chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The evening of vaccine, Saturday, I became achy and had a slight headache., went to bed early.  The next day, Sunday, I awoke with a splitting headache, achy all over, had a temp. of 100.6F.  I stayed in bed all day and drank plenty of fluids,  napped  throughout the day, fell asleep early and slept most of the night.  Day three, Monday, I awoke feeling OK, when I walked my dog for about 15 minutes, I got very dizzy and returned to bed for the day.  No other symptoms arose but, the dizziness remained for the entire day.
Patient is fully vaccinated. COVID + on 11/29/2021.  Hospitalized from 11/23-12/03, 2021.  Patient admitted with cellulitis and osteomyelitis of his right foot, and had a GI bleed.  Cardio and GI as well as ID and podiatry consulted.  Recent GI Bleed, s/p Left gastric artery embolization.  Given massive GI bleed, all anticoagulation and antiplatelets were discontinued.  Found to have COVID. Treatment RA,Clinically stable and no need for oxygen, decadron or Remdesivir.  Will monitor respiratory status closely.  Deemed stable by ID for discharge on augmentin and Zyvox until 12/13 when he can get cardiac clearance for surgery.  Discharged to home.
2days after my teeth! My teeth are in so much pain only on the left side and now I have swollen glands in my neck left side! My face is getting puffy on the left side as well! I just want to know am I the only one!? I am now laying on a heating pad around that area! And taking tylenol because ibuprofen makes it worse! I would do this over again but want to know if it is normal and how long will it take for it to come out of my teeth!? Thank you!
taken shingles vaccine, got the shingles; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-APR-2022 Reporter's Comments:  This case was received from consumer via interactive digital media. The patient got Shingle vaccine and still had shingles. Additional Supportive Information: This case described the occurrence of suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not provided. The follow-up would not possible as no contact details were available.
NO ADVERSE EVENT OCCURRED DUE TO ADMINISTRATION; WRONG MEDICATION/WRONG ROUTE.
Swelling; lymph node armpit swelled and were sore; lymph node armpit swelled and were sore; This is a spontaneous report from a contactable consumer (patient). This is second of two reports. A 71-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6207, Expiry date were not reported) via unspecified route of administration, administered in left arm (upper) on 09Mar2021 14:45 (ag at vaccination 71-year-old) as dose 2, single for COVID-19 immunization (Pharmacy or Drug store). The patient had no medical history. The concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200, Expiry date was not reported) via an unspecified route of administration in left arm (upper) on 16Feb2021 14:45 for COVID-19 immunization. On 09Mar2021, the patient had lymph node armpit swelled and were sore and swelling on 10Mar2021. It was reported that no treatment was taken for the event swelling. On 17Dec2020, the patient underwent sars-cov-2 test which was positive, the symptoms were included loss of smell, fatigue, otherwise no symptoms. The patient had not administered vaccine at military facility. The outcome of the event swelling was recovered on 11Mar2021, and other events was unknown.  No follow-up attempts are possible. No further information is expected.
Severe Hives all over body  -Started on right inner arm and back/side of abdomen the day after the vaccine dose 1. Spread continued and became more severe over the next 2 weeks - hives on 14 covered entire back, abdomen, neck, inner arms and chest. Large rashy spots as well as small red bump spots.   Prednisone 20mg was prescribed for 10 days.
5 hours after injection Patient started convulsing and lost consciousness. She came to but was very disoriented. Her face was pure pale and her lips were blue.  She then vomited 3 times and was taken by ambulance to the hospital. Her blood pressure dropped too low. She was severely dehydrated and needed fluids. Her body was hot but shaking uncontrollably because she was cold.
No adverse event; the vaccine leak during administration; Vaccine underdose; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (the vaccine leak during administration), UNDERDOSE (Vaccine underdose) and NO ADVERSE EVENT (No adverse event) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient did not provide their medical history, conditions, allergy, concomitant diseases and risk factor.  The patient's past medical history included COVID-19 in January 2023.    On 17-May-2023, 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 17-May-2023, the patient experienced DEVICE CONNECTION ISSUE (the vaccine leak during administration) and UNDERDOSE (Vaccine underdose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE CONNECTION ISSUE (the vaccine leak during administration), UNDERDOSE (Vaccine underdose) 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 assessments were provided for DEVICE CONNECTION ISSUE (the vaccine leak during administration) and UNDERDOSE (Vaccine underdose).    No concomitant medication details was reported. No treatment medication details was reported.
