chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This serious initial spontaneous case, was received from Other Non-Health Professional on 30-Oct-2017, concerning a male of unspecified age. On 01-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number, expiry date: not reported). On an unspecified date, within 2 weeks of vaccination, the patient developed vertigo and was hospitalized for 3 days. The patient underwent CT (computed tomography) scan, EKG (electrocardiogram) with all other tests were performed. The results were found to be okay and thought that it could be from the vaccine. The patient got sick with runny nose, sneezing, coughing after the vertigo and he was put on antibiotics amoxicillin. For the event vertigo he was put on meclizine. At the time of this report, the patient recovered from the events. The reporter assessed the event vertigo as serious due to hospitalization.
Cephalocaudally spreading maculopapular rash and fever (T max 104), self-resolving.
no adverse event; dose of PROQUAD that had been administered to patient over the age of 12 years old; This spontaneous report as received from a medical assistant refers to a 16 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 30-MAR-2021, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot# T021301 expiration date not reported, but upon internal validation established as 19-DEC-2021, for prophylaxis (strength, dose and route were not provided). No adverse event was reported.
Very swollen arm that began within 6 hours and pain and still swollen after 48 hours.  Fits of sneezing and roof of my mouth began to itch after 8 hours from vaccine and continue after 48 hours of vaccine.    Headache began within 8 hours of vaccine and  still after 48 hours.   Fever of 102 degrees began 8 hours hours after vaccine and fever still continues  after 48 hours . Chills 8 hours after vaccine and finally stopped after 40 hours.   Dizziness began 14 hours after after vaccine and still continue after 48 hours.  Fatigue began 18 hours after vaccine and still continuing after 48 hours from vaccine.
Vertigo, extreme fatigue, decreased energy and endurance, weakness in extremities and with walking, bodily shakiness.
2nd dose of Moderna administered after 1st dose of Pfizer vaccine to a 5 year old patient; 2nd dose of Moderna administered after 1st dose of Pfizer vaccine to a 5 year old patient; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 IMMUNISATION (2nd dose of Moderna administered after 1st dose of Pfizer vaccine to a 5 year old patient) and INTERCHANGE OF VACCINE PRODUCTS (2nd dose of Moderna administered after 1st dose of Pfizer vaccine to a 5 year old patient) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 IMMUNISATION (2nd dose of Moderna administered after 1st dose of Pfizer vaccine to a 5 year old patient) and INTERCHANGE OF VACCINE PRODUCTS (2nd dose of Moderna administered after 1st dose of Pfizer vaccine to a 5 year old patient). At the time of the report, COVID-19 IMMUNISATION (2nd dose of Moderna administered after 1st dose of Pfizer vaccine to a 5 year old patient) and INTERCHANGE OF VACCINE PRODUCTS (2nd dose of Moderna administered after 1st dose of Pfizer vaccine to a 5 year old patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. Patient had no known allergies for medications, food and other products.It was unknown that the patient ever  had or tested COVID-19 positive. It was unknown if patient experienced any symptoms or if patient was under any concomitant or regular medication. No treatment information were provided.   This case was linked to MOD-2022-616431 (Patient Link).
Pt began to get tunnel vision, dizziness, migraine, upper back pain, and extreme fatigue approximately 6 hours after the dose was injected. He denied treatment and decided to rest instead - which helped. He drank about 5 bottles of water, but his urine remained dark. The tunnel vision lasted for about an half-hour. The rest of the symptoms remain, and he now has a fever as well.
Myalgia & Rash Narrative: Mild rash right side of abd, with first dose. Severe rash with 2nd dose. same location. Urgent care visit 3//2021 and treated with oral and topical steroids.
Telephone call from clients mother, email from client reporting tenderness at injection site and a small bump there immediately after administration but swelling of her tongue and difficulty breathing 10 1/12 hours after administration. Took 2 BENADRYL, Went to ER.  11/23/09 Medical records received for DOS 11/12/2009. Final DX:  Allergic reaction. S/P vaccine tongue swelling, throat tightness. Resolved w/Benadryl tab, steroid tx.
Today there is a slight itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Today there is a slight itching) 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 20-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Today there is a slight itching). At the time of the report, PRURITUS (Today there is a slight itching) outcome was unknown.
Swelling and numbness at injection side. Increased blood pressure 199/99. Immediate headache. Workplace clinic called hospital ER, clinic administered Benadryl. Symptoms resolved.
