chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The adverse reaction occurred on March 13th, approximately 4 days after the 2nd dose on March 9th at 12:30 pm.  Reaction is a flushing and swelling of the facial cheeks that continues through the present, which is March 17th at 10:30 am. It has been 13 months since a minute amount of filler was applied to face (half a syringe). Redness is not in the exact location as filler was applied. Nurse who applied filler doesn't think the filler could be the cause of the reaction. Thinks it must be an allergic reaction. Patient also had brief chills 30 hours after receiving 2nd dose. No adverse reaction to 1st dose.
Developed a fever (up to 104 degrees); chills and headaches starting about 12 hours post vaccination; chills and headaches starting about 12 hours post vaccination; This is a spontaneous report from a contactable consumer (patient). A 50-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EP6955, patient was 50-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 25Mar2021 at 01:45 PM as DOSE 2, SINGLE for covid-19 immunisation. Medical history included addison's disease. Concomitant medication(s) included prednisone (PREDNISONE); fludrocortisone (FLUDROCORTISONE) both taken for addison's disease received within 2 weeks of vaccination, start and stop date were not reported. The patient previously took Bacrtum and sulfa antibiotics and experienced allergy. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL3247), via an unspecified route of administration, administered in Arm Left on 04Mar2021 at 09:15 AM as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 26Mar2021 at 01:30 AM, the patient experienced developed a fever (up to 104 degrees), chills and headaches starting about 12 hours post vaccination. The patient underwent lab tests and procedures which included body temperature: 104 on 26Mar2021 Developed a fever (up to 104 degrees). Patient received treatment for events with acetaminophen and increased dosage of prednisone in accordance with pre-specified fever response guidelines from endocrinologist who is managing Addison's disease. No seriousness criteria were reported but it was reported that symptoms resolved within 24 hours after initiation and no treatment received for the adverse event. The outcomes of events were recovered on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Patient was administered the incorrect dose of Pfizer. He received the pediatric formulation (5-11) instead of the 12 and older formulation.
Spontaneous pin prick bleeding on exterior of nose, large spontaneous bruises on cheeks, bleeding inside nose, bleeding from anus, blood spot on white of eye. The bleeding lasted approximately 3 months.
This is a deployed soldier who received the small pox vaccine on 13 Aug 2007.  On 21 August 2007 he developed chest pains consistent with pericarditis.  Only objective finding was a measureable troponin I of .24 at LRMC on 27 August 2007.  ECG showed nonspecific ST changes and the echo was normal.  Chest pain is responding well to indocin. Patient is AD Air Force.  The vaccine was administered down range.
1.5 - 2 hours after receiving Flucelvax, the patient began experiencing severe back spasms and her throat began to close up on her as her vocal cords began swelling.
Cellulitis on upper left arm. Treatment clindamycin 150mg 3 caps three times daily.
Patient is complaining about pain in the administered arm since the day after it was given. The pain is there when he moves his arm but not when there is no movement, and it feels like it is in the bone. The pain started 1/14/2013 to date 03/06/2013. Patient does not have a primary care physician and has not been evaluated professionaly.
This spontaneous report as received from a pharmacist refers to a 62 year old female patient with breast cancer. There was no information about the patent's concomitant medications and drug reactions or allergies reported. On 08-JUN-2016, the patient was vaccinated with PNEUMOVAX 23 injection (lot# L019835, 23-MAR-2017; dose and anatomical location were not reported) intramuscularly for prevention of pneumococcal disease. On the same day, the patient experienced a sore arm, swelling and redness which began in the evening, that she received the vaccine. The reporter also stated that the patient applied warm compresses to the arm. The outcome of the events was not recovered. The patient sought medical attention and called the reporting pharmacist. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Patient experienced fever, chills, and diarrhea after receiving the first SHINGRIX vaccine in her series. It lasted for a day or two.
