chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody, Measles antibody negative, Mumps antibody test, Pyrexia, Rash
Clinical narrative: MMR was administered on 03/03/2020 and pt. was seen on 03/18/20 with c/o fever and rash x 4 days. Pt. was advised to go home and quarantine.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash head to toes
Age: 0.5
Sex: F
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reports; one female patient was administered improperly stored RECOMBIVAX and ROTATEQ; This spontaneous report was received from a vaccine coordinator, regarding a 6-months-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions/allergies were not reported.  On 09-MAR-2020, the patient was vaccinated with improperly stored hepatitis b vaccine (recombinant) thimerosal free (RECOMBIVAX HB) 5/0.5 microgram/milliliger (mcrg/ml) (dose, route of administration and vaccination scheme were not reported; lot number R028529, expiration date 09-JUN-2021) as prophylaxis. Other suspect therapies include improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, route of administration and vaccination scheme were not reported; lot number 1658255, expiration date 07-FEB-2021) as prophylaxis (product storage error).  The call was due to a digital data logger, which showed that on 02-MAR-2020, the vaccines were stored in a temperature of 0.8 degrees Celcius (°C); for a timeframe of 5 hours and 9 minutes. On 04-MAR-2020, the vaccines were stored in a temperature of 0.9 °C for 11 hours; On 05-MAR-2020, the vaccines were stored in a temperature of -1.3 °C for 9 hours and 29 minutes. No additional adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA006305:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haematoma, Injection site pain, Injection site rash, Myalgia, Rash
Clinical narrative: 71/2 INCH BY 3 1/2 INCH RASH. Painful at site and also area of rash, muscle aches, also large hematoma at injection site
Age: 41.0
Sex: M
Vaccine: HEPA
Symptoms: Strabismus, Vision blurred
Clinical narrative: States blurry vision started day after receiving vaccine, states feels like he is going cross eyed. Advised him to go to his health department, PCP, or ER.
Age: 39.0
Sex: F
Vaccine: HPV9, HPV4, HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction; reporting as vaccine lot number was expired ( 02/2020) and not noticed until after administered by medical assistant.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia, Contusion, Fall, Headache, Injection site pain
Clinical narrative: Pt had 1st dose of Shingrix on Friday 3/6/2020. Pt called today, 3/23/20, to ask us if Shingrix could possibly cause a seizure. Pt states she left store after her vaccination in a MartCart with a stockman and the groceries she purchased before the vaccination. Says she got to her car, got off the MartCart to unlock the car, then went down and doesn't remember the rest. The stockman told her that he saw her go down to a seated position against the car and was having a seizure. He called Code White, an ambulance was called, and pt taken to the hospital. There, she was kept overnight and had a second seizure. Pt said many tests were done, and showed inconclusive of any head issues that otherwise may have caused a seizure. She was released on Sunday 3/8/2020 with a prescription for Keppra. Pt stated today that she gets annual flu shots, has had both her pneumonia shots and Zostavax. Pt states she has never had any adverse reactions with any prior vaccination. Pt states she still has some tenderness at the injection site (left arm) with pushing, as well as some soreness and bruising on the right arm, thigh, and right back side of her head
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test normal, Pain in extremity, Seizure
Clinical narrative: Pt had 1st dose of Shingrix on Friday 3/6/2020. Pt called today, 3/23/20, to ask us if Shingrix could possibly cause a seizure. Pt states she left store after her vaccination in a MartCart with a stockman and the groceries she purchased before the vaccination. Says she got to her car, got off the MartCart to unlock the car, then went down and doesn't remember the rest. The stockman told her that he saw her go down to a seated position against the car and was having a seizure. He called Code White, an ambulance was called, and pt taken to the hospital. There, she was kept overnight and had a second seizure. Pt said many tests were done, and showed inconclusive of any head issues that otherwise may have caused a seizure. She was released on Sunday 3/8/2020 with a prescription for Keppra. Pt stated today that she gets annual flu shots, has had both her pneumonia shots and Zostavax. Pt states she has never had any adverse reactions with any prior vaccination. Pt states she still has some tenderness at the injection site (left arm) with pushing, as well as some soreness and bruising on the right arm, thigh, and right back side of her head
Age: 67.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Amnesia, Asthenia, Deafness unilateral, Diplopia, Disorientation
Clinical narrative: Patient  is followed by our clinic for primary care, and received hepatitis A and B vaccinations on 1/22/2020 as part of his evaluation and treatment for chronic hepatitis C. After receiving the vaccines, Patient experienced several symptoms that he attributes to the vaccine that we are sharing with you for further monitoring and for consideration for the National Vaccine Injury Compensation Program. He describes his response as:   - weakness, dizziness, tiredness, blurred vision, double vision, and sensitivity to light - sore throat, muscle soreness, and sensation that his neck would fall off - multiple falls upon raising to standing - Mental Fogginess, disorientation, memory loss, ringing in the ears, loss of hearing in the right ear   His symptoms were persistent per his report through initiation of mavyret for his chronic hepatitis c, though the intensity of his symptoms was variable at times though he reports that it has persisted at least through today, March 5th.    Notably, his course was later complicated by development of Bell's Palsy on day 8 of mavyret therapy.
