chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt admitted to hospital with hypoxia; acute on chronic respiratory failure with hypoxia, COPD, CHF exacerbation, COVID test positive, COVID pneumonia and aspiration pneumonia; DNI/DNR; BiPAP; given lasix, solu-medrol, remdesivir, baricitinib, lovenox; pt's condition worsened; placed on comfort care and she died shortly afterwards in the hospital
Vaccinating pharmacist failed to swab/clean injection site on arm prior to administration of flu vaccine. Patient experienced redness and swelling at injection site 1 and 1/2 days later. Diagnosed with cellulitis and required treatment with antibiotic (levofloxacin 500mg daily for 7 days). Recovering as of 11/7/14 at 7:30 PM.
Received first dose and then like three weeks later got second dose, then got Covid and ended up in the hospital; Received first dose and then like three weeks later got second dose, then got Covid and ended up in the hospital; Tired; This is a spontaneous report from a contactable consumer (patient).  A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 07Apr2021 (Lot Number: EW0162) as single dose, dose 1 via an unspecified route of administration, administered in arm right on 17Mar2021 (Batch/Lot Number: ER8727) as single dose, both administered at the age of 58 years for covid-19 immunisation.  Medical history included ongoing lung carcinoma cell type unspecified stage iv diagnosed two years ago, recently broken collar bone on Feb2021, myocardial infarction from Oct2020 to an unknown date, severe allergic reaction to flu shot and something else can't remember years ago. The patient's concomitant medications were not reported. The patient received first dose and then like three weeks later got second dose, then on 07Apr2021 got covid and ended up in the hospital from 07Apr2021 to 19Apr2021. On an unspecified date the patient was tired. Caller was still tired but it was getting better. Caller states it has improved. Caller was diagnosed with Covid the same day the caller received the second dose Pfizer Covid Vaccine on 07Apr2021. Laboratory data included rapid test positive on unknown date. The outcome of the event got covid was unknown. The outcome of the event tired was resolving.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jun2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 51 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's relevant medical history included: "COPD" (unspecified if ongoing); "Asthma" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Sep2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Sep2022) Positive, notes: On 18Sep I tested positive for COVID and started taking Paxlovid; (22Sep2022) Negative, notes: On 22Sep I tested negative for COVID with no symptoms; (26Sep2022) Positive, notes: This morning 26Sep I tested positive for COVID again with symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No known allergies. No other medication in 2 weeks. Rebound covid. On 18Sep I tested positive for COVID and started taking Paxlovid. On 22Sep I tested negative for COVID with no symptoms. This morning 26Sep I tested positive for COVID again with symptoms.
No rxn at site of injection bi-lateral rash, painful oozing sores, stiff swollen hands, went to MD tmt-acyclovir 800 5x/day, amox 500 tid x10d, gabapentin 300 tid.
I experienced heart palpitations which began when I walked back to my car after waiting about 20-30 minutes in the store following my vaccine dose.  They lasted for only seconds but would come and go several times daily over the next 5 days. I do rarely get a heart palpitation, but never so consistently or for so long as after the vaccination. Now it has been 3 weeks and I am due for my second dose.  The palpitations have lessened a lot but I did have a couple yesterday and a few today. I don't know if these ones are vaccine related at this point. To be cautious, I am reporting this and will see my doctor prior to my next vaccine dose, as a nurse suggested. I just wanted to share this information in case it may be helpful.
This spontaneous report was received from a healthcare worker (also reported as nurse) refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 02-JAN-2015, the patient was vaccinated with a dose of RECOMBIVAX HB, (strength, dose, route and anatomical location were not reported), (lot# reported as H5H4E, expiration date: 29-JAN-2016), which was incorrect stored since 02-DEC-2014. No adverse effects were reported and no product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
p/ vax in 8/98 pt in 9/98 exp diffuse varicella-like rash & 23 crusted lesions
Flu like symptoms; Tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Tired) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BENAZEPRIL, ATORVASTATIN, PANTOPRAZOLE, OXYBUTYNIN HYDROCHLORIDE (OXYBUTININ ACCORD), VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL), HYDROCHLOROTHIAZIDE, ALENDRONATE SODIUM (FOSAMAX), CALCIUM, MAGNESIUM and VITAMIN D3 for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Tired). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications Benazepril, Atorvastatin, Pantoprazole, oxybutynin, valacyclovir hcl , hydrochlorothiazide, Fosamax, Calcium, magnesium, vitamin D3  Treatment information was not provided.
Approximately 48 hours after administration Pt called said there was 3 inch area around injection site that has warm to touch, red, and itchy. Recommended Pt contact primary care doctor for evaluation.
