chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Movement disorder, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Pt had a fever and pain at the top of her arm into her neck. Her arm was so sore and swollen she could not bend it.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Fatigue, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Pt's arm was swollen (softball size), red, warm, and tender. She experienced tiredness. No fever or nausea.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, tenderness, swelling (L) arm site of 2 vaccines. KEFLEX 500 mg BID x 7 days. TAC oint 0.1% apply TID.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Bone pain, Dysphagia, Headache, Lethargy, Myalgia
Clinical narrative: Patient stated she had severe muscle aches. "bone crushing", severe headache, extreme lethargy, and difficulty swallowing/throat closing. Had similar symptoms the year before but much more severe this year. Lasted approximately 2 1/2 days.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Throat tightness
Clinical narrative: Patient stated she had severe muscle aches. "bone crushing", severe headache, extreme lethargy, and difficulty swallowing/throat closing. Had similar symptoms the year before but much more severe this year. Lasted approximately 2 1/2 days.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient broke out in hives, pruritus post vaccination.
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site of shingles vaccine became red and swollen.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Musculoskeletal pain
Clinical narrative: Sharp pain in shoulder, been going for 1 month and 1/2. Received pain patches about 1 month after shot.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion
Clinical narrative: Bruising on the arm.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives - occur at night x2 nights, went away in morning patient took BENADRYL.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Pruritus, Urticaria
Clinical narrative: Immediate redness and swelling of the in site. Pt felt slight itching and hives. ZANTAC 300 mg 1 dose, 40 mg prednisone 1 dose, ZYRTEC 10 mg 1 dose.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Muscular weakness, Pain in extremity, Pyrexia
Clinical narrative: Fever, joint pain in hands, fingers, elbow, chills. Lasting few days, with pain subsiding slightly. Muscle weakness. Planning to see MD.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Paraesthesia, Urticaria
Clinical narrative: Patient developed hives, tingling, and shortness of breath.
Age: 77.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Below vaccination site about 2 inches redness, hot, muscle ached. Could not raise arm. Hurts. Left arm.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Induration, Injection site erythema, Muscle spasms, Skin warm
Clinical narrative: Swollen left leg. Warm and hard to touch. Redness around the area.
Age: 44.0
Sex: F
Vaccine: FLUC4, HEPAB, IPV, MMR, PPV, TDAP
Symptoms: Headache, Migraine, Pain, Pyrexia
Clinical narrative: Pt started feeling adverse reactions after work hrs on 09/30/16, including headaches, migraines, fever and body aches. Went to clinic on 10/2/16.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy
Clinical narrative: Lymph node near the neck got swollen.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Pt started having a pain in arm 1 hour after shot that has limited range of motion, no pain upon touch.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever, chills, myalgias - onset about 6-7 hours after shots given. Exam on 10-04-15 normal.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Discomfort, Neck pain, Pain in extremity
Clinical narrative: Pt received FLUARIX QUAD 2016-17 on 9/2/16. She felt immediate pain/discomfort after vaccine. On 9/23/16, patient reported continuous arm pain that is radiating to back/neck.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Very swollen arm with redness and vesicles clusters around injection site. Pt went to ED and was treated with antibiotics for cellulitis, antihistamines here.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Musculoskeletal pain
Clinical narrative: Shoulder pain lasting 2+ weeks. Patient treated with acetaminophen and ibuprofen. Suspect vaccine administered too high in arm.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Blister, Eye swelling, Urticaria
Clinical narrative: Day following vaccine pt developed hives (full body), blisters, swelling of eyes, seen by PCP on 10/3/16 and prescribed a course of prednisone. Symptoms started 9/30/16, seen in EHS 10/5/2016.
Age: 64.0
Sex: U
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Received vaccine 9/16/16. Called 10/4/16 complaining of upper body pains. Pain in both arms. Advised to contact her physician.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Loss of consciousness, Nausea, Pyrexia
Clinical narrative: Dizzy and nauseated on way home from store - started drinking water in case dehydrated. Went to bed early since still dizzy. Woke up around 1:30 AM and was nauseated and went to bathroom to throw up - passed out. Went to Dr in morning - had a fever. Tried to eat in morning - threw up. Dr did blood work - no issues found. Dr thinks from Flu shot and recommended pharmacy report to VAERS.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Nerve injury, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient came in stating she had pain after flu shot that lasted longer than expected, then progressed to sharp/shooting pain down the arm, then tingling in hand. Pt said went to MD and "shot hit a nerve". Pt states going to Physical Therapy.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Patient received vaccine 9/16/16. Patient reports sore arm on 9/16/16 and 9/17/16. On 9/18/16, patient's arm was red, sore, with warmth. On 9/19/16, the patient came back to pharmacy. Arm was visibly red, but patient reports improvement. Patient did not require any treatment.
