chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm getting worse more swollen; Arm getting worse more swollen, red; High fever; Vomiting still; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm getting worse more swollen), ERYTHEMA (Arm getting worse more swollen, red), PYREXIA (High fever) and VOMITING (Vomiting still) 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 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm getting worse more swollen), ERYTHEMA (Arm getting worse more swollen, red), PYREXIA (High fever) and VOMITING (Vomiting still). At the time of the report, PERIPHERAL SWELLING (Arm getting worse more swollen), ERYTHEMA (Arm getting worse more swollen, red), PYREXIA (High fever) and VOMITING (Vomiting still) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.; 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.
A pharmacy technician reported that a pt received an injection of TD Toxoids Adsorbed, Purogenated and subsequently developed an injection site reaction which the reporter did not describe. No further information was available at the date of this report. This is 1 of 2 pts from this facility who had an adverse experience following receipt of TD Adsorbed, Purogenated, lot 471638.
Low-grade fever (101F or less) that persisted for 48 hours, resolved, the patient developed a diffuse macular blanching rash c/w known MMR potential side effect.
Heart racing, sweating, dizzy and nausea then I passed out around 11:53pm
Has not gotten second dose; Got really sick; Violent bed shaking chills; Pain at injection site all the way up the right and left side of neck; Was white; Minor chills; Tunnel vision; Going to pass out; Sweaty; Increased heart rate; Blood sugar dropped; Dizzy; Pain at injection site all the way up the right and left side of neck; A spontaneous report was received from a consumer concerning a 58-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tunnel vision, felt like going to pass out/ presyncope, was white/ pallor and sweaty/ hyperhidrosis, increased heart rate/ heart rate increased, blood sugar dropped/ blood glucose decreased, minor chills/ chills, dizzy/ dizziness, pain at injection site/ vaccination site pain all the way up the right and left side of neck/ neck pain, got really sick/ illness, had violent bed shaking chills/ chills and has not gotten second dose/ product dose omission issue.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 039K20A) for prophylaxis of COVID-19 infection.  On 31 Dec 2020, immediately after receiving vaccine, the patient felt like she was going to pass out, tunnel vision a medically significant event, was white and sweaty, increased heart rate, blood sugar dropped, minor chills, dizzy, pain at injection site all the way up the right and left side of neck. The patient was monitored at a doctor's office for about 3 hours before she felt good enough to drive home and felt better. Pain injections lasted a week and other symptoms ended on an unspecified date. On 26 Feb 2021, the patient got really sick and had violent bed shaking chills (ended on an unknown date). The patient has not gotten her second dose but did test negative for COVID.  Laboratory details included increased heart rate, blood sugar dropped and test negative for COVID.  No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, tunnel vision, presyncope, pallor, hyperhidrosis, heart rate increased, blood glucose decreased, chills, dizziness and neck pain, was resolved on 31 Dec 2020. The outcome of events, vaccination site pain, illness and chills, was resolved on an unspecified date.; 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.
9 days Moderna Vaccine #1, extreme itching, Redness, Raised bump all around injection site. SHE WAS VERY Red as well
Case number PHEH2014US020299, is an initial spontaneous report received from a consumer on 08 Oct 2014. This report refers to a 12 year old male patient. His medical history and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: A14030) intramuscular on 13 Aug 2014. On the same day he experienced fever, headache, swollen arm including armpit and raised lacy rash which lasted 3 days. The final outcome of the events was recovered on 16 Aug 2014. Seriousness and causality assessment was not reported.
This case was reported in a literature article and described the occurrence of uveitis in a 11-year-old male subject who was vaccinated with Hepatitis B (manufacturer unspecified). On an unspecified date the subject received 2nd dose of Hepatitis B (unknown). Two days after vaccination with Hepatitis B, the subject experienced uveitis. This case was assessed as medically serious by GSK. This is one of the 32 reported cases (B0662264A till B0662297A) of uveitis which occurred after hepatitis B vaccine between 1982 and 2009. It appeared that all subjects recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurs because of hepatitis B infection there was evidence that immune complex deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the hepatitis B antibodies of the immune response after vaccination formed immune complexes, which initiated the ocular response of uveitis.
2" X 4" area of swelling. Center had small pustule. Scant drainage severe discomfort.
