chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation, from a lawyer, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2012, the patient was vaccinated with ZOSTAVAX, due to health care professional recommendation, for permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided). On an unknown date, the patient experienced shingles (herpes zoster) and other zoster-related injuries despite being inoculated with the ZOSTAVAX vaccine (vaccination failure). On 01-AUG-2013, the patient was treated by a health care provider for shingles. It was also reported that, on unknown dates, the patient suffered serious physical, emotional and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering (Emotional distress and pain), 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; diminished quality of life; increased risk of premature death, aggravation of pre-existing conditions and activations of laten conditions, lost wages, loss of earning capacity and other losses and damages. At the time of report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased, and the pre-existing unspecified conditions aggravated was unknown. The reporter considered the adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation, from a lawyer, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. In 2014, the patient was vaccinated with ZOSTAVAX, due to health care professional recommendation, for permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided). In 2014, the patient was treated by an advanced practice registered nurse for shingles, as the patient was diagnosed with shingles or other 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 had and would continue suffer ongoing injuries, included but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries; significant medical an related expenses as a result of these injuries, included but not limited to medical losses and cost include 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. At the time of report, the patient was not recovered from emotional distress, injury and pain. The outcome of vaccination failure, quality of life decreased, herpes zoster and the pre-existing unspecified conditions aggravated was unknown. The reporter considered the events to be disabling, life-threatening and medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On or about 02-APRI-2015, the patient was vaccinated with ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the healthcare professional. On an unknown date, the patient experienced shingles (herpes zoster) and on or about 28-NOV-2016, the patient was treated 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 patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered; 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 included 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. At the time of the report, the patient had not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On or about 22-NOV-2013, the patient was vaccinated with ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the healthcare professional. On an unknown date, the patient experienced shingles (herpes zoster) and on or about 25-NOV-2016, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (vaccination failure) and suffered serious physical, emotional, and economic damages (emotional distress), as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered (emotional distress, pain); 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 included 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 (condition aggravated); lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient was inoculated with ZOSTAVAX vaccine, on or about 07-NOV-2013, at a medical center, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and subsequently the patient contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2017, the patient was treated at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 03-DEC-2018, the patient who was 2-month-old infant (less than the recommended age) was vaccinated with PNEUMOVAX 23 for prophylaxis (lot # R012360, expiration date: 15-JAN-2020; dose, and route of administration were not reported). No adverse effects were reported.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Red from injection site to slightly below elbow with edema, pt was informed to take Benadryl 4 times per day, Ibuprofen 3 times per day and to apply warm compresses to sight.
Age: 41.0
Sex: F
Vaccine: YF
Symptoms: Injection site rash, Rash, Skin warm
Clinical narrative: Local rash about 1/2 of the patient's palm size. Raized non erythremous rash around injection site. No itching or respiratory symptoms. Rash is warm to the touch.
Age: 1.08
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Erythema, Injection site bruising, Injection site mass, Pruritus, Tenderness
Clinical narrative: 12/05/18- Right thigh noted a 5 x 4cm erythema, somewhat tender, no warmth but felt a lump at the needle site of a vaccine, and noticed a 1 cm bluish bruise. DiphenhydrAMINE HCl Elixir, 12.5 MG/5ML, 5 ml as needed, Orally, prn per every 8 hrs per itchiness. Return visit for evaluation scheduled for 12/07/18.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Patient was inadvertently given SHINGRIX as a subcutaneous injection, instead of the recommended intramuscular route.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Incorrect route of product administration, Influenza like illness, Injection site erythema
Clinical narrative: Patient was inadvertently given SHINGRIX as a subcutaneous injection, instead of the recommended intramuscular route.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Patient was inadvertently given SHINGRIX as a subcutaneous injection, instead of the recommended intramuscular route.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: The injection was given subcutaneously and not IM. Redness, swelling, warm to touch at the injection site and got larger over the next 2 days. Also had flu like symptoms beginning 24 hours after - fever of 102.7 F, chills, body aches, fatigue.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Incorrect route of product administration, Influenza like illness, Injection site erythema
Clinical narrative: The injection was given subcutaneously and not IM. Redness, swelling, warm to touch at the injection site and got larger over the next 2 days. Also had flu like symptoms beginning 24 hours after - fever of 102.7 F, chills, body aches, fatigue.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: The injection was given subcutaneously and not IM. Redness, swelling, warm to touch at the injection site and got larger over the next 2 days. Also had flu like symptoms beginning 24 hours after - fever of 102.7 F, chills, body aches, fatigue.
