chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; lump on arm; sore throat; feel like a large lump on the left side of throat and underneath the inside of the throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), SENSATION OF FOREIGN BODY (feel like a large lump on the left side of throat and underneath the inside of the throat), PAIN IN EXTREMITY (sore arm) and MASS (lump on arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy, Fragrance sensitivity (chemical sensitivity to fragrances, especially citrus perfumes), Drug allergy (Allergic to levofloxacin) and Asthma (No major incidents since 2015) since 2005. Concomitant products included BECLOMETASONE DIPROPIONATE (QVAR) from an unknown date to 05-Apr-2021 for Asthma, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Seasonal allergy, UBIDECARENONE (COQ10 [UBIDECARENONE]), VITAMIN B COMPLEX (VITAMIN B COMP [VITAMIN B COMPLEX]), POTASSIUM, IODINE, RIBES NIGRUM SEED OIL (BLACK CURRANT OIL [RIBES NIGRUM SEED OIL]) and PLANTAGO OVATA SEED HUSK (PSYLLIUM HUSKS) for an unknown indication.    On 24-Feb-2021 at 4:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced SENSATION OF FOREIGN BODY (feel like a large lump on the left side of throat and underneath the inside of the throat). On 26-Feb-2021 at 4:00 AM, the patient experienced OROPHARYNGEAL PAIN (sore throat). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and MASS (lump on arm). The patient was treated with BENZOCAINE, MENTHOL (CHLORASEPTIC SORE THROAT [BENZOCAINE;MENTHOL]) (topical) on 26-Feb-2021 for Sore throat, at a dose of 1 dosage form. On 07-Mar-2021, OROPHARYNGEAL PAIN (sore throat) and SENSATION OF FOREIGN BODY (feel like a large lump on the left side of throat and underneath the inside of the throat) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) and MASS (lump on arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient also reported taking an unspecified 24 hour antihistamine concomitantly.   This case was linked to MOD-2021-117024 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jul-2021: Completed ADR Form attached: Concomitant medication added
positive shingles test; This is a spontaneous report from Pfizer-sponsored program,  received from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 14May2021, patient had a positive shingles test. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Pt Right arm with pneumovax had localized reaction. warm raised red.  Pt Left arm warm and Red at injection site
pt developed an abcess to left thigh which needed to be drained.  Comvax was the only vaccine given in that leg.  The pt recieved the vaccine on 05/15/03 and was seen by her physicain on 05/18/03.
Other than soreness in my left arm for the first few days, I did not notice anything else (nor did I look at the injection site). However, today (5 days after the 2nd injection) I noticed my left arm is yellow in color (about 1 inch tall by 2 inches wide), but there is no soreness or any other associated complications.
COVID 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID 19) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart disease, unspecified. Previously administered products included for Product used for unknown indication: J and J (Dose number 1) in November 2020. Past adverse reactions to the above products included No adverse event with J and J. Concurrent medical conditions included Allergy (Unspecified allergy). Concomitant products included ROSUVASTATIN from January 2017 to 19-May-2022 and ASPIRIN [ACETYLSALICYLIC ACID] from January 2017 to an unknown date for an unknown indication.   In August 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID 19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 24-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID 19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) tested positive on day 9.         It was reported that Symptoms was cleared after 2 days of Paxlovid but then returned 8 days later. Device date was given as 31-MAY-2022.  Company comment: This spontaneous case concerns a 64-year-old male patient with no relevant medical history who experienced the unexpected non serious of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 19-May to 24-May. Symptoms cleared after 2 days of treatment with Paxlovid but then returned 8 days later. Patient again tested positive on day 9. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 64-year-old male patient with no relevant medical history who experienced the unexpected non serious of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 19-May to 24-May. Symptoms cleared after 2 days of treatment with Paxlovid but then returned 8 days later. Patient again tested positive on day 9. The benefit-risk relationship of mRNA-1273 is not affected by this report.
This spontaneous report was received from a registered nurse via a company representative and refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions and allergies and concomitant medications were not reported. On an unknown date, also reported as when the patient was 12 years old, the patient received two doses of GARDASIL intramuscularly (lot# and expiration date were not reported) or GARDASIL 9 intramuscularly (lot# and expiration date were not reported). On an unknown date, after receiving the first dose of GARDASIL or GARDASIL 9, the patient developed a "rash, a little itchiness, and a little welt". On an unknown date, after the second dose of GARDASIL or GARDASIL 9, the patient developed a "rash on their face, arms, and chest, and a bigger welt at the injection site". The patient did not seek medical attention. The patient was not given any treatment for the adverse events. The outcome of the adverse events was unknown. The relatedness between the adverse events and GARDASIL or GARDASIL 9 was not reported. Additional information has been requested.
