chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe redness and itchiness, skin rash on both feet, and right elbow, continues to spread and grow larger.
I had all of the "general side effects" listed:  fatigue (extreme), headache, muscle pain, joint pain, chills, nausea and vomiting, and fever.  This lasted for approximately 1 1/2 days.
My supraclavicular lymph nodes on my left side are swollen. They are visually noticeable. At first I only noticed one the next evening after the injection. And later that evening before going to bed I could feel 3 lumps. There is no pain even upon palpitation, just a little tinder if I move them to much which brings me to the observation that they are semi mobile.
Information has been received from an 81 year old female with arthritis, glaucoma and macular degeneration and a history of shingles, pain burning and murmur functional and no drug reactions/allergies who about a week ago (on approximately 13-AUG-2008) was vaccinated with ZOSTAVAX (Oka/Merck) on her left arm and did not have any pain on that side on her arm. Consumer reported that about 12 years ago she had the shingles, the first time she had the shingles she had a burning pain across her back for 6 weeks, the second time she had the shingles it was not very bad and was similar to the first time, and the third time she had the shingles she had an 8 inch band from the left arm across her breast and around the right arm and back. About two days ago on 18-AUG-2008, she started to have burning under the right arm and the burning has gotten so bad that she slept with an ice pack on it and has kept it on all day as well. At the time of the reporting, the patient had not recovered. Additional information has been requested.
Swollen, red, painful left thigh occurred on 4/17/11 next day. TYLENOL 1 1/2 tsp every 4 hrs as needed for pain.
shot given 6/14/22 inject site little red; 6/15/22 felt lethargic no fever; 6/16/22 felt ok injection site still red; 6/17/22 redness on arm spreading to elbow, not painful; pt went to urgent care and prescribed antibiotic for 7 days
really sleepy; arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (really sleepy) and VACCINATION SITE PAIN (arm was sore at the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039H20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced SOMNOLENCE (really sleepy) and VACCINATION SITE PAIN (arm was sore at the injection site). At the time of the report, SOMNOLENCE (really sleepy) and VACCINATION SITE PAIN (arm was sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided
Received an expired dose of the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna vaccine) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 030B12A) for COVID-19 vaccination.     Concurrent medical conditions included Obstructive sleep apnea syndrome since 15-Dec-2019, Atrial fibrillation since 07-Feb-2019 and Vitamin B12 deficiency since 13-May-2019. Concomitant products included APIXABAN (ELIQUIS) from 12-Jul-2021 to an unknown date and FLECAINIDE from 05-Jul-2019 to an unknown date for Atrial fibrillation, VITAMIN B12 NOS from 13-Jun-2019 to an unknown date for Vitamin B12 deficiency.   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna vaccine). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Follow-up document received on 01-Oct-2021 included Patient's race, historical condition, dosage information and concomitants.
arm soreness for 5 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 (Lot number: EN6204) at the age of 64 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 11Mar2021, outcome "recovered" (16Mar2021), described as "arm soreness for 5 days". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity.  Additional Information: The adverse event did not require Emergency Room or physician office visit. The patient had both 1st and 2nd Doses of the Pfizer COVID Vaccine within 4 weeks. Family history was reported as none. The event was reported as non serious by the reporter.     No follow-up attempts are possible. No further information is expected.
Pain began after work at 3:30 PM. Pain on Friday (day off) Saturday pain, Sunday pain (1/9, 1/10/21) Unable to work due to pain.  Not able to dress self without help until Monday 1/11/21.  Back to work on Tues. 1/12/21.
Arm pain, sore throat, weakness all over, throat swelling w/pulse, drainage in throat, hot & cold spells; pt went to ER;
Tightness in upper chest: Blood Sugar=66 Gave Apple juice and crackers, Blood Sugar=67  5min after juice/crackers; then blood sugar decreased back to 66;
The site of my injection in my right arm has been extremely sore to the point where I can barely lift it. My entire body hurts/aches as well. My shoulders, back, arms, and legs have been extremely sore all day to the point that it is hard to stand or turn my neck.
Vomiting, Diarrhea, Lightheaded, Fever, Chills all approximately 15 hours post vaccination.  Symptoms lasted over 24 hours post vaccination.
Intermittent strong sensation of electrical stimulation down both legs and to top of feet lasting  3 months.
Patient returned back to clinic after her observation time stating she had some heart palpitations and slight chest tightness.  Declines medical attention at this time.
Headache, Myalgia, NauseaVomiting, injection site pain, chills Narrative:  Employee reports injection site pain/discomfort, chills, headaches, and nausea. Reports taking Aleve (naproxen) (no dose/frequency reported).
