chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site mass
Clinical narrative: Lump under the armpit of the vaccinated arm (left); Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 02:30 (Lot number: 33030817) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: PRISTIQ; CLIMARA PRO; VITAMIN D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0151, Location of injection: Arm Left, Vaccine Administration Time: 11:15 AM), administration date: 28Mar2021, when the patient was 44 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 03:30 PM), administration date: 18Mar2021, when the patient was 44 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 23Nov2021, outcome "unknown", described as "Booster"; VACCINATION SITE MASS (non-serious) with onset 23Nov2021 20:30, outcome "not recovered", described as "Lump under the armpit of the vaccinated arm (left)". Therapeutic measures were not taken as a result of vaccination site mass.  Additional Information: Prior vaccination within 4 weeks was reported as none. The patient had no known allergies. Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: HEP
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood albumin decreased, Blood bilirubin normal, Hepatitis B
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, titled as stated below, and refers to a 71-year-old male patient with end-stage renal disease on peritoneal dialysis. His concomitant therapies were not reported. He had history of blood transfusion in 1988, but no history of tattoos, intravenous drug use (IVDU), or other risk factors for acquiring hepatitis B virus (HBV) infection. The patient had no previous history of liver disease, and his hepatitis B surface antigen (HBsAg) was negative one year prior to his presentation. On an unknown date, the patient was vaccinated with hepatitis B vaccine (recombinant) (manufacturer unknown) (dose, lot #, expiry date, and route of administration were not provided) for prophylaxis. On an unknown date, 5 days post-vaccination, during a routine evaluation for kidney transplant, the patient's blood tests showed positive HBsAg and he was referred for further investigations. His hepatitis B core antibody (HBcAb) and hepatitis B surface antibody (HBsAb) were negative. International normalised ratio (INR), total bilirubin, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were within normal limits. Albumin was low: 2.9 (unit not provided) due to the patient's chronic kidney disease. He was asymptomatic and denied abdominal pain, jaundice, fever, change in urine or stool color, or nausea/vomiting. On examination, vital signs were stable with no other findings except the presence of left-sided abdominal wall peritoneal dialysis catheter in place. Repeat testing for HBsAg, HBsAb, hepatitis B E antigen (HBeAg) and hepatitis B DNA (28 days post vaccination), all returned negative. The outcome of hepatitis B surface antigenemia was recovered. The authors considered positive HBsAg test to be related to recent hepatitis B vaccine (recombinant) (manufacturer unknown) vaccination, and they stated that hepatitis B virus vaccination can produce a transiently detectable level of HBsAg, which may be misdiagnosed as prior exposure to HBV, and be the cause of false positive HBsAg test. A copy of the published article is attached as further documentation of the patient's experience. On 23-NOV-2021, a follow-up with additional literature reference was added.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B DNA assay negative, Hepatitis B e antigen, Hepatitis B surface antigen, Hepatitis B surface antigen negative, International normalised ratio normal
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, titled as stated below, and refers to a 71-year-old male patient with end-stage renal disease on peritoneal dialysis. His concomitant therapies were not reported. He had history of blood transfusion in 1988, but no history of tattoos, intravenous drug use (IVDU), or other risk factors for acquiring hepatitis B virus (HBV) infection. The patient had no previous history of liver disease, and his hepatitis B surface antigen (HBsAg) was negative one year prior to his presentation. On an unknown date, the patient was vaccinated with hepatitis B vaccine (recombinant) (manufacturer unknown) (dose, lot #, expiry date, and route of administration were not provided) for prophylaxis. On an unknown date, 5 days post-vaccination, during a routine evaluation for kidney transplant, the patient's blood tests showed positive HBsAg and he was referred for further investigations. His hepatitis B core antibody (HBcAb) and hepatitis B surface antibody (HBsAb) were negative. International normalised ratio (INR), total bilirubin, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were within normal limits. Albumin was low: 2.9 (unit not provided) due to the patient's chronic kidney disease. He was asymptomatic and denied abdominal pain, jaundice, fever, change in urine or stool color, or nausea/vomiting. On examination, vital signs were stable with no other findings except the presence of left-sided abdominal wall peritoneal dialysis catheter in place. Repeat testing for HBsAg, HBsAb, hepatitis B E antigen (HBeAg) and hepatitis B DNA (28 days post vaccination), all returned negative. The outcome of hepatitis B surface antigenemia was recovered. The authors considered positive HBsAg test to be related to recent hepatitis B vaccine (recombinant) (manufacturer unknown) vaccination, and they stated that hepatitis B virus vaccination can produce a transiently detectable level of HBsAg, which may be misdiagnosed as prior exposure to HBV, and be the cause of false positive HBsAg test. A copy of the published article is attached as further documentation of the patient's experience. On 23-NOV-2021, a follow-up with additional literature reference was added.
