chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEADACHE; FEVER; FATIGUE; BUMPS ON THE HAND, FINGER AND WRIST THAT LOOK LIKE MOSQUITO BITES; ITCHY BUMPS; This spontaneous report received from a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, expiry: UNKNOWN) .5 ml, administered on 11-MAR-2021 10:00 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced itchy bumps. On 11-MAR-2021, the subject experienced bumps on the hand, finger and wrist that look like mosquito bites. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 12-MAR-2021, and had not recovered from headache, itchy bumps, fatigue, and bumps on the hand, finger and wrist that look like mosquito bites. This report was non-serious.
severe swelling of lips and tongue, severe itching and rash; severe swelling of lips and tongue, severe itching and rash; severe swelling of lips and tongue, severe itching and rash; severe swelling of lips and tongue, severe itching and rash; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732), dose 2 via an unspecified route of administration, administered in arm left on 22Apr2021 12:30 as 2nd dose, single for covid-19 immunisation. Medical history included fibromyalgia, ongoing diabetes type2, non-Alcoholic Cirrhosis, ongoing Chronic fatigue syndrome (CFS), spinal degeneration, hypo thyroid, gallbladder removal, hernia repair, hysterectomy, restless leg syndrome, sleep apnea, Known allergies with Wellbutrin, Naltrexone, tape. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198) administered in arm left on 23Mar2021 12:30 for COVID-19 Immunization. The patient reported to ER with severe swelling of lips and tongue, severe itching and rash on 30Apr2021 09:15. The adverse event result in emergency room/department or urgent care. The patient received treatment (IV of Solumedrol and Benedryl) for the adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Covid test post vaccination with Nasal swab and result was negative. The outcome of the events was resolved with sequelae.
Patient had an allergic reaction . Onsite EMS was called vitals BP 154/56  97% O2 room air HR 58   Patient treated, released  home against medcial advice.
COVID-19 with symptoms (patient tested positive for Covid); COVID-19 with symptoms (patient tested positive for Covid); This is a spontaneous report from a contactable consumer (patient's wife). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration administered in Arm Right on 13Sep2021 (Lot Number: FB8448) at age of 46-year-old at single dose, dose 2 via an unspecified route of administration administered in Arm Right on 04Oct2021 (Lot Number: FB8448) at age of 46-year-old at single dose for COVID-19 immunisation. Medical history included ongoing thyroid disorder diagnosed maybe two years ago. The patient's concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks prior to the first administration date of the suspect vaccine. The patient experienced covid-19 with symptoms (patient tested positive for COVID) on 06Oct2021. Caller stated because she and her husband got first vaccine on 13Sep2021 both got second dose on 04Oct2021 and late 06Oct2021 caller stated her husband was having what they thought were side effects, stated he had a high fever, was very sick, he was unable to get out of bed exhausted, coughing, thought it was side effects, caller stated he went to the doctor this morning and has tested positive for COVID, caller told him that because it was so soon after getting the vaccine he should call Pfizer to report. Caller clarified her husband tested this morning, 12Oct2021 at 10:15 AM. The AE(s) did not require a visit to emergency room. The outcome of the events was not recovered.
Per email received on 1/18-So I had my first dose of Pfizer?s covid vaccine last Friday (3pm). I experienced several side effects that day: lightheadedness, dizziness, fainting, nausea, throat constriction leading to shortness of breath and difficulty in swallowing, hives, flushed face, and fatigue. The throat constriction honestly frightened me and I almost went to the ER, but it eventually went away. For Saturday and Sunday, I developed fever, muscle ache, and extreme fatigue. Today, I thought it would get better but I still have fever and the extreme fatigue has not gone away. And unfortunately, as I am typing this, I think my tongue is getting quite swollen and is making it uncomfortable to breathe and swallow
Fatigue, headache, muscle pain, chills, nausea and fever for 36 hours from onset, followed by fatigue and slight nausea for 24 additional hours. The symptoms were serious enough that I could not participate in activities of daily living (could not go to work or get out of bed for the first 36 hours).
Lymph nodes swollen in left arm pit (hard to put arm all the way down, size of egg) fever 101.3 F., rash entire upper arm, left side of chest swollen/fluid.
Oval upper thigh induration 10x9cm, mild tenderness to left upper thigh.
