chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms; a patient was administered an improperly stored dose ofROTATEQ; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 09-APR-2020, the patient was administered an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# S028771, expiration date 09-APR-2021, oral; dose was unknown) for prophylaxis (product storage error).  Temperature excursion of this vaccine was 55.7degree Fahrenheit for 2 hours and 45 minutes. There was no previous temperature excursion. The patient experienced no symptoms. Data logger was involved.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse event reported; the patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a nurse referring to a 12 months old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug allergies/ reactions were not reported.  On 02-APR-2020, the patient was administered improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # S002393, expiration date: 23-JAN-2021, strength, dose and route were unknown) for prophylaxis (product storage error). The sterile diluent used to reconstitute the vaccine did not undergo a temperature excursion. The vaccine was exposed to minus 9 degrees Celsius to 8 degrees Celsius (minus 6.8 degrees Celsius) for 6 hours. There was no previous temperature excursion. The data logger was involved. No additional adverse event was reported.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: received the first dose of Shingrix on 16-Oct-2019. This patient experienced shingles starting on 10-Apr-2020; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number PF454, expiry date 26th January 2022) for prophylaxis.   On 16th October 2019, the patient received the 1st dose of Shingrix. On 10th April 2020, 177 days after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: A pharmacist reported that a patient experienced shingles starting on 10th April 2020. As a treatment, the patient was given valacyclovir. The symptoms were reported as ongoing. This patient has also not received dose two of Shingrix as of 13th April 2020. Consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Eczema
Clinical narrative: eczema lesion on the leg that spread to both legs, arms and part of the torso; This case was reported by a consumer via call center representative and described the occurrence of eczema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th February 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced eczema. On an unknown date, the outcome of the eczema was unknown.   It was unknown if the reporter considered the eczema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed an eczema lesion on the leg that spread to both legs, arms and part of the torso. No further data available.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal, Gait disturbance
Clinical narrative: Extremely dizzy and lightheaded, unstable when walking, felt loopy. This lasted over 24 hours. No medical treatment sought.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Starting the following day on 4/14/2020, employee started feeling light headed, headache, and dizzy as well as a sharp pain to site of injection. Injection site is warm to the touch, and red/swollen. Employee states she took Ibuprofen around 1500 hours. Today, 4/15/2020 employee still reports feeling lightheaded, dizzy, and still states she has a headache. Injection site still red and warm.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Injection site warmth
Clinical narrative: Starting the following day on 4/14/2020, employee started feeling light headed, headache, and dizzy as well as a sharp pain to site of injection. Injection site is warm to the touch, and red/swollen. Employee states she took Ibuprofen around 1500 hours. Today, 4/15/2020 employee still reports feeling lightheaded, dizzy, and still states she has a headache. Injection site still red and warm.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PPV, VARCEL
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: About an hour after the shots he started to break out on his stomach. I called the health department and they told me to give him Benadryl and if it got worse to call his pediatrician. By the next day it was under his arm pits and on his stomach. I called his pediatrician they told me it was normal and said continue the Benadryl. By Friday he was covered from head to toe in a a red whelped rash. I took him to facility to see him they told me it just has to run it?s course and continue the Benadryl and start Zyrtec. They also referred us to an allergy specialist at Allergy and Asthma but they won?t believe me when I say this is still an issue as of April 15th 2020. So I am not reporting it in hope this won?t happen to someone else and then just be swept under the rug. My sons face is still broken out and we have been on Zyrtec and a liquid steroid and nothing is helping.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pruritus, Paraesthesia
Clinical narrative: Worker stated site was itchy and red.  Later she stated she had numbness and tingling going down her arm.  No difficulty in breathing reported.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Diarrhoea, Fatigue, Hot flush
