chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Abulia, COVID-19, Intellectual disability, SARS-CoV-2 test positive
Clinical narrative: mental capacity is not the same/ brain fogginess; COVID test done and it was confirmed positive / on 02Jan2021; This case was reported by a consumer via other manufacturer and described the occurrence of indecisiveness in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th November 2020, the patient received the 1st dose of Shingrix. On 2nd January 2021, 56 days after receiving Shingrix, the patient experienced covid-19 virus test positive. On an unknown date, the patient experienced indecisiveness. On an unknown date, the outcome of the indecisiveness and covid-19 virus test positive were unknown.   It was unknown if the reporter considered the indecisiveness and covid-19 virus test positive to be related to Shingrix.   Additional details were provided as follow: This case was reported by the patient via other manufacturer. Patient received 1st dose of Shingrix on 7th November 2020 and experienced mental deficiency. Patient was tested Covid positive on Jananary 2021. On 19th March 2021 Patient received Covid vaccine in into left arm, batch number (EN6207) Part to the Pfizer COVID Vaccine and the patient mental capacity was not the same and was worse since then. No further information was reported. Consent to contact was given by the reporter. This case has been linked with US2021AMR069448 and US2021AMR069406, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR069406:same reporter - girlfriend´s case
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Herpes zoster, Illness, Neuralgia
Clinical narrative: reacted severely to the shingles vaccine (Shingrix) in Sept / suspected Vaccination failure; shingles; nerve pain; joint pain; like lupus my whole back was red and along the nerve pain and joint pain; sick; This case was reported by a consumer via other manufacturer and described the occurrence of suspected vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included systemic lupus erythematosus and central vision loss. Concomitant products included hydroxychloroquine (Plaquenil).   In September 2020, the patient received Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, sickness, nerve pain, joint pain and erythema. On an unknown date, the outcome of the vaccination failure, shingles, nerve pain, joint pain and erythema were unknown and the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, sickness, nerve pain, joint pain and erythema to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient reacted severely to the shingles vaccine. The patient was sick for 3 weeks almost having shingles and like lupus whole back was red and along the nerve pain and joint pain.  The patient had lupus (autoimmune disease) it was only on skin and after 8 years of being on it the patient had Plaquenil (hydroxychloroquine); toxicity to the central vision loss (permeant).  The patient's immune system was over reactive. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: reacted severely to the shingles vaccine (Shingrix) in Sept / suspected Vaccination failure; shingles; nerve pain; joint pain; like lupus my whole back was red and along the nerve pain and joint pain; sick; This case was reported by a consumer via other manufacturer and described the occurrence of suspected vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included systemic lupus erythematosus and central vision loss. Concomitant products included hydroxychloroquine (Plaquenil).   In September 2020, the patient received Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, sickness, nerve pain, joint pain and erythema. On an unknown date, the outcome of the vaccination failure, shingles, nerve pain, joint pain and erythema were unknown and the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, sickness, nerve pain, joint pain and erythema to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient reacted severely to the shingles vaccine. The patient was sick for 3 weeks almost having shingles and like lupus whole back was red and along the nerve pain and joint pain.  The patient had lupus (autoimmune disease) it was only on skin and after 8 years of being on it the patient had Plaquenil (hydroxychloroquine); toxicity to the central vision loss (permeant).  The patient's immune system was over reactive. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Induration, Swelling
Clinical narrative: swelling for approx. one week; induration; This case was reported by a nurse via sales rep and described the occurrence of swelling 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 and induration. On an unknown date, the outcome of the swelling and induration were recovered/resolved.   It was unknown if the reporter considered the swelling and induration to be related to Shingrix.  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 nurse mentioned that there was a staff member who received a dose of Shingrix and had induration and swelling for approximately one week. The reporter did not consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash papular
Clinical narrative: Developed a rash near the injection site again / raised but it does not itch; This case was reported by a consumer and described the occurrence of raised rash in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash papular (received 1st dose in November 2020, refer case US2021070489).   On 8th March 2021, the patient received the 2nd dose of Shingrix. In March 2021, less than 3 weeks after receiving Shingrix, the patient experienced raised rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the raised rash was not recovered/not resolved.   It was unknown if the reporter considered the raised rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient received Shingrix and developed a rash near the injection site. The reporter describes the rash as raised but it did not itch.  The patient would see a dermatologist soon.  No other information given by the patient. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021070489:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: rash at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th March 2021, the patient received the 2nd dose of Shingrix. In March 2021, less than 3 weeks after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was not recovered/not resolved.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. Till the time of reporting, the patient still had the rash at the injection site. The patient asked when that would go away. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia, Pain, Pyrexia
Clinical narrative: fever; flu like symptoms; general aches; muscle aches; This case was reported by a pharmacist and described the occurrence of fever in a female 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 fever, influenza-like symptoms, general body pain and muscle pain. On an unknown date, the outcome of the fever, influenza-like symptoms, general body pain and muscle pain were unknown.   The reporter considered the fever, influenza-like symptoms, general body pain and muscle pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's son. The age at vaccination was not reported. The patient received Shingrix and experienced flu like symptoms, fever, muscle aches and general aches due to the vaccine. No other information was received.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: I had a horrific rash after my second dose.; This case was reported by a consumer and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient need a list of vaccine ingredients for shingrix as the patient had a horrific rash after second dose. Ingredients were not forward facing on this site.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Felt sick; 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as an adult as per vaccine indication. The patient received Shingrix vaccine and felt sick. No further information reported.
