chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Whole left breast and under arm swelled up; Under arm swelled up; Slight fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BREAST SWELLING (Whole left breast and under arm swelled up) and LYMPHADENOPATHY (Under arm swelled up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BREAST SWELLING (Whole left breast and under arm swelled up) (seriousness criterion hospitalization), LYMPHADENOPATHY (Under arm swelled up) (seriousness criterion hospitalization) and PYREXIA (Slight fever). At the time of the report, BREAST SWELLING (Whole left breast and under arm swelled up), LYMPHADENOPATHY (Under arm swelled up) and PYREXIA (Slight fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: normal (normal) Normal.         On the advice of their primary care doctor, the patient went to the hospital for 4-5 hours. The health care professional at the hospital performed an ultrasound and results came back normal. They received a big bill from the hospital visit.   Very limited information regarding these events has been provided at this time. Further information has been requested.   No Concomitant product use was reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
PT DESCRIBES THE NEXT DAY A BRUISE AFTER RECEIVING THE SHINGRIX VACCINE
April 22 - 2PM Took vaccine dose 1 April 23,24,25 - Disturbed sleep, Irritability, Heightened emotions, Anger, Emotional breakdown, Stress, pressure in the head April 26, 27 - fever, chills, lymph node swollen under arms, pelvic region (no fever or chills beyond 27) April 28, 29, 30 - all symptoms except fever chills from 26 or 27, ankle pain, leg pain, severe pain near tailbone, feels bones are breaking, muscle pain May 1,2,3 - same symptoms increasing, dizziness, breathlessness up to 1 min  3 went to doctor
No additional AE reported; The nurse reports that the consumer also received a dose of PNEUMOVAX 23 about 2 years ago; a dose of PNEUMOVAX 23 was inadvertently administered instead of PREVNAR 13; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 13-OCT-2021, the patient was inadvertently administered pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot#T040202 verified as valid, expiration date: 11-SEP-2022) in dose 0.5 ml for prophylaxis (route of administration and anatomical location were not reported). The vaccine was administered inadvertently, instead of pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) (wrong product administered). The nurse reported that the patient also received a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) about 2 years ago, on an unspecified date in approximately 2019 (inappropriate schedule of product administration). No additional adverse events were reported. The outcome of the events was unknown.
Patient developed Shingles and was diagnosed as such despite the fact that she had never had Chicken Pox, only the vaccination.
covid 19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (covid 19) in a 67-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. 059A21A) for COVID-19 vaccination.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:DM, mild asthma. coronary artery disease.  Concurrent medical conditions included Diabetes mellitus, Asthma and Coronary artery disease.    On 08-Jun-2022, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 28-Aug-2023,  after starting SPIKEVAX NOS (SPIKEVAX NOS), the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2023, SARS-CoV-1 test: Positive.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant and treatment medication were provided. Patient had mild symptoms which lasted for 7 days and stayed at home. He took Paxlovid. It took him 14 days before he had 2 negative tests 48 hours apart. He had previous vaccinations of 1st dose on 22Dec2020 with lot number EK5730, 2nd dose on 11Jan2021 with lot number EK1283, 3rd dose on 19Aug2021 with lot number FC3181.
Shoulder and upper arm were tender and  any movement was painful for three days post-shot (Oct. 21-23), then pain slightly improved. Oct. 28, shoulder and upper arm became progressively more painful to move with weakness related to pain.
Child was given a 2nd dose of FluMist and only should had received 1 dose, due to age. Child is 10 years of age. No treatment. Per mother, child had cough noted after adverse event. Symptoms have resolved since adverse event.  Adverse event was reported to health department
pt recv vax 28JUN95 & on 6JAN97 it confirmed that pt had devel a mild case of chicken pox described as raised fluid blisters;
Hives and itchiness all over body, high blood pressure,  agitation, palpitations.  Vaccine administered by pharmacy.  I had to go to the emergency room on 10/22/2021 and was treated with Benadryl, Prednisone, and Ativan.
Pfizer-BioNTech COVID-19 Vaccine EUA: Shortly after administration of Pfizer-BioNTech COVID-19 vaccine patient became dizzy with blurred vision. Vital signs stable. Patient declined emergency department evaluation and left vaccine administration clinic ambulating independently with vision unchanged.
