chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rebound of Covid per antigen test after taking Paxlovid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound of Covid per antigen test after taking Paxlovid) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L214) for COVID-19 vaccination.     Concomitant products included DUTASTERIDE (AVODART) from 01-Jan-2018 to 01-Jun-2022 for an unknown indication.    On 16-Mar-2022 at 12:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2022 at 12:00 PM, the patient experienced COVID-19 (Rebound of Covid per antigen test after taking Paxlovid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-May-2022 to 28-May-2022 for COVID-19 prophylaxis, at an unspecified dose and frequency. On 02-Jun-2022, COVID-19 (Rebound of Covid per antigen test after taking Paxlovid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2022, SARS-CoV-2 test: rebound of covid-19 Rebound of COVID-19.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was taking other medications or products within 2 weeks of starting COVID-19 treatment and also received a COVID-19 Vaccine previously. It was reported as Rebound of COVID per antigen test after taking Paxlovid. Device Date was reported as 02 Jun 2022.  No treatment information was reported. COMPANY COMMENT: This is an spontaneous case concerning an 75-year-old male patient with  medical history of Concomitant products included DUTASTERIDE and PAXLOVID for COVID-19 treatment from 24-May-2022 to 28-May-2022 who experienced the unexpected event of COVID-19 (AESI) 73 days after  4th dose of  mRNA-1273 vaccine. On 28-May-2022, SARS-CoV-2 test: rebound of covid-19 The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an 75-year-old male patient with  medical history of Concomitant products included DUTASTERIDE and PAXLOVID for COVID-19 treatment from 24-May-2022 to 28-May-2022 who experienced the unexpected event of COVID-19 (AESI) 73 days after  4th dose of  mRNA-1273 vaccine. On 28-May-2022, SARS-CoV-2 test: rebound of covid-19 The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Per pt's mother pt c/o increased pain at 8 pm. Pt. began itching et crying at 1200 AM. Pt taken to ED, dx of hives, given Rx for Prednisone et IM inj. of BENADRYL. Pt's hives resolved this AM.
Initial report was received from a consumer on 18 December 2012 with additional information received on 19 December 2012. A seven-year-old female patient had received an injection of FLUZONE, lot number UH721AD (route, site and date of administration not reported) and within 12 hours her arm had a greater than three inch red, very hot, swollen ring at the site of the shot. It looked like a burn on her arm. She also had pain at the site. Initially she had a granular lump form at the site, but within a few hours the other reaction described previously ensued. Then the situation worsened. The size of the circle was not over five inches, hot, swollen and hard. Treatment included BENADRYL every four hours. The patient's father is a physician and felt it was now cellulitis. Outcome was not reported. Documents held by sender: None.
Patient tested positive for COVID-19 on 7/10/2021 s/p 2 doses of AZD vaccine (as part of a trial - 12/21/2021 & 01/15/2021); received Regeneron 7/14/2021.
Patient developed a rash on their left arm right around the site of administration. Rash developed about 5-6 days after receiving both injections. No itching was noticed by the patient but the soreness occurred for the next 3 days. Pateint received a 10 day course of Cephalexin in which she reported that it started to clear up by day 2. On completion of the 10 day course patient reported that the rash was fully cleared.
Patient went unconscious and rigid with seizure-like movements. unable to arouse with sternal rub. Patient gained consciousness momentarily before losing again. On instruction from EMS, laid patient on floor, and moments later he regained consciousness again. Took blood pressure shortly after, EMTs arrived after. They offered care & orange juice. Patient refused all medical treatment, took orange juice. Patient rested for about 30-45 minutes before leaving of his own will.
1-On the second day late evening  felt mild tenderness in my arm. 2- I developed mild intermittent headache.