with the first shot his wife developed a fever (100, 101); When she got the first 2 doses initially she got a fever, felt lousy and had malaise; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team for a Pfizer sponsored program (005570).  A 58 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) for 1 day as dose 1, single and (Batch/Lot number: unknown) for 1 day as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "with the first shot his wife developed a fever (100, 101)"; MALAISE (non-serious), outcome "unknown", described as "When she got the first 2 doses initially she got a fever, felt lousy and had malaise". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient recieved both of the Pfizer Covid 19 Vaccinations. She recieved the Pfizer Covid 19 Vaccine Booster about 1-2 weeks ago. Per caller with the first shot patient developed a fever (100, 101) and malaise. When she got the first 2 doses initially she got a fever, felt lousy and had malaise but this fever was higher than the previous fevers. With the first 2 she was just lousy the first 2 days then fine.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
10 hours after the booster dose the patient had a low grade fever; 10 hours after the booster dose the patient had  achiness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (10 hours after the booster dose the patient had a low grade fever) and PAIN (10 hours after the booster dose the patient had  achiness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 013M20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced PYREXIA (10 hours after the booster dose the patient had a low grade fever) and PAIN (10 hours after the booster dose the patient had  achiness). At the time of the report, PYREXIA (10 hours after the booster dose the patient had a low grade fever) and PAIN (10 hours after the booster dose the patient had  achiness) outcome was unknown.            No Concomitant medication reported.  The patient reports no Adverse events After first dose. Paitent self  reported as  not Immunocompromised.  Patient received Vaccine  in her right arm shoulder deltoid muscle.  No treatment medication reported.   This case was linked to MOD-2022-491822 (Patient Link).   Reporter did not allow further contact
approximately 10 days after receiving Pfizer COVID Vaccine #1 I started getting asthma. I tested negative for COVID. I saw my PCP who gave me a refill of Albuterol and gave me BREO. I saw him again later because the steroids were making my perimenopause symptoms worse. I got started on Spiriva at that time. I continued to take my regular supplements/ rx as well as the new inhalers.  Approximately 6/20 I got a UTI which seemed to go away after taking mannose, which my naturopath has prescribed in the past. I also had been developing a very dry throat and it got very sore so I stopped taking Spiriva. I only used the antihistamines, nasal sprays and albuterol to manage the asthma.  Due to PCP unavailability I went to Urgent care 7/9 due to the return of UTI symptoms. I tested positive for citrobacter freundii and Macrobid was rxed. My asthma symptoms completely cleared up during this time.  After 7 days I was still having abdominal and groin pain so I returned to Urgent Care 7/16 , who sent me away with antibiotics but the symptoms continued with some additional new pain approximately 2 inches left and 1 inch above my belly button. I went to the ER 7/17 who ran further tests and found my IBS -C was acting up. I had excess fecal matter, was rxed over the counter laxatives.  I had fatigue, decreased cognition and low mood that got worse especially from approximately 6/20 through around 8/4.  I saw my PCP for a follow up on 7/31. He took my timeline of history and the lab results and hypothesized that I had a bacterial overgrowth for a long time and rxed a probiotic, which  I am currently taking daily 1-2x per day. He was not specific, and gave  me a couple of brand names. I found one that has a higher count and am taking that- Vitamin Bounty Pro 100. He also had me start a health tracker which I've been doing daily since 7/31. I started having breathing problems approximately 8/12, and restarted albuterol inhaler 8/16, and my symptoms have again gone away today 8/19.
This spontaneous report as received from a healthcare worker (also reported as medical assistant) refers to a patient of unknown age and gender. On 07-AUG-2014, the patient was inadvertently vaccinated with the first dose of PNEUMOVAX23, injection, 0.5 ml, one time dose, intramuscular, (lot # H020684) that expired in April 2014. No concomitant therapy was reported. No adverse experience. Additional information has been requested.
patient received Janssen vaccine #1 on 06/21/2021 after receiving Moderna vaccine #1 on 02/03/2021.
pt recv vax 19JAN96 & 26FEB96 pt devel a fairly severe case of varicella;sx included a rash starting on 26FEB96, followed by a fever of 102, congestion & rt OM;seen by MD & recovered 27MAR96;
Suspect 6th Nerve Palsy; Double Vision; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 10Mar2021 10:30 AM (Batch/Lot Number: EN6208) as SINGLE DOSE for covid-19 immunization. Medical history included High Blood Pressure (controlled by medication) from an unknown date and unknown if ongoing. The patient had no known allergies. The patient has no COVID prior to vaccination, and not COVID tested post vaccination. No other vaccine in four weeks. Other medication in two weeks was noted (reported as yes) but it was unspecified. The patient previously vaccinated of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number: EN6200 on 17Feb2021 12:30 PM at the left arm single dose for COVID-19 immunization. It was reported that the patient experienced Double Vision and Suspect 6th Nerve Palsy on 11Mar2021 at 08:00 AM. The outcome of the events was recovering. There was no treatment for the event.
Report side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Report side effect) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Report side effect). At the time of the report, VACCINATION COMPLICATION (Report side effect) 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 assessment. treatment medications were not reported no concomitant medications were reported     This case was linked to MOD21-086996 (Patient Link).
Noticed on 10/24/2001 injection hot to touch and red and swollen. Area of redness 2 X 3 inches. On 10/25/2001, left upper arm with 805 X 7.0 cm with erythema and mild swelling, induration, warm-non tender. Instructed cool compresses and Benadryl. Lidocaine topical prn.
