chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Somnolence
Clinical narrative: felt like crap today; slept for 13 hours; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 4th July 2021, the patient received the 2nd dose of Shingles vaccine. On 5th July 2021, 1 days after receiving Shingles vaccine, the patient experienced feeling abnormal and sleepiness. On an unknown date, the outcome of the feeling abnormal and sleepiness were recovering/resolving.   It was unknown if the reporter considered the feeling abnormal and sleepiness to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the reporter himself/ herself. The patient received second dose of Shingles vaccine, a day before reporting date. On the day of reporting, the patient felt like crap and slept for 13 hours. The patient was feeling better in the evening and hoped to recovered fully by the next day.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: had shingles / got the shot afterward / about 6months later / had them again/ suspected vaccination failure; about 6months later / had them again; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (was back in early 90s).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had shingles back in early 90s. The patient got the shingles shot and then about 6 months later, the patient had shingles again. The both shingles were light cases but miserable none the less. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had shingles after the vaccine!/Suspected vaccination failure; I had shingles after the vaccine! / worst six weeks of my life; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The reporter had shingles after the vaccine. The worst six weeks of his life. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: We got both shots on the same day. One in each arm / got both shots on the same day / that was in 5/18/2021; This case was reported by a consumer via interactive digital media and described the occurrence of overdose in a unspecified number patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 18th May 2021, the patient received the 2nd dose of Shingles vaccine. On 18th May 2021, unknown after receiving Shingles vaccine, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patients got both shots on the same day one in each arm which led to overdose. The patient did not had any problem. This case has been linked with case US2021AMR148465, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR148465:Same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shots and then got shingles / Suspected vaccination failure; Got the shots and then got shingles.; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The patient got the shingles shots and then got shingles. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Wound
Clinical narrative: Itching / in different areas of his body; soars all over in different areas of his body; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced pruritus and pain. On an unknown date, the outcome of the pruritus and pain were unknown.   It was unknown if the reporter considered the pruritus and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the wife of patient. The age at vaccination was not reported. The patient received Shingles vaccine a year ago and experienced itching and soars all over in different areas of his body. The reporter asked that can you still getting shingles dr don't know all he did was it.
Sex: F
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: had to deal with a side effect of Bell's palsy; This case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine.  Additional information was provided as follows: The case was reported by patient's son/daughter. The age at vaccination was not reported. The patient got vaccine and had to deal with a side effect of Bell's Palsy. The reporter stated, researched for a different route. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: they are past due for dose two / they received dose one / in August on 2019 / they have not received dose two; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The consumer declined to provide demographics, lot number, or expiration date. The reporter did not consented to follow up  No additional details to report. This case has been linked with case US2021147629, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021147629:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; my father has had it more than once/ had it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's child. The age at vaccination was not reported. The patient had shingles more than once, even after the shot. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal distension, Erythema, Flatulence, Pain, Rash
Clinical narrative: redness; soreness; rash; I  also had severe bloating and gas for 3 days; I  also had/ gas for 3 days; This case was reported by a consumer via interactive digital media and described the occurrence of erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema, pain, rash, bloating and gas. On an unknown date, the outcome of the erythema, pain, rash, bloating and gas were recovered/resolved.   It was unknown if the reporter considered the erythema, pain, rash, bloating and gas to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The patient had received Shingrix and experienced redness, soreness, rash and also had severe bloating and gas for 3 days. The patient was fine at the time of reporting. The patient enquired if the symptoms were connected to Shingrix vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles from the vaccine a side affect they don't tell you/Suspected Vaccination failure; got shingles from the vaccine; This case was reported by a consumer via interactive digital media (Facebook) and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's wife. The age at vaccination was not reported. The reporter stated that the patient got shingles from the vaccine, a side effect that they did not tell you. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Product supply issue
Clinical narrative: due to lack of availability was unable to get a second dose within the 6 month period.; This case was reported by a consumer via interactive digital media and described the occurrence of product supply issue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: This case was reported by the patient's friend. The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of Shingrix due to lack of availability, within the 6 month period, which led to product supply issue. The reporter enquired if she needed to start over.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose / January 2020 / has been over a year / have to restart series ?; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details provided were as follows: The age at vaccination is not applicable for this report. Till the time of reporting patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter enquired whether patient need to restart the series. No further details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm/ I also had it (worse I might add); This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient herself/himself. The age at vaccination was not reported. The patient received 2 doses of shingrix vaccine and experienced worse sore arm. The patient stated that you were alive and did not had covid 19, then life is good. The follow-up would not possible as no contact details were available. For tolerance after 2nd dose refer case US2021AMR149448; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR149448:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Rheumatoid arthritis