Fever, seizure that would not stop on its own, had to use drugs and sedation to stop seizure after over an hour. Resulted in paramedic transport to emergency room, admission to PICU, on ventilator for 3 days, still in PICU today 2.22.2104.
flu; Initial information received on 29-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-HCP.  This case involves a patient with unknown demographics who experienced flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  No lab data was reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment.  Outcome: Unknown.
The vaccine did not prevent shingles as intended; vesicular outbreak, which was diagnosed as herpes zoster or shingles; Information was received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. In an unspecified date in 2011, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended (Vaccination failure), and the pt subsequently contracted a persistent strain of herpes zoster or shingles. In an unspecified date in 2015, the pt was treated for a severe vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving the vaccine for long-term prevention of shingles, the pt suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the pt suffered and would continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was not reported. The events were reported to be related to zoster vaccine live (ZOSTAVAX).
Drug ineffective; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jun2023, outcome "recovered" (21Jun2023); COVID-19 (medically significant) with onset Jun2023, outcome "recovered" (21Jun2023), described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2023) Negative; (28Jun2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 16Jun2023 to 21Jun2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300235007 same reporter/patient, different product/AE;
Diarrhea and sever onset neuropathic pain.  Pain was severe enough the pt. considered emergency room services.
Very swollen lymph nodes in armpits, which went away in a week.  Also, severe joint pain in all joints, including knuckles, that was not present before.  The joint pain is still ongoing with no relief by over the counter medication;  2 weeks since the 2nd injection.
The child received two 30mcg doses to complete the series at age 11 (dose not approved for his age population). Parent brought them willingly to get vaccinated and pharmacy staff did not double check his age prior to vaccinating. Patient did not experience any adverse events.
Patient vaccinated 5/28/21, tested positive for COVID-19 3/7/22 and expired 6/4/22.
Patient contracted COVID-19 disease on 4-20-21; Patient contracted COVID-19 disease on 4-20-21; This is a spontaneous report from a contactable other HCP. A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK5730) via intramuscular route administration at arm left on 24Mar2021 16:15 as single dose for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient had no relevant medical history. Concomitant medication was not reported. It is unknown if patient receive any other medications within 2 weeks of vaccination or any other vaccines within 4 weeks prior to the COVID vaccine. It is unknow if patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested positive for COVID-19 since the vaccination. Patient contracted COVID-19 disease on 20Apr2021. The patient did not received treatment for the event. The patient underwent lab tests and procedures which included polymerase chain reaction: positive on 20Apr2021 Nasal Swab. The clinical outcome of the event was not recovered.   Follow-up (27Apr2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of awareness of the date: 23Apr2021.  Additional information has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 1 week after the second dose.
Increased heart rate (85 compared to normal resting rate of 65); sweaty feet and hands; slight headache; This is a spontaneous report from a contactable consumer (patient).   A 38-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number: EN6207) via an unspecified route of administration, administered in Arm Left on 11Mar2021 09:00 (age at vaccination 38-years-old), as dose 1, single for covid-19 immunization. Medical history included psoriatic arthropathy, Known allergies to Penicillin, sulfamate drugs. Patient had a reaction to an iron infusion. Concomitant medications included vitamin d2 dose of 50,000 mg (MANUFACTURER UNKNOWN), mecobalamin (B12 MECOBALAMIN), calcium levomefolate (METHYL FOLATE), and zinc (MANUFACTURER UN-KNOWN) all received in two weeks. The patient previously took sulfameth/trimeth and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021 09:15, the patient experienced increased heart rate, sweaty feet and hands, slight headache. The patient did not receive any treatment for the events. The outcome of the events was recovering.   No follow-up attempts were needed; information about lot/batch number could not be obtained.
MD rpt 3 days p/vax pt exp lethargy; 14 days p/ vax pt to ER w/ lethargy, dehydration & dec LOC; adm to hosp. blood & CSF cultures neg for bacteria; tx w/ IV ATB for 10 days; dx w/pos aseptic meningitis
Woke up at 2 am to fever of 100.3, body aches, chills/sweating. Fever subsided at 10 am but body aches and exhaustion remain. Headache present at 10 am.
unusually high number of covid infections in fully vaccinated employees; unusually high number of covid infections in fully vaccinated employees; This is a spontaneous report from a contactable Physician. This Physician reported similar events for 11 patients. This is 5th of 11 reports.    A patient of unspecified age and gender received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on Dec2020 (reported as between 17Dec2020-30Dec2020 (lot number EH9899) and in Jan2021 (between range of 07Jan2021-20Jan2021) (lot number unknown), respectively, both via an unspecified route of administration (age at vaccination unknown), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician stated they were seeing an unusually high number of COVID infections in fully vaccinated employees, with second dose plus two weeks, plus well over two weeks.  All of whom received Pfizer and all of whom received their first dose from the same lot. The physician stated they may need an investigation, because they are seeing high viral loads in these individuals and symptoms. The physician reports it is not right. All eleven individuals received their first dose from the same lot: EH9899. They did the standard dosage with the standard vanishing needle. The outcome of the event was unknown.  The patent is not in a study or program.    Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), cannot be excluded. The case will be reevaluated should additional information become available. ,Linked Report(s) : US-PFIZER INC-2021392224 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021445810 same reporter/ vaccine/ event, different patients
It was reported that a 54 year old female received Fluzone SV '99-'00 on 9/29/99. Three days later, the pt developed a severe headache. No further information is available at this time. From additional information received on 11/10/99, it was reported that the "pt denied consent". Additional pt and responsible physician information was also provided.
