chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This was NOT an Adverse Event.  The vaccine was in freezer longer than 14 days.   The patient was advised to revaccinate per CDC.   Patient revaccinated on 11/2/2021  at 2:15pm
Developed fever, vomited several times, developed rash on torso & face swollen; Dx as Roseola;
feeling shaky, dizzy and not right; Blood pressure was 172/101 at 6am, now is improving at 159/94, but heir normal blood pressure; body aches; feeling shaky; fever; headaches; oxygen was not as good as usual, at 95% (usually between 97-99%); elevated heart rate of 110ppm and climbing, for 3 days; A spontaneous report was received from a Healthcare Professional and a consumer concerning a 76 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Heart rate increased, Hypoxia, Dizziness, Blood pressure increased, Pyrexia, Pain and Headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 029L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 30 Jan 2021, the patient experienced elevated heart rate of 110ppm and climbing for 3 days, felt they were having a heart attack, oxygen was not as good as usual, at 95 percent (usually between 97 to 99).   On 4 Feb 2021, the patient experienced the events feeling shaky, dizzy and not right, blood pressure was 172,101, now was improving at 159, 94, headache, fever and body aches. The Hypoxia was considered medically significant.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 2 Feb 2021 the outcome of elevated heart rate was resolved and for blood pressure was recovering.  On an unknown date the outcome of other event was unknown.; Reporter's Comments: This case concerns a 76 Y/O F with PMH of COVID-19 who had a serious unexpected event of hypoxia and nonserious unexpected blood pressure increased, heart rate increased, dizziness, nervousness, and expected pyrexia, headache.  Event onset on Day 4 after first dose mRNA-1273. Main event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This case was reported by a other health professional via call center representative and described the occurrence of gastrointestinal disturbance in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced gastrointestinal disturbance. On an unknown date, the outcome of the gastrointestinal disturbance was unknown. It was unknown if the reporter considered the gastrointestinal disturbance to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy intern. The age at vaccination was not reported. The patient experienced gastrointestinal side effects after receiving first dose of SHINGRIX. The caller declined to provided further details or identifiers without getting permission from patient involved. Limited report was filed. This case was 1 of the 3 linked cases, reported by the same reporter.
3/10 ? Extreme dizziness and imbalance. Could not work. 3/11 ? Sinus drainage, ear fullness ? Seen at Clinic -Exam, UA, EKG, CBC, BP ? all within normal limits. DX -ear/sinus fluid/infection- 7 day antibiotic, decongestant, allegra, nose spray. 3/24 ?Extreme dizziness and imbalance, unable to walk un-aided. Seen at Urgent Clinic - DX- ear/sinus fluid/infection. 10 day antibiotic, prednisone, Continue allegra, nose spray, OTC antivert. 4/5 ?Continued dizziness with motion and imbalance. Seen at Primary care office , BP, CBC -? DX- dizziness. continue allegra, nose spray, OTC antivert 4/8- Rash ? raised, pink, back and chest 4/23 ? Continued dizziness, Ear fullness- Seen at ENT Depersio - hearing and ear pressure test ? within normal limits. DX- vestibular neuritis. RX antivert, continue allegra, nose spray, referral to Physical Therapy. Continued but improved dizziness and imbalance.
