chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Influenza like illness, Injection site pain
Clinical narrative: Soreness at injection site; Flu like symptoms; Lack of energy; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st June 2019, the patient received the 1st dose of Shingrix. On 1st June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, influenza-like symptoms and loss of energy. On 2nd June 2019, the outcome of the injection site pain, influenza-like symptoms and loss of energy were recovered/resolved.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms and loss of energy to be related to Shingrix.  Additional information received were as follows: The patient received the Shingrix in right arm. The patient had injection site pain, influenza-like symptoms and loss of energy. The patient planned to follow up with her physician on an unknown date. The reporter did not consent to follow up. Limited information was provided.   The patient did not want to answer questions for this report and wanted to remain anonymous.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Pain in extremity
Clinical narrative: Sore Arm; Red Arm; Headache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. In August 2019, 1 day after receiving Shingrix, the patient experienced pain in arm, erythema of extremities and headache. On an unknown date, the outcome of the pain in arm, erythema of extremities and headache were recovered/resolved.   It was unknown if the reporter considered the pain in arm, erythema of extremities and headache to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix in her left arm approximately during the first week in August and later that day developed a headache that lasted approximately one day. The next day, caller reported her arm was sore, and noticed her arm was red as she took her shower in the morning, caller mentions her arm could have been red earlier, but she did not observe it until taking her shower.  The caller reported redness and soreness were not localized to the injection site and that it occurred on her upper arm.  The caller reported soreness lasted a while, but redness lasted up to 3 weeks.  The reporter consented to follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Papule, Pustule
Clinical narrative: possible the patient has an active case of shingles; Bumps appear to be pustules, and some have blood in them; Bumps appear to be pustules, and some have blood in them; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included anxiety. Concomitant products included alprazolam (Xanax) and sertraline hydrochloride (Zoloft).   On 9th April 2019, the patient received the 1st dose of Shingrix. In April 2019, less than 6 months after receiving Shingrix, the patient experienced shingles, papule and pustule. On an unknown date, the outcome of the shingles, papule and pustule were unknown.   It was unknown if the reporter considered the shingles, papule and pustule to be related to Shingrix.  Additional case details were reported as follows: The vaccine lot number was not readily available at the time of this call. The patient had bumps present when he received the first Shingrix dose. The bumps never resolved completely, but would flare up at times.  The patient did not have evaluation from a dermatologist and informed the reporter that the bumps improve if he takes his anxiety medications, Zoloft or Xanax.  The reporter stated at the time of reporting the bumps appear to be pustules, and some had blood in them.  The reporter was wondering if it was possible the patient had an active case of shingles. The reporter consent to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Dysstasia, Fall, Fatigue
Clinical narrative: Woke up several times at night; Fell; Feeling lightheaded; Difficulty standing up; Fainted; Shivers; Headaches; Nausea; General flu-like symptoms; Felt tired; Felt warm; This case was reported by a consumer via call center representative and described the occurrence of faint in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th October 2019, the patient received the 1st dose of Shingrix. On 8th October 2019, 7 hrs after receiving Shingrix, the patient experienced shivers, headache, nausea, flu-like symptoms, tiredness and feeling of warmth. On 9th October 2019, the patient experienced faint (serious criteria GSK medically significant), fall, light headedness and difficulty in standing. On an unknown date, the patient experienced nocturnal awakening. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the faint, shivers, headache, nausea, flu-like symptoms, tiredness, feeling of warmth and fall were recovered/resolved and the outcome of the light headedness and difficulty in standing were not recovered/not resolved and the outcome of the nocturnal awakening was unknown.   It was unknown if the reporter considered the faint, shivers, headache, nausea, flu-like symptoms, tiredness, feeling of warmth, fall, light headedness, difficulty in standing and nocturnal awakening to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that some patients got mild flu like symptoms after receiving Shingrix. The patient received Shingrix dose at mid-day. Around 7 pm that same day, 7 hours after receiving Shingrix, she started having shivers, headache, nausea and general flu like symptoms. Nine hours after receiving Shingrix, She went to bed about 9 pm because she felt tired. She slept okay but before she went to bed she had two Tylenol. She felt warm as well. She woke up several times at night and this morning she did not feel like walking, like she normally does early in the morning and stayed in bed until 8 AM.  She went to the bathroom to wash her hands and she fainted and she fell. It was not a bad fall and the reporter helped her to lay on the floor. She just came back to the bed and rested a little bit more. The patient stated that right now the only symptom that she has was still feeling lightheaded and having difficulty standing up which started 1 day after receiving Shingrix.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Headache, Influenza like illness, Middle insomnia, Nausea
