chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Ocular vascular disorder
Clinical narrative: Blood clot in the right eye; This is a spontaneous report from a contactable consumer(patient) based on information received by Pfizer, license party for apixaban (ELIQUIS).  This spontaneous case was reported by a consumer and describes the occurrence of OPHTHALMIC VEIN THROMBOSIS (Blood clot in the right eye) in male patient of an unknown age who received apixaban (Eliquis) for an unknown indication. CO-SUSPECT PRODUCTS included Covid-19 Vaccine for an unknown indication. On an unknown date, the patient started Eliquis (unknown route). On 07-Jan-2021, the patient started Covid-19 Vaccine (unknown route). In April 2021, the patient experienced OPHTHALMIC VEIN THROMBOSIS (seriousness criterion medically significant). The action taken with Eliquis (Unknown) was unknown. At the time of the report, OPHTHALMIC VEIN THROMBOSIS outcome was unknown. The consumer received his first Pfizer covid 19 shot on 07-Jan-2021 and the second one on 28-Jan- 2021, and 10 days prior to this report he got a blood clot in his right eye. He takes a blood thinner and remarks this should keep him from getting blood clots, should not it. Blood thinner provided was Eliquis. The event was related to covid 19 vaccine and causality with Eliquis was not provided. For Eliquis (Unknown), the reporter did not provide any causality assessments. This case was received via pfizer.  BMS Medical Evaluation Comment: This patient had ophthalmic vein thrombosis while on therapy with apixaban and after taking covid 19 vaccine. Underlying thromboembolic risk as ascertained by the use of apixaban is a significant factor that likely predisposed the patient to develop ophthalmic vein thrombosis and considered not related to apixaban therapy.  Causality Assessment: For apixaban: the causal relationship of the event Ophthalmic vein thrombosis with the suspect product apixaban was not provided Per Reporter; the causal relationship of the event Ophthalmic vein thrombosis with the suspect product apixaban was Not Related Per Company (Bristol-Myers Squibb)
Age: 80.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Ophthalmic vein thrombosis
Clinical narrative: Blood clot in right eye; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age 80-years old, dose 2 via an unspecified route of administration on 28Jan2021, on the right shoulder (lot number EL1283 expiry date was not provided) for COVID-19 immunization. The patient medical history was not reported.  The first dose was received on 07Jan2021 (lot number: ES1656). Concomitant medication included ELIQUIS as blood thinner and baby aspirin for an unspecified indication, start and stop date were not reported. There were no prior vaccinations within 4 weeks. The patient stated that blood clot in his right eye appeared about 10 days ago on Apr2021, but it does appear to be a little better. He did not know the exact date when it appeared. The doctor gave him eye drops and medicine to use at night. He goes back to see the doctor next week. Outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Ocular vascular disorder
Clinical narrative: Blood clot in right eye; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age 80-years old, dose 2 via an unspecified route of administration on 28Jan2021, on the right shoulder (lot number EL1283 expiry date was not provided) for COVID-19 immunization. The patient medical history was not reported.  The first dose was received on 07Jan2021 (lot number: ES1656). Concomitant medication included ELIQUIS as blood thinner and baby aspirin for an unspecified indication, start and stop date were not reported. There were no prior vaccinations within 4 weeks. The patient stated that blood clot in his right eye appeared about 10 days ago on Apr2021, but it does appear to be a little better. He did not know the exact date when it appeared. The doctor gave him eye drops and medicine to use at night. He goes back to see the doctor next week. Outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes virus infection
Clinical narrative: received the 2 dose vaccine / 12/7/20 / just got the herpes infection this past week; This case was reported by a consumer via (Shingrix GSK and described the occurrence of herpes virus infection in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th December 2020, the patient received the 2nd dose of Shingrix. In April 2021, between 4 and 5 months after receiving Shingrix, the patient experienced herpes virus infection. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the herpes virus infection was not recovered/not resolved.   It was unknown if the reporter considered the herpes virus infection to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The patient received the 2nd dose of Shingrix and just got the herpes infection this past week prior to the report. The patient used Valtrex to treat the herpes infection. The reporter inquired could we tell, what had happened or do the patient needed the booster dose.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: aches; This case was reported by a consumer and described the occurrence of pain in a 68-year-old male 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. On an unknown date, the outcome of the pain was recovered/resolved.   The reporter considered the pain to be related to Shingrix.  Additional information was provided as follows: The case was reported by the wife of patient. The age at vaccination was not reported but could be 68 or less than 68 years old . The patient experienced aches with the first dose of the vaccine. The reporter consented to follow up. For tolerance of 2nd dose refer case US2021091668.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021091668:Same patient, 2nd dose
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Hypoacusis, Toothache, Vaccination failure
