chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Relatively well to this shot other than some lethargy for 36 hours after receiving this inoculation.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 08Mar2021 08:35 (Lot number: EL9269) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Basal cell skin cancer removal", start date: 16Feb2021, stop date: 16Feb2021, notes: removed same day; "chickenpox", start date: 06Nov2016, stop date: 25Nov2016, notes: 2 weeks illness lasted; "Basal cell skin cancer removal", start date: 11Jun2016, stop date: 25Jun2016, notes: 2 weeks  illness lasted. There were no concomitant medications. The following information was reported: LETHARGY (non-serious) with onset Mar2021, outcome "unknown", described as "Relatively well to this shot other than some lethargy for 36 hours after receiving this inoculation."  Follow-up attempts are completed. No further information is expected.
Fevers x 60 hrs up to 102-103 degrees. Soreness until 8/18/13. Swollen to size of a baseball on 8/15/13.
Also received influenza vaccine in right deltoid at same time (no vaccine information supplied).  Five hours after COVID vaccine, developed palpitations and tachycardia. Went to ER and found to be in A-fib with RVR. No prior cardiac issues. Spontaneously converted back to sinus rhythm at 0830 11/30/21 in hospital. Complete cardiac work-up found to be normal, no ACS. Of note, markedly elevated Thyroid peroxidase antibody and slightly elevated TSH noted, prior thyroid testing normal. Normal CBC and CMP including electrolytes. No instigating factor identified by Cardiology.
Information has been received from a licensed practical nurses referring to a patient of unknown age and gender. No concurrent condition, medical history and concomitant medication were reported. On 05-JUL-2017, the patient was vaccinated with GARDASIL (lot # M014929 and expiration date 27-MAY-2017) (strength, dose, route and frequency were not reported) for prophylaxis (Expired product administered). No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006090.
started having dizziness and lightheadedness; Initial information received on 05-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 42 years old female patient who experienced started having dizziness and lightheadedness(Dizziness) while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Aug-2019, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6321AA of expiration date 07-Jun-2019, via unknown route in unknown administration site.  On 15-Aug-2019, the patient developed a non-serious dizziness and lightheadedness (Dizziness) within 24 hours following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Other relevant tests were not reported.  Final diagnosis was started having dizziness and lightheadedness.   It was not reported if the patient received a corrective treatment.  The patient event outcome is reported as Unknown.
Post vax, the pt developed a temperature of 102. Two days later became ataxic and hyperirritable. Hospitalized overnight. Back to normal within 48 hours.
pt recvd vax 1NOV92 & on 1DEC92 pt devel a rash over entire body, fever & an ear infect; FEB92 lab eval revealed a neg IgM for rubella & a pos IgM for rubeola;
Information has been received from a consumer concerning a 19 year old female patient who "approximately 3 years ago" (in approximately 2007) received all series GARDASIL (lot # and expire date not reported), intramuscularly. Concomitant medication included "on birth control". "Recently" (on an unspecified date), the patient had an abnormal pap smear. She was repapped. The outcome of both pap smears were for a high risk of HPV. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. No further information is available.
Reported not feeling well after receiving vaccine. Nausea, vomiting, diarrhea. Along with chest and epigastric pain, body aches, and chills
Woke up next morning after shot with very swollen arm that was hot and painful to the touch. I'm now nine days out and most of the swelling has gone down, but I still have a "lump" (and a little redness) at the site of the injection and that area of my arm is still painful.
Janssen  COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine  on 4/9/2021. Presented to ED on 12/1/21 c/o SOB and flu sx's x10 days. PMHx chronic Hep B, liver cirrhosis, IDDM and HTN admitted for acute respiratory failure with hypoxia 2/2 Covid PNA. Tx'd w/remdesivir, Vit C, steroids, and zinc. Developed acute renal failure and metabolic acidosis, anemia and thrombocytopenia. Started on Baricitinib but d/c'd due to abnormal liver function. Remained on BiPAP 2/2 DNAR status. Expired 12/17/21.
