chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from the patient's mother via company representative, concerning a currently 14-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, historical drugs or allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL injection, intramuscularly (anatomical location, strength, dose, frequency, lot number and expiry date were not reported) for prophylaxis, by a health professional at a doctor's office. The injection was reported to be painful. On an unknown date, also reported as exact time not known, the patient complained repeatedly of pain and swelling at the injection site. Which, persisted for months. The outcome of pain and swelling at the injection site was not provided. The events were reported to the doctor, who indicated that the issues were probably not related to GARDASIL. However, the pain was localized at the injection site and a palpable swelling was present at the injection site.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Low grade fever (100), chills, fatigue and headache beginning 6 hours after vaccination and lasting about 36 hours. I did not experience these symptoms after the first injection about 4 months ago, so was surprised to experience them after the second injection.
Age: 20.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure during pregnancy, Pregnancy test positive, Product administered to patient of inappropriate age
Clinical narrative: Dr. ordered SHINGRIX for this patient due to the patient having a history of shingles. Patient verified to RN on 12/7/18 prior to administration of SHINGRIX dose #2 that she was not pregnant as she had done a home pregnancy test with negative results on 12/5/18. She since reports having done home pregnancy tests on 12/18/18 and 12/28/18 with negative results. Then, on 1/3/19 the patient called  Health Services to report that she had a positive home pregnancy test on this day and reported her last menstrual period as 11/12/18. Dr was notified of positive pregnancy test on 1/3/19.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Eye pain, Headache, Nausea
Clinical narrative: Headaches behind eyes and constant nausea 2 days after the shot. Dizziness, high fever on 12/28 with shivering and vomiting. After 2 weeks still experiencing nausea and headaches. Never had flu shot reactions the years before. Not subject to migraine, neither to nausea. My husband had the same vaccine on same day. He experienced the same symptoms with diarrhea.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Headaches behind eyes and constant nausea 2 days after the shot. Dizziness, high fever on 12/28 with shivering and vomiting. After 2 weeks still experiencing nausea and headaches. Never had flu shot reactions the years before. Not subject to migraine, neither to nausea. My husband had the same vaccine on same day. He experienced the same symptoms with diarrhea.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: Several days after immunization patient experienced sudden onset of sever muscle/joint pain. Over the counter pain medications helped some. Pain lasted several hours from 11am to late afternoon.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Balance disorder, Headache, Myalgia, Pain
Clinical narrative: Several days after immunization patient experienced sudden onset of sever muscle/joint pain. Over the counter pain medications helped some. Pain lasted several hours from 11am to late afternoon.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: Intense onset of pain in joints and muscles, headache, pain came on suddenly the 12/29/2018. Had to lay down as pain was so strong that it made me unbalanced. Took 1 acetaminophen rapid release 500mg to relieve pain, 1 hr later took another 500mg acetaminophen. Make pain tolerable. 12/30/2018 my body was sore and I could finally get some rest. I am a retired LPN. I know what to expect when given an injection. The pharmacist gave the injection correctly and without pain. He did warn me my arm would be very sore for a few days. If the pain had not let up, I would have called 911.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Balance disorder, Headache, Myalgia, Pain
Clinical narrative: Intense onset of pain in joints and muscles, headache, pain came on suddenly the 12/29/2018. Had to lay down as pain was so strong that it made me unbalanced. Took 1 acetaminophen rapid release 500mg to relieve pain, 1 hr later took another 500mg acetaminophen. Make pain tolerable. 12/30/2018 my body was sore and I could finally get some rest. I am a retired LPN. I know what to expect when given an injection. The pharmacist gave the injection correctly and without pain. He did warn me my arm would be very sore for a few days. If the pain had not let up, I would have called 911.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Urticaria
