chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.67
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 20-month-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 13-JAN-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # T013204, expiration date was not provided, but upon internal validation process it was established as 03-DEC-2021 (dose, route of administration and anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 47.01 Fahrenheit (F) for 1 minute 30 seconds. Data logger was involved. There were no previous excursions reported. No additional adverse events were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA004059:
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Oropharyngeal pain, Rash, Rash papular, Sneezing
Clinical narrative: rash; hive like rash / patches of non-itchy hives all over my torso; rash raised; fatigue; sore throat; sneezing; This case was reported by a physician and described the occurrence of fatigue in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number ZY3X4, expiry date 28th April 2020) for prophylaxis.  On 2nd April 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 3rd April 2018, 1 days after receiving Shingrix, the patient experienced fatigue, sore throat and sneezing. On 8th April 2018, the patient experienced generalized rash, rash urticaria-like and raised rash. On an unknown date, the outcome of the fatigue, sore throat, sneezing, generalized rash, rash urticaria-like and raised rash were unknown.   It was unknown if the reporter considered the fatigue, sore throat, sneezing, generalized rash, rash urticaria-like and raised rash to be related to Shingrix.  Additional details were reported as follows: Six days after vaccination, the patient experienced rash which was described as full-body, hive-like and raised.   Follow up information received from the consumer on 5th February 2021: The batch details were updated. Previously administered products included Tdap vaccine received in recent years and flu vaccines. In April 2018, the patient received and week later broke out in huge patches of non-itchy hives all over my torso and took several days for it to dissipate.  The patient contacted the Shingrix representative and reported my side effect and was advised not to take a 2nd injection of Shingrix. The patient was curious to find out the potential ingredient in the Shingrix vaccine that could had triggered this side effect and never had an adverse reaction to any other vaccine that could recall.  The patient was treated with cetirizine hydrochloride (Zyrtec). It would be helpful to know the specific ingredient in the Shingrix vaccine that might had caused this reaction and any insight could provide would be most helpful. The brief chart that primary doctor had written documenting that had reported this to pharmaceutical representative. The patient consulted and asked pharma representative whether should get 2nd dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2018064604:Same reporter
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: rash; hive like rash / patches of non-itchy hives all over my torso; rash raised; fatigue; sore throat; sneezing; This case was reported by a physician and described the occurrence of fatigue in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number ZY3X4, expiry date 28th April 2020) for prophylaxis.  On 2nd April 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 3rd April 2018, 1 days after receiving Shingrix, the patient experienced fatigue, sore throat and sneezing. On 8th April 2018, the patient experienced generalized rash, rash urticaria-like and raised rash. On an unknown date, the outcome of the fatigue, sore throat, sneezing, generalized rash, rash urticaria-like and raised rash were unknown.   It was unknown if the reporter considered the fatigue, sore throat, sneezing, generalized rash, rash urticaria-like and raised rash to be related to Shingrix.  Additional details were reported as follows: Six days after vaccination, the patient experienced rash which was described as full-body, hive-like and raised.   Follow up information received from the consumer on 5th February 2021: The batch details were updated. Previously administered products included Tdap vaccine received in recent years and flu vaccines. In April 2018, the patient received and week later broke out in huge patches of non-itchy hives all over my torso and took several days for it to dissipate.  The patient contacted the Shingrix representative and reported my side effect and was advised not to take a 2nd injection of Shingrix. The patient was curious to find out the potential ingredient in the Shingrix vaccine that could had triggered this side effect and never had an adverse reaction to any other vaccine that could recall.  The patient was treated with cetirizine hydrochloride (Zyrtec). It would be helpful to know the specific ingredient in the Shingrix vaccine that might had caused this reaction and any insight could provide would be most helpful. The brief chart that primary doctor had written documenting that had reported this to pharmaceutical representative. The patient consulted and asked pharma representative whether should get 2nd dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2018064604:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I had the beginning symptoms of the Shingles/ now have a full outbreak / it is "getting worse."; This case was reported by a consumer and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 1st dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had 1st dose of Shingrix prior week to the report. The patient did not realized when she took the vaccine that had the beginning symptoms of shingles. Till the time of report, the patient had a full outbreak of shingles. The patient said that she would had never taken the vaccine had she known this. The patient asked should she had any health concerns. The patient also mentioned that she saw the physician for shingles and that it was not as bad as it could be but that it was getting worse. The information regarding consent to follow up was not reported.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest discomfort, Chills, Condition aggravated, Dyspnoea, Dyspnoea exertional