Received the Moderna COVID-19 booster and experienced diarrhea after taking her Xejanz a few hours later; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Received the Moderna COVID-19 booster and experienced diarrhea after taking her Xejanz a few hours later) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ) for an unknown indication.    The patient's medical history was not reported.  Concomitant products included BUPROPION HCL, ESCITALOPRAM OXALATE (LEXAPRO), FOLIC ACID, FERROUS SULFATE, PROPRANOLOL HYDROCHLORIDE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), SALBUTAMOL SULFATE (VENTOLIN HFA), HYDROXYCHLOROQUINE SULFATE, IBUPROFEN, TRAMADOL HCL and PREDNISONE for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TOFACITINIB CITRATE (XELJANZ) (Oral) 11 milligram once a day. On an unknown date, the patient experienced DIARRHOEA (Received the Moderna COVID-19 booster and experienced diarrhea after taking her Xejanz a few hours later). At the time of the report, DIARRHOEA (Received the Moderna COVID-19 booster and experienced diarrhea after taking her Xejanz a few hours later) had resolved.            The patient had 2 missed doses of Xeljanz when she was really sick and her MD was aware.   The patient was still taking her Xeljanz. It was reported she was still on Prednisone when she initially received Xeljanz. It was stated by her MD to complete therapy with Prednisone first before starting Xeljanz. Patient therefore had extra medication on hand due to starting later.  The patient had received Moderna COVID booster and experienced diarrhea after taking her Xejanz a few hours later. It was reported that the diarrhea only lasted that day.  No treatment information was provided by the reporter.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
it was sore first; his scalp and head were tender; his scalp and head were sore; he had a headache; it (injection site) started to itch; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Feb-2021 and was forwarded to Moderna on 01-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (it (injection site) started to itch), INJECTION SITE PAIN (it was sore first), TENDERNESS (his scalp and head were tender), PAIN (his scalp and head were sore) and HEADACHE (he had a headache) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. None) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced INJECTION SITE PRURITUS (it (injection site) started to itch). On an unknown date, the patient experienced INJECTION SITE PAIN (it was sore first), TENDERNESS (his scalp and head were tender), PAIN (his scalp and head were sore) and HEADACHE (he had a headache). At the time of the report, INJECTION SITE PRURITUS (it (injection site) started to itch), INJECTION SITE PAIN (it was sore first), TENDERNESS (his scalp and head were tender), PAIN (his scalp and head were sore) and HEADACHE (he had a headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment includes advil for headache.   Reporter did not allow further contact
Arm swelled up terribly; allergies and the reaction to pneumonia vaccine; This is spontaneous report from a non-contactable consumer reported for herself. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported years ago the patient had gotten pneumonia vaccine. Arm swelled up terribly. The patient was unsure of name of vaccine or who made it. Healthcare professional told patient not to get covid vaccine. The patient had allergies and the reaction to pneumonia vaccine and wanted to know what Pfizer suggest. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Patient reports she had pain and red lines/redness in injection arm after injection. Later on she experienced lip swelling and itching. The skin on her lips subsequently peeled off. Patient took BENADRYL at some point during the lip swelling. Vaccination was Thursday 7/19 and symptoms were reportedly resolved by Sunday 7/22.
I developed shingles approximately 5 days after I received flu shot and tetanus booster. Diagnosis of shingles given by Doctor.
Recurring and intermittent abdominal pains; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Recurring and intermittent abdominal pains) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021 at 7:49 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (Recurring and intermittent abdominal pains). At the time of the report, ABDOMINAL PAIN (Recurring and intermittent abdominal pains) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.
A pharmacist reported a pt received a vaccine 5/1 or 5/2/00, 15 minutes later the pt developed an injection site reaction characterized by induration, severe pruritus and redness.
Minor upset stomach; A spontaneous report was received from physician (reporting on self) and concerns a 41-year-old female patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced a minor upset stomach.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown day in Dec 2020, the patient experienced a minor upset stomach. There was no treatment information provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Information has been received from a licensed practical nurse (LPN) concerning a 6 months old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies or concurrent conditions were not reported. On 24-MAY-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ administered orally for prophylaxis (lot number M004508 with an expiration date of 29-JUN-2017) (dose was not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The temperature excursion reported was 1 degree Celsius (C) for 48 hours. A digital data logger was involved. There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1610USA013756.