Age: 67.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Dizziness, Facial paralysis, Fall, Fatigue, Feeling abnormal
Clinical narrative: Patient  is followed by our clinic for primary care, and received hepatitis A and B vaccinations on 1/22/2020 as part of his evaluation and treatment for chronic hepatitis C. After receiving the vaccines, Patient experienced several symptoms that he attributes to the vaccine that we are sharing with you for further monitoring and for consideration for the National Vaccine Injury Compensation Program. He describes his response as:   - weakness, dizziness, tiredness, blurred vision, double vision, and sensitivity to light - sore throat, muscle soreness, and sensation that his neck would fall off - multiple falls upon raising to standing - Mental Fogginess, disorientation, memory loss, ringing in the ears, loss of hearing in the right ear   His symptoms were persistent per his report through initiation of mavyret for his chronic hepatitis c, though the intensity of his symptoms was variable at times though he reports that it has persisted at least through today, March 5th.    Notably, his course was later complicated by development of Bell's Palsy on day 8 of mavyret therapy.
Age: 67.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Myalgia, Oropharyngeal pain, Photophobia, Sensory disturbance, Tinnitus
Clinical narrative: Patient  is followed by our clinic for primary care, and received hepatitis A and B vaccinations on 1/22/2020 as part of his evaluation and treatment for chronic hepatitis C. After receiving the vaccines, Patient experienced several symptoms that he attributes to the vaccine that we are sharing with you for further monitoring and for consideration for the National Vaccine Injury Compensation Program. He describes his response as:   - weakness, dizziness, tiredness, blurred vision, double vision, and sensitivity to light - sore throat, muscle soreness, and sensation that his neck would fall off - multiple falls upon raising to standing - Mental Fogginess, disorientation, memory loss, ringing in the ears, loss of hearing in the right ear   His symptoms were persistent per his report through initiation of mavyret for his chronic hepatitis c, though the intensity of his symptoms was variable at times though he reports that it has persisted at least through today, March 5th.    Notably, his course was later complicated by development of Bell's Palsy on day 8 of mavyret therapy.
