chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cardiac tamponade, Cardioversion, Chest pain, Chills
Clinical narrative: On 1/13/2023, I experienced fatigue, a heartrate of 150, a BP of about 70/40, midsternal chest pains, and chills. I went to the emergency room and was admitted to the hospital. While I was at the ER, I underwent CT scans of my chest and abdomen, an echocardiogram, and cardioversion. I tested positive for COVID-19 and was diagnosed with pericarditis. I was given metoprolol intravenously twice. I was given a calcium channel blocker, after which I bottomed out and had to be given epinephrine. I was given about three liters of saline solution intravenously. I stayed in the hospital for 24 hours and was released on 1/14/2023. I was prescribed aspirin (650 mg). which I was to take three times a day, and colchicine (0.6 mg) to take twice a day. On 1/22/2023, I was admitted again to the hospital with rapid heartrate and low blood pressure. I was given metoprolol intravenously and was admitted to the ICU. I underwent a pericardiocentesis. I was in the ICU for three days. I underwent several echocardiograms while I was in the hospital. I was diagnosed with pericarditis with tamponade. I was given colchicine, prednisone, digoxin, PROTONIX, ANAKINRA, and metoprolol while I was in the hospital. I was taken off the aspirin I had previously been prescribed and was then instructed to take ibuprofen (800 mg) three times a day. After I was discharged on 1/27/2023, I was prescribed all the aforementioned medications, except the digoxin, to take daily. As my conditioned improved after my release, I was gradually weaned off of prednisone, ibuprofen, PROTONIX, and ANAKINRA. On 5/17/2023, I had chills. I went to the ER and was admitted to the hospital for 24 hours. I underwent one echocardiogram, plus an MRI on 5/18/2023. I was diagnosed with recurring pericarditis. I was then started back on the prednisone, ibuprofen, PROTONIX, and ANAKINRA. At the time of this writing, I am doing okay. I am currently taking metoprolol (25 mg) once a day, colchicine (0.6 mg) twice a day, ibuprofen (800 mg) three times a day, and rilonacept (220 mg) once a week. I am off the prednisone, the PROTONIX, and the ANAKINRA. I still have pericarditis, though I am now asymptomatic. I was told it would be at least six months before it resolved.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Computerised tomogram abdomen, Computerised tomogram thorax, Echocardiogram, Fatigue, Heart rate increased
Clinical narrative: On 1/13/2023, I experienced fatigue, a heartrate of 150, a BP of about 70/40, midsternal chest pains, and chills. I went to the emergency room and was admitted to the hospital. While I was at the ER, I underwent CT scans of my chest and abdomen, an echocardiogram, and cardioversion. I tested positive for COVID-19 and was diagnosed with pericarditis. I was given metoprolol intravenously twice. I was given a calcium channel blocker, after which I bottomed out and had to be given epinephrine. I was given about three liters of saline solution intravenously. I stayed in the hospital for 24 hours and was released on 1/14/2023. I was prescribed aspirin (650 mg). which I was to take three times a day, and colchicine (0.6 mg) to take twice a day. On 1/22/2023, I was admitted again to the hospital with rapid heartrate and low blood pressure. I was given metoprolol intravenously and was admitted to the ICU. I underwent a pericardiocentesis. I was in the ICU for three days. I underwent several echocardiograms while I was in the hospital. I was diagnosed with pericarditis with tamponade. I was given colchicine, prednisone, digoxin, PROTONIX, ANAKINRA, and metoprolol while I was in the hospital. I was taken off the aspirin I had previously been prescribed and was then instructed to take ibuprofen (800 mg) three times a day. After I was discharged on 1/27/2023, I was prescribed all the aforementioned medications, except the digoxin, to take daily. As my conditioned improved after my release, I was gradually weaned off of prednisone, ibuprofen, PROTONIX, and ANAKINRA. On 5/17/2023, I had chills. I went to the ER and was admitted to the hospital for 24 hours. I underwent one echocardiogram, plus an MRI on 5/18/2023. I was diagnosed with recurring pericarditis. I was then started back on the prednisone, ibuprofen, PROTONIX, and ANAKINRA. At the time of this writing, I am doing okay. I am currently taking metoprolol (25 mg) once a day, colchicine (0.6 mg) twice a day, ibuprofen (800 mg) three times a day, and rilonacept (220 mg) once a week. I am off the prednisone, the PROTONIX, and the ANAKINRA. I still have pericarditis, though I am now asymptomatic. I was told it would be at least six months before it resolved.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypotension, Intensive care, Magnetic resonance imaging, Pericardial drainage, Pericarditis
