chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cyst in their right ear; Liquid pulsed from it in their ear; This spontaneous case was reported by a consumer and describes the occurrence of CYST (Cyst in their right ear) and OTORRHOEA (Liquid pulsed from it in their ear) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009D21A and 049C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROXYZINE HYDROCHLORIDE (VISTARIL [HYDROXYZINE HYDROCHLORIDE]), VENLAFAXINE HYDROCHLORIDE (EFFEXOR), GABAPENTIN and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CYST (Cyst in their right ear) and OTORRHOEA (Liquid pulsed from it in their ear). At the time of the report, CYST (Cyst in their right ear) and OTORRHOEA (Liquid pulsed from it in their ear) had not resolved.            The patient stated that a couple of days after the second dose patient noticed a cyst in their right ear, and had liquid pulsed from it in their ear. And consulted with an HCP who prescribed ear drops.
Fainting 15 hours later, bright red face, shaky despite eating. Felt better after taking Benadryl.  Also premedicated with Benadrayl before the vaccine and after because of medical history.
LETHARGIC/TIRED; NO APPETITE; MINOR ARM SORENESS; CHILLS; SLIGHT FEVER; SLIGHT NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced lethargic/tired, no appetite, minor arm soreness, chills, slight fever, slight nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from no appetite, and the outcome of minor arm soreness, chills, slight fever, lethargic/tired and slight nausea was not reported. This report was non-serious.
Patient's mother called clinic >24 hours after vaccines and and notified us that the patient had developed hives around 24 hours after vaccines were administered. She noted they started on his legs and had started to spread to his arms and torso. No other symptoms were reported. Mother took patient to a local urgent care where he was treated with Benadryl and a steroid (according to mother). Within 8-12 hours hives had almost completely resolved. Mother reported patient was slightly more tired than usual, but otherwise had no other symptoms or different behaviors. Mother reported that patient has returned to normal self after all treatment.
Mom reports that approximately 45 minutes following injection of vaccines last Friday, patient developed diffuse body hives. On arrival home, approximately 1.5 hrs after injection, had several episodes of vomiting/diarrhea. Mom gave Benadryl x2 doses, unsure of dose amount for hives with improvement. Patient never developed wheezing or respiratory distress. No other treatments. Tmax 102.6 that evening. No fevers since that time. Mom also noted red, induration along left thigh where patient received injections. That area has become smaller and less tender. Mom has been massaging the area.
Fever (Tmax 102F 2 days after shingles vaccine administration) and redness, warmth, tenderness at injection site. Fever deffervesced day 3 after injection. Redness persists at this time (day 4).
Left arm swelling that is from the forearm distal part of the arm to the end where elbow is.
Information has been received from a physician concerning a patient who was vaccinated with varicella virus vaccine live.  In September 2005, the patient developed breakthrough, which was described as a mild case with less than 30 lesions.  The lesions were reported as maculopapular in nature.  The adverse event was improved and the patient is recovering.  No further information was available regarding the adverse event.  There was no product quality complaint reported  The patient sought unspecified medical attention.  Additional information has been requested.  The physician reported that the patient's sibling also developed breakthrough following vaccination with varicella virus vaccine live.
One day post vax, the pt complained of feeling confused for several hours, also states her legs were wobbly and that she had a fever and aches. These lasted about 3 hours.
A non-serious spontaneous report of "slight shortness of breath, nasal congestion, runny nose, coughing, rash on arms, rash on palms, slight headache and sneezing" has been received from a consumer concerning himself, a 42-year-old male, subsequent to FLUMIST. The patient's medical history included seasonal allergies in spring (started in 2003), FLUMIST administration in 2009, experiencing cold symptoms in 2009, and no known food or drug allergies. The patient was treated with fluticasone/salmeterol for asthma symptoms for a month in 2003 and takes fluticasone propionate in April/May every year. The patient received one dose of FLUMIST on 11-Sep-2010 at 11:15 am. On 12-Sep-2010, in the evening, the patient experienced slight headache and nasal congestion. On 14-Sep-2010, he had an abrupt nasal congestion, coughing, rash on palms and arms which went away in approximately two hours. On 14-Sep-2010, around noon, he started sneezing repeatedly. There was a lot of clear nasal discharge, and he was not able to breathe through the nose. It was followed by coughing and slight shortness of breath. The patient also developed rash on the inside his palms and on upper arms. He took some nasal decongestant phenylephrine hydrochloride, 5 mg two times a day, and the symptoms subsided within two hours. He also used diphenhydramine later on the same day. All cold symptoms disappeared by 16-Sep-2010. The patient visited an allergy specialist and in his opinion, the reaction was not allergic in nature but rather a severe manifestation of cold symptoms. All events resolved.
