chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Noticed bleeding in the mouth/gums. Looked inside and found bloody holes in my cheeks about 1/2" big. I noticed the top of my hands we also very bruised although I did not get hurt. I went to the ER and they took me in and ran blood tests. They diagnosed me with Immune Thrombocytopenia Purpura. My platelet level was at 8,000, and 6 months prior I was at 180-200,000. They began giving me platelets and were working up to giving my Immunoglobulen. After 2 doses of platelets they gave me 2 doses of benadryl intravenously and I had a scary reaction (I've never had a reaction to benadryl prior to vaccine). My body went numb, it felt like my muscles fell asleep, I felt like I could not breath. It's as if my body attacked anything that came in. Then I was given a sedative to calm down.  As the sedative faded I began feeling immense pain in my abdomen, they thought it was internal bleeding, but after a CT scan they found 3 kidney stones. I was then put on fluids. Due to pain, my blood pressure went up and stayed up for about 8-10 hrs at around 255. I was given about 3 does of blood pressure medication throughout that time to lower it as well as morphine to help with the pain.  The next morning (Day 3) I was finally given the Immunoglobulin (3 bottles = 1 dose). platelets went up to about 60,000. Then I was given a second dose and released on day 4 (but the second dose was not completed in full, only 1 or 2 bottles of the 3 were given. I was released and came back after 2 days for a blood test. I was given steroids to take for a few months.   My platelets were at 120,000. I thought that I was getting better, but then a few days letter came in for another blood test and it showed I was back at 60,000 platelets. Thats where I am now.
PCR - proven disseminated VZV rash 20 d after 1st dose of VARIVAX (given 4/9/13). Patient exposed to person w/ chickenpox 4/17/13. Patient VZV IgG (-) 2/2013.
Currently having issues with low potassium and sodium; Currently having issues with low potassium and sodium; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Mar2021 (Lot number: EM9810) at the age of 51 years as dose 2,single for covid-19 immunisation. Relevant medical history included: "High Blood pressure" (unspecified if ongoing); "Shellfish allergies" (unspecified if ongoing), notes: known allergies : Yes, shellfish, codeine, and carmine; "Swelling in my leg" (unspecified if ongoing); "Mild asthma" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Codeine, reaction(s): "Allergy: Codeine", notes: known allergies : Yes, shellfish, codeine, and carmine; Carmine, reaction(s): "Allergy: Carmine", notes: known allergies : Yes, shellfish, codeine, and carmine. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number=EL9261, lot unknown=False, administration date=16/02/2021, administration time=09:45 AM, vaccine location=Right arm, dose number=1), administration date: 16Feb2021, when the patient was 51 years old. The following information was reported: HYPOKALAEMIC SYNDROME (non-serious), HYPONATRAEMIC SYNDROME (non-serious), outcome "unknown" and all described as "Currently having issues with low potassium and sodium". Therapeutic measures were taken as a result of hypokalaemic syndrome, hyponatraemic syndrome.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: Yes. Was treatment received for the adverse event?: Yes: I self administered Benadryl. Prior to vaccination, was the patient diagnosed with COVID-19?:No. Since the vaccination, has the patient been tested for COVID-19?:No. Allergies to medications, food, or other products: Yes, shellfish, codeine, and carmine. Location of injection information is available for all vaccines received on the same date. adverse event: I got hives that lasted for 4 days(evenings and overnights mostly) 1 week and 2 days after the first Covid shot. It was controlled with benedryl and went away on it's own after 4 days/nights. adverse event start date: 25/02/2021 adverse event start time: 3:00 Pm, adverse event country. ae resulted in: ae resulted in if patient recovered: recovered, if treatment ae: Yes, ae treatment: I self administered Benadryl, if covid prior vaccination: No, known allergies : Yes, shellfish, codeine, and carmine, other medical history: High Blood pressure, swelling in my legs, allergies, mild asthma, currently having issues with low potassium and sodium.  No follow-up attempts are possible. No further information is expected.
Injection site inflamed, red, warm to touch. Patient states it is 'itchy' and tender.
This spontaneous report was received from a physician refers to unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unspecified dates since 01-SEP-2016, the patients received improperly stored doses of VARIVAX (lot # M023384, expiry date: 11-MAY-2018). Physician reported that the vaccine underwent temperature excursion at -11.9C for 3 hours and 52 minutes. There were no previous temperature excursion. A data logger was used to record temperatures. No adverse effects were reported. Additional information has been requested.
