chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Hypervolaemia, Hypoxia, Lethargy, Malnutrition, Mental status changes
Clinical narrative: Prior VAERS submitted #929214 COVID+ 1/16/23.  Vaccination Status- pfizer x3 + Pfizer BIVALENT x1 Expand All Collapse All BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider: DO Admission Date: 1/16/2023 Discharge Date: Jan 19, 2023   Active Hospital Problems   Diagnosis Date Noted POA ? Unspecified severe protein-calorie malnutrition 01/17/2023 Unknown ? Community acquired pneumonia, unspecified laterality   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Community acquired pneumonia, unspecified laterality [J18.9] Sepsis with acute organ dysfunction without septic shock, due to unspecified organism, unspecified type [A41.9, R65.20] COVID-19 [U07.1]   HOSPITAL COURSE: 85yom pmhx LBD with Parkinsonism, dysphagia s/p G tube placement, prostate cancer on oral chemotherapy who was admitted for management of sepsis secondary to community acquired pneumonia. Reportedly started on Robinul several days prior to presentation and noted to have become increasingly lethargic and weak, with inability to clear secretions. Notably Covid19+ but suspected viral shedding from previous infection one month prior. He was treated with ceftriaxone and azithromycin and symptoms did improve over time. He was mildly hypoxic on presentation, corrected with 2L NC, and tachycardic 140-150s sinus corrected with sepsis bolus. Through his course his oxygen requirements improved but continued to have difficulty mobilizing thick secretions. Also developed mild fluid overload from resuscitation. Improved significantly with several doses of IV lasix. By day 4 he was off oxygen and mentation, activity, and sputum output had improved significantly. Wife was looking into hospice facilities prior to admission. She, along with her son, met with social work and hospice to discuss options for home hospice. Home hospice was set up and patient was discharged 1/19/23 in stable condition, with completion of 5 day course of antibiotics, transitioned from ceftriaxone and azithro IV to oral Augmentin for 1 additional day. Robinul discontinued and listed as allergy given severe AMS.
Age: 85.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Multiple organ dysfunction syndrome, Pneumonia, Resuscitation, SARS-CoV-2 test positive, Sepsis
Clinical narrative: Prior VAERS submitted #929214 COVID+ 1/16/23.  Vaccination Status- pfizer x3 + Pfizer BIVALENT x1 Expand All Collapse All BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider: DO Admission Date: 1/16/2023 Discharge Date: Jan 19, 2023   Active Hospital Problems   Diagnosis Date Noted POA ? Unspecified severe protein-calorie malnutrition 01/17/2023 Unknown ? Community acquired pneumonia, unspecified laterality   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Community acquired pneumonia, unspecified laterality [J18.9] Sepsis with acute organ dysfunction without septic shock, due to unspecified organism, unspecified type [A41.9, R65.20] COVID-19 [U07.1]   HOSPITAL COURSE: 85yom pmhx LBD with Parkinsonism, dysphagia s/p G tube placement, prostate cancer on oral chemotherapy who was admitted for management of sepsis secondary to community acquired pneumonia. Reportedly started on Robinul several days prior to presentation and noted to have become increasingly lethargic and weak, with inability to clear secretions. Notably Covid19+ but suspected viral shedding from previous infection one month prior. He was treated with ceftriaxone and azithromycin and symptoms did improve over time. He was mildly hypoxic on presentation, corrected with 2L NC, and tachycardic 140-150s sinus corrected with sepsis bolus. Through his course his oxygen requirements improved but continued to have difficulty mobilizing thick secretions. Also developed mild fluid overload from resuscitation. Improved significantly with several doses of IV lasix. By day 4 he was off oxygen and mentation, activity, and sputum output had improved significantly. Wife was looking into hospice facilities prior to admission. She, along with her son, met with social work and hospice to discuss options for home hospice. Home hospice was set up and patient was discharged 1/19/23 in stable condition, with completion of 5 day course of antibiotics, transitioned from ceftriaxone and azithro IV to oral Augmentin for 1 additional day. Robinul discontinued and listed as allergy given severe AMS.