Clinical narrative: don't tell what it can do to you / like Rheumatoid Arthritis / Thanks for the life long disease; This case was reported by a consumer via interactive digital media and described the occurrence of rheumatoid arthritis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant). On an unknown date, the outcome of the rheumatoid arthritis was not recovered/not resolved.   It was unknown if the reporter considered the rheumatoid arthritis to be related to Shingles vaccine.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The reporter mentioned that, you better read the insert, then go to the manufacturers data information, they did not tell what it could do to you and all the side effects, like rheumatoid arthritis and much more. The reporter mentioned that, thanks for the life long disease. Follow-up would not be possible, as no contact details were available.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: 1 dose powder only; 1 dose powder only; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amxa418a, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Menveo 5 mg. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient had taken Menveo 1 dose powder only which led to the inappropriate reconstitution technique and inappropriate dose of vaccine administered. The reporter did not agreed to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Had the first shingle shot over a year ago / can I get the second shot now?; This case was reported by a consumer via  interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on a year and two months ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient asked if he/she could get the second shot now. Follow-up would not be possible, as no contact details were available.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Put under the weather; This case was reported by a consumer via other manufacturer and described the occurrence of feeling unwell in a 71-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   The patient's past medical history included hypothyroidism (Thyroid low) and hysterectomy (patient had total hysterectomy when she was 42 years old). Concurrent medical conditions included osteoporosis.   In August 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at the vaccination was not reported. The patient got her Flu shot and experienced put under the weather.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR150404:Same reporter. US-GLAXOSMITHKLINE-US2021AMR150409:Same reporter. US-GLAXOSMITHKLINE-US2021AMR149519:Same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bone densitometry, Computerised tomogram, Echocardiogram, Illness
Clinical narrative: Put you under the weather; This case was reported by a consumer via other manufacturer and described the occurrence of illness in a 71-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included total hysterectomy and stroke. Previously administered products included Premarin. Concurrent medical conditions included osteoporosis and thyroid activity decreased. Additional patient notes included Patient Ethnicity. Concomitant products included bupropion hydrochloride (Wellbutrin), aspirin, caffeine, salicylamide (Aspirin + Caffeine + Salicylamide), hydrochlorothiazide, triamterene (Hydrochlorothiazide + Triamterene), estradiol, cetirizine hydrochloride (Zyrtec), vitamins nos (Vitamins) and atorvastatin calcium (Lipitor).   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 illness. On an unknown date, the outcome of the illness was unknown.   It was unknown if the reporter considered the illness to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient herself.  The age at vaccination was not reported. The patient's past medical history included stroke and total hysterectomy. Concurrent medical conditions included osteoporosis, thyroid activity decreased. Historical drug included included Premarin. Concomitant products included Wellbutrin, aspirin, hydrochlorothiazide, estradiol, Zyrtec, vitamins and Lipitor. The patient received first dose of Shingrix and felt under the weather. The patient had received the vaccine 1.5 to 2 years ago. The lab tests included bone density test with results osteopenia and osteoporosis, CT scan with results unknown, echocardiogram with results normal. The reporter consented to follow up. This case was linked with US2021AMR150392, US2021AMR150409 for same patient. This case was linked with US2021AMR149519, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR150392:Same reporter. US-GLAXOSMITHKLINE-US2021AMR150409:Same reporter. US-GLAXOSMITHKLINE-US2021AMR149519:Same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Balance disorder, Bone density abnormal, Dehydration, Laboratory test abnormal, Malaise
Clinical narrative: Put you under the weather; This case was reported by a consumer via other manufacturer and described the occurrence of illness in a 71-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included total hysterectomy and stroke. Previously administered products included Premarin. Concurrent medical conditions included osteoporosis and thyroid activity decreased. Additional patient notes included Patient Ethnicity. Concomitant products included bupropion hydrochloride (Wellbutrin), aspirin, caffeine, salicylamide (Aspirin + Caffeine + Salicylamide), hydrochlorothiazide, triamterene (Hydrochlorothiazide + Triamterene), estradiol, cetirizine hydrochloride (Zyrtec), vitamins nos (Vitamins) and atorvastatin calcium (Lipitor).   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 illness. On an unknown date, the outcome of the illness was unknown.   It was unknown if the reporter considered the illness to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient herself.  The age at vaccination was not reported. The patient's past medical history included stroke and total hysterectomy. Concurrent medical conditions included osteoporosis, thyroid activity decreased. Historical drug included included Premarin. Concomitant products included Wellbutrin, aspirin, hydrochlorothiazide, estradiol, Zyrtec, vitamins and Lipitor. The patient received first dose of Shingrix and felt under the weather. The patient had received the vaccine 1.5 to 2 years ago. The lab tests included bone density test with results osteopenia and osteoporosis, CT scan with results unknown, echocardiogram with results normal. The reporter consented to follow up. This case was linked with US2021AMR150392, US2021AMR150409 for same patient. This case was linked with US2021AMR149519, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR150392:Same reporter. US-GLAXOSMITHKLINE-US2021AMR150409:Same reporter. US-GLAXOSMITHKLINE-US2021AMR149519:Same reporter.
