chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: FLUA3, PPV, TDAP
Symptoms: Vomiting
Clinical narrative: Patient developed chills, body aches, loss of appetite, and general "weak" feeling hours after receiving the vaccinations. Patient later began vomiting a few hours later. All symptoms lasted almost two days. Patient's spouse suggested visiting a physician or the hospital but patient stopped vomiting and felt better late Wednesday morning and decided not to seek medical care. Patient's spouse came to the pharmacy to report adverse event and stated that patient was at home and still had chills, body aches, loss of appetite and nausea.
Age: 0.5
Sex: F
Vaccine: UNK
Symptoms: Eczema, Hypophagia, Hypopnoea, Loss of consciousness, Poor feeding infant
Clinical narrative: Intense screaming during  shot administered and lasted 16 hours until passed out, shallow breathing, high fever, and eczema developing within one hour. Wouldnt breastfeed and eat solids
Age: 0.5
Sex: F
Vaccine: UNK
Symptoms: Pyrexia, Screaming
Clinical narrative: Intense screaming during  shot administered and lasted 16 hours until passed out, shallow breathing, high fever, and eczema developing within one hour. Wouldnt breastfeed and eat solids
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity
Clinical narrative: Weakness in left arm, Numbness in left arm, Excruciating pain in left arm since injection given. Patient has been to urgent care 3 times and wants to go to hospital to get MRI done of left arm
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea, Vomiting
Clinical narrative: nausea,vomitted once, red,swollen, and pain at site of injection
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Pain, Rotator cuff syndrome
Clinical narrative: pt reported having lots of pain. went to md and md reported she had inflammation in her rotator cuff.
Age: 74.0
Sex: F
Vaccine: FLUR4, PNC13
Symptoms: Injection site swelling, Injection site warmth, Rash
Clinical narrative: Prevnar caused rash on arm. Arm around injection site was swollen and warm for several days. Pt will be going to doctor
Age: 73.0
Sex: M
Vaccine: FLUR4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Patient reports that soreness started about 2 days after vaccination was administered. For the first two weeks his arm was really sore. After that it improved significantly, but has worsened the last 4 days (he reports it is hard to lift his elbow). Patient does admit to having shoulder issues before the vaccination, but that the pain is originating from the injection site. Patient reports the vaccination is about two inches below the shoulder joint in the center of the muscle.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Bowel movement irregularity, Constipation, Diarrhoea, Dry skin, Eczema
Clinical narrative: A little over 24 hours after receiving her vaccine, patient broke out in hives on her forehead, right eyelid, left cheek, nose, and chin. The hives lasted for almost two weeks.  She was constipated for a week and a half after the vaccine, a problem she has never had before as she usually goes once a day. When she finally had a bowel movement it was runny and frequent, up to 5 or 6 times a day for a few days.  One week after the vaccine, as some of the hives were beginning to go away, she had an eczema breakout. Her skin was red and hot where patches of eczema were popping up. It was on her arms, legs, small spots on her back, and on her cheeks. In the creases of the backs of her knees and her ankles the skin would crack and bleed.  Almost a month has passed and the eczema has not gone away. Her skin stays rough in patches on her arms and legs and has flared up 2-3 times, lasting 3-4 days each time when it gets very red and hot and seems to itch. She still doesn?t have bowel movements regularly and gets very fussy. I called the pediatrician?s office after the reactions began and have sent them pictures of the hives but they did not need to see me in the office and no treatment was given. I have used moisturizer for the eczema daily.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Frequent bowel movements, Irritability, Pruritus, Skin fissures
Clinical narrative: A little over 24 hours after receiving her vaccine, patient broke out in hives on her forehead, right eyelid, left cheek, nose, and chin. The hives lasted for almost two weeks.  She was constipated for a week and a half after the vaccine, a problem she has never had before as she usually goes once a day. When she finally had a bowel movement it was runny and frequent, up to 5 or 6 times a day for a few days.  One week after the vaccine, as some of the hives were beginning to go away, she had an eczema breakout. Her skin was red and hot where patches of eczema were popping up. It was on her arms, legs, small spots on her back, and on her cheeks. In the creases of the backs of her knees and her ankles the skin would crack and bleed.  Almost a month has passed and the eczema has not gone away. Her skin stays rough in patches on her arms and legs and has flared up 2-3 times, lasting 3-4 days each time when it gets very red and hot and seems to itch. She still doesn?t have bowel movements regularly and gets very fussy. I called the pediatrician?s office after the reactions began and have sent them pictures of the hives but they did not need to see me in the office and no treatment was given. I have used moisturizer for the eczema daily.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Skin haemorrhage, Skin warm, Urticaria
