chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I got my second shingles shot which gave me the shingles / suspected vaccination failure; I got my second shingles shot which gave me the shingles; The pain breaking out is something you never forget; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the patient had it in his/her 20's) and chickenpox (the patient had it about 6 years ago from the date of reporting and before he/she never had the chickenpox).   On an unknown date, the patient received the 1st dose of Shingles vaccine. In September 2019, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine. The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine. It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient was currently in his/her late 60's. The patient stated he/she got 2nd shingles shot which gave him/her the shingles. The patient stated that the pain breaking out was something you never forget, and the physician swears that they did not give the live virus shot. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Uveitis
Clinical narrative: Activation of autoimmune phenomenon / Uveitis / similar to - sarcoidosis; This case was reported by a consumer and described the occurrence of uveitis in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced uveitis (serious criteria GSK medically significant). On an unknown date, the outcome of the uveitis was unknown.   It was unknown if the reporter considered the uveitis to be related to Shingrix.  Additional details were provided as follows: Additional details were provided as follows: The age at vaccination was not applicable for this report. There were case reported for people having activation of autoimmune phenomenon following Shingrix vaccination, including uveitis. This case was linked case US2021AMR102590 and US2021AMR092345 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR102590:Same reporter US-GLAXOSMITHKLINE-US2021AMR092345:Reporter's case
Sex: U
Vaccine: VARZOS
Symptoms: Neuralgia, Pain in extremity, Vaccination complication
Clinical narrative: caused me pain in my legs ever since I got them; was causing my nerve pain.; This case was reported by a consumer via interactive digital media and described the occurrence of leg pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (received shingle shot and experienced pain in leg and nerve pain, tolerance of 1st dose refer case US2021AMR102641).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 4 months after receiving Shingles vaccine, the patient experienced leg pain and nerve pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the leg pain and nerve pain were not recovered/not resolved.   The reporter considered the leg pain and nerve pain to be possibly related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient for himself/herself. The age at vaccination was not reported. The age group was selected as an adult as per vaccine indication. The patient received shingles shot and experienced pain in her/his legs ever since got them four months ago. The patient's orthopedic doctor said he thought that's what was causing her/his nerve pain. No further information was reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR102641:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had it but still got them/Suspected vaccination failure; Had it but still got them; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (years ago).   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication.  The patient had shot years prior to the reporting and last year, but still got shingles. The patient had shingles twice again recently. The physician put shot in spine for his/her neck and the patient stated that opened up spinal cord. The patient did not see shot helping. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, exact time to onset and laboratory confirmation were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: recieved my first Shingrix vaccine in November of 2019 / unable to get my second vaccination / did not complete the series; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. There was no adverse event. The patient was unable to get 2nd Shingrix vaccine due to loss of medical coverage.  The patient would like to get the Shingrix vaccine now that the patient have coverage again but do not know if  the patient need to start over with the 2 part vaccine. or if the patient could continue and just get the 2nd dose even though it had been 1 and half years.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Electric shock sensation, Headache, Neck pain
Clinical narrative: very bad neck-ache / electrical shocks / inside her head and neck area; headache/up the back of the neck to the top of her head/electrical shocks / inside her head and neck area; electrical shocks; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (received 1st dose in November 2020, for tolerance refer case US2021102746).   On 17th April 2021, the patient received the 2nd dose of Shingrix. On 18th April 2021, 1 days after receiving Shingrix, the patient experienced neck pain, headache and electric shock. On 21st April 2021, the outcome of the electric shock was recovered/resolved. On 25th April 2021, the outcome of the neck pain and headache were recovered/resolved.   It was unknown if the reporter considered the neck pain, headache and electric shock to be related to Shingrix.  Additional details were reported as follows: The patient reported for herself. The patient received Shingrix vaccine in the left arm and had very bad neck-ache, a headache that went up the back of the neck to the top of her head and electrical shocks that could feel inside her head and neck area. The patient reported the electrical shocks lessened each day and were gone by Wednesday and neck pain and headache diminished each day and was completely gone by Sunday. The patient did not consent to follow up and did not give permission to contact HCP (health care professional).; Sender's Comments:  US-GLAXOSMITHKLINE-US2021102746:Same reporter
