chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia
Clinical narrative: systemic side effects (fatigue); systemic side effects (myalgia); This case was reported by a pharmacist via sales rep and described the occurrence of fatigue in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue and myalgia. On an unknown date, the outcome of the fatigue and myalgia were recovered/resolved.   It was unknown if the reporter considered the fatigue and myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced systemic side effects fatigue, myalgia for a day. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: NOT RECONSTITUTED PROPERLY/the adjuvant may have been given without the lyophilized antigen; NOT RECONSTITUTED PROPERLY/the adjuvant may have been given without the lyophilized antigen; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number CK3PY, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided are as follows: The reporter was an operation manager. The age at vaccination was not reported. The patient might had received the adjuvant portion of Shingrix without the lyophilized antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Muscular weakness, Pain
Clinical narrative: Fatigue, had to miss work; muscle weakness, had to miss work; body aches, had to miss work; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy to antibiotic (allergic to Levaquin, Biaxin and Bactrim), allergic reaction to analgesics (allergic to codeine) and sulfonamide allergy (allergic to Sulfa).   On 1st November 2021, the patient received Shingrix. In November 2021, less than a week after receiving Shingrix, the patient experienced fatigue, muscle weakness and general body pain. On an unknown date, the outcome of the fatigue, muscle weakness and general body pain were unknown.   It was unknown if the reporter considered the fatigue, muscle weakness and general body pain to be related to Shingrix.  Additional details provided were as follows: Age at vaccination was not reported. The patient received a dose of Shingrix on Monday due to which he/she had missed work yesterday and at the day of reporting and experienced body aches, muscle weakness and fatigue. The patient was allergic to Sulfa, Levaquin, Biaxin, Bactrim and Codeine. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: The crappy week we had; This case was reported by a consumer and described the occurrence of malaise in a 60-year-old 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 malaise. On an unknown date, the outcome of the malaise was recovered/resolved.   It was unknown if the reporter considered the malaise 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 received the Shingles shot and had almost every side effect they said could happen and had a crappy week. The patient stated that it was much better than what the patient's dad went through when he had shingles, within 12 hours of breakout he spiked a high fever and was admitted to isolation with meningitis that within another 12 hours he had encephalitis. He died 6 weeks later due to kidney failure from the all the antibiotics to cure him .  The patient would encourage everyone to get this vaccine. This case was linked with US2021AMR227919, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR227919:Same reporter US-GLAXOSMITHKLINE-US2021AMR227919:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: had almost every side effect they said could happen/The crappy week we had; This case was reported by a consumer and described the occurrence of malaise in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced malaise. On an unknown date, the outcome of the malaise was recovered/resolved.   It was unknown if the reporter considered the malaise to be related to Shingles vaccine.   Additional details were reported as follows: This case was reported by the patients wife. The patients had almost every side effect they said could happen. The patients wife stated crappy week they had was much better than what her dad went through when he had shingles.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR227914:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/had shingles shot, I have it now worse than ever; shingles; This case was reported by a consumer via (Shingrix interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details provided were as follows: The case was self-reported by the patient. Age at vaccination was not reported. The patient had shingles shot 2 years ago and now experienced shingles which was worse than ever. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed shingles, had had only the first dose; This case was reported by a consumer via other manufacturer and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included tofacitinib citrate (Xeljanz) for ulcerative colitis.   Concurrent medical conditions included ulcerative colitis (UC).   On an unknown date, the patient received the 1st dose of Shingrix and Xeljanz 10 mg twice daily (20 mg daily). On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. Xeljanz was discontinued. On an unknown date, the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details provided were as follows: The age at vaccination was not reported. The patient developed shingles about one month after starting Xeljanz for her ulcerative colitis.  She had only the first dose of Shingrix. She had been discontinued (DCed) from Xeljanz and was recovering.  The reporter did not wish to be contacted for follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: had shingles, had the vaccination/ Suspected vaccination failure; shingles twice on nose; 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 (had shingles all one summer and fall) and pain burning (horrible burning pain).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient had shingles all one summer and fall and a horrible burning pain. The patient had shingles twice since on his/her nose and he/she believed because he/she had the vaccination he/she got right over them. The patient stated that even after your over them ,if your over tired or stressed it felt like it's coming back.  The patient would asked that anyone that has not had the vaccination go and get them. The follow up could not be possible as no contact details were available. 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: F
