chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Deafness, Tinnitus
Clinical narrative: Hearing loss; Ringing in his ears; This case was reported by a pharmacist via call center representative and described the occurrence of hearing loss in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 1st November 2019).   On 6th January 2020, the patient received the 2nd dose of Shingrix. On 8th January 2020, 2 days after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant) and ringing in ears. On an unknown date, the outcome of the hearing loss and ringing in ears were not recovered/not resolved.   It was unknown if the reporter considered the hearing loss and ringing in ears to be related to Shingrix.  Additional Details were provided as follows: The age at vaccination was not reported but it could be 66 or 67 years. The reporter stated that, after vaccination with 2nd dose of Shingrix, the patient experienced ringing in his ears followed by hearing loss. The ringing in his ears followed by hearing loss was ongoing. The patient has scheduled an appointment with an ear, nose, and throat (ENT) doctor. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Food allergy, Myalgia, Paraesthesia, Rash
Clinical narrative: Rash all over the body after eating peanut butter; Rash all over the body after eating peanut butter; Tingling cold in the body; Myalgia; This case was reported by a pharmacist via call center representative and described the occurrence of tingling sensation in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number FE272, expiry date 18th February 2022) for prophylaxis.   On 2nd December 2019, the patient received the 1st dose of Shingrix. On 4th December 2019, 2 days after receiving Shingrix, the patient experienced tingling sensation and myalgia. On an unknown date, the patient experienced rash and food allergy. On an unknown date, the outcome of the tingling sensation, myalgia, rash and food allergy were unknown.   It was unknown if the reporter considered the tingling sensation, myalgia, rash and food allergy to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient developed myalgia and felt tingling cold over the body. The patient developed rash all over the body after eating peanut butter, something that had never happened before receiving vaccine. The reporter was not sure if the expiration date of the vaccine was 18 February 2020 or 18 February 2022. The batch number was updated from  FE277 to FE272 as per sales data sheet. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Insomnia, Pain in extremity, Pruritus, Rash macular
Clinical narrative: Lingering pain in the arm; on the 4th night, unable to sleep because of the heat in the arm, itchiness, and tender to the touch.  Have raised blotches under my belly button area all across my stomach and it is itchy.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Lingering pain in the arm; on the 4th night, unable to sleep because of the heat in the arm, itchiness, and tender to the touch.  Have raised blotches under my belly button area all across my stomach and it is itchy.
Age: 38.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Pt c/o numbness and tingling in left arm.  Went to the ER for observation.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Patient states he has experienced pain and decrease range of motion since he got the shot.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: CHILLS AND BODY ACHES-  TOOK IBUPROFEN DURATION ~ 6 HRS
Age: 14.0
Sex: F
Vaccine: HEP, MMRV
Symptoms: Abdominal pain, Asthenia, Blood thyroid stimulating hormone increased, Cytomegalovirus test negative, Epstein-Barr virus antibody negative
Clinical narrative: complicated history. Intermittent numbness of right arm after shot for 2 days. Developed fever, sore throat, cervical adenopathy, fatigue and abdominal pain 5 days later. Felt to have mono like illness with elevated LFTs though EBV and CMV titers negative. Was also noted to have elevated TSH and low T4 at the time. Concern now is that she continues with generalized fatigue and weakness and a white ring at the site of the hep B vaccine. She has seen several specialists and is slowly improving though not back to baseline. She just recently was able to return to school half days. The issue of macrophagic myofasciitis has been raised given her symptoms and persistent white ring on her arm at the site of the hep B vaccine.
Age: 14.0
Sex: F
Vaccine: HEP, MMRV
Symptoms: Fatigue, Hypoaesthesia, Injection site discolouration, Liver function test increased, Loss of personal independence in daily activities
Clinical narrative: complicated history. Intermittent numbness of right arm after shot for 2 days. Developed fever, sore throat, cervical adenopathy, fatigue and abdominal pain 5 days later. Felt to have mono like illness with elevated LFTs though EBV and CMV titers negative. Was also noted to have elevated TSH and low T4 at the time. Concern now is that she continues with generalized fatigue and weakness and a white ring at the site of the hep B vaccine. She has seen several specialists and is slowly improving though not back to baseline. She just recently was able to return to school half days. The issue of macrophagic myofasciitis has been raised given her symptoms and persistent white ring on her arm at the site of the hep B vaccine.
Age: 14.0
Sex: F
Vaccine: HEP, MMRV
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pyrexia, Thyroxine decreased
Clinical narrative: complicated history. Intermittent numbness of right arm after shot for 2 days. Developed fever, sore throat, cervical adenopathy, fatigue and abdominal pain 5 days later. Felt to have mono like illness with elevated LFTs though EBV and CMV titers negative. Was also noted to have elevated TSH and low T4 at the time. Concern now is that she continues with generalized fatigue and weakness and a white ring at the site of the hep B vaccine. She has seen several specialists and is slowly improving though not back to baseline. She just recently was able to return to school half days. The issue of macrophagic myofasciitis has been raised given her symptoms and persistent white ring on her arm at the site of the hep B vaccine.
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Dermatitis atopic, Influenza like illness
Clinical narrative: Flu like symptoms starting on 02/07/2019 A topic Dermatitis first noticed after flu symptoms subsided.
Sex: M
Vaccine: FLU4
Symptoms: Abnormal behaviour, Affect lability, Autism spectrum disorder, Dark circles under eyes, Decreased eye contact
Clinical narrative: Within the next day he was Very lethargic, went from happy smiling baby to blank. Within a month after he  no longer had eye contact. In his own world. Didn?t respond to his name. No longer waved or clapped his hands. 4 months later banging his hands and blanket into his head. Black circle bags under his eyes. Swollen like eye & seemed sick. Started showing signs of autism.
Sex: M
Vaccine: FLU4
Symptoms: Eye swelling, Lethargy, Malaise, Unresponsive to stimuli
Clinical narrative: Within the next day he was Very lethargic, went from happy smiling baby to blank. Within a month after he  no longer had eye contact. In his own world. Didn?t respond to his name. No longer waved or clapped his hands. 4 months later banging his hands and blanket into his head. Black circle bags under his eyes. Swollen like eye & seemed sick. Started showing signs of autism.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Malaise
Clinical narrative: SORENESS AT INJECTION SITE, FATIGUE AND MALAISE
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Pruritus, Skin erosion
Clinical narrative: On 110519 (5 days post-vaccination), the patient presented with complaints of redness from the upper left arm to the elbow and initial signs of skin blistering, itchiness and "feels raw". She denied shortness of breath, difficulty swallowing, fever, diaphoresis. She was treated with a prednisone taper and hydroxyzine pamoate. The reaction was presumed resolved as the patient did not present any further complaints.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Patellofemoral pain syndrome, Poor quality sleep
Clinical narrative: sore arm, prevent a good night sleep.  Took Tylenol the next day of shot chill knee caps (both) pain run down
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Developed Bell's Palsy (right-sided) within 3 weeks of receiving vaccine.  Symptoms resolved in 6-8 weeks. Patient then experienced an ipsilateral recurrence on the left-side.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Paraesthesia
Clinical narrative: Patient reports a persistent tingling sensation and slight pain at injection site still to this day (almost 1 year later). Patient has a visible mark on his left shoulder area that he reports is where he received the immunization. He notified his physician shortly after receiving the immunization, and his physician told him to not get the 2nd dose of Shingrix. He is awaiting an appointment with dermatologist to have the mark on his arm inspected again by a specialist.
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 15 year old patient was administered with PROQUAD; Information has been received from a registered nurse concerning to a 15 year old patient (gender not reported). No medical history nor concurrent conditions were reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 20-DEC-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Lot No. S017244, expiration date not reported but upon internal validation determined to be 01-DEC-2020), rHA (strength and route of administration not reported) for prophylaxis (product administered to patient of inappropriate age).
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Deafness, Herpes zoster, Loss of personal independence in daily activities
Clinical narrative: hearing loss; vision loss; herpes zoster; Information has been received from a lawyer regarding a case in litigation, concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not reported.   On 02-NOV-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) at a pharmacy, for routine health maintenance and for its intended purpose of prevention of shingles (herpes zoster) (dose, route of administration, anatomical location, lot number and expiration date were not reported).   In approximately April 2018 ("within approximately 5 months of vaccination"), the pt experienced severe outbreaks of shingles and vision and hearing loss, requiring extensive medical treatment, which significantly affected the pt's daily life. It was reported that the pt suffered sustained severe, serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury, due to physical limitations and seriousness of her condition. Moreover, he has suffered economic losses due to her inability to work and incurred damages, including medical expenses, the loss of accumulations and other economic and non-economic damages. These injuries continued by the time of this report and were considered to be caused by zoster vaccine live (ZOSTAVAX).   Upon internal review, hearing loss and vision loss were considered to be medically significant events. Moreover, the reported events were considered to be disabling.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Headache; chills; myalgia; This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2020, the patient received Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced headache, chills and myalgia. On an unknown date, the outcome of the headache, chills and myalgia were not recovered/not resolved.   It was unknown if the reporter considered the headache, chills and myalgia to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had headache, chills and myalgia. Ptient ask can take acetaminophen aspirin or ibuprofen as tratment becuse patient do not want to interfere with the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Influenza like illness
Clinical narrative: flu like symptoms for 3 days; Had to be in bed; This case was reported by a pharmacist and described the occurrence of influenza-like symptoms in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms and bedridden. On an unknown date, the outcome of the influenza-like symptoms and bedridden were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, after vaccination with 1st dose of shingrix, the patient experienced bad reaction to be in bed with flu like symptoms for 3 days. The patient asked, if there was any statistical studies that proved to have less side effects if wait till 6 months versus 2 months to get 2nd dose of Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Erythema, Extensive swelling of vaccinated limb, Headache, Injection site pain
Clinical narrative: pain /muscle pain all over my body; injection site is warm; fever / high fever /feverish; Injection site pain; Became sicck; Muscle pain all over the body; redness /my arm is red / injection site redness; swelling at injection site / swollen all the way down to my elbow; chills /shiveriing; slite headaches; This case was reported by a consumer and described the occurrence of extensive swelling of vaccinated limb in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th January 2020, the patient received Shingrix. On 16th January 2020, 1 days after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, chills, headache, erythema of extremities, fever, injection site pain, sickness and generalized muscle aches. On 17th January 2020, the patient experienced general body pain and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, chills, general body pain, fever, injection site pain, sickness and generalized muscle aches were unknown and the outcome of the headache, erythema of extremities and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, chills, headache, general body pain, erythema of extremities, injection site warmth, fever, injection site pain, sickness and generalized muscle aches to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On Thursday night at 9 pm, the patient experienced chills, headache, fever, shivering, pain ,redness and swelling at the injection site and muscle pain all over the body. On Friday 17th January 2020, the patient could not get out of bed because of fever, body pain and chills. The reporter stated that, till the time of reporting the patient had the injection site red and warmth. The patient stated that, the arm was swollen all the way down to the elbow and was feverish till the time of reporting. The patient had slight headache at the time of reporting. The patient asked, if this was ok or should worry.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site warmth, Malaise, Myalgia, Pain, Pyrexia
Clinical narrative: pain /muscle pain all over my body; injection site is warm; fever / high fever /feverish; Injection site pain; Became sicck; Muscle pain all over the body; redness /my arm is red / injection site redness; swelling at injection site / swollen all the way down to my elbow; chills /shiveriing; slite headaches; This case was reported by a consumer and described the occurrence of extensive swelling of vaccinated limb in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th January 2020, the patient received Shingrix. On 16th January 2020, 1 days after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, chills, headache, erythema of extremities, fever, injection site pain, sickness and generalized muscle aches. On 17th January 2020, the patient experienced general body pain and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, chills, general body pain, fever, injection site pain, sickness and generalized muscle aches were unknown and the outcome of the headache, erythema of extremities and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, chills, headache, general body pain, erythema of extremities, injection site warmth, fever, injection site pain, sickness and generalized muscle aches to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On Thursday night at 9 pm, the patient experienced chills, headache, fever, shivering, pain ,redness and swelling at the injection site and muscle pain all over the body. On Friday 17th January 2020, the patient could not get out of bed because of fever, body pain and chills. The reporter stated that, till the time of reporting the patient had the injection site red and warmth. The patient stated that, the arm was swollen all the way down to the elbow and was feverish till the time of reporting. The patient had slight headache at the time of reporting. The patient asked, if this was ok or should worry.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Myalgia
Clinical narrative: muscle pain; weakness; fatigue; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced muscle pain, weakness and fatigue. On an unknown date, the outcome of the muscle pain, weakness and fatigue were unknown.   It was unknown if the reporter considered the muscle pain, weakness and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experiencing common side effects muscle pain, weakness, fatigue.  The reporter asked how long should expect these symptoms.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Loss of consciousness
Clinical narrative: knocked him out; shingles; administered 2 doses of Shingrix 6 months apart; This case was reported by a consumer via call center representative and described the occurrence of loss of consciousness in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 252N2, expiry date 8th March 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose in 2019, experienced Injection site pain(refer case US2020011363)).   On 16th December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 16th December 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 17th December 2019, the patient experienced shingles. On an unknown date, the patient experienced loss of consciousness (serious criteria GSK medically significant). The patient was treated with antihistamine (Antihistamines). On an unknown date, the outcome of the loss of consciousness, shingles and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the loss of consciousness and shingles to be related to Shingrix.  Additional details were reported as follows: On 16th December 2019 ,patient received 2nd dose of shingrix vaccine and had shingles on next day. The patient went back to the pharmacy where the Shingles vaccine was administered and was prescribed antihistamines which knocked him out. The reporter did not consent to follow up. The case was considered as medication error without harm. This case has been linked with US2020011363, reported by same reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site swelling, Vaccine positive rechallenge
Clinical narrative: Swelling in the injection site; Redness in the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number X4TJ3, expiry date 12th March 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (For tolerance of 1st dose refer case US2020012202.).   On 18th January 2020, the patient received the 2nd dose of Shingrix. On 19th January 2020, 1 days after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and injection site erythema. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient recevied vaccine and on next day had redness and swelling in the injection site of approximately 3 to 4 inches. The reporter consented to follow up. For tolerance of 1st dose refer case US2020012202.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles; rash on her chest /down the arm; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 3R774, expiry date unknown) for prophylaxis.   Concurrent medical conditions included upper back pain. Concomitant products included paracetamol (Tylenol).   On 16th January 2020, the patient received the 1st dose of Shingrix. On 18th January 2020, 2 days after receiving Shingrix, the patient experienced shingles and rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The patient came to physician's office with pain in upper right part of her back. The thought it may have been from a work out. The physician told patient to take a Tylenol and she started to feel better. She asked HCP if she had the shingles vaccine. The patient was given Shingrix. The patient developed a rash on her chest and on 18th January 2020, called the doctor and emailed a picture of the rash. On 20th January 2020, the patient returned to the office and was diagnosed with shingles. The rash was down the arm and the right upper side of back, as per HCP it was classic shingles presentation and not an allergic reaction. The physician could not be sure if patient was already in a pre-clinical presentation of shingles due to the original pain the patient discussed. The patient was prescribed Valtrex. The reporter gave consent for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: broke out with blister after first; This case was reported by a other health professional via interactive digital media and described the occurrence of blister in a adult 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 blister. On an unknown date, the outcome of the blister was unknown.   It was unknown if the reporter considered the blister to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient experienced blisters after receiving Shingrix and asked if it was common.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Appendicitis perforated, Incomplete course of vaccination
Clinical narrative: Rupture of appendix; Hasn't yet received their second dose; This case was reported by a pharmacist via call center representative and described the occurrence of ruptured appendix in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced ruptured appendix (serious criteria hospitalization and GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the ruptured appendix and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the ruptured appendix to be related to Shingrix.  Additional case details were reported as follows: In 2018, the patient experienced a rupture of appendix. The patient spend 4 days in the hospital. Till the time of reporting the patient did not receive the 2nd dose of vaccine, which led to incomplete course of vaccination.  The batch number and expiration date were not available since the first dose of Shingrix was administered on a different facility. The pharmacist did not have date of hospitalization for the patient. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Arm pain; Joint pain (in all joints); This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and joint pain. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the pain in arm and joint pain were unknown.   It was unknown if the reporter considered the pain in arm and joint pain to be related to Shingrix.  Additional details were provided as follows: The reporting nurse was the concerned patient. The age at vaccination was not reported. The patient experienced arm pain and Joint pain (in all joints) after receiving Shingrix. The patient was not alarmed as she expected it, and received Advil to minimize the impact. The reporter agreed to follow up from GSK.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Vaccine positive rechallenge
Clinical narrative: rash on her lower back with a patch on the back of one shoulder...; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number GX25K, expiry date 19th November 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash pruritic (On 11th July 2019,received 1st dose, refer case US2020012971).   On 8th November 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 1st January 2020, 54 days after receiving Shingrix, the patient experienced itchy rash. The patient was treated with steroids nos (Steroids). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the itchy rash was not recovered/not resolved.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient get the second dose of Shingrix and developed a similar rash,mostly on her lower back with a patch on the back of one shoulder, a little below her waist, a tiny bead on her breasts and a tiny patch on each elbow. The reporte rsaid to physician that the rash and itching have not resolved.  The follow up consent was granted. The patient required emergencyc room visit.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Pain
Clinical narrative: extreme body ache; intense dizziness; This case was reported by a physician via sales rep and described the occurrence of general body pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th October 2019 10:00, the patient received the 1st dose of Shingrix. On 24th October 2019 14:00, 4 hrs after receiving Shingrix, the patient experienced general body pain and dizziness. On 25th October 2019, the outcome of the general body pain and dizziness were recovered/resolved.   It was unknown if the reporter considered the general body pain and dizziness to be related to Shingrix.  Additional details were provided as follows: The patient experienced extreme body ache and intense dizziness which disappeared the next day. The patient was likely to return for the 2nd dose but was less doubtful regarding adverse events with 2nd dose of Shingrix.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash vesicular
Clinical narrative: Developed small shingles like outbreak; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included rituximab (Rituxan).   In March 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, less than 9 months after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix and experienced small shingles like outbreak on leg and at the time of reporting had small outbreak on back. The patient had rheumatoid arthritis as a current medical condition, because of that, the patient delayed for 2nd dose of Shingrix. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Developed small shingles like outbreak; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included rituximab (Rituxan).   In March 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, less than 9 months after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix and experienced small shingles like outbreak on leg and at the time of reporting had small outbreak on back. The patient had rheumatoid arthritis as a current medical condition, because of that, the patient delayed for 2nd dose of Shingrix. The reporter did not consent to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema
Clinical narrative: Swelling in the injection site.; Redness in the injection site.; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, between 1 and 3 months after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to Shingrix.  Additional details were provided as follows: Post vaccination the patient experienced redness and swelling in the injection site of approximately 3 to 4 inches. The reporter consented to follow up.  The reporter did not provide lot number and expiration date of the first dose of Shingrix. The case is linked to case US2020AMR012680 reported for the same patient (2nd dose).
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: shivering/CHILLS; headache; fever; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose and did not experienced any side effects).   On 21st January 2020, the patient received the 2nd dose of Shingrix. On 21st January 2020, less than a day after receiving Shingrix, the patient experienced shivering, headache and fever. The patient was treated with acetylsalicylic acid (Aspirin). On 22nd January 2020, the outcome of the shivering, headache and fever were recovered/resolved.   It was unknown if the reporter considered the shivering, headache and fever to be related to Shingrix.  Additional details were provided as follows: After receiving 2nd dose, the patient had shivering, chills, headache and fever. The patient took aspirin and this morning he was fine and all of the effects had resolved. The reporter gave consent for follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema, Injection site inflammation, Injection site mass
Clinical narrative: redness; inflammation; bumps/The site was bumpy underneath the skin; scar at the injection site; red streaks; tenderness; injection site very dark; Injection site bruising; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 9DE73, expiry date 6th December 2021) for prophylaxis.   On 9th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site erythema, injection site inflammation, injection site mass, injection site scar, injection site streaking, injection site pain, injection site discoloration and injection site bruising. On an unknown date, the outcome of the injection site erythema, injection site inflammation, injection site mass, injection site streaking, injection site pain and injection site bruising were recovered/resolved and the outcome of the injection site scar was not recovered/not resolved and the outcome of the injection site discoloration was unknown.   It was unknown if the reporter considered the injection site erythema, injection site inflammation, injection site mass, injection site scar, injection site streaking, injection site pain, injection site discoloration and injection site bruising to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and experienced a red, inflamed area about 2 by 3 inches at the injection site. The red streaks appearing like tentacles in several places. The site was bumpy underneath the skin and was so tender, she was unable to lie on it. When the patient went to the pharmacy a couple of days ago from the day of reporting, there was a nickel size area at the injection site that was very dark, almost like a bruise but under the skin like a scar.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site scar, Injection site streaking
Clinical narrative: redness; inflammation; bumps/The site was bumpy underneath the skin; scar at the injection site; red streaks; tenderness; injection site very dark; Injection site bruising; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 9DE73, expiry date 6th December 2021) for prophylaxis.   On 9th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site erythema, injection site inflammation, injection site mass, injection site scar, injection site streaking, injection site pain, injection site discoloration and injection site bruising. On an unknown date, the outcome of the injection site erythema, injection site inflammation, injection site mass, injection site streaking, injection site pain and injection site bruising were recovered/resolved and the outcome of the injection site scar was not recovered/not resolved and the outcome of the injection site discoloration was unknown.   It was unknown if the reporter considered the injection site erythema, injection site inflammation, injection site mass, injection site scar, injection site streaking, injection site pain, injection site discoloration and injection site bruising to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and experienced a red, inflamed area about 2 by 3 inches at the injection site. The red streaks appearing like tentacles in several places. The site was bumpy underneath the skin and was so tender, she was unable to lie on it. When the patient went to the pharmacy a couple of days ago from the day of reporting, there was a nickel size area at the injection site that was very dark, almost like a bruise but under the skin like a scar.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: itchy rash on her upper back; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number NE3TG, expiry date 10th August 2021) for prophylaxis.   On 11th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 45 days after receiving Shingrix, the patient experienced itchy rash. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the itchy rash was recovered/resolved.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, about 1.5 months later, the patient developed an itchy rash on her upper back. The rash lasted for about 1 month and she finally saw her health care professional and got a steroid injection and oral steroids. This case is linked to the case US2020AMR014194, reported by the same reporter.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Hyperaesthesia, Hypoaesthesia, Injection site hypoaesthesia, Injection site paraesthesia, Musculoskeletal stiffness
Clinical narrative: stiffness; soreness; numbness; tingling; his skin feels sensitive to touch in both arms; This case was reported by a pharmacist via call center representative and described the occurrence of stiffness in a 66-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number GA5Z5, expiry date 3rd May 2020) for prophylaxis.   On 12th December 2019, the patient received Boostrix. On an unknown date, less than 2 months after receiving Boostrix, the patient experienced stiffness, pain, numbness, tingling and touch sensitivity increased. On an unknown date, the outcome of the stiffness and pain were unknown and the outcome of the numbness, tingling and touch sensitivity increased were not recovered/not resolved.   It was unknown if the reporter considered the stiffness, pain, numbness, tingling and touch sensitivity increased to be related to Boostrix.  Additional details were provided as follows: After receiving Boostrix, the patient experienced the patient experienced stiffness and soreness.  The patient was also had numbness and tingling below the injection site which he also was experiencing in his left arm.  The patient's skin felt sensitive to touch in both arms. The reporter was consented to follow up.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Paraesthesia
Clinical narrative: stiffness; soreness; numbness; tingling; his skin feels sensitive to touch in both arms; This case was reported by a pharmacist via call center representative and described the occurrence of stiffness in a 66-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number GA5Z5, expiry date 3rd May 2020) for prophylaxis.   On 12th December 2019, the patient received Boostrix. On an unknown date, less than 2 months after receiving Boostrix, the patient experienced stiffness, pain, numbness, tingling and touch sensitivity increased. On an unknown date, the outcome of the stiffness and pain were unknown and the outcome of the numbness, tingling and touch sensitivity increased were not recovered/not resolved.   It was unknown if the reporter considered the stiffness, pain, numbness, tingling and touch sensitivity increased to be related to Boostrix.  Additional details were provided as follows: After receiving Boostrix, the patient experienced the patient experienced stiffness and soreness.  The patient was also had numbness and tingling below the injection site which he also was experiencing in his left arm.  The patient's skin felt sensitive to touch in both arms. The reporter was consented to follow up.
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Musculoskeletal pain, Myalgia
Clinical narrative: swelling at both injection sites; arm pain; redness; shoulder pain; joint pain; muscle pain; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   The patient's past medical history included surgical procedure (surgically installed in her right clavicle). Concurrent medical conditions included cancer (recent cancer, in remission prior to Shingrix), chemotherapy and radiotherapy.   In August 2019, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than 6 months after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced injection site swelling, pain in arm, injection site erythema, shoulder pain, joint pain and muscle pain. On an unknown date, the outcome of the injection site swelling was unknown and the outcome of the pain in arm and injection site erythema were recovered/resolved and the outcome of the shoulder pain, joint pain and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, pain in arm, injection site erythema, shoulder pain, joint pain and muscle pain to be related to Shingrix. It was unknown if the reporter considered the injection site swelling, pain in arm, injection site erythema, joint pain and muscle pain to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination not provided but it could be 75 or 76 years. In late August, 2019, the patient had dose one of Shingrix and an unspecified influenza vaccine on the same day. The flu shot was in the left arm, and Shingrix in the right arm.  The patient reports injection site pain at both the flu injection site and Shingrix site. She did experienced some swelling at both injection sites. The arm pain and redness resolved at both sites. The patient also reports shoulder pain which continues and has not resolved. It was in the right shoulder.  The patient had just been treated with radiation and chemotherapy prior to both injections. She had a port surgically installed in her right clavicle.  The patient was experienced the joint pain, muscle pain, and right shoulder pain. The follow up consent was not granted.
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Pain in extremity
Clinical narrative: swelling at both injection sites; arm pain; redness; shoulder pain; joint pain; muscle pain; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   The patient's past medical history included surgical procedure (surgically installed in her right clavicle). Concurrent medical conditions included cancer (recent cancer, in remission prior to Shingrix), chemotherapy and radiotherapy.   In August 2019, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than 6 months after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced injection site swelling, pain in arm, injection site erythema, shoulder pain, joint pain and muscle pain. On an unknown date, the outcome of the injection site swelling was unknown and the outcome of the pain in arm and injection site erythema were recovered/resolved and the outcome of the shoulder pain, joint pain and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, pain in arm, injection site erythema, shoulder pain, joint pain and muscle pain to be related to Shingrix. It was unknown if the reporter considered the injection site swelling, pain in arm, injection site erythema, joint pain and muscle pain to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination not provided but it could be 75 or 76 years. In late August, 2019, the patient had dose one of Shingrix and an unspecified influenza vaccine on the same day. The flu shot was in the left arm, and Shingrix in the right arm.  The patient reports injection site pain at both the flu injection site and Shingrix site. She did experienced some swelling at both injection sites. The arm pain and redness resolved at both sites. The patient also reports shoulder pain which continues and has not resolved. It was in the right shoulder.  The patient had just been treated with radiation and chemotherapy prior to both injections. She had a port surgically installed in her right clavicle.  The patient was experienced the joint pain, muscle pain, and right shoulder pain. The follow up consent was not granted.