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: no additional AE/PQC was reported at time of call; 6 month old patient has received 3 doses of PEDVAXHIB at 2 months, 4 months and 6 months of age; This spontaneous report was received from a pharmacist and refers to a 6-month-old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On an unknown date in July 2021 (reported as at 2 months of age), the patient was vaccinated with the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), 0.5 mL, for prophylaxis (route of administration, anatomical location, lot # and expiration date were not provided).  On an unknown date in September 2021 (reported as at 4 months of age), the patient was vaccinated with the second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), 0.5 mL, for prophylaxis (route of administration, anatomical location, lot # and expiration date were not provided).  On an unknown date in November 2021 (reported as at 6 months of age), the patient was vaccinated with the third dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), 0.5 mL, for prophylaxis (route of administration, anatomical location, lot # and expiration date were not provided) (inappropriate schedule of product administration).  It was noted that recommendations for three-dose series for patients aged 2-10 months at first dose, according to the product prescribing information, is 2 doses, 2 months apart and a booster at age 12-15 months. No additional information was provided. The reporter stated "it occurred at one of the clinics". No additional adverse event (AE) / product quality complaint (PQC) was reported at time of call.
Sex: F
Vaccine: RV5
Symptoms: Malaise, Nasopharyngitis
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a female patient of unreported age. The patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported. On 30-SEP-2021, the underwent vaccination with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot number 1707496 has been verified to be a valid lot number, the expiration date was reported and established as 29-MAR-2022; dose and vaccination scheme were not reported). On 01-DEC-2021 (reported as "today"; inconsistent information, also reported as "01-NOV-2021"), the patient was sick. The medical assistant further described that the patient was experiencing cold symptoms (nasopharyngitis) (not resolved). Therefore, the patient did not receive the subsequent dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) on that day (withdrawn). The medical assistant did not provide a causality assessment between nasopharyngitis and the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ).
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: no additional adverse effect; Incorrect product storage??; This spontaneous report was received from a medical assist concerning a patient of unknown age. No information about the patient's current condition, medical history or concomitant therapy was reported.      On 02-DEC-2021, the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) underwent a temperature excursion (product storage error) and was administered (dose and route were not reported; lot # U021995, 13-JAN-2023) as prophylaxis. This vaccine was stored above 9 degree Celsius (8.6 degree Celsius) for 15 minutes. No previous excursion was reported. No additional adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 06-DEC-2021, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated(VAQTA), lot number T017179 with expiration date 26-OCT-2021 (expired product administered), (dose, route and anatomical location were not reported) for prophylaxis. The of hepatitis a vaccine, inactivated(VAQTA) vaccine had no temperature excursion. No additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: No additional AE; intramuscular route instead of subcutaneous route; This spontaneous report was received from a pharmacist concerning a patient of unknown age. No information about the current condition, medical history or concomitant therapy was reported.    On 05-DEC-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) via intramuscular route instead of subcutaneous route (lot # T002842, expiration date 23-JAN-2022; dose was not reported) as prophylaxis (incorrect route of product administration). No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; an expired dose of M-M-R II was administered to patient on 6-DEC-2021 / expired on 20 NOV 2021; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-DEC-2021, the patient was vaccinated with expired measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II), recombinant human albumin (rHa), 0.5 milliliters, lot # S037497, expitation date 20-NOV-2021 (expired product administered) (dose number, site and route of administration not provided) for prophylaxis. The reporter stated that measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) did not experience any temperature excursions. No additional information provided (no adverse event).
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; was administered MMR-II that expired; This spontaneous report was received from an office manager and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 09-DEC-2021, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant Human Albumin (rHA) (M-M-R II) dose of 0.5 milliliter, lot #S039310, expiration date: 04-DEC-2021, administered as prophylaxis (strength, anatomical location and route of administration were not provided). The patient has not experienced any other adverse events. The office manager stated that there was no temperature excursion and that the only issue was that the vaccine expired.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: The spontaneous report was received from a nurse concerning to a patient of unknown gender. No information regarding the patient's concurrent condition, medical history, drug reactions or allergies and concomitant medications was provided. On an unspecified date, the patient was vaccinated with one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1821791, expiration date: 26-JUL-2022) (dose and vaccination site were not provided) as prophylaxis. Caller reported that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered after temperature excursion (product storage error). No additional information reported.
