chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (GOT MORE SPOTS ON PATIENT AGAIN) and STRESS (LOT OF STRESS with HUMIRA) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis. The patient's past medical history included Ulcerative colitis. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced SKIN DISORDER (GOT MORE SPOTS ON PATIENT AGAIN) and STRESS (LOT OF STRESS with HUMIRA). At the time of the report, SKIN DISORDER (GOT MORE SPOTS ON PATIENT AGAIN) and STRESS (LOT OF STRESS with HUMIRA) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event's of Skin disorder and Stress was not provided for Humira. No treatment drug details was reported. Reporter did not allow further contact.
almost immediately ie within 24 hours, fullness in ear, tinnitus, balance issues and ultimately and seemingly significant hearing loss
Myopericarditis; This is a literature report for the following literature source(s).  A 16-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: MYOPERICARDITIS (medically significant), 2 days after the suspect product(s) administration, outcome "recovered". The patient underwent the following laboratory tests and procedures: Ejection fraction: normal; Electrocardiogram: Diffuse ST segment elevation, notes: On admission; Troponin: Increased; Ultrasound scan: normal EF.  Clinical information: symptoms: chest pain, fever.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported event  myopericarditis and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
The day I received the shot I had fatigue and pain in all my joints as described though I am not sure if it was normal as I returned home at 10am and proceeded to fall asleep till 7pm even though the night before I had my regular 8hrs of slumber. The following week I was supposed to have my period. Instead I had abdominal cramping and the period did not come. It came 2 weeks after that (so 3 weeks total of abdominal cramping) aka my period was 2 weeks late. The period also did not discharge as normal (bloody mucus pieces over 5 days), it came out in one go as a decidual cast (with some bloody spotting for half a day tops). Honestly if I wasn't abstinent for 2021 I would have thought I got pregnant and just miscarried. After the  decidual cast left my body the abdominal cramping ceased. I have previously never had a decidual cast and at most in my entire life, my period has been 5 days late.  In addition, just 24 hrs after receiving the 1st dose and still ongoing today is that I erupted in cystic acne on my face, chest, shoulders, and back. I do have adult acne but on average I would have 2-3 pimples on my shoulders at any given time. After the shot I was sporting 15+ pimples in each of these locations. This may be hormonal acne due to the strange menstruation situation from above. I work from home and had to forge wearing a bra as the straps and bands would irritate the acne and cause them to form a 'head' and then rip open and burst from contact.
Completely debilitating migraine-type headache. I couldn't have any light in my room. I had to lie in a dark room for about 6 hours with cold compresses. The headache got so bad that I ended up crawling on my hands and knees to the bathroom and vomiting from the pain. It took me almost three full days to recover fully from this vaccine.
customer received   JJ vaccine  at another facility on 3/12/2021 and did not told us she had a vaccine of another manufacturer . we found out from the insurance when we try to bill . finally she admitted she had the JJ vaccine but her doctor told her to get another dose of another manufacturer .
1/10/21 APPROXIMATELY 6PM, NECK ACHE, BACK OF HEAD PAIN, UP NECK TO BOTH EARS.  I TOOK 2 EXTRA STRENGTH TYLENOL.  PAIN WENT FROM 8 TO 5.  APPROXIMATELY 7PM METAL TASTE IN MOUTH.  TODAY (1/11/21), PAIN MOSTLY RELIEVED, EXTREME FATIGUE.  STAYED HOME FROM WORK.
Severe body aches including chest pain treated with Vicodin and sleep. Felt better the next afternoon
pt recvd Hep B vax on 14FEB92 & 26FEB92 exp tightness in chest, urticaria & edema; no further details were provided;
if they received the 1st dose, can the second dose be given; A spontaneous report was received from a health care professional concerning a 17-year old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and if they received the 1st dose, can the second dose be given (Product administered to patient of inappropriate age).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first dose of two planned doses of MRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. No treatment for the event was provided. Pharmacist asked if a 17 year old received the 1st dose, can the second dose be given.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, if they received the 1st dose, can the second dose be given (Product administered to patient of inappropriate age) was considered as resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of product administered to patient of inappropriate age.
