chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Low Heart Rate (52 and 58); This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE DECREASED (Low Heart Rate (52 and 58)) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Overweight and Type 2 diabetes mellitus.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced HEART RATE DECREASED (Low Heart Rate (52 and 58)). At the time of the report, HEART RATE DECREASED (Low Heart Rate (52 and 58)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Aug-2021, Heart rate: 52-58 (Low) normally is about 70.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include a sugar pill for diabetes and blood pressure medication. Treatment information not reported.   Reporter did not allow further contact
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 02-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L012482, expiration date: 10-APR-2017) (Incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
shingles; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, . A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to know if she can receive her 2nd dose of vaccine as she was diagnosed with shingles on an unspecified date after receiving her first dose of the vaccine. The outcome of event was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Patient fell asleep shortly after having the vaccination. When I came home from work at 11pm it was difficult to wake her. She had a 104 fever. When I did manage to wake her she was making strange fish like motions with her mouth, couldn't seem to make eye contact and acted almost intoxicated, dizzy and completely out of it. We took her to the emergency room where they gave her a fever reducer. Four hours later when we finally saw a doctor she seemed better. The next day we noticed her having spacing episodes which we were later told were seizures. She no longer made eye contact, would no longer self feed or try to sit up. She regressed back to being a baby for 3 months. By the time we got an EEG and MRI scheduled the spacing episodes had subsided. The EEG and MRI were normal. She continues to have developmental delay, poor eye contact, and no speech. No ability to communicate, follow direction, or play constructively. She is walking, but very clumsy.
Started with itchy around injection. After 5 or 6 Days, Big, Red, Itchy Welt about 2" Round around the injection site. After a couple days, it traveled down my arm towards my elbow, still red, swollen and itchy.  This got better over the next days, getting less itchy and less red and not a welt anymore. By April 15, Morning: Just Lightly Discolored/ Darker Splotch/Stain over the itchy area and overall, slightly swollen compared to the other arm. Not Itchy at Top Area. Smaller Lightly Discolored/Darker Splotch/Stain and Overall, Slightly Swollen today.  I did not call the Doctor, found similar reactions on the internet.
Headache, Myalgia, Diarrhea, NauseaVomiting, etreme tiredness Narrative:
Received 1st dose on 2019 not received her 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received 1st dose in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 25-APR-2022 Reporter's Comment: The case was reported by the patient. The patient stated that, she was scheduled to receive her first Nucala injection in about a week.  The patient did not receive her second dose of the Shingrix vaccine. The reporter provided permission to contact healthcare professional but disconnected call before any details could be obtained. No additional details were provided by the patient. The reporter consented to follow up. Additional Supportive Information: The patient did not receive her second dose of the Shingrix vaccine till the time of reporting, which led to incomplete course of vaccination.
Broke out in with a small patch of shingles on left side of chest,  had chicken pox as a child but never shingles
Injection was at noon.  Six PM - left arm was extremely painful, (not "achy"), feverish and tender.  Fatigue had set in.  By 9PM  migraine headache and  extreme nausea .  Midnight brought shivering chills.  By 3AM  had a fever of 102.4 and nausea had worsened.  Throughout the next 48 hours the symptoms continued but slowly subsided:  by noon (24 hours after inoculation) the fever was 100.  Nausea subsided to allow broth and crackers by 30 hours after injection.  Within 60 hours symptoms were gone except for the arm.  On day three I did develop "Covid arm".  The red tender patch is still visible (one week after injection) but the rash is slowly diminishing.
