chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Some background: I normally react badly to flu/respiratory vaccines in that I generally get sicker after the vaccine than I do when I get the virus.  So this isn't entirely unexpected.   However, the timing is really strange and Now I wonder if I should get COVID tested.  Here is the chronology of events. Day of shot (Friday) - pain in arm lasted about 2 days but wasn't too intense. As the pain in the arm began to fade, I started getting really sleepy.  I slept probably 48 hours over the next three days but did not experience any pain except maybe slight muscle aches and a little of the accompanying eye burn that is associated muscle aches and sleepiness. By Tuesday, the sleepiness had passed. Thursday night (last night), I started to experience ALL general symptoms of a respiratory flu/COVID.  I developed an intense cough and associated phlem (though it is very sporadic rather than persistent) and the precursors to intense muscle pain.  I woke up at around 3am Friday with a fever, the muscle pain, burning eyes (associated with flu-muscle pain and fever), and extreme chills (though my windows was open... a normal practice as my computer makes it hot in my room).  I felt oddly rested however, as though the getting sick, while making me tired, was also helping me sleep better.  My body is definitely reacting to something.  If it wasn't 6 days afterward, I would say it was my normal reaction to virus shots.  However, the timing is alarming.  I have not knowingly been exposed to anyone with COVID.       This morning the chills are gone, the fever is down (though not entirely gone), but I still feel "down for the count."  Like I said... it is my normal reaction to virus vaccine except that it is about 6 days late (usually sets in within 24 hours).  This morning is the week "anniversary" of the shot.
high fevers, chills, aches, headache. have had a fever for 1 week
varicella - information has been received from a physician concerning a 6 year old caucasian female who on 27 jul 1998 was vaccinated sc with one dose of varicella virus vaccine live lot 625044/1568e site unknown.  on 03 may 2000 the patient developed a mild case of chicken pox that consisted of 1 vesical and less than 10 lesions.  the patient was noted to be playing in a field and her mother found two small sores in her hair.  they ere originally thought to be bug bites. After approximatley 3 days more lesions were noted on the right cheek right elbow and lower left leg. the patient remained afebrile.  a diagnosis of chicken pox was made however lesions did not appear typical none of the areas blistered.  on an unspecified date. the patient recovered no futher information is expected.
Patient is an 84-year-old female who presented for evaluation due to fatigue and weakness. The patient was found to be COVID positive in the ER (she is fully vaccinated). She was found to have a UTI as well. She did not have any leukocytosis or hypoxia. She was admitted for PT/OT evaluation. On the day of discharge, the patient was feeling much better. The patient continued to maintain her saturations on room air. She was given monoclonal antibodies for COVID and treated with keflex for her UTI. OT evaluated the patient and recommended that she have home health PT. Care management helped arrange for this. The patient was given a prescription for keflex at discharge to complete her course of antibiotics. She was encouraged to follow up with her PCP for continued monitoring after discharge
ADVERSE DRUG REACTION; FELT THE NEED TO SLEEP; CHILLS; LOW FEVER; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-MAR-2021, the subject experienced adverse drug reaction. On 30-MAR-2021, the subject experienced felt the need to sleep. On 30-MAR-2021, the subject experienced chills. On 30-MAR-2021, the subject experienced low fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the adverse drug reaction, chills, low fever and felt the need to sleep was not reported. This report was non-serious.
My period is early. This is remarkable because I am on birth control; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the arm left on 06Apr2021 at 08:15 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any known allergies. 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 unspecified medication for birth control from an unknown date and unknown if ongoing. On 19Apr2021, the patient's period was early which the patient thought was remarkable since the patient was on birth control. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event period is early was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 15-APR-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # 1660693, has been verified to be a valid lot number; expiration date 19-MAR-2021) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
Complete loss of appetite, nausea, vomiting when I try to eat as I did before Painful muscle cramps in my chest and abdomen, heart palpitations, shoulder/neck/back pain for 3 months following vaccination Persistent fatigue
blood pressure up, kidney infect, urinary tract infect, nauseated, bad chills;
A 24 day old patient was inadvertently administered a dose of PEDVAX HIB; This spontaneous report as received from a other health professional refers to a 24 day old patient. On 30-JAN-2020 the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # S006470, .5 milliliter for prophylaxis. On 30-JAN-2020, 1 day after onset of therapy the patient experienced product administered to patient of inappropriate age. The outcome of product administered to patient of inappropriate age is unknown.
