chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Weakness of right side of the body suddenly and couldn't balance herself and couldn't use her right hand and right leg for few hours.
tested positive; This is a spontaneous report from a Pfizer-sponsored Program. A contactable consumer (patient) reported.  A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EN6205) via an unspecified route of administration on 15Mar2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The Reporter stated, she tested, she got her first dose last 15Mar2021 and got exposed to the positive or carrier of Covid-19 virus. she tested positive as well and now she asked if she needs to restart the vaccine from the first shot or needs to return or continue the second shot instead." On 19Mar2021, the patient experienced symptoms and tested positive on 21Mar2021. The patient was tested on Friday as well but her next dose of second vaccine is past, and way past quarantine period, that is why she asked to start over or could she do the second one. The patient underwent lab tests and procedures which included SARS-CoV-2 test positive on 21Mar2021. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Muscle aches, chills, fatigue, headache, pain and redness at injection site.
.He had the Johnson and Johnson vaccine on March 8, 2021 and then started having a cough and was very tired. He died unexpectedly on March 28, 2021.
She states it felt like she may faint; she has been feeling unwell and not her normal self for 4 days now; she had 1 dizzy spell; This is a spontaneous report from a Pfizer sponsored program by a contactable consumer reported for self. This 84-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Feb2021 at single dose for covid-19 immunisation. Yesterday, 23Feb2021, she had 1 dizzy spell; she sat down and the dizziness went away within seconds. She states it felt like she may faint. She states she has been feeling unwell and not her normal self for 4 days now. She's wondering if this is a serious side effect, if she should still get the second dose, and how long do the symptoms last. Outcome of the event 1 dizzy spell was recovered on 23Feb2021. Outcome of the event feeling unwell was not recovered. Outcome of another event was unknown.  Information on Lot/Batch has been requested.
This is a spontaneous report from non-contactable consumer via Pfizer Sales Representative. A 74-year-old male patient received BNT162B2 (Pfizer COVID-19 Vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. Medical history included cardiovascular issues and has pacemaker. The patient concomitant medications were not reported. On an unknown date, the patient experienced rapid heart rate and had cardioversion to alleviate. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
NO ADVERSE REACTIONS.  The patient made an appointment via myTurn.com on 8/16/21. He wanted to get moderna vaccine on 8/16/21. He did not say anything that he already got other COVID 19 vaccines.  After Moderna 1 dose administration, this office documented CAIR2 and found that he already got Pfizer on 3/3/21 and 3/24/21 and J&J on 5/19/21. He stated that he did not feel safe, and he got Moderna today. We observed him for 15 mins. No adverse events were noted.
heart attack; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (death), outcome "fatal", described as "heart attack". The patient date of death was unknown. Reported cause of death: "heart attack". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: heart attack
Painful red blotch; Painful red blotch; This case was reported by a consumer via interactive digital media and described the occurrence of red blotches in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced red blotches and pain. On an unknown date, the outcome of the red blotches and pain were unknown.   It was unknown if the reporter considered the red blotches and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 6-May-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingrix vaccine into unknown arm and experienced painful red blotch on the same arm but not at the injection site. The patient asked was if it was normal. Additional supportive information: The follow-up would not possible, as no contact details were available.
This spontaneous report was received from a doctor of pharmacy refers to a 70 years old female patient with diabetes under control and no known allergies, who on 02-OCT-2012, was vaccinated subcutaneously on her left arm with a 0.65 ml dose of ZOSTAVAX (lot number 0468AE, Exp. Date: 04-APR-2013). No other co-suspects were reported. No concomitant medications were reported. The pharmacist that on 14-OCT-2012, the patient came into the pharmacy with was appeared to be shingles. The patient was seen by her doctor and shingles were confirmed on an unknown date, in October 2012. The patient was treated with a unspecified antiviral and was giving a unspecified steroid shot. At the time of the report, the patient was improving. The relatedness for patient was diagnosed with shingles was unknown for ZOSTAVAX. Additional information has been requested.