Vaccine: VARZOS
Symptoms: Dizziness, Vertigo
Clinical narrative: All day dizzy, head wouldn't stop spinning; head wouldn't stop spinning; This case was reported by a consumer and described the occurrence of dizziness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced dizziness and head spinning. On an unknown date, the outcome of the dizziness and head spinning were not recovered/not resolved.   It was unknown if the reporter considered the dizziness and head spinning to be related to Shingles vaccine.  Additional details provided were as follows: The reporter was the patient's brother/sister. The age at vaccination was not reported. The reporter stated that, his/her sister just got a shot and she said she would never in her life want to get another vaccine. The patient was at the doctors all day felt dizzy her head would not stop spinning immediately after the second shot. The reporter hope that it was just a rare occasion. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had both shots, now have 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.   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: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shots.  The patient was told by her/his surgeon that he/she now had a small case of shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot, still 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, 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: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got Shingles shots and still got Shingles.  The patient stated his/her physician said it just help with the outbreak. The follow-up would not possible as no contact details were available. 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.
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: developed Bell's palsy; This case was reported by a physician via sales rep and described the occurrence of bell's palsy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2021, the patient received the 1st dose of Shingrix. In October 2021, 24 hrs after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The first dose of Shingrix was administered to patient approximately on 20th october 2021 and the exact date was unknown at the time of reporting. The patient development Bell's palsy approximately 24 hours upon receipt of the first dose of Shingrix. The patient presented to urgent care and received steroids.  The physician followed-up with patient on 25th October 2021 and increased steroid dose because MD felt urgent care prescribed too low of a dose.  Additional follow-up with patient had been scheduled. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site warmth, Skin warm
Clinical narrative: unusual reaction, three inch circle of redness; warm to the touch; This case was reported by a consumer via interactive digital media and described the occurrence of localized erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2021, the patient received the 2nd dose of Shingrix. On 6th November 2021, 1 days after receiving Shingrix, the patient experienced localized erythema and skin warm. On an unknown date, the outcome of the localized erythema and skin warm were unknown.   It was unknown if the reporter considered the localized erythema and skin warm to be related to Shingrix.  Additional details were provided are as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix in unknown arm yesterday and had an unusual reaction. On his/her arm had a three inch circle of redness that was warm to the touch. The edge of redness was two inches away from the injection site. No itching. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise, Pruritus, Skin irritation, Vaccination failure
Clinical narrative: Taking Shingrix depleted my shingles by about 99%/ suspected vaccination failure; Malaise; itchy; irritates skin; Taking Shingrix depleted my shingles by about 99%; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 7th November 2021, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), malaise, pruritus and skin irritation. On an unknown date, the outcome of the vaccination failure, shingles, malaise, pruritus and skin irritation were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, malaise, pruritus and skin irritation to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she received Shingrix depleted her/his shingles by about 99 percent.   The patient stated he/she had malaise feeling (had to look up definition) so itchy, but he/she knew irritates skin, he/she stopped.  The follow-up would not possible as no contact details were available. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had shot.. got shingles/ suspected vaccination failure; shingles; painful; 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 pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   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: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shot and got shingles was painful. The follow-up would not possible as no contact details were available. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I got the vaccine, 5 mo later I blew up with Shingles/ suspected vaccination failure; shingles; pain; 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, 5 months 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, shingles and pain were unknown.   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: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got Shingles vaccine and 5 months later blew up with Shingles. In less than 6 months after vaccination the patient ever experienced most incredible pain. The follow-up would not possible as no contact details were available. 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. Note-For pain time to onset considered as less than 6 months as pain might occurred before shingles and shingles experienced 5 months later Shingles vaccine.
