chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; 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 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 75 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: "AFIB" (unspecified if ongoing); "HIGH BP" (unspecified if ongoing); "low GFR" (unspecified if ongoing), notes: low GFR 37-39 but steady. Concomitant medication(s) included: LOSARTAN, start date: 01Jan2001; ELIQUIS, start date: 01Jan2001; GLIMEPIRIDE, start date: 01Jan2001. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Oct2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Pt was given #6 vaccines (5 inj) on 11/9/11 - developed a fever of 103.5 degrees F. later that evening. She was given TYLENOL which helped to bring fever down. Pt woke with fever 102.3 degrees F am of 11/10/11 - seen by FNP. There was no sign of infection on clinical eval. Rx for ibu. suspension and TYLENOL liquid given for pt.
This spontaneous report was received from a register nurse refers to an unknown number of patients of an unknown age and gender. Medical history was not reported. On an unknown date the patients were vaccinated with (Oka-Merck) PROQUAD injection, (lot number, expiration date, dosage and route were not reported). Concomitant therapy was not reported. The reporter informed that on an unknown date the (Oka-Merck) PROQUAD reached temperatures outside of the prescribing information. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
cold symptoms going on; half congested; This is a spontaneous report from a contactable consumer (patient's caregiver). An 87-year-old patient of unspecified gender received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient had cold symptoms going on. The patient was "half congested." The outcomes of cold symptoms and congestion were unknown. It was also reported that since the vaccination the patient was tested for COVID-19 and did not have it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
No adverse event; Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023) and NO ADVERSE EVENT (No adverse event) in a 44-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date of March 29, 2023).    No concomitant product reported by the reporter.  Moderna Bivalent was administered to the patient past it's use by date of 29-Mar-2023.  No treatment medication reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2023: Significant live follow up added. Patient name updated.
Tight, full chest; rapid heart rate for 2.1 weeks. Arms and legs falling asleep.
Parent reported quarter sized red bump on right arm at injection site. No fever, redness or streaking
The patient is a 11 year, 1 month old male who presents with a complaint of Rash. Patient accompanied by and independent history obtained from father. The rash has been occurring for 1-2 days. The rash is characterized as raised above the skin. The rash is described as being located on the entire body. Symptoms include itching, drinking well, eating well and fatigue, while symptoms do not include fever, uri symptoms, runny nose, congestion, cough, sore throat, nausea, vomiting, diarrhea or headache. Medications used at home include other (Zyrtec for itching) . Note for "Rash": Started on abdomen and feet yesterday and has now spread diffuse all over the body. Described as raised, red, and mildly pruritic. No discharge of purulence. No new skin exposures or new skin products. No known skin contacts. On 7/26, received meningococcal, HPV, and TDap.
First shot I had two weeks of severe headaches and nausea. Second shot was on 8/24/21 first 2 days extreme fatigue, fever, general malaise. After that headaches and nausea for two weeks, nausea calmed down but headaches are still present daily. Taking Tylenol.
moderate sore arm; all hell broke loose; arm swollen; muscle that goes down the front of arm is also sore; hard to raise her arm; hurt too much to raise her arm; chills; shaking; threw up; stomch upset; freezing; could not get warm; teeth was shaking; became so disoriented that she was not capable figuring how to call her husband; running a feve; fever was 117; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (moderate sore arm), FEELING ABNORMAL (all hell broke loose), VACCINATION SITE SWELLING (arm swollen), MYALGIA (muscle that goes down the front of arm is also sore) and VACCINATION SITE MOVEMENT IMPAIRMENT (hard to raise her arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN, WARFARIN, PROPRANOLOL HYDROCHLORIDE (PROPANOLOL BOEHRINGER), BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET), MONTELUKAST SODIUM (SINGULAIR), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), Nasacort as needed, Supplements and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (moderate sore arm), FEELING ABNORMAL (all hell broke loose), VACCINATION SITE SWELLING (arm swollen), MYALGIA (muscle that goes down the front of arm is also sore), VACCINATION SITE MOVEMENT IMPAIRMENT (hard to raise her arm), VACCINATION SITE PAIN (hurt too much to raise her arm), CHILLS (chills), TREMOR (shaking), VOMITING (threw up), ABDOMINAL DISCOMFORT (stomch upset), FEELING COLD (freezing), FEELING COLD (could not get warm), CHILLS (teeth was shaking), DISORIENTATION (became so disoriented that she was not capable figuring how to call her husband), PYREXIA (running a feve) and PYREXIA (fever was 117). At the time of the report, MYALGIA (moderate sore arm), FEELING ABNORMAL (all hell broke loose), VACCINATION SITE SWELLING (arm swollen), MYALGIA (muscle that goes down the front of arm is also sore), VACCINATION SITE MOVEMENT IMPAIRMENT (hard to raise her arm), VACCINATION SITE PAIN (hurt too much to raise her arm), CHILLS (chills), TREMOR (shaking), VOMITING (threw up), ABDOMINAL DISCOMFORT (stomch upset), FEELING COLD (freezing), FEELING COLD (could not get warm), CHILLS (teeth was shaking), DISORIENTATION (became so disoriented that she was not capable figuring how to call her husband), PYREXIA (running a feve) and PYREXIA (fever was 117) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was unknown.
