chrisvoncsefalvay/vaers-outcomes huggingface dataset:
excessive urination since then.; This is a spontaneous report from a contactable consumer (patient daughter). A 90-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration on 09Feb2021 (Age at vaccination: 90-years-old) as dose 1, single for covid-19 immunization. Medical history included legs swell up (She said he started it many years ago), heart surgery (probably 3-4 years ago, She clarified her father said it was 10 years ago). Concomitant medication included ongoing furosemide taken for an unspecified indication from an unspecified start date and He was on water pills she did not know if that counts. He was taking 5 different pills per day. It was reported that patient received the first dose of the Pfizer Covid vaccine on 09Feb2021 and has been experiencing excessive urination since then. She wants to know if that was associated with the vaccine. It was reported that patient daughter stated as soon as he got the shot he peed 3 times immediately, as soon as he got home. It was still ongoing he has been on the toilet since around 10 am and he has not moved from getting off the toilet. She was not sure whether to call an ambulance. She called his doctor and he said to go to an urgent care center but she cannot get him there. She says it seems to be getting less. It was reported that Furosemide: His doctor prescribed it she does not know why, his legs swell up. She said he started it many years ago after his heart surgery probably 3-4 years ago. She clarified her father said it was 10 years ago and he has been taking it daily ever since. The patient has a second dose scheduled for 06Mar2021. The outcome for the event was reported as not resolved at the time of this report.   Follow-up attempts are completed. No further information is expected.
Bloody stools; upset stomach; diarrhea; fever 102; This is a spontaneous report from a contactable consumer (patient). A 13-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, in the left arm on 03Aug2021 at 11:30 (at the age of 13-years-old) as dose number unknown, single for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug Store. The patient medical history and concomitant medications were not reported. No known allergies. Prior to vaccination 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 vaccines within four weeks prior to the vaccination. On 03Aug2021 at 17:00, the patient experienced bloody stools, upset stomach, diarrhea and fever 102. Seriousness criteria reported as no. The patient received any treatment for the event was unknown. The patient underwent lab tests and procedures which included body temperature: fever 102 on 03Aug2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Outcome of the events was recovered with sequelae on Aug2021.
This is a spontaneous report from a contactable nurse received via Pfizer company representative. A 62-year-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on 31May2017 at single dose for immunization. Medical history included asplenia. The patient's concomitant medications were not reported. After vaccination patient experienced local inflammation and redness from his shoulder to his elbow as well as arm pain. Patient was still experiencing arm pain. Patient also experienced a cardiac event after vaccination. The outcome of event arm pain was not recovered, the outcome of the other events was unknown.
dose was given to adults mistakenly; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (dose was given to adults mistakenly).    No concomitant medication was reported.  It was reported patient received the error dose with instruction to re-vaccinate 2 months from the initial error doses.  This case was created for patient no. 36 out of 104 cases.  No treatment information was provided.
administration site started to turn red; slight pain at the sight; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (slight pain at the sight) and VACCINATION SITE ERYTHEMA (administration site started to turn red) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), ATORVASTATIN and LEVOTHYROXINE for an unknown indication.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE PAIN (slight pain at the sight). On 02-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (administration site started to turn red). On 26-Jan-2021, VACCINATION SITE PAIN (slight pain at the sight) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (administration site started to turn red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: 911 was called immediately and patient taken to hospital/er
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild
Muscle aches (back); Injection site pain; Headache; Flushing in face; Brain fog; This is a spontaneous report from a contactable other hcp (reporting for herself) A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1283), via an unspecified route of administration single dose on 06Feb2021 10:15 (at the age of 28) left arm  for covid-19 immunisation. The first dose (lot# EL12849) was taken on 15Jan2021 10:15 am, left arm. The patient medical history was not reported. There were no concomitant medications. No other vaccine was received in four weeks.  The patient experienced muscle aches on 06Feb2021 19:00, injection site pain on 06Feb2021 19:00, headache on 06Feb2021 19:00, flushing in face on 06Feb2021 19:00, brain fog on 06Feb2021 19:00. No treatment received. The events outcome was not recovered.
First day extreme lethargy and brain fog. Second day temperature 2.5 degrees above normal, aching all over, mild headache, extreme fatigue and lethargy, very sore arm, much worse than first day. Third day most okay except the sore arm. Today mostly okay but feeling a little strange and slightly dizzy. I?m never sick and would never do the moderne vaccine again. Maybe Johnson and Johnson if we have to do this again.
Patient began to feel extremely dizzy. Did not pass out. Patient was given water and removed mask. She expressed the desire to go home to lay down where someone would monitor her. She was taken by wheel chair to the vehicle where someone drove her home. At home she was monitored and pharmacy personnel checked on her around 12pm at which point she felt normal again.
Symptoms: severe shoulder pain and limited range of motion and shoulder injury related to vaccine administration (SIRVA).
