chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Amenorrhoea, Autoantibody positive, Autoimmune disorder, Blood follicle stimulating hormone increased, Blood luteinising hormone increased
Clinical narrative: Autoimmune/ inflammatory syndrome; Primary ovarian failure; Autoimmune/ inflammatory syndrome; Secondary amenorrhea; Low estradiol levels; Increased FSH and LH; Increased FSH and LH; Specific autoantibodies were detected (anti-ovarian and anti-thyroid); This spontaneous report was received from a physician via social media and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.      On an unknown date, the patient was vaccinated with human papillomavirus (HPV) vaccine (manufacturer unknown) (lot#, expiration date, dose, route of administration and anatomical location were not reported). On an unknown date, the patient experienced primary ovarian failure, autoimmune/ inflammatory syndrome, blood follicle stimulating hormone (FSH) and blood luteinising hormone (LH) increased, low estradiol levels, secondary amenorrhoea; and specific autoantibodies were detected (anti-ovarian and anti-thyroid). The outcome of the events unknown. Causality assessment was not provided.       Upon internal review, the event of autoimmune syndrome was considered to be medically significant.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Oestradiol decreased, Ovarian failure
Clinical narrative: Autoimmune/ inflammatory syndrome; Primary ovarian failure; Autoimmune/ inflammatory syndrome; Secondary amenorrhea; Low estradiol levels; Increased FSH and LH; Increased FSH and LH; Specific autoantibodies were detected (anti-ovarian and anti-thyroid); This spontaneous report was received from a physician via social media and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.      On an unknown date, the patient was vaccinated with human papillomavirus (HPV) vaccine (manufacturer unknown) (lot#, expiration date, dose, route of administration and anatomical location were not reported). On an unknown date, the patient experienced primary ovarian failure, autoimmune/ inflammatory syndrome, blood follicle stimulating hormone (FSH) and blood luteinising hormone (LH) increased, low estradiol levels, secondary amenorrhoea; and specific autoantibodies were detected (anti-ovarian and anti-thyroid). The outcome of the events unknown. Causality assessment was not provided.       Upon internal review, the event of autoimmune syndrome was considered to be medically significant.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Gave Expired Dose of HEPLISAV-B; Initial Report Received on 20-Aug-2021  A pharmacist  reported that a patient (age, gender, race, and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   Relevant medical history was not reported.    Relevant concomitant medications were not reported.  On an unknown date, the patient received an expired dose of HEPLISAV-B (Lot #, expiration date, NDC #, and serial # not provided) from a nurse. At the time of reporting, no additional information was provided.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 68.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: Received 40 mcg of Heplisav-B; Initial Report Received on 23-Aug-2021  A registered nurse ) reported that a 68 year-old female patient (race and ethnicity not provided) received a 40 mcg dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on the same day.   The patient was on dialysis and does not have any allergies. No other relevant medical history was reported.  No relevant concomitant medications were reported.  On 23-Aug-2021, the patient received a total of 40 mcg dose of HEPLISAV-B (Lot # 935840, expiration date 11-Sep-2022, NDC # 43528-003-05; serial number not reported). One dose of 20 mcg of HEPLISAV-B was given in the right deltoid and the other dose of 20 mcg was given in left deltoid; totaling 40 mcg of HEPLISAV-B given that day. The patient did not report any side effects.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 52.0
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Gave an Expired Dose of Heplisav-B; Initial Report Received on 31-Aug-2021   A registered nurse reported that a 52 year-old female (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.    The patient does not have any known allergies. Other relevant medical history was not reported.     Relevant concomitant medications were not reported.   On 31-Aug-2021, the patient received an expired dose of HEPLISAV-B (Lot # 933624, expiration date 10-Aug-2021, and NDC # 43528-003-05; serial # not reported) in the left deltoid by the registered nurse (reporter). The patient did not experience any adverse effects.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 32.0
Sex: U
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Administered Engerix Instead of Heplisav-B for Second Dose; Initial Report Received on 08-Sep-2021 and 10-Sep-2021  A nursing operation supervisor in the US reported that a 32 year-old male (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and Engerix as the second dose of the series.  The patient did not have any allergies. No other relevant medical history was reported.   No relevant concomitant medications were reported.   On 10-Aug-2021, the patient received the first dose of HEPLISAV-B (Lot # 934601, expiration date 16-Mar-2022, and NDC # 43528-002-05; serial # not reported) in the right deltoid.  On 08-Sep-2021, the patient received the second dose with Engerix (Lot # and expiration date not available) from a licensed practical nurse instead of HEPLISAV-B. No adverse effects were reported.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 31.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd Dose was Given 2 Weeks and 1 Day after the 1st; Initial Report Received on 10-Sep-2021  A registered nurse in the US reported that a 31 year-old female (race and ethnicity not provided) received a second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization two weeks and 1 day after the first dose.   