Bruising throughout my body for the first 6-10 months.  Severe nerve pain in my left shoulder blade that radiates pain from a specific area in my shoulder blade up through the left side in my neck and the left side of the bottom of my skull that continues to radiate up the left side of my jaw and temple and behind my left eye and into my forehead. This pain has flare ups and the sever pain flares up and lasts about a month or two, then subsides for a few weeks, then flares up again and lasts for a month or two and this severe nerve pain cycle has continued for over a year now. I told my doctor about it and when I did he ran a few labs and said everything was fine. I work in a pharmacy and feel like if I ever mention my symptoms to any healthcare professional they look at me like I?m crazy. The flare ups are continuing and I am considering seeking a pain or nerve doctor to try to diagnose where this nerve pain is coming from so I can hopefully be treated and get some relief.
NUMBNESS AND LOSS OF SENSATION STARTED ON ONE FINGER OF THE LEFT HAND AND SPREAD TO TWO MORE FINGERS ON THE 3-4 DAYS FOLLOWING VACCINATION
This spontaneous report has been received from a medical assistant, regarding an unspecified number of patients of unknown gender and age. On unspecified dates the patients were vaccinated with improperly stored doses of VARIVAX (lot # L017998, expiration date 19-MAY-2017), dose and route were not reported. No adverse effects were reported. It was reported that the vaccines were exposed at 7F for 12 hours, and there was a past excursion at 36F for another 12 hours. This was recorded as a result of a digital data logger. This is one of two reports from the same reporter. (see MARRS 1606USA005095). Additional information has been requested.
Patient showed up to vaccine appointment for Flu vaccine. Check-in area checked in the patient but missed labeled the vaccine patient should have received. Patient received Moderna Booster .25 instead of  Flu Vaccination. Patients last Moderna vaccine was 3/2021.
pt recv vax;18mar94, devel flu-like sx, described as fatigue & general malaise,w/ a feeling of being run down;devel n,v,d & an erythematous papular rash on upper extremities,shoulders & lateral chest;to MD 30mar94 & sx persisted;
Shortness of breath and increased heart rate, which are ongoing. Shortness of breath was more persistent the next day following vaccination, but still pronounced even with little exertion.
In August 2022, I got what I believed to be a urinary tract infection. I had a pain in right side and back. I had mild cold symptoms. I had one day of fever. It got worse through the week. I went to the emergency department. They did an abdominal CT. I did not have an infection. They gave me steroids. I had a sinus infection. At the time, I was diagnosed with auto immune flare up lichen planus and eustachian tube dysfunction and urticaria. I was seen on 8/22, 8/29 and 9/9. I was given antibiotics, but I was sick for 8 weeks. I did not feel better until the end of October. In January 2023 I had another sinus infection which went away. In early February, I had a sinus infection and double ear infection and began to have an upper respiratory infection. I had a fever and sore throat for one day. I began to cough a lot and short of breath. Friday, February 24, 2023, I had a doctor appointment. I had taken an antibiotic for one week, then another week. I then had an X-Ray. It showed infiltrates in my lungs. I had a CT scan on April 6th which showed pneumonitis, infiltrates, upper airway issues and some swirling effects. I continue to be short of breath, but my oxygen levels are normal.
Narrative:  Admission Date: Oct 6,2021 Discharge Date: Oct 7,2021 Condition of patient at discharge: Stable Primary Diagnosis during Admission/Treatment: COVID-19 Secondary Diagnosis during Admission/Treatment: AKI 71yoM with PMH HTN, HLD, DMII, CAD s/p CABG, GERD, CKD, PAD s/p femoral stent, who presented with 1 week of fever, chills, SOB, and malaise to the Emergency Department. Patient reported one week of shortness of breath that started on Monday 10/4/2021. Then he began to experience global myalgias and fatigue. In the ED, patient was initially hypoxic to 86% on Room Air, improved to 96% on 3L by Nasal Cannula. Otherwise febrile to 100.6F, tachycardic to 115, tachypneic to 24 resp rate. Labs are significant for elevated inflammatory markers ESR:130 CRP:9.14, d-dimer 0.52, creatinine 1.99 (BL 1.4), bicarb 17, ALP 55. CXR demonstrates mild-moderate right lung pneumonia. COVID positive despite being fully vaccinated with Pfizer COVID vaccine on 1/26/2021 and 2/18/2021. He was admitted for further mgmt of COVID-19 infection. The patient was started on dexamethasone and remdesivir as described in this report. The following day, he had no complaints of shortness of breath and was satting in the mid to high 90's on room air. He underwent a walk test with nusrsing staff on room air that afternoon. His lowest SpO2 recorded was 89%. Therefore, remdesivir and dexamethasone were discontinued and the patient was discharged later in the day.
