chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient fainted approximately 5 minutes after vaccinations. Patient was in a sitting position. Patient reported no previous adverse reactions to immunizations upon screening before administration. After administration he reports that he commonly gets dizzy and lightheaded and sometime passes out after vaccination. Patient came to approximately 5-10 seconds after initially fainting. Monitored for 20 minutes afterward until he was feeling back to normal and stated that he felt that he was ok to leave.
a patient received Menactra subcutaneously rather than IM; Initial information received on 20-Jun-2019 regarding an unsolicited valid non-serious case received from a physician by phone.  This case involves adult patient of unknown demographics who was vaccinated with a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Batch number, expiry date, dose, dose in series and site of administration not reported) via subcutaneous route on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was a  case of actual medication error due to inappropriate route of vaccination because patient received vaccine subcutaneously rather than intramuscular route.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Information on the batch number was requested.  Documents held by the sender: none.
On 4/18/00, the pt developed a red, papular  rash with increased lesions noted around both vaccine sites. Additionally, the child experienced red and swollen ankles. The events were treated with Benadryl.
vaccines are kept frozen in fridge about1-3 days/tend to store 1 to 3 bottles in fridge to thaw out/they would have been in fridge for about week if no one comes to be vaccinated; some of our sites administered Moderna vaccines beyond the use date and or expired.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (some of our sites administered Moderna vaccines beyond the use date and or expired.) and PRODUCT STORAGE ERROR (vaccines are kept frozen in fridge about1-3 days/tend to store 1 to 3 bottles in fridge to thaw out/they would have been in fridge for about week if no one comes to be vaccinated) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (some of our sites administered Moderna vaccines beyond the use date and or expired.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines are kept frozen in fridge about1-3 days/tend to store 1 to 3 bottles in fridge to thaw out/they would have been in fridge for about week if no one comes to be vaccinated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (some of our sites administered Moderna vaccines beyond the use date and or expired.) and PRODUCT STORAGE ERROR (vaccines are kept frozen in fridge about1-3 days/tend to store 1 to 3 bottles in fridge to thaw out/they would have been in fridge for about week if no one comes to be vaccinated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.
Stomach cramps started a few hours after the vaccination.  My menstrual cycle started about 24 hours after the vaccination. I was not due to start until the following week after the vaccine.
This spontaneous report has been received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot # N003701, expiration date 01-NOV-2019 and lot # N003536, expiration date 02-NOV-2019 (dose and route of administration were not reported). There was no adverse effect reported. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA011847:
death Narrative:  Patient received Moderna covid #1 on 1/14/21. On 1/29/21, a social worker note was placed that indicated that patient was now under home hospice care. No scanned records on file. No further notes regarding events from this time to date of death on 2/10/21. No autopsy results available. 27 days from date of vaccine to date of death.
Patient complained of arm pain on the injection site. She decided to consult the doctor about it and after further examinations doctor said that her bursa got punctured.
Pt. became lightheaded, confused. Returned to clinic. Vitals remeasured. BP 112/70, O2 100%, Pulse 64. Temp. 97.2. Dr. checked child over. Given water. Watched for 1/2 hour. Symptoms improving slowly. Child given electrolytes and lolipop. Vitals remeasured: BO 122/60, pulse 70, O2 100%. Child symptoms improved. Released home advised ER if symptoms return.
received the vaccine two months ago. You know get tested and the results are positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (received the vaccine two months ago. You know get tested and the results are positive) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (received the vaccine two months ago. You know get tested and the results are positive). At the time of the report, SARS-COV-2 TEST POSITIVE (received the vaccine two months ago. You know get tested and the results are positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: abnormal (Positive) Tested and the results are positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.    Reporter did not allow further contact
10MAY95 pain & swelling @ site w/in 2 hr; t103.9 x 3 days w/chills & sweating; pt states lt arm like a balloon w/swelling extending to underarm fr shoulder to elbows; saw MD on 18MAY95 swelling had subsided but no feeling lt arm; atrophy
