chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 4-months-old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 11-NOV-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) of lot # S004398 with expiration date 31-OCT-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 9-weeks-old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 23-OCT-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) of lot # S004398 with expiration date 31-OCT-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 4-months-old male patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 25-OCT-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) of lot # S004398 with expiration date 31-OCT-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 9-weeks-old male patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 30-OCT-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) of lot # S004398 with expiration date 31-OCT-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 6-months-old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 12-NOV-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) of lot # S004398 with expiration date 31-OCT-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 6-months-old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 22-OCT-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) of lot # S004398 with expiration date 31-OCT-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 4-months-old male patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 05-NOV-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) of lot # S004398 with expiration date 31-OCT-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
Sex: F
Vaccine: MENB
Symptoms: Injection site mass
Clinical narrative: lump at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site lump in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, less than 6 months after receiving Bexsero, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was not recovered/not resolved.   It was unknown if the reporter considered the injection site lump to be related to Bexsero.  Additional details were reported as follows The age at vaccination was not reported. The reporter indicated that her daughter received the first dose of Bexerso six weeks ago and still had a lump at the injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid Disease; This case was reported by a physician via call center representative and described the occurrence of rheumatoid arthritis in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant). On an unknown date, the outcome of the rheumatoid arthritis was unknown.   It was unknown if the reporter considered the rheumatoid arthritis to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had a rheumatoid disease and was going to start an immunosuppressive therapy before receiving the second dose of Shingrix. The physician mentioned that he had done the same with other patients, administering Shingrix while they were in an immunosuppressive therapy. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient received the first dose of Shingrix vaccine on November 6 or 7 of 2019.  The patient states she experienced arm pain after getting the first dose of Shingrix vaccine that lasted for 2 to 3 days.  Did not consent to follow-up. No further details were provided.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema of eyelid, Eye infection, Swelling of eyelid, Tic, Urticaria
Clinical narrative: Facial tics then progressing to eye injection, redness and mild swelling to eyelids, hives to face and neck
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Screaming
Clinical narrative: PATIENT SCREAMED FOR > 4 HOURS AFTER RECEIVING VACCINES
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Chills, Eructation, Headache, Hypersomnia
Clinical narrative: 12 hours after receiving the shot I developed a headache, chills, muscle aches and had to go to bed.  I slept for 13 hours (I normally sleep for about 7 hours) I still had a headache in the morning so I took some over the counter pain reliever and the headache went away.  I did not get nauseous, but I had made sure not to eat in the evening ... so I just was burping and feeling very full. I also checked the arm that received the injection.  The shot was on Friday.  On Saturday, Sunday and Monday a rash appeared 4 inches below the injection site.  The area was swollen and painful too.  The rash spread a little each day ... but then started to fade and welling started to subside later on Monday.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Myalgia
Clinical narrative: 12 hours after receiving the shot I developed a headache, chills, muscle aches and had to go to bed.  I slept for 13 hours (I normally sleep for about 7 hours) I still had a headache in the morning so I took some over the counter pain reliever and the headache went away.  I did not get nauseous, but I had made sure not to eat in the evening ... so I just was burping and feeling very full. I also checked the arm that received the injection.  The shot was on Friday.  On Saturday, Sunday and Monday a rash appeared 4 inches below the injection site.  The area was swollen and painful too.  The rash spread a little each day ... but then started to fade and welling started to subside later on Monday.
Age: 26.0
Sex: M
Vaccine: HEPAB, HPV9
Symptoms: Cold sweat, Feeling cold, Pallor, Seizure, Snoring
Clinical narrative: Patient became cool, clammy, and pale. Started snoring heavily and slumped forward with eyes opened. He began seizing and convulsing which lasted approximately 15 seconds and then slowly came to.
