAVAX inj. so I got one on 9-16-16 at 10:23AM. Within 1 day I broke out with full blown shingles. I suffered for 3 weeks w/painful blister under my arm and back and chest. Still scabs and pain.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Apparent life threatening event, Chest X-ray normal, Crying, Depressed level of consciousness, Hyporesponsive to stimuli
Clinical narrative: This is a 2M 0D year old female patient born full-term at 39 weeks via cesarean section with no perinatal complications who presented to the Emergency Department with an episode of altered mental status on 10/5/2016.  Per the mother, patient received her 2 month vaccinations. She went home and was taking the bottle as usual. Child then had a  bath. Around 5 PM mother noted that she was very difficult  to arouse, pale, and her extremities were limp. EMS was activated. Personnel state that child was initially minimally responsive. When they attempted to place an IV line the child barely moved or made a noise. Now that the child is in the emergency department she is returned to her baseline and is screaming and crying. Before today, mother reports child was in her usual state of health. She has no chronic medical issues and no daily medications. By the time the baby arrived in the emergency room baby was vigorous and crying loudly. All vitals in the emergency room were normal. The ER doctor did partial sepsis workup including a urine and a chest x-ray and everything came back to be negative. A diagnosis of acute life-threatening event was made and the baby was admitted for observation.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Hypotonia, Mental status changes, Pallor, Screaming, Urine analysis normal
Clinical narrative: This is a 2M 0D year old female patient born full-term at 39 weeks via cesarean section with no perinatal complications who presented to the Emergency Department with an episode of altered mental status on 10/5/2016.  Per the mother, patient received her 2 month vaccinations. She went home and was taking the bottle as usual. Child then had a  bath. Around 5 PM mother noted that she was very difficult  to arouse, pale, and her extremities were limp. EMS was activated. Personnel state that child was initially minimally responsive. When they attempted to place an IV line the child barely moved or made a noise. Now that the child is in the emergency department she is returned to her baseline and is screaming and crying. Before today, mother reports child was in her usual state of health. She has no chronic medical issues and no daily medications. By the time the baby arrived in the emergency room baby was vigorous and crying loudly. All vitals in the emergency room were normal. The ER doctor did partial sepsis workup including a urine and a chest x-ray and everything came back to be negative. A diagnosis of acute life-threatening event was made and the baby was admitted for observation.
Sex: M
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: This solicited report was received from a 53 year old male patient, as part of a market research, referring himself. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23 (strength, dosage schedule, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant medications were not provided. On unknown date, the patient got sick from the vaccination (malaise) when he was in army and he did not want to get sick from the vaccination again. The outcome of malaise was unknown at the time of reporting. The relatedness between the malaise and therapy with PNEUMOVAX 23 was not reported. Additional information is not expected, because the reporter contact details were not provided.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to patients of unknown age and gender. The patient's medical history, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with a dose of improperly stored ROTATEQ (incorrect product storage) orally, (dose, anatomical location, lot number and expiration date were not reported). There was not concomitant medication reported. No adverse effects were reported. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 12-OCT-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # L021602 and expiration date 10-SEP-2016) (dose number, frequency, dose and route were not reported). Concomitant medication information was not provide. No adverse effects were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to patients of unknown age and gender. The patient's medical history, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with a dose of improperly stored PNEUMOVAX 23 (incorrect product storage), (dose, anatomical location, lot number and expiration date were not reported). There was not concomitant medication reported. No adverse effects were reported. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to patients of unknown age and gender. The patient's concurrent conditions and medical history, were not reported. On 11-OCT-2016, the patients was vaccinated with a dose of PNEUMOVAX 23 expiration date of 28-JUN-2016 (route, dose number, concentration, dose, anatomical place of vaccination and lot # were not provided). Nevertheless, no adverse effects were reported. Additional information has been requested.
