chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DVT; MRSA; Left leg swelling; Pain; Hardened leg as hard as a rock; Skin is tight; This spontaneous case was reported by a patient and describes the occurrence of DEEP VEIN THROMBOSIS (DVT) and STAPHYLOCOCCAL INFECTION (MRSA) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Neuropathy and Blood pressure high. Concomitant products included CARVEDILOL (COREG) for Blood pressure high, GABAPENTIN for Neuropathy, DIGOXIN and SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO) for an unknown indication.    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 DEEP VEIN THROMBOSIS (DVT) (seriousness criterion medically significant), STAPHYLOCOCCAL INFECTION (MRSA) (seriousness criterion medically significant), PERIPHERAL SWELLING (Left leg swelling), PAIN IN EXTREMITY (Pain), LIMB DISCOMFORT (Hardened leg as hard as a rock) and SKIN TIGHTNESS (Skin is tight). The patient was treated with APIXABAN (ELIQUIS) ongoing since an unknown date for DVT, at a dose of UNK dosage form; VANCOMYCIN ongoing since an unknown date for MRSA wound infection, at a dose of 1 dosage form and CEFEPIME ongoing since an unknown date for MRSA wound infection, at a dose of 1 dosage form. At the time of the report, DEEP VEIN THROMBOSIS (DVT), STAPHYLOCOCCAL INFECTION (MRSA), PERIPHERAL SWELLING (Left leg swelling) and PAIN IN EXTREMITY (Pain) outcome was unknown and LIMB DISCOMFORT (Hardened leg as hard as a rock) and SKIN TIGHTNESS (Skin is tight) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   For the last 6 weeks, patient was being treated with vancomycin and cefepime for MRSA infection.  Company Comment : 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.; Sender'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.
tightness in chest; Diarrhea; light headedness; total exhaustion; weird heart palpations; heartburn; sleeping all the time; worse with movement and exertion; This is a spontaneous report from a contactable consumer (Patient) reported for herself that:  A 61-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0172) via an unspecified route of administration, on 04May2021 (At the age of 61 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included pericarditis, when she was 19 years old, cardiac disorder, dyspepsia and anaphylactic shock from an unknown date and unknown if ongoing. Concomitant medications included Ipratropium bromide taken for an unspecified indication from 22Apr2021 to an unspecified stop date; Fluticasone propionate taken for nasal drip issues, Mylanta for indigestion, Omeprazole was taken for unspecified indication, hydrochlorothiazide, lisinopril was taken for blood pressure measurement, start and stop date were not reported. On an unspecified date in May2021, the patient had experienced weird heart palpations, worse with movement and exertion, sleeping all the time and heartburn. On 04May2021, the patient had experienced total exhaustion and lightheaded. On 07May2021, the patient had experienced diarrhea. On8 May 2021, the patient had experienced tightness in chest. I am more concerned with the chest tightness because of my history of heart problems and lab test I have been checking my blood pressure and its been within the normal range I just don't know if I should go to the ER. On 09May2021, the event diarrhea was recovered. At the time of reporting, the events weird heart palpation, tightness in chest, light headedness and total exhaustion was not recovered whereas the events worse with movement and exertion, sleeping all the time and heartburn were unknown.  No follow-up attempts are needed. No further information is expected.
expired Ipol was administered with no reported adverse event; Initial information received on 17-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old female patient to whom expired IPV (VERO) [IPOL] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 23-Sep-2022, the patient received 0.5ml dose of suspect IPV (VERO) (strength was unknown, lot T1D482M and expiry date: 25-Jul-2022) via intramuscular route in the right deltoid for Immunization.  On 23-Sep-2022 the patient developed a non-serious event of expired ipol was administered with no reported adverse event (expired product administered) (Latency: same day) following the administration of IPV (VERO).  Action taken : not applicable.  Outcome: Unknown  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 in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
pt reports an uncomfortable  coin-shaped rash developing on face, first along left jaw, and then new lesions appearing on her forehead and scalp. Areas became increasingly irritated, blistered and then became raw and open over 1 week period of time before clearing. Rash recurred along neck, chest wall and torso, following the same pattern with blistering followed by healing. Patient now reports rash on bilateral knees. Using cortisone to treat. No fevers, no mucosal lesions of oral or eye areas. +brain fog, malaise and fatigue
This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 12-NOV-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1780867, expiration date 08-AUG-2023 for prophylaxis (exact dose, anatomical location and route of administration were not reported). While administering the vaccine, the finger flange broke (Syringe broken, poor quality device used) and cut the health care professional (HCP). The patient had no injury and received all of the vaccine (no adverse event). The office manager reported that they still have the defective product and no damage had been noted to the cartoon or that specific syringe before use. There was no difficulty trying to attach the syringe needle to the syringe and the syringe broke during use into 2 or more pieces. The syringe tip cap was attached properly prior to use and the syringe tray was intact and undamaged on receipt. This is a non-valid case due to lack of patient's identifier. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-2111USA008646.