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Illness, Pain, Pyrexia
Clinical narrative: Had a slight fever; Was achy; Run down; Was kind of sick for a day; This case was reported by a consumer via other manufacturer and described the occurrence of sickness in a 52-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included multiple sclerosis (probably since from 2001, but was not diagnosed until 2017), blood pressure high (was on Lisinopril for a while, a couple of years or something) and depression (was on antidipressant). Concomitant products included thyroxine sodium (Levothyroxine), bupropion hydrochloride (Bupropion), lisinopril and ocrelizumab (Ocrevus).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 3 months after receiving Shingles vaccine and an unknown time after starting Levothyroxine and Bupropion, the patient experienced sickness, fever, pain and tiredness. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the fever, pain and tiredness were unknown.   It was unknown if the reporter considered the sickness, fever, pain and tiredness to be related to Shingles vaccine.  Additional information was provided as follows: The patient has been on Levothyroxine since 2004 or 2005. The patient was on Bupropion probably since 2017 at a dose of 150mg extended release capsules or something like that. The patient received the 2nd dose of Shingrix in January or February of 2021 (unsure about the date). The patient was kind of a sick for a day, had a fever, slight achy and run down. No lot number or expiration date was available. The patient received both the doses of COVID vaccine and was negative for antibodies. The reporter consented to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: SARS-CoV-2 antibody test negative
Clinical narrative: Had a slight fever; Was achy; Run down; Was kind of sick for a day; This case was reported by a consumer via other manufacturer and described the occurrence of sickness in a 52-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included multiple sclerosis (probably since from 2001, but was not diagnosed until 2017), blood pressure high (was on Lisinopril for a while, a couple of years or something) and depression (was on antidipressant). Concomitant products included thyroxine sodium (Levothyroxine), bupropion hydrochloride (Bupropion), lisinopril and ocrelizumab (Ocrevus).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 3 months after receiving Shingles vaccine and an unknown time after starting Levothyroxine and Bupropion, the patient experienced sickness, fever, pain and tiredness. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the fever, pain and tiredness were unknown.   It was unknown if the reporter considered the sickness, fever, pain and tiredness to be related to Shingles vaccine.  Additional information was provided as follows: The patient has been on Levothyroxine since 2004 or 2005. The patient was on Bupropion probably since 2017 at a dose of 150mg extended release capsules or something like that. The patient received the 2nd dose of Shingrix in January or February of 2021 (unsure about the date). The patient was kind of a sick for a day, had a fever, slight achy and run down. No lot number or expiration date was available. The patient received both the doses of COVID vaccine and was negative for antibodies. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: That shot hurts for days but worth it; This case was reported by a consumer via  interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but taken as adult as per vaccine indication. The patient reported that the shot hurt for days but was worth it.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: redness; swelling; This case was reported by a nurse via sales rep and described the occurrence of erythema in an unspecified number of patients 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 erythema and swelling. On an unknown date, the outcome of the erythema and swelling were unknown.   It was unknown if the reporter considered the erythema and swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The nurse mentioned there were a few patients that experienced redness, swelling following 1st dose of Shingrix. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected Vaccination failure; got the shingles really bad; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's parent. The age at vaccination was not reported. The patient got vaccinated and got the shingles really bad. The reporter guess if it was in your make up you get them no matter what. This case considered as suspected vaccination failure since the details regarding time to onset, dose number and laboratory confirmation regarding shingles were not reported.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Received three doses of Shingrix vaccine.; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st and 2nd dose received on an unknown date).   On 5th May 2021, the patient received the 3rd dose of Shingrix. On 12th May 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: Patient received three doses of Shingrix vaccine, which led to extra dose of vaccine administered. Pharmacist asked for information about correct protocol for patient.
