chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blood clot in Left Arm; itchy rash from elbow to shoulder; lump on the underside of her biceps; nauseous; couldn't lift arm up; arm sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot in Left Arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included CLONAZEPAM for Anxiety, STEROIDS for Back disorder, CITALOPRAM and MORPHINE SULFATE for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm sore at the injection site). On 24-Mar-2021, the patient experienced MOVEMENT DISORDER (couldn't lift arm up). On 25-Mar-2021, the patient experienced RASH PRURITIC (itchy rash from elbow to shoulder), MASS (lump on the underside of her biceps) and NAUSEA (nauseous). On 27-Mar-2021, the patient experienced THROMBOSIS (Blood clot in Left Arm) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clot in Left Arm), RASH PRURITIC (itchy rash from elbow to shoulder), MASS (lump on the underside of her biceps), MOVEMENT DISORDER (couldn't lift arm up), NAUSEA (nauseous) and VACCINATION SITE PAIN (arm sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Benadryl for symptoms and Eliquis for blood clot.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
7/17/2008 4 AM (approximately) patient went to the bathroom to check and wash her eyes, as she picked up her head, she felt dizzy and started to see black, woke up in hallway. Hit right side of face and nose, cut to nose and mouth and confirmed broken nose (hospital ER visit at 4 PM on 07/17/08). Also swelling, bleeding to nose.
After receiving 5th DTaP in right thigh x 2 days developed redness and then has spread to area size of baseball non-tender. Tx with Septra x 10 days.
pt recv vax & exp muscle weakness, pain @ inj site, fatigue, flu like sx, n & d;the pharmacist reported that two other pt received the first shot of vax from he same vial & they exp the same sx;they were assigned WAES 96090111 & 96090112;
Almost a week after receiving the shot, both my upper arms started itching.  Within a few days, the itching got worse and a red, bumpy, splotchy rash developed on both upper arms.  I took allergy medication and used a steroid cream I have on hand for eczema to help with the itching.  The itchy rash lasted about a week and then slowly cleared up over the course of the next week.  I called  about it, but was told over the phone that it was normal - no one examined me or asked for photos, etc.
Hives; Allergy; This is a spontaneous report received from a contactable reporter(s) (Physician), Program ID: (RA).  A 49-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Drug Allergy", start date: 31Mar2023 (unspecified if ongoing); "Allergies: Tomato", start date: 31Mar2023 (unspecified if ongoing); "Itching", start date: 31Mar2023 (unspecified if ongoing); "Rash", start date: 31Mar2023 (unspecified if ongoing); "Swelling", start date: 31Mar2023 (unspecified if ongoing). Concomitant medication(s) included: IBRANCE oral, start date: 30Apr2023. The following information was reported: HYPERSENSITIVITY (medically significant) with onset 17Jul2023, outcome "unknown", described as "Allergy"; URTICARIA (medically significant) with onset 17Jul2023, outcome "unknown", described as "Hives".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the events urticaria, hypersensitivity and suspect drug BNT162B2 cannot be excluded.
This case was considered medically important. Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer, the mother of a male patient who as 15 months of age, received a fourth dose of Prevnar, At 26 months of age, the child developed pervasive developmental disease. No medical history or conditions. Indication for Prevnar was immunization. Product was administered on Sept 09 2003. Dose regimen was 1 dose 1 time per day (intramuscular). Additional suspect medication included Hib-Titer vaccine (haemophilus B conjugate vaccine (diphtheria crm 197 protein conjugate) injection). Patient was not taking concomitant therapy. On Sept 09 2003, the patient received a dose of Prevnar. The mother reported that around 1 and 1/2 years of age, her son lost speech and eye contact and doctors used the term regressive autism. In Aug 2004, at 26 months of age, the child was diagnosed with pervasive developmental disease (autism spectrum disorder). The patient had not recovered. No additional information was available at the time  of this report.