Sex: U
Vaccine: VARZOS
Symptoms: Cardiac failure, Cerebrovascular accident, Ill-defined disorder
Clinical narrative: Stroke; Heart Failure; Ill defined-disorder; This spontaneous report was received from a lawyer and refers to a patient of currently 78 year-old of unknown gender concerning a case in litigation. The patient's concurrent condition's, medical history, historical drugs and concomitant medications were not reported.  In 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced stroke (cerebrovascular accident), heart failure and other zoster related conditions (ill-defined disorder), the patient was treated with unspecified therapies.      The outcome of cerebrovascular accident, ill-defined disorder and cardiac failure was unknown.     The reporter considered cerebrovascular accident, ill-defined disorder and cardiac failure to be related to Zoster Vaccine Live (ZOSTAVAX).     Upon internal review, the events of heart failure and stroke was considered medically significant.
Sex: U
Vaccine: MMR
Symptoms: Product preparation error
Clinical narrative: Sterile diluent which was intended for MMR II reconstitution was unavailable; No addtional AE; Reconstituted M-M-R II with 0.4% saline solution instead of corresponding sterile diluent; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.  On 17-Nov-2021, The patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rha (recombinant human albumin) M-M-R II with lot# T018893 and expiration date: 06-FEB-2022 (dose, frequency, route of administration and anatomical location were not provided) for prophylaxis. The physician had reconstituted MMR II with 0.4% saline solution instead of corresponding sterile diluent since the corresponding sterile diluent which was intended for MMR II reconstitution was unavailable at that time. The patient was administered this affected 0.4% saline solution reconstituted measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rha (recombinant human albumin) M-M-R II.  No additional AE nor PQC reported.
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product use issue
Clinical narrative: No additional information provided, no additional adverse event reported; The patient was administered with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and patient is in her 50's; This spontaneous report as received from a pharmacist referring to a female patient of unknown age. The patient's concurrent conditions, medical history, historical drug and concomitant therapies were not reported.  On 22-NOV-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis. The patient was administered with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and patient is in her 50's (product use issue). No additional information provided, no additional adverse event reported (no adverse event).
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination
Clinical narrative: This spontaneous report was received from a physician referring to a currently 31-year-old female patient.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On approximately 2001 (reported as "around age 11"), the patient was vaccinated with her first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported) but never completed the series (incomplete course of vaccination). The reporter believed the patient only received 1 dose, but could not provide additional information since the patient did not receive the vaccine in the reporter's office.  No adverse event were reported (no adverse event).
Sex: F
Vaccine: COVID19
Symptoms: Psoriatic arthropathy
Clinical narrative: Flare of symptoms/pain and swelling in her joints that has lasted for several weeks; This serious solicited report (USASL2021195793) was reported to Agency on 08/DEC/2021 by a consumer from a commercial program and involves a 47 year old female patient who had flare of symptoms /pain and swelling in her joints that has lasted for several weeks [PT: psoriatic arthropathy] while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included psoriatic arthritis. No concomitant medications were provided. The patient's co-suspect medication included COVID-19 (Coronavirus disease of 2019) Vaccine. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. On an unknown date in 2021, the patient had a flare of symptoms after receiving her COVID-19 booster. The patient did not miss any of her injections but a day after her booster she had pain and swelling in her joints that has lasted for several weeks. The patient could not remember the exact date she received the COVID-19 booster but stated it was several weeks ago of an unknown date in 2021. The patient takes her weekly injections on Fridays. No treatment information was received. The outcome of the event psoriatic arthropathy was reported as recovered/resolved. The event psoriatic arthropathy was resolved on an unknown date in 2021. Action taken with Enbrel with Single Dose Prefilled Autoinjector was continued for the event psoriatic arthropathy. The causal relationship between the event psoriatic arthropathy and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. The patient declined to provide lot number. The reporter declined consent for follow up. No follow up attempts are possible. No further information is expected.  Amgen comment: This individual case report does not change the safety profile of the product.  Etanercept (ENBREL) is under agreement with Amgen.  The event "Psoriatic arthritis aggravated" was considered serious and unrelated to etanercept.; Sender's Comments: Based on the temporal association, the event Psoriatic arthritis flare is considered as related to the use of COVID-19 Vaccine and unrelated to the use of Etanercept. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: VARZOS
Symptoms: Hepatic pain, Renal pain
Clinical narrative: This case was reported by a consumer and described the occurrence of renal pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included renal disorder.   On an unknown date, the patient received the 1st dose of Shingrix. On 8th December 2021, unknown after receiving Shingrix, the patient experienced renal pain. On an unknown date, the patient experienced hepatic pain. On an unknown date, the outcome of the renal pain and hepatic pain were unknown.   It was unknown if the reporter considered the renal pain and hepatic pain to be related to Shingrix.  Additional details were provided are as follows: The age at vaccination was not reported. The patient received a dose of Shingrix and on the day of reporting (this AM), the patient had extreme live or kidney pain. The patient had a slight problem with kidney and would see urologist this Friday on 10th December 2021, but this pain was extreme. The patient asked that if this normal. The reporter consented to follow-up GSK note- Since not clearly specified, live pain is conservatively considered as liver pain.
