chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DEATH; COMA; BLOOD CLOTS ON BRAIN; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the subject experienced death, coma, and blood clots on brain. On an unspecified date, the patient died from blood clots on brain, and coma. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0-20210637172-COVID VACCINE AD26.COV2.S-Death, Coma, Blood clots on brain. This events are considered un-assessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: BLOOD CLOTS ON BRAIN; COMA
Painful palpable lump under arm lymph node area of vaccine side started about 36 hours following  vaccination. Low grade Fever and general aches and malaise starting 6 hours following vaccine and still present
body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) in a 20-year-old patient of an unknown 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 30-May-2021, the patient experienced MYALGIA (body aches). At the time of the report, MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.
Information has been received from a nurse concerning a 32 month old patient who on 09-SEP-2010 was vaccinated with a dose of VARIVAX (Merck) (lot# 666869/0469Z). The nurse mentioned that on 29-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. A lot check has been initiated. Additional information has been requested.
NUMBNESS IN THREE FINGERS OF RIGHT HAND; PAIN IN HAND OR FINGERS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced numbness in three fingers of right hand, and pain in hand or fingers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from numbness in three fingers of right hand, and the outcome of pain in hand or fingers was not reported. This report was non-serious.
Patient stopped breathing after the administration of single dose Prevnar - no other immunizations given.  She then went into a seizure lasting for approximately five minutes.  Dr. ran in called 911.  By the time the paramedics arrived to the pediatrician's office patient's seizure had stopped.  She was listless, limp, unresponsive.  She was taken to the hospital where she was released.  Further testing was done.  No neurological cause was found.
hives at injection site started on the same day.  The next day the patient started experiencing vertigo, dizziness, nausea and vomiting. The 3rd day she started getting hives and itching over torso.  On 11/6 the hives went over her entire body with severe itching.
Patient presented with itching and hive on face neck and right thigh one hour after receiving FLUMIST. Treated with BENADRYL 40 mg po.
Lymph node was very swollen underneath left armpit. Significant bump remained for two weeks after the second dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: EN6206), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TESTOSTERONE. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Is bivalent=False,, Prev dose lot number=EL3249,, Prev dose lot unknown=False,, Prev dose dose number=1,, Prev dose vaccine location=Left arm), for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "Lymph node was very swollen underneath left armpit. Significant bump remained for two weeks after the second dose".  Additional information: Lymph node was very swollen underneath left armpit. Significant bump remained for two weeks after the second dose and patient currently had the same after the third dose. Patient did not receive other vaccines within 4 weeks. Patient had no covid prior vaccination and was not tested for covid post vaccination. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 at 11:00 as dose 1, single (Lot number: EN6201), in left arm, on 04Mar2021 at 11:00 as dose 2, single (Lot number: EN6203), in left arm, on 04Oct2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 11Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FK9894) at the age of 65 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: METOPROLOL, start date: 01Jan2018 and Novast. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Other medication in 2 weeks brand= Novast. Other medication in 2 weeks start date=01Jan2018.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
?Covid arm?  Painful red area that was swollen and hard on injection site 7 days after injection.
She got a tingling and numbness sensation in her left arm within half an hour. Then she felt nauseated. She then threw up twice. She felt dizzy and had a severe migraine headache. I asked her to go to the ER but she didn't go. She went to her doctor's office the next day.
Post vax, the pt developed redness and swelling in the left arm. Pt states that it is just slightly pink with itching.
1 week after administration of the booster vaccine, the patient developed an incapacitating headache which persisted with minimal response to typical headache medications. About 7 - 8 weeks after vaccine administration, the patient developed a wide range of vision symptoms which led him to seek care from an optometrist who identified papilledema and referred him to me. My examination confirmed bilateral papilledema and the patient was acutely ill in my office, in severe pain and vomiting. I suspected venous sinus thrombosis and sent him for immediate admission and evaluation. He was found to have Dural venous sinus thrombosis (extensive - see below). There is absolutely NO reason for this young, healthy patient to experience extensive Dural venous sinus thrombosis other than as a vaccine complication.
2:30 PM - Immunization given; 3:10 PM - dull headache; 4:30 PM - Headache increased w/dry mouth. Took Ibuprofen and ate food. 5:30 - Nausea and vomiting - home from work. 6:30 - Laid down. 10;30 PM - Woke and felt fine. No others ill in the household.
He had second dose of Moderna COVID vaccine on March 13th. He was admitted with progressive SOB and acute right leg limb ischemia 4/7/21. He was found to have massive Bilateral PE and right common femoral artery and right external iliac atery occlusion. He was unstable and required embolectomy, tPA and EKOS for PE and embolectomy for right leg arterial occlusions. He remains sedated in ICU now.
Patient complaint of sweating and headached starting 3 hours after vaccination. Next day, complaint of seeing blurry, continued headache, nausea. Was off work several days, lost voice, still has hoarse voice
sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (sick) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included Tylenol                                                        not often for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (sick). At the time of the report, MALAISE (sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided by reporter.
