chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUX
Symptoms: Asthma, Autopsy, Cardio-respiratory arrest, Death, Wheezing
Clinical narrative: Initial literature full article received on 08-Apr-2019 regarding an unsolicited valid serious case. This case was linked to 2019SA111401, 2019SA111409, 2019SA106595, 2019SA111434, 2019SA111441, 2019SA111446  (same literature). Background: Anaphylaxis, a rare and potentially life-threatening hypersensitivity reaction, can occur after vaccination. Objective: We sought to describe reports of anaphylaxis after vaccination made to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. Conclusion: Anaphylaxis after vaccination is rare and can occur among persons with no history of hypersensitivity. Most persons recover fully with treatment, but serious complications, including death, can occur. This case involves a 46 years old male patient who experienced acute asthmatic bronchitis, wheezing and subsequent cardiopulmonary arrest, while he received vaccine INFLUENZA VACCINE (TRIVALENT). The patient's past medical history included, asthma; unspecified allergies; chronic headaches; gout and Hypertension. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant therapy was not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (TRIVALENT) produced by unknown manufacturer lot number not reported via unknown route. On an unknown date, the patient developed a serious acute asthmatic bronchitis (asthma) with wheezing and had subsequent cardiopulmonary arrest (Cardio-respiratory arrest) (unknown latency) following the administration of INFLUENZA VACCINE, (TRIVALENT). The event acute asthmatic bronchitis was leading to death. Brighton level was 2. Lab test not reported. Final diagnosis was (fatal) Acute asthmatic bronchitis and subsequent cardiopulmonary arrest. It was not reported if the patient received a corrective treatment. It was not reported if an autopsy was performed or not, however documented cause of death was reported as acute asthmatic bronchitis. Outcome for all the events was fatal. List of document held: none; Sender's Comments: This case is from a literature article concerning a 46-year-old male patient who died due to Acute asthmatic Bronchitis followed by wheezing with Subsequent cardiopulmonary arrest after vaccination with INFLUENZA VACCINE (TRIVALENT). Time to onset is unknown. Past medical history included Asthma; unspecified allergies;  chronic headaches; gout; hypertension. Autopsy results confirming the cause of death was due to Acute asthmatic bronchitis. Further information with patient's medical condition at time of vaccination and clinical course of the events, laboratory results, concomitant therapy, family history are needed for reassessment. Based upon the available information and considering the reported cause of death which is unrelated to vaccination, the role of individual vaccine is unlikely.; Reported Cause(s) of Death: Acute asthmatic bronchitis.
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Cardio-respiratory arrest, Death, Dyspnoea
Clinical narrative: Initial information regarding this serious valid case received from a literature article on 08-Apr-2019. This case is linked to cases 2019SA111409, 2019SA111401, 2019SA111422, 2019SA111434, 2019SA111446 and 2019SA106595 (same reporter). Literature abstract: Background: Anaphylaxis, a rare and potentially life-threatening hypersensitivity reaction, can occur after vaccination. Objective: We sought to describe reports of anaphylaxis after vaccination made to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. Conclusion: Anaphylaxis after vaccination is rare and can occur among persons with no history of hypersensitivity. Most persons recover fully with treatment, but serious complications, including death, can occur. This case involves a 70 years old male patient who experienced anaphylactic reaction, while he received vaccine INFLUENZA VACCINE (TRIVALENT). Patient had a medical history of chronic obstructive pulmonary disease and coronary artery disease but no hypersensitivities. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (TRIVALENT) produced by unknown manufacturer (lot number, expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a serious anaphylactic reaction with breathing difficult (Dyspnoea) and cardiopulmonary arrest (Cardio-respiratory arrest) 258 minutes following the administration of INFLUENZA VACCINE (TRIVALENT). This event was leading to death. No Lab data was reported. Final diagnosis was (fatal) anaphylactic reaction. It was not reported if the patient received a corrective treatment. The patient was died on an unknown date. (outcome fatal). It was unknown if an autopsy was done. The documented cause of death was reported as anaphylactic reaction. Document held by the sender: none.; Sender's Comments: This case concerns a 70-year old male infant who died due to  anaphylactic reaction with symptoms like difficulty in breathing and cardiopulmonary arrest, 258 minutes after vaccination with INFLUENZA TRIVALENT VACCINE. It was further reported that the most probable cause of death could be anaphylactic reaction. Notably, a history of chronic obstructive pulmonary disease and coronary artery disease, can increase the likelihood of a severe or even fatal episode of anaphylaxis, however no conclusion on the cause of death can be made at this point, as no autopsy results are available. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Anaphylactic reaction.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: Pt reported blurriness of (L) eye, originally saw a small shadow in bottom left of vision of (L) eye in the shape of a quarter moon and has progressed to a half-moon shape in (L) eye.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: hot, itchy, swollen arm.  She received prednisone taper and Benadryl
Age: 1.0
Sex: F
Vaccine: MMRV, PNC13
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Itchy rash all over body 1 day after vaccination, advised to give Benadryl and Aveeno or baking soda bath
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: Menveo was not mixed with diluent that comes with vaccine.  Patient has to be re-vaccinated.