A patch of dry skin showed up on my face sometime in May 2021. I had disregarded it for awhile. Then February 24, 2022 at my dermatology appointment the doctor diagnosed it as precancer. Then I had surgery to get the spot on my face burned off and now everything is fine.
6x4 cm area of erythema and edema around injection sight (Left deltoid).
MISSED THIRD DOSE; This spontaneous case (PVX2019-744, PVX2019-756) was received from a pharmacist and consumer on 27-Mar-2019. It describes a female consumer who "missed third dose", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.   Case report: The consumer took the first dose of Vivotif on 21-Mar-2019 and the second dose on 23-Mar-2019. Then, she missed her third dose, which was due on 25-Mar-2019.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "missed third dose" was unknown.  Company's Comment: The causality of the event "missed third dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed third dose" was considered as not applicable.
The vaccine was administered 3 days after the beyond use date. The dose was administered on 10/5/2021 when the beyond use date was 10/2/2021.  The expiration date of the vial was 10/31/21. The expiration date was used instead of the beyond use date. No outcome or adverse event occurred at this time
Patient stated feeling itchy and warmth over injection area the evening she received vaccine.  The area because more painful.  Patient took Benadryl which helped with itching.  Made appointment and was seen on Thursday 1/12.  Upon exam injection site was tender to palpation with 3x4 cm erythematous raised area.  Diagnosed with acute cellulitis secondary to vaccine administration and prescribed Bacrim DS 800mg-160 mg tablet BID x 14 days.
patient reported redness and swelling at injection site that was a lot more severe then she had ever had
I am suffering from auto immune deficiency disease; The arm in which my vaccine was given became magnetic and remained this way for about 4months; This spontaneous case was reported by a patient and describes the occurrence of AUTOIMMUNE DISORDER (I am suffering from auto immune deficiency disease) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (I am suffering from auto immune deficiency disease) (seriousness criterion medically significant) and VACCINATION SITE REACTION (The arm in which my vaccine was given became magnetic and remained this way for about 4months). At the time of the report, AUTOIMMUNE DISORDER (I am suffering from auto immune deficiency disease) and VACCINATION SITE REACTION (The arm in which my vaccine was given became magnetic and remained this way for about 4months) outcome was unknown.            Patient was not magnetic before received the vaccine Patient was totally healthy before and when received  two jabs from moderna and now had been told that suffering from an auto immune deficiency disease. Concomitant medications were not reported.  No treatment information was provided by the reporter.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the serious (due to medically significant) unexpected, event of Autoimmune disorder, which occurred after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. The outcome was not reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.    This case was linked to US-MODERNATX, INC.-MOD-2023-734384 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2023: Live follow-up include no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734384:
Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 28-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 23-JUL-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
chills; tinnitus; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 49-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown"; TINNITUS (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Moderna COVID-19 Vaccine: The morning after injection, she developed shortness of breath, fever, muscle pains, joint pains, delirium. 911 called.  EMTs transported her to Hospital where she was admitted after blood tests and CT angiogram of the chest indicated multiple pulmonary emboli in right upper and lower lobes of the lung.  Unconscious at the time of admission. Discharged after 3 days.  Continues to have significant shortness of breath. Unknown if this will be permanent or lead to death.  Reasonably stable at present time although unable to function.
Date: 1/11/2022: Patient came into the office with her friend for a COVID-19 booster vaccine Pfizer (batch/lot# FJ1611). She was injected with the vaccine at approximately 4:05 pm. Before her vaccine injection, she took 2 Benadryl 50mg (at 3:30 pm), because of the advice given by an allergist on June 21, 2021. At around 4:20 pm, she began to show redness on her left ear, and her face became flushed. At 4:25 pm, she was given Tylenol 1000mg PO. At 4:45, patient given Solu-Medrol 125mg batch/lot# EX6143, exp 9/23 NDC 0009-0047-22. Discharged patient at approximately 5:05 pm.
