chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On May 8, 2022, I noticed a recurrent dark patch on his wrist. It started to look swollen, raised, and skin cracking. I advised my son to go and wash his hands and put NEOSPORIN on the patch. After the NEOSPORIN we tried the steroid ointment that we had and that was not working; so we made a doctors appointment. The first doctor's appointment was on that very same week of May 9th, 2022. They prescribe antibiotic ointment mupirocin. A few days later, I called my son's doctor and they prescribed, KEFLEX which is a oral antibiotic. Once my son started to take the oral antibiotic, I noticed that he started to have another reaction and little small pimples appeared on the same arm and wrist with the dark patch. We went to the emergency room on May 15, 2022 and they prescribe my son prednisone and doxycycline. Once my son finished his prescribe meds his skin started to clear up but once he went and got his second dose the skin reaction happened again.
Hands and toes were cold and achy from the knuckle to tips and chills. Patient took acetaminophen and diphenhydramine at night for relief.  Resolved in 24 hours.
63 days since first shot without having second shot; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (63 days since first shot without having second shot) and PAIN IN EXTREMITY (sore arm ) in a female patient of an unknown age 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 PRODUCT DOSE OMISSION ISSUE (63 days since first shot without having second shot) and PAIN IN EXTREMITY (sore arm ). At the time of the report, PRODUCT DOSE OMISSION ISSUE (63 days since first shot without having second shot) had resolved and PAIN IN EXTREMITY (sore arm ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment was reported.   This case was linked to MOD21-089185, MOD-2021-118041 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-089185:Case for husband MOD-2021-118041:husband case
This spontaneous report as received from a medical assistant refers to a 2 month old patient of unknown age. The patient's medical history was not reported. On 16-AUG-2014 the patient was vaccinated with improperly stored ROTATEQ (dose and frequency were not reported, lot # J004944 and expiry date: 12-NOV-2014). No adverse symptoms were reported. The temperature excursion for the ROTATEQ was a supported excursion with in-house stability data. No product quality complaint (PQC) was reported for ROTATEQ. This case is linked to 1407USA010141, 1410USA009193, 1410USA009192, 1410USA009194 and 1410USA009195 (same reporter link). Additional information has been requested.
Case number PHEH2015US019586 is an initial spontaneous report from a health care professional received on 30 Sep 2015. This report refers to a 58 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX, (batch number: 173539) intramuscularly at a dose of 0.5 ml on 23 Sep 2015. It was reported that FLUCELVAX was kept at room temperature for 24 hours before administering the patient. No adverse event was reported following this maladministration (incorrect storage of drug).
pt recv vax 16AUG96 & AUG97 pt devel varicella consisting of a rash composed of between twenty & fifty fluid filled vesicles located on stomach, back & back of neck;pt recovered p/nl short course;
A Jan. 12, 2021 physical discovered a Vitamin D deficiency & an A1c level of 6.7 which I immediately started treatment for. Other than this my doctor stated that I was "Fit as an athlete". Around mid-April I  had an episode where my breathing was labored, I began to sweat and felt a sharp pain across my lower chest & was very nauseous. A series of tests later indicated possibly a gall bladder & gall stone attack. I was sent to several other doctors, one of whom prescribed Nitroglycerin for me in case I had another similar episode. On June 6, 2021 it happened again and after taking the pill as directed I was rushed by ambulance to the Emergency Room.   The medical staff at Hospital stated that I had a Heart Attack due to several severely blocked arteries. Later that evening I was transported by ambulance to Hospital. I arrived there around 2:00 a.m. on Monday morning June 7, 2021. The morning of June 10th  I underwent a quadruple open heart bypass surgery. I was told those arteries were 85%-98% blocked that caused the attack and that there were a couple minor, less than 30%, elsewhere. I was recovering nicely for a couple months. But then I started to have some breathing and loss of energy problems. After several tests I was informed that I had another blocked artery behind my heart.  On September 16th I went to Hospital again. This time it was for a Left Heart Cath-WI. While there the surgeon put in a stent implant during the procedure. I am slowly regaining some of my health but feel that I still have a long way to go before I experience a full recovery.   Prior to being vaccinated I was working full time, I had a lot of energy and I had no physical problems. I was also very active in several community, church organizations and activities after work & on weekends. After receiving both vaccines everything started going  downhill for me. My health has not been the same since and I have doubts that it ever will. Because of the trauma I sustained, I've decided to allow my personal doctor to make any recommendation on if or when I should get a booster vaccine. Right now I am feeling very apprehensive about getting another COVID-19 vaccine.