Initial information received on 27-Nov-2018 regarding an unsolicited valid non-serious case received from a physician via email. This case involves an Adult female patient (age not reported) who experienced migraines four days after injection, while she received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s),family history and concomitant medications were not provided. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number, expiry date, dose, dose in series were not reported) via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious migraines (migraine) after four days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. No lab test was reported.  Final diagnosis was migraines four days after injection. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for migraines four days after injection. Document held by the sender: none
BODY PAIN, FATIGUE, SORE INJECTION SITE, HOT FEET
NOTICED SHOULDER REDNESS AND SORENESS FOR OVER 1 WEEK FROM TIME OF RECEIVING SHOT FOR TWINRIX. Jan 25th, started to feel achy and stiff knees. Jan 26th, wrists and elbows started to feel sore and achy - started to take ALEVE to relieve from pain. By Jan 28 toes, ankles, knees, elbows, wrists and fingers were extremely stiff and extreme pain and discomfort. Feet and hands began to swell - feet showed signs of redness and became extremely and uncontrollably itchy. Used ice packs and ALEVE for relief. By Jan 30th, itchiness, swelling of hands and feet continued, extreme joint stiffness could barely stand up and walk across the room. Began researching "post vaccinal arthritis". Feb 1 - flight exacerbated swelling of hands and feet. Notified doctor of symptoms - suggested to take ADVIL. Feb 2 - iced swollen hands and feet for hours at a time and took ADVIL (3 pills every 6 hours) - extreme. Notified Health Clinic - responded response on Feb 5th by FNP, BC, Clinic Operations of Health stating that the symptoms I was experiencing were abnormal and "Systemic symptoms involving the joints are not typical following vaccine administration and to seek immediate medical care". Feb 5th - noticed some improvement in stiffness and itchiness of feet - felt a slight bit more mobility in joints, took ADVIL, drinking Fiji water (silica mineral water), ginger/garlic supplements for inflammation. Feb 8th - further improvement in mobililty, swelling reduced in feet, hands still extremely stiff and achy in knuckle joints. Feb12 -significant improvement - some discomfort in hands, all other joints improved.
pt recv vax; chest pain w/ chest wall hematoma, coagulopathy, asthma, acute flu like synd; coagulopathy : interaction between rubella vaccine and cumadin therapy;
26JAN96 pt recvd vax & 7FEB96 devel hives & itching over entire body denies any other c/o adverse rxn;phone call to pvt MD who prescribed DPH which appears to be taking care of the problem
Janssen COVID-19 Vaccine EUA ,      Accelerated Heart Rate of 115 / 120,   Acclerated Respirations, Fever with temp of 101.6 lasting for 23 hrs, Extreme body aches, headache, feeling very tired, minor dizziness, minor nausea
Developed fever and significant thigh redness and swelling overnight, fever and discomfort have improved, redness and swelling persist, diagnosed as large localized reaction without systemic symptoms
Night of vaccine, I started getting flu like systems at 11:30pm, achy but no temp. Next day I felt like I was hit by a mack truck and spent the day in bed until 5:30p m. Througout the night and still last night I perspired profusely having to change my pjs 3 times. On day 5 after shot, my arm started itching for several days with a red band around my arm just below where the shot was given. Then a week later on Fri. 4.16, I came down with a head cold at night and flu like symptoms on Sat. 4.17.  Sun. still achy with chills and 99.5 temp. My son had a head cold for several days that I must have caught but hit me worse. My son had a Covid test which was negative. Wondering if I should get one just to be safe?
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 08-AUG-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J009788, expiration date 17-MAR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
heart rate shot up; terrible bran fog/ tired; jaws were extremely tight; TERRIBLE taste; fever; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on the right arm on 30Mar2021 at 08:30(at the age of 43-year-old), as a single dose for COVID-19 immunisation. Medical history included no thyroid, raynaud's (autoimmune). The patient has known allergy to levaquin. Concomitant medications were not reported. The patient had received medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on the left arm on 09Mar2021 at 08:30, as a single dose for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 10:00, the patient experienced terrible bran fog/ tired, jaws were extremely tight, TERRIBLE taste in the mouth,100 temperature, these all cleared up by the next morning. On 31Mar2021, the next day the patient thought was fine to exercise (run) but then experienced heart rate immediately (less than 1/2 mile in) shot up to 170 and hovered there even when slowed pace, once the patient quit running heart rate returned to normal quickly. The patient guessed getting winded very easily was the complaint. The patient did not receive any treatment for the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events terrible bran fog/ tired, jaws were extremely tight, terrible taste, fever and heart rate shot up were recovered on 31Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a registered nurse regarding an unspecified number of patients greater than 26 years old age, who was vaccinated with a dose of GARDASIL (dose, route and lot number were not provided). No adverse symptoms reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned on this report. Additional information will be provided if available. Additional information has been requested.