Pt recvd 1 dose of Engerix-B & 6 to 8 hrs p/inject devel bronchospasm & fatigue; lost voice the next morning; lasted 3 days; inject site was warm & reddened; also had a wheeze;
A few days after receiving Zoster vaccine, pt started feeling intense itching and red bunps to scalp. Pt also received flu and pneumonia vaccine on 10/13/2007. After those vaccines also developed body aches, stiff neck and headache. Still experiencing symptoms. Instructed to call doctor to report.
Muscle aches; Passed out; Difficulty breathing; Wheezing; Voice was a whisper; Dizzy eyes glossy; Really dizzy [and weak]; [Really dizzy] and weak; Loss of memory; Fever; This is a serious spontaneous case reported by other non-health care professional (consumer) (reference number: SEQ19-05437) and initially received on 23-Oct-2019, concerning a 40-year-old, female patient.  The patient's medical history included allergies to grains, yeast, corn, melon and grasses.  No relevant concomitant medications were reported.  On 24-Sep-2018, the patient was administered Afluria Quadrivalent [influenza vaccine, route of administration: intramuscular, anatomical location: left deltoid, dose, batch number and expiration date: not reported] for influenza prophylaxis.  On the same day, after vaccination, the patient experienced difficulty breathing, wheezing, voice was a whisper, fever, muscle aches, dizzy eyes glossy.  On the same day, later that afternoon, the patient became really dizzy and weak and passed out in her hotel at about 7pm that evening. The patient also called her mom but did not remember calling her. Patient stated that she was preparing to see an allergist on 06-Nov-2019.  At the time of initial reporting, all events were considered resolved.  The reporter assessed the case as serious and thought that events might be a reaction to the flu vaccine.  The reporter assessed the case as possibly related to suspected Afluria Quadrivalent vaccine.  Company comment: The patient developed loss of consciousness, dyspnoea, wheezing, dysphonia, glassy eyes, dizziness, asthenia, amnesia, pyrexia, myalgia after administration of Afluria Quadrivalent. Chronology is plausible. The patient's atopic constitution may have contributed to development of the events. More information regarding patient's medical history is needed. Based on provided information, causal role of the suspect product is assessed as related.; Reporter's Comments: The patient thought the events might be a reaction to the flu vaccine.; Sender's Comments: The patient developed loss of consciousness, dyspnoea, wheezing, dysphonia, glassy eyes, dizziness, asthenia, amnesia, pyrexia, myalgia after administration of Afluria Quadrivalent. Chronology is plausible. The patient's atopic constitution may have contributed to development of the events. More information regarding patient's medical history is needed. Based on provided information, causal role of the suspect product is assessed as related.
Systemic: Dizziness / Lightheadness-Medium, Additional Details: PATIENT BECAME DIZZY WHILE SEATED AND FELL FORWARD AND HIT HIS HEAD ON THE FLOOR. EMT CAME BY AND ASSESSED. NO ISSUES REPORTED BY EMT. PT REFUSED CARE. EMT ADVISED HIM TO DRINK SPORTS DRINK AND SIT FOR FEW MINUTES. PT SAID HE FAINTS WHENEVER HE GIVES BLOOD OR GETS NEEDLES. GAVE ICE PACK FOR HIS HEAD AND SPORTS DRINK.
0.1ml of the liquid was left over in the syringe; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ACCIDENTAL UNDERDOSE (0.1ml of the liquid was left over in the syringe) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (0.1ml of the liquid was left over in the syringe). At the time of the report, ACCIDENTAL UNDERDOSE (0.1ml of the liquid was left over in the syringe) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: This report refers to a case of accidental underdose for mRNA-1273 with no associated AEs.
Patient received her first dose of the Moderna vaccine. Shortly after ( within seconds) she described feeling nauseous. Staff reported her slumping over in a chair. Prior to the vaccination she informed the vaccinator she has had episodes of fainting with vaccination in the past notably to Gardasil.The vaccinator who was a physician lowered her to the ground in a trendelenburg  position with her legs up in a chair. Patient quickly regained consciousness with a pulse of 65. She appeared pale, diaphoretic, but alert and oriented x4.  She was provided with a cold pack, apple juice and crackers. She was helped into a wheelchair , taken to the post vaccination area and observed for 30 mins by this writer who is a nurse.  She called a friend  to drive her home.
