chrisvoncsefalvay/vaers-outcomes huggingface dataset:
energy level down; incurred mild concussion and minor stroke; had spells where pass out while jogging; incurred mild concussion and minor stroke; This is a report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 77 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown) at citrate free, unk, subcutaneous for crohn's disease. The patient's relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose number: 1, Route: Intramuscular), administration date: 21Jan2021, when the patient was 76-year-old, for Covid-19 immunization; BNT162b2 (Dose number: 2, Route: Intramuscular), administration date: 11Feb2021, when the patient was 76-year-old, for Covid-19 immunization.  The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 08May2022, outcome "unknown", described as "had spells where pass out while jogging"; CONCUSSION (medically significant) with onset 08May2022, outcome "unknown", CEREBROVASCULAR ACCIDENT (medically significant) with onset Jul2022, outcome "unknown" and all described as "incurred mild concussion and minor stroke"; ASTHENIA (non-serious), outcome "recovering", described as "energy level down". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (Jul2022) Unknown results; SARS-CoV-2 test: (01Apr2022) Unknown results. The action taken for adalimumab was dosage not changed.  The reporter's assessment of the causal relationship of "had spells where pass out while jogging", "incurred mild concussion and minor stroke" and "energy level down" with the suspect product(s) BNT162b2 was "Possible"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported events and 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.,Linked Report(s) : US-PFIZER INC-PV202200055142 same patient/vaccine different dose and AE;
BEGINNING OF SEPTEMBER HAD EPISODES OF VOMITING ON AND OFF. DEVELOPED A BLISTER ON HER TONGUE AT THE END OF SEPTEMBER THAT MESSED UP HER TASTE BUDS. RIGHT EYE STARTED DRAINING ABOUT 2 WEEKS AGO AND THEN RIGHT SIDE OF FACE SEEMED HARD TO MOVE SO WENT TO URGENT CARE WHERE SHE WAS DXED WITH BELL'S PALSY.
Swelling, pain, bursitis was out on steroids and now have to see a ortho surgeon
After getting the second dose, I broke out in hives and my lymph nodes was swollen on my neck. My hives broke out around my injection site. I was also told that my kidney function had went down. With the first dose I had a fever of 103 for three days, I also had body aches and had COVID-19 like symptoms.
I?m not sure if this is from the vaccine but I have had bad panic and anxiety attacks with elevated heart rate I?ve even visited the ER they did a few tests said I was ok but I?m reporting this because I haven?t had this bad of panic and anxiety in years and want to make sure it?s not affecting me that way
Noticed two nodules swelling around Nov 15th on Right thigh. Slowly came to surface. No complaint of fever, pain, redness. No notice of decreased movement on extremities or any pus.
pt exp diplopia & frontal h/a 1 day p/receiving flu vax followed by diminished visual acuity in lt eye & lt ptosis; poss GBS;
COVID Vaccine Clinic.  Upon staff member receiving vaccination, collapsed after getting up from chair. Rapid Response was called. Staff member was positioned supine with legs elevated. Blood pressure 147/88 HR 92.Po2 at 100% on room air. Complained of feeling faint and dizzy. Assessed by Rapid Response RM and MD. Escorted via cart to mid hallway for further evaluation. SM symptoms continued to be concerning, transported to ED with MD escort.   Staff member was evaluated in ED.  fluids given, Zofran for nausea and Benadryl.  CTOH was completed and resulted as no abnormalities.  Staff member was discharged to home in stable condition.
vaccine itself hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 8th September 2022, the patient received Shingles vaccine. In September 2022, less than a week after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-SEP-2022 Reporter's Comment:  This case was reported via interactive digital media. The patient received shingles shot and  he/she said the vaccine itself hurt could not imagine actually getting shingles. Additional supportive information: The follow-up could not be possible as no contact details were available.
I'm 60 years old and have never had a nosebleed in my life. I had a severe nosebleed two weeks after first vaccine and two weeks after second vaccine. I was able to stop the bleed myself at home with pressure and ice.
injection site mass; red, round 2x2 inch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red, round 2x2 inch) and INJECTION SITE MASS (injection site mass) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 012A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN and LOSARTAN for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 22-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE ERYTHEMA (red, round 2x2 inch). On 24-Feb-2021, the patient experienced INJECTION SITE MASS (injection site mass). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE ERYTHEMA (red, round 2x2 inch) and INJECTION SITE MASS (injection site mass) outcome was unknown. Not Provided          This case was linked to US-MODERNATX, INC.-MOD-2021-051545 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-051545:Companion case
No additional AE details available; Nurse reports product that experienced temperature excursion over the weekend was administered to a patient. Product was administered 2/13/2023.       ?    Names of vaccines involved (including lot/exp) VAQTA W036135 5/13/2024        ?    Tempera; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.    On 13-FEB-2023, the patient was vaccinated with an improperly storage dose of Hepatitis A Vaccine, Inactivated (VAQTA) Intramuscular Injection as prophylaxis (lot number: W036135, which was determined to be valid, with an expiration date on 13-MAY-2024) (product storage error).   On approximately 10-FEB-2023 (reported as over the weekend), the administered dose underwent a temperature excursion of 13.25 degrees Celsius (C) for 2 hours and 32 minutes. There was not any previous temperature excursion and no adverse event was reported.