Age: 85.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Tachycardia
Clinical narrative: Prior VAERS submitted #929214 COVID+ 1/16/23.  Vaccination Status- pfizer x3 + Pfizer BIVALENT x1 Expand All Collapse All BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider: DO Admission Date: 1/16/2023 Discharge Date: Jan 19, 2023   Active Hospital Problems   Diagnosis Date Noted POA ? Unspecified severe protein-calorie malnutrition 01/17/2023 Unknown ? Community acquired pneumonia, unspecified laterality   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Community acquired pneumonia, unspecified laterality [J18.9] Sepsis with acute organ dysfunction without septic shock, due to unspecified organism, unspecified type [A41.9, R65.20] COVID-19 [U07.1]   HOSPITAL COURSE: 85yom pmhx LBD with Parkinsonism, dysphagia s/p G tube placement, prostate cancer on oral chemotherapy who was admitted for management of sepsis secondary to community acquired pneumonia. Reportedly started on Robinul several days prior to presentation and noted to have become increasingly lethargic and weak, with inability to clear secretions. Notably Covid19+ but suspected viral shedding from previous infection one month prior. He was treated with ceftriaxone and azithromycin and symptoms did improve over time. He was mildly hypoxic on presentation, corrected with 2L NC, and tachycardic 140-150s sinus corrected with sepsis bolus. Through his course his oxygen requirements improved but continued to have difficulty mobilizing thick secretions. Also developed mild fluid overload from resuscitation. Improved significantly with several doses of IV lasix. By day 4 he was off oxygen and mentation, activity, and sputum output had improved significantly. Wife was looking into hospice facilities prior to admission. She, along with her son, met with social work and hospice to discuss options for home hospice. Home hospice was set up and patient was discharged 1/19/23 in stable condition, with completion of 5 day course of antibiotics, transitioned from ceftriaxone and azithro IV to oral Augmentin for 1 additional day. Robinul discontinued and listed as allergy given severe AMS.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, COVID-19, SARS-CoV-2 test, Vaccination failure, Weight decreased
Clinical narrative: runny nose; sneezing; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHINORRHOEA (non-serious), outcome "recovering", described as "runny nose"; SNEEZING (non-serious), outcome "recovering"; FATIGUE (non-serious), outcome "recovering", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: I am 80 year old healthy female. Also it has nothing to do with anything about me or serious life threatening effects. I was asked a battery of questions when I called including the dates and all information on my COVID card. This is redundant with my issue. My only vaccine issue, and getting much better, is runny nose, sneezing and tired, but none of this affects my life in any way. When I called originally, it was only about the COVID cocktail and nothing to do with the vaccine. I made a point of that. My comment was the horrible immediate gastro effect, that continued for 5 days, when I took first group of pills. I know others had same effect. I could not eat for 5 days, because no stop light when to leave my body. I with oncologist and primary approval, stopped all pills because I didn't know what stayed and what went and they agreed with me so no problem of overdosing meds. They said no safety issue for short term. I asked to do this on 3rd day. I could have stopped but your instructions made it sound dangerous to do that. I felt better to have issue than to go to hospital. End of 5th day, doctor had me to blood work to check electrolytes and all ok. Gastro doctor said he had an abundance of patients contacting him for COVID cocktail reason. I made the call for two reasons, I felt important and I am a stock holder and as a mom, didn't want the company to get in any further trouble than this COVID cocktail was causing you. So you see, no reason for me to do a survey that has nothing to do with me. Also no blood clots or serious joint issues  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood electrolytes normal, Blood test normal, Decreased appetite, Fatigue, Rhinorrhoea
