chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Eyelid function disorder, Eyelid pain, Rash pruritic, Swelling of eyelid
Clinical narrative: Patients mother called the on-call physician on Saturday 03/28/2020 the day after getting the injection. Mother stated that patients eyelids are now swollen. Patient stated that she can't open eyes all the way, but can see fine. The eyelids are a little sore but not painful, and the eyes are not painful. She had a couple of little bumps on her skin that are itchy, but did not have any throat nor mouth symptoms.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU4, DTAPIPVHIB, FLU4
Symptoms: Irritability, Skin warm, Urticaria
Clinical narrative: Severe generalized welts ranging in size from 5 mm diameter to 12 inches X 4 inches (belly to knee, neck to diaper line & shoulder to elbow).  Would go away and return in new locations. Not itchy.  Afebrile. Good generalized demeanor of child but slightly irritable and warm.  Diphenhydramine 10 mg given ~q12 hours  - did not appear to help. First welts appeared ~28 hrs after vaccination and continued for 3 days.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU4, DTAPIPVHIB, FLU4
Symptoms: Urticaria
Clinical narrative: Severe generalized welts ranging in size from 5 mm diameter to 12 inches X 4 inches (belly to knee, neck to diaper line & shoulder to elbow).  Would go away and return in new locations. Not itchy.  Afebrile. Good generalized demeanor of child but slightly irritable and warm.  Diphenhydramine 10 mg given ~q12 hours  - did not appear to help. First welts appeared ~28 hrs after vaccination and continued for 3 days.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: a pregnant patient got VARIVAX within one month of conceiving; Information has been received from a physician referring to a female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. The patient was pregnant.  On an unknown date, the patient received varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose detail, route, lot # and expiration date were not reported) within one month of conceiving for prophylaxis (exposure during pregnancy).   The last menstrual period (LMP) and the estimated date of delivery (EDD) were unknown. The pregnancy outcome was pending. The fetal outcome was unknown.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypersensitivity, Rash
Clinical narrative: shingles; other health complication; allergic reaction; rash; This spontaneous report has been received from a lawyer regarding a case in litigation and refers to a 66-year-old patient of unknown gender. The patent's concurrent conditions, medical history and concomitant medications were not reported. On 29-SEP-2016, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided). As a result of her receipt or zoster vaccine live (ZOSTAVAX), on 08-NOV-2016, the patient was caused to suffer a severe rash and allergic reaction. As a result of her receipt of zoster vaccine live (ZOSTAVAX), she had been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions, she requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. The patient was informed and believes and further alleges that she will in the future be required to obtain further medical and/or hospital care, attention, and services. As a foreseeable, direct, and proximate consequence of zoster vaccine live (ZOSTAVAX), the patient suffered shingles and other related health complications. In addition, the patient required and will continue to require healthcare and services. The patient has incurred and will continue to incur medical and related expenses. The patient also had suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient's direct medical losses and costs include physician care, monitoring, and treatment. She has incurred and will continue to incur mental and physical pain and suffering. The patient's past and future damages, including but not limited to pain and suffering for severe injuries sustained, health care costs, loss of wages and/or earning capacity, and medical monitoring. The outcome of the events was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the events to be disabling.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 68 year old male patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.     On 29-JUL-2015, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported). As a result of his receipt of zoster vaccine live (ZOSTAVAX), in November 2015, patient was caused to suffer shingles, including any and all of its sequelae.  As a result of his receipt of zoster vaccine live (ZOSTAVAX), patient has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions, patient requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. Patient is informed and believes and further alleges that he will in the future be required to obtain further medical and/or hospital care, attention, and services. As a foreseeable, direct, and proximate consequence of Company's actions, omissions, and misrepresentations, patient suffered shingles and other related health complications. In addition, patient requires and will continue to require healthcare and services. Patient has incurred and will continue to incur medical and related expenses. Patient also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. Patient's direct medical losses and costs include physician care, monitoring, and treatment. Patient has incurred and will continue to incur mental and physical pain and suffering.  