Presented on 5/22/01 with seizures and transported to medical college, children's medical center and admitted by pediatric neurology. Dx'd with seizure and placed on Depakote.
Extreme pain of the left arm, from wrist to shoulder/neck area. Weakness in left arm. Unable to fully grip with left arm. Low grade fever (99.9 F), lethargy, malaise, light headedness, nausea.
Last night, as our son was getting ready for a shower, we noticed red splotches (about the size of a coin) on his back and one on his neck. I wondered if they could be related to the vaccine. My husband thought more likely from playing outside. Today, as he got ready for a shower (after 9 PM), he had a huge raised welt, all across his lower back. It was itchy, he said. We gave him Benadryl (1.5 teaspoons), and we plan to call our doctor tomorrow morning. (Saturday.) We didn't call about the splotches yesterday.
Swelling in bilateral legs; Erythema Nodosum; This is a spontaneous report from a contactable healthcare professional. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via intramuscular route of administration on 13Apr2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other concomitant medications in two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via intramuscular route of administration on 23Mar2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 the patient experienced swelling in bilateral legs that transformed into erythema nodosum over two weeks, on an unknown date in Apr2021. The reported events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of adverse events and included treatment with unspecified NSAIDS (MANUFACTURER UNKNOWN). The clinical outcome of the event swelling in bilateral legs and erythema nodosum was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected
Patient took a Pfizer vaccine in 2/2021 , 4 months ago and scheduled for a Moderna vaccine which was given on 6/10/21
Continuous vomiting, body pain, lightheaded, severe chills, abdominal pain, bronchitis, hypertension, pancreatic levels elevated, vaginal bleeding, confusion, trouble speaking and understanding, shortness of breath, severe fatigue, no appetite.
03/04/2021 I had my last period. Then I had the second dose and a month later I knew I was pregnant and then I had a missed miscarriage. They gave me misoprostol and misoprostol. After the missed miscarriage I was dizzy because I lost blood.
Flublok had been administered to 3 year old patient with no AE; Initial information received on 04-Jan-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years old patient who received a 0.5 ml dose of vaccine QUADRIVALENT RECOMBINANT INFLUENZA VACCINE [FLUBLOK QIV] prefilled syringe (lot: UJ509AA, expiry date: 10-May-2021), via intramuscular route at the left deltoid, on 29-Dec-2020 (Product administered to patient of inappropriate age)  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was an actual medication error due to Inappropriate age at vaccine administration. (Latency same day). It was reported nurse with question regarding administration of FLUBLOK to patients under 18 years of age. Caller reported FLUBLOK had been administered to 11 patients and would like to know if they are "covered" for influenza vaccination for the season   At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
pt recv vax & became dizzy, diaphoretic & pale;pt devel blood shot eyes, & redness & swelling @ the inj site;12 hr p/vax became SOB;this is 1 of 12 pt from this site to have adverse rxn;
Patient received expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number Y29KL, expiry date 21st February 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th February 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 24th February 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received an expired dose of Havrix, which led to expired vaccine used. This was all the data that was provided by the healthcare professional. The reporter consented to follow up.
Had a heart attack, 100% blockage of the right coronary artery, no heart disease or atherosclerosis present, no history of heart disease or any risk factors. Physician said have been caused by a blood clot.