Age: 68.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Nerve injury, Pain, Vaccination failure
Clinical narrative: Got the two shot vaccine at 68 and still got internal shingles/ suspected vaccination failure; internal shingles; nerve damage inside; severe pain; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received at the age of 60 years).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, nerve damage and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the nerve damage and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, nerve damage and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The patient got the vaccine at age of 60 years but was told that patient needed the new vaccine because that one was no good.  The patient got the two shot vaccine at age of 68 years and still got internal shingles and had been in severe pain for a year from the nerve damage inside. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Age: 0.25
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: baby (4 month) have any protection after one dose/We made it in 3 month; This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-month-old female 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 the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   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 case was reported by patient's parent. The patient received dose of bexsero at the age of 3 months, which led to inappropriate age at vaccine administration. The reporter inquired that was the patient had any protection after one dose. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: First shot / arm was sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Tetanus with an associated reaction of no adverse event (received tetanus shot on an unknown date.).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient age was reported as over 50 years. The physician told the patient to go and get the shingles shot. The patient received 1st dose of Shingrix and his/her arm was sore. The follow up would not possible as no contact details were available. For tolerance of 2nd dose, refer case US2021AMR103510, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR103510:same patient (2nd dose)
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphocyte count decreased, Pyrexia, Vaccine positive rechallenge
Clinical narrative: fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose on 6th November 2020, refer case US2021103231).   On 6th May 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 6th May 2021, less than a day after receiving Shingrix, the patient experienced fever. Rechallenge with Shingrix was positive. In May 2021, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient experienced fever that lasted 24 hours then resolved.  The patient also had bloodwork which showed low lymphocytes and it was unknown whether the low lymphocytes had resolved by the time of reporting.  The reporter did not consent to follow-up. No further information was reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021103231:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain of skin, Scar, Skin ulcer
Clinical narrative: a low grade case of the shingles; I woke up with sores on my hips; Felt like someone had taken sandpaper to my skin; have two permanent "racing stripes" (scars) from it all; This case was reported by a consumer via facebook interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date, refer case US2021AMR103501).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced shingles, skin ulcer, skin pain and scar. On an unknown date, the outcome of the shingles, skin ulcer and skin pain were unknown and the outcome of the scar was not recovered/not resolved.   It was unknown if the reporter considered the shingles, skin ulcer, skin pain and scar to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient age was reported as over 50 years. The patient waited 6 months after 1st shot and then took the 2nd dose of Shingrix.  A week after taking 2nd dose of Shingrix, the patient woke up with sores on hips and felt like someone had taken sandpaper to patient's skin.  The patient was sure enough that it was a low grade case of the shingles.  At the time of reporting, the patient had two permanent racing stripes (scars) from it all.  The physician wanted the patient to take the experimental covid vaccine. The patient said he/she did not think so. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR103501:same patient (1st dose)
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: side affects made me sick for 24 hours; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were reported. The age at vaccination was not reported. The age group was not reported but it was captured as an adult as per vaccine indication. The shingles could be the pain but the vaccine was not nice either. The side effects made the patient sick for 24 hours and just thought need 2 vaccines like the covid. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: My arm hurt; I had a slight fever; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and fever. On an unknown date, the outcome of the pain in arm and fever were unknown.   It was unknown if the reporter considered the pain in arm and fever to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient. Age at vaccination was not reported. The age grp was selected as an adult as vaccine indication. Patient reported that he/she decided to get the shingles shot after patient cousin had shingles and had to be hospitalized. Patient experienced arm hurt and slight fever. The reporter reported its better than the shingles pain.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: My arm is swollen; My arm is /red; My arm is/feverish; This case was reported by a consumer interactive digital media and described the occurrence of swelling arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis  On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling arm, erythema of extremities and fever. On an unknown date, the outcome of the swelling arm, erythema of extremities and fever were unknown.   It was unknown if the reporter considered the swelling arm, erythema of extremities and fever to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient. Age at vaccination was not reported. The age grp was captured as an adult as per vaccine indication. Patient received shingrix shot and experienced arm swollen, red, and feverish. The reporter wanted to know how long would it take for the swelling to go down.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury, Neuralgia, Vaccination failure