Age: 73.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Musculoskeletal pain, Vaccination site swelling
Clinical narrative: Shoulder pain, soreness and redness of muscle under the vaccine site, swelling-present after 2 days still.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Hot flush, Hyperhidrosis, Pruritus
Clinical narrative: I never had any sort of reaction to flu shots the past 40+ years. Hot flashes (sweating) 2 hrs after shot. Blisters (itchy) on left hand.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site discharge, Injection site pain, Injection site reaction, Injection site swelling, Wound
Clinical narrative: Pt received HPV9 #1 dose 8/3/16 (IM (L) Deltoid without discomfort/complaint). Pt returned 9/29/16 for 2nd dose HPV9, however reported swelling at the site of first dose. Staff and Dr examined area and discussed with mother and pt and decided to hold 2nd dose of HPV9 and observe area for improvement before going ahead with 2nd dose. Pt returns today 10/13/16 with area still swollen but now with serosanguinous drainage, pain at 8/10 at worse and approx dime sized open wound. Pt reports these changes happened Tue. 10/11/16. MSD Lot number M020103, Exp. 2/15/18. TX - Clindamycin 300 mg TID per Doctor.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Discomfort, Headache, Hyperaesthesia, Hypersensitivity
Clinical narrative: Patient received Meningitis B from Pfizer TRUMENBA on 10-12-16 in the PM. Patient returned to office on 10-13-16 due to pain on the left arm, headaches, changes in skin texture, feeling weak and sensitivity on the left arm. Discomfort began in the AM on 10-13-16. Physician examined: hypersensitivity on entire (L) upper limb, local skin induration, no moderate deficit, normal skin color, no axillary adenopathy.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site hypersensitivity, Laboratory test normal, Pain in extremity, Skin induration, Skin texture abnormal
Clinical narrative: Patient received Meningitis B from Pfizer TRUMENBA on 10-12-16 in the PM. Patient returned to office on 10-13-16 due to pain on the left arm, headaches, changes in skin texture, feeling weak and sensitivity on the left arm. Discomfort began in the AM on 10-13-16. Physician examined: hypersensitivity on entire (L) upper limb, local skin induration, no moderate deficit, normal skin color, no axillary adenopathy.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Seizure, Vomiting
Clinical narrative: Vomiting. Seizure.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain, Arthralgia, Decreased appetite, Diarrhoea, Erythema
Clinical narrative: Pain, redness, swelling, hard lump, muscle/joint aches, fever, drowsiness, irritability, loss of appetite, nausea, diarrhea, fatigue patient explained Sx lasted 5 plus days after vaccine.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Induration, Irritability, Mass, Myalgia
Clinical narrative: Pain, redness, swelling, hard lump, muscle/joint aches, fever, drowsiness, irritability, loss of appetite, nausea, diarrhea, fatigue patient explained Sx lasted 5 plus days after vaccine.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Pyrexia, Somnolence, Swelling
Clinical narrative: Pain, redness, swelling, hard lump, muscle/joint aches, fever, drowsiness, irritability, loss of appetite, nausea, diarrhea, fatigue patient explained Sx lasted 5 plus days after vaccine.
Age: 48.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm, Urticaria
Clinical narrative: Patient received PNEUMOVAX 23 in rt. deltoid and ALFURIA flu in left deltoid at same time. Left arm had swelling and red welts. 1st day noticed and then swelling has gone down by 2nd day still warm to touch. Patient took BENADRYL in am and HS. AFLURIA Lot - WT52005.
Age: 1.0
Sex: M
Vaccine: HEP, MMR, PNC13, VARCEL
Symptoms: Cough, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Fever for 9 day then two days after broke out in a rash. Also has cough, runny nose. Was given prednisone in the ED.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Nuclear magnetic resonance imaging, Tendonitis
Clinical narrative: Reported to pharmacy on Monday 9/26/2016. Has experienced limited range of motion in the left shoulder since receiving vaccine. 1 month of PT, diagnosis of tendonitis.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Lymphadenopathy
Clinical narrative: Lymphadenopathy, axilla same arm.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Insomnia, Myalgia
Clinical narrative: Since last vaccine patient experienced insomnia and muscle and joint pain.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Blood pressure immeasurable, Circumstance or information capable of leading to medication error, Laboratory test normal, Nerve injury, Oxygen saturation decreased
Clinical narrative: Patient fainted, faint pulse, EMS couldn't get BP reading so went to ER to be checked - (Tried to give FLUZONE HD when patient jerked had to stop-so then gave PREVNAR 13).