Clinical narrative: Patient said her whole shoulder swelled at injection site and she got hives all down her arm the morning following injection.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient experienced severe swelling, redness, and warmth at vaccine site. Patient also described itchiness. Symptoms lasted for about 5 days and were treated with OTC Ibuprofen.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: PROSTRATION  3 DAYS  RECOVERED--SYMPTOMATIC TREATMENT; FATIGUE 3 DAYS  RECOVERED--SYMPTOMATIC TREATMENT; MYALGIAS  3 DAYS  RECOVERED-- SYMPTOMATIC TREATMENT; ARTHRALGIAS. 3 DAYS  RECOVERED --SYMPTOMATIC TREATMENT; HA. 3 DAYS  RECOVERED--SYMPTOMATIC TREATMENT.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Left arm of injection site sore, shivering at night, slight fever 37.4-37.7.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever 100.4, headache, body ache. Took ADVIL and TYLENOL, lasted about 24 hours.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Injection site pain. No redness or swelling.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood test, Breast discomfort, Cardiac monitoring, Chest X-ray
Clinical narrative: Slight dizziness on 12/26/2018 and 12/27/2018. Extreme dizziness 12/28/2018 and right chest pain. Noticeable red areas on right upper back on 12/30/2018 with itching which are still present. Persistent  discomfort under right breast which is still present. Lack of energy since 12/30/2018 is still noticeable.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Computerised tomogram head, Dizziness, Electrocardiogram, Erythema
Clinical narrative: Slight dizziness on 12/26/2018 and 12/27/2018. Extreme dizziness 12/28/2018 and right chest pain. Noticeable red areas on right upper back on 12/30/2018 with itching which are still present. Persistent  discomfort under right breast which is still present. Lack of energy since 12/30/2018 is still noticeable.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urine analysis
Clinical narrative: Slight dizziness on 12/26/2018 and 12/27/2018. Extreme dizziness 12/28/2018 and right chest pain. Noticeable red areas on right upper back on 12/30/2018 with itching which are still present. Persistent  discomfort under right breast which is still present. Lack of energy since 12/30/2018 is still noticeable.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Swelling
Clinical narrative: At the time of injection patient experienced pain at injection site but not enough to notify administering pharmacist on 11/19/2018. Pain persisted and some swelling occurred. Patient visited and urgent care on 01/01/2019 and filled Rx at another pharmacy. Patient notified RPh on 01/03/2019. RPh discussed importance of notifying any adverse effects right away in the future and gave further counseling on the antibiotics and pain medication from the other pharmacy. RPh will follow up with patient in 2-3 days.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Fever 12/27/18. Rash 12/28/18 -> 12/29/18 - 48hrs. Swollen lymph node 1/3/19.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Antinuclear antibody negative, Back pain, Bartonella test negative, Blood culture negative, Blood lactate dehydrogenase increased
Clinical narrative: 11/30/18 Received flu vaccine for the first time. 12/3/18 - Developed fever, sore throat, headache, nausea, back pain, loose stools. Temp. to 103. 12/6/18 - Negative for flu and Strep. Negative throat culture. Few/mild cervical nodes. 12/12/18 - Fever continued. Further workup done. No rash.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Blood magnesium increased, Blood phosphorus normal, Blood potassium decreased, Blood uric acid increased, Blood urine present
Clinical narrative: 11/30/18 Received flu vaccine for the first time. 12/3/18 - Developed fever, sore throat, headache, nausea, back pain, loose stools. Temp. to 103. 12/6/18 - Negative for flu and Strep. Negative throat culture. Few/mild cervical nodes. 12/12/18 - Fever continued. Further workup done. No rash.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: C-reactive protein increased, Chest X-ray normal, Cough, Culture throat negative, Cytomegalovirus test negative
Clinical narrative: 11/30/18 Received flu vaccine for the first time. 12/3/18 - Developed fever, sore throat, headache, nausea, back pain, loose stools. Temp. to 103. 12/6/18 - Negative for flu and Strep. Negative throat culture. Few/mild cervical nodes. 12/12/18 - Fever continued. Further workup done. No rash.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Echocardiogram normal, Epstein-Barr virus test negative, Haematocrit normal, Haemoglobin normal
Clinical narrative: 11/30/18 Received flu vaccine for the first time. 12/3/18 - Developed fever, sore throat, headache, nausea, back pain, loose stools. Temp. to 103. 12/6/18 - Negative for flu and Strep. Negative throat culture. Few/mild cervical nodes. 12/12/18 - Fever continued. Further workup done. No rash.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Influenza virus test negative, Lymphadenopathy, Metabolic function test normal, Mononucleosis heterophile test negative
