chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Elevated BP 166/99; Nausea; Heart palpitations hr 111; Heart palpitations hr 111; Sweating; Muscle cramps; Swollen lymph nodes; Dizzy; Body weakness; Fatigue; Pain moving across my neck/chest/back; Pain moving across my neck/chest/back; pain moving across my neck/chest/back; Trouble sleeping; Pressure in my chest; Splotchy skin; This is a spontaneous report from a contactable other health professional reporting for herself. A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), via an unspecified route of administration, on the left arm, on 20Jan2021 at single dose for COVID-19 immunisation. Medical history included sinusitis, placenta accreta, infertility, caesarean section, seasonal allergy, sulfa allergy, and coriander allergy all from an unknown date. The patient did not have COVID-19 prior to vaccination. The patient is not pregnant. Concomitant medication included prednisone from an unspecified date. The patient previously took hydrocodone and experienced drug allergy. The patient previously received the first dose of BNT162B2 (lot number: EL1284) on 30Dec2020 for COVID-19 immunisation and experienced left arm completely numb and tingling for 4 weeks. No other vaccines were given in four weeks. On an unspecified date after the second shot, it was reported that the patient experienced elevated BP of 166/99, nausea, heart palpitations HR 111, sweating, muscle cramps, swollen lymph nodes, dizzy, body weakness, fatigue, pain moving across the neck/chest/back, trouble sleeping, and pressure in chest. On 30Jan2021, 10 days after the second vaccination, the patient experienced splotchy skin. The events resulted in doctor clinic visit and emergency room care. The patient was given an unspecified treatment for the events. The patient was tested for COVID-19 post vaccination via nasal swab on 26Jan2021 with a negative result. The vaccine was administered in the workplace clinic. The outcome of the events were reported as recovering.; Sender's Comments: A causal association between BNT162B2 and the reported elevated blood pressure cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Fatigue, pain that seems to radiate from the back of the arm to the front. some nausea off and on. Also some decreased appetite
Fever 102.3F; fatigue, myalgias/arthralgias; nausea
Angioedema peri-orbital Narrative: employee self treated with benadryl-fully resolved
This case was reported by a nurse via call center representative and described the occurrence of respiratory tract infection viral in a 58-year-old female patient who received Influenza vaccine Quadrivalent. Concomitant products included vitamin B3, vitamin C and XALATAN eye drops. On 15th November 2015, the patient received Influenza vaccine Quadrivalent. In November 2015, several days after receiving Influenza vaccine Quadrivalent, the patient experienced respiratory tract infection viral (serious criteria GSK medically significant) and fatigue. On 15th November 2015, the patient experienced chills and feeling unwell. On 16th November 2015, the patient experienced headache and general body pain. On an unknown date, the outcome of the respiratory tract infection viral, chills, feeling unwell, fatigue, headache and general body pain were recovered/resolved. The reporter considered the respiratory tract infection viral, chills, feeling unwell, fatigue, headache and general body pain to be almost certainly related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The exact flu vaccine was not known. The reporter only knew that it was Quadrivalent. On 15th November 2015, she received the vaccine at 8:30 pm and within 30 minutes she felt the chills. It felt like she was getting sick. She woke up the next day with headache and body aches that lasted for a few days. The respiratory infection presented a few days later following those symptoms. She could not provide the lot and expiration date at the time of the call but said she would call back to provide it. She reported her symptoms to a nurse on her floor who monitored her until it resolved.
DIFFICULTY BREATHING; SWELLING OF FACE; TROUBLE SLEEPING; COUGH; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced trouble sleeping. On 2021, the subject experienced cough. On 2021, the subject experienced fever. On 29-APR-2021, the subject experienced difficulty breathing. On 29-APR-2021, the subject experienced swelling of face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trouble sleeping, cough, and fever on 2021, and had not recovered from difficulty breathing, and swelling of face. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
pt recvd vax; devel fever on 3feb96; febrile convuls in pm on 4feb96;re examined, possible pharyngitis
8-22-14 rec'd MCV lf arm TDAP rt arm - woke up 8-23-14 10AM Rt arm red, swollen, slightly warm, mom gave motrin today 8-26-14 and sent him to school.
