chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient feeling hot, flushed, diaphoresis, dry throat 15 minutes after vaccine; denies shortness of breath, rash, hives. BP 150/100, pulse 104; notes higher than normal although doesn't know normal. Given water, monitored. Continued with BP same; pulse down in high 80s, low 90s; bit better. Refused ED monitored. Monitored for another 15 minutes or so. Ambulated without lightheadedness; BP down to 140/90, pulse 90s. Felt about "80%"; stable; ready to go home. Lives with wife/children. Knows if not feeling well, seek medical attention.
Pfizer-BioNTech COVID-10 Vaccine EUA  Fever (spiked up to 101.6 three times), chills, headache, body ache, some nausea from 6/2/2021 12:30 PM through 6/4/2021 7:00 AM.
Facial flushing and hotness, dizziness and nausea, abdominal burning and feeling like throat was tightening and having trouble swallowing. 50mg Benadryl given IM, 0.5mg epinephrine IM.
This spontaneous report was received from a clinical supervisor who was a medical assistant, regarding to multiple (unspecified number) patients. Patient demographics were not reported. Information on concurrent conditions, medical history and drug allergies of the patients were not reported. Illness of the patients/siblings at the time of/prior to vaccination were not reported. On an unknown date in January 2016 (at unspecified times between 09-JAN-2016 and 15-JAN-2016) the patient was vaccinated with M-M-R II (lot # L011528, expiry date 03-APR-2017), (lot/batch # L015280, expiry date 30-APR-2017) (dose number dosage units, route and anatomical location not specified). Concomitant medication were not reported. On an unknown date in January 2016 (at unspecified times between 09-JAN-2016 and 15-JAN-2016), the reporter stated that unspecified number of patients received unspecified doses in series of M-M-R II that were improperly stored. Temperature at which the vaccines were maintained was reported to be 54.1 (units not provided), time frame was 3.5 hours, no previous temperature excursions were performed. No adverse effects were reported. Additional information has been requested.
Full body hives starting on 12/23. Itching and redness still not resolved.  12/25 left knee pain and significant swelling. Red and hot to the touch. Progressed to right hand and wrist. Hospitalization required for IV antibiotics and steroids.
Severe pain in left shoulder. Started to not be able to lift my left arm up or outwards. Caused trouble sleeping. Arm numbness at night when sleeping on left side. Worsened over a weeks time. Called doctor and was told to take ibuprofen for swelling and possible nerve damage. Phoned in on 02/03/17 in AM to get appt that day at 3:30PM. PA confirmed nerve damage, prescribed prednisone for 9 days. Check back in at the end of the medicine to see if any better.
This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (her husband was also sick after receiving Moderna vaccine) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced vaccination complication (her husband was also sick after receiving Moderna vaccine). At the time of the report, vaccination complication (her husband was also sick after receiving Moderna vaccine) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.
Received 1ml as oppose to 0.5 ml of the vaccine; A spontaneous report was received from a health care professional concerning a 60-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and reported that patient received 1 milliliter (ml) of vaccine instead of usual 0.5ml dose.  The patient's medical history included diabetes mellites. Concomitant medications were not reported.  On 12 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly in her right arm for prophylaxis of COVID-19 infection.  On 12 JAN 2021, the patient received first dose of vaccine and reported that patient received 1ml of vaccine instead of usual 0.5ml dose.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, patient received 1ml of vaccine instead of usual 0.5ml dose, was considered recovered.; Reporter's Comments: This report refers to a case of incorrect dose administered (patient received 1 milliliter (ml) of vaccine instead of usual 0.5ml dose) for mRNA-1273, lot # 025J20-2A  There were no reported AEs associated with this case of incorrect dose administered. The reported event is unlisted and company causality was assessed s not applicable.