Clinical narrative: Woke up several times at night; Fell; Feeling lightheaded; Difficulty standing up; Fainted; Shivers; Headaches; Nausea; General flu-like symptoms; Felt tired; Felt warm; This case was reported by a consumer via call center representative and described the occurrence of faint in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th October 2019, the patient received the 1st dose of Shingrix. On 8th October 2019, 7 hrs after receiving Shingrix, the patient experienced shivers, headache, nausea, flu-like symptoms, tiredness and feeling of warmth. On 9th October 2019, the patient experienced faint (serious criteria GSK medically significant), fall, light headedness and difficulty in standing. On an unknown date, the patient experienced nocturnal awakening. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the faint, shivers, headache, nausea, flu-like symptoms, tiredness, feeling of warmth and fall were recovered/resolved and the outcome of the light headedness and difficulty in standing were not recovered/not resolved and the outcome of the nocturnal awakening was unknown.   It was unknown if the reporter considered the faint, shivers, headache, nausea, flu-like symptoms, tiredness, feeling of warmth, fall, light headedness, difficulty in standing and nocturnal awakening to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that some patients got mild flu like symptoms after receiving Shingrix. The patient received Shingrix dose at mid-day. Around 7 pm that same day, 7 hours after receiving Shingrix, she started having shivers, headache, nausea and general flu like symptoms. Nine hours after receiving Shingrix, She went to bed about 9 pm because she felt tired. She slept okay but before she went to bed she had two Tylenol. She felt warm as well. She woke up several times at night and this morning she did not feel like walking, like she normally does early in the morning and stayed in bed until 8 AM.  She went to the bathroom to wash her hands and she fainted and she fell. It was not a bad fall and the reporter helped her to lay on the floor. She just came back to the bed and rested a little bit more. The patient stated that right now the only symptom that she has was still feeling lightheaded and having difficulty standing up which started 1 day after receiving Shingrix.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Woke up several times at night; Fell; Feeling lightheaded; Difficulty standing up; Fainted; Shivers; Headaches; Nausea; General flu-like symptoms; Felt tired; Felt warm; This case was reported by a consumer via call center representative and described the occurrence of faint in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th October 2019, the patient received the 1st dose of Shingrix. On 8th October 2019, 7 hrs after receiving Shingrix, the patient experienced shivers, headache, nausea, flu-like symptoms, tiredness and feeling of warmth. On 9th October 2019, the patient experienced faint (serious criteria GSK medically significant), fall, light headedness and difficulty in standing. On an unknown date, the patient experienced nocturnal awakening. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the faint, shivers, headache, nausea, flu-like symptoms, tiredness, feeling of warmth and fall were recovered/resolved and the outcome of the light headedness and difficulty in standing were not recovered/not resolved and the outcome of the nocturnal awakening was unknown.   It was unknown if the reporter considered the faint, shivers, headache, nausea, flu-like symptoms, tiredness, feeling of warmth, fall, light headedness, difficulty in standing and nocturnal awakening to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that some patients got mild flu like symptoms after receiving Shingrix. The patient received Shingrix dose at mid-day. Around 7 pm that same day, 7 hours after receiving Shingrix, she started having shivers, headache, nausea and general flu like symptoms. Nine hours after receiving Shingrix, She went to bed about 9 pm because she felt tired. She slept okay but before she went to bed she had two Tylenol. She felt warm as well. She woke up several times at night and this morning she did not feel like walking, like she normally does early in the morning and stayed in bed until 8 AM.  She went to the bathroom to wash her hands and she fainted and she fell. It was not a bad fall and the reporter helped her to lay on the floor. She just came back to the bed and rested a little bit more. The patient stated that right now the only symptom that she has was still feeling lightheaded and having difficulty standing up which started 1 day after receiving Shingrix.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Acne, Headache, Herpes zoster, Miliaria