Sex: U
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: groin lymph node swollen; This case was reported by a consumer via interactive digital media and described the occurrence of inguinal lymph nodes enlarged in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 4 days after receiving Shingrix, the patient experienced inguinal lymph nodes enlarged. On an unknown date, the outcome of the inguinal lymph nodes enlarged was unknown.   It was unknown if the reporter considered the inguinal lymph nodes enlarged to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient 's groin lymph node swollen after 2nd dose of Shingrix. Thus asked was this a normal side effect.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Headachy; Feverish; With achy muscles; Tiredness; This case was reported by a consumer and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd March 2021, the patient received the 2nd dose of Shingrix. On 23rd March 2021, 1 days after receiving Shingrix, the patient experienced headache, fever, muscle pain and tiredness. On an unknown date, the outcome of the headache, fever, muscle pain and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the headache, fever, muscle pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The got second Shingrix shot on Monday. The felt a bit headachy, feverish with achy muscles and tiredness on Tuesday. Some of this was lingering, though milder. The patient wanted to know how long these symptoms last on average.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: I've been having a rash where I had shingles; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles before vaccination).   On an unknown date, the patient received Shingrix. On an unknown date, 1 year after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient had shingles before and got vaccinated but a year after the patient had a rash where the patient had shingles. The patient asked if it was that normal?
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Had the two doses of Shingrex over a year ago but am having an outbreak; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with antivirals nos. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Over a year ago, the patient two doses of Shingrix and had an outbreak of shingles. The patient had taken 7 days of an antiviral but still having symptoms. The patient asked did they have a suggestion or have booster shots. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: body aches; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th March 2021, the patient received Shingrix. In March 2021, less than a week after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was not recovered/not resolved.   It was unknown if the reporter considered the general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient was vaccinated with Shingrix and experienced  body aches.  The patient wanted to know how long do the last?
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: I have a lot of allergies / I had a bad reaction to the Shingrix vaccine; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included multiple allergies (had a lot of allergies).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per the vaccine indication. The patient had a bad reaction to the Shingrix vaccine and was trying to figure out which (if any) of the Covid vaccines he/she could try. The patient stated that he/she had a lot of allergies and needed a list of ingredients in the Shingrix vaccine. The patient had also seen the package insert online but could not find the list of actual ingredients.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Severe allergic reaction; This case was reported by a consumer and described the occurrence of allergic reaction 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 allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as an adult as per vaccine indication. The reporter needed to know the components of Shingrix to compare with COVID-19 vaccine. The patient received Shingrix vaccine and experienced severe allergic reaction. The patient required medical treatment. The case was reported to VAERS. No further information reported.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: injection site pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 18-year-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 25th March 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. In March 2021, less than a week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Case was reported by a pharmacist for his/her daughter. The reporter asked if Bexsero injection had a longer than normal injection site pain. The patient's arm was still hurting at the time of reporting. The reporter would reach back to healthcare professional if the patient did not feel well by Wednesday.
