chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Ear congestion, Influenza like illness, Musculoskeletal chest pain
Clinical narrative: Fluttering in ear; Her back hurt; Flu-like symptoms; Body aches; Joint aches; Rib cage hurts; Congestion; Sore throat; This case was reported by a consumer via call center representative and described the occurrence of flu-like symptoms in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th April 2019, the patient received the 1st dose of Shingrix. In April 2019, less than a week after receiving Shingrix, the patient experienced flu-like symptoms, general body pain, joint ache, rib pain, ear congestion, sore throat and back pain. On 20th April 2019, the patient experienced ear noises. On an unknown date, the outcome of the flu-like symptoms, general body pain, joint ache, rib pain, ear congestion and sore throat were not recovered/not resolved and the outcome of the ear noises was recovered/resolved and the outcome of the back pain was unknown.   It was unknown if the reporter considered the flu-like symptoms, general body pain, joint ache, rib pain, ear congestion, sore throat, ear noises and back pain to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix vaccine in left arm. Some unknown time 1 day after receiving Shingrix, the patient experienced fluttering in her ears (she said this always occurs when she has ear congestion). The patient then developed flu like symptoms, including body aches, joint aches, her rib cage hurt, her back hurt when she was lying down, congestion, and a sore throat. The fluttering in her ear had resolved but she still had all of the other symptoms.  The reporter did not consent to follow up. The reporter would not provide any additional information. This case had been linked to the case US2019GSK079464, reported by same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pain, Tinnitus
Clinical narrative: Fluttering in ear; Her back hurt; Flu-like symptoms; Body aches; Joint aches; Rib cage hurts; Congestion; Sore throat; This case was reported by a consumer via call center representative and described the occurrence of flu-like symptoms in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th April 2019, the patient received the 1st dose of Shingrix. In April 2019, less than a week after receiving Shingrix, the patient experienced flu-like symptoms, general body pain, joint ache, rib pain, ear congestion, sore throat and back pain. On 20th April 2019, the patient experienced ear noises. On an unknown date, the outcome of the flu-like symptoms, general body pain, joint ache, rib pain, ear congestion and sore throat were not recovered/not resolved and the outcome of the ear noises was recovered/resolved and the outcome of the back pain was unknown.   It was unknown if the reporter considered the flu-like symptoms, general body pain, joint ache, rib pain, ear congestion, sore throat, ear noises and back pain to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix vaccine in left arm. Some unknown time 1 day after receiving Shingrix, the patient experienced fluttering in her ears (she said this always occurs when she has ear congestion). The patient then developed flu like symptoms, including body aches, joint aches, her rib cage hurt, her back hurt when she was lying down, congestion, and a sore throat. The fluttering in her ear had resolved but she still had all of the other symptoms.  The reporter did not consent to follow up. The reporter would not provide any additional information. This case had been linked to the case US2019GSK079464, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included ibuprofen.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient took ibuprofen before the 2nd dose and still experienced mild headache. The reporter did not have additional information. The reporter did not consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Condition aggravated, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Injection site redness; injection site swelling; myalgia; joint stiffness; fatigue; sore shoulder; soreness of joints; Condition aggravated; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included kidney abscess. Concurrent medical conditions included fibromyalgia, psoriatic arthritis, fatigue (worsened after receiving the 1st dose of Shingrix) and stiff joint (worsened after receiving the 1st dose of Shingrix).   On 22nd April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 22nd April 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, myalgia, stiff joint, fatigue, shoulder pain, joint pain and condition aggravated. On 23rd April 2019, the outcome of the injection site swelling was recovered/resolved. On an unknown date, the outcome of the injection site erythema, myalgia, stiff joint, fatigue and shoulder pain were not recovered/not resolved and the outcome of the joint pain was recovered/resolved and the outcome of the condition aggravated was unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, myalgia, stiff joint, fatigue, shoulder pain, joint pain and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right deltoid. On the day of vaccination, the patient experienced redness, swelling at the injection site.  The patient also experienced soreness of joints and shoulder, joint stiffness, myalgia that  The reporter consented to follow up. This case has been linked with case US2019073215 reported by the same reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint stiffness, Musculoskeletal pain, Myalgia
Clinical narrative: Injection site redness; injection site swelling; myalgia; joint stiffness; fatigue; sore shoulder; soreness of joints; Condition aggravated; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included kidney abscess. Concurrent medical conditions included fibromyalgia, psoriatic arthritis, fatigue (worsened after receiving the 1st dose of Shingrix) and stiff joint (worsened after receiving the 1st dose of Shingrix).   On 22nd April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 22nd April 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, myalgia, stiff joint, fatigue, shoulder pain, joint pain and condition aggravated. On 23rd April 2019, the outcome of the injection site swelling was recovered/resolved. On an unknown date, the outcome of the injection site erythema, myalgia, stiff joint, fatigue and shoulder pain were not recovered/not resolved and the outcome of the joint pain was recovered/resolved and the outcome of the condition aggravated was unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, myalgia, stiff joint, fatigue, shoulder pain, joint pain and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right deltoid. On the day of vaccination, the patient experienced redness, swelling at the injection site.  The patient also experienced soreness of joints and shoulder, joint stiffness, myalgia that  The reporter consented to follow up. This case has been linked with case US2019073215 reported by the same reporter.
Age: 34.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of product administration, Therapy non-responder
Clinical narrative: non seroconversion; Inappropriate schedule of vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 34-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number NL4J9, expiry date 14th September 2020) for prophylaxis.   Previously administered products included Engerix-B (1st dose received 6 month prior to the reporting date).   On an unknown date, the patient received Hepatitis B vaccine. On 23rd April 2019, the patient received the 2nd dose of Engerix B. On 23rd April 2019, not applicable after receiving Hepatitis B vaccine and unknown after receiving Engerix B, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine.  Additional details were reported as follows: The age at vaccination was not reported for Hepatitis b vaccine. The pharmacist reported that patient had a prior Hepatitis b series, but showed no titer when drawn, was instructed to get another series.      Lab Comments: lab test were done on an unknown date
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: Injection Site Redness; Injection Site Swelling; Injection Site Pain; Rash underside of upper arm; This case was reported by a consumer via call center representative and described the occurrence of rash in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. In April 2019, 1 day after receiving Shingrix, the patient experienced rash, injection site erythema, injection site swelling and injection site pain. In April 2019, the outcome of the injection site erythema, injection site swelling and injection site pain were recovered/resolved. On an unknown date, the outcome of the rash was recovering/resolving.   It was unknown if the reporter considered the rash, injection site erythema, injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: Approximately one week before the date of reporting, in the evening, the patient received Shingrix on an unknown deltoid. The next day, the patient got a rash on the underside of her upper arm. The rash had almost cleared up. Less than a week after receiving Shingrix, the patient experienced redness, swelling, and pain at the injection site for a couple of days. The reporter consented to follow up.  In core outcome of the events injection site erythema, injection site swelling and injection site pain were recovered/resolved, however in source document the outcome of this events were reported as recovered/resolved with sequel.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: Itching; This case was reported by a pharmacist via call center representative and described the occurrence of generalized itching in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included drug allergy (Nonsteroidal anti-inflammatory drugs). Concomitant products included diclofenac sodium (Voltaren (Diclofenac Sodium)).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized itching. The patient was treated with prednisone. On an unknown date, the outcome of the generalized itching was not recovered/not resolved.   It was unknown if the reporter considered the generalized itching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The Pharmacist reported that a patient had experienced generalized itching four months in duration after receiving the first dose of Shingrix.  The patient had seen their physician who prescribed prednisone. After the prednisone therapy the itching returned. At the time of reporting, the patient was on topical Voltaren gel. Till the time of reporting, the physician and pharmacist were still monitoring and following this reaction. No additional detials were provided.
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Pruritus, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling in a 69-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced swelling, pruritus and feeling hot. On an unknown date, the outcome of the swelling was recovered/resolved and the outcome of the pruritus and feeling hot were unknown. It was unknown if the reporter considered the swelling, pruritus and feeling hot to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. The patient received flu vaccine and experienced swelling, itching and hot fever in her arm. The patient experienced same event when she received Shingles vaccine (refer case US2019GSK079252). The reporter consented for follow up. This case has been linked to case US2019GSK079252, reported by the same reporter for the same patient.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea
Clinical narrative: Patient called office to report that after receiving the Shingrix at pharmacy on 04/30/19 - the next day 05/01/19, she developed fatigue with chills and nausea. Patient states she contacted the pharmacist who informed her that he has had several patients report side effects to him after receiving the second dose of Shingrix and that she should also notify her physicians office of this occurring.
Age: 61.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Dyspnoea, Pain in extremity
Clinical narrative: Patient c/o left arm pain, shortness of breath no redness or swelling
Sex: U
Vaccine: VARZOS
Symptoms: Sepsis
Clinical narrative: This spontaneous report as received from a lawyer regarding a case in litigation refers to a currently 65 year old patient. On approximately 26-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced sepsis and was treated by a healthcare professional. At the time of the report, the patient's outcome was unknown. The reporter considered sepsis to be related to ZOSTAVAX. Upon internal review sepsis was considered to be medically significant. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: The patient did not have an adverse event or side effect from the vaccine given
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Chills, nausea, headache, fever achy
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Influenza virus test negative, Pain, Pain in extremity, Pyrexia
Clinical narrative: Left arm tender and warm to touch (no swelling or erythema).  Overall bodyaches, headache and fever of 100.3 when presented to clinic 2 days after vaccine. flu test negative, no recent sick contacts, reports similar reaction to Tdap vaccine in past.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: Left arm tender and warm to touch (no swelling or erythema).  Overall bodyaches, headache and fever of 100.3 when presented to clinic 2 days after vaccine. flu test negative, no recent sick contacts, reports similar reaction to Tdap vaccine in past.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: Around 5pm arm was hot, sore, swollen, red, and affected area was large.  Put cool compress.   Next day, fever was around 99.9, had muscle aches, headache, and nausea; symptoms lasted for about 3.5 days--basically had to stay in bed.   Used cold compresses in area but did not seem to help.  Took ibuprofen to help.   Patient did not call doctor.   Eventually symptoms started to disappear but soreness and redness on arm lasted 3 more days.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Around 5pm arm was hot, sore, swollen, red, and affected area was large.  Put cool compress.   Next day, fever was around 99.9, had muscle aches, headache, and nausea; symptoms lasted for about 3.5 days--basically had to stay in bed.   Used cold compresses in area but did not seem to help.  Took ibuprofen to help.   Patient did not call doctor.   Eventually symptoms started to disappear but soreness and redness on arm lasted 3 more days.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Dysphonia, Rash
Clinical narrative: Per Dr, pt went home and developed hoarseness in voice and rash on back; no difficulty breathing or swallowing. Mom took daughter to ER.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Nausea
Clinical narrative: On Thursday April 25, 2019 at around 10:00 am I started to feel nausea coming on which increased to the point where I could not drink any fluids without the continuing nausea. I did not vomit although I tried. I drank around 4 or 5 sips of water, cranberry juice and 7-Up during the 10 hour period. I took 2 Tums with no relief. Around 10:00pm the nausea started subsiding and I had a few tablespoons of chicken broth. Went to bed and was fine in the morning.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Blood pressure increased, Dysarthria, Feeling abnormal, Headache
Clinical narrative: nausea, weakness, slurred speech, felt foggy ,increased blood pressure, hives, flushed/ hot, and headache.   Sx's started 15- 20 min post injection and lasted several hours.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Hot flush, Nausea
Clinical narrative: nausea, weakness, slurred speech, felt foggy ,increased blood pressure, hives, flushed/ hot, and headache.   Sx's started 15- 20 min post injection and lasted several hours.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site pain, Paraesthesia, Peripheral swelling
Clinical narrative: pain at injection site, swelling in arm, tingling, headache
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Fatigue, Injection site pain, Injection site paraesthesia, Malaise
Clinical narrative: pain at injection site, swelling in arm, tingling, headache
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling
Clinical narrative: pain at injection site, swelling in arm, tingling, headache
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Decreased appetite, Headache, Injection site erythema
Clinical narrative: Fever, Chills, Anorexia, Arthralgias, Myalgias, Headache, Tenderness/Erythema/Warmth at the injection site Started the morning after vaccine was given Used Ice packs to the injection site, Tylenol with improvement in symptoms Improving by ~ 72 hours after onset
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Fever, Chills, Anorexia, Arthralgias, Myalgias, Headache, Tenderness/Erythema/Warmth at the injection site Started the morning after vaccine was given Used Ice packs to the injection site, Tylenol with improvement in symptoms Improving by ~ 72 hours after onset
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a female patient. The patient's age was unknown. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2016, at approximately 62 years of age, the patient was administered the zoster vaccine live (ZOSTAVAX) by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unspecified date in 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for long term prevention of shingles and zoster related conditions. On an unknown date, the patient experienced herpes zoster. It was reported that the patient was treated by a physician for the herpes zoster. The outcome of the herpes zoster was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 11-SEP-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, dose#, administration route and anatomical location were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster and an infection in eye due to herpes zoster. On an unknown date, the patient was treated by a physician and an ophthalmologist for the herpes zoster and the infection in eye due to herpes zoster resulting from the ZOSTAVAX use. The outcome of the herpes zoster and an infection in eye due to herpes zoster was not reported. The reporter considered the events to be related to ZOSTAVAX. Upon internal review, the event infection in eye due to herpes zoster was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Therapy non-responder
Clinical narrative: Has no immunity; This spontaneous report was received from a female adult patient of an unknown age concerning herself. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported.  On an unknown date (reported as the best dates she has was between 1981 and 1985), the patient was vaccinated with varicella vaccine  (manufacturer unknown) (dose, frequency, units, route, batch, lot# and expiry date were unknown) for prophylaxis. The patient was involved in adult clinical trial on varicella vaccine (the patient was sure it was a Merck study. However, she didn't had identification card which contains the MK#, protocol# and investigator information). During the study, some people got one dose while others got two doses. It was reported that when the merck study performed the testing, the study stated the patient had immunity. When she went to a unspecified tester, the results of the "regular testing" showed she had no immunity (therapeutic non-responder). The outcome of the event was unknown. The reporter did not provide any causality assessment. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Cellulitis, Deformity, Eye abscess, Pain
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 07-JUN-2016, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On 24-JUN-2016, the patient suffered debilitating injuries including bilateral facial cellulitis, abscesses to her face and eye and peri orbital soft tissue swelling and edema which caused severe pain and disfigurement resulting in hospitalization for approximately four (4) days. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition and has suffered economic losses due to her inability to work. As a result of ZOSTAVAX, the patient sustained severe and disfiguring personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events were considered not recovered/not resolved. The aforementioned events were considered related to ZOSTAVAX. Upon internal review, the cellulitis, subcutaneous abscess and eye abscess were considered a medically significant events. All the events were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Periorbital oedema, Periorbital swelling, Subcutaneous abscess
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 07-JUN-2016, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On 24-JUN-2016, the patient suffered debilitating injuries including bilateral facial cellulitis, abscesses to her face and eye and peri orbital soft tissue swelling and edema which caused severe pain and disfigurement resulting in hospitalization for approximately four (4) days. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition and has suffered economic losses due to her inability to work. As a result of ZOSTAVAX, the patient sustained severe and disfiguring personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events were considered not recovered/not resolved. The aforementioned events were considered related to ZOSTAVAX. Upon internal review, the cellulitis, subcutaneous abscess and eye abscess were considered a medically significant events. All the events were considered to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discomfort
Clinical narrative: Discomfort at Injection Site; This case was reported by a physician via call center representative and described the occurrence of injection site discomfort in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site discomfort. On an unknown date, the outcome of the injection site discomfort was recovered/resolved.   It was unknown if the reporter considered the injection site discomfort to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient experienced mild-moderate discomfort at the injection site for about 3 days. No additional details were provided. For tolerance to the 2nd dose of Shingrix, refer case US2019075342.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: left shoulder decrease range of motion; left shoulder pain; left shoulder stiffness; This case was reported by a pharmacist via call center representative and described the occurrence of joint range of motion decreased in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 4257F, expiry date 11th September 2021) for prophylaxis.   On 2nd April 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 10th April 2019, 8 days after receiving Shingrix, the patient experienced joint range of motion decreased, shoulder pain and stiffness shoulder. On an unknown date, the outcome of the joint range of motion decreased, shoulder pain and stiffness shoulder were not recovered/not resolved.   It was unknown if the reporter considered the joint range of motion decreased, shoulder pain and stiffness shoulder to be related to Shingrix.  Additional details were provided as follows: This case was reported by pharmacist for herself. The patient received Shingrix on left arm. Two weeks after the 2nd dose of Shingrix, the patient experienced shoulder stiffness, decrease in shoulder range of motion and shoulder pain, however as per onset date the patient experienced events 8 day after receiving Shingrix. The affected shoulder was the left shoulder. Core outcome of the joint range of motion decreased, shoulder pain and stiffness shoulder were not recovered/not resolved, however in source document the outcome of this events were reported as recovering/resolving. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Muscle tightness, Pain in extremity
Clinical narrative: pain/ shooting pain down her arm; injection site pain; Injection site tightness; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 92M54, expiry date 2nd June 2021) for prophylaxis.   Concurrent medical conditions included ehlers-danlos syndrome and connective tissue disorder.   On 16th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 17th April 2019, 1 days after receiving Shingrix, the patient experienced pain in arm, injection site muscle pain and muscle tightness. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the injection site muscle pain and muscle tightness were unknown.   The reporter considered the pain in arm to be related to Shingrix. It was unknown if the reporter considered the injection site muscle pain and muscle tightness to be related to Shingrix.  Additional details were provoded as follows: The patient received the Shingrix in the left deltoid. The day after vaccination, the patient sarted to experience a tightness and pain in the muscle at the site of injection. The patient also had shooting pain down her arm.
Sex: U
Vaccine: HEPAB
Symptoms: Allergic reaction to excipient, Fungal skin infection, Skin test positive
Clinical narrative: skin allergy; skin allergy; This case was reported by a pharmacist via call center representative and described the occurrence of yeast infection of the skin in a patient who received HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received Twinrix at an unknown dose. On an unknown date, unknown after receiving Twinrix, the patient experienced yeast infection of the skin and allergic reaction to drug excipient. On an unknown date, the outcome of the yeast infection of the skin and allergic reaction to drug excipient were unknown.   It was unknown if the reporter considered the yeast infection of the skin and allergic reaction to drug excipient to be related to Twinrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient tested positive for yeast with skin test. The patient read in the package insert (PI) that administration of Twinrix was contraindicated for those who have allergies to yeast, and was calling to get additional information or guidance on how to proceed with dosing. The patient was not sure if the skin test was positive prior to receiving the vaccine or after receiving the vaccine.      Lab Comments: On an unknown date, the lab test was performed
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Condition aggravated, Dermatitis, Drug interaction
Clinical narrative: recurring dermatitis; condition aggravated; possible drug interaction; This case was reported by a consumer via call center representative and described the occurrence of dermatitis in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Medrol for an unknown indication.   Concurrent medical conditions included dermatitis.   On 23rd April 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Medrol at an unknown dose and frequency. In April 2019, less than a week after receiving Shingrix, the patient experienced dermatitis, condition aggravated and drug interaction. On an unknown date, the outcome of the dermatitis and condition aggravated were recovering/resolving and the outcome of the drug interaction was unknown.   It was unknown if the reporter considered the dermatitis and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The patient reported that she got her first Shingrix shot on Tuesday of this week and her dermatitis was flaring up.  The patient does not know if it was related but asked about possibly taking a Medrol dose pack and if that would interfere with the vaccine, which led to possible drug interaction. She was referred to her physician for discussion. Call declined health care professional (HCP) information at this time but open to receive authorization form later, she was not sure if she will pursue the Medrol dose pack.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu-like Symptoms; This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site discomfort (for tolerance of 1st, refer case US2019GSK079348).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The reporting physician was the concerned patient.  The age at vaccination was not reported. The patient experienced systemic flu-like symptoms. No additional details were provided.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Rash erythematous
Clinical narrative: Red, Bullseye rash surrounding area, painful area. Being treated with Cephalexin 500 mg three times a day for seven days.
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling at injection site 9cm x 5cm, with central bruising.  Not tender, did not interfere with walking, no fever
Age: 23.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Angiogram normal, Blood creatinine increased, Cerebrovascular disorder, Electroencephalogram normal, Encephalopathy
Clinical narrative: 2 hours after receiving vaccines, patient had altered mental status and had 2 seizures without returning to her baseline. She was brought to the Er where she was found to be in status epilepticus and hypoxic. So, she was intubated and transferred to NeuroICU. She was also loaded with IV keppra 2 grams and ativan. In the NeuroICU, she was hooked up to continuous EEG and was continued on high dose versed drip and propofol drip. We continued vimpat at her home dose and added keppra. She was also found to have persistent tachycardia and fever. She had worsening renal function with Cr peaked at 2.51. EEG didn't show any seizure like activity. So, propofol and versed were weaned off. Even after stopping propofol and versed drips for more than 36 hours, she is still encephalopathic.
Age: 23.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Endotracheal intubation, Hypoxia, Intensive care, Lumbar puncture normal, Mental status changes
Clinical narrative: 2 hours after receiving vaccines, patient had altered mental status and had 2 seizures without returning to her baseline. She was brought to the Er where she was found to be in status epilepticus and hypoxic. So, she was intubated and transferred to NeuroICU. She was also loaded with IV keppra 2 grams and ativan. In the NeuroICU, she was hooked up to continuous EEG and was continued on high dose versed drip and propofol drip. We continued vimpat at her home dose and added keppra. She was also found to have persistent tachycardia and fever. She had worsening renal function with Cr peaked at 2.51. EEG didn't show any seizure like activity. So, propofol and versed were weaned off. Even after stopping propofol and versed drips for more than 36 hours, she is still encephalopathic.
Age: 23.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Pyrexia, Renal impairment, Seizure, Status epilepticus
Clinical narrative: 2 hours after receiving vaccines, patient had altered mental status and had 2 seizures without returning to her baseline. She was brought to the Er where she was found to be in status epilepticus and hypoxic. So, she was intubated and transferred to NeuroICU. She was also loaded with IV keppra 2 grams and ativan. In the NeuroICU, she was hooked up to continuous EEG and was continued on high dose versed drip and propofol drip. We continued vimpat at her home dose and added keppra. She was also found to have persistent tachycardia and fever. She had worsening renal function with Cr peaked at 2.51. EEG didn't show any seizure like activity. So, propofol and versed were weaned off. Even after stopping propofol and versed drips for more than 36 hours, she is still encephalopathic.
Age: 23.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Tachycardia, Venogram normal
Clinical narrative: 2 hours after receiving vaccines, patient had altered mental status and had 2 seizures without returning to her baseline. She was brought to the Er where she was found to be in status epilepticus and hypoxic. So, she was intubated and transferred to NeuroICU. She was also loaded with IV keppra 2 grams and ativan. In the NeuroICU, she was hooked up to continuous EEG and was continued on high dose versed drip and propofol drip. We continued vimpat at her home dose and added keppra. She was also found to have persistent tachycardia and fever. She had worsening renal function with Cr peaked at 2.51. EEG didn't show any seizure like activity. So, propofol and versed were weaned off. Even after stopping propofol and versed drips for more than 36 hours, she is still encephalopathic.
Age: 1.92
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Consciousness fluctuating, Cyanosis, Hypotonia, Muscular weakness, Oxygen therapy
Clinical narrative: Patient received 2 vaccinations left thigh and then right thigh. patient tolerated injection well.  After about 5 minutes, mom tried to get patient to stand up off the floor and noticed that patient looked pale.  At this time it was also noticed that patient's feet were weak like pt did not want to stand but I think that is when she began to have a reaction.  Mom picked up patient informed me patient looks pale, I had her bring pt over to injection table while mom was laying pt down pt went limp in her hands and eyes closed like she had passed out.  Lips were blueish in color as well.  This all happened approx at 1020 AM.  MD and RN were informed they came, oxygen per mask at 6 liters was administered to the patient, vitals taken at which time patient seemed to being going in and out of sleep/consciousness. she was unresponsive for about one minute.  then she recovered but was still cyanotic around her lips and pale for several minutes after that.   patient slowly pinked up and po2 was at 100 this entire time.  911 was called for patient and patient was transported to E.R.
Age: 1.92
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Pallor, Unresponsive to stimuli
Clinical narrative: Patient received 2 vaccinations left thigh and then right thigh. patient tolerated injection well.  After about 5 minutes, mom tried to get patient to stand up off the floor and noticed that patient looked pale.  At this time it was also noticed that patient's feet were weak like pt did not want to stand but I think that is when she began to have a reaction.  Mom picked up patient informed me patient looks pale, I had her bring pt over to injection table while mom was laying pt down pt went limp in her hands and eyes closed like she had passed out.  Lips were blueish in color as well.  This all happened approx at 1020 AM.  MD and RN were informed they came, oxygen per mask at 6 liters was administered to the patient, vitals taken at which time patient seemed to being going in and out of sleep/consciousness. she was unresponsive for about one minute.  then she recovered but was still cyanotic around her lips and pale for several minutes after that.   patient slowly pinked up and po2 was at 100 this entire time.  911 was called for patient and patient was transported to E.R.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: PATIENT RECEIVED ONLY THE LIQUID COMPONENT.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: PATIENT RECEIVED THE LIQUID COMPONENT ONLY .
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Fatigue, Fibromyalgia, Myalgia, Pyrexia
Clinical narrative: patient experienced fever, rash, muscle aches, fatigue and exacerbation of fibromyalgia
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: patient experienced fever, rash, muscle aches, fatigue and exacerbation of fibromyalgia
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Body temperature increased, Chest X-ray normal, Chest pain, Chills, Dizziness
Clinical narrative: symptoms began about 4 hours after the vaccine. Chills and body aches, right sided chest pain and shortness of breath. temp of 102.5. mild headache and dizziness. seen in the ER emergently and the clinic the following today (5/3/19). still complaining of fatigue on 5/3/19.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dyspnoea, Electrocardiogram normal, Fatigue, Full blood count, Headache
Clinical narrative: symptoms began about 4 hours after the vaccine. Chills and body aches, right sided chest pain and shortness of breath. temp of 102.5. mild headache and dizziness. seen in the ER emergently and the clinic the following today (5/3/19). still complaining of fatigue on 5/3/19.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Metabolic function test, Neutrophil percentage increased, Pain, Troponin, White blood cell count normal
Clinical narrative: symptoms began about 4 hours after the vaccine. Chills and body aches, right sided chest pain and shortness of breath. temp of 102.5. mild headache and dizziness. seen in the ER emergently and the clinic the following today (5/3/19). still complaining of fatigue on 5/3/19.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chest X-ray, Differential white blood cell count, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: symptoms began about 4 hours after the vaccine. Chills and body aches, right sided chest pain and shortness of breath. temp of 102.5. mild headache and dizziness. seen in the ER emergently and the clinic the following today (5/3/19). still complaining of fatigue on 5/3/19.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Full blood count, Metabolic function test, Pyrexia, Troponin I
Clinical narrative: symptoms began about 4 hours after the vaccine. Chills and body aches, right sided chest pain and shortness of breath. temp of 102.5. mild headache and dizziness. seen in the ER emergently and the clinic the following today (5/3/19). still complaining of fatigue on 5/3/19.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pain in extremity, Pyrexia
Clinical narrative: patient reported low fever, nausea, fatigue and didn't  get out of bed for 3 days (til Thursday).  Her arm hurt but was not swollen
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: PATIENT PRESENTED WITH SMALL,  UNIFORMED, RED,  CIRCULAR POX-LIKE RASH ON LEFT ARM THAT APPEARED APPROXIMATELY 2 DAYS AFTER HER SECOND SHINGRIX SHOT. SHE REPORTED NO ITCHING, NO FEVER, OR BODY ACHES OR PAINS.
Age: 0.58
Sex: M
Vaccine: UNK
Symptoms: Crying, Intentional self-injury, Screaming
Clinical narrative: Approximately four hours after the vaccine was administered, my son gradually, over the course of maybe five to ten minutes, went from contemt and crawling around to screaming louder than I?ve ever heard a baby scream. In the midst of a high-pitched scream, he would  somehow suddenly burst into an even higher-pitched scream. He was swatting at his ears through the screaming episode as well. Nothing we tried could calm him, not even nursing, and we tried everything. After three or more hours we considered bringing him into the E.R. but after speaking with my husband chose not to for different reasons, and he finally cried himself to sleepafter three to four hours of high-pitched, inconsolable crying and screaming. He typically nursed a few times during the night at that point, but that night he slept until the morning. When he awoke, he seemed to be back to acting like himself for the most part.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash macular
Clinical narrative: diffuse symmetric macular pink rash
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: PATIENT CALLED PHARMACY 2 DAYS LATER COMPLAINING OF RASH ON OPPOSITE ARM THAT SHE RECEIVED IMMUNIZATION.  SHE DESCRIBED THE RASH AS RED AND CIRCULAR, AND ITCHY (BUT NOT RINGWORM).  INSTRUCTED PATIENT TO USE OTC AIDS (HYDROCORTISONE CREAM) AND GO TO URGENT CARE/EMERGENCY IF RASH ESCALATES.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Muscle spasms, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: Tingling on tongue, lips, and throat a few hours after the vaccination and. Muscle spasms in legs started later that night. Symptoms constantly coming and going. Going to seek medical attention.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Hyperhidrosis, Influenza like illness, Pyrexia
Clinical narrative: Flu like, light-headed, chills and severe shivers all night, fever and sweats.  Was OK in AM.