Clinical narrative: On 1/13/2023, I experienced fatigue, a heartrate of 150, a BP of about 70/40, midsternal chest pains, and chills. I went to the emergency room and was admitted to the hospital. While I was at the ER, I underwent CT scans of my chest and abdomen, an echocardiogram, and cardioversion. I tested positive for COVID-19 and was diagnosed with pericarditis. I was given metoprolol intravenously twice. I was given a calcium channel blocker, after which I bottomed out and had to be given epinephrine. I was given about three liters of saline solution intravenously. I stayed in the hospital for 24 hours and was released on 1/14/2023. I was prescribed aspirin (650 mg). which I was to take three times a day, and colchicine (0.6 mg) to take twice a day. On 1/22/2023, I was admitted again to the hospital with rapid heartrate and low blood pressure. I was given metoprolol intravenously and was admitted to the ICU. I underwent a pericardiocentesis. I was in the ICU for three days. I underwent several echocardiograms while I was in the hospital. I was diagnosed with pericarditis with tamponade. I was given colchicine, prednisone, digoxin, PROTONIX, ANAKINRA, and metoprolol while I was in the hospital. I was taken off the aspirin I had previously been prescribed and was then instructed to take ibuprofen (800 mg) three times a day. After I was discharged on 1/27/2023, I was prescribed all the aforementioned medications, except the digoxin, to take daily. As my conditioned improved after my release, I was gradually weaned off of prednisone, ibuprofen, PROTONIX, and ANAKINRA. On 5/17/2023, I had chills. I went to the ER and was admitted to the hospital for 24 hours. I underwent one echocardiogram, plus an MRI on 5/18/2023. I was diagnosed with recurring pericarditis. I was then started back on the prednisone, ibuprofen, PROTONIX, and ANAKINRA. At the time of this writing, I am doing okay. I am currently taking metoprolol (25 mg) once a day, colchicine (0.6 mg) twice a day, ibuprofen (800 mg) three times a day, and rilonacept (220 mg) once a week. I am off the prednisone, the PROTONIX, and the ANAKINRA. I still have pericarditis, though I am now asymptomatic. I was told it would be at least six months before it resolved.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: On 1/13/2023, I experienced fatigue, a heartrate of 150, a BP of about 70/40, midsternal chest pains, and chills. I went to the emergency room and was admitted to the hospital. While I was at the ER, I underwent CT scans of my chest and abdomen, an echocardiogram, and cardioversion. I tested positive for COVID-19 and was diagnosed with pericarditis. I was given metoprolol intravenously twice. I was given a calcium channel blocker, after which I bottomed out and had to be given epinephrine. I was given about three liters of saline solution intravenously. I stayed in the hospital for 24 hours and was released on 1/14/2023. I was prescribed aspirin (650 mg). which I was to take three times a day, and colchicine (0.6 mg) to take twice a day. On 1/22/2023, I was admitted again to the hospital with rapid heartrate and low blood pressure. I was given metoprolol intravenously and was admitted to the ICU. I underwent a pericardiocentesis. I was in the ICU for three days. I underwent several echocardiograms while I was in the hospital. I was diagnosed with pericarditis with tamponade. I was given colchicine, prednisone, digoxin, PROTONIX, ANAKINRA, and metoprolol while I was in the hospital. I was taken off the aspirin I had previously been prescribed and was then instructed to take ibuprofen (800 mg) three times a day. After I was discharged on 1/27/2023, I was prescribed all the aforementioned medications, except the digoxin, to take daily. As my conditioned improved after my release, I was gradually weaned off of prednisone, ibuprofen, PROTONIX, and ANAKINRA. On 5/17/2023, I had chills. I went to the ER and was admitted to the hospital for 24 hours. I underwent one echocardiogram, plus an MRI on 5/18/2023. I was diagnosed with recurring pericarditis. I was then started back on the prednisone, ibuprofen, PROTONIX, and ANAKINRA. At the time of this writing, I am doing okay. I am currently taking metoprolol (25 mg) once a day, colchicine (0.6 mg) twice a day, ibuprofen (800 mg) three times a day, and rilonacept (220 mg) once a week. I am off the prednisone, the PROTONIX, and the ANAKINRA. I still have pericarditis, though I am now asymptomatic. I was told it would be at least six months before it resolved.
