chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  Patient is experiencing continued dizziness/unsteadiness since second  vaccine dose per progress note 3/8/21. Patient states that she feels unsteady on her  feet. The symptoms developed the day after her second dose. States that she has a  weird sensation in her head. Feels like a fog. States that she has occasional mild  headache, however that resolved. Denies a feeling of her head spinning, or world  spinning. States that she felt dizzy once when she was doing exercises for vertigo  [in the past?]. no nausea, vomiting, problems with vision. No new tingling,  numbness or weakness. c/o loss of hearing on the right, this is old, seen by ENT  and awaiting a hearing test. States that she only took 2 doses of meclizine - took  one dose in the am - caused a lot of drowsiness and 1 dose at night - - took a hour  prior to bed. states that she was still felt drowsy the next day, could not tell if it  helped her symptoms. There is documentation of a history of vertigo from  PCP 10/17/2016 in 2/14/18 progress note.
Information has been received from a nurse referring to a 37 year old male patient with no pertinent medical history or drug reactions/allergies. On 22-JAN-2016 the patient was vaccinated with a dose of MMR II (lot#, dose, dose# and route unknown). The patient did not take any concomitant medication. On 26-JAN-2016 the patient was diagnosed with conjunctivitis and was administered Erythromycin Optical ointment as treatment on 29-JAN-2016. No lab diagnostics studies were performed. The outcome of conjunctivitis was reported as recovering. Additional information has been requested.
the ACTHIB portion was not administered and the caller was just administered the diluent portion of the vaccine with no adverse event; the vaccine when left out on the counter is still viable and if it can be mixed with saline. Room temperature was 71.0 Fahrenheit and left out for 18 hours with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00753871) and transmitted to Sanofi on 03-Sep-2021.  This case involved 6-month-old male patient was just administered the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] their diluent portion of the vaccine and acthib portion was not administered (product preparation issue) and the vaccine when left out on the counter is still viable and if it can be mixed with saline room temperature was 71.0 fahrenheit and left out for 18 hours (product storage error).  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), HEPATITIS B VACCINE and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) reported as ROTOTEK for prophylactic vaccination.  On 01-Sep-2021, the patient received a dose DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot: UJ52AA and expiry date: not reported) (Frequency = once) (Strength = standard) via unknown route in unknown administration site for prophylactic vaccination their diluent portion of the vaccine and acthib portion was not administered (product preparation issue) and the vaccine when left out on the counter is still viable and if it can be mixed with saline room temperature was 71.0 fahrenheit and left out for 18 hours (product storage error).  It was reported,"Materials Manager states patient received un-reconstituted PENTACEL".  This case was an actual medication error due to inappropriate reconstitution technique and incorrect product storage (latency: same day).  At the time of reporting, 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 the guidelines. 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.
Presented with vomiting. Dx: Intussusception per radiology report. Reduced and sent home.  10/20/09 PCP medical records received service dates 9/28/09 to 10/6/09. Assessment: Suspicious for bowel obstruction. Patient presents with abdominal pain and vomiting.  10/26/09 ED report received service date 10/6/09. Assessment: Vomiting (Possible small bowel obstruction). Patient presents with vomiting that started last night and is still present. Nausea and decreased oral intake. Black stools. Difficulty with urination, decreased activity, lethargic. Poor muscle tone. Sleepier that usual. Nasal discharge. Appears "sick'. Bilious vomiting. NGT placed. Transfer to higher level facility.
Unexplained body itching, progressed to hives and low grade temp (100.3) over a period of approx 10 hours.  Took 2 over the counter Benedryl for the hives and 2 ibuprophen for the temp.
After patient had his shot, waiting for 15 minutes, he felt dizzy and nauseous. Patient when he stood up and started to walk felt weak and collapsed on the floor briefly. Patient was attended to right away by mother , pharmacy staff and pharmacist. Patient was assisted in the bathroom with the mother and vomited a little, had him sat on the toilet and then transferred to a chair where we was given water and some food. Patient's blood pressure was taken and was 99/70. Patient stayed and observed, he felt better after about 10 minutes. They were asked to stay and released after 20 more minutes. Patient did not eat breakfast before getting the vaccine.
