chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial vertigo type symptoms, followed by nausea and vomiting. (B/P WDL, temp 95.9).1 episode then several hours of sleep. Slight dizziness upon awakening with mild fatigue. Mild lightheadedness today. No fatigue. No aches or pains.
pt recvd vax & began crying; crying lasted all noc; cried off & on for 1wk; seen by MD 4 days p/vax; probable rxn to pertussis vax according to MD;
I developed tinnitus after receiving the COVID-19 vaccine in March of 2021 but was not sure of the correlation.  Yesterday I received the COVID-19 booster and the tinnitus sound increased in intensity (loudness).  The tinnitus is continuous.
8 days after vaccination I came down with a cold. Started with a sore throat then progressed to stuffy and runny nose and a dry cough
1st shot: sore arm 2nd shot: woke up the next morning with a low grade fever, headache, chills and body aches
This spontaneous report as received from a physician refers to a 2 years and 5 months old female patient. On 19-NOV-2013 the patient was vaccinated with the first dose of M-M-R II (lot # 1579AA, expiry date 12-OCT-2013, 0.5 ml, intramuscular) and it was expired. No adverse effects reported. Additional information has been requested.
Patient with severe pain in right arm (believes the shingles shot was on that side as also rec'd on the left). Patient did not have pain immediately. Arrived to ER in severe pain with decreased ROM
Patient reached out on 2/8/21 to ask about getting second dose of Moderna COVID19 vaccine after having a reaction to the first dose. Patient received first dose on 1/13/21, lot number 027L20A. Patient reports that 1-2 hours after receiving first dose she began to feel feverish, nauseaus, and fatigued. Pateint reports that she developed a rash and hives about 2 hours after vaccination, which started at the site of the injection and spread down her arm and across her chest, under her breasts. Patient reports she experienced fever, chills, nausea, vomiting, and fatigue that lasted from 1/13/21 to 1/17/21. She states her rash and hives lasted from 1/13/21 through 1/20/21. Patients reports that she still has intermittent diarrhea through today, 2/12/21. Patient reports that she called her doctor on 1/14/21 but did not hear back. She did not seek additional medical attention. Patient advised that TCHD would recommend not receiving the second dose of the Moderna COVID19 vaccine, due to suspicion of hypersensitivity reaction. Advised to consult with primary care provider or immunologist if she wishes to pursue COVID vaccination.
Seen in immediate care 10/25/03 (Saturday) for suspected allergic reaction. States got pneumonia vaccine 10/23/03 left arm (got flu vaccine right arm; no problem reported). Positive pain, redness going outside of deltoid area, chills. No axillary adenopathy. Had pneumovax 54 years prior. There is a report on the computer this day I am filling out (11/03/03) from 10/27/032. Saw PCP who feels patient has likely has an allergic reaction to the Pneumovax injection rather than an infection (had been started on Azithromycin 250mg at IC 10/25).
Information has been received from a nurse practitioner concerning a 71 year old female with high blood pressure, hypercholesterolaemia and hypersensitivity to codeine who on 15-NOV-2007 was vaccinated subcutaneously with "one dose" of zoster vaccine live (Oka/Merck) (lot # 658604/1088U). Concomitant therapy included TOPROL XL TABLETS, PLAVIX, DETROL LA, VALIUM, AMBIEN AND ADVAIR. On 22-FEB-2008, the patient developed discomfort on or around her ear and face, followed by a rash the next day. The patient was diagnosed with herpes zoster on 25 FEB 2008. A VZV titer was performed (on an unspecified date) the results of which were not reported. At the time of reporting the patient had not yet recovered. The NP was not interested in getting a VZV analysis. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
The expiration date they sent is also not correct, so she is not sure if it's monovalent; No adverse event; An immunization was flagged as a monovalent dose after the authorization had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (An immunization was flagged as a monovalent dose after the authorization had expired), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The expiration date they sent is also not correct, so she is not sure if it's monovalent) and NO ADVERSE EVENT (No adverse event) in a 24-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 067H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Apr-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (An immunization was flagged as a monovalent dose after the authorization had expired). On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The expiration date they sent is also not correct, so she is not sure if it's monovalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (An immunization was flagged as a monovalent dose after the authorization had expired), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The expiration date they sent is also not correct, so she is not sure if it's monovalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (An immunization was flagged as a monovalent dose after the authorization had expired) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The expiration date they sent is also not correct, so she is not sure if it's monovalent).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
After 24 hrs-next day: 1)L arm slight swollen and red at the site; 2)Arm moved only with difficulty and pain; 3)Lymph glands in axilla swollen and painful; 4)pain across back and down L breast when movement of arms.