Sex: F
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 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: This case was reported by reporter's mother. The age at vaccination was not reported. The reporter stated she got Shingles 3 weeks after been treated. The follow-up would not possible as no contact details were available. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Feel lousy today; This case was reported by a consumer and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 4th November 2021, the patient received the 1st dose of Shingles vaccine. On 5th November 2021, 1 days after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was not recovered/not resolved.   It was unknown if the reporter considered the feeling bad 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 had received first Shingle shot one day before reporting and felt lousy on the day of reporting. The patient stated that she/he was told that would for day or two.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vaccination and still got the 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, 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: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles vaccination and still got the shingles. The follow-up would not possible as no contact details were available. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Illness, Paraesthesia, Vaccination failure
Clinical narrative: After vx, acyclovir on hand in case I feel the tingling before an outbreak/ Suspected vaccination failure; Outbreak; keep acyclovir on hand in case I start to feel the tingling; Extremely sick; 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, tingling of extremity and sickness. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure, shingles, tingling of extremity and sickness were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, tingling of extremity and sickness to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got extremely sick for at least 2 weeks after the shingles vaccine. The patient stated he/she would never get Shingles again. The patient was keeps acyclovir on hand in case he/she start to feel the tingling that always comes before an outbreak. The follow-up would not possible as no contact details were available. 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. This case has been linked to the case US2021AMR230926 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR230926:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Vaccine positive rechallenge
Clinical narrative: extremely sick from shingles shots; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine with an associated reaction of illness (received 1st dose on an unknown date, for tolerance refer case US2021AMR230973).   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.   The reporter considered the sickness to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received 2nd dose of Shingles vaccine and got extremely sick from the shingles vaccine but he/she was glad to received them. The case was linked with case US2021AMR230973, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR230973:1st dose, same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: have been dealing with nerve pain; This case was reported by a consumer and described the occurrence of nerve pain 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 nerve pain. On an unknown date, the outcome of the nerve pain was not recovered/not resolved.   It was unknown if the reporter considered the nerve pain 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 Shingle vaccine three years ago and now patient had been dealing with nerve pain ever since.  The patient never had this pain before.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Is a side effect of the shingles vaccine a rash?; This case was reported by a consumer via (Shingrix GSK and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received a dose of Shingles vaccine and experienced rash. The patient enquired if the rash was a side effect of shingles vaccine. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Mild rash after vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Shingrix Vaccine and had a mild rash after vaccine.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: half of the dose administrated; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 12-month-old female patient who received HAV (Havrix) (batch number 2k57n, expiry date 11th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe (batch number 2k57n, expiry date 11th December 2022) for prophylaxis.   On 25th October 2021, the patient received the 1st dose of Havrix (intramuscular) and Havrix Pre-Filled Syringe Device. On 25th October 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced accidental underdose. The action taken with Havrix was unknown. On an unknown date, the outcome of the accidental underdose 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 reported as follows: The patient had received half of the dose of Havrix due to improper attachment of Pre-filled syringe. No further events were reported. The patient had granted consent for follow-up.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number AVXA68AA, expiry date 31st October 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 1st November 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 1st November 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 reported as follows: Medical Assistant reported that a patient received an expired dose of Bexsero. Which led to expired vaccine used. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Second dose not yet received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose two-three years ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, it had been greater than 6 months after 1st dose of Shingrix vaccine and the 2nd dose not given till the time of reporting, which led to incomplete course of vaccination. The reporter unable to provide exact data, any adverse event information. The reporter gave consent for safety team to follow up. GSK note- Regarding discrepancy about 2nd dose date, a follow up was done but had no reply.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, C-reactive protein increased, Chest X-ray normal, Chest pain, Chills
