chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK LAST DOSE OF VIVOTIF THAT WAS FROZEN; A spontaneous case report was received from a consumer on 24-Oct-2019 for two consumers.  Based on the information obtained from the consumer two individual case safety report PVX201910-000818 (PVX2019-2655; husband) and PVX201910-000819 (PVX2019-2658; wife) were created and cross-linked in the database.   This case (PVX2019-2655) described a male consumer who "took last dose of Vivotif that was frozen" (PT: Product storage error), while being on Vivotif capsule for typhoid prophylaxis.  Case report: The consumer took three doses of Vivotif. Then, on 18-Oct-2019, he took last dose that was frozen.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took last dose of Vivotif that was frozen" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took last dose of Vivotif that was frozen" was considered as not applicable US-PaxVax Berna GmbH-PVX201910-000819:
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis
Clinical narrative: Cellulitis
Sex: U
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Broke out in an unspecified rash; This is a spontaneous report from a contactable consumer based on the information received by Pfizer from Merck & Co., Inc. (Case Number: 01530794). A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on 10Jul2015 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced broke out in an unspecified rash on 10Jul2015 with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Rash, Urticaria
Clinical narrative: Twenty two hours after shots being administered, parent stated that patient broke in hives. Rash started on the trunk and spread in upper and lower extremities rapidly. When patient presented in the office, rash started spreading on patient's face as well. The baby was feeding om and no accompanying fever present.  Benadryl 1/2 tsp TID was prescribed and patient was discharged. Follow up visit was recommended.
Age: 1.0
Sex: M
Vaccine: FLU4, HIBV, MMR, PNC13
Symptoms: Expired product administered
Clinical narrative: MMR vaccine was expired on 3/20/20 and given. Parents notified and will return at a later date for another MMR.
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Loss of consciousness, Nausea, Pallor, Seizure
Clinical narrative: The MMR was given and client appeared fine. She walked with her mother about 10 feet to the billing room where after she had sat for a moment the mother reported that client  made "convulsing " motions with her arms and slid to the floor and lost consciousness for less than 10 sec. I (RN) was called to room. Client was conscious but very pale and experiencing some nausea. Her b/p was 102/64 and pulse 84. Since the mother said she had eaten a granola bar only today we gave her a soda and water refused bar.  After sitting on the floor for 10 more minutes she slowly sat in chair and had a little more dizziness. We put a cool compress on the back on her neck and offered to let her lie down.  About 15 minutes later she felt well enough to walk to the car. Encourage to see family doctor  to be checked out and discuss future vaccinations. A phone call to Mom the next day revealed client had a headache but other than that was fine. They were going to see doctor.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Large extremely sore red bump around injection site lasting 3 weeks
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Bursitis, Electromyogram, Injection site pain, Magnetic resonance imaging abnormal, Rotator cuff syndrome
Clinical narrative: Within hours of the shot I had burning, dull pain in my right shoulder. This pain steadily increased in severity over the next 72 hours and my range of motion both up/down and side/side became severely limited. I went to a general urgent care on 11/29/19 to reassess possible shingles and the pain in my shoulder but was told to see if it would dissipate on its own. I then went to an orthopedic urgent care on 12/8/19 and had x-rays and was diagnosed with impingement with probable subchromial bursitis secondary to a recent flu shot, and was told to see a orthopedic MD. I had an appointment with Dr. on 12/18/19 in which she gave a cortisone shot in the right shoulder and she ordered an MRI that was performed on 12/19/19. I followed up with Dr. on 12/23 and was told the MRI showed I had mild sub-chromial bursitis and possible Parsonage Turner syndrome. Dr. ordered physical therapy and continued monitoring. Symptoms continued to persist and Dr. ordered an EMG which was performed on 1/27/20. On 2/10/20 I followed up with Dr. and was told the EMG was normal and to continue PT. On 2/24/20 symptoms continued to persist and Dr. gave a 2nd cortisone shot. Symptoms continued to persist and Dr. ordered a 2nd MRI which was performed on 4/8/20.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: X-ray
