chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This report was identified from a line listing obtained on request by the Company from the FDA (VAERS number: 692220) under the Act on 17-AUG-2017. This spontaneous report was received from a physician referring to a 13 year old female patient. She had no current illnesses and no known medical history. On 24-APR-2017 at 8:00, the patient was vaccinated with GARDASIL 9 lot # M034780, intramuscular in the left arm (dose 2, expiry date were not provided). She was not taking concomitant medications. Swelling and bruising in a left deltoid began at same day as vaccination, in evening and lessened by next day. The patient was vomiting 2 times in the evening after vaccine administration. The patient also experienced nausea with no vomiting on an unknown date approximately in April 2017 (reported as "today" and also child reported she started "yesterday" after vaccine given, but vaccine actually given "2 days ago"). The final outcome of the events was unknown. Causality assessment was not provided. Additional information is not expected. Follow-up information was received from the nurse Practitioner on 02-APR-2019. The patient reportedly recovered from the events. The reporter shared that she can find 2 subsequent physicals for the patient (dates unavailable) and patient is doing well. The patient has also completed her vaccination regime and is up to date on all vaccinations.
Enlarged right supraclavicular Lymph node, dizziness, lightheadedness and vaselvagal.
Severe chills, overall muscle aches and debilitating fatigue that started around 10:30 on the morning after the vaccination date. After going to bed early, I awoke still fatigued and did not sufficiently awaken until near noon. It was not until the following morning that I felt sufficiently better to return to near normal activities.
Pt recvd 1st dose Recomvivax & 2nd dose Engerix-B; p/2nd dose Engerix-B exp nausea & upset stomach;
Reported developing fever, generalized malaise, full body erythematous non-itchy rash which resolved with Benadryl. Also, one episode of blood in his semen.
Suspected vaccinatin failure; gave me up; 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: Suspected vaccinatin failure) (serious criteria GSK medically significant) and shingles (Verbatim: gave me up). 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: 04-JUL-2023 The case was received from the patient interactive digital media. The patient reported that it was a lie, he/she was already vaccinated and so he gave me. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This case was reported in a literature article and described the occurrence of anaphylaxis in a 4-year-old female subject who received Flu seasonal TIV Dresden. This case refers to patient 3 in the literature article. Concurrent medical conditions included asthma. Historical condition included atopic dermatitis. On an unknown date, less than an hour after receiving Flu seasonal TIV Dresden, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included generalized urticaria, wheezing, respiratory distress with serious criteria of GSK medically significant and vomiting. The subject was treated with epinephrine, antihistamine, oxygen and albuterol nebulizer. The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included generalized urticaria (recovered/resolved), wheezing (recovered/resolved), respiratory distress (recovered/resolved) and vomiting (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, generalized urticaria, wheezing, respiratory distress and vomiting may have been caused by Flu seasonal TIV Dresden. Additional information was provided: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 4-year-old female patient who had received an unspecified trivalent influenza vaccine (manufacturer unknown). The subject's medical history included atopic dermatitis with asthma and atopic dermatitis. No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On an unspecified date, between the 1st of January of 2009 and the 31st of December of 2011, the patient received an unspecified dose of an unspecified trivalent influenza vaccine (dosage unknown; administration route and site unspecified; batch number not provided). On an unspecified date, within 30 minutes and less than 1 hour after the vaccination, the patient developed generalized urticaria, wheeze, respiratory distress and vomiting. This was classified as anaphylaxis by the family nurse practitioner. According to the authors the case was considered as Brighton level 1 and setting of initial evaluation was clinic. The patient was treated by epinephrine, oral antihistamine, oxygen and albuterol nebulizer. At the time of reporting the outcome of the events was recovered. This event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.
Onset generalized body aches & slight temp 30NOV 101.4 x 24 hrs; 1DEC temp 102; 2DEC saw MD when dxd viral synd;
developed life threatening high blood pressure; This is a spontaneous report from a contactable nurse (patient). A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: EN6199), via an unspecified route of administration in the left arm on 03Mar2021 at 10:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 had not received any other vaccine within 4 weeks prior to the vaccine. On 04Mar2021 at 02:30, the patient developed life threatening high blood pressure. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient did not receive any treatment for the event. The outcome of events was not recovered.; Sender's Comments: Based on the strong temporal relation in the case report, a causal relationship between adverse event Blood pressure increased and suspect product BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Unilateral headache on the Right side, vertigo, skin and scalp sensitivity on right side. Headache is ongoing since the first week of receiving the vaccine. Worsens with activity.
2 days after vaccine, itchy rash on the ribcage, back, neck, chest-took Benadryl. Got itchier. After Benadryl wore off, was ok until 5 hours later when I started feeling ill and the rash seemed a little worse, so I took a Claritin. It is now the next day and the rash is still there, but I think it is going away. I don't feel great, but not terrible either. I put a call into a walk-in clinic yesterday, but they did not call me back and my doctor does not have an answering service and it is a holiday weekend. These symptoms were similar to what happened when I had an allergic reaction to a Tetanus Booster, so I treated myself and it seems to be working.
