chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I think I have an enlarged spleen.; I feel constantly bloated and full; I feel constantly bloated and full; This is a spontaneous report from a non-contactable consumer, the patient. A patient of unknown age and unknown gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 05May2021 at 16:30 as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 at 04:30 as a single dose for COVID-19 immunisation. 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 06May2021 at 05:00 the patient thought the patient had an enlarged spleen and the patient feel constantly bloated and full. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event enlarged spleen, felt constantly bloated and full were not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mom reports possible fever; states that patient feels warm. Nausea and vomiting  X4, diarrhea X2 on the way home from getting vaccines.
After the 2nd dose, I was able to work and walk. I took a Tylenol, I felt the same way the second day. The second or third day, I was trying to stand, and I was unable to stand and I fell on the floor. My wife helped me get back to bed. I called my family doctor, she was booked, the person told me to who advised me to go to ER, I did not go to the ER, I called a specialist. I went to see the specialist right away. I exercise, I run, and now it is always hurting. I always have pain in both knees. I went to therapy for 6-7 months, it helped a little bit. The specialist has given me shots in the knee.  I cannot even walk one mile now. I have braces on both knees.
Systemic: Metallic taste in mouth within mins of dose; happened 1st dose too (lasted over a day with 1st dose)-Mild
Shortly after the injection part of my arm down to my pinky finger became mildly numb and it still is 3 days later.  The following morning I awakened to sweats yet it resolved quickly.  I am a psychologist and began telehealth session with a client and during that appt my heart fell heavy and like it was being squeezed causing mild to mod pain.  I attempted to relax. The pain would come and go but I knew something was wrong.  My blood pressure is typically very steady and consistently normal.  I stopped my  appt and took my blood pressure and it was 142 over 92.  This is high for me.  I stayed calm took an 81 mg baby asperin and called a COVID hotline nurse through the hospital to go to the ER so I did.  They triaged me quickly.  Thankfully my labs, portable chest x-ray came back normal and I was released 8 hours ish later.  The dr. mentioned that when we have injury in the past a vaccine may inflame an old condition.  I remain tired and dizzy, with a minor headache.  The ER visit was 04/20/2022
shivering/CHILLS; headache; fever; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose and did not experienced any side effects).   On 21st January 2020, the patient received the 2nd dose of Shingrix. On 21st January 2020, less than a day after receiving Shingrix, the patient experienced shivering, headache and fever. The patient was treated with acetylsalicylic acid (Aspirin). On 22nd January 2020, the outcome of the shivering, headache and fever were recovered/resolved.   It was unknown if the reporter considered the shivering, headache and fever to be related to Shingrix.  Additional details were provided as follows: After receiving 2nd dose, the patient had shivering, chills, headache and fever. The patient took aspirin and this morning he was fine and all of the effects had resolved. The reporter gave consent for follow up.
Arm swollen, itchy, started 10/6. Not gotten worse or better as of 10/8.
Nausea and dizziness about 5 hours post receiving vaccine. At time of report patient is still symptomatic. At the ER he was prescribed meclizine and ZOFRAN. ER doctor attributed his symptoms to vaccine.
My face slowly started to swell and then on Tuesday afternoon it was extreme and very uncomfortable and scary because the sides of my face and Tongue was very swollen. Which made me panic and made it worse. I have the feeling in my cheeks like you were about to eat a lemon or lime were thinking about eating it the little tingling feeling but it was that times like 10. Went to the ER in And they gave me antibiotics and told me to eat a bunch of lemons or lemon drops and drink water. At first I didn?t even think it would be a reaction because it was three days later but the emergency doctor believes it was from the shot.
Pt was administered DTaP #5 in right thigh on 04/08/2003. Seen in office on 04/11/2003 and had a 8cm x 6 1/2 cm pink indurated area.