Age: 56.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Tenderness
Clinical narrative: Patient stated had reaction to PNUEMOVAX site on injection pain, red from inner elbow to top of shoulder as well as neck tenderness for 3 days (right arm).
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Hyperhidrosis, Pallor, Syncope
Clinical narrative: Patient fainted after shot-was visibly pale and sweaty.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia
Clinical narrative: Pt stated arm numb; went to ER for treatment.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hypoaesthesia, Injection site swelling, Injection site warmth, Oropharyngeal pain
Clinical narrative: Arm swollen, numbing, redness, soreness in throat. PM took BENADRYL, Sx are decreasing throat feels better. D/C to husband. Plan to take BENADRYL 25 mg. PO every 4 hr.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: Arm swollen, numbing, redness, soreness in throat. PM took BENADRYL, Sx are decreasing throat feels better. D/C to husband. Plan to take BENADRYL 25 mg. PO every 4 hr.
Age: 96.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Dizziness day after administration, patient went to the ER.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Red/swollen injection site on day 4 and 5 after immunization. On day 5 arm is warm to touch and itchy. Told to use ice pack and take BENADRYL. Suspect not vaccine related allergy issue but patient and I could find no potential cause.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Peripheral swelling
Clinical narrative: Upon getting home on 9/18/16, patient's arm began to swell (the size of a baseball, burn, and become red at the injection site). She went to her PCP, who diagnosed her with cellulitis and gave her a 10 day course of antibiotics.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: Patient received Flu shot 9/26/16 in afternoon, has anaphylaxis response on drive home and went to urgent care. Received EPIPEN at urgent care.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Arthralgia, Injection site pain, Pain in extremity
Clinical narrative: Pain in left arm. Starting from shoulder and extending towards wrist.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Rash generalised
Clinical narrative: Generalized rash. No itching or pain. Symptoms slightly improved with BENADRYL.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site irritation, Lymphadenopathy
Clinical narrative: After less than a day pt began to feel sick. Lymph nodes are swollen. Not feeling nausea. Irritation at site of injection, pt can tell it was from pneumo and not flu shot.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Peripheral swelling, Skin reaction, Skin warm
Clinical narrative: Patient called to report marked swelling in right bicep where she received vaccine. Arm was red, hot, swollen.
Age: 73.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Diarrhoea, Urticaria
Clinical narrative: Diarrhea within 6 hours and hives in 12 hours. Diarrhea resolved within 48 hours with no treatment. Hives resolved within 72 hours.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received PREVNAR 13. She reported redness, warmth and swelling below injection site starting day after. Patient was told to apply ice and take BENADRYL. Patient said she was going to the doctor, but we never heard back from pt.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Local injection site reaction - red painful site. Went to hospital cleared and sent home.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt. reported a lot of pain at the site of injection; she also said she has very limited range of motion. She has been taking ibuprofen for pain and inflamm. and itching.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt reported prolonged soreness/immobility in arm in weeks follow vaccination pt followed up w/MD.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Anxiety, Flushing, Syncope, Vomiting
Clinical narrative: Syncope reaction following vaccine administration. Patient recovered within seconds. Patient was flushed and vomited once. Severe anxiety prior to shot administration.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Abdominal pain upper, Arthralgia, Cellulitis, Chest pain, Decreased appetite
Clinical narrative: The patient is a 12 year, 0 month old male who presents with vaccine allergy. Prior to the reaction the patient received HPV vaccine and inactivated influenza vaccine. Allergenic triggers include an unknown source. Presentation included injection site reaction. This problem has not been previously evaluated. This problem has not been previously treated. The last clinic visit was 1 day(s) ago. Symptoms included rash, swelling, warmth and pain. The reaction is located on the left upper extremity. The patient describes the pain as aching. Onset was gradual. Onset followed a vaccination. The patient describes this as moderate in severity. Associated symptoms do not include malaise, irritability, drowsiness, arthralgias, myalgias, anorexia, nausea, vomiting, diarrhea, lightheadedness, palpitations, chest pain or syncope. The patient is not currently being treated for this problem. Note for "Vaccine