Hives; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare.  This case is linked to case 2019SA307047 (same reporter).  This case involves a patient of an unknown demographics who experienced hives (urticaria), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a 0.25 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious hives (urticaria), Unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Lab data was not reported.  Final diagnosis was urticaria.   It was not reported if the patient received a corrective treatment.  The outcome of the event was not reported.  Information on the batch number was requested.
Whelp came up and popped after blistering. Skin peeling off. Fever in site. Itching and red. Warm to touch.
Patient complained of exaggerated local reaction vs. cellulitis noted within 48 hours at shot site . Also a fever, which went as high as 102 and increased fussiness. Patient was treated with oral reflex and motrin.
approx 1 month p/flu vax, painful stiff neck, pain lt leg, lt foot drop; neurological tests indicated neuro disease; spinal tap hos dx A-myotrophic lateral sceloris (ALS); JUL93 lt side nerve degeneration & speech affected; also devel itch
Guillain Barre syndrome. IVIG for 5 days. Follow up on 05/06/04: "Final diagnosis is still Guillian-Barre Syndrome.  Diagnosis of GBS was made by neurologist.  The pt experienced other illnesses within the 4 weeks before onset of GBS symptoms, this included a stuffy nose.  The pt never had GBS or a related illness.  The pt never previously received influenza vaccination. "  Nurse follow up on 05/18/04 states: weakness lower extremities, urinary incontinence Medical records states rhinitis. msv
Pfizer-BioNTech COVID- 19 Vaccine EUA: Vaccine recipient has a history of vasovagal reaction when getting injections or blood. Her mother was holding the patient, assisted her to the floor, protecting her head, turned her to the side to protect her airway. Patient experienced loss of consciousness for a few seconds and then came back.  Her mother described this as "normal" and patient had many work ups. EMS came to assess the patient and patient was placed in wheelchair and taken to observation.
irst shot, no problems.Second shot has practically destroyed my life as I knew it.. First side effect  started the first night after being vaccinated. Urinated every 45-60 minutes, excessive amounts. This has continued, though after about 10 days, it became every hour to 1.5 hours. Then, the vaccine seemed to attack everywhere I had had a muscle injury over the last year and a half. Not all at once,but rotating. First the right shoulder for 3 days, then the left for three days. Moved to the wrists and hands, again 3days. My began to ache and stiffen.knees,mostly the left. My left  calf swelled up to a third larger than normal. That lasted about 10 days. The cycle repeated itself, though not as intense as the first round...shoulders, wrists, hand then knees. At this point, my left ankle and foot swelled and looked like a sprain, though no pain and I hadn't trwist it. Than lasted 3 days. On the fourth day I got up and my left ankle and foott appeared normal size. Doctor says I have arthritis in my knees. I did not have any arthritic pain in my knees prior to the vaccine. Now I can barely walk, cannot get out of a chair or otff the toilet without assistance. I try heat, rubs and icing my knees to no avail.I attempt to walk a few 100 feet several times a day. Sometimes it slightly relieves the pain, sometimes no. People who know me come up and exclaim "what did you do to your knee?" because it is so swollen. Can be either knee. Started with my left knee after the vaccination, now it's my right knee. The medical profession refuses to acknowledge my pain and discomfort as being the result of the vaccine and give little advice or direction in what to do to stop this misery. It may be of interest that in thefirst1-3weeks of my life I was given at least2 shots of penicillin. It is my understanding that this altered my immune system for life and could effect how I react to live vaccines.
pain at the site of injection for 2 days duration; This is a spontaneous report from a contactable consumer (patient) via Pfizer sales representative. A patient of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. After receiving second vaccination, the patient experienced pain at the site of injection for 2 days duration. No other symptoms. Event took place after use of product. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Pfizer BioNTech COVID vaccine dose 1, felt lip tingling and sweating 90 minutes post vaccination Observed in ED
13 year old male who received his first dose of vaccination stated that he felt his throat was swelling and nausea. Vital sign were taken and they were all within normal limits including Oxygen saturation of 100%. No tearing, nasal discharge, no rash, No wheezing per EMS.  EMS evaluated the sound of heart and the lungs and did EKG on the site. He was alert and oriented in place and time. He was able to communicate. EMS were on site and no medication were given. Patient and his parent chose to go to the ED by ambulance. He was stable when he left with the ambulance.
Swelling beneath left axilla following Moderna vaccine on03/29/21. Pt. first noted swelling 2 days ago worsening through the night. No known fever. Pt. also received tattoo to left forearm on 03/28/21. Modified activity for lifting.. Symptomatic care.
Developed a fever of 103.6, 36 hours post vaccination. Fever resolved in 24 hours. Developed a cough which also resolved spontaneously.
Severe bowel distress. All symptoms of irritable bowel syndrome with no associated physical conditions. Colonoscopy performed. No adverse conditions. Extensive blood workup showed no underlying causes.  Palliative care only, OTC Imodium to control symptoms.