This spontaneous report was received from a Certified Medical Assistant via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route anatomical location, lot number and expiration date not reported). There was no concomitant medication reported. It was reported that the diluent (lot number and expiration date were not reported) used to reconstitute the vaccine was expired. NO adverse event was reported. This is one of two reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. On 27-MAY-2015, the patient was vaccinated with improperly stored M-M-R II (route of administration and dose were not reported) (lot number reported as: K016152, expiry date: 24-SEP-2016). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Lymph node tenderness; Lymph node under right arm became enlarged; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 20Apr2021 at 14:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. The patient had no known past drug history. Concomitant medications included lisinopril 10 mg (MANUFACTURER UNKNOWN) and omeprazole 20 mg (MANUFACTURER UNKNOWN) both from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 30Mar2021 at 14:30 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Apr2021 at 03:00,  the patient experienced lymph node  enlarged and lymph node pain. Its reported that the patient's lymph node under right arm became enlarged. This happened a day and a half later than the shot. It was tender and uncomfortable and lasted for 6 days. The clinical outcome of the events of lymph node enlarged and lymph node tenderness were recovered on 28Apr2021.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a registered nurse, reporting on herself a 65 year old female patient. The patient's medical history included an splenectomy, lymphoma, No immunoglobulin M (IgM) and shingles. The patient's stated an allergy to penicillin, KEFLEX, tuberculosis test serum, CYMBALTA and intravenous BENADRYL. Ramipril, sotalol, DEXILANT, domperidone, ibuprofen, SKELAXIN, ZOLOFT, ZYRTEC, potassium, magnesium, ZOFRAN, PHENERGAN, SYNTHROID, SINGULAIR, were reported as concomitant medications. On 27-OCT-2017, an unspecified amount of VARIVAX for prevention of chickenpox (lot # M034585, expiration date 27-JUL-2018) and sterile diluent (Lot # and expiration date not provided) "got in" in the patient's right eye and right cheek while she was preparing the dose for an unspecified patient. Then, the patient flushed her right eye with water. Since on an unspecified date in October 2017, the skin underneath patient's right eye was dry and irritated. Besides, she had "2 raised welts" on her right cheek. The patient reported that a treatment was given for the events and, additionally, laboratory diagnostics studies were not performed. The outcome for the events of irritated skin and dry skin was not recovered at the time of reporting, and for urticaria was not reported. The causal relationship between the aforementioned events and VARIVAX and the sterile diluent was not provided. There was no product quality complaint involved.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Headache-Severe, Systemic: Nausea-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Nerve pain across the shoulders and neck started within 24 hours of shot.  Unable to lift arms overhead.  unable to lift objects overhead.  Progressively worse symptoms since the shot.  Started seeing a Chiropractor to relieve pain and give me temporary relief recently.
Patient had redness and swelling from injection site down to wrist and was painful to the touch.
A non-serious report of wheezing has been received from a nurse concerning a three-year-old female subsequent to FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  No relevant medical history has been reported for this patient; however, the patient did not have a history of asthma, allergies of wheezing.  The patient's concomitant medications includes: TIV in 2006.  The subject received her first dose of FLUMIST on 30-Sep-2008.  On 09-Oct-2008, the mother of the three year old patient called the office indicating that the child experienced wheezing after receiving FLUMIST on 30-Sep-2008; the wheezing lasted for about 30-minutes and then resolved without reoccurrence.  The patient was doing well and the event resolved.  Per the reporter, they do not recommend that the patient receive the vaccine next year.
Extreme Arm Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Extreme Arm Pain) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (Extreme Arm Pain). On 18-Mar-2021, PAIN IN EXTREMITY (Extreme Arm Pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
8 days after Moderna 1: Arm welt, arm and fingers itching amd tingling 6 hours after Moderna 2: fatigue, headache, flu-like symptoms without fever, chills sweats. Full Symptoms  for 30 hours; 10 more hours of fatigue. Most symptoms gone by 54 hours after 2nd shot )injected 845am 3/27)
Pt was given Varicella vaccination in the left deltoid on 2-16-16 and per pt's mother noticed reaction on 2-17-16 at 0730. Pt was seen at clinic on 2-17-16 and provider noted "red plaque on the left deltoid (near the varicella immunization he had yesterday) warm, firm, slightly tender to touch, no excoriation marks, no open area". Per pt's mother pt recovered fully by 2-2-16.
p/approx 10min pt very cold, dizzy, weak;EMS personnel were @ the scene & began monitoring pt;color pale, HR 110-120, hands icy cold;throat felt tight & began to get anxious;given epi & taken to ER;
FEVER (101.4), ARM SWELLING..BENADRYL DID NOT HELP..PT WILL WAIT IF IT GETS WORST HE WILL CONTACT DR
Client presented at a HCF vaccination site on 01.11.22. Client reported he received first dose of Pfizer COVID vaccine on 04/27/21 without any issues. Client reported received second dose of Pfizer COVID vaccine on 05/18/21, he had a headache and body ache for two hours after receiving the Pfizer COVID vaccine which lasted five to six hours. Client told he didn?t take any medications for his headache and body ache but just rested. Client reported he didn?t follow-up with his PCP. Client stated he doesn?t have any known allergy. Client denied any shortness of breath or any anaphylactic symptoms with both doses. Client reported he has history of migraine controlled with OTC CBD and ADHD controlled with Prozac. Today, he reported he has an 8/10 headache on a pain scale of 10 and consumed CBD four hours ago. Client is requesting for a booster dose of Pfizer COVID vaccine for a different day since client told he must return to work and is unable to wait for the approval but will call him once approval is received and reschedule him for a different day. PHN submitted a medical consult via text message to clinical project coordinator requesting to proceed with the booster dose of Pfizer COVID vaccine for a different day. Per the doctor, approval to proceed with the booster dose of Pfizer COVID vaccine was obtained via text message from clinical project coordinator. The booster dose of Pfizer COVID vaccine was not administered to client today since client left the vaccination site before his approval was received. PHN called client?s cell phone and left him a message that he got approved to come get his booster dose of Pfizer COVID vaccine when the vaccination site is open or call back if he has any questions.
suspected vaccination failure; I got the shot but still got; No lasting pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included chemotherapy.   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), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter reported for himself or herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The reporter stated that, got shingles shot and still got shingles during chemotherapy but the patient bet it would have been a lot worse if the patient had not received it. The reporter stated that, no lasting pain either. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
bleeding from the rectum; pain in her stomach area; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (bleeding from the rectum) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Intestinal cyst.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced RECTAL HAEMORRHAGE (bleeding from the rectum) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (pain in her stomach area) and DIARRHOEA (diarrhea). At the time of the report, RECTAL HAEMORRHAGE (bleeding from the rectum), ABDOMINAL PAIN UPPER (pain in her stomach area) and DIARRHOEA (diarrhea) outcome was unknown.            Patient was treated with antibiotics No concomitant medications were reported. Patient stated a colonoscopy has been ordered.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events which was greater than one month and the patient's pre-existing intestinal condition the Company believes a causal relationship is unlikely.