Pt in observation area for ten minutes before describing onset of "lump in throat." Confirmed she experienced the same issue after receiving the first dose. Took a Benadryl after the first dose and it improved symptoms. No other issues (no redness, rash, hives, difficulty breathing). EMT, took pt's vital signs - all WNL. Pt had oral Benadryl on hand and took one orally. EMT took vital signs again after ten minutes - vitals stable and WNL. Approximately 30 mins after taking oral Benadryl pt reported symptoms better. Pt stayed in observation area for approximately one hour total, stood up and walked out after symptoms resolved.
Information has been received from a pharmacist referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored ROTATEQ (lot number, dose and route were unknown). No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
Very sore arm, below injection site, around muscle and tightness and throbbing, tried ibuprofen and used ice, no welt on injection but warmness.
One minute after receiving the vaccination, she developed ringing in both ears. She was monitored for 20 minutes. Her symptoms resolved within several minutes.
The patient was given their Pfizer booster around 12:34pm, around 12:39pm the patient reported feeling dizzy. We asked him to lie down on several chairs. He said he did not have any difficulty breathing and we took his blood pressure, which was relatively low (103/72), then called EMS. The fire department arrived around 1:01pm, and EMS left with the patient around 1:06pm.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 29-OCT-2018, the patient was vaccinated with a dose of VARIVAX (lot # N017394, expiration date: 07-JUN-2019) and PROQUAD (lot # R006218, expiration date: 28-AUG-2019) (dose and route of administration were not provided for both) for prophylaxis which was considered to be an medication error. Both vaccines were reconstituted with a sterile diluent. No adverse effects were reported.
Information has been received from  a registered nurse concerning a 7 year old female pt who on 12/28/1998 was vaccinated in the LA  with a first dose of varicella virus vaccine live. On 02/28/2005 the pt developed a rash on her face, which was described as mild breakthrough. It was reported that the pt is recovering. Unspecified medical attention was sought. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/16/2005. Information has been received from a registered nurse and a physician concerning a seven-year-old female patient, who on 28-DEC-1998 was vaccinated in the left arm with a first dose of VARIVAX (Merck) (Lot# 628182/1372H). Concomitant vaccination given on that same day included the first dose of MMR II (lot# 28905/1362H) given in the right arm. On 28-FEB-2005 the patient developed a rash on her face, unspecified medical lalttlention was sought. It was diagnosed as a mild case of varicella. It was reported that the patient is recovering well. Additional information is not expected.
This case was reported in a literature article and described the occurrence of minimal change disease in a 80-year-old male patient who received FLULAVAL TETRA. Concurrent medical conditions included Waldenstrom's macroglobulinemia (in remission state). On an unknown date, the patient received FLULAVAL TETRA. On an unknown date, 8 days after receiving FLULAVAL TETRA, the patient experienced minimal change disease (serious criteria hospitalization and GSK medically significant), proteinuria (serious criteria hospitalization), leg edema (serious criteria hospitalization) and facial swelling (serious criteria hospitalization). The patient was treated with Ace Inhibitor and Statin (NOS). On an unknown date, the outcome of the minimal change disease, proteinuria, leg edema and facial swelling were unknown. The reporter considered the minimal change disease, proteinuria, leg edema and facial swelling to be related to FLULAVAL TETRA. Additional information was provided. This case was reported in a literature and described the occurrence of Minimal Change Disease in a 80 year old male who was vaccinated with FLULAVAL TETRA (GlaxoSmithKline). The patient had history of Waldenstrom's macroglobulinemia. The patient was following oncology for Waldenstrom's Macroglobulinemia and was considered in remission. No information on patient's family history or concomitant medication was provided. On an unspecified date, the patient received FLULAVAL TETRA (administration site and route unspecified, dosage unknown; Lot: 9335Z, NDC: 19515-912-41). The age of vaccination was not provided. On an unspecified date, 8 days after vaccination, the patient presented with abrupt onset facial swelling, leg oedema. Laboratory findings showed elevated creatinine compared to the baseline with heavy proteinuria. Urine protein: creatinine ratio (UPCR) was 10 with evaluation in the Hospital showing 24 hour urine protein to be 1226 gram. Albumin level was noticeably low at 1.5. Immunology testing was negative, complement levels were normal. Biopsy revealed minimal change disease with thin Basement Membrane. Fibrillary deposits on Electron microscopy noted and negative for congo stain. Tubules stained for both kappa and lambda with absence of monoclonality. This case has been considered serious due to hospitalisation. The patient was started on Angiotensin converting enzyme inhibitors and statin therapy. The outcome of the event was not reported. The authors commented "Few cases of Minimal Change Disease have been reported in the literature related to the influenza vaccination and Waldenstrom's macroglobulinemia. The abruptness of onset with temporal association of symptoms just days of vaccination lead us to conclude that Influenza vaccination was the culprit for Minimal Change Disease in this patient". The authors concluded "This case highlights a very rare complication related to the Influenza vaccination".
