chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 time of arrival) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, 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 time 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 time of arrival) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient MRN Id was 00422227. No concomitant medications were reported. No treatment medications were reported. It was reported that the vial was moved to fridge on 06-Oct-2021. The storage condition of the vial at the time of the excursion was frozen storage/refrigerated storage/ambient room temperature frozen storage/refrigerated storage. The state of the vaccine at the time of the excursion was reported as partially thawed/liquid. The maximum or minimum temperature reached by the vial was 8 degree Celsius. It was reported that the total duration of excursion at refrigerated temperature was for a maximum of 4 hours. It was reported that the vials were re-frozen. Temperature fluctuations had occurred from frozen state to refrigerated state to being re-frozen.
Sensitive to touch, The shosulder area is hot to touch, Nausea about 60 mintes later,  Muscular pain ratating from shoulder to soine in the C5, C6 area, Headache, The next day Vomiting, Headache, tremors, fatigue,
The patient received dose from vial beyond 30-day use by date.; The patient received dose from vial beyond 30-day use by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date.) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date.) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date.). On 16-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date.). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date.) had resolved. On 16-Oct-2021, PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported. Vaccine was refrigerated on 07 May 2021.
Initial Report Received on 02-Apr-2019. A pharmacist reported that a female patient (age and race not provided) was administered with HEPLISAV-B for hepatitis B immunization and developed bleeding and bruising at the injection site, and reported that the HEPLISAV-B injection "may not be effective." Relevant medical history and concomitant medications were not provided. On 19-Mar-2019, the patient received the first dose of HEPLISAV-B from a pre-filled syringe (lot #, expiration date, and NDC # not provided). On 02-Apr-2019, a pharmacist reported that a female patient reported that she was concerned that the HEPLISAV-B injection may not be effective as she had a little blood from the injection site at the time of administration and she developed bruising a few days later. The patient requested to be administered a repeat first dose due to bleeding and bruising at the site. It was also reported that the caller (pharmacist), stated that the product was already discarded. No further information was provided. At the time of the report, the outcome of the events were unknown. The reporter did not provide a seriousness assessment for the event. Company comment: The company assessed the events of injection site haemorrhage, injection site bruising and lack of effect as non-serious. The events of injection site haemorrhage and injection site bruising are unlisted, and the event of lack of effect is listed per HEPLISAV-B USPI. Sender's Comments: The company assessed the events of injection site haemorrhage, injection site bruising and lack of effect as non-serious. The events of injection site haemorrhage and injection site bruising are unlisted, and the event of lack of effect is listed per HEPLISAV-B USPI.
I only had a sore arm with the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm, administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "I only had a sore arm with the first dose". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Reporter received the first dose the syringe contained a cloudy solution whereas the second dose was clear. The girl didn't even prepare the second shot in front of me. She said she prepare them overnight and keeps them in the fridge. The guy who gave me the first dose prepared it in front of me. I don't know what the young lady gave me. They could've  administered anything. Store should really set a protocol to draw the vaccine from the vial in front of patients. Reporter received second shot of the Pfizer vaccine. Her arm was not sure it just felt like something kind of pinched me. She was sweating in the face. Her cloth masked was full of sweat inside out. The back of her neck and forehead was also wet in sweat. Reporter only had a sore arm with the first dose which lasted a day and the next day everything was fine. Is sweat reported with the vaccine?". Response received was vaccine will be an off-white suspension. After the vaccine is prepared there should be no particulates or discoloration. The stored vials between 2°C to 25°C (35°F to 77°F) and use within 6 hours from the time of dilution. Upon Follow up (08April2021) information reported by reporter that she had her second shot yesterday. This time around, said she has experienced some soreness in her arm, and a good deal of sweating. Reporter took a couple of aspirins for her soreness. Stated doesn't feel sick though. She also is really concerned if she in fact got the vaccine or not. Said for her first shot, the person loaded the syringe and gave her the shot right there, and it may have been "grayish in color" but she couldn't quite see. For her second shot, the lady just came out of the back with the syringe prefilled already. Reporter said doesn't trust, or know what she got, since the lady is going back and forth to a back room. This caused her great concern.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Full body convulsions. Violent, alarming. Extreme headache, sweating and thirst, dramatic dizziness and lethargy.  Muscle spasms.  1st convulsion lasted 10 minutes, fully conscious, breathing labored but still effective. Slept 15 hours in total, waking every 1.5 to 2 hours, convulsing less upon awakening each time.  Drank six bottles of 16 oz water in an 8 hour period without urination.  For the next 2 days, the symptoms occurred but became dramatically muted.  My stomach is still spasming 4 days removed.  Following emergency (as to pain) lower lumbar epidural injections (4) on 10/01, neurologist administering shots said the x-ray showed my stomach to be in spasm and asked how long.  He also said that my calf muscle was spasming.  I was only aware of the stomach as it was a tangible physical effect. Following 1st dose of Moderna vaccine, inexperienced headache, extremeextreme dizziness and dry heaves (absent vomitting) on the 2nd day.
