chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very cold,  chills,  many many trips to the bathroom, flu-like very upset stomach,  101 temp,  throwing up ,
Fever 102F, body aches, chills, Fatigue. He took tylenol and helped fever. Fever free 7/10/19 today without medication use.
Shaking & limpness lasting for about1 to 1 1/2 minutes; no definite loss of consciousness, no choking, no resp distress; some crankiness for a few hrs;
Large sore red area with redder ring around reaction with heat lasting more than 9 days at site of injection
Doses were administered after 30-day Use By Date after being thawed/Vial was initially stored in the refrigerator on 07-Apr-2022 and administered on 10-May-2022 or 11-May-2022; Doses were administered after 30-day Use By Date after being thawed; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after 30-day Use By Date after being thawed) and PRODUCT STORAGE ERROR (Doses were administered after 30-day Use By Date after being thawed/Vial was initially stored in the refrigerator on 07-Apr-2022 and administered on 10-May-2022 or 11-May-2022) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after 30-day Use By Date after being thawed). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Doses were administered after 30-day Use By Date after being thawed/Vial was initially stored in the refrigerator on 07-Apr-2022 and administered on 10-May-2022 or 11-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after 30-day Use By Date after being thawed) and PRODUCT STORAGE ERROR (Doses were administered after 30-day Use By Date after being thawed/Vial was initially stored in the refrigerator on 07-Apr-2022 and administered on 10-May-2022 or 11-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported.   The vial did not undergo any temperature excursions.  The patient received second Moderna booster dose either on 10-May-2022 or on 11-May-2022.  No treatment information was provided.
Breakthrough case admission after 5 vaccines Moderna 3/2/21 lot# 025A21A;  Moderna 3/30/21 lot# 028A21A;  Moderna 10/28/21 lot# 939903;  Moderna 5/9/22 lot# 004M21A;  Moderna 9/15/22 lot# AB7145B
diarrhea; blotchy red rash; Nauseous; chills; fever; wheezing; This is a spontaneous report from a contactable consumer or other non-health care professional. A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot number: not reported), intramuscular in left arm on 27Jan2021 at 14:00 (at the age of 38-years-old) as 1st dose single for COVID-19 immunization. It was reported that patient was not getting the vaccine at the hospital but at the local facility. Patient's medical history was reported as none. Concomitant medications were not reported. Patient did not had vaccine prior to vaccination in four weeks. On 27Jan2021, (After the first vaccine last Wednesday and right afterward), patient developed a blotchy, red rash on chest and collarbone less that 10 minutes after getting it. Patient mentioned that she reported it to the observer and they said that it looked like a reaction and she was given a Benadryl. After 40 minutes it was going away and she was sent home. She said that she took another Benadryl after she went home. The rash went away and had not come back. On the same day, patient reported that she also felt really nauseous (had a feeling of sick) that night, chills occurred few hours after the injection probably around 1800 and a fever of 99.9. Patient reported that the chills were extreme and she was layered with clothing and she was still freezing. She has never had that happened before. She took Tylenol for her chills and fever. On 28Jan2021, the patient had diarrhea. On an unspecified date in Jan2021, the patient had wheezing. The patient reported that she was scheduled for the second dose on 17Feb2021. She did a follow up phone appointment with her doctor because she was worried. Her doctor told her to contact Pfizer concerning her symptoms because they were unsure. Patient wanted to know if it was contraindicated to get the second dose, if the second dose would be worse and if the symptoms contraindicated for the second dose. It was reported that patient mentioned that a Vancomycin (intravenous (IV) antibiotic, Lot, NDC, or expiry date: Not available) had before given her a similar reaction. Outcome of the blotchy, red rash, chills (went away within hour) and fever was recovered on 27Jan2021. Patient did not have fever later that evening or the next day, recovered from nauseous (in the evening) and diarrhea on 28Jan2021 and for wheezing was unknown.  Information about lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
both Pfizer vaccines I have recently received made the pain in my ankle go down a lot!; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Active diffuse lymphoma" (unspecified if ongoing), notes: I have active diffuse lymphoma in my right ankle, waiting for chemo and radiation. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "both Pfizer vaccines I have recently received made the pain in my ankle go down a lot!".  Additional information: A Doctor of Chiropractic, but also a non-Hodgkin's lymphoma survivor and patient for 20 years. First diagnosed elsewhere. I have active diffuse lymphoma in my right ankle, waiting for chemo and radiation. Funny part is though, both Pfizer vaccines I have recently received made the pain in my ankle go down a lot! I'm wondering, are any of the markers targeted for Covid 19 the same as for potential cancer gene therapies? I'd be very curious, also if this is relevant to possible coming cancer treatments from BioNTech.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I went back to work, and I was completely fine but then my arm started to hurt (that was 1/2 hour ish after the injection). But at 04:00 it was hurting, really swollen and red. I started to feel a little feverish and generally off around 04:00, also. Around 10:00PM that night, I felt like I was hit by a bus: headache, nausea, achiness, feverish, chills, nausea and joint started to hurt. I took Ibuprofen before I went to bed. The next morning, on the 26th, I woke up and felt a little bit worse. I still went to work that day, but my joint aches were more noticeable; and I was feverishness, had chills and achiness and arm got more red and swollen and the headache was come and go that day. On Wednesday, most of the symptoms were pretty noticeable. I went to work but was told I didn't look too hot and that's when the symptoms got pretty bad and I talked to my NP, and I got a Toradol shot because the ibuprofen wasn't touching anything. My arm was still swollen and hurt, had fever and chills and it was like needles in my joints. It was like both ankles, both knees and both shoulders. I went home and slept it off. That night, I started to get more of the muscle aches rather than the joint pain. So, I missed the next morning of work, I came in late and then in a couple hours it all flipped off and I was fine. It was all just gone and that was midday yesterday.
