chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient woke up at 12:30am with fever 101.9 then had seizure, shaking all over with drooling. Lasted 1 minute. Parent gave TYLENOL and called 911. Medic came and cleared her. She was leaning to left side and had left side weakness for a hour after episode. Patient woke up normal the next day. Advised parents to make a f/u with her neurologist.
Adverse effects started 5/12 - present. Significant increase in right ear tinnitus/fullness/pain; new left ear tinnitus; significant increase in dizziness; intermittent vertigo/nausea; eye pressure/blurring. Treatment: Have not seen a doctor yet but I am going to consult one prior to deciding to receive 2nd shot.
Initial low grade temp (99F) treated with Tylenol within 3 hours of injections. Within 10 hours, high temp of 103. Extreme restlessness, rapid breathing, back arching (as if in pain). Inconsolable crying/screaming. Extreme thirst. Piggybacked Tylenol with Advil. Temp brought down to moderate. Reported to child's pediatrician's nurse.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Aug2021 as dose 3 (bootser), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anklosyng spondylitis" (unspecified if ongoing); "chronic Lyme" (unspecified if ongoing); "Alpha-1" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient received nebulizer, steroids, oral inhaler after ER visit. The patient had Paxlovid rebound two days after testing negative and the sickness was much worse than while taking Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Low grade fever 3 days (highest 101.7)  The episodic ataxia  episodes are now uncontrolled after the vaccine when they were under control before the vaccine was given.  Neurologist thinks that the vaccine has increased the events leading them to be uncontrolled.
shoulder was stiff; shoulder was sore; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (shoulder was stiff) and ARTHRALGIA (shoulder was sore) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (shoulder was stiff) and ARTHRALGIA (shoulder was sore). At the time of the report, MUSCULOSKELETAL STIFFNESS (shoulder was stiff) and ARTHRALGIA (shoulder was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.
I received the flu shot around 05:30pm. The vaccine was Influenza vaccine, Quadrivalent Preservative Free. Around 9:30pm I started feeling I had something stuck in my troat, and it was painful to swallow. Around 10pm, the entire mouth was feeling tingling and numb, I started not being able to swollow properly and I started coughing. Around 10:30pm, I developed a burning sensetion on tongue and lips. I was not able to properly swallow and talk. Lips and face were swollen. I entered the ER around 11pm, there I started feeling cold and having a slight burning sensation on my chest. I recevied an EPIPEN and other medications around 12am. After around 1h, I was feeling better. Left ER around 2.45am.
Sore arm, moderate pain like a bad bruise, light skin redness within half hour. Later in evening (9 hrs later), headache, chills, general muscle aching throughout body, restlessness
"Throat and hands itching", difficulty breathing and talking.  Patient had her own epi-pen, Benadryl, Allegra, and fluticasone. She initially took Benadryl and Allegra, then had epi-pen before using her fluticasone nasal spray. The difficulty breathing/talking and itching resolved within 20 minutes.
shortness of breath; arm was swollen, hot, and red; arm was swollen, hot, and red; arm was swollen, hot, and red; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), VACCINATION SITE WARMTH (arm was swollen, hot, and red), VACCINATION SITE SWELLING (arm was swollen, hot, and red) and VACCINATION SITE ERYTHEMA (arm was swollen, hot, and red) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced DYSPNOEA (shortness of breath), VACCINATION SITE WARMTH (arm was swollen, hot, and red), VACCINATION SITE SWELLING (arm was swollen, hot, and red) and VACCINATION SITE ERYTHEMA (arm was swollen, hot, and red). On 10-Jan-2021, VACCINATION SITE WARMTH (arm was swollen, hot, and red), VACCINATION SITE SWELLING (arm was swollen, hot, and red) and VACCINATION SITE ERYTHEMA (arm was swollen, hot, and red) had resolved. At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded.
in the 36 hours after the vaccine, I had a high fever (102), chills, fatigues and dizzy spells.  On July 26, 2022 I tested positive for COVID.
This spontaneous report as received from a nurse refers to a female patient of unknown age. On 09-AUG-2013 the patient was vaccinated with GARDASIL (dose 1) (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On 25-NOV-2013 the patient was vaccinated with GARDASIL (lot number and expiry date unknown) (dosing regimen and frequency unknown) dose 2. No adverse events were reported. Action taken with the therapy with GARDASIL was unknown. The relatedness of the events to the therapy with GARDASIL was unknown. No product quality issue was reported. Additional information has been requested.
Vaccination site was red; Vaccination site was raised; Vaccination site was bruised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Vaccination site was red), VACCINATION SITE SWELLING (Vaccination site was raised) and VACCINATION SITE BRUISING (Vaccination site was bruised) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site was red), VACCINATION SITE SWELLING (Vaccination site was raised) and VACCINATION SITE BRUISING (Vaccination site was bruised). At the time of the report, VACCINATION SITE ERYTHEMA (Vaccination site was red), VACCINATION SITE SWELLING (Vaccination site was raised) and VACCINATION SITE BRUISING (Vaccination site was bruised) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No treatment information was provided. No relevant concomitant medications reported.
