chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was swimming which I do every day and then when I got out of the pool was when I became dizzy and it bothered me walking; I was swimming which I do every day and then when I got out of the pool was when I became dizzy and it bothered me walking; This is a spontaneous report from a contactable consumer (patient). An 87-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), via an unspecified route of administration on 11Jan2021 at 11:45 at a single dose for COVID-19 immunization. The patient's medical history included high blood pressure. Concomitant medications included metoprolol for high blood pressure and rosuvastatin calcium (CRESTOR). On 13Jan2021, the patient stated, "I was swimming which I do every day and then when I got out of the pool was when I became dizzy and it bothered me walking". The patient wanted to know if the vaccine could have been the cause. The patient did not receive any treatment for the reported events. The patient recovered from the events on 13Jan2021.
pt devel a red edematous area which was painful to the touch & generalized achiness coincident w/a flu inject;
Patient had received Moderna for his first two doses ( 1/7/21 and 2/4/21) , then presented for a booster dose and received Pfizer
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: PT WAS CRYING AND UPSET PRIOR TO VACCINE AND RESISTING
after about 45 minutes, both wrists starting to rash and itch.  It spread to my chest, neck, back and stomach.  The itch was kind of a stinging itch and my palms were hot.   I called the facility and they asked me to come by so they could look at it.   They said it was a reaction but not severe enough for an epi pen.  They told me to go to my Dr, which had left for the day so I went to MedExpress.   My bp on arrival was 150/98.  They gave me a shot of Decadron.    My bp went down to 120/80 before leaving and my itch had eased a little.  They prescribed 5 days of Prednisone and Zyrtec.  The next morning, I had a severe headache and could not concentrate, I felt a little itchy and tired.   Today, no rash or itch just nervousness on the inside from the prednisone and my hands are still hot sometimes.
Rash similar to hives started on April 23 and have continued to date. The rash is itchy and hasnt responded to allergy medications.; The rash is itchy and hasnt responded to allergy medications.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm left on 21Apr2021 at 12:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. The patient had no known allergies. Prior to the 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 concomitant medications included ursodeoxycholic acid (URSODIOL) for an unknown indication from an unknown date and unknown if ongoing. The patient previously patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the arm left on 29Mar2021 at 14:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 18Mar2021, the patient underwent SARS-CoV-2 test (nasal swab) and the result was negative. On 23Apr2021 at 08:00, the patient experienced rash which was similar to hives and had continued to date. The rash was itchy and was not responded to allergy medications. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported events which included treatment with allergy medications. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events rash similar to hives and rash was itchy were not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Developed a red, warm area on the inside posterior surface of his right arm that is somewhat tender to pressure.  5 x 5 cm in diameter.
After the second dose of the vaccine I started to have sweats and dizziness. My blood pressure was also high which was very unusual for me. I was shivering and having tremors. I had bloodwork done. My Thyroid and Vitamin D numbers were not right. I was referred to an Endocrinologist and I have been diagnosed with an Autoimmune disease. I had to have a vascular procedure on my left leg.  I have not worked since 06/03/2021. I am still having problems with my leg and some swelling near my ankle and it is like it is not healing.
Participant was in the observation area when she complained of  tingling, numbness in throat and tongue. BS clear bilaterally. Was transported via EMS
I developed shingles (herpes zoster) 2 weeks after my second dose of the Covid vaccine. Diagnosed by a physician. I am taking antiviral medication for it.
Engerix-B dose expired on 7/3/2023 and was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received HBV (Engerix B adult) (batch number S73DG, expiry date 03-JUL-2023) for prophylaxis.   On 05-JUL-2023, the patient received the 2nd dose of Engerix B adult. On 05-JUL-2023, an unknown time after receiving Engerix B adult, the patient experienced expired vaccine used (Verbatim: Engerix-B dose expired on 7/3/2023 and was administered to a patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 5-Jul-2023 and 6-Jul-2023 The registered nurse only provided gender of the patient. Lot number S73DG did not identify as a valid lot number but was repeated back to the reporter and F73DG did identify as a valid Engerix-B dose, but was not provided by the reporter. No additional adverse event or product quality complaint. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal. The patient received an expired dose of Engerix-B adult, which led to expired vaccine used.
13 minutes after receiving first dose of Moderna Vaccination as patient was waiting observation time she fell out of her chair when she lost consciousness and hit her head on the floor. When she regained consciousness she asked what happened and she was told what happened as described above. Then she states that "this has happened before when she sees other people get shots". She was alert and oriented to person, place, and time. Swelling appeared on her head above her right eye. Blood preasure reading 76/45 pulse 51 respirations 20 and patient states that she is "ok". Due to the fact that she lost consciousness and hit her head on the floor the ambulance was called. Prior to ambulance arrival blood pressure recheck was 125/93 pulse 91.Patient was talking on the phone to her mother when ambulance arrived. Patient was taken to local ER by EMS for further evaluation.
Bulls eye white surrounded by redness at shot site and 3 " below. Redness and bruising on arm, swelling, tenderness. Swelling of lymph nodes in injected arm D. Chills, sweating, extreme fatigue.