Vertigo like dizziness; Vertigo like dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Vertigo like dizziness) and VERTIGO (Vertigo like dizziness) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VERTIGO (Vertigo like dizziness). On an unknown date, the patient experienced DIZZINESS (Vertigo like dizziness). At the time of the report, DIZZINESS (Vertigo like dizziness) and VERTIGO (Vertigo like dizziness) outcome was unknown.      No treatment information was provided. No relevant concomitant medications reported.
Development of mild tinnitus - occurs 1-2 times weekly and last for about 1 minute each occurrence. No treatment required, currently.
Information has been received from a health professional concerning a 25 year old female who on 15-JAN-2008 was vaccinated IM, 0.5mL with a 1st dose of Gardasil (lot# 6582219/0755U).  On 17-MAR-2008 the patient was vaccinated IM, 0.5mL with a 2nd dose of Gardasil (lot# 654272/0073X).  Concomitant therapy included hormonal contraceptives (unspecified) and TWINRIX "given in the other arm".  On 17-MAR-2008 the patient experienced soreness, redness and a bump under skin size of a dime at injection site.  The patient's soreness at injection site and redness at injection site and bump under skin size of a dime at injection site persisted.  On an unspecified date, the patient sought unspecified medical attention at her physician's office.  The patient was treated with ice.  At the time of this report the patient had not recovered from the reaction.  Additional information has been requested.
Patient received his second COVID vaccine on 1/22/22. He developed fever on 1/23/22. He developed urticaria on 1/27/22 which continued through 1/28/22
This spontaneous report was received from a certificated medical assistant and refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history and concomitant medication were not reported. On 02-NOV-2016 or 03-NOV-2016, the patients were vaccinated with an improperly stored dose of GARDASIL (dose, frequency, route of administration, lot# and expiration date were not reported). There was no adverse effect reported. The call was made due to digital data logger. The dose of the administered vaccine was exposed to temperature of 9.5 degrees Celsius for 28 hours. The vaccine was exposed to previous temperature excursion. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
1/12/21 - developed significant redness, warmth, swelling L upper arm and area near collarbone.
Patient was given 2 doses of Moderna Covid 19 vaccine.  She became extremely fatigued soon after the second dose, she stopped cleaning house and working in her yard, she complained of blurry vision in her right eye around 4-6 weeks post 2nd dose.  On Sept 4 2021 she was having heavy, slurred speech.  By Sept 6 her left arm started having erratic movements and would hit her in her face randomly.  Sept 8 her left arm felt like pins and needles and she just felt "off".  She was tested for COVID at an urgent care but was negative.  Sept 14 was her first ER visit, they suspected she had a stroke but CT and MRI were normal.  She was sent home.  Her symptoms progressed to where her entire left side of her body was numb and she couldn't walk, she felt off balance.  She returned to the ER and was admitted from Sept 22-Sept 25.  During that time she had more tests, scans, and her first lumbar puncture - all normal.  She was sent home with home health nurses and therapists.  Over the following two weeks she continued to decline.  She began choking on her food and was unable to sleep.  She had a complete personality change, she was aggressive, easily irritable, and was very apathetic towards others.  She was brought to the ER a third time at a different hospital, was told she HAD to have suffered a stroke but again, CT was normal and she was sent home.  On October 11 her OT noted she was consistently choking on food and water and recommended she been seen again in the ER.  She was brought in again but discharged home.  On October 14 she fainted at home and was rushed to the ER via ambulance, this time she was admitted from October 14-Nov 1.  During that stay she lost the ability to swallow and went 5-7 days without eating until finally a PEG tube was placed.  The paralysis moved to the entire right side of her body and she was no longer able to use any part of her body.  She was completely bedridden.  She underwent more tests, more scans, more bloodwork and a second lumbar puncture, all normal.  She was treated with steroids and IVIG then discharged to an inpatient therapy hospital.  She was given antipsychotic medications that worsened and rapidly progressed her symptoms.  She was brought to another ER after 2 weeks at the inpatient facility and finally transferred to hospital on Nov 29-Dec 13.  There she had more MRI, blood, and a third lumbar puncture.  She was diagnosed with autoimmune encephalitis although all of her testing remained normal.  She was given 5 plasma exchange treatments with no drastic improvement.  She has been at her home since then and remains bedridden.  She has no feeling in her limbs or body, she cannot sit up, she cannot roll over, she cannot speak, she cannot swallow, she is incontinent.  She was a completely healthy 63 year old who chose to get this vaccine and now is a completely bedridden, dependent on others to stay alive 64 year old.