The patient had a Vasovagal response. She  had a 15 second seizure ,blood pressure dropped, was flush, tired and nauseated. She has no memory of the event.
Fever 3/26-3/28/12. Rash onset 3/26 PM body and mouth. Atypical rash with papules, tiny vesicles, mouth resembling herpangina.
The patient came to the pharmacy on 11/21/2023 to ask for someone to look at her arm where she received vaccinations on 11/13/2023.  After talking with the pt. I learned that she had her Seasonal FLU vaccine at her MD the morning of 11/13/2023.  She then came to the pharmacy to receive her COVID - Pfizer and her Abrysvo - RSV.  She said she informed the Pharmacist that she had her FLU in her LEFT arm while at her MD.  The Pharmacist entered into the computer and injected the vaccines in the pts LEFT arm.  The pt stated her LEFT arm was pink in color starting day1.  The pt stated her LEFT arm started to itch and pain started on 11/20/2023 so the pt massaged it.  Her arm became swollen and bruised from a few inched below her shoulder to her elbow.  She did not have a fever, no breathing issues, and no BP issues.  Pt was taking APAP for discomfort.
patient needed mengingococcal  for school received trumenba instead of MenQuadfi menogococcal acwy -135.    Patient did not experience any side effects or symptoms   Patient returned to the office 12/8/22 to receive MenQuadfi.
Mom stated that two weeks after receiving flu vaccine on 11/7/03, the child's hair started falling out.  Follow up on 09/01/04 states: "She also developed trouble with her language use 1-2 weeks post vaccine. The child could only speak the beginning syllable of a word and not finish it.  All MRI's were normal. Medical records state speech disorder. msv
Pt developed 2 in. x 3 in. red, slightly raised rash on arm vaccine was administered in 8 days after vaccine. No pain, no itching,
8AUG91 tc from parent states pt began running fever 7AUG91 of 103F; Has been alternating giving Panadol & Tempra; Seen by MD & told perhaps rxn to MMR; needs no meds; 9AUG91 t103, forcing fluids, denies any other signs or sx of illness;
Patient called the day after her immunization stating that her shoulder was painful and what should she do. Instructed her to take Tylenol and use ice on the area as needed. 7 days later she called back stating she was still in pain and the ice helped but it still hurts when she moves it.
Chickenpox marks on belly, shoulders, arms and itchy. Afebrile.
Expanding hematoma and blood accumulation at elbow, now spreading to left pectoral area to elbow with increasing induration and edema. She was sent to ER for evaluation.
patient received Fluzone Quadrivalent and was supposed to get Fluzone High -Dose; Initial information was received on 02-Oct-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 68 year old male patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and was supposed to get INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] on 02-Oct-2020 (wrong product administered)  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 02-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong vaccine administered.(Latency: at the same time of vaccination).   At the time of report, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Classic henoch-schonlein purpura with typical skin lesions, abd pain, joint pain and hematuria.  Normal BP 12/3/09 Medical records received for dates 11/3/09 to 11/16/09.  DX: henoch-schonlein purpura HSP. OV 11/3/09 presented w/ vomiting 2x in 24hrs. Pt had H1N1 vax 8 days ago, seasonal flu vax 5 days ago. Assessment: (+)vomit, (-)joint swelling, (+)urinary urgency. 11/4/09 Pt. parent placed call to MD stated has developed inflammation in middle of back/spines. OV: Pt parent states 2 day h/o rash, vomiting. Assessment: rash, red papules on back, (+)swelling. DX: rash secondary to h/o HSP. OV 11/16 DX: back ache.  Pt seen for c/o BA, SA. For f/u rash(+), back ache, same SA. Assessment: no blood in stool, UA(+)protein and blood, (-)blood in stool, (+)BA, (+)SA. Prev OV 9/27/09 for croupy cough.
Itchy chickenpox like rash that is continuing to pop up. Had chickenpox badly 23 years ago but had to have vaccine for college.
During my 2 covid injection, vaccine appeared to leak out from injection site. The person who administered used two cotton swabs wipe up leakage. The vaccine injection site did not appeared to be entered into the deltoid muscle. It looks to be too low and forward on my arm. I have a big bruise on my arm.  This not like the first shot. I do not feel any pain on my arm  from this shot, which is contrary to what most folks have said about the second shot.  I do not believe I received adequate amount of the vaccine and am not sure of my protection.  I do not know what to do or expect now.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Reported area around vaccine site, red, swollen oblong rash, circular around site; appears lumpy and hard in certain areas and warm to touch; very little to no pain when pressed.