Information has been received from a consumer concerning her 77 year old grandmother who about a month ago, was vaccinated with ZOSTAVAX (Oka/Merck).  Concomitant therapy included baby aspirin.  The consumer reported that her grandmother experienced a severe skin reaction about one week after receiving ZOSTAVAX (Oka/Merck).  Physician ruled out shingles.  The patient had a rash all over including her abdomen, arms and legs.  She was in extreme pain and was not able to work for a while.  She was treated with unspecified antibiotics and creams.  Lab diagnostics studies performed was reported as: negative for shingles.  Patient had recovered.  Unspecified medical attention was sought.  There was no product quality complaint.  No further information is available.
A patient was given a vaccine past the beyond use date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was given a vaccine past the beyond use date) 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)) (batch no. AS7173B) for COVID-19 prophylaxis.     It was unknown that patient receive other vaccines in the 4 weeks prior to COVID-19 vaccine.     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) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient was given a vaccine past the beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient was given a vaccine past the beyond use date) 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 EXPIRED PRODUCT ADMINISTERED (A patient was given a vaccine past the beyond use date).    No concomitant medication details was reported. No treatment medication details was reported.  It was reported that Moderna Bivalent for 12years was prepared into a syringe and stored in a refrigerator for 15 hours and 37 minutes prior to administration to the patient. The vial had not been involved in any prior temperature excursions, and the prepared syringe was stored in the refrigerator without excursion for that duration. One patient was impacted and received the syringe dose past the syringe beyond use date.
Patient developed hives, Headache, Tachycardia and flushing. The following day she was seen in the emergency room and received Zantac 300mg, Prednisone  60mg and Vistaril 50mg  IM. She was placed on a tapering dose of prednisone for home use.
Red line from mid upper arm extending to wrist. Swelling in elbow and posterior forearm. Saw PA, she said shot was given in wrong place.  Saw Dr and he said it was a reaction.  1 week later, I still have redness, pain and swelling.
pt recv vax;arm sore because vax burned while pt being vaccinated; pain was not too bad until 1 wk later; had chest cold w/ fever; arm hurt of laid on it wrong or w/ lateral movements; arm still sore but improved; inc pain w/ immobility;
Child received MCV vaccine @ approximately 03:20 PM.  Child remained seated for approximately 7 minutes following injection.  Got-up from chair & proceeded out of room down the hall.  Child fell against the wall about 3 feet from the room & onto the floor face down.  Father immediately rolled child over & asked what was wrong, "are you alright"?  Child was conscious & alert when rolled over by father.  Child stated she felt extremely dizzy & does not remember anything after that.  Child remained on the floor & conscious.  We elevated her legs & applied ice to her head (small abrasion on left upper forehead @ base of hairline, approximately 11/2-2cm in length).  We gave her a lollipop to suck on since she had not eaten since breakfast earlier that morning.  We moved her to an upright position in a chair after about 10 minutes of being on the floor.  Child walked out without difficulty 10 minutes after being in the chair.
Weakness; Vomiting; body aches; vomiting and had body aches, weakness and chills; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Weakness), VOMITING (Vomiting), PAIN (body aches) and CHILLS (vomiting and had body aches, weakness and chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010a21a) for COVID-19 immunization.     No Medical History information was reported.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced ASTHENIA (Weakness), VOMITING (Vomiting), PAIN (body aches) and CHILLS (vomiting and had body aches, weakness and chills). At the time of the report, ASTHENIA (Weakness), VOMITING (Vomiting), PAIN (body aches) and CHILLS (vomiting and had body aches, weakness and chills) had resolved.            Concomitant product use was A-lot provided by the reporter.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Case outcome
Pfizer-BioNTech COVID-19 Vaccine EUA: patient hospitalized with COVID-19 infection and pneumonia seven months after completing COVID-19 immunizations. Received remdesivir, steroids, antibiotics, and discharged to home.
DID NOT SLEEP; CHILLS LIKE IN FLU; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast cancer survivor, and concurrent conditions included heart disease, copd, back and nerve damage, and iodine dye allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025) dose was not reported, once a total administered vaccinated on right deltoid on 17-MAR-2021 09:20 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021 21:00, the subject experienced did not sleep. On 17-MAR-2021 21:00, the subject experienced chills like in flu. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills like in flu on 19-MAR-2021, and was recovering from did not sleep. This report was non-serious.