Patient is a 59 y.o. female patient of, MD with history of Atrial fibrillation/flutter, COPD, DM type 2, Depression, Hypertension, parkinson's disease who presented to Hospital with shortness of breath was found to have acute hypoxic respiratory failure, COVID infection, COPD, and CHF exacerbation.   Acute hypoxic respiratory failure Covid-19 Virus Infection Date of onset of symptoms: 4/15/2023 Symptoms present on admission: cough and shortness of breath Date of covid positive test: 4/19/23 Vaccination status: vaccinated Imaging: CXR with mild CHF and background pHTN pattern consistent with COPD Oxygen requirements on admission: 2LNC Current oxygen requirements: 1LNC (not on home O2) Medical therapy: remdesivir and steroids Consultants following: none  Anticipated special isolation end date: 4/29/23 Home O2 eval revealed no home O2 needs and patient declined home O2 setup even if qualified as family members are smokers and she is concerned for fire   Acute COPD exacerbation Dyspnea, coughing CXR mild CHF and COPD changes Improved with albuterol inhalation Continue spiriva, xopenex, symbicort, azithromycin decadron Wean O2 to RA, did not qualify for home O2   Acute on chronic HFpEF exacerbation Dyspnea and hypoxia on admit CXR with mild CHF vascular congestion Received IV lasix x1 with clinical improvement TTE 08/2022 with EF 70% with severe MS Lowered home PO lasix with renal recovery Clinically appears euvolemic 4/21 Severe mitral valve stenosis Afib with RVR Warfarin induced coagulopathy Trop 15-17, flat HR 140's in RVR on 4/19 Due to hypoxia/COVID and albuterol inh Resumed home metoprolol and cardizem Goal HR<120 prn lopressor IVP Switched albuterol to xopenex INR 3.7 on warfarin, pharmacy to dose HR controlled since 4/20, INR 1.9   Uncontrolled DM type 2 BG 422, not in DKA; HbA1c 10.3 Suspect due to systemic steroids for COVID/COPD and lack of home insulin Uncontrolled despite home lantus and SSI Increased lantus to 50 U BID in addition to lispor 25U Qac and home metformin Adjust insulin as needed for optimal control   Pseudohyponatremia Na 129 due to hyperglycemia Corrected Na normal on 4/21   Depression and anxiety Wellbutrin    Obesity BMI 44.29 Lifestyle changes recommended
Swelling and redness of left arm after PNEUMOVAX administration. Patient self treated with BENADRYL and TYLENOL. Swelling began to subside after 3 days.
After receiving first rabies vaccine with 1/2 hour she became hot, shaking, flu like symptoms, she went to bed and stayed in bed for three days.  Had chills, nausea and vomiting.  Did not check temperature.  She did not seek medical attention
LIVER ENZYMES ELEVATED; NAUSEA; VOMITING; HEADACHES; This spontaneous report received from consumer via other manufacturer Novavax concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: autoimmune issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total (first dose) administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced nausea, vomiting, headaches, she could not keep fluids down. She went to the ER the next day and was hospitalized (date unspecified). They looked at her liver enzymes because they were elevated (liver enzymes elevated) and they kept her overnight. They took her blood and gave her fluids. The next day (date unspecified), she was discharged and followed by her medical team.The number of days of hospitalization was reported as 1.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, vomiting, headaches and liver enzymes elevated was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220859708-Covid-19 vaccine ad26.cov2.s- liver enzymes elevated. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.   20220859708- Covid-19 vaccine ad26.cov2.s- nausea, vomiting, headaches .This event(s) is labeled per RSI and is therefore considered potentially related
shingles; debilitating with extreme pain episodes; acute pancreatitis; fibromyalgia; chronic fatigue syndrome; restless leg syndrome; illnesses; Initial information was received on 28-Nov-2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional under reference number US-SA-SAC20211201000141.  This case involves Adult female patient who experienced shingles (herpes zoster), debilitating with extreme pain episodes (pain), acute pancreatitis (pancreatitis acute), fibromyalgia, chronic fatigue syndrome, restless leg syndrome (restless legs syndrome) and illness, after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PREGABALIN (LYRICA) for Fibromyalgia.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date was not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious shingles (herpes zoster), debilitating with extreme pain episodes (pain), acute pancreatitis (pancreatitis acute), fibromyalgia, chronic fatigue syndrome, restless leg syndrome (restless legs syndrome) (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  On an unknown date the patient developed a non-serious illness (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for event.  At the time of reporting, outcome of all the events were unknown.  There will be no information available on batch number for this case.; Sender's Comments: This case involves adult female patient who experienced herpes zoster, pain, pancreatitis acute, fibromyalgia, chronic fatigue syndrome, restless legs syndrome and illness after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is not known. However, patient's medical condition at time of vaccination, Lab data and other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the individual vaccines cannot be assessed.