I had regular menstrual cycles averaging 30-34 days. I missed a period in March and did not have a period for 55 days.  Multiple neg pregnancy tests via urine and blood. Then my period was regular for a few month.  My last cycle started on July 23 and lasted 5 days. I have not had a period since. I went to my OB and had labs and a exam and all were normal. No signs of menopause either. I then found info about the Covid vaccine making your periods irregular.
experienced tiredness; This is a spontaneous report received from a contactable female consumer (patient) via medical information team. A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8734), via an unspecified route of administration on 31Mar2021 (at the age of 65-year-old) as dose 2, single for COVID-19 immunisation. Medical history included gluten intolerance from an unknown date and unknown if ongoing, crohn's disease from an unknown date and unknown if ongoing (Consumer stated, which was in remission), hashimoto's disease from an unknown date and unknown if ongoing, barrett's oesophagus from an unknown date and unknown if ongoing (Consumer stated, so can take medication for that. she takes prescription Famotidine), synthroid from an unknown date and unknown if ongoing (Consumer stated, for her thyroid disease). Concomitant medications included colecalciferol (VITAMIN D 3) taken for an unspecified indication, start and stop date were not reported; famotidine taken for an unspecified indication, start and stop date were not reported; folic acid taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6207), via an unspecified route of administration on 10Mar2021 (at the age of 65-year-old) as dose 1, single for COVID-19 immunisation and experienced the needle in perpendicular in her arm it went real deep that was painful. When they went to inject the fluid content and that was extremely painful; the site turns red. Quarter size red mark on arm, headache, chills, muscle pain, joint pain, fever, nausea, swollen lymph glands under her chin and on her armpit, may be the second shot did not take hold because she did not have any reaction at all, flu like symptoms. She only experienced tiredness and asking if it was normal not to have more side effects on the 2nd dose. The patient wanted to know if she needs to have antibody testing to see if she developed immunity after getting the 2 doses of the PFIZER-BIONTECH COVID-19 VACCINE. According to her she only experienced tiredness and not sure if she developed immunity from the vaccine. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Liver lymphoma; This is a spontaneous report received from a contactable nurse.  A 62-year-old female patient received BNT162b2, BNT162b2 OMI ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization, reaction(s): "Liver lymphoma"; Bnt162b2 (DOSE 2), for COVID-19 immunization, reaction(s): "Liver lymphoma". The following information was reported: LYMPHOMA (medically significant), outcome "unknown", described as "Liver lymphoma". The patient developed liver lymphoma after receiving both COVID-19 shots and booster. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the event Hepatic lymphoma  and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200106296 Same patient, product, and event; different dose;
Case number PHEH2014US021327, is a combined initial and follow up spontaneous report received from a consumer (patient) on 21 Oct 2014 and on 22 Oct 2014. This report refers to a male patient of unknown age. He was vaccinated with FLUVIRIN (batch number: 1411101, expiry date: Apr 2015) intramuscular into right deltoid on 17 Sep 2014. On the same day post vaccination he experienced right arm swelling of the area, itchy, redness, warmth to touch and fever. Outcome of the event, seriousness and causality assessment was not reported. No further information was provided.
RECORDS RECEIVED FROM ER 05/10/18 IMMUNIZATION REACTION- INITIAL ENCOUNTER -SIGNIFICANT ERYTHEMA INDURATION AND INCREASE TEMPERATURE OF HIS ENTIRE RIGHT UPPER ARM LATERALLY. SMALL AREA OF INDUCATION AND ERYTHEMA ON HIS LEFY ARM- POSTERIORLY BOTH ARMS HE RECEIVED IMMUNIZATIONS YESTERDAY. PT RECEIVED DECADROM 12.68 MG AND HAD BENADRYL PRIOR. TOLERATED WELL. CONFIRMED BOTH DTAP AND IPV GIVEN IN R ARM.
FEELING A LITTLE BIT GOOFY AND DULL; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight was 101.4 kilograms, and height was not reported. The patient's concurrent conditions included: pulmonary arterial hypertension. The patient received epoprostenol sodium (powder for solution for infusion, intravenous drip, batch number: MM257M01P1 expiry: 30-SEP-2022) dose and frequency were not reported from 25-OCT-2018 for pulmonary arterial hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/ lot numbers. Concomitant medications included ambrisentan, and warfarin.  On an unspecified date, the patient experienced feeling a little bit goofy and dull, off label use, and inappropriate schedule of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of epoprostenol sodium was not changed. The outcome of the feeling a little bit goofy and dull, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
About 5 minutes after Menactra was given IM, pt fell backward and onto floor. pt had lose of control for about 10 sec duration, patient was pale and diaphoretic also at this time. Upon awaking pt was a&o x 3. Pt laid on floor about 5 minutes, then was assisted to a chair, denied dizziness, h/a or neck pain or other injury. VS V'd - T 98.8, P 72, BP 92/60. Pt rests in chair about 10 minutes states feels fine, able to amb without assistance, gait steady. PAC notified.
