chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm during the first 3 days after the first dose on 03-23-2021 and then disappeared After a week for the first dose, itchy skin over the body.. In two more days, rash appears over the upper body (under breast, on the waist) and already lasting for  3 days and not disappear yet.
Red area RA .5-1": slightly warm to touch. Cool compresses and IB.
Presented to hospital on 9/28 with worsening shortness of breath. Diagnosed with COVID-19 pneumonia. Received dexamethasone and remdesivir with Vapotherm support.  Saturations continued to decrease and was intubated. Also received PICC line and vascular catheter for renal replacement therapy. Developed candid fungemia and given antifungal therapy. Develope renal failure requiring CRRT. Had cardiac arrest on 10/16 with 3 rounds of CPR and received calcium and epinephrine with continued asystole. After discussion with patient sister the code was called.
Patient was given the vaccine at age 17, and it is only approved for 18+. No adverse reaction. Patient notified. No treatment needed at this time
First 24, flu like symptoms: fever, chills, body aches, fatigue, and pain in the left arm into the neck. One week later, left arm is feverish, swollen, and bruised with a red circle
ADMINISTRATION OF 0.3ML OF JANSSEN COVID-19 VACCINE INSTEAD OF PFIZER; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported. On an unspecified date, the patient experienced administration of 0.3ml of JANSSEN COVID-19 VACCINE instead of pfizer. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of 0.3ml of JANSSEN COVID-19 VACCINE instead of pfizer was not reported. This report was non-serious. This case, from the same reporter is linked to 20220626340.
Sudden onset 3 days after vaccine 1/16/2021 of paresthesia starting B/L plantar aspect feet advancing to tops feet, shin/calves, thighs(anterior and posterior) and B/L groin 1/17-20th.  By 1/21, rotating paresthesia LES with intermittent nerve like shooting pains B/L UEs.  1/22-26 more UE and occasional facial paresthesia. 1/27 to present  improved LE paresthesia, mild BL feet.
COVID-19; COVID-19; This is a spontaneous report from a contactable consumer. The reporter is the patient. A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single at the age of 27 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single and as dose 2, single for covid-19 immunisation. The patient's relevant medical history included: "papillary necrosis"; "known allergies to penicillin, sulfa, shellfish". The patient's concomitant medications were not reported. The following information was reported: drug ineffective (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included PAXLOVID since 16May2022 to 20May2022.  Rebound case - tested positive again 29May (9 days after last dose).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Having a difficult time breathing; This is a spontaneous report received from a contactable consumer or other non hcp. A 47-years-old female patient received second dose of bnt162b2 (PFIZER BIONTECH-COVID19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 18Jun2021 09:00 as single dose for COVID-19 immunization. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing, known allergies: Macro Bid antibiotic. Concomitant medications included sertraline hydrochloride (ZOLOFT) and gabapentin taken for an unspecified indication, start and stop date were not reported. Prior and since the vaccination, patient was not tested and diagnosed with COVID19.The patient was not hospitalized after vaccination. The patient did not received any other vaccine within 4 weeks prior to COVID-19 Vaccine. The patient experienced having a difficult time breathing (dyspnoea) on 03Jul2021.The outcome of the event was not resolved.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
This spontaneous report as received from medical assistant refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with VARIVAX (Merck) injection 0.5 ml, with lot # J005688 and expired date 07-MAY-2015, subcutaneously. On an unknown date of October 2013, VARIVAX (Merck) was actually exposed to temperature below 5 F, 4C for 288 hours (12 days). On an unknown date patient received one dose of the VARIVAX (Merck). No adverse effect was reported. The outcome of VARIVAX (Merck) was exposed to 4C for 288 hours and no adverse event was unknown. The reporter did not provide causality of VARIVAX (Merck) to event. No further information was provided. Additional information has been requested.
Redness and swelling. Stiffness. Extremely sore and achy. Went to the ER and was diagnosed with Pneumonia
Initial report received from health care professional on 07 Jan 2010: This patient was vaccinated with FLUVIRIN (batch no. 1008134P) 0.5 ml, intramuscular, on 07 Jan 2010. The vaccine was inadvertently given to 3 years old. No adverse effect were noted after administration. The outcome of the event was not reported.