Ramsay Hunt syndrome triggered by sun light; Ramsay-Hunt syndrome; This is a solicited report based on the information received by Pfizer. A non-contactable consumer (patient) reported that a 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) intramuscular on Feb2021 as 1st dose, single for COVID-19 immunization; adalimumab (HUMIRA), subcutaneous from an unspecified date and ongoing, at an unspecified dose and frequency for moderate to severe rheumatoid arthritis. Medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. The patient experienced Ramsay-Hunt syndrome on 15Mar2021 and Ramsay Hunt syndrome triggered by sun light on 04Apr2021. The patient was treated with PREDNISONE. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the events for adalimumab was unknown. Outcome of the events was recovered in 2021. The reporter's causality for the events and adalimumab was not provided.   The reporter's assessment of the causal relationship of the event with the suspect drug was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Ramsay-Hunt syndrome and Photosensitivity reaction  due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
still not feeling better after 7 days after 1st dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient via from a Pfizer sponsored Support.   A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MALAISE (non-serious), outcome "not recovered", described as "still not feeling better after 7 days after 1st dose".  Additional information: she stated tomorrow will be 7 days after getting the 1st dose and she still is not feeling better. She stated she feels very sick.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Non-IC patient received Moderna 0.5mL as  AD on 11/01/21 in error instead of receiving Moderna 0.25mL as B1. Error discovered today.
Patient experienced severe soreness at site of injection, loss of range in motion in arm, and unresolved pain with NSAIDs and ice.
Patient presented to Clinic 1/7/2011 late afternoon, c/o Rt. upper arm swelling, redness, burning. Went to Emergency, given antihistamine, other med.
After about a week the muscle in my left arm became very sore and was painful to lay on in bed at night. Has hurt every day but more at night for over a week now.
Information has been received from a licensed practical nurse concerning a patient who on approximately Nov 01 2004 (over the last two weeks) was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). Subsequently, the patient developed a reaction at the injection site including soreness, warmth, erythema, and swelling. the patient sought unspecified medical attention, It was also reported that the patient was treated with antibiotics and recovering. There was no product quality complaint involved. Three other patients experienced adverse events following administration of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P) (WAES0411USA02548). Additional information has been requested.
By 9 a.m. I was running a temperature of 100.1. Over the next few hours, it rose to 104.1. I had chills, a headache, a ringing in my ears, nausea and body aches. Tylenol reduced the fever, somewhat.  I still ran a fever on Tuesday. Since Wednesday, it has been between 99.8 and 100.1 and feel mostly better.
--chills starting at 4:00 a.m. --low fever (temperature was 99.2 when I woke up at 7:30 a.m.) --splitting headache (took 1 500 mg acetaminophen at 10:30 a.m.) --red spot and soreness at injection site --other muscle aches (neck) --slight cough --ears/nose congestion
Platelet count plummeted from 80 to 15 , considered severe Thrombocytopenia. Prednisone being prescribed - was not on medication for this condition before.
Moderna COVID-19 Vaccine EUA -  vaccine administered 12/31/20.  mild injection site soreness 1/1/21 and 1/2/21.  no events 1/3.  On 1/4/21, developed temperature of 100.6 intermittently throughout the day.  1/5-1/8, no symptoms.   Covid-19 test on 1/8 generated negative result.  On 1/9/21, injection site red, warm to touch, itchy and swollen.
Recent admission for pneumonia 8/21-8/26 and 8/30-9/1 for decompensated cirrhosis with heaptic encephalopathy. Presented on 9/5 with similar complaints as last admission. CT of head showed bilateral extra-axial fluid collections. Neurosurgery recommeded conservative management and serial CTs. Ultrasound confirmed ascites and paracentesis done.STarted on antibiotics. Has tracheostomy secondary to prior resection of laryngeal cncaer years ago. ENT consulted due to bleeding issues from site. Unable to embolize site. Bilirubin climbing and INR worsening. Palliative care consulted. Renal improvemnt shown with lasix, albumin and octreotide. On 9/21 developed new fever and tahcycardia. Repeat blood work showed + covid and procalcitronin. Continued to decline. NG placed for tube feedings. No increased oxygen requirments. Family requested transition to hospice. Unfortunatley epired before this could be arranged.
monovalent in stock & bivalent not available.  Given after EUA date change. No known ill effects.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EM6206), in left arm, on 21Mar2021 as dose 2, single (Lot number: ER2613), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: EW0187), in left arm and on 16Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Discoid lupus" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Covid rebound., notes: Return of symptoms 2 days after testing negative after 5 day course of Paxlovid; negative, notes: Covid rebound. Return of symptoms 2 days after testing negative after 5 day course of Paxlovid. Therapeutic measures were taken with Paxlovid as a result of vaccination failure, covid-19.  Clinical information: Patient did not received other medication in 2 weeks. Patient treated with Paxlovid from 07Jun2022 to 11Jun2022. Covid rebound. Return of symptoms 2 days after testing negative after 5 day course of Paxlovid (from 16Jun2022 02:00 PM) and outcome was Recovering. Ae treatment: Penicillin  No follow up attempts are possible. No further information is expected.
Tested positive for covid 19. Muscle and body aches, fever, chills, headache etc. Moderate symptoms and took off work for a week.