chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 58 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: BIJUVA, start date: 10Jul2022, stop date: 14Jul2022; SERTRALINE, start date: 10Jul2022, stop date: 14Jul2022; HYDROCHLOROTHIAZIDE, start date: 10Jul2022, stop date: 14Jul2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 19Jul2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jul2022) Positive. Therapeutic measures were not taken as a result of covid-19, drug ineffective. Clinical course: It was reported that the patient had symptoms including cough, congestion, fatigue.
case was admitted to Hospital  on 7/3 or 7/4 for non-COVID reason then discharged on 7/10. Then patient was rushed to another Hospital on 7/10 for fever, muscle aches and low oxygen. She is still in ICU as of 8/07/2021.
Symptoms: myalgia, nausea, muscle swelling, rash. Treatment: Benadryl
Large "ping pong ball sized" reaction at immunization site 12 days after shot given.  Minimal tenderness, no fever.  Cool compresses, ibuprofen x 48 hours.  Resolved slowly in 2-3 days.  Don't give second vaccine!
Woke up morning after the vaccine with a fever of 101.4, head pounding and all over body aches; primarily in my back.  Later that day I started having sharp stabbing pains in different locations in my legs.  This continued for 2 days.   I medicated with 3 motrin (200 mg pills) every 6 hours and piggybacked 2 tylenol (200 mg pills) at the 3 hour mark in between motrin  dosages; my fever never came down.  I remained achy, feverish, with headache and stabbing pains in my legs for entire 2 days.  In the middle of the night,  3rd day after the vaccine going into the 4th day, I woke 5 times drenched in sweat.  By the morning on the 4th day after the vaccine, my fever had finally broke and I felt better.   A slight dry cough started the 4th day and has persisted into the 5th day.   Additional note:  I was diagnosed CoVid Positive (with symptoms) in October 2020.
Pronounced face flush; Facial numbness; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Pronounced face flush) and HYPOAESTHESIA (Facial numbness) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced FLUSHING (Pronounced face flush) and HYPOAESTHESIA (Facial numbness). On 03-Mar-2021, FLUSHING (Pronounced face flush) and HYPOAESTHESIA (Facial numbness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Sudden onset of tachycardia 8 hours following dose #1 of Moderna vaccine
Information has been received from a medical assistant, for GARDASIL,  a Pregnancy Registry product, concerning her daughter, an approximately 16 year old female with penicillin allergy and history of unspecified sexually transmitted disease who in February 2009, was vaccinated with the first dose of GARDASIL, IM, 0.5ml and then was determined to be pregnant. Concomitant therapy included " a nasal spray for headaches" and Zithromax. There had been no AE related to pregnancy. The medical assistant was unable to provide her daughter's physician's name and demographic information. The medical assistant added that her daughter had also noticed mucus in her stool since she received GARDASIL. The patient had pregnancy and unspecified blood work performed. At the time of the report the patient was "11 weeks" gestation. The patient sought medical attention by office visit. Follow-up information has been received from a medical assistant concerning her daughter, a 16 year old female, who was vaccinated with the first dose of GARDASIL (lot # 661841/0653X) on 26-FEB-2009. No further information is available.
Patient reported that ~24 hours after vaccination she experienced body aches, chills, and fever of 103 degrees. She said this lasted for about 24 hours and then went away.
Site injection redness, ithcing, nodule w/ same sided axillary lymphadema
Patient had TIA affecting left side of body with symptoms persistent out to 2 hours after onset.
Patient with history of CKD and type II diabetes. She was brought to the ED by EMS on 2/4/23 for evaluation of a fall. She had an unwitnessed fall at her apartment earlier that night and fell to her knees. In the ED, she reported weakness and dizziness, and also reported a cough, shortness of breath, and nausea that had been going on for the past few days. She was found to have a fever of 101.1, and required supplemental oxygen for hypoxia with O2 sats in the high 80s. A COVID PCR test performed in the ED returned positive. Patient was admitted 2/4/23 - 2/9/23. Discharge diagnoses included sepsis and acute hypoxic respiratory failure due to COVID-19 pneumonia and possible community-acquired pneumonia. She required supplemental O2 during admission but was able to be weaned off completely by discharge. Of note, she has received the primary COVID vaccine series and one booster dose.
pt recv vax 22AUG95 & pt devel 10pox 2OCT98 by 3OCT98 >75 pox (blistered) pt started on Acyclovir;
pt recvd vax; red SQ swelling w/ thinned skin & pointing was noted; lesion was warm & tender to touch;
Pain at injection site and slight swelling, fever, large rash itchy rash near injection site.