Initial unsolicited report received from a consumer (patient herself) on 03-Jul-2017. This case involves a 56-year-old female patient who was vaccinated with a dose of FLUZONE QIV (Batch number: UI441AB, Expiry date: 30-Jun-2016, dose, dose in series, route and site of administration were not reported) on 09-Oct-2015. Patient's Illness at time of vaccination was reported as none as per reporter. Patient's pre-existing physician diagnosed allergies includes latex and sodium pentothal and other medical history was reported as none. Concomitant medications were not reported. On an unknown date, about 3 to 6 weeks following the vaccination, the patient gradually developed generalized, extreme muscle pain and joint pain. On an unknown date, the patient also experienced tiredness and nausea. The patient stated that she received vaccination as part of Employee Health Program, and it was reported as the patient had seen her own family physician and a Rheumatologist for numerous visits. The patient previously received several doses of FLUZONE QIV on an unknown dates. It was stated that, since Oct-2015 she has received another Flu vaccination in 2016 with no change in the muscle pain and joint pain following the 2016 vaccination. Patient's x-rays, and other tests have been negative for other causes of her muscle and joint pain. Corrective treatment was not reported. The outcome of all the events were reported as not yet recovered. (It was reported that the patient still has generalized, extreme muscle pain and joint pain which continues to today, as of 03-Jul-2017) List of documents held by sender: none.
Information has been received from a consumer concerning her 11 year old daughter with constipation chronic and no drugs allergies, who on 15-JUN-2009 was vaccinated with a first dose of GARDASIL. The patient's mother reported that her daughter has been having constant joint pain in her back, knees and ankles since about 2.5 weeks ago. The patient also had occasional headaches. She was dizzy about 1-2 days after vaccination. The patient had been treated with MIDOL for pain. The patient had normal blood tests. The patient sought medical attention through an office visit. At the time of this report the patient had not recovered. Follow up information received on 30-JUL-2009 from a licensed practical nurse indicated that on 15-JUN-2009 the patient was vaccinated with a first dose of GARDASIL (lot # 658271/0558X) and concomitantly with a second dose of VARIVAX (Merck) (MSD) (lot # 663817/0488Y), a dose of MENACTRA (lot # U2817AA) and a dose of ADACEL (lot # C3246BA). The patient's mother called the physician's office on 16-JUN-2009 to report that her daughter had abdominal pain and was nauseous. It was documented that the patient's mother was "panicked after seeing the internet". The patient was seeing by the physician on 21-JUL-2009. The physician documented that the patient had malaise and arthralgia. The patient had blood work drawn and the results were normal. The blood work revealed that the patient had a previous mononucleosis infection. On 24-JUL-2009, it was documented in the patient's chart that the patient may need referral to a Rheumatologist. Follow-up information was received from a physician via medical records. The physician reported that the patient is an 11 year old female and on 16-JUN-2009, complained of arthralgias in back, knees and ankles within one day of immunizations. The patient complained of extreme fatigue and significant lower body joint pain which restricted her activity. The patient had full work of labs which were normal. On 21-JUL-2009, Epstein-Barr viral capsid antigen immunoglobulin G antibody test was >8.0, serum Epstein-Barr virus nuclear antigen immunoglobulin G antibody test: >8.0 and Streptozyme was elevated to 1:200. On 31-JUL-2009, Streptozyme was elevated to 1:200 and Anti-DNase B Strep Antibodies were 1:170. The patient improved after Nonsteroidal Anti-Inflammatory Drugs for 2 weeks. There was no illness at time of vaccination. The patient recovered in middle August 2009. No further information is available.
ended up in the hospital; throwing up; Based on additional information received on 19-Dec-2020, this case initially considered as non-valid was re-assessed as valid.   Initial information was received on 08-Nov-2020 regarding an unsolicited non-valid serious case from a consumer/non-health care professional (patient) via social media (Facebook) in the United States.  This case involves a male patient (age unspecified) who was throwing up (vomiting) and ended up in the hospital (hospitalisation) after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination in the school  On an unknown date, the patient ended up in the hospital (hospitalisation) (unknown latency) following the administration of INFLUENZA VACCINE.  On an unknown date, the patient was throwing up his heels (vomiting) before the day was out (unknown latency) following the administration of INFLUENZA VACCINE. This was a non-serious event   No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time reports, the outcome was of events was unknown.  Information on lot number was requested for this case.  Additional information was received on 19-Dec-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional (patient) via social media (Facebook) in the United States.  -Case was updated to valid -patient gender and event (vomiting) was added; Sender's Comments: Follow up information received on 19-Dec-2020 changes the previous assessment. This case concerns a male patient who had vomiting and ended up in hospital following the administration of INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.  .