Clinical narrative: Night sweats; Elevated d-dimer; rapid heart rate of 120; lab tests showed elevated reactive protein; chest pain when she inhaled; Chills; Fever; feeling achy; sore arm after the injection; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2021, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 19th October 2021, less than 3 weeks after receiving Shingrix, the patient experienced pain in arm. On 20th October 2021, the patient experienced pain. On 21st October 2021, the patient experienced chest pain, chills and fever. On an unknown date, the patient experienced night sweat, fibrin d dimer increased, heart rate increased and c-reactive protein increased. The patient was treated with ibuprofen and paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm and heart rate increased were recovered/resolved and the outcome of the night sweat, chills and fever were not recovered/not resolved and the outcome of the fibrin d dimer increased, c-reactive protein increased, chest pain and pain were unknown.   The reporter considered the pain in arm to be related to Shingrix. It was unknown if the reporter considered the night sweat, fibrin d dimer increased, heart rate increased, c-reactive protein increased, chest pain, chills, fever and pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received Shingrix in her left deltoid intramuscularly and experienced sore arm after the injection which was resolved.  One day after the vaccine, she reported feeling achy (unknown if currently resolved). Two days after the vaccine, she reported chest pain when she inhaled (unknown if resolved), and a fever for which she went to the doctor.  The physician sent her to the emergency room twice over the course of the past 2 weeks (dates unknown) due to chest pain, fever, chills, and rapid heart rate of 120.  Patient reported that her lab tests showed elevated reactive protein and elevated d-dimer (exact date and lab value unknown).  CT scan, chest x-ray, blood tests, and EKG performed on the patient were all normal (dates performed unknown).  Patient's cardiologist had told her that her heart appeared normal but the doctor ordered and echocardiogram once her fever was resolved.  Patient currently reported her elevated heart rate had resolved, but that she still had fever and night sweats which were unresolved and the patient reported taking Tylenol and Ibuprofen for symptom relief. Patient did not have lot or expiration date of vaccine given. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram normal, Electrocardiogram normal, Fibrin D dimer increased, Heart rate increased, Night sweats
Clinical narrative: Night sweats; Elevated d-dimer; rapid heart rate of 120; lab tests showed elevated reactive protein; chest pain when she inhaled; Chills; Fever; feeling achy; sore arm after the injection; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2021, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 19th October 2021, less than 3 weeks after receiving Shingrix, the patient experienced pain in arm. On 20th October 2021, the patient experienced pain. On 21st October 2021, the patient experienced chest pain, chills and fever. On an unknown date, the patient experienced night sweat, fibrin d dimer increased, heart rate increased and c-reactive protein increased. The patient was treated with ibuprofen and paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm and heart rate increased were recovered/resolved and the outcome of the night sweat, chills and fever were not recovered/not resolved and the outcome of the fibrin d dimer increased, c-reactive protein increased, chest pain and pain were unknown.   The reporter considered the pain in arm to be related to Shingrix. It was unknown if the reporter considered the night sweat, fibrin d dimer increased, heart rate increased, c-reactive protein increased, chest pain, chills, fever and pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received Shingrix in her left deltoid intramuscularly and experienced sore arm after the injection which was resolved.  One day after the vaccine, she reported feeling achy (unknown if currently resolved). Two days after the vaccine, she reported chest pain when she inhaled (unknown if resolved), and a fever for which she went to the doctor.  The physician sent her to the emergency room twice over the course of the past 2 weeks (dates unknown) due to chest pain, fever, chills, and rapid heart rate of 120.  Patient reported that her lab tests showed elevated reactive protein and elevated d-dimer (exact date and lab value unknown).  CT scan, chest x-ray, blood tests, and EKG performed on the patient were all normal (dates performed unknown).  Patient's cardiologist had told her that her heart appeared normal but the doctor ordered and echocardiogram once her fever was resolved.  Patient currently reported her elevated heart rate had resolved, but that she still had fever and night sweats which were unresolved and the patient reported taking Tylenol and Ibuprofen for symptom relief. Patient did not have lot or expiration date of vaccine given. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Painful respiration, Pyrexia