Sex: F
Vaccine: VARZOS
Symptoms: Dialysis, Renal impairment
Clinical narrative: strong reaction, lost her kidneyfunction. She's on dialysis; This case was reported by a consumer via interactive digital media and described the occurrence of impaired renal function 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 impaired renal function (serious criteria GSK medically significant). On an unknown date, the outcome of the impaired renal function was unknown.   The reporter considered the impaired renal function to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient's friend. The age at vaccination was not reported. The patient lost her kidney function from the vaccine. She was on dialysis for 3 months.  The patient had a very strong reaction and it would never be the same. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Pain, Pruritus, Spinal pain
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of pain in spine in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (patient had a very mild case of the shingles many years ago). On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in spine, burning sensation, pruritus and pain. On an unknown date, the outcome of the pain in spine, burning sensation, pruritus and pain were not recovered/not resolved. It was unknown if the reporter considered the pain in spine, burning sensation, pruritus and pain to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient had a one spot on head and one on tongue. The patient did have the shingles shot way back when. At the time of reporting, patient had pain alongside spine radiating outward. It's a burning, stabbing itching pain.
Sex: U
Vaccine: VARZOS
Symptoms: Chest pain, Cough, Dyspnoea, Mobility decreased, Pain
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd December 2021, the patient received the 1st dose of Shingrix. On 4th December 2021, 1 days after receiving Shingrix, the patient experienced headache, fever and chills. In December 2021, the patient experienced chest pain, movements reduced, difficulty breathing, pain, painful cough and sneezing. On 5th December 2021, the outcome of the headache, fever and chills were recovered/resolved. On an unknown date, the outcome of the chest pain, pain, painful cough and sneezing were not recovered/not resolved and the outcome of the movements reduced and difficulty breathing were unknown.   It was unknown if the reporter considered the headache, fever, chills, chest pain, movements reduced, difficulty breathing, pain, painful cough and sneezing to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced numerous common side effects including headache, fever, chills, pain in the right side of his/her chest, near the sternum. The other side effects went away by 5th December 2021 but not the pain in the chest. The pain in his/her chest not only limited his/her movement but also made it hard to breathe and was painful if he/she coughed or sneezed. The pain worsened on 6th December 2021 so his/her doctor advised going to the emergency room, which he/she did. The patient had a work up to rule out a pulmonary embolism but no other cause of the pain was found.  It was now a week after the emergency room visit and he/she was still experiencing pain, although less that a week ago.  The patient asked GlaxoSmithKline had this type of pain been reported as a side effect of Shingrix,  If so, how long should he/she expect the pain to last and what was the recommended treatment. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Painful respiration, Sneezing
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd December 2021, the patient received the 1st dose of Shingrix. On 4th December 2021, 1 days after receiving Shingrix, the patient experienced headache, fever and chills. In December 2021, the patient experienced chest pain, movements reduced, difficulty breathing, pain, painful cough and sneezing. On 5th December 2021, the outcome of the headache, fever and chills were recovered/resolved. On an unknown date, the outcome of the chest pain, pain, painful cough and sneezing were not recovered/not resolved and the outcome of the movements reduced and difficulty breathing were unknown.   It was unknown if the reporter considered the headache, fever, chills, chest pain, movements reduced, difficulty breathing, pain, painful cough and sneezing to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced numerous common side effects including headache, fever, chills, pain in the right side of his/her chest, near the sternum. The other side effects went away by 5th December 2021 but not the pain in the chest. The pain in his/her chest not only limited his/her movement but also made it hard to breathe and was painful if he/she coughed or sneezed. The pain worsened on 6th December 2021 so his/her doctor advised going to the emergency room, which he/she did. The patient had a work up to rule out a pulmonary embolism but no other cause of the pain was found.  It was now a week after the emergency room visit and he/she was still experiencing pain, although less that a week ago.  The patient asked GlaxoSmithKline had this type of pain been reported as a side effect of Shingrix,  If so, how long should he/she expect the pain to last and what was the recommended treatment. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 12th December 2021 12:00, the patient received Shingrix. In December 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were provided are as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received a dose of Shingrix at noon, 24 hours ago of reporting and had experienced sore arm. The patient asked that he/she would have any additional side effects or was a lucky one who did not had bad side effects. The patient not asking for medical advice. The patient simply want to know how long after getting Shingrix did he/she get unpleasant side effects and realized that the answer would be general, just as the listing of possible side effects was a general statement. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Received a 3rd dose; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The patient recently received a 3rd dose of the vaccine by accident, which led to extra dose administered.  The reporter asked if there was any information on 3 doses. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st and 2nd dose received in 2018).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got two shots of Shingrix which he/she forgot about and got another Shingrix shot recently, which led to extra dose administered.  