Patient reported chest tightness and pain; she also reported heart palpitations for days after the vaccine
Rash, hives, hot in the face within 4 hours of shot (11:30am) lasted throughout the day and into next day.
No additional AE reported; Customer calls and reports a temperature excursion. She reports that some of the vaccines were administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 27-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), lot # T023918, expiration date 09-JAN-2022 for prophylaxis (dose, anatomical location and route of administration were not reported).  Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 8.3 degrees of Fahrenheit for 9 minutes. There was no previous temperature excursion reported.  No additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000657: US-009507513-2108USA000658:
My left arm was sore the first week and I randomly took Tylenol. After the week passed, my arm would be sore in random times .... i.e. getting dressed, stretching my arm over my head, lifting anything with that arm only, sleeping on that arm, etc..  This pain continues 5.5 weeks later with no sign of it going away.  I'm still struggling with the pain today and expect it to continue.  I received my second COVID Moderna shot on May 5, but in my right arm. I'm not having any pain at all in my right arm.
I experienced loss of hearing in my left ear. Went to ER, there was fluid behind my ear drum.
This case was reported by a other health professional and described the occurrence of injection site redness in a 11-week-old male patient who received ENGERIX B (batch number 9423K, expiry date 3rd February 2016). Concomitant products included PREVNAR, Rotavirus, ZANTAC and erythromycin. On 13th August 2014, the patient received ENGERIX B (injection) .5 ml. On 13th August 2014, Less than a day after receiving ENGERIX B, the patient experienced injection site redness. On an unknown date, the outcome of the injection site redness was recovered/resolved. The reporter considered the injection site redness to be possibly related to ENGERIX B. Additional information received: Other vaccine given the same day: PENTOPHIL (Sanofi Pasteur: C4683AA; 07 August 2015). No known drug allergy. No previous reactions. Pediatric patient experienced redness from the knee to the top of the thigh of both legs after vaccinations were given. Issue had resolved at time of reporting.
Information has been received from a physician concerning a male with no medical history or allergies who in 2001 was vaccinated with the first 0.5 mL dose of Varivax. There was no concomitantly therapy. The physician reported that the patient subsequently developed a case of breakthrough chickenpox. Unspecified medical attention was sought. No laboratory/diagnostic tests were provided. At the time of this report, the outcome was unknown. No further information is available.
Patient was supposed to receive MMR. Patient received MMRV, when staff realized that wrong vaccine was administered staff called parent to explain what happened and let mom know we will be monitoring the patient for the next 5 to 12 days. Patient at this time was asymptomatic.
Patient is a 68 y.o. male patient of MD with history of Cancer, GERD, depression, HTn, OSA, COPD presented to Hospital with shortness of breath  .   Sepsis, Acute hypoxic respiratory failure d/t COVID-19 pneumonia, COPD exacerbation  OSA  Elevated D dimer P/w SOB, HA, N/V/D.vaccination unknown  on arrival temp 99 increased to 101.5 , HR 10, RR 26, BP 133/61, satting 88% on RA< increased to 93% 2L Initial CBC w WBC 4., repeat LA 1.1 Troponin normal, BNP 641, D Dimer 1.0, CRP 43.8 CT Chest : no PE, emphysema and fibrosis, nodular opacity in RML possible round pneumonia , cannot exclude nodule   Solumedrol given in ER  Blood Cx NGTD   Decadron 6mg daily for 10 days  Continue cefdinir, Zithromax and home inhalers Follow up with pcp   Renal Cell Carcinoma S/p partial nephrectomy in 201  Follows with urology at hospital    AAA  S/p repair endovascualr infrarenal aorta/iliac artery at hospital  On admit CT has dilated of the aortic arch 3.6 cm, descending thoracic aorta 3 cm Will need vascular follow up    CKD stage 3 a Creatinine over last year 1.3-1.46 At baseline on admit, 1.35   Nicotine dependence Current 1 PPD smoker Discussed and encouraged smoking cessation, >3min total time spent   Nodular opacity in lung Most Likely pneumonia, follow up CT in 3 months recommended.  Alternatively PET-CT could also be considered.   T2DM - uncontrolled A1C: 7.8 continue oral meds F/u with pcp
Pain, swelling at injection site. Exam at one week later; only redness and slight discomfort, no induration.