Clinical narrative: 11/30/18 Received flu vaccine for the first time. 12/3/18 - Developed fever, sore throat, headache, nausea, back pain, loose stools. Temp. to 103. 12/6/18 - Negative for flu and Strep. Negative throat culture. Few/mild cervical nodes. 12/12/18 - Fever continued. Further workup done. No rash.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Mycoplasma test positive, Nausea, Oropharyngeal pain, Pain, Platelet count increased
Clinical narrative: 11/30/18 Received flu vaccine for the first time. 12/3/18 - Developed fever, sore throat, headache, nausea, back pain, loose stools. Temp. to 103. 12/6/18 - Negative for flu and Strep. Negative throat culture. Few/mild cervical nodes. 12/12/18 - Fever continued. Further workup done. No rash.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, Red blood cells urine positive, Respiratory syncytial virus test negative, Streptococcus test negative
Clinical narrative: 11/30/18 Received flu vaccine for the first time. 12/3/18 - Developed fever, sore throat, headache, nausea, back pain, loose stools. Temp. to 103. 12/6/18 - Negative for flu and Strep. Negative throat culture. Few/mild cervical nodes. 12/12/18 - Fever continued. Further workup done. No rash.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Tuberculin test negative, Ultrasound biliary tract, Ultrasound scan normal, Urine analysis normal, White blood cell count normal
Clinical narrative: 11/30/18 Received flu vaccine for the first time. 12/3/18 - Developed fever, sore throat, headache, nausea, back pain, loose stools. Temp. to 103. 12/6/18 - Negative for flu and Strep. Negative throat culture. Few/mild cervical nodes. 12/12/18 - Fever continued. Further workup done. No rash.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: White blood cells urine negative
Clinical narrative: 11/30/18 Received flu vaccine for the first time. 12/3/18 - Developed fever, sore throat, headache, nausea, back pain, loose stools. Temp. to 103. 12/6/18 - Negative for flu and Strep. Negative throat culture. Few/mild cervical nodes. 12/12/18 - Fever continued. Further workup done. No rash.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Contusion, Face injury, Fall, Headache
Clinical narrative: Patient had a headache and chills the next morning after vaccine was administered. She was very faint and fell the next morning as well. Patient was in bed most of the day. She hit her cheekbone on floor and has a black/blue bruise but did not seek medical attention for it.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Patient had a headache and chills the next morning after vaccine was administered. She was very faint and fell the next morning as well. Patient was in bed most of the day. She hit her cheekbone on floor and has a black/blue bruise but did not seek medical attention for it.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Myalgia, Pain in extremity
Clinical narrative: Muscle aches and pains-throughout body as well as left arm. Headache-2 days. Severe redness in upper left arm from shoulder to elbow. 4 days to resolve. No fever-ongoing muscle pain in right arm for several weeks after injection.
Age: 1.58
Sex: U
Vaccine: FLU4
Symptoms: Abdominal pain, Allergy test, Urticaria, Vomiting
Clinical narrative: Hives, vomiting, and abdominal pain w/in 48 hours of vaccine administration.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Abscess, Fungal test, Gram stain, Incisional drainage, Mycobacterium test
Clinical narrative: I&D of bilateral arm abscesses.
Age: 34.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Dysuria, Headache, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a nurse referring to a 34-year-old female patient. The patient's medical history and concomitant therapies were not reported. Her drug allergies included hypersensitivity to amoxicillin and penicillin. Her food allergies included hypersensitivity to cherries, apricots, kiwi and nuts. On 12-DEC-2018, the patient was vaccinated with PNEUMOVAX 23, (strength, dose and frequency were not provided), lot number R011632, expiration date 02-FEB-2020, intramuscular; and with influenza virus vaccine (unspecified) (strength, dose, frequency, route of administration, lot number and expiration date were not provided); as prophylaxis. On 13-DEC-2018, the patient called the office and reported that she "had significant right arm injection site redness (site erythema), itching (injection site pruritus), pain (injection site pain) (reported as a "9 out of 10 pain score"), nausea, body aches (pain), chills, headache, stiff neck (musculoskeletal stiffness) and dysuria. The nurse reported that the patient went back to the office on 17-DEC-2018, and was recommended cool compresses for the right arm injection site, TYLENOL, an unspecified non-sedating antihistamine, ondansetron for nausea, and to take a single dose of BENADRYL at bedtime. She also reported that an urinalysis was performed on an unspecified date in December 2018 (results were not provided) and that was expected that the patient returned to the office on 28-DEC-2018, for dysuria follow-up. The outcome in regards to all the events was unknown by reporter. Relatedness between vaccines PNEUMOVAX 23 and influenza virus vaccine (unspecified) with the events was not provided.
