chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He got his vaccine, his arm hurt a little bit at first.  He woke up about 5 days later with shingles, adn became very depressed and stayed at home in bed.  He had a blood clot in his leg, irregular heart beat and had pneumonia.  He was in the hospital for about a week for that, but the blood clot and the irregular heart beat cleared up.  He has been traveling and feeling pretty good most of the time up until now.  He then developed some blisters, some of them fell off and felt it was related to allergy to the cat.  He went to  his old doctor and he diagnosed as spongiotic dermatitis, and then perhaps bullous pemphigoid.  He is seeing a dermatologist that is treating him for this condition now. The did a biopsy into a blood blister and felt that it could be contact dermatitis or bullous pemphigoid and labs sent out indicated this.  He was told that it takes a long time to heal.  He is not itching anymore, but has anxiety now due to this condition and taking a lot of vitamins as is afraid to take the Prednisone for so long.    He was on some blood thinning medicines and something for fluid retention, was taken off of those as it could cause itching.  He has been off of that medicine for 6 months, and is on 3 medicines now with meals and then the vitamins.  He is to FU with his doctor on Friday, 3/31/23.  He will probably go to another Dr. who did his biopsy and has an APT on 4/14/23.
stabbing pain; itching along the left side under her arm were severe; mild outbreak of shingles/suspected vaccination failure; mild outbreak of shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included stress.   In JAN-2023, the patient received the 2nd dose of Shingrix (injection, right arm). In JUL-2022, the patient received the 1st dose of Shingrix (injection, left arm). On 24-JUL-2023, 7 months after receiving Shingrix and less than a year after receiving Shingrix, the patient experienced vaccination failure (Verbatim: mild outbreak of shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: mild outbreak of shingles). On an unknown date, the patient experienced pain (Verbatim: stabbing pain) and pruritus (Verbatim: itching along the left side under her arm were severe). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure and shingles were unknown and the outcome of the pain and pruritus were resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingrix and Shingrix.   It was unknown if the company considered the vaccination failure, shingles, pain and pruritus to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 27-JUL-2023 The reporter called to report a mild outbreak of shingles. She reported that she had shingles in the past before receiving Shingrix. The recent outbreak did not involve a rash or blisters/vesicles but stabbing pain and itching along the left side under her arm were severe.  She visited an urgent care and received a prescription for Valtrex which she said helped greatly. The pain and itching had calmed now and she said that she felt ok at the time of reporting but would continue the Valtrex until all doses were taken which was a 7-day supply. She said her pharmacist told her she must be in the unlucky 3 percent who still get shingles after being fully vaccinated. She said that she was under a lot of stress at the time of the outbreak. The reporter did not consent to follow-up. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting.
COAGULOPATHY, UNSPECIFIED TYPE 10/10/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA ANGIOEDEMA, INIT 8/21/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA COAGULOPATHY, UNSPECIFIED TYPE 10/10/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA    GASTROPATHY    HX OF STROKE WO RESIDUAL DEFICITS ANGIOEDEMA, INIT 8/21/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA    GASTROPATHY    HX OF STROKE WO RESIDUAL DEFICITS COAGULOPATHY, UNSPECIFIED TYPE 10/10/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED ANGIOEDEMA, INIT 8/21/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED COAGULOPATHY, UNSPECIFIED TYPE 10/10/2022 NONTRAUMATIC ACUTE KIDNEY INJURY  ANGIOEDEMA, INIT 8/21/2022 NONTRAUMATIC ACUTE KIDNEY INJURY COAGULOPATHY, UNSPECIFIED TYPE 10/10/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED ANGIOEDEMA, INIT 8/21/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED COAGULOPATHY, UNSPECIFIED TYPE 10/10/2022 GI HEMORRHAGE ANGIOEDEMA, INIT 8/21/2022 GI HEMORRHAGE COAGULOPATHY, UNSPECIFIED TYPE 10/10/2022 CHF, STAGE D ANGIOEDEMA, INIT 8/21/2022 CHF, STAGE D COAGULOPATHY, UNSPECIFIED TYPE 10/10/2022 PRESENCE OF HEART ASSIST DEVICE    THROMBOCYTOPENIA, UNSPECIFIED. ANGIOEDEMA, INIT 8/21/2022 PRESENCE OF HEART ASSIST DEVICE    THROMBOCYTOPENIA, UNSPECIFIED. COAGULOPATHY, UNSPECIFIED TYPE 10/10/2022 ALTERED MENTAL STATUS, UNSPECIFIED ANGIOEDEMA, INIT 8/21/2022 ALTERED MENTAL STATUS, UNSPECIFIED
I had nauseas, fever, muscle soreness, chills, loss of appetite, fatigue, and a massive headache. I did miss a lot of days of work. On 10/28/2021 I went to the doctor. They gave me an injection to help with the pain. I got prescribed a medication for Ketorolac to take 1 every 6 hours. My doctor said I was having an adverse reaction from the COVID-19 vaccine. I still have muscle soreness now, but it's not as bad as it was before.