I did not personally give vaccine since administration of vaccine on 9/13/2021 pt has had pain in upper arm- but then subsequent- after normal immune redness and swelling pt has been experiencing numbness and weakness of upper arm from deltoid to elbow.
BLOOD CLOTS IN BOTH LEGS; This spontaneous report received from a patient concerned a 59 year old white female of unspecified ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: hysterectomy, gall bladder removal, varicose veins and underwent surgery, knee replacement surgery, and concurrent conditions included: non alcohol user, and non smoker. The patient had no known drug allergies and no history of bleeding or blood clot disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1808980, expiry: 18-SEP-2021) dose was not reported, 1 total administered on 01-APR-2021 to right arm for prophylactic vaccination. Dose number series was 1. No concomitant medications were reported.  After vaccination, on an unspecified date in AUG-2021, the patient went to a doctor and they did a doppler ultrasound for her and found one blood clot in leg. A month later, they checked her again and found another blood clot in her leg. Then a week ago, they found a third blood clot in her leg. She had a total of 3 blood clots, 2 clots in her right leg and 1 clot in her left leg. The patient was doubtful if the vaccine could have caused the blood clots. The patient was receiving treatment from two different doctors for her blood clots at the time of reporting. Treatment medications (dates unspecified) included: apixaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clots in both legs. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20211217781-COVID-19 VACCINE AD26.COV2.S-blood clots in both legs. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Within 24 hours of receiving the PNEUMOVAX 23 injection the patient experience a hot sensation, swelling, and redness radiating from the injection site. The redness expanded to encompass parts of shoulder, bicep and forearm. Evidence of bruising under the skin present as well. Patient denied itchiness, shortness of breath, elevated heart rate. He only reported discomfort and did state that the bruising and swelling had improved by the 48 hour mark. Patient was observed after 72 hours.
Blood clot on her lungs; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PULMONARY THROMBOSIS (Blood clot on her lungs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY THROMBOSIS (Blood clot on her lungs) (seriousness criterion medically significant). At the time of the report, PULMONARY THROMBOSIS (Blood clot on her lungs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No corrective treatment was provided.  Very little information is available at this time for evaluation. Further information has been requested. Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.; Sender's Comments: Very little information is available at this time for evaluation. Further information has been requested. Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.
no adverse events reported.  patient was expected to receive 10mcg dose of the pfizer pediatric 5-11 bivalent booster and received the adult dose 12+
I had chest and nasal congestion. I also had a headache, body ache, low-grade fever, cough, and fatigue. I still have the fatigue and congestive. On Jan 2nd, I tested positive for Covid-19. I have received about 80% from these symptoms.
It felt like I had a head cold. It was accompanied by a fever of about 101-degrees. I tested for COVID-19 the next day. The result was positive. The symptoms included severe lack of energy, extreme sinus issues, and headache. I received PAXLOVID. They gave me a lighter dose because of my previous kidney issues. I took ibuprofen on a regular basis during that time as well. They told me to stop taking atorvastatin while I was taking PAXLOVID.
Three to five days later, the right side of my neck was swollen. Glands were swollen.  I could hardly swallow. I lost my sense of smell and taste. I still have the swollen glands and I still do not have smell or taste.
Information has been received from a registered nurse concerning a 62 year old female patient with dermatitis and oxycodone allergy, who on 23-MAR-2011 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) subcutaneously, (Lot number 669191/1456Z). Concomitant therapy included MAXZIDE, SYNTHROID, omega-3 marine triglycerides and FLEXERIL. The nurse reported that the patient developed shingle like rash after receiving the vaccine. The rash appeared bilateral on scalp, neck and face along with nerve pain. Prednisone and dexamethasone IM were given as a treatment for the experience. No labs diagnostics studies were performed. The patient sought unspecified medical attention. At the time of the report, the patient was recovering. Additional information has been requested.
Fatigue, Dizzy, Nausea, Loss of taste, Loss of smell (lasted about a week, then disappeared) Fatigue, Dizzy, Nausea, Loss of taste, Loss of smell, trouble breathing, headaches, loss of appetite(05/09/2021, went to hospital twice, was discharged too early the first time; 11 May 2021; returned to the hospital 21 May 2021 due to shortness of breath, fatigue, dizzy, nausea, loss of appetite, which the trouble breathing and shortness of breath was due to fluid build-up around the heart and his lungs). Admitted approximately late afternoon 21 May 2021 and did not get discharged, died on 9 June 2021 in the Hospice house.