Information has been received from a physician concerning a female who on 19-MAY-2010 was vaccinated with the first dose of GARDASIL (lot # not reported) and had not menstruated since. The patient was scheduled to receive dose two on 19-JUL-2010. The patient had not recovered. Unspecified medical attention was sought. Additional information has been requested.
Patient seen in the ED on 7/3 for weakness, chest pain, shortness of breath, dry cough, and dizziness. COVID-19 PCR test was done in the ED which was positive. Patient was admitted to the hospital from 7/3-7/5. Ultimately diagnosed with community-acquired pneumonia, bacterial infection suspected. This meets criteria for vaccine breakthrough case review.
SICK FOR ABOUT A WEEK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 19-JUL-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced sick for about a week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick for about a week. This report was non-serious.
1400 hrs pt projectile vomited, mild temp @ that time then started lt sided twitching was dx w/tonic clonic contractions was treated w/Phenabarbitol & versed; pt has underlying epilepsy; pt was just taken off reg dose of Phenabarb
Left arm remained sore until; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient received BNT162b2 (BNT162B2), on 20Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 83 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "2 pregnancies", start date: 1964 (unspecified if ongoing), notes: Second pregnancy: 1966, Pertinent details: Cesarian births; "Temporal arthritis", start date: 2013, stop date: 2015, notes: Pertinent details: Took prednisone to stop the pain.; "Low thyroid" (ongoing), notes: Onset date: greater than 10 yrs, Pertinent details: medication; "High blood pressure" (ongoing), notes: Onset date: greater than 15 , Pertinent details: medication; "Blood thinner" (ongoing); "Allergy" (ongoing), notes: Onset date: greater than 6 mos, Pertinent details: medication. Concomitant medication(s) included: LEVOTHYROXINE oral taken for hypothyroidism (ongoing); HYDROCHLOROTHIAZIDE oral taken for hypertension (ongoing); ASPIRIN 81 taken for blood disorder (ongoing); LORATADINE oral taken for hypersensitivity (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot number: EN6198, Route of Administration: Intramuscular, Anatomical Site of Injection: Left Arm), administration date: 04Mar2021, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot number: EN6205, Route of Administration: Intramuscular, Anatomical Site of Injection: Left Arm), administration date: 26Mar2021, for COVID-19 immunization; Shingrix (DOSE NUMBER UNKNOWN , SINGLE, 3 (illegible) of shingles , Onset date: onsets, 1. 18 yrs old, 2. 20 yrs +, 3. my 60 yr old, Pertinent details: Had shingrix vaccine within the last 8 yrs had the previous shingles vaccine also.), for Shingles immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Left arm remained sore until". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: There was no Family medical history relevant to adverse events (AEs). There was specific relevant test for Thromboembolic events with Thrombocytopenia. Patient preferencing her written response by stating that in 2021 she had a blood test taken after living with her husband who was diagnosed with having covid-19. The results of her blood test determined that she was immune to covid. Yet she still took her first dose of covid 19 on 04Mar2021, because she was afraid that she might come down with it and she did not want to infect anyone else. She was expecting a new great grandchild within a couple of months, plus she was continuing to go to the senior centre for exercise etc.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300231375 same patient, same product, different dose (dose 4) and events.;
dizzines was turbulent; falling on floor, like she was serverly drunk; was very wonky, fogginess; nausea; not being able to get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzines was turbulent), FALL (falling on floor, like she was serverly drunk), FEELING ABNORMAL (was very wonky, fogginess), NAUSEA (nausea) and FATIGUE (not being able to get out of bed) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE BESILATE, TELMISARTAN (MICARDIS AMLO) and VITAMIN D AND ANALOGUES for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (dizzines was turbulent), FALL (falling on floor, like she was serverly drunk), FEELING ABNORMAL (was very wonky, fogginess), NAUSEA (nausea) and FATIGUE (not being able to get out of bed). On 03-Mar-2021, DIZZINESS (dizzines was turbulent), FALL (falling on floor, like she was serverly drunk), FEELING ABNORMAL (was very wonky, fogginess), NAUSEA (nausea) and FATIGUE (not being able to get out of bed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included ALLERGY MEDICATION. No treatment medication details was reported.