When I was resting my pulse rate would shoot up really high. Then go back to normal fast. An episode could go for a few minutes up to 15 minutes periodically throughout the day.
fever; Is very tired; Sore Arm; Feels Dirty; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), FATIGUE (Is very tired), PAIN IN EXTREMITY (Sore Arm), FEELING ABNORMAL (Feels Dirty) and FATIGUE (Fatigue) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concomitant products included LITHIUM, CLOZAPINE, TRAZODONE, PALIPERIDONE (INVEGA [PALIPERIDONE]), PALIPERIDONE (INVEGA [PALIPERIDONE]) and PARACETAMOL (TYLENOL) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), FATIGUE (Is very tired), PAIN IN EXTREMITY (Sore Arm), FEELING ABNORMAL (Feels Dirty) and FATIGUE (Fatigue). At the time of the report, PYREXIA (fever), FATIGUE (Is very tired), PAIN IN EXTREMITY (Sore Arm), FEELING ABNORMAL (Feels Dirty) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided   Reporter did not allow further contact
Pt received a ZOSTAVAX vaccine on 2/1/12 SQ in his (L) arm. Next day noted pain, swelling and papular/vesicular rash within an approximately 7 cm diameter area of erythema. Pain scale 5/10. Temp on 2/3/12 99.2.
Fever, chills, sensitive skin, spasms, headache, congestion, body aches, fatigue, the sore arm that went into the breast area and all the way down to fingertips, and shortness of breath.
Started to feel a little dizzy, w/in 30 minutes was having a full on vertigo attack, took a phenegren and rested, feeling better now- you may want to put a warning for people with Meniere's disease, increases chance of vertigo attack.
pt recv vax 27OCT95 & 4hr later pt devel hives which have since resolved;a few days post vax pt c/o sore arm, 1wk p/inj devel cellulitis @ the inj site;sx are subsiding but inj site is still hot & inflamed
"Covid Arm".  Peri injection rash.  Significant in size. Shoulder to antecubital fossa.
Initial unsolicited report received from a consumer on 20-MAR-2017. This case involves a female patient (Onset age unknown) who was intramuscularly vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose were not reported) in an unknown site on an unknown date of OCT-2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as allergy to mushroom and Illness at the time of vaccination was reported as not provided. Any other vaccinations within four weeks of vaccinations were also not reported. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient's eyes became irritated and crusty and she was sick for a couple of days and also had fever, red and crusty eyes, and was sick for a few days on previous vaccination. The patient also had a previous vaccination with FLUZONE HD 2 years ago. The patient did not required emergency room (ER)/ doctor visit. Laboratory investigations were reported as none. Corrective treatment was not reported. The outcome of event was reported as recovered. List of documents held by sender: none.
About a week after the flu shot, I noticed a persistent dull pain in my left shoulder and upper arm, along with limited range of motion & pain when I tried to pull a shirt over my head. Ibuprofen provided some relief, but I eventually went to my doctor?s office in early October for evaluation. I was prescribed a course of prednisone, which helped, but after several days without it the achiness and pain returned.
Fainting and seizure at about 3:30 on August 18. Fainted from sitting on stool, fell to ground and hit head face-on. Seizure movements and unresponsive to coworkers for 4-5 minutes. Paramedics arrived afteri awoke slightly and took me to emergency room where I stayed from Wednesday afternoon until Friday afternoon for tests and observation.
Within hours of getting vaccine, she developed pain, swelling, redness in arm injected, and sore throat.  Better 24 hours later.
This spontaneous report as received from a registered nurse refers to an unspecified number patients of unknown age and gender. Since 02-SEP-2014, the patients were vaccinated with M-M-R II (HSA), subcutaneous, lot #K002036, expiration date 10-FEB-2016. Since 02-SEP-2014, the patients had been administered M-M-R II (HSA) which was improperly stored. This temperature excursion was not supported. No adverse effects were reported. It was unknown if the patient's sought medical attention. At the time of the report, the patient's status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: product=COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hives on back and arms. Benadryl taken.  Hives continue at this time 02/23/2015 at 11:23 PM.
Mother reports the following: Child had normal behavior throughout day until approximately 7 hours post vaccination, (7 PM) the child became lethargic and spiked a fever and started shivering.  Acetaminophen was administered at 8:15 PM.  Parents became worried and took child to the local ER for evaluation.  There he was observed and given Prednisilone 4ml (15mg/5ml) po.  In addition the child was encouraged to take fluids po.  He was later D/C from ER with diagnosis of probable allergic reaction to influenza vaccine.  Mother of child contacted via phone this date (03/13/09) and she reports that child exhibited no further symptoms and has returned to normal behavior.