It started on 02/05/2023 with a scratchy throat. Nothing too bad, just noted that I had a scratchy throat. I went home from the airport coming from vacation. I was okay Sunday and there was nothing too specific. I just thought I was getting a cold. Monday, I did not feel well. I slept a lot and felt bad everywhere. I had body aches, sore throat, headache, and felt cold. I assumed I had a fever because I was so cold. When we got to our hotel that night, I didn't eat much because I didn't feel like eating. I think I went to bed at 5 or 6 pm at night. I woke up Tuesday, and I was very sick. I felt miserable. I got home at about 3pm and sat in the recliner and tried to rest. Around 4pm I felt a little bit short of breath. I told my husband we need to go see the doctor as soon as possible. We went to two different clinics that did not take us. We went to the hospital and we were in the ER waiting for 6 hours. I knew I had COVID-19 because of my positive test on 02/07/2023. We sat in the corner of the ER away from everyone for hours. I was so tired and miserable and felt like I could barely talk. I slept half the time we sat in the ER. They triaged me right away and I waited 3 hours and they did a chest x-ray. They didn't say anything then another half hour they did some blood work. Another half hour later, they finally took me into a room. It took approximately 4 1/2 to 5 hours to actually get me into a room. The doctor came in and said the chest x-ray wasn't good and the blood work wasn't good. They were worried about blood clots. I was in a car for 2 and a half days prior to here. I noted that they may have over read the x-ray so I had to get a CT scan another half hour later. After that, a half hour later, the doctor came in and noted that I only have COVID-19 and no blood clots or pneumonia. They overread the x-ray and there's no problems except for just having COVID-19. She prescribed Paxlovid and we were able to pick it up tomorrow. My oxygen was also 98-99% and said I was fine. BYnow it's 02/08/2023 at 1AM. We slept and woke up at 8am and my husband picked up my Paxlovid prescription. After sleeping all night Wednesday, I felt much better by that point. I took the Paxlovid that night, then the next day, I was sicker than I was before. Even more than the start. I took another dose 12 hours later and I was even sicker. I couldn't sit or lay or do anything really. I couldn't concentrate and felt horrible. I never took it again. I took 2 doses then stopped. After a day being off the medication, I was fine. I wasn't sure if it was the Paxlovid or the course of the sickness. But by Friday, I felt better, Saturday felt better. And by Monday I was active again on 02/13/2023. My husband never got COVID-19. My adult children and grand children also didn't get it. I tested negative 2 weeks later on 02/17/2023.
Patient returned for a rash that developed on his ears, trunk, and extremities. Occurred 30 min. after leaving office. Rash was itchy. 3PM - he had diffuse erythema and warmth of ears bilaterally. He has several variable size urticarial lesion on the inner thigh and proximal arms. Gave pt 1 1/2 teaspoon of BENADRYL and 1 1/2 teaspoon ORAPRED. O2 sat 99%. See attached for additional records.
No adverse event., but the vaccine was inadvertently given to 17 year old when approved age is 18. Patient waited for recommended 15 minutes with no adverse events.
After the 2nd dose, he had a gushing bloody nose for over 20 min 3 hrs and 10 min after.; After the first dose, he had a bloody nose for about 10 min 6 hours after.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Jul2021 20:30 (Lot number: FA8484) at the age of 13 years as dose 1, single and administered in arm left, administration date 13Aug2021 09:00 (Lot number: FC3180) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: EPISTAXIS (non-serious) with onset 13Aug2021 12:15, outcome "recovering", described as "After the 2nd dose, he had a gushing bloody nose for over 20 min 3 hrs and 10 min after."; EPISTAXIS (non-serious) with onset 24Jul2021 12:30, outcome "recovering", described as "After the first dose, he had a bloody nose for about 10 min 6 hours after.". Therapeutic measures were not taken as a result of epistaxis, epistaxis.  Additional information: No treatment was given. No Covid prior vaccination. No Covid tested post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
Occupational health nurse at patient's worksite (hospital) called to report patient's right arm had two hard red lumps about halfway down the upper arm at the site of the varicella injection. The site of the injection is the smaller reddened raised hard area that looks to be approximately 1 inch in diameter, with a 21/2 inch diameter area adjacent to it. Patient told the Occupation Nurse that her entire arm was red and swollen yesterday and that it is better today with just the two noted areas of redness.
Pt recvd 3 doses of Engerix-B vax & titers were checked 6 months p/last dose & titer result was 7.7, indicating a low pos response;