Information has been received from the husband of a 63 year old female with "heart condition" who was vaccinated with a dose of PNEUMOVAX 23 and influenza virus vaccine (unspecified). The patient was hospitalized after receiving the vaccines. The patient's husband reported his wife might be allergic to eggs and the egg component of the vaccines. The husband did not specify the manufacturers of any of the vaccines, however mentioned that she got the vaccines sometime in the 90s. At the report time the outcome was unknown. Additional information is not expected.
Excessively heavy menstrual cycle started following 2nd dose of Covid vaccine. Just had finished cycle two weeks prior and cycles are lengthened- not shortened. Bleeding was excessive.
Pretty sure I had covid 19 in the whole month of December 2019.  Was so sick I ended up at 2 urgent care and two emergency room.  I had a horrible headaches, chills, fever, a rash on my forehead, no one was able to diagnosis it.  1st urgent care, gave me steroids , a shot, pills and steroids ointment for my face.  I had the first co
first dose of Shingrix in August 2019 / not received a second dose; eczema that involved both arms; This case was reported by a pharmacist via call center representative and described the occurrence of eczema in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In May 2020, between 8 and 10 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced eczema. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with topical steroid nos (Topical Steroids). On an unknown date, the outcome of the eczema was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the eczema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for 1st dose and was not applicable for 2nd dose. The reporter stated that, the patient received 1st dose in August 2019 and 2 months before reporting, the patient experienced eczema in both arms. Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The patient received topical steroids which was ongoing. The reporter consented to follow up.
I had flu-like symptoms including extreme fatigue, slight fever for a day or two, stuffiness, loss of taste and smell, coughing. I took 2 at-home COVID-19 test that came back positive, so I decided to go to a clinic and get PCR tested; that test came back positive the next day. I went to the clinic to make sure my lungs were okay. I saw my primary care physician, and they sent me home. So I took Advil gel caps every morning and night to help to try to relieve my symptoms. It wasn't helping, so I went to the emergency room, and they advised me not to take it anymore and let the symptoms relieve themselves.
pt recvd vax SEP94 & following vax 27SEP94 pt exp redness & swelling @ the inj site;rxn lasted approx 3 to 4 days;
Patient became lightheaded, short of breath, and shaking 10 mins after receiving vaccine. Vitals were checked and member had elevated BP of 159/95mmhg and HR of 149bpm, SpO2 of 99% on room air. Resolved completely after 20-30 mins of rest and water. No oral swelling. Lungs and heart auscultated and normal. No medications or labs provided - only reassurance and close monitoring. Member was quite nervous going into this first COVID vaccination - mandated.
Hospitalization: 4/15/2023 - 4/20/2023 (5 days) Presentation to the ED: slurred speech COVID + date: 4/15/2023 Treatment: remdesivir and Decadron  Discharge to: HOME.   031L20A 2/3/2021 03M20A 2/23/2021 031H21A 11/20/2021
A few days later, patient took Medrol and on August 3rd, she developed Mumps
4 hrs p/vax pt cried for 1 hr w/high pitched shrill cry;
chills; body aches; nausea; low grade fever that began approximately 8 hrs after vaccination and continued for at least 24 hours; Pfizer BioNTech 2023 2024 formulation; administartion date: 19Sep2023, Flu vaccine; administartion date: 19Sep2023; Pfizer BioNTech 2023 2024 formulation; administartion date: 19Sep2023, Flu vaccine; administartion date: 19Sep2023; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 12-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 12 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 19Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 19Sep2023 at 17:00, outcome "unknown" and all described as "Pfizer BioNTech 2023 2024 formulation; administartion date: 19Sep2023, Flu vaccine; administartion date: 19Sep2023"; PAIN (non-serious) with onset 20Sep2023 at 02:00, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 20Sep2023 at 02:00, outcome "recovering"; PYREXIA (non-serious) with onset 20Sep2023 at 02:00, outcome "recovering", described as "low grade fever that began approximately 8 hrs after vaccination and continued for at least 24 hours"; NAUSEA (non-serious) with onset 20Sep2023 at 02:00, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, pain, nausea, pyrexia.  Additional information: The patient experienced chills, body aches, nausea, low grade fever that began "approximately 8 hours" (as reported) after vaccination and continued for at least 24 hours. The patient did not receive other vaccine in four weeks. Treatment received for the events included acetaminophen (TYLENOL) and ibuprofen. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] has been requested and will be submitted if and when received.
shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On or about 03-FEB-2016, pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not provided), as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by a healthcare provider for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Phone call 4/2/03 - mother stated pt had light case of chicken pox last week. Flared up her eczema, was weeping and crusty, just real red now. Had been using Elidel cream bid and Zyrtec syrup. Not helping. Dr recommended Aristocort .1 % bid. RTC if no improvement or further problems.