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Complaint of painful sore left upper arm/shoulder pain for several weeks with movement.  Continues to have pain with internal rotation and abduction of the left shoulder which has not improved.   Seen by an MD on 4/22/19 and advised to use naproxen and a PT referral was made.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Underdose
Clinical narrative: Medication disk did not fully dissolve. Patient only received a partial dose of the vaccine.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Injection site pain, Malaise
Clinical narrative: l developed chills, extreme headache, fever, soreness in arm where shot was administered was not feeling well for 3 days. Developed red sores on both arms the next day, that are still there today. Sores where red blotchy and broke open to secret liquid, they are now scabbing over and look terrible. They have still not cleared up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Measles antibody negative, Mumps antibody test negative, Pyrexia, Rash macular, Rubella antibody negative
Clinical narrative: l developed chills, extreme headache, fever, soreness in arm where shot was administered was not feeling well for 3 days. Developed red sores on both arms the next day, that are still there today. Sores where red blotchy and broke open to secret liquid, they are now scabbing over and look terrible. They have still not cleared up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Scab, Secretion discharge, Skin ulcer
Clinical narrative: l developed chills, extreme headache, fever, soreness in arm where shot was administered was not feeling well for 3 days. Developed red sores on both arms the next day, that are still there today. Sores where red blotchy and broke open to secret liquid, they are now scabbing over and look terrible. They have still not cleared up.
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: Measles like rash covered entire body for about 4 days. Took her to the doctor. He said while it was in the window to be caused by the vaccine, it was unlikely. No treatment or follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Mouth swelling
Clinical narrative: Woke up with left side of mouth swollen significantly. Normal injection site, no heat, or swelling was observed. He was concerned that the vaccine did it. The only other thing he did per his report was mow the lawn. After 2 hours, he did state it seemed to be going down.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Dizziness postural, Fatigue, Headache
Clinical narrative: I started the evening of the injection with uncontrollable shaking, I shook all night.  The next morning I was sick to my stomach and each time I stood up became dizzy.  I had a very bad headache at the forehead.  Tylenol, Aleve, or Ibuprofen, would not help.  I was very fatigued and slept for two days.  My right deltoid was very, very sore.  I felt better on Thursday but was tired and took a lot more energy to do things.  My stomach is still a bit off but i'm much better now.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersomnia, Injection site pain, Tremor
Clinical narrative: I started the evening of the injection with uncontrollable shaking, I shook all night.  The next morning I was sick to my stomach and each time I stood up became dizzy.  I had a very bad headache at the forehead.  Tylenol, Aleve, or Ibuprofen, would not help.  I was very fatigued and slept for two days.  My right deltoid was very, very sore.  I felt better on Thursday but was tired and took a lot more energy to do things.  My stomach is still a bit off but i'm much better now.
Age: 32.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: The patient was administered a second dose of MMR II. After administration, the MMR II dose expired 3/20/19. I contacted patient who denied any adverse reactions. The manufacture Merck advised  the company has data to support the potency of the dose administered after the expiration date  of 03/20/2019.