Clinical narrative: - loss of appetite  - fatigue (slept much more) = still feeling that way, but seems to be gradually improving  - chills and hot flashes = still feeling this way, but gradually improving  - feels like they started going away last Wednesday 4/8/20, starting having an improved appetite at that time  - diarrhea worsened after the vaccine, still having this symptom, and gradually improving
Age: 13.0
Sex: F
Vaccine: TD
Symptoms: Feeling abnormal, Headache, Lethargy, Nausea
Clinical narrative: Felt like metal running through blood, nausea, headache, lethargic
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pyrexia
Clinical narrative: Diarrhea; Nausea; Shivering; Fever; Headache; This case was reported by a consumer via call center representative and described the occurrence of shivering in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th March 2020, the patient received the 1st dose of Shingrix. On 10th March 2020, 1 days after receiving Shingrix, the patient experienced nausea. On 11th March 2020, the patient experienced diarrhea. In March 2020, the patient experienced shivering, fever and headache. On 10th March 2020, the outcome of the shivering and fever were recovered/resolved. On 11th March 2020, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the nausea and diarrhea were not recovered/not resolved.   It was unknown if the reporter considered the shivering, fever, headache, nausea and diarrhea to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The patient was a citizen who received her first dose of Shingrix vaccine at Hospital. The patient received the vaccine at noon.  At the night, she experienced shivering, fever and headache. On Tuesday,1 day after vaccination, she recovered from shivering and fever, but she experienced headache and nausea.  On Wednesday, 2 days after vaccination, she recovered from headache, but she experienced nausea and diarrhea.  She was still experiencing nausea and diarrhea. She had taken local medications. The reporter did not consent to follow-up
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was inadvertently administered an expired Menveo vaccine; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA097A, expiry date 31st March 2020) for prophylaxis.   On 8th April 2020, the patient received Menveo. On 8th April 2020, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The Medical Assistant (MA) reported that on 8th April  2020, their patient was inadvertently administered an Menveo vaccine which was already expired on 31 March 2020. The MA reported that the patient experienced no issues.  The MA was transferred to GSK Medical Information for additional information. This case was considered as medication error without harm.
Sex: M
Vaccine: PNC13
Symptoms: Mental disorder
Clinical narrative: mental illness; This is a spontaneous report from a Pfizer-sponsored program. A contactable healthcare professional reported that a 54-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration from an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced mental illness on an unspecified date. The outcome of event was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: DT, TD
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 71 year old patient received DT instead of TD vaccine/No AE; Initial information was received on 16-Mar-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 71-year-old female patient who received DIPHTHERIA AND TETANUS TOXOIDS vaccine instead of DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TD) vaccine.  Medical history, medical treatment, vaccination, concomitant therapy and family history were not provided.  On an unknown date, the patient received a 0.5 mL booster dose of suspect DIPHTHERIA AND TETANUS TOXOIDS (produced by unknown manufacturer) [lot C5J11AA, expiry date: 30-Aug-2020] via an unknown route at an unknown administration site instead of TD vaccine for prophylactic vaccination (wrong product administered).  It was case of actual medication error due to wrong vaccine administered to patient.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 6.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a dose of Adacel was inadvertently administered to a six year old patient/ No AE; Initial information was received on 17-Mar-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a six years old female patient who on 11-Mar-2020 inadvertently received a 0.5 mL dose one of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6638AA and expiry date 12-Apr-2022) via intramuscular route in the left deltoid for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.     It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of reporting no adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Skin reaction, Urticaria
Clinical narrative: Urticaria scattered of neck and upper chest within 10 minutes Skin reaction suspected secondary to vaccines provided in the clinic.  Patient was given Diphenhydramine 12.5mg/5ml, 2 mls po once and monitored for 30 min,  Hives subside without any noted worsening sxs.  Lung sounds clear, no wheezing. No edema noted of face, mouth, lips, or tongue.  Mother was provided handout on allergic reactions and advised to follow up sooner for worsening rash, swelling of mouth/face/tongue, difficulty breathing/feeding etc.  Advised she may administer Diphenhydramine 12.5ml/5mls, 2 mls po once every 6 hrs PRN allergic symptoms.  She stated she understood.  Subsequent vaccines will be provided after WCC only to allow for provider monitoring