Clinical narrative: Suspected vaccination failure/Had shingles 10 times in the last seven years / I got the two shingles shot; Had shingles 10 times in the last seven years / I got the two shingles shot; Almost lost my hearing; My teeth hurt every day it's an absolute nightmare; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, hearing impaired and toothache. On an unknown date, the outcome of the vaccination failure, shingles, hearing impaired and toothache were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, hearing impaired and toothache to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient had shingles 10 times in the last 7 years and almost lost his/her hearing, teeth hurt every day and it was absolute nightmare. Two weeks after receiving 2nd dose of Shingles vaccine, the patient got shingles. The patient stated that he/she received 2 Shingles shot and neither of them worked. This case was considered as suspected vaccination failure as details regarding event onset time and laboratory confirmation for shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got my shot, had a light case a year later, suspected vaccination failure; got my shot , had a light case a year later; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year 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 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 received the shingles and had a light case a year later. The patient's physician said if he/she had not gotten the shot then it would have been bad.  The patient was glad he/she received the vaccine. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule and laboratory test confirming shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Mass, Pain, Swelling
Clinical narrative: Even after the 2nd shot, I still have remnants of sore bumps; Even after the 2nd shot, I still have remnants of sore bumps; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain and local swelling. On an unknown date, the outcome of the pain and local swelling were unknown.   It was unknown if the reporter considered the pain and local swelling to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received 1st dose of shingles vaccine and the patient had sore bumps on his/her forehead close to his/her eye. The follow-up would not possible as no contact details were available. For tolerance of 2nd dose, refer case US2021AMR093216.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR093216:Same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Inappropriate schedule of product administration, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got the shingles shot & booster. It keeps trying to come back but the next day or two, it's gone; Itching; Burning; Got the 2nd one (booster) 21 days after the 1st shot; This case was reported by a consumer via media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (patient had shingles boils in past).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pruritus, burning sensation and drug dose administration interval too short. On an unknown date, the outcome of the vaccination failure and drug dose administration interval too short were unknown and the outcome of the shingles, pruritus and burning sensation were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and burning sensation to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. 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 had received the shingles shot a year before the date of reporting and had the second dose (booster) 21 days or 2 weeks after the 1st shot. The patient states that shingles (itching and burning) keeps trying to come back, but then it goes away after a day or two and felt that it was crazy. The itching and burning goes away in a day or two. The patient did not want the shingles boils ever again. The reporter was thankful that they got the shingles shot.  Note: Discrepancy is noted in the interval of 1st and 2nd dose and narrative states 21 days and 2 weeks as gap in two different statements, events has been coded considering more precise value (21 days) and both information is captured in narrative conservatively as no follow-up is possible.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Full blown chickenpox from head to toe; This case was reported by a physician via sales rep and described the occurrence of chickenpox in a 82-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 5th December 2020, refer case US2021093359). Concomitant products included COVID-19 MRNA-1273 VACCINE (COVID-19 VACCINE MODERNA) and COVID-19 MRNA-1273 VACCINE (COVID-19 VACCINE MODERNA).   On 26th March 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced chickenpox. On an unknown date, the outcome of the chickenpox was unknown.   It was unknown if the reporter considered the chickenpox to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received vaccine and experienced full blown chickenpox from head to toe. The patient was seen at the physician's office and that was when the physician learned about the side effects that patient had after 1st dose of vaccine. The reporter did not have information about when the patient was seen at the physician's office. Sales representative was unaware about when the side effects occurred after getting the vaccine and if the side effects was resolved or not and sales representative, physician's office did not know the information about dose, route of administration, site of injection, lot number or expiration date. physician's office did not have detailed information because the patient received the vaccine at the pharmacy. Sales representative did not have additional information about the patient such as demographics or telephone number. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021093359:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had the shot. Still got the Shingles/ suspected vaccination failure; Had the shot. Still got the Shingles; Still have pain; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per the vaccine indication. The patient had the shot and still got the shingles, which was cured but still had pain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation confiding shingles were unknown at the time of reporting.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: 4 doses of expired Bexsero were inadvertently administered; This case was reported by a nurse via sales rep and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA14BA, expiry date March 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th April 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 26th April 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: During a school vaccination clinic, a dose of expired Bexsero was inadvertently administered to the patient which led to expired vaccine used. This was one of 4 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR094019:same reporter US-GLAXOSMITHKLINE-US2021AMR094020:same reporter US-GLAXOSMITHKLINE-US2021AMR094018:same reporter