Age: 34.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site pruritus, Musculoskeletal stiffness, Nausea, Pain, Urine analysis
Clinical narrative: This spontaneous report as received from a nurse referring to a 34-year-old female patient. The patient's medical history and concomitant therapies were not reported. Her drug allergies included hypersensitivity to amoxicillin and penicillin. Her food allergies included hypersensitivity to cherries, apricots, kiwi and nuts. On 12-DEC-2018, the patient was vaccinated with PNEUMOVAX 23, (strength, dose and frequency were not provided), lot number R011632, expiration date 02-FEB-2020, intramuscular; and with influenza virus vaccine (unspecified) (strength, dose, frequency, route of administration, lot number and expiration date were not provided); as prophylaxis. On 13-DEC-2018, the patient called the office and reported that she "had significant right arm injection site redness (site erythema), itching (injection site pruritus), pain (injection site pain) (reported as a "9 out of 10 pain score"), nausea, body aches (pain), chills, headache, stiff neck (musculoskeletal stiffness) and dysuria. The nurse reported that the patient went back to the office on 17-DEC-2018, and was recommended cool compresses for the right arm injection site, TYLENOL, an unspecified non-sedating antihistamine, ondansetron for nausea, and to take a single dose of BENADRYL at bedtime. She also reported that an urinalysis was performed on an unspecified date in December 2018 (results were not provided) and that was expected that the patient returned to the office on 28-DEC-2018, for dysuria follow-up. The outcome in regards to all the events was unknown by reporter. Relatedness between vaccines PNEUMOVAX 23 and influenza virus vaccine (unspecified) with the events was not provided.
Age: 40.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Hypoaesthesia, Injection site pain
Clinical narrative: Adverse Events: Strong pain at site, this increased for 24 hours, then slowly decreased from 24-72 hours. At about 6 days, numbness in toes and hands developed. This was followed by outbreak of multiple blisters on hands, and grouped blisters of larger size on the sides of the lower torso.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Rash macular
Clinical narrative: Immediatly after ROTATEQ was given pt. had red blotches appear on her trunk, chest, and lower ext.   No s/s resp distress, n/v, and pt. remained happy without behavior change.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Patient states that a few days after receiving the ADACEL she is experiencing a red, hot, hard lump at the injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chapped lips, Limb discomfort, Pyrexia
Clinical narrative: The patient told that she started developing fever, lips were breaking and felt discomfort in the arm that was vaccinated during the night. The next day (1/4/2019) she reported the adverse event to the pharmacy, She said that she took Acetaminophen for the fever and pain the day after she was vaccinated. It was recommended to the patient to visit the physician or other healthcare professional. She said that she was going to wait to see if the medications she took help her, if not, she was going to visit the physician.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 66 year old female patient with depression. Information about pertinent medical history was unknown, the patient's drug reactions/allergies included tetracyclin, augmentin (reported as audmentin), erythromycin (reported as euirthyromycin) and codeine. The patient's concomitant medications included dapagliflozin (FARXIGA), glipizide (GLIPIZIDE), levothyroxine sodium(SYNTHROID), famotidine (FAMOTIDINE), pantoprazole (PANTOPRAZOLE), pramipexole dihydrochloride (MIRAPEX), hydrochlorothiazide, lisinopril (HYDROCHLOROTHIAZIDE (+) LISINOPRIL), cyanocobalamin (CYANOCOBALAMIN), albuterol sulfate (PROAIR (ALBUTEROL SULFATE)), metformin hydrochloride, sitagliptin phosphate (JANUMET XR), fluticasone propionate (FLONASE), insulin glargine (TOUJEO), pregabalin (LYRICA), paroxetine hydrochloride (PAXIL), montelukast sodium (SINGULAIR), pravastatin and dicyclomine. On 07-DEC-2018, the patient was vaccinated with an injection of PNEUMOVAX 23 injection in the medical office (lot # R016638 with expiration date 28-JAN-2020,in the right arm, dose detail and route were not reported) for avoid pneumococcal disease (prophylaxis). On the same day, several hours after injection, the patient called the medical office stated the arm that received the vaccination was swollen, red at the injection site and itching at the injection site. The physician told the patient to put ice on the swollen arm and take unspecified diphenhydramine hydrochloride (BENADRYL) and ibuprofen (ADVIL). The outcome of events were reported as not recovered. The causality assessments between events and PNEUMOVAX 23 were not reported.
