chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Scar, Swelling
Clinical narrative: About 11/15/2018 until today I experience an outbreak of shingles on my face, neck and upper chest (of all places!). Each day new spots appear blisters, red, swollen, some with puss at center, leaves scar. I had no prior history of shingles, herpes or any skin disorder. I did not/will not have 2nd dose. The expense of this overpriced drug, notwithstanding, I am claiming that I have been infected with shingles as a result of vaccine and results in dermatology expense and stress to cope. Nowhere and from no one have I been able to determine if these warnings have been made known to public. Had I known the risk, I would not have gotten the vaccine. I think the public should be told of this possibility!
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Right upper arm swollen, red, and itching. Area hot to touch. Child is irritable. Patient given triamacinolone cream .1% to apply to area twice daily.
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose normal, Head injury, Laboratory test normal, Loss of consciousness, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Vaccine used was FLUARIX QUADRIVLAENT (GSK) Patient voluntarily received annual flu vaccine as part of our company annual free flu vaccine campaign where our employees are offered the vaccine free of charge. Patient received the vaccine from our pharmacist on duty with no problem or complaint. He returned to his work station where he stands and enters orders in the computer (he's a pharmacy technician). About 5 min later, he passed out and his head hit the counter that was behind him. He remained passed out for about 10-15 seconds. Assistance was provided by myself (I am also a pharmacist) and our staff pharmacist. 911 was called as a small wound was present on his occipital region due to contacting the countertop on his way down, and to provide further medical evaluation. He was evaluated at the ED. All imaging was negative and the small laceration was repaired. The attending provider concluded that a vagal response to the injection was likely responsible for the post-vaccination syncopal event. This patient has received flu vaccines for the past 3 plus years without any reaction of this sort.
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Skin laceration, Syncope
Clinical narrative: Vaccine used was FLUARIX QUADRIVLAENT (GSK) Patient voluntarily received annual flu vaccine as part of our company annual free flu vaccine campaign where our employees are offered the vaccine free of charge. Patient received the vaccine from our pharmacist on duty with no problem or complaint. He returned to his work station where he stands and enters orders in the computer (he's a pharmacy technician). About 5 min later, he passed out and his head hit the counter that was behind him. He remained passed out for about 10-15 seconds. Assistance was provided by myself (I am also a pharmacist) and our staff pharmacist. 911 was called as a small wound was present on his occipital region due to contacting the countertop on his way down, and to provide further medical evaluation. He was evaluated at the ED. All imaging was negative and the small laceration was repaired. The attending provider concluded that a vagal response to the injection was likely responsible for the post-vaccination syncopal event. This patient has received flu vaccines for the past 3 plus years without any reaction of this sort.
Age: 76.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 76 year old female patient. The patient did not have any pertinent medical history or drug reactions/allergies. Information about concurrent conditions and concomitant medication was not reported. On 23-NOV-2018, the patient was vaccinated with PNEUMOVAX 23 lot # R018735 with expiration date 06-APR-2020 intramuscularly in the right arm (dose detail was not reported) for prophylaxis (reported as pneumonia) and also vaccinated with influenza virus vaccine intramuscularly in the right arm (dose detail, lot# and expiration date were not reported) for prophylaxis. On an unknown date in 2018, the patient experienced erythema in the right arm and unspecified swelling at the elbow. The patient self medicated with topical diphenhydramine hydrochloride (BENADRYL) (reported as manufacture unknown) and topical cortisone cream (reported as manufacture unknown) without relief. On 03-DEC-2018, the patient returned to the pharmacy and pharmacist advised patient to take oral diphenhydramine hydrochloride (BENADRYL) (unspecified dose). There was no lab diagnostics/studies preformed. The outcome of events were reported as not recovered. The causality assessment between events, PNEUMOVAX 23 and influenza virus vaccine were not reported.