Age: 1.5
Sex: F
Vaccine: COVID19-2, MMR
Symptoms: Incorrect dose administered, Injection site erythema, Injection site swelling, Irritability, Product preparation error
Clinical narrative: Medical assistant administered new, undiluted 10-dose vial of Pfizer Bivalent 6m-4y vaccine as a single dose to patient in error. Parent was contacted the following day (6/22/23) when error was discovered.  Parent reported patient to have experienced fever of 102F on the evening following vaccination, rash from belly to left thigh, and redness and swelling at both injection sites. Follow up by phone on 6/23/23, parent reported fever waxed and waned over 6/22/23, but at present no longer experiencing fever, belly/thigh rash no longer present, continued clinically expected redness at both injection sites. Parent noted increased fussiness as well.
Age: 1.5
Sex: F
Vaccine: COVID19-2, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Medical assistant administered new, undiluted 10-dose vial of Pfizer Bivalent 6m-4y vaccine as a single dose to patient in error. Parent was contacted the following day (6/22/23) when error was discovered.  Parent reported patient to have experienced fever of 102F on the evening following vaccination, rash from belly to left thigh, and redness and swelling at both injection sites. Follow up by phone on 6/23/23, parent reported fever waxed and waned over 6/22/23, but at present no longer experiencing fever, belly/thigh rash no longer present, continued clinically expected redness at both injection sites. Parent noted increased fussiness as well.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient tolerated well no adverse reaction, dose given after moderna bivalent vial was in fridge longer than 30 days.
Age: 92.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient tolerated well no adverse reaction, dose was given after moderna bivalent vial was in the fridge after 30 days.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient tolerated well no adverse reaction, dose given after moderna bivalent vial was in the fridge longer than 30 days.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient tolerated well no adverse reaction, dose was given after vial was in fridge longer than 30 days
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood pressure increased, Computerised tomogram head normal, Head discomfort, Headache, Heart rate increased
Clinical narrative: Exactly one week after receiving my 6th Pfizer Covid Vaccine (  the 2nd Bivalent version ),  I got a heavy headache with a twinge of nausea feeling.  The pain was like weights on top of my brain and up the back of my head.  There was a bit of blurry vision.  Since there was absolutely NO REASON that I could think of for this headache, I wondered if it might be a side-effect of my Covid Vaccine even though I had done very well with my previous 5 Pfizer vaccines and if I got any minor side-effects ( headache, fatigue, low-grade fever ) the mild side-effects happened the day after receiving the vaccine and went away by the next day after that.    This heavy headache did not occur until 7 days after receiving the vaccine,  and then, it lasted for FIVE (5) days!   So I went to the EMERGENCY ROOM at the local hospital on DAY THREE of having the persistent heavy headache to see if I had CVT  ( Cerebral Venous Thrombosis ) or similar.  The hospital did two CT SCANS ( CT-A & CT-V ).  The result was that "I did not have any venous dural thrombosis nor any clots in the arteries of my brain".  Finally, on the 5th & 6th days after the heavy headache began, it started to subside and appears to have disappeared by the 7th day after it started.   At the Emergency Room,  they also gave me fluids and Ativan to get my racing heart beat down from the 120's to 108 moving back towards the 90's,  My blood pressure also went up from my normal 142 / 84  to  165 / 114.  The fast hearbeat & high blood pressure may be somewhat attributable to being in the Emergency Room for NINE ( 9 ) HOURS.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Nausea, Palpitations, Vision blurred
Clinical narrative: Exactly one week after receiving my 6th Pfizer Covid Vaccine (  the 2nd Bivalent version ),  I got a heavy headache with a twinge of nausea feeling.  The pain was like weights on top of my brain and up the back of my head.  There was a bit of blurry vision.  Since there was absolutely NO REASON that I could think of for this headache, I wondered if it might be a side-effect of my Covid Vaccine even though I had done very well with my previous 5 Pfizer vaccines and if I got any minor side-effects ( headache, fatigue, low-grade fever ) the mild side-effects happened the day after receiving the vaccine and went away by the next day after that.    This heavy headache did not occur until 7 days after receiving the vaccine,  and then, it lasted for FIVE (5) days!   So I went to the EMERGENCY ROOM at the local hospital on DAY THREE of having the persistent heavy headache to see if I had CVT  ( Cerebral Venous Thrombosis ) or similar.  The hospital did two CT SCANS ( CT-A & CT-V ).  The result was that "I did not have any venous dural thrombosis nor any clots in the arteries of my brain".  Finally, on the 5th & 6th days after the heavy headache began, it started to subside and appears to have disappeared by the 7th day after it started.   At the Emergency Room,  they also gave me fluids and Ativan to get my racing heart beat down from the 120's to 108 moving back towards the 90's,  My blood pressure also went up from my normal 142 / 84  to  165 / 114.  The fast hearbeat & high blood pressure may be somewhat attributable to being in the Emergency Room for NINE ( 9 ) HOURS.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient tolerated well no adverse reaction, dose was given after vial had been in fridge longer than 30 days.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was vaccinated with Pfizer vaccine after use by date.