Injection site soreness  makes it painful to lift arm   Fatigue Headache Swollen lymph node in left armpit  Treated with ibuprofen to minimal effect
Fever and chills within a couple hours. Ongoing for almost 3 days. Redness at injection site started about 48 hours after injection. The redness spread to almost the entire outside of the upper left arm. Treated fever with acetaminophen around the clock. An online doctor visit 36 hours after injection suggested the same. Went to emergency department 72 hours after injection. Doctors there treated infection empirically in addition to fluids, steroids and acetaminophen. Fever subsided. No source of infection found, so antibiotics stopped. Theory presented was SIRS, systemic inflammation response syndrome. Kidney function also affected adversely.
Reported rash/hives on both sides of the neck, torso and inner thighs - 2 days after immunization. Feels fine, typically gets this type of break out when sick with anything.
This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site warmth) and VACCINATION SITE REACTION (vaccination site reaction) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced INJECTION SITE WARMTH (Injection site warmth). 14-Jan-2021, the patient experienced VACCINATION SITE REACTION (vaccination site reaction). At the time of the report, INJECTION SITE WARMTH (Injection site warmth) and VACCINATION SITE REACTION (vaccination site reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient received the expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021 at 11:33 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided.
Swollen lip; Brain fog; Headache; Arm pain; This is a spontaneous report from a non-contactable consumer, the patient. A 20-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown if the patient was diagnosed with COVID-19 . Since the vaccination, the patient had not been tested for COVID-19. On an unknown date the patient experienced headache, swollen lip, brain fog and arm pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of headache, swollen lip, brain fog and arm pain were unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
SWELLING, REDNESS, WARM, PAINFUL, FEVER.  WAS SEEN BACK IN OFFICE AND AT EMERGENCY ROOM.  LOCAL ALLERGIC REACTION VERSES CELLULITIS.  GIVEN AUGMENTIN 875MG X7 DAYS, GIVEN ANTIHISTAMINE.
A spontaneous report was received from a pharmacist concerning a 17 year old, female patient who received COVID-19 vaccine at an inappropriate age.  The pharmacist would like guidance on how to report this. Medical director is in contact with the patient's primary care provider and they think it will be fine. Just want to make sure we are reporting correctly. The patient's medical history was not provided. No concomitant medication was reported. On 03 Feb 21, the patient received their first of two planned doses of (Batch number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection. Treatment information was not provided. Action taken in response to the event was not provided. The outcome of the event was considered resolved on 03 Feb 21; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for.  There were no reported adverse events associated with this case.
5/7/2009 KNOT (SIZE NICKEL) AND FEVER WHERE SHOT WAS GIVEN.  ALSO ACHY ALL OVER.   COULD NOT GET OUT OF BED UNTIL TOOK ADVIL THAT DAY.  5/13/2009 STILL HAS SMALL KNOT ON ARM WHERE SHOT WAS GIVEN.
Passed out for 40 secs; Chills; Cardiac issues; A spontaneous report was received from a consumer who was also a 34-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced passed out for 40 secs/ loss of consciousness, chills, and cardiac issues/ cardiac disorder.  The patient's medical history included depression. Products known to have been used by the patient, within two weeks prior to the event, included quetiapine fumarate (Seroquel) since 2014.  The patient received the first of two planned doses of mRNA-1273 (Batch number: 039K20A) on 12 Jan 2021. On 10 Feb 2021, approximately one day prior to the onset of the symptoms, the patient received the second of two planned doses of mRNA-1273 (Batch number: 028L20A) for prophylaxis of COVID-19 infection.  On 10 Feb 2021, after receiving the second dose of the vaccine the patient, had experienced cardiac issues.  On 11 Feb 2021, the patient started experiencing chills and passed out for 40 seconds (secs). The patient had visited the emergency room (ER) and EKG (electrocardiogram) showed slight abnormality. She was given heart monitor for 14 days. She was scheduled for Stress test and Echo. She was on antipsychotic medications for seven years. She was curious whether the antipsychotic drugs caused the cardiac abnormalities in response to Covid-19 vaccine. Treatment information was not provided. The adverse event of passed out for 40 secs was assessed as medically significant.  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 chills and cardiac issues was unknown. Outcome of the event passed out for 40 secs was recovered on 11 Feb 2021.; 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.