I did not go to the doctor nor did I call the clinic.  My feet/heels started itching slightly that I would itch them into the carpet.  As the itching got worse I checked my feet and there was skin that was loose, looked like a lg blister but it wasn't.  The skin was loose so I started peeling it.  The skin was a bit thick and pulled it almost intact off of my feet.  The itching stopped after that.  This occurred to both feet.  They were slightly tender in areas that rubbed on anything...After that they started healing up.  Did not have increased pain with it...it actually felt kind of good once the layer of skin was removed.  I had the other symptoms also from the shot, really painful arm, overall body aches, arm very sore, kind of nauseated, just didn't feel good, lasted a couple of days then fine after that.  The amount of time it lasted, the feet skin peeling, lasted until I pulled off the entire skin from the heel to the toes and side to side.  After the second shot, there was a little skin left on the upper part of the feet that also became loose and needed pulling off, but this time did not itch.  Also had same ill feeling for about 36 hrs.  I just wanted to report these symptoms in case others were having similar effects.  I don't know if this was d/t the vaccine or not or if it was just a coincident.  I do have a somewhat compromised immune system that makes it take longer to heal sometimes from being ill.  I have severe skin issues that may have been exaserbated by the vaccine.  I just didn't know if this was d/t to the vaccine or not and felt I should at least report it just in case there were others having the same issues.  I didn't get real sick with the feet peeling, just a little pain d/t the skin being raw for a few days until the new skin ...just put lotion on till the skin toughened up.  No actual doctor visit or treatment.
Rash on trunk & back, itching, crying.  Itching only when rash exposed to air.  Rash pink, ubiquitous on trunk--barely macular without obvious vesicles.  Stools ok.  Appitite sl. reduced.  Much better by 1-17 but rash basically unchanged.
Covid-19 Breakthrough Infection  Vaccine Site:  EMP COVID19 CLINIC
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe
Exhausted; Night terrors; This is a spontaneous report from a contactable consumer, the patient. This 51year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3248), DOSE 1, single dose via unknown route of administration in the left arm on 25Jan2021 about 3:45pm (at the age of 51 years-old)  for COVID-19 vaccination. Medical history included ongoing severe asthmatic onset date unknown, probably during childhood but worsened with age and became really bad after hurricane, ongoing irregular heartbeat, ongoing menopause, ongoing food allergies includes banana peppers, jalepenos and nuts; anything spicy; these cause anaphylactic reactions where her throat is itching and swells, ongoing Hashimoto's disease, thyroid, endocrine abnormality and compromises immune system, to keep her brain going through menopause, seizure disorder and high blood pressure. Past drug events included Demerol-Vistaril: ate part of her leg away, top layer of her leg just fell off; she had all the skin done and had plastic surgery to repair this in 1988; Lot/NDC/Expiry: Unknown, does not have product, anaphylactic reactions to: penicillin: Lot/NDC/Expiry: Unknown, does not have product; clindamycin: Lot/NDC/Expiry: Unknown, does not have product; sulfa: Lot/NDC/Expiry: Unknown, does not have product; Darvocet: Lot/NDC/Expiry: Unknown, does not have product; Ceclor: Lot/NDC/Expiry: Unknown, does not have product. There was no family medical history relevant to events, night terrors  and exhausted. Concomitant medications included atenolol 12.5mg taken once daily (1/2 of 25mg tablet) for irregular heartbeat, levothyroxine 125mcg taken once daily for thyroid,  bupropion (WELLBUTRIN) 300mg taken once daily for menopause, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 20mg extended release taken once daily to keep her brain going through menopause, topiramate (TOPAMATE) 25mg taken once daily for seizure disorder and lisinopril 10mg taken daily for high blood pressure.  On 26Jan2021, the patient had night terrors where she started screaming in her sleep at midnight and was exhausted at 05:00 and ongoing. There were no relevant tests. The night terrors and exhausted did not require a visit to the physician's office or emergency room. The clinical outcome of night terrors was recovered with sequel and  not recovered for exhausted. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): None.
