chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; temperature excursion; This spontaneous report was received from a medical assistant referring to a 4 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 12-MAY-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (therapy type: rHA) (strength, dose and route were not provided; lot# was U002535 and expiration date was 24-JUL-2021) for prophylaxis, which was involved a temperature excursion (product storage error). No additional adverse event was reported.  The administered dose experienced an temperature excursion from -50 degree Celsius (C) to -15 degree C (16.8 degree C) for 1 hour 45 minutes 0 seconds. There was no previous temperature excursion. It was detected by a data logger.
Yeast infection 4-6 days after 1st and 2nd dose.; This is a spontaneous report from a contactable consumer or other non hcp. A 45-years-old patient of an unspecified gender received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8739), via an unspecified route of administration in Arm Left on 30Mar2021 08:00(age at vaccination: 45 years) as DOSE 1, SINGLE, second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0169) via an unspecified route of administration in Arm Left on 20Apr2021 08:00(age at vaccination: 45 years) as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination, patient didn't had covid prior to vaccination. The patient medical history and concomitant medications were not reported. Patient had no allergies. The patient experienced yeast infection 4-6 days after 1st and 2nd dose on 03Apr2021. Therapeutic measures were taken as a result of yeast infection 4-6 days after 1st and 2nd dose was Monistat. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown result on unspecified date. The outcome of the event fungal infection was recovering.  No follow-up attempts are Possible. No further information is expected.
IN FEW HOURS AFTER INJECTION HAD BLURRED VISION. NEXT MORNING COULD NOT LIFT LEGS, COULD NOT GET OUT OF BED FOR SEVEREAL MINUTES. WHEN SHE WAS ABLE TO SCOOT HERSELF OVER, LEGS WERE SPASTIC. SHE HAD GREAT DIFFICULTY WALKING. ACCORDING TO HER, SHE WAS TOTALLY INCOMPTETENT. THE ARM WAS VERY SORE. SYMPTOMS LASTES FOR 4 HOURS. SHE HAD FEVER&CHILS ABOUT ALL DAY. SHE SLEP ALL DAY. FEVER LASTED ON THE SECON DAY ALSO. SHE CAME TO THE PHARMACY TO RECORD THIS IN IN AUGUST 05/2022
Symptoms of Measles, Mumps and Chicken Pox intermittently for over two months. Subnormal temps, chills, nausea, rash, arthritis, blisters, welts, shingle symptoms. Blood sugar elevation. Increasing trouble with my hands.     Vaccination record received, no additional information. Received  OV note of 10/21/2006 from above provider for PE which was WNL except for pharynx red, and rash (neck).  Medrol dose pak given.  Notation made that pt. did not require MMR given past disease history and age.  Office visit 2/12/2007 with c/o swelling  and pain in hands/forearms x 6 months which pt. believes is r/t her vaccine.  Patient also states that her hands feel cold.  DX: Neuropathy to hands.  Refered to neurologist.
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 53-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Nov-2022, 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 03-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) 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 (113 Bivalent doses administered after the BUD to patients 12 and up).    60 doses was received to several patient from Lot AS7148B.  Concomitant medications were not reported.  No treatment information was provided
Urticaria- given steroid injection IM in the clinic then 5 days of oral prednisone 20 mg. Benadryl, Zyrtec and Xzyal taken orally. Still taking antihistamines daily
Swelling of lips, rash on neck, sensation of throat "closing off" Likely anaphylaxis. Treated with epinephrine, Solumedrol, Benadryl. 11/18/09:  ED reocrds and Discharge Summary received for dates of service 11/16/09 to 11/17/09.  Dx:  Angioedema, Anaphylaxis.   11/23/09 DC summary received for date 11/16/09. Same info as prev. records received. Assessment: (+)angioedema of lips, uvula. Pt was admitted and tx overnight. pt. stable at dc.  Assessment:  Presents with swelling of the lips, upper more than lower, also involvement of the uvula,  feeling of throat "closing off" and puritic rash on the neck.  No difficulty breathing or swallowing.  Oxygen saturation 100% on room air.  Given epinepherine and IV Solumedrol.  Admitted for a short stay in stable condition.    ICD 9 Codes:  995.0, 995.1.
s/p 15 minutes after vaccination, patient began experiencing blurry vision, seeing "halos", dizziness, bradycardia and diaphoresis. Symptoms worsened when sitting up or standing. BP 110/72 when symptoms first began. Pt placed in supine position with cold compress to back of neck. Given water to drink and stated he ate breakfast prior to his appt. Pt reports no h/o adverse reactions to other vaccines. No improvement in symptoms after 30 minutes, pt reported worsening "halos", so patient taken to ER via EMS.
hip is very sore; This is a spontaneous report from a contactable consumer (patient). A 64-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 11Mar2021 08:30 (at the age of 64-years-old) as DOSE 1, SINGLE for covid-19 immunisation at Hospital. Medical history included arthritis, diabetes, known allergies of penicillin, hip replacement 8 years ago. Concomitant medications included yes, as prescribed (other medications in two weeks). No other vaccine in four weeks. No covid prior vaccination, no covid tested post vaccination. On 12Mar2021 08:00, the patient experienced hip was very sore morning after covid vaccine. There were no other injuries to this hip. No treatment received for event. Outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
hypotension, transaminitis, thrombocytopenia, anemia ,pericaditis, hypoxia,  Acute respiratory distress syndrome,renal failure, hepatitis, acute high fever, weakness and fatigue ,myositis and arthralgis
I did not get my period for over 72 days. I?ve never been late. I took multiple pregnancy tests. I had abdominal cramping.