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Influenza like illness, Malaise, Mobility decreased, Pain in extremity
Clinical narrative: Very sore arm; Knocked her off her feet; Vomiting; Diarrhea; Couldn't keep anything down; Flu like symptoms; This case was reported by a consumer and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, unwell, influenza-like symptoms, vomiting, diarrhea and mobility decreased. On an unknown date, the outcome of the pain in arm, unwell, influenza-like symptoms, vomiting, diarrhea and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the pain in arm, unwell, influenza-like symptoms, vomiting, diarrhea and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter is the friend of the patient.  The patient received the 2nd dose and the 2nd dose knocked her off her feet.  The patient had flu like symptoms for 2 to 3 days.  The patient also experienced vomiting and diarrhea and could not keep anything down. The patient also had a very, very sore arm.  The reporter did not consent to follow-up. This case has been linked with US2021008399 and US2021AMR008922, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021008399:same reporter US-GLAXOSMITHKLINE-US2021AMR008922:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Very sore arm; Knocked her off her feet; Vomiting; Diarrhea; Couldn't keep anything down; Flu like symptoms; This case was reported by a consumer and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, unwell, influenza-like symptoms, vomiting, diarrhea and mobility decreased. On an unknown date, the outcome of the pain in arm, unwell, influenza-like symptoms, vomiting, diarrhea and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the pain in arm, unwell, influenza-like symptoms, vomiting, diarrhea and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter is the friend of the patient.  The patient received the 2nd dose and the 2nd dose knocked her off her feet.  The patient had flu like symptoms for 2 to 3 days.  The patient also experienced vomiting and diarrhea and could not keep anything down. The patient also had a very, very sore arm.  The reporter did not consent to follow-up. This case has been linked with US2021008399 and US2021AMR008922, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021008399:same reporter US-GLAXOSMITHKLINE-US2021AMR008922:same reporter
Age: 0.92
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the first dose of Havrix outside recommended schedule /  fist dose  was administrated on July 16 2018; 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 11-month-old male patient who received HAV (Havrix) (batch number 334PA, expiry date 7th December 2018) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th July 2018, the patient received the 1st dose of Havrix and Havrix Pre-Filled Syringe Device. On 16th July 2018, unknown after receiving Havrix and Havrix 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 patient received the 1st dose of Havrix outside recommended schedule at the age of 11 months, which led to inappropriate age at vaccine administration.  The vaccine was recommended to be administered to children and adolescents from 1 year of age up to and including 15 years of age. No known side effect were reported. The reporter consented to follow up.
Age: 48.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: swelling at the injection site; pain at the injection site; This case was reported by a consumer and described the occurrence of injection site swelling in a 49-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2021, the patient received the 2nd dose of Shingrix. In March 2021, less than a week after receiving Shingrix, the patient experienced injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The patient received the 2nd dose of the shingrix vaccine a week before the reporting date. The patient would not provide any additional information. The reporter did not consent to follow-up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash papular
Clinical narrative: Rash / near the injection site that resolved; This case was reported by a consumer via call center representative and described the occurrence of raised rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months 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 patient herself. The patient received 1st dose of Shingrix and developed a rash on right arm near the injection site that resolved, and she described the rash as raised but it did not itch. The reporter consented to follow up. No other information given by the patient. For tolerances of 2nd dose, refer case US2021AMR070842, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR070842:Same reporter.
Sex: F
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Received 31 JUL 2020 / Received 26 NOV 2020 / developed shingles/ suspected vaccination failure; developed shingles and still has outbreaks on her face and chin; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a adult female patient who received Herpes zoster (Shingrix) (batch number 5KM49, expiry date 26th November 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number XG52X, expiry date 28th November 2021) for prophylaxis and COVID 19 VACCINE MODERNA for prophylaxis.   The patient's past medical history included shingles (in February 2020), shingles (in March 2020) and shingles (in June 2020).   On 26th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 31st July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 28th February 2021, the patient received the 1st dose of COVID 19 VACCINE MODERNA. On 22nd March 2021, 116 days after receiving Shingrix and 234 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. On Monday 22nd March 2021, the patient developed shingles and still had outbreaks on her face and chin. This shingles outbreak has prevented her from getting her second Moderna COVID-19 dose. The patient was upset and concerned about the shingles vaccine failure and its interference with her COVID series. It was unknown if the reporter considered the shingles to be related to Moderna COVID-19 vaccine. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Lymphadenopathy, Swelling
Clinical narrative: 1ST  / SHOT / GOLF BALL LIKE SWELLING IN THE RIGHT ARM PIT; Incomplete course of vaccination; This case was reported by a consumer via call center representative and described the occurrence of local swelling in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In June 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced local swelling and incomplete course of vaccination. On an unknown date, the outcome of the local swelling was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the local swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose. The patient received 1st  shingrix shot June 2018 in upper right arm and experienced golf ball like swelling in the right arm pit.    Till the time of reporting, the patient had not taken the 2nd shingrix shot, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Blood pressure decreased, Blood pressure measurement, Chills, Overdose, Product administered at inappropriate site