Age: 20.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient received second dose of bivalent vaccine unnecessarily
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Patient started having pain and swelling at injection site approximately 6-8 hours after injection, the next morning her left arm had increasing swelling and pain along with fevers and chills. Took tylenol and ibuprofen. Continued worsening over the course of the day then 2 days after injection noticed redness going up side of arm and continued fevers and now myalgias. Was seen 2 days after injection and prescribed antibiotic Cephalexin due to possible infection at injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient started having pain and swelling at injection site approximately 6-8 hours after injection, the next morning her left arm had increasing swelling and pain along with fevers and chills. Took tylenol and ibuprofen. Continued worsening over the course of the day then 2 days after injection noticed redness going up side of arm and continued fevers and now myalgias. Was seen 2 days after injection and prescribed antibiotic Cephalexin due to possible infection at injection site.
Age: 17.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was vaccinated with Pfizer vaccine after use by date.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was vaccinated with Pfizer vaccine after use by date.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 2.0
Sex: M
Vaccine: COVID19-2, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pfizer Bivalent 6m-4y vaccine given after the beyond use date of 06/06/23.  No signs or symptoms reported at this time. Pfizer contacted and had no recommended action. Consulting with provider and reviewing CDC guidelines.   Lot: GP4345 Fridge exp: 06/06/23 Manufacturing exp: 04/30/23
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was vaccinated with Pfizer vaccine after use by date.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was vaccinated with Pfizer vaccine after use by date.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was vaccinated with Pfizer vaccine after use by date.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 48.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received Jynneos 0.5ml SQ on 6/13/23. The vaccine that was administered was 5 days beyond the best use by date indicated by pharmacy. Patient declined having any adverse events.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Feeling hot, Illness, Malaise
Clinical narrative: On about 9/17/2022, I went to a party and came into contact with someone who later tested positive for COVID-19. On 9/22/2022, I had body aches and a runny nose. I work at a nursing home, so I requested a COVID-19 test. The result was negative, but the following morning of 9/23/2022, I still felt ill. When I tested again on that day, I got a positive result. On the first day, I had a low-grade temperature of 99.9; my baseline temperature is usually 97.6 or lower, so it felt like a fever. After the first day of my illness, though, I didn't get another fever. My doctor prescribed me a Z-Pak (250 mg) on 9/23/2022, which I took for five days, and a four-day supply of prednisone (10 mg).  The main symptoms I experienced were sinus congestion, a constantly runny nose, and body aches. My symptoms lasted for maybe five days. While I was taking my medications, though, I felt better after the second day and was cleaning. I also never lost my appetite.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rhinorrhoea, SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: On about 9/17/2022, I went to a party and came into contact with someone who later tested positive for COVID-19. On 9/22/2022, I had body aches and a runny nose. I work at a nursing home, so I requested a COVID-19 test. The result was negative, but the following morning of 9/23/2022, I still felt ill. When I tested again on that day, I got a positive result. On the first day, I had a low-grade temperature of 99.9; my baseline temperature is usually 97.6 or lower, so it felt like a fever. After the first day of my illness, though, I didn't get another fever. My doctor prescribed me a Z-Pak (250 mg) on 9/23/2022, which I took for five days, and a four-day supply of prednisone (10 mg).  The main symptoms I experienced were sinus congestion, a constantly runny nose, and body aches. My symptoms lasted for maybe five days. While I was taking my medications, though, I felt better after the second day and was cleaning. I also never lost my appetite.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from an administrator referring to a 5 years old patient of unknown gender. The patient had no known drug allergies. The patient's concurrent condition, pertinent medical history and concomitant medication were not reported. On 20-MAY-2019, 04-JAN-2022 and 03-MAY-2023, the patient received vaccination with PROQUAD (strength, exact dose, route, lot # and expiry date were not provided) for prophylaxis (Extra dose administered). Confirmed no other adverse event (AE) occurred. Inquired about adverse events that would occur if a third dose of PROQUAD was given to a patient.