Age: 26.0
Sex: M
Vaccine: HEPAB, HPV9
Symptoms: Syncope
Clinical narrative: Patient became cool, clammy, and pale. Started snoring heavily and slumped forward with eyes opened. He began seizing and convulsing which lasted approximately 15 seconds and then slowly came to.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Nodule
Clinical narrative: Patient said large red mark and knot in shoulder and was seen by a quick clinic and given an antibiotic.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Inflammation, Injected limb mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Within an hour or two - extreme pain.  Had to move the vaccinated arm with my good arm.  It was way too painful to move on its own.  I had the chills and extreme shivering.  I may have had a temperature but did not have a thermometer.  The pain lasted a week.  It would not go away.  Ended up in physical therapy for about 2 months. The inflammation from the vaccine settled in my left shoulder. The physical therapy did help, but my shoulder still hurts, but not like it did in the beginning.  I am not taking the second dose due to the adverse effects of the first one.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Acoustic stimulation tests, Deafness, Dysacusis, Hearing aid user, Pain in jaw
Clinical narrative: My  adverse reactions to the Fluzone HD was hearing loss and jaw pain.  I cannot prove that but my husband, who is also reporting to you, had the same vaccine at the same time and has had the same two problems at the same times as I have had them.  Such has never happened before therefore we am convienced the Fluzone HD was the cause. My hearing loss started as a hollow echoing sound.  The loss continues and the hollow echoing sound comes and goes.   I have since gotten hearing aids. A week after the hearing loss, my right jaw joint started hurting.  The pain has continued  since then, some days less some days more.  My husband's jaw joint pain started the same week in both his jaws.  We don't think this is coincidence.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Dyskinesia, Injection site swelling, Neck pain, Pain in extremity
Clinical narrative: Patient states that on 4/24/20  her left arm became achy and sore  and stated that her joints are sore . Joints that are  sore mostly on her left side and include knees and hips . On Saturday patient stated that the pain hurt on back of neck and was hard to open her mouth. Patient took IBU and placed cool wash cloth on site. States site looks a little swollen. Patient states that symptoms are better today 4/28/20 and was advised to monitor for changes , push fluids and take Tylenol.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Acoustic stimulation tests, Deafness unilateral, Hearing aid user, Pain in jaw
Clinical narrative: My  adverse reactions to the Fluzone HD was hearing loss and jaw pain.  I cannot prove that but my wife, who is also reporting to you, had the same vaccine at the same time and had the same two problems at the same times as I have had them.  Such has never happened before therefore we am convienced Fluzone HD was the cause. I have been deaf in my left ear for several years however my hearing was good in my right ear untl November 2, 2019, three days after receiving the Fluzone HD vaccine.   I lost most of my hearing in my "good" ear that day.  I was virtually deaf intil I got my hearing aids Feb 13th, two and half months later.  A week after my hearing loss, I started having pain in both my jaw joints and it continues more some days and less other days.  My wife's jaw joint pain which started the same week is only in her right jaw.  We don't think this could be coincidence.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema
Clinical narrative: The patient experienced a red band all the way around her arm that lasted for two weeks.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Gait disturbance, Hypersomnia, Memory impairment
Clinical narrative: A few hours following vaccination patient reported being "knocked out" and explains that she slept for almost 12 hours which she normally does not do. Patient states when she woke up she was very confused, had trouble recalling simple facts such as place and time. Patient states she also had a hard time walking.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: other unspecified patients were administered GARDASIL 9 outside of recommended dosing schedules; no adverse event; Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.      On unknown dates, the patient was administered with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route, lot # and expiration date were unknown) for prophylaxis outside of recommended dosing schedules (inappropriate schedule of product administration). No additional adverse events were reported.  This is a non-valid case due to lack of patient's identifier.; Sender's Comments:  US-009507513-2002USA008507:
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: I started experiencing slight itching / started receiving slight itching several months later / Itching is in the trunk area; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes (pre diabetes).   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, several months after receiving Shingrix, the patient experienced pruritus. The patient was treated with hydrocortisone acetate (Cortisone (Hydrocortisone Acetate)) and dermatologicals nos (Lotion). On an unknown date, the outcome of the pruritus was recovered/resolved.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received Shingrix several years ago and several months later experiencing slight itching and itching in the trunk area. The patient had itching for 3 years on trunk of body. No rash just itch. The reporter thought it was related to my pre diabetes and so tolerated it and used lotions. The patient reported physician finally put on Cortisone and had relief.