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Peripheral swelling
Clinical narrative: & Shoulder pain/swelling of arm that vaccine was given in
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Myalgia, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Chills; Fever; Myalgia; weakness; This case was reported by a physician via call center representative and described the occurrence of chills in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included varicella (in childhood), breast cancer (received chemo therapy and radiation therapy), ovarian cancer (received chemo therapy and radiation therapy) and varicella zoster (in 2019). Previously administered products included Shingrix (1st dose received on 27th September 2019, refer linked case US2019231590), Varicella zoster vaccine (received many years before the date of reporting and experienced varicella) and valcyclovir.   On 10th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced chills, fever, myalgia and weakness. Rechallenge with Shingrix was positive. On 15th January 2020, the outcome of the chills, fever, myalgia and weakness were recovered/resolved.   It was unknown if the reporter considered the chills, fever, myalgia and weakness to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix and recurrent events did not involve a rash but did expereince fever, chills, weakness and myalgia. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Feeling hot, Headache, Nausea
Clinical narrative: Time: 1059AM:  Pt. calls to report that she is having side effects from the shingrix vaccine.  Of note, she did NOT react to the first vaccination.  Pt. reports that she felt okay last night.  She woke this AM with a pounding headache and stomach ache.  She has some nausea but has not vomited.  She has soreness in her arm but no redness, streaking, drainage at the IM injection site. Pt. does not have a thermometer at home.  She is calling pharmacy to see if she can purchase one.  She has had chills off and on and her whole body has felt warmer than normal.  Denies SOB, itching in throat, or swelling in face.  Advised for her to obtain thermometer and monitor her temp.  Advised she can alternate Tylenol/ibuprofen.  She asks about returning to work due to COVID-19 Pandemic.  Advised that per current CDC guidelines she should refrain from work until she has been fever and symptom free for, at minimum, 72 hours.  She is unsure if she will need a note or not.  Advised her to push fluids, rest, and touch base with me this afternoon.  Notify me promptly if s/s worsen.  She verbalizes understanding.  Time: 1452- Courtesy call to patient.  How is she doing?  She did get a thermometer and her temperature was 100.1.  She took a dose of Tylenol and the temp came down to 98.5 (checked while I was on the phone with her).  She feels better since taking the Tylenol.  Her stomach ache has resolved.  ER precautions reviewed at length.  If s/s worsen she is to notify me or go promptly to ER.  She verbalizes understanding.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Time: 1059AM:  Pt. calls to report that she is having side effects from the shingrix vaccine.  Of note, she did NOT react to the first vaccination.  Pt. reports that she felt okay last night.  She woke this AM with a pounding headache and stomach ache.  She has some nausea but has not vomited.  She has soreness in her arm but no redness, streaking, drainage at the IM injection site. Pt. does not have a thermometer at home.  She is calling pharmacy to see if she can purchase one.  She has had chills off and on and her whole body has felt warmer than normal.  Denies SOB, itching in throat, or swelling in face.  Advised for her to obtain thermometer and monitor her temp.  Advised she can alternate Tylenol/ibuprofen.  She asks about returning to work due to COVID-19 Pandemic.  Advised that per current CDC guidelines she should refrain from work until she has been fever and symptom free for, at minimum, 72 hours.  She is unsure if she will need a note or not.  Advised her to push fluids, rest, and touch base with me this afternoon.  Notify me promptly if s/s worsen.  She verbalizes understanding.  Time: 1452- Courtesy call to patient.  How is she doing?  She did get a thermometer and her temperature was 100.1.  She took a dose of Tylenol and the temp came down to 98.5 (checked while I was on the phone with her).  She feels better since taking the Tylenol.  Her stomach ache has resolved.  ER precautions reviewed at length.  If s/s worsen she is to notify me or go promptly to ER.  She verbalizes understanding.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Feeling of body temperature change, Injection site pain, Injection site paraesthesia, Injection site pruritus
Clinical narrative: Hot and cold sensation, tingling, aching, and itching at site of injection. No treatment at this time.
