chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Irregularities in my menstrual cycle: I missed my period that comes exactly on time EVERY month like clockwork. I have never had a late or missed period so it was alarming. My period resumed the following month; however, it is now irregular and comes at varying days each month. It now comes during the first or second week of the month instead of at the last week of the month. Furthermore, my cycle no longer lasts 3 days, which was fantastic. Now, my period will start for a day or two, who knows?! And then it stops! For maybe a day or two or three, it?s a guessing game. But, it starts again, infuriatingly so and lasts a week! It?s heavy and long and so miserable. I?m absolutely irate and if I knew that this was a possibility, I would never have gotten the shots. No one mentioned this as a possible side effect and this was not informed consent. I?m angry that this has happened to me and I?m so grateful that I will not be having any more children, because family planning and tracking your cycle would be a nightmare in this situation.
Rash all over my legs.; It Didn't itch but it was red spots all over my legs; This is a spontaneous report from a contactable consumer. A 30-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection; Batch/lot number: ER8736), dose 1 via an unspecified route of administration at left arm on 01May2021 (age at the time of vaccination 30-year-old) as first dose, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. consumer stated, "It happened a week after my vaccination I had rash all over my legs, It Didn't itch but it was red spots all over my legs. I did go to the minute clinic and they prescribed me a steroidal cream (further clarification unknown, captured as unspecified medication) and that I used on my legs, It seemed to go away but then kind a came back, then it went away and came back again, so it's been on and off for 3 weeks now." consumer stated, about 2nd shot of Vaccine scheduled " I was actually scheduled for yesterday, 22May2021." The outcome of the event rash was not recovered and for red spots all over legs was unknown.  Follow-up attempts completed. No further information is expected.
reported Fever, body aches. chills, Nausea, Severe headache which made me take her to Emergency Room on 6/11/21. Severe headache possibly from Covid Vaccine.
nerve pain; joint pain; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 05-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the prevention of shingles (the dosage regimen information was not reported) in a pharmacy. Shortly thereafter, the vaccine caused the patient to suffer from severe and persistent joint and nerve pain. As a direct and proximate result of vaccination, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and would continue suffered significant medical expenses, pain, and suffering and other damages. The outcome of the events was considered as not recovered. The events were considered to be related to zoster vaccine live (ZOSTAVAX). The adverse events were considered to be disabling as the patient suffered serious and persistent injuries.
Full body tremors; bones/body contracturing; felt like a parasites was moving from injection site; headache; fever; fatigue; This is a spontaneous report from a contactable Nurse (Patient), who reported for herself.  A 54-years-old non-pregnant female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EL9262) via an intramuscular route of administration on 20Janl2021 (at 20:45), administered in right arm (age at the time of vaccination was 54-years-old) as a DOSE 2, SINGLE dose for COVID-19 immunization. The patient's medical history included Hashimotos Thyroiditis, vit D deficiency, Attention deficit hyperactivity disorder, pet dander allergy, HLD, acne, hormone replacements and Medals, no, but so food intolerance from an unspecified date. The patient's concomitant medications included LEVOTHYROXINE SODIUM, Ambien (ZOLPIDEM TARTRATE), Adderall (AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE), Vitamin B2 (RIBOFLAVIN), Vitamin B3 (NICOTINAMIDE) and Vitamin B12 (CYANOCOBALAMIN) taken for an unspecified indication. The patient had no other vaccine in 4 weeks. The patient did not have COVID prior to vaccination and was not tested for COVID post the vaccination. Previously, the patient also received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EL1685) via an unspecified route of administration on 29Dec2020 (at 18:30), administered in right arm (age at the time of vaccination was 54-years-old) as a DOSE 1, SINGLE dose for COVID-19 immunization. On 20Jan2021 (at 22:15), the patient experienced Full body tremors, bones/body contracturing, felt like a parasites was moving from injection site, headache, fever and fatigue. The clinical outcome of all the events was recovered with sequel.  Follow-up (07Oct2021): 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. .
bad case of diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (bad case of diarrhea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included high blood pressure medication for Blood pressure high, IBUPROFEN (ADVIL [IBUPROFEN]) from 07-Feb-2021 to an unknown date for an unknown indication.    On 07-Feb-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021 at 7:00 AM, the patient experienced DIARRHOEA (bad case of diarrhea). At the time of the report, DIARRHOEA (bad case of diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient was given his Covid booster and flu shot at the same time. Patient was fine after he got his Covid vaccine. Right after he got his flu shot he passed out. He was sitting in his father's lap, once he fainted he fell out of his father's lap onto the ground hitting his chin. Blood pressure and pulse were normal. EMS was called to check him out just to make sure every thing was okay since he hit his chin. EMS gave the all clear and after he sat for a few minutes he was feeling better.