even had the shot/suspected vaccination failure; getting over them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: even had the shot/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: getting over them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-MAR-2023 This case was reported by a patient via interactive digital media. The patient even had the shingles shot. The patient was just getting over them (shingles).  The reporter stated that it was worse than any other health issues.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
mom states child ran temp of 104.9 x 5 days  p/vax;also states child screamed x 5 days;talked w/MD who told not to give child pertussis vax again;
Patient reported chest pain and feeling like chest/throat is closing off - consistent with pt previous hx of anaphalyaxis. STAT team called - Patient rapidly assessed - audible wheezing and visible anxiety and inability to speak followed rapidly - epi 0.3 mg administered in L thigh at 0905 - MD arrived at 0909 - 50mg IM given R deltoid @ 0910, Pt not improving - 2nd dose 0.3mg epi IM R thigh given per MD at 0912.  Pt transferred to ED cot and sent to ER STAT. No V/S obtained d/t rapid interventions needed.   Chart review indicates treatment in ED with solumedrol, Pepcid, additional Benadryl IVP, DUONEB, ALBUTEROL, MAD SULFATE, HYDRALAZINE - and placed on BiPap.  Transferred to ICU bed currently
Patient was in recovery area at the time, when his 15 min. was up to wait after his vaccination, when he was checked on, the  patient was in a daze, not responding, but conscious. pt then became verbal/ lucid after approx. 1 minute afterwards, he was AAOX3. pt, denied any SOB, Chest pain, headache/dizziness/ N/V/D. pt lung clear to auscultation, pulse ox read O2 stat 99% on RA, Pulse 88, resp. 20. EMS was called while patient was being assessed, within 5 min. EMS arrived, care was then taken over by emergency services. pt was asked if he wanted to go to the hospital by EMS, pt. verbalized yes. patient was then transported out of the facility.
Patient presented to ED on 3/28/21 with the following information:  patient reports home daughter was diagnosed with COVID-19 infection a few days ago.  For about a week now the patient herself has had severe fatigue, loss of taste, loss of appetite, nausea, vomiting and diarrhea.  She denies fevers.  She has however had a persistent cough and over the last few days has been short of breath.  Tested positive for COVID-19 on 3/27/2021 at outside facility.  Last night patient had multiple episodes of diarrhea making her fatigue significantly worse today.  Has been drinking a lot of free water.  Additionally noted increased cough and shortness of breath. Patient was admitted to the hospital with COVID-19 pneumonia on 3/28/21 and expired on 4/13/21.
arm is still swollen; arm warm; red skin expanded almost to elbow; This case was reported by a consumer and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2022, the patient received the 1st dose of Shingrix. In April 2022, less than a week after receiving Shingrix, the patient experienced swelling arm, skin warm and erythema of extremities. On an unknown date, the outcome of the swelling arm, skin warm and erythema of extremities were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, skin warm and erythema of extremities to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine 5 days ago (from the date of reporting) and his/her arm was still swollen, warm and the red skin has expanded almost to his/her elbow.  The patient asked how should he/she treat this. Additional supportive information: The follow-up would not possible, as no contact details were available.
On 2/1/2021 they performed CBC, the result was aseptic bacteria so it came out and she was taken to the hospital. They removed the tube in the hospital, (she remained in the hospital) First she was hospitalized and then she was transferred to the Medical Center Hospital to auscultate bleeding in the stool and to be evaluated by the Gastroenterologist. This specialist performs the necessary studies, they do not give a diagnosis and in the process she dies. The hospital indicated that she had a blood drain and heart failure.
Per chart note documentation: "Developed a rash around injection site the same day.   The rash was faint pink initially, and then got significantly worse last night.   Rash was spreading and raised when called yesterday".
Information has been received from a licensed practical nurse concerning a 60 year old white female with pollen allergies, hypertension, and hyperthyroidism who on 11/18/03 in the AM was vaccinated IM in the right deltoid with a third dose of pneumococcal 23v polysaccharide vaccine (lot # 644217/1026M). Concomitant vaccination on the same day in the AM included a fifth dose in the left deltoid of influenza virus split virion 3v vaccine inactivated  (FLUZONE) (lot # U1136AA). There was no illness at the time of vaccination. Subsequently the patient developed redness, swelling and pain at the injection site. The patient was treated for the symptoms with over the counter acetaminophen, diphenhydramine hydrochloride, and ice. Unspecified medical attention was sought and it was noted that a prescription drug was required. A product quality complaint was not involved. Follow up information received from the licensed practical nurse which indicated that in the AM on 11/18/03, the patient developed redness and swelling instantly after receiving pneumococcal 23v polysaccharide vaccine in the right deltoid. Ice was applied and the patient was told to take diphenhydramine hydrochloride and acetaminophen every four hours. The nurse talked to the patient two days later and the swelling had gone to her elbow. The patient recovered on 11/25/03. Additional information has been requested.