***No previous history of Shortness Of Breath before Vaccincation ___________________________________________________________ Occasional Shortness/Shallow Of Breath began one week after vaccination and gradually became frequent. The conditions became severe in mid of January and requires multiple admissions into the hospital.  Currently still under follow up and treatments. Symptoms are still experienced on daily basis. ___________________________________________________________ Allergy to various types of foods (couldn't precisely identify) became more untolerable
developed blood clots in my left leg that began swelling some on 12Mar2021 and by Monday 15Mar2021 it was huge and 16Mar2021 big and hurting; developed blood clots in my left leg that began swelling some on 12Mar2021 and by Monday 15Mar2021 it was huge and 16Mar2021 big and hurting; developed blood clots in my left leg that began swelling some on 12Mar2021 and by Monday 15Mar2021 it was huge and 16Mar2021 big and hurting; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 02Mar2021 16:00 (at 71-year-old) as single dose for COVID-19 immunization. Medical history included Arthritis in knee. High blood pressure. Patient had no covid prior vaccination and no covid tested post vaccination. Patient has no known allergies. Concomitant medication included hydrochlorothiazide. The patient previously took first dose of BNT162B2 for COVID-19 immunization. The patient developed blood clots in my left leg that began swelling some on 12Mar2021 17:00 and by Monday 15Mar2021 it was huge and 16Mar2021 big and hurting. So he went to urgent care and they sent him to hospital ER. The patient was hospitalized for 3 days. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. Events treatment included Ultra sound, CT scan, heparin blood thinner. The outcome of the events was not recovered.
Sore arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna (mRNA-1273) and experienced a sore arm.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On an unknown date in 2020, the patient reported having a sore arm. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event having a sore arm was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
pt states the day after vaccines were given (9/9/2020) some, small, red, painful welts/stripes developed by the site of the flu injection and radiated toward her underarms.  Pt states the pain and welts seemed to be resolving as of  9/10/2020.
He received the Pfitzer BioNTech vaccine (Lot Number: EW0177, Exp.: 8/31/2021). During a routine doctor's visit on May 17, Patient's pediatrician noticed an elevated heart rate. A cardiologist diagnosed him with asymptomatic supraventricular tachycardia (SVT) (abnormal ECG, heart rate around 150) on May 20. Patient has no other cardiorespiratory symptoms (dizziness, shortness of breath etc.).
Initial report was received 17 June 2010 via lay press publication from an agency dated 16 June 2010 which involved six patients in the same geographical area who had been diagnosed with pertussis after they had received five previous DTaP vaccinations (lot number not reported). the information contained in the lay press publication had been retrieved from an immediate publication news released posted by a County Health and Human Services (HHSA) on 16 June 2010. This case represents one of the six reported patients. The other patient are captured in case numbers 2010-03433, 2010-03434, 2010-03435, 2010-03436 and 2010-03438. A 12-year-old patient (gender not reported) had received five prior doses of DTaP vaccine (manufacturers, lot numbers, routes, sites and dates of administration not reported) and an unspecified amount of time after receiving their fifth dose of DTaP vaccination, the patient was diagnosed with pertussis. This patient was one out of six local children who had been diagnosed with pertussis. Outcome was not reported. No additional information was provided at the time of the report.
Initially had body aches, fever CBC showed WBC count 2.8K on 5/23/2022 3.1K on 9/09/2022 neutrophils low at 42 on 5/23/22 then 41 on 9/9/22 monocytes high 14 on 5/23/22 then 14 on 9/9/22
extreme body chills, chattering teeth body muscle aches soreness at injection site itching at injection site lethargy
2wk p/vax pt noticed red raised rash on arms, chests, back, abd & a sore throat; 2wks after 1st dose of Hep B Vaccine- Pt noticed a red raised rash on arms, chest, back & abdomen, also has a sore throat. On 3/3 received 2nd dose of Hep B, Am of 3/4 noticed a red raised rash that was itchy on arms, chest, back abdomen. Rash was fading in the afternoon.