threw up bile this morning; Four Shingrix doses were administered; Four Shingrix doses were administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of bile reflux (esophageal) in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number X9KC7, expiry date 25-OCT-2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on 25 September 2018) and shingrix (received 2nd dose on 11th December 2018). Concurrent medical conditions included neoplasm malignant, cigarette smoker, chronic obstructive pulmonary disease and polyp.   On 26-JUN-2023, the patient received the 4th dose of Shingrix. On 28-MAR-2023, the patient received the 3rd dose of Shingrix. On 28-MAR-2023, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Four Shingrix doses were administered). On 26-JUN-2023, the patient experienced extra dose administered (Verbatim: Four Shingrix doses were administered). On 27-JUN-2023, the patient experienced bile reflux (esophageal) (Verbatim: threw up bile this morning). The outcome of the bile reflux (esophageal) was resolving and the outcome of the extra dose administered and extra dose administered were unknown.   It was unknown if the reporter considered the bile reflux (esophageal) to be related to Shingrix.     It was unknown if the company considered the bile reflux (esophageal) to be related to Shingrix.   Additional Information: GSK receipt date 29 Jun 2023. The pharmacist reported that a patient received two doses of Shingrix this year on 2023, but there were a prior vaccination history of 2 Shingrix doses administered on 2018.  On 27th Jul 2023, patient reported the he threw up bile this morning and after this episode he felt better. The reporter consented to follow up via email. HCP declined providing patient´s date of birth and initials. The patient received 4 doses of shingrix vaccine which led to extra dose administered.
Everything went downhill after second immediately starting throwing up 3 or four days after drank ginger ale. Sent doctor emails, doctor prescribed antibiotic. I was out of work for 3 weeks.
first dose of the Pfizer vaccine and they were sneezing repeatedly for about 24 hours. They reported that they were sneezing so much that they could hardly work that day; This is a spontaneous report received from a contactable consumer or other non hcp. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on Jan2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced a friend told me they received the first dose of the Pfizer vaccine and they were sneezing repeatedly for about 24 hours. they reported that they were sneezing so much that they could hardly work that day unspecified date in Jan2021. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient given 0.25ml instead of 0.5ml; A spontaneous report was received from a physician concerning a patient of unknown age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) was given 0.25ml instead of 0.5ml.   There were no medical history and concomitant medications reported.  On 16 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 16 Jan 2021, the patient was vaccinated with 0.25ml instead of 0.5ml.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, "patient given 0.25ml instead of 0.5m" was considered resolved on 16 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of incorrect dose administered.
They are calling about a patient asking about re-vaccination for the COVID-19 vaccine after a bone marrow transplant about a week ago.; This spontaneous case was reported by a consumer and describes the occurrence of BONE MARROW TRANSPLANT (They are calling about a patient asking about re-vaccination for the COVID-19 vaccine after a bone marrow transplant about a week ago.) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient did not have the Medical history or condition.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced BONE MARROW TRANSPLANT (They are calling about a patient asking about re-vaccination for the COVID-19 vaccine after a bone marrow transplant about a week ago.). At the time of the report, BONE MARROW TRANSPLANT (They are calling about a patient asking about re-vaccination for the COVID-19 vaccine after a bone marrow transplant about a week ago.) 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.   It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Dosage text was reported as unknown. Treatment details was not reported by the reporter.
Moderna COVID-19 vaccine for healthcare worker given 1/14/2021, that night started chills and fever, headache and malaise lasting 3 days, the headache and fatigue continued through the 2nd Moderna COVID-19 vaccine 1 month later, on 2/11/2021. She again had chills and fever, just for 2 days, but again headache and fatigue continued. I last saw her on 3/15/2021, and she still had persistent headache and fatigue. She is to f/u in 6 months.
STARTED TO FEEL LIKE SOMEONE IS STANDING ON MY STOMACH IN THE MORNING/HE THOUGHT HE WAS CONSTIPATED/ PAIN THEN STARTED TO MOVE FROM THE LEFT SIDE THEN IN HIS BACK; BLACK AND  BLUE AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient's past medical history included liver transplant, and concurrent conditions included diabetes, and spider bite. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 05-AUG-2021) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-JUL-2021, the subject experienced black and blue at the injection site. On 06-JUL-2021, the subject experienced started to feel like someone is standing on my stomach in the morning/he thought he was constipated/ pain then started to move from the left side then in his back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from black and blue at the injection site on JUL-2021, and had not recovered from started to feel like someone is standing on my stomach in the morning/he thought he was constipated/ pain then started to move from the left side then in his back. This report was non-serious.
she received the Pfizer vaccine on 29Dec2020. She tested positive for coronavirus on 01Jan2021. Is the efficacy of the vaccine after the second dose?; tested positive for coronavirus; This is a spontaneous report from a contactable nurse reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. VA nurse calling stating that she received the Pfizer vaccine on 29Dec2020. She tested positive for coronavirus on 01Jan2021. She wanted to know how to proceed with getting her second vaccine, and if the efficacy of the vaccine is after the second dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and Coronavirus test positive cannot be totally excluded.  The case will be reassessed if additional information becomes available.