chrisvoncsefalvay/vaers-outcomes huggingface dataset:
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vials were frozen, shipped in refrigerated temperature and then refroze for storage once arrive at facility. On 1-Dec-2021 vaccine was moved to fridge and vaccine administered post 30 days from the initial storage at 2C to 8C. No treatment medications were reported. MRN ID-00451624
Patient reported axillary swelling and pain about the size of her palm beginning two days after vaccination. This is on the same side as the vaccination. Explained to the patient that this is a known adverse effect of the vaccine and if it does not start to improve as the week progresses that she should be seen by a doctor. Also supplied her with the fact sheets for recipients and providers updated on 1/31/22. Patient reported this on 2/7/22.
This spontaneous report received from a registered nurse, via company representative, refers to a 13 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 02-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # L043214 (dose, frequency, expiry date were not reported), for prophylaxis, under Vaccine for children program (VFC) . On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one the several reports received from  the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Swollen lymph nodes in the arm pit.; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 09May2021 at 09:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, penicillin allergy and antihistamines allergy (drug allergy). Concomitant medications included over the counter medications vitamin d nos (VITAMIN D) and vitamin b complex (MANUFACTURER UNKNOWN); taken from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 18Apr2021 at 10:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10May2021 at 07:00, the patient experienced swollen lymph nodes in the armpit. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes in the armpit was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
REDNESS, SWELLING, AND WARM AROUND VACCINE INJECTION SITE SINCE DAY AFTER VACCINE; SIDE EFFECTS ARE STILL VISIBLE AND AFFECTED PT BUT HAS GONE DONE SINCE FIRST DAY, PT HAS NOT SEEN A PHYSICIAN FOR REACTION; ADVISED PT TO  VISIT ER OR  URGENT CARE CENTER
pt reported feeling extremely tired and achy, especially her legs (feeling weak/could barely walk) at work later that night after receiving the vaccine. reports going home and sleeping over the next day and says she feels a lot better today, although her arm is sore. pt did not seek medical attention for her reaction
This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of both Oka/Merck VARIVAX lot # N017700, expiry date 09-JUN-2019 or lot # N023960, expiry date: 01-SEP-2019 and M-M-R II lot # N009800, expiry date: 24-MAR-2018, lot # N013280, expiry date: 28-APR-2019 or lot # N034411, expiry date: 04-DEC-2019 for prophylaxis (strength, dose, frequency, route and anatomical location were not provided) (product storage error). It was unknown which of the lots of Oka/Merck VARIVAX and M-M-R II were administered to the patient. Also, the nurse reported that MERCK STERILE DILUENT used for reconstitution of vaccines was properly stored. No adverse effects reported. The temperature excursion and time frame for Oka/Merck VARIVAX was between -14°C to -10°C (-9.9°C) for a time frame of 3 hours and 57 minutes and for M-M-R II was between 9°C to 25°C (13.4°C) for a time frame of 2 hours and 36 minutes. No previous temperature excursion was reported. Data logger was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA004219: US-009507513-1808USA004218: US-009507513-1808USA004216: US-009507513-1808USA004220: US-009507513-1808USA004192.