Deltoid was sore; palpitation; tinnitus; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Deltoid was sore), PALPITATIONS (palpitation) and TINNITUS (tinnitus) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 639k20-2A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (Deltoid was sore), PALPITATIONS (palpitation) and TINNITUS (tinnitus). On 30-Dec-2020, VACCINATION SITE PAIN (Deltoid was sore), PALPITATIONS (palpitation) and TINNITUS (tinnitus) had resolved. Not Provided          concomitant medications are not provided.  No treatment information was provided.
Redness, swelling and itching 4"x6" area left upper arm 24 hours after shot, fever 99.6. I saw him 48 hours after the shot and thought this was likely a reaction but the red area was more painful and larger and not helped by Benadryl, so I wanted to cover the possibility of cellulitis (Rx Keflex). T 97.6; improvement by 11/07/06.
Day 2 arm was very red,  hot, swollen, and hurt. It felt like my arm had been a punching bag. I could barely raise my arm. The next day the arm was swollen and the fluid started to drop down towards my elbow. Still very red but less sore. Returned to clinic to let them see what had happened. She suggested Zyrtec during the day and Benadryl at night. Following day (Day 3 of symptoms, the fluid has drained below the elbow. Arm still read on the back side.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Dec2021 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (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), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated for COVID-19 with Paxlovid. It was reported that patient had Rebound of covid infection after a negative test result. The patient was not taking any other medications or products within 2 weeks of starting COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
1/7/09@1000-Patient calls this office and speaks to this nurse.  States that @ approx. 0630 today she woke up to itchy red bumps all over her (R) arm and (R) arm was swollen, when itched the rash left a greasy residue on her fingers and stated "it felt like my arm was on fire".  Patient states @ this time the (L) arm that she got the gardasil injection in was not bothering her at all.  Patient stated that she took benedryl (1)p.o. at approx 1100 and itching stopped shortly there after, but rash remained.    Patient denies any S.O.B. scratchy throat, or any difficulty breathing.  Instructed patient to take benedryl as directed on box and if symptoms worsened to contact Primary physician or Emergency room if needed.  I requested at this time for her to come to the clinic for evaluation.  1/7/09@1300 Patient states that rash started on (L) forearm and started to itch and spread up to (L)deltoid.  1/7/09@1620 Patient is here at clinic raised red bumps are seen to (R) & (L) arm that cover the forearm and extend to the deltoid.  Patient raised her shirt and no bumps are noted to her back, abdomen, or breast area.  Does state that the back of lower (R) leg is itchy but I did not visually see this part and patient states that it is not bothering her like the arms are.  Encouraged at this time to follow up with a primary care provider and to continue taking the benedryl as directed on the box.  Also encouraged either calamine lotion or over the counter benedryl cream/spray to help with itching. Patient denies anything else new being introduced to her that could cause a reaction at this time.   1/8/09 Was contacted by RN, on this day. Patient states that there is no more itching and the red areas are almost gone.
Information has been received from a consumer concerning her daughter, who on 17-JAN-2008 was vaccinated with her first dose of Gardasil. Patient is two days delayed with her period. No further information was provided. Additional information has been requested.
Stiffness; Numbness in arm; Swelling; Fingers getting cold; Injection site redness; General weakness; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm left on 26Apr2021 at 10:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol and polycystic ovarian syndrome (PCOS). The patient had no known allergies reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included pravastatin 20 mg (MANUFACTURER UNKNOWN) for unspecified indication on an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FP6955) via an unspecified route of administration in the arm left on 05Apr2021 at 10:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 26Apr2021 at 10:45, the patient experienced injection site redness, swelling, numbness in arm, stiffness, fingers getting cold and general weakness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events injection site redness, swelling, numbness in arm, stiffness, fingers getting cold and general weakness were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
nausea, vomiting, fatigue, body aches. required DR visit, had blood work done. results that i know about is high liver enzymes. Waiting for follow up visit with PCP. taken 3 weeks off work
Upon presentation for his 2nd dose, patient reported experiencing delayed onset arm soreness about 2 weeks after his first dose.
chronic lymphocytic leukaemia (CLL); This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date as unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated he did not have a response/did not generate any antibodies on an unspecified date after taking the Pfizer-BioNTech COVID-19 vaccine. He stated it was due to having chronic lymphocytic leukaemia (CLL). The outcome of the adverse event was unknown.  Information about the lot/batch number has been requested.