Clinical narrative: I had them the same place you did/Suspected Vaccination failure; I had them the same place you did; have some nerve damage; caused some pain to return; This case was reported by a consumer via media and described the occurrence of Suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, nerve damage and nerve pain. On an unknown date, the outcome of the vaccination failure, shingles, nerve damage and nerve pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, nerve damage and nerve pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient got Shingles after vaccination. The patient had some nerve damage. The shot activated the nerves somewhat, no breaking out, but caused some pain to return. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Facial pain, Headache, Neuralgia, Pain
Clinical narrative: can have a side effect of Neuralgia; pain on side of face; head aches on one side; When I say pain, I mean excruciating pain!; This case was reported by a consumer via interactive digital media and described the occurrence of neuralgia in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced neuralgia, facial pain, headache and pain. On an unknown date, the outcome of the neuralgia, facial pain, headache and pain were unknown.   It was unknown if the reporter considered the neuralgia, facial pain, headache and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had side effect of Neuralgia, pain on side of face and head aches on one side.  The patient had pain mean excruciating pain.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Shots are mildly painful in arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (received 1st dose on an unknown date. For the tolerance of 1st dose, refer linked case US2021AMR103686).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The reporter had reported for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. The patient stated that, the shingles shot was mildly painful in arm for four days but better than shingles.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR103686:1st dose
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Immediate post-injection reaction, Inappropriate schedule of product administration, Injection site erythema, Injection site inflammation
Clinical narrative: a round (approximately 2.5 inches in diameter) area of inflammation / at the injection site; redness at the injection site; skin was warm to touch; also experienced a headache; first dose of Shingrix April 5, 2021 / on May 3, 2021 / received the second vaccine; This case was reported by a consumer via call center representative and described the occurrence of injection site inflammation in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number F5XN2, expiry date 8th October 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 3rd May 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd May 2021, immediately after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced injection site inflammation, injection site erythema, skin warm, headache and drug dose administration interval too short. On 7th May 2021, the outcome of the injection site inflammation was recovering/resolving. On an unknown date, the outcome of the injection site erythema and skin warm were recovering/resolving and the outcome of the headache was not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the injection site inflammation, injection site erythema, skin warm and headache to be related to Shingrix.  Additional information was provided as follows:  On 5th April 2021, the patient received 1st dose of Shingrix. The patient was instructed to return to receive 2nd dose of shingrix and the patient received 2nd dose of Shingrix, less than the recommended interval, which led to shortening of vaccination schedule. Immediately after receiving 2nd dose, the patient noticed a round (approximately 2.5 inches in diameter) area of inflammation and redness at the injection site. The skin was warm to touch. Those symptoms had improved. On the same day, she also experienced a headache and continued till the reporting date. The reporter consented to follow up via email as well as with her HCP (health care professional).
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: a round (approximately 2.5 inches in diameter) area of inflammation / at the injection site; redness at the injection site; skin was warm to touch; also experienced a headache; first dose of Shingrix April 5, 2021 / on May 3, 2021 / received the second vaccine; This case was reported by a consumer via call center representative and described the occurrence of injection site inflammation in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number F5XN2, expiry date 8th October 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 3rd May 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd May 2021, immediately after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced injection site inflammation, injection site erythema, skin warm, headache and drug dose administration interval too short. On 7th May 2021, the outcome of the injection site inflammation was recovering/resolving. On an unknown date, the outcome of the injection site erythema and skin warm were recovering/resolving and the outcome of the headache was not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the injection site inflammation, injection site erythema, skin warm and headache to be related to Shingrix.  Additional information was provided as follows:  On 5th April 2021, the patient received 1st dose of Shingrix. The patient was instructed to return to receive 2nd dose of shingrix and the patient received 2nd dose of Shingrix, less than the recommended interval, which led to shortening of vaccination schedule. Immediately after receiving 2nd dose, the patient noticed a round (approximately 2.5 inches in diameter) area of inflammation and redness at the injection site. The skin was warm to touch. Those symptoms had improved. On the same day, she also experienced a headache and continued till the reporting date. The reporter consented to follow up via email as well as with her HCP (health care professional).