Clinical narrative: Suspected vaccination failure; shingles; Rash on left chest area that is just above left breast and moves over to sternum area, itchy; red Red; Pimples that was extremely itchy; Pimples sore to touch / Whole body aches; Low grade fever; Some weeping; headache; stomach pain; heat rash; Itchy rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure high.   In January 2019, the patient received the 1st dose of Shingrix. In March 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a year after receiving Shingrix and between 6 and 7 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, itchy rash, red rash, pimples, pain, low grade fever, secretion discharge, headache, stomach pain, heat rash and itchy rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure, shingles, itchy rash, red rash, pimples, pain, low grade fever, secretion discharge, headache, stomach pain, heat rash and itchy rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, itchy rash, red rash, pimples, pain, low grade fever, secretion discharge, headache, stomach pain, heat rash and itchy rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient could be 68 or 69 years old. She noted she takes a blood pressure medication but otherwise was healthy. Within the last week, 5 days before the date of reporting, the patient started with a rash on her left chest area that was just above her left breast and moves over to her sternum area. It was red, has pimples that was extremely itchy and sore to touch.  The patient stated there was some weeping, but she put alcohol on the rash because she thought it was a heat rash. This case was considered as suspected vaccination failure since the details regarding completion of time to onset and laboratory confirmation were unknown at the time of reporting. The patient had not started the Valtrex yet, because she wants to be sure, so she has an appointment with her primary physician office in the afternoon of reporting day. The patient had low grade fever of 100 to 102 degree C, with whole body aches, headache and stomach pain.  She was concerned because she had both doses of Shingrix and now got the shingles. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Suspected vaccination failure; shingles; Rash on left chest area that is just above left breast and moves over to sternum area, itchy; red Red; Pimples that was extremely itchy; Pimples sore to touch / Whole body aches; Low grade fever; Some weeping; headache; stomach pain; heat rash; Itchy rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure high.   In January 2019, the patient received the 1st dose of Shingrix. In March 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a year after receiving Shingrix and between 6 and 7 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, itchy rash, red rash, pimples, pain, low grade fever, secretion discharge, headache, stomach pain, heat rash and itchy rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure, shingles, itchy rash, red rash, pimples, pain, low grade fever, secretion discharge, headache, stomach pain, heat rash and itchy rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, itchy rash, red rash, pimples, pain, low grade fever, secretion discharge, headache, stomach pain, heat rash and itchy rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient could be 68 or 69 years old. She noted she takes a blood pressure medication but otherwise was healthy. Within the last week, 5 days before the date of reporting, the patient started with a rash on her left chest area that was just above her left breast and moves over to her sternum area. It was red, has pimples that was extremely itchy and sore to touch.  The patient stated there was some weeping, but she put alcohol on the rash because she thought it was a heat rash. This case was considered as suspected vaccination failure since the details regarding completion of time to onset and laboratory confirmation were unknown at the time of reporting. The patient had not started the Valtrex yet, because she wants to be sure, so she has an appointment with her primary physician office in the afternoon of reporting day. The patient had low grade fever of 100 to 102 degree C, with whole body aches, headache and stomach pain.  She was concerned because she had both doses of Shingrix and now got the shingles. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Secretion discharge, Tenderness, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; Rash on left chest area that is just above left breast and moves over to sternum area, itchy; red Red; Pimples that was extremely itchy; Pimples sore to touch / Whole body aches; Low grade fever; Some weeping; headache; stomach pain; heat rash; Itchy rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure high.   In January 2019, the patient received the 1st dose of Shingrix. In March 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a year after receiving Shingrix and between 6 and 7 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, itchy rash, red rash, pimples, pain, low grade fever, secretion discharge, headache, stomach pain, heat rash and itchy rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure, shingles, itchy rash, red rash, pimples, pain, low grade fever, secretion discharge, headache, stomach pain, heat rash and itchy rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, itchy rash, red rash, pimples, pain, low grade fever, secretion discharge, headache, stomach pain, heat rash and itchy rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient could be 68 or 69 years old. She noted she takes a blood pressure medication but otherwise was healthy. Within the last week, 5 days before the date of reporting, the patient started with a rash on her left chest area that was just above her left breast and moves over to her sternum area. It was red, has pimples that was extremely itchy and sore to touch.  The patient stated there was some weeping, but she put alcohol on the rash because she thought it was a heat rash. This case was considered as suspected vaccination failure since the details regarding completion of time to onset and laboratory confirmation were unknown at the time of reporting. The patient had not started the Valtrex yet, because she wants to be sure, so she has an appointment with her primary physician office in the afternoon of reporting day. The patient had low grade fever of 100 to 102 degree C, with whole body aches, headache and stomach pain.  