Sex: U
Vaccine: HEPAB
Symptoms: Social problem
Clinical narrative: Some patients  / received / 1st / doses / in 2020 and due to covid are / coming / to finish / series; This case was reported by a nurse via call center representative and described the occurrence of social problem in an unspecified number of patients who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in 2020).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patients received 1st dose of Twinrix in 2020 and due to covid they were not coming back in to finish their series. The reporter consent to follow up via email. This case has been linked with case US2021149566 and US2021AMR150416 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021149566:Same reporter. Only pt identified. US-GLAXOSMITHKLINE-US2021AMR150416:Same reporter. "Some patients" who only got 1st and 2nd dose.
Sex: U
Vaccine: HEPAB
Symptoms: Social problem
Clinical narrative: Some patients  / received / 1st or 2nd doses  / in 2020 and due to covid are / coming / to finish / series; This case was reported by a nurse via call center representative and described the occurrence of social problem in an unspecified number of patients who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st or 2nd dose of Twinrix in 2020).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patients did not receive the 3rd dose of Twinrix due to Covid-19 pandemic, which led to social problem. No further information was reported. The reporter consented to follow up. This is 1 of the 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR150415:Same reporter. "Some patients" who only got 1st dose. US-GLAXOSMITHKLINE-US2021149566:Same reporter. Only pt identified.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had one shot and the second exactly one year later; This case was reported by a consumer via (Chatbot) interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: This case was reported by the patient himself/herself. The age at vaccination was not reported. The patient received second dose of shingrix vaccine exactly one year later from 1st dose. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The patient was told to get a third vaccine by one person and was also told that it was ok to having two by another person. No other information was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose/ August 5th 2019.; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 5th August 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter wanted to know if the patient needs to restart series or if they should administer the 2nd dose now. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first injection in Aug 2020/Didn't get 2nd injection till June 2021.; This case was reported by a consumer via Shingrix GSK and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2020).   In June 2021, the patient received the 2nd dose of Shingrix. In June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient was due for 2nd dose of Shingrix in October 2020 but didn't get it until June 2021, eight months after it was due, which led to lengthening of vaccine schedule. The patient want to know if the patient would be safe from Shingles, or if the patient should get 3rd injection. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspect vaccination failure; I got both shots and I've had shingles six times since; This case was reported by a consumer via interactive digital media (Facebook) and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient herself/himself. The age at vaccination was not reported. The patient stated that he/she received the both shots and had shingles six times since. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: DTAPHEPBIP, DTAPIPVHIB
Symptoms: No adverse event, Off label use
Clinical narrative: Using Pentacel off Label with Pediarix/prophylactic vaccination (Immunisation); This case was reported by a consumer via other manufacturer and described the occurrence of off label use in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and PENTACEL (DTAP + HIB + IPV) for prophylaxis.   On an unknown date, the patient received Pediarix, Pediarix Pre-Filled Syringe Device and PENTACEL (DTAP + HIB + IPV). On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Pentacel off label with Pediarix, which led to off label use of product. At the time of report, no adverse event reported. There will be no information available on batch number for this case. The reporter did not consented to follow up
Sex: U
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Have these red spot on my arm; This case was reported by a consumer via interactive digital media and described the occurrence of red rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th July 2021, the patient received the 1st dose of Shingrix. In July 2021, less than a week after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was not recovered/not resolved.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received the 1st dose of Shingrix and less than a week after the vaccination the patient had all the side effects but also had red spot on his/her arm. The reporter asked was that normal.