Received COVID vaccine (Pfizer) 3 days prior to admission which was followed by subjective fevers and chills x 2 days but no longer endorses this. Had a headache one day prior to admission that resolved with tylenol. Reports that he has hx HTN but home BPs (which he takes infrequently) have been 140s-150s systolic in the past. Has never been on meds for blood pressure. Chest pain was substernal 5/10 lasted 2 hours and believes it relieved with his blood pressure coming down. Does not describe any other alleviating factors. It was nonradiating, just happens for have left arm pain after vaccine that was present prior to chest pain.
very itchy rash/ feels itchy/ she had rashes on and off anyway prior to the vaccine/ have gotten worse over period of time; very itchy rash/ feels itchy/ she had rashes on and off anyway prior to the vaccine/ have gotten worse over period of time; bladder infection; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 17Feb2021 (Batch/Lot Number: EL8982) (at the age of 68 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included eczema (she has some skin allergies anyway and she has them worse in the wintertime like eczema stuff), rashes, skin allergy. Concomitant medication included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. Patient previously took Nitrofurantoin Mono MCR and experienced no reactions. The patient experienced very itchy rash/ feels itchy/ she had rashes on and off anyway prior to the vaccine/ have gotten worse over period of time and bladder infection. The events resulted to physician office visit. The course of events was as follows: Patient noticed a very itchy rash that goes from her legs to her stomach and back. She stated she feels itchy all the way to the top of her head. She then said she had rashes on and off anyway prior to the vaccine and her dermatologist gave her a cream to use on the rash. She wants to know could that possibly related the vaccine. She got the vaccine last Wednesday which was 17Feb2021. It has been quite a few days since it started. She sometimes has skin allergies anyway and she has them worse in the winter time like eczema stuff so she didn't think too much about it when it started, she thinks it had started by Friday 19Feb2021 but it could have before then. It seems to have gotten worse over period of time. She had an ointment that the dermatologist had given her for a similar situation, but it doesn't seem to be as effective as it was back then when she first got it. She had also been taking Benadryl. She was having bladder infection symptoms and Friday she went to her primary care and he gave her Nitrofurantoin Mono MCR, 100 mg. She says he gave her the prescription Friday 19Feb2021. She says she believes the rash had begun before starting that and she has taken it before with no reactions. The outcome of events very itchy rash/ feels itchy/ she had rashes on and off anyway prior to the vaccine/ have gotten worse over period of time was not recovered while for other event was unknown. Therapeutic measures were taken as a result of events.  No follow-up attempts are possible. No further information is expected.
Information has been received via the Merck pregnancy registry, from a certified medical assistant (CMA) and a healthcare professional (HCP), concerning a 36 year old caucasian female patient, who on 03-JAN-2008 was vaccinated IM with the first dose of GARDASIL (lot #659441/1446U). Concomitant therapy included ZOLOFT. The HCP indicated that on 04-FEB-2008, a colposcopy was performed, due to LSIL (Low grade squamous intraepithelial lesion) (date of onset and diagnostic test not specified). The CMA reported that on 05-FEb-2008 the patient had her LMP, and subsequently became pregnant. On 03-MAR-2008, the second dose, 0.5 ml, IM of GARDASIL (lot #659180/1758U) was administered. The patient subsequently confirmed her pregnancy with a positive home pregnancy test. The patient was seen by the physician (details not specified). The estimated date of delivery was 11-NOV-2008. Additional information has been requested.
Information has been received from an RN regarding a pt who was vaccinated with MMRII. The nurse reported that a consumer told her that the pt, a friend's child, subsequently, had "problems". Additional information has been requested.