Clinical narrative: runny nose; sneezing; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHINORRHOEA (non-serious), outcome "recovering", described as "runny nose"; SNEEZING (non-serious), outcome "recovering"; FATIGUE (non-serious), outcome "recovering", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: I am 80 year old healthy female. Also it has nothing to do with anything about me or serious life threatening effects. I was asked a battery of questions when I called including the dates and all information on my COVID card. This is redundant with my issue. My only vaccine issue, and getting much better, is runny nose, sneezing and tired, but none of this affects my life in any way. When I called originally, it was only about the COVID cocktail and nothing to do with the vaccine. I made a point of that. My comment was the horrible immediate gastro effect, that continued for 5 days, when I took first group of pills. I know others had same effect. I could not eat for 5 days, because no stop light when to leave my body. I with oncologist and primary approval, stopped all pills because I didn't know what stayed and what went and they agreed with me so no problem of overdosing meds. They said no safety issue for short term. I asked to do this on 3rd day. I could have stopped but your instructions made it sound dangerous to do that. I felt better to have issue than to go to hospital. End of 5th day, doctor had me to blood work to check electrolytes and all ok. Gastro doctor said he had an abundance of patients contacting him for COVID cocktail reason. I made the call for two reasons, I felt important and I am a stock holder and as a mom, didn't want the company to get in any further trouble than this COVID cocktail was causing you. So you see, no reason for me to do a survey that has nothing to do with me. Also no blood clots or serious joint issues  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sneezing
Clinical narrative: runny nose; sneezing; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHINORRHOEA (non-serious), outcome "recovering", described as "runny nose"; SNEEZING (non-serious), outcome "recovering"; FATIGUE (non-serious), outcome "recovering", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: I am 80 year old healthy female. Also it has nothing to do with anything about me or serious life threatening effects. I was asked a battery of questions when I called including the dates and all information on my COVID card. This is redundant with my issue. My only vaccine issue, and getting much better, is runny nose, sneezing and tired, but none of this affects my life in any way. When I called originally, it was only about the COVID cocktail and nothing to do with the vaccine. I made a point of that. My comment was the horrible immediate gastro effect, that continued for 5 days, when I took first group of pills. I know others had same effect. I could not eat for 5 days, because no stop light when to leave my body. I with oncologist and primary approval, stopped all pills because I didn't know what stayed and what went and they agreed with me so no problem of overdosing meds. They said no safety issue for short term. I asked to do this on 3rd day. I could have stopped but your instructions made it sound dangerous to do that. I felt better to have issue than to go to hospital. End of 5th day, doctor had me to blood work to check electrolytes and all ok. Gastro doctor said he had an abundance of patients contacting him for COVID cocktail reason. I made the call for two reasons, I felt important and I am a stock holder and as a mom, didn't want the company to get in any further trouble than this COVID cocktail was causing you. So you see, no reason for me to do a survey that has nothing to do with me. Also no blood clots or serious joint issues  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Paraesthesia, Pruritus
Clinical narrative: Shingles; itching  on left lower back to naval area; stingy on left lower back to naval area; blisters; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd January 2023, the patient received the 1st dose of Shingrix. On 7th January 2023, 5 days after receiving Shingrix, the patient experienced shingles, pruritus, pricking skin sensation and blister. On an unknown date, the outcome of the shingles, pruritus, pricking skin sensation and blister were not recovered/not resolved.   It was unknown if the reporter considered the shingles, pruritus, pricking skin sensation and blister to be related to Shingrix.     Additional Information: GSK Receipt Date: 11-JAN-2023 Reporter's Comment: The reporter was the patient. The reporter stated that patient got her first Shingrix vaccine. On 07th Jan 2023 the patient started with itching and stingy on her left lower back that reached around her side to her left naval area.  The patient also stated that blisters started to appear. The patient followed up with her doctor and was diagnosed with Shingles. The shingles symptoms were still present.  The reporter did not consent to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Paraesthesia, Rash pruritic
