chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt dizzy after the first Moderna Covid-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt dizzy after the first Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Felt dizzy after the first Moderna Covid-19 vaccine). At the time of the report, DIZZINESS (Felt dizzy after the first Moderna Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported . No treatment medication was reported .  This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious, unexpected event of dizziness. The event occurred  on unknown date after first dose of mRNA 1273 vaccine. The rechallenge is unknown as the outcome of the event is unknown, although different events were reported after second dose. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-381102, MOD-2021-380629 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow-up document received, included dose number added and narrative updated. On 09-Nov-2021: Follow-up document received, and the document contains no new information.; Sender's Comments: This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious, unexpected event of dizziness. The event occurred  on unknown date after first dose of mRNA 1273 vaccine. The rechallenge is unknown as the outcome of the event is unknown, although different events were reported after second dose. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Intractable headache that started 1 day after the vaccine was received.  Still having headache as of today, 12/28/2020.   Has been taking Ibuprofen around the clock with no relief
This case was reported by a nurse via sales rep and described the occurrence of head injury in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced head injury, light headedness and fall. On an unknown date, the outcome of the head injury, lightheadedness and fall were unknown. It was unknown if the reporter considered the head injury, lightheadedness and fall to be related to SHINGRIX. Additional details were provided as follows: The age of vaccination was not reported. The patient got lightheaded and dizzy, fell down at home and cracked head open on same day of injection. The reporter did not agree to follow up from GlaxoSmithKline.
AIDP (Acute Inflammatory Demyelinating Polyradiculopathy); This is a spontaneous report from a contactable Physician. A 59-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) vaccination at the age of 59 years old as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included bunion surgery between CCPD and vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient had acute onset peripheral and central demyelination as confirmed on MRI (magnetic resonance imaging) brain and spine with and without contrast. AIDP (Acute Inflammatory Demyelinating Polyradiculopathy) confirmed with two NCC/EMG (NCC Electromyography). Patient presented with lower extremity weakness, upper and lower motor neuron signs, somnolence, upper extremity dysmetria, and right lower facial droop.  This occurred 22 days after first vaccine. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Treatment received for the adverse event included PLEX (Plasmapheresis) x 5 treatments, and methylprednisone x 5 days followed by prednisone taper. The outcome was recovering.   Information of the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the event AIDP (Acute Inflammatory Demyelinating Polyradiculopathy) cannot be excluded completely. The case will be reassessed once more information become available. 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.
Some people are experiencing you know heart burn maybe I am only that's getting heartburn; it is like substernal chest pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Covid 19 Vaccine; formulation: solution for injection; manufacturer: Unspecified; Lot number and Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as unknown dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that ''I am actually a health care provider and actually have a question, few people just mentioned, I mean not at all the warming side effect, nothing adverse effect anything like that, I had mentioned the side effects of heart burn on an unknown date. Just the heart burn in suggestion, it is like substernal chest pain, following the covid vaccination on an unknown date and the first couple of people who asked me about it. I have heard that and obviously you know one really have any answers for the kind of that trend continue and I was surprised only when I got the vaccine, I have the same side effects, so, I guess I have multi heart question. So I guess its curiosity. Trying to find out more information to pass that information to the patient when they ask." The outcome of the events was unknown.
Local reaction to left leg following flu shot. 8.5 by 10.5cm local reaction, red, hot and spreading.
Pt said she got the vaccine on 5/25/21 and a week later 5/31/21 she broke out with a rash on Both arms and it started to blister It started to go away on its own pt had Bx done 6/16/21
Pfizer Covid 19 vaccine vial was mixed with 1.4 instead of 1.8 ml of diluent. Spoke to patient on 04/10/2021 and she stated she was feeling fine. provided patient counseling regarding possible side effects and what to do if she experiences any.
Tingling sensation to face, puffiness around eyes and difficulty breathing. Epinephrine given, EMS called. Taken to ER by mother.