Relevant medical history was not reported.    Relevant concomitant medications were not reported.  On 23-Aug-2021, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, and serial number not reported).  On 07-Sep-2021, two weeks and 1 day after the first dose of HEPLISAV-B, the patient was given the second dose of HEPLISAV-B (Lot # 934975, expiration date 13-Aug-2022, NDC # 43528-003-05, and serial # 565252922606) in the left deltoid. No adverse reactions were reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had a case of shingles in 2017) and shingles (had shingles on forehead and cheek and also had sore arm post vaccination in September 2020, refer case US2021AMR197172).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix (intramuscular). In September 2021, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself. The age at vaccination was not reported. In 2019, the patient received 2 doses of Shingrix in left arm. In September 2021 the patient again had a case of shingles. The patient stated that the current case of shingles, involves shingles on the left side of the face, two lines across forehead, around the left eye, on the left side of the nose but not on the bridge of the nose, under the chin, chest, left side of torso, and right arm and were not resolved. The patient did not have the exact date of administration; therefore, it could not be determined how soon were the shingles experienced post vaccination. The patient stated that she had an appointment with eye doctor and was told that shingles were surrounding the left eye, but not in the eye. The reporter gave a consent to follow-up with health care professional. The patient does not have an email address to health care professional. The patient provided her personal email. The patient provided contact information to the pharmacy where she received both doses of Shingrix. The reporter consented to follow-up. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles was unknown at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR197172:same reporter
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain in extremity, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had a case of shingles in 2017) and shingles (had shingles on forehead and cheek and also had sore arm post vaccination in September 2020, refer case US2021AMR197172).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix (intramuscular). In September 2021, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself. The age at vaccination was not reported. In 2019, the patient received 2 doses of Shingrix in left arm. In September 2021 the patient again had a case of shingles. The patient stated that the current case of shingles, involves shingles on the left side of the face, two lines across forehead, around the left eye, on the left side of the nose but not on the bridge of the nose, under the chin, chest, left side of torso, and right arm and were not resolved. The patient did not have the exact date of administration; therefore, it could not be determined how soon were the shingles experienced post vaccination. The patient stated that she had an appointment with eye doctor and was told that shingles were surrounding the left eye, but not in the eye. The reporter gave a consent to follow-up with health care professional. The patient does not have an email address to health care professional. The patient provided her personal email. The patient provided contact information to the pharmacy where she received both doses of Shingrix. The reporter consented to follow-up. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles was unknown at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR197172:same reporter
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: vaccination failure; sore arm; Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in 2017).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) and the 1st dose of Shingrix (intramuscular). In September 2020, less than 2 years after receiving Shingrix and Shingrix, the patient experienced shingles. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant) and pain in arm. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain in arm to be related to Shingrix and Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received 2 doses of Shingrix in 2019, by intramuscular in left arm. The reporter stated that, despite getting shingrix, she had 2 cases of shingles, September 2020 and September 2021. A case of shingles in September 2020, involved shingles on forehead and cheek. Current case of shingles (September 2021), involves shingles on the left side of the face, two lines across forehead, around the left eye, on the left side of the nose (but not on the bridge of the nose), under the chin, chest, left side of torso, and right arm. The patient currently had shingles and were not resolved. The patient also mentioned having sore arm post vaccination, which was resolved. The reporter did not have information about lot/exp date, date of administration of both doses and the dose administered, exact date of administration, could not determined how soon were the shingles experienced post vaccination. The reporter provided contact information to the pharmacy where she received both doses of Shingrix. The current case shingles was still on going and not resolved. The reporter also mentioned that she recently had an appointment with an eye doctor and was told that shingles are surrounding the left eye, but not in the eye. The reporter gave a consent to follow-up with health care professional. However, the reporter did not have an email address to health care professional. The reporter provided her personal email address. This case was linked with case US2021196608, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021196608:same reporter