PATIENT EXPERIENCE MIGRAINE ,  HEADACHE, COUGH, VOMITING ON THE DAY AFTER VACCINATION.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10May2022 as dose 4 (booster), single (Batch/Lot number: unknown), 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's relevant medical history included: "Heart attack in 2017", start date: 2017 (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Home antigen test is positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
knot in her arm from when she received Bexsero a few years ago; This case was reported by a nurse via sales rep and described the occurrence of skin mass in a 20-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, less than a year after receiving Bexsero, the patient experienced skin mass. On an unknown date, the outcome of the skin mass was not recovered/not resolved.   It was unknown if the reporter considered the skin mass to be related to Bexsero.  Additional case details were provided as follows: The reporter was patient's mother. The age at vaccination was not reported. The patient still complained about a knot in her arm from when she received Bexsero, a few years ago. The reporter consented to follow up.
Extreme itching and rash of bilateral upper extremities starting on arm of injection; Extreme itching and rash of bilateral upper extremities starting on arm of injection; This is a spontaneous report from a non-contactable nurse (patient). A 24-year-old female patient (age at vaccination: 24 years) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL0142 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 07Jan2021, as a single dose for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3248 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 25Jan2021, as a single dose for COVID-19 immunization at hospital. The patient was not pregnant at the time of vaccination. The patient's medical history included known allergies: pineapple. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), methylphenidate hydrochloride (CONCERTA), buspirone, and birth control. Past drug included Dexamethasone (known allergies: Dexamethasone) and Bactrim (known allergies: Bactrim). The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 11Jan2021, the patient experienced extreme itching and rash of bilateral upper extremities starting on arm of injection and then moving lower. The adverse events were resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. Outcome of the events was recovering.  No follow-up attempts are possible; no further information expected.
3/3 to 3/6 sore arm at injection site   3/5 in the morning high pressure in my right sinus (bloody nose) it subsided.  3/6  Pain in my right breast tissue that lasted a couple of days.  3/8 started getting a sore right hip in the afternoon and could barely lay down. The pain lasted all night and in the morning I could barely get out of bed.  I was able to slide out of bed with considerable pain.  Once up I struggled to bend at all. My husband had to put my socks and shoes on.  I had to take him to get a medical procedure that morning and I could barely get in the car.  I took an Alieve before we left because   sitting down was excruciating.  I had everything I could do to get up and down from chairs while waiting.  When we got back about 10:30 I took another Alieve.  It was starting to calm down.  I took another Alieve later in the evening and today it still hurts but not as bad.  Now it includes my right Knee.   I have never had these pains before.   I am concerned about my second shot.
shortness of breath, aches, and fever 2 days after receiving 1st dose of COVID
her right foot became numb like it was asleep; felt nerve pain; pain / up her leg; pain / up her leg to her back; This case was reported by a consumer via call center representative and described the occurrence of numbness in feet in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 14th November 2020, 24 hrs after receiving Shingrix, the patient experienced numbness in feet, nerve pain, leg pain and pain. The patient was treated with steroids nos (Steroid Injection). On an unknown date, the outcome of the numbness in feet, nerve pain, leg pain and pain were not recovered/not resolved.   It was unknown if the reporter considered the numbness in feet, nerve pain, leg pain and pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received 1st dose of Shingrix in right arm and 24 hours after receiving the Shingrix vaccine her right foot became numb like it was asleep and as she walked around the pain when up her leg to her back and she felt nerve pain.  The healthcare professional ordered an MRI (magnetic resonance imaging) that showed nothing.  Since March 2021, the patient had received 3 steroid injections in her lower back that had only helped minimally with the pain. The patient was not sure whether or not to receive the 2nd Shingrix vaccine. The reporter did not given permission to contact healthcare professional. The reporter did not consent to follow-up.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The registered nurse reported that doses of VAQTA were stored improperly and were administered to an unspecified number of patients (doses, routes and lot numbers not provided), on unspecified dates. No adverse effects reported. This case is linked to cases MARRSD # 1408USA000288 and MARRS # 1408USA000500 (same reporter link). Additional information has been requested.
Pain, redness, and swelling at injection site. Chills.  Fever from 100.5 to 102 Fahrenheit. Headache. Lightheaded ness. Mental cloudiness. Body aches. Muscle aches. Lethargy.  Hot flashes.
Pt. had swelling on salivary gland (diagnosed - parotitis) 3 days after receiving immunizations.
About 10 min after receiving injection, patient began to feel hot, lightheaded and unable to swallow.  Patient was provided with a dose of 50mg of diphenhydramine.  Patient sat down and was able to leave on her own accord within an hour.  Patient reported feeling much better after a couple of hours.