Age: 8.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Urticaria
Clinical narrative: Patient's entire right upper arm and shoulder became red, painful, and swollen which lasted for about 2 weeks He also developed hives on his hands and feet which lasted for 1-2 months
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting only on 04/13/202020
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Cryotherapy, Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: left arm throbs when weather is going to change,    Arm goes numb from neck to middle two fingers  Can not touch spot of injection , Can no longer get any shots in left arm as it is to painful ,  Right after I got shot I developed a rapid spreading skin cancer at 5 locations on arm onew of which had to be surgically removed four were frozen off ,  It is now almost a year and nothing has changed still have pain and it still throbs                                              NEVER SHOULD HAVE GOTTEN SHOT
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Skin cancer, Skin neoplasm excision
Clinical narrative: left arm throbs when weather is going to change,    Arm goes numb from neck to middle two fingers  Can not touch spot of injection , Can no longer get any shots in left arm as it is to painful ,  Right after I got shot I developed a rapid spreading skin cancer at 5 locations on arm onew of which had to be surgically removed four were frozen off ,  It is now almost a year and nothing has changed still have pain and it still throbs                                              NEVER SHOULD HAVE GOTTEN SHOT
Age: 51.0
Sex: M
Vaccine: VARCEL
Symptoms: Bacterial test, Fatigue, Herpes simplex test, Malaise, Penis disorder
Clinical narrative: "fatigue and malaise"  day of vaccination to present Penile lesion,day of vaccination to present
Age: 51.0
Sex: M
Vaccine: VARCEL
Symptoms: Treponema test
Clinical narrative: "fatigue and malaise"  day of vaccination to present Penile lesion,day of vaccination to present
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Hypertension, Injection site swelling, Nausea, Speech disorder
Clinical narrative: PT STATING SHE WAS NAUSEATED, SHAKING, HAD HEADACHE ,NECK TENDERNESS, EAR RINGING AND HYPERTENSION (180)  AND SPEAKING PROBLEM AND BIG BUMP AT INJECTION SITE
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness, Tinnitus, Tremor
Clinical narrative: PT STATING SHE WAS NAUSEATED, SHAKING, HAD HEADACHE ,NECK TENDERNESS, EAR RINGING AND HYPERTENSION (180)  AND SPEAKING PROBLEM AND BIG BUMP AT INJECTION SITE
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Anaphylactic reaction, Cellulitis, Rash
Clinical narrative: Anaphylaxis, SkinRash & CELLULITIS
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Dyspnoea, Pain, Rash, Urticaria
Clinical narrative: Hives on face and neck within 4 hrs of vaccine admin chest pressure, 6/10 pain, shortness of breath. Rash on hands 0715 Benadryl PO, 1 hr prior to administration. Benadryl 2-3 hrs later, reduced reaction Sx but still directed (self) to ER, Directed to cont. Benadryl & follow up with PCP.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyskinesia, Feeling hot, Headache, Heart rate increased, Vertigo
Clinical narrative: Mild, momentary vertigo and leaden movements approximately 7 hours after injection. Dissipated within 10 minutes. Fast heart rate noticed approximately 10 hours after injection, measured at  about 15 BMP higher than average (Measured 90, average 75-80) Heart rate dropped back to normal range within half hour of measuring. Feverish feeling, but temperature measured normal. Mild headache developing after heart rate returned to normal. Feeling reminiscent of mildly high blood pressure, but no equipment to monitor available.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Loss of personal independence in daily activities, Muscular weakness, Neuropathy peripheral, Paraesthesia
Clinical narrative: idiopathic progressive neuropathy; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.   On 21-JAN-2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for prevention of shingles (herpes zoster). On an unspecified date, shortly after vaccination, the patient suffered numbness, weakness and tingling in both hands with the difficulty of picking things up. The patient was hospitalized and diagnosed with idiopathic progressive neuropathy.  As a result of her receipt of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to vaccination; the patient had also experienced mental and emotional distress due to resulting physical limitation and seriousness of her condition. Consequently, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, loss of enjoyment life, physical impairment and injury.  At the time of the report, the outcome of idiopathic progressive neuropathy was not recovered. The reporter considered the event previously mentioned to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of idiopathic progressive neuropathy was considered as medically significant. The reporters considered the event to by disabling.
Sex: M
Vaccine: VARZOS
Symptoms: Chest discomfort, Chest pain, Coronary artery disease, Myocardial infarction
Clinical narrative: myocardial infarction and coronary artery disease; myocardial infarction and coronary artery disease; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.   In on around 13-FEB-2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for prevention of shingles (herpes zoster). On an unspecified date, shortly after vaccination, the patient suffered severe chest pain and pressure. The patient was hospitalized and diagnosed with myocardial infarction and coronary artery disease.  As a result of his receipt of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to vaccination; the patient had also experienced mental and emotional distress due to resulting physical limitation and seriousness of his condition. Consequently, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, loss of enjoyment life, physical impairment and injury.  At the time of the report, the outcome of myocardial infarction and coronary artery disease were not recovered. The reporter considered the events previously mentioned to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review the event of myocardial infarction was considered as medically significant.The reporters considered the events to be disabling.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: a patient was administered an expired dose of ROTA TEQ on 4/9/2020; This spontaneous report was received from a licensed practical nurse referring to a 6-month old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication was not provided.     On 09-APR-2020, the patient was administered an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R021065, expiration date 01-APR-2020; dose was unknown) via oral for prophylaxis (expired product administered).
