chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Infected fistula in buttocks; Abscess; This spontaneous case was reported by a physician and describes the occurrence of INFECTED FISTULA (Infected fistula in buttocks) and ABSCESS (Abscess) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Crohn's disease.    The patient's past medical history included Coronary artery occlusion in November 2019, Stoma creation in 2017, Colon cancer in 2017, Cardiac arrhythmia in December 2019, Dehydration in August 2017, Night sweats on 19-Mar-2021, Chronic kidney disease stage 3, Alcohol use (FIVE COCKTAILS A WEEk) in 1975, Smoker (A PACK A WEEK) in 2006, Obstruction, Ostomy obstruction in 2017, Stent placement (he had blockage in heart artery and cardiologist placed a stent in the heart) in December 2019, Stent placement (he had heart stent placement) in 2021 and Surgery (surgery to reconnect intestines and remove ostomy because of dehydration.) in August 2019. Concomitant products included PRASUGREL for Coagulation disorder, METOPROLOL for Heart rate abnormal, ATORVASTATIN for Hypercholesteraemia, FENOFIBRATE, ATORVASTATIN CALCIUM, FUROSEMIDE (LASIX [FUROSEMIDE]), OMEPRAZOLE, METOPROLOL SUCCINATE, PRASUGREL HCL and ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-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 ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. In May 2021, the patient experienced ABSCESS (Abscess). On 11-Jun-2021, the patient experienced INFECTED FISTULA (Infected fistula in buttocks). At the time of the report, INFECTED FISTULA (Infected fistula in buttocks) and ABSCESS (Abscess) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2019, Blood pressure measurement: high (High) ELEVATED BLOOD PRESSURE. In November 2019, Computerised tomogram: abnormal (abnormal) Blockage in the artery of the heart. In February 2020, Cardiac stress test: normal (normal) Basically ok.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's lab data included: November 2019 CHEST X-RAY: Unknown results. December 2020 STRESS TEST: Unknown result.  The patient was treated with FLAGYL.  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.; 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.
ADMINISTERED SINGLE DOSE OF JANSSEN COVID-19 VACCINATION; PATIENT IMMEDIATELY POST INJECTION FAINTED AND EXHIBITED SEIZURE LIKE SYMPTOMS; BODILY TWITCHING, ETC.
she had heard of tingling and numbness in hands.; she had heard of tingling and numbness in hands.; This is the spontaneous report from a contactable consumer. A contactable consumer reported similar events for 2 patients. This is first of 2 reports. This consumer reported that:  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Caller stated when she got the vaccine on Sunday the nurse said 2 people the day before, 10Apr2021, complained of tingling in their hands and this was the first time she had heard of tingling and numbness in hands. The nurse was unsure how they made out. Outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021454473 Same reporter/product/events, different patient
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Batch/Lot number: unknown), on 08Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 01Sep2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid rebound mild symptoms and positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures included PAXLOVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sudden chest pain, about 30 hours after the 1st dose of the Pfizer-BioNTech vaccine. Described as an intense, clawing sensation inside the chess. Diminished upon calm, deep breathing, but persisted on-and-off for about an hour, until patient fell asleep. A few hours later, at night, woke up with a sensation of an electrical streak across his chest and back. It diminished/disappeared quickly. Some remnants in the morning. No problems reported afterwards.
Right temporal lobe stroke on 10/7/22, symptoms included left hand numbness, and weakness in left arm and left leg through 10/10/22.
Patient was give Covid 19 vaccine beyond use date/expiration date.  Vaccine was maintained at proper storage/handling temperatures.  Pfizer and CDC have been contacted for stability information.  Revaccination is not needed.
Time in at 1104. 0 PMH, Vitamin C & D. 0 CP, 0 Swelling, 0 injection reactions in past. patient reported dizzy and flushed. initial VS 77, 98%, 156/115. Water was provided, snack offered. dizziness decreased and patient reported feeling less flushed. repeated BP 147/108, 166/100, 154/102. patient reported feeling normal and left to return to home at 1125.
Upper body soreness (chest, left and right arms), consistent fever (101.2), chills, stomach pains.   Upper body soreness and fever presented 30 minutes after vaccination and continues as of filing this report. Chills and stomach pains subsided after two days of vaccination.