I was fine when I went to bed on the 12th, at 00:30 on the 13th Feb, 2021 I woke up and felt like I needed to vomit. I made my way to the bathroom where I no longer felt nauseous, but began to feel very unwell and needed to get back to bed to lay down. I was sweating quite profusely and just wanted to close my eyes and lay there. My husband took my temp. 95.5F which restored to 97.7 after I stopped sweating. My blood pressure was normal 119/78 with a HB of 54 bpm. At this time I began to experience intense waves of pain and cramps in my lower bowel region. This continued for around an hour, after which time I returned to the bathroom to empty my bowels - although this was not diarrhea. I settled back to sleep with no more cramping and at 05.30 am I awoke with the feeling that I needed to empty my bowels again, this time it was like the end of a colonoscopy preparation., with little more fecal matter to come. I got up at 06.30 am and although I felt washed out, did not have any further issues.
COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that symptoms were kept mild and tolerable. No concomitant medications were provided. No treatment information was provided. As patient took second dose of Moderna vaccine and experienced COVID-19 event so action taken with the drug will be Not applicable  This case concerns a male patient of an unknown age with no relevant medical history who experienced non-serious unexpected event of COVID-19. The precise temporal relationship cannot be determined, having in mind that the exact vaccination date was not provided. The rechallenge was not applicable as the event occurred following the second dose of the vaccine. It was reported that the patient's symptoms were mild and tolerable, however, detailed information regarding the clinical course of the event was not provided.  Based on biological implausibility, causal relationship between the reported event COVID-19 is not applicable. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a male patient of an unknown age with no relevant medical history who experienced non-serious unexpected event of COVID-19. The precise temporal relationship cannot be determined, having in mind that the exact vaccination date was not provided. The rechallenge was not applicable as the event occurred following the second dose of the vaccine. It was reported that the patient's symptoms were mild and tolerable, however, detailed information regarding the clinical course of the event was not provided.  Based on biological implausibility, causal relationship between the reported event COVID-19 is not applicable. The benefit-risk relationship of Spikevax is not affected by this report.
tingling on top of tongue about 1 to 10 minutes post injection (during the 15 min wait post vaccination). tongue was not scratchy, just tingled for a few minutes.; This is a spontaneous report from a contactable consumer(patient). A 38-year-old male patient received bnt162b2 (BNT162B2, Batch/Lot Number: EJ1685) via an unspecified route of administration, administered in left arm on 02Mar2021 at 16:45 PM (age at vaccination 38 years) as DOSE 1, SINGLE for covid-19 immunization. Medical history included egg allergy from an unknown date and unknown if ongoing. He did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 02Mar2021 at 16:45, the patient experienced tingling on top of tongue about 1 to 10 minutes post injection (during the 15 min wait post vaccination). Tongue was not scratchy, just tingled for a few minutes. The reporter stated that this is likely not related to the vaccine but as a Pfizer employee he wanted to record this event. Patient did not receive treatment for adverse event. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.
When medical assistant was injecting vaccine into pt's arm, some of the vaccine leaked out at the syringe/needle connection point.  Patient did not receive full dose of vaccine.  Office will repeat the dose at next visit.
Fever/chills with cold feet and hands temperature  100.1 all day Tuesday, November 2, 2021. Gave (2)Tylenol 325mg every 6hrs. Highest temperature was 101.4. Also developed severe cold sore on entire upper lip.  Upper lip was red, tingling burning sensation on Tuesday. Applied Abreva at approximately 3:00pm. Continued to apply Abreva every 5hrs for the next 6 days. Gently washing lips with Dial anti-bacterial soap between each application. Wednesday November 3, 2021, upper lip was inflamed and swollen with pustules across entire lip. Thursday, November 4, 2021, cold sore started scabbing. Scabbing  continued until Sunday, November 7, 2021 and started falling off. All scabs gone on Thursday November 11, 2021. Lip still a bit red.