feels like she got whacked/ Right ankle has two screws and a plate and that area feels so mad and angry; Hands are ice cold; hip replacement and that area feels so bad; stiff, sore and angry.  It's her arms and shoulders; stiff, sore and angry.  It's her arms and shoulders; stiff, sore and angry.  It's her arms and shoulders; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feels like she got whacked/ Right ankle has two screws and a plate and that area feels so mad and angry), PERIPHERAL COLDNESS (Hands are ice cold), MUSCULOSKELETAL DISCOMFORT (hip replacement and that area feels so bad), JOINT STIFFNESS (stiff, sore and angry.  It's her arms and shoulders) and PAIN IN EXTREMITY (stiff, sore and angry.  It's her arms and shoulders) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A and 939901) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hip replacement and Ankle operation (Right ankle has two screws and a plate).   On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced FEELING ABNORMAL (feels like she got whacked/ Right ankle has two screws and a plate and that area feels so mad and angry), PERIPHERAL COLDNESS (Hands are ice cold), MUSCULOSKELETAL DISCOMFORT (hip replacement and that area feels so bad), JOINT STIFFNESS (stiff, sore and angry.  It's her arms and shoulders), PAIN IN EXTREMITY (stiff, sore and angry.  It's her arms and shoulders) and ARTHRALGIA (stiff, sore and angry.  It's her arms and shoulders). At the time of the report, FEELING ABNORMAL (feels like she got whacked/ Right ankle has two screws and a plate and that area feels so mad and angry), PERIPHERAL COLDNESS (Hands are ice cold), MUSCULOSKELETAL DISCOMFORT (hip replacement and that area feels so bad), JOINT STIFFNESS (stiff, sore and angry.  It's her arms and shoulders), PAIN IN EXTREMITY (stiff, sore and angry.  It's her arms and shoulders) and ARTHRALGIA (stiff, sore and angry.  It's her arms and shoulders) outcome was unknown.            No concomitant medication was given by reporter.  No treatment medication was given by reporter
states immediately after getting vaccine had pressure in head that lasted all day. later had chills and an asthma attack
Problem: Moderna Covid Vaccine caused deactivation of Umbilical Stem Cells that were given for pain relief. Background History: Relapsing Remitting Multiple Sclerosis diagnosed 1981 at age of 26. Advanced to Secondary Progressive MS 2007. Still independent with activities of daily living. Walker and wheelchair used in the home, scooter for outside errands. Do not drive now. Umbilical Stem Cells-Wharton's Jelly: Injection sites: Bilateral Intervertebral muscles -- 2 Cervical injections & 2 Upper Thoracic injections (1/24/20) for neck, shoulder, and upper back pain. Pain was relieved bilaterally. Received Moderna Covid vaccines one year later in left arm and all pain relief on left side was sadly eliminated that very night of the first vaccine! Fortunately, pain relief from stem cells continues on the right side. Additional details regarding the vaccine: Feedback on Moderna Covid Vaccines (left arm) ? Sent to Neurologist on 02/27/2021 (13 months after vaccine) 1st shot: 1/27/2021, 1:45pm Minor: arm sore right away. very tired that afternoon--took a nap which I never do. Dull headache left side of head only, began that evening, lasted for 2 days. Brain fog for a day. (No unusual movements, injuries, or falls.) More concerning: The neck, shoulder, and back pain that I received from the stem cell injections 13 months ago. The right side is still experiencing the positive effects of the stem cells. 2nd shot: 2/25/2021, 12:15 pm Minor: Arm more sore than last time. Intense fatigue--slept all afternoon. More concerning: Headache began within a few hours--entire head this time; very intense by 2:00 am and the entire next day. Left neck stiffness and pain increased within a few hours and has not decreased. From 2:00-3:30 am, chilling and trembling, like ice running through my veins, until I fell asleep around 3:30 am. Too cold to get out from under the covers to get a thermometer to check my temp. Hot and extremely weak when I woke up the next morning. Couldn't get out of bed or stand to use the walker. Husband lifter me to wheelchair and pushed me to bathroom. Needed help to get my clothes on and off and to clean up. Took my temp then. Only 2 degrees above what it normally runs. Felt higher during the night. Intense lethargy, weakness, imbalance, and brain fog the entire next day. Two days post-shot: No temp or headache. Still somewhat foggy. very weak and off balance. Minimal use of walker due to safety concerns. More shortness of breath trying to get around. Extremely aggravated about the loss of effectiveness from half of my stem cells, as well as the thousands of dollars I spent for that welcome pain relief! FYI: I did not take any Tylenol for either shot, as previously discussed. Current Addition (09-11-2021): I have also noticed the following areas of rapid decline since receiving the Moderna vaccines: Cognitive skills, memory, and word recall. More rapid progression of MS in general. Much more difficulty with balance and ambulation, along with more shortness of breath. Decreased quality of life. Interestingly, I have also noticed a remarkable decline in my husband's memory since he received the Moderna vaccines.
muscle weakness and pain in right arm and right shoulder girdle, extreme tiredness, Parsonage-Turner Syndrome
Patient received Moderna covid 19 vaccine on 11:15am 1/5/2021. Patient had rested for 15 minutes after vaccination and reported felt fine. Patient went back to work. Patient fainted around 3:30pm. Patient regained the conscious quickly and the Paramedics said her blood sugar was normal and she had little orthostatic hypotension. The Paramedics gave her some fluid.