Clinical narrative: Within hours of the shot I had burning, dull pain in my right shoulder. This pain steadily increased in severity over the next 72 hours and my range of motion both up/down and side/side became severely limited. I went to a general urgent care on 11/29/19 to reassess possible shingles and the pain in my shoulder but was told to see if it would dissipate on its own. I then went to an orthopedic urgent care on 12/8/19 and had x-rays and was diagnosed with impingement with probable subchromial bursitis secondary to a recent flu shot, and was told to see a orthopedic MD. I had an appointment with Dr. on 12/18/19 in which she gave a cortisone shot in the right shoulder and she ordered an MRI that was performed on 12/19/19. I followed up with Dr. on 12/23 and was told the MRI showed I had mild sub-chromial bursitis and possible Parsonage Turner syndrome. Dr. ordered physical therapy and continued monitoring. Symptoms continued to persist and Dr. ordered an EMG which was performed on 1/27/20. On 2/10/20 I followed up with Dr. and was told the EMG was normal and to continue PT. On 2/24/20 symptoms continued to persist and Dr. gave a 2nd cortisone shot. Symptoms continued to persist and Dr. ordered a 2nd MRI which was performed on 4/8/20.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Patient states that he has pain in the arm upon raising and moving the arm since receiving the vaccine for about a month
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Malaise, Pain
Clinical narrative: body aches, headache, chills, general malaise.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Computerised tomogram head, Full blood count, Headache, Loss of consciousness
Clinical narrative: Had two episodes of syncope (passing out), headache, nausea and vertigo, subjective fevers and chills
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Metabolic function test, Nausea, Pyrexia, Syncope, Vertigo
Clinical narrative: Had two episodes of syncope (passing out), headache, nausea and vertigo, subjective fevers and chills
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Seen in office yesterday 4/13/20 for her 4 year well visit. Received Kinrix only (had already received MMRV). Developed fever to 103 at 4AM this morning (4/14/20), which came down with Tylenol. fever returned around 8:15AM to 1025. one episode of emesis. Temp at 1pm virtual office visit was 99-101 using mom's thermometer.
Age: 11.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Erythema, Pruritus, Rash macular
Clinical narrative: Itchy large raised blotch to right arm/circular area red with smaller blotches surrounding; Itchy large raised blotch to right arm/circular area red with smaller blotches surrounding; Itchy large raised blotch to right arm/circular area red with smaller blotches surrounding; This spontaneous report was received from a healthcare professional via Food and Drug Administration (FDA) (VAERS # 815091), referring to a child. The patient's prescriptions, over the counter medications, diatary supplements or herbal remedies being taken at the time of vaccination were not listed. The patient had none allergies to medications, food, or other products. Other illnesses at the time of vaccination and up to one month prior were not reported. The patient's chronic or long standing health conditions were not reported.  On 15-MAY-2019, the patient was vaccinated at the age of 11 years old, with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (IM) in the right arm  as prophylaxis (lot number R011630 has been verified to be valid, expiration date not reported but validated as 12-DEC-2020), and with the first dose of diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) administered IM in the right arm (strength, dose, frequency and indication were not reported; lot number 97NL3, expiration date not reported).  On 20-MAY-2019, the patient experienced itchy large raised blotch to right arm, newly noticed 5 days after receiving vaccines (rash macular and pruritus). The area was about 3 inches, circular area was red with smaller blotches surrounding (erythema). He was advised to try diphenhydramine hydrochloride (BENADRYL) over-the-counter (OTC) topical and oral at bedtime and to go to doctor if condition worsens or does not improve by "AM".   The outcome of the events was reported as not recovered. The causality assessment between the events and the suspect therapies was not provided.  As of 13-APR-2020, a telephone call attempt trying to obtain information has been unssuccesful.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: pain, pressure, swelling and mild itching of her left upper arm; pain, pressure, swelling and mild itching of her left upper arm; pain, pressure, swelling and mild itching of her left upper arm; pain, pressure, swelling and mild itching of her left upper arm; This spontaneous report was received from a physician and refers to two patients of unknown age and gender. No information regarding the patients' concurrent conditions, medical history and concomitant medications was reported.  On an unknown dates, the patients were vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S021740, expiration date 25-MAR-2021 (strength, dose, frequency and route of administration were not reported) for prophylaxis. On an unknown date, both patients had significant swelling in the upper arm after the injection. The outcome of the event was unknown. The causal relationship between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.   Follow up information was received from practice manager on 13-APR-2020 and refers to one of the patients, who was 67-year-old female. On 08-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in the left upper arm. On 10-OCT-2019, the patient saw the physician due to pain, pressure, swelling and mild itching of her left upper arm. She had no fever or chills and no hand or finger pain. The patient was treated with unspecified doses of ibuprofen (ADVIL) and diphenhydramine hydrochloride (BENADRYL) which helped. It was reported that she had mild relief from taking ibuprofen (ADVIL). She was advised to call the physician if her condition worsened. No call was received from the patient. The outcome of the events was recovering/resolving (it was also reported that the date the pain, pressure, swelling and mild itching resolved was not provided). Additional information was not expected.  