No other AE reported; The patient inadvertently received an expired dose of MMR II; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 13-JUL-2021, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live, recombinant human albumin (rHA) (M-M-R II) (lot# S020160 has been verified to be a valid lot number and expiration date was 30-JUN-2021; strength, dose, frequency and route were not reported) for prophylaxis (expired product administered). The reporter wanted to know if the dose was valid. There was no prior temperature excursion on this vaccine. There was no other adverse event reported. The outcome of the events was unknown.
This spontaneous report received from a nurse refers to a 12 month old patient of unknown gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 12-SEP-2016, the patient was vaccinated with improperly stored M-M-R II lot #M004305 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/insurance. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered until 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513-1609USA014830: US-009507513-1610USA004339.
Throat drainage, severe cough, severe weakness, elevated pulse and BP.  Patient went to Urgent care facility at 10 PM.  She was there ~2 hours and received IV fluids and prednisone.  Today 9-15-10 patient reports feeling better, but still a little week as if had flu....
Nausea, fatigue, congestion, cough, mucus, spitting up blood and mucus, fainted/dizziness/blacked out, respiratory infection.
Sudden sensorineural hearing loss  experienced- increased tinnitus, reduced hearing ability,  initial onset 2/8/2021; treatment- oral steroids started on 2-11-2021; Outcome-tinnitus returned to original levels, hearing loss seems to be permanent.
13 days after MMR (first) administration, mother called to report mild rash on child's neck and back, not itchy, no fever, no other sx. of allergic rxn.  Uncertain whether vaccine related or not. Pt. is out of town on vacation, so not able to come to office to see the rash.  Given instructions re: when to seek care.  Given self care instructions re: symptom relief.
Received pfizer vaccine on 2/12/21 and 3/5/21. Presented to ER on 1/27/22. COVID positive 1/26/22. Was sent to the nursing home because of being more lethargic with failure to thrive.  The patient says that because of the pain in her foot and ankle, she is unable to ambulate at all.  Workup in the ER revealed her to  have an abnormal urinalysis.  Patient was started on Rocephin and then the  hospitalist service was called for admission. She was diagnosed with COVID -19 but without pneumonia. No COVID19 treatment. Discharged on 2/9/22
pt reports intermittent redness and itching to administration site, sts some days appears to improve but then itching returns
1 week Redness with swelling, Pain to the area with blisters. No fever mom putting ice pack daily.    Treatment given benadryl and steroid cream.
fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 64 year-old male patient received bnt162b2 (BNT162B2), administration date 12Feb2021 (Batch/Lot number: unknown) at the age of 64 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "allergies to plants" (unspecified if ongoing); "allergies to dogs, allergies to cats" (unspecified if ongoing), notes: allergies to dogs, allergies to cats; "balance issues" (unspecified if ongoing), notes: balance issues; "Lhermitte's Sign" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: On an unspecified date, the patient underwent the laboratory tests and procedures which showed no COVID antibodies, CD19 B cells 0L, Absolute CD19+ cells less than 20L.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a pharmacy technician refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' pertinent medical history, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L048237, expiry date: 08-MAY-2017). Pharmacy technician stated that the vaccine underwent temperature excursion at 30.1 F for a duration of 13 hours 50 minutes. No data logger was involved and there was no previous temperature excursion. No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Patient says initial injection caused immediate cold sensation down his arm, RPh said, per patient injection is no good and went back to pharmacy to get a brand new vaccine and then gave patient the vaccine - pt does not think any vaccine was inserted with initial penetration. Says although pain has gotten little better, still cannot sleep on left side or shower with left arm and has limited range of motion with left arm, says pain is just in upper left arm above injection site, although does sometimes have numbness that radiates down his arm. Got pain medication from ER 2-8-14 for his arm.
This spontaneous report was received from a registered nurse and refers to 9 patients of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection, lot # L041204 with expiry date 20-OCT-2017 (exact dose and route of administration were not reported). The doses were exposed to the temperature of -14 degrees Celsius for 15 minutes. Previous temperature excursions included exposure to temperatures between -9 degrees Celsius to 8 degrees Celsius (-3 degrees Celsius) for 6 hours, between -9 degrees Celsius to 8 degrees Celsius (0.8 degrees Celsius) for 45 minutes, between -14 degrees Celsius to -10 degrees Celsius (-13 degrees Celsius) for 1 hour 30 minutes and between -14 degrees Celsius to -10 degrees Celsius (-14 degrees Celsius) for 16 hours 40 minutes. Digital data logger was involved. No adverse effects were reported. Additional information has been requested.