Severe fever and chills began 4 hours after vaccine administration and lasted for 24 hours. Nausea, vomiting, and abdominal distress began 12 hours after administration. Vomiting ceased after 8 hours while nausea and abdominal distress are still present 48 hours after administration. Severe headache has been present since the fever and chills began and is resistant to any medication. Sleep is greatly disturbed and headache is still as bad as it was initially.
ENDED WITH THE DISEASE THAT CAUSED ON BRAKES IN THE SYNDROME; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. 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, batch number and expiry were not reported) dose was not reported, 1 total administered on an unspecified date 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, a month after receiving the vaccine, patient ended up with the disease which caused on brakes in the syndrome, and was hospitalized on an unspecified date for unspecified days. The patient visited to the emergency room. On an unspecified date, the patient got discharged from the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of ended with the disease that caused on brakes in the syndrome was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220336274-COVID-19 VACCINE AD26.COV2.S-Ended with the disease causes on brakes in the syndrome. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
I started having symptoms on 10/11/21 with shingles on the left side of my face and the treatment was Zovarax 1mg tablets that the physician prescribed and I also had a 2nd episode of the shingles in November.  I immediately started my medication again.  It lasted a few days with each eruption.
Date and time of vaccination: 24 March, 2021 @ 10:30 Date and time of adverse event: Not sure exact date of sxs, but shortly after she was given her vaccine. Patient states she has been experiencing shortness of breath since she had her Vaccine 3 weeks ago, difficulty taking a deep breath. At first she thought it was caused by her ALS, but now she is not so sure after being aware of about Johnson and Johnson statement about the vaccine. She put a call into her PMD and Neurologist about 1 hr ago and is waiting to hear back from them. Symptoms are: Dyspnea, Headache
Information has been received concerning a pt who was vaccinated on 06/10/96 with varicella vaccine. There was no concomitant medication. On 06/22/00, the pt developed chickenpox that consisted of 10-20 lesions. The pt sought unspecified medical attention.
hair falling out; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair falling out) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (hair falling out). At the time of the report, ALOPECIA (hair falling out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.
Painful red welt. About 2.5 x 1.5". Pt monitored and it resolved.
Information has been received from a consumer who reported that his 5 years old niece's daughter with a history of unspecified surgeries was vaccinated with VARIVAX (Merck) (lot # not reported) on an unspecified date.  Concomitant therapy included antibiotics (unspecified).  It was reported that the patient was 4 years old when she received VARIVAX (Merck) and developed weird outbreaks whenever she got colds.  The outbreaks started on approximately 04-JAN-2009 "about a year ago".  The outbreaks were always on one side of her body and they were blister rashes.  One physician who checked the patient said that it was shingles.  The patient had another outbreak recently but she was over it at the time of this report.  The reporter indicated that the patient had received H1N1 in the last few months.  On an unknown date, the patient recovered.  Follow-up information from her physician revealed that the patient did not currently have a rash but was checking in the event the patient developed another episode.  Additional information has been requested.
So far no adverse reaction. Vaccine given past 6 hours after being diluted. Family aware but unsure if repeat is needed.
beginning mid March fatigue, progressively worse, admitted to hospital May, blood counts substantially below bottom line of standards, (RBC, WBC, Hemoglobin, Hemocrit, Platelets)....bone marrow biopsy diagnoses AML
Pt hospitalized for grade 3 immune-related colitis. Pt received cycle 3 of durvalumab/tremelimumab on 10/7/21. Pt had mild diarrhea from 10/12 - 10/14 - ~2 episodes per day. On 10/15 pt received Moderna COVID booster vaccine and had fevers, chills, and frequent diarrhea with 5-6 episodes per day associated w/ cramping through 10/17. Pt admitted to hospital on 10/20. CT abdomen pelvis on 10/20 showed diffuse mild pancolitis; cdiff and stool cultures were negative. GI was consulted, colonoscopy was deferred in light of risk of perforation in setting of pancolitis. Pt currently receiving prednisone 1 mg/kg daily, IV ceftriaxone 1000mg, and Flagyl 500mg. Symptoms of diarrhea and cramping improved with initiation of high-dose steroids
COVID 19 Pfizer dose given beyond use date.  Patient developed itchy bumps over her arms, legs, shoulders and hands one week after receiving the vaccine dose.  She has not received any treatment and is scheduled for a medical appointment on 7/15/2022.