Age: 1.33
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Differential white blood cell count, Full blood count abnormal, Mouth ulceration, Rash papular, Rash pruritic
Clinical narrative: Developed papular rash under chin, initially under chin and now several more to face, mouth, hands  with mild excoriation and itching. Multiple sores to soft palate, hard palate, and tip of tongue (appearing like canker sores). Pustule to tip of left index finger.
Age: 1.33
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Rash pustular, Skin abrasion
Clinical narrative: Developed papular rash under chin, initially under chin and now several more to face, mouth, hands  with mild excoriation and itching. Multiple sores to soft palate, hard palate, and tip of tongue (appearing like canker sores). Pustule to tip of left index finger.
Age: 0.58
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: HPV given in error to a 7 mo. old infant. Poison Control/Toxicologist called. MD/PCP notified. Mother notified. IMMPACT called. VAERS report.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Post herpetic neuralgia, Rash
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 30-NOV-2016, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  In approximately December 2016 (reported as less than one (1) month after receiving ZOSTAVAX), the patient suffered severe right arm pain, rash on the lateral part of her lower arm and another rash on the palmar surface of her right hand and was diagnosed with herpes zoster.  The severe pain of her right arm led to the diagnosis of post herpetic neuralgia (onset date of this diagnosis was not specified). As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, 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 were considered not recovered/not resolved. The events were considered related to ZOSTAVAX. Herpes zoster and post herpetic neuralgia were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Herpes zoster, Pain in extremity, Peripheral swelling
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 05-JUN-2017, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (dose, route, and lot # not reported). Shortly after being administered ZOSTAVAX, the patient suffered rashes all over the left side of her body and was diagnosed with herpes zoster. On an unspecified date, the patient also suffered redness, swelling and pain on her leg and was diagnosed with cellulitis. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, 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 were considered not recovered/not resolved. The events were considered related to ZOSTAVAX. Herpes zoster and cellulitis were considered disabling. Upon internal review, cellulitis was considered to be a medically significant event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 05-JUN-2017, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (dose, route, and lot # not reported). Shortly after being administered ZOSTAVAX, the patient suffered rashes all over the left side of her body and was diagnosed with herpes zoster. On an unspecified date, the patient also suffered redness, swelling and pain on her leg and was diagnosed with cellulitis. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, 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 were considered not recovered/not resolved. The events were considered related to ZOSTAVAX. Herpes zoster and cellulitis were considered disabling. Upon internal review, cellulitis was considered to be a medically significant event. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician's assistant regarding to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, past drugs and concomitant medications were unknown. On 27-JUN-2018, the patient was vaccinated with first dose of GARDASIL 9 (dose, frequency, lot# and indication were unknown) via intramuscular route for prophylaxis and subsequently the patient received GARDASIL 9 second dose on 29-AUG-2018, third dose on 06-FEB-2019 and fourth dose (extra dose administered) on 18-APR-2019. No known adverse effects (no adverse event) were reported. No product quality complaint involved.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: he administered one of PROQUAD at 12 months of age, then the dose two two of PROQUAD at 2 years of age. this can be considered alternate dosing; This spontaneous report was received from a physician regarding to 4 children, who were 2-year-old and their gender was unknown. The patient's concurrent conditions, historical conditions, past drugs and concomitant medications were unknown. On an unknown date, patients at 12 months of age were vaccinated with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, frequency, route, therapy type, lot# and expiry date were unknown) for prophylaxis. At 2 years of age, the patients were vaccinated with second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, frequency, route, therapy type, lot# and expiry date were unknown) for prophylaxis (inappropriate schedule of product administration).
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Feeling abnormal, Headache, Injection site erythema, Pyrexia
Clinical narrative: Fever, headache, head fog, stiff arm, fatigue and redness at site
Age: 19.0
Sex: F
Vaccine: YF
Symptoms: Blood test, Computerised tomogram, Dysarthria, Gait disturbance, Headache
Clinical narrative: As reported by the patient's mother: 4 days after vaccination patient experienced extreme headaches, vision changes, slurred speech, difficulty walking, nausea, prickling skin and numbness. She had three ER visits. She was admitted to a psychiatric facility due to concerns of self harm.
