chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I woke up shortly after falling asleep feeling as though someone had punched me in the chest as hard as they could. I was unable to draw in a breath or breathe at all. I shook my boyfriend awake and he could see I was passing out. My head began to fall back as I passed out from lack of oxygen. After this I was weak and was short of breath. An ambulance was called. I also ended up going to the ER. Throughout weeks after I had other heart episodes and tests. It was believed to be possible heart arrhythmias. I had a heart monitor for about two and a half weeks for testing. We have still not found answers and I still have episodes where my heart will randomly take off and race uncontrollably and I will get faint. I deal with chest pain on a regular basis. I have no history of heart issues and previously was always told I had a healthy heart. My current medications I have been on for some time and have never caused me issues. Ever since I received my second vaccination my heart hasn?t been the same.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 05-AUG-2013 the patient was vaccinated with the first dose of PNEUMOVAX23 lot # 671416/1241AA (reported as 1241AA) with expiry date 12-APR-2013. Route of administration, anatomical location and indication were not reported. This dose was expired when the patient was vaccinated with it on 05-AUG-2013. No product quality complaint was filed, no adverse symptoms were reported. Additional information has been requested.
Case number PHEH2014US022000, is an initial spontaneous report received from a health care professional on 31 Oct 2014. This report refers to a 16 years old male patient. Past medical history and concomitant medication were not reported. He inadvertently received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X14069), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 28 Oct 2014. No adverse event was reported following this administration error (inappropriate preparation of medication).
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 72-year-old male patient received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: EL3249), on 04Feb2021 as dose 2, single (Lot number: EM9810), in left arm, on 29Sep2021 as dose 3 (booster), single (Lot number: FC3163), in left arm and on 06Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: other medical history: HTN; "BPH" (unspecified if ongoing), notes: other medical history: BPH; "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin; "known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included in 2weeks product: TAMSULOSINA AUROBINDO; LISINOPRIL LUPIN (brand: Pharmacy); HYDROCHLOROTHIAZIDE; DILTIAZEM CD; PREVAGEN [APOAEQUORIN], stop date: 30Sep2022; COQ-10,, stop date: 30Sep2022; VITAMIN D3, stop date: 30Sep2022; CALCIUM CITRATE + D3, stop date: 30Sep2022; ASPIRIN LOW, stop date: 30Sep2022; AIRBORNE, start date: 20Sep2022, stop date: 22Sep2022. Other medication in 2weeks product also included Men's 50+ Formula multivitamin/multimineral/Herbal supplement, Other medication in 2weeks, Other medication in 2weeks stop date: 30Sep2022. Other medication in 2weeks product: Movement Advanced dietary supplement, Other medication in 2weeks, Other medication in 2weeks stop date: 30Sep2022, Other medication in 2weeks lot number: 109796. Past drug history included: Codiene, reaction(s): "Allergy", notes: known allergies: Codeine; Amoxicillin, reaction(s): "Allergy", notes: known allergies: amoxicillin. Anti-viral details: Product-COVID 19 Treatment, Brand-Pfizer Paxlovid, [Treatment start date- 29Sep2022, Treatment stop date- 04Oct2022, Indication-Treatment of COVID-19]. Adverse event: Rebound Covid 19 infection (Onset date 08Oct2022, 05:00 PM). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: Rebound Covid 19 infection. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
On 07/06/2021 I got a call from my cardiologist that informed me that I was experiencing Atrial Fibrillation. I have a Pacemaker so the AFib had showed up on my monitoring. I was scheduled a stress test after that and they did not find anything with that. I am scheduled to see my cardiologist again to get information.
On 3/5/00, pt experienced deltoid muscle soreness upon touch and movement. Soreness didn't stop until 3 days later. Pt also experienced a syncope episode with loss of consciousness, vision blackout and lost equilibrium. Assistance by coworkers prevented from falling and from further injury.   On 3/6/00, missed 1 day of work due to feeling ill and sore.
Swelling and redness of the night thigh the day dater  (24 hours). Treatment- Benadryl for 3 days. Keflex for 7 days. Cold compress for 2 days. Follow-up on 9-11-07 swelling and redness subsided.
I recognized about 24 hours after my 1st COVID vaccine I had hives spanning flank to flank, across my abdomen, as high as my arms pits and low as my waistline.
Initially was believed to be pancreatitis or a pancreas problem and had an MRI scan done and it found no issues anywhere but i still have extreme nausea waking up in the mornings and diarrhea that still hasnt really stopped since
Shortly after injection (~5 minutes), Patient felt dizzy and lightheaded and without much warning experienced a syncopal episode (diaphoretic, pale, and fainting) . She was assessed by on-site RN and CNP and EMS was called per pharmacy protocol/policy. Vital signs remained good throughout, including blood pressure and heart rate. No itching or swelling noted, no shortness of breath or rash. Neurologically intact. She was feeling much better within 10-15 minutes and was cleared to go home. Patient continued with a headache, upset stomach, and weakness/fatigue for the remainder of the day but otherwise is doing okay.