pt recv vax; low grade fever started immed; apap q 4 hr; to er;no cause found through tests done;pt still w/ low grade T;
Angioedema BLOTCHY REDDENED SKIN, MILD SENSATION O TONGUE SWELLING/ANGIOEDEMA Narrative: EMPLOYEE COMPLAINED OF SENSATION OF MILD TONGUE TINGLING/SWELLING WITH BLOTCHY SKIN. EMPLOYEE EXCORTED TO OCCUPATIONAL HEALTH BY NURSE MANAGER, AFTER 11 MIN OF VACCINATION ADMINISTRATION, EMPLOYEE RECEIVED 50MG BENADRYL AND WILL CONTINUE TO BE MONITORED BY HEALTH STAFF.
(L) arm sore, fever 102. Chills, malaise, vomiting, nausea. To MD 10-23-10 Tx with LEVAQUIN for sinus infection.
tested positive for Covid this week; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid this week) in a 62-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 000000) for COVID-19 prophylaxis.     The patient's past medical history included Blood pressure high (High blood). Previously administered products included for Product used for unknown indication: COVID-19 vaccine (1st dose) in January 2021, COVID-19 vaccine (2nd dose) in February 2021, COVID-19 vaccine (3rd dose) in November 2021, COVID-19 vaccine (4th dose) in July 2022, PFIZER BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/5) (5th dose) on 15-Oct-2022, COVID-19 vaccine (6th dose - late Mar-2023) in March 2023 and Albiterol. Past adverse reactions to the above products included No adverse event with Albiterol, COVID-19 vaccine, COVID-19 vaccine, COVID-19 vaccine, COVID-19 vaccine, COVID-19 vaccine, PFIZER BIONTECH COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/5). Concurrent medical conditions included Asthma.  On 26-Sep-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 03-Oct-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced COVID-19 (tested positive for Covid this week). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 04-Oct-2023 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for Covid this week) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Oct-2023, Body temperature: Eleveated temperature at 99.5. On 03-Oct-2023, SARS-CoV-2 test: Positive and Negative. On 04-Oct-2023, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient received new vaccine last Tuesday, 26-Sep-2023, and tested positive for Covid this week. He stated that he was not blaming the vaccine for this and in fact he was pro vaccine. He asked if this negates the effect of the vaccine since he had the disease very close to the time, he got the vaccine.  On 02-Oct-2023, the patient started having symptoms of scratchy throat and elevated temperature at 99.5 and took a home test on 03-Oct-2023 which turned positive. He went to an Urgent Care where they took a "quick test" and a PCR. The quick test turned negative, and he was still awaiting for the results of the PCR. He again did a home test on Wednesday, 04-Oct-2023 which was still positive. He was taking Paxlovid, and he states that his symptoms are negligible, and he is attributing it to the vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-744329 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744329:Mother's case, Same reporter
It was reported that a 41 year old male sustained a trampoline injury and was treated for a broken nose and stitches. The pt was given a TD booster in the right deltoid. Reportedly, the pt was fine until 6-7 days later, at which time he developed an intermittent pain in the right forearm; severe enough to awaken him during sleep at night. The pain is reportedly not subsiding.
I loss 7 pounds due to my diarrhea; my food is not digested everything I eat is not digested; Diarrhea; Magnesium low; my heart skip beat like it was skipping one beat skip; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 66-years-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EW0150, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 10Apr2021 12:00 as DOSE 2, SINGLE for covid-19 immunization (at the age of 66-year-old). Medical history included diabetes mellitus from an unknown date, and blood pressure high from an unknown date. Concomitant medications included metformin (METFORMIN) 1000 mg twice a day taken for diabetes mellitus, from an unknown start date; and lisinopril (LISINOPRIL) 10mg taken for hypertension, from an unknown start date. The patient previously received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EN6205, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 10Mar2021 12:00, as DOSE 1, SINGLE for covid-19 immunization (at the age of 66-year-old).   On 15Apr2021, the patient experienced diarrhea like for two weeks, 2-3 times a day and then patient started on probiotic (Further clarification unknown), then patient was ok for like 4 weeks and now patient was having diarrhea everyday once or twice. And that caused patient's magnesium to go down, it was also reported he experienced heart skip beat like it was skipping one beat skip, skip and patient ended up in emergency, but patient's magnesium was low because of diarrhea they did stool test everything came back negative, DNA stool test the other test. The patient reported that he lost 7pounds of weight due to the diarrhea during the 3 months prior to this report (last 3months). The patient had lab test on an unknown date which included blood cholesterol results were less than 139, blood magnesium was low, full blood count results unknown, A1C (glycosylated haemoglobin) was 6.9, Stool analysis was also negative, patient had weight loss in 3months. On an unknown date, the patient also experienced that food was not digested every-thing he eat was not digested. The patient had to take therapeutic measures and the patient was on probiotic but it was not helping. The outcome of the events was unknown.   Follow-up attempts were completed. No further information was expected.