Patient received Pfizer COVID vaccine on 1/28/21 and 2/25/21. On 12/14/21, patient came to our ED and was admitted to our inpatient unit for acute hypoxemic respiratory failure and pneumonia due to COVID-19 and uncontrolled BG and HTN in the setting of DM type 2 .  As of today (12/17/21), patient is still admitted in the med/surg unit.
PATIENT WAS VACCINATED WITH FLU 3+ AND WAS ONLY 2Y 10M AT THE TIME OF THE VACCINATION THERE WAS NO ADVERSE REACTION TO THIS DOSE.
This spontaneous report was received from a medical assistant refers to an unspecified patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patients were vaccinated with GARDASIL, (lot number/expiry date and dose not reported). On an unknown date, the patients were vaccinated with unspecified doses of GARDASIL 9 injection (lot number/expiry date and dose not reported), to continue or complete a HPV vaccination series that was started with GARDASIL. No adverse effects have been reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of GARDASIL (dose, route, and lot# not reported). Subsequently the patient experienced low platelets. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Fainting spell that resulted in head injury.  Within 15 minutes of first fainting spell and getting assistance from family members, two additional fainting spells.
This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 01-FEB-2016, the patient was vaccinated with a dose of oral, ROTATEQ (lot # L013192 and expiration date January 2017), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
After injection patient was experiencing limited upward movement of his arm, tingling and numbness in his fingers and pain. This started within a week after the injection. Patient has seen PCP and VOLTAREN gel was prescribed for treatment but is waiting for prior authorization. Physician is ordering further evaluation.
General malaise, ekeavated temperatures, bilateral ear nfections, fatigue, swelling to left arm @ vaccination site
Initial misuse report received from a healthcare professional on 06 February 2014. This case is invalid as no patient information is available. An unknown patient had received only dtap ipv portion of PENTACEL on an unspecified date. No adverse event was reported. List of documents held by sender: None.
1 Week after injection (Feb 10) developed swelling, redness, itching around injection site.  Also felt know in muscle at injection site.  after one week treated site with Cortisone cream relived symptoms.  On Feb 17 developed symptoms of Bell's Paulsy on left side of face: lip and left nostril felt swollen, gums  sore, difficulty drinking from straw and eating.  Saw neurologists on Feb 25 said symptoms were consistent with Bell's Paulsy.
Information has been received from a pharmacist concerning a male who was vaccinated with four 10 mcg doses of Hepatitis B vaccination was received on 05-Jun-2000, and the fourth dose of the Hepatitis B vaccine recombinant (yeast) vaccination was on 03-Aug-2001. It was reported that the patient subsequently experienced generalized arthralgia on occasion, and was noted to have elevation of his liver enzymes (lab. date not provided). Unspecified medical attention was sought, and at the time of this report the outcome of the events was unknown. Additional information has been requested. Follow up information was received on 2/28/02. The pharmacist reported that the reactions were not due to vaccination with hepatitis B vaccine recombinant (yeast) (MSD). Additional follow up information was received on 6/10/02. It was reported that the patient did recovered shortly following. No further information is available.