Clinical narrative: Blood pressure was low; Chills; Shaking/ shaking throughout her entire body; Given an menveo and menactra injection today; received both vaccines on left arm; This case was reported by a nurse via call center representative and described the occurrence of low blood pressure in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included MENACTRA for prophylaxis.   On 26th March 2021, the patient received Menveo and MENACTRA. On 26th March 2021, 3 hrs after receiving Menveo, the patient experienced low blood pressure, chills, tremor, overdose and vaccine administered at inappropriate site. On an unknown date, the outcome of the low blood pressure, chills and tremor were recovered/resolved and the outcome of the overdose and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the low blood pressure, chills and tremor to be related to Menveo.  Additional details were provided as follows: The patient was given an menveo and menactra injection, both in the left arm which led to overdose and vaccine administered at inappropriate site. After getting the injections, 3 hours later she had shaking throughout her entire body, chills and when she went to the emergency room her blood pressure was low. The patient was not admitted. The reporter consented to follow up.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Tremor
Clinical narrative: Blood pressure was low; Chills; Shaking/ shaking throughout her entire body; Given an menveo and menactra injection today; received both vaccines on left arm; This case was reported by a nurse via call center representative and described the occurrence of low blood pressure in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included MENACTRA for prophylaxis.   On 26th March 2021, the patient received Menveo and MENACTRA. On 26th March 2021, 3 hrs after receiving Menveo, the patient experienced low blood pressure, chills, tremor, overdose and vaccine administered at inappropriate site. On an unknown date, the outcome of the low blood pressure, chills and tremor were recovered/resolved and the outcome of the overdose and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the low blood pressure, chills and tremor to be related to Menveo.  Additional details were provided as follows: The patient was given an menveo and menactra injection, both in the left arm which led to overdose and vaccine administered at inappropriate site. After getting the injections, 3 hours later she had shaking throughout her entire body, chills and when she went to the emergency room her blood pressure was low. The patient was not admitted. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Chills and shivering; This case was reported by a consumer and described the occurrence of shivering in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix, Influenza vaccine Quadrivalent 2020-2021 season and PNEUMONIA VACCINE. On an unknown date, less than 9 months after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced shivering. On an unknown date, the outcome of the shivering was unknown.   It was unknown if the reporter considered the shivering to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The case was reported by patient for herself. The age at vaccination was not reported. The patient received 1st Shingrix and on the same day received the flu shot and pneumonia shot, and less than 9 months after vaccination, the patient experienced chills with shivering.  Reporter declined to provide demographic information and declined to answer any adverse event related questions. It was unknown if the reporter considered the shivering to be related to pneumonia vaccine. No other information was provided. The reporter declined to provide health care professional information. The reporter did not consent to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Mobility decreased, Pain in extremity
Clinical narrative: Numbness / in her arm; Pain in her arm / Pain is so intense; Consumer cannot lift her arm to a horizontal level; This case was reported by a pharmacist via call center representative and described the occurrence of numbness of upper extremities in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 04th October 2020).   On 14th January 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced numbness of upper extremities, pain in arm and mobility decreased. On an unknown date, the outcome of the numbness of upper extremities, pain in arm and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the numbness of upper extremities, pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix in left arm. After receiving Shingrix, the patient had numbness and pain in arm. The pain was so intense that the patient could not lift her arm to a horizontal level. The reporter did not consent to follow up. AIl information was not available.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site rash
Clinical narrative: She has not received her second Shingrix vaccination; Rash / similar to poison oak, from her elbow to her shoulder; This case was reported by a consumer via call center representative and described the occurrence of rash in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 31st July 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 1st August 2020, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rash. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with prednisone. On 19th August 2020, the outcome of the rash was recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional information was provided as follows: This case was reported by patient herself. The patient received 1st dose of Shingrix in her left arm at her physician's office and reported a rash, similar to poison oak, from her elbow to her shoulder on her left arm.  The patient was prescribed Prednisone on 11th August 2020 and took until 21st August 2020. Till the time of reporting, the patient had not received her 2nd dose of Shingrix vaccination, which led to incomplete course of vaccination. The patient gives consent to follow up with her healthcare professional and also gives consent to email her Shingrix PI (package insert). The reporter consent to follow up. The age at vaccination was not applicable for 2nd dose of Shingrix.