Pfizer Covid 19 EUA The 61 YOF felt dizzy in Observation and was seeing spots. Upon further talking to her and her husband she has a history of anxiety. All vitals were within normal limits. She rufused treastment and transport. ED was contacted and an AMA was completed. Her husband was with her and assured us if she had any more issues he would take her to the ER. 2021-000202257
expired dose of Engerix-B / given on 09Apr2021 / expired on 05Feb2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number 97Y27, expiry date 5th February 2021) for prophylaxis.   On 9th April 2021, the patient received Engerix B (unknown). On 9th April 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received an expired dose of vaccine. The reporter could not provide follow up due to them not being able to be in the premises at any time in the future. The reporter did not consent to follow up.
side effects after a month later of having their second shot; rash on my right arm; Baseball size Red rash at injection site; hot to touch; It was hard at injection site; It was sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (side effects after a month later of having their second shot), VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE INDURATION (It was hard at injection site), VACCINATION SITE PAIN (It was sore at injection site) and VACCINATION SITE RASH (rash on my right arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bile acid malabsorption since 2018, Idiopathic hypersomnia since 2018, Hyperlipidemia, Cholesterol high since 2010, Drug allergy (Allergy to Prednisolone (anxiety)), Allergy to antibiotic (Allergy to Vancomycin(Redman syndrome)), Drug allergy (Allergy  to codeine (headache, confusion)) and Allergy to antibiotic (Allergy to levofloxacin (rash)). Concomitant products included COLESEVELAM HYDROCHLORIDE (WELCHOL) for Bile acid malabsorption, ATORVASTATIN for Hyperlipidemia, MODAFINIL for an unknown indication.   On 27-Apr-2021 at 2:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021 at 2:10 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE INDURATION (It was hard at injection site) and VACCINATION SITE PAIN (It was sore at injection site). On 28-Apr-2021, the patient experienced VACCINATION SITE RASH (rash on my right arm) and VACCINATION SITE ERYTHEMA (Baseball size Red rash at injection site). On an unknown date, the patient experienced ADVERSE REACTION (side effects after a month later of having their second shot). On 01-May-2021, VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE INDURATION (It was hard at injection site), VACCINATION SITE PAIN (It was sore at injection site), VACCINATION SITE RASH (rash on my right arm) and VACCINATION SITE ERYTHEMA (Baseball size Red rash at injection site) had resolved. At the time of the report, ADVERSE REACTION (side effects after a month later of having their second shot) had resolved.            No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received contains no new information On 27-Jul-2021: Follow up amendment : Start date, stop date and event outcome added which were provided in last FU.
Shot itself was very painful, 3 days later my arm in area of injection site continues to be red, painful, swollen, deep ache, cannot sleep on that side. I will NOT be getting the 2nd shot. I'm not brave enough.
Covid Arm - at day 7 after receiving my 1st dose of the Moderna vaccine my arm became itchy at the injection site. Inspecting it the next morning, it was red and blotchy/inflamed in a circle around the injection site. Also firm and warm to the touch. It lasted about 48 hours.