Patient called pharmacy 3/3/18 2 PM to report AE. She stated she had pain/soreness starting 5:30 PM on 3/1. Also, she noticed redness above injection site which partially wrapped around arm. Less pain on 3/3. On 3/4 - Rash resolving, pain only when pressing on site.
Symptoms developed over days following vaccine.  Unusual arm soreness, followed by "pain" that moved from neck to shoulder to back, then chest per pain.  Patient was concerned and asked to report the symptoms.
aches in joints & muscle area x 3 days w/temp 99-101 consistent 100 temp x 3 days;
covid positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (covid positive) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (covid positive). At the time of the report, SARS-COV-2 TEST POSITIVE (covid positive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information provided.
Tachycardia, rapid resp, ha, nausea, body aches, o skin painful to touch, fever
Starting 2 hours after the vaccine, I began having chest tightness, shortness of breath. I felt light-headed. Heart palpitations. My trachea felt very constricted. I couldn't expand my lungs. A lot of inflammation in my chest area & respiratory tract. I have still been having breathing difficulties and chest pain since the vaccine.
Swelling; Pain; Erythema; Skin warm Information has been received from a Certified Medical Assistant (CMA) concerning a 63 year old female with allergy to tetanus vaccine, depress and acid reflux (esophageal) and a history of hysterectomy, sinus operation and kidney stone who on 19-OCT-1-2005 was vaccination with 0.5ml pneumococcal 23v polysaccharide vaccine (lot #650454/0751P) subcutaneously. Concomitant therapy included lansoprazole (Prevacid), venlafaxine HCL (Effexor) and imatinibmesylate (Gleevec). On 19-OCT-2005 the patient experienced swelling, pain and hot skin to touch. The patient was treated with cephalexin (Keflex). The symptoms persisted and on 21-OCT-2005 she went to the emergency room for treatment with unspecified IV antibiotics. The patient was not hospitalized. It was reported that the patient was recovering. Follow up information has been received from a CMA concerning the 63 year old white female vet tech with high blood pressure and gastroesophageal reflux disease who on 19-OCT-2005 was vaccinated in the right arm with a dose of pneumococcal 23v polysaccharide vaccine, lot # 651524/0605R (lot number confirmed, the CMA state when she pulled the patient's chart to fill out the follow up form she saw that the lot number was different than originally reported). On the same day, the patient was vaccinated in the left arm with a dose of influenza virus vaccine (unspecified). It was reported that subsequently on 20-OCT-2005 the patient developed "red, hot swelling" that radiated down her right arm and that required an office visit for an oral antibiotic and an ER visit for IV antibiotic. The patient recovered.  Additional information is not expected.
I had a fever that went up to 101. I had chest and nasal congestion. I had a headache and felt fatigue; after the first 48 hours.
pneumonia; pneumonia; This is a spontaneous report from a contactable physician via Pfizer sales representative. This physician reported similar event for two patients. This is the first of two reports.  An elderly male patient of unspecified age but over 65, received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose and pneumococcal vaccine polysacch 23v (PNEUMOVAX), via an unspecified route of administration on an unspecified date at unknown does, both for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced pneumonia on an unspecified date and was hospitalized. The outcome of the event was unknown.  The information on the batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.  Further information like confirmative pathological/serotype results are needed for full medical assessment.,Linked Report(s) : US-PFIZER INC-2019241924 same reporter, different patient, same product and event
SWOLLEN RT UPPER EYELID AND SWOLLEN SITE OF RT. DELTOID WHERE 2 SHOTS (PROQUAD AND PEDIARIX) WERE GIVEN. CAREGIVER BROUGHT BACK TO CLINIC AT ABOUT 4:45 P.M. AND EVALUATED BY DOCTOR TO HAVE THE ABOVE - NO WHEEZING OR SOB NOTED; JUST THE ABOVE SSX) AND GIVEN EPIPEN 0.15 MG IN RT. THIGH. ABOUT 15 MIN. LATER CHILD STATED SHE COULD FEEL SWELLING COMING DOWN IN EYELID AND RT. FOREARM AND NOTED TO HAVE DECREASED SWELLING, AND SHE WAS D/C HOME.