Client was seated on mother's lap - mother was pregnant and unable to bind legs of child between her own legs.  Child lunged away when needle was inserted causing needle to be removed.  No vaccine administered.  Vanishpoint was being used.  A new dose of vaccine with a new Vanishpoint was successfully administered with 2nd attempt.
This spontaneous report was received from a nurse and refers to a 25 year old female patient with "high-risk lifestyle". The patient had an unknown adverse reaction to ZITHROMAX in the past. On 18-SEP-2009, 16-NOV-2009 and 17-MAR-2010 the patient received, respectively, the first, the second and the third dose of GARDASIL (dose, route of administration, lot # and expiration date were not reported). The patient's concomitant therapies include SPRINTEC 28. On 28-DEC-2015, the patient was administered a dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). On 28-DEC-2015, the patient had a Pap test performed with an abnormal result. The Pap test detected human papillomavirus (HPV) High Risk HPV MRNA E6/E7. The patient sought medical attention via an office visit. On 29-FEB-2016, the patient received the fourth dose of GARDASIL (dose, route of administration, lot # and expiration date were not reported). The outcome of abnormal pap smear result was reported as not recovered. The relatedness between the event and GARDASIL and GARDASIL 9 was not provided. Additional information has been requested.
64 yo gentleman with ESRD from fibrillary GN on HD at clinic was admitted at hospital at the beginning of this month with a stroke and was found to have incidental COVID 19 + (asymptomatic) had been transferred, but while there aspirated a piece of broccoli with resultant respiratory distress and transferred to the medical center. He had been on BiPAP, but now on O2 per NC.     Discharged 06/13/2022 Discharge Dx:  1. Acute hypoxic respiratory failure secondary to acute food aspiration with     bacterial aspiration pneumonia. 2. COVID-19 positive. 3. History of recent cerebrovascular accident. 4. End-stage renal disease, on hemodialysis. 5. Chronic anemia, likely due to chronic kidney disease. 6. Chronic hypertension
got the shot and still got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had Shingles shots and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Diagnosed with Shingles 2 weeks after vaccine. Had rash 4 days before diagnosis.
65 y.o. male was transferred from another facility on 8/17/2021 for additional evaluation and management of acute on chronic respiratory failure with hypoxia due to COVID-19 and acute on chronic renal failure in need of hemodialysis. The patient initially presented there with generalized weakness associated malaise, sore throat,  and a fever of 101F of this morning. Patient reports he has a dry cough, chills, and worsening fatigue over the past 2-3 days. As of this morning, he woke up feeling as if he could not sit up due to a deeper cough and severe fatigue. He tested positive for COVID-19 on 8/17/2021 prior to being transferred. The patient reports that he received both doses of his COVID-19 vaccine in March.  The patient received dexamethasone, oxygen.  He was discharged to home on 8/20/2021
Patient's stepmom called the day after patient received vaccines and left a message that patient was not feeling well and felt very weak and at one time went down on his knees from being so weak. This nurse returned the call and left a message to call this nurse back - no call was returned to this nurse. Today (1/24/19) this nurse received a call from patient's mother, stating patient was taken to the ER on 1/17/19 due to having a grand mal seizure. The mother states patient went down on his knees and clawed at the couch cushion to get himself up and had a grand mal seizure. Mother states she was not present, patient was with his stepmother. Patient's mom states many tests were done at the ER including a CT scan and blood work and everything came back normal. Patient's mom states the ER doctor told them these symptoms were most likely caused from the vaccines. The mother called this nurse wanting to report this happened.