Age: 18.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: accidently gave an 18 year old patient the adult dose; accidently gave an 18 year old patient the adult dose; This case was reported by a other health professional via other manufacturer and described the occurrence of adult product administered to child in a 18-year-old patient who received HAV (Havrix 1440 adult) for prophylaxis.   On an unknown date, the patient received Havrix 1440 adult. On an unknown date, unknown after receiving Havrix 1440 adult, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.  Additional details were provided as follows: The health care professional stated that she accidently gave an 18 year old patient the adult dose of Havrix,which led to overdose and adult product administered to child. The HCP asked for the further guidance. The HCP was advised that Merck did not manufacture Havrix product and therefore did not have the information she was requesting and suggested that the Merck Service Center could still file an AE and send it to the vaccines manufacturer. The HCP declined to provide any additional information, stating that she needed to speak to the manufacturer of the product and was not interested in filing an AE at that time and she was provided with contact information for the manufacturer of Havrix. No additional information available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Nervous system disorder, Pain, Rash
Clinical narrative: GOING THROUGH CHANGES AND MY NERVES GOT SO BAD; BROCK OUT A YEAR LATER; BELIEVE ME IT'S SO PAINFUL; I TOOK ONE SHOT AND FORGOT TO TAKE THE SECOND; This case was reported by a consumer via interactive digital media and described the occurrence of nervous system disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced nervous system disorder, skin eruption, pain and incomplete course of vaccination. On an unknown date, the outcome of the nervous system disorder, skin eruption, pain and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the nervous system disorder, skin eruption and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not applicable or the 2nd dose of Shingrix. The case was reported by the patient himself/herself. The age at vaccination was not reported for 1st dose and age at vaccination was not applicable for the 2nd dose of Shingrix. The patient received the 1st dose of Shingles vaccine and one year later patient stated his/her nerves got so bad and broke out. The reporter stated it was so painful. Till the time of reporting the patient did not receive the 2nd dose of Shingles vaccine,which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Have taken shingle shot it is after six months do I need to start all over?; This case was reported by a consumer via Shingrix GSK and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received 2nd dose of shingrix vaccine after six months,which led to lengthening of the schedule. The patient asked did he/she need to restart the schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: sick for a night; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's parent. The age at vaccination was not reported. The patient received 2nd shot of Shingles vaccine and sick for night. The follow up would not be possible as no contact details were available. This case has been linked with case US2021AMR084069, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR084069:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: have really itchy rash; This case was reported by a consumer via interactive digital media and described the occurrence of itchy rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the itchy rash to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingrix vaccine and experienced itchy rash. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; had shingles a few months ago and they would have been worse without the vaccine; This case was reported by a consumer via interactive digital media (Facebook) and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported this case for him/herself. The age at vaccination was not reported. The patient got shingles a few months before the date of reporting. The patient stated, he/she was so glad to have the vaccine otherwise shingles would had been worse without the vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; have had them 3.times / believe I have them now / have had the shots; This case was reported by a consumer via interactive digital media (Facebook) and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  The patient's past medical history included shingles (3 times).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient received shingles shots. The patient reported that he or she had shingles 3 times and he or she believed having shingles at the time of reporting. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Malnutrition, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got sick from shingles; Dr implied / anti viral meds were a factor / Every nutrients in my body seemed depleted; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and malnutrition. On an unknown date, the outcome of the vaccination failure, shingles and malnutrition were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and malnutrition to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient got sick from shingles but the patient's husband was convinced that the vaccine caused the patient to get shingles and the patient's cardiac doctor implied that the anti-viral medications were a factor every nutrients in the patient's body seemed depleted but not sure what caused all of it. Antiviral medications were also considered suspect for depletion of nutrients in body. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; still got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.    This case had been linked with US2021AMR151371, reported for the reporter's husband.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR151371:Same reporter