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pulse abnormal, Syncope
Clinical narrative: Patient fainted, faint pulse, EMS couldn't get BP reading so went to ER to be checked - (Tried to give FLUZONE HD when patient jerked had to stop-so then gave PREVNAR 13).
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Headache, Muscle strain, Nausea
Clinical narrative: Symptoms started around 6:00 P.M. Had intense left calf pain, left knee pain and went up into left thigh. Also had nausea and headache. Pain was so bad thought she had a blood clot, went to ER. Dr. ordered venous doppler was negative, told muscle strain and gave FLEXERIL, told to take Naproxen for pain. That night her husband noted her left arm was very red, hot to touch and swollen 2" x 3" area. Patient was still nauseated the following day and ongoing left knee pain, and arm red and swollen.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Skin warm, Ultrasound Doppler normal
Clinical narrative: Symptoms started around 6:00 P.M. Had intense left calf pain, left knee pain and went up into left thigh. Also had nausea and headache. Pain was so bad thought she had a blood clot, went to ER. Dr. ordered venous doppler was negative, told muscle strain and gave FLEXERIL, told to take Naproxen for pain. That night her husband noted her left arm was very red, hot to touch and swollen 2" x 3" area. Patient was still nauseated the following day and ongoing left knee pain, and arm red and swollen.
Age: 13.0
Sex: U
Vaccine: HEPA, HPV9
Symptoms: Abdominal pain lower, Blood creatine phosphokinase, C-reactive protein, Full blood count normal, Metabolic function test
Clinical narrative: Pt developed lower abd pain radiating to (R) thigh on 9/21. Normal exam. Then complained of myalgia (L) arm and both legs on visit 9/29. Normal exam and labs. By 10/3, marked improvement. Back to normal activities.
Age: 13.0
Sex: U
Vaccine: HEPA, HPV9
Symptoms: Myalgia, Red blood cell sedimentation rate
Clinical narrative: Pt developed lower abd pain radiating to (R) thigh on 9/21. Normal exam. Then complained of myalgia (L) arm and both legs on visit 9/29. Normal exam and labs. By 10/3, marked improvement. Back to normal activities.
Age: 1.58
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Urticarial lesion at injection site with surround red pruritic skin 1.5x2.0 cm.
Age: 54.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Gave ZOSTAVAX 10-1-16. Saw pt. on 10-2-16 with 2x3" red rash at injection site. Treated with hydrocortisone cream. 10-4-16 pt reported going to urgent care as "rash" spread to upper arm elbow to shoulder.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Enema administration, Intussusception
Clinical narrative: Intussusception. Treated with air in colon. Resolved.
Age: 37.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Bursa injury, Pain in extremity
Clinical narrative: Patient called at 8:00 am on 9-29-16 stating her arm hurt so bad she could hardly move it. She decided to see PCP and called back at noon to say that PCP said the vaccine ruptured her bursa and would take about two weeks for recovery. Patient states she is in a lot of pain.
Age: 37.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthritis bacterial, Blood test, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: Patient called at 8:00 am on 9-29-16 stating her arm hurt so bad she could hardly move it. She decided to see PCP and called back at noon to say that PCP said the vaccine ruptured her bursa and would take about two weeks for recovery. Patient states she is in a lot of pain.
Age: 37.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Surgery, X-ray
Clinical narrative: Patient called at 8:00 am on 9-29-16 stating her arm hurt so bad she could hardly move it. She decided to see PCP and called back at noon to say that PCP said the vaccine ruptured her bursa and would take about two weeks for recovery. Patient states she is in a lot of pain.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test normal, Pruritus, Urticaria
Clinical narrative: Itching, rushes and hives, breaking out on a daily basis, lasting up to two hours. ALLEGRA (60 mg) causes it to subside quickly.