Chills; headache; nausea; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (headache), NAUSEA (nausea), PYREXIA (fever) and FATIGUE (fatigue) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Dyslipidemia.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), HEADACHE (headache), NAUSEA (nausea), PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, CHILLS (Chills), HEADACHE (headache), NAUSEA (nausea), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
arm soreness 12 hours after vaccination; inadvertently administered with Moderna COVID-19 Vaccine Bivalent instead of the 1st dose of the primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (arm soreness 12 hours after vaccination) and WRONG PRODUCT ADMINISTERED (inadvertently administered with Moderna COVID-19 Vaccine Bivalent instead of the 1st dose of the primary series) in a 20-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for COVID-19 prophylaxis.     Patient's relevant medical history/conditions, allergy, concomitant medications and risk factor was unknown.     On 09-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 5 milliliter. On 09-Dec-2022, the patient experienced VACCINATION SITE PAIN (arm soreness 12 hours after vaccination) and WRONG PRODUCT ADMINISTERED (inadvertently administered with Moderna COVID-19 Vaccine Bivalent instead of the 1st dose of the primary series). At the time of the report, VACCINATION SITE PAIN (arm soreness 12 hours after vaccination) and WRONG PRODUCT ADMINISTERED (inadvertently administered with Moderna COVID-19 Vaccine Bivalent instead of the 1st dose of the primary series) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
On December 2, 2021, I received the Moderna COVID 19 booster shot. My first 2 COVID shots were also Moderna (4/29/2021 for the first and 5/27/2021 for the second shot). On December 17, 2021,  I started having itchy skin and broke out in hives. The hives continued and I saw a dermatologist on January 25th, 2022 and the dermatologist referred me to an Immunologist. I saw the Immunologist for the first time on February  18th, 2022. During this time, all other allergens were eliminated (like food, laundry detergent, etc). and the Immunologist ran a series of tests on me to test for COVID infection, autoimmune conditions, etc. Nothing yielded any answers except that this was caused by the booster shot. I was then prescribed 4 Zyrtec a day, Singulair, and 4 Pepcid - every day. I still continued to break out into hives and this was very visible, uncomfortable, and interfered with my daily living. On May 2, 2022, I started Xolair injections (2 shots, 150 mg. each), in addition to my other medications,  and receive these injections every 28 days. I have been diagnosed with Chronic Spontaneous Uticaria.
I tested positive for Covid-19, 3 months after my 2nd dose.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I tested positive for Covid-19, 3 months after my 2nd dose.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (I tested positive for Covid-19, 3 months after my 2nd dose.). At the time of the report, COVID-19 (I tested positive for Covid-19, 3 months after my 2nd dose.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) tested positive for Covid-19.         No concomitant medications were reported. No treatment information was provided. The AE caused patient to seek medical care (office visit, Urgent care, ER, hospitalized).  Company comment:This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected non serious AESI of COVID 19, about 3 months after receiving the second dose of mRNA-1273 vaccine. The interval between the first and the second doses was approximately 1 month. The patient tested positive for COVID 19. The COVID 19 pandemic could be a confounder for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected non serious AESI of COVID 19, about 3 months after receiving the second dose of mRNA-1273 vaccine. The interval between the first and the second doses was approximately 1 month. The patient tested positive for COVID 19. The COVID 19 pandemic could be a confounder for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient got flu + pneumonia vaccine in left arm 11/13/08.  Arm became red the following day and gradually worsened and became swollen.  Patient went to primary care physician who sent to hospital.  It was originally thought to be MRSA but was eventually determined to be Cellulitis.  Required surgical draining of tissue.  12/23/08 Reviewed hospital medical records of 11/15-11/16/2008. FINAL DX: Cellulitis  Records reveal patient experienced left arm redness, swelling & pain along w/nausea & fever day after receiveing both vaccines in left arm.  Saw PCP & tx w/oral antibiotics.  Condition worsened & admitted for IV antibiotics.  Taken to OR for exploration, I&D done.  Improved markedly s/p surgery & d/c to home on continued oral antibiotics.
After administration of vaccine, we were notified by local Authority that the vaccine had experienced a temperature monitoring event outside of our facility.  Patient was notified of CDC guidelines that recommend revaccination.  As of this report, patient has not returned for revaccination.