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a 11 year old female patient, who was also the pharmacist's daughter. No information regarding the patient's pertinent medical history, concomitant medications and drug reaction or allergies was reported. In October 2018, the patient was vaccinated with GARDASIL 9 injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) for prophylaxis. On an unknown date in 2018, the patient had a small bump in the area of injection. The outcome of the event was unknown. The reporter did not provide the causality assessment between the event and GARDASIL 9.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 01-NOV-2016, a healthcare provider at a physician's office administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 08-NOV-2016, the patient was treated by a healthcare provider at a dermatology office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or about late 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to  contract a persistent strain of herpes zoster. In late 2015, the patient developed a painful rash accompanied by persistent pain. In response to these complaints, the patient presented to a physician and was diagnosed as suffering from shingles. As a direct and proximate result of the ZOSTAVAX vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 14-MAR-2011, a healthcare provider at the county health department administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 03-FEB-2017 and 13-JUN-2017, the patient was treated by a physician at a primary care office for shingles and post herpetic neuralgia. The patient was diagnosed with shingles, post herpetic neuralgia and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 03-FEB-2015, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 22-SEP-2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Delusion, Dyspnoea, Feeling abnormal
Clinical narrative: Pt received the SHINGRIX vaccine at 0855 and at 0910 she returned to the clinic reporting that she felt "delusional and short of breath". Upon further assessment by the provider the pt reported shortness of breath and just not "feeling right". Pt was given 50 mg benadryl and placed on 2 LPM of oxygen and monitored in clinic. Pt improved after this and was released to home by the provider.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Altered state of consciousness, Feeling cold, Hyperhidrosis, Myalgia, Tremor
Clinical narrative: 100 hours after injection I had to be escorted off golf course. Intense muscle pain, shaking, sweating, freezing. Almost passed out.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Urticaria
Clinical narrative: Hives and rash to upper back and arms, neck and jaw. Home treatment of oral BENADRYL and topical GOLD BOND itch cream. Symptoms improving after 3 days of home treatment as noted.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dysphonia, Dyspnoea, Erythema, Laboratory test normal
Clinical narrative: Almost immediately after receiving influenza vaccine, pt started experiencing significant acute onset chills, nausea, shakiness, erythema and a scratchy voice. This continued to progress into SOB, wheezing, throat swelling, pruritic erythematous rash on arms, chest and abdomen in the emergency department. Initially given BENADRYL 25mg IM x 1 in the office without response, but pt became more nauseous and drowsy. At 1525 500mcg of epinephrine was administered and EMS was called, after about 10-15 minutes the erythema started to recede from the face. Vitals remained stable throughout entire clinic course. Second dose of epinephrine 500mcg was administered at 1540, with continued improvement in symptoms but did not entirely resolve. Erythema returned and began to worsen during discussion with EMS and pt was transported to the ED for further care. Additional anti-histamines and epinephrine were administered during ED course and pt was monitored overnight.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pharyngeal oedema, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Almost immediately after receiving influenza vaccine, pt started experiencing significant acute onset chills, nausea, shakiness, erythema and a scratchy voice. This continued to progress into SOB, wheezing, throat swelling, pruritic erythematous rash on arms, chest and abdomen in the emergency department. Initially given BENADRYL 25mg IM x 1 in the office without response, but pt became more nauseous and drowsy. At 1525 500mcg of epinephrine was administered and EMS was called, after about 10-15 minutes the erythema started to recede from the face. Vitals remained stable throughout entire clinic course. Second dose of epinephrine 500mcg was administered at 1540, with continued improvement in symptoms but did not entirely resolve. Erythema returned and began to worsen during discussion with EMS and pt was transported to the ED for further care. Additional anti-histamines and epinephrine were administered during ED course and pt was monitored overnight.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Somnolence, Tremor, Wheezing
Clinical narrative: Almost immediately after receiving influenza vaccine, pt started experiencing significant acute onset chills, nausea, shakiness, erythema and a scratchy voice. This continued to progress into SOB, wheezing, throat swelling, pruritic erythematous rash on arms, chest and abdomen in the emergency department. Initially given BENADRYL 25mg IM x 1 in the office without response, but pt became more nauseous and drowsy. At 1525 500mcg of epinephrine was administered and EMS was called, after about 10-15 minutes the erythema started to recede from the face. Vitals remained stable throughout entire clinic course. Second dose of epinephrine 500mcg was administered at 1540, with continued improvement in symptoms but did not entirely resolve. Erythema returned and began to worsen during discussion with EMS and pt was transported to the ED for further care. Additional anti-histamines and epinephrine were administered during ED course and pt was monitored overnight.
