chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling of right breast; Swelling around past surgical site on left foot; Severe swelling in lymph nodes of right armpit, right neck, right jaw; Fatigue; Nausea; Fever (101.5 F); This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via unspecified route of administration in right arm, on 14Mar2021 at 16:45 (at the age of 29-years-old as a single dose for COVID-19 immunisation. Medical history included asthma, allergies to peanuts, tree nuts, fish, shellfish, sesame, strawberry, mango, vanilla, insect stings and other environmental, also had allergies to medications iodine, penicillin, clindamycin, human papillomavirus (HPV) Vaccine and latex. The patient underwent surgery (unspecified). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included escitalopram 20mg (MANUFACTURER UNKNOWN) and cetirizine 10mg (MANUFACTURER UNKNOWN) these medications were used within 2 weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via unspecified route of administration in the right arm on 21Feb2021 as a single dose for COVID-19 Immunisation. On 15Mar2021 at 02:00 hours, the patient experienced severe swelling in lymph nodes of right armpit, right neck, right jaw, swelling of right breast, swelling around past surgical site on left foot, fever 101.5 degrees Fahrenheit, fatigue and nausea. No therapeutic measures were taken for the events. The clinical outcome for severe swelling in lymph nodes of right armpit, right neck, right jaw, swelling of right breast, swelling around past surgical site on left foot, fever (101.5 F), fatigue and nausea was not recovered. No follow-up attempts are needed. No further information is expected.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild
PSORIASIS FLARE UP ON LEGS; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (PSORIASIS FLARE UP ON LEGS) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (PSORIASIS FLARE UP ON LEGS). At the time of the report, PSORIASIS (PSORIASIS FLARE UP ON LEGS) outcome was unknown.            Concomitant medication was not reported.  Patient skin was almost completely clear. Patient took the Moderna vaccine and had a flare up on legs. Patient believed it was a direct cause of the vaccine. Treatment details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Toes got tingly the evening of shot. Tingling next day progressed up the legs to the knees on day 2. Day 3 in the evening, symptoms started to regress. By the end of the week all but tingling in toes was gone. In 2015 I now only have tingling & numbness in one big toe.
I am experiencing a Brain Fog and feeling scared, anxiety and cannot concentrate to do my job.  Please help me.  It has been 1 week since I took the shot and I am still feeling this way.
Febrile x 24hrs with increased WBC to 17.3. Rx'ed with antibiotic. Improved after 24hrs after vaccination.
Severe headache, body aches, chest hurt.  Tired.  lasted for 7 days, took Advil and tynelol, went into the Dr. office on Monday Oct. 4, bloodwork, flu test along with Covid test, both came out negative.  Still have headaches but not as severe. and get tired easily.
Weakness, dizziness, rash on shoulders, shortness of breath for 4 weeks after injections.
EYES FELT SWOLLEN/ RANDOM FEELING OF EYES BEING FULL OR SWOLLEN, EVEN THOUGH THEY DID NOT APPEARED SWOLLEN; GLOSSY AND RED EYES AS THOUGH SHE HAD BEEN CRYING; This spontaneous report received from a patient concerned a 33 year old female. 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced eyes felt swollen/ random feeling of eyes being full or swollen, even though they did not appeared swollen. On 24-MAR-2021, the subject experienced glossy and red eyes as though she had been crying. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eyes felt swollen/ random feeling of eyes being full or swollen, even though they did not appeared swollen, and glossy and red eyes as though she had been crying. This report was non-serious.
I went into the doctor for my med check and asked her because i was feeling a lot of day time fatigue, sleepiness and weakness. She did bloodwork and my thyroid level was off.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.   Additional information has been requested.
day after second vaccination  I experienced fever, migraine, Chills, muscle soreness, chest pains , fatigue, loss of appetite.
I have Vertigo and the second week after my shot began having  mini dizzy spells throughout the day. This had been happening  for  a few days. I usually  do not have many episodes for months at a time .
arm is sore and tender again; itchy; hot to touch,hot; red in color about 2-3 inches in diameter; itchy rash; red rash; pain under arm; sore lymph node(which is still sore to date); headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (pain under arm), LYMPH NODE PAIN (sore lymph node(which is still sore to date)) and TENDERNESS (arm is sore and tender again) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced HEADACHE (headache) and PAIN IN EXTREMITY (sore arm). On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain under arm) and LYMPH NODE PAIN (sore lymph node(which is still sore to date)). On 21-Apr-2021, the patient experienced TENDERNESS (arm is sore and tender again), PRURITUS (itchy), FEELING HOT (hot to touch,hot), ERYTHEMA (red in color about 2-3 inches in diameter), RASH PRURITIC (itchy rash) and RASH ERYTHEMATOUS (red rash). On 30-Apr-2021, RASH PRURITIC (itchy rash) and RASH ERYTHEMATOUS (red rash) had resolved. At the time of the report, HEADACHE (headache), PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (pain under arm), LYMPH NODE PAIN (sore lymph node(which is still sore to date)), TENDERNESS (arm is sore and tender again), PRURITUS (itchy), FEELING HOT (hot to touch,hot) and ERYTHEMA (red in color about 2-3 inches in diameter) outcome was unknown.        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.   This case was linked to MOD-2021-225207 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: No specific follow-up information recorded.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/16/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
She was given an adult dose of Hepatitis A vaccine (1.0cc) rather than the pediatric/adolescent dose. CDC contacted. Their response "We do not expect to see a serious reaction. Second dose (pediatric Hepatitis A) should be given in six months."