allergy": Two to four hours after admin of the vaccine, noticed heat, soreness, redness was about the size of a half dollar yesterday, this morning during school it progressed in size. Has been putting ice pack on it. Around 9 am, he saw school nurse. Did not have a temperature of fever. Put an ice pack on it. No fevers or vomiting or difficulty breathing but has a mild stomach ache, thinks it is something he ate at lunch today. Otherwise good energy, appetite, urination and bowel movements are WNL. Pain starts when he moves it, with writing, touching it. Feels like a sore muscle and a little itchy at the top. Still feels very hot. Phone Note 9-30-2016: Received the HPV and flu vaccine yesterday. In the past, he developed cellulitis to one of his arms where he received a vaccine. The area is swollen and red. Mom drew a circle to the reddened area and the redness has now spread beyond the marking. He is having pain to his arm. No fever. Still able to move his arm. He is at school now and called mom c/o pain. Plan: appt.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Diarrhoea, Dizziness, Erythema, Irritability, Malaise
Clinical narrative: The patient is a 12 year, 0 month old male who presents with vaccine allergy. Prior to the reaction the patient received HPV vaccine and inactivated influenza vaccine. Allergenic triggers include an unknown source. Presentation included injection site reaction. This problem has not been previously evaluated. This problem has not been previously treated. The last clinic visit was 1 day(s) ago. Symptoms included rash, swelling, warmth and pain. The reaction is located on the left upper extremity. The patient describes the pain as aching. Onset was gradual. Onset followed a vaccination. The patient describes this as moderate in severity. Associated symptoms do not include malaise, irritability, drowsiness, arthralgias, myalgias, anorexia, nausea, vomiting, diarrhea, lightheadedness, palpitations, chest pain or syncope. The patient is not currently being treated for this problem. Note for "Vaccine allergy": Two to four hours after admin of the vaccine, noticed heat, soreness, redness was about the size of a half dollar yesterday, this morning during school it progressed in size. Has been putting ice pack on it. Around 9 am, he saw school nurse. Did not have a temperature of fever. Put an ice pack on it. No fevers or vomiting or difficulty breathing but has a mild stomach ache, thinks it is something he ate at lunch today. Otherwise good energy, appetite, urination and bowel movements are WNL. Pain starts when he moves it, with writing, touching it. Feels like a sore muscle and a little itchy at the top. Still feels very hot. Phone Note 9-30-2016: Received the HPV and flu vaccine yesterday. In the past, he developed cellulitis to one of his arms where he received a vaccine. The area is swollen and red. Mom drew a circle to the reddened area and the redness has now spread beyond the marking. He is having pain to his arm. No fever. Still able to move his arm. He is at school now and called mom c/o pain. Plan: appt.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Myalgia, Nausea, Pain, Palpitations, Pruritus
Clinical narrative: The patient is a 12 year, 0 month old male who presents with vaccine allergy. Prior to the reaction the patient received HPV vaccine and inactivated influenza vaccine. Allergenic triggers include an unknown source. Presentation included injection site reaction. This problem has not been previously evaluated. This problem has not been previously treated. The last clinic visit was 1 day(s) ago. Symptoms included rash, swelling, warmth and pain. The reaction is located on the left upper extremity. The patient describes the pain as aching. Onset was gradual. Onset followed a vaccination. The patient describes this as moderate in severity. Associated symptoms do not include malaise, irritability, drowsiness, arthralgias, myalgias, anorexia, nausea, vomiting, diarrhea, lightheadedness, palpitations, chest pain or syncope. The patient is not currently being treated for this problem. Note for "Vaccine allergy": Two to four hours after admin of the vaccine, noticed heat, soreness, redness was about the size of a half dollar yesterday, this morning during school it progressed in size. Has been putting ice pack on it. Around 9 am, he saw school nurse. Did not have a temperature of fever. Put an ice pack on it. No fevers or vomiting or difficulty breathing but has a mild stomach ache, thinks it is something he ate at lunch today. Otherwise good energy, appetite, urination and bowel movements are WNL. Pain starts when he moves it, with writing, touching it. Feels like a sore muscle and a little itchy at the top. Still feels very hot. Phone Note 9-30-2016: Received the HPV and flu vaccine yesterday. In the past, he developed cellulitis to one of his arms where he received a vaccine. The area is swollen and red. Mom drew a circle to the reddened area and the redness has now spread beyond the marking. He is having pain to his arm. No fever. Still able to move his arm. He is at school now and called mom c/o pain. Plan: appt.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Skin warm, Somnolence, Swelling, Syncope, Vomiting