Morning after receiving booster was extremely weak, nauseous and dizzy. Fainted and hit head on tile floor causing gash on forehead. Paramedics arrived, recommended I go to hospital for CT scan and stitches. CT was normal, continued using butterfly bandaids for gash as too much time had passed from time of injury until I was seen in the ER.
Vasovagal episode within 10 minutes of shots. Pallor, no SOB, no hives, pulse ox maintained at 98-100 in room air. Raised, red around IPV site, 8 hours later. No rash at D/C from office. 90 minutes was.
New onset on Lichen Sclerosus et Atrophicus to gentalia, also to multiple sites on face.  No family History of any autoimmune disease.
Sore joints, becoming much more sore over the first 5 days after vaccination.  Very sore joints lasted about 2 weeks. Then, extremely tired, and required four days to recover from a partial day of canning (extreme tired for me).  Still ill with exhaustion, I developed a fever of about +1.5 degrees F, for about 12 hours.  Quite lightheaded, with pain around my left lung.  Often this signals a systemic fungal flare (for me). Strong chest wall pains went on for about 5 days, and were then joined by what I believe are Epstein-Barr flare symptoms, and CMV flare symptoms.  As of today, 10/15/21 I still have the EBV and CMV flare symptoms.  Current symptoms include chills, lightheadedness, brain fog, feeling flushed, stiffness, sore joints, some minor pain around left lung, nerve pain in groin, exhaustion, unsteady on feet.   (FYI: I have been tested numerous times with the left chest wall muscle pain, and know to rest with it until it subsides.)
Presented w/ recent fall now w/ lft ankle pain. Covid + approx 1-2 weeks ago/recovered. Tested covid + on arrival.
Information has been received for the Pregnancy Registry for Gardasil from a certified medical assistant concerning a 17 year old female with no birth defects in previous pregnancies and no infant complications in previous pregnancy, no pertinent medical history and no drug reactions/allergies who on 30-JUL-2007 was vaccinated with Gardasil (lot # unknown) at another clinic.  Concomitant therapy included tuberculin test and meningococcal vaccine (unspecified).  The patient's date of last menstrual period was 07-APR-2007 and the patient is pregnant.  On 14-AUG-2007 the patient was given prenatal vitamins (type unspecified) and iron pills for the pregnancy.  On an unspecified date lab tests were performed for an OB panel and a urine collection was performed because the patient was complaining (type of complaint unknown) but blood was found in the urine.  On 22-AUG-2007 the patient was treated with ZITHROMAX 1 gram dose for the chlamydial infection.  The estimated date of delivery is 10-APR-2008.  No further information is available.  Additional information has been requested. 07/08/08 Follow-up information was received from the physician's office. The patient had one full-term delivery. On 30-OCT-2007 the patient had a routine maternal serum alpha-fetoprotein test and was negative. On 27-MAR-2008 the patient delivered a healthy female baby weighing 6 pounds and 11 ounces, 17.21/2 in length and 37 weeks from LMP. Additional information is not expected.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 08-DEC-2011 at 8:00, ZOSTAVAX (Lot # 671140/1266AA) was exposed to - 13 degrees C for an estimated total time out of range of 10.5 hours. On 27-DEC-2011, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671140/1266AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Upper left leg swelling into knee area. As reported by mother child was unable to walk or bend knee.  Mother stated that she gave him Tylenol, and applied home remedy cream.
Per patient 1 day after he received his COVID vaccine he had a mild chest pain that happened in a split second approximately 15-20 minutes apart for the last half of the day into the evening.  Per patient it took 6 hours for the symptom to subside.   Patient's PCP, has been alerted.
6x6cm red, hot, varied induration, swollen, bandaid visible imprint left deltoid.
Local site reaction with induration, erythema, swelling, pain, itching started the following day.  Treated with Benadryl, ibuprofen, ice, elevation.