Age: 40.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Erythema, Inflammation, Needle issue, Nodule, Syringe issue
Clinical narrative: Inflammatory Nodule that is red and tender to touch.
Age: 40.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Tenderness
Clinical narrative: Inflammatory Nodule that is red and tender to touch.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Patient was administered SHINGRIX as subcutaneous injection inadvertently. The injection should have been intramuscular according to manufacturer information. Did not revaccinate due to CDC recommendation that if this were to occur the dose is still considered valid.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site rash, Injection site swelling, Rash pruritic
Clinical narrative: Patient had minor swelling at the injection site, followed by a headache. A rash developed the same day as the vaccine below the injection site. The rash has been there for one weeks time as of today and is slowly getting more itchy and spreading slightly.Patient came in with concern because the rash was spreading and getting itchier.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: Site sore and red, generalized muscle aches, headache, nausea, chills and T 100.8.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Nausea
Clinical narrative: Site sore and red, generalized muscle aches, headache, nausea, chills and T 100.8.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Swelling up and down arm, warm to touch, swelling subsiding by time she came in.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Dizziness
Clinical narrative: Severe dizziness and unsteadiness.
Age: 1.0
Sex: M
Vaccine: FLUX, HEPA, MMR, PPV
Symptoms: Anaphylactic reaction, Angioedema, Cough, Pruritus, Radioallergosorbent test positive
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 12-month-old male patient. No information regarding the patient's pertinent medical history and concomitant medications was provided. On an unknown date, at 12 months of age, the patient received initial doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), hepatitis A virus vaccine live, influenza virus vaccine (unspecified) and pneumococcal 13v conj vaccine (crm197) for prophylaxis (dose, route and site of administration, lot# and expiration date were not provided for any of the vaccines). Fifteen minutes following administration he developed coughing, pruritus, and facial/lip angioedema. He was evaluated in an emergency department (ED) and received intramuscular epinephrine for presumed influenza virus vaccine (unspecified) anaphylaxis secondary to egg hypersensitivity. Three months later, he developed cough and facial/lip angioedema within five minutes of his 15-months immunization with varicella virus vaccine live (oka/Merck) (manufacturer unknown), Hib conj vaccine (unspecified carrier) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (dose, route and site of administration, lot# and expiration date were not provided for any of the vaccines). On an unknown date, at 17 months of age, the patient was referred for evaluation of anaphylaxis to vaccines. Skin testing was positive for gelatin (11mm), egg (9mm), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (5mm) and varicella virus vaccine live (oka/Merck) (manufacturer unknown) (9mm) and negative to influenza virus vaccine (unspecified) (3mm) with appropriate histamine and saline controls. Radioallergosorbent Testing (RAST) was positive to bovine gelatin (25.1kU/L) and negative to egg. The outcome of the event was not reported. The authors concluded that the patient was sensitized to gelatin, and reacted to gelatin-containing vaccines. They mentioned that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and varicella virus vaccine live (oka/Merck) (manufacturer unknown) vaccines contain over 10000 micrograms of gelatin per dose, and influenza vaccines include much smaller amounts. The authors considered the event of anaphylactic reaction to be related to vaccines which contained gelatin: measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), varicella virus vaccine live (oka/Merck) (manufacturer unknown) and influenza virus vaccine (unspecified). Upon internal review, the event of anaphylactic reaction was considered to be medically significant.