The outcome of shingles was reported as not recovered/not resolved. The reporter considered the event to be related to Zoster Vaccine Live(ZOSTAVAX).     Shingles was considered to be disabling.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse symptoms reported; Inadvertently received an expired dose of VAQTA; Information has been received from a physician concerning to a patient (age and gender not reported). No medical history, concomitant medications nor concurrent conditions were reported. On 27-SEP-2019,  the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) (Lot No. R021233, exp. date 05-SEP-2019) for prophylaxis. No adverse symptoms were reported.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information was received from a lawyer regarding a case in litigation concerning a 60-year-old female patient (pt). The pt's medical history, concurrent conditions, or concomitant medication were not provided. On an unspecified day in 12-JUL-2016, the pt was inoculated at a pharmacy with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date not provided) for prophylaxis. As a result of her receipt of zoster vaccine live (ZOSTAVAX), on an unspecified day in 2016, the pt suffered serious and dangerous side effects including shingles (herpes zoster) including any and all its sequelae as well as other severe and personal injuries which were permanent and lasting in nature. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the pt suffered severe personal injuries, pain, suffering, and emotional distress, as well as to incurred substantial economic damages. In addition, the pt required and would continue to require healthcare and services. The pt incurred and would continue to incur medical and related expenses. The pt also suffered and would continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The pt 's direct medical losses and costs include physician care, monitoring, and treatment. Patient has incurred and will continue to incur mental and physical pain and suffering. Outcome of herpes zoster was reported as not resolved. The causal relationship between the event was reported as related to zoster vaccine live (ZOSTAVAX).  The reporter herpes zoster to be a disabling event.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Herpes zoster
Clinical narrative: vision loss; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 64-year-old female patient. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On 19-AUG-2008, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, lot # and expiration date were not provided) at a public health center. As a result of her receipt of vaccination, on unspecified date in 2008, the patient was treated for vision loss (blindness) and shingles including any and all its sequelae. It has been caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. At the time of the report, the patient's outcome was unknown, and the reporter considered blindness and shingles to be related to Zoster Vaccine Live (ZOSTAVAX).  The reporter considered the event of blindness and shingles to be disabling.  Upon internal review, the event of blindness was considered medically significant.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Herpes zoster
Clinical narrative: shingles; vision loss; Information was received from a lawyer regarding a case in litigation concerning a 67-year-old female patient (pt). The pt's medical history, concurrent conditions, or concomitant medication were not provided. On an unspecified day in January 2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date not provided) for prophylaxis. As a result of her receipt of zoster vaccine live (ZOSTAVAX), on an unspecified day in June 2016, the pt suffered vision loss (blindness) including any and all its sequelae. As a result, the pt suffered serious and dangerous side effects including shingles (herpes zoster), as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the pt suffered severe personal injuries, pain, suffering, and emotional distress, as well as to incurred substantial economic damages. As a result, the pt required and/or would require more health care and services and incurred medical, health, incidental and related expenses. The pt informed and believed and further alleged that she would, in the future, be required to obtain further medical and/or hospital care, attention, and services. Outcome of blindness and herpes zoster was reported as not resolved. The causal relationship between these events was reported as related to zoster vaccine live (ZOSTAVAX).  The reporter considered blindness and herpes zoster to be disabling events.  Upon internal review, blindness was determined to be a medically significant event.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 57 years old male patient. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for prophylaxis (dose, route, anatomical location, lot number and expiration date were not provided). On an unknown date in 2016, the patient experienced herpes zoster (shingles). As a direct and proximate result of the zoster Vaccine Live (ZOSTAVAX) vaccination, the patient's symptoms have resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The outcome of the event of shingles was considered as not recovered. The reporter considered the event to be related to zoster Vaccine Live (ZOSTAVAX).