She was concerned because she had both doses of Shingrix and now got the shingles. The reporter consented to follow up.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness around the injection site; Itching around the injection site; Feels like someone punched her; It looks like it does when someone takes a bandaid off their skin; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 21-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number Y5X93, expiry date 30th June 2020) for prophylaxis.   Concurrent medical conditions included latex allergy.   On 9th October 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular). On 9th October 2019, less than an hour after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site erythema, injection site itching, injection site pain and injection site discoloration. On an unknown date, the outcome of the injection site erythema, injection site itching, injection site pain and injection site discoloration were unknown.   It was unknown if the reporter considered the injection site erythema, injection site itching, injection site pain and injection site discoloration to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patient received dose of Shingrix in the right arm. Within 30 minutes after vaccination with dose of Shingrix, the patient experienced redness and itching around injection site. The nurse reported that, it was barely red and dfid not worsen.It looks like it did when someone takes a bandaid off their skin. It was not swollen. the  patient stated that every time got vaccine and experienced red and itch and feels like someone punched. The reporter consented to follow up. This case was 1 of 4 linked cases reported by same reporter.
Age: 51.0
Sex: F
Vaccine: UNK, VARZOS, VARZOS
Symptoms: Blood test abnormal, Herpes zoster, Inappropriate schedule of product administration, Rash, Vaccination failure
Clinical narrative: Vaccination failure; shingles; shingles pain/painful rash; inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and etanercept (Enbrel) for rheumatoid arthritis.   Previously administered products included Enbrel with an associated reaction of herpes zoster. Concurrent medical conditions included rheumatoid arthritis.   In April 2018, the patient received the 1st dose of Shingrix (intramuscular). In May 2018, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the patient started Enbrel at an unknown dose and frequency. In May 2018, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. In January 2019, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and painful rash. On an unknown date, the outcome of the vaccination failure and drug dose administration interval too short were unknown and the outcome of the shingles and painful rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and painful rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: It was reported that prior to getting Shingrix she developed shingles while taking Enbrel. The patient stopped taking Enbrel and waited sometime after shingles resolved before getting Shingrix. The patient received 1st dose dose of Shingrix in April 2018 and the 2nd dose of Shingrix in May 2018, only one month later, which led to shortening of vaccination schedule.  About one month after the 2nd dose of Shingrix, she restarted Enbrel. She developed shingles in January 2019 and had 2 to 3 cases since then and currently had shingles.  She stated each time she started taking Enbrel, she developed shingles.  She had seen her primary care physician, an emergency room doctor, her rheumatologist, an infections disease doctor and an after hours doctor about the cases of shingles she had experienced.  At least twice the provider she saw stated that she did not have shingles and a blood tests was performed which came back positive for shingles. Several of the providers never looked at her back, where she was experiencing the shingles pain, while declaring she didn't have shingles. Since it was on her back she could not see if she had a rash. For her most recent case of shingles she saw the after hours doctor, who actually looked at her back, and stated she did have shingles. The reporter considered shingles and painful rash to be related to Shingrix and Shingrix. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site infection, Injection site pain, Injection site swelling
Clinical narrative: Red injection site; Swollen injection site; Painful injection site; Could not move right arm and shoulder; The site "might be infected"; shoulder mobility decreased; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose, refer case US2019183587).   On 7th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 7th October 2019, 3 hrs after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site pain, injected limb mobility decreased, injection site infection and joint range of motion decreased. The patient was treated with non-drug therapy (Ice Pack (No Medication)) and ibuprofen (Advil). On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the injection site swelling, injection site pain, injected limb mobility decreased, injection site infection and joint range of motion decreased were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain, injected limb mobility decreased, injection site infection and joint range of motion decreased to be related to Shingrix.  Additional information received were as follows: The patient developed a red, swollen, painful injection site on her right arm. She states the pain and swelling were so bad that she could not move her right arm and shoulder. She states that the pain decreased but persists, as did not the redness and swelling. She states she sought treatment with her dermatologist who stated the site might be infected. Treatment to site was ice and heat compresses and Advil. Th reporter consented to follow up. Emergency room visit required. The consumer did not have any further vaccine information for this adverse event.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint range of motion decreased