9-4-18 Tuesday, had flu shot in the afternoon. Went to bed 11:PM to 8AM. I couldn't wake up. Went back to bed by 8:10 AM and slept until midnight, only getting up twice to go to the bathroom. Back to bed 1 AM and slept until 10:30 AM on Thursday 9-6-18. Never had anything like that happen to me before. I was fine after that. Not sick before or after all that sleeping. It was scary. I did not eat nor drink during all that time. I never smoked, always was a non-drinker. I am 77 years old and other than acid reflux, I am physically fine. I am just reporting this as something highly unusual. I did not go to a doctor. Flu shot was given in my right shoulder. I slept 32 hours.
Pustular psoriasis (autoimmune disorder) sores started developing on palms of hands. Eventually leading to completely envelope both hands and feet with blisters and sores. Could not move fingers because there were so many tiny blisters enveloping them. Patient had to take 20mg of Prednisone over the course of weeks to control and minimize symptoms. Currently taking Clobetasol daily since 2015 but minor symptoms are still present.
Patient reported pain and  erythema at injection site  that lasted over a week.  Patient stated she had a physician examine the injection site and was told to come back if it was not improved in 3-4 more days.  Patient stated that the pain and redness resolved within 2 more days.
Started to feel sx on 1/24 with nausea, fatigue, feeling of warmth, dry mouth, and her face and eyes were swollen. The injection site was red, hot, throbbing and the size of a tennis ball. On 1/25 she was congested, had a headache and the injection site was red, hot, sore to the touch and sensitive. Most likely is an allergic reaction with facial swelling and local reaction, treated with Benadryl Motrin and add Pepcid or Zyrtec.  On 1/27 she was better with no fever x > 24 hours and less fatigue. No body aches and no trouble breathing.
noticed ringing in my ears beginning in November-December 2021.  It has been a steady hum since then.  I never had hearing problems or tinnitus before the Covid booster shot.   I thought it had lessened last night and this morning (March 1, 2022), but it's back.
Vaccination was given a little further back on left arm - not midline on deltoid. The same day as vaccination, developed a hard knot in vaccination area under the skin, about the size of a pea. Is not painful, a little bruising, but no change in size. Have had this knot now for 2 months.
Bone spurs; Cannot sleep at night; pain that goes from her shoulder to her elbow/pain from shoulder to elbow; This is a Spontaneous case report received via Pfizer Sponsored Program from a Contactable Consumer (Patient). A 71-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: N 6199, Expiry Date: unknown), via an unspecified route of administration on 18Mar2021 administered in upper right arm as single dose for covid-19 immunisation. Medical history included heart alternation from an unknown date and unknown if ongoing. The patient takes regular (unspecified) medicines for her heart condition. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Expiry Date: unknown, Lot number: EN6201), via an unspecified route of administration on 25Feb2021 administered in upper right arm as single dose for COVID-19 immunisation. Caller stated she has had both doses of the Pfizer covid 19 vaccine. Caller stated the second dose is suspected dose for her AE. Caller stated she has a pain that goes from her shoulder to her elbow on Apr2021. It is a kind of pain that feels like her arm will fall off. She doesn't know if it's from vaccine or from other things. Pain has improved a little bit, but she can still feel it. Caller does not know if maybe there is a pinched nerve in her neck maybe it worked its way down to her arm. She just wants to rule things out. She has never had this problem before that she can remember. The patient experienced bone spurs on unspecified date, and Caller cannot sleep at night on unspecified date. Caller states her sister wanted her to call in and find out in order to rule something out. Just to make sure that the pain doesn't have anything to do with the vaccine. Pain from shoulder to elbow: Event start was in April, but she is not really sure. Pain has improved a little bit, but she can still feel it and she has a hard time sleeping at night, she switches sides back and forth. The patient underwent lab tests and procedures which included magnetic resonance imaging on neck on May2021; result: bone spurs, X-ray on May2021 result bone spurs. Therapeutic measures were taken with pain reliever and it kind of helped at first, but she can still feel it. The outcome of the event "The patient experienced bone spurs", "cannot sleep at night" was "unknown" and for event "pain that goes from her shoulder to her elbow/pain from shoulder to elbow" was "not recovered".