Shortness of breath; made stomach worse; doesn't know if he will get the second one; This is a spontaneous report from a contactable consumer or other non -healthcare professional (Patient himself).  A 42-year-old male patient received BNT162B2 (BNT162B2 Formulation: Solution for injection Batch/Lot number: not reported Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization.  Patients Medical history included hypersensitivity bad allergies, and allergies in his blood , psoriasis. The patient's concomitant medications were not reported. On an unspecified date patient experienced shortness of breath, made stomach worse, doesn't know if he will get the second one.  The patient underwent lab tests and procedures which included blood test: allergies. Outcome of events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
24 hours receiving Td vaccine, I began to fever, stiff neck, sore stiff joints, shortness of breath with slight improvement.  These symptoms lasted 2 and one half days.  Injection site was hot, red and swollen from my shoulder to elbow.
Pt recvd HIB vax on 15JUL91 & on 23SEP91 pt returned for 2nd vax & devel palpable nodule @ prev inject site; pt devel 2cm nodule or abscess in lt thigh @ inject site;
pt recv vax 26AUG96 & 7SEP96 pt exp joint stiffness in the ankles & knees;pitting edema (swelling); joint pain in the wrist;h/a;was not feeling well;presented to MD;lab eval revealed as ESR of 18;
I developed shingles (herpes zoster) on my R upper chest and back ~3 weeks after my 2nd Pfizer COVID-19 vaccine. I was evaluated by my primary care doctor and completed a course of valacyclovir.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a 11-years-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 18-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the left upper arm for prophylaxis (lot # 1621931, expiration date on 26-JAN-2022) (strength, dose, frequency and route of administration were not reported) (incorrect product storage).  The improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without a previous temperature excursion. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2009USA006106:
pt recvd vax 17AUG95 & seen in ER 26AUG95 for T102.7; discharged w/Keflex for 3 days; poss UTI; 31UAG95 admitted to hosp until 7SEP95 w/discharge dx strep pneu bacteremia unk source; discharged w/Pen VK 500mg q 5 hrs x 7 days
Information has been received from a licensed practical nurse concerning a 95 year old female who in August 2007, was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Oka/Merck). On 16-OCT-2008 the patient developed shingles. The patient was recovering from shingles. The patient was seen by the physician and sought unspecified medical attention. Additional information has been requested.
The baby reportedly was well prior to his vaccines. Cried briefly after vaccinations (20 seconds). Feel asleep in his mother's arms, but approx. 5-10min after she noted he was pale and lethargic with poor tone. He improved with stimulation and at time of clinic visit approx. 20min after his vaccines had recovered back to baseline.
Patient received  covid booster on Friday around 9:45 am.    "  I just wanted to let y'all know that I've had extreme redness, pain, and itchiness in the injection sight. I've also had a terrible headache since Friday. I had body aches that kept me from taking care of my kids on Saturday. The body aches are still there, but they are manageable now. "  Message from patient.
Severe chest tightness and severe pain; Severe chest tightness and severe pain; flu like symptoms; chest pains have gotten worse; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 28-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: EW0185), via an unspecified route of administration, administered in Arm Left on 28Jul2021 15:00 (at the age of 28-Years-old) as dose 1, single for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was reported as other. Medical history was reported as none. There were no concomitant medications. No known allergies were reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine (prior vaccination was none). No other medications the patient received within 2 weeks of vaccination. The patient experienced severe chest tightness and severe pain, flu like symptoms and chest pains have gotten worse on 29Jul2021. The patient was hospitalized for severe chest tightness and severe pain, flu like symptoms and chest pains have gotten worse for 1 day. The adverse event resulted in visiting of emergency room/ department or urgent care. The adverse events were considered as serious with seriousness criteria of hospitalization. Patient went to the emergency room for pain and chest pain was worse over 9 days. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 07Aug2021. No treatment was received for the reported events. The outcome of the events was reported as not recovered.