Age: 67.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Vision blurred
Clinical narrative: Patient  is followed by our clinic for primary care, and received hepatitis A and B vaccinations on 1/22/2020 as part of his evaluation and treatment for chronic hepatitis C. After receiving the vaccines, Patient experienced several symptoms that he attributes to the vaccine that we are sharing with you for further monitoring and for consideration for the National Vaccine Injury Compensation Program. He describes his response as:   - weakness, dizziness, tiredness, blurred vision, double vision, and sensitivity to light - sore throat, muscle soreness, and sensation that his neck would fall off - multiple falls upon raising to standing - Mental Fogginess, disorientation, memory loss, ringing in the ears, loss of hearing in the right ear   His symptoms were persistent per his report through initiation of mavyret for his chronic hepatitis c, though the intensity of his symptoms was variable at times though he reports that it has persisted at least through today, March 5th.    Notably, his course was later complicated by development of Bell's Palsy on day 8 of mavyret therapy.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Headache, Influenza like illness, Injection site pain, Malaise
Clinical narrative: This was my 2nd dose of the vaccine--required by my age. Had NO ill effects on the first vaccination. None! It hurt at the site of injection--lasting all week. 10-12 hrs following injection, when I awoke during the early morning, I felted sort of ill. Body ached. Felt a little feverish. As an hour or two went by, my head felt hot, and my whole body ached like when you have the flu. These flu-like symptoms got stronger. I felt so sick. Took my temperature around 10am. 100.1 Stayed in bed all day. Fluids only. Continued feeling very achy all over my body.  NO vomiting or diarrhea. Slight headache.  Temp around 2pm 100.3 Normally my temperature is lower than the standard 98.6.  (it's around 97.something) Rarely have a fever. These flu-like symptoms lasted all day and up to when I went to sleep for the night. When I awoke the next morning, I was back to normal--except for the arm aching from the needle.  I haven't had the real flu in a very long time--don't remember. Occasional cold--every winter. Cough now and then.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This was my 2nd dose of the vaccine--required by my age. Had NO ill effects on the first vaccination. None! It hurt at the site of injection--lasting all week. 10-12 hrs following injection, when I awoke during the early morning, I felted sort of ill. Body ached. Felt a little feverish. As an hour or two went by, my head felt hot, and my whole body ached like when you have the flu. These flu-like symptoms got stronger. I felt so sick. Took my temperature around 10am. 100.1 Stayed in bed all day. Fluids only. Continued feeling very achy all over my body.  NO vomiting or diarrhea. Slight headache.  Temp around 2pm 100.3 Normally my temperature is lower than the standard 98.6.  (it's around 97.something) Rarely have a fever. These flu-like symptoms lasted all day and up to when I went to sleep for the night. When I awoke the next morning, I was back to normal--except for the arm aching from the needle.  I haven't had the real flu in a very long time--don't remember. Occasional cold--every winter. Cough now and then.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Product preparation error
Clinical narrative: Vaccine, was diluted with incorrect diluent solution.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Myalgia, Rash erythematous
Clinical narrative: Red rash, muscle pain, it has been over 1 week, the red rash , stiff muscle, and pain not going away
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: Dysphonia
Clinical narrative: Following 2 mos vaccines (Rotavirus, Pediarix, HiB, + Prevnar) - pt developed hoarseness 2 days after. Persisted x2 weeks within no other sx. At 4 mos - received Rotavirus + Pediarix - 2 day after developed hoarse voice. No fever, cough or nasal sx.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site urticaria, Local reaction
Clinical narrative: Local reaction, upper left arm 5cm wheal on/around injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Urticaria
Clinical narrative: Hives
Age: 66.0
Sex: M
Vaccine: TD
Symptoms: Dyskinesia, Headache, Neck pain, Pain in jaw
Clinical narrative: Neck Pain, Jaw pain unable to open mouth, Headache
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Immunisation reaction, Joint range of motion decreased, Nausea, Pain, Pain in extremity
Clinical narrative: Began having  pain in my left arm a few hours after receiving the flu shot. The next morning I was in severe pain which increased upon movement of my arm. The pain was so severe when I moved my arm that I almost threw up from the nausea it caused. I immediately called the doctor's office Where I received the shot and Dr. told me to go to ER. Upon examination there I had decreased range of motion and tenderness in my arm and had a fever. Diagnosis was Immunization Reaction.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Tenderness
Clinical narrative: Began having  pain in my left arm a few hours after receiving the flu shot. The next morning I was in severe pain which increased upon movement of my arm. The pain was so severe when I moved my arm that I almost threw up from the nausea it caused. I immediately called the doctor's office Where I received the shot and Dr. told me to go to ER. Upon examination there I had decreased range of motion and tenderness in my arm and had a fever. Diagnosis was Immunization Reaction.