Age: 1.0
Sex: M
Vaccine: FLUX, HEPA, MMR, PPV
Symptoms: Skin test positive, Vaccination complication
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 12-month-old male patient. No information regarding the patient's pertinent medical history and concomitant medications was provided. On an unknown date, at 12 months of age, the patient received initial doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), hepatitis A virus vaccine live, influenza virus vaccine (unspecified) and pneumococcal 13v conj vaccine (crm197) for prophylaxis (dose, route and site of administration, lot# and expiration date were not provided for any of the vaccines). Fifteen minutes following administration he developed coughing, pruritus, and facial/lip angioedema. He was evaluated in an emergency department (ED) and received intramuscular epinephrine for presumed influenza virus vaccine (unspecified) anaphylaxis secondary to egg hypersensitivity. Three months later, he developed cough and facial/lip angioedema within five minutes of his 15-months immunization with varicella virus vaccine live (oka/Merck) (manufacturer unknown), Hib conj vaccine (unspecified carrier) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (dose, route and site of administration, lot# and expiration date were not provided for any of the vaccines). On an unknown date, at 17 months of age, the patient was referred for evaluation of anaphylaxis to vaccines. Skin testing was positive for gelatin (11mm), egg (9mm), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (5mm) and varicella virus vaccine live (oka/Merck) (manufacturer unknown) (9mm) and negative to influenza virus vaccine (unspecified) (3mm) with appropriate histamine and saline controls. Radioallergosorbent Testing (RAST) was positive to bovine gelatin (25.1kU/L) and negative to egg. The outcome of the event was not reported. The authors concluded that the patient was sensitized to gelatin, and reacted to gelatin-containing vaccines. They mentioned that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and varicella virus vaccine live (oka/Merck) (manufacturer unknown) vaccines contain over 10000 micrograms of gelatin per dose, and influenza vaccines include much smaller amounts. The authors considered the event of anaphylactic reaction to be related to vaccines which contained gelatin: measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), varicella virus vaccine live (oka/Merck) (manufacturer unknown) and influenza virus vaccine (unspecified). Upon internal review, the event of anaphylactic reaction was considered to be medically significant.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning to a 38-year old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 28-NOV-2018, the patient was inadvertently vaccinated with a dose of M-M-R II (therapy type: recombinant human albumin (rHA)) via subcutaneous route (lot # M045394, expiration date: 14-NOV-2018) after it's labeled expiration date for prophylaxis (expired product administered). No adverse effect was reported in the patient. No product quality complaint was involved.
Sex: F
Vaccine: HPV9
Symptoms: Guillain-Barre syndrome
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On unknown dates in 2018, the patient was vaccinated with two doses of GARDASIL 9 injection (exact dose, route, site of administration, lot# and expiry date were not reported) for prophylaxis. On an unknown date in 2018 (reported as "sometime after receipt of the vaccines"), the patient was diagnosed with Guillain-Barre Syndrome. The outcome of the event was not recovered (reported as "ongoing"). Causality between the event and the suspect vaccine was not provided. Upon internal review, the event of Guillain-Barre Syndrome was considered to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Intensive care
Clinical narrative: Information was received from a pharmacist via field representative concerning a female of unknown age. Information about concurrent condition, concomitant medication and medical history of the patient was unknown. On 14-NOV-2018, the patient received PNEUMOVAX 23 (strength, dose, route, lot# and expiration date were not reported) for prevention of pneumonia. On an unknown date in November 2018 (reported as an unspecified amount of time later), the patient developed an unspecified allergic reaction. On an unknown date in November 2018, the patient was admitted to the hospital in the intensive care unit for an unspecified reason (adverse event). The outcome of events was unknown. Information about treatment given for the event, lab diagnostics/studies was unknown. The causality assessment was not provided.