I came home and two hours later, I felt light headed and wanted to throw up, I sat there in the kitchen I wanted to throw up. I was weak and light headed and was vomited. I was close enough to my bathroom to vomit, I was so weak. Vomiting and diarrhea and then I try to manage to stand up, and then I made it to the bed, but every 5 mins I had to get up to go to the bathroom with diarrhea. I took my blood pressure at 1:30 and it was 112/47 and my heart rate was 80. I didn't have the energy to get up, I almost crawled back to my bed, it was so bad. Took my temperature and it was 100.2. I was so cold and freezing. I had to go and use my electric blanket. I had chills and fever. I am going to call my doctor.
about 12 hours after vaccine I started having chills, headache & muscle ache.  Had flu like symptoms all day 3/28 with general feeling of fogginess and fatigue.  3/29 felt better in the morning but fatigued/tired later in the day. Same thing Monday 3/30. Started to feel better on 3/31 and then experienced dizziness.  Having been feeling tired since  4/1/21 and I'm a person who usually never gets tired.  I have had 3 or 4 bouts of dizziness and today (4/9) my left arm is sore where I received the injection. It's been two weeks and I just don't feel like myself.
elevated blood pressure; a sensation of tingling on the right side of her chest and her right arm; burning sensation in my chest and right arm; felling dizzy/light-headed and "crummy"; This is a spontaneous report received from a contactable consumer (patient herself) via a Pfizer sponsored program Pfizer First Connect, and via Medical Information Team. An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number was not reported), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunization. Medical history included cancer and blood pressure issues (she had been treated prior to vaccination). The patient's concomitant medications were not reported. It was reported that, the patient received her first dose of Pfizer-Biontech Covid19 vaccine on 27Jan2021. She has since been feeling dizzy, light-headed and "crummy" in Jan2021. She reports going to the ER (emergency room) yesterday morning (08Feb2021) reporting an elevated blood pressure, with dizziness and a sensation of tingling on the right side of her chest and her right arm (the same arm that was vaccinated). Her MD says that she should not take the second dose, but her daughter-in-law who is a nurse says that it is her (the patient's) decision. On 27Jan2021, patient had been having issues with her blood pressure- sent to the ER yesterday morning- blood tests twice already. BP elevated and dizzy because she had a burning sensation in her chest and right arm in 2021. The patient supposed to get second dose on Wednesday doctor says not to take it, since she was experiencing adverse event, and her HCP sited the deaths in as a reason for her not to receive the second dose. The outcome of the events was reported as unknown.  Information on the lot/ batch number has been requested.
Final dx: serum sickness. Onset of s/s 9/25/02, seen MD on 9/26/02 and referred for skin biopsy 9/26-hospitalized overnight for obs. Discharge summary received on 2/27/2003 indicates purpura and fever.
Bronchitis; Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis) and COVID-19 (Tested positive for COVID) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025520A) for COVID-19 vaccination.    Co-suspect product included non-company product DULAGLUTIDE (TRULICITY) for an unknown indication.    Concurrent medical conditions included Diabetes, Chronic kidney disease stage 4 and Asthma. Concomitant products included INSULIN ASPART, INSULIN ASPART PROTAMINE (NOVOLOG MIX) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started DULAGLUTIDE (TRULICITY) (unknown route) at an unspecified dose. On 25-Jan-2021, the patient experienced BRONCHITIS (Bronchitis) and COVID-19 (Tested positive for COVID). At the time of the report, BRONCHITIS (Bronchitis) and COVID-19 (Tested positive for COVID) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided
recieved a pediatric dose of Engerix B; recieved a pediatric dose of Engerix B; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 25-year-old male patient who received HBV (Engerix B pediatric) (batch number D423N, expiry date 1st June 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th May 2021, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 7th May 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product 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 details were provided as follows: Medical assistant reported that male adult patient received on May 7th 2021 a pediatric dose of Engerix B, which led to underdose and adult use of a child product. The Vaccine Administration Facility is the same as Primary Reporter. The reporter did not consent to follow up.