Clinical narrative: Red injection site; Swollen injection site; Painful injection site; Could not move right arm and shoulder; The site "might be infected"; shoulder mobility decreased; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose, refer case US2019183587).   On 7th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 7th October 2019, 3 hrs after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site pain, injected limb mobility decreased, injection site infection and joint range of motion decreased. The patient was treated with non-drug therapy (Ice Pack (No Medication)) and ibuprofen (Advil). On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the injection site swelling, injection site pain, injected limb mobility decreased, injection site infection and joint range of motion decreased were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain, injected limb mobility decreased, injection site infection and joint range of motion decreased to be related to Shingrix.  Additional information received were as follows: The patient developed a red, swollen, painful injection site on her right arm. She states the pain and swelling were so bad that she could not move her right arm and shoulder. She states that the pain decreased but persists, as did not the redness and swelling. She states she sought treatment with her dermatologist who stated the site might be infected. Treatment to site was ice and heat compresses and Advil. Th reporter consented to follow up. Emergency room visit required. The consumer did not have any further vaccine information for this adverse event.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. 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 Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient said that the injection caused pain in his arm for a few days. The patient consented to follow up. This case has been linked to US2019183610, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: pain in arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. 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 Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced pain in her arm for 6-7 days after receiving it. The reporter did not consent to follow up. This case linked with US2019183609, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Depressed mood, Malaise, Pain, Swelling
Clinical narrative: Extreme soreness / Achiness; Swelling; Feeling down  for a couple of days; Didn't feel well; This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain, swelling, feeling down and feeling unwell. On an unknown date, the outcome of the pain, swelling and feeling unwell were unknown and the outcome of the feeling down was recovered/resolved.   It was unknown if the reporter considered the pain, swelling, feeling down and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient's age group was not reported but captured as adult as per vaccine indication. The reporter was a floater pharmacist. She worked in a lot of different pharmacies and tons of patients had told her that, they had issues after getting Shingrix.  Those patients had experienced extreme soreness, achiness, swelling, feeling down for a couple of days, did not feel well after getting one or both Shingrix vaccines. The reporter did not have specific details regarding product or patient(s) to provide at time of report, and did not want to be contacted regarding events reported. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Miliaria, Rash, Rash pruritic
Clinical narrative: Hot and itchy rash across her chest and back; Itchy rash across her chest and back; Injection site soreness; This case was reported by a other health professional via call center representative and described the occurrence of heat rash in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. In September 2019, 1 day 12 hrs after receiving Shingrix, the patient experienced heat rash, itchy rash and injection site pain. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the heat rash, itchy rash and injection site pain were recovered/resolved.   It was unknown if the reporter considered the heat rash, itchy rash and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 63 years or 64 years. On an unknown date in September 2019, approximately 2 weeks ago of reporting date, the patient received her 1st Shingrix vaccine at a local pharmacy. After 36 hours of receiving the Shingrix, the patient developed a hot and itchy rash across her chest and back and injection site soreness.  The patient self treated with Benadryl and the events were resolved without medical intervention on an unknown date.  The reporter did not consent to follow-up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass, Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: hard lump at injection site; hard lump at injection site; swelling right arm; soreness right arm; warmth at injection site; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 9DE73, expiry date 6th December 2021) for prophylaxis.   On 28th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 28th September 2019, less than a day after receiving Shingrix, the patient experienced swelling arm, pain in arm and injection site warmth. On an unknown date, the patient experienced injection site lump and injection site induration. On an unknown date, the outcome of the swelling arm, pain in arm, injection site warmth, injection site lump and injection site induration were recovering/resolving.   It was unknown if the reporter considered the swelling arm, pain in arm, injection site warmth, injection site lump and injection site induration to be related to Shingrix.  Additional details were provided as follows: The reporter was a patient.  The patient received Shingrix in her right arm.  After receiving the vaccine, she developed swelling and soreness in the right arm, warmth at the injection site and less than 3 weeks, had a hard lump at the injection site. The patient consented to follow up and also provided her physician's address.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site swelling, Pain, Rash, Vaccination failure