Upon injection, My daughter immediately put her head back and said I don't feel very good. I feel like I'm going to faint. The nurse was standing behind her I was in front of her and she passed out in my arms. The attending nurse and I laid her back on the table and she started to involuntarily jerking. I put my head out of the door and started calling for help. The whole incident lasted less than a minute. I was scared to death. I have never seen an immediate reaction to a vaccine before. I understand that there are three shots to be given. She will not get the remaining two shots. At first I thought my daughter just fainted, When we arrived home we looked up fainting on the internet to reassure my daughter that she would be fine and all I saw was all these web sited on the HPV vaccine. This also gave me cause for concern. I guess at this point I would take my chances with the virus then have my daughter get any more adverse reactions. When I read the side effects on the (What you need to know sheet) It said that the HPV vaccine does not appear to cause andy serious side effects. (?) Then I found all these web sites where people have died and fainted with seizures, Severe illness, Vomiting. None of these symptoms were listed on the (What you need to know ) informational sheet. Why not? If I had known any of this she would not have received this injection. I will continue to monitor my daughter through the night. I pray this is all the reaction she will have with this vaccine. Thank you for your time in this matter.
Patient developed a rash on her neck and upper back and rash while being observed in the clinic COVID-19 post-vaccination area. RN immediately notified provider of the observed reaction.  Patient stated the area was mildly itchy.  Zyrtec 5mg given and Benadryl given; vital signs taken, and patient observed until 4:00pm.  Patient prescribed Benadryl 25-50 mg tablets at bedtime for 5 nights, Zantac or over the counter histamine 2 blocker one table every morning for 5 days, an epipen, and for patient to take Zyrtec 5mg tablet one hour prior to receiving the 2nd dose vaccine and to be observed for 30 minutes after receiving the 2nd vaccine.  Patient informed to make a follow-up visit with provider, for 8/11/2021.
Patient developed pain and swelling over the right upper arm and right shoulder area within few hours of vaccine (pneumonia vaccine) administration. Continues to have limitation ROM on day # 15. Inflammation & rotator cuff tear on MRI.
ACUTE NON ST ELEVATION MI ACUTE CORONARY SYNDROME, UNSPECIFIED ACUTE HYPERCAPNIC RESPIRATORY FAILURE 11/29/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
I had a tonic clonic seizure for the first time 12 hours after receiving the vaccine.
Full body rash lasting longer than 1 week even with steroids.  Currently put on stonger steroids and possibly needing further treatment.
Right sided jaw pain  started 12/22/20 in the am progressed through the evening. When I woke up I had numbness and weakness in the right of my tongue which I quickly realized included the right portion of my face. Included tongue was numb and I couldn't move it. An Er trip and CT scan confirmed it was Bells Palsy. Today,  My symptoms continue. Top of my head all the way to the  way to bottom of neck is experiencing paralysis.  Can move tongue now and it's partly numb but it's cooperating a bit more now. Nerve pain has worsened all over all the right side of face. Feels like someone  has kicked  face and I have a deep bruise.  It's a deep ache. Nothing will take away the ache away. My eye doesn't lubricate like it should. So I have to either manually close it and wet it manually or tape it closed.
Vaccinated on 1/30/21 and 2/27/21 with Moderna.  Symptom onset 6/1/21 with cough, runny nose, shortness of breath, nasal congestion, and pain/pressure in the chest.  Patient has history of lung and sinus infections.  Sample sent for genomic sequencing.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Mar2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: Rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient has no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
pain, numbness, weakness,  tingling of left arm down into left hand, palm, and fingers.  steroid taper complete with some resolution of numbness/tingling but pain and uncomfortable feeling/ pressure remains.  pain keeps me from sleeping sometimes and even wakes me up over night frequently.  the greater I use the arm and hand/fingers during the day the more it will bother me that evening.
36 hours after receiving the second vaccination, I developed high fever, nausea, dizziness that is still lingering 4 days after the shot
Pain at injection site; abnormal dehydration; nausea; vomiting; fever of 100.8; headaches; muscle aches; chills; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021(at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included mild asthma. Concomitant medications included intrauterine contraceptive device (MANUFACTURER UNKNOWN) implant from an unknown date and for an unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 11:00 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 14:00, the patient experienced pain at injection site(vaccination site pain), abnormal dehydration, nausea, vomiting, fever of 100.8, headaches, muscle aches and chills. The patient did not receive any treatment for the reported events. On an unknown date, the patient underwent lab tests which included body temperature and the result was 100.8 (unit unknown). The clinical outcome of the events  pain at injection site, abnormal dehydration, nausea, vomiting, fever of 100.8, headaches, muscle aches and chills were resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever of 102.1 -102-4 for over 36 hour.  Severe chills and crushing headache; cold sweats, nausea. Vertigo (only once) on trying to stand. After 36-37 hours, fever between 101 - 101.5 for another full day. Five days in, I was still running a low-grade fever. All fever and aches gone after 5th day.   My husband contacted our doctor on the second day. Once the high fever broke I opted to ride the symptoms out at home.
Mother reports that she woke up in the middle of the night crying and having repeated tensing/shaking episodes.  So mother brought daughter to the ER to be checked.  I evaluated her and found no abnormalities.