Age: 19.0
Sex: F
Vaccine: YF
Symptoms: Hypoaesthesia, Intentional self-injury, Lumbar puncture, Nausea, Nuclear magnetic resonance imaging
Clinical narrative: As reported by the patient's mother: 4 days after vaccination patient experienced extreme headaches, vision changes, slurred speech, difficulty walking, nausea, prickling skin and numbness. She had three ER visits. She was admitted to a psychiatric facility due to concerns of self harm.
Age: 19.0
Sex: F
Vaccine: YF
Symptoms: Paraesthesia, Visual impairment
Clinical narrative: As reported by the patient's mother: 4 days after vaccination patient experienced extreme headaches, vision changes, slurred speech, difficulty walking, nausea, prickling skin and numbness. She had three ER visits. She was admitted to a psychiatric facility due to concerns of self harm.
Age: 51.0
Sex: F
Vaccine: HEP, HEPA, MMR, TDAP, TYP
Symptoms: Lymphadenopathy, Rash generalised
Clinical narrative: Client was seen at PCP office 2 weeks after receiving vaccine.  Client presented with rash all over body and swollen lymph nodes.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Diarrhoea, Injection site rash, Nausea, Pyrexia
Clinical narrative: Rash from site of injection to elbow, fever of 101'f, chills, diarrhea, nausea, vomiting and shakey hands.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Tremor, Vomiting
Clinical narrative: Rash from site of injection to elbow, fever of 101'f, chills, diarrhea, nausea, vomiting and shakey hands.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given an adult dose of Havrix Hepatitis A vaccine at 16 years old, should have received a pediatric dose. No adverse reactions or symptoms have been reported to Health department.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Activated partial thromboplastin time, Blood urine present, Henoch-Schonlein purpura, Pain in extremity, Prothrombin time
Clinical narrative: White blood cell count increased; Rash all over her legs / lesions on her legs that were diagnosed as Henoch-Schonlein purpura (HSP) / ongoing and worsening purpura / patient had blood draws which showed trace blood in the urine - "5-10 RBC"; An ultrasound was performed on the patient's left calf due to pain / "pain around her great toe" - physician feels this is due to the vasculitis associated with the HSP.; This spontaneous report was received from a physician referring to a 18 year old non-pregnant female patient. The patient had no any concurrent condition, medical history, previously drug reactions or allergies and had no concomitant medications.  On 24-JAN-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided) as vaccination (prophylaxis) without incident.   On 28-MAR-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on left deltoid intramuscularly, lot number N017686 with expiration date on 02-FEB-2020 (strength and dose were not provided) as vaccination (prophylaxis).  On 01-APR-2019 (also reported as: within a few days), the patient experienced a rash all over her legs. She went to the emergency care and they were unable to diagnose her. Then, the patient contacted the physician who recommended again a emergency room visit. On 03-APR-2019, the patient was seen at emergency room and there the lesions on her legs were diagnosed as Henoch-Schonlein Purpura (HSP).On the same date, at the emergency department, she also had blood draws which showed an elevated white blood cell count (WBC) (white blood cell count increased), trace blood in the urine 5  10 red blood cells (RBC) (units not provided) and her blood pressure was within normal limits.   On an unspecified date in April 2019, an ultrasound was performed on the patient's left calf due to pain and ruled out a deep vein thrombosis (DVT). The prothrombin time (PT) and partial thromboplastin time (PTT) was drawn without results provided. On 05-APR-2019, the patient was seen again by the physician because she had pain around her great toe (pain in extremity), and physician felt this was due to the vasculitis associated with the HSP.  At the time of the report, the patient had ongoing and worsening HSP which had been treating with prednisolone for 2 weeks; and the patient had neither recovered from the other adverse events. The physician stated that patient would need to have several repeat uroanalysis.   The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)( GARDASIL 9) was not reported.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Rash, Red blood cells urine positive, Ultrasound scan normal, Vasculitis, White blood cell count increased