Clinical narrative: Vaccination failure; Shingles outbreak; Bumps that were on back; Painful; Swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number MX2LT, expiry date unknown) for prophylaxis.   Concurrent medical conditions included parkinson's disease.   On an unknown date, the patient received the 1st dose of Shingrix. On 11th February 2019, the patient received the 2nd dose of Shingrix (intramuscular). In February 2019, not applicable after receiving Shingrix and less than a month after receiving Shingrix, the patient experienced injection site swelling. On 30th September 2019, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and pain. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure, shingles, rash and pain were unknown and the outcome of the injection site swelling was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash and pain to be related to Shingrix and Shingrix. It was unknown if the reporter considered the injection site swelling to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient experienced bumps that were on her back and painful and was later seen by her physician and diagnosed with shingles. The patient was prescribed a course of Acyclovir. The patient experienced swelling at injection site after receiving Shingrix. The reporter consented to follow up. The reporter requested to be copied on any letters sent to her physicians.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site haematoma, Injection site pain
Clinical narrative: Hematoma at injection site; Redness at injection site; Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site hematoma in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 4th August 2019, 1 days after receiving Shingrix, the patient experienced injection site hematoma, injection site erythema and injection site pain. On 17th August 2019, the outcome of the injection site hematoma, injection site erythema and injection site pain were resolved with sequelae.   It was unknown if the reporter considered the injection site hematoma, injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced injection site hematoma, injection site erythema and injection site pain after vaccination. The patient consented to follow up. This case has been linked with case US2019185226, reported by the same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Paraesthesia, Rash, Vaccination failure
Clinical narrative: vaccination failure; Shingles; rash; sensation was described as electric shocky; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number C7B9P, expiry date 27th February 2021) for prophylaxis.   On 26th September 2018, the patient received the 1st dose of Shingrix. On 11th January 2019, the patient received the 2nd dose of Shingrix. On 25th September 2019, 364 days after receiving Shingrix and 257 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and electric shock sensation. The patient was treated with azithromycin and valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the vaccination failure, shingles, rash and electric shock sensation were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, rash and electric shock sensation to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient experienced a rash on her right buttock. The sensation was described as electric shocky. On 28th September 2019, the patient was seen by a doctor who diagnosed shingles. The patient was prescribed azithromycin 250 mg for 5 days and  valacyclovir 1 gram three times daily. At the time of reporting, it was not known if the patient has improved. The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Rash on face / Rash is dry and is on forehead and some below the eyes; This case was reported by a pharmacist via call center representative and described the occurrence of red rash in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number LD3NH, expiry date 11th December 2021) for prophylaxis.   On 8th October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, less than a week after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was unknown.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient received first dose of Shingrix and experienced rash on his face. The reporter stated that the rash was red and dry and is on forehead and some below the eyes.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Head discomfort, Headache, Myalgia, Pyrexia
Clinical narrative: muscle aches; joint aches; fever; headache; stuffiness in her head; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th October 2019, the patient received the 1st dose of Shingrix. On 10th October 2019, 1 days after receiving Shingrix, the patient experienced muscle pain, joint pain, fever, headache and head discomfort. On an unknown date, the outcome of the muscle pain, joint pain and fever were resolved with sequelae and the outcome of the headache was unknown and the outcome of the head discomfort was recovering/resolving.   It was unknown if the reporter considered the muscle pain, joint pain, fever, headache and head discomfort to be related to Shingrix.  Additional details were provided as follows: The patient experienced muscle and joint aches, fever and headache and some stuffiness in her head. The patient consented to follow up.
