chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart skipped a beat, then fluttered, then was beating extremely hard for over 24 hours.  I went to the ER, they were unable to find anything wrong.  I did not feel better for several days
Achy arm, heavy arm, pain under arm into breast laying 4 days, diarrhea, achy joints extreme fatigue lasting 5 days, nausea
slept a lot; soreness is like size of Orange; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept a lot), PAIN (soreness is like size of Orange), FATIGUE (fatigue) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN (soreness is like size of Orange), FATIGUE (fatigue) and CHILLS (chills). On 12-Mar-2021, the patient experienced SOMNOLENCE (slept a lot). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (slept a lot), PAIN (soreness is like size of Orange), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  On, 15-Mar-2021 her orange size injection site had shrieked as she used ice pack..
2NOV97 pt recv vax & pre-adm to hosp for chemo;6NOV97 d/c in AM  general weakness, SOB, neuropathy;by 930PM 100% vent dependent, paralysis, tetra plegic;dx & tx for neuroblastoma;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 13:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 72 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Jan2021 at 15:45 as dose 1, single (Lot number: EL9261), in right arm, on 24Feb2021 as dose 2, single (Lot number: EL6201), in right arm, on 02Oct2021 at 14:00 as dose 3 (booster), single (Lot number: FF8841), in right arm and on 08Apr2022 at 10:30 as dose 4 (booster), single (Lot number: FJ9943), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma; "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "hiatal hernia" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Negative, notes: 2 negative rapid antigen tests 48 hrs; (Nov2022) Positive again; (Nov2022) Negative, notes: 2 negative rapid antigen tests 48 hrs. Therapeutic measures were taken as a result of vaccination failure, covid-19: Paxlovid from 01Nov2022 to 06Nov2022.
Patient did not experience any symptoms; a patient was administered a dose of improperly stored VARIVAX that was reconstituted with Merck DILUENT that did not experience a temperature excursion.; Nurse reports route of administration to be "intramuscular" rather than subcutaneous; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were unknown. The patient's concomitant therapy included sterile diluent. On 14-AUG-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) of lot # R002057 with expiry date 22-JAN-2022 via intramuscular route rather than subcutaneous (frequency unspecified) for prophylaxis (incorrect route of product administration and product storage error). The sterile diluent used to reconstitute the vaccine was properly stored. It was reported that the vaccine was exposed to 15-46 degree Fahrenheit (18.3 F) temperature for 1 hour 15 minutes. Previous temperature excursion was at 15-46 degree Fahrenheit (34.5 F) temperature for 2 hours and 33 minutes. Digital data logger was involved. The patient did not experienced any symptoms (no adverse event).
Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: ems called and evaluated pt. determined proper procudure and instructed okay to go home after 15 more minutes-Mild
"A company representative reported that a 2 month old received vaccines on 6/24/00. On 8/13/00, the infant developed a seizure. Seizures are considered "Medically Important".
Administered age appropriate Bivalent instead of Monovalent for correct age, to child who didn't receive Monovalent series.   Contacted family 10/27/22  Mother reports normal side effects and returned to school today.