Clinical narrative: Shingles; itching  on left lower back to naval area; stingy on left lower back to naval area; blisters; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd January 2023, the patient received the 1st dose of Shingrix. On 7th January 2023, 5 days after receiving Shingrix, the patient experienced shingles, pruritus, pricking skin sensation and blister. On an unknown date, the outcome of the shingles, pruritus, pricking skin sensation and blister were not recovered/not resolved.   It was unknown if the reporter considered the shingles, pruritus, pricking skin sensation and blister to be related to Shingrix.     Additional Information: GSK Receipt Date: 11-JAN-2023 Reporter's Comment: The reporter was the patient. The reporter stated that patient got her first Shingrix vaccine. On 07th Jan 2023 the patient started with itching and stingy on her left lower back that reached around her side to her left naval area.  The patient also stated that blisters started to appear. The patient followed up with her doctor and was diagnosed with Shingles. The shingles symptoms were still present.  The reporter did not consent to follow up.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia
Clinical narrative: Had all four of them and did get Covid; Had all four of them and did get Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 4 (booster), single (Lot number: GM9703) at the age of 58 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Jul2021 as dose 1, single (Lot number: EW0198), on 29Jul2021 as dose 2, single (Lot number: FA6780) and on 02Feb2022 as dose 3 (booster), single (Lot number: FJ5682) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: WELLBUTRIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Had all four of them and did get Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Had all four of them and did get Covid.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot FA6780 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FA6780, fill lot ET8450, and the formulated drug product lot EP8632. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Conclusion of Previously Completed Investigation: The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FJ5682. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause were identified as the complaint was not confirmed.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Had all four of them and did get Covid; Had all four of them and did get Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 4 (booster), single (Lot number: GM9703) at the age of 58 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Jul2021 as dose 1, single (Lot number: EW0198), on 29Jul2021 as dose 2, single (Lot number: FA6780) and on 02Feb2022 as dose 3 (booster), single (Lot number: FJ5682) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: WELLBUTRIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Had all four of them and did get Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Had all four of them and did get Covid.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot FA6780 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FA6780, fill lot ET8450, and the formulated drug product lot EP8632. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Conclusion of Previously Completed Investigation: The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FJ5682. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause were identified as the complaint was not confirmed.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue, Malaise, Viral infection
Clinical narrative: immediately after getting the 2nd dose, I experienced severe body aches, headache, chills, body quivering, extreme fatigue.  This lasted 2 days.  I never came out of the fatigue, it just got worse and worse and became debilitating.  A doctor's visit showed the EBV virus had been reactivated in my body.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Chills, Condition aggravated, Epstein-Barr virus infection reactivation
Clinical narrative: immediately after getting the 2nd dose, I experienced severe body aches, headache, chills, body quivering, extreme fatigue.  This lasted 2 days.  I never came out of the fatigue, it just got worse and worse and became debilitating.  A doctor's visit showed the EBV virus had been reactivated in my body.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Epstein-Barr virus test positive, Fatigue, Headache, Immediate post-injection reaction, Pain
Clinical narrative: immediately after getting the 2nd dose, I experienced severe body aches, headache, chills, body quivering, extreme fatigue.  This lasted 2 days.  I never came out of the fatigue, it just got worse and worse and became debilitating.  A doctor's visit showed the EBV virus had been reactivated in my body.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thyroid function test, Tremor
Clinical narrative: immediately after getting the 2nd dose, I experienced severe body aches, headache, chills, body quivering, extreme fatigue.  This lasted 2 days.  I never came out of the fatigue, it just got worse and worse and became debilitating.  A doctor's visit showed the EBV virus had been reactivated in my body.