Sore injection site, 102.5 degree fever, dizziness, fatigue, blurred vision.
Headache, Myalgia, Arthralgia, Diarrhea,  NauseaVomiting,  fatigue
Site: Pain at Injection Site-Mild, Systemic: Blood Disorder  (diagnosed by MD)-Mild, Systemic: blood clot in left leg-Mild, Systemic: Weakness-Mild, Additional Details: pt went to er where they found a small blood clot in left leg and put pt on eliquis
Within 15 minutes of the injection, I experienced an irratic and elevated heartbeat, severe nausea, severe dizziness, difficulty breathing, weakness in limbs, and sudden sweating with chills. My sister said my face turned grey. I felt like I would pass out and die. I don't remember much afterwards, but I was taken home and told to rest. I had continued dizziness and bodily ichiness for one week.
Myalgia, Fever FATIGUE; CHILLS; LYMPHADENOPATHY Narrative:
After vaccination red line started to appear above band aid. Band aid removed. the skin was bright red at injection site, and started to spread. Skin hot to touch, Swelling involved Entire upper arm down to elbow joint making movement painful. Redness went around my arm approximately 5 inches long by 3 inches wide. On April 19 redness starting to subside. Arm still hurts, skin color now pink in color still as large as has been.
Pfizer contacted due to diluent error, patient contacted no adverse reactions at the time of reporting
roof of mouth felt numb; heart raced, then felt palpitations; strong headache; face flushed; exhaustion for 36 hours; This is a spontaneous report from a contactable consumer (patient reported herself). A 73-year-old non-pregnant female patient received BNT162B2 (COVID 19, Formulation: Solution for injection, Lot number: EL9269) via an unspecified route of administration on 06Feb2021 11:00 AM at single dose for Covid-19 immunization. The patient's medical history included coronary artery disease (CAD), arthritis and known allergies/allergies. Concomitant medications were not reported. Other medications in two weeks: Yes. Facility type vaccine: facility. On 06Feb2021 11:00 AM, the patient experienced roof of mouth felt numb, heart raced, then felt palpitations, strong headache across eyes and forehead, face flushed and exhaustion for 36 hours. Covid was not tested prior or post vaccination. The patient did not receive any treatment for the events. Outcome of the events was recovered on an unspecified date.
This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 62-year-old female patient who received ENGERIX B (batch number 995J5, expiry date 6th February 2017). In December 2014, the patient received ENGERIX B. In December 2014, the patient received ENGERIX B. In December 2014, an unknown time after receiving ENGERIX B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Office was sent a recall notification from their distributor regarding ENGERIX B and storage temperature. The office has already administered the vaccine to 5 adults. Reporter is not certain what type of excursion took place (high or low temperatures). At this time, no reports to the office have been received from the patients following vaccination. Vaccines were given this week. Follow-up received on 08 December 2014: Age added. Patient got ENGERIX B which was not stable. No adverse event reported.
Information has been received from a health professional concerning a 33 month old female who on 29 OCT 1999 was vaccinated with varicella virus vaccine live. On 18 JUL 2001, the patient presented with a "break-through" chicken pox rash on the trunk of her body, with no fever. The health professional also reported about another patient (WAES #01072287). No further information is available.