Clinical narrative: A little over 24 hours after receiving her vaccine, patient broke out in hives on her forehead, right eyelid, left cheek, nose, and chin. The hives lasted for almost two weeks.  She was constipated for a week and a half after the vaccine, a problem she has never had before as she usually goes once a day. When she finally had a bowel movement it was runny and frequent, up to 5 or 6 times a day for a few days.  One week after the vaccine, as some of the hives were beginning to go away, she had an eczema breakout. Her skin was red and hot where patches of eczema were popping up. It was on her arms, legs, small spots on her back, and on her cheeks. In the creases of the backs of her knees and her ankles the skin would crack and bleed.  Almost a month has passed and the eczema has not gone away. Her skin stays rough in patches on her arms and legs and has flared up 2-3 times, lasting 3-4 days each time when it gets very red and hot and seems to itch. She still doesn?t have bowel movements regularly and gets very fussy. I called the pediatrician?s office after the reactions began and have sent them pictures of the hives but they did not need to see me in the office and no treatment was given. I have used moisturizer for the eczema daily.
Age: 53.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Chills, Dizziness, Fatigue, Headache, Injection site cellulitis
Clinical narrative: Headache, Chills/Shakes, Redness at site and it was growing, warm/hot at site, eventual fever and dry heaves, nauseated/feeling like I need to vomit, light headed/dizziness, fatigued
Age: 53.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Injection site erythema, Injection site warmth, Nausea, Pyrexia, Retching
Clinical narrative: Headache, Chills/Shakes, Redness at site and it was growing, warm/hot at site, eventual fever and dry heaves, nauseated/feeling like I need to vomit, light headed/dizziness, fatigued
Age: 53.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Swelling, Tremor
Clinical narrative: Headache, Chills/Shakes, Redness at site and it was growing, warm/hot at site, eventual fever and dry heaves, nauseated/feeling like I need to vomit, light headed/dizziness, fatigued
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Chills
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Cough, Diarrhoea, Erythema, Fatigue
Clinical narrative: red swollen arm, chills, low-grade fever, weak, tired, Headache, diarrhea, cough, muscle pain
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Peripheral swelling, Pyrexia
Clinical narrative: red swollen arm, chills, low-grade fever, weak, tired, Headache, diarrhea, cough, muscle pain
Age: 81.0
Sex: M
Vaccine: FLUR4
Symptoms: Eye swelling, Fall, Head injury, Skin laceration
Clinical narrative: Patient received flu vaccine. After waiting a few minutes patient was helped with putting sweater and leather coat back on. Patient was walked out to wife in waiting room a few minutes later patient said shoe traction stuck on carpet making him fall and hit head on wall. Patient was helped up by staff, put in a wheelchair and was examined by provider in office. Ice pack was given to patient to apply to swelling on eye (right) and bandage placed on left hand where there was a small skin tear. Vital signs were taken and patient was released to home with spouse.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Patient developed rash consistent with varicella on 11/6/19
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Rash erythematous
Clinical narrative: After receiving the shot, patient noticed redness to area. After 6 hr she had red rash on the deltoid area. The rash was not itching and resolved 1 day later.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient was seen by Dr. 11/7/19 and stated that her left arm still painful since injection of flu vaccine 10/14/19. Level of pain 6/10 on this date. Follow up appointment scheduled 11/20/19 with Dr.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Migraine, Mobility decreased, Vertigo
Clinical narrative: -Severe migraine 12-13 post admin -Next morning could not raise head + severe vertigo
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Fatigue, Injection site pain