Itchy throat; took Benadryl and it resided Itchy Rash on back of both hands, no treatments have been suggested; offices are closed  Pain/Swelling on left shoulder; suggested ice and heat intervals, still taking Benadryl and Tylenol, no change or improvement  Swollen/painful  lump above clavicle; no change or improvement  Painful shoulder joint: no change Appointment not until New Years since offices including vsafe are closed for holidays. Will try telemedicine if symptoms persist
Shot 1 - fatigue, joint pain - then rash. Misdiagnosed as poison ivy  Shot 2 - rash, fever, joint pain in hands and knees, muscle fatigue/dead arm (not injection arm)
Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Received the flu vaccine on the same day as receiving the PFIZER vaccine (booster). Knot appeared under the arm the size of a golf ball.
Information has been received from a physician concerning a 13 year old female who on 09-OCT-2007 was vaccinated(route and site not reported) with the 2nd 0.5ml dose of GARDASIL vaccine (yeast) (lot # not reported). On 19-Oct-2007, the doctor was informed that the patient had hives on and off for 1 week. Patient sought unspecified medical attention and no additional information is available at this time. Outcome is unknown at the time of this report. Additional information has been requested.
Case number PHEH2015US026899 is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 24-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 29 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day, the temperature was fine. It was a new refrigerator and there had not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Patient presented 4/3 stating received Pfizer COVID-19 vaccine on Monday and began having sympoms about Wednesday.  Developed fever by Thursday and cough/nausea/vomiting by Friday.  Cough ongoing and feels like he should have production but is not able sputum out.  The pain is chest is described as not being able to fully expand his lungs when he tries to inhale. Patient presented 4/6-DOA
This patient had immediate development of hives at the injection site then progressed to hives over the left eye and later shortness of breath and periorbital swelling. She was treated with Benadryl PO, and Solumedrol IV. She developed nausea and vomiting. She was admitted over night, and discharged 02/21/01. She has continued with generalized hives. The patient is being seen by the allergist, dermatologist, and internist.
Approx. 1 month after initial vaccine on 03/20/21 and approx. 1 month after booster (11/20/21) I began having retinal migraines. I have had no migraines in my life until these vaccines. I wondered about it after the first vaccine (and reported on vsafe) but now that it has happened again after the booster it seems much more likely related to the vaccine.
Information has been received from a health professional concerning a 19 year old female patient who on 17-DEC-2008 was vaccinated with the first dose of GARDASIL IM into her right arm (lot # 661766/0652X). On 17-DEC-2008 the patient also received MENACTRA and Tdap in her left upper arm. On 17-DEC-2008 ("a few seconds later") the patient experienced convulsed and passed out. The patient stated that she didn't feel funny after the first two shots. When she received GARDASIL she felt a rush of warmth in her arm then she experienced lightheaded and blacked out. At the time of reporting, the patient had recovered. It is unknown if the patient sought medical attention. Upon internal review, convulsed was determined to be an other important medical event. Additional information has been requested.
Per provider notes, " patient got his Varicella vaccine 2 weeks ago and developed a rash 3 days ago and has about 12 lesions over his trunk and buttocks area. Patient has been well-appearing with no fever and is eating well. He has no other symptoms." No testing, no antiviral treatment. "Symptomatic care discussed with mom and the fact that this a vaccine side effect. Patient to follow up with her PCP for new concerns. Patient is happy and well-appearing and discussed contagiousness".
Had flu vaccine 11/2 at 13:00.  By 14:00 had throat tightening and shweezing.  Took Benadryl 25mg and by 14:30 had tongue and lip swelling.  Co-workers recommended she go to the ED for Epi but she went home and continued Benadryl every 3 hours.  Had temt of 101.3 during the night, gone by morning of 11/3.  At report on 11/3 had no respiratory symptoms but lips and tongue still swollen.  Reports that recent tetanus booster made arm very swollen as well.  Not sure if this vaccine was right or left arm - guessed left.
16 weeks old patient with papular rash, non-erythematous over whole of antero-lateral aspect of left thigh. Had a small 4 mm induration underneath area below site of vaccine injection.
Administration error - patient was 17 years when vaccine was administered. Vaccine is authorized for use in 18 and older. No know adverse events.