bruise at the injection site; bumpy skin; diarrhea; sick; itching; my arm was bright red from injection site to elbow; bumpy skin and itching and the next day my arm was bright red from injection site to elbow and achy; bad headache; chills; low grade fever; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE BRUISING (bruise at the injection site), VACCINATION SITE MASS (bumpy skin), DIARRHOEA (diarrhea), ILLNESS (sick) and VACCINATION SITE PRURITUS (itching) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chemotherapy in 2008 and Radiotherapy NOS in 2008. Previously administered products included for Product used for unknown indication: Flu vaccine (3 years ago but had no problem with flu shot this year.). Past adverse reactions to the above products included Tongue swelling non-specific with Flu vaccine. Concurrent medical conditions included Cancer (cervical, 2 breast cancers left side, and 4 skin cancers.), Penicillin allergy, Drug allergy (Ampecillin.) and Drug allergy.    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 VACCINATION SITE BRUISING (bruise at the injection site), VACCINATION SITE MASS (bumpy skin), DIARRHOEA (diarrhea), ILLNESS (sick), VACCINATION SITE PRURITUS (itching), VACCINATION SITE ERYTHEMA (my arm was bright red from injection site to elbow), VACCINATION SITE PAIN (bumpy skin and itching and the next day my arm was bright red from injection site to elbow and achy), HEADACHE (bad headache), CHILLS (chills) and PYREXIA (low grade fever). At the time of the report, VACCINATION SITE BRUISING (bruise at the injection site), VACCINATION SITE MASS (bumpy skin), DIARRHOEA (diarrhea), ILLNESS (sick), VACCINATION SITE PRURITUS (itching), VACCINATION SITE ERYTHEMA (my arm was bright red from injection site to elbow), VACCINATION SITE PAIN (bumpy skin and itching and the next day my arm was bright red from injection site to elbow and achy), HEADACHE (bad headache), CHILLS (chills) and PYREXIA (low grade fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication details was reported. Treatment information was not provided. Patient was scheduled for second Covid Vaccine (Moderna) on 3/28/21
Bruising at the injection site was obvious for a month.  Noticed shortness of breath, wheezing, lack of stamina soon after vaccination. It became increasingly worse and I saw my doctor on May 4th. He took a chest x-ray and detected lung issues. Prescribed Albuterol Sulfate inhaler. FYI...I know my body well and seek regular health services. I am absolutely sure that my current health condition is tied to the vaccine. The shortness of breath was very soon after the vaccination.
3-4 days after injection I developed Covid Arm. Inflammation, swelling and intense itching . Lasted 5-7 days.
pt had severe vomiting with red color and an order it.  He had massive pain in his leg. Patient had loss of appetite, nausea, and headaches.   His eyes were rolling in the back of his head, which this symptom would come and go.  He would have hallucinations.  On unspecified date Pt woke up screaming the house was on fire and there was a dog by the bed and a person in the closet, talking out of his head.  An ambulance came and brought him to ER.  Pt coded in the ambulance and brought back. Pt was coherent upon arriving to the ER.  He had to be intubated and bagged and died about 15 minutes later.  Pt had blood work which was totally out of whack.   Family was told they did not understand what had happened to him.  The only thing the family could think of that was different was he had recently been vaccinated.
Approx 7cm swelling at inj. site - improving fever of 100 degrees thru 10/23/ decreased energy - improving seizure-like tremor whole L. side - resolved numb fingers (all) - resolved/generalized arthralgia - resolved/major S.O.B - resolved/HA -improving.
numbness at injection site that travels from shoulder to right hand (pins and needles) and total numbness on index. pointer and thumb tips 24-7
PT EXPERIENCED CONVULSIONS, TEMPORARY LOSS OF CONSCIOUSNESS, WITNESSED BY BYSTANDER. PT THEN REGAINED CONSCIOUSNESS BUT PRESENTED W/ ALTERED MENTAL STATUS FOR APPROXIMATELY 5-10 MINUTES. PATIENT PRESENTED W/ FOLLOWING SYMPTOMS:   LOSS OF CONSCIOUSNESS CONVULSIONS BP: 118/74 O2: 98 PULSE: 85  PT DECLINED TRANSPORT, WAS TRANSPORTED TO HOSPITAL IN PRIVATELY OWNED VEHICLE.
Overnight patient developed red swollen area on left thigh about 15cm x 7cm. Also developed right thigh lesion of redness and induration about  2cm x 1cm
Patient began to feel some itching sensation around the upper lip and left temple area on face. This happened about 10 minutes after receiving the Havrix vaccination. Patient then took two diphenhydramine capsules and was observed for the next 40 minutes without any further escalation of symptoms. She then left the pharmacy.
red blotches below inject site; moderate swelling of lt arm; painful to move arm; started on ATB for possible cellulitis;
Hives on neck, forearms, torso, and perineum. Pt. declined antihistamines.
coughing a lot now it's worst; Initial information received on 10-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult patient of an unknown gender who was coughing a lot then it's worst after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any  concomitant disease or risk factor.    On an unknown date in Dec-2022, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer, with an unknown formulation and strength, ( lot number and expiry date: not reported)  via unknown route in unknown administration site for flu(influenza). Information regarding batch number has been requested.  On an unknown date in Dec-2022,  the patient was coughing a lot then it was worst (cough) (latency: unknown) following the administration of INFLUENZA VACCINE.. It is unknown if there were lab data/results available  Action taken:  not applicable.  Corrective treatment: not reported  Outcome: unknown