Age: 14.0
Sex: F
Vaccine: FLUC4
Symptoms: Cold sweat, Crying, Fall, Pallor, Syncope
Clinical narrative: Pt had a syncopal episode status post influenza vaccination. Vaccine administered while pt sat on exam table, she declined to be supine for the vaccine. After vaccine administration pt requested to lay down, she was then assisted to a supine position for about 10-15 minutes. Pt chatted with mother about an upcoming family vacation and used her phone while supine. Pt was discharged after she reported she felt fine and exited exam room. About 5-10 minutes later provider was called to assess pt after a syncopal episode at stores register. Upon assessment, pt was supine and was pale and clammy to touch.  Pt was alert and oriented X4, she denied pain and was crying. BP supine 118/60, HR 60, oxygen saturation on room air 98%, BP sitting up 102/70, HR 65, oxygen saturation 98% on room air. Mother reported they were checking out at register and pt fell forward. Customer who was a paramedic was also on site. Witnesses including mother reported pt did not hit head. Paramedics were called by store personnel and parent declined for paramedics to come and assess pt. Police officer came to the scene and took information from provider and mother. After assessment pt left store with mother in a private vehicle.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Skin rash.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Feeling of body temperature change, Nausea, Tremor
Clinical narrative: Patient stated that approximately 24 hours after receiving vaccine she developed shaking legs, cold then hot, off balance, and nausea. Patient's symptoms have resolved.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Chest discomfort, Conversion disorder, Dizziness, Dyspnoea, Laboratory test normal
Clinical narrative: Within 2 days of receiving the shot, she began to have muscle contractions in her right bicep/tricep, causing severe tremors in that arm. They started intermittently and then progressed to constantly, even while she slept. A week later it moved to her right leg and now has progressed to her face. She has also had 2 episodes of her chest tightening, having difficulty breathing and being dizzy. Our pediatrician's office saw her 5 days after the shot when the contractions were only in her arm. They brought in 3 doctors, none of which knew what was happening, but all said, "its not the GARDASIL" They referred us to neurology that day. The neurologist performed an exam and ordered tests, all of which came back normal. She said she is not ready to rule out the GARDASIL but she 98% sure it is "conversion syndrome" That is a disorder caused by the brain's reaction to some stressor and according to the neurologist, often sexual abuse. Our daughter adamantly denies any form of sexual abuse, but we did start her in therapy to try and find a cause. She has seen the therapist 6 times and the therapist says there is absolutely no evidence of any trauma or stressor. This girl was a healthy, active 14 year old student. She has a great group of friends, makes straight A's and has good family support. She is a dancer and had to take a medical leave from the studio due to her issues.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of personal independence in daily activities, Muscle contractions involuntary, Muscle twitching, Neurological examination normal, Tremor
Clinical narrative: Within 2 days of receiving the shot, she began to have muscle contractions in her right bicep/tricep, causing severe tremors in that arm. They started intermittently and then progressed to constantly, even while she slept. A week later it moved to her right leg and now has progressed to her face. She has also had 2 episodes of her chest tightening, having difficulty breathing and being dizzy. Our pediatrician's office saw her 5 days after the shot when the contractions were only in her arm. They brought in 3 doctors, none of which knew what was happening, but all said, "its not the GARDASIL" They referred us to neurology that day. The neurologist performed an exam and ordered tests, all of which came back normal. She said she is not ready to rule out the GARDASIL but she 98% sure it is "conversion syndrome" That is a disorder caused by the brain's reaction to some stressor and according to the neurologist, often sexual abuse. Our daughter adamantly denies any form of sexual abuse, but we did start her in therapy to try and find a cause. She has seen the therapist 6 times and the therapist says there is absolutely no evidence of any trauma or stressor. This girl was a healthy, active 14 year old student. She has a great group of friends, makes straight A's and has good family support. She is a dancer and had to take a medical leave from the studio due to her issues.
Age: 73.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site pain
Clinical narrative: Pain in the arm around injection area.