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash macular
Clinical narrative: The patient developed a macular rash over his entire body; HCP was administering a dose of MMR II when the patient knocked the syringe out of her hand, possibly causing administration of a partial dose; This spontaneous report was received from a physician regarding to a male patient of unknown age. The patient's medical history, concomitant medications, drug reactions or allergies were not reported.  On 10-APR-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 milliliter, lot # S0185595, subcutaneously (expiration date and anatomical location not provided); and with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 mL (lot # S025913, expiration date not provided, but upon internal review stablished as 20-AUG-2021) (route of administration and anatomical location not provided) both as vaccination. The reporter stated that when the health care professional (HCP) was administering measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), the patient knocked the syringe out of her hand, which possibly caused the administration of a partial dose (incorrect dose administered). On the same date, several hours of receiving the vaccinations, the patient developed a macular rash over his entire body. Medical attention was sought in physician's office at the time, but not treatment was given. At the reporting time, the patient had not recovered from the macular rash.   The causality between macular rash and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and varicella virus vaccine live (Oka/Merck)(VARIVAX) was not reported.  Lot number S0185595 is an invalid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live.
Sex: F
Vaccine: TYP
Symptoms: Product dose omission
Clinical narrative: FORGOT TO TAKE THIRD DOSE; This spontaneous case report (PVX2019-2622) was received from a consumer on 21-Oct-2019. It described a 22-year-old adult female consumer who "forgot to take third dose" (PT: Product dose omission), while being on Vivotif for an unknown indication.  Case report: The consumer received first and second dose of Vivotif on 16-Oct-2019 and 18-Oct-2019 respectively however, she forgot to take the third dose that was scheduled on 20-Oct-2019.  Action taken with Vivotif with respect to event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "forgot to take third dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "forgot to take third dose" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Expired product administered
Clinical narrative: TOOK FOUR DOSES OF EXPIRED VIVOTIF; This spontaneous case (PVX2019-1558) report was received from a pharmacist on 17-Jun-2019. It describes a 32-year-old female consumer who "took four doses of expired Vivotif". She was receiving oral Vivotif (one dose every other day; expiry date: May 2019) for typhoid fever prophylaxis.  Case report: The consumer took four doses of expired Vivotif. The vaccine got expired in May 2019. However, she completed all the doses in Jun 2019 and the last dose was taken on 17-Jun-2019.  Action taken with Vivotif was not applicable.   The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took four doses of expired Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took four doses of expired Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK AN UNREFRIGERATED DOSE OF VIVOTIF; This spontaneous case (PVX2019-1574) report was received from a pharmacist on 17-Jun-2019. It describes a female consumer who "took an unrefrigerated dose of Vivotif". She was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took an unrefrigerated dose of Vivotif on 17-Jun-2019.  Action taken with Vivotif was not applicable.   The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took an unrefrigerated dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose of Vivotif" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product dose omission
Clinical narrative: MISSED TO TAKE THIRD AND FOURTH DOSE ON SCHEDULE; A spontaneous case report was received from a nurse on 19-Jun-2019 for two consumers.  Based on the information obtained from the nurse, two individual case safety reports PVX201906-000516 (PVX2019-1598; husband) and PVX201906-000517 (PVX2019-1599, wife) were created and cross-linked in the database.  This case describes a 63-year-old adult male consumer who "missed to take third and fourth dose on schedule", while being on oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took the first two dose of Vivotif on 03-Jun-2019 and 05-Jun-2019. Then, he went to a non-endemic zone trip from 07-Jun-2019 to 17-Jun-2019. Hence, missed to take the remaining two doses.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed to take third and fourth dose on schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take third and fourth dose on schedule" was considered as not applicable. US-PaxVax Berna GmbH-PVX201906-000517:
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK VIVOTIF ON CONSECUTIVE DAYS INSTEAD OF EVERY OTHER DAY; This spontaneous case report (PVX2019-1881) was received from a pharmacist on 22-Jul-2019. It describes a 31-year-old female consumer who "took Vivotif on consecutive days instead of every other day" (PT: Inappropriate schedule of product administration), while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took doses of Vivotif on consecutive days instead of every other day. She completed Vivotif course a couple of weeks ago.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took Vivotif on consecutive days instead of every other day" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif on consecutive days instead of every other day" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK TWO DOSES IN A ROW; A spontaneous case report was received from a consumer on 22-Jul-2019 for two consumers.  Based on the information obtained from the consumer, two individual case safety reports PVX201907-000615 (PVX2019-1882; wife) and PVX201907-000616 (PVX2019-1883; husband) were created and cross-linked in the database.  This case describes a 60-year-old female consumer who "took two doses in a row" (PT: Inappropriate schedule of product administration), during therapy with Vivotif for an unknown indication.  Case report: The consumer took two doses of Vivotif in a row. The doses were taken on 18-Jul-2019, 20-Jul-2019, and 21-Jul-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable. US-PaxVax Berna GmbH-PVX201907-000616:
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK TWO DOSES IN A ROW; A spontaneous case report was received from a consumer on 22-Jul-2019 for two consumers.  Based on the information obtained from the consumer, two individual case safety reports PVX201907-000615 (PVX2019-1882; wife) and PVX201907-000616 (PVX2019-1883; husband) were created and cross-linked in the database.  This case describes a 66-year-old male consumer who "took two doses in a row" (PT: Inappropriate schedule of product administration), during therapy with Vivotif for an unknown indication.  Case report: The consumer took two doses of Vivotif in a row. The doses were taken on 18-Jul-2019, 20-Jul-2019, and 21-Jul-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable. US-PaxVax Berna GmbH-PVX201907-000615:
Sex: M
Vaccine: TYP
Symptoms: Product dose omission
Clinical narrative: MISSED TO TAKE FOURTH DOSE OF VIVOTIF ACCORDING TO SCHEDULE; This spontaneous case report (PVX2019-1886) was received from a consumer on 22-Jul-2019. It described a 33-year-old male consumer who "missed to take fourth dose of Vivotif according to schedule" (PT: Product dose omission), while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took first three doses of Vivotif according to schedule, but forgot to take the fourth dose on 21-Jul-2019.  Action taken with Vivotif was not applicable.  The clinical outcome was unknown.  Company's Comment: The causality of the event "missed to take fourth dose of Vivotif according to schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take fourth dose of Vivotif according to schedule" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK VIVOTIF EVERYDAY; This spontaneous case report (PVX2019-1923) was received from a pharmacist on 25-Jul-2019. It described a male consumer who "took Vivotif everyday" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took a dose of Vivotif on 24-Jul-2019 and 25-Jul-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took Vivotif everyday" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif everyday" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK ONE DOSE OF UNREFRIGERATED VIVOTIF; This spontaneous case report (PVX2019-1934) was received from a pharmacist on 26-Jul-2019. It described a male consumer who "took one dose of unrefrigerated Vivotif" (PT: Product storage error). The consumer was receiving oral Vivotif (one dose every other day; lot number: 3003276 and expiry date: 28-May-2020) for typhoid fever prophylaxis.  Case report: The consumer took first dose of Vivotif on 26-Jul-2019, which was unrefrigerated since 21-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took one dose of unrefrigerated Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took one dose of unrefrigerated Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK ONE DOSE OF UNREFRIGERATED VIVOTIF; This spontaneous case report (PVX2019-1942) was received from a consumer on 26-Jul-2019. It described a female consumer who "took one dose of unrefrigerated Vivotif" (PT: Product storage error). The consumer was receiving oral Vivotif (lot number: 3003281) for typhoid fever prophylaxis.  Case report: The consumer stated that she picked up Vivotif on the night of 24-Jul-2019 and left it unrefrigerated until 26-Jul-2019. The consumer took the first unrefrigerated dose of Vivotif on 25-Jul-2019, empty stomach.   Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took one dose of unrefrigerated Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took one dose of unrefrigerated Vivotif" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: DID NOT TAKE VIVOTIF ACCORDING TO SCHEDULE; This spontaneous case report (PVX2019-1925) was received from a pharmacist on 25-Jul-2019. It described a male consumer who "did not take Vivotif according to schedule" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took his first dose on Sunday and missed to take the second dose on Tuesday. The consumer did not take Vivotif according to schedule.   Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not take Vivotif according to schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take Vivotif according to schedule" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK UNREFRIGERATED DOSES; This spontaneous case report (PVX2019-1946) was received from a pharmacist on 29-Jul-2019. It described a 42-year-old adult female consumer who "took unrefrigerated doses", while being on oral Vivotif (one capsule every other day) for typhoid prophylaxis.   Case report: The consumer left Vivotif out of the fridge for about 3 days. The consumer refrigerated it after she realized, and took it as directed. The doses were taken on 7-Jul-2019, 9-Jul-2019, 11-Jul-2019, and 13-Jul-2019.  Action taken with Vivotif was unknown.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK VIVOTIF THAT WAS IN A 50 DEGREE FAHRENHEIT REFRIGERATOR; This spontaneous case report (PVX2019-1969) was received from a caregiver on 30-Jul-2019. It described a 15-year-old adolescent female consumer who reported "took Vivotif that was stored out of range" (PT: Product storage error). The consumer was receiving Vivotif (lot number: 3003278) for an unknown indication.  Case report: A caregiver reported that they had kept Vivotif in a refrigerator at 46 degree Fahrenheit before leaving on a vacation.  When they returned after 10-11 days, the refrigerator was at 50 degree Fahrenheit. The Vivotif was exposed to 50 degree Fahrenheit for about 10 days.  On 30-Jul-2019, her daughter took the first dose of Vivotif.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took Vivotif that was stored out of range" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif that was stored out of range" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK UNREFRIGERATED DOSES; This spontaneous case report (PVX2019-1979) was received from a pharmacist on 31-Jul-2019. It described an adult female consumer who "took unrefrigerated doses" (PT: Product storage error). The consumer was receiving Vivotif for an unknown indication.  Case report: The Vivotif was dispensed on 23-Jul-2019 and the first dose was taken within hours of dispensing. The consumer took all doses of Vivotif, but did not store it in the refrigerator.   Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product dose omission
Clinical narrative: MISSED LAST DOSE; This spontaneous case report (PVX2019-1983) was received from a consumer on 01-Aug-2019. It describes a female consumer who "missed last dose" (PT: Product dose omission), while being on Vivotif for an unknown indication.  Case report: The consumer missed her last dose that was due on 31-Jul-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "missed last dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed last dose" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product dose omission
Clinical narrative: MISSED THIRD DOSE OF VIVOTIF; This spontaneous case report (PVX2019-1992) was received from a healthcare professional on 01-Aug-2019. It described a male consumer who "missed third dose of Vivotif" (PT: Product dose omission), while being on Vivotif for an unknown indication.  Case report: The consumer took the first and the second dose of Vivotif on 25-Jul-2019 and 27-Jul-2019, respectively. The consumer missed to take the third dose.  Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "missed third dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed third dose of Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK TWO DOSES IN A ROW; This spontaneous case report (PVX2019-2005) was received from a consumer on 02-Aug-2019. It described a female consumer who "took two doses in a row" (PT: Inappropriate schedule of product administration), while being on Vivotif for an unknown indication.  Case report: The consumer took first two doses in a row. The doses were taken on 01-Aug-2019 and 02-Aug-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK SECOND AND FOURTH DOSE OF VIVOTIF A DAY LATE; This spontaneous case report (PVX2019-2024) was received from a pharmacist on 05-Aug-2019 and additional information received on 20-Aug-2019. It described a male consumer who "took second and fourth dose of Vivotif a day late" (PT: Inappropriate schedule of product administration), while being on Vivotif for an unknown indication.  Case report: The consumer took the second and the fourth dose of Vivotif a day late. He completed his course in 8 days.  Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took second and fourth dose of Vivotif a day late" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took the fourth dose a day late" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK A DOSE TOO CLOSE TO TRAVEL; This spontaneous case report (PVX2019-2055) was received from a pharmacist 08-Aug-2019. It described a female consumer who "took a dose too close to travel" (PT: Inappropriate schedule of vaccine administered), while being on Vivotif for travel to endemic area.  Case report: The consumer took a dose of Vivotif on 07-Aug-2019. On 10-Aug-2019, she would be traveling.  Action taken with Vivotif was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took a dose too close to travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took a dose too close to travel" was considered as not applicable.