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 58 years old male patient. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown day in May 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for prophylaxis (dose, route, anatomical location, lot number and expiration date were not provided). On an unknown date in 2016, the patient experienced herpes zoster (shingles). As a direct and proximate result of the zoster Vaccine Live (ZOSTAVAX) vaccination, the patient's symptoms have resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The outcome of the event of shingles was considered as not recovered. The reporter considered the event to be related to zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional Adverse effects were reported; patient received improperly stored PROQUAD; Information has been 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 reported.  On 26-MAR-2020, the patient received improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (0.5 milliliter (ml), once, lot # S027463, expiration date 02-MAR-2021) (dose detail and route of administration were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT) (lot number R032353 and expiration date 10-JUN-2021).  According to the reporter, the temperature excursions were ranged from 6 degrees Fahrenheit (F) to 14 degrees Fahrenheit (-14 degrees Celsius to -10 degrees Celsius) (-14.3 degrees Celsius) for 54 minutes, which was detected by a digital data logger. There was no previous excursion reported. No additional adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Deafness, Deafness neurosensory, Visual impairment
Clinical narrative: vision problems; moderately severe hearing loss; sensorineural moderate hearing loss; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or around 10-MAR-2010, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date in 2010 (reported as shortly after receiving the vaccine), he suffered hearing loss and was diagnosed with moderately severe hearing loss and sensorineural moderate hearing loss. The patient also suffered from vision problems after receiving the vaccine. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to vaccination. He also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), 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 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 to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events were determined to be disabling by the reporter. Upon internal review, the events of moderately severe hearing loss and sensorineural moderate hearing loss were considered to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Vaccination complication
Clinical narrative: since march 2nd, his arm is still killing him'.; This spontaneous report was received from the patient's wife via Pfizer referring to her husband, an 83 years old male patient. The patient was in excellent condition prior to diagnosed of 2 tumors left kidney. And reported cancer in adrenal gland and spleen, vena cava vein. The patient was also taking pembrolizumab (KEYTRUDA).  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23 valent) (PNEUMOVAX23) (dose, strength, route, lot# and expiration date were not provided) for prophylaxis. Since 02-MAR-2020, the patient had a very bad reaction to pneumococcal vaccine, polyvalent (23 valent) (PNEUMOVAX23), the patient's arm was still killing him (pain in extremity). The outcome of pain in extremity was unknown.     The causality between pain in extremity and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was related.
Sex: F
Vaccine: MENB
Symptoms: Tendonitis
Clinical narrative: Tendonitis in her wrist; This is a spontaneous report from a contactable consumer (patient's mother). A 19-year-old female patient received second dose of meningococcal group b rlp2086 (meningococcal serogroup B conjugate vaccine) (TRUMENBA Suspension for injection; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for immunization. The patient's medical history included being diagnosed with Lyme disease and Bell's palsy previously. The patient previously took first dose of meningococcal group b rlp2086 (meningococcal serogroup B conjugate vaccine) (TRUMENBA) for immunization. The patient's concomitant medications were not reported. The patient's mother was calling on behalf of the patient who is due on 02Apr2020 for the third dose. The patient was needed to be on 3-dose schedule as per healthcare professional. If the patient was late for her third dose related to COVID precautions, they were wanting recommendations on how long she can wait to get the third dose and still be effective. The patient's mother was also asking for recommendations on safe location (away from COVID risk) to get third dose in her area. The patient thought that the second dose was on 26Dec2019 but was not sure. The patient's mother confirmed that the patient was on time for the first two doses. On an unspecified date, the patient developed tendonitis in her wrist and had to have steroid injection in her wrist. The patient was advised to have the third dose at least 30 days after the steroid injections. The patient's mother stated that the tendonitis had nothing to do with the vaccine. The outcome of the event was unknown. The reporting consumer considered the event as unrelated to the suspect product.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Rash vesicular