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. In 2016, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 15-NOV-2016, 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation, from a lawyer, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2012, the patient was vaccinated with ZOSTAVAX, due to health care professional recommendation, for permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided). On an unknown date, the patient experienced shingles (herpes zoster) and other zoster-related injuries despite being inoculated with the ZOSTAVAX vaccine (vaccination failure). On an unknown date in 2016, the patient was treated by a health care provider for shingles. It was also reported that, on unknown dates, the patient suffered serious physical, emotional and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering (Emotional distress and pain), 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; diminished quality of life; increased risk of premature death, aggravation of pre-existing conditions and activations of laten conditions, lost wages, loss of earning capacity and other losses and damages. At the time of report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased, and the pre-existing unspecified conditions aggravated was unknown. The reporter considered the adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-treathening and medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On an unspecified date in or about 2007, the patient was vaccinated with ZOSTAVAX (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries as recommended by the healthcare professional. On an unknown date, the patient experienced shingles and on an unspecified date in 2016, the patient was treated for shingles at doctor's office. 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 patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered; 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 included 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. At the time of the report, the patient had not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
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 concomitant medications, concurrent conditions or medical history.On or about 02-SEP-2016, a pharmacist administered the ZOSTAVAX (dose, route, and lot # not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. On or about 11-SEP-2016, 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, the patient had and would continue 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 include 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 event was not recovered/not resolved. Causality assessments were related.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Depression, Gait disturbance, Influenza like illness, Nausea
Clinical narrative: On 12/4/18, patient contacted pharmacy and detailed a severe reaction post-vaccination to the FLUZONE HD flu vaccination (NDC#49281-0403-65). Patient stated that she had severe flu-like symptoms. She also reported having nausea, vertigo, loss of equilibrium, depression and difficulty walking long distances. Patient states that these symptoms have persisted for several months after the vaccine was administered on 9/17/18. Patient states that she has made multiple visits to various physicians to address these symptoms.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: On 12/4/18, patient contacted pharmacy and detailed a severe reaction post-vaccination to the FLUZONE HD flu vaccination (NDC#49281-0403-65). Patient stated that she had severe flu-like symptoms. She also reported having nausea, vertigo, loss of equilibrium, depression and difficulty walking long distances. Patient states that these symptoms have persisted for several months after the vaccine was administered on 9/17/18. Patient states that she has made multiple visits to various physicians to address these symptoms.
Age: 57.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Asthenia, Erythema, Feeling cold, Headache, Influenza virus test negative
Clinical narrative: Went to Pharmacy to get my flu and pneumonia vaccines. Informed pharmacist that I needed preservative free vaccines due to allergy to thimerosal. Was assured that I was getting PF. Received both shots around 4pm. That next morning at 0100, I developed a fever of 101.7, was weak, chilling, achy and had a headache. Unable to get rid of fever and continue today with all of the symptoms. Was seen my by Dr. yesterday. She feel I'm having an adverse reaction to one or both of my shots. I had FLUZONE Quad and PNEUMOVAX 23. Also, the arm I had the injection in is extremely sore, swollen and red.
Age: 57.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia, Streptococcus test negative
Clinical narrative: Went to Pharmacy to get my flu and pneumonia vaccines. Informed pharmacist that I needed preservative free vaccines due to allergy to thimerosal. Was assured that I was getting PF. Received both shots around 4pm. That next morning at 0100, I developed a fever of 101.7, was weak, chilling, achy and had a headache. Unable to get rid of fever and continue today with all of the symptoms. Was seen my by Dr. yesterday. She feel I'm having an adverse reaction to one or both of my shots. I had FLUZONE Quad and PNEUMOVAX 23. Also, the arm I had the injection in is extremely sore, swollen and red.
Age: 57.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Vaccination complication
Clinical narrative: Went to Pharmacy to get my flu and pneumonia vaccines. Informed pharmacist that I needed preservative free vaccines due to allergy to thimerosal. Was assured that I was getting PF. Received both shots around 4pm. That next morning at 0100, I developed a fever of 101.7, was weak, chilling, achy and had a headache. Unable to get rid of fever and continue today with all of the symptoms. Was seen my by Dr. yesterday. She feel I'm having an adverse reaction to one or both of my shots. I had FLUZONE Quad and PNEUMOVAX 23. Also, the arm I had the injection in is extremely sore, swollen and red.
Age: 41.0
Sex: U
Vaccine: FLU4
Symptoms: Axillary pain, Lymphadenitis
Clinical narrative: Soreness and swelling in armpit of left arm.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Dizziness, Injection site pain, Myalgia
Clinical narrative: Muscle & Joint Pain, Fever 100.3 deg. Dizzy, Nauseous, Weak, Pain at injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Muscle & Joint Pain, Fever 100.3 deg. Dizzy, Nauseous, Weak, Pain at injection site.
Age: 8.0
Sex: F
Vaccine: OPV, UNK
Symptoms: Bed rest, Conversion disorder, Depression, Diet refusal, Disability
Clinical narrative: When I was 15, I realize now the CFS/ME virus must have been triggered by the Mono virus. I became severely ill which was triggered by my first kiss. I later took the DTaP of some kind for a food handlers' permit. There were many times I nearly died. My throat swelled up to where I could hardly breathe. Mom took me to a Dr. who dx'd me with mono. I got sick again at 16 when I tried to work. It happened again at 18, after I had sex the first time, and I had to have bed rest for 6 weeks. Around 20, dx'ed with "Chronic Fatigue/Epstein Barr," after I got married. At 22, nearly lost my life after childbirth. Became skinny as a rail. It was only years later, after my children with Asperger's had been victims many times, and were medicated for several years, that my son ended up in kidney failure, after Crohn's that developed after he was assaulted at school. The school covered it all up. He developed pancreatitis and was treated like a drug addict by hospital staff. My son was never a drug addict. He was so sick, and dying, and abused. I became ill from repeated trauma after that, which has now disabled me. The pain is unbelievable, yet I refuse medication, so doctors will not help me. I had to fight for dx other than "conversion disorder," which is what they tried to pin on me. Cruel. Doctors told me for years it was "all in my  head." It wasn't and isn't. It's virally-caused, and I even have photographs of myself before and after the vaccinations in 1973.
Age: 8.0
Sex: F
Vaccine: OPV, UNK
Symptoms: Dyspnoea, Epstein-Barr virus infection, Fatigue, Feeding disorder, Infectious mononucleosis
Clinical narrative: When I was 15, I realize now the CFS/ME virus must have been triggered by the Mono virus. I became severely ill which was triggered by my first kiss. I later took the DTaP of some kind for a food handlers' permit. There were many times I nearly died. My throat swelled up to where I could hardly breathe. Mom took me to a Dr. who dx'd me with mono. I got sick again at 16 when I tried to work. It happened again at 18, after I had sex the first time, and I had to have bed rest for 6 weeks. Around 20, dx'ed with "Chronic Fatigue/Epstein Barr," after I got married. At 22, nearly lost my life after childbirth. Became skinny as a rail. It was only years later, after my children with Asperger's had been victims many times, and were medicated for several years, that my son ended up in kidney failure, after Crohn's that developed after he was assaulted at school. The school covered it all up. He developed pancreatitis and was treated like a drug addict by hospital staff. My son was never a drug addict. He was so sick, and dying, and abused. I became ill from repeated trauma after that, which has now disabled me. The pain is unbelievable, yet I refuse medication, so doctors will not help me. I had to fight for dx other than "conversion disorder," which is what they tried to pin on me. Cruel. Doctors told me for years it was "all in my  head." It wasn't and isn't. It's virally-caused, and I even have photographs of myself before and after the vaccinations in 1973.
Age: 8.0
Sex: F
Vaccine: OPV, UNK
Symptoms: Injury, Jaundice, Laboratory test, Malaise, Pain
Clinical narrative: When I was 15, I realize now the CFS/ME virus must have been triggered by the Mono virus. I became severely ill which was triggered by my first kiss. I later took the DTaP of some kind for a food handlers' permit. There were many times I nearly died. My throat swelled up to where I could hardly breathe. Mom took me to a Dr. who dx'd me with mono. I got sick again at 16 when I tried to work. It happened again at 18, after I had sex the first time, and I had to have bed rest for 6 weeks. Around 20, dx'ed with "Chronic Fatigue/Epstein Barr," after I got married. At 22, nearly lost my life after childbirth. Became skinny as a rail. It was only years later, after my children with Asperger's had been victims many times, and were medicated for several years, that my son ended up in kidney failure, after Crohn's that developed after he was assaulted at school. The school covered it all up. He developed pancreatitis and was treated like a drug addict by hospital staff. My son was never a drug addict. He was so sick, and dying, and abused. I became ill from repeated trauma after that, which has now disabled me. The pain is unbelievable, yet I refuse medication, so doctors will not help me. I had to fight for dx other than "conversion disorder," which is what they tried to pin on me. Cruel. Doctors told me for years it was "all in my  head." It wasn't and isn't. It's virally-caused, and I even have photographs of myself before and after the vaccinations in 1973.
Age: 8.0
Sex: F
Vaccine: OPV, UNK
Symptoms: Pharyngeal oedema, Post viral fatigue syndrome, Weight decreased
Clinical narrative: When I was 15, I realize now the CFS/ME virus must have been triggered by the Mono virus. I became severely ill which was triggered by my first kiss. I later took the DTaP of some kind for a food handlers' permit. There were many times I nearly died. My throat swelled up to where I could hardly breathe. Mom took me to a Dr. who dx'd me with mono. I got sick again at 16 when I tried to work. It happened again at 18, after I had sex the first time, and I had to have bed rest for 6 weeks. Around 20, dx'ed with "Chronic Fatigue/Epstein Barr," after I got married. At 22, nearly lost my life after childbirth. Became skinny as a rail. It was only years later, after my children with Asperger's had been victims many times, and were medicated for several years, that my son ended up in kidney failure, after Crohn's that developed after he was assaulted at school. The school covered it all up. He developed pancreatitis and was treated like a drug addict by hospital staff. My son was never a drug addict. He was so sick, and dying, and abused. I became ill from repeated trauma after that, which has now disabled me. The pain is unbelievable, yet I refuse medication, so doctors will not help me. I had to fight for dx other than "conversion disorder," which is what they tried to pin on me. Cruel. Doctors told me for years it was "all in my  head." It wasn't and isn't. It's virally-caused, and I even have photographs of myself before and after the vaccinations in 1973.
Age: 1.25
Sex: F
Vaccine: DTAP, PPV
Symptoms: Injection site urticaria, Lethargy, Pyrexia, Urticaria
Clinical narrative: Two days after the vaccines my daughter was sent home from daycare with a 102 fever and lethargy. Shortly after her fever reduced, she starting developing hives on her wrists, back and legs over the next couple of days. I contacted our physician's office on Aug 28th because some of the hives started to become quite large (3 + inches) and they recommended BENADRYL. Nothing new was added to her diet and no other known contributing factors besides the vaccines earlier in the week.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Adverse event: patient had swelling around injection site. Redness around injection site. Symptoms started morning of 12/06/18. Treatment: Patient stated that placed ice on injection site but did not help. Recommended to use ibuprofen for the pain and swelling and to seek medical attention from physician as soon as possible. Outcomes: patient stated that they will go have the swelling looked at by their physician today 12/06/18.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: 12/6/2018 1130am pt came into office area red, warm, slightly swollen below injection site.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Delirium, Dizziness, Malaise, Nausea, Photophobia
Clinical narrative: Sleepless, dizziness, delirium, nausea, fever, vomiting, light sensitivity, sick for 24 hrs.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Somnolence, Vomiting
Clinical narrative: Sleepless, dizziness, delirium, nausea, fever, vomiting, light sensitivity, sick for 24 hrs.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm with swelling, warmth, redness at site of injection influenza. KEFLEX Capsule, 500 MG, 1 capsule, Orally, every 12 hrs, 7 days.
Age: 33.0
Sex: M
Vaccine: PPV, UNK
Symptoms: Asthenia, Bedridden, Chills, Contusion, Erythema
Clinical narrative: Swelling of right arm, massive bruise about the size of an orange and red/purple as a berry. Low-grade fever, chills and hot flashes so severe that sometimes I can't put on five blankets and get warm and/or take off all the blankets and get cool. Systemic weakness that makes it next to impossible to move and/or do any activity; this issue has kept me housebound since the evening of the injections. A migraine so terrible that if I move my head, it sends sharp shots of pain all over my skull. And finally, random aches, throbs and pains in various muscles across my body that seem to have no pattern whatsoever. Again, these symptoms have kept me bedridden since the injections.
Age: 33.0
Sex: M
Vaccine: PPV, UNK
Symptoms: Hot flush, Loss of personal independence in daily activities, Migraine, Myalgia, Pain
Clinical narrative: Swelling of right arm, massive bruise about the size of an orange and red/purple as a berry. Low-grade fever, chills and hot flashes so severe that sometimes I can't put on five blankets and get warm and/or take off all the blankets and get cool. Systemic weakness that makes it next to impossible to move and/or do any activity; this issue has kept me housebound since the evening of the injections. A migraine so terrible that if I move my head, it sends sharp shots of pain all over my skull. And finally, random aches, throbs and pains in various muscles across my body that seem to have no pattern whatsoever. Again, these symptoms have kept me bedridden since the injections.
Age: 33.0
Sex: M
Vaccine: PPV, UNK
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Swelling of right arm, massive bruise about the size of an orange and red/purple as a berry. Low-grade fever, chills and hot flashes so severe that sometimes I can't put on five blankets and get warm and/or take off all the blankets and get cool. Systemic weakness that makes it next to impossible to move and/or do any activity; this issue has kept me housebound since the evening of the injections. A migraine so terrible that if I move my head, it sends sharp shots of pain all over my skull. And finally, random aches, throbs and pains in various muscles across my body that seem to have no pattern whatsoever. Again, these symptoms have kept me bedridden since the injections.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Chills, Headache, Lymphadenopathy, Myalgia
Clinical narrative: Headaches, chills, muscle and joint pain, vomited x 1, low grade fever, sore throat, mild enlargement nodes under throat, itchy rash starting in neck area and then progressing through body.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Oropharyngeal pain, Pyrexia, Rash generalised, Rash pruritic, Streptococcus test negative
Clinical narrative: Headaches, chills, muscle and joint pain, vomited x 1, low grade fever, sore throat, mild enlargement nodes under throat, itchy rash starting in neck area and then progressing through body.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Headaches, chills, muscle and joint pain, vomited x 1, low grade fever, sore throat, mild enlargement nodes under throat, itchy rash starting in neck area and then progressing through body.
Age: 1.83
Sex: M
Vaccine: UNK, UNK
Symptoms: Deafness, Decreased eye contact, Diarrhoea, Encephalitis, Encephalopathy
Clinical narrative: I was called to pick him up at daycare. He had diarrhea and was repeating everything I said in a pitiful voice. I kept asking him what was wrong and how he felt, but he could only repeat what I was saying. I cared for him that day. He was very lethargic, and would not even look at me when I spoke to him. Drs. later told his parents that he was deaf, and that he needed tubes and adenoids out. They never caught his symptoms, which were very obvious. Just a few months ago, doctors took out his tonsils, saying they were too big. They have been bullied by doctors who want to treat without looking into his obvious reactions and symptoms of encephalitis and encephalopathy. My son reported to me he'd beat his head on the crib and the floor. Doctors are ignorant and our kids feel like they have to follow doctors orders. When they first refused vaccinations, under a year old, the Dr. made them sign a refusal form, then apparently they sent letters stating they'd better get the shots, I don't know when all he might have gotten them, but the 2 year ones (I assume that included the MMR,) were incredibly devastating. Prior, he'd take his baba, lay down for a nap, no problem. He developed sleep disorders that his tonsils were blamed for. They never looked into patient's health history, even though I had myself and my son tested for MTHFR, both homozygous, resulting in about 70% mitochondrial dysfunction.