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain in extremity, Vaccination failure
Clinical narrative: vaccination failure; sore arm; Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in 2017).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) and the 1st dose of Shingrix (intramuscular). In September 2020, less than 2 years after receiving Shingrix and Shingrix, the patient experienced shingles. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant) and pain in arm. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain in arm to be related to Shingrix and Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received 2 doses of Shingrix in 2019, by intramuscular in left arm. The reporter stated that, despite getting shingrix, she had 2 cases of shingles, September 2020 and September 2021. A case of shingles in September 2020, involved shingles on forehead and cheek. Current case of shingles (September 2021), involves shingles on the left side of the face, two lines across forehead, around the left eye, on the left side of the nose (but not on the bridge of the nose), under the chin, chest, left side of torso, and right arm. The patient currently had shingles and were not resolved. The patient also mentioned having sore arm post vaccination, which was resolved. The reporter did not have information about lot/exp date, date of administration of both doses and the dose administered, exact date of administration, could not determined how soon were the shingles experienced post vaccination. The reporter provided contact information to the pharmacy where she received both doses of Shingrix. The current case shingles was still on going and not resolved. The reporter also mentioned that she recently had an appointment with an eye doctor and was told that shingles are surrounding the left eye, but not in the eye. The reporter gave a consent to follow-up with health care professional. However, the reporter did not have an email address to health care professional. The reporter provided her personal email address. This case was linked with case US2021196608, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021196608:same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; 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.   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 patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles, but it was not very bad. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a consumer 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 for him/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 of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got shingles; 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.   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 patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles anyways. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Pain, Sleep disorder, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; it hurt to much; had a total of three singles vaccine; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and extra dose administered. On an unknown date, the outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine, Shingles vaccine and 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 total of three doses of Shingles vaccine which led to extra dose administered. After receiving Shingles vaccine, the patient got shingles above right hip and he/she could not lay down on right side when went to bed and it hurt too much. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had it once after vaccine; 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.   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 him/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 of shingles were not provided.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Nurse accidentally administered another dose; Wrong vaccine administered; This case was reported by a other health professional via sales rep and described the occurrence of extra dose administered in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concomitant products included DTPa (Reduced antigen) (Boostrix).   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced extra dose administered and wrong vaccine administered. On an unknown date, the outcome of the extra dose administered and wrong vaccine administered were unknown.  Additional details were provided as follows: The patient recieved Boostrix and patient returned 4 weeks later to get Meningitis ACYW vaccine.  The nurse accidentally administered another dose of Boostrix, which led to extra dose administered and wrong vaccine administered. The patient and his mother were notified immediately after Boostrix dose of the mistake and monitored for adverse events. The incident was reported into the medical group community care physicians legal department as the mother was very upset and said they ruined her son.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Bad case near my eye; Bad case on face; This case was reported by a consumer via media and described the occurrence of ophthalmic herpes zoster 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 ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the ophthalmic herpes zoster and shingles were recovered/resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient herself/herself. The patient received shingles vaccine and 2 years before the date of reporting, got bad case all over one side of face and near eye.  The follow-up could be not possible as no contact details were available. The case was linked with case US2021AMR196932 reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR196932:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shot and had them 3 times; Had them 3 times lately; 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.   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 reported as follows: The age at vaccination was not reported. The patient had the shot and had them 3 times lately.  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 were unknown at the time of reporting.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Loss of personal independence in daily activities