Blurred Vision in right eye,  Headaches.  I have an appointment with Dr on Monday 5/24
PATIENT PASSED OUT EVEN AFTER SITTING IN THE EXAM ROOM FOR 10 MINS AFTER IMMUNIZATION HAD TO BE TAKEN TO THE ER BY AMBULANCE , STILL AFTER A HALF HOUR COMPLAINING OF DIZZINESS AND HEAD/NECK PAIN.
she came to me and sait her arm keeps on iching bad i looked and she had hives but not bad about 7 of them a couple on her arm and under her arm pit so i gave her benadril for the inching she havent complained it going away she have alittle bit of hives left
Came in to hospital from nursing home due to altered mental status and garbled speech. Mentation retruned to baseline. Required a thoacentesis for a right pleural effusion. Asymptomatic for covid. pt discarged back to nursing home.
Patient had not received the Moderna primary series doses prior to receiving the Moderna bivalent booster.
expired MENACTRA was administered to a patient with no AE; Initial information was received on 19-Nov-2021 regarding an unsolicited valid non-serious case from a pharmacist via Global Medical Information (GMI) (under reference: 00866702).  This case involves a 13-year-old female patient who was administered expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 16-Nov-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (0.5mL, lot U6586BA, expiry date Apr-2021) via intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency: same day).  It was reported "An expired MENACTRA was administered to a patient. Pharmacist wants to know what to do?"  At time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. 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.
Information has been received from a physician concerning a 12 month old male who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The patient experienced 10 lesions all over his body after receiving varicella virus vaccine live (Oka/Merck). The patient sought unspecified medical attention. A product quality complaint was not involved. Additional information has been requested.
(L) deltoid swelling per parents. Parent reported 01/05/12. Vaccine given 9/27/11.
Patient had #3 Moderna booster and had Congestive hospital Hospitalization 2 days later.
PT GOT 3 ADACEL, MMR , AND TWINRX. SHE STARTED TO LOSE CONSCIOUSNESS AFTER 3RD SHOT. SHE WAS ABLE TO UNDERSTAND ME, BUT WAS NOT ABLE TO RESPOND. TECH CALLED 911. HER HUSBAND CAME IN TO TALK TO HER TO TRY TO KEEP HER ALERT. PT IS  DIABETIC. I ASK PT THAT MAYBE HER SUGAR WAS TOO LOW? HUSBAND AGREED TO GIVE HER A GLUCOSE TABLET. I CHECKED HER SUGAR LEVEL AFTER 5 MINS- IT WAS 184. SHE STARTED TO FEEL BETTER WHEN EMS ARRIVED. THEY CHECKED HER AND AFTER SITTING THERE FOR AWHILE, SHE REFUSED TO GO TO THE HOSPITAL WITH THEM
Body aches, brain fog, nausea, injection site pain and redness.  All treated at home with Excedrin.  Felt much better after 48 hours, except for injection site pain.
COVID 19 Treatment; COVID 19 Treatment; Dose #1: Pfizer/ Dose #2: Pfizer/ Dose #3: Moderna/ Dose #4: Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 13Feb2021 at 09:00 as dose 1, single (Lot number: EN5318), in left arm, on 21Mar2021 at 09:00 as dose 2, single (Lot number: EN6208), in left arm and on 27Apr2022 at 09:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 60 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Dec2021 at 09:00 as dose 3 (booster), single (Lot number: 012H21B), in left leg for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Dec2021 at 09:00, outcome "unknown", described as "Dose #1: Pfizer/ Dose #2: Pfizer/ Dose #3: Moderna/ Dose #4: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19 from 20Aug2023 to 24Aug2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300288024 same reporter/ patient, different drug/ event;
Client switched over to Moderna as a booster Lot#070H21A. Client stated to vaccinator that she had no reactions to the first two doses. Client received vaccine and walked over to observation area. At approximately 1242 Client was sitting with husband when, he alerted one of the vaccinators that his wife was feeling dizzy.  RN was alerted about client. Client was placed in zero gravity chair for further assessment. Client was given water and denied having trouble swallowing. Client had sips of water. Client was AAOX3. Client was in no respiratory dress. No pallor was observed by RN. Client was grabbing her chest and nodded when asked by husband if she was having chest pain. EMS was activated at 1243 by RN. After grabbing her chest for a few seconds Client stated, ?I feel better?. Vitals taken at 1245 Client denies medical conditions or heart problems. Client denies any allergies. Client stated the chest pain was on and off. Client began grabbing her chest again and moaning. At 1248 02 sat 99%. Epi-pen 0.3ml was going to be administered when paramedics arrived and assumed care at 1250. Client had more water before standing up and walking over and laying on to the transport gurney. Client was taken via ambulance to hospital at 1255.