Depression, Myalgia, Arthralgia, NauseaVomiting, pain at injection site Narrative:
Continued dizziness, dry mouth, sore throat, nausea, headache, vertigo, with intermittent sweating and hot flashes over 48 hrs after vaccination. Improvement with Tylenol 1000mg.
Feverish, malaise, body aches, nausea, vomiting, weakness.  Symptoms resolved over next 24-48 hours per patient, and no further treatment was rendered.
Bronchoconstriction -minimally responsive to albuterol inhaler, nasal congestion, facial & eyelid edema, severe headache, brick-red sclera.
Swelling and redness and heat at injection site on left leg for DTaP. No fever. Lasted 6 days. Treated with IC Cephalexin 250mg/5ml susp by mouth twice daily.
no adverse event- issue was that vaccine had past 6 hours after being reconstituted.  vaccine was prepared 7 hours 20 minutes before giving
tested + for covid3-10-22  at hospital and was admitted from 3-10-22 until her passing 3-25-22.  had fever and shortness of breath.  Pneumonia.  initially thought it was community acquired but she was + for covid.  They used broad spectrum antibiotics, iv decadron, remdesivir, baricitinib and bipap.  bipap failed and she was mechanically ventilated and later required levophed, had bradycardia, .  She was changed to DNR and comfort care.
This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 24-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 552 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Arm swelled past the elbow and was hot and itchy. Patient had a temp of 102 degrees and was in bed all day. The reaction started within an hour of the vaccination.
Received Pfizer vaccines on 3/10, 3/31, 10/5/21 COVID positive home test on 4/20/22 admitted to hospital on 4/24/22 w/ chest pain, coughing, h/a. Treated w/ monoclonal antibodies, remdesivir and prednisone. Underlying  obesity, HTN, asthma.
Flublok given to 14 yo patient.  This is intended for 18 and older only.
I got bit by a dog on my right middle finger on October 24th 2018. Prior to this I was normal. I went to an occupational health center and received a TdaP vaccine that afternoon. The bite was superficial and healed without incident. Clinical signs started within a couple days of vaccination with numbness to my pinky and lateral surface of my vaccinated arm. Then a week later I developed severe neck pain and weakness in my right arm and down my legs.  I went to an ER and was told to just rest. My limbs would fall asleep and felt difficult to move and at times even though i was trying to move my arms, they wouldnt go.  I also developed weakness and couldnt lift things that I was able to in the past.   Around October 30th I developed shifting joint pain (large and small joints) that lasted about 6 months (although progressively improved).  I was placed on ibuprofen from a rheumatologist. Around November 30th I developed trouble breathing and was eventually diagnosed with vocal cord dysfunction. I saw two pulmonologists and was placed on inhaled steroids, spiriva, albuterol, amoxilcillin for 2 weeks and oral steroids for 2 months, none of which led to any improvement. I frequented the ER multiple times but treatments never helped.  I then went to an ENT around march 2020 and was diagnosed with VCD And placed on doxy for 6 weeks in case of a lyme component. It did not help. I developed an enlarged axillary and submandibular lymph node on the right. My right armpit was uncomfortable. About 1.5 years later the joint pain and neurological weakness subsided. The lymph nodes are shrinking as of 9/2021 and my breathing has improved although VCD signs are still present
About 12 days following vaccination, patient developed chest pain and shortness of breath. He went to the ED and was found to have multiple bilateral pulmonary emboli with signs of right heart strain. It is not clear if the vaccine was the cause of the embolism, but there are no other provoking factors that could be identified. He has been started on anticoagulants with improvement in symptoms, but he has persistent dyspnea with exertion.
Oversight of child's age, 16 at the time of injection. No standing order for this age group to recieve their pfizer booster shot. Child recieved booster with mom present and parental consent signed prior to vaccine appointment.
Patient received Janssen COVID19 vaccine at 10:15am. Upon receiving vaccine she sat down on chair to wait for 15 minutes post-vaccination. Just minutes after sitting down patient lost consciousness, fell from chair, hit her head on the floor, seize for a short moment, only to momentarily regain consciousness,  and faint for a second time.  EMS were called and patient was transported to Emergency Department for testing and observation. Patient believes she fainted the first time due to not having eaten much by that point in the day and due to anxiety about receiving the vaccine, and she was told she fainted a second time due to hypotension. She states she has a history of previously fainting during other medical procedures, though no similar previous reactions she can recall after vaccines.
sudden onset of chills & SOB @ approx 130PM;vomited x 1;MD notified;taken to ER, T101.1;IV fluids & ATB, 02 given @ noc as blood 02 level was low;11OCT97 pt dismissed w/ATB;Zithromax which was completed;21OCT97 pt recovered;
No reaction to the vaccine.  Got COVID 19 on July 19, 20222. Scratchy throat, congestion, fatigue, had a home test was positive. No fever. I took medicine on the 20th. My visit to the doctor was by phone only.