L shoulder abscess/septic joint. Underwent debridement. Started antibiotics, plan for 4-6 weeks
Pt recv vax on 9/16/98; on same day pt exp fever (101.2), cough, mouth sores, facial rash-9/20; dx=URI & possible pneumonia; tx=Pediazole; 9/25 pt exp croup, fever
Several weeks of diarrhea, foul-smelling, green and liquid stool with tenesmus, per Mother. No fever or other symptoms. Feeding well and has good urine output. Diarrhea is lasting longer than the 1 week that is expected. First dose of rotavirus received at 2 months of age, patient had diarrhea lasting almost 8 weeks (mother stated diarrhea lasted from his 2 month well check to his 4 month well check)
Left side of face became numb, including to behind the left ear.  Happened within 10 minutes of injection.  Subsided within 30 minutes.  The next day, some numbness returned at about 9pm in the evening.  Pain behind left ear.
Within 24 hours extreme fatigue, joint pain, overall body weakness. On the date of the adverse reaction noted, ice pick headaches in left eye. Multiple times a day for one week, and sporadic thereafter.
projectile vomiting, painful nausea, weakness, SOB, dizziness, red rash around arm, unsteady.
VOMITING; CHILLS; NAUSEA; This spontaneous report received from a patient concerned a 34 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced vomiting. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, vomiting, and chills. This report was non-serious.
"Covid Arm" with symptoms appearing a week after the vaccination. Symptoms are large red lesion around vaccination site, lesion is firm and itches. Researched online to identify possible remedies. Have started taking Benadryl for itching. No other treatment.
02/19/2022 I started with a sore throat and congestion with muscle aches and clogged ears. I took a speed test and it came out positive so I went to public health to get a free test on 2/21 and it came back negative. I later informed my doctor via telehealth on 2/21 to set up an appt. to find out what I needed. I got two prescription some steroid pills and Z-pak for the duration. On 2/22 I took another home test which came back positive. Currently taking the pills and have been doing so for 5 days.
Injection site is itchy, red, and swollen, which began 6 days after injection
Severe chills  Fever 102.8 Body aches Fatigue  Headache  Metallic taste for days
Multiple and ongoing seizures. Seizures started two days after vaccinations and have continued currently but are less intense with medical intervention.
VOMITING; HIGH HEART RATE; DIZZINESS; HEADACHE; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-APR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested.No concomitant medications were reported. On an unspecified date, the subject experienced vomiting, high heart rate, dizziness, headache, nausea, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, nausea, vomiting, fever, high heart rate and dizziness was not reported. This report was non-serious.
mild flu symptoms for 24 hours.; This is a spontaneous report from a contactable physician via Pfizer sales representative. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Dec2020 (reported as 3 weeks ago) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced mild flu symptoms for 24 hours in Dec2020.  Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Pt states her eye became red, swollen and itchy the next morning after receiving the vax. She returned to the Board of Health two days post vax and her eyes were still red and itchy.
Information has been received from a 79 year old male physician with no medical history and no drug allergies concerning himself who in 1999 was vaccinated subcutaneously with a first 0.5ml PNEUMOVAX 23 and on 15-OCT-2009 was vaccinated subcutaneously with a second 0.5ml PNEUMOVAX 23 (lot number 662905/1162X). Secondary suspect therapy included HYZAAR. Concomitant therapy included LIPITOR, ZYRTEC and aspirin. On the same day, after receiving the vaccination the physician experienced chills, fever and cellulitis on the injected arm. On 20-OCT-2009 the physician recovered. There was no laboratory diagnostics studies performed. Additional information has been requested.
Moderna 2/5/21, 4/22/21, 9/15/21. Positive on 4/10/22