The causal relationship between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.  Upon receipt of follow-up information it was determined that the case is now valid because the patients' identifiers were received.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA015594:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: I was experiencing flu like symptoms; Really bad; Sleeping all day; with headache; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse drug reaction (1st dose received on an unknown date, refer case US2020AMR053979).   On 20th March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced malaise, somnolence and headache. On 23rd March 2020, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms, malaise, somnolence and headache were unknown.   It was unknown if the reporter considered the influenza-like symptoms, malaise, somnolence and headache to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient received second dose on a Friday and was experiencing flu like symptoms on a Monday. It was really bad. The patient sleeping all day with headache. The patient thought might he or she had coronavirus but might be it was vaccine. Also thought second dose should be better. The reporter requesting consent to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Influenza like illness, Malaise, Somnolence
Clinical narrative: I was experiencing flu like symptoms; Really bad; Sleeping all day; with headache; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse drug reaction (1st dose received on an unknown date, refer case US2020AMR053979).   On 20th March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced malaise, somnolence and headache. On 23rd March 2020, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms, malaise, somnolence and headache were unknown.   It was unknown if the reporter considered the influenza-like symptoms, malaise, somnolence and headache to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient received second dose on a Friday and was experiencing flu like symptoms on a Monday. It was really bad. The patient sleeping all day with headache. The patient thought might he or she had coronavirus but might be it was vaccine. Also thought second dose should be better. The reporter requesting consent to follow up.
Sex: F
Vaccine: HEP, HEPA
Symptoms: Allergy to vaccine, Urticaria
Clinical narrative: allergy; hives; Information has been received from a nurse practitioner referring to a 58 year old female patient. This case was split form a case in litigation (captured into 1902USA008631). The patient's medical history, concomitant therapy and concurrent condition has been captured into the case in litigation.   On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (manufacturer unknown) and/or hepatitis b vaccine (recombinant)(manufacturer unknown) (dose, concentration, lot#, expiation date, route and frequency unknown) for prophylaxis. The patient could not recall if it was hepatitis A or B or both vaccines. The patient was allergic to hepatitis a vaccine, inactivated (manufacturer unknown) and/or hepatitis b vaccine (recombinant)(manufacturer unknown) on 09-APR-2015 (side effect: hives). The outcome of events was unknown. The reporter considered events to be related to hepatitis a vaccine, inactivated (manufacturer unknown) and/or hepatitis b vaccine (recombinant)(manufacturer unknown).; Sender's Comments:  US-009507513-1902USA008631:
Sex: F
Vaccine: HIBV
Symptoms: Unevaluable event
Clinical narrative: No additional adverse effects; Adult female patient following a steam cell transplant, who received a dose of LIQUID PEDVAXHIB, as prescribed by her physician; This spontaneous report was received from a pharmacist, referring to an adult female patient of unknown age. The patient's historical conditions included a stem cell transplant; her concurrent conditions, concomitant therapies and previous drug reactions or allergies were not provided.  On 31-MAR-2020, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) at a dose of 0.5 milliliter (mL), intramuscularly (IM) (formulation, vaccination schedule, and site of vaccination were not provided; lot numer R004962 verified to be valid, expiration date of 20-NOV-2020) as prophylaxis, per physician's prescription (product use issue). No additional adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Deafness unilateral, Hearing aid user, Sudden hearing loss
Clinical narrative: sudden hearing loss; sensorineural hearing loss; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a male patient of unknown age. His concurrent conditions, medical history and concomitant medications were not provided. In or around 07-OCT-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, injection anatomical location and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after vaccination, he suffered sudden hearing loss on his right ear requiring use of a hearing aid. The patient was diagnosed with sudden hearing loss and sensorineural hearing loss (deafness neurosensory). As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to vaccination. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, he 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, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The reporter considered sudden hearing loss and deafness neurosensory to be disabling events.  Upon internal review, the sudden hearing loss and deafness neurosensory were considered medically significant events.