Clinical narrative: Patient experienced a rash eruption on around entire abdomen and upper right back that was pruritic. She developed a secondary rash on night of 3/29/2020 that was painful and limited to a small area above the right shoulder blade - this appeared more vesicular in nature and limited to this area (different from the trunk rash). She was prescribed prednisone and valtrex on 3/30/2020
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Unevaluable event
Clinical narrative: Per doctor orders: warm compresses and Tylenol and waiting to see if instructions are going to work if not the next step will be to give Benadryl
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Joint swelling, Pain
Clinical narrative: Within 24 hours of vaccination patient had acute, severe (8-9/10) knee arthralgias and swelling for 3-4 days, with pain persisting for 2 weeks but slowly decreasing in severity.  Patient reported the reaction in early January 2020 during a routine health screening (PHA) and said he realized he didn't seek care initially, but was embarrassed.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Blood glucose normal, Hyperhidrosis, Pallor
Clinical narrative: Pt received bexsero and menactra by MA with another supervising. Pt moved from exam table to chair, sitting next to mother. Brother received vaccines. Patient asked for water, MA brought it to her in the doorway. Everyone was standing. Patient took a sip of water and stumbled. MA guided the patient to the floor and called for help. I, PA-C, assessed the patient. She was pale and diaphoretic. She was adequately profused and breathing. Pt states she has had previous episodes of vasovagal syncope following injections. She also states she did not eat breakfast this morning. After about 4 minutes, patient was able to stand and was asked to wait in the waiting room. She was given tea and offered food. Her BG was 109. Patient was allowed to leave after 15 minutes in the waiting room recovering.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Soreness and ache in shoulder of arm vaccinated starting about 6 pm, followed by chills until about 1 am the following morning.  Fever of 99.8 at 7 am on 3/24/2020.  Fever subsided by 6 pm on 3/24/2020.  Soreness lessened until it disappeared on 3/28/2020.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pt stated that a rash started to appear on the forearm of her left arm the evening she received the vaccine.  The rash continued to work up her arm over the next two weeks to almost the shoulder area.  The rash also started to appear on her right arm.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Insomnia, Joint range of motion decreased, Laboratory test, Loss of personal independence in daily activities
Clinical narrative: Symptoms started directly after painful  injection,  then worsened, continued over weeks/months. Resulted in extreme shoulder pain, limited shoulder arm rotation.  Injection site still painful if pressed. Constant sharp shoulder pain, exacerbated by any exercise activity, lifting or moderate alcohol consumption. Sleep deprivation incurred, hard to get dressed. Going on 5 months now. Never had this reaction after other Flu injections...but this was my first high dose injection recommended at 65. Not allergic to eggs, however, prepared a Quiche Lorraine meal few weeks later and had a severe side-effect/pain throughout. Could not put wait on limbs for several days.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Musculoskeletal pain, Weight bearing difficulty
Clinical narrative: Symptoms started directly after painful  injection,  then worsened, continued over weeks/months. Resulted in extreme shoulder pain, limited shoulder arm rotation.  Injection site still painful if pressed. Constant sharp shoulder pain, exacerbated by any exercise activity, lifting or moderate alcohol consumption. Sleep deprivation incurred, hard to get dressed. Going on 5 months now. Never had this reaction after other Flu injections...but this was my first high dose injection recommended at 65. Not allergic to eggs, however, prepared a Quiche Lorraine meal few weeks later and had a severe side-effect/pain throughout. Could not put wait on limbs for several days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: soreness right arm after immunization ongoing
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site pain, Pain, Pain in extremity
Clinical narrative: Pt is complaining for pain at the injection site, sore arm, discolored around injection site, small pin prick dot where needle was injected. Sore to lift arm. Arm is not swollen, not hot to touch.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Injection site pain, Injection site warmth, Lymphadenopathy
Clinical narrative: (L) arm injection site warm to touch/tender headache, nausea, ache, pain, diarrhea. Supraclavicular lymph node enlargement.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: (L) arm injection site warm to touch/tender headache, nausea, ache, pain, diarrhea. Supraclavicular lymph node enlargement.