Clinical narrative: Intense lethargy; tightness in chest; exertion/Some difficulty in breathing upon exertion; injection site bicep is still red; impairment prevented me from working; Muscle soreness at the site; extreme shaking; Could barely walk; Severe chills; This case was reported by a consumer and described the occurrence of injection site muscle pain in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 3R45T, expiry date September 2022) for prophylaxis.   On 22nd December 2020 10:30, the patient received Shingrix (intramuscular) .5 ml. In December 2020, 14 hrs 30 min after receiving Shingrix, the patient experienced chills, tremor and walking difficulty. On 22nd December 2020, the patient experienced injection site muscle pain, injection site erythema and activities of daily living impaired. On 23rd December 2020, the patient experienced lethargy, chest tightness and exertional dyspnea. On an unknown date, the outcome of the injection site muscle pain, tremor, walking difficulty, lethargy, chest tightness, exertional dyspnea, injection site erythema and activities of daily living impaired were recovering/resolving and the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the injection site muscle pain, chills, tremor, walking difficulty, lethargy, chest tightness, exertional dyspnea, injection site erythema and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient administered the Shingrix vaccine at 10:30 AM. Initially experienced muscle soreness at the site but not much else. The patient went on a 7 mile hike without any issues.  The patient woke up at 1:00 AM (14.5 hours later) to severe chills. The patient reported that worst chills ever experienced. The patient could barely walk into bathroom due to chills and had difficulty opening Advil bottle due to extreme shaking.  Extreme chills lasted for 2 hours and then subsided. The patient experienced intense lethargy on 23rd December 2020. The symptoms included tightness in chest and some difficulty in breathing upon exertion. The degree of impairment would have prevented the patient from working. On 24th December 2020 at 3:04 PM after more that 52 hours, still the patient's injection site bicep was red 60 cm in all directions. Other symptoms were reduced, but still present at the time of reporting. The patient suggested increasing patient warning regarding possible side effects. The case was linked with the case US2020AMR256584 (wife's case).; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR256584:Wife's case
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Gait disturbance, Impaired work ability, Injection site erythema, Injection site pain
Clinical narrative: Intense lethargy; tightness in chest; exertion/Some difficulty in breathing upon exertion; injection site bicep is still red; impairment prevented me from working; Muscle soreness at the site; extreme shaking; Could barely walk; Severe chills; This case was reported by a consumer and described the occurrence of injection site muscle pain in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 3R45T, expiry date September 2022) for prophylaxis.   On 22nd December 2020 10:30, the patient received Shingrix (intramuscular) .5 ml. In December 2020, 14 hrs 30 min after receiving Shingrix, the patient experienced chills, tremor and walking difficulty. On 22nd December 2020, the patient experienced injection site muscle pain, injection site erythema and activities of daily living impaired. On 23rd December 2020, the patient experienced lethargy, chest tightness and exertional dyspnea. On an unknown date, the outcome of the injection site muscle pain, tremor, walking difficulty, lethargy, chest tightness, exertional dyspnea, injection site erythema and activities of daily living impaired were recovering/resolving and the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the injection site muscle pain, chills, tremor, walking difficulty, lethargy, chest tightness, exertional dyspnea, injection site erythema and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient administered the Shingrix vaccine at 10:30 AM. Initially experienced muscle soreness at the site but not much else. The patient went on a 7 mile hike without any issues.  The patient woke up at 1:00 AM (14.5 hours later) to severe chills. The patient reported that worst chills ever experienced. The patient could barely walk into bathroom due to chills and had difficulty opening Advil bottle due to extreme shaking.  Extreme chills lasted for 2 hours and then subsided. The patient experienced intense lethargy on 23rd December 2020. The symptoms included tightness in chest and some difficulty in breathing upon exertion. The degree of impairment would have prevented the patient from working. On 24th December 2020 at 3:04 PM after more that 52 hours, still the patient's injection site bicep was red 60 cm in all directions. Other symptoms were reduced, but still present at the time of reporting. The patient suggested increasing patient warning regarding possible side effects. The case was linked with the case US2020AMR256584 (wife's case).; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR256584:Wife's case
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Loss of personal independence in daily activities, Tremor