Irritability started 4AUg97PM & up a lot @ noc when usually sleeps;high pitched cry started;lump in rt thigh noted 6AUG97;(size quarter);pt seen in ER 10AUG97 for MMR rxn;allerg rxn rubella;sl redness w/swelling @  inj site;malaise;
Information has been received from licensed practical nurse concerning a 50 year old female who on Nov 17 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 649692/0371P). Concomitant therapy that day and in the same arm included influenza virus vaccine (unspecified, manufacture unknown). On Nov 17 2004 the patient experienced soreness, redness in injection are, flu like symptoms and fatigue, Over the counter anti inflammatory medication and ice were prescribed, The patient called the office on Nov 18 2004 with no improvement. It was reported that another patient had a similar reaction (WAES0412USA00149). Additional information has been requested.
The patient's arm swelled about 1 inch high and SA 4x7 inch approx. ED physician prescribed Vicodin and prednisone.
Information has been received from a medical assistant concerning a 60 year old female who on 06-NOV-2007 was vaccinated with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) instead of a dose of zoster vaccine live (Oka/Merck). It was reported that the product confusion happened because the names of both vaccines sounded the same to her. No adverse reaction was reported. A product quality complaint was not involved. Additional information has been requested.
I woke up with shingles in a line extending from my left breast to my left underarm.  I received the vaccination in my left arm.  I am taking anti-viral medication.
Complex partial seizure, head nodding, eyes blinking slowly, not responding for 20 seconds or so. Fifteen minutes - hour of abnormal behavior. Five days after Hep A vaccination. Primary physician does not feel this event is related to the vaccine.
back pain; difficulty breathing; heart racing; heart hurting; felt like she would pass out; A spontaneous report was received from a consumer who was also a 38-years-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced heart racing (palpitations), heart hurting (angina pectoris), difficulty breathing (dyspnea), felt like she would pass out (presyncope) and back pain.  The patient's medical history was not provided. Concomitant product use was not provided.  On 22 Jan 2021, the patient received the first of two planned doses of mRNA-1273 on (Batch# 043L20A) (route of administration unknown) for prophylaxis of COVID-19 infection.   On 22 Jan 2021, after three weeks post vaccination, the patient reported still having symptoms of her heart racing and hurting, difficulty breathing, felt as if she was going to pass out, and about a week of back pain.   On 12 Feb 2021, the patient went to the emergency room (ER) for heart symptoms. She reported everything was fine at the ER. The patient was to have second dose on 16 Feb 2021 and inquired on whether to have the second dose if experiencing all of these symptoms.  No treatment information was provided..  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events was unknown.; Reporter'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.
This spontaneous report as received from a pharmacy intern refers to a patient of unknown age (gender unspecified). On unknown dates in approximately 2008, "six years ago", the patient was vaccinated with dose one and two of GARDASIL. Lot# and administration route were not provided. On 04-AUG-2014 the patient might be vaccinated with the dose three of GARDASIL. No adverse effects reported. Additional information has been requested.
Patient presented to the ED after intentional acetaminophen overdose within 6 weeks of receiving COVID vaccination.