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient needed to receive Dtap and was given Tdap instead. The patient had no adverse reaction, and the state registry states the vaccine will count and does not need to be repeated.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: fever 103.8 per mother red, swollen area at site, quarter size, started the night following vaccines into next morning.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Brain scan normal, Chest X-ray normal, Electrocardiogram normal, Orthostatic hypotension, Syncope
Clinical narrative: The day after my Shingles shot, I fainted twice. I thought it was an allergic reaction to the vaccine. - Called 911, after instructions from my Doctor, was admitted for 2 days. The diagnosis was orthostatic hypotension - not a reaction to the vaccine. I thought I should let you know there was NO allergic reaction
Sex: U
Vaccine: UNK
Symptoms: Dyspepsia
Clinical narrative: DYSPEPSIA; This spontaneous case report (809277-1) was extracted through VAERS database on 19-Jul-2019. The case was reported from a pharmacist via health authority. The report describes a consumer who experienced dyspepsia (PT: Dyspepsia), after the administration of Typhoid live oral TY21A for an unknown indication.  Case report: The consumer took Vivotif dose on an unknown date and experienced dyspepsia.   The action taken with Typhoid live oral TY21A was unknown.  The clinical outcome of the event was unknown.  Company's Comment: In this case, it was reported that the consumer experienced dyspepsia (PT: Dyspepsia), after the administration of Typhoid live oral vaccine. There seems to be a temporal association between the intake of the vaccine and the event. A. Hence, the causality of the event with Typhoid live oral vaccine is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced dyspepsia (PT: Dyspepsia), after the administration of Typhoid live oral vaccine. There seems to be a temporal association between the intake of the vaccine and the event. A. Hence, the causality of the event with Typhoid live oral vaccine is assessed as possible.
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: STOMACH PAIN; NAUSEA; This spontaneous case report (813307-1) was extracted through VAERS database on 30-Aug-2019. The case was reported from a consumer via health authority. The report described a 9-year-old male consumer who experienced stomach pain (PT: Abdominal pain upper) and nausea (PT: Nausea), after the administration of oral Vivotif (lot number: 3003242) for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 08-May-2019. On 09-May-2019, he experienced stomach pains and nausea. The consumer had to skip his school.  Current illness included a cold, cough, runny nose, or possible seasonal allergies.  Concomitant medication included Claritin (loratadine) for kids.  The action taken with Vivotif with respect to the events was unknown.  The consumer had not recovered from the reported events.  Company's Comment: In this case, it was reported that the consumer experienced stomach pain and nausea 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. Also, stomach pain and nausea are labelled as per CCDS. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced stomach pain and nausea 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. Also, stomach pain and nausea are labelled as per CCDS.
Sex: F
Vaccine: TYP
Symptoms: Abdominal distension, Abdominal pain upper
Clinical narrative: FELT BLOATED; STOMACH ACHE; This spontaneous case report (813614-1) was extracted through VAERS database on 30-Aug-2019. The case was reported from a consumer via health authority. The report describes a 17-year-old female consumer who felt bloated (PT: Abdominal distension) and stomach ache (PT: Abdominal pain upper), after the administration of oral Vivotif for an unknown indication.  Case report: The consumer took the fourth dose of Vivotif on 10-May-2019. On 11-May-2019 in the morning, she had severe stomach ache and felt bloated in the early morning.  The consumer's medical history included eczema and had allergy with gluten.  The action taken with Vivotif with respect to the events was not applicable.  The consumer had not recovered from the reported events.  Company's Comment: In this case, it was reported that the consumer felt bloated and stomach ache 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. Also, stomach ache is labelled as per CCDS. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer felt bloated and stomach ache 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. Also, stomach ache is labelled as per CCDS.
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Diarrhoea, Gastrointestinal disorder
Clinical narrative: GASTROINTESTINAL ISSUES; TERRIBLE CRAMPS; DIARRHOEA; This spontaneous case report (815848-1) was extracted through VAERS database on 30-Aug-2019. The case was reported from a consumer via health authority. The report described a 52-year-old female consumer who had gastrointestinal (GI) issues (PT: Abdominal discomfort), diarrhea (PT: Diarrhea), and terrible cramps (PT: Abdominal pain), while being on oral Vivotif for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 01-Apr-2019. On 01-Apr-2019, she had GI issues, had diarrhea, and had terrible cramps, which were lasted for 3 days.  The action taken with Vivotif with respect to the events was unknown.  The consumer had recovered from the reported events.  Company's Comment: In this case, it was reported that the consumer had gastrointestinal (GI) issues, diarrhea, and terrible cramps following intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the event with Vivotif is assessed as possible. Also, gastrointestinal (GI) issues, diarrhea and terrible cramps are labelled as per CCDS.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had gastrointestinal (GI) issues, diarrhea, and terrible cramps following intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. . Hence, the causality of the event with Vivotif is assessed as possible. Also, gastrointestinal (GI) issues , diarrhea and terrible cramps are labelled as per CCDS.