Age: 49.0
Sex: F
Vaccine: UNK
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: Excessively heavy menstrual cycle/off normal menstrual cycle/My menstrual cycle has been tapering off as; Now I'm having heavier flow an more intense cramping than anyother time in my life; Now I'm having heavier flow an more intense cramping than anyother time in my life; Information has been received from the patient via the FDA under the Freedom of Information Act (FOI Service Control# 6241256) on 19-DEC-2022.  This spontaneous report referred to a 49-year-old non-pregnant female patient (ethnicity). Prescriptions, over-the counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination was reported as ibuprofen (ADVIL) and multivitamins. Allergies to medications, food, or other products was reported as mild seasonal allergies. Other illnesses at the time of vaccination and up to one month prior was reported as none. Chronic or longstanding health conditions was reported as insomnia.  On 08-APR-2021 10:00, the patient was vaccinated with zaire ebolavirus (kikwit) glycoprotein recombinant vector vaccine (vesicular stomatitis virus) (ERVEBO) injection, Lot# ER8737, has been verified to be invalid (strength, expiry date and route of administration were not provided) for prophylaxis.  On an unknown date, the patient experienced excessively heavy menstrual cycle within a couple days of second dose, off normal menstrual cycle as well as the following (normal time) 3 cycles. Her menstrual cycle had been tapering off as 50. She was having heavier flow and more intense cramping than anyother time in her life. The patient had not recovered from the adverse events. Medical tests and laboratory results related to the adverse events was reported as none. The patient had no ever had an adverse event following any previous vaccine.  The causal relationship between all the events and zaire ebolavirus (kikwit) glycoprotein recombinant vector vaccine (vesicular stomatitis virus) (ERVEBO) was not provided.  Follow-up information has been received from a healthcare worker regarding the 49 year old female patient. The healthcare worker was unable to locate any information about this patient.  Furthermore, she said they had never administered zaire ebolavirus (kikwit) glycoprotein recombinant vector vaccine (vesicular stomatitis virus) (ERVEBO) at their facility, so they did not have a patient who received that vaccine.
Age: 0.5
Sex: U
Vaccine: PNC15
Symptoms: Expired product administered
Clinical narrative: a patient received a expired dose of VAXNUVANCE on 12/7/2022; This spontaneous report was received from a pharmacist referring to a 6-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported.   On 07-DEC-2022, the patient was vaccinated with an expired dose (1 dosage form) of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, lot # U030015, expiration date: 16-NOV-2022 for prophylaxis (strength and route of administration were not provided) (expired product administered). No temperature excursion occurred.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: post-herpetic neuralgia; herpes zoster; Information has been received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown gender who at the time of report was approximately 71 years old. No information was provided regarding the pt's medical history, concurrent conditions, or concomitant medications. On or about 17-NOV-2014, the pt was vaccinated at a pharmacy with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot #, and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by healthcare providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster and post-herpetic neuralgia. The outcome of the events was not reported.  The reporter considered the events of herpes zoster and post-herpetic neuralgia to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; Caller reported that GARDASIL 9 that underwent a temperature excursion was administered; This spontaneous report has been received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On an unknown date in December 2022 (reported as between 06-DEC-2022 and 22-DEC-2022), the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, lot # 004648 is an invalid lot number for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and does not match any Company product (exact dose, dose number, route of administration, and anatomical location were not reported) for prophylaxis. On an unknown date before administration, the vaccine underwent a temperature excursion, however exact time and temperature of excursion were unknown. There was no previous temperature excursion. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Nurse reporting an AE for PROQUAD administered on 14JUN2022 after expiration on 16MAR2022. Caller stated this was noticed when a coworker was checking the shot record. Per caller, the product underwent no temperature excursion before administration.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent condition or concomitant therapies was provided.  On 14-JUN-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, lot #T031825, expiration date: 16-MAR-2022 (strength and route of administration were not provided) for prophylaxis (Expired product administered). No adverse events were reported (No adverse event).
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: there have been no additional adverse experiences reported; an improperly stored vaccine was administered to a patient; This spontaneous report was received from a physician referring to a 4-year-old patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not provided.  On 12-JAN-2023, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 1 dosage form, administered for prophylaxis (lot# W024966 with an expiration date on 05-FEB-2024) (strength, anatomical location and route of administration were not provided).  The dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was exposed to a temperature excursion of 10 degrees Celsius (°C) during a time frame of 1 hour 28 minutes (product storage error). No previous temperature excursion was reported.  There have been no additional adverse experiences reported. No product quality complaints reported.          ?
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Nurse Aid called in to report a temperature excursion for VARIVAX where one dose was administered on 01/05/2023; This spontaneous report has been received from a Nurse aid, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 05-JAN-2023, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, 0.5 milliliters once as prophylaxis (lot number: U026207, which was determined to be valid, with an expiration date on 24-AUG-2023) (product storage error). The administered dose underwent a temperature excursion of 5.7 degrees Fahrenheit (F) for 9 minutes. It was reported that there was no any  previous temperature excursion. No additional adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Product dose omission issue
Clinical narrative: patient missed her third dose in the GARDASIL 9 vaccine series; This spontaneous report was received from a nurse and refers to a 19-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in August 2022, the patient missed her third dose in the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine series (Vaccine dose omission).