Sex: M
Vaccine: FLUX, PPV, VARZOS, VARZOS
Symptoms: Gait disturbance, Incomplete course of vaccination
Clinical narrative: He did not receive the second dose of the Shingrix; He could not walk and had to crawl / to go to the restroom; This case was reported by a consumer via call center representative and described the occurrence of walking difficulty in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis, PNEUMOCOCCAL VACCINE for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix, the 1st dose of Influenza vaccine Quadrivalent 2019-2020 season, the 1st dose of PNEUMOCOCCAL VACCINE and the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, Influenza vaccine Quadrivalent 2019-2020 season and PNEUMOCOCCAL VACCINE and not applicable after receiving Shingrix, the patient experienced walking difficulty and incomplete course of vaccination. On an unknown date, the outcome of the walking difficulty was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the walking difficulty to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: This case was reported by patient himself. The age at vaccination was not reported but could be 69 or 70 years and was not applicable for 2nd dose of Shingriix. In 2019 on the same day, the patient received the 1st dose of Shingrix vaccine, a pneumococcal vaccine and an influenza vaccine all at the pharmacy and stated might be all were given to him on his left arm (he did not remember) and by the time patient reached home, he could not walk and had to crawl on his hands and knees to go to the restroom and slowly the ability to walk returned in about a week. Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix vaccine, which led to incomplete course of vaccination. It was unknown if the reporter considered the walking difficulty to be related to Pneumococcal vaccine. The reporter consent to follow up. For tolerance of influenza vaccine received in 2020, refer case US2021AMR072042.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR072042:Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Syncope
Clinical narrative: FAINTED AFTER GETTING VACCINE; FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNWON) .5 ml, start therapy date was not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced fainted after getting vaccine, and flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms and fainted after getting vaccine was not reported. The reporter considered the causality between JNJ-78436735, and faint and flu like symptoms as possible. Company causality between JNJ-78436735, and faint and flu like symptoms was possible. The batch number was not reported and has been requested. This report was serious (Other Medically Important Condition).  Additional information was received from consumer on 12-Mar-2021 following information was updated and incorporated into case narrative: Patient demographic details (patient initials and sex) and other identification numbers was added.; Sender's Comments: V1 Follow up information updates Patient demographic details (patient initials and sex) and other identification numbers. This updated information does not alter prior casuality assessment of reported events. Flu-like symptoms and fainted. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug.
Sex: U
Vaccine: COVID19
Symptoms: Hypotension, Loss of consciousness
Clinical narrative: LOSS OF CONSCIOUSNESS; HYPOTENSIVE; This spontaneous report received from a physician concerned a multiple patients of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced loss of consciousness. On 11-MAR-2021, the subject experienced hypotensive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patients was recovering from loss of consciousness, and hypotensive. Reporter considered causality between covid-19 vaccine ad26.cov2.s and  loss of consciousness, and hypotensive as possible. Company causality between  covid-19 vaccine ad26.cov2.s and  loss of consciousness, and hypotensive considered as possible. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210321527-covid-19 vaccine ad26.cov2.s-loss of consciousness, hypotensive. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Dizziness
Clinical narrative: HIGH GRADE FEVER; BODY ACHES; SEVERE CHILLS; JOINT PAIN; FEELING WEAK; MUSCLE ACHES; HEADACHE; PAIN AT INJECTION SITE; DIZZINESS; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight, height, and medical history were not reported. On an unknown date in NOV-2020, she had a negative COVID-19 test result. On 08-MAR-2021, she had a SubQ TB test done (results not provided). The patient received COVID-19 vaccine AD26.COV2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: unknown) dose was not reported, administered on right arm on 09-MAR-2021 approximately at 10:00 for vaccination. No concomitant medications were reported. Six hours post vaccination, all her symptoms started. On 09-MAR-2021, immediately post vaccination, she experienced slight pain/burning at injection site, followed by dizziness. On 09-MAR-2021, at 18:00 in the evening, she was feeling weak, lethargic, had fever, severe chills, body aches, headache and joint pain. The patient stated that her fever rose to 106 degrees Fahrenheit by 20:00 and she couldn't move. At this point, she took 200mg of Ibuprofen per oral every 6 hours for approximately 24 hours. On 10-MAR-2021, at about 8:30, she took another single dose of ibuprofen to keep her fever down and help with the body pain. The patient also stated that she stayed in bed most of the day and had general weakness and dizziness that lasted all day. On the morning of 11-MAR-2021, the patient reported that her fever was gone but muscle aches, body aches and pain at injection site persisted. On an unknown date in MAR-2021, after 2 weeks from initial date of vaccination, the patient had full resolution of his symptoms. The action taken with COVID-19 vaccine AD26.COV2.s was not applicable. The patient recovered from high grade fever, pain at injection site, body aches, headache, muscle aches, dizziness, feeling weak, severe chills and joint pain. This report was serious (Other Medically Important Condition).  Additional information was received from reporter on 22-Mar-2021. The following information was updated and incorporated into the case narrative: Onset and end date for all the events, Laboratory tests and Treatment drug.; Sender's Comments: V2: Additional information received updates : event details (Onset and end dates for all the events), Laboratory tests and Treatment drug. This updated information does not alter prior causality assessment of reported event. 20210323883-COVID-19 VACCINE AD26.COV2.s-High grade fever. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event.