Sex: M
Vaccine: VARZOS
Symptoms: Infectious pleural effusion, Pneumonia
Clinical narrative: left upper lobe pneumonia with a benign parapneumonic effusion; Information has been received from a lawyer regarding a case in litigation referring to a male patient of unknown age. The patient's medical history, concomitant therapy and concurrent condition were not provided.  On 24-JUN-2010 the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, patient suffered left upper lobe pneumonia with a benign parapneumonic effusion (pneumonia). The outcome of event was unknown.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using product. Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the wrongful conduct, 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, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.
Sex: M
Vaccine: VARZOS
Symptoms: Eye pain, Iritis, Ocular hyperaemia, Ophthalmic herpes simplex, Uveitis
Clinical narrative: right eye iritis/herpes simplex iritis/right eye uveitis; right posterior vitreous detachment; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or around 20-MAY-2014 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date in 2014 (reported as shortly after the vaccination), the patient suffered severe eye pain and eye redness. Patient was diagnosed with right eye iritis, right eye uveitis, right posterior vitreous detachment and herpes simplex iritis (viral iritis and posterior vitreous detachment). As a result of vaccine live(ZOSTAVAX), the patient suffered serious, progressive, severe, 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. He also suffered medical expenses, the loss of accumulations and other economic and non-economic damages. The outcome of viral uveitis and vitreous detachment was considered as not recovered. The reporter considered the events to be disable and related to Zoster Vaccine Live(ZOSTAVAX).  Upon internal review, viral iritis and posterior vitreous detachment were determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Vitreous detachment
Clinical narrative: right eye iritis/herpes simplex iritis/right eye uveitis; right posterior vitreous detachment; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or around 20-MAY-2014 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date in 2014 (reported as shortly after the vaccination), the patient suffered severe eye pain and eye redness. Patient was diagnosed with right eye iritis, right eye uveitis, right posterior vitreous detachment and herpes simplex iritis (viral iritis and posterior vitreous detachment). As a result of vaccine live(ZOSTAVAX), the patient suffered serious, progressive, severe, 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. He also suffered medical expenses, the loss of accumulations and other economic and non-economic damages. The outcome of viral uveitis and vitreous detachment was considered as not recovered. The reporter considered the events to be disable and related to Zoster Vaccine Live(ZOSTAVAX).  Upon internal review, viral iritis and posterior vitreous detachment were determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes virus infection, Keratitis viral, Ophthalmic herpes simplex, Ophthalmic herpes zoster, Skin lesion
Clinical narrative: Herpesviral infection, zoster keratitis, herpesviral keratitis, and herpes dendritic keratitis; Herpesviral infection, zoster keratitis, herpesviral keratitis, and herpes dendritic keratitis; Information has been received on from a lawyer and the patient (pt), regarding a case in litigation referring a female pt  of unknown age. Medical history, concurrent conditions and concomitant medications were not reported.  In or around 13-NOV-2015, the pt was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (route, anatomical location, lot number and expiration date were 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 pt suffered skin lesions and was diagnosed with herpes viral infection, zoster keratitis, herpesviral keratitis and herpes dendritic keratitis. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX), pt's symptoms resulted in physical limitations not present prior to using Zoster Vaccine Live (ZOSTAVAX). She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. She sustained severe and permanent personal injuries, as a tragic consequence of Zoster Vaccine Live (ZOSTAVAX). She 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.   Upon internal review ophthalmic herpes zoster was considered as medically significant. The reporters considered herpes zoster and ophthalmic herpes zoster to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness bilateral, Deafness neurosensory, Tinnitus
Clinical narrative: bilateral sensorineural hearing loss and bilateral tinnitus.; bilateral sensorineural hearing loss and bilateral tinnitus.; Information has been received on from a lawyer and the patient (pt), regarding a case in litigation referring a female pt of unknown age. Medical history, concurrent conditions and concomitant medications were not reported.  In or around 29-APR-2017, the pt was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (route, anatomical location, lot number and expiration date were 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 pt suffered bilateral hearing loss with ringing tinnitus and was diagnosed with bilateral sensorineural hearing loss and bilateral tinnitus. As a direct and proximate result of defective Zoster Vaccine Live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using Zoster Vaccine Live (ZOSTAVAX). She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. She sustained severe and permanent personal injuries; serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  The reporters considered bilateral sensorineural hearing loss and bilateral tinnitus to be disabling. Upon internal review bilateral sensorineural hearing loss was considered as medical significant.