This report was received from a 52 years old female consumer via Pfizer referring to herself. The patient's current conditions included lupus and rheumatoid arthritis (RA). The patient was vaccinated with PREVNAR 13 about 5 years ago and also received a different pneumonia vaccine before the PREVNAR 13. On an unknown date in 2014 (reported as one year after the PREVNAR 13), the patient was vaccinated with PNEUMOVAX 23 (dose, route, lot# and expiration date were unknown) for prophylaxis. On unknown dates, the patient developed pneumonia several times since receiving all of these vaccines. The outcome of pneumonia was unknown. The causality assessment was not provided. Upon internal review, pneumonia was determined to be medically significant.
Headache; Foggy brain; Body aches; This is a spontaneous report from a contactable consumer. A 4-decade-old (early 40s) healthy male patient received unknown dose of BNT162B2 (BNT162B2, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced headache, foggy brain and body aches. The outcome of the all the events was reported as unknown.   Reporter does not wish to be contacted for follow-up. No follow-up attempts are possible; information about lot/batch number could not be obtained.
Deep venous thrombosis at the site of vascular access line-Initially started on heparin, now switched to Rivaroxaban Thrombocytopenia-Supportive treatment and monitoring
Pt. states that after receiving the 1st dose of J&J 10/12/2021, started experiencing symptoms that evening of severe leg (both) cramping, fever, headache, fatigue, and muscle aches. Primary visit/telehealth 10/20/2021 recommendation for Blood Work. 10/26/2021 Blood Work came back Abnormal "Auto-Immune" Un-diagnosed. Follow-Up 10/29/2021 recommended self-treating with "Ibuprofen". Still continuing to experience symptoms.
Patient received 2nd dose of Pfizer vaccine at 15 days.  This was caught after administration.  It was discovered that patient had duplicate charts in state system.  1st shot was documented under work phone number and patient re-registered using personal phone number and today's dose was put into that chart.  Date on vaccine card for 1st dose was missed (4/27/21).  Patient's information was obtained and he was instructed to wait his 15min observatory period.  I also made him aware  I would contact him once I spoke with our medical personnel for further direction regarding future status of vaccination.  Email was then sent for further instruction and I was told that I could offer another dose in about a month but that seemed unnecessary to him at this point.  I then phoned patient around 12pm to make him aware that no repeat dose was necessary.  I also instructed him to please call us or his doctor if any abnormal symptoms or questions arose.  Patient agreed and had no further questions.
Pt developed a 5" oval area of erythema, heat and slight sensitivity to touch at injection site. 2-3 cm of the inside oval has a slight induration.
Case number PHEH2017US005198, is an initial spontaneous report received from a pharmacist on 16 Feb 2017. This report refers to an 18 years old male patient. Medical history was not reported. Concomitant medication was not reported. The pharmacist reported that, the temperature excursion was occurred in Jan for 10 hours, max temperature of 51.8 Fahrenheit and the patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186867, expiry date: May 2017) at a dose of 0.5 ml, intramuscularly on 05 Feb 2017, following the temperature excursion. No adverse event was reported following this medication error.
Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 18-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) on deltoid.  No concomitant medications reported by reporter.  No treatment medications provided by the reporter.   This case was linked to MOD-2021-313106 (Patient Link).
Vial was initally stored in refrigrator of 08-Jul-2022 and was adminstered on 09-Aug-2022; No Adverse Event; Patient administered vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-Jul-2022 and was adminstered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. as1414b) for COVID-19 vaccination. No Medical History information was reported. On 09-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 09-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator of 08-Jul-2022 and was administered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator of 08-Jul-2022 and was administered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator of 08-Jul-2022 and was administered on 09-Aug-2022). No concomitant medications was provided by the reporter. The vial did not undergo the temperature excursion. The healthcare professional was not aware of any symptoms for any patient after the vaccine was given. No treatment medications was provided by the reporter.
First week of April I noticed an irregular heartbeat. It was skipping and was irregular. I visited my cardiologist on April 5 2022. I wore the cardiac monitor for two weeks. April 8-22 and then mailed it back. I also had a cardiac ultrasound. The doctor stated after reviewing the report that there was nothing to worry about. It persisted and I visited him again May 10th and he doubled metoprolol. May 20th he gave me a different cardiac monitor for 24 hours. I went back to see him May 24th for results. It showed the irregularity but doctor said it wasn't anything to be concerned about. I was tired and short of breath all the time. He switched from metoprolol to CARDIZEM and that was on May 24th. After that things went from bad to worse. Saturday before May 30th weekend with shortness of breath my heart rate was too high at 127 and spoke to doctor over the phone. I was advised to go ER. I was admitted Saturday night for 5 days, released June 1st. During my stay I was on the cardiac unit and monitored 24 hours. I was then diagnosed with Atrial Fibrillation. June 1st while at the hospital the doctors wanted to try Cardioversion. It was not successful. I was referred to another cardiac specialist that I saw on June 9th, 'electro physiologist'. He recommended the Cardiac Ablation to treat. I had this procedure July 20th and was there for about 30 hours. I am feeling better today. I am recuperating from the procedure and tired from the anesthesia. My heart rate seems to be a bit normal as of now.
pt recvd vax & several days following vax devel swollen legs, arms, trunk & neck; no further details were provided;