Patient received Pfizer COVID vaccine #1 on 5/17/21, and during the post vaccination 15 minute observation period, the patient had a pre-syncopal episode where she felt a warm sensation in the arm where she received vaccine.  HR was in the 40s in the ER, increased on exertion.
Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 63 years old female patient who was vaccinated with a 0.5 ml once dose of FLUZONE HIGH DOSE (batch number UJ006AB and expiration date 14-Apr-2019) (route and site of administration was not reported) on 20-SEP-2018. The patients medical history and concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration. No specific adverse event symptoms reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/17/2021. Covid + 1/10/22 had exhibited symptoms 10 days prior, Presented to ED 1/9/22 c/o SOB and cough. Admitted for hypoxic respiratory failure, covid pneumonia, sepsis and acute encephalopathy  Treated with dexamethasone, ceftriaxone and doxycycline EOT 1/15/22, vancomycin, cefepime, micafungin and 1,2 Beta D glucan. Admitted to ICU with septic/cardiogenic shock. Course complicated by shock liver, thrombocytopenia, and ongoing hyopoxic respiratory failure. BP remianed low with MAPs in 50-60s. DNR Status. Pt HR and O2 suddenly dropped. Patient expired on 1/24/2022.
nasal congestion; diarrhea; fever of 100.5; chills; fatigue; quite a few symptoms, but not severe; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (quite a few symptoms, but not severe), NASAL CONGESTION (nasal congestion), DIARRHOEA (diarrhea), PYREXIA (fever of 100.5) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced COVID-19 (quite a few symptoms, but not severe). On an unknown date, the patient experienced NASAL CONGESTION (nasal congestion), DIARRHOEA (diarrhea), PYREXIA (fever of 100.5), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, COVID-19 (quite a few symptoms, but not severe), NASAL CONGESTION (nasal congestion), DIARRHOEA (diarrhea), PYREXIA (fever of 100.5), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, SARS-CoV-2 test: positive (Positive) Covid-19 test positive.     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 information were provided.  No treatment medication information were provided   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up received does not contain any significant information.
I believe the vaccine has caused an autoimmune flare; I believe the vaccine has caused an autoimmune flare; Extreme muscle pain; blood blisters in mouth tissue plus tissue swelling; blood blisters in mouth tissue plus tissue swelling; This is a spontaneous report from a contactable consumer (patient). A 73-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and expiration date: was not reported) via an unspecified route of administration on 22Feb2021 at 15:30 (73-year-old at vaccination) as a Dose number unknown, Single for COVID-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history included Lupus, Rheumatoid arthritis, Hashimoto's thyroid disorder. There were no concomitant medications within two weeks of vaccination. The patient previously took Penicillin, Levaquin and had allergies to it. The patient had not received any other vaccine within four weeks prior to vaccination. The patient was not diagnosed with COVID prior to vaccination. The patient was not tested for Covid post vaccination. On an unknown date in 2021, the patient had experienced extreme muscle pain; blood blisters in mouth tissue plus tissue swelling. She had Lupus and RA and she believed the vaccine had caused an autoimmune flare (which she wasn't had for over a year). She does not take any medications for her autoimmune issues because she doesn't tolerate them well. She was hesitated to get the vaccine and now felt that it would be a mistake to get the second dose. If her symptoms get worse, she worried her doctor would want to put her on prednisone which she hate's taking it. No treatment received for the resulted events. The outcome of the event was not recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information was expected.
Expired vaccine was placed back into refrigerator and was given to this patient when arrived. No reported adverse reaction experienced.