Patient received a flu shot on 9/30/17. C/O swelling of upper arm (shoulder to lower forearm). Pt seen in office 10/3/17 -seems to be little better. -loos like localized vaccine reaction.
4/1/2021 vaccination  4/26/2021 MISCARRIAGE *Fetus died 2 days after the vaccine; 4/3/2021; per medical staff (ultra sound). Went to midwife then OB.  Dr. did 2nd scan to verify the first scan.  Pregnancy HX; 3rd pregnancy, 10/8/2021; 16.5 weeks pregnant at time of miscarriage
Child had diarrhea for 2 weeks, lethargy for 5-7 days, and eczema rash all over body- lasted for 5-6 weeks, worsened drastically.
Within 5 min of being vaccinated the pt. passed out.  His B/P was taken and it was 100/50.  He was transported to a room where he passed out again.  Rescue was called and administered care.
I got the shot on Wednesday Sep 29th and by 1:45 in the morning on Thursday the 30th I woke up with a fever, chills, a sore throat, and a loss of energy.
I had Johnson and Johnson booster. A couple days after I noticed a small spot on my wrist. Then it slowly kept spreading and looked like a bruise on my left wrist ans into my fingers. Then a couple weeks later a spot started on my left wrist. The doctor I work with said that is a common symptom he has seen for the bruising on the hands. I did start getting  random sharp head pain and then goes away pretty fast this last week. Not sure if it is related. The bruising look on my hand is still there. Looks almost like burns but so far stopped spreading.
Information has been received from a registered nurse concerning a 10 year old male with no medical history or allergies who on 07-AUG-2007 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). On approximately 07-AUG-2007, (within 24 hours of vaccination, the patient experienced an injection site reaction. The patient had a hard raised swelling area the size of a "half dollar" following the varicella virus vaccine live (Oka/Merck) vaccination. The overall size of the swelling was about 6 to 8 inches in diameter on the arm. It was reported the patient contacted their physician. No diagnostic laboratory tests were performed. At the time of the report the patient was recovering. A product quality complaint was not involved. Follow-up information received on 11-OCT-2007 from a registered nurse concerning a 10-year old male with an allergy to penicillin who on 08-AUG-2007 was vaccinated subcutaneous in the left arm with his second 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot# 657192/0362U). There were no illnesses at the time of vaccination. Concomitant vaccine administered intramuscularly on 08-AUG-2007 in the right arm included Havrix A (lot# AHAVB186AA). On 09-AUG-2007, the patient developed a hard raised edematous area at the injection site approximately about the size of a half dollar with overall reaction approximately 6-8 inches in diameter. The patient sought unspecified medical attention. No diagnostic labs were performed. On an unspecified date the patient recovered from all adverse events. This is one of several reports received from the same source. Additional information is not expected.
Pfizer 1/5/21, 1/26/21, 2/26/21, 10/13/21; Positive on 3/9/22
Tested Positive for Covid 19 after receiving 4 doses of the Covid 19 Vaccine and 1 Dose of the Bivalent Vaccine; Tested Positive for Covid 19 after receiving 4 doses of the Covid 19 Vaccine and 1 Dose of the Bivalent Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 58 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EN6198), on 19Apr2021 as dose 2, single (Lot number: EP7534), on 23Oct2021 as dose 3 (booster), single (Lot number: FA8839) and on 10Apr2022 as dose 4 (booster), single (Lot number: FK9893) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (ongoing), notes: Comments: High Blood Pressure; "Overweight for her Height" (ongoing), notes: Comments: Overweight for her Height. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Oct2022, outcome "unknown" and all described as "Tested Positive for Covid 19 after receiving 4 doses of the Covid 19 Vaccine and 1 Dose of the Bivalent Vaccine". The events "tested positive for covid 19 after receiving 4 doses of the covid 19 vaccine and 1 dose of the bivalent vaccine" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Oct2022) Positive, notes: she tested positive for Covid 19 on 15Oct2022.