Sex: F
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; Mumps antibody test negative; Inappropriate age at vaccine administration; Mumps antibody test negative; Measles antibody negative; Rubella antibody negative; This spontaneous report was received from a nurse, calling on behalf of herself, a female patient of unknown age. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On an unknown date, the patient received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, strength, lot #, expiry date, and route of administration were not provided) series as a child. Then, on an unknown date, the patient received an additional dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, strength, lot #, expiry date, and route of administration were not provided) in her twenties (Product administered to patient of inappropriate age).   The patient had a blood titer drawn on 19-NOV-2021 and the results were the following: Mumps- less than 9 (unit not provided) (Mumps antibody test negative), Measles- less than 13.5 (unit not provided) (Measles antibody negative), Rubella- 3.8 (unit not provided) (Rubella antibody negative). Because patient's titers came back as not immune, her university required her to get an additional dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) recombinant Human albumin (rHA) for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (lot: T007232, expiration date was not reported, but upon internal validation established as 27-FEB-2022) which she received on 30-JAN-2022 (Product administered to patient of inappropriate age). The patient then had a second blood titer drawn on 09-MAY-2023 and the results were the following: Mumps- less than 9 (unit not provided), Measles- 26.2 (unit not provided), Rubella- 9.0 (unit not provided). The most recent titer result showed that the patient was not immune to mumps (Mumps antibody test negative). No further information provided. The outcome of all events was unknown. The action taken with M-M-R II regarding all events was not applicable.   The causal relationship between events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
Sex: U
Vaccine: PNC15
Symptoms: Crying
Clinical narrative: cry more; This spontaneous report was received from a physician via a company representative and referred to unspecified number of infant patients of unknown age.  The patients' medical history was not reported. The patients' concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the babies they had vaccinated with pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) (for prophylaxis; anatomical location, strength, dose, route, lot number, and expiration date were not reported)cried more (crying) than the babies that they had vaccinated with pneumococcal vaccine conj 13v (crm197) (PREVNAR 13)
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No Adverse Event; HCP called to report an expired dose of VARIVAX was administered to Multiple patients. Patient Demographics provided for all patients, please see notes for additional case numbers. HCP gave permission to contact. No symptoms reported. No further AE d; Product storage error; This spontaneous report was received from a pharmacist refers to a 2-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  07-JUN-2023, the patient was vaccinated with one dose of expired and improper storage varicella virus vaccine live (oka/merck)(VARIVAX), lot#: W0252273, expiration date reported as: 02-JUN-2023, 0.5 milliliter (route of administration and anatomical location were not provided) for prophylaxis.  On 02-MAR-2023, administered dose of vaccine was exposed to the temperature excursion of 70 degrees Fahrenheit for 9 minutes. There were no additional adverse events reported (expired product administered, product storage error, no adverse event).  Lot number W0252273 has been verified to be non-valid lot number for varicella virus vaccine live (oka/merck) (VARIVAX) and does not match any Company product.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA007830: US-009507513-2306USA007844: US-009507513-2306USA007881: US-009507513-2306USA007905: US-009507513-2306USA007844:
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No further AE; improper storage of prduct in use; HCP called to report an expired dose of VARIVAX was administered to Multiple patients. Patient Demographics provided for all patients, please see notes for additional case numbers. HCP gave permission to contact. No symptoms reported. No further AE d; This spontaneous report was received from a pharmacist referring to a 3-year-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 02-MAR-2023 the varicella virus vaccine live (oka/merck)(VARIVAX) underwent a temperature excursion of 70 degrees Fahrenheit for 9 minutes and on 07-JUN-2023, was administered to a patient, 0.5 milliliter, lot number W0252273, expiration date reported as 02-JUN-2023 (route of administration not reported) for prophylaxis (expired product administered and product storage error). No adverse event was reported.  Lot number W0252273 is an invalid lot number for varicella virus vaccine live (oka/merck)(VARIVAX).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No symptoms reported. No further AE details; HCP called to report an expired dose of VARIVAX was administered to Multiple patients.; Improper storage of product in use; This spontaneous report was received from a pharmacist and refers to a 12-month-old patient. Information regarding medical history, concurrent conditions and concomitant medication was not provided.  On 08-JUN-2023, the patient was vaccinated with improper storage varicella virus vaccine live (oka/merck) (VARIVAX) Lot Number reported as W0252273, expiration date 02-JUN-2023, confirmed as an invalid lot number for varicella virus vaccine live (oka/merck), 0.5 milliliter for prophylaxis (route was not reported). On 02-MAR-2023, temperature: 70F, time frame: 0 Hours 9 Minutes 0 Seconds (expired product administered and product storage error). No symptoms reported. No further AE details.  