The patient was vaccinated in 1996 with a first dose of varicella virus vaccine live. Subsequently, the patient experienced mild chickenpox. On an unspecified date the patient recovered. Two other patients had similar experiences following exposure to varicella virus vaccine live.
50 - 75 vesicles and pustules on face, neck, leg after Varicella.
On not sure of the exact date of the vaccine but the Hosp. I work for will have the exact date. That night I went to the ER with severe muscle and joint pain and abd pain. The day after the vaccine I started having twitching to my left side-arm and leg. Vaccine was administed in left deltoids. Sunday the twitching slowed down. Monday I went to my PCP dr with myoclonic jerks on the left side. He referred me to a neurologist and the myoclonic jerks have become worse and are now affecting my right side. Its difficult to walk stand or do anything and they are painful. All work up is normal so they are. Calling psychogenic because it does not fit any diagnostic criteria. I have had no recent trauma or stressor that could cause this.
HOARSE VOICE; STILL IN CHEST; COVID HEADACHE; HIT LUNGS/TRYING TO BREATHE THROUGH COBWEBS; MUCUS IN THROAT; LOSS OF TASTE; WEIRD AND FUZZY TONGUE; FUZZY THROAT; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 220 pounds, and height was 66 inches. The patient's past medical history included encephalitis, covid-19, covid-19, pin head rash, and covid in her eyes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A,expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced weird and fuzzy tongue. On JUL-2021, the subject experienced fuzzy throat. On 13-JUL-2021, the subject experienced loss of taste. On 15-JUL-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 16-JUL-2021, the subject experienced mucus in throat. On 17-JUL-2021, the subject experienced hit lungs/trying to breathe through cobwebs. On 18-JUL-2021, the subject experienced covid headache. On 26-JUL-2021, the subject experienced hoarse voice. On 26-JUL-2021, the subject experienced still in chest. Treatment medications (dates unspecified) included: ergocalciferol, nicotinic acid, and cresol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hit lungs/trying to breathe through cobwebs, and covid headache on 18-JUL-2021, was recovering from loss of taste, had not recovered from hoarse voice, and still in chest, and the outcome of weird and fuzzy tongue, mucus in throat and fuzzy throat was not reported. This report was non-serious. This report was associated with a product quality complaint 90000187320. The suspected product quality complaint has been confirmed to be voided (confirmed no pqc was identified within the complaint reported.) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
I didn't have any allergic reaction to the vaccine but on 9/29 I had a mammogram performed it was discovered that the both axillary lymph nodes were was swollen.  With the left side being swollen a little more swollen than the right.   I have another Mammogram scheduled within the next 6months and we are just monitoring it to date.  An ultrasound of both breast was performed but all looks good
hyperpyrexia (temp to 105.9)-shivering-no sz activity-hyperirritability;adm to r/o sepsis/meningitis;rx IV ATB until negative cult returned;
several weeks after 2nd vaccine - noticed that tinnitus had gotten much worse than 'usual'.  its now 5 months later and it has not gotten better - it is constantly loud buzzing all day and night
This is a spontaneous report from a contactable consumer. A male patient, of an unspecified age, received the 1st dose of BNT162B2 (Comirnaty, batch/lot# not reported), via an unspecified route of administration, on Aug 18, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Their mom and dad felt haziness in their brain on 2021. Outcome of the event: unknown.