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Headache
Clinical narrative: DIARRHOEA; HEADACHE; This spontaneous case report (815941-1) was extracted through VAERS database on 30-Aug-2019. The case was reported from a consumer via health authority. The report described a 52-year-old male consumer who experienced diarrhoea (PT: Diarrhoea) and headache (PT: Headache), after the administration of oral Vivotif for an unknown indication.  Case report: The consumer took the fourth dose of Vivotif on 20-May-2019. On 25-May-2019, he experienced diarrhoea, and low-grade headache upon walking, usually gone within 2 hours untreated.   The patient's medical history included high triglycerides.  The action taken with Vivotif with respect to the events was not applicable.  The patient had recovered from the event headache while the clinical outcome of diarrhoea was unknown.  Company's Comment: In this case, it was reported that the consumer had diarrhoea and headache after five days of intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif is assessed as possible. Also, diarrhoea and headache is labelled as per CCDS. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had diarrhoea and headcahe after five days of  intake of Vivotif. . There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif is assessed as possible. Also, diarrhoea and headache is labelled as per CCDS.
Sex: M
Vaccine: TYP
Symptoms: Computerised tomogram abdomen abnormal, Diarrhoea, Enteritis, Nausea, Vomiting
Clinical narrative: NAUSEA; VOMITING; DIARRHEA; This spontaneous case (818370-1) report was extracted through VAERS database on 27-Sep-2019. The case was reported by a consumer via health authority. The report described a 68-year-old male consumer who experienced nausea (PT: Nausea), vomiting (PT: Vomiting), and diarrhea (PT: Diarrhoea), while being on oral Vivotif for an unknown indication.  Case report: The consumer started Vivotif from 09-Jun-2019. On 11-Jun-2019, he experienced nausea, vomiting and diarrhea right before the second dose. His laboratory data revealed elevated white blood cells (WBC: 17000) and computerized tomogram (CT) scan revealed abdomen with mild jejunitis, without other findings.  Action taken with Vivotif with respect to the events was unknown.  The consumer had recovered from the reported events.  Company's Comment: In this case, it was reported that the consumer experienced nausea, vomiting, and diarrhea after intake of 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. Also, fever and abdominal pain are labelled as per CCDS.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced nausea, vomiting , and diarrhea after intake of 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. Also, fever and abdominal pain are labelled as per CCDS.
Sex: M
Vaccine: TYP
Symptoms: White blood cell count increased
Clinical narrative: NAUSEA; VOMITING; DIARRHEA; This spontaneous case (818370-1) report was extracted through VAERS database on 27-Sep-2019. The case was reported by a consumer via health authority. The report described a 68-year-old male consumer who experienced nausea (PT: Nausea), vomiting (PT: Vomiting), and diarrhea (PT: Diarrhoea), while being on oral Vivotif for an unknown indication.  Case report: The consumer started Vivotif from 09-Jun-2019. On 11-Jun-2019, he experienced nausea, vomiting and diarrhea right before the second dose. His laboratory data revealed elevated white blood cells (WBC: 17000) and computerized tomogram (CT) scan revealed abdomen with mild jejunitis, without other findings.  Action taken with Vivotif with respect to the events was unknown.  The consumer had recovered from the reported events.  Company's Comment: In this case, it was reported that the consumer experienced nausea, vomiting, and diarrhea after intake of 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. Also, fever and abdominal pain are labelled as per CCDS.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced nausea, vomiting , and diarrhea after intake of 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. Also, fever and abdominal pain are labelled as per CCDS.