Lymph Node swelling in Armpit and pectoral region of left arm, cause pain discomfort, a large bump, and causing arm to not being able to drop fully to side of torso. Just about 2 weeks to finally be able to move correctly, without pain and discomfort.
bloody stools, upset stomach, a lot of gas & gurgling noises, green stools;major discomfort from initial vaccine lasted a week;green stools & gas pains lasted 2months;tx off breast milk & on laimentum formula;
Temperature of 104 /w local rxn described as red /w "knot", also vomiting
Fever; 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 (Fever) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided. No concomitant medications information was reported.   Reporter did not allow further contact
24 hours following vaccination, patient began experiencing "muscle spasms" in arms & legs and "radiating" pain all over her body. In the 3 1/2 weeks that followed, the pain intensified & her muscles tightened so much that even sitting is extremely painful - it was at this point that client sought medical attention.
Red skin rash about 2 inchs x 1 inch about 3 inchs from vaccine site. Seems like what is being referred to as covid arm
About 26 hours after 2nd dose of Covid 19 vaccine I had a series of short intense attacks of pain in my left center chest.  The pain is not as severe as that day but still feels like there is an infection or blockage of sorts in that exact area.
Soreness in her arm; Headache; Hadn't slept much the night before; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Food allergies" (unspecified if ongoing), notes: She used to take Benadryl, Zyrtec and Hydroxyzine.; "hives" (unspecified if ongoing), notes: hives all over her body and it was relentless, it kept getting worse and worse. Concomitant medication(s) included: BENADRYL taken for food allergy; ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for food allergy; HYDROXYZINE taken for food allergy. The following information was reported: HEADACHE (non-serious) with onset 15Mar2021, outcome "unknown", described as "Headache"; INSOMNIA (non-serious) with onset 15Mar2021, outcome "unknown", described as "Hadn't slept much the night before"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Soreness in her arm". Therapeutic measures were taken as a result of headache.  Additional information: Mother calling on behalf of her daughter, aged 17, who received first dose of Pfizer BioNTech Covid 19 Vaccine, 18 days later she had a headache, during her period and had not slept much the night before. She used to take Benadryl, Zyrtec and Hydroxyzine would work but once she goes off the medications her allergies come back but when she was on them, she was super tired. Other products were not provided. This past summer the daughter started breaking out in hives all over her body and it was relentless, it kept getting worse and worse. Every doctor that they saw said to take this or that and all these medicines made the patient so sleepy, and she could not function, and she was a kid and she need to be awake and do her work. Anyways her daughter got the first Pfizer COVID vaccine, and she was fine. She was fine, she just had soreness in her arm. Then, 18 days later, so a bit after the COVID vaccine she got a headache. The caller thought well there is starch in Ibuprofen so her daughter should not be taking it because of the starch.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a pharmacist referring to a currently 23 year old patient of unknown gender. Information of pertinent medical history and drug reactions/allergies was not reported. On an unknown date, the patient was received an improperly stored dose of VARIVAX (lot # R008394, expiration date: 20-MAR-2020, strength and frequency were unknown) subcutaneously for prophylaxis. Sterile diluent (lot # and expiration date were unknown) used to reconstitute was properly stored. The vaccines was exposed to temperature of 15 F to 46 F (19F) for 1 hour 30 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.
Shortness of breath. Joint pain redness and swelling to arm. Hard to concentrate. Fever 102.0.
Information has been received from pharmacist concerning a patient who on unspecified date was vaccinated with the third dose of RECOMBIVAX HB (Lot number not reported). It was reported that on 2-JUL-2008, the patient experienced coughing and swelling of the face and lips. The patient did not experience any problems with previous RECOMBIVAX vaccinations. The patient sought unspecified medical attention by seeing the physician. At the time of reporting, the patient was recovering. Additional information has been requested.
pt recv vax 21OCT95 & 23OCT95 pt became ill & c/o nausea, vomiting & chills;pt has recovered;
Patient felt faint, dizzy within 2 minutes of receiving first dose of Moderna Covid-19 vaccine. Appeared very pale, slow to respond. Called for medical assistance. Dr. responded. Patient found to have pulse of 68, complained of tightness of chest. 911 called - EMS responded. Patient given oxygen and taken ED with father.,  12/01/2020. Dosage No: 1.