Tinnitus, a  great amount of ringing and noise in ears beginning after 2nd covid-19 booster.  There has been no easing of my symptoms.  I have not had any treatment for this because I don't think there is any help available.  It is disabling.
drowsiness; reduction in the chronic mucus phlegm in his air passageways; This is a spontaneous report from a contactable consumer (patient himself). A 79-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on 15Feb2021 as a single dose for COVID-19 immunization. Relevant medical history included chronic congestion, which he had for many years; hard of hearing; and he was about 10 pounds overweight (he had weight of 219; further reported that he was good, but during this COVID stuff, all he did was to eat the whole day), from an unknown date and unknown if ongoing. Concomitant medications included fluticasone propionate (FLONASE, the cortisone nasal inhaler) and formoterol fumarate, mometasone furoate (DULERA, a Merck product); both taken for his mucus and congestion, start and stop date were not reported. The reporter got some good news about the Pfizer COVID-19 vaccine shot and it was very positive. The patient received the shot actually about 49 hours prior reporting (on 15Feb2021) and within that 30 plus hours, he noticed a reduction in the chronic mucus phlegm in his air passageways. The patient had chronic congestion for many years and this was a congestion, for which he was on his other regimen, Flonase and Dulera. The patient wanted to report that this was a very positive thing as it really helped reduce his mucus in conjunction with ingesting of the other 2 drugs (Flonase and Dulera) that he was taking. The patient had no adverse side effects other than drowsiness from taking the shot on an unspecified date. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Itchiness, Swelling, Erythema given Medrol Dose Pak, and advised to seek medical attention if worsened.
have had constant ache at injection site since received-at times certain movements would increase pain. No pain is significantly worse without movement.
I had a terrible crick in my neck, that was causing excoriating pain in my shoulder. I could not turn my head; I called my doctor's office to find out if I should come in or have a telehealth visit. I spoke with the nurse practitioner who advised me to take up to 8 of the 200mg of the ibuprofen a day to help alleviate the pain. I have an appointment to see the doctor in August about my right arm going to sleep and feeling numb.
05/01/2021:     02:19: blood sugar >600, then 556, then 911/ambulance to above facility for probable diabetic ketoacidosis, because of history of previous similar DKA emergencies     In EmergencyRoom/"CDU" "observation" status: "mild" DKA per anion gap lab BUT:     1) elevated troponins (in "50s/60s") and 2) depressed ST segment in lateral leads on 12-lead EKGs,   both repeated MULTIPLE TIMES through the night and into next day to rule out ACS (acute coronary syndrome) Normal echocardiogram and no cardiac history, including normal stres/treadmill echo 09/04/2021..      Above tests resolved to normal 2nd day, with no ischemia or infarction. Discharged with no followup/referral. I fear getting the 2nd Moderna
About 12 hours after receiving my bivalent booster, I began expericing normal side effects such as a sore arm, aches, and chills. The next day (12/27) these had not gone away, and I had developed additional symptoms of a runny nose and cough. As the week went on, these symptoms became progressively worse as my sinuses and lungs became congested and I had difficulty breathing. I had an extremely low appetite and low energy.   On 1/1/23 I went to urgent care. The Nurse Practitioner I saw told me I was most likely expericeing side effects from the covid vaccine. I was prescribed a methylprednisolone dosepak. As of today (1/5) I am recovering, but still experiecing symptoms.   I visited my PCP on 1/4. He believes I am most likely experiencing a viral infection unrelated to the covid booster, but did not entirely rule out the possibility of my symptoms being side effects.   This is my fourth dose of the Pfizer covid vaccine in total.
This is a spontaneous report from a contactable physician via a Company representative. A 71-years-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration in the left arm on 02Mar2016 at 0.5 ml, single. Medical history included sensitive skin. The patient's concomitant medications were not reported. Within 24 hours patient had red rash and itching approximately 3 inches in diameter at injection site and local swelling. On the evening of 07Mar2016 the patient developed more extensive rash on that arm and hives like rash on her arms and anterior neck. Patient was prescribed antihistamines and low dose steroids for the symptoms. The outcome of the events was unknown. Follow-up (05May2016): Follow-up attempts completed. No further information expected.