Clinical narrative: White blood cell count increased; Rash all over her legs / lesions on her legs that were diagnosed as Henoch-Schonlein purpura (HSP) / ongoing and worsening purpura / patient had blood draws which showed trace blood in the urine - "5-10 RBC"; An ultrasound was performed on the patient's left calf due to pain / "pain around her great toe" - physician feels this is due to the vasculitis associated with the HSP.; This spontaneous report was received from a physician referring to a 18 year old non-pregnant female patient. The patient had no any concurrent condition, medical history, previously drug reactions or allergies and had no concomitant medications.  On 24-JAN-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided) as vaccination (prophylaxis) without incident.   On 28-MAR-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on left deltoid intramuscularly, lot number N017686 with expiration date on 02-FEB-2020 (strength and dose were not provided) as vaccination (prophylaxis).  On 01-APR-2019 (also reported as: within a few days), the patient experienced a rash all over her legs. She went to the emergency care and they were unable to diagnose her. Then, the patient contacted the physician who recommended again a emergency room visit. On 03-APR-2019, the patient was seen at emergency room and there the lesions on her legs were diagnosed as Henoch-Schonlein Purpura (HSP).On the same date, at the emergency department, she also had blood draws which showed an elevated white blood cell count (WBC) (white blood cell count increased), trace blood in the urine 5  10 red blood cells (RBC) (units not provided) and her blood pressure was within normal limits.   On an unspecified date in April 2019, an ultrasound was performed on the patient's left calf due to pain and ruled out a deep vein thrombosis (DVT). The prothrombin time (PT) and partial thromboplastin time (PTT) was drawn without results provided. On 05-APR-2019, the patient was seen again by the physician because she had pain around her great toe (pain in extremity), and physician felt this was due to the vasculitis associated with the HSP.  At the time of the report, the patient had ongoing and worsening HSP which had been treating with prednisolone for 2 weeks; and the patient had neither recovered from the other adverse events. The physician stated that patient would need to have several repeat uroanalysis.   The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)( GARDASIL 9) was not reported.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; products liability: defective design/manufacturing defect; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 78-year-old patient of unknown gender. No information was received regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2010, the patient was administered zoster vaccine live (ZOSTAVAX) by a healthcare provider at a Private's Doctor's Office (dose, route of administration, vaccination site, lot # and expiration date were not provided). On an unspecified date, the patient was treated by a physician at the Private's Doctor's Office for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: Herpes Zoster. The outcome of the events was unknown. The causality assessment between the event of Herpes Zoster and zoster vaccine live (ZOSTAVAX) was reported as related. The causality assessment for product quality issue was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: one patient received one dose of Varivax following a temperature excurision; no adverse effects were reported; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On an unknown date, the patient was vaccinated with a one dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R029517, expiration date 14-OCT-2020, subcutaneously (dose and anatomical location were not provided) for prophylaxis or R029519, expiration date 14-OCT-2020 subcutaneously (dose and anatomical location were not provided) for prophylaxis. The lot number and expiration date of the dose that patient received could not be determined by the reporter, so both lots affected by the temperature excursion were reported. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 36 degrees Fahrenheit for 18 hours and 5 minutes (multiple excursions). There was no previous temperature excursion. Data logger was involved.  The outcome of product storage error and no adverse event was unknown.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect reported; patient was inadvertently administered a dose of Vaqta that was expired; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 16-APR-2019, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) injection, lot # R010369, expiration date 25-MAR-2019 (exact dose and route of administration were not reported) for prophylaxis.  No adverse effect was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; one dose of improperly stored VARIVAX was administered; This spontaneous report was received from the nurse regarding a patient of unknown age and gender. Information on patient's concurrent conditions, medical history, drug allergies and concomitant medications were not reported. On 18-APR-2019, the patient was vaccinated with one dose of improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, unit, anatomical location was not reported) (lot# R021097 and expiry date 23-JUL-2020) for prophylaxis (product storage error). No adverse effects was reported. The vaccine experienced a temperature excursion at -14.4° Celsius (°C) degrees with a time frame of 30 minutes. The vaccine had experienced a previous temperature excursion at -14.5° C for 3 hours and 45 minutes. It was reported that this call was due to a data logger.   Furthermore, no product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA009355:
Sex: F
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Mobility decreased
Clinical narrative: This spontaneous report was received from a nurse practitioner via company representative regarding a 17-year-old female patient (reported as "daughter"). The patient's relevant medical history, current conditions and concomitant medications were not provided. Approximately in 2010 (reported as "9 years ago"), the patient received second dose of GARDASIL (strength, lot# and expiry date were not reported) for prophylaxis. On an unknown date (reported as "two weeks post vaccination"), the patient experienced one hour of leg numbness and could not move her legs. The patient did seek treatment with the pediatrician. It all resolved. The patient was able to walk. It lasted one hour. The pediatrician suspected it could be Guillain-Barre Syndrome and thought it possibly related to the vaccine. There was no negative outcome. The patient could walk at the time of report. No product quality complaint (PQC) was involved. The outcome of Guillain-Barre Syndrome was reported as recovered. The reporter's causality assessment was not reported. Upon internal review, Guillain-Barre Syndrome was determined to be medically significant.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Myalgia, Paraesthesia oral, Pyrexia
Clinical narrative: Shivers the first night with fever (102 degrees), muscle aches, and chills. Chills gone by morning, but flu like symptoms persisted for almost two days. My lips started to tingle five days after the vaccine and has continued off and on for the last two days (7+ days from the vaccine). My teeth also feel like they are "on edge." By far, this is the worst reaction to a vaccine I have ever had. Not sure I'm going to take the second dose. If symptoms do not clear by day ten, I will contact my physician.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Tooth disorder, Vaccination complication
Clinical narrative: Shivers the first night with fever (102 degrees), muscle aches, and chills. Chills gone by morning, but flu like symptoms persisted for almost two days. My lips started to tingle five days after the vaccine and has continued off and on for the last two days (7+ days from the vaccine). My teeth also feel like they are "on edge." By far, this is the worst reaction to a vaccine I have ever had. Not sure I'm going to take the second dose. If symptoms do not clear by day ten, I will contact my physician.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Feeling abnormal, Peripheral swelling
Clinical narrative: Patient reported severely swollen arm which had resolved by report date of 4/23. She also stated she experienced confusion for approximately 2 days after the vaccination. She described the confusion as feeling off and almost a depression.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, PNC13, UNK, UNK, VARCEL
Symptoms: Gaze palsy, Injection site erythema, Injection site induration, Injection site rash, Strabismus
Clinical narrative: Rash, redness, hardness in the area of shot injection, crossing of eyes/ eyes rolling back, difficulty breathing, loss of ability to stand or walk around, muscle weakness, fever of 104, and restlessness.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Crying, Hypotonia, Irritability, Lethargy, Pyrexia
Clinical narrative: Patient had a fever of 102.7, staring, her eyes not moving, seizure, limp, crying, fussy. I called doctor  after hour phone number and was told to go to the ER. My husband and I took our baby to the ER. At the ER she was given tylenol which brought her fever down 101.6 rectal. She was still very lethargic the ER doctor gave us the option of keeping her in the hospital or taking her home. We took her home as the doctor thought she would be fine at home. We were instructed to give Tylenol every 4 hrs prn.  Her fever would come back after about 4 hours and I would have to give Tylenol again. She was very fussy, cried and her fever lasted about 7 days.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Seizure, Staring
Clinical narrative: Patient had a fever of 102.7, staring, her eyes not moving, seizure, limp, crying, fussy. I called doctor  after hour phone number and was told to go to the ER. My husband and I took our baby to the ER. At the ER she was given tylenol which brought her fever down 101.6 rectal. She was still very lethargic the ER doctor gave us the option of keeping her in the hospital or taking her home. We took her home as the doctor thought she would be fine at home. We were instructed to give Tylenol every 4 hrs prn.  Her fever would come back after about 4 hours and I would have to give Tylenol again. She was very fussy, cried and her fever lasted about 7 days.