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medications, pertinent medical histories and drug reactions or allergies were not provided. On unknown dates, the patients were administered improperly stored PNEUMOVAX 23, lot # M042324 with expiration date on 10-JUN-2018 (doses and routes of administration were not reported). Administered doses of vaccines underwent a temperature excursion from 47 degrees Fahrenheit to 77 degrees Fahrenheit (56.3 degrees Fahrenheit), which lasted for 3 hours and 51 minutes. There was no previous temperature excursion reported. A digital data logger was not involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007887: US-009507513-1709USA005504.
a patient was administered two doses of FLUZONE High Dose Quadrivalent after 10 days by mistake from 2 different nurses with no AE; Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist via Medical Information (MI) (Reference number- 00309495).   This case involves a 93 years old male patient who was vaccinated with two 0.7 mL doses of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number: UJ470AB expiry date 30-JUN-2021) via an unknown route and left deltoid administration site on 29-Sep-2020 and left deltoid administration site on 08-Oct-2020 for prophylactic vaccination (extra dose administered) respectively by 2 different nurse.  Medical history, medical treatment, vaccination, family history were not provided.   Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) in arm.  It was a case of an actual medication error due to extra dose administered (latency unknown).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Myalgia bilateral leg and right ankle pain, reports calf tightness and cramping to lower extremities Narrative: developed bilateral leg pain, tightness of calf muscles within one hour of receiving vaccine. Headache on 12/23/2020
ED to Hosp-Admission  Current 10/25/2021 - present (10 days) Hospital NSTEMI (non-ST elevated myocardial infarction  Patient presents with ? Syncope     1. NSTEMI in the setting of CAD.  Admit to general medical floor, monitor on telemetry.  Trend troponins to peak, check 2D echocardiogram.  Consult cardiology for evaluation.  Started on heparin infusion, will continue for now.  Continue aspirin, statin, beta-blocker. 2. Syncope x2.  Monitor on telemetry, check orthostatic vitals.  Gentle IV hydration support, monitor BMP.  Check TSH.  Obtain neurology evaluation. 3. COVID-19 infection.  Covid testing is positive on admission.  Patient is tolerating room air, not requiring supplemental oxygen.  Monitor clinically for now.  Supportive care with Tylenol, albuterol inhalers. 4. Hypothyroidism.  Continue Synthroid per home regimen, Check TSH. 5. Paroxysmal A. Fib.  Continue beta-blocker.  Normal sinus rhythm on admission.  Hold Eliquis, patient to be placed on heparin infusion. 6. Type 2 diabetes.  Continue long-acting insulin per home regimen.  Will place on insulin sliding scale and Accu-Cheks per protocol. 7. History of kidney transplant.  Continue tacrolimus, CellCept per home regimen. 8. History of CVA.
An attorney reported that a 54 year old male, received an injection of Flu Shield (1998-1999 Formula) on 11/17/1998 and within 10 days, developed vomiting and diarrhea. He was seen by the MD on 11/30/1998. The reporter indicated that "it was believed at that time that he had some type of virus". On 12/6/1998, the pt was admitted to the hospital due to general paralysis; he was unable to move his hands, arms or legs. The pt was paralyzed for months and was dx'd "as suffering from Guillain-Barre Syndrome". He was transferred to a rehabilitation center on 12/22/1998 for long term rehabilitation. He was discharged on 6/30/1999 and received physical therapy at home for 4 to 6 weeks. The pt continues to be weak and disabled; he is unable to walk in a "normal fashion" and is only able to ambulate with the assistance of a "stand-up" walker for very short periods of time. The pt is only able to lift a few pounds of weight with either arm or hand. This report of a serious, labeled event is being submitted in a 15-day time frame, as requested.
Sore arm started after 12 hours and became hard and itchy 3 days later. Sore, bruised, and red 6 days after injection.
The patient had a seizure 6 hours after the vaccine was given to him. The patient was given the vaccine at 1 PM and had a seizure at 7 PM.
LIGHT-HEADED, NAUSEA. GIVEN CRACKERS. PATIENT FELT MUCH BETTER PRIOR LEAVING.
17x14cm hard swollen area, red, warm and tender to touch. Pt placed on Cephalexin 250mg/5mL, 10mL TID for 7 days. Pt was given BENADRYL and TYLENOL in office also.