Immediate intense pain in shoulder joint.  Injection was very high up on shoulder.  Severe main and difficulty using affected arm was immediate.  Reported to PMD after one week.  MRI done 9/23/2016.  PT started 9/28/2016.  Pain and ROM limitation persist.
Very bad muscle and joint pains, carpel tunnel syndrome kind of pains. Weakness in arms and legs. Then I was checked for Vit D, it was low, then my thyroid started giving up. TSH kept increasing. So doc gave Vita D and Synthroid starting dose 25mcg. There was no relief. Checked a lot of antibodies like ANA and RF factor. None was present. Now after two years I am still struggling with auto immune thyroid disease and myopathies involving arm muscles, joint pains, constipation etc. Need high doses of thyroid medication to feel better. I should have been warned of this risk of developing auto immune diseases with this vaccination.
Chicken pox x 3 in past 3 yrs. Mother reports Dx'd by MD's last/currently Dx 3/3/03.
3 DAYS (4/19) AFTER VACCINE STARTING FEELING NUMBNESS IN LIPS THAT SLOWLY PROGRESSED TO SIDES OF FACE, FORHEAD, CHIN AND EVENTUALLY IN THE HAIRLINE.  WENT TO THE DOCTOR 4/26 WHEN IT BECAME IMPOSSIBLE TO IGNORE, THOUGHT I WAS HAVING POSSIBLE STROKE, THE DOCTOR SENT ME FOR A CT SCAN ON 4/26.  I DID  NOT REALIZE IT WAS A REACTION TOTHE VACCINE.  I WAS LOOKING FOR A RASH OR ACHES WHICH I DID NOT HAVE.  I WAS PERSCRIBED A STERIOD REGIME BY MY FAMILY DOCTOR WHICH I STARTED 4/28.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (seven patients received a dose from an expired Moderna vial.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 037F21A and 076C21A) for COVID-19 prophylaxis. No Medical History information was reported. On 08-Jul-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (seven patients received a dose from an expired Moderna vial.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (seven patients received a dose from an expired Moderna vial.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment information was provided by the reporter.
HE HAD CHEST PAIN AT THE NIGHT OF VACCINATION AND IT WENT THROUGH FOR 6 HOURS.  FELT BAD FOR 2 DAYS, AND STILL FEEL BAD
Fever 101 even after Tylenol and Advil  Headache Chills Lightheaded Nausea Fatigue Foggy feeling
ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 6/25/2022 CKD STAGE 4 (GFR 15-29)
The arm that had the injection was sore.  Limited range of motion and sensitive to the touch.  Lasted 36 hours  Developed, headache, tiredness in the eyes (stinging), and a fever of 99.8F on 27Feb2021; took Tylenol/Ibuprofen.  No symptoms on 28Feb2021.
Tinnitus; Red circle on arm and shoulder; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of TINNITUS (Tinnitus) and VACCINATION SITE ERYTHEMA (Red circle on arm and shoulder) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus) and VACCINATION SITE ERYTHEMA (Red circle on arm and shoulder). At the time of the report, TINNITUS (Tinnitus) and VACCINATION SITE ERYTHEMA (Red circle on arm and shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Vomiting for over 24 hours followed by a rash and hives on trunk and arms. Itching all over body. Attempted to control with Benadryl but after 24 hours of hives dr called in steroids
No adverse symptoms were reported; the patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a study coordinator concerning a 12 month old patient of unknown gender. Information on pertinent medical history and drug reactions/allergies was not reported.   On 17-JUL-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose, dose number, route of administration and location of administration were not reported) (lot # S0077963, expiration date 02-AUG-2021), administered for prophylaxis. The vaccine was reconstituted on a properly stored sterile diluent.   The vaccine was exposed to a temperature of -14 degrees Celsius (C) to -10 C (-12.8 C) for a time frame of 46 minutes as recorded by a digital data logger. There were no previous temperature excursions. No adverse symptoms were reported.   This is one of multiple reports from the same reporter.  Lot number S0077963 is an invalid lot number for varicella virus vaccine live (oka/merck).; Sender's Comments:  US-009507513-2008USA000587: US-009507513-2008USA000665:
Headache; Chills; Neck Ache; Soreness; Swelling; Low White Blood Cells; This case was reported by a consumer via call center representative and described the occurrence of white blood cell decreased in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included ibuprofen (Advil).   On 7th June 2020, the patient received Shingrix. On 7th June 2020, less than a day after receiving Shingrix, the patient experienced pain and swelling. On 8th June 2020, the patient experienced headache, chills and neck pain. In June 2020, the patient experienced white blood cell decreased. On an unknown date, the outcome of the white blood cell decreased was unknown and the outcome of the headache was not recovered/not resolved and the outcome of the pain, swelling, chills and neck pain were recovered/resolved.   It was unknown if the reporter considered the white blood cell decreased, headache, pain, swelling, chills and neck pain to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the white blood cell count was lower and desired to know if Shingrix could cause this.   The reporter stated that into the night and next day he had headache, soreness, swelling, and chills and had mild headache every but other symptoms were gone.   The reporter also received phone number to Medical information to provide to his doctor. The reporter consented to follow up.