RHEUMATOID ARTHRITIS; NIPPLE RIGIDITY/HARD; TENDER NIPPLES; BREASTS SWELLING; BREASTS TENDERNESS; LEFT ARM TENDERNESS (INJECTION SITE PAIN); This spontaneous report received from a patient concerned a 57 year old White and not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's past medical history included pulmonary embolism (left side of the lung), and concurrent conditions included lyme disease, alcoholic, non-smoker, and menopause, and other pre-existing medical conditions included the patient had no drug abuse nor illicit drug usage. The patient was previously treated with enoxaparin for pulmonary embolism (left side of the lung- difficulty/trouble in breathing, chest pain and stroke-like symptoms), and Pradaxa (dabigatran etexilate mesilate) for pulmonary embolism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: Unknown) dose was not reported, 1 total administered on 09-APR-2021 on left arm for prophylactic vaccination. Concomitant medications included natural hormones for menopause (antiaging to keep menstrual period as long as possible). The patient felt left arm tenderness (injection site pain) not immediately but 1 day after the patient took vaccine, on 10-APR-2021. The patient had soreness of the arm and the pain was tolerable. Patient stated that on 25-APR-2021, nipple was hard as rock, mostly left nipple (nipple rigidity/hard and tender nipples). Patient called doctor and was prescribed Primrose (Oenothera Biennis) oil pill. On the same day, patient experienced breasts swelling and tenderness, which was worse on the left breast and right breast had minimal pain. Patient stated that wearing bra and T-shirt was painful. The doctor had prescribed anti-depressant to the patient, but patient had refused to take it, not unless needed. On 05-MAY-2021, the patient was diagnosed with rheumatoid arthritis. Patient felt inflammation and pain mostly in the hand. Patient was prescribed meloxicam for rheumatoid arthritis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left arm tenderness (injection site pain) on 23-APR-2021, had not recovered from nipple rigidity/hard, and tender nipples, and the outcome of breasts swelling, rheumatoid arthritis and breasts tenderness was not reported.  This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210421576.; Sender's Comments: V0:20210509036- covid-19 vaccine ad26.cov2.s-Rheumatoid arthritis. 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).
Information has been received from a physician via a company representative concerning a 4 year old white male pt who on 30Aug00 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Concomitant vaccinations on 30Aug00 included a fourth dose of Hib conj vaccine and a fourth dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid into the left thigh. The physician drew a titer for MMR (reported as an MMR Immunity Profile) and it came back on 29Jul03 that this pt had no immunity against mumps (no seroconversion). It was noted that the pt had no adverse events following prior vaccinations. No other information was available. Additional information has been requested.
Developed abdominal pain and vomiting on 12/14/21; seen in our office and diagnosed as early acute gastroenteritis.  Due to worsening symptoms, presented to CHOA ER and was subsequently admitted and diagnosed with HSP (nonthrombocytopenic purpura).  Admission dates of 12/18-12/24/21.  Received IV hydration, pain control and Solumedrol.  Was seen for follow-up after discharge on 12/27/21 and continuing to slowly improve with no nephritis based on normal urinalysis and Creatine (later done during admit).
Bilateral kidney pain (1 day), low back pain (1 day), headache (1 day)
We received the follow information from a foreign regulatory agency: A 20 year old female patient received a second injection of Rabipur (lot # 320011) on 7/22/03 for prophylactic vaccination. The first vaccination occurred on 7/15/03. On the second vaccination day she developed headache, nausea, muscle pain, high fever, neuralgia, back pain and restlessness and was hospitalized. She recovered and was discharged on 7/25/03.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No medical history, concurrent condition or concomitant medication was reported. On an unknown date, the patient was vaccinated with improperly stored VARIVAX (Merck) lot # L026405, expiry date 15-JUL-2017 (dose, route and site of administration were not reported). No adverse effects were reported. No product quality complaint (PQC) was reported. Additional information has been requested.
Information has been received from a 25 year old female patient with polytrim eye drops allergy and a history of a tumor taken out of her chest and blood transfusion at age 4, and nose surgery because of a sinus problem in 2005, who received all 3 doses of GARDASIL. In 2007 (last year) was vaccinated with the first dose of GARDASIL (Lot # not reported). On approximately 15-MAY-2008 (mid May 2008), was vaccinated with the third dose of GARDASIL (Lot # not reported). Concomitant therapy included ADVAIR and "birth control". Around July 2008, the patient got pregnant. The patient is feeling fine, however the ultrasound discovered that the baby has a club foot. The patient also mentioned that before receiving the third dose she had a surgery because endometriosis, and had an ovarian cyst drained. The patient sought unspecified medical attention. Normal laboratory tests and first trimester screen were performed (results not provided). Last menstrual period was approximately on 25-JUL-2008 and estimated delivery date is on 01-May-2009. Upon internal review club foot was determined to a congenital anomaly. Additional information has been requested.
Chills, fever, 40 F, muscle pain, body pain, and cellulitis on right arm.