Clinical narrative: Intense lethargy; tightness in chest; exertion/Some difficulty in breathing upon exertion; injection site bicep is still red; impairment prevented me from working; Muscle soreness at the site; extreme shaking; Could barely walk; Severe chills; This case was reported by a consumer and described the occurrence of injection site muscle pain in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 3R45T, expiry date September 2022) for prophylaxis.   On 22nd December 2020 10:30, the patient received Shingrix (intramuscular) .5 ml. In December 2020, 14 hrs 30 min after receiving Shingrix, the patient experienced chills, tremor and walking difficulty. On 22nd December 2020, the patient experienced injection site muscle pain, injection site erythema and activities of daily living impaired. On 23rd December 2020, the patient experienced lethargy, chest tightness and exertional dyspnea. On an unknown date, the outcome of the injection site muscle pain, tremor, walking difficulty, lethargy, chest tightness, exertional dyspnea, injection site erythema and activities of daily living impaired were recovering/resolving and the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the injection site muscle pain, chills, tremor, walking difficulty, lethargy, chest tightness, exertional dyspnea, injection site erythema and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient administered the Shingrix vaccine at 10:30 AM. Initially experienced muscle soreness at the site but not much else. The patient went on a 7 mile hike without any issues.  The patient woke up at 1:00 AM (14.5 hours later) to severe chills. The patient reported that worst chills ever experienced. The patient could barely walk into bathroom due to chills and had difficulty opening Advil bottle due to extreme shaking.  Extreme chills lasted for 2 hours and then subsided. The patient experienced intense lethargy on 23rd December 2020. The symptoms included tightness in chest and some difficulty in breathing upon exertion. The degree of impairment would have prevented the patient from working. On 24th December 2020 at 3:04 PM after more that 52 hours, still the patient's injection site bicep was red 60 cm in all directions. Other symptoms were reduced, but still present at the time of reporting. The patient suggested increasing patient warning regarding possible side effects. The case was linked with the case US2020AMR256584 (wife's case).; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR256584:Wife's case
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Chills, Dyspnoea, Dyspnoea exertional, Gait disturbance
Clinical narrative: Intense lethargy; tightness in chest; Some difficulty in breathing upon exertion; Muscle soreness at the site; Severe chills; extreme shaking; Could Barely walk; This case was reported by a consumer and described the occurrence of injection site muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd December 2020, the patient received Shingrix. In December 2020, less than a day after receiving Shingrix, the patient experienced chills, tremor and walking difficulty. On 22nd December 2020, the patient experienced injection site muscle pain. On 23rd December 2020, the patient experienced lethargy, chest tightness and exertional dyspnea. On an unknown date, the outcome of the injection site muscle pain, chills, tremor, walking difficulty, lethargy, chest tightness and exertional dyspnea were unknown.   It was unknown if the reporter considered the injection site muscle pain, chills, tremor, walking difficulty, lethargy, chest tightness and exertional dyspnea to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced muscle soreness at the site but not much else.  Also experienced severe chills that she could barely walk and had difficulty opening Advil bottle due to extreme shaking.  She had intense lethargy on 23rd December 2020.  Symptoms included tightness in chest and some difficulty in breathing upon exertion. This case had been linked with US2020AMR256527 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR256527:Husband's case
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Lethargy, Tremor
Clinical narrative: Intense lethargy; tightness in chest; Some difficulty in breathing upon exertion; Muscle soreness at the site; Severe chills; extreme shaking; Could Barely walk; This case was reported by a consumer and described the occurrence of injection site muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd December 2020, the patient received Shingrix. In December 2020, less than a day after receiving Shingrix, the patient experienced chills, tremor and walking difficulty. On 22nd December 2020, the patient experienced injection site muscle pain. On 23rd December 2020, the patient experienced lethargy, chest tightness and exertional dyspnea. On an unknown date, the outcome of the injection site muscle pain, chills, tremor, walking difficulty, lethargy, chest tightness and exertional dyspnea were unknown.   It was unknown if the reporter considered the injection site muscle pain, chills, tremor, walking difficulty, lethargy, chest tightness and exertional dyspnea to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced muscle soreness at the site but not much else.  Also experienced severe chills that she could barely walk and had difficulty opening Advil bottle due to extreme shaking.  She had intense lethargy on 23rd December 2020.  Symptoms included tightness in chest and some difficulty in breathing upon exertion. This case had been linked with US2020AMR256527 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR256527:Husband's case
Sex: U
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: red blotches; This case was reported by a consumer via interactive digital media and described the occurrence of red blotches 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 red blotches. On an unknown date, the outcome of the red blotches was not recovered/not resolved.   It was unknown if the reporter considered the red blotches to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient just got her/his 2nd shingles shot and had a few red blotches on arm. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Injection site erythema, Injection site mass