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Coma, Dysstasia, Hypokinesia
Clinical narrative: Coma; Difficulty standing; Motion difficulties; This case was reported by a consumer via call center representative and described the occurrence of coma in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis.   On 29th September 2018, the patient received the 2nd dose of Shingrix and Influenza vaccine Quadrivalent 2018-2019 season. In September 2018, 18 hrs after receiving Shingrix and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced coma (serious criteria hospitalization and GSK medically significant), difficulty in standing (serious criteria hospitalization) and movements reduced (serious criteria hospitalization). On an unknown date, the outcome of the coma, difficulty in standing and movements reduced were recovered/resolved.   It was unknown if the reporter considered the coma, difficulty in standing and movements reduced to be related to Shingrix and Influenza vaccine Quadrivalent 2018-2019 season.  Additional details were provided as follows: The case was reported by patient's husband. The age at vaccination was not reported, but the patient was 81 years old at the time of reporting. About 18 hours after receiving vaccines, the patient went into coma and was hospitalized for a month. The patient also experienced difficulty standing and motion difficulties for 2 months.  The reporter did not consent to follow up. No further details were provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Malaise, Pain in extremity
Clinical narrative: arm sore; "did not feel well"; inapproriate dosing schedule; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 52-year-old female 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 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm, feeling unwell and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm, feeling unwell and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the pain in arm and feeling unwell to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, but it could be 51 or 52 years. The patient received 1st dose of Shingrix a few months ago.  The patient reported arm soreness and did not feel well.  The patient may not come back for 2nd dose, which led to incomplete course of vaccination. The reporter consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Bedridden, Influenza like illness, Vomiting
Clinical narrative: vomiting; flu like symptoms; bedridden; This case was reported by a pharmacist via call center representative and described the occurrence of vomiting in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced vomiting, influenza-like symptoms and bedridden. On an unknown date, the outcome of the vomiting, influenza-like symptoms and bedridden were recovered/resolved.   It was unknown if the reporter considered the vomiting, influenza-like symptoms and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per the vaccine indication. The patient experienced significant reactions after receiving Shingrix. The patient was bedridden with vomiting and flu like symptoms for 2 days. The reporter consented to follow up. This case was linked with the case US2019186076, reported by the same reporter.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: two softball sized red lumps located on each arm injection site that were hot; This is a spontaneous report from contactable pharmacist via Pfizer Sales Representative.   A 67-year-old (probably between the age of 66 and 68) female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration at single dose on an unspecified date in 2019 for immunisation, at physician's office.  The patient medical history and concomitant medications were not reported.  On an unspecified date in 2019 after the shot, while in the pharmacy, she showed pharmacy manager two softball sized red lumps located on each arm injection site that were hot to the touch and were results of the vaccinations. She showed pharmacy manager this about a week before this report. The outcome of the event was unknown.