Starting three hours after vaccine, fever 100.5 (lasted four days), never pain in arm where recieved vaccine (lasted three days, aches all over body (lasted four days), sweats and chills (ongoing), sever headaches (ongoing), pain while deep breathing (started three days later, ongoing), nausea and vomiting (lasted three days) and SEVERE hives starting the day after (ongoing and getting worse). Two trips to urgent care, medication for nausea and told to alternate tylenol and ibuprofen for everything else. Given prednisone for hives and told to take Benadryl also, continues to worsen.
person reported 48 hrs of feeling bad after 2nd dose including chills (low body temp); person reported 48 hrs of feeling bad after 2nd dose including chills (low body temp); person reported 48 hrs of feeling bad after 2nd dose including chills (low body temp); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot_unknown=False,, dose_number=1), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), CHILLS (non-serious), BODY TEMPERATURE DECREASED (non-serious) all with onset 25Mar2021, outcome "recovered" (Mar2021) and all described as "person reported 48 hrs of feeling bad after 2nd dose including chills (low body temp)". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of feeling abnormal, chills, body temperature decreased.  Additional information: It was unknown prior to vaccination, was the patient diagnosed with COVID-19.It was unknown since the vaccination, has the patient been tested for COVID-19.It was unknown that patient  received any other vaccine within 4weeks prior to covid-19 and does not have any adverse event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Bright red rash, hot to the touch. Did not burn or itch. Appeared 72 hours after second shot on April 16th. The redness calmed down and faded within a few hours.
Swollen tongue; has affected her speech and she speaks slowly; having a little bit of problem swallowing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 06Apr2022 as dose 1, single (Lot number: FK9893) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWOLLEN TONGUE (non-serious), outcome "not recovered"; SLOW SPEECH (non-serious), outcome "unknown", described as "has affected her speech and she speaks slowly"; DYSPHAGIA (non-serious), outcome "unknown", described as "having a little bit of problem swallowing".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200962221 same product, different dose and event;
1 tonic-clonic sz 5min stopped w/diastat (rectal valium);febrile sz, T103;
Patient was vaccinated on 8/28/21. On 9/3/21 patient broke out into hives over entire body. The patient was seen at a walk in clinic and was given a steroid injection.
pt recv vax 7AUG96 & w/in 1wk of vax pt exp diarrhea, gassiness & abd pain;pt also devel swelling of lt parotid 22AUG96;pt recovered from the swelling of lt parotid 3SEP96;
Information has been received from a 32 year old female consumer with sulfa and shellfish allergies and a history of endometriosis who on 16-JUN-2009 was vaccinated with the first 0.5ml dose of GARDASIL. Concomitant therapy included NORTREL. On 19-JUN-2009, the patient developed a painful, itchy rash on her arms, legs, chest and abdomen. Medical attention was sought by a phone call. There were no lab studies performed. The patient reported that she was now taking BENADRYL and the rash was improving. Additional information has been requested.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN HYPOTENSION ACUTE PULMONARY EMBOLISM
Pt rec. DTaP, HIB, IPV vaccines on 2/23 spiked temp to 104 on 2/26/17 Mom want Rx done.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (sore arm where the shot was given) and arthralgia (sore shoulder) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site pain (sore arm where the shot was given) and arthralgia (sore shoulder). At the time of the report, vaccination site pain (sore arm where the shot was given) and arthralgia (sore shoulder) outcome: unknown. No concomitant medication or treatment information provided. Patient received 2 Moderna COVID-19 doses in the months before. With the booster, patient had soreness in her shoulder too. Patient was still disoriented and dizzy since Friday. Reporter will make patient an appointment with her local GP. Patient was physically fine, walks, but won't drive now because of adverse event. This case linked to MOD-2022-440044 (patient link).
Recieved 4 month vaccine including Tdap at PCP clinic during the afternoon. Patient had a fever in the reaching 102 F. Generalized seisure at home. Transfered to hospital. Had witnessed generalized seizures in ED and on floor. Transfered to the PICU and treated with fosphenotonin, Tylenol.  Defeverenced and returned to baseline.
FEVER; HEADACHE; ACHES; DEHYDRATION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, and expiry: not reported) .5 ml, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced dehydration. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dehydration on 12-MAR-2021, and had not recovered from fever, headache, and aches. This report was non-serious.
ADACEL administered 10/21/14 IM into (L) deltoid. Pt reported feeling achy. (L) deltoid became red, warm, swollen. Reported to facility on 10/24/14.