Patient called on 12/10/12 after receiving the immunization on 12/8/12 asking what she could take for a rash that had developed at site of injection. Patient advised to take BENADRYL and or hydrocortisone if discomfort continues.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 25 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "3rd time with covid", start date: Apr2020 (unspecified if ongoing), notes: 3rd time with covid. Had pneumonia the 1st time I had covid in Apr2020; "Latex allergy" (unspecified if ongoing); "Pneumonia", start date: Apr2020 (unspecified if ongoing), notes: 3rd time with covid. Had pneumonia the 1st time I had covid in Apr2020. There were no concomitant medications. Past drug history included: Neosporin, reaction(s): "known allergies: Neosporin". 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. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had not received other medication in 2 weeks. Patient received anti-viral drug Paxlovid (Lot number: GC7458) from Dec2022 for the treatment of COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
sick; upper respiratory infection; This is a spontaneous report received from Pfizer-sponsored program COVAX US Support. An unspecified age female consumer (patient) received Bnt162b2 (BNT162B2; Formulation: Solution for injection), dose 1 via unknown route of administration, administered in unspecified location 26Mar2021 as SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. It was reported that caller, received her 1st dose on March 26 and 2nd dose should be on April 16. Caller did not go on her scheduled 2nd dose schedule because she's very sick. Caller said not from the vaccine, it's from her upper respiratory infection. Caller is asking if she can get the 2nd dose in more than 21 days or should she start all over again. The outcome of event was "unknown". Medical Information were any medical questions addressed by this program forwarded/referred to Medical Information?: Yes No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient describes within two hours after receiving the vaccine, that he felt his throat swelling. No shortness of breath, no reaction at the injection site or other rashes. The feeling he had was similar to the oral/pharyngeal symptoms he has with his oral allergy syndrome. He tool his allergy medications as usual, with the symptoms persisting until examination the following morning. He was able to swallow, although it was uncomfortable. It was difficult to breath through his throat while exercising, although it did not feel like his asthma.
Injection site pain, Chills, 102 fever 24 hours for 3 days, headache, tiredness, muscle pain, joint pain, feeling unwell
Narrative: COVID infections following completion of COVID vaccine series 05/21/21 COVID vaccine dose #1 (J&J) 07/26/21 Pt presents to screening reporting sore throat and exposure x1 week ago; COVID POSITIVE 08/02/21 Pt reports cough, shortness of breath, fatigue, muscle pain, headaches, loss of taste and smell
Information has been received from a registered nurse concerning a 3 year old patient who on 05/24/98 was vaccinated with a dose of Varivax (site unknown). Subsequently, the patient developed chicken pox. The reporter indicated that there was a chicken pox breakout at a day care in her area. It was reported on 01/04/02 that 15 children had developed chicken pox since the end of !2/01. The first onset date was 12/31/01 and the last was 01/03/02. the number of lesions were reported to be unknown. It was also reported tha t7 of the children were vaccinated with Varivax. (WAES0201USA00351, 0201USA00756, 0201USA00757, 0201USA01038, 0201USA01039 and 0201USA01041). Additional information has been requested.
had two severe rashes on their arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed a rash.   The patient's medical history was not provided.  No relevant concomitant medications were reported.   On 16 Jan 2021, approximately nine days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   The patient experienced two rashes on her arm on 25 Jan 2021.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event rash was not reported.  Reporter causality for the events was not provided.
