chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5 mins p/shots pt fell asleep & put in stroller; 20 mins later father noted pt to be limp & unresponsive w/shallow rapid breathing; 15-20 mins later in clinic pt alert no treatment;
pt recv vax 7OCT98 & 13OCT98 pt to ER w/several day hx of T103;CXR revealed rt upper lobe infiltrate;adm to hosp;cough, myalgia, MD felt had bacterial endocarditis;
woke up with chest hot; red spot on arm; delayed reaction arm pain; delayed reaction arm swollen; delayed reaction rash injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST DISCOMFORT (woke up with chest hot), VACCINATION SITE RASH (delayed reaction rash injection site), VACCINATION SITE ERYTHEMA (red spot on arm), VACCINATION SITE PAIN (delayed reaction arm pain) and VACCINATION SITE SWELLING (delayed reaction arm swollen) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE RASH (delayed reaction rash injection site). On an unknown date, the patient experienced CHEST DISCOMFORT (woke up with chest hot), VACCINATION SITE ERYTHEMA (red spot on arm), VACCINATION SITE PAIN (delayed reaction arm pain) and VACCINATION SITE SWELLING (delayed reaction arm swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site pain and Vaccination site swelling, at an unspecified dose and frequency and HYDROCORTISONE for Vaccination site pain and Vaccination site swelling, at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (woke up with chest hot), VACCINATION SITE RASH (delayed reaction rash injection site), VACCINATION SITE ERYTHEMA (red spot on arm), VACCINATION SITE PAIN (delayed reaction arm pain) and VACCINATION SITE SWELLING (delayed reaction arm swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
MOG Antibody disease.  Episode of ADEM with extensive myelitis. progressive weakness over a 1-2 week period
next morning noted 3 erythemetous papular lesions at area of injection. very pruritic
Pain at injection site (resolved within 48 hours).  Chills, lightheadedness, warm (not feverish), abdominal cramping, loose stool x 5 over 48 hours.  Extreme fatigue (over 5 days)
June 20, 2007, Patient received Pediarix in right anterior thigh #4 and Hepatitis A in left anterior thigh x 2. Patient moved quickly while being held by nurse and mother and Pediarix with needle came out with most of vaccine wasted. LPN revaccinated with Pediarix in right anterior thigh. Two days later increased swelling and redness at site on right leg to involve whole thigh on right. Mom brought patient to see FNP on 6-22-07 and diagnosis of cellulitis, treatment with Keflex. Patient returned again on 6-26-07 for resolving erythema, saw doctor.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age.   On 11-JUL-2017, the patient was vaccinated with ZOSTAVAX lot # M014310, expiration date 26-MAY-2017, for prophylaxis.No adverse effect.
Migraine headaches, stiff joints, sore muscles, fever, eyes ache.  Site swollen, hot and red. Current dimensions 5.5" x 4".  Employee reports that swelling/redness has gone down substantially.
Breakthrough case admission after 2 vaccines Moderna 6/8/21 Lot# 011M20A;  Moderna 7/7/21 Lot# 011M2
Stuffy nose; Sore throat; Headache; Elevated temperature; Injection site was sore; Neck was stiff; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received first dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN)via an unspecified route of administration on an unknown date(at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history included depression, generalized anxiety disorder(GAD), conversion disorder, 4 concussion, hypermobility and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included buspirone (MANUFACTURER UNKNOWN) , fluoxetine (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN) and omeprazole magnesium (OMEPRAL); all from unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 07:00, the patient experienced injection site was sore, neck was stiff and dizziness. On 15Apr2021, the patient experienced stuffy nose, sore throat, headache and elevated temperature. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events injection site was sore, neck was stiff dizziness, stuffy nose, sore throat, headache and elevated temperature were resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Pt felt with generalizet itching, started with SOB, and 1 dose of epipen 0.3 was administered.  The rescue took the patient to the hospital.  The patient had normal vital signs and was breathing properly when the rescue arrived.
fever, chills, lower leg pain, similar to shin splints, in both legs. Leg pain lasted about 8 hours. Others lasted about 36 hours
Nausea; Muscle aches; General unwell; Anxiety; Body feels heavy and hard to move; Body feels heavy and hard to move; Arm where injected is very uncomfortable; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 12Jan2021 at a single dose on left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Zk5730), via an unspecified route of administration on 22Dec2020 at a single dose on left arm for COVID-19 immunization (at 29 years old). The patient experienced nausea, Muscle aches, General unwell, Anxiety, Body feels heavy and hard to move around, Arm where injected is very uncomfortable on 13Jan2021 01:30 AM. The outcome of the events was recovering. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Client received Moderna #1 4/25/2021 #2 5/23/2021 by pharmacy  Client then received Janssen shot on 8/3/2021.  He completed a vaccine release form and checked NO if he had previously  received any covid-19 vaccine.  Client was called the following day when discovered by nurse entering previous nights  vaccine information in system.  Client denies verbally on phone receiving 2 doses of Moderna in the past. pharmacy called and pharmacist stated client did receive Moderna series.  Client states he is feeling fine-no adverse reactions.