First, my arm got sore, then I got some aches, then I got a fever, followed by a small red rash between the front of my legs, then I got dizzy, followed by nausea, then 3 times the whole room started spinning (extreme dizziness where I had to hold onto something our of fear of falling) followed by extreme nausea. I got the shot on Friday and Sunday night was the worst. By Wed., all I had left is a little dizziness occasionally but it is mostly gone. By Thur. all signs were gone.
Around 9/12 or 9/13, I was feeling under the weather, like a cold or sinus infection. Like I had fluid in my head. It persisted for a month or 2 months later. The cough was persistent.  I could not take a breath or talk without losing my breath. On 9/26/2022, I went to see my doctor and I was prescribed steroid and albuterol, and cough suppressants. She diagnosed with bronco spasm. I did not have infection. I did not have fluids in my lungs. The steroids helped a little bit, but once I completed dexamethasone, the cough came back again. I went back to the doctor who gave me an antibiotic, amoxiclav, that helped better, and over the next couple of weeks, it has been getter better and better. I have recovered about 90 to 95 percent. It does not limit me anymore.
had very minimal sore in the arm after the vaccine; This is a spontaneous report from a contactable consumer reporting for himself from a Pfizer sponsored program.   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced very minimal sore in the arm after the vaccine on an unspecified date. Patient stated that he already took the first dose and will be having an appointment with his knee doctor and might get a few injections during that time. Patient was asking if he can take the injections on his knee appointment. Clinical outcome for the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (19Apr2021): 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.
Narrative:  This is being reported as a SUSPECTED POSSIBLE ADR: 40 y/o m with epilepsy secondary to TBI (2014) who had a breakthrough seizure on 03/16/2021 and was admitted to sister hospital for post-ictal confusion. He was found to have L scalp fracture, R subdural and epidural hematomas with mass effect. CT head 03/16/21 (on admission): R temporal epidural hematoma measuring 1.1cm with mass effect, minimally displaced fracture of L orbital roof and foci of subarachnoid hemorrhage along with anterior falx. Pt had emergency craniotomy and evacuation or R subdural hematoma done on 03/16/21 and patient had uneventful post-operative course. Prior to this pt had been seizure free x 4 yrs and had received the Moderna vaccine 8 days earlier.
pt became fussy & acted like hurt all over staring about 1800 & screamed all noc;t103+  & mom reports pt was no longer screaming the next AM but was tired & didn't eat the next day;
the doctor who was the head of vaccine group, took a covid 19 vaccine; he developed tinnitus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: TINNITUS (non-serious), outcome "unknown", described as "the doctor who was the head of vaccine group, took a covid 19 vaccine; he developed tinnitus".  Additional Information: Reporter called Pfizer earlier and  reported an adverse reaction because reporter think it's important if a patient has any adverse reaction to let the drug company know with the understanding that, you know, we were in middle of the pandemic. And that, you know, it was more important to, you know, try to protect ourselves from the virus and do something than not do anything so that you wouldn't get sick. But that being said where do reporter get medical information about the Pfizer booster (Covid-19 Vaccine). Further stated that event happened after the Pfizer, my Pfizer booster shot, 18Nov2021. After that shot, I developed an onset of tinnitus and its been with me ever since, it's a radiator is going on in my head. So, what I want to understand is, I understand this is happening with other patient's as well, ok. I just go even to my primary care, he has seen patients (further clarifications unknown) with the same type of situation, where they had the vaccine and they developed tinnitus in their ears. At the (Name) clinic the doctor who was the head of vaccine group, took a covid 19 vaccine, and he was involved in the research of it, and he developed tinnitus (hence, split made by (Name)). So, there is a small group of that, it is a rare side effect but I want to know what Pfizer knows about it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200759687 Same reporter and drug, different patient
agitation; feeling of depression; insomnia; anxiety; ringing in the ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 67 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single.), for Covid-19 immunization. The following information was reported: AGITATION (non-serious), outcome "unknown", described as "agitation"; DEPRESSION (non-serious), outcome "unknown", described as "feeling of depression"; INSOMNIA (non-serious), outcome "unknown", described as "insomnia"; ANXIETY (non-serious), outcome "unknown", described as "anxiety"; TINNITUS (non-serious), outcome "unknown", described as "ringing in the ear".  Additional information; In general local side effects, the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that you may experience throughout the rest of your body (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter Swollen lymph nodes (lymphadenopathy) which generally resolved within 10 days is likely to have resulted from a robust vaccine-elicited immune response.2  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Soreness on left deltoid Headache, chills, shakiness, fatigue, malaise and body aches
Initial misuse report received from a healthcare professional on 28 March 2013. DAPTACEL vaccine was administered to a 10-year-old patient. No adverse event was reported. List of documents held by sender: none.