nauseous; chills; 100 fever; achey all over- neck, shoulders, hips,knees; headache; tired; weakness; fatigue; This is a spontaneous report received from a contactable other HCP(patient). A 21-year-old female patient received second dose of BNT162B2 (BNT162B2, Solution for injection, Lot Number: EN5318) via an Intramuscular route of administration right arm on unspecified date at 09:30 AM (at the age of 21 year old) as single dose for covid-19 immunization.Other medications in two weeks included Birth control medication(contraception). No concomitant medications was reported. Patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Lot Number: EL8982) via an Intramuscular route of administration left arm on 23Jan2021 at 10:30 AM (at the age of 21 year old) as single dose for covid-19 immunization.No other vaccine in four weeks. The patient didn't take any treatment.No covid prior vaccination.No covid tested post vaccination. No Known allergies were reported.On 14Feb2021 at 03:00 AM, the patient experienced nauseous (nausea),chills (chills),100 fever (pyrexia), achey all over- neck, shoulders, hips,knees (pain), headache (headache),tired (fatigue),weakness (asthenia), fatigue (fatigue).The patient underwent lab tests and procedures which included body temperature: 100 on 14FEB2021.all the events were non serious. Outcome of the events was unknown.
Headache, chills, muscle ache, stomach ache, loss of appetite, sore glands in neck under chin, entire arm that received this second shot was unusually sore, achy and tender.
Rash on left arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02AL20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), Anxiety meds, Vitamin pack, ZINC and MELOXICAM for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced RASH (Rash on left arm). At the time of the report, RASH (Rash on left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Within 30 min of vaccine neuralgia in administered arm, Left, started occurring spreading to the fingertips including pins and needles, weakness and pain.  About one hour later spread to left leg.  Continues at this time 3/20/2015 at 11:00 AM.  Additionally, at about 11:30 pm 3/19/15 started with intermittent severe right ear pain that with each episode lasting less than 30 seconds.
According to the CDC, if someone 16 or 17 is given the Moderna vaccine, they can get the Moderna vaccine as the second dose. It just needs to be filed under off-label use since it's not authorized for that age group.
Nagging headache; Body aches; Backache; Feels extremely tired; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), HEADACHE (Nagging headache), PAIN (Body aches), BACK PAIN (Backache) and FATIGUE (Feels extremely tired) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included High Blood Pressure Medication, Antihyperlipidemic, LEVOTHYROXINE, ESCITALOPRAM OXALATE (LEXAPRO), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), COLECALCIFEROL, UBIDECARENONE (CO-Q10+VITAMIN D3) and VITAMIN B COMPLEX for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced FATIGUE (Tiredness). On 24-Feb-2021, the patient experienced HEADACHE (Nagging headache), PAIN (Body aches), BACK PAIN (Backache) and FATIGUE (Feels extremely tired). At the time of the report, FATIGUE (Tiredness), HEADACHE (Nagging headache), PAIN (Body aches), BACK PAIN (Backache) and FATIGUE (Feels extremely tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment details were provided.
Information has been received from a health professional concerning a 17 year old female with a possible allergy to food additives who on 08-JAN-2007 was vaccinated intramuscularly in the right deltoid with a first dose of Gardasil (Lot # 654389/0961F).  On 08-JAN-2007 the patient developed right arm swelling at the site down to the wrist, redness, and pain.  There were no laboratory or diagnostic tests performed.  On approximately, 12-JAN-2007 the patient recovered.  Additional information has been requested.
After vaccine reaction appears pale/cyanotic, unresponsive has history of atypical seizure disorder and on medication (anti-seizure) daily.
Swollen arm from top to hands. Swollen and red. Started with swelling and moved down and got redder and redder.
Patient (11 year old male) had anaphylaxis. Symptoms of flushing and "not feeling well" began about 10-15 minutes after receiving the vaccine. He then developed hives to his thighs and trunk just moments later. He self-administered his Epinephrine auto-injector in the car while mother drove to nearby Emergency Room (ER). They arrived to ER within 5 minutes of symptom onset/Epi administration, and he was noted to have generalized hives, facial puffiness (eyelids and lip angioedema, mild-moderate), and was developing a dry, hacky cough. He was given another dose of Epinephrine (0.3mg IM) in the ER, as well as H1-antihistamine, Prednisone and IV fluids, and was monitored closely for about 3 hours before being discharged home in improved/stable condition.