Clinical narrative: shivering/cannot seem to get warm; red spot / at injection site; lump at injection site; This case was reported by a consumer and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site lump. On 29th December 2020, the patient experienced shivering. On an unknown date, the outcome of the injection site erythema, injection site lump and shivering were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site lump and shivering to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient experienced large red spot and lump at injection site, approximately 2 across and also shivering and he/she could not seem to get warm on the night of 29th December 2020. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: FEVER; BODY ACHES; CHILLS; HEADACHE; This case was reported by a consumer and described the occurrence of fever 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, 5 hrs after receiving Shingrix, the patient experienced fever, general body pain, chills and headache. On an unknown date, the outcome of the fever, general body pain, chills and headache were not recovered/not resolved.   It was unknown if the reporter considered the fever, general body pain, chills and headache to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient experienced fever, body aches, chills and headache about five hours after receiving second dose of Shingrix. The reporter asked how long would these side effects last. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site rash, Rash erythematous, Rash macular
Clinical narrative: red rash below the injection site / redness stayed localized; blotchy red rash below the injection site; still hurts; still hurts; This case was reported by a consumer via interactive digital media and described the occurrence of red 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 red rash, blotchy rash, painful rash and pain localized. On an unknown date, the outcome of the red rash, blotchy rash and painful rash were unknown and the outcome of the pain localized was not recovered/not resolved.   It was unknown if the reporter considered the red rash, blotchy rash, painful rash and pain localized to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The age group,of the patient was not reported but selected as an adult as per vaccine indiaction. The reporter stated that, with 1st dose did not have this problem. The patient experience blotchy rash, it was red and was still hurting on day 2 to 3. The reporter stated that, the redness stayed localized. The reporter asked if it was normal.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: chills; Body aches; This case was reported by a consumer via call center representative and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received primary schedule on an unknown date).   On 14th January 2021, the patient received the 2nd dose of Shingrix. In January 2021, less than a week after receiving Shingrix, the patient experienced chills and general body pain. On an unknown date, the outcome of the chills and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the chills and general body pain to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. The patient received booster dose. After receiving Shingrix, the patient experienced chills and body pain. The patient was asking, how long would this last.
Sex: U
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: Blurring in one eye; This case was reported by a consumer via interactive digital media and described the occurrence of blurred vision in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 1st dose of Shingrix. In January 2021, 1 day after receiving Shingrix, the patient experienced blurred vision. On an unknown date, the outcome of the blurred vision was unknown.   It was unknown if the reporter considered the blurred vision 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 received the first dose of Shingrix 4 days ago and experienced blurring in one eye starting the day after vaccination.  The patient saw nothing on side about that being a possible side effects. The patient asked if the patient could get any more information.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache
Clinical narrative: headache; Achy joints; This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-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 headache and joint pain. On an unknown date, the outcome of the headache and joint pain were not recovered/not resolved.   It was unknown if the reporter considered the headache and joint pain to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The age at vaccination was not reported. The patient experienced headache and achy joints and asked if she take an over the counter medicine would it made the vaccine ineffective. The patient asked if she could take acetaminophen after receiving second dose. The patient was recommend to speak with her healthcare provider regarding above question and healthcare provider would determine the right treatment plan for her. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: had the second dose yesterday / my arm barely hurts; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date refer case US2021015583).   On 21st January 2021, the patient received the 2nd dose of Shingrix. In January 2021, less than a week after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself. The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  The patient had the 2nd dose of Shingrix yesterday from the day of reporting and arm barely hurts and no other side effects. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021015583:Same reporter
Sex: U
Vaccine: MNQ
Symptoms: Injection site pruritus
Clinical narrative: itching at the injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site itching in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo .5 ml. On an unknown date, unknown after receiving Menveo, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was unknown.   It was unknown if the reporter considered the injection site itching to be related to Menveo.  Additional details were provided as follows: The age at vaccination was not reported. The patient was teenager. The patient received Menveo and experienced injection site itching. This case has been linked with US2021AMR020783 and US2020AMR239598, reported by same reporter.