Pt passed out while in hall after receiving vaccines.  Hit back of head- small 1/4 " laceration.  Given juice to drink & allowed to recover with feet up.  Sent to ER for stitch eval.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2022 as dose number unknown, single (Lot number: FK9894), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Occasional extrasystoles" (unspecified if ongoing), notes: Occasional extrasystoles. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Mar2023) Positive, notes: Day zero was the day I developed symptoms and had a positive antigen and PCR test; (11Mar2023) Negative, notes: My rapid antigen test was negative on day six; (12Mar2023) Negative, notes: My rapid antigen test was negative on day seven; (13Mar2023) Positive, notes: turned positive on day eight. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The rapid antigen test was negative on day six and seven but turned positive on day eight. Day zero was the day he developed symptoms and had a positive antigen and PCR test. His symptoms lasted about 24 hours and were mild. This was what is conventionally called a Paxlovid rebound. Known allergies: O.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness cannot be ruled out.
Pt. states that after receiving the 2nd dose of Phizer 03/18/2021, started experiencing symptoms of Blood Clot (verified) Urgent Care, shortness of breath (Albuterol), High counts of White Blood Cell Count, Ecoli, and severe kidney disease. Still continuing with planned Primary visits.
Pt had possible shingles outbreak on face within 1 week of vaccine - then developed primary genital herpes outbreak approximately 3 months later.
Red swelling at injection site, progressing by morning to painful red swelling, nausea, fever. Urgent care visit 28 hours after vaccination, given Keflex 500 mg (4 times a day) for 10 days.  Severe Cellulitis.
Pt exhibited an episode of syncope/lightheadedness directly after the vaccination. Counseled patient about the risks of standing after a vaccination. Immediately gave Benadryl to the patient upon initial assessment.
My left shoulder and arm feel 20lbs heavier than before. I can only lift my left arm so high before it hurts. I can not hold anything heavy in my left arm. If I lift anything, like a casserole dish, putting it in or taking it out is difficult because my left are is weak and hurts. It also hurts if I lay on my left side. When I reach out with my left arm to open my sliding glass door it hurts and I have to change arms. Sometimes my neck and spine hurt too, more than usual.
she developed a large red circle on the right inner leg. It was sore to the touch.; she developed a large red circle on the right inner leg. It was sore to the touch.; hives on both wrist; turned into black and blue look and she did not recall banging at all; This is a spontaneous report from a contactable consumer. This consumer (husband) reported for a 75-year-old female patient (wife) received second dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264), via an unspecified route of administration on 05Feb2021 between 11:15 and 11:20 and first dose on 14Jan2021 (Lot number: EL8982) both as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient developed just one hive on her right inner wrist area couple hours after the first vaccine which stayed for 3 to 4 hours and then dissipated. On 05Feb2021, several hours after the second dose vaccination, the patient developed hives on both wrist area more than one. The patient applied cream on it and it dissipated right after. On 06Feb2021, the patient developed a large red circle on the right inner leg. It was sore to the touch and it lessened over a three day period. It turned into a black and blue look. Treatment received for event hives was cream. The outcome of the events was recovering.