I have been diagnosed as having mild tricuspid regurgitation; I began chest pains within a day of getting the first shot; This is a spontaneous report from a contactable consumer (patient). A 43-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on Aug2021 (Lot Number: FA7484) (at the age of 43-years-old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient was healthy and had no known allergies. There were no concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient began chest pains within a day of getting the first shot in 2021. After many heart tests and ER (emergency room) visits, she was diagnosed as having mild tricuspid regurgitation. The patient received treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient reported that the events was serious as disabling/incapacitating. The patient was going to a cardiologist to find out the treatment. The patient received second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on Aug2021 (Lot Number: FA7484) (at the age of 43-years-old) as dose 2, single for covid-19 immunisation. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Mother filled out Informed Consent Form for Immunization with birthday making patient eligible for Pfizer covid vaccine. After the injection and after patient and mother left store insurance claim rejected for age. I called the mother and she stated that she had put the wrong birthday on form so we would think her son 16 years old. Correct birthday given. This patient was not eligible to receive the Pfizer vaccine he was injected with.
4 months after COVID vaccine but only weeks after tetanus vaccine he developed sensory symptoms that fit with small fiber neuropathy.
Fever over 99°F for 48 hours Fatigue for 2+ weeks Chills for first night
Injection site hurts when she uses her left arm; Arm hurt immediately / became increasingly worse; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and pain in arm to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported. 2 years ago, the patient received 2nd dose of Shingrix vaccines and her arm hurt immediately and became increasingly worse. The patient stated that her left arm was painful to touch, and that the injection site hurts when she uses her left arm. The reporter consented to follow-up.
pt recv vax 26FEB96 & pt ran temp 103 & had nausea & vomiting;nausea lasted for several days;mom stated the pt had flu sx was very ill;APAP was administered & the pt fever came down;by the next day,pt was feeling much better;resp arrest
I have muscle pain on my left side, especially my leg. Frequent chills, and a headache on the left side
Diagnosed with rheumatoid arthritis; Whole right side of body swelled up; My hands were so swollen that I could not make a fist/I had difficulty walking because my foot was swollen; Swollen from her face; A spontaneous report was received from a consumer concerning a 49 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced whole right side of body swelling/swelling, peripheral swelling, swollen from her face/swelling face and rheumatoid arthritis.   On 11 Mar 2021, an update was received providing additional information on medical history and concurrent medications.The patient's current medical conditions, as reported by her HCP, include Obesity, Asthma, Hypertension, Sleep apnea, GERD, Diabetes, Polycystic ovarian syndrome, Fibromyalgia, Debilitating anxiety, Supraventricular tachycardia, and Hyperlipidemia.   Concomitant medications were reported included  warfarin, potassium chloride, magnesium oxide, metoprolol tartrate,  hydrochlorothiazide,  amlodipine, folic acid,  metformin, Dexlansoprazole, alprazolam, Duloxetine, vitamin B complex, hydrocodone, vitamin D,  albuterol, fluticasone propionate, voltaren (Diclofenac) gel , tiotropium bromide, prednisone, methotrexate, symbicort, atorvastatin and empagliflozin.  On 15 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number:024M20A) intramuscularly in her left arm for prophylaxis of COVID-19 infection.    On the 5th or 6th day after receiving the vaccine, her whole right side of the body swelled from her face down to her feet. Her hands were swollen that she couldn't make a fist and she had difficulty walking due to the swelling. She had been diagnosed with Rheumatoid Arthritis which was medical significant.  On 12 Mar 2021, an update was received providing additional details of the patient's symptoms. Patient reported swelling and inflammation involving the right arm, right hand, right  knuckles, right knee, right leg and right foot. The patient reported the swelling is finally going down.  Treatment information were reported included prednisone(tapered dose) and methotrexate.  Lab details were not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events- whole right side of body swelling, facial swelling, peripheral swelling were recovering. The outcome of event rheumatoid arthritis was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.