cell death and necrosis of organs; vaccine killing of my heart; vaccine killing of my body; This spontaneous case was reported by a consumer and describes the occurrence of NECROSIS (cell death and necrosis of organs) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECROSIS (cell death and necrosis of organs) (seriousness criterion medically significant), CARDIAC DISORDER (vaccine killing of my heart) and IMMUNISATION REACTION (vaccine killing of my body). At the time of the report, NECROSIS (cell death and necrosis of organs), CARDIAC DISORDER (vaccine killing of my heart) and IMMUNISATION REACTION (vaccine killing of my body) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were provided.  Patient reported that Comirnaty pfizer and moderna corona virus spike proteins are evil and cause cell death and necrosis of organs 38 39 low count hard time retention. Patient reported that vaccine is killing patient's heart and body.  Company comment: This spontaneous case concerns a patient of unknown age and gender, with no medical history information reported, who experienced the unexpected serious (medically significant) event of necrosis and unexpected non serious events of cardiac disorder and immunisation reaction. The events occurred on an unknown date. Temporal relationship with dose of SPIKEVAX 2023-2024 is unclear. The patient reported that Comirnaty pfizer and moderna corona virus spike proteins are evil and cause cell death and necrosis of organs describing additionally 38 39 low count hard time retention (unclear information). Patient also reported that vaccine is killing patient's heart and body. Additional information provided by the patient is incoherent. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Nausea, headache, fatigue, lung tightness, muscle heaviness, foggy brain (lack of concentration and focus) , GI Increase in bowel movements,  general malaise.   These symptoms have lasted 6 days so far at varying intensity The lung tightness occurred on day 1 and day 4.  The nausea has been persistent.  The headache was on day 1 and 3.  Foggy brain on day 2 and 5.  Fatigue everyday.   I am concerned about getting the second shot
given FluLaval after being frozen at -0.45C; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2021-2022 season) (batch number AD49D, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd November 2021, the patient received FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse given FluLaval after being frozen at minus 0.45 Celsius for 15 minutes to the patient, which led to incorrect storage of drug. The reporter consented to follow up. This case was 1 of 10 linked cases, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021230181:same reporter US-GLAXOSMITHKLINE-US2021230173:same reporter US-GLAXOSMITHKLINE-US2021230178:same reporter US-GLAXOSMITHKLINE-US2021230191:same reporter US-GLAXOSMITHKLINE-US2021230186:same reporter US-GLAXOSMITHKLINE-US2021230195:same reporter US-GLAXOSMITHKLINE-US2021230177:same reporter US-GLAXOSMITHKLINE-US2021230188:same reporter US-GLAXOSMITHKLINE-US2021230192:same reporter
It was reported in a published article, that a PT who was vax'd on unknown dates with a 1st and 2nd dose of "measles containing vax," either MMRII or measles-rubella vax suffered late developmental regression after the 2nd dose only. Upon internal review, regression was determined to be an other important medical event (OMIC). This article also discussed the experiences of other parties following vax with MMRII. No further info is available.
I had like a fibromyalgia-esque pain/body aches/fatigue/malaise on 3/4 /21 that  was EXACTLY like the body aches and fatigue I felt after the 2nd shot on 1/20/21.  Sudden onset.  Had to leave work in tears everything hurt. While I  do not have any known immune deficiencies, I do have pain problems from my  time in the military, frequent migraines and two discectomy/laminectomys in 2014.  Everything hurt, like I couldn't move or touch anything, my cats would step on  me while I was in bed and I would cry. This episode lasted till 0230 in the morning, after the 2nd shot that pain episdone lasted from 0730 pm to 1030 the next day.  Never have I ever  have felt such pain and now I have had  two episodes.
Fever, headache, sore arm at injection site, 72 hours after injection. resolved in 48 hours
Patient received an incorrect vaccine Janssen instead of Pfizer.  Patient is 16 years of age. Mother of patient wanted me to know that her 16 year old daughter is 5'10" and 230 pounds.  Patient experence nausea and fever and chills. Happen 6 hour after receiving vaccines and lasted one day. Mother states both of her daughters had the exact same symptoms and received the same vaccine at the same time . Her other daughter is 26 years of age .
right-side pain from her back to her front; soreness in her left arm; left arm itching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her left arm), PRURITUS (left arm itching) and BACK PAIN (right-side pain from her back to her front) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Diabetes, Reflux esophagitis, Anxiety disorder, Bipolar disorder, Cardiovascular disease, unspecified, Blood pressure high, Cholesterol high and Drug allergy (Gemfibrozil and Zoloft). Concomitant products included GABAPENTIN, AMLODIPINE BESYLATE, DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID, TOCOPHEROL (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]), LOSARTAN POTASSIUM, MONTELUKAST, SIMVASTATIN, PROPRANOLOL, PANTOPRAZOLE, MAGNESIUM, BIOTIN, MELATONIN, INSULIN GLARGINE, INSULIN LISPRO and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in her left arm) and PRURITUS (left arm itching). On 14-Feb-2021, the patient experienced BACK PAIN (right-side pain from her back to her front). At the time of the report, PAIN IN EXTREMITY (soreness in her left arm) and PRURITUS (left arm itching) outcome was unknown and BACK PAIN (right-side pain from her back to her front) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
My resting heart rate the day after the shot was between 120-130.  i was dizzy and weak could barely make it to the bathroom.