Discharge Provider: MD Primary Care Provider at Discharge: MD  Admission Date: 7/29/2022 Discharge Date: 8/1/2022  PRESENTING PROBLEM: COVID-19 virus infection [U07.1] COVID-19 [U07.1]   HOSPITAL COURSE:      Patient is an 85 y.o. male with a prior medical history of hypertension, chronic obstructive pulmonary disease, type 2 diabetes, systolic CHF and obstructive sleep apnea who presented to hospital on 7/29/2022 with Generalized weakness and fever.  The patient was found to have COVID-19 viral pneumonia with chronic obstructive pulmonary disease exacerbation..  Chest x-ray was negative for infiltrate however he was found to be hypoxic and required 2 L nasal cannula to maintain oxygen saturations over 92%.  The patient was admitted to the hospital for further monitoring. While hospitalized he was treated with Decadron initially and then transitioned to IV Solu-Medrol due to poor air flow throughout his entire lungs. He improved quickly with IV solumedrol and was transitioned to PO prednisone prior to discharge, will continue prednisone 20mg for 5 days. Was also started on remdesivir and received a total of 3 doses.  Physical therapy evaluated the patient and does not recommend any additional skilled services. The patient has been weaned off supplemental oxygen. Recommend post-hospitalization follow-up with PCP in 1-week.
Client arrives with mother to receive vaccines for school. He sits in chair and answers questions. He is administered 5 vaccines, listed above. He verbalizes his left arm is stiff, so his mom rubs it. He then rolls his eyes back, head tilts back, legs out stiff, and body shakes. Client is lowered to floor then opens eyes and able to report his name. Vitals taken by PHNs and 911 called. Client pale. Mom denies any history of seizures or any other medical conditions. EMS arrives at 1505. Client able to walk to stretcher and taken to hospital.
I found a lump between my left armpit & left breast & it's swollen/I found a lump on my left collarbone; I found a lump between my left armpit & left breast & it's swollen; soreness in left shoulder at the injection site; I was feeling pain in the middle of my chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (I was feeling pain in the middle of my chest), SKIN MASS (I found a lump between my left armpit & left breast & it's swollen/I found a lump on my left collarbone), SWELLING (I found a lump between my left armpit & left breast & it's swollen) and VACCINATION SITE PAIN (soreness in left shoulder at the injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     The patient's past medical history included Heart murmur.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced CHEST PAIN (I was feeling pain in the middle of my chest) and VACCINATION SITE PAIN (soreness in left shoulder at the injection site). On 07-Sep-2021, the patient experienced SKIN MASS (I found a lump between my left armpit & left breast & it's swollen/I found a lump on my left collarbone) and SWELLING (I found a lump between my left armpit & left breast & it's swollen). At the time of the report, CHEST PAIN (I was feeling pain in the middle of my chest), SKIN MASS (I found a lump between my left armpit & left breast & it's swollen/I found a lump on my left collarbone), SWELLING (I found a lump between my left armpit & left breast & it's swollen) and VACCINATION SITE PAIN (soreness in left shoulder at the injection site) 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 assessments.   No concomitant drug details were reported. No treatment details were reported.
pt had routine visit 28MAY97;was well on 30MAY had gen afeb sz;w/u negative so far;
Shot was not painful; soreness started at local site after 3 hours, made sleeping difficult. Arm pain worse next day, followed by mild fever appx. 18 hours after injection. Fever continued up to 100° at 24 hrs after injection, as well as dizziness/severe headache. Headache could not be overcome by aspirin/ibuprofen. Fever relented at 48 hrs after injection; headache subsided by 60 hours after injection.
Administered incorrect PEDS vaccine on a 43 y/o patient. Missed reading the box correctly, sticker was covering the age limits on the vaccine Box.
Onset of moderate to severe dizziness, immediately followed by tingling sensation, then severe numbness on entire left side of face (left lips) and entire outside left side body, from head to toes. Face, neck shoulder, arm, torso, leg, foot and toes
TIA, right upper extremity circulatory changes suggestive of venous thromboembolism. Resident declined transfer for further eval.