Myalgia; Muscle weakness; Pain in the lower back; Has not regained all his physical strength back; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A 60-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Nov2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (INFLUENZA VACCINE), in Nov2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "Muscle weakness"; BACK PAIN (non-serious), outcome "not recovered", described as "Pain in the lower back"; ASTHENIA (non-serious), outcome "not recovered", described as "Has not regained all his physical strength back".  Additional information: Patient in good physical condition. He was able to do 50 pushups before receiving the two vaccines.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Headache, body aches, fatigue,  really bad coughing, sore throat.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 02-MAR-2018, the patient received a dose of Oka/Merck VARIVAX subcutaneously, for prophylaxis (strength, lot # and expiration date were not reported). On 20-MAR-2018, two weeks and 4 days after first dose, the patient was vaccinated with another dose of Oka/Merck VARIVAX subcutaneously, for prophylaxis (strength, lot # and expiration date were not reported). No adverse effects were reported in the patient.
Missed work due to feeling ill and having arm pain at injection. Large welt present and warm to the touch. He declined a visit at this time. Vaccines of Tdap and PREVNAR 13 given in (L) arm as requested by patient.
sickness; Initial information received on 03-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media. This case involves patient (unknown demographics) who experienced sickness (malaise), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sickness (malaise) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for malaise.  There will be no information available on the batch number for this case.
Patient states that she has pruritus throughout her body and swelling of her lips. She is treated  with over the counter Benadryl 25mg 2-3 times a day initially on days 1-3 of symptoms.  Employee declined appointment in the clinic and is choosing to continue with OTC treatment. She will notify us if symptoms become worse.
the evening of vax pt became ill w/high fever 103 & diarrhea;lasted 4 more dasy;dad called MD who dx pt w/intestinal virus;pt recovered spontaneously p/5 days;
Febrile exanthem; 4 days prior to admission nausea, vomiting & diarrhea. 1 day prior to admission generalized erythematous rash beginning on extremities & progressing to trunk; Epistaxis & rhinorrhea w/mild cough. Febrile to 101.9; Conjuct.
Starting 1 h after the flu shot: achiness in the arm where was put the injection, gradually increasing, but well  tolerable.  Starting 5-6 h after the flu shot for the last 9 years: body aches, muscle aches, especially in jar, gums; bone pain; fever; chills, sweatiness, muscle spasms, racing heart rate, increased respirations and using a mouth to breath; dizziness, weakness,  difficulty urination with painful urination, nausea, multiply vomiting with inability to hold urine while vomiting, muscle cramps, muscle twitching, pumping headache, excessive sweating and weakness, dizziness with ambulation.  Lasts for about 3-4h.   I am not sure about the type of the flu vaccine (see item 17)
I had a sore throat, cough, runny nose, nasal congestion and headache. I tested myself for COVID-19 on 01/07/2022 and it was positive. I went into urgent care and obtained a PCR COVID-19 home test which was also positive. I was taking  FLONASE and methylprednisolone because on January 04, 2023 I was diagnosed with allergic sinusitis which was incorrect. I was prescribed PAXLOVID and took the whole course and was back to normal in about a week. I have recovered from all my symptoms currently.
Vertigo and nausea (1st day) . Vertigo was extreme for 3 days, striking rapidly. Quick and short instances of vertigo on and off for 3 weeks before subsiding.  I had meclizine which I had received for an instance of vertigo over 5 years ago, which was not very effective in this instance. I waited out the vertigo, knowing that it was vertigo, and not wanting to see a doctor at the time.
No additional AE information provided; they are 31 weeks pregnant and were administered GARDASIL; visit to receive their Tdap vaccine and they were accidentally given GARDASIL; This spontaneous report was received from a consumer referring to herself, a 31-weeks pregnant female patient of unspecified age. Her pertinent medical history, concomitant medications, past drug reactions or allergies were not reported.  On 25-FEB-2022, the patient went to facility for a schedule visit to receive a Tdap vaccine (manufacturer unknown) but stated that they accidentally gave her either HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) or Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) as she was unsure which one was administered, with a route of administration reported as injection (unidentified Merck hpv vaccine administered (lot number not provided); dose, vaccination scheme frequency, exact route of administration and anatomical site of application were also not reported) (exposure during pregnancy and wrong product administered) for prophylaxis.  No additional adverse event (AE) information was provided (no adverse event).