First dose: shot site a little bit pink and sore; First dose: shot site a little bit pink and sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 91 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2021 14:35 (Lot number: EC1283) at the age of 91 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (ongoing), notes: she take a bunch of medicine.  She takes for her thyroid, and for her High Blood Pressure.; "flu shot" (unspecified if ongoing); "thyroid" (ongoing), notes: she take a bunch of medicine. She takes for her thyroid; "eyes" (ongoing), notes: She uses drops for her eyes. The patient's concomitant medications were not reported. Past drug history included: Tylenol for headaches, notes: She normally doesn't get headaches and doesn't take Tylenol often, so when she does take it, it is effective and she hardly takes it. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 14Jan2021, outcome "recovered" (17Jan2021) and all described as "First dose: shot site a little bit pink and sore".  Additional Information: Patient was 91 years old and a retired secretary. She is calling about the Covid-19 shot. She got 2 shots. She received her first dose on 14Jan2021, and 2nd dose on 02Feb2021. About 2 and a half weeks apart. After her first dose, the 1st site, the shot site was no more than after a flu shot. After her 2nd dose, the shot site was more red and more swollen. She also experienced a rash that was gone in 10 days. she also experienced little bits of aches and pain. She clarified that after the 1st dose the site was a little bit pink and sore: for 2-3 days, lasted couple days, and expected nothing.she normally takes Tylenol for headaches, but she didn't have a headache with the vaccines.Dose suggested was 500mg, she takes 2 at a time.She hasn't taken them all, there were 24. She needed to get her magnifying glass to read the label, she blames it on old age. She take a bunch of medicine. She takes for her thyroid, and for her High Blood Pressure. She uses drops for her eyes. Patient hadn't taken any prior Vaccinations (within 4 weeks) and hadn't  PMH (including any illness at time of vaccination) & no relevant test.  No follow-up attempts are possible. No further information is expected.
This morning, I have been turning my arm and shoulder, and its pain in the joint and stuff. I have the tingling in my leg and hand and a little muscle pain around my shoulder and it's tingling too.
The patient had a seizure that started minutes after injection. The seizure lasted approximately  3-4 minutes. In had my tech call 911 and stayed with the patient. After the seizures he started hyperventilating, sweating profusely, and his hands and feet were cramping so he could not move them. The paramedics arrived and  took him to the hospital.
07/29/2020 205pm client came to me saying she has rash. Rash, small bumps, about half dollar size noted on bil arm pits & elbow bend, and on neck. 1 Zurtec 10mg administered P.O. D.O.N. notified. Monitored client. 300pm clients rash is noted to be diminishing, another zurtec 1-mg PO given. Con't to  monitored client. 07/29/2020 300pm D.O.N. made aware of clients situation. 325pm client now C/O "throat swelling". D.O.N. made aware of situation. Client is in no respiratory distress, no wheezing etc. Sipping ice water without difficulty, swallows without problems. D.O.N. took over care of client. LVN.
Fever, body aches, headaches, ear aches, swollen arm, chills, lethargic, cough
Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is related to case- 2018SA236721 (second female child). This case involves a 2 months old male who received inappropriately diluted lyophilized Hib component (first primary dose 0.5ml) of vaccine PENTACEL lot C5439AA, expiry date 20 Oct 2018 via intramuscular route in the left thigh on 17-Aug-2018. The patients past medical history and family history were not provided. Concomitant medications included HEPATITIS B VACCINE and PREVNAR 13 vaccines (Lot number, expiry date, dose and route of administration not provided). It was an actual medication error due to inappropriate reconstitution technique. It was reported that PENTACEL vaccine one full dose was split among two children and one child received invalid HIB. There were no known reports of symptoms or need for treatment. 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 Good Pharmacovigilance 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.
Felt awful; Inappropriate Schedule of Vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of feels awful in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 27J4P, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and INFLUENZA VIRUS VACCINE INACTIVATED (AFLURIA) for prophylaxis.   On 2nd November 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix and AFLURIA at an unknown dose. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced feels awful and incomplete course of vaccination. On an unknown date, the outcome of the feels awful was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the feels awful to be related to Shingrix.  Additional details were received as follows: After 1st dose, the patient felt awful after receiving Shingrix and Afluria did not come back for second dose but now would like to receive their second dose. This led to incomplete course of vaccination. The patient received Shingrix in one arm and Afluria in the another. The reporter consented to follow up. No true expiration date available since system only puts in a year expiration date (system states 02NOV2019) as expiration. RPh couldn't further clarify "felt awful"
Within 5 minutes of administration of DTaP, HIB, Prevnar, developed facial flushing, papular/urticarial reaction on trunk, papules on face. No WOB. Gave Benadryl 6.25mg, vomited immediately; became irritable; vomited formula one time 4 hours after vaccines, continued to be irritable day after vaccine; low grade fever. Otherwise well.