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: 4 doses of expired Bexsero were inadvertently administered; This case was reported by a nurse via sales rep and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA14BA, expiry date March 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th April 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 26th April 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: During a school vaccination clinic, the patient was inadvertently administered a dose of expired Bexsero, which led to expired vaccine used. The reporter consented to follow up. This case was 1 of 4 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR094019:same reporter US-GLAXOSMITHKLINE-US2021AMR094010:same reporter US-GLAXOSMITHKLINE-US2021AMR094020:same reporter
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: 4 doses of expired Bexsero were inadvertently administered; This case was reported by a nurse via sales rep and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA14BA, expiry date March 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th April 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 26th April 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 follow: During a school vaccination clinic, a dose of expired Bexsero was inadvertently administered to the patient, the vaccine was expired in March 2021, which led to expired vaccine used. The reporter consented to follow up. This was one of 4 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR094018:same reporter US-GLAXOSMITHKLINE-US2021AMR094020:same reporter US-GLAXOSMITHKLINE-US2021AMR094010:same reporter
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: 4 doses of expired Bexsero were inadvertently administered; This case was reported by a nurse via sales rep and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA14BA, expiry date March 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th April 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 26th April 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: During a school vaccination clinic, a dose of expired Bexsero was inadvertently administered to the patient which led to expired vaccine used. This was one of 4 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR094018:same reporter US-GLAXOSMITHKLINE-US2021AMR094019:same reporter US-GLAXOSMITHKLINE-US2021AMR094010:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got vaccine and still got shingles/ suspected vaccination failure; I got vaccine and still got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) 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 reported case for herself/ himself. The age at vaccination was not reported. The age group was not reported, however it was captured as an adult as per vaccine indication. The patient stated he/she got vaccine and still got shingles. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: Has not had the 2nd dose because of the "Covid pandemic"; This case was reported by a consumer and described the occurrence of social problem in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of erythema (received 1st dose around January 2020, for tolerance refer case US2021093364).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, due to covid-19 pandemic. The patient did not have the virus but did not get appointment for 2nd dose of Shingrix. The patient asked if still he could get the 2nd dose. No all information was available. This case has been linked to US2021093365 and US2021AMR094049, reported by same reporter for his wife.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021093364:Same reporter. US-GLAXOSMITHKLINE-US2021093365:Same reporter. Wife's case. 1st dose. US-GLAXOSMITHKLINE-US2021AMR094049:Same reporter. Wife's case. 2nd dose.
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Arm soreness/ at injection site / started getting sore after / it felt like a flu shot; Arm /stiffness; This case was reported by a consumer via licensee and described the occurrence of injection site pain in a 49-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID 19 VACCINE) (batch number EN6204, expiry date June 2021) for prophylaxis.   The patient's past medical history included covid-19 (Family History) (patient's mother passed away on 15th March 2021 and she was fighting Covid). Previously administered products included Pneumonia vaccine (2 or 3 years ago from the date of reporting at the age of 46 years). Concurrent medical conditions included asthma.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On 13th March 2021 09:30, the patient received COVID 19 VACCINE. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site pain and injection site movement impairment. On an unknown date, the outcome of the injection site pain and injection site movement impairment were unknown.   It was unknown if the reporter considered the injection site pain and injection site movement impairment to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient had reported for herself. The age at vaccination was not reported. After receiving Flu vaccine arounf 12 or 1 PM, the patient had soreness and stiffness at the injection site. The patient was getting sore after the vaccine and it felf lke a Flu shot. On 13th March 2021 09:30, the patient received COVID 19 VACCINE. in left arm.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: Has not had the 2nd dose because of the " Covid pandemic "; This case was reported by a consumer and described the occurrence of social problem in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of erythema (1st dose received in January 2020 and patient had red hot patch on her arm and flu symptoms refer the case US2021093365).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were reported as follows: The case was reported by the patient's spouse. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix because of the Covid pandemic. The patient did not have the virus but did not get an appointment for the second Shingrix dose. The reporter inquired could the patient still get her 2nd dose. All information was not available. This case has been also linked to US2021093364 and US2021AMR094040, created for the reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021093365:Same reporter, Same patient. 1st dose. US-GLAXOSMITHKLINE-US2021093364:Same reporter. Husband's case. 1st dose. US-GLAXOSMITHKLINE-US2021AMR094040:Same reporter. Husband's case. 2nd dose.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, SARS-CoV-2 test negative