Clinical narrative: Night sweats; Elevated d-dimer; rapid heart rate of 120; lab tests showed elevated reactive protein; chest pain when she inhaled; Chills; Fever; feeling achy; sore arm after the injection; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2021, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 19th October 2021, less than 3 weeks after receiving Shingrix, the patient experienced pain in arm. On 20th October 2021, the patient experienced pain. On 21st October 2021, the patient experienced chest pain, chills and fever. On an unknown date, the patient experienced night sweat, fibrin d dimer increased, heart rate increased and c-reactive protein increased. The patient was treated with ibuprofen and paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm and heart rate increased were recovered/resolved and the outcome of the night sweat, chills and fever were not recovered/not resolved and the outcome of the fibrin d dimer increased, c-reactive protein increased, chest pain and pain were unknown.   The reporter considered the pain in arm to be related to Shingrix. It was unknown if the reporter considered the night sweat, fibrin d dimer increased, heart rate increased, c-reactive protein increased, chest pain, chills, fever and pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received Shingrix in her left deltoid intramuscularly and experienced sore arm after the injection which was resolved.  One day after the vaccine, she reported feeling achy (unknown if currently resolved). Two days after the vaccine, she reported chest pain when she inhaled (unknown if resolved), and a fever for which she went to the doctor.  The physician sent her to the emergency room twice over the course of the past 2 weeks (dates unknown) due to chest pain, fever, chills, and rapid heart rate of 120.  Patient reported that her lab tests showed elevated reactive protein and elevated d-dimer (exact date and lab value unknown).  CT scan, chest x-ray, blood tests, and EKG performed on the patient were all normal (dates performed unknown).  Patient's cardiologist had told her that her heart appeared normal but the doctor ordered and echocardiogram once her fever was resolved.  Patient currently reported her elevated heart rate had resolved, but that she still had fever and night sweats which were unresolved and the patient reported taking Tylenol and Ibuprofen for symptom relief. Patient did not have lot or expiration date of vaccine given. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Rash pruritic
Clinical narrative: rash under her left breast; Redness; itchy red bumps; This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash, erythema and itchy rash. On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the erythema and itchy rash were unknown.   It was unknown if the reporter considered the rash, erythema and itchy rash to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient herself. Age at vaccination was not reported. The patient stated that she received her first dose of Shingrix the other day. The patient stated that she now experienced a rash under her left breast. The patient also stated that she has redness and itchy red bumps. The patient stated that the rash was not there a few days ago. The patient inquirred if receiving the Shingrix vaccine could have caused this reaction. The patient also inquired if Shingrix vaccine made her contagious. The patient provided medical advice disclaimer.  The patient also provided Shingrix FAQ's information per content.  The patient was referred to health care professional. The reporter consented to follow up. The patient did provide permission to contact health care professional
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose one on 11Jun2021, dose two  02Nov2021; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a 2-year-old female patient who received HAV (Havrix) (batch number 2K57N, expiry date unknown) for prophylaxis.   Previously administered products included Havrix (received first dose on 11th June 2021).   On 2nd November 2021, the patient received the 2nd dose of Havrix. On 2nd November 2021, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: Physician stated a patient was given dose two of Havrix earlier than recommended interval, which led to shortening of schedule. Physician was ok with follow up from safety.  Expiration date of second dose was not available at time of call.  No further details provided at time of call. The reporter consented to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia
Clinical narrative: Muscle pain every night and in the mornings; Upper left arm injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd August 2021, the patient received the 1st dose of Shingrix. On 2nd August 2021, less than 4 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced muscle pain. The action taken with Shingrix was unknown (Dechallenge was unknown). Rechallenge with Shingrix was unknown. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and muscle pain to be related to Shingrix.  The patient's age at vaccination was reported as 78 years old. The patient experienced pain at injection site on upper left arm which had recovered and one month later had experienced muscle pain in both forearms which had not recovered. She had experienced the pain every night and morning after waking up. The patient had consented for follow up.