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Dose Administered; Initial Report Received on 02-DEC-2022  This is a spontaneous report received from a registered nurse regarding a 18-year-old female patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 29-NOV-2022, a dose of HEPLISAV B (Lot #935843, expiration date 08-OCT-2022, NDC # 43528-002-01), route not specified, was administered in the left deltoid for hepatitis B immunisation.   The dose was 52 days past the expiration date. No adverse events were reported by the patient.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 1st dose 12Jul2022/ 2nd 27Sep2022/ Shingles 05Jan2023 / suspected vaccination failure; Shingles (light case); This case was reported by a consumer and described the occurrence of vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 12th July 2022, the patient received the 1st dose of Shingrix (intramuscular). On 5th January 2023, 100 days after receiving Shingrix and 177 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with acyclovir (Zovirax Tablets). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Linked case(s) involving the same patient:  US2023004775, US2023AMR005517   Additional Information: GSK receipt date: 11 JAN 2023 and 12 JAN 2023 Reporters comment: The reporter is the patient. The patient reported that received the 2 dose series of Shingrix vaccine.  The patient stated that both doses were administered in her right at a pharmacy facility.  The patient reported that the episode of Shingles started on 5th January 2023. The patient described it as a light case, was prescribed Zovirax tablets to treat the condition it was not resolved. The patient still had a light case that has dried over but they were not gone. Additional supportive information: This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. Reporter consented to follow up.; Sender's Comments:  US-GSK-US2023004775:Same reporter / FU1 US-GSK-US2023AMR005517:Shingrix
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had Shingrix and still got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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 Shingrix.   Additional Information: GSK Receipt Date: 15-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter had the Shingrix shot and still got shingles. The reporter wanted to know why that was. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination 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: U
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Very serious chicken pox; This case was reported by a consumer and described the occurrence of chickenpox in a adult 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 chickenpox (serious criteria other: Serious by reporter). On an unknown date, the outcome of the chickenpox was unknown.   It was unknown if the reporter considered the chickenpox to be related to Shingrix.     Additional Information: GSK receipt date: 17-JAN-2023 Reporter's comment:  The reporter asked about what does the research show for adults who had very serious chicken pox then they receive the Shingrix vaccine. The reporter asked about potential side effect for this type of person.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: It was used passed the "BUD"
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Condition aggravated, Diarrhoea, Feeling cold, Gastrointestinal disorder
Clinical narrative: I started experiencing a severe migraine, chills, and body aches. For the past few days, the symptoms have not gotten better. I now have GI symptoms as well, such as nausea, abdominal pain, and diarrhea. My migraine has not gone away, and it has been almost 4 days now. During the first two days, I was taking tylenol, but I didn?t want to take too much tylenol so I stopped taking it, which is when the migraine got worse because I no longer had pain relief. The pain in my body is pretty bad, but my legs feel the worst.  I am not an antivaxxer. I was excited to get the vaccine. However, I am feeling seriously ill with not many answers and it is very concerning. The CDC says the side effects should only last a day or two. I am now several days in with no relief and it feels like i?m just getting worse.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Migraine, Nausea, Pain
Clinical narrative: I started experiencing a severe migraine, chills, and body aches. For the past few days, the symptoms have not gotten better. I now have GI symptoms as well, such as nausea, abdominal pain, and diarrhea. My migraine has not gone away, and it has been almost 4 days now. During the first two days, I was taking tylenol, but I didn?t want to take too much tylenol so I stopped taking it, which is when the migraine got worse because I no longer had pain relief. The pain in my body is pretty bad, but my legs feel the worst.  I am not an antivaxxer. I was excited to get the vaccine. However, I am feeling seriously ill with not many answers and it is very concerning. The CDC says the side effects should only last a day or two. I am now several days in with no relief and it feels like i?m just getting worse.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Arthralgia, Biopsy, Biopsy lymph gland abnormal, Blood test