Day 3: some swelling at injection, little aching and feverish. Took Tylenol and felt better, after fever broke during the night. Same on day 4. Didn?t feel normal over the weekend, but no concerns. Day eight arm really hurt  and  was red and swollen. Felt aching and feverish...took Tylenol fever broke. Arm became worse. Redness began spreading over the arm and became more swollen. Wellness saw me on day nine. She advised Benadryl and ibuprofen. Fever broke that. Health department finally called back on day ten and said it was normal. My body is just doing what it is supposed to do. Today is day 12 and the redness and swelling is almost at my elbow around my arm. Shot location is now a bruised area. Everything else is red.
Headache, Fever, Body Aches, Nausea, Chills, Asthenopia, fatigue for 36 hrs
Intermittent chest pain and aches starting 1 day after the vaccine and still occurring at this time.
Notified by local Registry of Immunization Transactions that this dose of monovalent vaccine was no longer recommended by FDA.
On day 8 injection site swelled, became hot and itchy.  Resolved in 48 hours. On day 14 large red welt, circled the injection site and is very itchy.  Also have itching on back, face and head.   I have not gone to clinic or doctor, but am concerned about weather I should get the second shot.
dizzy,room was going round and round; weak; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy,room was going round and round) and ASTHENIA (weak) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 013M20A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced DIZZINESS (dizzy,room was going round and round) and ASTHENIA (weak). At the time of the report, DIZZINESS (dizzy,room was going round and round) and ASTHENIA (weak) was resolving.            No Concomitant medications were reported.  No Treatment information was reported.
Information has been received from an RN concerning a patient who has an allergic reaction after being vaccinated with a dose of Gardasil vaccine (yeast). The patient's outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2007.  Initial and follow up information has been received from an RN concerning a 16 year old female student who on 14-DEC-2006 at 5:00 P.M. was vaccinated IM in left deltoid with her second dose of GARDASIL, lot #653736/0868F.  The patient developed an allergic reaction after being vaccinated (onset reported as the morning of "05-DEC-2006"), an itchy rash on the inside of her arms.  She was treated with BENADRYL and recovered.  Additional information is not expected.
Muscle and joint pain - 9:30pm 04/06/2021 - 6pm 04/7/2021 Headache - 9:30pm 04/06/2021 - 10am 04/9/2021 Chills - 3:30am 04/07/2021 - 6:00 am 04/7/2021 Fever - 3:30 am 04/07/2021 - 12pm 04/7/2021 Nausea - 9:30pm 04/06/2021 - 3pm 04/8/2021 Vomiting - one instance 7:30am 04/07/2021
breasts kind of swollen; back of nipples sore; breasts kind of swollen; back of nipples sore; 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), intramuscular, administered in arm right, administration date 24Feb2021 11:00 (Lot number: EL9267) at the age of 72 years as 1st dose, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BREAST SWELLING (non-serious), NIPPLE PAIN (non-serious) all with onset 26Feb2021, outcome "not recovered" and all described as "breasts kind of swollen; back of nipples sore". Additional information: RA number and Expiry Date of Pfizer COVID 19 vaccine were unknown. Reporter noticed a couple days after receiving the shot his breasts were kind of swollen, like back in his nipples, it was kind of sore and has stayed sore. He was asking had Pfizer seen this type of reaction before, He was assuming it was from the vaccine. He has read that some females had had some gland issues and under their arms with lymph nodes. He had also read something about mammograms being falsely read. Reporter declined to include a healthcare professional. Reporter explained he noticed this swelling and soreness in his breasts/nipples about 48 hours after receiving the shot, clarified as 26Feb2021. He clarified it was like a lumpy feeling back in his nipple area and its sore to touch. He stated this had stayed about the same. Vaccine Administered was not at Facility. No additional vaccines was administered on same date of the Pfizer suspect. No visit to emergency room or physician office was required. No prior vaccination in four weeks was there and no adverse events following prior vaccination occurred. No relevant lab tests were there.  No follow-up attempts are possible. No further information is expected.