Initially I had a high fever around 102 degrees, aches, pains, diarrhea, nausea, and a headache. After this, I had cramps in my hands, feet, and legs. I've had cramps before, but I've never had them in my hands. I noticed is that my teeth are so sensitive now. I have very strong teeth, but now there is noticeable sensitivity. I'm having joint pains, aches, brain fog that is lasting. I feel an emotional effect as well. Last year before I received my vaccines, I noticed that I am very tired all the time. I feel that these vaccines are not good for anyone.
102.0 now 102.8 F Fever.; Can't walk; Can't form a sentence; Extremely weak; A spontaneous report was received from a consumer concerning a 83 year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever/pyrexia, weakness/asthenia, can't walk/gait inability, couldn't form a sentence (aphasia).  The patient's medical history was not provided by the reporter. Concomitant product use was not reported.   On an unknown date in Jan 2021, patient received their first of two planned doses of mRNA-1273 vaccine (Batch number: Unknown).  On 15 Feb 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot number: 030M20A) intramuscularly for prophylaxis of COVID-19 infection.   After receiving the mRNA-1273 vaccine, on 16 Feb 2021, the patient experienced a fever of 102-102.8 degrees Fahrenheit.  She was extremely weak, couldn't walk or form a sentence.    Treatment details for events were not reported.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.  The  outcome of the events, fever/pyrexia, weakness/asthenia, can't walk/gait inability, can't form a sentence/aphasia were 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 event (Pyrexia, asthenia) a causal relationship cannot be excluded. Very limited information regarding the event (gait instability, aphasia) has been provided at this time. Noting advance age is a risk factor. Further information has been requested.
neck getting inflamed; he has a little ball on top of her collar bone; This is a spontaneous report from a contactable consumer or other non hcp (patients caregiver). A 49-years-old female patient (reporters mother) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced neck getting inflamed and has a little ball on top of her collar bone. The reporter reported on the behalf of her Mother (Patient). The patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine, and her neck getting inflamed, she had a little ball on top of her collar bone. The reporter asked what to do about that side effect. The outcome of all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Bone directly in front of right ear, as well as the space between the bone and the ear, are tender to the touch. Lower jaw out of whack with upper one, which affected teeth alignment. Painful to open mouth. Much better by Monday.  The area by the ear is not nearly as sensitive to  the touch, on Tuesday it's gone, but the jaw still doesn't feel normal.
feeling cold; tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feeling cold) and FATIGUE (tired) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced FEELING COLD (feeling cold) and FATIGUE (tired). At the time of the report, FEELING COLD (feeling cold) and FATIGUE (tired) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided It was reported that patient was a participant for the Novovaxclinical trial and had the 2nd dose of its vaccine on 12May2021 .He had cold and tired afterward.He waited for the booster dose of the company and it has not become available yet.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jan-2022: Followup information received include suspect product Moderna details and newevents were added.
The patient received the vaccination on 9/30/18 by pharmacist. The shot was administered in the left deltoid, 2-3 fingers width below the top of the shoulder. The patient was seated with her arm at her side. Patient reported to the pharmacy on 11/10 that since receiving the flu shot in her left arm she has experienced left arm pain. The pt stated the pain started a couple days after the shot. The pain is located in the left arm and radiates up to the neck/collarbones. Pt reported a painful spot on her arm. The pharmacist, palpated pt's arm on 11/10, and pt reported a tender spot approximately 2-3 fingers width below the edge of the shoulder. When speaking to the patient on the phone on 11/11, patient reported to the pharmacist that the pain makes it difficult for the patient to elevate her arm. When asked to measure the location of the tender spot of the left arm, pt stated it was 2 fingers width below the shoulder. The patient has informed her doctor of the pain. The patient has tried using ICY HOT and ibuprofen but states it does not help the pain. As of 11/11 the patient states she thinks the pain is getting better but it is still present.
LOCAL INJECTION SITE REACTIONS INCLUDING RASH, TENDERNESS, SWELLING. PRIMARY CARE PHYSICIAN PRESCRIBED TRIAMCINOLONE OINTMENT AND BENADRYL TABLETS WHICH DID NOT HELP. NEXT TREATMENT PICKED UP TODAY IS AMOXICILLIN.