Hot to the touch; Hurts underneath also; Swollen; Hurting at the injection site; Shoulder hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to the touch), PAIN (Hurts underneath also), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PAIN (Hurting at the injection site) and ARTHRALGIA (Shoulder hurt) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot to the touch), PAIN (Hurts underneath also), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PAIN (Hurting at the injection site) and ARTHRALGIA (Shoulder hurt). At the time of the report, VACCINATION SITE WARMTH (Hot to the touch), PAIN (Hurts underneath also), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (Hurting at the injection site) outcome was unknown and ARTHRALGIA (Shoulder hurt) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were taken by the patient. No treatment medications were taken by the patient.  The patient initially stated booster shot but then stated that she received her 3rd dose. The patient stated that this did not happen with the other shots.
10 days after second vaccine began to experience right sided, below the knee a pins and needles feeling on the inside of the leg to the top of the big toe.; Both legs felt tired as well.; Four days after second vaccine began to experience restless legs.; This is a spontaneous report from a contactable healthcare professional, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the right arm on 28Jan2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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. Concomitant medications included salbutamol (ALBUTEROL), testosterone (MANUFACTURER UNKNOWN), anastrozole (ARIMIDEX) and chorionic gonadotrophin (HCG) ); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9231) via an unspecified route of administration in the left arm on 07Jan2021 at 12:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 01Feb2021, 4 days after the second vaccine, the patient began to experience restless legs and both legs felt tired as well. On 07Feb2021,10 days after the second vaccine, the patient began to experience right sided, below the knee a pins and needles feeling on the inside of the leg to the top of the big toe. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event restless legs, both legs felt tired as well and right sided, below the knee a pins and needles feeling on the inside of the leg to the top of the big toe was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
treatment of COVID-19; treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 4 (booster), single (batch/lot number: unknown) at the age of 45 years, in left arm for covid-19 immunization; BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (batch/lot number: unknown), in left arm, on 02Apr2021 as dose 2, single (batch/lot number: unknown), in left arm and on 15Oct2021 as dose 3 (booster), single (batch/lot number: unknown), in left arm for covid-19 immunization. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "allergies to sulfa drugs" (unspecified if ongoing). Concomitant medications included: SYNTHROID, start date: 01Jan2018, stop date: 08Jul2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: on day 7; positive, notes: on day 9 and 10 with substantial return of symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 28Jun2023 to 03Jul2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Low grade fever, restlessness all over (jittery), feeling cold/chills, body aches (especially lower back), stomachache, loss of appetite, headache.
fever to 103-irritable, vomiting, crying non-stop the evening & next 48hr p/vax;pt had mushy stools & sl watery stool-rotavirus & stool culture negative;
rash/legs are all rash/checked her back and told her there was a rash; itchy in back; This is a spontaneous report from a contactable healthcare professional. A 61-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 22Dec2020 at left arm at single dose for COVID-19 immunisation. Medical history included ongoing diabetes from about 3-4 years before, and an allergic reaction to the dye when testing heart - couldn't remember the dye put in. She was allergic to that and sent to the ER because her throat was starting to close up about 3 years before. Concomitant medications were none. Patient received the Covid vaccine and developed rash on 24Dec2020 that was worsening and she asked if there was any recommendation on whether this was it going to get worse. Patient received the vaccine and was very worried because she was really itchy in back and her legs were all rash and in her back. She was starting to itch really bad. This was after 2 days of the vaccine (on 24Dec2020). She didn't take note until it came to her back and her friend checked her back and told her there was a rash. She asked if this could be related to the vaccine. She asked was this a severe reaction and should she receive the next dose. Her second dose was scheduled for 08Jan2021. She did not know at this time if she would get the second dose as scheduled or not. Onset of rashes started on her legs; she thought it would go away; but the rashes had worsened; they were now on her back and were getting really itchy; she had a friend look at it who told her she had patches of rashes on her back. She reported that she was going to contact her doctor about this information because she was scared about the rashes. Outcome of the events was not resolved.  Lot/Batch and Expiration date has been requested.
PAIN TO LEFT AXILLARY AREA, SWELLING AND INDURATION TO INJECTION SITE STARTED 12/24/20, 12/31/20 REDDENED AREA ~4IN IN DIAMETER AT INJECTION SITE THAT LASTED A FEW DAYS; REPORTS THOSE SYMPTOMS RESOLVED NOW; HOWEVER, HAS CLEAR FLUID FILLED VESICULAR RASH T
patient who received an expired dose / it expired on 20May2021 and was administered on 26May2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-month-old male patient who received Hib (Hiberix) (batch number 49S44, expiry date 20th May 2021) for prophylaxis.   On 26th May 2021, the patient received Hiberix. On 26th May 2021, unknown after receiving Hiberix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details provided were as follows: The reported batch number was not found in the sales data sheet and captured as 49S44 according to sales data sheet. On 28th May 2021, the reporter reported that the patient received an expired dose of Hiberix, which was already expired on 20th May 2021.  The health care professional declined to provide the last name of the patient but consented follow up and provided mailing address.