Clinical narrative: The patient is a 12 year, 0 month old male who presents with vaccine allergy. Prior to the reaction the patient received HPV vaccine and inactivated influenza vaccine. Allergenic triggers include an unknown source. Presentation included injection site reaction. This problem has not been previously evaluated. This problem has not been previously treated. The last clinic visit was 1 day(s) ago. Symptoms included rash, swelling, warmth and pain. The reaction is located on the left upper extremity. The patient describes the pain as aching. Onset was gradual. Onset followed a vaccination. The patient describes this as moderate in severity. Associated symptoms do not include malaise, irritability, drowsiness, arthralgias, myalgias, anorexia, nausea, vomiting, diarrhea, lightheadedness, palpitations, chest pain or syncope. The patient is not currently being treated for this problem. Note for "Vaccine allergy": Two to four hours after admin of the vaccine, noticed heat, soreness, redness was about the size of a half dollar yesterday, this morning during school it progressed in size. Has been putting ice pack on it. Around 9 am, he saw school nurse. Did not have a temperature of fever. Put an ice pack on it. No fevers or vomiting or difficulty breathing but has a mild stomach ache, thinks it is something he ate at lunch today. Otherwise good energy, appetite, urination and bowel movements are WNL. Pain starts when he moves it, with writing, touching it. Feels like a sore muscle and a little itchy at the top. Still feels very hot. Phone Note 9-30-2016: Received the HPV and flu vaccine yesterday. In the past, he developed cellulitis to one of his arms where he received a vaccine. The area is swollen and red. Mom drew a circle to the reddened area and the redness has now spread beyond the marking. He is having pain to his arm. No fever. Still able to move his arm. He is at school now and called mom c/o pain. Plan: appt.
Age: 74.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: 1 shot each in left arm. Pain when PCV13 injected. 1/2 hour later, arm tightened, swelled, redness, heat, bumpy, very sore shoulder to elbow. For 7 days.
Age: 74.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Injection site warmth, Skin tightness
Clinical narrative: 1 shot each in left arm. Pain when PCV13 injected. 1/2 hour later, arm tightened, swelled, redness, heat, bumpy, very sore shoulder to elbow. For 7 days.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Body temperature increased, Chills, Myalgia
Clinical narrative: I received FLUZONE HIGH-DOSE 0.5ML SYR and within two hours was experiencing extreme chills and later a temperature. I have had aching joints and muscles, although that is now going away. I saw the Dr. today was told to notify you of the reaction. It was manufactured by Sanofi Pasteur with NDC: 49281-0399-65. I have never received the HIGH DOSE before, and I've never had a reaction before to flu shots.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions and concomitant medications were not reported. On 15-SEP-2016, the patient was vaccinated with an expired dose of M-M-R II (lot# unknown, expiration date of 26-AUG-2016) (strength, dose, frequency and route not reported). No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from a non-pregnant female patient of unknown age (who is also the physician) via company representative regarding herself. The patient's concurrent condition included asthma. On an unknown date in 2014 (reported as 2 years ago), the patient was vaccinated with PNEUMOVAX 23. On an unknown date, the patient experienced injection site reactions after receiving PNEUMOVAX 23. There was a "large red bump/induration" on the patient's arm and "swelling". The patient did not seek any medical attention and did not receive any treatment for the events. It lasted about one week and then it resolved on an unknown date. The outcome of the events was reported as recovered. The causality of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 28-AUG-2015, the patient was vaccinated with ZOSTAVAX (lot # and expiration date were unknown) (route: subcutaneous). On 13-SEP-2016, the patient was inadvertently vaccinated with second dose of ZOSTAVAX, (lot # M026874, expiry date: 19-JUL-2017) (inappropriate schedule of vaccine administered). No adverse effects were reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 20-SEP-2016 (reported as "six days after the vaccine had expired"), the patient was inadvertently vaccinated with a dose of expired M-M-R II (expiration date 14-SEP-2016, dose and lot# were not reported) subcutaneously. No apparent adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (dose and route unknown, lot# L026598, expiration date: 26-JUN-2017; lot# reported as M011839, expiration date: 13-SEP-2017). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with doses of improperly stored ROTATEQ (dose unknown, lot# M019706, expiration date: 24-OCT-2017) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. There was no information regarding concomitant medication, concurrent condition and medical history. On an unspecified day, the patient was vaccinated with 2 doses of VARIVAX (lot #, expiration date and route were not reported. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 16-SEP-2016, the patient received an improperly stored dose of ZOSTAVAX (lot # M009773, expiration date 17-MAY-2017; dose and route were unknown). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a pharmacist refers to an unknown patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23. The pharmacist asked if PREVNAR 13 contained phenol before administering the vaccine to a patient allergic to that substance. The pharmacist said that the patient had a really bad reaction after vaccination with PNEUMOVAX 23. The patient had not been vaccinated with PREVNAR 13. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 26-SEP-2016 the patient was inadvertently vaccinated with PROQUAD (lot # M010478 and expiry date 01-SEP-2017) and a dose of VARIVAX (M023379 and expiry date 11-MAY-2018) (dosing regimen was not known for both vaccines). No adverse effect were reported. No product quality complaint (PQC) filed. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician via Pfizer refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was supposedly vaccinated with PREVNAR 13 from lot # J23864 (dose, route and expiry date not reported) but the patient gave consent for receiving PNEUMOVAX 23 (Wrong vaccine administered). The physician asked if lot # J23864 was valid for PREVNAR 13 or PNEUMOVAX 23. It was reported that lot # J23864 was not valid for PREVNAR 13. Lot number J23864 is an invalid lot number for PNEUMOVAX 23. Additional information is not expected as the reporter declined to provide further information.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 7 unspecified patients of unknown demographics. Patients pertinent medical history, concurrent condition and concomitant medications were not reported. No previous drug reactions/ allergies were reported. On an unknown date in 2016 these patients were vaccinated with improperly stored doses of GARDASIL (lot # L040459 and expiry date 06-APR-2017) (strength, dosing details, anatomical location were unknown). No adverse effects were reported. On 26-APR-2016, the vaccines were exposed to a temperature of 34 degree Fahrenheit for 15 hours. On 26-JUL-2016, the vaccines were exposed to a temperature of 35 degree Fahrenheit for 23 hours 30 minutes. On 27-JUL-2016, the vaccines were exposed to the temperature of 34 degree Fahrenheit for 17 hours 15 minutes. On 28-JUL-2016, the vaccines were exposed to the temperature of 33 degree Fahrenheit for 15 hours 30 minutes. The temperature excursion was detected by a data logger. No previous temperature excursion were reported. No product quality complaint was involved. This is one of the 3 reports received from the same reporter source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 3 unspecified patients of unknown demographics. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On an unknown date 2016, these patients were vaccinated with improperly stored doses of VAQTA (lot # L023936 and expiry date 15-MAR-2017) (strength, dosing details, anatomical location were unknown). No adverse effects were reported. On 26-APR-2016, the vaccines were exposed to a temperature of 34 degree Fahrenheit for 15 hours. On 26-JUL-2016, the vaccines were exposed to a temperature of 35 degree Fahrenheit for 23 hours 30 minutes. On 27-JUL-2016, the vaccines were exposed to the temperature of 34 degree Fahrenheit for 17 hours 15 minutes. On 28-JUL-2016, the vaccines were exposed to the temperature of 33 degree Fahrenheit for 15 hours 30 minutes. The temperature excursion was detected by a data logger. No previous temperature excursion was reported. No product quality complaint was involved. This is one of the 3 reports received from the same reporter source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: Information has been received from a female pharmacist of unknown age concerning herself. The patient's concurrent conditions, medical histories and concomitant therapies were not provided. On 22-SEP-2016, when the patient went to twist the cap off she inadvertently stuck herself with the needle after reconstituting the ZOSTAVAX (lot #, expiration date, dose and route were unknown) with it. Then she removed the needle and placed a new needle on the syringe to administer the full dose to an unspecified patient. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified number of patients of unknown demographics. The patients' pertinent medical history, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of PROQUAD (dose and route were not reported) lot # M014304 and expiry date: 22-SEP-2017. The vaccine was exposed to a temperature of 23.5 Fahrenheit for a time frame of 63 hours. The call was received because of a data logger. No previous temperature excursions were reported. There were no adverse effects reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 2 unspecified patients of unknown demographics. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On an unknown date in 2016, these patients were vaccinated with improperly stored doses of VAQTA (lot # L009445 and expiry date 01-JUL-2017) (strength, dosing details, anatomical location were unknown). No adverse effects were reported. On 26-APR-2016, the vaccines were exposed to a temperature of 34 degree Fahrenheit for 15 hours. On 26-JUL-2016, the vaccines were exposed to a temperature of 35 degree Fahrenheit for 23 hours 30 minutes. On 27-JUL-2016, the vaccines were exposed to the temperature of 34 degree Fahrenheit for 17 hours 15 minutes. On 28-JUL-2016, the vaccines were exposed to the temperature of 33 degree Fahrenheit for 15 hours 30 minutes. The temperature excursion was detected by a data logger. No previous temperature excursion was reported. No product quality complaint was involved. This is one of the 3 reports received from the same reporter source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown demographics. The patients' pertinent medical history, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of VARIVAX (dose and route were not reported) lot # L046887 and expiry date: 23-NOV-2017. The vaccine was exposed to a temperature of 23.5 Fahrenheit for a time frame of 63 hours. The call was received because of a data logger. No previous temperature excursions were reported. There was no adverse effects reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 27-SEP-2016, the patient was inadvertently administered with a dose of PROQUAD, (route: subcutaneous) and a dose of M-M-R II. No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a pharmacist, via Pfizer (Source document # 2016428486), concerning a 71 years old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not informed. On unspecified date in October of 2015, the patient was vaccinated with PREVNAR 13 (lot #, expiration date, concentration, dosage and therapy route were not provided), and a couple of weeks later the patient was inadvertently given the PNEUMOVAX 23 (lot #, expiration date, concentration, dosage and therapy route were not provided), instead of waiting for a year. Concomitant therapies were not informed. The pharmacist asked if the vaccination need to be repeated. Additionally mentioned a possible adverse event. The outcome of possible adverse event was unknown at the time of the report. The causal relationship between possible adverse event and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, patients' were vaccinated with improperly stored PEDVAXHIB (dose, and route unknown) from lot # L051122 with expiry date of 18-DEC-2018. No adverse effects were reported. No product quality complaint was involved. Additional information is not expected as consent to contact was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. Patients' pertinent medical history, drug reaction/allergies or concomitant information were not performed. On an unspecified date, the patients were vaccinated with a dose of improperly storaged VARIVAX, lot # M012992, expiration date: 14-MAR-2018 (strength, dose and route were not provided). No adverse event was reported. There was any product quality complaint (PQC) involved. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site rash, Pain in extremity, Rash
Clinical narrative: This spontaneous report was received from a pharmacist via company representative regarding a 77 year old male patient. Information regarding the pertinent medical history, drug reactions or allergies and concomitant therapy were not provided. On 14-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 lot # L003227 with an expiry date 13-OCT-2016 (dosing details and anatomical location not known). On an unspecified date in September 2016 reported as after administration of PNEUMOVAX 23, the patient experienced "pain in the left arm and a rash at the injection site, on the left leg and on his trunk". On 26-SEP-2016, the patient called pharmacy, reported the adverse effects and sought medical attention. At the time of reporting, the pain in the left arm, as well as the rash at the injection site and on his trunk had resolved (unknown date in September 2016) but he still had the rash on his left leg. Causality assessment was not provided. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 14-AUG-2016, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # I049744, expiration date 12-OCT-2017, dose and route were not reported). No adverse reactions were reported. This is one of the 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: This spontaneous report was received from a registered nurse and refers to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of PROQUAD (lot # M012986, expiration date 12-SEP-2017, dose and route of administration were not reported) which were improperly stored. The administered doses of vaccine experienced a temperature excursion of 35.4 Fahrenheit degrees for 19 hours and 22 minutes. There were no previous temperature excursions. The temperature excursions were detected by a data logger. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored GARDASIL, lot number was L035105 and expiration date of 04-MAY-2017 (strength, route of administration and dose were not reported). There was no concomitant therapies nor adverse effect reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored GARDASIL 9, lot number was either M011117 with expiration date of 07-DEC-2017 or lot number L043214 with expiration date of 30-AUG-2017 (strength, route of administration and dose were not reported). There were no concomitant therapies nor adverse effect reported. No product quality complaint was involved. This is one of several cases form the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored VAQTA, lot number was M018644 and expiration date of 20-SEP-2017(strength, route of administration and dose were not reported). There were no concomitant therapies nor adverse effect reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored VARIVAX, lot number was M024702 and expiration date of 18-MAY-2018 (strength, route of administration and dose were not reported). There were no concomitant therapies nor adverse effect reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, which had a lot # of M019691 and expiration date of 02-NOV-2017 (dose number, dose and concentration were not provided). It was also reported that the ROTATEQ was exposed to a temperature excursion of 47 F for 3 hours. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Headache, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 66 year old female patient. No pertinent medical history were reported. None drug allergies or drug reactions were reported. On 19-SEP-2016 the patient was vaccinated with ZOSTAVAX, (lot, expiration date and dose were not reported) subcutaneously. No concomitant medications were reported. On 19-SEP-2016(reported as the patient began to experience symptoms same evening after receiving the vaccine) the patient experienced burning, soreness and itching at the injection site, face feels like its burning and headache. The patient sought medical attention to the pharmacist. The reporter stated that the patient is still experiencing the symptoms (not recovered). The causality assessment was not provided by the reporter. No product quality complaint (PQC) was filed. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Paraesthesia
Clinical narrative: Information has been received from an 80 year old male patient concerning himself. The patient did not have pertinent medical history, drug reactions or allergies. Concurrent conditions were not reported. In October 2012, the patient was vaccinated with an unspecified dose of ZOSTAVAX (strength, dosage schedule, route, anatomical location, lot number and expiration date were not reported). Concomitant therapies included ZOCOR and terazosin. Other suspect medications were not reported. The patient stated that on 11-JUN-2016, "while on ZOSTAVAX, he got the shingles, and he still had nerve pain and tingling in his legs". The patient sought medical attention by visited the doctor, on an unspecified date and an unspecified treatment was given for the adverse event. Laboratory diagnostic studies were not performed. No product quality complaint was involved. At the time of reporting, the patient was not recovered from the herpes zoster. The relatedness between the herpes zoster and therapy with ZOSTAVAX was not reported. Additional information is not expected because the reporter did not consent for further follow up.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a patient of unknown age. Concurrent condition, medical history and concomitant therapy were not reported. On 16-SEP-2016 the patient was vaccinated with an expired dose of M-M-R II injection (lot # K011317, expiration date 13-AUG-2016). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Chills, Fatigue, Muscular weakness, Pyrexia
Clinical narrative: Information has been received from a consumer concerning a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies, concurrent conditions or concomitant therapies were reported. On 20-SEP-2016, 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) and at the same time was vaccinated with an unspecified dose of influenza virus vaccine (unspecified) (reported as "a flu vaccination") (strength, dosage schedule, route, anatomical location, lot number and expiration date were not reported). On an unspecified date in September 2016, after the vaccination with PNEUMOVAX 23, the patient experienced joint pain (arthralgia), fatigue, chills without fever, pyrexia and muscle weakness. No product quality complaint was involved. At the time of reporting, the outcome of arthralgia, fatigue, chills, pyrexia and muscle weakness was unknown .The relatedness between the events and therapy with PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant therapies were not reported. On 12-SEP-2016 (reported as "last Monday"), the patient was vaccinated with the first dose of RECOMBIVAX HB (lot #, expiration date, dose and route were unknown). On an unknown date in September 2016, the patient was inadvertently administered the second dose of RECOMBIVAX HB. No adverse effect was reported. No product quality complaint (PQC) was involved. 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 pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant medications were not provided. On 28-SEP-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # L021612, expiration date: 10-OCT-2016, 0.65 ml, subcutaneously). No adverse effects were reported. Additional information has been requested.