The evening after shot she developed pain from her left shoulder to elbow. Pain was not relieved with tylenol. Still has some discomfort on the day of this report. This report received RN
3/10: felt fine 3/11: arm sore and red 3/12: tired 3/13 and 3/14: tired, chills, nausea, h/a, right mid-back pain, fever as high as 102.3 3/15: still low fever 99-101, tired, nausea, h/a. but feeling a little better. new mild diarrhea.
pain in shoulder for 5 or 6 days, 2 day after receiving the shot he had a severe pain on left side of his neck
HCP stated that when she was administering the vaccine to the patient the liquid leaked between the needle and the syringe and she does not know the volume administered (not a full dose); HCP stated that when she was administering the vaccine to the patient the liquid leaked between the needle and the syringe and she does not know the volume administered (not a full dose); This spontaneous case was received on 28-Feb-2022 from pharmacist via Regulatory Authority (reference number: SEQW22-00775) with additional information via Product Technical Complaint (PTC reference number: 1096593) (being processed together) on 01-Mar-2022 and concerned patient of unreported age and gender.  The patient's medical history and concomitant medications were not reported.  On 27-Feb-2022, Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent) liquid leaked between the needle and the syringe, during vaccination for influenza prophylaxis (explicitly coded as 'Syringe leak'). The batch number reported was P100386145 and expiry date 30-Jun-2022. The reporter was not sure how much of the vaccine was administered to the patient (explicitly coded as 'Incorrect dose administered') (dose: 0.5 ml, route of administration, anatomical location: no reported). The patient did not receive any treatment measures.  At the time of initial reporting on 28-Feb-2022, it was not reported whether the patient experienced any adverse reaction since administration.   The case was assessed as non-serious.  Company comment: The patient was vaccinated with Flucelvax Quadrivalent. Reportedly, liquid leaked between the needle and the syringe, during vaccination. The reporter was not sure how much of the vaccine was administered to the patient. It was not reported whether the patient experienced any adverse reaction. Syringe issue and Incorrect dose administered are assessed as not related to the vaccine and related to the luer lock syringe.; Sender's Comments: The patient was vaccinated with Flucelvax Quadrivalent. Reportedly, liquid leaked between the needle and the syringe, during vaccination. The reporter was not sure how much of the vaccine was administered to the patient. It was not reported whether the patient experienced any adverse reaction. Syringe issue and Incorrect dose administered are assessed as not related to the vaccine and related to the luer lock syringe.
This spontaneous report received from a health care professional concerned multiple patients (five patients) of unspecified age and sex.  The patient's height and weight were not reported. The patient's medical history or concurrent conditions were not reported.  The reporter stated that, none of the 5 patients had a history of cardiovascular issues. The patient's received JANSSEN COVID-19 VACCINE Ad26.COV2.S (suspension for injection, unspecified route, batch number:  1805022 expiry:  25-MAY-2021),  dose was not reported,  administered on 11-MAR-2021 for COVID-19 vaccination.  No concomitant medications were reported. On 08-MAR-2021, it was noted that, the package insert was blank. On 11-MAR-2021, five patients experienced hypotension, and were hospitalized.  A public health manager reported that, she had 5 cases of hypotension after administering Janssen COVID 19 vaccine.  The action taken with COVID-19 vaccineAd26.COV2.S was not reported.  The patients were recovering from hypotension and the outcome of package insert was blank was not reported. The report was associated with product quality complaint number 90000172674. This report was serious  (Hospitalization Caused / Prolonged) .
It was reported to me by the pharmacist who was on duty on April 6, 2021 that the patient presented to the pharmacy on April 6, 2021 for her COVID-19 vaccination and was anxious prior to the appointment. The patient stated that immediately after receiving the vaccination, she felt a shooting pain in the injection site. The patient stated that within a few minutes, she felt lightheaded and nauseous. The patient then stated that within 20 minutes, she felt like she was having an asthma attack and had to use her rescue inhaler (albuterol HFA). It was reported that the patient left the pharmacy about 45 minutes after receiving the vaccination and the patient stated she was feeling better. The patient the reported to the pharmacy that the morning of April 7, 2021 that her symptoms of shortness of breath and wheezing returned and she went to an emergency room for treatment. The patient stated that after admission into the ER, the medical staff performed two EKGs and one chest X-ray, which were unremarkable. The patient stated she received treatment with Duoneb because she was wheezing and and treatment with IV methylprednisolone because her throat and tongue appeared swollen. The patient stated she was discharged on April 7, 2021 and was prescribed albuterol solution for nebulization and prednisone 10 mg tablets.