Soreness at injection site; Soreness at injection site The night of vaccine being given, noted fever, chills, malaise, and fatigue. Resolved next morning.; Soreness at injection site The night of vaccine being given, noted fever, chills, malaise, and fatigue. Resolved next morning.; Soreness at injection site The night of vaccine being given, noted fever, chills, malaise, and fatigue. Resolved next morning.; Soreness at injection site The night of vaccine being given, noted fever, chills, malaise, and fatigue. Resolved next morning.; This is a spontaneous report from a non-contactable Physician. A 25-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:9899), intramuscularly on 21Dec2020 12:00 PM at left arm, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced fever, chills, malaise, and fatigue from 21Dec2020 16:00. Resolved next morning on 22Dec2020. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.  No follow-up attempts are possible. No further information is expected.
Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 80 and suffering with untreatable lung cancer since 2019 for which he was being referred to hospice before his passing on 2/27/21. Patient was experiencing increased shortness of breath and mucous in the airways before his death.
On 6/4/2020 he had onset of TIA like sxs.  Arm numbness, slurred speech, drooping of the face, mental confusion.  He presented to local ER where his sxs had subsided spontaneously however he was transferred to Hospital for further workup.
I woke up the morning after receiving the second dose of the Covid-19 vaccine with a severe headache, nausea, vomiting, fever of 101.3, body aches, fatigue, and a sore throat. I took Tylenol twice that day and felt a small amount of relief. I woke up the following day, 2 days after the vaccine, still feeling nauseous, had a headache, temperature 100.4, fatigue, and body aches. I woke up in the middle of the night drenched in sweat. 3 days following the vaccine I am still having nausea with vomiting, body aches, and fatigue, my temperature day 3 is 100.1. I had to call into work because of my symptoms and the screening tool used to get into work flagged me.
shot @5:44 pm by 8:00 pm severe pain due to "dead arm" lasted from 6/30/2021 to 7/3/2021. On 7/1/2021 the following began: hot flashes, temp 100.1, severe headache (behind the eyes), severe body aches, severe bone achiness, "electric burning" body cell pain (generalized nerve pain) --as if every cell was being zapped with electricity, more frequent/longer lasting hot flashes with markedly increased profuse body sweating, fatigue, claustrophobia accompanying hot flashes.  By 07/17 all but the hot flashes and Shingles symptoms/pain resolved. New urgent care visit for hotflashes/shingles 07/17-18/2021
44 y/o Medical Records Manager at Clinic, ref by Occ Hlth to HC for eval of AEFI s/p flu shot on 16NOV05. Facial and hand swelling / wheezing, difficulty breathing 2 hrs after receipt of IIV3.
arm soreness; arm swollen; red rash down half his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), PERIPHERAL SWELLING (arm swollen) and RASH (red rash down half his arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), PERIPHERAL SWELLING (arm swollen) and RASH (red rash down half his arm). At the time of the report, PAIN IN EXTREMITY (arm soreness), PERIPHERAL SWELLING (arm swollen) and RASH (red rash down half his arm) outcome was unknown. Not Provided          concomitant medication include blood thinner, antihypertensive and anticholesterol . no treatment medication reported.   Reporter did not allow further contact
Generalize raised, red, itching rash on bilateral arms, bilateral hands, trunk, upper back.
Vaccine administered at approx.3:45pm 0n 11/08/05 At approx. 7:15pm My throat started to feel like someone was cutting it with a knife and I became hoarse. Maybe 15 minutes later I began to have labored breathing as if something was heavy on my chest. At this time I was in bed laying down trying to take a nap. I got up and went to the bathroom and in the mirror I could see my bottom lip was swollen about 4-5 times its normal size and my scalera in both eyes were beet red. I was due to work overtime on the 11-7 shift and went on. By the time I got there I was having chills and sharp needle pains in my legs, arms, neck, head and in my back. I was sent to the emergency room by the night supervisor. When I got there I had a fever of 102.0. I was given Benadryl and Tylenol and was discharged several hours later. I am having bouts of fatigue since then.
some numbness on her tongue, right side of her tongue and lips became numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (some numbness on her tongue, right side of her tongue and lips became numb) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOAESTHESIA ORAL (some numbness on her tongue, right side of her tongue and lips became numb). At the time of the report, HYPOAESTHESIA ORAL (some numbness on her tongue, right side of her tongue and lips became numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included acetaminophen.
Nausea and vomiting 14 hours after 2nd vaccine. Lasted 24 hours along with fatigue