Clinical narrative: fatigue upset stomach inj. site soreness
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: TRUMENBA was given as an alternative to MENACTRA; no adverse event; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act.  This spontaneous report as received from a regulatory authority refers to a 18 year old female patient. The patient's medical history included overweight and immunisation.  On 20-DEC-2017 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # M044717 dose 1, intramuscular in the left arm for prophylaxis.  Other suspect therapies included meningococcal b rfhbp vaccine (e. coli)(TRUMENBA). Concomitant therapies included ethinyl estradiol, norgestimate(TRI-SPRINTEC) and vitamins (unspecified)(VITAMINS (UNSPECIFIED)).   On 20-DEC-2017, 1 day after onset of therapy the patient experienced wrong drug administered and no adverse event was reported.  meningococcal b rfhbp vaccine (e. coli)(TRUMENBA) was given as an alternative to  meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). The outcome of wrong drug administered is unknown.     Follow up information has been received from Nurse on 13-NOV-2019, regarding reported event wrong product administered. The patient identification information was not available, but patient demographic information (gender, race, and age at time or vaccination) was available and provided to nurse so that she may attempt to locate the patient's identification information and any additional details regarding the reported event. No additional information reported.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Facial paralysis, Laboratory test
Clinical narrative: Labwork; Bell's Palsy- right side; This report was identified from a line listing obtained on request by the Company from the FDA (agency # 755270) under the Freedom of Information Act.  This spontaneous report has been received from agency referring to a 11 years old female patient. The patient's current illnesses included tinea versicolour, keratosis pilaris and obesity. The patient's other medications included econazole nitrate and mometasone furoate. The patient's medical history, concomitant medication and prior vaccinations were not reported.       On 06-JUN-2018 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength were not reported; lot # N020353, expiration date expiration date not reported but upon internal validation established as 28-APR-2020; 1 dosage form (DF)), intramuscularly in the right arm for prophylaxis.      On the same date, the patient experienced Bell's palsy on the right side (captured as facial paralysis by agency). On 07-JUN-2018 the patient had labwork performed (captured as laboratory test by agency). Action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not applicable. The outcome of the events was reported as not recovered/not resolved. The causality assessment was not reported.  Follow up information was received from the FDA on 08-AUG-2019 the no pregnant patient. Mometasone furoate and econazole nitrate were being taken at the time of vaccination. The date and time of vaccination was 06-JUN-2018 at 14:32. As a result of adverse events, the patient went to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The doctor's contact information was provided.  Follow-up information was received on 12-NOV-2019. A phone call was placed to the licensed practical nurse (LPN) which was answered by the receptionist and then was transferred to the registered nurse. The requested information was not readily available and had to be reviewed with the staff.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3, PNC13
Symptoms: Erythema, Pain in extremity
Clinical narrative: Pt. developed injection site reaction on left arm that consisted of soreness and redness that lasted approximately 3 days.  Condition resolved after 3 days.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt. developed injection site reaction on left arm that consisted of soreness and redness that lasted approximately 3 days.  Condition resolved after 3 days.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discolouration
Clinical narrative: Left Arm discoloration around the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site discoloration in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 359Y3, expiry date 26th January 2022) for prophylaxis.   On 13th October 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site discoloration. On an unknown date, the outcome of the injection site discoloration was recovering/resolving.   It was unknown if the reporter considered the injection site discoloration to be related to Shingrix.  Additional details were provided as follows: The reporter stated the patient received the 2nd dose of Shingrix and around the injection site had been ashen grey. The reporter consented to follow up.