Age: 0.17
Sex: U
Vaccine: HIBV, MMRV
Symptoms: Incorrect route of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a nurse referring to a 2 mouths old patient of unknown gender. Concomitant therapies included LIQUID PEDVAXHIB. Information about medical history, concurrent conditions and drug or allergy reactions was unknown. On 13-DEC-2018, the patient was administered a dose of PROQUAD (lot # R017800, expiration date 19-DEC-2019, strength and frequency were unknown) intramuscular for prophylaxis (Inappropriate age at vaccine administration). No adverse effects was reported.
Age: 0.5
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a physician referring to a 6 month old patient of an unknown gender. Information about pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medication was not reported. On 17-DEC-2018, the patient was inadvertently vaccinated with a pediatric dose of VAQTA injection (dose detail, route, lot # and expiration date were not reported) for prophylaxis (incorrect dosage administered and product administered to patient of inappropriate age). No adverse effects reported.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a currently 4 years old male patient. Information about medical history, concurrent conditions concomitant medication and drug reactions/allergies was not provided. On an unknown date the patient received an improperly stored dose of PROQUAD (rHA (recombinant Human albumin)) (lot number: R012413; expiration date: 28-OCT-2019; dose detail, strength and route were unknown) for prophylaxis (product storage error), which was reconstituted with properly stored sterile diluent. The vaccine was stored between 15 degrees Fahrenheit to 46 degrees Fahrenheit for 4 hours. There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: Information has been received from the patient's mother referring to a female patient of unknown age. Information about concomitant medication, pertinent medical history, drug reactions/allergies was not provided. In 2013, the patient was vaccinated with GARDASIL 9 for prophylaxis (strength, dose, frequency, route, lot # and expiration date were not reported) and did not complete the full dosing regimen (inappropriate schedule of product administration). Information about treatment given for the event, lab diagnostics/studies and medical attention was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 05-DEC-2018, the patient was vaccinated with improperly stored dose of VARIVAX (strength and dose were not reported) (lot # R018931 and expiry date: 02-JUL-2020), via subcutaneous for prophylaxis (product storage error). The vaccine vas reconstituted with properly stored sterile diluent (manufacturer unknown). The vaccine was stored in between -14 degree Celsius (C) to -10 C (-14 C) for 27 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This report is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1812USA005671.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 05-DEC-2018, the patient was vaccinated with improperly stored dose of VARIVAX (strength and dose were not reported) (lot # R018931 and expiry date: 02-JUL-2020), via subcutaneous for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). The vaccine was stored in between -14 degree Celsius (C) to -10 C (-14 C) for 27 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This report is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1812USA005671.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 06-DEC-2018, the patient was vaccinated with improperly stored dose of VARIVAX (strength and dose were not reported) (lot # R018931 and expiry date: 02-JUL-2020), via subcutaneous for prophylaxis (product storage error). The vaccine vas reconstituted with properly stored sterile diluent (manufacturer unknown). The vaccine was stored in between -14 degree Celsius (C) to -10 C (-14 C) for 27 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This report is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1812USA005671.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 21-DEC-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (Strength, dose, frequency and anatomical location were not reported) (Route defaulted to oral) of lot # R015607 with an expiry date of 21-APR-2020 for prophylaxis. There was no adverse effect reported. The ROTATEQ was exposed to a temperature below 32 Fahrenheit (29 Fahrenheit) for a timeframe of 1 hour 15 minutes. There were no previous temperature excursions. A digital data logger was involved. There was no product quality complaint associated with this report. This is one of the three reports received from the same reporter. Sender's Comments: US-009507513-1812USA012134; US-009507513-1812USA012132.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, past drugs and concomitant medications were unknown. On 21-DEC-2018, the patient was vaccinated with an improperly stored dose (temperature was below 32 Fahrenheit (29 Fahrenheit) for 1 hour 15 minutes) of ROTATEQ (dose, frequency and route were unknown) (lot# R015607; expiration date: 21-APR-2020) for prophylaxis. No adverse effects reported. There were no previous temperature excursions. A digital data logger was involved. This is one of the three reports from the same reporter.