Sex: M
Vaccine: VARZOS
Symptoms: Blindness
Clinical narrative: vision loss; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 18-JAN-2018, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route and lot # not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).               On an unknown date "shortly after" receiving zoster vaccine live (ZOSTAVAX), the patient experienced vision loss. As a direct and proximate result of the defective Zoster Vaccine Live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. The patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of vision loss was considered as not recovered.   The event was considered to be related to zoster vaccine live (ZOSTAVAX).    Vision loss was considered to be disabling by the reporter.  Upon internal review vision loss was considered to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Exposure during pregnancy, Pain in extremity, Peripheral swelling
Clinical narrative: My arm was sore and swollen for 2 days after the shot; My arm was sore and swollen for 2 days after the shot; I received the PNEUMOVAX 23 shot while I was unknowingly 3 weeks pregnant.; Indication: "Pneumonia"; This spontaneous prospective pregnancy report was received from a 26 year old female patient, reporting on herself. The patient's historical conditions included pneumonia and the patient's concurrent conditions included asthma. The patient had no allergies and her concomitant therapies included albuterol inhaler (manufacturer unknown).  On 19-MAR-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, one dose (strength, route of administration, anatomical location, lot number and expiration date were not reported) for pneumonia. At the vaccination time, the patient was unknowingly 3 weeks pregnant (the last menstrual period (LMP) was calculated as 27-FEB-2020 and estimated date of delivery (EDD) was calculated as 03-DEC-2020).   On 19-MAR-2020, the patient's arm was sore (pain in extremity) and swollen (peripheral swelling). No treatment was provided and laboratory diagnostics studies were not performed. On 21-MAR-2020, 2 days after the shot, the patient recovered from the events. The patient did not report any other adverse reactions. At the reporting time, the pregnancy outcome was pending. The reporter did not assess the causal relationship between therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; an expired dose of MMR II was inadvertently administered; This spontaneous report was received from a certified medical assistant referring to a 12-month-old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 13-APR-2020, the patient was inadvertently vaccinated with and expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R010714 (expiration date: 11-APR-2020, additional dosage regimen information was not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No known adverse effects.; A patient received an expired dose of VARlVAX; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 13-APR-2020, the patient was vaccinated with an an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, route, dose, frequency, and anatomical location were unknown) with lot # R009820 and expiration date 03-APR-2020 for prophylaxis. No known adverse effects were reported.
Sex: U
Vaccine: HEPA, UNK
Symptoms: Incorrect dosage administered, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse event; the pediatric patient was inadvertently administered an adult dose of VAQTA; the pediatric patient was inadvertently administered an adult dose of VAQTA; This spontaneous report was received from a medical assistant referring to a pediatric patient of unknown age and gender. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not reported.  On 13-APR-2020, the patient was inadvertently administered an adult dose of hepatitis a vaccine, inactivated (VAQTA) (lot# S025258 with expiration date 05-NOV-2020, route was not reported) for prophylaxis (incorrect dosage administered and product administered to patient of inappropriate age). The hepatitis a vaccine, inactivated (VAQTA) was administered with hepatitis a vaccine, inactivated (VAQTA SYRINGE (DEVICE)). No additional adverse event was reported. For hepatitis a vaccine, inactivated (VAQTA SYRINGE (DEVICE)), the lot number was reported as S025258 and the serial number was not available.   combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025258; expirationdate: 05-NOV-2020; 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
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: pharmacy has suspended given 2nd dose of Shingrix to patients / not sure how long past the recommended 6 month; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were received as follows: The age at vaccination was not applicable for this report. The reporter stated that due to safety concerns the pharmacy has suspended giving 2nd dose to the patients. The reporter stated that they are not sure when it will resume and how long past the recommended 6 months.