Age: 1.5
Sex: F
Vaccine: MMR
Symptoms: Full blood count normal, Petechiae, Pyrexia, Rash maculo-papular
Clinical narrative: Petechial/maculopapular rash.  Rash, low grade fever Treatment = observation
Age: 78.0
Sex: F
Vaccine: HEPA
Symptoms: Immediate post-injection reaction, Insomnia, Mobility decreased, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Client reported immediate pain shot down right arm to finger tips. Later that day it was sore but she could use it both Friday and Saturday. Sunday she couldn't lift her arm past her waist. She alternated 2 Tylenol or 2 Advil every 4 hours. Monday night she was unable to sleep, difficulty lifting arm. She had to sit in recliner all night. Her husband took her early April 2nd to hospital Downtown. She stated that the nurse practitioner ask her where she got the shot and she stated "the shot was too high". She was given a prescription for Tramadol 50 mg for pain and she was referred to an orthopedic doctor. The patient saw Dr. at the Center on Wed., April 3rd. Doctor stated "the shot was too high on the rotator cuff" per client. She was ordered a physical therapy evaluation for PT for 4-6 weeks. She reports the pain was better April 4th and is able to move her shoulder. Today, April 5th she state "it feels so much better" able to move arm freely, but slightly sore.
Age: 78.0
Sex: F
Vaccine: HEPA
Symptoms: X-ray limb
Clinical narrative: Client reported immediate pain shot down right arm to finger tips. Later that day it was sore but she could use it both Friday and Saturday. Sunday she couldn't lift her arm past her waist. She alternated 2 Tylenol or 2 Advil every 4 hours. Monday night she was unable to sleep, difficulty lifting arm. She had to sit in recliner all night. Her husband took her early April 2nd to hospital Downtown. She stated that the nurse practitioner ask her where she got the shot and she stated "the shot was too high". She was given a prescription for Tramadol 50 mg for pain and she was referred to an orthopedic doctor. The patient saw Dr. at the Center on Wed., April 3rd. Doctor stated "the shot was too high on the rotator cuff" per client. She was ordered a physical therapy evaluation for PT for 4-6 weeks. She reports the pain was better April 4th and is able to move her shoulder. Today, April 5th she state "it feels so much better" able to move arm freely, but slightly sore.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: flu like symptom, fever, headache, sore throat, the injection site was red, swelling and painful.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: flu like symptom, fever, headache, sore throat, the injection site was red, swelling and painful.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pain, Pain in extremity
Clinical narrative: Within 3 hours of receiving vaccine, I experienced pain in my right arm, chills, fatigue, fever, muscle aches, shooting pains in my legs. This lasted 24 hours.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Within 3 hours of receiving vaccine, I experienced pain in my right arm, chills, fatigue, fever, muscle aches, shooting pains in my legs. This lasted 24 hours.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, VARCEL
Symptoms: Ecchymosis, Eye swelling, Injection site erythema, Throat irritation, Urticaria
Clinical narrative: Itchy throat and swelling right eye. Hives on legs, Right deltoid mild erythema and ecchymosis. Was seen at ER on 4/16/2019 and prescribed Benadryl.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Severe chills, fever and severe headache. Lasted about 12 hours. TYLENOL helped.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Tremor, Unresponsive to stimuli
Clinical narrative: DTR BECAME DIZZY AND LIGHTHEADED. I INSTRUCTED MY DTR TO LAY DOWN,  WITHIN SECONDS SHE STARTED TO SHAKE AND WAS UNRESPONSIVE. I SCREAMED  FOR HELP DR, NURSE AND MA CAME IN WITHIN SECONDS.