The day of the vaccine I was fine The next morning I got up, got out of bed, made coffee, and soon felt very faint. Vision was starting to cloud from the outside to the center. I walked back to the bedroom and fainted on the floor. I collapsed straight down and luckily didn't hit my head on nearby furniture. I had to pull myself up by holding on the drawers of a large bureau. I didn't call my doctor, because I thought he would send me to the ER, and I was ok after that. I had a low grade fever and went to bed. If was the only time in my years that I ever fainted!
On August 10, 2023 Medical gave Pedvax Hib to a 4 year old patient instead of giving Proquad.  No signs or symptoms were reported. Parents were called and advised to bring patient in for
I tested positive for COVID-19 on 3/11/23. I had body aches, headaches, and overall didn't feel good. I took a home test and tested negative. My fever got up to 103 and I went to Urgent Care, and they tested me for COVID-19 and Flu, and I tested positive for both. I was not able to be prescribed Paxlovid because the doctor said it would react with other medications I am taking, so I was prescribed Molnupiravir.
Swollen lymph node in underarm of left arm. Started shortly after 2nd dose of vaccine (Tuesday, 3/30/21) and is still present as of today (Friday, 4/2/21).
POSITIVE COVID-19; This spontaneous report received from a patient via a company representative concerned a patient of an 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, start therapy date were not reported 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 positive covid-19. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of positive covid-19 was not reported. This report was non-serious. This report was associated with a product quality complaint 90000224711. The suspected product quality complaint has been confirmed to be voided (did not meet  criteria as the report indicated medical adverse events for the patient, there was no product quality issue described in the information reported and did not meet the criteria for lack of effect for the vaccine) based on the evaluation/investigation performed.
pt recvd vax 31AUG95 & 20SEP95 devel varicella-like rash w/ 6 or 7 lesions/papules on one leg;devel no fever or pruritus;pt recovered;no further details were provided;
My son received the Covid booster on Saturday afternoon and by bedtime Sunday night he said his hands were itching really badly. I thought maybe it was dry skin and had him use lotion. By the next morning, the itching was more intense and also involved his feet, especially between his toes. I gave him benadryl which helped with the itching, however, by Tuesday morning he had joint pains in his fingers, his feet hurt to walk on, he had red splotchy areas over the palms of both hands and his fingertips were red. He was also experiencing continued itching despite taking round the clock benadryl for 2 days. He is scheduled to see his pediatrician this afternoon at 5pm.
This spontaneous report was received from a nurse referring to a patient of unknown age or gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 30-MAY-2017, the patient was inadvertently vaccinated with an expired dose of VAQTA, intramuscular, with lot # M003025 and an expiration date on 26-MAY-2017 (strength and dose were not reported) for prophylaxis. No adverse effects were reported in the patient. Additional information has been requested.
15 days after 1st shot I had a dizzy feeling when I got up in the morning. It passed after about 40-45 min but then today it again happened and a "off" feeling lasted for about 90-120 minutes. This is not normal for me.
After receiving my first covid-19 vaccine I developed server neck, arm and upper back pain on my left side. I received both my vaccines in my left arm.  The pain soon traveled down the whole left side of my body. This has effect my daily activities. The pain also interferes with my sleep.  My doctor did pain injection in the left arm and neck. Those only lasted about a week and the pain returned. I have tried over the counter pain meds and nothing helps. I has also developed swelling in my left leg and foot.
I was fine until later that evening when I started feeling just a bit off.  The next day I was sick and it continued for three days.  On the third day I started getting dizzy and was dizzy through the afternoon into the evening.  The next morning I felt fine but noticed a twinge in the middle of my back.  That twinge grew to significant pain and has migrated from my back to my sides and is significant enough that I cannot hold a coffee cup.  I am also getting headaches that come and go.  The headache will last a few minutes then go away.  Shortly thereafter I get another one an I never get headaches.  I CANNOT  attribute this to anything other than the flu shot.
Immediately after the vaccine was given I felt a tingling feeling in my left fingers.  Once I sat down for the 15 min evaluation I then felt tingling in left toes.  at around the 10 min mark I had a wave of nausea and my hands got clammy.    at around the 14 min. I had a burning sensation at the tip of my nose that lasted a minute or so.  Right after was a burning numbness above my upper lip and then shortly after a numbness in both cheeks.  I also then saw that my cheeks were flushed when I was able to look in a mirror.   The flushed cheeks lasted over an hour as well as the numbness above my upper lip.  at about 6 hours later felt a pressure between my eyes.