Clinical narrative: itchy bumps; very tired.; chills; extreamly weak/ feeling weak; couldn't get out of bed; every joint in her body was in pain; This case was reported by a consumer via other manufacturer and described the occurrence of itchy rash in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2021, the patient received Shingrix. On 14th September 2021, 1 days after receiving Shingrix, the patient experienced chills, weakness, activities of daily living impaired and generalized joint pain. On 15th September 2021, the patient experienced itchy rash and tiredness. On an unknown date, the outcome of the itchy rash, chills, weakness, activities of daily living impaired, generalized joint pain and tiredness were unknown.   It was unknown if the reporter considered the itchy rash, chills, weakness, activities of daily living impaired, generalized joint pain and tiredness to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient herself. The patient received a dose of Shingrix at pharmacy and had chills, extremely weak, could not get out of bed, total every joint in her body was in pain. On 15th September 2021, in morning patient woke up with woke up feeling weak and very tired, had 3 bumps in her left temple near her hairline. The patient stated that those bumps were not blisters which she knew that usually shingles presents with a blister type thing but the bumps were a bit itchy, but not painful which were also not typical to shingles. The patient was concerned about what she should do, if she should be seen by her doctor as she did not know how to proceed.  The patient stated about a scary arrangement with the pharmacist, who did not even do proper hygiene with hand washing, it was scary. The reporter consented to follow-up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: itchy bumps; very tired.; chills; extreamly weak/ feeling weak; couldn't get out of bed; every joint in her body was in pain; This case was reported by a consumer via other manufacturer and described the occurrence of itchy rash in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2021, the patient received Shingrix. On 14th September 2021, 1 days after receiving Shingrix, the patient experienced chills, weakness, activities of daily living impaired and generalized joint pain. On 15th September 2021, the patient experienced itchy rash and tiredness. On an unknown date, the outcome of the itchy rash, chills, weakness, activities of daily living impaired, generalized joint pain and tiredness were unknown.   It was unknown if the reporter considered the itchy rash, chills, weakness, activities of daily living impaired, generalized joint pain and tiredness to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient herself. The patient received a dose of Shingrix at pharmacy and had chills, extremely weak, could not get out of bed, total every joint in her body was in pain. On 15th September 2021, in morning patient woke up with woke up feeling weak and very tired, had 3 bumps in her left temple near her hairline. The patient stated that those bumps were not blisters which she knew that usually shingles presents with a blister type thing but the bumps were a bit itchy, but not painful which were also not typical to shingles. The patient was concerned about what she should do, if she should be seen by her doctor as she did not know how to proceed.  The patient stated about a scary arrangement with the pharmacist, who did not even do proper hygiene with hand washing, it was scary. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Got the shot and got sick; This case was reported by a consumer and described the occurrence of sickness in a 73-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (patient had shingles on the whole right side of head into the neck). Previously administered products included Shingles vaccine with an associated reaction of illness (patient received 1st dose on an unknown dose and got sick, refer linked case US2021AMR197141).   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. Rechallenge with Shingles vaccine was positive. 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 reporter was the patient. The age at vaccination was not reported. The patient had shingles in the past for almost a year on the whole right side of head into neck which felt like it divided the head in half. The patient was vaccinated with 2nd shot of vaccine and got sick. The patient does not take any kind of medicines presently and it worried them as per their current age.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR197141:Same patient, same reporter, same suspect, different dose (1st dose)
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Localised infection, Peripheral swelling, Rash
Clinical narrative: arm was red; arm swollen; hot to the touch; infection 3x4 inch area; patch was 3x4 inches; This case was reported by a consumer and described the occurrence of erythema of extremities in a 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 erythema of extremities, swelling arm, feeling hot, arm infection and patchy rash. On an unknown date, the outcome of the erythema of extremities, swelling arm, feeling hot, arm infection and patchy rash were unknown.   It was unknown if the reporter considered the erythema of extremities, swelling arm, feeling hot, arm infection and patchy rash to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient herself/himself. Age at vaccination was not reported. The patient received a shot of Shingles vaccine and had red and swollen arm, hot to touch, it looked like it was infection 3x4 inches area. The patient did not went back for the 2nd shot after his/her arms got swollen, red and hot to touch and patch was 3x4 inches. The patient went back to the person who gave the shot and she replied that it usually happens but the second shot would not be so bad. Follow-up would not be possible as no contact details available. The case was linked with case US2021AMR197155, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR197155:same reporter