Sex: F
Vaccine: TYP
Symptoms: Body temperature increased, Headache, Nausea
Clinical narrative: STARTED WEEKLY MEFLOQUINE WHILE ON VIVOTIF; NAUSEA; HEADACHE; This spontaneous case report (826738-1) was extracted through VAERS database on 25-Oct-2019. The report described a 28-year-old female consumer who experienced nausea (PT: Nausea) and headache (PT: Headache), while being on oral Vivotif for an unknown indication. She "started Mefloquine weekly while on Vivotif" (PT: Labelled drug-drug interaction medication error) for malarial prophylaxis.  Case report: The consumer started Vivotif on 27-Jul-2019. She experienced nausea, headache, and maximum body temperature was 100.4 on 29-Jul-2019. She also started weekly Mefloquine for malarial prophylaxis.   The consumer had a penicillin allergy.  Action taken with Vivotif with respect to the reported events nausea and headache was unknown while with respect to the event "Vivotif with weekly Mefloquine" was not applicable.  Action taken with Mefloquine with respect to the reported events was not applicable.  The clinical outcome of the reported events was unknown.  Company's Comment: In this case, it was reported that the consumer had nausea and headaches after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, nausea and headaches are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. The causality of the event "Vivotif with weekly Mefloquine" was considered as not applicable.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had nausea and headaches after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also,nausea and headaches are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. The causality of the event "Vivotif with weekly Mefloquine" was considered as not applicable.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injury, Poor quality product administered
Clinical narrative: patient recieved tainted flu shot that caused personal injuries; patient recieved tainted flu shot; Initial information was received on 05-Mar-2020 regarding an unsolicited valid non-serious legal case received from a lawyer.  This case involves a 67 year old female patient who received tainted flu shot, which caused personal injuries (poor quality vaccine administered and injury), while she received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant thetapy,  and family history were not provided. At the time of the event, the patient had ongoing diabetes mellitus.  On 31-Aug-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UJ238AA, Exp. Date 14-Apr-2020) via intramuscular route in the right arm for prophylactic vaccination.  On an unknown date, the patient had personal injuries (injury) unknown latency following the administration of a tainted INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE.   It was also a case of poor quality vaccine administered.  No relevant laboratory tests reported.  Final diagnosis was injury.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome for injury was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Myalgia, Oropharyngeal pain
Clinical narrative: Swelling, redness, pain, widespread heat, hot to touch at injection site elbow to shoulder within 24 hours, Hives near injection site, also near underarm, stomach area and hip. Sore throat-ride side, fever, muscle pain, mouth sores started 4-5 days after injection. Pain and BURNING sensation throughout body.  Pneumonia vaccine received approx 35 days before Shingrix but not within one month prior.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Stomatitis, Urticaria
Clinical narrative: Swelling, redness, pain, widespread heat, hot to touch at injection site elbow to shoulder within 24 hours, Hives near injection site, also near underarm, stomach area and hip. Sore throat-ride side, fever, muscle pain, mouth sores started 4-5 days after injection. Pain and BURNING sensation throughout body.  Pneumonia vaccine received approx 35 days before Shingrix but not within one month prior.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: Swelling, redness, pain, widespread heat, hot to touch at injection site elbow to shoulder within 24 hours, Hives near injection site, also near underarm, stomach area and hip. Sore throat-ride side, fever, muscle pain, mouth sores started 4-5 days after injection. Pain and BURNING sensation throughout body.  Pneumonia vaccine received approx 35 days before Shingrix but not within one month prior.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Myalgia, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Swelling, redness, pain, widespread heat, hot to touch at injection site elbow to shoulder within 24 hours, Hives near injection site, also near underarm, stomach area and hip. Sore throat-ride side, fever, muscle pain, mouth sores started 4-5 days after injection. Pain and BURNING sensation throughout body.  Pneumonia vaccine received approx 35 days before Shingrix but not within one month prior.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal pain, Arthralgia, Asthenia, Chills, Crying
Clinical narrative: arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experinced arm soreness. Consented to follow up. This case has been linked with case US2020044414 and US2020046854, reported by same reporter.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Diarrhoea, Dizziness, Hypersomnia, Muscle spasms, Pain
Clinical narrative: arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experinced arm soreness. Consented to follow up. This case has been linked with case US2020044414 and US2020046854, reported by same reporter.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pallor, Vomiting, Weight decreased
Clinical narrative: arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experinced arm soreness. Consented to follow up. This case has been linked with case US2020044414 and US2020046854, reported by same reporter.