Age: 34.0
Sex: F
Vaccine: DTAP, FLU4
Symptoms: Asthenia, Blood test, Fatigue
Clinical narrative: I am overly fatigued. I have no energy to do anything more than go to work in a day. On the weekends, I have to rest. The extreme fatigue began after I got the flu shot and DTAP on October 4.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness, Pain, Pain in extremity
Clinical narrative: The vaccine was administered very high up, more in the shoulder than in the arm. When the needle went into my shoulder, there was great pain. Unlike any I've had with the 40 or so flu shots I've had in my lifetime. By the end of that day, I had pain from the shoulder and down my arm. In the next few days, severe pain, muscle weakness, very immobile (unable to lift my arm without extreme pain).
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: The vaccine was administered very high up, more in the shoulder than in the arm. When the needle went into my shoulder, there was great pain. Unlike any I've had with the 40 or so flu shots I've had in my lifetime. By the end of that day, I had pain from the shoulder and down my arm. In the next few days, severe pain, muscle weakness, very immobile (unable to lift my arm without extreme pain).
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Injection site reaction, Muscle spasms
Clinical narrative: Flu shot administered R shoulder deltoid IM. Soreness in R deltoid and trapezius muscle began that day. Progressed and continued to shoulder pain and numbness/tingling R shoulder area and upper arm muscle spasms along with R bicep area. This is day 14 and symptoms not letting up. Infection Preventionist notified.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Extreme vomiting
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Rash
Clinical narrative: patient had pain at the injection side and states had a rash on his arms and legs .
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; patient received improperly stored dose of vaccine; This spontaneous report was received from a nurse and refers to a 11-year-old patient on unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 23-SEP-2019, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1637641, expiration date 16-FEB-2022 (exact dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. Administered dose of vaccine experienced the lowest temperature excursion below 36 degrees Fahrenheit (F) (29F) for 3 days. The digital data logger was involved in recording the temperature excursion details. There was no previous temperature excursion.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects; received VAQTA that expired on 10/12/2019; This spontaneous report was received from a medical assistant referring to a 6 years old male patient. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.  On 21-OCT-2019, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) 25/0.5 (lot # R024007, expiration date was 12-OCT-2019)(exact dose was not reported)intramuscularly for prophylaxis(expired product administered). No adverse effects were reported.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Weight decreased
Clinical narrative: The Patient stated that he had a moderate to severe swelling of his non-dominant arm along with arm pain; lost 5-10 pounds in the week; The Patient stated that he had a moderate to severe swelling of his non-dominant arm along with arm pain; This spontaneous report was received from a consumer referring to a 70 years old male patient. The patient's concurrent condition included sarcoidosis. No pertinent medical history and no drug reactions/allergies.  On 14-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(lot# and expiration date were unknown) intramuscularly, non-dominant arm for prophylaxis.  On 14-OCT-2019, the patient experienced a moderate to severe swelling of his non-dominant arm along with arm pain. The patient stated that he lost 5-10 pounds in the week since he had the vaccine. The patient had sought medical attention. The Patient spoke with his physician and was started treatment with cephalexin 500 mg one capsule twice daily. No lab diagnostics or studies performed. The arm swelling and pain have improved but not completely resolved and the outcome of the events was recovering. The outcome of weight decreased was unknown. The reporter considered the events to be related to pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23).