Pt recv vax on 10/17/97; on same day pt exp fever, chills, malaise; tx=Motrin
positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms; This is a spontaneous report from a contactable Other Health Professional and a contactable consumer (patient). A 58-year-old female patient received both doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/batch number and Expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient had no event from vaccine. She tested positive for Covid after receiving vaccine and had another test performed that came back negative.  The outcome of events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: A contributory role of BNT162B2 to event tested positive for Covid after receiving cannot be excluded based on temporal association and limited information.
No adverse event; Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster).    No concomitant medication was reported.    Patient received vaccine at an off site clinic.Pharmacist stated that they called the CDC and they were instructed to go ahead and administer the other half of the dose (0.25ml) on the same day. No treatment information was reported.  This case contains information for the 12th adult patient out of 15 adult patients described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2022-658139, MODERNATX, INC.-MOD-2022-658149, MODERNATX, INC.-MOD-2022-658150, MODERNATX, INC.-MOD-2022-658154, MODERNATX, INC.-MOD-2022-658155, MODERNATX, INC.-MOD-2022-658156, MODERNATX, INC.-MOD-2022-658157, MODERNATX, INC.-MOD-2022-658159, MODERNATX, INC.-MOD-2022-658162, MODERNATX, INC.-MOD-2022-658168, MODERNATX, INC.-MOD-2022-658173, US-MODERNATX, INC.-MOD-2022-658160 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658139:Adult patient 1 US-MODERNATX, INC.-MOD-2022-658149:Adult patient 2 US-MODERNATX, INC.-MOD-2022-658150:Adult patient 3 US-MODERNATX, INC.-MOD-2022-658154:Adult patient 5 US-MODERNATX, INC.-MOD-2022-658155:Adult patient 6 US-MODERNATX, INC.-MOD-2022-658156:Adult patient 7 US-MODERNATX, INC.-MOD-2022-658157:Adult patient 8 US-MODERNATX, INC.-MOD-2022-658159:Adult patient 10 US-MODERNATX, INC.-MOD-2022-658162:Adult patient 13 US-MODERNATX, INC.-MOD-2022-658168:Adult patient 14 US-MODERNATX, INC.-MOD-2022-658173:Adult patient 15 US-MODERNATX, INC.-MOD-2022-658160:Adult patient 11
Fever 102.9  at 1:45pm  Ibuprofen 400mg given at 1:50pm
She came to the hospital 2/10/22 with a chief complaint of chest pain.  She had substernal chest pain, sharp in nature, 5 to 6/10, associated with some nausea but denies any episodes of vomiting.  Had some episode of near-syncope.  Felt extremely flushed and restless.  Her heart rate was in 180s according to her.  She does have a history of supraventricular tachycardia.  She called the clinic of her cardiologist Dr.  and was advised to come to the hospital for further evaluation and treatment.  Denies any fevers, chills, cough.  Denies any abdominal pain, burning or painful urination, diarrhea.  Discharged 2/11/22.  Vaccinated with Moderna 4/1/21, 6/19/21
Initial report was received from a health care professional on 23 September 2011. This case is one of a cluster of three patients who experienced adverse events following administration of FLUZONE HIGH-DOSE, lot number UH452AB. The events for the other two patients were captured in cases 2011-09288 and 2011-09290. A female patient (name and date of birth not reported) who was reported to be greater than or equal to 65 years of age with a history of A fib, had received on 09 September 2011 an intramuscular right arm injection of FLUZONE HIGH-DOSE, lot number UH452AB and within minutes, complained of her left ear felt hot, felt warm, flushed, she had chest discomfort lasting approximately two to three minutes and an irregular pulse. The patient was transported to the ER (emergency department). She was evaluated, treated and released. Treatments were not reported. Diagnostic test included a normal EKG and her systolic blood pressure was increased to 200. No further information was available at the time of the report. The patient's outcome was recovered. Follow-up information was received from a healthcare professional on 31 October 2011. The patient received corrective treatment within a hospital. No further information was available at the time of the report. Documents held by sender: none.