Sex: F
Vaccine: VARZOS
Symptoms: Audiogram abnormal, Deafness, Deafness neurosensory, Deafness unilateral, Ear discomfort
Clinical narrative: difficulty with all sounds/severe left ear hearing loss; severe sensorineural hearing loss of left ear/worsening left-sided sensorineural hearing loss/bilateral asymmetric sensorineural hearing loss; mild vibration in the left ear; speech discrimination; tinnitus/subjective tinnitus of left ear.; left side of the face was slightly numb; This case was reported by a lawyer and described the occurrence of hearing loss in a 55-year-old female patient who received Herpes zoster (Shingrix) for shingles.   On 19th March 2019, the patient received Shingrix (unknown) 50 mcg/mg. On an unknown date, 1 month after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant), sensorineural hearing loss (serious criteria GSK medically significant), abnormal sensation in ear, speech disorder, tinnitus and numbness facial. The action taken with Shingrix was unknown. On an unknown date, the outcome of the hearing loss, sensorineural hearing loss, abnormal sensation in ear, speech disorder, tinnitus and numbness facial were unknown.   It was unknown if the reporter considered the hearing loss, sensorineural hearing loss, abnormal sensation in ear, speech disorder, tinnitus and numbness facial to be related to Shingrix.  Additional information: As per legal complaint, the patient had sustained sensorineural hearing loss of left ear.  The initial information was received on 21 April 2020 via medical records (case now medically confirmed).The patient current condition included non-smoker and social alcohol use. On 19 March 2019, the patient had shingrix 50mcg (shingles vaccine), patient had left-sided sensorineural hearing loss after using Shingrix. As per record dated on 29 April 2019, the patient had mild vibration in the left ear. As per record dated on 03 May 2019, the patient noted sudden hearing loss in the left ear. She feels continued hearing loss on that side; the left side of the face was  slightly numb. Audiometric evaluation shows there had been worsening of her left sensorineural hearing loss in the left ear. She continues to have 4 percentage speech discrimination and a severe sensorineural hearing loss throughout rest of the frequencies in the left ear. As per record dated on 06 May 2019, the patient presents with complaints of sudden onset of constant episodes of severe left ear hearing loss, described as difficulty with all sounds. The Patient experiencing hearing loss associated symptoms include tinnitus. As per record dated on 25 June 2019, patient had on bilateral asymmetric sensorineural hearing loss , hearing loss, sudden, subjective tinnitus of left ear.      Lab Comments: Audiometric evaluation shows there has been worsening of her left sensorineural hearing loss in the left ear.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Speech disorder, Sudden hearing loss, Tinnitus
Clinical narrative: difficulty with all sounds/severe left ear hearing loss; severe sensorineural hearing loss of left ear/worsening left-sided sensorineural hearing loss/bilateral asymmetric sensorineural hearing loss; mild vibration in the left ear; speech discrimination; tinnitus/subjective tinnitus of left ear.; left side of the face was slightly numb; This case was reported by a lawyer and described the occurrence of hearing loss in a 55-year-old female patient who received Herpes zoster (Shingrix) for shingles.   On 19th March 2019, the patient received Shingrix (unknown) 50 mcg/mg. On an unknown date, 1 month after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant), sensorineural hearing loss (serious criteria GSK medically significant), abnormal sensation in ear, speech disorder, tinnitus and numbness facial. The action taken with Shingrix was unknown. On an unknown date, the outcome of the hearing loss, sensorineural hearing loss, abnormal sensation in ear, speech disorder, tinnitus and numbness facial were unknown.   It was unknown if the reporter considered the hearing loss, sensorineural hearing loss, abnormal sensation in ear, speech disorder, tinnitus and numbness facial to be related to Shingrix.  Additional information: As per legal complaint, the patient had sustained sensorineural hearing loss of left ear.  The initial information was received on 21 April 2020 via medical records (case now medically confirmed).The patient current condition included non-smoker and social alcohol use. On 19 March 2019, the patient had shingrix 50mcg (shingles vaccine), patient had left-sided sensorineural hearing loss after using Shingrix. As per record dated on 29 April 2019, the patient had mild vibration in the left ear. As per record dated on 03 May 2019, the patient noted sudden hearing loss in the left ear. She feels continued hearing loss on that side; the left side of the face was  slightly numb. Audiometric evaluation shows there had been worsening of her left sensorineural hearing loss in the left ear. She continues to have 4 percentage speech discrimination and a severe sensorineural hearing loss throughout rest of the frequencies in the left ear. As per record dated on 06 May 2019, the patient presents with complaints of sudden onset of constant episodes of severe left ear hearing loss, described as difficulty with all sounds. The Patient experiencing hearing loss associated symptoms include tinnitus. As per record dated on 25 June 2019, patient had on bilateral asymmetric sensorineural hearing loss , hearing loss, sudden, subjective tinnitus of left ear.      Lab Comments: Audiometric evaluation shows there has been worsening of her left sensorineural hearing loss in the left ear.