Patient presented to the ED with complaints of shortness of breath for 2-3 days. She was found to have right lower lobe pneumonia, sepsis, and acute respiratory insufficiency. She was subsequently admitted for further management and discharged home 3 days later in improving condition.
This spontaneous report as received from a physician via field employee refers to a 11 year old male patient. No medical history or current condition was reported. ON 28-AUG-2014 the patient was vaccinated with GARDASIL lot # K009202, expiry 17-DEC-2016, dose 1. No concomitant medication was reported. On 28-AUG-2014, the patient experienced vomiting and light headedness and paleness after receiving the first dose of GARDASIL. The patient sought medical attention by office visit on 28-AUG-2014. There was no product quality complaint. The action taken,  causality and outcome is unknown. Additional information has been requested.
103 fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (103 fever) in a 20-year-old male patient 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 PYREXIA (103 fever). At the time of the report, PYREXIA (103 fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of events was not reported. Concomitant medication use was not provided by the reporter.
pt recv vax on 8/18/98 1 dose of mmr& 1 dose of hepb & 1 dose dtp, on 8/20/98 pt exp swelling ``in front of her right ear'',  swelling extended down pt jaw. pt sought unspecified medical atten.
PROQAD was inadvertently administered to a 49 year old patient; No additional AEs; This spontaneous report was received from a consumer and refers to a 49-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (formulation, strength, dose, anatomical location, route of administration, lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). The reporter did not have any additional information as she stated that the administration did not occur in their clinic. No additional adverse events reported. The outcome of the event was unknown.
Patient has been experiencing soreness and redness that radiated from the injection site on left deltoid to the elbow and shoulder.  It started within 2 days of the injection.  The soreness and redness disappeared from the elbow area and now radiates to the shoulder.  It has somewhat diminished but is still present by day 7.  Patient takes acetaminophen every 4 to 6 hours for pain control.
Rt arm red circular rash 6" x8" inches. Hives systemically -no itch- fever up to 101 degrees little relief with Tylenol- swollen- painful into under arm and breast area. Monday still 6" x 8" circular, headache too, rash painful- fever decreased to 99 degrees. Cellulitis and put on Antibiotics, Not able to take Antitictamines, ocepinphrine, lcartisma.
Information has been received from a nurse concerning a 9 year old female with an allergy to penicillin who on 10-Mar-2000 was vaccinated with a first does and 14-Sep-2007 was vaccinated SQ with a 0.5 mL second dose of varicella virus vaccine live (Oka/Merck) (lot# 658373/1116U). The patient was seen in the office on 17-Sep-2007 and had a 3 inch raised red area at the injection site. The reaction was noticed on 15-Sep-2007. The patient was recovered from the red area on 19-Sep-2007 but the area the injection was given was still visible. No product complaint was involved. This is one of the multiple reports of the same source. Additional information has been requested.
Racy heart, chills, nausea ,slight runny nose,.The racy heat happen several times which I noticed.I was very sleepy and took a short nap around 4 pm which lasted 30 minutes. I got up to start dinner.But as I was cooking I became very nauseated  with stomach cramps.Yikkes .I rested again drank a glass of water and continued making dinner .I had bone broth ,myself  for dinner.
Macular Rash started on neck and chest then began to spread to face, arms, legs. Mother first noticed when picking up from daycare same day child had gotten vaccines.  Got worried and took him to Emergency room because the last time he had a reaction to PCN he began to have respiratory problems.  He was given Prednisone in the emergency room and mother was given a prescription for liquid prednisone to give the child x's two days.