Patient felt lightheaded, dizzy, diaphoretic and c/o feeling faint at time of injection.  She has a history of anxiety and feels it may that. Repeat BP 149/85  HR 98  POC glucose 98.  Patient monitored for 50 minutes after episode began.  Patient stated she felt much better and felt comfortable and wanted to leave.  Patient escorted out by RN to car.  Patient walked out of building with assistance and reported she felt good with the cold air.  EMS offered patient to go to ED but patient declined
67-year-old male status post travel via plane.  Towards the end of the plane patient felt a little bit off.  Apparently had some dizziness and a headache with some dysphagia.  Patient had flown with his daughter to be with family.  Daughter was asymptomatic.  Original chart comments on lightheadedness and slight slurred speech.  Symptoms were rapid and he had not had much sleep he does have headaches and most recently had been on a course of steroids 3 tablets a day for the last 9 of 10 days.  Patient had been given that anti-inflammatory for his right ankle.  He states he does have a history of sinus congestion he does use nasal inhaler and trilogy.  Patient was transferred from 1 institution to another to evaluate for possible TIA . Patient is normally very active..  Previous hikes and biking.  Patient developed some right ankle swelling found to have microfractures patient has been evaluated for Charcot joint.  .  Patient is surprised that he actually is testing positive for COVID. History of COVID end of May.  By a home test patient had sinus congestion at that time relatively asymptomatic lasted 1 to 2 days.  Previous COVID in 2020 in November. Initial imaging was negative for stroke.  He was then transferred to hospital for further evaluation and management. He mentions that he had been diagnosed with COVID-19 about a month ago.   Patient was admitted for stroke work-up. Patient has declined the acute stroke clinic for now. Patient plans to create appointments with PCP and Neurologist.
Within 20 hours of receiving my second vaccine, I experienced fatigue, chills, and body aches. Slightly more than 24 hours later, my temperature rose to 100.3 and remained that high for the next ten hours. Approximately 60 hours after receiving the vaccine, I developed a sore throat, which turned into draining sinuses, and then a cough. The cough becomes pronounced at times and continues (as well as the sinus drainage) now one week after vaccination and 5 days after onset of first symptom. Interestingly, sinuses and expectorant from cough is CLEAR. There is no sign of infection, only symptoms.
SUDDEN HARD COUGH WITH URINE DISCARD SORE THROAT TIREDNESS
Shortness of breath, chest tightness. BP 179/111, pulse 103, 97% O2 sat.
Within 12 hours of vaccine I had sharp stomach pains. It got worse thru the night. The next day it felt slightly better but overnight to Saturday morning it came back horribly and radiated to lower right side to where I could not even sleep on my side. I went to the ER, they did a cat scan and immed told to have emergency surgery to get appedix out. While in surgery they ended up having to do a hemi colectomy due to how bad the appendicitis was.
Bone pain right femur, still occurring after more than one week.  It's lessening, but still acute when waking.
Pt walked to waiting area and was light headed and pale.  Pt fainted and immediately recovered.
Patient presented to the ER on 3/20/21 with complaints of cough and nasal congestion since Thursday 3/18/21. Patient received both doses of the COVID-19 vaccine on 12/22/20 and 1/12/21. Patient tested COVID-19 positive on 3/22/21. SARS COV2 tested using PCR Cepheid.
Diagnosed with iron deficiency anemia. Started taking ferrous sulfate 220mg liquid daily. Had normal upper endoscopy on August 3, 2021, normal colonoscopy on August 24, 2021 and scheduled for capsule endoscopy. Have had intermittent low O2 SATs between 87-92 with a baseline of 97. Occasional mild SOB and some mild orthostatic hypotension.
right arm sore within hour of 2nd dose, continued through 3rd day.  Bruise developed on left arm that evening of shot, continues through today.  Within 12 hours, developed fever (under 100.9), controlled with Tylenol, and some tiredness.  No fever by 3rd day.  Still bruised on left arm and sore on right arm (site of injection)