Heart and chest pressure, unusual heart palpitations; began a day after booster shot and continued for a week following with another episode a week after that.
first dose in 5/21/21, second in 12/16/21.; first dose in 5/21/21, second in 12/16/21.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 72-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose of Twinrix was received on 21st May 2021).   On 16th December 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 16th December 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-MAY-2022 Reporter's Comments:  The reporter wanted to know that how to proceed with Twinrix series. The pharmacist reported that a patient received second dose later and 3rd dose had not received yet. The reporter did not give consent to follow up.
DEVELOPED A RASH ON STOMACH THE NEXT DAY, THEN ADVANCED TO CHEST, ARMS, NECK, FACE AND GROIN AREAS, ON THE THIRD DAY. THE FORTH DAY I WAS DIZZY MOST OF THE DAY. I TOOK BENEDRILS TABLETS EACH OF THE DAYS AS DIRECTED.  MY SKIN WAS ITCHY FOR 5 DAYS, STILL A LITTLE TODAY, THE 6TH DAY.
I ended up losing consciousness & fell down a flight of concrete stairs; I ended up losing consciousness & fell down a flight of concrete stairs; Body aches; Fever; Chills; Eye pain; Diarrhea; Nausea; Extreme fatigue; Extreme shortness of breath; Dizziness/ Feeling lightheaded; I have multiple facial abrasions; a deep wound sustained from my face hitting the bolts that hold the rail down; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FF2588), via an unspecified route of administration, administered in left arm on 20Sep2021 14:30 (at the age of 42 years) as dose 2, single for COVID-19 immunization. She also received Influenza Vaccine (INFLUENZA) via an unspecified route of administration, administered in left deltoid on 20Sep2021 (Batch/Lot number was not reported), at unspecified dose for an unspecified indication. Patient had no relevant medical history and concurrent conditions. Patient had no relevant past drug history including no known drug allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FF2588), via an unspecified route of administration, administered in arm right on 30Aug2021 15:00 (at the age of 42 years) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID- 19. Concomitant medication included Hepatitis B Vaccine (HEPATITIS-B) taken for an unspecified indication on 14Sep2021. On 21Sep2021 13:30 (day after her shot) patient had all the common side effects all morning; body aches, fever, chills, eye pain, diarrhea, nausea, extreme fatigue. By the early afternoon she was experiencing extreme shortness of breath, dizziness and feeling lightheaded. She ended up losing consciousness and fell down a flight of concrete stairs. She had multiple facial abrasions and a deep wound sustained from her face hitting the bolts that hold the rail down. This resulted in visit to Emergency room/department or urgent care but didn't prolong hospitalization. On an unspecified date patient underwent lab tests and procedures which included Head CT scan, leg and chest X-ray, EKG. The result of which are unknown. Therapeutic measures were taken because of events. Outcome of all the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported loss of consciousness cannot be completely excluded based on information provided. 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.
2 weeks after receiving FluBlok vaccine: right eye scleritis triggered into flare-up. Symptoms include throbbing pain in right eye, redness in right eye, right neck and eye pain, and systemic body aches, muscle pain.
This spontaneous report as received from a clinical medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On 12-MAY-2015, 13-MAY-2015, 18-MAY-2015, 27-MAY-2015 and 9-JUN-2015, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (strength, dose, route of administration, lot# and expiration date were not reported). No information on patients concomitant medications was provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports from the same reporter. Additional information has been requested.
Aside from already reported s8de effects such as muscle aching, feeling flu like, inability to regulate temperature, their is a terrible taste I. My mouth that started about 24 hours after getting the shots.
Pt experienced erythema and fine 2mm papules in 4 x 8 cm patch on left deltoid only.
patient says that her and her husband had Covid-19 in August of 2022 after they had received 3 Moderna Covid-19 vaccines.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (patient says that her and her husband had Covid-19 in August of 2022 after they had received 3 Moderna Covid-19 vaccines.) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2022, the patient experienced COVID-19 (patient says that her and her husband had Covid-19 in August of 2022 after they had received 3 Moderna Covid-19 vaccines.). At the time of the report, COVID-19 (patient says that her and her husband had Covid-19 in August of 2022 after they had received 3 Moderna Covid-19 vaccines.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test: Positive.         No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-674609 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-674609:cross link MOD-2022-674609 (husband case)
Based on results of an antibody test, my doctor suspects that I experienced a breakthrough COVID-19 infection beginning July 14, about 2 months after my second Pfizer dose (May 3). I continue to suffer persistent fatigue from that infection. Fatigue and related problems (intestinal discomfort, light dizziness/lightheadedness) were my only clear symptoms during the infection itself, and continue to be my only symptoms.
Tinnitus, still present 7 months later.  Appears to have worsened after recently receiving my 3rd booster in Nov 2022.    Note that I received both doses of the original vaccine in 2021 (all 3  Pfizer), but both the 2nd booster in May?22 and in Nov?22 were. Moderna.