Age: 0.08
Sex: F
Vaccine: DTAP
Symptoms: Irritability, Muscle spasms, Selective eating disorder, Vomiting
Clinical narrative: Vomit x 3 days starting within 24 hrs, fussy, decreased quality of feedings for 2 weeks - approximately 2 weeks after vaccine, new spasms developed - refer to neuro for eval.
Sex: F
Vaccine: TDAP
Symptoms: Rash, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced rash and skin warm. On an unknown date, the outcome of the rash and skin warm were unknown. It was unknown if the reported the rash and skin warm to be related to BOOSTRIX.  Additional details were provided as follows: The age at vaccination was not reported. The patient had experienced a delayed reaction after receiving BOOSTRIX. She had a rash and the skin was hot to touch in the area also.
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Erythema, Rash, Rash pruritic, Skin irritation
Clinical narrative: This spontaneous report as received from a physician refers to a 42 year old male patient. Patient's pertinent medical history, previous drug reactions/allergies and concomitant medication were reported as none. The patient had an unspecified titer test in 2008 and the results were negative. On 24-AUG-2016, the patient was vaccinated with VARIVAX (strength, dosing details, anatomical location, lot# and expiration date were unknown). The reporting physician did not vaccinate the patient. About 2 weeks later (unknown date in SEP-2016), the patient experienced significant irritation, redness and bumps which were itchy on both posterior legs and back of thighs. The rash resolved after 2 weeks. The reporting physician did not see the rash and felt that it was a non varicella rash. A second titer was performed and the results were negative. No treatment was given for the adverse event. The outcome of rash was reported as resolved and the rest of the events outcome was unknown. Causality assessment was not provided. No product quality complaint was involved. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a pharmacist referring to a 50 year old female patient. The patient's concurrent condition included diabetes mellitus. Concomitant therapies included atorvastatin, amantadine, propranolol hydrochloride (manufacturer unknown), escitalopram and gabapentin. The patient had no drug reactions/allergies. On 26-SEP-2016, the patient was vaccinated with ZOSTAVAX (lot # L046295, expiration date 17-FEB-2017, subcutaneous; dose was unknown). On 28-SEP-2016, the patient experienced 1/2 inch size redness at the injection site with soreness and headache, pain level 5. No treatment was given. No lab test was performed. The outcome of the events was reported as recovering. The causality was not provided. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received from a registered pharmacist referring to an 84 years old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 26-MAY-2016, the patient received a dose of expired PNEUMOVAX 23 injection (lot # K010523, expired on 25-FEB-2016; dose and route were unknown). No adverse effects were reported. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Information has been received from a pharmacist referring to a 54 years old female patient. The patient had no concomitant medication or pertinent medical history. On 28-SEP-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (route and dose unknown, lot # M027552, expiration date unknown). On 28-SEP-2016, the patient experienced fever and extreme soreness in the arm where she received the injection within a few hours of vaccination. The patient emailed the pharmacist to seek medical attention. Treatment had been given for the events. No lab was performed. The patient was recovering from the events. The causal relationship between the events and PNEUMOVAX 23 was unknown. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine administrator (non health care professional) referring to unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reaction/allergies or concomitant medication information were not reported. On 03-OCT-2016, the patients were vaccinated with improperly stored doses (wistar ra 27-3) M-M-R II lot # M004899, expiration date: 27-JAN-2018 (route, strength, dose and route were not provided. No adverse reactions were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Information has been received from a pharmacist referring to a 49 years old female patient. The patient had no concomitant medication. The patient had a history of penicillin (unspecified) allergy. On 28-SEP-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (route and dose unknown, lot # M027552, expiration date unknown). On 28-SEP-2016, the patient experienced fever and extreme soreness in the arm where she received the injection within a few hours of vaccination. The patient emailed the pharmacist to seek medical attention. Treatment had been given for the events. No lab was performed. The patient was recovering from the events. The causal relationship between the events and PNEUMOVAX 23 was unknown. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to multiple patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) PROQUAD (lot # L030591, expiration date 10-FEB-2017; dose and route were unknown). No adverse effects were reported. The temperature excursion included 30 Minutes at -11.6 Celsius degree, 2 Hours and 30 Minutes at -8.7 Celsius degree, 1 Hour and 30 Minutes at -9.2 Celsius degree, 1 Hour and 15 Minutes at -9.8 Celsius degree. Data logger was involved. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: ANTH, RAB, TYP
Symptoms: Arthralgia, Borrelia test positive, Musculoskeletal stiffness, Pain in extremity, X-ray limb normal
Clinical narrative: 3/16/2016: The pt. developed Right wrist, finger hand pain and stiffness and was seen at Medical Center - stroke was ruled out. XR R hand XR was normal. Joint pain migrated to all over the body since. Her Rheumatoid factor was elevated and she was seen by multiple specialists including Rheumatologist, pain management, neurologist and still did not achieve good symptoms control. Pertinent labs and imagings as below. I ordered Lyme titer which was positive and consulted infectious disease, but without exposure history, it was concluded as sero-reactivity and not true infection.