Shingles started on march 9th after second shot of Vaccine. took antiviral medicine for 7 days, still in pain taking Gabapentin for pain
Pt recvd 1st Engerix-B vax & exp sedation & sleeping on 19JUL91 & on 26JUL91 exp resolution of all signs & sx;
24 hours of fever, chills, aches, shooting pains in the ears, headache, fatigue.  Fever not relieved by Tylenol or ibuprofen. Temp to 101F. Given a course of prednisone by urgent care provider which stopped the symptoms after the first dose.
Rash; Allergic reaction; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERSENSITIVITY (Allergic reaction) (seriousness criterion medically significant). On 18-Jan-2021, the patient experienced RASH (Rash). At the time of the report, HYPERSENSITIVITY (Allergic reaction) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was mentioned. The patient stated 2 days after receiving the vaccine she went to the emergency room for an allergic reaction and 10 days after vaccination she developed a rash.; Sender's Comments: This case concerns an adult female with a serious unexpected hypersensitivity and nonserious expected rash. Latency 2 days after mRNA-1273. Based on 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.
Reports immobility and pain with movement in left shoulder only. Reports that pain started a few hours after vaccine and continues to hurt. No previous reports of vaccine reactions.
but did state the clinic has a protocol for deviation of dose by one day, and the patient did come on 18Apr2022 to receive her missed dose with no reported adverse event; Initial information received on 19-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional via call canter.  This case involves a patient of unknown gender and age reported that the clinic has a protocol for deviation of dose by one day, and the patient did come on 18-Apr-2022 to receive her missed dose with no reported adverse event while receiving vaccine Rabies (Hdc) Vaccine [Imovax Rabies].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 18-Apr-2022, the patient received a dose of suspect rabies (HDC) vaccine lot T1E943M and expiry date: 14-Oct-2022 (dose, route, strength, formulation, frequency: unknown) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "but did state the clinic has a protocol for deviation of dose by one day, and the patient did come on 18apr2022 to receive her missed dose with no reported adverse event" (inappropriate schedule of product administration) (latency unknown) following the administration of rabies (HDC) vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (inappropriate schedule of product administration).  At time of reporting, the outcome was Unknown for the event inappropriate schedule of product administration.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Arm pain and inflammation of a lymph node (enlargement , pain) in the left armpit. Duration - day 2 to day 9 after vaccination.  Other issues - chills, tiredness, headaches - continues on and off day 1 to day 9
subacute thyroiditis; This is a literature report.  A 41-year-old female 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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: THYROIDITIS SUBACUTE (medically significant), 20 days after the suspect product(s) administration, outcome "unknown", described as "subacute thyroiditis". The patient underwent the following laboratory tests and procedures: Anti-thyroid antibody: negative; negative; Blood thyroid stimulating hormone: 0.07 MiU/mL, notes: Low; Free thyroxine index: 3.04 ng/dL, notes: elevated; Histology: A heterogeneous and swol len thyroid, without, notes: nodules; Physical examination of thyroid: A heterogeneous and swol len thyroid, without, notes: nodules; Thyroid stimulating immunoglobulin: negative; Tri-iodothyronine: 200 ng/dL, notes: elevated; Ultrasound scan: A heterogeneous and swollen thyroid, without, notes: nodules. Therapeutic measures were taken as a result of thyroiditis subacute.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new 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.,Linked Report(s) : US-PFIZER INC-PV202200008403 Same article/drug/event and Different patient.;
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 030B21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included LISINOPRIL and HYDROXYZINE for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage unit. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            Concomitant products also included inhaler for COPD.  No treatment information was provided.   This case was linked to MOD-2021-075204 (Patient Link).
low grade fever; chills; body ache; joint pain; Pain; Recurring headaches; This spontaneous case was reported by a dental hygienist and describes the occurrence of HEADACHE (Recurring headaches), PYREXIA (low grade fever), CHILLS (chills), MYALGIA (body ache) and ARTHRALGIA (joint pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced HEADACHE (Recurring headaches). On an unknown date, the patient experienced PYREXIA (low grade fever), CHILLS (chills), MYALGIA (body ache), ARTHRALGIA (joint pain) and INJECTION SITE PAIN (Pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, HEADACHE (Recurring headaches), PYREXIA (low grade fever), CHILLS (chills), MYALGIA (body ache), ARTHRALGIA (joint pain) and INJECTION SITE PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient developed fever, new onset erythematous rash on face and trunk, limping on L leg and toe walking, soft tissue swelling, and conjunctival injection. Patient admitted to hospital on 2/12/21 with diagnosis of Kawasaki disease and received treatment with IVIG and aspirin. Discharged on 2/15/21 with continued aspirin until follow-up. Re-admitted on 2/16/21 for overnight admission and received another dose of IVIG.