Herpes Zoster starting from the umbilical area which wrapped to the right, lower and middle portion; Information has been received from a male patient of unknown age and a lawyer referring to himself. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On or about 02-SEP-2017, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for routine health maintenance and the prevention of shingles (herpes zoster).  On an unknown date, the patient experienced herpes zoster starting from the umbilical area which wrapped to the right, lower and middle portion. The patient did not recover from the event.   The reporter considered the event were disability.  The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).
606 doses were given after expiration date; Vaccine was stored after expiration date in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored after expiration date in the refrigerator) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored after expiration date in the refrigerator). On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored after expiration date in the refrigerator) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications and treatment were reported.  No adverse events reported.   No temperature excursion of the product was reported.  There was no product complaint associated. Vaccine was refrigerated on 18-Oct-2021.   This case was linked to MOD-2022-491837 (Patient Link).
No adverse event. Noted by billing that KINRIX was given to patient less than 4 years old.
I started developing local swelling on my lower left arm below my elbow, and rashes on my left eye lid. The symptoms are mild, yet itchy. No pain and no medication was taken after the symptoms developed.
Auto-immune hepatitis, lifetime use of immuran, azathioprine, steroids as needed.
25OCT91 pt devel SOB 20-30 minutes p/recvd 3rd dose of Engerix-B;  pt also exp diaphoresis; events resolved w/o tx; 27MAR92 pt recvd 2nd dose of Engerix-B w/o exp any adverse effects;
Information has been received from a physician concerning a patient who on 10-FEB-2009 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). The physician reported that the patient on 12-FEB-2009 experienced shingles 2 days after receiving ZOSTAVAX (Oka/Merck). The patient sought unspecified medical attention. Additional information has been requested. Follow up information was received from a Medical Assistant from the reporting physician's office that a lesion culture taken on 16-FEB-2009 came back positive for VZV (Varicella Zoster Virus). Additional information has been requested.
Red, tender, cellulitis-appearing rash in area of inj site (Left deltoid) starting about 24 hours after injection of pneumoccal vaccine. No treatment required.
had 4 doses of unspecified Covid vaccines; "3 weeks ago" she fainted, was unconscious and had a concussion; "3 weeks ago" she fainted, was unconscious and had a concussion; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. Other Case identifier(s): private (Merck).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 4 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose:2, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose:3, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: SYNCOPE (medically significant), CONCUSSION (non-serious) all with onset Jan2022, outcome "unknown" and all described as ""3 weeks ago" she fainted, was unconscious and had a concussion"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "had 4 doses of unspecified Covid vaccines". The patient underwent the following laboratory tests and procedures: antibody test: never produced antibodies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 01-FEB-2016 the patient was inadvertently received an expired dose of M-M-R II (lot K001231, expiry date 27-JAN-2016, dose, route and dose number were unspecified). No adverse effect was reported. Additional information has been requested.
I had my 1st dose about 2 years ago. I have not had my 2nd dose.; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose about 2 years ago).   On an unknown date, the patient received 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: 26-MAY-2022 Reporter's Comments: This case was reported via interactive digital media. Patient stated that he/she had the first shot of the Shingrix vaccination about 2 years ago from the date of reporting and did not receive his/her second dose. Patient enquired about further course of action. Additional Supportive Information: Till the time of reporting, the patient did not received the 2nd dose of Shingrix, which led to incomplete course of vaccination.
muscle problems; neurological problems; This case was reported by a other health professional via sales rep and described the occurrence of muscle disorder in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced muscle disorder and neurological disorder nos. On an unknown date, the outcome of the muscle disorder and neurological disorder nos were unknown.   It was unknown if the reporter considered the muscle disorder and neurological disorder nos to be related to Bexsero.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient had a severe reaction, the patient experienced muscle and neurologic problems and was sent to the emergency room. The reporter was unable to provide any additional information.
Information has been received from a registered nurse concerning an actually 23 year old male who on 07-JUL-1989 was vaccinated with the first dose of MMR II (Lot number 1342P) (not valid MMRII lot number) (dose, route and site not reported) and on 04-JUN-1993 received the second dose of MMR II (Lot number 603965/0536W) (dose, route and site not reported). The registered nurse stated that the patient was reported to have a presumed case of measles. He was now hospitalized with severe brain injury (date of hospitalization unspecified) and initially presented with a rash on his hands, feet and mouth. He also had a cough along with nasal drainage and a fever of 101.8 degrees F. The date of probable infection with measles was not provided. At the time of the report, the patient had not recovered. This is one of several reports from the same source. Additional information has been requested.
101 fever and small pink bumps all over face and trunk as well as extremities. about 1 week after the vaccine. She did have a blistery rash @ site of injection within a couple days that resolved.
On 01/23/13, we administered a FLUZONE INTRADERMAL. Patient came back on 05/01/13 and informed me that there is a lump which is 3-4 mm wide which comes and goes and also associated with flu like symptoms.
Patient reported an egg size & shape red area at site of injection that itched for several days after injection.
