chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Pfizer vaccine on 03/11/21 and 4/1/21. COVID positive on 1/12/22. Presented to ER on 1/12/22 with mental obtundation, confusion, high  fever documented at 103 at home, diaphoresis, urinary incontinence, and  essentially a near bedridden state for the last 24 hours.   She at no time was complaining of respiratory complaints at home  and family was more upset early this morning when he noted her to be  diaphoretic and having a high temperature and confusional state, which  prompted him to bring her straight to the emergency room.   She looked mildly dehydrated.   She was started on IV fluids.  Appropriate laboratory studies were done and  she was screened for COVID, which did eventually come back positive.  A better history was obtainable from her about 6 hours late and all she knows and can recall is that she has just been weak in bed for the preceding 12-18 hours, but had little recollection of her diaphoresis and  fever through the night. Admitted and started on dexamethasone, remdesivir, ceftraixone, and azithromycin. She was feeling better within just  several hours of admission and IV fluids.  She remained in the hospital for 4  days.  Her oxygen requirements rapidly dropped to the point where she was  well saturated on room air.  In light of this, her remdesivir was discontinued  after 3 doses, and she was transitioned to p.o. Decadron.  All blood cultures  remained negative, and it was not felt she had a bacterial superinfection, so  Rocephin was discontinued.  However, she was to continue  a 7-day course of  azithromycin. Her oxygen requirements abated, and she was sent home without  O2 on 1/15/22
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE OBSTRUCTIVE SLEEP APNEA HYPOTENSION CHRONIC RESPIRATORY FAILURE
Patient received MMR on 3/24/04. At day care 3/25/04, had a brief generalized seizure lasting <1minute, seemed post-ictal around 1 hour. Full recovery.
Headache; body aches; injection site pain; This is a spontaneous report from a contactable pharmacist, the patient. A 44-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 23Mar2021 at 09:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN) (not specified) 1000 IU oral daily for an unspecified indication. The past drug history included known allergies: acetaminophen, nonsteroidal anti-inflammatory drug (NSAIDs). The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 15:00, the patient experienced headache, body aches and injection site pain (vaccination site pain). The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, body ache and vaccination site pain were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
PAIN BEHIND HER EYES; FELT HUNG OVER; BODY ACHES; HEADACHE; This spontaneous report received from a patient concerned a 45 year old female. 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: Unk) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 17-MAR-2021, the subject experienced pain behind her eyes. On 17-MAR-2021, the subject experienced felt hung over. On 17-MAR-2021, the subject experienced body aches. On 17-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain behind her eyes, felt hung over, body aches, and headache. This report was non-serious.
BLOOD CLOTS IN BOTH LUNGS; This solicited report received from a health care professional via PPSPHN002323: concerned a 69-year-old female. The patient's weight was 86.4 kilograms, and height was not reported. The patient's concurrent conditions included: primary pulmonary hypertension. The patient was treated with macitentan (tablet, oral, batch number: ZE025A0101 expiry: 31-AUG-2025) 10 mg, 1 time every 1 day, therapy dates were not reported; and selexipag (tablet, oral, batch number: 117381701 expiry: 28-FEB-2023) 200 ug, 2 times every 1 day, therapy dates were not reported for primary pulmonary hypertension. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (Janssen series 1, suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On 07-OCT-2021, the patient experienced blood clots in both lungs, and was hospitalized for four days from 07-OCT-2021 to 11-OCT-2021. The doctor placed selexipag on hold for now. The patient has an appointment on 09-NOV-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; treatment with selexipag was withdrawn; and dose of macitentan was not changed. The outcome of blood clots in both lungs was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and blood clots in both lungs was not related; between selexipag, and blood clots in both lungs was not related; and between macitentan, and blood clots in both lungs was not related.  This report was serious (Hospitalization Caused / Prolonged).  This case, involving the same patient is linked to 20210346375 and 20210335753.  Additional information was received from other health professional on 29-NOV-2021. The following information was updated and incorporated into the case narrative: new reporter and Janssen covid-19 vaccine added and ranked as primary suspect.; Sender's Comments: V1: Follow up information updates about addition of new reporter and Janssen covid-19 vaccine as primary suspect. 20211047780-covid-19 vaccine ad26.cov2.s-blood clots in both lungs. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE 20211047780 -selexipag and macitentan-blood clots in both lungs. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE
Redness; Broken out in a rash; A few small hives; Blotches on my left forearm; Experiencing itchy skin around my neck/ itchiness; Pain; Swelling; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3181), dose 2 via an unspecified route of administration in left arm on 03Sep2021 at 13:30 (Age at vaccination: 30-years-old) as dose 2, single for COVID-19 immunization. The patient had no known allergies. Medical history and concomitant medications were reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3181), via an unspecified route of administration in left arm on 13Aug2021 at 05:45PM (Age at vaccination: 30-years-old) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received no other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Sep2021 at 09:00 AM, the patient was experiencing itchy skin around her neck, had itchiness, pain, and swelling. On 08Sep2021, she woke to a few small hives and blotches on my left forearm. By 2pm, she had broken out in a rash and by 5pm, her entire upper body was covered in hives and redness. The adverse events result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event was Benadryl and Pepcid. The outcome of events was not recovered.  Follow-up attempts were completed. No further information was expected.
Initial information received on 02-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old male patient who received vaccine MENACTRA. The patients past medical history, concomitant medication and family history were not provided. On 07-Nov-2009, the patient received a first dose of suspect MENACTRA lot number, expiry date not reported via unknown route in unknown administration site. 2 other doses were administered on 21-Nov-2012 and again on 20-Dec-2015 for suspect MENACTRA. It was an actual medication error due to extra dose administered. It was asked by nurse if patient Should be MENACTRA be given to a 11-12-year-old adolescent who previously received MENACTRA before the 10th birthday. Child received at another practice meningococcal vaccine on 07-Nov-2009, on 21-Nov-2012 and again on 20-Dec-2015. It was unknown whether patient experienced any adverse reaction after the injection. 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. List of documents held by sender- none.
hardness at injection site; swelling at the injection site; A spontaneous report was received from a health care professional concerning a 57 year old female patient who received Moderna's COVID-19 vaccine and experienced swelling and hardness at the injection site.  The patient's medical history was not provided. No concomitant medications were reported.  On 26-Dec-2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly for prophylaxis of COVID-19 infection. Soon after, the patient experienced swelling and hardness at the injection site. The patient reported that the size of the hardness at the injection site is increasing on 27 Dec 2020. No treatment was administered.   The Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the events, swelling and hardness at the injection site, were considered unknown.; Reporter's Comments: This case concerns a 57-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 026L20A), and who experienced the non-serious listed events of swelling and hardness at the injection site.  Based on the current available information and temporal association between the use of the product and the onset of events on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
sore arm; injection site swelling; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A female patient of unspecified age (reporter's wife) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 16Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. The reporter called because his wife experienced sore arm and injection site swelling after the second dose of the vaccine. The clinical outcomes of sore arm and injection site swelling were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This spontaneous report as received from a physician refers to a patient of unknown age who on an unknown date was vaccinated subcutaneously with one dose of ZOSTAVAX (dose and lot number not reported). The physician reported that on an unknown date the patient experienced zoster like rash at the injection site after receiving ZOSTAVAX. At the time of the report, the patient's outcome was unknown. The relatedness for zoster like rash at the injection site and ZOSTAVAX was unknown. Additional information has been requested.
whole body ached and right arm, the arm injection was given, now goes numb when i lay down
MOM CALLED @ 1:45 pm with hives to face, red on face and swollen eye. Told to watch for SOB go to ER.