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Local reaction, Pain, Pain in extremity, Rash
Clinical narrative: she experienced "a localized reaction, the injection site was red, she had a rash, and it hurt to raise her arm to get dressed"; she experienced "a localized reaction, the injection site was red, she had a rash, and it hurt to raise her arm to get dressed"; she experienced "a localized reaction, the injection site was red, she had a rash, and it hurt to raise her arm to get dressed"; This spontaneous report was received from a 57 years old female registered nurse referring to herself. Concurrent condition included cancer. Information about medical history, drug reactions/allergies and concomitant therapies was not provided.    In approximately 2018 (reported as within the last year), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (vaccine dosage detail, route of administration, lot# and expiration date were not reported) for prophylaxis (indication reported as "under 65 year old and cancer diagnosis").   In approximately 2018, the patient experienced a localized reaction, the injection site was red, she had a rash, and it hurt to raise her arm when got dressed. The patient did not seek medical attention and received no treatment for the events. It was unknown if lab diagnostics was performed. The outcome of the events was recovered within a week.  The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Sex: F
Vaccine: PPV
Symptoms: Body temperature, Chills, Fatigue, Headache, Injection site swelling
Clinical narrative: the patient received dose of PNEUMOVAX 23 and developed temperature for 1.5 days, "teeth chattering", chills, headache, nausea and tiredness and swelling at injection site; the patient received dose of PNEUMOVAX 23 and developed temperature for 1.5 days, "teeth chattering", chills, headache, nausea and tiredness and swelling at injection site; the patient received dose of PNEUMOVAX 23 and developed temperature for 1.5 days, "teeth chattering", chills, headache, nausea and tiredness and swelling at injection site; the patient received dose of PNEUMOVAX 23 and developed temperature for 1.5 days, "teeth chattering", chills, headache, nausea and tiredness and swelling at injection site; the patient received dose of PNEUMOVAX 23 and developed temperature for 1.5 days, "teeth chattering", chills, headache, nausea and tiredness and swelling at injection site; the patient received dose of PNEUMOVAX 23 and developed temperature for 1.5 days, "teeth chattering", chills, headache, nausea and tiredness and swelling at injection site; This spontaneous report was received from a pharmacist and refers to a female patient of an unknown age. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On 05-SEP-2019, the patient was vaccinated with (PNEUMOVAX23) injection, one dose, for prophylaxis, lot number: S005857, expiration date: 03-DEC-2020 (also reported as 30-DEC-2020) (exact dose and route of administration were not provided). It was reported that (PNEUMOVAX 23) was in a syringe, not in a vial.  On the same day, the patient developed temperature for 1.5 days, "teeth chattering" chills, headache, nausea, tiredness and swelling at the injection site.  The outcome of the events was unknown. The causality assessment was not provided.
Sex: F
Vaccine: PPV
Symptoms: Nausea
Clinical narrative: the patient received dose of PNEUMOVAX 23 and developed temperature for 1.5 days, "teeth chattering", chills, headache, nausea and tiredness and swelling at injection site; the patient received dose of PNEUMOVAX 23 and developed temperature for 1.5 days, "teeth chattering", chills, headache, nausea and tiredness and swelling at injection site; the patient received dose of PNEUMOVAX 23 and developed temperature for 1.5 days, "teeth chattering", chills, headache, nausea and tiredness and swelling at injection site; the patient received dose of PNEUMOVAX 23 and developed temperature for 1.5 days, "teeth chattering", chills, headache, nausea and tiredness and swelling at injection site; the patient received dose of PNEUMOVAX 23 and developed temperature for 1.5 days, "teeth chattering", chills, headache, nausea and tiredness and swelling at injection site; the patient received dose of PNEUMOVAX 23 and developed temperature for 1.5 days, "teeth chattering", chills, headache, nausea and tiredness and swelling at injection site; This spontaneous report was received from a pharmacist and refers to a female patient of an unknown age. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On 05-SEP-2019, the patient was vaccinated with (PNEUMOVAX23) injection, one dose, for prophylaxis, lot number: S005857, expiration date: 03-DEC-2020 (also reported as 30-DEC-2020) (exact dose and route of administration were not provided). It was reported that (PNEUMOVAX 23) was in a syringe, not in a vial.  On the same day, the patient developed temperature for 1.5 days, "teeth chattering" chills, headache, nausea, tiredness and swelling at the injection site.  The outcome of the events was unknown. The causality assessment was not provided.