This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 28-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included rheumatoid arthritis. On 14 October 2011 at 11:00 the subject received a dose of FLUARIX (.5 ml, unknown route, right deltoid), and experienced vaccine exposure during the second trimester of her pregnancy. Gestational age at the time of vaccination was not specified. Date of last menstrual period was not reported. The estimated date of delivery was 05 February 2012. At the time of reporting the subject had not experienced adverse events. The healthcare professional reported 6 subjects who received FLUARIX during pregnancy. See case IDs A0952863A, A0952838A-A0952840A, A0952842A for details of the other reports. Follow-up information was received on 02 December 2011. It was reported that the conception was normal with one fetus noted. The date of last menstrual period was 02 May 2011. FLUARIX was administered intramuscularly at 24 weeks gestation on 14 October 2011. The lot number was reported to be AFUA653AA on follow-up, but kept the original reported lot number, AFLUA653AA, as it was more appropriately matched GSK batch numbers. Follow-up information was received on 24 April 2012 via healthcare professional. The subject had a previous history of one spontaneous abortion and one therapeutic abortion. On 17 January 2012, at 36 weeks and 5 days gestation age the subject was induced due to gestational hypertension. The subject gave birth to a female live infant via normal vaginal delivery, weight 3420 grams, length 51 centimeters, head circumference 31.5 and Apgar score of 8/9. The neonate was born had persistent hypoxia immature lungs. The outcome of the gestational hypertension was unknown. Please see report A0952841B for details regarding the baby case. Follow-up information was received on 08 May 2012 via healthcare professional who reported the event of gestational hypertension resolved on "14 December 1982". Additional medical conditions included obesity, preeclampsia and "MIID". At the time of the report no other information was available.
This spontaneous report has been received from a registered nurse concerning a 2 year old male patient. The patient had no pre-existing physician-diagnosed allergies, birth defects or medical conditions. On 12-OCT-2017, the patient was vaccinated at private doctor's office/hospital with an improperly stored dose of PROQUAD dose 1, lot number N014758 and expiration date on 08-NOV-2018, administered subcutaneously in the right arm for prophylaxis, reconstituted using the sterile diluent (MERCK), which did not experience temperature excursion. It was reported that on an unspecified date, the vaccine was exposed to a temperature between -14 Centigrade degrees and -10 Centigrade degrees for 50 minutes. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA005693: US-009507513-1711USA005694.
Erythema, swelling (L) upper arm, decreased motion whole (L) arm, tender to light touch, upper arm.
pain lt deltoid w/progressed to pain in lt trapezius;swelling & redness of lt deltoid region & guarded movement lt axillary nose swelling;keflex, Ibuprofen, pred;
Dyspnea/tachypnea; Dyspnea/tachypnea; Diagnosed with coronavirus after receiving both doses of Moderna; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Diagnosed with coronavirus after receiving both doses of Moderna), DYSPNOEA (Dyspnea/tachypnea) and TACHYPNOEA (Dyspnea/tachypnea) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Obesity (BMI reported 30.4).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Diagnosed with coronavirus after receiving both doses of Moderna). On 10-May-2021, the patient experienced DYSPNOEA (Dyspnea/tachypnea) and TACHYPNOEA (Dyspnea/tachypnea). The patient was treated with ALBUTEROL [SALBUTAMOL] (nasal) on 03-May-2021 for COVID-19, at a dose of 90 microgram 2 puffs q 4 hours. On 10-May-2021, DYSPNOEA (Dyspnea/tachypnea) and TACHYPNOEA (Dyspnea/tachypnea) had resolved. At the time of the report, COVID-19 (Diagnosed with coronavirus after receiving both doses of Moderna) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, SARS-CoV-2 test: positive (Positive) Nasal swab. On 10-May-2021, Cytokine test: 5.4 (Inconclusive) 5.4 K/mcl. On 10-May-2021, Fibrin D dimer: 513 ng/mL (Inconclusive) 513ng/ml DDU. On 10-May-2021, Lymphocyte count: 5.4 (Inconclusive) 5.4K/mcl. On 10-May-2021, Procalcitonin: 5.4 (Inconclusive) 5.4 K/mcl. On 10-May-2021, Red blood cell sedimentation rate: 5.4 (Inconclusive) 5.4K/mcl. On 10-May-2021, Serum ferritin: 16.2 (Inconclusive) 16.2.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  The patient experienced COVID-19 symptoms like cough, muscle aches, headache, loss of taste, loss of smell, Nasal congestion/runny nose.     Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up received does not contain any significant information. On 07-Jun-2021: Follow-up information received updated lab data, treatment medication, new events (dyspnea and tachypnea) were added. On 28-Jun-2021: Follow-up received updated lab data and treatment information.