Sex: F
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site. Seen in Peds clinic and prescribed Clindamycin on 30 Sept 2016.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered, Musculoskeletal pain
Clinical narrative: Patient new to us-seen one before today. He had appointment this morning-given PNEUMOVAX -already had PREVNAR. He presented with severe right shoulder pain 10/10 and vomiting started 3 hours after inj. We ordered Prednisone, Tramadol, Phenergan.
Age: 7.0
Sex: M
Vaccine: FLUX, FLU4
Symptoms: Erythema, Local swelling, Pain, Rash
Clinical narrative: Mother of child, complained that the child had significant swollen gland under the arm and child complained that the swollen gland was painful. Mother gave patient one dose of BENADRYL and later that day on October 5th child's pediatrician looked at it on a routine visit and said it was nothing at all to be concerned or worried about.
Age: 7.0
Sex: M
Vaccine: FLUX, FLU4
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Mother of child, complained that the child had significant swollen gland under the arm and child complained that the swollen gland was painful. Mother gave patient one dose of BENADRYL and later that day on October 5th child's pediatrician looked at it on a routine visit and said it was nothing at all to be concerned or worried about.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site induration, Injection site infection, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: RED RAISED RASH AT BOTH SITES OF INJECTION. HOT TO TOUCH AND PNEUMONIA SITE FIRMER THAN OTHER. PATIENT RECIEVED COURSE OF CEPHALEXIN FOR SUSPECTED INFECTION 10/13/2016.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Deafness
Clinical narrative: Per patient's verbal report, a few hours after receiving the influenza vaccine, he "lost all hearing in [his] right ear and about 10% in the left ear." I was no longer present when the adverse reaction began. He quickly sought medication attention from his primary provider but was later referred to an ear/nose/throat specialist. He states he has had two rounds of prednisone treatment (dosage unknown), the first which was a 4-day course, and he has still not seen any improvement so far. He states he has never had an adverse reaction to the influenza vaccine and has received it several times.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram, Echocardiogram, Hypoaesthesia, Neurological examination, Nuclear magnetic resonance imaging
Clinical narrative: Numbness on the left side of my face. It spread to my left arm and waist and hip and leg. Was seen at the ER on 10/7, received MRI, CAT Scan, carotid ultrasound, echocardiogram released on 10/8. Then on 10/11 saw neurologist currently taking  Prednisone. Some feeling returning.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Ultrasound Doppler
Clinical narrative: Numbness on the left side of my face. It spread to my left arm and waist and hip and leg. Was seen at the ER on 10/7, received MRI, CAT Scan, carotid ultrasound, echocardiogram released on 10/8. Then on 10/11 saw neurologist currently taking  Prednisone. Some feeling returning.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Erythema, Pruritus
Clinical narrative: Redness to the area and down my arm. Redness to other arm as well and itching on both limbs. My head also itched and my stomach became upset. These are the symptoms so far.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Swollen lymph nodes in armpit in the same arm the injection was given. Quite a bit of pain and will be going back to the doctor.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red blotches, warm to the touch, around injection site.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: Initial unsolicited report received from a physician on 16 Sep 2016. This case was linked to 2016SA172869 (same reporter). This case involves a four-year-old male patient who was vaccinated with a fifth dose of Daptacel (batch number: C5101AA, expiry date: 26 Nov 2018, site of administration not reported) intramuscularly on 15 Sep 2016. The patient was also vaccinated with a dose of FLUARIX and a dose of PROQUAD on an unspecified date. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was not known and illness at time of vaccination was reported as none. Concomitant medications were not provided. On 15 Sep 2016, immediately after vaccinations, the patient had vomiting. Lab data and corrective treatment was not reported. Outcome of event was reported as unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Middle insomnia, Mobility decreased, Myalgia