Sex: M
Vaccine: VARZOS
Symptoms: Pemphigoid
Clinical narrative: bullous pemphigoid; This case was reported by a consumer via call center representative and described the occurrence of bullous pemphigoid in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced bullous pemphigoid (serious criteria GSK medically significant). On an unknown date, the outcome of the bullous pemphigoid was unknown.   It was unknown if the reporter considered the bullous pemphigoid to be related to Shingrix.  Additional details were provide as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient experienced bullous pemphigoid since receiving the vaccine. The reporter wanted to know, what were the ingredients that caused this horrible disease to occurred.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Her first vaccine was hard hot; Her first vaccine was painful for several days.; Her first vaccine was hard hot; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, injection site warmth and injection site induration. On an unknown date, the outcome of the injection site pain, injection site warmth and injection site induration were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site warmth and injection site induration to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced hard, hot and painful at site for several days. For the tolerability of 2nd dose, refer case US2020AMR063770 reported for same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Injection site induration, Injection site warmth
Clinical narrative: She is experiencing chills; The site again is hard and hot; The site again is hard and hot; She is experiencing chills and overall fatigue; feeling terrible; This case was reported by a consumer and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of injection site induration, shingrix with an associated reaction of injection site warmth and shingrix with an associated reaction of injection site pain (For the tolerability of 1st dose, refer case US2020AMR063768 reported for same patient).   On 10th April 2020, the patient received the 2nd dose of Shingrix. On 11th April 2020, 1 days after receiving Shingrix, the patient experienced chills, injection site warmth, injection site induration, fatigue and feels awful. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chills, injection site warmth, injection site induration, fatigue and feels awful were not recovered/not resolved.   It was unknown if the reporter considered the chills, injection site warmth, injection site induration, fatigue and feels awful to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was feeling terrible. The site again was hard and hot. The patient was experiencing chills and overall fatigue.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: She is experiencing chills; The site again is hard and hot; The site again is hard and hot; She is experiencing chills and overall fatigue; feeling terrible; This case was reported by a consumer and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of injection site induration, shingrix with an associated reaction of injection site warmth and shingrix with an associated reaction of injection site pain (For the tolerability of 1st dose, refer case US2020AMR063768 reported for same patient).   On 10th April 2020, the patient received the 2nd dose of Shingrix. On 11th April 2020, 1 days after receiving Shingrix, the patient experienced chills, injection site warmth, injection site induration, fatigue and feels awful. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chills, injection site warmth, injection site induration, fatigue and feels awful were not recovered/not resolved.   It was unknown if the reporter considered the chills, injection site warmth, injection site induration, fatigue and feels awful to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was feeling terrible. The site again was hard and hot. The patient was experiencing chills and overall fatigue.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Bordetella test positive, Pertussis, Vaccination failure
Clinical narrative: received a diagnosis of pertussis today despite getting vaccinated on 1/3/19.; pertussis; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a 57-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number TF422, expiry date unknown) for prophylaxis.   On 1st March 2019, the patient received Boostrix. On 13th April 2020, 409 days after receiving Boostrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and pertussis (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and pertussis were unknown.   It was unknown if the reporter considered the vaccination failure and pertussis to be related to Boostrix.  Additional details were provide as follows: This case was reported by patient himself. The age at vaccination was not reported. The patient was diagnosis with pertussis. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding primary vaccination schedule were unknown at the time of reporting.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever was 102; This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE for prophylaxis.   On 15th October 2019, the patient received the 1st dose of Shingrix (intramuscular) and PNEUMOCOCCAL VACCINE. On 16th October 2019, 1 days after receiving Shingrix and an unknown time after receiving PNEUMOCOCCAL VACCINE, the patient experienced fever. On 17th October 2019, the outcome of the fever was recovered/resolved.   The reporter considered the fever to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not applicable for this report. In afternoon, the patient stated she got the shot.  When she woke up the next morning, her fever was 102 degree C.  It stayed that way all day then the next day, she was fine.  She later mentioned she had a pneumonia vaccine the same day of her Shingrix shot but had not considered that her fever may have been caused by that vaccine. The reporter did not consented to follow up.  She saw no need to provide her doctor's information. The reporter considered the fever to be related to PNEUMOCOCCAL VACCINE .