Age: 4.0
Sex: F
Vaccine: DTAP, PNC13, UNK, UNK, VARCEL
Symptoms: Computerised tomogram normal, Culture urine negative, Electroencephalogram normal, Injection site pain, Loss of consciousness
Clinical narrative: Friday got vaccines night time showed no high fever she woke up next day saying arms hurt gave her some medicine (ibuprofen) she ate was getting ready to take her a bath after 5 mins of being in the bath I turn around and she fell I pick her up n notice shes shaking she's had a fever seizure before so I called 911 they came we went to hospital they ran test on her ended up discharging her even tho she was still unconscious they prescribed her some medicine and told me to give her fluids. We came home after about 2 hrs of being up she still wasn't awake much she couldn't even keep her eyes open long enough to drink water or take medicine. Called the hospital it was around 8pm the same day they discahrged her n they told me to bring her back in. We went back to the hospital as soon as we got there they tried to wake her up started trying to put an iv in her something they didn't do first time we went to hospital. They decided they wanted to run a cat scan & x-ray on her and a spinal tap. So we gave them permission. They did those then came back n ask if they can do urine test after I told them they did one earlier they said they would have to do another. Later they came back said her test came back good but she's was gonna have to b admitted. So we end up staying over night while they watch her
Age: 4.0
Sex: F
Vaccine: DTAP, PNC13, UNK, UNK, VARCEL
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging normal, Tremor, Urine analysis normal
Clinical narrative: Friday got vaccines night time showed no high fever she woke up next day saying arms hurt gave her some medicine (ibuprofen) she ate was getting ready to take her a bath after 5 mins of being in the bath I turn around and she fell I pick her up n notice shes shaking she's had a fever seizure before so I called 911 they came we went to hospital they ran test on her ended up discharging her even tho she was still unconscious they prescribed her some medicine and told me to give her fluids. We came home after about 2 hrs of being up she still wasn't awake much she couldn't even keep her eyes open long enough to drink water or take medicine. Called the hospital it was around 8pm the same day they discahrged her n they told me to bring her back in. We went back to the hospital as soon as we got there they tried to wake her up started trying to put an iv in her something they didn't do first time we went to hospital. They decided they wanted to run a cat scan & x-ray on her and a spinal tap. So we gave them permission. They did those then came back n ask if they can do urine test after I told them they did one earlier they said they would have to do another. Later they came back said her test came back good but she's was gonna have to b admitted. So we end up staying over night while they watch her
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect reported; Expired product administered; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.      On 10-APR-2019, the patient was vaccinated with an expire vaccine of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # N009800  and expiration date 24-MAR-2019, for prophylaxis (dosage schedule, route, and anatomical location were not reported).  No adverse effect reported.   The outcome of expired product administered was unknown.
Age: 1.25
Sex: U
Vaccine: MMR
Symptoms: Circumstance or information capable of leading to medication error, Exposure via skin contact, No adverse event
Clinical narrative: No adverse effect reported; patient may have only received a partial dose of M-M-R II; some of the vaccine went on the patient's skin; patient was "moving a lot" during administration of a dose of M-M-R II which made administration difficult. As a result, patient may have only received a partial dose of M-M-R II; This spontaneous report was received from a nurse and refers to a 15-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 14-MAR-2019, the patient was moving a lot (which was clarified as a normal movement for a 15-month-old child who did not want an injection) during administration of a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot # R002049, expiration date 22-JAN-2020 (exact dose and site of administration were not reported) for prophylaxis. As a result, the patient may have only received a partial dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), as some of the vaccine went on the patient's skin.  No adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: has arm pain that goes all through my arm up into my shoulder; Redness, swelling and bruising at the injection site; Redness, swelling and bruising at the injection site; Redness, swelling and bruising at the injection site; This spontaneous report was received from a consumer regarding herself as a 68-year-old, elderly, female patient. The patient's historical drug included penicillin, historical condition included penicillin allergy and her concurrent condition included pre-diabetes. The patient's concomitant therapy included metformin. On 15-APR-2019 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23), single 0.5 ml dose (strength, frequency, route of administration, lot # and expiration date were not provided) for prevention of pneumonia (prophylaxis). On 15-APR-2019, the patient experienced redness (injection site erythema), swelling (injection site swelling) and bruising (injection site bruising) at the injection site that went away the next day. But, the patient still experienced arm pain (pain in extremity) that went all through her arm up into her shoulder. On 16-APR-2019, (also reported as next day) the patient had recovered from the events injection site erythema, injection site bruising and injection site swelling. No treatment was given for the adverse events. The patient had not recovered from the event pain in extremity. Causality assessment was not provided by the reporter. There was not involvement of product quality complaint (PQC).