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Dyspnoea, Injected limb mobility decreased, Injection site bruising
Clinical narrative: This spontaneous report as received from a nurse referring to a 64-year old female patient. Patient's concurrent condition included erythromycin allergy. Historical drug included erythromycin. Patient's medical history was not reported. On 18-DEC-2018, the patient was vaccinated with PNEUMOVAX 23 (lot # R011632, expiry date: 02-FEB-2020), 1 dosage form intramuscularly in the arm for prophylaxis. Concomitant therapies included as vitamin d (unspecified) and fluticasone (FLONASE). On 19-DEC-2018, the patient developed a temperature of 101 F (temperature increased), bruised, mottled appearance at the injection site and chills. The nurse reported that the patient had a scheduled appointment with an unspecified pulmonologist who made unspecified changes in her unspecified medications due to respiratory distress. The patient returned to the office on 20-DEC-2018 and was wheezing and having shortness of breath and that the injection site appearance looked like hives. The patient received an unspecified dose of oral prednisone, Ipratropium bromide/salbutamol (DUONEB) and albuterol sulfate (ALBUTEROL) nebulizer treatment (also reported as concomitant medication), unspecified dose of ibuprofen, paracetamol (TYLENOL) and an unspecified dose of diphenhydramine (BENADRYL). The patient called to the office on 27-DEC-2018 and reported she still had extreme injection site pain and difficulty moving her arm to dress (dyskinesia). The patient would return to the office on 28-DEC-2018 to office for further examination. The outcome of events was reported as not recovered/not resolved. The reporter did not provide any causality assessment for events. Upon internal review, the events the event dyskinesia was considered to be serious due to disability and the event respiratory distress was found to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site urticaria, Livedo reticularis, Respiratory distress
Clinical narrative: This spontaneous report as received from a nurse referring to a 64-year old female patient. Patient's concurrent condition included erythromycin allergy. Historical drug included erythromycin. Patient's medical history was not reported. On 18-DEC-2018, the patient was vaccinated with PNEUMOVAX 23 (lot # R011632, expiry date: 02-FEB-2020), 1 dosage form intramuscularly in the arm for prophylaxis. Concomitant therapies included as vitamin d (unspecified) and fluticasone (FLONASE). On 19-DEC-2018, the patient developed a temperature of 101 F (temperature increased), bruised, mottled appearance at the injection site and chills. The nurse reported that the patient had a scheduled appointment with an unspecified pulmonologist who made unspecified changes in her unspecified medications due to respiratory distress. The patient returned to the office on 20-DEC-2018 and was wheezing and having shortness of breath and that the injection site appearance looked like hives. The patient received an unspecified dose of oral prednisone, Ipratropium bromide/salbutamol (DUONEB) and albuterol sulfate (ALBUTEROL) nebulizer treatment (also reported as concomitant medication), unspecified dose of ibuprofen, paracetamol (TYLENOL) and an unspecified dose of diphenhydramine (BENADRYL). The patient called to the office on 27-DEC-2018 and reported she still had extreme injection site pain and difficulty moving her arm to dress (dyskinesia). The patient would return to the office on 28-DEC-2018 to office for further examination. The outcome of events was reported as not recovered/not resolved. The reporter did not provide any causality assessment for events. Upon internal review, the events the event dyskinesia was considered to be serious due to disability and the event respiratory distress was found to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Wheezing
Clinical narrative: This spontaneous report as received from a nurse referring to a 64-year old female patient. Patient's concurrent condition included erythromycin allergy. Historical drug included erythromycin. Patient's medical history was not reported. On 18-DEC-2018, the patient was vaccinated with PNEUMOVAX 23 (lot # R011632, expiry date: 02-FEB-2020), 1 dosage form intramuscularly in the arm for prophylaxis. Concomitant therapies included as vitamin d (unspecified) and fluticasone (FLONASE). On 19-DEC-2018, the patient developed a temperature of 101 F (temperature increased), bruised, mottled appearance at the injection site and chills. The nurse reported that the patient had a scheduled