Diffuse papular rash, which began hours after administration of aforementioned vaccinations. No fever.
No additional AE; MMR II was administered to a patient that was improperly stored.; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On 05-AUG-2020, the patient received one improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) as prophylaxis (formulation, strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported, lot number S015427 which has been verified to be valid, expiration date reported; and validated as 20-MAY-2021). The vaccine was exposed to a temperature and excursion of -4.1 degrees Celsius (C) during 45 minutes (product storage error), as recorded by the data logger. There was no previous temperature excursion. No additional adverse event was reported.
The pt developed swelling left arm pit, left breast, left neck, body aches, headache, fever, rash on legs on 05/23 and all over by 05/29, red/pink rash with individual "bumps" larger then pinpoint.
Pt came in and talked with RPh after receiving flu shot. Large bump appeared over flu shot area. Went to ER where diagnosis was allergic reaction.
Vaccine placed in a hazard ziplock bag (temperature excursion or expired); Expired Vaccine Used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine placed in a hazard ziplock bag (temperature excursion or expired)) and EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine placed in a hazard ziplock bag (temperature excursion or expired)) and EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used). At the time of the report, PRODUCT STORAGE ERROR (Vaccine placed in a hazard ziplock bag (temperature excursion or expired)) and EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) had resolved.        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 and concomitant medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Follow up received and it contains NNI
Uterine bleeding started approximately 12 days after receiving 1st dose of Moderna Covid 19 vaccine.  I had an ablation almost 1 yr earlier on May 21, 2020 and had not had any menstrual cycle or bleeding since the ablation.
Chills; Achy; Severe diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 18Mar2021 at 08:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient was allergic to codeine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 25Feb2021 at 11:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 07:00, the patient experienced chills, achy and severe diarrhea. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the chills, achy and severe diarrhea were not resolved at the time of this report.  No follow up attempts are possible; information about lot number cannot be obtained.
Sore arm; Vaccination site pain; little headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PAIN (Vaccination site pain) and HEADACHE (little headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PAIN (Vaccination site pain) and HEADACHE (little headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PAIN (Vaccination site pain) and HEADACHE (little headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment medicines include Tylenol for Pain relief.
Red welt appeared on his arm; Itching at the site of injection; A spontaneous report  was received from a 76-year-old male patient, who received Moderna's COVID-19 vaccine and experienced itching at the site of injection/vaccination site pruritus and red welt appeared on his arm/vaccination site urticaria.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unspecified date, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (batch number 013M20A) via intramuscular route for COVID-19 infection prophylaxis.  On an unspecified date, the patient thought the nurse did a poor job administering the vaccine. The patient experienced itching at the site of injection and red welt appeared on his arm. It was not painful . No treatment medication was reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, itching at the site of injection was resolved on an unspecified date and outcome of red welt on his arm was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Tingling/numbness in left hand and fingers lasting multiple days, 6x hive-like bumps plus redness around injection site, large visible bruising following injection, abnormal amount of bleeding at injection site immediately following injection
High pitch non-stop crying/scream that lasted from 11 PM - 6 AM. We called the nurse. She did not do anything or even check him. Around 4 AM, we called the nurse again, and she took him to the nursery, and she returned him an hour later, and he was still screaming.
The customer came in for a SHINGRIX vaccine 8/17/18 and came back 8/18/18 stating his arm opposite the injection site became red and swollen. The time course was 24 hours. His arm appeared red mostly opposite the injection site on the same arm.
pt presented back to office on 10-16-20 with quite large local reaction with redness, warmth, and local itching, but no tenderness, no fever, no systemic s/s of allergic reaction, I placed pt on hydroxyzine as needed for itching and a 3 day course of oral steroid for swelling, advised family to apply cool compress as tolerated and monitor for worsening s/s, advised family that this looks to be a local reaction and not an allergic reaction to the vaccine, antibiotic is not indicated at this time, family to call if worsening or concerns
"It was extremely painful so I went to the emergency room 06Apr2021 and was diagnosed with shingles."; "Having lots of pain."; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN ("Having lots of pain.") and HERPES ZOSTER ("It was extremely painful so I went to the emergency room 06Apr2021 and was diagnosed with shingles.") in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced PAIN ("Having lots of pain."). On 06-Apr-2021, the patient experienced HERPES ZOSTER ("It was extremely painful so I went to the emergency room 06Apr2021 and was diagnosed with shingles."). The patient was treated with PREDNISONE at a dose of 50 mg; ACYCLOVIR [ACICLOVIR] at a dose of 800 mg and HYDROCODONE at a dose of hydrocodone pain pills to help relieve side effects. At the time of the report, PAIN ("Having lots of pain.") and HERPES ZOSTER ("It was extremely painful so I went to the emergency room 06Apr2021 and was diagnosed with shingles.") outcome was unknown. Not Provided          No Relevant concomitant medications was reported
Appx. 10 days after dose 1 of 2 of Pfizer COVID-19 Vaccine, patient began to feel fevers and chills, dehydration, and acute acid reflux. Pt went to urgent care facility for evaluation. Was tested for COVID-19 and Influenza and both were negative. Pt was given 2 liters normal saline. Next day, Pt went to ER with same complaint. Numerous laboratory tests were ordered, with numerous values being atypical, and a POSITIVE Epstein-Barr Virus (EBV) test. Pt had tested POSITIVE for EBV in 1989, but had had no recurrences since then, symptoms lasted 6 days.