Patient stated that later the same evening her bottom lip swelled up, then her left jaw and cheek swelled up also. She called the next morning and said she was still swollen.
Several pts were weakly positive p/ recving series of 3 hep B vax.Pts seroconverted p/ recving booster vax.
2 weeks following first Moderna vaccine noticed red rash and tenderness in vaccine arm. Redness extended toward elbow. Headache and arm achiness. No fever.
Redness at injection site - soreness at injection site - swelling at injection site - sore throat on same side as injection.
Pain at fingertips (left hand); Numbness at fingertips (left hand); Fingertips turned blue (left hand); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain at fingertips (left hand)), HYPOAESTHESIA (Numbness at fingertips (left hand)) and SKIN DISCOLOURATION (Fingertips turned blue (left hand)) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient experienced PAIN IN EXTREMITY (Pain at fingertips (left hand)), HYPOAESTHESIA (Numbness at fingertips (left hand)) and SKIN DISCOLOURATION (Fingertips turned blue (left hand)). At the time of the report, PAIN IN EXTREMITY (Pain at fingertips (left hand)), HYPOAESTHESIA (Numbness at fingertips (left hand)) and SKIN DISCOLOURATION (Fingertips turned blue (left hand)) outcome was unknown.            Patient went to emergency room and had some tests but didn't figure out what happened exactly. No concomitant medications was reported. No treatment drug details was reported.
a few days after my covid shot my right should be to hurt.  I am left handed and have had a torn rotor cuff in my left arm and now my right arm where the shot was given is having the same painful symptoms as a torn rotor cuff.  Before the shot i had absolutely no problems with my right arm
Woken up with heavy chest pains for 2 days while recovering after second COVID vaccine.
Metallic taste in mouth as it was being administered. I told them I could taste it.   Eyes started hurting with burning sensation, pressure in both ears and slight numbness across face from ear to ear and under nose.  Uncomfortable tightness in chest and a lot of pressure on face feeling like it was hot. I felt a little better after 15 minutes while waiting but never told anyone about symptoms. I walked out and drove home but monitored my symptoms.  The symptoms gradually became less and were gone after 1 hour and 45 minutes. I took a dose of benadryl at that time.  I slept well that night and woke up with no symptoms and none since.
The wrong diluent was mixed with vaccine.  Medical assistant used the wrong diluent - sterile diluent (sterile water) instead of the sterile solution (citrate bicarbonate buffer) when mixing the vaccine. Administered with to patient with sterile water
Arm pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist stated that the patient received Shingrix vaccine and continues to experience arm pain.  The pharmacist did not provide any additional information. There is discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Presented for 1st dose Moderna  COVID vaccine at 1350.   Approximately 20 minutes following administration of  vaccine, complained of dry mouth, feeling of thickness in tongue, and fullness in throat. Able to drink water, speak clearly, and no signs of respiratory distress.   1402  BP 148/96  HR 102 Pulse oximetry 99 1405  Administered 50 mg Diphenhydramine IM RD  1410  States right side of throat less thick and tongue and left throat unchanged.  Speech clear and not in respiratory distress  1411  BP 150/88  HR 88  Pulse oximetry 98 1440 States throat and tongue unchanged 1440  Patient phoned family to accompany home  1442  Paged Emergency for consultation  1445  Team arrived  1445  BP 144/88  HR 77  Pulse oximeter 88  1446 Response team administered Epinepherine pen 0.3 mg/ml  Lot 0FM501  1447 Patient conversing with team  1450  Reports throat and tongue improved  1500  Ambulated to bathroom  1515  States no symptoms of fullness in mouth or throat 1515  BP 154/88  HR 100  Pulse oximetry 98   Instructed to follow up with her provider for follow up  1516  Daughter accompanied patient upon discharge home
Arterial occlusion right axillary/proximal brachial artery Thrombus right internal jugular vein
Patient started to retain water. Her eyes were puffy. On June 16 2014 she was diagnosed with nephrotic syndrome. 4.5 weeks later she has kidney biopsy and we found out she has FSGS.
Swelling and pain in the arm at injection site,  plus Soreness and light pain from shoulder to elbow, now in its second day.
Within 6-8 hours of both vaccine shots and now the booster I experienced a fever up to 102 degrees, chills, sweats, joint pain, headache, and fatigue. I could not get out of bed for two days and had to miss work.
Bilateral tinnitus, starting on April 2, 2021.  Consistently present since then, although spiking up and receding at times.