patient came into our office today to receive her Moderna Covid booster.  She was accidently given 2.5 ml of vaccine instead of 0.25 ml by medical assistant.  Patient was observed in the office for 1 hour and did not have any adverse reactions while in office.  Patient was notified of mistake and was instructed to go to the Emergence room immediately if develops any symptoms at all.  Patient verbalized understanding and intent to comply
12NOV92 c/o rash on face back & lt hand c/o itching; rash occurred 6 days p/MMR; pt seen by MD 12NOV92;
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms, generalized aching, teeth chattering, feeling cold, burning skin and pruritus. The patient was treated with Valacyclovir. On an unknown date, the outcome of the influenza-like symptoms, generalized aching, teeth chattering, feeling cold, burning skin and pruritus were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, generalized aching, teeth chattering, feeling cold, burning skin and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller (patient) stated that she had dose SHINGRIX vaccine in early June 2018 in the left arm. The patient sated that she experienced flu like symptoms about 24 hours after receiving the vaccine. The patient felt achy all over, her teeth were chattering, felt cold, and ended up laying in bed for the rest of the day. The patient's symptoms resolved about 6 hours later. The patient started experiencing prodromal symptoms of a shingles outbreak about 10 months (discrepant data, however no clarification could be obtained) after dose of the SHINGRIX. The patient started experiencing burning and itching along her dermatone which prompted her to go to urgent care. The patient was given a 7 day cycle of Valacyclovir and her prodromal symptoms relieved in the first day. The patient was hesitant to receive the 2nd dose of medication as she worries about the side effects. No further information were provided.
Pt. c/o not being able to walk, stated both of her legs very painful.  Pt remained in office for approx. 1 hour and was able to walk to her car.  Called back the next day stating that her legs were still sore but she was significantly improved.
patient reported to pharmacy on thursday 7/18/19 that she was still having sore arm.  redness and swelling at injection site.  patient has been icing and using tylenol for the pain.
Patient came to clinic to receive Moderna Bivalent COVID vaccine on 12/28/22. However, the MDV was  left overnight without any documentation when it was drawn (vial is only good 12 hours after puncture). Patient has been notified and will return in 2 months for another bivalent dose. This event is reported as an administration error, no adverse event.
STIFFNESS IN ARM ALONG WITH DECREASED MOBILITY IN ARM, BRUISING NOTICED ON PM ON 6/17/11.
Information has been received from a registered nurse concerning an 18 year old female with sulfa drugs allergy and no pertinent medical history who on 22-AUG-2008 was vaccinated IM with GARDASIL 0.5 ml. Concomitant therapy included meningococcal vaccine (manufacturer unknown). The registered nurse reported that on 22-AUG-2008 the patient developed generalized itching after receiving her first dose of GARDASIL. On unspecified date the patient recovered. No lab diagnostics were performed. The patient sought medical attention, "AE was mentioned at the next office visit". Additional information has been requested.
Facial swelling and breathing difficulty Benadryl given, placed on 02 by EMS. Transported to hospital.
Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Mild, Additional Details: PT. FAINTED, BUT HER VITALS WERE NORMAL AND LAID HER FLAT ON FLOOR. ACCORDING TO HUSBAND, PT. HAD NEEDLE FEAR AND WHEN SHE GETS ANXIOUS USUALLY FAINTS OR DIZZY. AFTER 3 TO 4 MINUTES , WITH WATER AND GATORADE DRINK, PT. WAS FINE WITH NORMAL VITALS AND LEFT STORE WITH SPOUSE
Diarrhea; Anything I eat or drink comes; I have not had a solid bowl movement; It is interfering with my daily life now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown), for COVID-19 Immunization. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; VOMITING (non-serious), outcome "unknown", described as "Anything I eat or drink comes"; BOWEL MOVEMENT IRREGULARITY (non-serious), outcome "unknown", described as "I have not had a solid bowl movement"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "It is interfering with my daily life now".  Additional information: Consumer stated that the patient had the Pfizer BioNTech, the patient had two other vaccines with one of the booster, had constant diarrhea since, the patient was part of the three percent and the patient need all to send the doctor something, or something because the patient mean it was interfering with the patient's daily life now, the patient cannot. 24 hours almost, anything the patient eat or drink comes, the patient had not had a solid bowl movement since the patient had both vaccines and a booster. The patient had constant diarrhea. The patient had not had a solid bowl movement since the patient had taken vaccine and booster. When clarified the suspect as Pfizer COVID-19 vaccine: Consumer stated, both and a booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Injection site redness, heat slight swelling at site approx 3 1/2" diameter.