No addtional adverse events; Administration of improperly stored ROTATEQ; This spontaneous report has been received from medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies and previous drug reactions or allergies were not provided.   On 21-DEC-2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error) (lot number 1741817 has been verified to be a valid lot number, expiration date was reported and established as 30-JUL-2022; vaccination scheme, and anatomical site of vaccination were not reported), 2 milliliters for prophylaxis.   The vaccine was exposed to a temperature of 50.5 Fahrenheit (F), for a time frame of 57 minutes. There were no previous temperature excursions. No additional adverse events (no adverse event) and no product quality complaints were reported.
After child received rotavirus vaccine, she was difficult to feed, felt cold. The next day she had BMs with frank blood. She was admitted overnight, BMs continued to be frequent but frank blood resolved.  7/30/09 Hospital records received DOS 7/9/09 to 7/10/09. Assessment: Bloody diarrhea, likely infectious. Father reports child at end of feed appeared uncomfortable and felt cool. Blood in stool for 3 days. Twin sister with bloody and mucousy stools. Mother had blood in stools and abdominal cramping.  10/5/09 ICD-9 Codes Received: 578.1 Blood in Stool, 009.2 Infectious Diarrhea.
Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and VOMITING (Vomiting) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901 and 040C21A) for COVID-19 vaccination.     Concurrent medical conditions included Eczema. Concomitant products included DUPILUMAB (DUPIXENT) for Eczema.   On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, the patient experienced NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved.            Treatment information was not provided After 2nd dose patient stated that was laying around and ended up running to the bathroom vomiting. Almost 24 hours later the same thing happened, and the same thing happened again an hour before the case was reported.    This case was linked to MOD-2021-302066 (Patient Link).
Patient began with fever 12 hours prior to receiving the COVID 19 vaccine (9/26/21). Then patient then began with joint swelling, joint pain and rash, on 9/29/2021 hives and swollen lymph nodes.
Patient states that she had redness at the site that was warm to the touch on day one, on day two she woke up with a rash and itchiness, on day three she started to have hives on her chest and back which spread to her left arm below the injection site.
Patient presented with two days of headache most consistent with a migraine after receiving the second dose of the Moderna vaccine. Her neurologic exam was normal and she was treated with oral medications and her headache resolved.
w/in 4 hrs of shot throat felt like it was closing up; heaviness in chest; rash, red & itchy & burning began on face; w/in 2 days hives were generalized; some as large as silver dollars & confluent; fever 103, hospitalized; allergic react;
Left shoulder pain immediately after injection given and pain has persisted almost 1 month later. Shoulder pain (aching) with movement of arm. Treatment with rest, tylenol -- no improvement thus far
Dose of the Moderna Covid Bivalent booster was given 4 days after the vial's BUD.  The vial had been in the refrigerator since 1/11/23 (unpunctured) and should have been salvaged on 2/10/23 (30 days after being removed from freezer).  Vaccine vial was first punctured 2/14/23 and dose was given that same day. Patient states that he had some arm soreness and some swelling for 1 day, but denied any lasting effects.
During administration some of the vaccine leaked out from the syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (During administration some of the vaccine leaked out from the syringe) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, the patient experienced UNDERDOSE (During administration some of the vaccine leaked out from the syringe). On 26-May-2021, UNDERDOSE (During administration some of the vaccine leaked out from the syringe) had resolved.        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.   No concomitant medications were reported. No treatment was reported.
Pt recvd Hep B vax on 11MAY88, 15JUN88, 16NOV88 & 25JAN89 lab eval revealed anti-HBc pos & HBsAg pos (a hep screening panel on 20JAN88 was neg); 2MAR89 repeat tests showed anti-HBe pos, anti-HBS pos, HBsAg neg, HBeAg neg, & anti-HBc pos;
2MAY93 devel sore arm, headache, nausea, vomiting, sore thrat, general muscle & jont pains;
Pt recvd vax 10DEC92 & between 30 mins & 1 hr following vax pt devel chest pain, dizziness & weakness in legs; also felt faint & hot all over, perspired heavily & had clammy skin; weak & achy & had hysterical reaction;
Both arms feeling like on fire. Headache, body aches, stomach ache, throat feels tight
Patient seen 12/3/10 got shots & next day he got rash on face & legs. Fever but is also teething and has been having fevers.