I have a port wine birthmark on my right upper arm and across my back to the midline.  It was a dark purple to dark read in color all my adult life, but since having both vaccines administered in that arm, the birthmark has faded to almost none existent.  In normal lighting you can't see it at all, in florescent lighting you can see a slight pink coloring where the birthmark was purple.  I believe this has been gradually happening.  It was noticed that it was no longer on my arm on 3-26-2021.  We found a picture from early March that we do not see the birthmark on my arm, but it is just a partial picture of my arm.  Have a picture from 3-24-2021 that the birthmark is not visible.  I feel like this is an important finding.
Rash; a bit of swelling; Heat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 11Oct2021 15:00 (Batch/Lot number: unknown) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm right, administration date 11Oct2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient had no relevant medical history. Concomitant medication(s) included: CHOLESTYRAMINE. Vaccination history included: Bnt162b2 (dose number: 1), administration date: 2021, for COVID-19 Immunization; Bnt162b2 (dose number: 2), administration date: Feb2021, when the patient was 78 years old, for COVID-19 Immunization. The following information was reported: RASH (non-serious) with onset 12Oct2021 10:00, outcome "recovering", described as "Rash"; SWELLING (non-serious) with onset 12Oct2021 10:00, outcome "recovering", described as "a bit of swelling"; FEELING HOT (non-serious) with onset 12Oct2021 10:00, outcome "recovering", described as "Heat". Therapeutic measures were not taken as a result of rash, swelling, feeling hot.  Additional information: Facility type vaccine was Pharmacy or Drug Store. There was no vaccine in four weeks. Adverse event: Appprox 20 hrs after vaccine I developed a rash with a bit of swelling and heat. The same exact reaction occurred after my second dose in Feb2021. There was no covid prior vaccination. There was no covid tested post vaccination. There was no known allergies. There was no other medical history. Device timestamp: 14Oct2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
On 10/9/07 at about 8:00PM: Headache, Fatigue, Swollen and sore lymph nodes under right arm and right elbow sore, Soreness in right deltoid site of injection.  At about 9:30 Fever started.  At about 10:00PM began Wheezing and coughing.  On 10/10/07 Awoke with Headache and Fatigue. Headache subsided midafternoon.  Fatigue lasted all day. Lymph nodes were still sore but less than previous night soreness lasted all day. It is now 8:30Pm on 10/10/07.
Arm of the injection site became red, swollen, and hot to touch from the shoulder down to hand.; Arm of the injection site became red, swollen, and hot to touch from the shoulder down to hand.; Arm of the injection site became red, swollen, and hot to touch from the shoulder down to hand.; Arm of the injection site became red, swollen, and hot to touch from the shoulder down to hand.; Arm of the injection site became red, swollen, and hot to touch from the shoulder down to hand.; Arm of the injection site became red, swollen, and hot to touch from the shoulder down to hand.; This is a spontaneous report from a contactable nurse (patient herself). A 47-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 03Aug2021 16:00 as dose 1, single (at the age of 47-years-old) for COVID-19 immunization. Vaccination facility type was reported as Pharmacy/drug store. Patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 since vaccination. Patient was not pregnant at the time of vaccination. Patient medical history included hypothyroidism. Patient had known allergies to latex sensitivity, environmental allergies and flu shot. The concomitant medications included birth control, biotin, Cytomel and Synthroid. Patient experienced arm of the injection site became red, swollen, and hot to touch from the shoulder down to hand on 03Aug2021 18:00. Patient received Benadryl 50 mg as treatment. The outcome of the event was resolved on an unspecified date in Aug2021.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
UNKNOWN COVID VACCINE BRAND; chief complaint of generalized body aches and increased heart rate onset today. Per the patient, symptoms are beginning in the context of having received the second dose of her COVID-19 vaccine. Patient reports similar symptoms after her initial dose; however, these resolved shortly after. Patient states that she went to an urgent care for her symptoms but was sent to the ED for further evaluation. Back pain is describes as achy and constant.This initially began at the injection site but began to involve the back. Patient reports taking Tylenol around 1000 today without improvement in symptoms. Administered acetaminophen, magnesium (hypomagnesemia), 1 L NS bolus
Covid-19 infection positive home test 7/4/2022 stuffy nose, fatigue, sleepiness, trouble concentrating, 3-5 days duration for needing extra rest, Negative Home test 7/11/2022, mostly symptom-free. I was prescribed the Paxlovid and completed the 5 day course 7/8/2022.
Patient reported on 9/22/16 with redness, swelling, and warm to the touch at injection site of PREVNAR (right arm). Patient is reporting to their PCP for evaluation.
COVID-19 Vaccine EUA; Over a week after first vaccination, the injection site appeared red and inflamed in an uneven circle, about 3 inches in diameter. I also felt a resurgence in headache and muscle pain.  The redness decreased over the following 3 days and muscle soreness subsided after 24-36 hours.
A pharmacist reported that a female received an injection of Tetanus Toxoid Adsorbed, on 02/29/00. On 03/01/00, the patient developed an injection site reaction characterized by induration, erythema and tenderness. Additional info received 05/09/00 indicated that the patient recovered.