Exposed to Covid-19; Diarrhea; Chested cough; Vomits; This spontaneous case was reported by a nurse and describes the occurrence of EXPOSURE TO SARS-COV-2 (Exposed to Covid-19), DIARRHOEA (Diarrhea), COUGH (Chested cough) and VOMITING (Vomits) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy, Celiac disease and Asthma. Concomitant products included VITAMINS NOS for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced DIARRHOEA (Diarrhea), COUGH (Chested cough) and VOMITING (Vomits). On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (Exposed to Covid-19). At the time of the report, EXPOSURE TO SARS-COV-2 (Exposed to Covid-19), DIARRHOEA (Diarrhea), COUGH (Chested cough) and VOMITING (Vomits) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: negative (Negative) Negative, negative (Negative) Negative and negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details were not reported by the reporter.
Headache began morning of 2/24, lasted until 2/25 AM. Diarrhea began shortly after headache onset on 2/24, lasted until 2/25. Night sweats and chills on 2/27 PM until 2/28 AM.
Patient called 3:50 pm on 11/09/2021 and states she has a rash that appeared recently after receiving her Moderna booster on 11/4/2021.  Patient stated she does not feel bad but has a rash going around her arm similar to how "COVID Arm" is described and was not immediate.  Patient was calling because she was curious if it was a serious reaction and had not stated getting medical treatment but may in the future if the rash does not go away "soon.".  She stated she would let me know if gets worse. I contacted her physician at 4:14pm (Dr. ) and spoke to Assistant who would make sure the physician got the message and would put a note in the patient's records.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of an unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates from November 2015 to 25-FEB-2016, the patients were vaccinated with an unspecified number of doses of improperly stored GARDASIL lot# K003520, expiration date: 20-NOV-2016 and lot# L016429, expiration date: 09-AUG-2017 (dose and route of administration were not reported). Administered doses of GARDASIL underwent temperature excursions at 46.72 Fahrenheit degrees, for 23 hours and 49 minutes (over 3 months frame). There were no adverse effects reported. Product quality complaint (PQC) was not involved. Reporter reported GARDASIL with lot# L016429, which was not valid for GARDASIL. However, lot# L016429 is valid for GARDASIL 9. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a pharmacist concerning his 12 month old son with no pertinent medical history or drug allergies who on 28-AUG-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 17-SEP-2007 the patient developed a rash. Medical attention was sought via contact to the physician's office. No lab diagnostic studies were performed. It was noted that the patient was not recovered. There was no product quality complaint. Follow-up information has been received from a pharmacist indicating that the rash that developed on approximately 18-SEP-2007 3 weeks after vaccination, was a reaction not associated with varicella virus vaccine live (Oka/Merck), but caused by another viral infection (ROSEOLA). No further information is available.
I already had some tremors in one of my legs, and I developed COVID19 after my 3rd COVID19 vaccination, it was pretty mild. Then I started to have leg tremors in both legs over the summer, in July 2022. I also experienced some toe pain in both feet, the third and forth toes. I started to get some muscle stiffness and lightheadedness. I'm an avid skier and I noticed in the fall that I was no longer able to balance correctly which was alarming. The lightheadedness started to get worse as well. In January 2023 I finally went to the doctor, and they gave me a referral to a neurologist. I had an MRI last month and it was determined that I had Parkinson's. I have started taking medication, the last day of February. I tried skiing about a week ago since the medication and was finally able to balance on my skis.