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th November 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th November 2020, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. The age at vaccination was not reported but could be 60 or 61 years. The patient received the 1st dose of Shingrix and experienced fever which lasted for 24 hours and then resolved.  The patient did not consent to follow up. For tolerance of 2nd dose refer case US2021AMR103508, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR103508:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first Shingrix dose in October of 2019 / not received their second dose yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose (intramuscular) 0.5 ml in unknown arm in October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details provided were as follows: This case was reported by patient herself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose. which led to incomplete course of vaccination. The reporter did not consent to follow-up. This case had been linked with US2021103256, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021103256:same reporter. husband case.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First / dose in October of 2019 and have not received their second dose yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose (intramuscular) 0.5 ml in unknown arm in October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: This case was reported by patient's wife. The age at vaccination was not applicable for this report.   Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccination, which led to incomplete course of vaccination. The reporter did not consent to follow up. This case had been linked with US2021103257, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021103257:same reporter. wife case.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Dose 1 shingrix on 1/17/2019, never got the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 17th January 2019 with batch number 9277N and expiry date 27th June 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The pharmacist asked if need to give the 2nd dose immediately or should revaccinate. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose/ on 10/08/2020 and Dose 2 on 5/13/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th October 2020.).   On 13th May 2021, the patient received the 2nd dose of Shingrix. On 13th May 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows:  The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The 2nd dose administered was later informed to the 2nd line agent. No other details of the vaccine were available. The reporter consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: had a knot/all at injection site on left deltoid; very sore; all at injection site on left deltoid; redness/all at injection site on left deltoid; warmth/ all at injection site on left deltoid; This case was reported by a other health professional via call center representative and described the occurrence of injection site lump in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number F29KK, expiry date October 2021) for prophylaxis.   On 6th May 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th May 2021, less than a day after receiving Shingrix, the patient experienced injection site lump, injection site pain, injection site erythema and injection site warmth. On 8th May 2021, the outcome of the injection site lump, injection site pain, injection site erythema and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site lump, injection site pain, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received her first Shingrix dose then had a knot with redness, warmth and very sore all at injection site on left deltoid.  All adverse events resolved after 2 days. The reporter did not consent to follow-up and not given permission to contact her HCP (health care provider).
Age: 0.08
Sex: U
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: menveo vaccine to 6.5 week old; menveo vaccine to 6.5 week old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-week-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate age at vaccine administration and off label use. On an unknown date, the outcome of the inappropriate age at vaccine administration and off label use were unknown.  Additional details were provided as follows: The 6.5 week patient received Menveo, which led to inappropriate age at vaccine administration and off label use. The reporter stated that, next week patient was going overseas. No more information was available. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received her first Shingrix shot on 05-Nov-2020 / second Shingrix shot on 13-May-2021.; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 5th November 2020). Concomitant products included covid 19 vaccine pfizer.   On 13th May 2021, the patient received the 2nd dose of Shingrix. On 13th May 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The case was reported by the patient for herself. The age at vaccination was not reported. The patient received her second Shingrix shot later than the recommended interval, which led to lengthening of vaccination schedule. The patient also received a Pfizer Covid-19 shot on 18th March 2021. No further information was reported. The patient consent to follow up was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hepatitis, Platelet count decreased, Thrombosis
Clinical narrative: LOW PLATELET COUNT; INFLAMED LIVER; BLOOD CLOTS; HEADACHES; This spontaneous report received from a patient, via social media, via a company representative concerned a 33 year old male. The patient's weight, height, and medical history were not reported.  The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, two weeks after vaccination, the patient experienced headaches, low platelet count, inflamed liver, and blood clots. It was stated the patient had an inflamed liver because of all the blood clots found; the patient is now on blood thinners for a minimum of 6 months. Laboratory data (dates unspecified) included: Low platelets (NR: not provided) 26K. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The outcome of the headaches, inflamed liver, blood clots and low platelet count was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a patient, via social media, via a company representative concerned a 33-year-old man who experienced blood clots and low platelet (26,000) count two weeks after vaccine. Medical history, concomitant medications, and other details were not reported. It was stated the patient had an "inflamed liver because of all the blood clots found"; the patient is now on blood thinners for a minimum of 6 months. Information is limited in this case, and the occurrence of blood clots and low platelet count could represent background incidence of such events in the general population. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate (Brighton Collaboration Criteria level 5).