Patient received covid-19 vaccine at 1000 and 15 minutes after patient informed immunizer (pharmacist) she was having a little hard time swallowing and felt slightly light headed. Pharmacist offered her some water and propped her leg up in a chair. After a few minutes patient stated it hadn't gotten worse but she still felt like she couldn't swallow very well. Medical response team was called and patient was transferred to the Emergency Room for further observation and possible treatment.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided. It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine. No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow up received wherein I Narrative was updated.
fever of 103 chills- over the course of 12 hours sweating- over the course of 12 hours muscle aches and pains  severe migraine
Immediate projectile vomiting, diarrhea, excessive sleeping, slight fever, tenderness in both legs and feet, staring for long periods of time. Shots were given Friday, 05/25/01, baby passed away Monday in her sleep, general lethargy 05/28/01. Autopsy gives cause of death as sudden infant death syndrome.
Shortly after receiving my second covid vaccine, I experienced a high pitched buzzing / ringing in both ears. It has now been 3 days since and it has not subsided. It is adversely effecting my quality of life. I have an appointment with my primary care physician next week (week ending 9/24/22).
Patient called today (10/04/2017) complaining of a severe sore arm with pain referring to her shoulder on the back and of Flu like symptoms which she described as being Fluishy.
Breakthrough case admission after 3 vaccines Moderna 1/21/21 Lot# 012L20A;  Moderna 2/18/21 Lot# 004M20A;  Moderna 11/23/21 Lot# 077C21B
ADVERSE EFFECTS AND WERE SUFFERING; This spontaneous report received from a consumer via social media via a company representative concerned multiple patients.  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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients experienced adverse effects and were suffering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse effects and were suffering was not reported. This report was non-serious.
Patient complained of burning deep where injection was given. No treatment given. Patient contacted our office several days later to report and it had improved.
BODY ACHES; CHILLS; FEVER; HEADACHE; FATIGUE; SORENESS AT INJECTION SITE; NO SENSE OF SMELL; This spontaneous report received from a patient concerned a male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included osteoarthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced no sense of smell. On 02-JUN-2021, the subject experienced body aches. On 02-JUN-2021, the subject experienced chills. On 02-JUN-2021, the subject experienced fever. On 02-JUN-2021, the subject experienced headache. On 02-JUN-2021, the subject experienced fatigue. On 02-JUN-2021, the subject experienced soreness at injection site. Laboratory data included: Body temperature (NR: not provided) 99, 100.9. Treatment medications included: naproxen sodium. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness at injection site, fever, body aches, headache, and chills, and the outcome of fatigue and no sense of smell was not reported. This report was non-serious. This case, from the same reporter is linked to 20210604773.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case is assessed as non serious.
Fever (temperature up to 102), nasal discharge, cough.  Seen in office for bilateral acute otitis media and bronchitis.  Treated with a course of Augmentin-ES antibiotic.
Headache; Body aches; Stomach cramps; Dirrhea; Stomach still feels little irritated; A spontaneous report was received from a consumer concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, body aches, stomach cramps, dirrhea, stomach still feels little irritated.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: D31M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient experienced the event(s) headache, body aches, stomach cramps, dirrhea, stomach still feels little irritated.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), headache, body aches, stomach cramps, dirrhea, stomach still feels little irritated was unknown.
In May 2022, I got COVID-19, I was given the monoclonial infusion and I recovered from the virus and was doing good. In December 2022, I don't recall calling my neighbors at 4:00am in the morning asking them to take me to the emergency room. I was recovering from COVID-19, my doctor had given my Paxlovid. I had been given Jardiance, that we have discovered I am allergic to. I cannot remember the test they ran on me as I was in and out of it for days. I felt like I was going to die, I did not flat line but was close to it, my son pushed for me to be put on a dialysis machine.  I was released from the hospital after seven days.
Pt reported after 4th day of vaccination he was extremely achy all over with joint pain much worse after the 2nd Hepatitis B. He stated "it would get bad in his shoulders then go to his knees" pt went to North Central Medical Center on 02/03/2005 (ER) The tx was Morphine and steroid injection, then to flu with steroid dose pack. Methyl Prednisone. Per pt.
Patient had a fever, rash, and was extremely irritable after all of his immunizations. Later developed autism.  11/16/07  Reviewed medical records which reveal patient experienced PT beginning at 2 mo of age & early intervention services beginning at 3 mo of age.  D/C from PT 8/2006.  Parent expressed concern about behavior beginning 8/2006 or 15 mos of age, speech delay, not following commands & not responding to his name.  Referred for ST & OT.  Diagnosed w/PDD-NOS 11/2006.  Returned to neurosurgeon when CT scan revealed fused metopic cranial sutures but was d/c w/o additional treatment.  Placed on gluten & dairy free diet.  Developed hypotonia & light sensitivity.  1/4/08 Reviewed vax record which provided vax brand info but no lot#s.  VAERS database updated w/same.
severe muscle achy in lower body, especially legs, trunk, & back;most painful @ noc;could not sleep lasted about a week;
Patient's Rheumatoid Arthritis flared after 2nd dose.  Increased joint pain and joint swelling in the right elbow and bilateral hand MCPs and PIP joints