appointment with an unspecified pulmonologist who made unspecified changes in her unspecified medications due to respiratory distress. The patient returned to the office on 20-DEC-2018 and was wheezing and having shortness of breath and that the injection site appearance looked like hives. The patient received an unspecified dose of oral prednisone, Ipratropium bromide/salbutamol (DUONEB) and albuterol sulfate (ALBUTEROL) nebulizer treatment (also reported as concomitant medication), unspecified dose of ibuprofen, paracetamol (TYLENOL) and an unspecified dose of diphenhydramine (BENADRYL). The patient called to the office on 27-DEC-2018 and reported she still had extreme injection site pain and difficulty moving her arm to dress (dyskinesia). The patient would return to the office on 28-DEC-2018 to office for further examination. The outcome of events was reported as not recovered/not resolved. The reporter did not provide any causality assessment for events. Upon internal review, the events the event dyskinesia was considered to be serious due to disability and the event respiratory distress was found to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Ophthalmic herpes simplex
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or around JANUARY 2017, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for its intended purpose:  the prevention of shingles. Shortly after receiving ZOSTAVAX, the patient suffered Herpes simplex keratitis and vision loss. As a direct and proximate result of ZOSTVAX, the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his (Conflicting information, as patient is reported as a female (female name)) condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, 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. As a direct and proximate result of ZOSTAVAX, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The reporter considered the events to be related to ZOSTAVAX. Upon internal review, Herpes simplex keratitis and vision loss were determined to be medically significant events. The events of Herpes simplex keratitis and vision loss were considered to be disabling. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Infectious mononucleosis
Clinical narrative: This spontaneous report as received from a other health professional refers to a 19 year old female patient with fatigue and immunisation. On 25-JUL-2018 the patient was vaccinated with GARDASIL 9 lot # N004798, intramuscular for immunisation. On OCT-2018 the patient experienced infectious mononucleosis. The outcome of infectious mononucleosis was reported as recovered/resolved.  {Additional information has been requested. / Additional information is not expected.}
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-JAN-2019, the patient was vaccinated with improperly stored VARIVAX (dose not reported, lot # N028711, expiration date 13-OCT-2019) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# R002208, expiration date 06-DEC-2019). No adverse effects reported. Digital Data Logger was involved. The vaccine experienced temperature excursion from 9 degrees Celsius to 25 degrees Celsius for 17 minutes. There were no previous temperature excursions.
Age: 1.17
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Computerised tomogram normal, Crying, Encephalopathy, Pyrexia, Seizure
Clinical narrative: Information has been downloaded from database (US-GlaxoSmithKline-A0707509A). Information has been received from a physician referring to a 14 month old female patient. The patient's medical history, current condition and concomitant therapy were unknown. In January 2008, the patient was vaccinated with varicella virus vaccine live (oka/merck)(manufacturer unknown) (dose 1, route, batch/lot number and expiration date were not provided), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) (dose 1, route, batch/lot number and expiration date were not provided) and PEDIARIX (0.5 ml, single dose;  route, batch/lot number and expiration date were not provided), all for prophylaxis. In January 2008, the patient experienced sepsis, fever, crying, seizure and encephalopathy. In January 2008, a body temperature test was performed and showed increased. A computerised tomogram (CAT) scan was performed and showed normal. The outcome of all the events was unknown. The event sepsis were considered to be related to all suspect products. The causality assessments between other events and suspect products were not provided by the reporter. Rechallenge was done for all suspect products, outcome was unknown. All of the evens were considered to be serious for the following reason: life threatening.