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Ringing in ears; This case was reported by a consumer via call center representative and described the occurrence of ringing in ears in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number G537F, expiry date 14th March 2022) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix (intramuscular). In January 2020, 1 month after receiving Shingrix, the patient experienced ringing in ears. On an unknown date, the outcome of the ringing in ears was recovering/resolving.   The reporter considered the ringing in ears to be possibly related to Shingrix.  Additional details were provided as follows: The patient had the first dose of Shingrix right in left deltoid before Christmas day but could not provide exact date. 19th December 2019, was an estimated date of administration. About a month later in January of 2020, she developed ringing in her ears. She saw her doctor in March who said it could be a result of the vaccine. Consented to follow up. Emergency room visit required.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: vaccination failure; shingles; itching; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included chronic pain. Concomitant products included gabapentin.   On an unknown date, the patient received the 1st dose of Shingrix. On 13th November 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 13th January 2020, unknown after receiving Shingrix and 61 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pruritus. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingrix and Shingrix.  Additional details were provide as follows: This case was reported by the patient's husband. About three months after vaccination, the patient experienced shingles after 2nd dose, although the shingles had been mild compared to shingles she has had in the past and were on her right arm, neck, and under her left breast. The patient planned to continue follow-up with her physician on an unknown date. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding laboratory confirmation were unknown at the time of reporting.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Choking, Respiratory arrest, Skin discolouration
Clinical narrative: Approximately 5 pm i started feeding my daughter. I was holding her sideline like i was showed in the hospital. After about a few mins of her beggining her feed she started choking and spitting milk out of her nose and mouth. She turned purple from head to toe and stop breathing for approximately 30 seconds we rubbed her back to get her to breathe and called 911 when they arrived eveerything sounded good and looked good. Prior to this incident she has never had any problems no acid reflux or any kind of health problems other then being born 3 months early
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Axillary pain, Chills, Discomfort, Erythema, Headache
Clinical narrative: within a short  period of injection: low grade fever, chills, extreme muscle soreness, swelling at injection site (hardness of area too), redness, itching, swelling/pain of armpit, headache, lethargic, some insomnia, inability to move arm without significant discomfort. after 72 hours fever, chills, extreme soreness abated. It is now 120 hours (5 days), I STILL have redness, itching, swelling/mild pain of armpit, occasional headaches, still sore at injection site. please note I do not know the brand of the vaccine, only that it was a Tdap vaccine
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Insomnia, Lethargy, Myalgia
Clinical narrative: within a short  period of injection: low grade fever, chills, extreme muscle soreness, swelling at injection site (hardness of area too), redness, itching, swelling/pain of armpit, headache, lethargic, some insomnia, inability to move arm without significant discomfort. after 72 hours fever, chills, extreme soreness abated. It is now 120 hours (5 days), I STILL have redness, itching, swelling/mild pain of armpit, occasional headaches, still sore at injection site. please note I do not know the brand of the vaccine, only that it was a Tdap vaccine
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Pyrexia, Swelling
Clinical narrative: within a short  period of injection: low grade fever, chills, extreme muscle soreness, swelling at injection site (hardness of area too), redness, itching, swelling/pain of armpit, headache, lethargic, some insomnia, inability to move arm without significant discomfort. after 72 hours fever, chills, extreme soreness abated. It is now 120 hours (5 days), I STILL have redness, itching, swelling/mild pain of armpit, occasional headaches, still sore at injection site. please note I do not know the brand of the vaccine, only that it was a Tdap vaccine