Body aches abs lethargy  12 hrs after; GI issues, nausea and loose stools from 24-48 hrs post vaccine
Hemoglobin low; Infection; SMALL ULCERATIVE COLITIS FLARE UP AFTER COVID SHOT; Face injury; Laceration; This is a solicited report based on information received by Pfizer from Regulatory Authority (Mfr. Control No.: 21K-163-3860847-00).   Solicited report from the RA by a consumer of a 71 year old male with events of small ulcerative colitis flare up after covid shot squirrel hitting patient in face, cut arm, hemoglobin low and infection with Humira (adalimumab) for moderate to severe ulcerative colitis. There was no reported medical history. Concomitant medication included prednisone. On an unknown date, the patient experienced hemoglobin low. In 2021, the patient experienced small ulcerative colitis flare up after covid shot squirrel hitting patient in face and cut arm/laceration. In Jun2021, the patient experienced small ulcerative colitis flare up after covid shot squirrel hitting patient in face and infection. In 2021, the infection resolved. Pfizer bioNtech covid-19 vaccine (BNT162B2) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient received COVID-19 Vaccine manufactured by Pfizer/BioNTech. The action taken in response to the events for adalimumab was unknown. The outcome of event infection was recovered in 2021, outcome of event hemoglobin low was not recovered, outcome of event small ulcerative colitis flare up after covid shot squirrel hitting patient in face and cut arm/laceration was recovering.   Causality for adalimumab (HUMIRA) The reporter's causality for the event(s) of small ulcerative colitis flare up after covid shot squirrel hitting patient in face onset in 2021, hemoglobin low and small ulcerative colitis flare up after covid shot squirrel hitting patient in face onset in Jun2021 was not provided. The reporter's causality for the event(s) of cut arm and infection with humira (Adalimumab) was no reasonable possibility.  The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  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 event Ulcerative colitis, Face injury, Laceration, Haemoglobin low, Infection  and the suspect vaccine 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.
Patient received her first Pfizer dose at 4:06pm at 4:20 mom brought patient over to me to tell me she was feeling like her neck and leg felt swollen, we all discussed that it could be swollen lymph nodes and they choose to go and check out up front. At 4:30 Mom brought patient back to the pharmacy and said she was feeling strange. Patient said her throat felt weird, she felt dizzy and was having ear pressure, but was not having difficultly breathing.  I offered Benadryl and to call 911, Mom denied her needing that at the time.  While we were asking patient questions her eyes started to roll and flutter and her head would fall back, but she was alert and talking and stated that she was seeing spots. I told Mom that we were going to call 911 at that time so they could come and check her out. I also go an ice pack and we placed it on her neck, her face was flushed and I took her temperature it was 99.2 at 4:42pm. Ambulance arrived at 4:45pm and they did her vitals and she walked out to the ambulance with them to be checked out.  I called Mom at 6pm to check on patient and she was doing much better and did not have to go to ER.
body aches, back ache, numbness in extremities, tremors ,  chills, delusional,  rapid hear rate, rapid breathing and seizure like activity followed by a fever
Patient is fully vaccinated.  COVID + 1/21/2022 on admission to hospital. The patient was admitted because of difficulty breathing along with nonproductive cough. Positive for pleuritic chest pain, just fatigue and weakness. D dimer 947.  CXR: No suspicious pulmonary or pleural abnormality.The patient has been at home with 3 L. The patient is onthe Decadron and Lovenox for DVT prophylaxis, albuterol. Discharged to home.
I was feeling bad, chest was heavy, throat tight, nausea. I had about 4 seizures over the course of the next day.
Cough; Hotness; Lack of appetite; Bone and muscle ache; Fatigue; Fever; Bone and muscle ache; Tested positive to Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive to Covid-19), COUGH (Cough), FEELING HOT (Hotness), DECREASED APPETITE (Lack of appetite) and BONE PAIN (Bone and muscle ache) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced COVID-19 (Tested positive to Covid-19). On an unknown date, the patient experienced COUGH (Cough), FEELING HOT (Hotness), DECREASED APPETITE (Lack of appetite), BONE PAIN (Bone and muscle ache), FATIGUE (Fatigue), PYREXIA (Fever) and MYALGIA (Bone and muscle ache). At the time of the report, COVID-19 (Tested positive to Covid-19), COUGH (Cough), FEELING HOT (Hotness), DECREASED APPETITE (Lack of appetite), BONE PAIN (Bone and muscle ache), FATIGUE (Fatigue), PYREXIA (Fever) and MYALGIA (Bone and muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, SARS-CoV-2 test: positive (Positive) Tested positive to Covid-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included cough and fever medicine to treat symptoms and was given an injection. Second dose was scheduled on 02Apr2021. No relevant concomitant medications were reported.