Age: 1.25
Sex: U
Vaccine: RV5
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effects; ROTATEQ vaccine series on 10/18/2019 that was administered outside the Prescribing Information forROTATEQ; ROTATEQ vaccine series on 10/18/2019 that was administered outside the Prescribing Information forROTATEQ; This spontaneous report as received from a registered nurse and refers to a 15 month old patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 18-OCT-2019, the patient was vaccinated with a fourth dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 milliliter, oral(lot# and expiration date were not provided), for prophylaxis  that was administered outside the Prescribing Information for rotavirus vaccine, live, oral, pentavalent(ROTATEQ). Nurse reported no adverse effects for the patient.
Age: 12.0
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: the unspecified patient did not had positive antibody titers after either dose; the unspecified patient did not had positive antibody titers after either dose; Information has been received from a nurse, referring to a 12 years old female patient. The patient's medical history, concurrent condition and concomitant medications were not provided.  On an unknown date, when the patient was 12 years old, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, route, lot # and expiration date were unknown) for prophylaxis. On an unknown date, when the patient was 22 years old, the patient was vaccinated with a second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, route, lot # and expiration date were unknown) for prophylaxis.   On unknown dates, after both doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), the patient did not have positive antibody titers. It was unknown if the patient received any "measles, mumps or rubella containing vaccine" prior to age of 12 years old. The outcome of antibody test negative was unknown. The causality assessment was not reported.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pain, Pain in extremity
Clinical narrative: pain in her arms, hands and legs; she had severe pain that radiated down the arm from the injection site; the patient experienced severe swelling the size of golf ball at the injection site; she had severe pain that radiated down the arm from the injection site; This spontaneous report was received from a registered nurse refers to a 39-year-old female patient. The patient's medical history included anxiety, depression and post bariatric surgery. The patient's current conditions included drug hypersensitivity, pancytopenia, pelvic pain, perineal pain, bilateral arthritis knee, osteoarthritis, pulmonary sarcoidosis, vertigo, vitamin d deficiency, sarcoidosis, thrombocytopenia, enlarged spleen, steroid inducted diabetes, arthritis, bradycardia, pacemaker, chronic fatigue syndrome, dizziness, dorsalgia, hypertension, folate deficiency, dyspepsia, hyper-somnolence, ovarian cyst, major depressive disorder, migraines, obesity and neuropathy. The patient is allergic to codeine, contrast dye, ZOFRAN, penicillin and sulfa drugs (unspecified). Concomitant therapies included prednisone(daily), sertraline hydrochloride (ZOLOFT), folic acid, cholecalciferol (Vitamin D3), metoprolol, methotrexate, cyanocobalamin (B12 injections), meclizine, sumatriptan (IMITREX) and alprazolam (XANAX).  On 29-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose and anatomical location were not reported) lot # S018405 with expiration date:23-MAR-2021, intramuscular for prophylaxis. On the same day, patient experienced severe swelling which is of the size of golf ball at the injection site (injection site swelling). It was also reported that the patient had severe pain that radiated down the arm from the injection site (pain, injection site pain) and soreness in her arms, hands and legs (pain in extremity). The patient sought medical attention and was treated with oral prednisone. No lab diagnostics/studies were performed. The outcome of pain in extremity, injection site pain, injection site swelling, and pain was reported as not recovered. The causality assessment was not provided. No product quality complaint was involved.   This is one of the two reports from the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 13-JUL-2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported) prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) vaccination, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The relatedness between the event and zoster vaccine live (ZOSTAVAX) was reported as related.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous report was received from a lawyer referring to a female patient of unknown age. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On or about 23-JUN-2010, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, route, dosage schedule, lot number and expiration date were not reported). On an unknown date, the patient was treated by a healthcare provider for shingles. As a direct and proximate result, the patient had suffered and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions. The outcome of herpes zoster was not recovered, and the reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Tenderness