Sex: M
Vaccine: TYP
Symptoms: Eye pruritus, Lacrimation increased, Sneezing
Clinical narrative: WATERY EYES; SNEEZING; ITCHY EYES; This spontaneous case (795887-1) was extracted through VAERS database on 26-Apr-2019. The case was reported by a consumer. It describes a 63-year-old male consumer who had watery eyes, itchy eyes, and sneezing, after the administration of oral Vivotif (one capsule every other day) for an unknown indication.  Case report: The consumer took the last dose of Vivotif on 09-Jan-2019. On 10-Jan-2019, she had severe watering of the eyes, especially in the morning, accompanied by itchy eyes and sneezing.  The consumer's concurrent medical history included common cold which started on 01-Jan-2019 and ends on 04-Jan-2019.  Concomitant medication at the time of events included allopurinol and Livalo (pitavastatin calcium) for unknown indications.  The consumer had no laboratory tests.  Action taken with Vivotif was not applicable.  The consumer had not recovered from the events of watery eyes, itchy eye, and sneezing.  Company's Comment: In this case, it was reported that the consumer had watery eyes, itchy eyes, and sneezing, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had watery eyes, itchy eyes, and sneezing, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea, Rash, Rash erythematous
Clinical narrative: DIARRHEA; RED RASH ON UPPER CHEST; This spontaneous case report (800884-1) was extracted through VAERS database on 24-May-2019. It describes a 61-year-old female consumer who had diarrhea and red rash on upper chest, after the administration of oral Vivotif (lot no: 3003241) for an unknown indication.  Case report: The consumer took two doses of Vivotif after which she experienced diarrhea on 09-Feb-2019. She also developed red rash on upper chest. She took the first dose on 07-Feb-2019.  The consumer's medical history included hypothyroid, seasonal pollen allergies, and mild lactose intolerance.  Concomitant medication included Synthroid (levothyroxine).  Action taken with Vivotif was dosage maintained.  The clinical outcome of the reported events was unknown.  Company's Comment: In this case, it was reported that the consumer had diarrhea and red rash on upper chest after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, diarrhea and rash are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had diarrhea and red rash on upper chest after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, diarrhea and rash are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: arm sore\ Injection site pain; arm where she got the injection was swollen; arm where she got the injection was swollen, painful and red; Muscle pain; may have Shivers; Sick; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 7 days after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema, muscle pain, shivers and sickness. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, muscle pain, shivers and sickness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, muscle pain, shivers and sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and was sick and had muscle pain and that the arm where she got the injection was swollen, painful and red after a week. She stated she might had shivers but did not remember. For tolerance of 2nd dose, refer linked case US2020AMR032845, reported by same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: arm sore\ Injection site pain; arm where she got the injection was swollen; arm where she got the injection was swollen, painful and red; Muscle pain; may have Shivers; Sick; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 7 days after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema, muscle pain, shivers and sickness. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, muscle pain, shivers and sickness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, muscle pain, shivers and sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and was sick and had muscle pain and that the arm where she got the injection was swollen, painful and red after a week. She stated she might had shivers but did not remember. For tolerance of 2nd dose, refer linked case US2020AMR032845, reported by same reporter
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no symptoms; on 3/2/2020 a patient was administered a dose of PNEUMOV AX 23 (lot S029542, expiration 6/10/2021); a shipment of PNEUMOVAX 23 (lot S029542, expiration 6/10/2021) was due to be delivered on 2/26/2020 but was not delivered until 2/27/2020; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.  Until 27-FEB-2020, a shipment of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S029542 with expiration date 10-JUN-2021)was not delivered which was due to be delivered on 26-FEB-2020 (product distribution issue). On 02-MAR-2020, the patient was administered a dose of  pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S029542 with expiration date 10-JUN-2021; dose detail, frequency and route were not reported) for prophylaxis (circumstance or information capable of leading to medication error). The patient experienced no symptoms. No further information provided.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2003USA004890:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; Patient received a dose of improperly stored ROTATEQ; This spontaneous report was received from a Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.     On 13-FEB-2020, the patient received one dose of an improperly stored dose (product storage error) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally for prophylaxis (strength and frequency not reported) (lot # 1660112 had been verified to be valid lot numbers; expiration date: 18-OCT-2020). The temperature excursion was at below 2 degrees Celsius (C) (1.28 C), for a time frame of 2 hours and 30 hours, and no had previous temperature excursion. It was reported that the call was due to data logger. No additional adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA005842:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; a patient was administered a dose of improperly stored MMRII; the patient had two previous administrations of MMRII in the past in addition to current dose; This spontaneous report was received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history and previous drug reactions/allergies were not reported. Concomitant therapies included sterile diluent (lot number S022090 expiration date 21-FEB-2022).  