Moderna vaccine was administered outside of clinic- reported by patient ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------------------- EPILEPSY, GENERALIZED CONVULSIVE, INTRACTABLE 4/6/2023 LATE EFFECT OF STROKE
Nurse administrating vaccine used the syringe  system provided with the vaccine. Upon removal of the needle, the nurse laid the syringe on the table and simultaneously the patient felt a wet spray on her arm. The patient (an infectious diseases specialist very familiar with vaccine administration) observed that the needle was aimed at her and not retracted at all. The proper use of the brand of safety syringe would result in the needle retracting into the syringe before  the administrator moves the syringe hub off the injection site of the arm. Given the needle was not retracted and the patient was sprayed with fluid, I conclude the patient received at best a partial dose.  I will invalidate this dose in Epic (deleting it with the reasons quantity not sufficient) and order a follow-up visit where the patient can receive a valid second dose. We will not wait any minimum interval between this invalid dose and the valid dose.
Pt presented with redness and some swelling to Rt arm at the site the Pneumo 23 was given. Some tenderness to palpation and slightly warm to touch. Redness measures 6 by 5 in size. Instructed by advice of Provider to apply warm compresses and Ibuprofen. Come back in to reevaluate site to see if redness has grown. Redness marked with black pen.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Medium
Information has been received from a licensed visiting nurse (LVN) concerning a 17-week-old patient who on 19-JAN-2007 was vaccinated PO with the first 2.0 ml dose of Rotateq (human-bovine) (Lot#654969/1016F). It was unknown if medical attention was sought. No adverse experience was reported. Additional information has been requested. This was reported as there was a concern from the patient's mother as a sibling of the patient's developed Steven Johnson Syndrome secondary to medications not vaccine. additonal information is not expected.
Several of the side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2019, the patient received Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was not recovered/not resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received shingrix and had several of the side effects. The patient was looking for medical advice.
Prolonged, unconsolable crying for 1 hr, about 3 hrs /p the injection of DTP vaccine.
Information has been received from a woman working in a physician's office concerning a child who was vaccinated with a dose of Varivax. "Very recently", in 2006, the patient experienced breakthrough chickenpox. It was reported that the child was being boostered. It was also noted that the child was in an unspecified stage of breaking out with lesions. It was reported that the patient's experience was currently ongoing. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow-up information from a physician indicated that he was aware of the breakthrough of chickenpox at the local school, but had "no idea" about any additional information. Additional information is not expected.
patient started experiencing swelling, pain and redness the day after vaccine. got worse and more painful and patient decided to visit doctor. he diagnosed her with cellulitis
Pt received DT booster and had local reaction. Followed by flu like illness. Later had multiple neurological symptoms. Per 60 day follow up: Recipeint has not recovered, has decreased memory, mentation, generalized weakness consistent with encephalopathy. Patient is to be referred to immunologist by her neurologist.
redness; weird feeling in his mouth; lip numbness; loss of taste; sore arm; taste like copper; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), ORAL DISCOMFORT (weird feeling in his mouth), HYPOAESTHESIA ORAL (lip numbness), AGEUSIA (loss of taste) and PAIN IN EXTREMITY (sore arm) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced ERYTHEMA (redness), ORAL DISCOMFORT (weird feeling in his mouth), HYPOAESTHESIA ORAL (lip numbness), AGEUSIA (loss of taste), PAIN IN EXTREMITY (sore arm), DYSGEUSIA (taste like copper) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (redness), ORAL DISCOMFORT (weird feeling in his mouth), HYPOAESTHESIA ORAL (lip numbness), AGEUSIA (loss of taste), PAIN IN EXTREMITY (sore arm), DYSGEUSIA (taste like copper) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
c/o L arm tenderness with slight erythema and tenderness to touch.  Increase fluids.  Motrin and benedryl prn.  F/u with patient provider prn.
This solicited report was received from a 67 year old male patient reporting on himself, as part of a market research program conducted by Research Group. The patient's concurrent conditions included diabetes and bypass (12 years ago). The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection (lot#, expiration date, dose and route of administration were not reported) for shingles prophylaxis. On an unknown date, it was reported that the patient's arm was sore/aching the day after getting the shot and got a little red at the injection site. The outcome of the event was reported as recovered on an unspecified date in MAY 2016 (also reported as gone after 2 days).  The action taken with ZOSTAVAX was reported as not applicable. The reporter considered the event to be related to ZOSTAVAX. Additional information has been requested.