I am a nurse, I would like to report a strange side effect that occurred after my second Moderna injection. I became severely depressed for several hours, a depression I have never experienced before. I had intrusive thoughts about comitting suicide. It went away after several hours on its own.  I forced myself to stay in my bed and not act on anything. It was really hard. I haven't said anything because as a healthcare professional, I didn't want to discourage others from getting vaccinated.
Patient received vaccine in office at approximately 10:45am. At approximately 11:45am, patient began experience swelling in eyes, face. Grandmother took him to an Urgent Care facility where he began having wheezing and difficulty breathing. Urgent Care staff immediately administered Decadron 10mg IM. Wheezing and difficulty breathing improved quickly. Urgent Care prescribed Prednisone 10mg Oral Tablets: Take 3 tablets for 3 days, 2 tablets for 3 days, 1 tablet for 4 day. Patient was also referred to Allergist for evaluation, scheduled 9/24/20.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were unknown. On 30-SEP-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (dose and route unknown, lot # M009764, expiration date: 23-FEB-2018). The vaccines were stored at 28 Fahrenheit degree for 18 hours. There was no previous temperature excursion. The call was not due to a "data logger". No adverse effect was reported. Additional information has been requested.
Case previously recorded as MA2009-3726. Initial case report received from a consumer, via Novartis Medical Communications, on 04 NOV 2009. A female patient was vaccinated with S-OIV FLUVIRIN (batch no. unknown) on an unknown date, while 6 months pregnant. No adverse event was reported. Agency reference no.: NA09-007580.
Hospitalization for chest pain, accelerated hypertension, elevated troponin level, hypomagnesemia, and COVID-19 on dates 8/9/2023-8/12/2023.  Treated with dexamethasone, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
red hives from wrist to above elbows on both arms less than 5 minutes after injection.; broke out in red hives from wrist to above elbows on both arms less than 5 minutes after injection.; week later the injection site was red; a week later the injection site was red and inflamed in about a half inch circle took over a week to heal.; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 11Mar2021(at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, TBI(traumatic brain injury) and heart blockage. The patient received other medications(unspecified) within two weeks of vaccination. The patient previously took amoxicillin, clavulanic acid (AUGMENTIN), metformin hydrochloride (GLUCOPHAGE), metformin(MANUFACTURER UNKNOWN) on unknown dates and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021 less than 5 minutes after injection, the patient experienced red hives from wrist to above elbows on both arms. On an unknown date in Mar2021 a week later,  the patient's injection site was red and inflamed in about a half inch circle and took over a week to heal and left a scar. Therapeutic measures were taken as a result of reported events which included treatment with Benadryl administered multiple doses by a pharmacist. The clinical outcome of the event red hives, the injection site red (vaccination site erythema) and inflamed in about a half inch circle (vaccination site inflammation) was recovered with sequelae on an unknown date in 2021 at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Lymphangitis of left underarm, swollen out to size of softball; administration date=16Jan2021/ 31Dec2020; This is a spontaneous report from a contactable other HCP(patient).  A 37-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK4176), via an unspecified route of administration at left arm on 16Jan2021 16:45 at single dose for COVID-19 immunization.  Medical history included gastrooesophageal reflux disease(GERD), insomnia. There was no Known allergies.  Concomitant medication included zolpidem tartrate (AMBIEN), pantoprazole sodium sesquihydrate (PROTONIX). There was no other vaccine in four weeks. Patient previously first dose BNT162B2(lot number=EK5730) on 31Dec2020, 19:00 at Left arm at single dose for COVID-19 immunization.   The patient experienced Lymphangitis of left underarm, swollen out to size of softball on 18Jan2021 10:00, occupational health advised to get seen,went to Emergency room, urgent care recommended paracetamol (TYLENOL)for swelling and no anti-inflammatories that may hinder the immune process. Treatment paracetamol was received. Outcome of the event was recovering. There was no covid tested post vaccination.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "Lymphangitis of left underarm, swollen out to size of softball" and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations.   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 RA, IEC, as appropriate.
Pt vaccinated with DTP/HIB/OPV developed screaming spells that lasted for a few hrs at a time. Slept briefly between these episodes, would not drink overnight. Temp 101.9, less irritable by following morning. Received acetominophen.