Phone call from patient complaining of slight redness at the injection site (Lt deltoid), pain with arm movement and enlarged axilliary lymph nodes. No fevers.
12 days after 4th shot developed itchy rash throughout body with  dermatographia
No adverse events occurred.  We had a Moderna Covid-19 Vaccine reach its beyond use date due to being under refrigeration for 30 days on 12/19/2021. On the morning of 12/20/2021, the patient received the vaccine that was roughly 10 hours beyond use. The beyond use date was clearly marked on the package, but our pharmacy has never had a vaccine reach expiration date, and it was not until after the vaccine was given that the beyond use date was noticed.
Symptoms began 12/18/2020 at 9pm with severe fatigue and chills.  Woke up at 0030 12/19/2020 with severe shaking chills, headache, body aches, dry cough and nausea, temperature spiked to 103.2 @ 0230, took 600mg Motrin and 500mg Tylenol but fever stayed at 103 until 0600 and slowly came down to 98 by 0900 12/19/2020; symptoms were resolved except for fatigue until approx 5pm 12/19/2020 when fatigue increased and chills came back with headache and body aches, fever spiked to 102.3 and lasted until approx 9pm after taking 600mg Motrin and 500mg  Tylenol,  I was able to sleep well Saturday night.  Woke up Sunday 12/20/2020 at 0730 feeling well but within an hour I developed a dry cough and shortness of breath with exertion and noted elevated heart rate (90-120bpm).  This lasted all day.  At 3pm 12/20 I began to get fatigued again.  I felt very clammy and flushed and checked my temperature and it was back up to 101.6.  Fever came down to 100 by 7pm and stayed there until approx 930pm.  I woke up this morning feeling slightly better.  I still have  a cough and shortness of breath
felt sicker than dogs; in bed for 3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sicker than dogs) and BED REST (in bed for 3 weeks) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017Z21A and 031BZ1A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN and CLONAZEPAM for an unknown indication.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced ILLNESS (felt sicker than dogs) and BED REST (in bed for 3 weeks). In May 2021, ILLNESS (felt sicker than dogs) and BED REST (in bed for 3 weeks) had resolved.            Patient reported unspecified pain pills as treatment medication to treat adverse effects of the vaccine. Follow up received on 27-Jul-2021 included no new information.  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.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Non-significant follow-up appended On 02-Aug-2021: Follow up received on 02 AUG 2021 contains no new information.; 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.
Discharge Provider: MD Primary Care Provider at Discharge: MD  Admission Date: 7/4/2022 Discharge Date: 7/6/2022  PRESENTING PROBLEM: Hypokalemia  COVID-19    HOSPITAL COURSE:  Patient presented to the ER in respiratory distress.  she was at a family gathering 38 minutes away and started feeling ill the night before coming to the ER.  Her shortness of breath cough worsens and she was found to be tachycardic tachypneic and hypoxic requiring supplemental oxygen.  She had electrolyte abnormalities which were replaced.  She was found to have COVID-19 and was admitted and had a 3 day course of remdisivir and dexamethasone.  She was able to be weaned off oxygen.  She complained of a headache which was relieved by Fioricet.  On the day of discharge patient was feeling well off oxygen is anxious to go home.  She was discharged with dexamethasone to complete a 10 day course.  She was given p.r.n. albuterol inhaler and Fioricet.
My first dose simply resulted in a sore arm.  The second dose gave me an extremely sore arm...at 3 pm I couldn't lift a small glass of water to take ibuprofen.  It hurt over my entire shoulder, up my neck and down my arm.  I had no appetite , eating made me queasy and I went to bed at 10.  I woke up a little after midnight in terrible pain:  excruciating headache, all my lymph nodes hurt (both arms, groin, thighs), body aches all over.  I was chilling, but I was in too much pain to shiver, and had horrible nausea --?from the pain??.   I managed to get more  blankets and fell back asleep.  I woke again at 4 am in even more pain and nausea, and a fever of 102.6.  (My baseline body temp is usually around 96.5.  I rarely get fever that high). The pain was so bad I wanted to chop my head and arm off.  I got a cold wet washcloth for my head, put on lighter weight clothing ( it took a lot of effort to do anything  with the pain.  I was dizzy and stumbling).  And was able to fall back asleep for a few hours.  Fever started coming down around 9am, so I tried drinking water.  Slowly improved as the day progressed
After 1st dose he tested positive for covid; Cough; Nasal congestion; Headache; Nausea/ vomiting; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (After 1st dose he tested positive for covid), COUGH (Cough), NASAL CONGESTION (Nasal congestion), HEADACHE (Headache) and NAUSEA (Nausea/ vomiting) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L204) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (After 1st dose he tested positive for covid), COUGH (Cough), NASAL CONGESTION (Nasal congestion), HEADACHE (Headache) and NAUSEA (Nausea/ vomiting). At the time of the report, COVID-19 (After 1st dose he tested positive for covid), COUGH (Cough), NASAL CONGESTION (Nasal congestion), HEADACHE (Headache) and NAUSEA (Nausea/ vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant  medications were reported.  Treatment medications included antibodies.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received on 15-JUN-2021. All events were resolved before the patient received second dose according to FU source.