Patient came in on 1-26-23 and states she has had a heart arrhythmia and has since started the Metoprolol Tartrate 25mg twice daily written by Dr. I am not positive what tests the MD did but they told her it was likely due to the Flu shot.
? Fever     With mom and dad,  started 5/13/22. Tmax 103.4.  Less frequent now. None today. Vomiting last night. Feeding well. Normal wet diapers. 1 episode of spit up.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/6/2022 ANEMIA  ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/6/2022 COVID-19 PNEUMONIA
4 hours post vax, the pt spiked a fever and started vomiting. This continued for 3 days. Pt experienced a fever as high as 104.6.
A report has been received from a Health Professional via medical representative concerning, a female patient. The reporter for four patients and this case relates to one of the four patients. The patient's medical history and concurrent diseases were not provided. The patient's concomitant medications were not provided. The patient received FLUMIST (intranasal) started on 08-Nov-2013. The reporter said there were 6 patients with 1 doctor who tested positive for influenza A. She thought that 3 of those patients had FLUMIST, the other 3 received a different product. After review of the files from that day, there were only 2 patients who received FLUMIST and 2 employees who received FLUMIST and tested positive for influenza A. On unspecified date, the patient experienced Influenza A. It was reported that there were positive tests for influenza A in the past few weeks. Patients were not hospitalized due to event. It was also reported that none of the patients/employees were treated. All of the other patients diagnosed with the flu on Monday had either the shot or no flu prophylaxis. The outcome of the event of Influenza A was unknown. The reporter considered the event to be non-serious.
Recurring blood in semen, no prior occurrences, and happened soon after the 2nd dose. Additionally, very intense dreams every single night.  Other than that, just the normal side effects that i was  warned about.
Information has been received from a physician concerning a 19 year old female patient with headaches (one every couple of months) and a history of aspirin causing a rash and a bee sting causing a local reaction who was vaccinated intramuscular (right arm) with 0.5 ml dose of GARDASIL on 05-AUG-2009 (Lot # 659054/0315Y) and on 30-SEP-2009 (Lot # 662304/1013Y) respectively. The physician reported an increase in headaches after administration of GARDASIL. The reporter mentioned that a week after receiving her first dose of GARDASIL "approximately on 12-AUG-2009" the patient started experiencing headaches 2 to 3 times a week. It was reported that five days after her second dose "on 05-OCT-2009" the patient started to experience disabling headaches 2 to 3 times a day, severe involuntary muscle spasms in her right arm, tremors, nausea and weakness. Also was reported that the patient was so weak that she was not able to work. The patient was examined in two emergency rooms on 07-OCT-2009 and on 11-OCT-2009 respectively but the patient was not admitted to the hospital either time. The reporter mentioned that she was treated with IMITREX, BENADRYL, "pain medicine", and ondanstron. The patient will have an appointment with a Neurologist (name not provided) on 15-OCT-2009. It was reported on 14-AUG-2009 as laboratory and diagnostics test a CAT (Computed Axial tomography) scan and MRI (Magnetic resonance Imaging) of brain: normal; Blood chem., CBC (Complete Blood Cell Count) and urinalysis: all negative and a PAP (Papanicolaou test) smear without results. The patient sought medical attention in office visit. at the time of reporting the patient was not recovered. Additional information has been requested.   01/04/, 01/06 & 01/07/10:  ED Record and Primary Careand Vaccine Records received for dates of service 8/5/09 to 10/22/09.  Headaches, fatigue, gastritis, tremors, conjunctivitis  Presented to ED with c/o HA's x 1 year with nausea and photophobia, sometimes with twitching in RUE.  Started on Topamax.   Also seen for weakness, legs giving out and no energy and pink eye.  Pap smear done.
Urgency to urinate. No infection or prior history of UTI or cystitis prior to second vaccination dose.
Left arm swelling with erythema & urticarial papules 6cm x 3 1/2cm at deltoid area. Pt given 1 bt BENADRYL.