soreness at injection site, pain and itching  with swelling, no use of bandages, unable to wear long sleeve shirt, no fever.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021 at 2:18 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Jan-2021 at 2:18 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 44.76. Concomitant products were not provided. On 12-Jan-2021, Excursion time was 08 AM, temperature was 34, Excursion time was 09 AM, temperature was 34, total doses given for the day was 30 for 08 AM, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 12-Jan-2021. 3 vials were sent to clinic. Vaccine BUD date was 7-Feb-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
on the 18th he started to hallucinate and has continued for the last 4 days. seeing people sitting on the couch and all over the house
Irritability, fever 103 11JAN92 @ 8PM; fever 105, vomiting 12JAN92;
At the end of February, I had running nose, next morning I took the home test, and it was Positive. I called the doctor, they prescribed Paxlovid, for 5 days, and cough medicine, but I never used. On day 6 I tested Negative for COVID-19
Adjuvant only administered; Adjuvant only administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old patient who received Herpes zoster (Shingrix) (batch number MY2Y2, expiry date 08-JUL-2024) for prophylaxis.   On 18-APR-2023, the patient received the 1st dose of Shingrix. On 18-APR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Adjuvant only administered) and inappropriate dose of vaccine administered (Verbatim: Adjuvant only administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-APR-2023 The certified medical assistant informed that earlier on the day of reporting the patient received 1st dose of Shingrix. Only the adjuvant part of the Shingrix was administer to the patient. The reporter did not consent to follow up. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
I had a red rash on my arm that appeared about 8 days after I had the first vaccine.  It was itchy and warm to the touch. It was about 2 inches high and wide.   It lasted about 48 hours.  No other adverse affects.   I read in a magazine that the "COVID arm" rash  was "annoying but harmless" so I didn't worry about it.  I told the woman who vaccinated me about it, and she suggested that I report it.
Patient was given GARDASIL 9 while pregnant and given in Lt Gluteus Medius IM, last menstral period 12-25-17, has follow up appt with OBGYN 1-23-18 at 2pm EDC 10-1-18.
A non-serious spontaneous report of administration to pregnant female was received from a physician concerning a 30-year-old female who received FLUMIST.  Neither medical nor obstetrical history was provided.  FLUMIST was given to the pregnant woman by mistake.  There was no adverse event reported to date.  Treatment and reporter/sponsor causality assessments are not applicable.  The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
This spontaneous report as received from a nurse regarding four unspecified patients (age and gender unknown). Medical history, concurrent conditions and concomitant medication use not specified. On an unknown date the patients were vaccinated with GARDASIL 9 (lot # M009378, expiration date 23-APR-2018) (total dosage and route not specified). The nurse reported that on unspecified dates, four unspecified patients received improperly stored GARDASIL 9. No adverse effects were reported. Additional information has been requested.
Extreme vertigo, dizziness, spinning, vomiting - Rushed to the hospital in an ambulance and was in the hospital for 3 days.
Breakthrough case admission after 2 vaccines Pfizer 12/29/21 lot# 331308A;  Pfizer 12/10/22 lot# FR2587
Information has been received from a registered nurse concerning a currently 18 year old female patient with allergic reaction to antibiotics (AUGMENTIN) and no pertinent medical history who on 19-JAN-2007 was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL (Lot # 654702/0011U), on 23-MAR-2007 was vaccinated intramuscularly with her second 0.5 ml dose of GARDASIL (Lot # 656051/0244U) and on 13-SEP-2007 was vaccinated intramuscularly with her third 0.5 ml dose of GARDASIL. There was no concomitant medication. It was reported that the patient had an abnormal PAP smear and tested positive for HPV after receiving the three doses of GARDASIL. The patient sought unspecified medical attention. At the time of the report the patient's status was not specified. Follow up information has been received from the registered nurse who indicated that the patient did not have any known drug allergy/reaction and no pertinent medical history. On 05-JAN-2010, the patient had an abnormal pap smear plus a high risk for HPV. The patient required further testing. The nurse also mentioned that the patient's aunt had ovarian cancer. No diagnostic or laboratory tests were performed. Additional information is not expected.
Information has been received from a nurse referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # M042858, expiration date 21-OCT-2018, dose and route were not reported) for prophylaxis, which was reconstituted with properly stored sterile diluent (lot # and expiration date were unknown). The vaccine was exposed to temperature excursion -9 degrees Celsius to 8 degrees Celsius for 6 hours and 18 minutes and the data logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA008698.