Sex: F
Vaccine: TYP, YF
Symptoms: Abdominal pain upper, Chills, Pyrexia
Clinical narrative: CHILLS; ABDOMINAL PAIN UPPER; FEVERISH; This case (817519-1) was extracted through VAERS database on 30-Aug-2019. The case was reported from a healthcare professional via health authority. It described a 30-year-old female consumer who felt feverish (PT: Pyrexia), experienced chills (PT: Chills) and stomachache (PT: Abdominal pain upper), after the administration of oral Vivotif (lot number: 3003253; dose 1) and subcutaneous Stamaril (yellow fever vaccine; lot number: R3H491V) in the left arm for unknown indications.  Case report: The consumer took first dose of Vivotif on 21-May-2019. After 4 days of having Vivotif, she felt feverish and experienced chills and stomachache on 25-May-2019. She also took Stamaril along with Vivotif on the same day. On 01-Jun-2019, she was hospitalized for a day and was sent back home. However, she was re-admitted to hospital upon primary care physician's (PCP) instruction on 04-Jun-2019. She was feeling fine at the time of report however not good enough to be discharged.  The consumer was allergic to shellfish. His current illness included sinus infection (3 weeks prior to vaccination) and rash due to amoxicillin.   Concomitant medication included birth control pills.  Action taken with Vivotif and Stamaril with respect to the events was unknown.  The consumer was recovering from the reported events.  Company's Comment: In this case, the consumer felt feverish and experienced chills and stomachache following administration of Vivotif and subcutaneous Stamaril vaccines. There seems to be a temporal association between the intake of Vivotif and the events. Hence, the causality of the events with Vivotif is assessed as possible. Additionally, co-administration of stamaril vaccine also provides an alternative explanation for the reported events.; Sender's Comments: Company's Comment: In this case, the consumer felt feverish and experienced chills and stomachache following administration of Vivotif and subcutaneous Stamaril vaccines. There seems to be a temporal association between the intake of Vivotif and the events. Hence, the causality of the events with Vivotif is assessed as possible. Additionally, co-administration of stamaril also provides an alternative explanation for the reported events.
Sex: F
Vaccine: TYP, TYP
Symptoms: Electrocauterisation, Epistaxis
Clinical narrative: NOSE BLEED; This spontaneous case report (825198-1) was extracted through VAERS database on 25-Oct-2019. It described a 46-year-old female consumer who had "nose bleed" (PT: Epistaxis), while being on oral Vivotif (lot# 3003272) or an unknown indication.  Case report: The consumer took first dose of Vivotif on 15-Jul-2019 at bedtime. Next day on 16-Jul-2019, she experienced nose bleed at 2pm. On 17-Jul-2019, she had nose bleed in evening and took second dose of Vivotif at bedtime. Next day (18-Jul-2019) in afternoon, she again had nose bleed and was referred to ER (emergency room), where she had nose electrocauterization. On 19-Jul-2019, she took third dose of Vivotif at bedtime and had no nose bleed on that day. However, on next day (20-Jul-2019) at 08:30 pm she had another episode of nose bleed and visited to ER again from 9pm-midnight where she was told that there was nothing they could do and didn't want to risk another nose bleed with cauterization. She was also advised to stop taking Vivotif along with the use of humidifier and Vaseline in nasal cavity. She had nose bleed on 21-Jul-2019, 22-Jul-2019 (at 06:00 pm) and again on 23-Jul-2019 afternoon. Since then, she had no further episode of nose bleed. She did not take the last dose of Vivotif scheduled on 21-Jul-2019,   Patient's concomitant medications included daily supplements such as, vitamin B, co-enzyme Q-10, calcium vitamin D, calcium + magnesium + zinc, vitamin E, vitamin C, women's renewal pro-biotic and RepHresh pro-biotc.  Action taken with Vivotif with respect to reported event was vaccine discontinued.   The consumer recovered from the reported events.  Company's Comment: In this case, it was reported that the consumer had episodes of "nose bleed" following administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. the causal role of vaccine cannot be ruled out. Hence, the causality of the event with Vivotif is assessed as possible. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had episodes of "nose bleed" following administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. the causal role of vaccine cannot be ruled out. Hence, the causality of the event with Vivotif is assessed as possible.