Vaginal discharge; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL DISCHARGE (Vaginal discharge) and DIARRHEA (Diarrhea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced DIARRHEA (Diarrhea). On 04-Sep-2021, the patient experienced VAGINAL DISCHARGE (Vaginal discharge). The patient was treated with BISMUTH SUBSALICYLATE (KAOPECTATE [BISMUTH SUBSALICYLATE]) on 02-Sep-2021 for Diarrhea, at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM AD) 02-Sep-2021 for Diarrhea, at a dose of one tab. On 02-Sep-2021, DIARRHEA (Diarrhea) had resolved. In September 2021, VAGINAL DISCHARGE (Vaginal discharge) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication of the patient was not reported.  Due to vaginal discharge, the patient went to the doctor, who gave her a shot and the discharge went away. She was allergic to the shot and had to take Benadryl.   This case was linked to MOD-2021-335094 (Patient Link).
Patient was 30 weeks pregnancy with an uncomplicated pregnancy. She was found to have a fetal demise 3 days after her 2nd Covid19 vaccine. Vaccine 2/11/21, fetal demise 2/14/21. The fetus appears to have had an intracranial hemorrhage; work-up for this by parental testing is ongoing.
Swelling and heat in left arm, shoulder to hand, reported 20 hrs after vaccination. Arm is tender and patient is guarding and restricting movement. Mom gave TYLENOL and BENADRYL and cool compresses. Patient does not otherwise appear ill.
booster shot; Chills; Ache; Ear infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 17Dec2021 (Batch/Lot number: unknown) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, LOT: ER8727 or ER8121, Anatomical location: first dose injected in her arm, no EXP was provided), administration date: 01Apr2021, when the patient was 61 years old, for COVID-19 Immunization; Bnt162b2 (Dose:2, LOT: EW0162, no EXP provided), administration date: 22Apr2021, when the patient was 61 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021, outcome "unknown", described as "booster shot"; CHILLS (non-serious) with onset 17Dec2021, outcome "recovering", described as "Chills"; PAIN (non-serious) with onset 17Dec2021, outcome "unknown", described as "Ache"; EAR INFECTION (non-serious) with onset Dec2021, outcome "recovering", described as "Ear infection". Therapeutic measures were taken as a result of chills, pain, ear infection.  Additional information: She says her booster dose was given 17Dec2021, and that the LOT number was cut off so it is either E or F then J8762. Caller clarifies that her potential side effects were: chills, aches, and ear infection. She said the chills started within a few hours of booster shot, and for treatment she took Tylenol, dose unknown, and they eventually got better. She says the aches started within a few hours of the booster shot, and she took Tylenol also for this. She said the chills eventually got better. She said the ear infection started within a week of the booster shot, during December, and for treatment she took an antibiotic, which was Amoxicillin. Amoxicillin dose unknown, caller said she took it for 7 days, twice daily. She says the ear infection has gotten better.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient received the Pfizer COVID-19 vaccine on 3/18/21 and 4/8/21, so was fully vaccinated when they tested positive for COVID-19 on 8/20/21.
with no health conditions died after the vaccine; This is a spontaneous report from a contactable consumer (patient's friend). A 25-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. A friend's 25 year old daughter (the patient) with no health conditions died after the vaccine. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: with no health conditions died after the vaccine
This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. On an unknown dates the patients were vaccinated with improperly stored ROTATEQ (dosing regimen unspecified) (lot # L013202, expiry 27-JAN-2017). Excursion details are as follows: which were exposed to the following conditions, were administered to unspecified patients: temperature: 31.55 F, time frame: 45 seconds, there was no previous temperature excursion. It was a call because of a data logger. No adverse effect reported. No further information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Very painful aching rotator cuff near injection site.  Seems to be more prevalent in the evening during sleeping.
I woke up to a rashon my left arm (injection site) and was itchy all day with it spreading a little more before subsiding.
8cm area of erythema, induration, tenderness and heat in upper left arm after receiving flu vaccine on 10/21/02. Treated with Benadryl 25mg po q 9 prn, ice packs.
C/o tenderness after vaccine. Noticed redness & swelling next day - swelling & redness from deltoid to elbow (Lt Del). Swelling & redness still present on 10/30 @ visit.
Patient reported swelling and pain in arm. Patient came to pharmacy on 2/13 and rash was on interior of arm and was red, hot, and about 4-6 inches in diameter. Patient said that rash spread from outer to inner side of upper arm. Patient was instructed by pharmacist to take Benadryl 25mg every 6 hours and Tylenol 500mg every 6 hours.