Constant headaches and head pressure. Random headaches when waking up.  Pressure all around the head and front of the face. Since I got the vaccine I had woken up with headaches 3 - 4 times. I feel pressure almost everyday.
Patient presented to our ED with complaint of bad shakes started on evening of 10/3/23.  These shakes where whole body shakes that started ~2000 and lasted 30 minutes and were resolved on arrival to ED.
1/21/16 seen in ER for DVT (deep venous thrombosis) in left leg. Deep venous thrombosis of the left lower extremity from common femoral through femoral vein, including saphenous vein, poss. related to contraceptive use. COUMADIN prescribed.
fatigue; This is a spontaneous report from a contactable other hcp (patient). A 74-year-old female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: ER8727), via intramuscular route of administration in arm left on 01Apr2021 at 13:00 (at the age of 74-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included ongoing migraine. The concomitant medications of the patient were not reported. The patient previously took flu vaccine and had a Guillain Barre reaction to Flu vaccine in 1965 when she was 18 years of age and she also took first dose of BNT162B2(solution for injection, Batch/Lot number: EN6206), via intramuscular route of administration in arm right on 011Mar2021 at 12:45 (at the age of 74-years-old) as single dose for COVID-19 immunisation and experienced sore arm and Fatigue. She had never taken a flu vaccine since. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The family medical history relevant to AE(s) was reported as severe reactions to vaccines and nephew's child- Respiratory arrest with 1st childhood vaccine. On 02Apr2021, the patient experienced fatigue. The patient stated, she had concerns about taking the Covid 19 vaccine because of the reaction she had to the flu vaccine. She had read that the Influenza virus and the Covid 19 virus are both in the family of Corona Viruses. She was concerned that there was something in the Covid 19 vaccine or during the production that would cause a worse reaction than what she had to the flu vaccine. She sated no confirmed testing for anyone in her family but because of their history of alcoholism and reactions to vaccines, was this enzyme studied during the clinical trial. The reporter reported the events as not serious. The patient recovered from the event on 10Apr2021.  Follow-up(30Jul2021): This is a follow up  spontaneous report from a contactable other HCP. This 74-year-old female consumer (patient) reported for herself that included: Patient age at vaccination, patient medical history, Family medical history relevant to AE(s), date and time of vaccination, Lot numbers, route of administration, Anatomical site of injection of both first and second doses, adverse events, onset date and outcome of the events.  Follow-up attempts are completed. No further information is expected.
Tight chest, shortness of breath, high BP x3, sweating. Symptons began within 15 minutes of administration  Went to ER for further evaluation
Chart review showed he received 2 Moderna COVID-19 mRNA vaccines on 7/20/21 and 8/17/21. Wife called PCP on 8/19/21 to report that he had developed loss of appetite and fatigue and appeared ill. PCP recommended ED eval, but pt did not go until 9/29.  At that time he was found to have profound thrombocytopenia with platelets of 18000 and wbc 2700.  Previous CBC on 7/21/21 showed wbc 6200 and platelets 150,000.  INR initially 1.7 (9/29) then increased to 2.8 (10/3).  PT 18 -- >27, PTT 45-- >62, Fibrinogen 110 then decreased to <80 mg/dl. Blood and urine cultures did not show any growth.  CT C/A/P showed airspace opacities LLL/RUL/RLL and moderate right pleural effusion, hepatic cirrhosis, large ascites, NORMAL spleen. He was started on broad spectrum abx.  ALso started on high dose dexamethasone per hem/onc for possible ITP.  He received multiple platelet transfusions. He had chronic hep C, mRNA load 1209 mIU/mL. He developed hypotension refractory to IVF and had to be transferred to the ICU on 10/3/21 and subsequently passed on 10/4/21.
Patient passed out about 5-10min after the vaccine, then found consciousness. Pt was shaking, sweating, and looked pale.
This case was reported by a consumer and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On 26th September 2018, the patient received the 1st dose of SHINGRIX. On 27th September 2018, 1 days after receiving SHINGRIX, the patient experienced fever, joint pain, headache and feels awful. On an unknown date, the outcome of the fever, joint pain, headache and feels awful were unknown. It was unknown if the reporter considered the fever, joint pain, headache and feels awful to be related to SHINGRIX. Additional details were provided as follows: The patient received the 1st injection on the evening of 26th September 2018 and then the patient felt horrible on 27th September 2018. The patient wished his physician would have informed him of the side effects, and most likely would have declined. The patient had a fever, joint pain, headache and it was not fun, and was thinking of not following through with second injection. The patient went to VAERS site to share information, but the website was cumbersome.