12/15/2022 It started off with a sore throat, a little bit of congestion and a killer headache. I thought it was a cold. On 12/16/22, I felt worse, like I had the flu. My headache was still bad. I took a COVID test, and it was negative.  On 12/17/22, I got up and felt like I had been hit by a truck. I had body aches, fever, fatigue and headache. My husband had just tested positive for COVID, so I took a COVID test, and it was positive. I called my PCP and he prescribed the Paxlovid.  I did not take it because I have borderline high blood pressure and since one of the side effects can be elevating your blood pressure.  He prescribed it and told me I did not have to take it, but if I felt worse, to take it.  On 12/18/22 when I picked the prescription up, I did not feel worse, so I did not take the Paxlovid.  Once I got rid of the horrible headache that lasted three days, I started having a cough with phlegm, One day I had fever, one day I had an altered sense of smell. One day I had brain fog.  I was thankful I did not get all the symptoms at once on the same day.  I still have a tiny bit of congestion, a slight cough and am slowly getting over the fatigue which lasted for 2 weeks.
Intense chills; high fever of 102; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9262) via an unspecified route of administration in Arm Right on 10Feb2021 10:15 (at the age of 75 years old) as dose 1, single for COVID-19 immunisation at workplace clinic. Medical history included diabetes, high blood pressure, cholesterol, quadruple bypass, defibrillator, 1 eye, allergies to statin medication. Concomitant medication(s) included clopidogrel (CLOPIDOGREL), captopril (CAPTOPRIL), glipizide (GLIPIZIDE), metformin (METFORMIN), all taken for an unspecified indication, start and stop date were not reported. Patient did not received other vaccine in four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. On 15Feb2021 02:00 the patient experienced intense chills, high fever of 102, which lasted for 6 hours. Disappeared after taking 2 extra strength tylenol. Patient did not tested for COVID post vaccination. The patient underwent lab tests and procedures which included body temperature: 102 on 15Feb2021. Therapeutic measures were taken as a result of intense chills, high fever of 102. Outcome of all the events were recovered on 15Feb2021 08:00.  Follow-up attempts completed. No further information expected.
Patient had a fever of 100.4, sore shoulder, tricep hurt, legs were sore, body aches
Given 2 mo immunizations 9/13. Returned 9/15/04 with urticaria. Mom states child had fever 9/13/04 of 102.6 that evening.
SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (SORE ARM) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (SORE ARM). On 08-Jan-2021, VACCINATION SITE PAIN (SORE ARM) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
got the shots still got shingles/suspected vaccination failure; got shingles/ going thru that now; eye in pain; eye blurry; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 94-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shots still got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got shingles/ going thru that now), eye pain (Verbatim: eye in pain) and blurred vision (Verbatim: eye blurry). The outcome of the vaccination failure was unknown and the outcome of the shingles and eye pain were not recovered/not resolved and the outcome of the blurred vision was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, eye pain and blurred vision to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, eye pain and blurred vision to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-Mar-2023 The case was received from the patient's child via interactive digital media. The patient got the shots and still got shingles. The patient was going thru that now at 94. The patient's eye was still in pain and blurry but slowly getting better. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. The case was linked with case US2023AMR043158, reported by same reporter for his/her mother.; Sender's Comments:  US-GSK-US2023AMR043158:same reporter
Patient believes the shot was administered too high.  She said it was administered into her shoulder instead of her deltoid muscle.  Eight days later she still has constant pain that is unresponsive to pain meds.  She said her arm is red and the injection site hurts.