This is one report of several cases from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No further AE details; HCP called to report an expired dose of PROQUAD was administered to Multiple patients.; Date of excursion: 3/2/2023/Date of administration: 6/14/2023; This spontaneous report was received from a pharmacist and refers to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-JUN-2023, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHa)(PROQUAD) injection, 1 dose, lot #W034210, expiration date: 24-APR-2024 (also reported as 02-JUN-2023), administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered ). On 02-MAR-2023, this vaccine underwent temperature excursion of 70 Fahrenheit (F) for 9 minutes (Product storage error). No additional adverse event were reported.; Sender's Comments:  US-009507513-2306USA007844:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No Adverse Event; HCP called to report t/e on case 02411801 and ROTATEQ was administered. No additional AE/No PQC.   ROTATEQ- 1968378 EXP 5/2/2024 Temperature 48F Time frame 2hours 0minutes 0seconds Previous temperature excursion? No; This spontaneous report was received from medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 21-JUN-2023, the patient was vaccinated with one dose of improper storage rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #1968378, expiration date: 20-MAY-2024, 2 milliliters for prophylaxis.  Administered dose of vaccine experienced the temperature excursion of 48 degrees Fahrenheit for 2 hours. No previous temperature excursion had occurred. There were no additional adverse events reported (product storage error, no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptomatic adverse events were reported / No additional AE; Product was administered to patient following the temperature excursion; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 20-APR-2023, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml, once (lot number W004648 was verified to be valid, expiration date reported and confirmed as 06-OCT-2024), administered as prophylaxis (route of administration and anatomical location were not provided). The vaccine was administered to the patient following a temperature excursion of 34.4 degree Fahrenheit (F), for a time frame of 15 hours 0 minutes 0 seconds, and did not suffered previous temperature excursion (Product storage error).  No symptomatic adverse events (AEs) were reported. No additional information at that time. ; Sender's Comments:  US-009507513-2306USA010406: US-009507513-2306USA010676:
Sex: F
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: and has developed neuropathy in both her feet.; This serious case was reported by a other health professional via sales rep and described the occurrence of peripheral neuropathy in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced peripheral neuropathy (Verbatim: and has developed neuropathy in both her feet.) (serious criteria GSK medically significant). The outcome of the peripheral neuropathy was not resolved.   The reporter considered the peripheral neuropathy to be related to Shingrix.     The company considered the peripheral neuropathy to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-JUN-2023. The reporter reported that individual reporter know from the gym approached him last night at the gym in and began to tell reporter about an adverse event that had occurred to his mother.  The patient received the Shingrix vaccine a few months back and had developed neuropathy in both her feet.  The patient had been to the doctor's office and was currently dealing with the issue, the patient believed it was from the Shingrix vaccine.  The reporter did give his phone number and agreed to follow up from GSK.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the old vaccine and the new vaccine for shingles and still got shingles/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (had the old vaccine).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the old vaccine and the new vaccine for shingles and still got shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-JUN-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she had the old vaccine and the new vaccine for shingles and still got shingles. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles was unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shringrix shots in 2020 when that came out and I still got it on my leg twice the size of a quarter /Suspected vaccination failure; I still got it on my leg twice the size of a quarter; I still got it on my leg twice the size of a quarter last october and february each one lasting a month.; This serious 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.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received Shingles shot at 60 year of age).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In OCT-2022, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Shringrix shots in 2020 when that came out and I still got it on my leg twice the size of a quarter /Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I still got it on my leg twice the size of a quarter). In FEB-2023, the patient experienced shingles (Verbatim: I still got it on my leg twice the size of a quarter last october and february each one lasting a month.). The outcome of the vaccination failure was unknown and the outcome of the shingles and shingles were resolved (duration 1 month).   It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 18-JUN-2023 This case was reported by a patient via interactive digital media. The patient got the shingles shot at 60 then the two Shringrix shots in 2020, when that came out. The patient still got shingles on leg twice the size of a quarter last October and February each one lasting a month. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles and battering shingles now; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles and battering shingles now). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   The reporter considered the vaccination failure and shingles to be possibly related to Shingrix.     The company considered the vaccination failure and shingles to be possibly related to Shingrix.   Additional Information: GSK receipt date: 09-MAY-2023 The case was received from the patient interactive digital media. The patient had the shots and four or five years ago and battering shingles now (at the time of reporting). 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 could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got both shots and a few years ago I got the shingles again/ Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got both shots and a few years ago I got the shingles again/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 20-JUN-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she had shingles and then received two doses of Shingles vaccine and few years ago again experienced shingles. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: It shows swelling should only show in the injection area.; This non-serious case was reported by a consumer and described the occurrence of injection site swelling in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Covid-19 vaccine with an associated reaction of peripheral swelling (had a large lump under patient's whole arm as when she got the Covid-19 shot each time). Additional patient notes included The patient had a long history of medical malpractice if team could find if an error was made it would help..   On 13-JUN-2023, the patient received Shingrix (unknown arm). On 13-JUN-2023, less than a day after receiving Shingrix, the patient experienced injection site swelling (Verbatim: It shows swelling should only show in the injection area.). The outcome of the injection site swelling was not reported.   It was unknown if the reporter considered the injection site swelling to be related to Shingrix.     It was unknown if the company considered the injection site swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-JUN-2023 The patient was reporter. The patient was supposed to get shingles vaccine (Shingrix) shot in the office. The symptoms were not treated. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: left side of my face tingled after the first shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tingling 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, 45 min after receiving Shingles vaccine, the patient experienced tingling (Verbatim: left side of my face tingled after the first shot). The outcome of the tingling was resolved.   It was unknown if the reporter considered the tingling to be related to Shingles vaccine.     It was unknown if the company considered the tingling to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JUN-2023 The case was received from the patient via interactive digital media. The reporter stated his/her left side of face tingled after the first shot of Shingles vaccine. It started about the 45 minutes after the administration of vaccine after until he/she woke up the next day. It was not super bad and might not be related. His/her doctor advised against the second dose.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza, Injection site pain, Pyrexia
Clinical narrative: Today I have a low grade fever; today the pain at the injection site is like I had had a Tetanus shot; flu symptoms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of low grade fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 14-JUN-2023, the patient received the 1st dose of Shingles vaccine. On 15-JUN-2023, 1 days after receiving Shingles vaccine, the patient experienced low grade fever (Verbatim: Today I have a low grade fever), injection site pain (Verbatim: today the pain at the injection site is like I had had a Tetanus shot) and flu symptoms (Verbatim: flu symptoms). The outcome of the low grade fever, injection site pain and flu symptoms were not resolved.   It was unknown if the reporter considered the low grade fever, injection site pain and flu symptoms to be related to Shingles vaccine.     It was unknown if the company considered the low grade fever, injection site pain and flu symptoms to be related to Shingles vaccine.   Additional Information: GSK receipt date: 15-JUN-2023 This case was reported by a consumer via interactive digital media. The patient had first shot yesterday (from the date of reporting). Today (on the day of reporting) had a low grade fever and flu symptoms which was told was normal and to expect it.  Didn't feel the shot at all but today the pain at the injection site was like he/she had had a Tetanus shot.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Lethargy
Clinical narrative: Chills; Lethargic after 2nd SHINGRIX vaccination on 6/16/2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On unknown date patient received 1st dose).   On 16-JUN-2023, the patient received the 2nd dose of Shingrix. In JUN-2023, an unknown time after receiving Shingrix, the patient experienced chills (Verbatim: Chills) and lethargic (Verbatim: Lethargic after 2nd SHINGRIX vaccination on 6/16/2023). The outcome of the chills and lethargic were not reported.   It was unknown if the reporter considered the chills and lethargic to be related to Shingrix.     It was unknown if the company considered the chills and lethargic to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-JUN-2023 The patient received 2nd dose of Shingrix. Patient experienced chills and being lethargic after the vaccination.