Headache, Myalgia, malaise Narrative; had dose #2 yesterday at 3 pm. This morning, headache, myalgia, malaise.
head numb; face numb; neck numb; heart racing; Pain behind eyes; Pain on the top of head; Blood pressure high; This is a spontaneous report received from contactable consumer, a patient. A 72-year-old female patient received a first single dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE ; Lot number: EP7534) ( vaccination at the age of 72-year-old) via an unspecified route of administration to left arm on 03Mar2021 at 10:30am for COVID-19 immunisation. The patients medical history included glaucoma. The patient had sensitivity to medications and also had allergies to glue, smoke, perfume, molds and pollen. The patient did not received any other vaccine prior to the covid-19 vaccine. The patient took Lumigan and adopt eye drops as a concomitant medications within two weeks of vaccination. The patient was not pregnant. The patient was not diagnosed with covid-19, prior to vaccination. Since the vaccination, patient had not tested positive for covid-19. On 16Mar2021, the patient had experienced head, face and neck was lightly numbed this lasted until patient went to the bed, patient also had heart racing which was lasted for 45 minutes. After an hour, patient could not catch breath. Breathing was normal but the oxygen was not getting into her body. This was lasted about 1-2 hours. And her BP was above than her normal. The patient also had pain behind the eyes, pain on the top of head and sore arm. The clinical outcome of these events were recovering at this time of report.   No follow-up attempts are needed. No further information is expected.
Heart pain on 10/23/21 (that i attributed to a record low pressure front), but following 10/23/21 to now, i have daily heart palpitations and it feels like i have high blood pressure (I don't, but that's what it feels like).  I'm concerned that i may heart inflammation.  My mom reported to me that her doctor told her not to take the vaccine because of her condition (which she seemed to be telling me was heart related).  Anyway, I've never had this before, i'm only 50 and in great shape, don't drink, don't smoke, don't have any underlying conditions....but now this missing heart beat every 10 or so.......
Swelling of lymph nodes - lymphadenopathy. Grew to size of 2 golf balls and eventually resolved after about 2 months.
I felt mild side effects on the first day of the dose for a few hours (slight dizziness, aches, some chills) and soreness in my upper left arm but these went away within a day or two. Then, on day 7, I woke up with swelling around the injection site on my left arm with a lump and tenderness. Today is day 8 post-vaccine and while the swelling has gone down a little, the area is tender and there is a light red mark around it (it looks a bit like a very large mosquito or spider bite). The area is not painful, but it is tender and feels swollen.
This spontaneous report as received from a healthcare worker refers to a 2 unspecified patients of unknown age and gender. No medical history and current conditions were reported. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (lot # K004542, Expiry: 19-AUG-2015, intramuscular) (dose unknown) for vaccination. No concomitant medications were reported, On an unknown date the 2 unspecified patients experienced severe inflammation in their arms, an unspecified amount of time after receiving doses from the same lot of PNEUMOVAX 23. The inflammation was described as originating at the injection site in the upper arm and spreading down through the fingers. The outcome of the event severe inflammation in their arms was unknown. The reporter causality was not provided. No additional information was provided. Additional information has been requested.
Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case was linked to cases 2018SA298495, 2018SA298512, 2018SA298536, 2018SA298536, 2018SA298573, 2018SA298603, 2018SA298611, 2018SA298622, 2018SA298593, 2018SA298644, 2018SA298649, 2018SA297575, 2018SA298692, 2018SA298695, 2018SA298701 and 2018SA298573 (same reporter). This case involves a patient (age and gender unspecified) who received previously frozen vaccine, FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were administered with the FLUZONE HD. On an unknown date (in between 01-Oct-2018 to 08-Oct-2018), the patient received a once dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot U1995AB (expiry date- 20-Jun-2019) via intramuscular route in unknown administration site (either the left arm or right arm). It was a case of actual medication error due to incorrect product storage and overdose. It was reported that there was a possible temperature excursion of vaccine when it was known that the temperature report from the refrigerator showed that the FLUZONE HD was already frozen previously. The reporter also stated the patient was called and scheduled to be re-injected. It was unknown if the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
From armpit to elbow on the inside of the arm towards the body was swollen, painful, and almost a purple color. The patient also reported a headache
This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 47-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced pain in arm and general body pain. On an unknown date, the outcome of the pain in arm and general body pain were unknown. It was unknown if the reporter considered the pain in arm and general body pain to be related to SHINGRIX. Additional detail were provided as follows: The age at vaccination was not reported. After receiving a dose of SHINGRIX the patient complained of pain in the arm as well as through out his body. The patient had received his dose of SHINGRIX 1 day before. The reporter agreed to contact for follow up.