Age: 19.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site urticaria, Pain in extremity, Urticaria
Clinical narrative: Red area developed around injection site in the right arm several hours after receiving the PCV23 vaccine and became the size of a half dollar per patient's mother. Hives also developed in upper right arm after several hours and gradually spread to the lower arm. Right arm described as very sore. Patient denied fever, denied shortness of breath, and denied throat swelling/closing. The vaccines were given on 12/14/2018 and adverse reaction was reported to us by the patient's mother on 12/17/2018. Patient's PCP, NP was informed immediately. NP recommended cold compresses, ibuprofen as needed for discomfort, and to follow-up with an office visit if redness persists/worsens or if pt. develops a fever. Explained that the symptoms would improve slowly. NP also informed staff to do VAERS report.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous non-valid report as received from a medical assistant refers to a unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # R012413, expiration date 28-OCT-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 15 to 46 (22.1) degrees Fahrenheit for 1 hour and 1 minute. There were no previous excursions reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 10-JUN-2013, a healthcare provider at an outpatient clinic administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2015, the patient was treated by a healthcare provider at an outpatient clinic for shingles. The patient was diagnosed with shingles and or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (not further specified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 03-AUG-2013, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. On or about 30-JAN-2017, the patient was treated by a physician at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In DECEMBER 2016, a healthcare provider at a clinic administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. In JANUARY 2017, the patient was treated by a healthcare provider at a clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Age: 27.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 27-year old-patient of unknown gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 09-NOV-2018, the patient was vaccinated with PROQUAD, subcutaneously (dose, dose number, lot# and expiration date were not reported) for prophylaxis. No known adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In September 2015, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In January 2016, the patient was treated by a physician's assistant at a medical group for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In 2016, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 06-JAN-2017 the patient was treated by a healthcare provider at a family practice for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site macule, Injection site rash, Pallor
Clinical narrative: Cutaneous macular and blanchable rash at injection site. Approx. 6 cm diameter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swollen, hot to touch.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: VACCINES GIVEN, WHILE PARENT PUTTING CHILD INTO CAR SEAT, INFANT STARTED TO VOMIT, VOMITED LARGE AMOUNT CLEAR FLUID. MOTHER STATES CHILD COMPLETELY ACTING HER NORMAL SELF.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: Arm pain began about 30 minutes after vaccination. About 90 minutes after vaccination, headache, chills, and fatigue began. Woke with chills and headache this AM.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: Swelling along right upper arm, blister at injection site.
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Neurological examination, Presyncope
Clinical narrative: Vasovagal response treated with first aid, rest, ice, lowering extremities. Neurological assessment. Vital signs and fluids.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Angiogram, Angiogram abnormal, Antinuclear antibody negative, Cardiac stress test normal, Chest X-ray abnormal
Clinical narrative: Multiple CBC with differential, CMP, ANA (negative); Pericardial fluid culture (7/14/2018).
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram thorax abnormal, Culture, Differential white blood cell count, Echocardiogram, Echocardiogram abnormal
Clinical narrative: Multiple CBC with differential, CMP, ANA (negative); Pericardial fluid culture (7/14/2018).
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Full blood count, Metabolic function test, Pericardial drainage, Pericardial effusion, Ultrasound kidney
Clinical narrative: Multiple CBC with differential, CMP, ANA (negative); Pericardial fluid culture (7/14/2018).
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient sent an electronic message several days after the injection reporting pain in her arm and mobility problems.
Age: 42.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Immunoglobulin therapy
Clinical narrative: Mainly lower extem.
Age: 42.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Asthenia, Guillain-Barre syndrome
Clinical narrative: Mainly lower extem.
Age: 43.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Immunoglobulin therapy
Clinical narrative: Lower body weakness.
Age: 43.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Asthenia, Guillain-Barre syndrome
Clinical narrative: Lower body weakness.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Urticaria, Vomiting
Clinical narrative: On the evening that the vaccine was given, pt became "itchy" and was covered with hives on arms, legs and face. Mother gave him Benadryl around the clock for following 2 Days. Also had a couple of episodes of vomiting 2 days after the vaccine. Then recovered.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site rash, Pain, Pyrexia
Clinical narrative: HEADACHE FROM 9:00 AM 12/15/18 UNTIL 12:00 PM 12/17/18. ACHES AND LOW GRADE FEVER FROM 9:00 AM 12/15/18 UNTIL 10:00 PM 12/16/18. SORE ARM AT INJECTION SITE, DON'T REMEMBER WHEN BEGAN, UNTIL APPROXIMATELY 1:00 PM 12/18/2018. RASH AT INJECTION SITE, 8 INCHES X 2 INCHES. 8:00 AM 9/16/18, STILL PRESENT APPROXIMATELY 1:00 PM 12/18/2018 BUT LESSENING.
Age: 10.0
Sex: M
Vaccine: FLUC4
Symptoms: Pallor
Clinical narrative: Nurse returned from flu clinic and student looked very pale. He had received flu shot. Nurse completed vital signs, feet elevated. O2 sat of 98 percent. Pulse 76. Resp rate 18. BP 106/72. He rested and his color returned and he reported feeling better. Rested for awhile. Notified mom. Eventually student returned to class.