Clinical narrative: sicker then a dog for over a month; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female 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 sickness. Shingles vaccine was discontinued. On an unknown date, the outcome of the sickness was recovered/resolved.   The reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporter's best friend. The age at vaccination was not reported. The patient got the shot and she was sicker than a dog for over a month, thought she had Covid. The patient got tested and it was from the Shingles shot and she was advised by her doctor not to get the 2nd shot. Follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: All I got was a sore arm for a day; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included chronic obstructive pulmonary disease.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient had Shingles vaccine and experienced sore arm for a day. The patient feels lucky compared to other COPD (chronic obstructive pulmonary disease) patient. The follow-up would not possible as no contact details were available. For tolerance of Flu vaccine refer case US2021AMR094074, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR094074:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had shingles after I got the vaccine; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) 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 reporter was the patient. 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 had got shingles after receiving the vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and lab test confirmation was unknown at the time of reporting.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: All I got was a sore arm for a day; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a patient who received Flu unspecified (Influenza vaccine) (batch number UNK, expiry date unknown) for prophylaxis.   Concurrent medical conditions included chronic obstructive pulmonary disease.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine.   Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient had flu vaccine and experienced sore arm for a day. The patient feels lucky compared to other COPD (chronic obstructive pulmonary disease) patient. The follow-up would not possible as no contact details were available. For tolerance of Shingles vaccine refer case US2021AMR094067, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR094067:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: The second one was so awful for about 6 hours; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on an unknown date).   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 feeling abnormal. On an unknown date, the outcome of the feeling abnormal was recovered/resolved.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient himself/herself. The age group was not reported but was selected as adult as per vaccine indication. The patient's mother had Shingles many years ago and died due to it as it had affected her heart so badly and painful for her to fight it. Due to this the patient got vaccinated with Shingrix. The patient received second dose of Shingrix and felt awful for about 6 hours. The patient could put up with it.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: chills; sore arm; arm slightly swollen; rash but on my arm and chest (the rash is not welts); This case was reported by a consumer via interactive digital media and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 26th April 2021, the patient received the 2nd dose of Shingrix. In April 2021, less than a week after receiving Shingrix, the patient experienced chills, pain in extremity, swelling arm and rash. On an unknown date, the outcome of the chills, pain in extremity, swelling arm and rash were unknown.   It was unknown if the reporter considered the chills, pain in extremity, swelling arm and rash to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient. The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient had experienced chills ,sore arm that was slightly swollen and rash on arm and chest. The patient asked whether he/she need to call the doctor because the rash was not welts. No other information was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm really hurt; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received on an unknown date and the patient arm did not hurt with it). Concomitant products included thyroxine sodium (Levothyroxine) and estradiol (Estrace).   In October 2018, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after starting Levothyroxine, 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 provided as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient had no underlying disease and historical condition. The patient received Shingrix and experienced pain in arm. The patient stated she understands that arm hurt was a common side effect.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Computerised tomogram, Herpes zoster, Impaired work ability, Injected limb mobility decreased
Clinical narrative: Losing range of motion,making it hard to do my job; Nerve pain was horrible; I'm on lanican patches. Yo help sleep; making it hard to do my job; Shingrix / on dec 30 2020 / March 9 2021 / diagnosed with shingles / Suspected vaccination failure; Diagnosed with shingles / have had 3 shingle outbreaks; My right arm, where I got my injection starting to hurt / it throb; Hurt / It went up to my shoulder / achie should; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th December 2020, the patient received Shingrix. On 3rd January 2021, 4 days after receiving Shingrix, the patient experienced injection site pain and shoulder pain. On 9th March 2021, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced injected limb mobility decreased, nerve pain, difficulty sleeping and activities of daily living impaired. The patient was treated with steroids nos (Steroid (Not Specified)), oxycodone hydrochloride + paracetamol (Percocet) and pregabalin (Lyrica). On an unknown date, the outcome of the vaccination failure and activities of daily living impaired were unknown and the