Deep vein thrombosis; This spontaneous report received from a patient concerned a 61 year old. The patient's height, and weight were not reported.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: 21-JUL-2021) dose was not reported, frequency one total, at left arm, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-AUG-2021, the patient experienced calf muscles were tight. On 08-AUG-2021, the patient went to the emergency room and was diagnosed with deep vein thrombosis. Multiple locations from calf up to behind the knee. Treatment medications (dates unspecified) included: rivaroxaban. The hematologist were running tests because the cause was unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from deep vein thrombosis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211055705-covid-19 vaccine ad26.cov2.s-deep vein thrombosis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Throat swelling,  Zyrtec at 1240; Epinephrine at 1340
Narrative: Admission Date: AUG 27,2021 Discharge Date: SEP 4,2021 Admit Diagnosis: COVID PNEUMONIA Condition of patient at discharge: Stable 71 yo male presents to Emergency Dept with complaints of fatigue, weakness, myalgias. He reports that he fell earlier due to generalized weakness and just wanted to get checked out. Reports that he tested positive for covid-19 on Sun 08/22 at another urgent care. Reports that he developed a non-productive cough and body aches on Sat 08/21, developed fever and worsening cough on 8/22 which prompted him to seek testing (the first time). He denies fever since 8/22, denies n/v/d/cp/sob/abd pn/back pn/urinary sxs. COVID test positive on admission on 8/27 and CXR with bilateral infiltrates consistent with atypical pneumonia despite being fully vaccinated with Pfizer COVID vaccine on 2/4/2021 and 2/25/2021. Patient completed 10 days of dexamethasone and 10 days of remdesivir while admitted. Patient initially treated for community acquired pneumonia but antibiotics were discontinued shortly after admission due to procal < 0.05. DDimer elevated on admission and patient maintained on therapeutic doses of enoxaparin while admitted. Patient underwent walk test on 9/4 which showed 1L O2 req at rest and 4L O2 req with exertion. At time, he had escalating O2 requirements from 3 to 5L. Patient discharged home on 9/4/2021 with home O2 to isolate until 9/6.
Tingling of limbs, numbness in face and limbs, voice hoarseness, chest pain, nausea, dizziness, mental confusion.
received first dose on 8Feb2021, unsure if she got the second dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received first dose on 8Feb2021, unsure if she got the second dose.) 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 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (received first dose on 8Feb2021, unsure if she got the second dose.). On 08-Feb-2021, PRODUCT DOSE OMISSION ISSUE (received first dose on 8Feb2021, unsure if she got the second dose.) had 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.   No concomitant medications were reported  No treatment drugs were reported   Reporter did not allow further contact
pt father reported that more than 48hr p/vax pt had a 5-hr episode of inconsolable unusual wailing;pt had recovered @ the date of this report;additional info was recv from MD 9MAY97;2 days post vax pt was fussy & not eating well;
No additional AE reported.; A nurse reported V ARlV AX was improperly stored and administered.; This spontaneous report was received from a licensed practical nurse regarding a 4 year old female patient with 2 siblings, birth weight of 6.5 lb. Her concomitant therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II).   Since 02-DEC-2020, the varicella virus vaccine live (oka/merck)(VARIVAX) experienced temperature excursions with a total of 29.5h.    On 13-JAN-2021, the patient was vaccinated with her first dose of this improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) Lot# T017682,  expiration date 21-MAY-2022, subcutaneously in the left arm, for prophylaxis, on a private doctor's office/hospital with private funds.  This is one of several reports from the same reporter (US-009507513-2101USA011364).; Sender's Comments:  US-009507513-2101USA011364:Original Case : 2101USA011364
Left foot pain, numbness started 2-3 days after vaccination.  Foot pain got increasingly worse over the next few days, months, then right foot also started hurting after walking/ standing .
This case was reported by a healthcare professional (nurse) and described the occurrence of international normalized ratio increased in a male subject of unspecified age who was vaccinated with FLULAVAL. Concurrent medications included Warfarin. The nurse documented that reactions experienced with previous flu shots as "last year was Sanofi." It was unclear from the report what this statement meant. On an unspecified date (s) the subject received a dose of FLULAVAL (.5 ml, unknown details). The nurse documented "about 5 men" received FLULAVAL and provided the following as dates of administration: 1 October 2013, 3 October 2013 and August 2013. It was unclear from the report which date the subject received his vaccination. See details for other subjects in case A1045974A. In 2013, at an unspecified time after vaccination with FLULAVAL, the subject experienced international normalized ratio increased. The healthcare professional considered the event was clinically significant (or requiring intervention). The nurse stated that this subject's "event may have been life-threatening if he did not get the proper treatment." Relevant test results included international normalized ratio level taken in 2013 and the result was 11. The subject was treated with vitamin K. At the time of reporting the event was unresolved. The nurse reported another case with FLULAVAL. See case A1045974A for details on the other case.
Raised/swollen red rash around injection point that was warm to the touch, and painful to touch.  Spread/enlarged for two days, then got lighter in color but was itchy for three more days.   Gave Benadryl and applied anti-itch cream to the rash.    Has been bruising easily as well.
Less than 30 minutes after receiving the vaccine she developed itching and redness on her neck, upper chest, and on her right ear lobe.