Very sore arm right after the injection.  Got worse as the day went on.  I don't ordinarily take anything for pain. In the middle of the night so painful took tylenol.  It seemed to attack my weakest joints.  My hands my bad knee and terrible headache. Everything resolved about 24 hours after the injection.
This spontaneous report was received from a medical assistant concerning an unknown number of patients of an unknown gender and age. On an unknown date, the patients were vaccinated with a dose of GARDASIL (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The medical assistant reported doses of GARDASIL that were exposed to a supported temperature excursion have been administered to unspecified patients on unspecified dates. No adverse effects have been observed or reported. This is one (1) of five (5) reports from the same source. Additional information has been requested.
Dizziness; Weakness; Swelling of lips; Swelling of face; Swelling of tongue; Slurry speech; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness), LIP SWELLING (Swelling of lips), SWELLING FACE (Swelling of face) and SWOLLEN TONGUE (Swelling of tongue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness), LIP SWELLING (Swelling of lips), SWELLING FACE (Swelling of face), SWOLLEN TONGUE (Swelling of tongue) and DYSARTHRIA (Slurry speech). At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness), SWELLING FACE (Swelling of face), SWOLLEN TONGUE (Swelling of tongue) and DYSARTHRIA (Slurry speech) was resolving and LIP SWELLING (Swelling of lips) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Blood pressure measurement: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included unspecified blood pressure medication.  No treatment information was provided.  Patient was kept for observation at vaccination center for 30 minutes and then to emergency room  where patient was kept for observation for three hours.
States started having tingling in her right foot post vaccine. Thought it resolved but started having some tingling again 10-28-2021.
Around 2 hours after received shot my entire body has major aches, I am drained, have a headache and black stool (which is abnormal). It continued into the next day.  Shot location  has anticipated (all side affects shared that may get) by medical provider).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EM7809), in left arm, on 16Mar2021 as dose 2, single (Lot number: EN6206), in left arm, on 13Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm, on 26Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and as dose 5 (booster), single (Lot number: GJS342), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease" (unspecified if ongoing); "dairy allergy" (ongoing); "gluten allergy" (ongoing); "sulfa allergy" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: Jan1983; ESTRADIOL, start date: May2016. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received treatment with Paxlovid from 04Mar2023 to 08Mar2023 for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300120120 same reporter, same patient, same product, different dose, different event;US-PFIZER INC-202300118971 same reporter, same patient, different product, different event;
07/13/2022, I started having coughing, fatigue, sneezing and a low-grade fever. I went to a conference and a concert within 5 days. I was surrounded by thousands of people. I attended these events with a friend of mine along with my husband. The friend in question told me she wasn't feeling well so she was going to test, and she did, and it was positive for COVID-19. 07/14/2022. So, my husband went to the pharmacy and tested positive. My husband then went to his doctor which also confirmed a positive COVID-19 test, and he went to the doctor. All symptoms continued. Before taking this trip that took me around thousands of people my doctor wrote a prescription for Z-PAK and prednisone just as a precaution. I started taking this medication at this point. 07/18/2022, I am still having all the cough, congestion, fatigue, and sneezing. These things are minor, but I can still tell that I am sick. I have been isolating since 07/14/2022.
I had zero known side effects after my first COVID19 vaccination. I had very mild muscle pain and fatigue x1 days, with mild left armpit lymph node swelling and pain on my 2nd COVID-19 vaccination. I had more than mild muscle pain and overall fatigue and flulike symptoms x2 days (currently on my second day after vaccination) with significantly more left armpit lymph node swelling and pain. All sides effects seem to increase each shot.
Throat got very tight, trouble swallowing, wheezing, congestion, coughing, sore arm, back and chest pain, lightheadedness. Never felt like I was going to be in danger of dying.  When I realized what was happening I took Benadryl.  Symptoms other than aches and mild wheeze were gone by 10 pm.