Patient received first dose of Pfizer on 3/9/2021 and the second dose on 3/30/2021. Patient does not have any immuncompromising conditions that are known. 99 yo m with HTN, HFpEF, pulmonary HTN, s/p PPM, BPH, fully vaccinated for COVID in March 2021, presented with cough, congestion, decreased appetite x 1 week (symptoms started 8/9/2021).  No known sick contacts.  He developed worsening SOB so his wife took him for COVID testing 8/15/2021 which was + at urgent care; pt was transferred to Hospital. In the ED, pt was hypoxemic to 87%. Patient tested positive via PCR in the Emergency Department of Hospital. Patient is currently hospitalized receiving oxygen (non-rebreather mask 6L/min), remdesivir and steroids.
arm hurt, devel 1" diameter bump, redness 2" in diameter;hot-cont to get worse;hurt to touch or move-got larger everyday @ inj site;
After taking the 3rd dose, the lymph nodes under my arm were swollen, I had body aches, chills, headache, muscle pain, and redness around the injection site. Some of these symptoms lasted between 24-48 hours.   I developed symptoms for Covid-19 on 12/31/21.  I went to the ER on 01/06/2022. I experienced shortness of breath and coughing. I had breathing issues. I was diagnosed with Covid pneumonia and Covid infiltrate on my lungs. Some of my treatment included Erythromycin antibiotic, albuterol inhaler, Z-pak, and cough syrup.  I'm still dealing with shortness of breath and I tremble sometimes.
Vaccine administered 1/23/13. Client calls 1/25/13 to report local redness, "1/2 dollar" sized around site where Zoster administered. States mild itching, no pain. States slight lightheadedness/dizziness day of 1/24/13. Instructed client to make appointment with primary care provider.
I had running nose, lower back pain, and cough.  It has been mild in general.  These are still ongoing.  It has been 5 days now.  I took the home COVID-19 test on Dec 24th, positive results.  I also have a low-grade fever of 101.
Migraines (dizzy, blurry vision), Unable to walk, nausea, vomiting, muscle aches
Approximately 20 minutes after receiving the vaccine she stood up to leave the vaccine clinic. She said she felt like she was having palpitations. She denied chest pain and shortness of breath. She was placed cardiac monitor showing  a rapid Atrial Fibrillation. VS were - 5:25 pm 137/97, HR 133 - 140, R 18, O2sat 98% 5:30pm 145/107, HR 141, R 15, O2sat 98% 5:40pm 117/101, HR 128, R 15, O2sat 98% 5:46pm 152/109, HR 146, R 16, O2sat 98% - Sent to Emergency Department with ED staff after Code Green was called. She remained awake, alert, and oriented x3 throughout.
Wife came in yesterday and said that her husband got the moderna booster at around 12pm and he started to have symptoms at 9pm that same day. He had swelling of the chin, face, lips and neck, sob, diff breathing, and numbness started from the right face to the left face. She took him to the urgent care and now he is all better and back to normal. Apologized to the wife that happened to her husband but she was fine she just wanted to let us know. She also said he got 2 moderna vaccines and he was fine just the 3rd dose he got really bad reactions. put in database and vaers
This initial spontaneous case, was received on 09-Oct-2017 from other non-health professional concerning a female pregnant adult patient of unspecified age. On an unspecified date, the patient was administered with AFLURIA QUADRIVALENT (dose, route of administration, anatomical location, batch number, expiry date: not reported). It was reported that, the pregnant patient was administered with vaccine in the past. The outcome of the event was not reported. The reporter considered the case as non-serious.
Patient received J&J COVID-19 vaccine on 3/26/21. Due to breakthrough infection, he was hospitalized from 7/9 to 7/12/21. Patient with sepsis presumed from COVID-19 infection. Blood culture negative at time of admission. Patient was weaned off O2 and did not receive steroids. Received empiric vancomycin and cefepime.
Injection given on 12:15pm 08/25/04.  Soreness at site began at 15:00. Increased to tremors, cold chills, body aches especially back. Episode at 03:00am 08/26/04 of tingling/numbness in arms-feeling back to normal. Feel "feverish", hot to touch but no thermometer to check temperature.
Fussy, crying for more than 2 hours. Had a low-grade fever 99-100.5 and had hardness and swelling at injection site of left upper thigh.