Pfizer vaccine was administered outside of source - reported by patient- ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------- G62.9 NEUROPATHY 4/12/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA G62.9 NEUROPATHY 4/12/2022 SPEECH PROBLEM
I received the Moderna Covid Shot on January 15,2021 and about 1/2 an hour later I had a migraine headache, joint pain and swelling, fatigue, nausea, and dizziness.  I have had migrating joint pain and swelling every since and it has been 2 weeks since the shot.  I'm in a lot of pain.
pt said he had a rash that developed under her breasts an hour after receiving the vaccine. pt took Benadryl and went to sleep. Rash was there still when she woke up and she also had flu-like symptoms
I woke up the day after the vaccine with nausea, chills, loss of appetite, and severe panic attacks (I don?t typically have panic attacks). The anxiety has subsided slightly, but I am still severely nauseated every morning and weak/lightheaded throughout the day.  I vomit most mornings. I have been to urgent care, called 911 and gone to the ER, and seen my GP twice. No one knows how to help me.
Hives - less than 8 hours - Benadryl (2-3 tsp)
Body Aches and pains, headache, swelling and pain at injection site all which lasted around  20 hours.
Lethargic, weak, vomiting, nausea, headache, eye pain and blurred vision, difficulty breathing, labored breaths, gas.
Slight circular welt at injection site with red ring around the edges. Ring was about 2inches in diameter.  No pain and slight warmth to touch. Symptoms remained for about 2-3 days then dissipated.
I95.9 HYPOTENSION 9/29/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R57.0 CARDIOGENIC SHOCK 11/29/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I95.9 HYPOTENSION 9/29/2022 ELEVATED PSA R57.0 CARDIOGENIC SHOCK 11/29/2022 ELEVATED PSA I95.9 HYPOTENSION 9/29/2022 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC R57.0 CARDIOGENIC SHOCK 11/29/2022 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC I95.9 HYPOTENSION 9/29/2022 ATRIAL FIBRILLATION, UNSPECIFIED    CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R57.0 CARDIOGENIC SHOCK 11/29/2022 ATRIAL FIBRILLATION, UNSPECIFIED    CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I95.9 HYPOTENSION 9/29/2022 ATRIAL FIBRILLATION, UNSPECIFIED    CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R57.0 CARDIOGENIC SHOCK 11/29/2022 ATRIAL FIBRILLATION, UNSPECIFIED    CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I95.9 HYPOTENSION 9/29/2022 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC R57.0 CARDIOGENIC SHOCK 11/29/2022 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC
Vaccine administered Rt Deltoid 5/21/2020. 1AM 5/23 awoke with shaking chills, severe whole body muscle & joint pain, headache and Rt Deltoid swollen, 2inch red, tender. Resolved over 48hours.
Vaccine was not diluted per manufacturer before dose was drawn and given. Followed up with mother of patient to inform her of what had happened and to check on patient. Mother informed me that the patient was ok, no adverse side effects, just a sore arm. Also informed the mother that if any adverse event did occur than to contact us and/or the doctor.
seen in ER 6DEC94; pt was running low grade temp of 101.5 earlier this PM; pt recvd vax 1130AM & was treated for ear infect; mom awakened by convuls which lasted 20 mins; couple seconds later pt had a 5-10 sec convuls; pt drowsy;
Got shot on Friday, had hives on Monday. Took Benadryl, didn't help, went back to (primary) Dr who prescribed Atarax on Tuesday, didn't help. He prescribed Prednisone, that worked, it went away. Hives in all warm areas, tops of legs, underarms, arms, behind ears, behind knees. Follow up on 12/10/03: "Please let me know if I need any kind of follow up on influenza shot."
OBSTRUCTIVE SLEEP APNEA ACUTE RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 02-DEC-2011, the patient was inoculated with ZOSTAVAX by a physician (MD) at a medical clinic center as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 10-MAR-2016, the patient was treated by the physician (same physician who administered the vaccine) at a medical clinic center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Report received from a pharmacist on 28-SEP-2010 (received via Merck WAES: 1009USA05341). A male patient (initials: unknown, date of birth: unknown) received one dose of unknown seasonal flu vaccine (unknown brand/manufacturer, batch number and expiry not provided, route of administration: not specified) for unspecified indication on an unknown date. The patient's medical history and concomitant medications were not specified. On an unknown date, after receiving the suspect drug, the patient had an anaphylactic reaction with breathing difficulties and went to the Emergency Department. The patient's outcome was not provided at the time of reporting. The reporter did not provide a causality assessment in relation to the suspect drug. The company considered events serious due to medical significance. The company considered events unassessable due to lack of information regarding time to onset. Information derived from this AE report does not change the current safety profile of the product.
pt recv vax & pt presented w/a varicella like rash totaling 35 lesions;the rash was non pruritic & pt was afebrile;
Pt was exposed to a sibling who received one dose of varicella virus vaccine live on 06/02/1999. 6 days later pt developed a mild version of chickenpox. The vaccinee did not experience any post vaccination rash.