I had two incidents of blood in my urine the night of receiving my fifth COVID-19 vaccine . I have had two more since that date as well.
Exactly six hours post dose (8pm), joint aches, fatigue,  slight chills and lite headache began. Took 2 Tylenol went to bed. Approx 1 hour later(9pm), severe, body shaking chills and low back pain began and lasted many hours. Tylenol, additional clothes, blanket and heating pad for low back added. All symptoms continued with headache now with pounding and pressure that required 50mg of Sumatripan. Fever began at this time, mid grade. Additional Tylenol and sweating began fever reduced to low grade. Slept. Woke once again  to the same pressure and pounding headache, severe chills. Took temperature and it was an astounding 107.7.  I had experienced a high 106 as a teen, so the "feeling" was familiar. To be sure and calibrate, we took my temp x3, changed batteries, checked my girlfriend's and then rechecked mine. 107.7. At this time, took a cool shower, applied a cool compress and weighted down with blankets. Temperature broke within an hour and maintained til Monday morning when it returned at 103.6. Tylenol , fluid and rest. Today (Tuesday). I feel " off" but have no fever or other symptoms with exception of site soreness.
Initial report was received 17 April 2008 from a consumer, who is the patient's parent. a four-month-old male patient with no pre-existing medical conditions, had received a second dose injection of DTaP, and a second dose injection of Hib vaccine, and a second dose of Polio vaccine (manufacturers, lot numbers, route/sites of administration not provided) on 31 August 1992 and within hours of vaccination, he developed a fever of 108 degrees Farenheit (rectally) and became lethargic. The patient was taken to the emergency room where he experienced two to three episodes of convulsions back to back. Motrin and Tylenol were administered but were not effective in reducing the fever. The patient was placed in a tub of cool water and the fever gradually lowered to 100-101 degrees Fahrenheit. The patient was sent home and had not been admitted to the hospital. The fever resolved and the patient fully recovered from the event. It was noted by the reporter that this patient experienced a fever of 100-101 degrees Fahrenheit after receipt of their first dose of DTaP, Hib and Polio vaccinations at two months of age. No further information was provided at the time of the report. Documents held by sender: Certificate of Immunizations. This patient experienced two other events which have been captured in cases 2008-01108 and 2008-01110.
Client was given Pfizer 0.2ml Dose for 5 to 11 year olds
I received the second dose of the vaccine on the last day of my period. However, two weeks after I began bleeding again and had pelvic pain. Didn't think much of it until my September cycle was much heavier than usual. I also bled during my ovulation week in September (which is very unusual for me to bleed during ovulation). In October, my cycle was longer (I bled for 8 days, usual is 5) and the flow was still heavier than normal. In November, my cycle also lasted 8 days.  I scheduled an appointment to see my Ob/GYN but she is booked until January.
This is a spontaneous report from a contactable consumer reporting for herself. This 69-year-old female patient received on 04Dec2015 PREVNAR 13 at single dose and influenza vaccine (manufacturer unknown). Medical history included blood pressure (under control). The patient received an influenza vaccine in Sep2015. Concomitant medications were none. On an unspecified date, the patient experienced dehydration, loss of energy, appetite lost and diarrhea. Reactions were described as follows: The patient reported that she really had a hard time on vaccination. She had to go to ER because she had dehydration and they gave her some fluids there. Blood work was performed on an unspecified date at the hospital and on 01Mar2016, results were not available. Blood work was performed since she had dehydration due to a whole week of diarrhea. She had no energy and no appetite. She thinks too many toxins were there in her body at one time. The patient was not experiencing any side effects right now and on 01Mar2016 was the first day when she felt normal.
This spontaneous report as received from a certified medical assistant to a 12 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL (lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported). No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
Patient received only the liquid conjugate portion of the vaccine Menveo.  She was receiving this dose for entry to college. The vaccine was not reconstituted with the Lyophilized component vial 2.  We are working to contact patient. The provider administering the vaccine accidentally pulled only the liquid portion from the box.