Sex: U
Vaccine: MNQ
Symptoms: Injection site pruritus
Clinical narrative: itching at the injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site itching in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo .5 ml. On an unknown date, unknown after receiving Menveo, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was unknown.   It was unknown if the reporter considered the injection site itching to be related to Menveo.  Additional details were provided as follows: The age at vaccination was not reported. The patient was teenager. The patient received Menveo and experienced injection site itching. This case has been linked with US2021AMR020769 and US2020AMR239598, reported by same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pain in extremity
Clinical narrative: It was painful going through my arm; never went back for part 2; This case was reported by a consumer via and described the occurrence of pain in arm in a adult 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 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself/himself. The age at vaccination was not reported for 1st suspect vaccine. The age group was not reported but was captured as an adult as per vaccine indication.  The age at vaccination was not applicable for the 2nd suspect vaccine. The patient received 1st Shingrix shot about two years ago from the reporting date and he/she was hated it. The reporter mentioned that, it was painful going through his/her arm therefore he/she never went back for part 2. The reporter was considering getting the shot again and asked if he/she would need two shots since it had been so long in between them or just one. Till the time of reporting patient did not receive 2nd dose, which led to incomplete course of vaccination. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: headache; This case was reported by a consumer via interactive digital media and described the occurrence of headache 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 headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient received 2nd vaccine and had many sidedeffects, none of them were serious, however he/she asked what should take for a headache. The follow-up would not possible, as no contact details were available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pain in extremity, Rash
Clinical narrative: Rash; muscle pain; headache; sore arm; This case was reported by a physician and described the occurrence of rash in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash (1st dose received on 29th July 2020, reference case US2020213894).   On 21st December 2020, the patient received the 2nd dose of Shingrix. On 21st December 2020, less than a day after receiving Shingrix, the patient experienced rash, muscle pain, headache and pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the rash, muscle pain, headache and pain in arm were recovered/resolved.   The reporter considered the rash, muscle pain, headache and pain in arm to be almost certainly related to Shingrix.  Additional details were provided as follows: The patient experienced rash, muscle pain, headache and sore arm. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020213894:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Wouldn't feel very good the next day; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient received first dose of the new vaccine and not felt very good the next day. The reporter mentioned that, it would better than having shingles of course. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: developed / serious case; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles (serious criteria other: serious per reporter). On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported The age group was not reported but was captured as adult as per vaccine indication.  The patient received Shingrix and developed another serious case in the last two weeks. Patient mentioned that because of that patient did not do vaccines, patient also stated that would not getting the Covid vaccine. This case linked with US2021AMR041410, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR041410:same reporter
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Slight tenderness at the injection site; Slight redness / at the injection site/2.5 inch slight redness; This case was reported by a consumer and described the occurrence of injection site tenderness in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd December 2020, the patient received the 2nd dose of Shingrix. On 23rd December 2020, 1 days after receiving Shingrix, the patient experienced injection site tenderness and injection site erythema. On an unknown date, the outcome of the injection site tenderness and injection site erythema were unknown.   It was unknown if the reporter considered the injection site tenderness and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in his left arm at the doctor's office and on 23rd December 2020 noticed a 2.5 inch slight redness and slight tenderness at the injection site.  The reporter felt the tenderness at the injection site when lays down on his side. The reporter did not consent to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Hemiparesis, Hypokinesia, Mobility decreased
Clinical narrative: weakness on the right side of the body; she cannot lift her arm; This case was reported by a pharmacist via call center representative and described the occurrence of weakness generalized in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 3PD3E, expiry date 8th October 2022) for prophylaxis.   On 10th December 2020, the patient received the 2nd dose of Shingrix. In December 2020, an unknown time after receiving Shingrix, the patient experienced weakness generalized and mobility decreased. On an unknown date, the outcome of the weakness generalized and mobility decreased were unknown.   It was unknown if the reporter considered the weakness generalized and mobility decreased to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in left arm and presented weakness on the right side of the body and could not lift her arm. The reporter stated, it had been 14 days and it still had not resolved.  The reporter consented to follow up.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, White blood cell count