Clinical narrative: Initial intermittent joint pain. Other cold and sinus symptoms started in February leading to intense joint pain and difficulty walking extreme shortness of breath Lofgren /multi organ sarcoidosis - dx through biopsy of mediastinal lymph nodes. Prednisone, cytotoxic drugs, 60%of hair has dumped out. Difficulty keeping pace at work. Needong to call in with exhaustion and body aches with shortness of breath intermittently.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dyspnoea, Fatigue, Gait disturbance, Impaired work ability
Clinical narrative: Initial intermittent joint pain. Other cold and sinus symptoms started in February leading to intense joint pain and difficulty walking extreme shortness of breath Lofgren /multi organ sarcoidosis - dx through biopsy of mediastinal lymph nodes. Prednisone, cytotoxic drugs, 60%of hair has dumped out. Difficulty keeping pace at work. Needong to call in with exhaustion and body aches with shortness of breath intermittently.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Nasopharyngitis, Pain, Sarcoidosis, Sinus disorder
Clinical narrative: Initial intermittent joint pain. Other cold and sinus symptoms started in February leading to intense joint pain and difficulty walking extreme shortness of breath Lofgren /multi organ sarcoidosis - dx through biopsy of mediastinal lymph nodes. Prednisone, cytotoxic drugs, 60%of hair has dumped out. Difficulty keeping pace at work. Needong to call in with exhaustion and body aches with shortness of breath intermittently.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Adjuvant not mixed with  antigen/only adjuvant administered; Adjuvant not mixed with  antigen/only adjuvant administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication 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 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 Information: GSK receipt date: 12-Jan-2023 Reporter's comment: The reporter was pressed for time during the call, but follow-up via email would be okay. The reporter consented to follow-up. Additional supportive information: The patient inadvertently was administered only the adjuvant component of Shingrix without the powder antigen component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Neck pain, Pyrexia
Clinical narrative: vxs are very painful; gave me temperature; severe neck pain; headache; 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.   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, fever, neck pain and headache. On an unknown date, the outcome of the injection site pain, fever, neck pain and headache were recovered/resolved.   It was unknown if the reporter considered the injection site pain, fever, neck pain and headache to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2023AMR003441   Additional Information: GSK Receipt Date: 09-JAN-2023 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient received 2 doses of Shingles vaccine. The patient said they were very painful, gave him/her temperature, severe neck pain on the side where he/she got the vaccine and also headache like for two days but he/she imagine that this was nothing compared to suffering from shingles. Additional Supportive Information: For tolerance of 2nd dose refer case US2023AMR003441, reported by the same reporter. Follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR003441:same reporter - 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Neck pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: they are very painful/ it was on the side where I got the vaccine; severe neck pain; gave me temperature; headache like for two days; 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.   Previously administered products included Shingles Vaccine with an associated reaction of injection site pain (1st dose was received on unknown date refer case US2023AMR003429).   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 injection site pain, neck pain, fever and headache. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the injection site pain, neck pain and fever were unknown and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the injection site pain, neck pain, fever and headache to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2023AMR003429   Additional Information: GSK Receipt Date: 09-JAN-2023 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient received two doses of Shingles vaccine. The patient had stated that they were very painful, gave him/her temperature, severe neck pain. The patient had stated that it was on the side where he/she got the vaccine and also the headache was like for two days, but he/she had asked that imagined that this was nothing as compared to suffering from shingles. Additional supportive information: Follow-up would not possible, as no contact, details were available.; Sender's Comments:  US-GSK-US2023AMR003429:same reporter - 1st dose
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Got first dose but not the second; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (On an unknown date the patient received the 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 10-Jan-2023 Reporter's Comment: This case was received from consumer via  interactive digital media. The reporter stated that the patient got first dose but not the second and reporter said what to do. Additional supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The follow up would not possible as no contact details were available.