Clinical narrative: Initial unsolicited report received from other non-healthcare professional on 04 October 2016. This case involves four patients (age and gender not reported) who were vaccinated with dose of Fluzone QIV (Batch number: UI625AB, expiration date 30 June 2017, site and route of administration was not reported) on 13 September 2016. Patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions: none reported. Concomitant medication was not reported as denies. On 13 September 2016, same day following vaccination patients experienced muscle soreness to arm that was still bothersome, waking them up at night and some patient unable to lift arm over head. Lab data and corrective treatment were not reported. Outcome of events reported as unknown. List of documents held by sender: none.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Paraesthesia
Clinical narrative: Initial unsolicited report received from a pharmacist on 05 Oct 2016. This case involves a 79-year-old female patient who was vaccinated with a dose of Fluzone HD (batch number: UI697AB, expiry date: 06 May 2017, dose not reported) via intramuscular route in the left arm on 05 Oct 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify), any other vaccinations within 4 weeks of vaccinations and illness at the time of vaccination was reported as none. Concomitant medications were not provided. On 05 Oct 2016, few hours following the vaccination, the patient experienced tingling in fingers of vaccinated arm as well as immobility to that arm. Lab data and corrective treatment was not reported. The patient's outcome was reported as unknown. List of documents held by sender: none.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Incorrect route of drug administration, Pain, X-ray
Clinical narrative: Initial unsolicited report received from a pharmacist on 05 Oct 2016. This case involves a 79-year-old female patient who was vaccinated with a dose of Fluzone HD (batch number: UI697AB, expiry date: 06 May 2017, dose not reported) via intramuscular route in the left arm on 05 Oct 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify), any other vaccinations within 4 weeks of vaccinations and illness at the time of vaccination was reported as none. Concomitant medications were not provided. On 05 Oct 2016, few hours following the vaccination, the patient experienced tingling in fingers of vaccinated arm as well as immobility to that arm. Lab data and corrective treatment was not reported. The patient's outcome was reported as unknown. List of documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial unsolicited report received from a Consumer (patient mother) on 04 October 2016. This case involves a five-year-old female patient who was vaccinated with a dose of FLUZONE (batch number-U2169NA, expiry date not reported) by intramuscularly in thigh on 25 October 2006. The patient had allergy to penicillin and illness at time of vaccination was none as per reporter. Concomitant medications was not reported. On an unspecified date following the vaccination, the patient had experienced a large amount of swelling, redness, and pain from knee to hip. Lab data and corrective treatment were not reported. On an unspecified date, the patient was recovered from the events. List of documents held by sender: none.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Bone pain, Influenza like illness
Clinical narrative: Initial unsolicited report received from a consumer on 07 Oct 2016. This case involves a 42 year old male patient who was vaccinated with 0.5 ml of FLUZONE QIV) (Batch number: UT5673KA, expiry date: 30 Jun 2016, route, and site of administration was not reported) on 04 Oct 2016. The patient illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions and any other vaccinations within four weeks of vaccinations were reported as none. The patient concomitant medications were not reported. On 05 Oct 2016 one day after vaccination (reported as overnight) the patient woke up overnight and developed achy bones and flu like symptoms. The patient relevant diagnostic tests/laboratory data was reported as none. The patient took Motrin 600 mg as a corrective treatment. The patient recovered from the events on an unknown date. List of documents held by sender: none.