approx 2PM began crying which progressed to screaming cry which lasted most of noc; took only a couple of formula during that time;
flu; Initial information received on 06-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves an unknown age and unknown gender patient who was diagnosed with flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer (dose, strength, frequency, formulation, batch number, expiry date: unknown) via unknown route in unknown administration site for Flu (influenza immunization)  On an unknown date the patient diagnosed with a non-serious flu (influenza) (unknown latency) following the administration of influenza vaccine.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was Unknown.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be exclude
redness, warmth, soreness at swelling site about 2-3 inches across.
Moderate pain at injection site. Severe sinus headache, pain in jaw, nausea and fatigue. Took Acetaminophen, drank lots of fluids and ate saltines and buttered toast, and took a nap.  Started to feel better about 4PM.
(noted 48 hrs post inj) Itchy Rash originating at injection site, moving down left arm, around thorax (upper back, upper chest, down right arm).  Treated with PREDNISONE 72hrs later rash was mostly gone itch remained another 24 hrs.
Continued headache, fever, and exhaustion past the expected side effect window. On 2/8/2021 I woke up with vaginal sores with no explanation. This continues to be an issue on day of filing out this report on 2/13/2021. Fevers have been mostly low grade 99.3 to a highest fever being 100.8 degrees Fahrenheit. I have been taking Tylenol and motrin to help with fevers and headaches.  On 2/10/2021 I was put on  valACYclovir 500 mg tablet to take twice daily in case the vaginal sores were herpes. I discontinued that later the next day per doctor since the results came back negative.
AstraZeneca 10/6/21 and 11/8/21. Vaccinated: 14:14. Reaction: 14:34. Episode of vomiting and dizziness. Vitals: 168/92, 110, 22. EMS called at 14:58. EMS arrived. Placed IV and administered IVF bolus x1. Taken to ER. No further info available.
pt recv vax; had sz; shaking & becoming stiff; infant cont to have frequent sz; dx sz disorder
This spontaneous report as received from a healthcare worker via Merck Vaccines.com and via company representative refers to a patient of unknown age (reported as: "pediatric") and unknown gender. Information regarding drug reactions or allergies and medical history was not reported. On an unknown date the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, anatomical location, lot#, expiration date were not reported). The second booster dose of GARDASIL (dose, route of administration, anatomical location, lot#, expiration date were not reported) was administered 13 months after the initial dose/first dose. Concomitant medications were not reported. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 67 year old female patient with allergy to vaccine. On an unknown date of October 2013, patient was vaccinated with FLUVIRINE (strength, dose number, route, lot number and expiry date unknown). On 14-OCT-2013, patient experienced similar injection site reactions after vaccination with FLUVIRINE as ZOSTAVAX. Patient had no other pertinent medical history or drug allergic reactions. On 06-MAR-2014 the patient was vaccinated with ZOSTAVAX (strength, dose number, route, lot number and expiry date unknown). Concomitant therapies included warfarin sodium (manufacturer unknown), atorvastatin (manufacturer unknown) and methocarbamol (manufacturer unknown). On an unknown date of March 2014, after vaccination with ZOSTAVAX the patient developed injectio site reaction. She has redness around the injection site that measures approximately 40mm by 50mm. Patient contacted pharmacist for medical attention. Patient took BENADRYL and the area did not get larger, once BENADRYL was taken. The outcome of injection site reaction and she has redness was unknown. No further information provided. Additional information has been requested.
The patient went to the ER on 10/22/2011 since he was swollen and itchy.  Later he went to the doctor on 10/26/11.
This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 23-DEC-2014 the patient was vaccinated with the third dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored (incorrect product storage). There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Feeling crappy; Tiredness; Fatigue; Headache; Fever of 102 degrees; A spontaneous report was received from a consumer concerning a 49-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tiredness, fatigue, headache, fever of 102 degrees and feeling bad.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 02M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the event(s) tiredness, fatigue, headache, fever of 102 degrees, feeling bad.  Treatment details included tylenol, motrin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), tiredness, fatigue, headache, fever of 102 degrees, feeling bad was unknown.
Headache, Fever, fatigue Narrative:  Employee reported fever 101.2 1/25/2021 and 101.4 1/26/2021. Severe headache 1/25/2021 and 1/26/2021. Mild headache 1/26/2021. Muscle pain 1/25/2021 through 1/27/2021. Moderate fatigue 1/25/2021 and 1/26/2021. 1/27/2021. Resulted in unable to work 1/26/2021. Did not seek medical attention for the symptoms.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2016, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.