Patient is fully vaccinated and boosted.  COVID positive at ED visit on 5/9/2022. 74-year-old male with history of atrial fibrillation, anemia, anxiety, coronary artery disease, depression, fatigue, reflux disease, MI and sleep apnea reports he has been sick over the last 4 days with cough and congestion.  He does have a productive cough of sputum.  He has had a fever.  He does have body aches and rhinorrhea as well as a sore throat.  No diarrhea. CXR: No suspicious acute pulmonary or pleural abnormality. O2 sat 98%. No difficulty breathing.  Recommend zinc and vitamin D.  Self-isolation.  Discharge stable
This is a spontaneous report from a contactable consumer. A 66-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN 60205), via an unspecified route of administration on 25Fen2021 at 13:00 (at the age of 66-year-old) as 1st dose, single dose in left arm for COVID-19 immunization at Physician Office. The patient's medical history included migraines. Patient had allergies to legumes. Concomitant medications in 2 weeks included vitamin B complex [B-COMPLEX], curcuma longa root [TURMERIC CURCUMIN], and Vitamin D. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Feb2021 at 20:00, the patient experienced sore arm, fatigue, lightheadedness, and headache. There was no treatment given for adverse events. The patient had no COVID-19 prior vaccination and was not tested COVID-19 post vaccination. The clinical outcome of the events was resolved. No follow-up attempts are possible. No further information is expected.
pain around injection site; mild fatigue; mild headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 16Jul2022 at 17:00 as dose 4 (booster), single (Lot number: FP7134) at the age of 54 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 17Jul2022, outcome "recovered" (Jul2022), described as "mild fatigue"; HEADACHE (non-serious) with onset 17Jul2022, outcome "recovered" (Jul2022), described as "mild headache"; VACCINATION SITE PAIN (non-serious) with onset 17Jul2022, outcome "recovered" (Jul2022), described as "pain around injection site". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, headache.
Headache, bodyaches, elevated temp, site pain, tiredness, weakness. Tylenol/ibuprofen
03:30 am woke up with severe aches from shoulders to ankles. I was sweating. I woke up at 06:30 am and had chills and fever of 101.6. I took two Tylenol and drank some water. I went back to sleep and checked temperature throughout the day and it never went below 99.5 even while alternating Tylenol and Ibuprofen. On Sunday, 3/21, I still had sweating and started with a bad headache. I slept all day.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions and allergies were not provided. Concomitant therapies included sterile diluent. On an unknown date, the patient was vaccinated with VARIVAX lot # R020651 for prophylaxis. Call was due to a data logger Temperature/time (47 Fahrenheit to 77 Fahrenheit) 11 hours 28 minutes and (15 Fahrenheit to 46 Fahrenheit) 13 hours and 1 minute. On an unknown date, the nurse stated patients received unspecified doses of VARIVAX that were improperly stored.
Pt was administered the Fluzone Quad flu shot at around 7 pm tonight. About 5-10 min later patient approached the pharmacy saying that he was wheezing and felt like his throat was swelling. I took patient back into the immunization booth and had him sit down. He I had a technician page code white while I got an epi-pen. I administered the Epi-pen and had my technician call 911. I asked the patient if he thought he could swallow benadryl liquid and he said yes, so I gave him 50 mg of benadryl liquid and then gave him a water to sip. I checked his blood pressure every 5 minutes until EMS arrived to take over. EMS ran a EKG, listened to his breathing an checked blood pressure. They asked pt if he wanted to go to the hospital and pt declined. Pt stayed at the pharmacy for another hour while we frequently monitored his blood pressure and pulse ox. Pt was starting to feel better at that time so went home.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 11 year-old male patient who received MENVEO. Concomitant products included ADACEL. On 9th March 2016, the patient received the 1st dose of MENVEO. On 9th March 2016, immediately after receiving MENVEO, the patient experienced injection site pain and inappropriate preparation of medication. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the inappropriate preparation of medication was unknown. The reporter considered the injection site pain to be possibly related to MENVEO. The reporter considered the inappropriate preparation of medication to be unrelated to MENVEO. Additional details were received as follows: This case was previously reported to a doctor. This case was reported by the patient's father. The patient only received the liquid portion of the MENVEO and not the lyophilized powder portion, which led to an inappropriate preparation of medication. The reporter stated that the physician office called and let him know about the maladministration. The reporter noted his sone also received ADACEL in the opposite arm but did not known which product was given in which arm. The reporter noted his son also had pain at the time of injection as any 11 years old would experience.