The reporter asked if this was a problem. No contact details were available.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only the diluent portion was given; Only the diluent portion was given; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2021, the patient received Shingrix. On 15th September 2021, 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 as follows: The reporter reported that the patient was administrated only the diluent portion of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No further events were reported. The reporter agreed to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: another patient in the past went 10-11 months between doses.; This case was reported by a pharmacist via call center representative 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 an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter mentioned the patient in the past who went 10 to 11 months between doses, which led to drug dose administration interval too long. The reporter had not provided details. The reporter informed that specialist attempted to collect additional details, but pharmacist declined to answer. The reporter did not consent to follow up. The case has been linked to US2021257786,reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021257786:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: loose stool; This case was reported by a consumer via GSK interactive digital media and described the occurrence of loose stools in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th December 2021, the patient received the 2nd dose of Shingrix. On 14th December 2021, 8 days after receiving Shingrix, the patient experienced loose stools. On an unknown date, the outcome of the loose stools was unknown.   It was unknown if the reporter considered the loose stools to be related to Shingrix.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 2nd dose of Shingrix 10 days ago from reporting date and 2 days ago from reporting date, the patient developed very loose stool. The patient asked would he/she still get side effects. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Pain
Clinical narrative: 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. 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 and pain. On an unknown date, the outcome of the shingles and pain were unknown. It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got shingles on his/her back, very painful.  The patient was due for 2nd shot of shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Loss of personal independence in daily activities
Clinical narrative: Really fatigued, called out from work; even called out from; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th December 2021, the patient received the 2nd dose of Shingrix. In December 2021, less than a week after receiving Shingrix, the patient experienced fatigue and activities of daily living impaired. On an unknown date, the outcome of the fatigue and activities of daily living impaired were not recovered/not resolved.   It was unknown if the reporter considered the fatigue and activities of daily living impaired to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported. The patient received second dose of Shingrix and experienced fatigue. The patient even called out from work. The reporter wanted to know how long, on average, do recipients felt like this. Consent to follow up was not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 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 shingle shot years ago and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pain
Clinical narrative: the vaccine did hurt; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain 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 injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she had shingles and they were the worst.  The reporter also stated that, the vaccine did hurt some but he/she would take the 2 shots any day over having shingles again. The follow-up would not possible as no contact details were available. For the tolerance of 2nd dose, refer case- US2021AMR259656, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR259656:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Vaccination failure
Clinical narrative: 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 them in 2013 and lasted for 6 to 7 weeks). 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: The case was self reported by the patient. The age at vaccination was not reported. The reporter stated that, shingles hurt so bad, he/she went and got the shot after he/she had got over the earlier shingles and thought that was it. But just before thanksgiving day in the reporting year he/she came down with shingles again. The reporter tried everything people had suggested and what the Doctor gave and thought he/she was getting better but still had them and they still hurt so bad. The reporter adviced to take the shot as soon as possible if not gotten yet and also to have a short talk to doctor. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 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 case was self reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she got the vaccine and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (on an unknown date in April 2019 had a mild case compared to mother-in-law) and shingles (Family History) (mother in-laws, had them at the same time). In June 2020, the patient received the 2nd dose of Shingles vaccine. In January 2020, the patient received the 1st dose of Shingles vaccine. In March 2021, between 8 and 10 months after receiving Shingles vaccine and between 1 and 2 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 and Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient was 49 years old when he/she got Shingles in April 2019, so doctor suggested to get the vaccine. In March 2021, the patient got shingles again and this time they were much worse. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 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 shingle shot and still got shingles. The patient would not say that the vaccine prevents anyone from getting shingles but it could make the outbreak more tolerable if anyone gets them. The patient was speaking from self experience. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient's son/daughter. The age at vaccination was not reported. The reporter reported that his/her mom had the shot and has had shingles twice now. The reporter stated you just did not know. The follow 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.