Clinical narrative: extreme soreness./ red patch painful to touch; red stripe on side of arm; This spontaneous report was received from a 56 year old female patient, who was also a company representative. The patient's concurrent conditions included hypersensitivity to "cillins and mycins". The patient's concomitant therapies included fluticasone propionate (+) salmeterol xinafoate(ADVAIR).  On 04-NOV-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 0,5 milliliter, intramuscular with lot number S006777 with expiration date on 28-NOV-2020 for prophylaxis. On 06-NOV-2019,  by morning, the patient noted a red stripe on side of an arm 1" x 2" plus some additional spots not near the injection site with extreme soreness and a red patch painful to touch (erythema and pain). That day, the patient was started on methylprednisolone for 5 days and at the time of report was recovering from the events. No laboratory work was performed.  The causal relationship between pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and the events were not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: changes in vision; Information has been received from a lawyer referring to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On an unknown date, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unknown date, the patient experienced changes in his vision. The patient did not recover from the event. As per the reporter, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The event was disabling.   The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope, Vasodilatation
Clinical narrative: patient experienced a syncope episode for 60 seconds; patient experienced a syncope episode for 60 seconds; vasodilation; Information has received from a nurse via a field representative, referring to a 9 years old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.  On 23-OCT-2019, the patient was given the first hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose of the series (lot number 1614898, expiration date was not reported defaulted as 15-NOV-2021; frequency, anatomical location and route of administration were unknown) for prophylaxis.  On the same date, the patient experienced a syncope episode for 60 seconds, then recovered. The patient was kept for 30 minutes in the office after the event for observation. The patient's mom reported her daughter had vasodilation and other syncopal episodes after this event due to injuries.  The outcome of vasodilation and syncope episodes occurred later was reported as ongoing. The causality assessment was not provided.  Upon internal review, the event syncope episodes was determined to be medically significant.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse effects; patient was administered VARIVAX and PROQUAD on the same day; Information has been received from a nurse regarding a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 11-NOV-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously, lot # S019461, expiration date 24-JUN-2021, for prophylaxis. On the same day, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) intramuscularly, lot #S006830, expiration date 02-SEP-2020, also for prophylaxis (inappropriate schedule of product administration). No adverse effects were reported.  The outcome of inappropriate schedule of product administration and the causal relationship between the event and therapy with varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) were not reported.
Age: 18.0
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effecct; 18 year old was inadvertently administered a dose of Proquad; This spontaneous report as received from a health professional via employee referring to a 18-year-old patient.    The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 11-NOV-2019, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot# and expiry date, strength, dosage information, route of administration and anatomical locations were unknown) for prophylaxis (product administered to patient of inappropriate age). On the same day, other suspect therapies included sterile diluent (MERCK STERILE DILUENT) (lot# and expiry date, strength, dosage information, route of administration, anatomical locations and indication were unknown). No adverse effects were reported. No additional information was provided. No product quality compliant (PQC) was reported. The outcome of product administered to patient of inappropriate age and no adverse event was unknown.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: one prefilled syringe of PNEUMOVAX 23 which was leaking during administration; No adverse effects; one prefilled syringe of PNEUMOVAX 23 which was leaking during administration; one prefilled syringe of PNEUMOVAX 23 which was leaking during administration; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, historical drugs, drug reactions/ allergies and concomitant medications were not reported. On 12-NOV-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (1 DS X 10 SYRINGES) prefilled syringe, lot # S012247 and expiration date 10-FEB-2021 (dose, route and anatomical location not reported) for prophylaxis. It was reported that one prefilled syringe of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) which was leaking during administration (product quality issue), (circumstance or information capable of leading to medication error) and (incorrect dose administered). The leaking occurred between the syringe hub /Luer lock and syringe needle, while the plunger rod was being pushed forward. No adverse effects reported.