Age: 1.17
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Sepsis
Clinical narrative: Information has been downloaded from database (US-GlaxoSmithKline-A0707509A). Information has been received from a physician referring to a 14 month old female patient. The patient's medical history, current condition and concomitant therapy were unknown. In January 2008, the patient was vaccinated with varicella virus vaccine live (oka/merck)(manufacturer unknown) (dose 1, route, batch/lot number and expiration date were not provided), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) (dose 1, route, batch/lot number and expiration date were not provided) and PEDIARIX (0.5 ml, single dose;  route, batch/lot number and expiration date were not provided), all for prophylaxis. In January 2008, the patient experienced sepsis, fever, crying, seizure and encephalopathy. In January 2008, a body temperature test was performed and showed increased. A computerised tomogram (CAT) scan was performed and showed normal. The outcome of all the events was unknown. The event sepsis were considered to be related to all suspect products. The causality assessments between other events and suspect products were not provided by the reporter. Rechallenge was done for all suspect products, outcome was unknown. All of the evens were considered to be serious for the following reason: life threatening.
Sex: F
Vaccine: PNC13
Symptoms: Back pain, Loss of personal independence in daily activities, Neck pain, Palpitations, Pelvic pain
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). A 70-year-old female patient received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported experiencing some palpitations, lower back pain and pelvic pain that totally incapacitated her to do her daily routines. The patient added that she also experienced neck pain that has subsided. The patient reported that the pain has been so severe that she cannot bend over, could not sleep, it was just constant that nothing like ADVIL or ALEVE do not help. The patient reported that she has already seen various doctors (gynecologist, orthopedic and rheumatologist) none of which knew what was going on. The patient searched information on the internet where she found that this was a reported side effect with the vaccine. The patient added that a doctor wanted to inject her with medication to alleviate pain. The outcome of event 'neck pain' was recovered on unspecified date; all other events was not recovered. Information on the batch number has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Vomiting
Clinical narrative: Chills, headache, aches, nausea/vomiting.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Syncopal episode and falling forward off the table and hit head on the floor.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pain
Clinical narrative: Shivering, headache, chills & muscle and body aches.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Lip discolouration, Pyrexia, Rash pustular
Clinical narrative: Fever, chills, headache then on 6/25 I broke out with 2 pustules on my lip and left ear lobe.
Age: 51.0
Sex: F
Vaccine: FLU4, HEPAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient has not reported any adverse events but third vaccine was given early. Patient received first dose 5/30/18, second dose 7/11/18, and third dose 9/26/18 (last dose was 2 months early). I spoke with GSK this morning and they recommended the patient get one dose of HAVRIX adult for full protection against Hepatitis A.
Age: 26.0
Sex: M
Vaccine: HPV9
Symptoms: Anogenital warts
Clinical narrative: This spontaneous report as received from a nurse practitioner via a field representative regarding a 26 year old male patient. His concurrent conditions, medical history, and concomitant medications were unknown. On 19-OCT-2018, the patient was vaccinated with first dose of GARDASIL 9 in the right arm (lot# N023238, expiry 25-JUN-2020) for preventing human papilloma virus (HPV). On an unknown date in November 2018 (reported as about a month after the vaccine), the patient experienced anal warts (anogenital warts). The patient sought medical attention with an office visit and was treated with unspecified treatment. The outcome of anogenital warts was reported as recovering/resolving. Causality was unknown.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a medical assistant and refers to a 21-year-old female patient. Her medical history, concurrent conditions and concomitant drugs were not reported. On 24-DEC-2018, the patient came to the office for wellness checkup and was vaccinated with GARDASIL 9, intramuscularly, lot# R026380, expiration date 23-JUN-2021 (exact dose and site of administration were not reported) for prophylaxis (reported as for vaccination). On the same day, after the vaccination, an unspecified pregnancy test results came back positive. The date of last menstrual period (LMP) was 03-DEC-2018 (as the patient reported) and estimated delivery date (EDD) was 09-SEP-2019. It was reported that at the time of the report, the patient was still pregnant and she did not experienced any adverse reactions. The pregnancy outcome was pending.
Age: 13.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 13-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored dose of VAQTA, lot # R018935, expiration date 05-SEP-2019 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12-months-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored dose of VAQTA, lot # R018935, expiration date 05-SEP-2019 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 4.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 20-DEC-2018, the patient was vaccinated with improperly stored dose of VAQTA, lot # R018935, expiration date 05-SEP-2019 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.