23 y/o with hx of hodgkins lymphoma (completed tx in 2016), anxiety, and depression and today noted L axillary lump and here for evaluation.  Covid 2nd vaccine 2 days ago in L arm.  PE: afeb/nontoxic, remarkable for 2x2 cm, tender, rubbery, mobile, nonfluctuant lymph node medial aspect of L axilla c/w local reaction to covid vaccination.  Symptoms most consistent with known side-effect of COVID-19 vaccine of ipsilateral axillary lymphadenopathy, and is likely self-limited. Systemic infection is also possible, though less likely given time course. Unlikely recurrence of lymphoma with absence of B symptoms.   Recommended Tylenol for pain. Provided reassurance and recommended following up with PCP if persists longer than 1 week.
inconsolable crying x 5 hrs high pitch; hot flaccid; not wanting to nurse as vigorously as a/immun;
He developed tenderness and swelling in his armpit within 24 hours/swelling is not in his lymph nodes but in his rib cage; He developed tenderness and swelling in his armpit within 24 hours/swelling is not in his lymph nodes but in his rib cage; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 16-year-old male patient received BNT162b2 (COMIRNATY), on 08Apr2022 as dose 1, single (Batch/Lot number: unknown) at the age of 16 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING (non-serious), AXILLARY PAIN (non-serious) all with onset Apr2022, outcome "unknown" and all described as "He developed tenderness and swelling in his armpit within 24 hours/swelling is not in his lymph nodes but in his rib cage". The events "he developed tenderness and swelling in his armpit within 24 hours/swelling is not in his lymph nodes but in his rib cage" required physician office visit.  Additional Information: He developed tenderness and swelling in his armpit within 24 hours. He went to his pediatrician's office this morning on 11Apr2022 and the doctor said the swelling is not in his lymph nodes but in his rib cage. She advised him not to get his second dose and to follow-up with the practice if the pain gets worse or he develops a fever.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
VOMITING; FELT LIKE COULD NOT BREATHE; PAIN IN LOWER BACK; PAIN IN ENTIRE BODY; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 27-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-JUL-2021, the subject experienced vomiting. On 28-JUL-2021, the subject experienced felt like could not breathe. On 28-JUL-2021, the subject experienced pain in lower back. On 28-JUL-2021, the subject experienced pain in entire body. On 28-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, felt like could not breathe, pain in lower back, and headache, and the outcome of pain in entire body was not reported. This report was non-serious.
Diffuse, maculopapular lesion that progressed to petechiae. Developed fever as well.
01/22/2021 pt noticed hives 5-6pm on torso, a 'little bit' on his leg, pt took 25mg Benadryl, about 1 hour later,  hives extended to legs, took another 25mg Benadryl at 8pm. Next day 01/23/2021, no hives, went to work. At home hives flared up over pressure points, i.e., waistband, under his backpack, over knees, that had been flexed while snowmobiling. Took 50mg Benadryl prior to bedtime. On 01/24/21 felt feverish, sore arm, body aches, stayed home from work. No hives since.
Cellulitis & Severe Swelling and pain Bone/muscle pain, headache, etc Treated at hospital with antibiotics for the infection
This spontaneous report was received from a licensed practical nurse concerning a female patient of unknown age. The patient had a loop electrosurgical excision procedure (LEEP) procedure on an unknown date in December 2011 for low grade squamous cells that appeared on the pap smear of the patient that showed that she was positive for human papilloma virus (HPV) on 18-AUG-2011. On 18-AUg-2011, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified). On 18-OCT-2011, the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date, dose and route unspecified) and on 05-APR-2013 (at the time of reporting), the patient was in the office to receive her third dose of GARDASIL (lot number and expiry date unspecified). No concomitant medications were reported. No adverse symptoms were reported. Additional information has been requested.
pt reports red rash extending from inj site down around arm to elbow. started later in the day after vaccination. Reported initial soreness and redness at inj site on 11/13.  Pt called to report that the redness had gone to the elbow but felt that it was improving with less pain on 11/15.  No angio edema, hives, itching etc.  Rash is not weeping or inflamed. Advised to mark the margin to watch for continued advancing (indicating possible cellulitis).  No reports of fever or other constitutional symptoms.
began crying 1 1/2 hrs p/vax; cried non stop 4 1/2 plus hrs; given Pandadol;
Pt was incorrectly administered MMRV & Varicella simultaneously. No adverse reaction appreciated.
Flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Flu symptoms). At the time of the report, INFLUENZA (Flu symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
ACUTE RESPIRATORY FAILURE 4/5/2023 ESOPHAGEAL CANCER, UNSPECIFIED SITE ACUTE RESPIRATORY FAILURE 4/5/2023 ADVANCE DIRECTIVE DISCUSSED W PATIENT
Had pneum 23 in left upper arm - immediate pain which lasted through the day. For few days while out of town, she had increased swelling from top of shoulder to her elbow. Along with redness. Had acupuncturist and applied oil to left arm & states shortly there after swelling went away 5/6/19 Back to normal per pt.
MD ofc reported on 6JUL95 pt stopped breathing was having sz like activity & was taken to hosp ER 22MAY95 then transfered on another hosp;currently under MD care
Nausea, dry heaves from 11:30 pm the night of the vaccine and still going on 4/30 at 10:30pm. Tiredness from same time period.
Temporary blindness for 10 minutes in only one eye; A spontaneous report was received from a nurse concerning a 85-year-old, elderly male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced temporary blindness for 10 minutes in only one eye/blindness transient .  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 01 Mar 2021, approximately 2 days prior to the event, the patient received their first of two planned doses of mRNA-1273 (Batch number: 022M20A) intramuscularly in left non dominant arm  for prophylaxis of COVID-19 infection prophylaxis.   On 03 Mar 2021, after first dose of vaccine, the patient experienced temporary blindness for 10 minutes in only one eye. The event temporary blindness for 10 minutes in only one eye was considered as medically significant. He visited doctor and after the investigation, it was confirmed that patient was fine. Treatment medication for the event included Clopidogrel bisulfate.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, temporary blindness for 10 minutes in only one eye was resolved on 03 Mar 2021.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Received the second dose less than  25 days from the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose less than  25 days from the first dose) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose less than  25 days from the first dose). On 08-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose less than  25 days from the first dose) had resolved.            No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up received , contains non significant information experiencing any adverse events aftereither dose of vaccine and denied further follow up.
Report A0366404A describes limb swelling in a 4 year old male who received Infanrix. Medical history, concurrent conditions, and concurrent medications were not provided. During the week of 4/15/02, the vaccinee received his fifth injection of Infanrix in his left arm. At unspecified time later that week, he experienced redness and swelling from the left side to the left elbow. Treatment and outcome were not provided. The vaccine provider considered the events to be probably related to Infanrix administration. Please refer to case numbers A0366401A and A0366404A by the same reporter.
While seated, approximately three to five minutes following immunizations, patient had syncopal episode lasting less than one minute, resulting in patient falling from chair to floor. A small cut to the right side of patient's inner lower lip and c/o right upper tooth numbness was noted. Patient remained supine with lower extremities elevated for five minutes and pressure applied to lower lip. Gradual rise to upright position followed by standing to enable return to seat was achieved where patient remained for thirty minutes observation. Full level of consciousness was noted. Instructions given to notify medical doctor of any nausea/vomiting, headache, disorientation, confusion or any noted change to level of wellness/consciousness. Encouraged to consult dentist for tooth evaluation.
Patient began to become tachypnec, short of breath, hives, was given epi immediately
Information has been received from a licensed practical nurse concerning a 4-year-old female with no pertinent medical history and no history of drug reaction/allergies who on 26-SEP-2003 was vaccinated subcutaneously with a dose of Varivax (645578/0439N). There were no concomitant medications. On 01-DEC-2006, the patient experienced confirmed zoster. It was reported that the rash developed on the mid upper back and spread to her left shoulder and back of her left arm, and that there were some small spots on her chest. The patient also experienced a painful arm and stomach pain. Unspecified medical attention was sought. A TZANCK prep was obtained. VZV analysis by polymerase chain reaction was offered but refused. The patient status was reported as recovering. No additional information to report. Additional information has been requested.