Age: 33.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse effect; pediatric dose of vaqta was administered to adult patient; one pediatric dose of VAQTA was less than the one adult dose; This spontaneous report as received from a medical assistant refers to one unspecified 33 years old adult patient. The patient's medical history, concurrent conditions and concomitant mediations were not reported.      On 11-NOV-2019, the patient was vaccinated with pediatric dose of hepatitis a vaccine, inactivated(VAQTA), at a dose of 0.5 milliliter (Lot # and expiry date was not reported) for prophylaxis (product administered to patient of inappropriate age). Medical assistant reported that the one pediatric dose of the hepatitis a vaccine, inactivated(VAQTA) was less than the one adult dose of the hepatitis a vaccine, inactivated(VAQTA) that should have been administered to the patient (incorrect dose administered). No adverse events were reported.
Sex: M
Vaccine: FLUX
Symptoms: Upper respiratory tract infection
Clinical narrative: Upper respiratory infection; This case was reported by a consumer via interactive digital media and described the occurrence of respiratory infection in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, several days after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced respiratory infection (serious criteria GSK medically significant). On an unknown date, the outcome of the respiratory infection was unknown.   It was unknown if the reporter considered the respiratory infection to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient experienced an upper respiratory infection days after receiving the Flu vaccine, just like clockwork. It was reported that, the doctors said same thing it was a coincidence. The reporter felt that the doctors were lying through their teeth. As far as the whooping cough was concerned, the people were being injected then shedding the vaccine. It was reported that, if the reporter was obviously coughing and knew was sick, I would not be around a baby, or an elderly person. It was reported that, when you were vaccinated, there may be no symptoms, until had been already infected by another person. This is 1 of the 3 cases reported by the same reporter.
Sex: F
Vaccine: FLUX
Symptoms: Atypical pneumonia
Clinical narrative: Walking pneumonia; This case was reported by a consumer via interactive digital media and described the occurrence of walking pneumonia in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, 3 days after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced walking pneumonia (serious criteria GSK medically significant). On an unknown date, the outcome of the walking pneumonia was unknown.   It was unknown if the reporter considered the walking pneumonia to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The case was reported by patient's daughter. The age at vaccination was not reported. The patient experienced walking pneumonia after receiving Flu vaccine. It was reported that, the doctors said same thing it was a coincidence. The reporter felt that the doctors were lying through their teeth. As far as the whooping cough was concerned, the people were being injected then shedding the vaccine. It was reported that, if the reporter was obviously coughing and knew was sick, I would not be around a baby, or an elderly person. It was reported that, when you were vaccinated, there may be no symptoms, until had been already infected by another person. This is 1 of the 3 cases reported by the same reporter.
Sex: U
Vaccine: FLUX
Symptoms: Adverse drug reaction
Clinical narrative: Hospitalized; This case was reported by a consumer via interactive digital media and described the occurrence of adverse drug reaction in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, several days after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse drug reaction (serious criteria hospitalization). On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The case was reported by reporter's neighbour. The age at vaccination was not reported. The patient was hospitalized just days after receiving the Flu vaccine. It was reported that, the doctors said same thing it was a coincidence. The reporter felt that the doctors were lying through their teeth. As far as the whooping cough was concerned, the people were being injected then shedding the vaccine. It was reported that, if the reporter was obviously coughing and knew was sick, I would not be around a baby, or an elderly person. It was reported that, when you were vaccinated, there may be no symptoms, until had been already infected by another person. This is 1 of the 3 cases reported by the same reporter.
Age: 75.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Vaccination failure; Shingles; This case was reported by a pharmacist and described the occurrence of vaccination failure in a 75-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and 183 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that, 6 months before the date of reporting, the patient received Shingrix. At the time of reporting, the patient had just been diagnosed with shingles. It was reported that, unlike many people who had shingles the patient did not experience any pain.  The patient asked if there were any studies indicating that when one who receive Shingrix, had experienced the shingles that was less intense.