On 17-DEC-1992, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) as prophylaxis. On an unknown date, the patient received the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) as prophylaxis.  On 16-MAR-2020, the patient was vaccinated with a third dose of an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) subcutaneous (strength, dose and anatomical site of vaccination were not reported; lot number S022754, expiration date 22-JUL-2021) as prophylaxis (inappropriate schedule of product administration and product storage error). The vaccine was stored in a temperature of 12 degrees Celcius (°C) for a timeframe of 45 minutes. There was no previous temperature excursion. No additional adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: The patient experienced no symptoms; on 3/17/2020 an unspecified patient pulled away from the provider who was attempting to administer a dose of MMR II (lot S002503 ,expiration 7/23/2020)." The nurse reports that the patient did not receive the dose; Information has been received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.      On 17-MAR-2020, the patient pulled away from the provider who was attempting to administer a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) (strength, dose detail and route were unknown; lot # S002503 and expiration date 23-JUL-2020) for prophylaxis. The patient did not receive the dose (circumstance or information capable of leading to medication error). The patient experienced no symptoms.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; the patient received one improperly stored dose of PROQUAD; Information has been received from a nurse prescriber 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 25-FEB-2020, the patient received one improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), lot # S012532 and expiration date 20-OCT-2020 for prophylaxis (dosage schedule, anatomical location and route of administration were not reported) (product storage error). The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT) (lot number and expiration date were not reported).  The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (5.69F)  for 1 second, as recorded by a data logger. There was a previous temperature excursion of 6°F to 14°F (5.81F) for 28 minutes. No additional adverse effect was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Cerebrovascular accident, Confusional state, Ischaemic stroke, Left ventricular failure
Clinical narrative: middle cerebral artery territory ischemic stroke; systolic congestive heart failure; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 06-APR-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered confusion and altered mental status requiring hospitalization and extensive rehabilitation and was diagnosed with middle cerebral artery territory ischemic stroke and systolic congestive heart failure (onset date of this diagnosis was not specified). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered not recovered. The events were considered related to zoster vaccine live (ZOSTAVAX).   Upon internal review, both events were considered to be medically significant. The lawyer considered the events to be disability.
Sex: F
Vaccine: VARZOS
Symptoms: Mental status changes
Clinical narrative: middle cerebral artery territory ischemic stroke; systolic congestive heart failure; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 06-APR-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered confusion and altered mental status requiring hospitalization and extensive rehabilitation and was diagnosed with middle cerebral artery territory ischemic stroke and systolic congestive heart failure (onset date of this diagnosis was not specified). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered not recovered. The events were considered related to zoster vaccine live (ZOSTAVAX).   Upon internal review, both events were considered to be medically significant. The lawyer considered the events to be disability.
Sex: U
Vaccine: MMRV, UNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No other adverse effects were reported; patient received a dose of PROQUAD by intramuscular route instead of subcutaneous route; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant medications were not reported.  On 20-MAR-2020, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant Human albumin (rHA) (PROQUAD) (lot number S012530 has been verified to be a valid lot number, expiration date reported and validated as 20-OCT-2020) for prophylaxis, via intramuscular instead of subcutaneously (incorrect route of product administration) (concentration, frequency of vaccination scheme and anatomical location of vaccination were not reported). Other suspect therapy included the sterile diluent (indication, concentration, and dose were not reported; lot number and expiry date were unknown to the reporter).   No adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; An improperly stored dose of MMRII was administered to a patient; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies.   On 20-FEB-2020, the patient received an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), lot number S013415, expiration date 01-MAY-2021 for prophylaxis (dosage schedule, anatomical location and route of administration were not reported) (product storage error).  The administered dose of the vaccine experienced a temperature excursion of 10 C for 16 hours, as recorded by a data logger. No previous temperature excursion was reported. No additional adverse effects reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; patient inadvertently received a dose of PROQUAD instead of MMR II; This spontaneous report was received from an other healthcare professional (medical assistance) referring to a patient of unknown age and gender. The patient's concomitant medications included sterile diluent. The patient's pertinent medication history and drug reactions/allergies were not reported. On 20-MAR-2020, the patient was inadvertently administered with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) of lot number S003865, expiry date 08-AUG-2020 (dose, strength, route of administration were not reported) for prophylaxis instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, strength, lot number, expiry date, route of administration were not reported) for prophylaxis (wrong product administered). There were no adverse events.