Large local reaction, approx 5 inches in diameter, red, warm, swollen, painful, itchy.  Swelling and pain of middle interphalangeal joint of left second finger.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022; Patient received vaccine past its 30 day expiry date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 day expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     It was reported Acute illness at the time of vaccination and up to one month before and Chronic or long-standing health conditions were unknown.     On 31-Jan-2022 at 1:32 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Jan-2022 at 1:32 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 day expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 day expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at time of vaccination and/or at the time of adverse event were unknown. Other vaccine given on the same day as that of Moderna vaccine was unknown. Other vaccines received within one month prior to any dose of Moderna COVID-19 vaccine was unknown.  A patient was administered vaccine past its 30 days expiry date vaccine went into 2 to 8 Celsius thaw state on or about to 24-Dec-2021, this vaccine administered was until its manufacturing (Mfg) expiration date of 04-Apr-2022. Patient received the booster dose of vaccine on 31-Jan-2022, with manufacturer expiry date 04-Apr-2022.  No treatment medication information provided.
Walked out to get the mail 5 hours after receiving the vaccine.  Feeling fine, just some soreness in the arm.  Had collected the mail in my hand and the next thing I knew I was on the pavement in the street.  My face took the brunt of the fall after fainting/blacking out.
Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a 6 month old male patient who experienced fever as high a 103 degrees F and became irritable. At 6 months of age, the patient received the third dose on 2/10/2005. The patient previously experienced pyrexia and agitation while taking Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection). Indication for Prevnar was immunisation. Product was administered on 2/10/2005. Dose regimen was 1 dose intramuscular. Concomitant medications were not reported. A mother reported that her son developed fever as high as 103 degrees F (pyrexia) and became irritable (agitation) on 2/10/2005 after receiving a Prevnar injection. The child recovered within a couple days. See related case HQWYE270407SEP05 Adverse event, non expedited, and HQWYE997413OCT05 adverse event, non expedited). No additional information was available at the time of this report.
Fever, Vomiting, Diarrhea, inconsolable crying, stomach pain, and unusual fussiness.
Some dizziness, definite muscle weakness and "brain fog". Still has symptoms 5 days after injection.  Loss of appetite, lethargic. Despite having diabetes, vigorous and usually works out at least 5 days a week at the gym. Since having Covid, he has had difficulty regaining muscle strength. We purchased an oxygen fingertip meter and oxygen sat has been consistently at 98-99%.  These symptoms are similar to when he had Covid 19 in May/June of 2020. We were advised to get the shot even though we already had it.
Subsequent to receiving varicella virus vaccine live the pt developed a local reaction characterized by erythema. Additional information has been requested.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications of the patients were not provided. On unspecified dates, the patients received improperly stored dose of GARDASIL 9 Lot # M017983 and expiration date: 30-MAY-2018 (dose numbers, dose and route of administration were not reported) for prophylaxis. The vaccine underwent a temperature of 35.6 Fahrenheit during 10 minutes, detected by data logger. No previous temperature excursions were reported. Additional information has been requested.
her eyes are swollen; her body is itching; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient) reported for herself. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 08Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient received her 1st dose of the vaccine 08Apr2021 but when she woke up on 11Apr2021 (today), her eyes are swollen and her body is itching. Outcome of events was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Severe rash all over my body; Swelling and tingling of tongue and lips; Swelling and tingling of tongue and lips; Swelling and tingling of tongue and lips; slight heart beat increase; have a big bump on my left arm that is warm to the touch; have a big bump on my left arm that is warm to the touch; This is a spontaneous report from a contactable other health care professional reporting for herself. A 56-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6202, Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 27Feb2021 13:30 as single dose for covid-19 immunization. Medical history included type 2 diabetes mellitus, essential tremor and patient reported she had too many allergies to list. The patient had COVID prior to vaccination. Concomitant medication included chromic chloride, cinnamomum spp., gymnema sylvestre, thioctic acid (DIABETES). The patient did not receive any other vaccine in four weeks. Patient tested COVID post vaccination. On 27Jan2021 13:45 the patient experienced and reported that, "severe rash all over my body, swelling and tingling of tongue and lips, slight heartbeat increase, I still have a big bump on my left arm that was warm to the touch". Therapeutic measures taken as result of adverse events: treatment included Benadryl and Motrin. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal swab test) negative on 31Jan2021. The outcome of events was not resolved.  No follow-up attempts are possible. No further information is expected.
7 days later macular and fewer popular red rash in groin and arm and right ear. no fevers or illness.
About 30 minutes after receiving her first dose of Moderna Vaccine, she started to feel burning in her mouth, swollen tongue, and taste of metal.  In the weeks to follow, it progressed to burning/tingling lips.
patient had COVID vaccine on 01/12/2021 -on 01/13 and 01/14/2021 arm pain on the injection side, left arm - 01/15/2021 arm pain improving, developed headaches, tiredness - 01/16/2021 subjective fever, chills, fatigue - 01/17/2021 at the telephone conversation with urgent care provider: low grade fever, Temp 99.0, chills, sweating, fatigue