Sex: F
Vaccine: TDAP
Symptoms: Diplegia, Feeding disorder
Clinical narrative: lost the use of her legs; couldn't eat; This case was reported by a consumer via media and described the occurrence of paralysis legs in a female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced paralysis legs (serious criteria hospitalization, disability and GSK medically significant) and unable to eat (serious criteria hospitalization). On an unknown date, the outcome of the paralysis legs and unable to eat were unknown.   It was unknown if the reporter considered the paralysis legs and unable to eat to be related to Tdap Vaccine.  Additional details were provided as follows: This case was reported patient's family member. The age at vaccination was not reported. The patient got the Tdap shot and lost the use of her legs and could not eat. The patient ended up in hospital. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got mine, 3 years later, got shingles/ suspected vaccination failure; shingles; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 years 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 self-reported this case. The age at vaccination was not reported. The patient got the shingles shot and 3 years later got shingles. The Shingles were not too bad. After that, the patient had to get 2 more shots. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR197180:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: as I waited for the second vax I got it again; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient reported that, he/she got Shingles vaccine and as the patient waited for the second vaccine he/she got the shingles again.  The patient said, not fun, take care of yourself.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; 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.   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 him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got a horrible case of shingles. The patient's doctor said, worse case that the patient had ever seen. 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 of shingles were not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a consumer 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 patient. The age at vaccination was not reported. The patient got the two shots of shingles vaccine and still experienced shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose on on 10-18-19 / second dose almost 24 months later; 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 18th October 2019).   On 15th September 2021, the patient received the 2nd dose of Shingrix. On 15th September 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 reporter was the patient. The age at vaccination was not reported. The patient received 2nd dsoe almost 24 months later the 1st dose of Shingrix. The patient received 2nd dose later than the recommended time interval, which led to lengthening of vaccination schedule The reporter asked under this situation, did you recommend that, get a third does in 4 to 6 months.
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: got chills; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of feeling abnormal (1st dose received on an unknown date and had kicked rear end, refer case US2021AMR197865).   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 chills. On an unknown date, the outcome of the chills was unknown.   It was unknown if the reporter considered the chills 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 the Shingles shot and just got chills.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR197865:same reporter, same patient, different dose, 1st dose
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; rash; 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.   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 rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash 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 patient received shingles vaccine and experienced the shingles earlier this year. The patient was so glad that he/she had gotten the vaccine. The patient did not experience pain, just had a rash. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Pain
Clinical narrative: sick; pain; This case was reported by a consumer via (facebook) interactive digital media and described the occurrence of sickness in a patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced sickness and pain. On an unknown date, the outcome of the sickness and pain were recovered/resolved.   It was unknown if the reporter considered the sickness and pain to be related to Influenza vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Flu shot and got a little sick and pain for about 2 days. The follow-up would not possible as no contact details were available. The case had been linked with US2021AMR171208 reported by the same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR171208:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shot had shingles/ suspected vaccination failure; shingles twice; 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.   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 self-reported this case. The age at vaccination was not reported. The patient got the shingles shot and had shingles twice. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.