Flu-like symptoms 2 days after vaccination that resolved. Left upper arm with erythema and warmth and mild edema extending distally about 15 cm in length, 9.5 cm in diameter, no streaking, no tenderness, slight itching. Final outcome not known yet.
Edema at site approx 3 hours post injection.  Approx. 9cm by 4cm.  Pt crying and retracting RIGHT leg when leg touched.  Was taken to the doctor at 2pm after giving one dose of Benadryl.  Edema was gone by 3-4pm
Five days after vaccination of first dose of Moderna COVID vaccine, the patient noticed that the area around the injection site was itchy, red, tender to touch, and had hives.  On 5/4/21, ten days after vaccination, the patient noticed mouth sores inside her bottom lip.
Tinnitus:  persistent high pitch ringing (more prominent in the right ear).  No prior history of Tinnitus.  No prior issues with hearing acuity or medical complications related to my ears
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 41 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958425.
Pt. had swelling all over her body starting 4/8/21 at 8:45pm, she had these symptoms for two weeks. Pt went to the ER on 4/21/21 since symptoms did not go away or got better. Pt had a CAT Scan and blood work done during that visit, and she was discharged and was diagnosed with foot edemas. Pt reported having the following symptoms continue after ER visit: inflammation in all of her body, swelling of hands and legs, sharp pain in eyes, toes, and arm, extreme fatigue, at night she has difficulty breathing, itching all over her body, headache, pain in lower calf and ankles of both legs but more severe on left calf.
IZ given 10/7/2010. (L) leg became swollen and indurated area. Swelling and redness began to enlarge on day 4 after vaccination. Seen 10/11/10 swelling/redness = 21x2-cm and indurated area = 10 cm circular. Area warm.  Possible IZ local reaction vs cellulitis with worsening day 4. Given KEFLEX.
This is a spontaneous report from a contactable nurse and medical assistant reporting on behalf of the nurse. An 18-year-old female patient received TRUMENBA (Lot number R56655, Expiry Date 23Mar2017, NDC number 00050100010), intramuscular at single dose in the left deltoid on 27Feb2017 16:35 for immunisation. The patient medical history was not reported. Concomitant medication included FLONASE 50 mcg nasal spray suspension. The patient previously took GARDASIL intramuscular in right deltoid on 21Nov2016 for immunisation. On an unspecified date, the patient experienced innervated area like a raised hard area underneath her skin where the immunization was given one month ago, redness, swelling. Therapeutic measures were taken as a result of the events included Ibuprofen 400 mg, 3 times a day. The outcome was unknown.
issue with menstrual cycles. Being late and an ungodly amount of blood, clots, and cramps; issue with menstrual cycles. Being late and an ungodly amount of blood, clots, and cramps; issue with menstrual cycles. Being late and an ungodly amount of blood, clots, and cramps; issue with menstrual cycles. Being late and an ungodly amount of blood, clots, and cramps; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 09:30 (Batch/Lot number: unknown) at the age of 30 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: MENSTRUATION DELAYED (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious), MENSTRUAL DISORDER (non-serious), DYSMENORRHOEA (non-serious) all with onset 29Nov2021, outcome "not recovered" and all described as "issue with menstrual cycles. Being late and an ungodly amount of blood, clots, and cramps". Therapeutic measures were not taken as a result of menstruation delayed, heavy menstrual bleeding, menstrual disorder, dysmenorrhoea. Additional information: No other vaccine was given in four weeks. The adverse events started on 29Nov2021, 12:00 AM. The patient had no COVID-19 prior to vaccination. It was unknown if patient was tested with COVID-19 post vaccination. The patient has no known allergies, other medical history: none. The patient received Pfizer COVID-19 Vaccine dose 2 on 12Jan2022, 02:30 PM at the right arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.