Age: 12.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash
Clinical narrative: Developed rash on face same day as receiving the flu vaccine.
Age: 0.08
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Wound
Clinical narrative: Body went into High Alert for 12 hrs. 5 hrs after getting shot. Week later red mark on left cheek about 1" wide. Took a week to subside. Uncomfortable under the red mark. A week later red dot appeared on right arm (not injection arm) that was open. Used hydron peroxide & NEOSPORIN.  Several days later wiped with alcohol but it didn't burn?? Started to dry up. Still red dot.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Computerised tomogram abnormal, Mass, Pleurisy
Clinical narrative: Patient developed chest pain and visited the emergency room the evening after she received her FLUZONE HD. She was diagnosed with Pleurisy. TORADOL was administered for the pain. During the hospital stay, a CT scan was performed and a mass was discovered. Biopsy is pending.
Age: 0.17
Sex: F
Vaccine: HIBV, IPV, RV1
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Hib and IPV were administered 2 weeks after 1st dose due to documentation error on immunization card from NICU.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Induration, Local reaction, Skin warm
Clinical narrative: Localized reaction 11 x 9 cm warm, erythema indurated will treat with BENADRYL.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Rash, Tenderness, Vomiting
Clinical narrative: Patient received SHINGRIX vaccine on 12/07/18 and developed fever on 12/08 at 2 am which patient describes as being profound and highest temp noted was 101 degrees. Patient stated she had violent vomiting and was nauseous. No swelling of arm but tender to touch. Patient also developed red spots on face. Patient was advised by MD to report adverse effect.
Age: 32.0
Sex: M
Vaccine: HEPA
Symptoms: Chills, Cold sweat, Diarrhoea, Pain, Vomiting
Clinical narrative: Received Hepatitis A vaccine yesterday, and approx. 8 hours later I developed adverse side effects - vomiting, diarrhea, chills, body aches, and cold diaphoresis. I just wanted to report profound side effects. My sister received the same vaccine and had to leave work early for the same symptoms. We both take thyroid medication, not sure if polypharmacy is a researched issue in this case.
Age: 57.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Vertigo, Vestibular neuronitis
Clinical narrative: I was given the second part of the SHINGRIX vaccine by my provider, along with an annual flu vaccine. 5 days later, I had an acute attack of vertigo and was subsequently diagnosed with vestibular neuritis which I continue to suffer from. The ENT theorizes that the SHINGRIX vaccine attacked a dormant virus sitting on my vestibular nerve.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient came in 12/18/18 stating she has arm soreness/stiffness that started about 7days post immunization. This pain has been consistent for 2 months with no improvement yet. No other symptoms notes by patient. Pain is localized to center up the upper arm (near the bottom of the deltoid muscle). She does not report pain near the top of the shoulder. Pt has not felt like the pain was significant enough to call the doctor yet.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain upper, Chest pain, Diarrhoea, Headache, Paraesthesia oral
Clinical narrative: Exactly 12 hours after HPV injection, vomiting, diarrhea, severe stomach pains, severe headache, chest pain, skin rash, tingling tongue.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Rash, Vomiting
Clinical narrative: Exactly 12 hours after HPV injection, vomiting, diarrhea, severe stomach pains, severe headache, chest pain, skin rash, tingling tongue.
Age: 79.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Increased swelling, pain and bruising noticed about 10 days after receiving FLUAD vaccine waking patient up in the middle of the night. Pain was described as hurting and awareness. As time passed, pain has lessened to intermittent frequency and on 12/18/18 site is observed as a dark, yellow bruise about 2in in diameter. Initial injection site was described as slightly bruised, with lessening bruising over time until the night darkening of site was drastically increased.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Generalised erythema, Urticaria
Clinical narrative: Patient received Tdap vaccination around 1300 and states that generalized uriticaria and erythema began around 1830 that evening. Patient reports no change in detergents, soaps, medication or diet.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Headache, Muscle tightness, Musculoskeletal stiffness, Neck pain
Clinical narrative: AFB patient. MEDICATIONS: Diltiazem ER 240 mg, XARELTO 20 mg, citalopram 20 mg, meloxicam 1/2 tab = 7.5 mg. 11/20/2018 - Late afternoon muscles started to tighten up - body very painful - pain and stiffness all during the night - felt as if the muscles were paralyzed - neck and head felt if ready to explode this continued all the next day. 11-21-2018 around supper time, stiffness started to go away, the next day 22 Nov 2018 my mind felt as if I had had a minor stroke - never had one before but mind was slightly confused in remembering - this was a very frightening experience. I simply rested quietly those days - am doubtful if I will get the second shot.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: AFB patient. MEDICATIONS: Diltiazem ER 240 mg, XARELTO 20 mg, citalopram 20 mg, meloxicam 1/2 tab = 7.5 mg. 11/20/2018 - Late afternoon muscles started to tighten up - body very painful - pain and stiffness all during the night - felt as if the muscles were paralyzed - neck and head felt if ready to explode this continued all the next day. 11-21-2018 around supper time, stiffness started to go away, the next day 22 Nov 2018 my mind felt as if I had had a minor stroke - never had one before but mind was slightly confused in remembering - this was a very frightening experience. I simply rested quietly those days - am doubtful if I will get the second shot.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Major chills, entire body aches, 100.6 fever, headache.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLUX, HEP, PNC13, RV5
Symptoms: Chest X-ray normal, Febrile convulsion, Flushing, Influenza virus test negative, Pyrexia
Clinical narrative: FLUSHED, HIGH FEVER (103 F, RECTAL), FEBRILE SEIZURE LASTED 20+ MINUTES.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLUX, HEP, PNC13, RV5
Symptoms: Respiratory syncytial virus test negative, Streptococcus test negative
Clinical narrative: FLUSHED, HIGH FEVER (103 F, RECTAL), FEBRILE SEIZURE LASTED 20+ MINUTES.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: Patient complained about soreness in shoulder joint lasting over a month and still a little bit of discomfort when lifting arm up all the way.Most of the pain and discomfort is resolved but not recovered completely.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Approximately 12 hours after the injection, chills and shivering began followed by fever and headache. The same reaction occurred after receiving first dose in September 2018.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Ear infection, Epstein-Barr virus test positive, Feeling abnormal, Headache, Infectious mononucleosis
Clinical narrative: After 8/15/18 immunizations, started feeling bad in Mid Oct 2018-C/O Headache, Body aches-Mom took Pt to Immediate Care and told Pt had ear infection - Pt. continues feeling bad - Took Pt to Hospital E.R. on 11-30-2018 - was told had UTI. Follow-up visit at Med Clinic 12-12-18 - was told Pt has Mono and tested positive for Epstein-Barr virus - Mom says this came from Immunizations.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pain, Urinary tract infection
Clinical narrative: After 8/15/18 immunizations, started feeling bad in Mid Oct 2018-C/O Headache, Body aches-Mom took Pt to Immediate Care and told Pt had ear infection - Pt. continues feeling bad - Took Pt to Hospital E.R. on 11-30-2018 - was told had UTI. Follow-up visit at Med Clinic 12-12-18 - was told Pt has Mono and tested positive for Epstein-Barr virus - Mom says this came from Immunizations.
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a healthcare professional via social media refers to female patients of unknown age. The patients medical history, concurrent condition and concomitant medications were not reported. On an unknown date, the patients were vaccinated with GARDASIL for prophylaxis (strength, dose, frequency, route, lot#  and expiry were not reported). On an unknown date, 7 out of the 8 women died in protocol GARDASIL (death), some experienced cough, erythema, swelling and pain. The cause of death was not reported and it was unknown if autopsy was performed. Outcome of pain, cough, erythema and swelling was unknown. Causality assessment of the events was not reported.
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from the mother of a 6 month old male patient, referring to the child. No information was provided regarding the patient's medical history, concurrent conditions, drug reaction/allergies or concomitant medications. It was reported that in approximately August and October 2018 (reported as "at two months and at four months"), the patient was administered first and second doses of LIQUID PEDVAXHIB, for routine vaccination (dose, route and site of administration, lot number and expiration date were not reported). The mother reported that on 10-DEC-2018, the patient, now six months old, was administered another dose of a "generic" form of the hib conj vaccine (unspecified carrier) (manufacturer unspecified) at a new pediatric office. The mother reported that on the same date her child experienced fever. At the time of the report, the event of pyrexia was reported as "ongoing" (not recovered). The patient did not seek medical attention. The reporter did not assess the causal relationship between therapy with LIQUID PEDVAXHIB and the event. There was no PQC reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving the ZOSTAVAX, the patient developed a painful rash accompanied by persistent pain. In response to these complaints, the patient presented to a physician and was diagnosed as suffering from shingles. As a direct and proximate result of the ZOSTAVAX vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.