This spontaneous report was received from a physician refers to a 12 year old male patient. The patient received first and second dose of GARDASIL on 08-JUL-2013 and 18-SEP-2013. Due to an error in his practice's transcription, the patient also received a dose 3 of GARDASIL on 08-OCT-2013. The patient was not currently exhibiting any adverse effects. The physician will report any adverse effects. Additional information has been requested.
swelling and itching after receiving injection, next day no itching. swollen and red and hot bicep to elbow. Started Keflex 500mg bid x10d and medrol dose pak.
1/7- felt nauseated (history of celiac); 1/8- itchiness, especially above the knees, blotchy rash on arms and legs, legs felt weak and shaky; slight improvement by afternoon of 1/8
fever, chills, body aches.  Since my second vaccine, I have had difficulty taking a deep breath.  I have seen my IM doctor, a pulmonologist and a cardiologist.  I was tested for antibodies -IGG and they think I had covid.  My antibodies were high.   I am not 100% sure when I had Covid - I still don?t have sense of taste back. still have pain when taking a deep breath.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M037652 with expiration date 28-FEB-2018, for prophylaxis (route was not reported). The vaccine was exposed to a temperature between > -15 but < -10 Celsius degrees with a highest temperature of -12.97 Celsius degrees. The time frame was 4.5 hours. No previous temperature excursions were reported. A data logger was used to log temperatures. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
A week after first shot I developed covid arm started out as a medium size circular rash and now is a larger circular rash all around the injection site
Acute pericarditis. Treated with colchicine and ibuprofen. Promptly improved.
Three patient that received the second  booster to early; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Three patient that received the second  booster to early) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L21A, 069H21A, 006B21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Three patient that received the second  booster to early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Three patient that received the second  booster to early) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was reported.  It was unknown if other vaccines had been given to patient within 1 month prior to Moderna COVID-19 vaccine. It was unknown if patient had seek medical care (office visit, Urgent care, ER, hospitalized).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Follow up received contain Non-significant information. Reporters contact details updated.
Red swollen arm, itchy.  Fever and body aches. Pt received vaccine on 11/23/22 and presented with these symptoms on 11/26/22.  Pt took Tylenol for fever and body aches.  I advised pt to not get second vaccine and to take Benadryl for the apparent allergic reaction.  Also told pt to seek medical care if the reaction progresses or affects her respiratory symptom.
Initial information received on 19-Sep-2018 regarding an unsolicited valid non-serious case received from our licensed partner on 19-Sep-2018 and transmitted to Sanofi on 19-Sep-2018. This case involves a 66 years old female patient who experienced allergic reaction, raised white welts between throat and groin, pain, and itchiness, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported. On an unknown date, the patient developed a non-serious allergic reaction, raised white welts between throat and groin, pain, and itchiness following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. No lab data reported. Final diagnosis was allergic reaction, raised white welts between throat and groin, pain, and itchiness. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for allergic reaction, raised white welts between throat and groin, pain, and itchiness.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "sports asthma" (unspecified if ongoing); "mononucleosis", start date: 2020 (unspecified if ongoing); "known allergies: penicillin (potential)" (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 "recovering" and all described as "COVID 19". Therapeutic measures Paxlovid 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.
After getting the Booster shot (3rd in the Pfizer series) my left arm was a little sore in the area I was penetrated. A few days later, on that Friday, I woke up and took a shower. As I was showering, I noticed my left armpit was a bit swollen. I got out and checked in the mirror and confirmed that my left side was swollen. It wasn't very painful to the touch, but it would sting sometimes when I squeezed my armpit or went to put my weight on my left arm. I called Pharmacy and reported this and they told me to report it here and take some medicine (ibuprofen). The swelling has already gone done a ton, but I want to report this because I've never had any sort of issue like this before in my life so I know it was a direct side effect of the vaccine I got.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose (12 Hours post puncture)) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination. No medical history was provided by the reporter.  Concomitant products included FUROSEMIDE and URSODEOXYCHOLIC ACID (URSODIOL) for an unknown indication.On 21-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose (12 Hours post puncture)). On 21-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose (12 Hours post puncture)) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Concomitant medication information was not provided by the reporter.Treatment information was not provided by the reporter.Date the vial was initially stored in the refrigerator: 20 Nov 2021. Date(s) and time(S) vial was first punctured: 03:25 PM 20 Nov 2021.
Both arms and legs breaking out in hives-like spots. Might be psoriasis flare from monkeypox vaccine injections, but I have never flared up like this before. I noticed it in August 2022 after my first dose, and it worsened after my second dose which was almost two weeks ago.
He developed hives exactly a week later - the hives started appearing on his arms and then spread all over his body - he was very uncomfortable/ itchy all over body It?s still going on now and it?s been 4 days now