On Monday, the day of the shot, I started to feel achy. That night I was up all throughout the night with a deep aching in my muscles from my head to toe.  It was very painful and there was very little I could do to relieve it.The following day, the 23rd I continued to be achy and weak, I did also feel very tired and slept a lot. The third day I just was feeling weak and sleepy.
Local redness, slight swelling 2 1/2 inches wide x 3 3/4 inches long. Examined by doctor, instructed to use BENADRYL as needed for itching and redness, and MOTRIN for pain.
Note, I do not believe this is related to my receipt of Covid-19 vaccine, but am reporting in case there is any possibility it could have been an adverse event (5 months after vaccination.)  My left knee locked in a bent position,  after sitting on the ground with legs under/to the side of me.  I was unable to straighten left leg without pain for 5 days.  I used crutches during that time.  I iced the knee and used  ibuprofen in case the cause was inflammation.  Urgent care visit X-ray was normal (i.e., no torn patella or other physical issue.)  MRI a  week later was also normal (only slight effusion.)   I have had a finger in my left hand (middle finger) also lock in a bent position on occasion, but all other instances of  locked/bent joints have resolved  in under 10 minutes before.
This spontaneous report as received from a healthcare worker (medical assistant, M.A.) refers to an unknown number of patients of unknown age and gender. Pertinent medical history and drug reactions or allergies were not specified. On an unknown date, the patient's were vaccinated with doses of ROTATEQ 2 ml, oral, lot number K000471, expiration date 31-MAR-2015 and lot number J012518, expiration date 24-APR-2015, (unknown dose in series) that were stored at 34.7 Fahrenheit (F) for 36 hours. Concomitant medications were not specified. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine administered at 1145. At 1200 patient reported that her heart was racing, dizziness, lightheadedness, and throat feeling "tight." BP 110/70. Symptoms progressed. 911 Called. EpiPen administered in L thigh at 1210. 1211 BP 112/60, still complaining of "throat swelling" and lightheadedness. EMS arrived at 1213 and transported patient by ambulance to Hospital emergency department at 1217.
Received flu vaccine at about 8:00a.m.  Chills started at about 2 to 3 p.m.  Fever at about 5p.m.  Reaching 101.6 by 8p.m.  Fever continued thru the night; breaking about 6a.m. on the 10th.  I first began taking asprin.   Talked with my Dr. and he recommended Tylenol every four hrs.  I feel very weak today but feel like I will continue to improve.
Chicken pox booster shots on 9/11, swelling in the middle of the night due to itch, the swelling grow bigger (size like a egg broke in a pot) on 9/12, on 9/13, the right arm also grow a blister can't put arm naturally down because pain.
Patient states she developed hives 12 hours after GARDASIL vaccine administration.  She describes red, warm, welt-like, pruritic lesions and generalized itchiness on arms, legs bilateral and abdomen and back.  They resolved after use of over the counter Benadryl but pruritis remained.  Denied shortness of breath, wheezing, oral swelling, dizziness, syncopy.  She was advised to continue Benadryl (plus over the counter Claritin/Zyrtec) until symptoms completely resolved by our nurse 7/2/08 and myself 7/3/08.
Temperature over 100; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Temperature over 100) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Egg allergy, Drug allergy (morphine, vibramycin, clindamycin(pediatric) , Carafate, amoxicillin), Latex allergy and Penicillin allergy. Concomitant products included LISINOPRIL, VITAMIN D3, ONDANSETRON HCL, NAPHAZOLINE HYDROCHLORIDE, PHENIRAMINE MALEATE (NAPHCON-A), CARMELLOSE (LUBRICATING PLUS), PEMBROLIZUMAB (KEYTRUDA), LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETRIZINE HYDROCHLORIDE), ALBUTEROL SULFATE, HYDROXYZINE HCL, MIRTAZAPINE (MIRTAZAPINE A), FAMOTIDINE and LEVOTHYROXINE for an unknown indication, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).    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 PYREXIA (Temperature over 100). At the time of the report, PYREXIA (Temperature over 100) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were not provided.