Sex: M
Vaccine: TYP
Symptoms: Acute kidney injury, Blood creatinine increased, Vomiting
Clinical narrative: ACUTE KIDNEY INJURY; VOMITING; This spontaneous case report (833335-1) was extracted through VAERS database on 25-Oct-2019. It described a 19-year-old male consumer who had "acute kidney injury" (PT: Acute kidney injury) and "vomiting" (PT: Vomiting) while being on oral Vivotif for an unknown indication.  Case report: The consumer took his last dose of Vivotif (lot number: 3003285) on 06-Sep-2019 and the next day (07-Sep-2019) he started vomiting. After vomiting all day, he was hospitalized, and IV fluids were administered. During hospitalization, it was also found that his creatinine levels were at 2.9 which lead to acute kidney injury. He was kept at the hospital from Saturday until Wednesday (for 5 days) when his levels have finally dropped to 1.5.  Action taken with Vivotif was not applicable.  The clinical outcome of the reported events was unknown.  Company's Comment: In this case, a 19-year-old male consumer had vomiting, and following hospitalization was diagnosed with acute kidney injury following administration of Vivotif. The events were reported with reasonable time relationship to intake of the vaccine therefore, the causality of the events with Vivotif is assessed as possible. Though there is limited information regarding the medical history, concomitant medications and events in this case, causal role vaccine could not be ruled out. ; Sender's Comments: Company's Comment: In this case, a 19-year-old male consumer had vomiting and following hospitalization was diagnosed with acute kidney injury following administration of Vivotif. The events were reported with reasonable time relationship to intake of the vaccine therefore, the causality of the events with Vivotif is assessed as possible. Though there is limited information regarding the medical history, concomitant medications and events in this case, causal role vaccine could not be ruled out.
Age: 0.58
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 7-months-old male patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 11-NOV-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial of lot # S004251 with expiry date 22-SEP-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 6-months-old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 21-OCT-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial of lot# S005878, expiration date reported as 26-NOV-2020, but upon internal validation established as 25-NOV-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (10.7 C) for 33 minutes, 47 degrees Fahrenheit/9 degree Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 6-months-old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 22-OCT-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial of lot# S005878, expiration date reported as 26-NOV-2020, but upon internal validation established as 25-NOV-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (10.7 C) for 33 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 4-months-old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 25-OCT-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial of lot# S005878, expiration date reported as 26-NOV-2020, but upon internal validation established as 25-NOV-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (10.7 C) for 33 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 4-months-old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 08-NOV-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial of lot# S005878, expiration date reported as 26-NOV-2020, but upon internal validation established as 25-NOV-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (10.7 C) for 33 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 4-months-old male patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 22-OCT-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial of lot# S005878, expiration date reported as 26-NOV-2020, but upon internal validation established as 25-NOV-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (10.7 C) for 33 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 9-weeks-old male patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 22-OCT-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial of lot# S005878, expiration date reported as 26-NOV-2020, but upon internal validation established as 25-NOV-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (10.7 C) for 33 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 4-months-old male patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 21-OCT-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial of lot # S004251 with expiration date 22-SEP-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 10-weeks-old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 25-OCT-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial of lot# S005878, expiration date reported as 26-NOV-2020, but upon internal validation established as 25-NOV-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (10.7 C) for 33 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 6-months-old male patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 22-OCT-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial of lot # S004251 with expiration date 22-SEP-2020 (strength, dose, dose number and route of administration unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 11-weeks-old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 06-NOV-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial of lot # S004398 with expiration date 31-OCT-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749: