chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: still red; still / swollen; soreness is finally getting better / a week still sore; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included WHOOPING COUGH VACCINE for prophylaxis.   On 13th November 2020, the patient received Shingles vaccine and WHOOPING COUGH VACCINE. In November 2020, less than a week after receiving Shingles vaccine, the patient experienced erythema of extremities, swelling arm and pain in arm. On an unknown date, the outcome of the erythema of extremities, swelling arm and pain in arm were recovering/resolving.   It was unknown if the reporter considered the erythema of extremities, swelling arm and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The patient received whooping cough and shingles and they both were still red swollen and the soreness was finally getting better. boo boos on both arms. The patient same here but it's been a week still sore at the time of report.
Sex: U
Vaccine: MENB
Symptoms: Gait inability
Clinical narrative: was crippled due to an adverse reaction; This case was reported by a consumer via interactive digital media and described the occurrence of gait inability in a child patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced gait inability. On an unknown date, the outcome of the gait inability was unknown.   It was unknown if the reporter considered the gait inability to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient got the vaccine and it was not mandatory where they lived. The patient was crippled due to an adverse reaction.
Sex: M
Vaccine: MEN
Symptoms: Brain injury, Meningitis bacterial, Paralysis, Staphylococcal infection, Vaccination failure
Clinical narrative: brain surgery; ended up paralyzed from the mouth down; contracted staff infection from hospital during his stay; Hospitalisation; DID NOT PROTECT HIM FROM BACTERIAL MENINGITIS,; DID NOT PROTECT HIM FROM BACTERIAL MENINGITIS,; This case was reported by a consumer via interactive digital media and described the occurrence of sus[ected vaccination failure in a 16-year-old male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), bacterial meningitis (serious criteria GSK medically significant), brain injury (serious criteria hospitalization and GSK medically significant), paralysis (serious criteria GSK medically significant), staphylococcal infection (serious criteria GSK medically significant) and hospitalization. On an unknown date, the outcome of the vaccination failure, bacterial meningitis, brain injury, paralysis, staphylococcal infection and hospitalization were unknown.   The reporter considered the vaccination failure, bacterial meningitis and paralysis to be related to Meningococcal B vaccine. It was unknown if the reporter considered the brain injury, staphylococcal infection and hospitalization to be related to Meningococcal B vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The patient received meningococcal b vaccine and experienced bacterial meningitis. The reporter stated not to believe on vaccine his son got meningitis it did not protected his son. The patient went in to brain surgery on his sixteenth birthday and ended up paralyzed from the mouth down, also contracted staphylococcus infection from hospital during his stay.  This case was considered as vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were not provided. The information regarding consent to follow up was not reported. This case was linked with case US2020AMR232425, US2020AMR232424, US2020AMR232426 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR232425:same reporter US-GLAXOSMITHKLINE-US2020AMR232424:same reporter US-GLAXOSMITHKLINE-US2020AMR232426:same reporter
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: GOT GUILAIN-BARRE SYNDROME FROM THE FLU VACCINE; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a 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 guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   The reporter considered the guillain barre syndrome to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient got guillain barre syndrome from the flu vaccine. This case has been linked with US2020AMR232535 and US2020AMR232534 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR232534:same reporter US-GLAXOSMITHKLINE-US2020AMR232535:same reporter
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Patient got Guillain-Barre syndrome from Flu vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a 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 guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   The reporter considered the guillain barre syndrome to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient got guillain barre syndrome from the flu vaccine. This case has been linked with US2020AMR232526 and US2020AMR232535, (same reporter and same events).; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR232526:same reporter US-GLAXOSMITHKLINE-US2020AMR232535:same reporter
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: GOT GUILLAIN-BARRE SYNDROME FROM THE FLU VACCINE; This case was reported by a consumer via interactive digital media and described the occurrence of Guillain Barre Syndrome in a 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 guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient got Guilain-Barre-Syndrome from the flu vaccine. This case has been linked with US2020AMR232526 and US2020AMR232534 (same reporter and same events).; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR232526:same reporter US-GLAXOSMITHKLINE-US2020AMR232534:same reporter
Age: 51.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Body temperature increased, Chills, Pain
Clinical narrative: Caller reports having 102 temperature, chills, body aches.
Sex: M
Vaccine: VARZOS
Symptoms: Exposure via eye contact, Eye irritation, Occupational exposure to product, Syringe issue
Clinical narrative: eye which has been irritated/burning eye; got into his left eye; got into his left eye; This case was reported by a pharmacist via call center representative and described the occurrence of eye irritation in a male pharmacist who was preparing Herpes zoster (Shingrix) to administer the patient for prophylaxis.   On 13th November 2020, the patient received Shingrix. On 13th November 2020, less than a day after receiving Shingrix, the patient experienced eye irritation, exposure via eye contact and accidental occupational exposure to product. The patient was treated with ophthalmologicals (nos) (Eye Drops (Ingredients Unknown)). On an unknown date, the outcome of the eye irritation, exposure via eye contact and accidental occupational exposure to product were unknown.   It was unknown if the reporter considered the eye irritation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist was mixing a Shingrix shot and the vaccine sprayed out of the base of the needle that came loose from the syringe and it got into left eye which had been irritated and burns occasionally, which led to exposure via eye contact and accidental occupational exposure to product. It was not severe but thought would be healed till the time of reporting. The patient had been using Eye drops to relieve the burning.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Feeling cold, Headache, Myalgia
Clinical narrative: Fever of 99 degrees, severe chills and shaking, extreme fatigue, headache, some muscle aches especially at base of neck; lasted until 6a next day and still feel mild cold but not severe chills as did.  Took 2 Tylenol at 5:10p and 8:40p on Nov 29 and at 3:10a Nov 30, which has not totally worn off so unsure if symptoms will recur or still exist.  It is less than 24 hours since injection.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Tremor
Clinical narrative: Fever of 99 degrees, severe chills and shaking, extreme fatigue, headache, some muscle aches especially at base of neck; lasted until 6a next day and still feel mild cold but not severe chills as did.  Took 2 Tylenol at 5:10p and 8:40p on Nov 29 and at 3:10a Nov 30, which has not totally worn off so unsure if symptoms will recur or still exist.  It is less than 24 hours since injection.
Sex: F
Vaccine: FLU4
Symptoms: Chills, Cough, Dyspnoea, Headache, Pain
Clinical narrative: Heart palpatations; Coughing; Swollen tongue; Achiness; Headache; Shakiness; Chills; Inability to breathe; This case was reported by a consumer via call center representative and described the occurrence of palpitation in a female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th November 2020, the patient received FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On 11th November 2020, less than a day after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced palpitation, cough, swollen tongue, pain, headache, tremor, chills and difficulty breathing. On 16th November 2020, the outcome of the palpitation, cough, swollen tongue, pain, headache, tremor, chills and difficulty breathing were recovered/resolved.   The reporter considered the palpitation, cough, swollen tongue, pain, headache, tremor, chills and difficulty breathing to be related to FluLaval Tetra 2020-2021 season. It was unknown if the reporter considered the palpitation, cough, swollen tongue, pain, headache, tremor, chills and difficulty breathing to be related to Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported The patient received vaccine of Flulaval and within a few hours she began to experience heart palpatations, coughing, a swollen tongue, achiness, headache, shakiness, chills, and an inability to breathe. The patient reported that these symptoms have subsided. The reporter did not consent to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Palpitations, Swollen tongue, Tremor
Clinical narrative: Heart palpatations; Coughing; Swollen tongue; Achiness; Headache; Shakiness; Chills; Inability to breathe; This case was reported by a consumer via call center representative and described the occurrence of palpitation in a female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th November 2020, the patient received FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On 11th November 2020, less than a day after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced palpitation, cough, swollen tongue, pain, headache, tremor, chills and difficulty breathing. On 16th November 2020, the outcome of the palpitation, cough, swollen tongue, pain, headache, tremor, chills and difficulty breathing were recovered/resolved.   The reporter considered the palpitation, cough, swollen tongue, pain, headache, tremor, chills and difficulty breathing to be related to FluLaval Tetra 2020-2021 season. It was unknown if the reporter considered the palpitation, cough, swollen tongue, pain, headache, tremor, chills and difficulty breathing to be related to Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported The patient received vaccine of Flulaval and within a few hours she began to experience heart palpatations, coughing, a swollen tongue, achiness, headache, shakiness, chills, and an inability to breathe. The patient reported that these symptoms have subsided. The reporter did not consent to follow up.
Age: 23.0
Sex: M
Vaccine: ANTH, JEV1
Symptoms: Ataxia, Autonomic nervous system imbalance, CSF culture negative, CSF glucose decreased, CSF red blood cell count positive
Clinical narrative: 24 year old otherwise healthy patient with numbness to bilateral legs w/ radiation up to thighs/buttocks w/ progression including arms up to shoulders and now including the face and tongue. Symptoms started on 31 Oct 2020. Numbness/tingling started in the R hand approx. on 31 Oct then the L hand the same day w/ subsequent involvement of the bilateral lower extremities. Physical exam in the ED on 04Nov notable for R eyelid pstosis, decreased patellar and Achilles reflexes but otherwise nml neuro exam as documented in record. Recent immunizations including JEV on 04 Sep 2020 and Anthrax, JEV, and Rabies on 07Aug20. He uderwent IVIG therapy for GBS. He has made significant recovery from dysmetria and ataxia. He also experienced postural tachycardia, most likely secondary to dysautonomia from GBS. Current HR in the normal range with ACEI and beta blockers. He is currently in physical therapy for follow up exercises for motor weakness.
Age: 23.0
Sex: M
Vaccine: ANTH, JEV1
Symptoms: CSF white blood cell count negative, Computerised tomogram head normal, Dysmetria, Eyelid ptosis, Full blood count normal
Clinical narrative: 24 year old otherwise healthy patient with numbness to bilateral legs w/ radiation up to thighs/buttocks w/ progression including arms up to shoulders and now including the face and tongue. Symptoms started on 31 Oct 2020. Numbness/tingling started in the R hand approx. on 31 Oct then the L hand the same day w/ subsequent involvement of the bilateral lower extremities. Physical exam in the ED on 04Nov notable for R eyelid pstosis, decreased patellar and Achilles reflexes but otherwise nml neuro exam as documented in record. Recent immunizations including JEV on 04 Sep 2020 and Anthrax, JEV, and Rabies on 07Aug20. He uderwent IVIG therapy for GBS. He has made significant recovery from dysmetria and ataxia. He also experienced postural tachycardia, most likely secondary to dysautonomia from GBS. Current HR in the normal range with ACEI and beta blockers. He is currently in physical therapy for follow up exercises for motor weakness.
Age: 23.0
Sex: M
Vaccine: ANTH, JEV1
Symptoms: Gram stain, Guillain-Barre syndrome, Herpes simplex test negative, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: 24 year old otherwise healthy patient with numbness to bilateral legs w/ radiation up to thighs/buttocks w/ progression including arms up to shoulders and now including the face and tongue. Symptoms started on 31 Oct 2020. Numbness/tingling started in the R hand approx. on 31 Oct then the L hand the same day w/ subsequent involvement of the bilateral lower extremities. Physical exam in the ED on 04Nov notable for R eyelid pstosis, decreased patellar and Achilles reflexes but otherwise nml neuro exam as documented in record. Recent immunizations including JEV on 04 Sep 2020 and Anthrax, JEV, and Rabies on 07Aug20. He uderwent IVIG therapy for GBS. He has made significant recovery from dysmetria and ataxia. He also experienced postural tachycardia, most likely secondary to dysautonomia from GBS. Current HR in the normal range with ACEI and beta blockers. He is currently in physical therapy for follow up exercises for motor weakness.
Age: 23.0
Sex: M
Vaccine: ANTH, JEV1
Symptoms: Hyporeflexia, Immunoglobulin therapy, Injection site hypoaesthesia, Metabolic function test normal, Muscular weakness
Clinical narrative: 24 year old otherwise healthy patient with numbness to bilateral legs w/ radiation up to thighs/buttocks w/ progression including arms up to shoulders and now including the face and tongue. Symptoms started on 31 Oct 2020. Numbness/tingling started in the R hand approx. on 31 Oct then the L hand the same day w/ subsequent involvement of the bilateral lower extremities. Physical exam in the ED on 04Nov notable for R eyelid pstosis, decreased patellar and Achilles reflexes but otherwise nml neuro exam as documented in record. Recent immunizations including JEV on 04 Sep 2020 and Anthrax, JEV, and Rabies on 07Aug20. He uderwent IVIG therapy for GBS. He has made significant recovery from dysmetria and ataxia. He also experienced postural tachycardia, most likely secondary to dysautonomia from GBS. Current HR in the normal range with ACEI and beta blockers. He is currently in physical therapy for follow up exercises for motor weakness.
Age: 23.0
Sex: M
Vaccine: ANTH, JEV1
Symptoms: Neurological examination abnormal, Paraesthesia, Postural orthostatic tachycardia syndrome, SARS-CoV-2 test negative
Clinical narrative: 24 year old otherwise healthy patient with numbness to bilateral legs w/ radiation up to thighs/buttocks w/ progression including arms up to shoulders and now including the face and tongue. Symptoms started on 31 Oct 2020. Numbness/tingling started in the R hand approx. on 31 Oct then the L hand the same day w/ subsequent involvement of the bilateral lower extremities. Physical exam in the ED on 04Nov notable for R eyelid pstosis, decreased patellar and Achilles reflexes but otherwise nml neuro exam as documented in record. Recent immunizations including JEV on 04 Sep 2020 and Anthrax, JEV, and Rabies on 07Aug20. He uderwent IVIG therapy for GBS. He has made significant recovery from dysmetria and ataxia. He also experienced postural tachycardia, most likely secondary to dysautonomia from GBS. Current HR in the normal range with ACEI and beta blockers. He is currently in physical therapy for follow up exercises for motor weakness.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: 2 small wheals at the site of injection; This case was reported by a physician via call center representative and described the occurrence of injection site wheal in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number C7EX2, expiry date 26th January 2022) for prophylaxis.   On 26th August 2020, the patient received the 1st dose of Shingrix. On 27th August 2020, 1 days after receiving Shingrix, the patient experienced injection site wheal. On an unknown date, the outcome of the injection site wheal was recovered/resolved.   It was unknown if the reporter considered the injection site wheal to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Shingrix vaccine in her left arm and the next day experienced around 2 small wheals at the site of injection which resolved in a few days.  The reporter consented to follow up.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Caller reports fatigue as adverse  event to her second Shingles vaccine. She was back to normal after three days.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash papular, SARS-CoV-2 antibody test negative
Clinical narrative: Raised rashes on their feet and legs; This case was reported by a consumer via call center representative and described the occurrence of raised rash in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd August 2020, the patient received the 1st dose of Shingrix (intramuscular). In September 2020, 2 weeks after receiving Shingrix, the patient experienced raised rash. On an unknown date, the outcome of the raised rash was recovered/resolved.   It was unknown if the reporter considered the raised rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself. The patient received Shingrix in the right arm and about two weeks afterwards developed raised rashes on feet and some areas of their legs.   It would fade then come back and resolved after about four weeks.  The doctor could not say it was related to the Shingrix and given Covid tests but they were negative. The reporter consented to follow up. This case linked with US2020226576, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020226576:Same reporter
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular, SARS-CoV-2 antibody test negative
Clinical narrative: Raised rashes on their feet and legs; This case was reported by a consumer via call center representative and described the occurrence of raised rash in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd August 2020, the patient received the 1st dose of Shingrix. In September 2020, 2 weeks after receiving Shingrix, the patient experienced raised rash. On an unknown date, the outcome of the raised rash was unknown.   It was unknown if the reporter considered the raised rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patien's husband. The patient received Shingrix in the unknown arm and about two weeks afterwards developed raised rashes on feet and some areas of their legs.   It would fade then come back and resolved after about four weeks.  The doctor could not say it was related to the Shingrix and given COVID tests but they were negative. The reporter consented to follow up. This case linked with US2020226568, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020226568:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache
Clinical narrative: headache; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (received 1st dose on unknown date, refer case US2020AMR229311). Concurrent medical conditions included shingles.   In November 2020, the patient received the 2nd dose of Shingrix. In November 2020, 1 day after receiving Shingrix, the patient experienced headache and upset stomach. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache and upset stomach were recovering/resolving.   It was unknown if the reporter considered the headache and upset stomach to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix a week ago and had headache and an upset stomach. The patient starting to feel better. The reporter did not consent to follow up. The reporter refused to provide any demographics, declined any additional information for these adverse events for this case. This case linked with US2020AMR229312, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR229312:Husband's case US-GLAXOSMITHKLINE-US2020AMR229311:same reporter
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Illness, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Feeling "really sick"; Fever; Headache; Achiness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in August 2020, refer case US2020AMR229347).   On 14th November 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 15th November 2020, 1 days after receiving Shingrix, the patient experienced pain in arm, sickness, fever, headache and pain. Rechallenge with Shingrix was positive. On 16th November 2020, the outcome of the pain in arm, sickness, fever, headache and pain were not recovered/not resolved.   The reporter considered the pain in arm, sickness, fever, headache and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced sore arm, feeling sick, fever, headache and achiness.   No lot number and date were known. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR229347:same reporter
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: Sore arm; Feeling "really sick"; Fever; Headache; Achiness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in August 2020, refer case US2020AMR229347).   On 14th November 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 15th November 2020, 1 days after receiving Shingrix, the patient experienced pain in arm, sickness, fever, headache and pain. Rechallenge with Shingrix was positive. On 16th November 2020, the outcome of the pain in arm, sickness, fever, headache and pain were not recovered/not resolved.   The reporter considered the pain in arm, sickness, fever, headache and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced sore arm, feeling sick, fever, headache and achiness.   No lot number and date were known. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR229347:same reporter
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye contusion, Influenza like illness
Clinical narrative: Bruising under the eye / Left eye; Flu like symptoms; This case was reported by a physician via sales rep and described the occurrence of eye contusion in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number 3L3PR, expiry date 11th December 2021) for prophylaxis.   On 14th November 2020, the patient received Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced eye contusion and influenza-like symptoms. On an unknown date, the outcome of the eye contusion and influenza-like symptoms were unknown.   It was unknown if the reporter considered the eye contusion and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number of Shingrix was updated from 303PR to 3L3PR, as per sales data sheet. The patient Flu like symptoms and bruising under the left eye.  No other information about the patient of vaccine available not provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020226582:same reporter
Age: 66.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Arthralgia, Fatigue, Gait inability, Influenza like illness, Insomnia
Clinical narrative: tiredness; cramp like pain from between the right hip and the right knee; flu-like symptoms; muscle / pain all over the body / right leg muscle started to hurt / pain had increased; joint pain all over the body; difficulty sleeping; he cannot walk and cannot weight bear on the right leg; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 12th November 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On 12th November 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced influenza-like symptoms, muscle pain, generalized joint pain and difficulty sleeping. On 14th November 2020, the patient experienced tiredness and muscle cramp. In November 2020, the patient experienced mobility decreased. The patient was treated with paracetamol (Tylenol), naproxen (Aleve) and non-drug therapy (Warm Compress). On an unknown date, the outcome of the influenza-like symptoms, generalized joint pain, difficulty sleeping, tiredness, muscle cramp and mobility decreased were unknown and the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, muscle pain, generalized joint pain, difficulty sleeping, tiredness, muscle cramp and mobility decreased to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: This case reported by patient himself. The patient received shingrix in the right arm and a flu vaccine (name-unknown) in the left arm. On the same night of vaccination the patient had flu-like symptoms, mostly muscle and joint pain all over the body and the patient took Tylenol. The patient had difficulty sleeping and then on 13th November 2020, he did sleep well. The patient had some tiredness, but his right leg muscle started to hurt, cramp like pain from between the right hip and the right knee. The patient contacted the health care professional and told him to take Aleve and apply ice alternating with warm compressor. The patient states the pain had increased that he could not walk and weight bear on the right leg. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Mobility decreased, Muscle spasms, Myalgia, Weight bearing difficulty
Clinical narrative: tiredness; cramp like pain from between the right hip and the right knee; flu-like symptoms; muscle / pain all over the body / right leg muscle started to hurt / pain had increased; joint pain all over the body; difficulty sleeping; he cannot walk and cannot weight bear on the right leg; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 12th November 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On 12th November 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced influenza-like symptoms, muscle pain, generalized joint pain and difficulty sleeping. On 14th November 2020, the patient experienced tiredness and muscle cramp. In November 2020, the patient experienced mobility decreased. The patient was treated with paracetamol (Tylenol), naproxen (Aleve) and non-drug therapy (Warm Compress). On an unknown date, the outcome of the influenza-like symptoms, generalized joint pain, difficulty sleeping, tiredness, muscle cramp and mobility decreased were unknown and the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, muscle pain, generalized joint pain, difficulty sleeping, tiredness, muscle cramp and mobility decreased to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: This case reported by patient himself. The patient received shingrix in the right arm and a flu vaccine (name-unknown) in the left arm. On the same night of vaccination the patient had flu-like symptoms, mostly muscle and joint pain all over the body and the patient took Tylenol. The patient had difficulty sleeping and then on 13th November 2020, he did sleep well. The patient had some tiredness, but his right leg muscle started to hurt, cramp like pain from between the right hip and the right knee. The patient contacted the health care professional and told him to take Aleve and apply ice alternating with warm compressor. The patient states the pain had increased that he could not walk and weight bear on the right leg. The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash vesicular
Clinical narrative: suspected shingles; blistered rash on her face; painful, blistered rash on her face; This case was reported by a physician via call center representative and described the occurrence of shingles in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced shingles, blistery rash and painful rash. On an unknown date, the outcome of the shingles, blistery rash and painful rash were unknown.   It was unknown if the reporter considered the shingles, blistery rash and painful rash to be related to Shingrix.  Additional details were provided as follows: The patient had painful, blistered rash on her face. When asked if HCP believes that the rash was shingles. It sounds that way based on her description, but waiting for pictures (Coded as suspected shingles). At the time of reporting, no vaccine details (lot, expiry date) nor event details (timing of rash). The reporter consented to follow up.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: fever of 101.6; Fatigue; Headache; Sore Arm of injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type i diabetes mellitus.   On 12th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 12th November 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, fatigue and headache. On 13th November 2020, the patient experienced fever. On 14th November 2020, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site pain and headache were unknown and the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever, fatigue and headache to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patient experienced sore arm at injection site. On 13th November 2020, 1 days after vaccination, the patient had a fever of 101.6 degree F. On 14th November 2020, the patient's temperature was normal. The patient continued to feel fatigue. All information was not available. The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles; Rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number JP427, expiry date 15th May 2022) for prophylaxis.   Previously administered products included Zostavax (received Zostavax years ago). Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season).   On 26th October 2020, the patient received the 1st dose of Shingrix. On 12th November 2020, 17 days after receiving Shingrix, the patient experienced shingles and rash. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles and rash were recovered/resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional information was provided as follows: On 26th October 2020, the patient received 1st dose of Shingrix. On 12th November 2020, the patient experienced rash on the upper part of left arm, which was diagnosed as shingles by the patient's dermatologist. On 8th September 2020, the patient had received a flu shot. The patient had been taking Valacyclovir daily. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Hyperhidrosis, Injection site erythema, Pain
Clinical narrative: fever; sweats; chills; aches and pains; weak; injection site redness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 5J7FE, expiry date 19th June 2022) for prophylaxis.   On 13th November 2020, the patient received the 2nd dose of Shingrix. On 13th November 2020, less than a day after receiving Shingrix, the patient experienced fever, sweating, chills, pain, weakness and injection site erythema. On 16th November 2020, the outcome of the fever, sweating, chills, pain and weakness were recovered/resolved. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the fever, sweating, chills, pain, weakness and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient experienced fever, sweats, chills, aches and pains, weak and injection site redness. The patient stated that all events resolved except for the injection site redness. The reporter did not consent to follow up. This case has been linked to US2020226619, US2020226621 cases; Sender's Comments:  US-GLAXOSMITHKLINE-US2020226621:same reporter (husband´s case) US-GLAXOSMITHKLINE-US2020226619:SAME PATIENT (2ND DOSE)
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; sweats; chills; aches and pains; weak; injection site redness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 5J7FE, expiry date 19th June 2022) for prophylaxis.   On 13th November 2020, the patient received the 2nd dose of Shingrix. On 13th November 2020, less than a day after receiving Shingrix, the patient experienced fever, sweating, chills, pain, weakness and injection site erythema. On 16th November 2020, the outcome of the fever, sweating, chills, pain and weakness were recovered/resolved. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the fever, sweating, chills, pain, weakness and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient experienced fever, sweats, chills, aches and pains, weak and injection site redness. The patient stated that all events resolved except for the injection site redness. The reporter did not consent to follow up. This case has been linked to US2020226619, US2020226621 cases; Sender's Comments:  US-GLAXOSMITHKLINE-US2020226621:same reporter (husband´s case) US-GLAXOSMITHKLINE-US2020226619:SAME PATIENT (2ND DOSE)
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: fever; sweats; chills; aches and pains; weakness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a day after receiving Shingrix, the patient experienced fever, sweating, chills, pain and weakness. On an unknown date, the outcome of the fever, sweating, chills, pain and weakness were recovered/resolved.   It was unknown if the reporter considered the fever, sweating, chills, pain and weakness to be related to Shingrix.  Additional details were provided as follows: The patient developed fever, sweats, chills, aches and pains, and weakness.  The patient states that these symptoms resolved after 2.5 days.  The patient did not have additional information for this case. The reporter did not consent to follow-up. For the tolerance of 2nd dose of Shingrix, refer linked case US2020226615. This case has been linked to US2020226621, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020226621:same reporter (husband´s case) US-GLAXOSMITHKLINE-US2020226615:SAME PATIENT (2ND DOSE)
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Fever; Sweats; Chills; Aches and pains; Weakness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th November 2020, the patient received the 2nd dose of Shingrix. On 14th November 2020, less than a day after receiving Shingrix, the patient experienced fever, sweating, chills, pain and weakness. On 16th November 2020, the outcome of the fever, sweating, chills, pain and weakness were recovered/resolved.   It was unknown if the reporter considered the fever, sweating, chills, pain and weakness to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient's wife. The patient had fever, sweats, chills, aches and pains, and weakness that lasted for 2.5 days and had resolved. The reporter did not consent to follow up. No additional details for this case. This is 1 of the 3 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020226615:same reporter (reporter´s case) US-GLAXOSMITHKLINE-US2020226619:same reporter (reporter´s case)
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Headache, Inappropriate schedule of product administration, Myalgia, Pain
Clinical narrative: Body aches; Terrible headache; Pain started in her back; Pain / shin, legs and calves; Like deep sore muscle pain; 1st dose 9/21/2020 - 2nd dose 11/03/2020; This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 33TL7, expiry date 30th September 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 3rd November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd November 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On 4th November 2020, the patient experienced general body pain, headache, back pain, pain of lower extremities and muscle pain. On an unknown date, the outcome of the general body pain and headache were not recovered/not resolved and the outcome of the back pain, pain of lower extremities, muscle pain and drug dose administration interval too short were unknown.   The reporter considered the general body pain to be related to Shingrix. It was unknown if the reporter considered the headache, back pain, pain of lower extremities and muscle pain to be related to Shingrix.  Additional details were provided as follows: On 23rd September 2020, the patient received 1st dose of Shingrix. On 3rd November 2020, the patient received 2nd dose of Shingrix in the left deltoid, which led to shortening of vaccination schedule. The patient had body aches and a terrible headache. One day after the vaccination the pain started in her back, shin, legs and calves like deep sore muscle pain. It's worse when she first wakes up in the morning and she suffered periodically during the day. She likens it to a cold without symptoms such as runny nose. The patient stated it did seem to be getting better.