Pt recvd vax & was hospitalized for poss epilepsy;pt had exp blackouts & szs & was unable to drive;addtl info is being sought
Neuropathy; Chronic pain; Numbness; Tingling/Needles in the abdomen; Burning sensation in feet and hand; Muscle weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Jan2022 17:30 (Lot number: FKA729) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: seafood" (unspecified if ongoing), notes: Known allergies: seafood. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; VIT B COMPLEX; ALLEGRA; ALIGN. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro", notes: Known allergies: Cipro. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EOW217, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 08Jul2021, when the patient was 40 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EWO202, Location of injection: Arm Left, Vaccine Administration Time: 06:30 PM), administration date: 17Jun2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 17Jan2022 12:00, outcome "not recovered", described as "Neuropathy"; PAIN (non-serious) with onset 17Jan2022 12:00, outcome "not recovered", described as "Chronic pain"; HYPOAESTHESIA (non-serious) with onset 17Jan2022 12:00, outcome "not recovered", described as "Numbness"; PARAESTHESIA (non-serious) with onset 17Jan2022 12:00, outcome "not recovered", described as "Tingling/Needles in the abdomen"; BURNING SENSATION (non-serious) with onset 17Jan2022 12:00, outcome "not recovered", described as "Burning sensation in feet and hand"; MUSCULAR WEAKNESS (non-serious) with onset 17Jan2022 12:00, outcome "not recovered", described as "Muscle weakness". The events "neuropathy", "chronic pain", "numbness", "tingling/needles in the abdomen", "burning sensation in feet and hand" and "muscle weakness" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of neuropathy peripheral, pain, hypoaesthesia, paraesthesia, burning sensation, muscular weakness.  No follow-up attempts are possible. No further information is expected.
Received vaccine 7/24/15. Reports local reaction 7/25/15 AM. Seen by Dr. on 7/27/15 with large area erythema, warmth and reddened skin. Rx'd antibiotic and oral steroid. Severe local reaction diagnosed.
fatigue arm pain, metallic taste, jaw pain, abdominal cramping, loose stool
Woke up with a fever of 101, crying, diarrhea. Gave him a cool bath after changing him to get him clean/cool him down. He could not grab the water from the faucet, he missed it as if his hand wasn't going where his brain told to. Tried to give him water, he wouldn't drink any. He snuggled back to sleep, we transferred him to his crib. At 9am, he threw up in his sleep without even stirring, eyes had deep dark circles. We picked him up and he was limp. We took him to the ER where they said had severe brain damage. They treated him for sepsis.
I received my first Moderna Vaccine Dose 1 on Saturday, January 30, 2021 at the Clinic at/or around seven thirty p.m. Initially there were no after effects. On or about February 4th/5th I began experiencing mild chills. Nothing to go to bed for, but noticeable. And a day or so later I broke out in a mild rash ? from my upper chest, upper arms and pelvic area ? again nothing to go to bed for.
Ate before the vaccine.  Since I'd never had one and have an intolerance to latex, they were going to monitor me for 15 minutes. About five minutes after vaccine, I started getting very dizzy and my vision changed.  I was in the sun, so they moved me to another chair.  Very dizzy with movement.  They got me water, I sat there.  Developed a headache.  Arm felt warm, shoulder and elbow felt sore/burned.  After 20-25 minutes, my vision cleared (it was like the aura you get before a migraine).  Still felt dizzy.  Older nurse there gave me candy, insisted I needed sugar and I should get a coke.  Headache lessened, felt like burning in my head.  Dizziness lessened and I could stand.  Was there probably half an hour being monitored.  Went out and got a coke.  Got dizzy again after that, but not as bad.  Got a little food.  Small appetite change, but not nauseous.  Still dizzy at 1pm, my breathing easier, headache is less.  Feel like I have an aura on vision again, akin to post migraine.  Dizziness is less, but not gone.
Pt recv vax on 8/21/97; post vax pt exp hair loss.
Pt. states that after receiving the 1st dose of J&J 05/04/2021, started experiencing symptoms 06/01/2021 of severe knee (both) pain, self treatment with Tylenol. Still continuing, No noted Primary visit/Urgent Care.