The first vaccine I experienced mensural bleeding, bleeding and having clump, one side clump; I have arm soreness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 07Jul2021 (Lot number: EW0187) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "The first vaccine I experienced mensural bleeding, bleeding and having clump, one side clump"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I have arm soreness".  Additional information: Nurse stated, "I am calling, I probably have some side effects from this vaccine because I am experiencing, the first one I was done I experienced some menstrual bleeding. The first vaccine I experienced mensural bleeding." Nurse stated, "Yes, bleeding and having clump, one side clump. Bleeding with the clump and this one and when I took the second dose then the bleeding started again."When confirmed the events occurred the same day vaccine was administered, Nurse stated, "Yes, I know I have arm soreness which is expected you know the area. I have soreness on the site which is expected. You know I expect soreness on the arm but I wasn't expecting the bleeding.  No follow-up attempts are possible. No further information is expected.
Laid down and woke with acute headache/migraine pain focal point behind left eye - extreme photosensitivity - pain led to increased gastric emptying and severe nausea and vomiting - unable to respond/vocalize at times during the pain. Subsided around 2AM 5/18/13 - most intense headache of my life 9/10 pain.
Information has been received from a physician assistant concerning a 21 year old female patient who on 08-JAN-2009 was vaccinated with the first dose of GARDASIL (lot# not provided) 0.5ml. Subsequently, on 08-JAN-2009, the patient experienced mild itching at the injection site. On 09-MAR-2009 patient received the second dose of GARDASIL (lot# not provided) and also experienced rash and itching at injection site. Patient sought unspecified medical attention. Subsequently, the patient recovered. Additional information has been requested.
Are is sre at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Are is sre at injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Prostate cancer.   In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Are is sre at injection site). At the time of the report, MYALGIA (Are is sre at injection site) outcome was unknown.      No Concomitant medication information was reported. No treatment medications were provided.   This case was linked to MOD-2021-301904 (Patient Link).
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 72-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL8982), in left arm, on 18Feb2021 as dose 2, single (Lot number: EM9810), in left arm and on 06Oct2021 as dose 3 (booster), single (Lot number: FF2589), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: Patient received Paxlovid from 23Jul2022 to 27Jul2022 for the treatment of COVID-19. Patient had rebound of Covid 5 days after finishing Paxlovid.
I95.9 HYPOTENSION 5/12/2022 GERD (GASTROESOPHAGEAL REFLUX DISEASE) I95.9 HYPOTENSION 5/12/2022 ASYMMETRIC BILAT SENSORINEURAL HEARING LOSS I95.9 HYPOTENSION 5/12/2022 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE
Temp 100; puking; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temp 100) and VOMITING (puking) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Temp 100) and VOMITING (puking). At the time of the report, PYREXIA (Temp 100) and VOMITING (puking) outcome was unknown.
Diarrhea (usually 4+ times per day) began on 2/20/2021, and continues  to today (3/12/2021).  Fainted 2/26/2021.  To Urgent Care and then ER 2/27/2021.  Suspected dehydration.
Child received a 2 dose of this year's flu vaccine even though she had previously received the two dose amounts last season. She only needed one vaccine this year and received two.
FLU-LIKE SYMPTOMS, NIGHTMARES/HULLICINATIONS, FEVER.
Pt recvd 1st dose of Hep B (Recomb) on 19JUN91 & on 21JUN91 pt devel vomiting, diarrhea & gastrointestinal cramps; Pt was treated w/bismuth & Maalox; 25JUN91 pt recovered;
cold; cough; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 15Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient called in and took her first dose on 15Mar2021 and she was experiencing a cold and cough (on an unspecified date in 2021). She wanted to know if she would continue the second shot which is on 02Apr2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Bright red and itching at injection site of an area abouth 3in x 3in. Back and Legs with lesions resembling chicken pox blisters and itching.