PAINFUL LUMP ON ARM; SEVERE LEG PAIN; FATIGUE; NAUSEA; This spontaneous report received from a consumer concerned a 64 year old male. The patient's weight was 375 pounds, and height was 62 inches. The patient's concurrent conditions included chronic pain, no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, and expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-JUN-2021, the subject experienced painful lump on arm. On 23-JUN-2021, the subject experienced severe leg pain. On 23-JUN-2021, the subject experienced fatigue. On 23-JUN-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, and painful lump on arm, and had not recovered from fatigue, and severe leg pain. This report was non-serious.
no adverse events (patient reported slight burning around injection sites both arms 2/1-2/3 - no reaction seen at all by mother (no erythema, no swelling, no induration, no fever)
Itching and hives around 24 hours after receiving vaccine. Mainly around neck area, some areas to side of stomach. States happened with the first vaccine but didn't occur until a couple days after. Patient has been taking Benadryl. States symptoms aren't severe, just present. Denies any other symptoms or side effects.
pass out a few hours later; Initial information received on 19-Nov-2022 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who passed out a few hours later while receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer reported via unknown route in unknown administration site (dose, frequency, route, formulation, strength, lot/batch number and expiration date: not provided) for prophylactic vaccination.  On an unknown date the patient passed out a few hours later (loss of consciousness) (unknown latency) following the administration of Influenza vaccine.   Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (loss of consciousness).  At time of reporting, the outcome was Unknown for the event made me pass out a few hours later.  Seriousness criteria: Medically significant for loss of consciousness.; Sender's Comments: Sanofi company comment dated 23-Nov-2022: This case involves an unknown age and unknown gender patient who passed out a few hours later while receiving vaccine Influenza vaccine. Based on information provided, the causal role of company suspect cannot excluded. Case will be re-evaluated post further update on information regarding other underlying disease, risk precipitating factor, concomitant medication, past medical history and patient lifestyle which will preclude a comprehensive assessment of this case.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 5/23/2021 and 6/20/2021. Covid + 1/11/22, Presented to ED 1/11/22 c/o weakness and AMS. Covid + with O2 sats WNL on RA, CXR with COVID PNA and acute encephalopathy. Developed rhabdomyolysis and AKI in the setting of dehydration due to covid 19. Treated with augmentin, zosyn and decadron. Pt's lethargy worsened throughout stay. Noted to be in V-fib on 1/26/2022. DNR Status. Patient expired on 1/26/2022.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case involves an 81 years old male patient who received vaccine FLUZONE HIGH DOSE (lot UJ039AA, expiration date 15-May-2019) via unknown route in the left deltoid on an unknown date. Medical history and concomitant therapies not reported. It was actual medication error due to vaccine underdose, exposure via skin contact and product issue due to syringe leak. It was reported that FLUZONE high dose leaked from had Leaked from the syringe during administration and patient had received a less than recommended dose. During administration the patient noticed that there was a leakage down his arm to his elbow, may be the whole dose had leaked. Reporter was unsure if it leaked from patients arm or from the tip of syringe where needle screws onto. It was not reported if the patient experienced any adverse event. 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.
No adverse effects; Inadvertently administered a dose of PROQUAD, rather than MMRII; 44 year old patient was inadverently administered a dose of PROQUAD, rather than MMRII; This spontaneous report was received from a registered nurse and refers to a 44-year-old patient of unknown gender. The patient's medical history, concurrent conditions, past drug reactions or allergies and concomitant medications were not reported. On 20-JUN-2019, the patient was inadvertently administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (therapy type as rHA (recombinant Human albumin)) subcutaneously, lot # R024018, expiration date as 19-FEB-2020 (dose number, dose were not reported) for prophylaxis, rather than measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)(wrong product administered and product administered to patient of inappropriate age). No adverse effects were reported. The outcome of wrong product administered, product administered to patient of inappropriate age and no adverse event was unknown.
Pt began feeling flushed, tremulous, c/o weird sensation in throat. developed rash. Had near syncope. 1-2hrs of symptoms.
Information has been received from a physician concerning a 15 year old female who was vaccinated with a dose of GARDASIL on an unspecified date. Concomitant therapy included MENACTRA, (manufacturer unspecified) and Tdap (manufacturer unspecified). On an unspecified date, the patient experienced syncope. There were no labs or diagnostic tests performed. The patient received unspecified medical attention. The patient recovered from syncope on an unspecified date. No further information is available.
Refridgeration excursions identified; No Adverse Event; Poor quality product administered; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No Adverse Event) in a 57-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2022 at 12:55 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 21-Sep-2022 at 12:55 PM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified).    No concomitant medications were reported. Patient received the vaccine in deltoid muscle. On 07-Sep-2022, the vials were initially moved from freezer to refrigerator.  The nurse reported that, Moderna Monovalent and Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back in Aug-2022. It was reported that, refrigeration excursions were identified, and state vaccines were housed in these units. The manufactures were notified, and the state department made aware of the situation. The storage condition of vial at the time of excursion was in refrigerator. The vials were not visually inspected. No adverse reactions reported for the patient. No treatment medications were reported.