Sex: F
Vaccine: TYP
Symptoms: Ear discomfort, Inappropriate schedule of product administration
Clinical narrative: PLUGGED EARS; TOOK THE THIRD DOSE OF VIVOTIF A DAY LATE; This spontaneous case (PVX2019-964) was received from a consumer on 23-Apr-2019. It describes a female consumer who had plugged ears, while on oral Vivotif (one capsule every other day) for typhoid prophylaxis. She also reported that she took the third dose of Vivotif a day late.  Case report: The consumer took the third dose of Vivotif a day late. The doses were taken on 18-Apr-2019, 20-Apr-2019, and 23-Apr-2019 respectively. She stated that she took the third dose about 20 minutes to 8:00 am on 23-Apr-2019, against her schedule of 8:00 pm on 22-Apr-2019. She also reported that her ears were plugged when she woke up on 23-Apr-2019. Her ears were not plugged when she picked up Vivotif last week, but were plugged when she woke up in the morning on 23-Apr-2019. She stated that her ears do not hurt. She had not taken any treatment for the events.  The consumer's concurrent condition included head cold, (which she had off and on), and sinus drainage. She was unsure if she had a cold or if she had water in her ears. She explained it as this was something that happened to her quite a bit even before starting Vivotif.  The consumer did not have any other medical condition and was on no concomitant medication.  Action taken with Vivotif with respect to the event plugged ears was unknown while with respect to the event "took the third dose of Vivotif a day late" was not applicable.   The consumer had not recovered from the event plugged ears, while it was unknown for the event "took the third dose of Vivotif a day late"  Company's Comment: In this case, the patient reported that she had  plugged ears following administration of third dose of vivotif. The patient's concurrent condition included head cold which she had off and on type and sinus drainage which could have attributed to the event .h Hence, the causality has been assessed as unlikely for event "ears plugged". The causality of the event "took the third dose of Vivotif a day late" was considered as not applicable.; Sender's Comments: Company's Comment: In this case, the patient reported that she had  plugged ears following administration of third dose of vivotif. The patient's concurrent condition included head cold which she had off and on type and sinus drainage which could have attributed to the event .h Hence, the causality has been assessed as unlikely for event "ears plugged". The causality of the event "took the third dose of Vivotif a day late" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea
Clinical narrative: DIARRHEA; This spontaneous case (PVX2019-1339) report was received from a consumer on 24-May-2019. It describes a 53-year-old adult male consumer who had diarrhea, after the administration of oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took three doses of Vivotif on 18-May-2019, 20-May-2019, and 22-May-2019, respectively. After taking the second dose, he had only one bout of diarrhea on 20-May-2019. He did not take any treatment for it. He did not take any contaminated and unhygienic food or water intake before the bout of diarrhea.  Concomitant medications included tamsulosin (0.4 mg; once a day) and epleronone (25 mg; once a day).   Action taken with Vivotif was dosage maintained.  The consumer had recovered from the event on 20-May-2019.  Company's Comment: In this case, it was reported that the consumer had diarrhea, after the administration of oral Vivotif . There seems to be a temporal association between the intake of the vaccine and the event. Also, diarrhoea is labelled as per CCDS. 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 diarrhea, after the administration of oral Vivotif . There seems to be a temporal association between the intake of the vaccine and the event. Also, diarrhoea is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Pyrexia
Clinical narrative: STOMACH PAIN; FEVER; This spontaneous case (PVX2019-1476) was received from a caregiver on 07-Jun-2019. It describes a 15- year-old female consumer who had stomach pain and fever, after administration of Vivotif for typhoid prophylaxis.  Case report: The consumer took the first two doses of Vivotif on 04-Jun-2019 and 06-Jun-2019. She had stomach pain and fever after a few hour of the dose. The stomach pain was getting worse after taking the doses and she assumed that the fever was around 38.2 degree to 38.5 degree Celsius.  The consumer was not taking any other medication and she had no medical history.  Action taken with Vivotif was dosage maintained.  The consumer had not recovered from the events.  Company's Comment: In this case, it was reported that the consumer had stomach pain and fever after the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, stomach pain and fever are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had stomach pain and fever after the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, stomach pain and fever are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea, Nausea, Product storage error, Pyrexia