outcome of the shingles, injection site pain, shoulder pain, injected limb mobility decreased and nerve pain were not recovered/not resolved and the outcome of the difficulty sleeping was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, injection site pain, shoulder pain, injected limb mobility decreased, nerve pain, difficulty sleeping and activities of daily living impaired 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 received vaccine on his/her right arm. The patient's right arm, where he/she got injection starting to hurt, the evening it throb and it went up to his/her shoulder. The patient was now losing range of motion,making it hard to do his/her job. On 9th March 2021, the patient went to the doctor and he/she was put on steroid pills to take for arm. At that time patient was diagnosed with shingles and the nerve pain was horrible. The patient was still dealing with his/her throwing arm and achie shoulder and he/she went and had a CT scan (computerized tomography). The patient also seen a pain doctor and he/she was on lanican patches, which helped sleep. The patient was on Percocet for pain and Lyrica for the nerve pain. In the past 6 weeks from the reporting date patient had 3 shingle outbreaks and he/she asked to help him/her. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule was unknown at the time of reporting. The consent for follow-up was requested.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Vaccination failure
Clinical narrative: Losing range of motion,making it hard to do my job; Nerve pain was horrible; I'm on lanican patches. Yo help sleep; making it hard to do my job; Shingrix / on dec 30 2020 / March 9 2021 / diagnosed with shingles / Suspected vaccination failure; Diagnosed with shingles / have had 3 shingle outbreaks; My right arm, where I got my injection starting to hurt / it throb; Hurt / It went up to my shoulder / achie should; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th December 2020, the patient received Shingrix. On 3rd January 2021, 4 days after receiving Shingrix, the patient experienced injection site pain and shoulder pain. On 9th March 2021, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced injected limb mobility decreased, nerve pain, difficulty sleeping and activities of daily living impaired. The patient was treated with steroids nos (Steroid (Not Specified)), oxycodone hydrochloride + paracetamol (Percocet) and pregabalin (Lyrica). On an unknown date, the outcome of the vaccination failure and activities of daily living impaired were unknown and the outcome of the shingles, injection site pain, shoulder pain, injected limb mobility decreased and nerve pain were not recovered/not resolved and the outcome of the difficulty sleeping was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, injection site pain, shoulder pain, injected limb mobility decreased, nerve pain, difficulty sleeping and activities of daily living impaired 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 received vaccine on his/her right arm. The patient's right arm, where he/she got injection starting to hurt, the evening it throb and it went up to his/her shoulder. The patient was now losing range of motion,making it hard to do his/her job. On 9th March 2021, the patient went to the doctor and he/she was put on steroid pills to take for arm. At that time patient was diagnosed with shingles and the nerve pain was horrible. The patient was still dealing with his/her throwing arm and achie shoulder and he/she went and had a CT scan (computerized tomography). The patient also seen a pain doctor and he/she was on lanican patches, which helped sleep. The patient was on Percocet for pain and Lyrica for the nerve pain. In the past 6 weeks from the reporting date patient had 3 shingle outbreaks and he/she asked to help him/her. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule was unknown at the time of reporting. The consent for follow-up was requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got the worst case of shingles; This case was reported by a consumer via 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 age at vaccination was not reported. The patient received the dose of Shingles vaccine and got the worst case of shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Dysphonia, Incomplete course of vaccination
Clinical narrative: pretty much left without much of a voice; Did not get the 2nd shingles shot; This case was reported by a consumer via  interactive digital media and described the occurrence of voice lowered in a adult 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 not applicable after receiving Shingles vaccine, the patient experienced voice lowered and incomplete course of vaccination. On an unknown date, the outcome of the voice lowered and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the voice lowered to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The patient had experienced horrible reaction after the 1st dose, and he/she was pretty much left without much of a voice. Till the time of reporting, the patient did not receive the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Pain, Pyrexia
Clinical narrative: Low grade fever; Aches; This case was reported by a other health professional via other manufacturer and described the occurrence of low grade fever in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hypertension and obesity (BMI (Body Mass Index) was 30).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced low grade fever and pain. On an unknown date, the outcome of the low grade fever and pain were unknown.   It was unknown if the reporter considered the low grade fever and pain to be related to Shingrix.  Additional details were provided as follows: At the time of reporting, the patient was 68 years of age. The age at vaccination was not reported. The Shingrix administration date was not provided. The patient had low grade fever and ache after vaccination with Shingrix. The patient received Pfizer covid 19 vaccine on 23rd December 2020 (batch number EJ1685, Expiry date April 2021) and on 12th January 2021 (batch number EL3249). On 30th December 2020, the patient was positive with covid 19 and also had sickness on 1st January 2021.  After 2nd dose, the patient had Fever (101.5 F), body ache, malaise and fatigue for 4 days. The patient was treated with Ibuprofen(oral).