Information has been received from a consumer concerning a friend's daughter who was vaccinated with a 0.5 mL fourth dose of GARDASIL. Follow up information was received on 09-OCT-2009 from the patient's mother. It was reported that she was willing to provide information and that she was "now noticing symptoms that she would like to report". At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Covid-19 vaccine associated myocarditis; This is a literature report for the following literature source(s):  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "Covid-19 vaccine associated myocarditis".  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 available information in the case, the causal association between the event myocarditis and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
At 1428, patient mother alerted medical staff, stating her daughter had a seizure. Upon arrival, daughter was sitting upright in passenger seat, mother holding her, eyes open, appearing pale. No convulsions , incontinence, or other seizure activity noted. EMS notified and arrived within a minute and evaluated patient. No medications or additional treatment given. Patient ambulated to EMS stretcher with one person assistance. Awake and talking. Patient transported via ambulance at 1437.
eczema; rashes; skin sheds severely; itch all over; Dose Number: 1 01May2021 Dose: 2 15May2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 28 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical location: Left arm), administration date: 01May2021, when the patient was 28-year-old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (medically significant) with onset 15May2021, outcome "unknown", described as "Dose Number: 1 01May2021 Dose: 2 15May2021"; ECZEMA (disability, medically significant) with onset 01Jul2021, outcome "not recovered"; PRURITUS (disability, medically significant) with onset 01Jul2021, outcome "not recovered", described as "itch all over"; RASH (disability, medically significant) with onset 01Jul2021, outcome "not recovered", described as "rashes"; SKIN FISSURES (disability, medically significant) with onset 01Jul2021, outcome "not recovered", described as "skin sheds severely". The events "eczema", "rashes", "skin sheds severely" and "itch all over" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of eczema, rash, skin fissures, pruritus.  Clinical course: It was reported that I have never experienced eczema in my life until after receiving 2 doses of the Covid vaccine. Shortly after receiving my doses, my arms began breaking out in eczema rashes. That was over 2 years ago. Since then the eczema has spread throughout my entire body. My skin sheds severely and I itch all over with no relief. It has only started and gotten worse after the vaccine. The patient has not received any other vaccine in four weeks or medication in two weeks. Steroids, creams, allergy meds were taken as treatment . Patient was not tested for covid prior or post vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Felt dizzy fifteen minutes after the injection - at thirty minutes felt better and did not want to go to ED for evaluation.  Came back to vaccine center an hour later and said she felt "itchy all over," and was going to ED for evaluation.  No other symptoms reported.
The above info is available but it is as my mothers....She had a bad reaction ( very flu like for several days). I proceeded with second shot in February....she did not feel well, but just sorta didn't want to get up anymore. She slept more and more and more. Her appetite declined. I got her up and she was ravenous. She slept more and seemed in a lethargic way to take less and less interest. She was living independently and had been most of her life. We scheduled an internist report. She passed labs with flying colors....... when you are 96 they look at everything as remarkable ( will live for 10 more years). I also was not equating any of this with the vaccine. However, we could not ignore it any longer Saturday the 4-10-21. I took her to ER. She was lucid and walking with difficulty. I took her in by ambulance as she was just saying, "I'm so week!" I'm so whoozie! On Sunday they are talking immediate intensive rehab. Neurologist leave for 5 days and in next 48 hours she becomes 200% less. First delusional, then sleeps all day. He showed me an MRI that to a layperson looked like little hives all over the brain ( I had also gotten hives from somewhere on my skin that I originally equated with Covid but no one thought so. I have also had the two shots.) One week out I was looking at Hospic eand long term care placement. Yesterday they couldn't get a diagnosis for Hospice ( the person sent to sign her up). I thought what? After all these tests and  maybe it is cardio, maybe it is exchemic  strokes, they don't have a diagnosis because she hasn't changed much since 2017? We have to take this totally fine independent  woman and in one week say, "She has Dementia?" It's possible but what caused it? It's not age......we live until we are 110. Yes, that MRI showed me little formations of clotting all over ( no major bleed if any in a lobe). Over the last week I have been looking at her health and how we just slowly went downhill. It's easy to blame a vaccine, but still..........I am saying that there were NO OTHER reasons other than she didn't seem to tolerate the shots well........first was acute, and the second was long term and slow...........