I have not had a period since I got the vaccine.  Before the vaccine was administered I would sometimes go 4-5 weeks in between periods.  It has been almost 3 months.
Patient was given initial dose on 6/1/2021, dose given at the time was Pfizer.  Today, July 7, 2021 patient arrives for 2nd dose, nurse reviewed papers completed by father which states Moderna and the child is given Moderna  instead of the Pfizer vaccine.  Patient was monitored for the 15 minutes and parent was notified of the error.
Intermittent loss of taste and smell. I was diagnosed with covid Nov 10, 2020 and lost my sense of smell and taste through Nov 24, 2020, since then I have had full taste and smell. About 6 hours after my 2nd shot things began to taste like cigarette ash, but my smell was fine. Then that evening things returned to normal. The next morning through about 1pm I was fine, things began a bit off around 1pm. By 4pm my taste and smell was gone on Sunday. Monday I have some smell and taste but it comes and goes. For instance I could taste the arugula in my salad but not the tomato. I could not taste a tangelo, but could taste a blood orange, eaten one right after the other.  I now have most smell back as of 2pm Monday, but taste is intermitten.
Headache, Fever, chills, fatigue, lymphadenopathy Narrative:  I received my 1st COVID vaccine on 12/18 and only experienced arm pain that started the day after vaccine and only lasted 2 days. My second vaccine was 1/8/21. 12 hours after vaccination I got headache, chills/low grade fever, fatigue and myalgias that lasted for 15 hours. 36 hours after vaccination I developed swollen lymphnodes in my armpit on the saem side as vaccination. Initially it was very painful and was the size of a tennis ball. After 24 hours it shrunk to the size of a golfball and was less painful. It fully resolved after 4 days so on day 5 after vaccination.
Developed polymyalgia rheumatica; This is a spontaneous report received from a contactable Physician. A 40-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration in Apr2021 at the age of 40-years-old (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included hypertension, known allergies: Sulfa drugs. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as dose 1 for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL/HYDROCHLOROTHIAZIDE). Event on 26Apr2021: Developed polymyalgia rheumatica 2 weeks after second vaccination. Diagnosed via symptoms, elevated inflammatory markers, and abrupt response to prednisone. AE resulted in Doctor or other healthcare professional office/clinic visit. AE treatment was prednisone. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the event "polymyalgia rheumatica" and the suspect drug 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.
Extremely weak; Trouble lifting her own body weight up off the cough; Fatigue; Fever of 102 degrees; received the vaccination on April 1st (1st shot) and April 12 (2nd Shot); cough; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Extremely weak), MOBILITY DECREASED (Trouble lifting her own body weight up off the cough), FATIGUE (Fatigue), PYREXIA (Fever of 102 degrees) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the vaccination on April 1st (1st shot) and April 12 (2nd Shot)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bipolar disorder.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced ASTHENIA (Extremely weak), MOBILITY DECREASED (Trouble lifting her own body weight up off the cough), FATIGUE (Fatigue), PYREXIA (Fever of 102 degrees), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the vaccination on April 1st (1st shot) and April 12 (2nd Shot)) and COUGH (cough). On 12-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the vaccination on April 1st (1st shot) and April 12 (2nd Shot)) outcome was unknown. On 16-Apr-2021, ASTHENIA (Extremely weak), MOBILITY DECREASED (Trouble lifting her own body weight up off the cough), PYREXIA (Fever of 102 degrees) and COUGH (cough) had resolved. At the time of the report, FATIGUE (Fatigue) outcome was unknown.            Concomitant medications were not provided.  Treatment medications were not provided.
pt w/swelling of lt upper arm;tender to touch;itchy;inc in size daily seen 24OCT97;tx hydrocortisone cream, advil, DPH;will return to be seen 28NOV97;
serious bleeding disorder; This case was reported by a consumer via interactive digital media and described the occurrence of hemorrhagic disorder in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, couple of weeks after receiving Meningococcal B vaccine, the patient experienced hemorrhagic disorder (serious criteria GSK medically significant). On an unknown date, the outcome of the hemorrhagic disorder was unknown.   It was unknown if the reporter considered the hemorrhagic disorder to be related to Meningococcal B vaccine.  Additional details were provided as follows: The case was reported by patient's parent. The age at vaccination was not reported. my daughter developed a serious chronic bleeding disorder, within just a few weeks after her meningitis shot.