Clinical narrative: received her first shot / 1 year ago / has not received a second shot; after / first shot / was sick in bed for 3 days; This case was reported by a consumer and described the occurrence of sickness in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rheumatoid arthritis and white blood cell count low (low white count).   In December 2019, 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, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced sickness and incomplete course of vaccination. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The age at vaccination was not applicable for the second suspect vaccine. The patient received her first shot of Shingrix 1 year ago from the reporting date and has not received a second shot till the time of reporting, which led to incomplete course of vaccination. The patient's doctor advised her against a second shot of Shingrix because after first shot she was sick in bed for 3 days. The reporter did not consent to follow-up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash, Rash macular, Rash pruritic
Clinical narrative: prolonged itchy rash/reaction / itchy rash; allergic reaction; rash is little dots on her entire body; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced itchy rash, allergic reaction and blotchy rash. On an unknown date, the outcome of the itchy rash and blotchy rash were not recovered/not resolved and the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the itchy rash, allergic reaction and blotchy rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself.  The patient received the 1st Shingrix shot and was experiencing a prolonged itchy rash/reaction.  She was calling to see if anyone in clinical trials reported a prolonged itchy rash and to see if she should get the 2nd Shingrix dose or not. The patient said the itchiness was more bothersome than the rash.  The rash was little dots on her entire body.  The rash started initially on her stomach. The patient had gone to the doctor (including a dermatologist) on 3 occasions regarding this issue but they had not been able to definitively give her an answer as to what was causing the itchy rash.  The patient thought might be she had shingles but the doctor said no.  The doctor thought that she had a fungal infection but later she was told that was not the case.  The next step was for her to get allergy testing to confirm if it was an allergic reaction. The reporter said she did not know the exact onset date but it had been an ongoing issue since after the shot.  The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Injection site rash, Rash
Clinical narrative: Continued to get worse and spread down all the way to her left wrist/Localized rash around the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number ZR979, expiry date 28th March 2022) for prophylaxis.   On 2nd October 2020, the patient received the 1st dose of Shingrix. On 5th October 2020, 3 days after receiving Shingrix, the patient experienced injection site rash. The patient was treated with triamcinolone (Triamcinolone Cream) and clobetasol propionate (Clobetasol Cream). On an unknown date, the outcome of the injection site rash was recovered/resolved.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient received Shingrix vaccine in the upper part of her left arm and 3 days later she developed a localized rash around the injection site, it continued to get worse and spread down all the way to her left wrist.  The patient tried Triamcinolone cream which did not help, then tried Clobetasol cream for 14 days which did clear up the rash. The reporter did not consent to follow-up.
Age: 60.0
Sex: F
Vaccine: FLUX(H1N1), VARZOS
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Fever of 101; Swollen lymph node; This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date). Concurrent medical conditions included shingles.   On 14th December 2020, the patient received Shingrix (intramuscular). On 15th December 2020, 1 days after receiving Shingrix, the patient experienced fever and enlargement of lymph nodes. The patient was treated with paracetamol (Tylenol). On 17th December 2020, the outcome of the fever was recovered/resolved. On 20th December 2020, the outcome of the enlargement of lymph nodes was recovered/resolved.   It was unknown if the reporter considered the fever and enlargement of lymph nodes to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. The patient received 2nd dose of Shingrix in the left arm. On the next day, the patient had a fever of 101 degree F which lasted for two days.  The reporter also stated that she had a swollen lymph node for five days.  The patient took Tylenol for these symptoms. The reporter did not consent to follow-up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site warmth, Skin warm
Clinical narrative: below the injection site / hot /  and warm to touch; below the injection site  pink; This case was reported by a consumer via call center representative and described the occurrence of skin warm in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th January 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 4th January 2021, less than a day after receiving Shingrix, the patient experienced skin warm and skin red. On an unknown date, the outcome of the skin warm and skin red were not recovered/not resolved.   It was unknown if the reporter considered the skin warm and skin red to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The reporter stated that, after vaccination just below the injection site, the patient had 2 inch circle which was hot, pink and warm to the touch. The reporter did not consent to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Burning sensation, Fatigue, Rash
Clinical narrative: Fatigue; Weakness; Rash on the upper abdomen; Rash on the upper abdomen / felt like burning; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included tremor, arrhythmia and fibromyalgia. Concurrent medical conditions included arthritis.   In October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, less than a day after receiving Shingrix, the patient experienced fatigue and weakness. On an unknown date, the patient experienced rash and burning sensation. On an unknown date, the outcome of the fatigue, weakness, rash and burning sensation were recovered/resolved.   It was unknown if the reporter considered the fatigue, weakness, rash and burning sensation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 62 years or 63 years. The patient received dose of Shingrix in the left arm. Within 12 hours after vaccination, the patient experienced fatigue and weakness, lasted for about a day and then resolved. One week after the injection, the patient developed a rash on the upper abdomen that felt like burning. It lasted for about a week and then resolved. The reporter did not consent to follow up.