Pain in left arm came 14 days after receiving 2nd vaccination. Deltoid on left arm  is very sore. There?s a red spot and warmth where the shot was injected, but not visible swelling. Arm feels very weak, it shakes when I lift my arm.  I feel a throbbing pain while my arm is at rest.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 at 16:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Negative, notes: test negative for COVID-19 on day 4 of the treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 04Jan2023 to 09Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Day after  booster  felt not right.  Heart palpitations, shortness  of breath.  General feeling of malaise. Called DR 6 days after shot. She had me come in for EKG. Results showed I have incomplete right branch blockage in my heart cause can be myocarditious,  and some extra beats . Last 2 EKGs from previous years were fine.  Dr said she didn?t ?think? the vaccine caused this but I do.
My vaccine arm cleared up perfectly in two days, but exactly one month to the day I received it my arm started hurting when touched and it black and blue where I received the shot.   Very curious
This spontaneous report was received from a healthcare worker referring to a 10 week old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 23-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
24 hours -->72 hours : 5 x 7 cm erythematous raised area with small papules (no vesicles). Recovered with Rx. Sl. increased color. Afebrile.
Hx of DVT not on blood thinners. 3 days after 2nd moderna vaccine developed symptoms of pulmonary embolism, but not diagnosed until a month later.
No additional AE details were provided.; a patient received a dose of ROTATEQ on 26SEP2022 that expired on 19SEP2022.; This spontaneous report was received from a nurse and refers to an unknown patient of unspecified age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 26-SEP-2022, the patient received a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (2ml, lot # 1742462, expiration date: 19-SEP-2022) orally for prophylaxis (expired product administered). The product had no temperature excursions and the patient had no reported symptoms. No additional adverse event details were provided.
she had the same reaction to the first one also/weak/no strength; she had the same reaction to the first one also/couldn't stand; she had the same reaction to the first one also/heartburn; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (she had the same reaction to the first one also/weak/no strength ), DYSSTASIA (she had the same reaction to the first one also/couldn't stand) and DYSPEPSIA (she had the same reaction to the first one also/heartburn ) in a 5-decade-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (she had the same reaction to the first one also/weak/no strength ), DYSSTASIA (she had the same reaction to the first one also/couldn't stand) and DYSPEPSIA (she had the same reaction to the first one also/heartburn ). At the time of the report, ASTHENIA (she had the same reaction to the first one also/weak/no strength ), DYSSTASIA (she had the same reaction to the first one also/couldn't stand) and DYSPEPSIA (she had the same reaction to the first one also/heartburn ) outcome was unknown. Not Provided      The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       The patient was in her 40s. No relevant concomitant medications were reported. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-746992 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746992:Different patient, same reporter
Info has been received from a registered nurse concerning a 48 year old male pt with no allergies and no medical history, who on 03/25/2002 was vaccinated intramuscularly in the left deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #640981/1050L). There were no concomitant vaccinations and there was no illness at the time of vaccination. On 03/27/2002, the pt developed a 3cm in diameter raised, red and swollen area of the left arm. Unspecified medical attention was sought and the pt was treated with cetirizine hydrochloride (ZYRTEC) 10 mg daily, orally. Subsequently, the pt recovered. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. It was also reported that another pt experienced an adverse event following vaccination with pneumococcal vaccine 23 polyvalent (lot #640981/1050L) (WAES #0210USA02350) and a 3rd pt experienced an adverse event following vaccination with pneumococcal vaccine 23 polyvalent (lot #637345/1449K) (WAES #0210USA02517). Additional info is not expected.
Pt presented to urgent care for cellulitis left leg after vaccines on Friday at health department was given MMR/varicella together and DTaP and IPV 2 in each leg. Mother is not aware which leg got which vaccines he has had all 4 of these vaccines in the past without reaction. We did not give the vaccines so do not have lot numbers you will need to follow up with his primary's office that gave them.