Cold sore, fever, dizziness  - both persisted through week of 10/5/09; cold symptoms began 10/17/09 (runny nose, congestion, coughing)....current.
Pt recvd a series of 3 Engerix-B vax 6DEC90, 9JAN91 & 6JUN91 & pt was a poss non-responder;
Initial solicited report received on 08 March 2017 and follow up information received on 13 March 2017 from an investigator (Defense Health Agency/Immunization Healthcare Branch) in the trial. A 21 year-old male subject with no significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000, (lot number and route, site of administration not reported) on 25 April 2016. On 10 May 2016, 15 days after vaccination the subject was diagnosed with acute pericarditis unspecified and on 11 May 2016, 16 days after vaccination the subject was diagnosed with acute pericarditis. Lab data included: on 10 May 2016, the subject had ECG which was abnormal and on 11 May 2016, the subject had blood test in which Troponin I was abnormal with the highest value of 01.79 ng/ml and also had echocardiogram which was abnormal. The MRI (heart, brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a healthy 21-year-old male who developed acute pericarditis with favorable temporal association post vaccination with ACAM2000. Acute pericarditis is a listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccines. Alternative etiologies could be Myocardial infarction, pulmonary embolism, Pneumonia, Costochondritis, pneumothorax. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, biopsy, role of study vaccine can not be ruled out.
Right arm very sore - hurts to raise arm, no redness or edema. *Missed 1.5 days of work. *Used 1" needle for administration. *Percocet 1-296 prn.
Patient received Zoster (SHINGRIX) on 09/14/18. Today, 09/17/18, she came in to the pharmacy to report injection site reaction, swelling, erythema, tenderness, pain and soreness right after receiving the shot. Today, she states that she is feeling a lot better and just wanted to know if this was normal. Patient appeared to be satisfied after I told her that it is possible to have an injection site reaction. Also, the reaction was resolving and she was feeling better. She left the pharmacy satisfied with the way I handle it. I promised to check in on her in a couple of days.
Pt got myalgia, fever 24 ph after vaccine. By noct am, edema, erythema and warmth at injection site.   by 4-5 days.
Foggy brain, hand tremors, chills, fever, feet throbbing, muscle aches, joint pain , nasal  congestion, headache, earache
Information has been received from a registered nurse concerning a 86 year old male who on 26-AUG-2008 was vaccinated via subcutaneous route into right arm with a first dose of PNEUMOVAX (lot # 659150/1384U) and or DTaP (manufacturer unknown) and developed cellulitis after after administration of the PNEUMOVAX and or DTaP. On 27-AUG-2008 the patient developed a fever of 103 F and chills. He also experienced edema and redness of his right arm. His right hand was cooler to touch than his left hand. The nurse reported that the patient underwent imaging study for right hand which was negative. The patient sought medical attention via an office visit. On an unknown date, the patient recovered from cellulitis, fever of 103, chills, edema and redness of his right arm. No additional information was provided. Additional information has been requested.
Pain, swelling, redness at injection site.  Nausea, vomiting, diarrhea.  Sharp pains down legs and arms.change in kidney function. eyes hurting--Went to ER on 9/23/16 diagnosed with cellulitis and given septra ds and voltaren.
6month-5 yr old patient received 0.2mL of Moderna Covid-19 (monovalent) for 2nd dose.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (6month-5 yr old patient received 0.2mL of Moderna Covid-19 (monovalent) for 2nd dose.) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .2 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (6month-5 yr old patient received 0.2mL of Moderna Covid-19 (monovalent) for 2nd dose.) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (6month-5 yr old patient received 0.2mL of Moderna Covid-19 (monovalent) for 2nd dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (6month-5 yr old patient received 0.2mL of Moderna Covid-19 (monovalent) for 2nd dose.).    No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Dec-2022: Significant follow up received contains patient details updated. On 29-Dec-2022: Live follow up received contains no new information.
Client received Sinovac COVID vaccine, no reaction. Sinovac vaccine unavailable, Janssen given as an alternative on 09/15/21.
I started to develop medium sized (4+cm) ovarian cysts. Never had them before the vaccine. I have a surgery scheduled for 7/20/2021 to remove one of them.
Narrative:  Unknown if patient passing away was due to COVID-19 vaccine however, it is being reported as a Vaccine Adverse Drug Reaction since it happened with 42 days of receiving the vaccine.