Pfizer-BioNTech COVID-19 Vaccine EUA  Right side of the face has different levels of numbness.  On a scale of 1-10, the numbness varies from 2-4 at different parts of the right side of the face.
Symptoms: hearing loss and tinnitus.  States he had an evaluation by PCP and an ENT was treated with a steroid shot.  Unknown if symptoms related.  Plans to continue to follow up with MD's.
Within 24 hours of 2nd DTAP (pt also got IPV, Comvax and Prevnar), pt had high fever of 103F and very irritable for 48 hours. Two siblings in the family had similar reactions to 2nd DTAP.
Pt felt lightheaded and nauseous. Face slightly reddish. No signs of anaphylaxis. Pt did drink water, Pt laid down on 2 chairs. Mother Present.
Patient states that he received Moderna COVID vaccine x2 plus booster. Now admitted to hospital with shortness of breath.
This spontaneous report was received from a nurse via field representative refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with oral ROTATEQ, (lot #, expiry date, dose and frequency not reported). After giving oral ROTATEQ, the patient almost immediately started projectile vomiting. The outcome of the event was unknown. Causality assessment was not provided. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
Patient had Pfizer dose #1 on 3/5/21, same night she started to develop left leg swelling and pain. Patient went to ER on 3/8/21, showed superficial venous thrombosis with occlusion of left greater saphenous vein, currently on Eliquis
This spontaneous report as received from a pharmacist refers to a patient of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. On 29-SEP-2014 the patient was vaccinated with expired dose of PNEUMOVAX 23 lot # H014196, expiration date 19-MAR-2014 (dose strength, route not reported). No adverse events were reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
chronic hives; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's family history included: "autoimmune disease and inflammatory disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: URTICARIA CHRONIC (non-serious), outcome "not recovered", described as "chronic hives". Therapeutic measures were taken as a result of urticaria chronic.  Additional information: HCP reported to colleague that patient after receiving second dose of Pfizer vaccine now has chronic hives. Pfizer vaccine two Dose no booster. Six months after second vaccination patient experienced on going chronic hives. Patient now is on medication plus food restriction to avoid breakouts. HCP suggested family history of autoimmune disease and inflammatory disease within patient's family. Understands that six months is long duration after Vaccine but still feels correlation. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Serious Vertigo and Headache, because of the vertigo patient is not able to move or function.
Client states that her (R) arm bled heavily after administered. C/O pain & swelling of (R) upper arm - worsening as day went on. Went to ER 1/25/13 with c/o & also swollen hard gland in neck. Dx'd with hematoma of (R) arm 1/27/13 visit to different ER d/t gland still swollen. Issue resolved now. Took over 1 week to do so.
Pt seen in the ED on 6/17 with progressive dyspnea, acute on chronic hypoxic respiratory failure, and was intubated . Tested positive for COVID-19 on 6/17 via PCR. Due to worsening respiratory failure in the new setting of positive COVID test, family decided to extubate and patient passed on 6/17. History of breast cancer diagnosed 2/2021, has had marked decline in her condition since April/Early May 2022.
On 11/8 (8 days after my moderna booster) around 10pm i suddenly became itchy everywhere including my head and oddly my palms. The area I scratch will rise in hives and rash.   The first 6 weeks itchiness was worst at night and  unbearable but Zyrtec totally takes care of the itching. 1% hydrocortisone cream or Benadryl 25 mg only mildly helpful So have not used them after the first week.  I have been taking Zyrtec or the generic equivalent nearly every night but in past week about 2 months after the start of the rash, it appears to be getting worse with now daytime itching and last few days I have been taking the Zyrtec twice a day.