Clinical narrative: NAUSEA; DIARRHEA; SLIGHT FEVER; TOOK UNREFRIGERATED VIVOTIF; This spontaneous case (PVX2019-1486) was received from a caregiver on 10-Jun-2019. It describes a female consumer who had nausea, diarrhea, and slight fever, after the administration of Vivotif for an unknown indication. She also "took unrefrigerated doses of Vivotif".  Case report: The consumer completed all the doses of Vivotif which were placed unrefrigerated for three weeks. She had nausea, diarrhea, and slight fever, just after she started taking it. She took the last dose on 08-Jun-2019.  The consumer had no medical history and did not take any unhygienic food or water.  She did not receive any concomitant and treatment medicines.  Action taken with Vivotif with respect to the events nausea, diarrhea, and slight fever was dosage maintained while with respect to the event "took unrefrigerated doses of Vivotif" was not applicable.  The consumer had recovered from the events nausea, diarrhea, and slight fever on 09-Jun-2019, while the clinical outcome of the event "took unrefrigerated doses of Vivotif" was unknown.  Company's Comment: In this case, it was reported that the consumer had nausea, diarrhea, and slight fever after intake of Vivotif. She also "took unrefrigerated doses of Vivotif".There seems to be a temporal association between the intake of the vaccine and the events. Also, nausea, diarrhea, and slight fever are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. The causality of the event "took unrefrigerated doses of Vivotif" was considered as not applicable. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had nausea, diarrhea, and slight fever after intake of Vivotif. She also "took unrefrigerated doses of Vivotif".There seems to be a temporal association between the intake of the vaccine and the events. Also, nausea, diarrhea, and slight fever are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. The causality of the event "took unrefrigerated doses of Vivotif" was considered as not applicable.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Erythema, Localised oedema, Loss of personal independence in daily activities, Malaise
Clinical narrative: localized reaction including erythema, edema and soreness; localized reaction including erythema, edema and soreness; localized reaction including erythema, edema and soreness; Myalgia; Malaise; Shivering; Nausea; Possibly fever; interfere with daily activities.; This case was reported by a consumer and described the occurrence of localized erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced localized erythema, localized edema, pain localized, myalgia, malaise, shivering, nausea, fever and activities of daily living impaired. On an unknown date, the outcome of the localized erythema, localized edema, pain localized, myalgia, malaise, shivering, nausea, fever and activities of daily living impaired were unknown.   It was unknown if the reporter considered the localized erythema, localized edema, pain localized, myalgia, malaise, shivering, nausea, fever and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose 2 days ago from  the date of reporting. The reporter stated that after vaccination, the patient had localized reaction including erythema, edema and soreness. The patient also had systemic symptoms including myalgia, malaise, shivering, nausea and possibly fever. The reporter stated that the symptoms were severe enough to interfere with daily activities. The pharmacist reported to the patient that, most people had more side effects with the second dose, therefore the patient concerned about the reaction to the next suggested dose to complete the series.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: localized reaction including erythema, edema and soreness; localized reaction including erythema, edema and soreness; localized reaction including erythema, edema and soreness; Myalgia; Malaise; Shivering; Nausea; Possibly fever; interfere with daily activities.; This case was reported by a consumer and described the occurrence of localized erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced localized erythema, localized edema, pain localized, myalgia, malaise, shivering, nausea, fever and activities of daily living impaired. On an unknown date, the outcome of the localized erythema, localized edema, pain localized, myalgia, malaise, shivering, nausea, fever and activities of daily living impaired were unknown.   It was unknown if the reporter considered the localized erythema, localized edema, pain localized, myalgia, malaise, shivering, nausea, fever and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose 2 days ago from  the date of reporting. The reporter stated that after vaccination, the patient had localized reaction including erythema, edema and soreness. The patient also had systemic symptoms including myalgia, malaise, shivering, nausea and possibly fever. The reporter stated that the symptoms were severe enough to interfere with daily activities. The pharmacist reported to the patient that, most people had more side effects with the second dose, therefore the patient concerned about the reaction to the next suggested dose to complete the series.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Pyrexia
Clinical narrative: headache; upset stomach; fever; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, upset stomach and fever. On an unknown date, the outcome of the headache, upset stomach and fever were unknown.   It was unknown if the reporter considered the headache, upset stomach and fever to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient wanted to know how long could someone expect the side effects to last such as headache, upset stomach and fever.