Mild GI upset after first shot; Mild diarrhea after first shot; Sore Injected arm after first shot; Swollen Injected arm after first shot; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Mild GI upset after first shot), DIARRHOEA (Mild diarrhea after first shot), VACCINATION SITE PAIN (Sore Injected arm after first shot) and VACCINATION SITE SWELLING (Swollen Injected arm after first shot) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (Mild GI upset after first shot), DIARRHOEA (Mild diarrhea after first shot), VACCINATION SITE PAIN (Sore Injected arm after first shot) and VACCINATION SITE SWELLING (Swollen Injected arm after first shot). On 20-Apr-2021, ABDOMINAL DISCOMFORT (Mild GI upset after first shot), DIARRHOEA (Mild diarrhea after first shot), VACCINATION SITE PAIN (Sore Injected arm after first shot) and VACCINATION SITE SWELLING (Swollen Injected arm after first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.   This case was linked to MOD-2021-396447, MOD-2021-396448, MOD-2021-395897 (Patient Link).
I felt like I had a cold, but my throat wasn't sore or tender. It was like the lymph nodes and muscles in my neck were sore. Whenever I woke up, it was especially sore in my neck after having slept all night, but after I sat up for a while, the soreness subsided, and it then just felt like a cold afterwards. I was taking Advil for a fractured wrist at this time, so that may have helped, also. I tested positive for COVID-19 on 1/31/2023. I then tested negative for COVID-19 on 2/10/2023. After I tested negative, I developed a runny nose and a  bit of a cough. Whenever I had the cough, I just sucked on a hard candy to relieve it, because was caused mainly by drainage.  When I contacted my GP, I was not prescribed anything. During my time with the breakthrough case, I didn't feel really bad. I just continued taking my usual OTC medicines like Flonase, Zyrtec, and Advil.
pt presents in ED on 12/15/2021 with Chest pain. Recently dx with pneumonia and had completed Levaquin .
Presented to cinic with herpes zoster rash on back and chest that started 5/19.  No known chicken pox before vaccine or exposure to Zoster or chicken pox
Very swollen at injection site, sore / sensitive to even light touch, redness, itchy, severe headache, discomfort when moving arm, fever around 100 degrees Fahrenheit. Shot was given just over a week ago, soreness the day after and then everything felt mostly fine. Yesterday, these symptoms began. Hoping to speak to a doctor in the day.
Body Aches and sore arm started 12 hours after vaccine was administered and still continues High Fever of 103 started 24  hours after vaccine was administered and still continues.  Sweating profusely and confusion and chills Difficulty urinating started 12 hours after vaccine was administered and still continues Loss of appetite and fatigue  SOB started 24 hours after and continues slightly
No adverse affects; two doses of MMR II were reconstitured and administered with expired MERCK STERILE diluent; two doses of MMR II were reconstitured and administered with expired MERCK STERILE diluent; This spontaneous report has been received from a pharmacist, concerning a patient of unknown age and gender.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 09-MAY-2019,  the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, anatomical location, lot and expiration date were not reported) for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine was reconstituted and administered with expired sterile diluent (MERCK STERILE DILUENT) (lot # M010690 and expiration date 02-SEP-2018) administered subcutaneously. No adverse effects reported.This one of two reports from the same reporter.; Sender's Comments:  US-009507513-1905USA006145:
Fevers; body aches; lower extremity cramps; fast heart rate overnight. Self resolved.
Pt called 4/21/10 stating 3 days ago noted a 2" golf ball like lump in left lower inj site.  Also has rash all over - "zit-like", and knots on head.  Has not been to PMD.  PHN advised Pt. to go to PMD asap.  Pt complied & went to PMD.  PMD stated it was normal reaction to shots.  Pt further explains - few of raised bumps have clear filled blisters.  Face, head, arms, trunk, None on legs.  Has Rx for BENADRYL.  C/o HA 4/17, 4/18.
7PM started crying, jerking of head & upper body, moaning & bad sniffling, crying & screaming & moaning stopped about 10PM about 1230PM sniffling & jerking stopped; next day still fussy & got sick to stomach;
about 1hr p/vax devel sz by upward rolling of eyeball, circumoral cyanosis & tonic, clonic movement of extremities for about 3-6seconds;