At day 20 after the vaccination I got up in the middle of the night & could barely walk. My knees were very painful 10 out of 10. As the day progressed it got worse & I needed a walker & eventually a wheelchair.
fever 99 F, extreme fatigue, severe head ache, started 12-36 hours after vaccine
Dec 26th I woke up and I had a severe cough shortness of breath and chills I took sudafed and it helped a little but I was just sore  and the 27th we went to an urgent care and tested positive for Covid I felt better by the 31st. I received my second covid shot and I had a fever 102.8 but I havent had symptoms since then
On 8/18/00, this pt had a single convulsion. This episode occurred several weeks ago and occurred 5 months after receiving a Hep-B, the 1st of her series. She was anxious and tense about getting this and was anxious after she received it. When she was putting her sister in another seat, she noticed that she had made an unusual sound and that her upper body was turned to one side and her right leg was stiffened. She then noticed that she stiffened all over and was unresponsive. She did bite her tongue, although she had tonic posturing, there is no report of clonic activity. I think that it is worthwhile withholding her Hep-B IZ for now and let us reevaluate things in 6 months. It is difficult for me to relate this to any type of immune reaction to the vaccine.
I received the shot in my left arm.  I have repeated numbness in whole left side of my body.  my entire left jaw feels like lockjaw, or gets really tight when i eat to the point where i can't open it.
Pt developed swelling, inflammation and pain at left deltoid. DTaP injection (3" x 3.5") day after injection. Continued redness and swelling today. PHN instructed pt to apply warm compress to edematous  area and give pt Tylenol pcn q 4 hours. Take to MD if symptoms increase.
horner's syndrome; This case was reported by a consumer and described the occurrence of horner's syndrome in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced horner's syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the horner's syndrome was unknown.   It was unknown if the reporter considered the horner's syndrome to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-MAY-2022 Reporters comment: The patient self-reported the case. The patient's other medical histories and any concomitant medications he might be taking were not reported. After receiving Shingrix, the patient experienced horners syndrome. No dates of the vaccination or the event start date were reported.  No other information was available at the time of the reporting.  The patient contact information was considered to be confidential as permission to forward it was not obtained. The AE associated with Shingrix would not be submitted to the Food and Drug Administration.
pt recvd vax;had fever of 104, inject site react & axillary lymph node enlargement; to md; tx atb, steroid,dph & apap
Nausea, dizziness, headache, extremely red face,  swollen bottom lip,  pressure and tightness in chest, oxygen levels dropped, difficult breathing, and heart rate was elevated.   Treatment at clinic:  Oxygen mask was put on to 4 litters, breathing treatment done,  Benadryl, Pepcid, Tylenol, and then  eppy shot was given.  Ambulance then came to clinic and took my son to the ER.  Most of the same thing was done in the ER.  Patient still felt bad after 4 or 5 hrs in ER room.  So he was admitted to stay in the hospital.  He stayed 3 days and 2 nights in the hospital.  He had breathing issues, nausea, headaches, and Elevated heart rate for the first 2 days. Wasn?t till the 3 day that he felt well enough to go home.
Approximately 2 weeks after dose 1 of Moderna the patient developed septic arthritis in his left wrist leading to staph bacteremia requiring hospitalization and incision and drainage of the wrist.
Long lasting fatigue and urge to sleep during the day, long lasting pain at injection site (left shoulder), loss of overall body strength and muscle tone, sporadic borderline high/high blood pressure readings with no prior history of BP problems, headaches (worsening over time) memory loss (worsening over time)
2wk p/vax c/o back, knee & hip pain lasted a few days;
pt recvd vax & had large erythematous area on arm; 10cm x 6cm; hot & tender; still spreading;
Initially, there was only a bit of arm soreness that lasted a week or so. Not sure if it is related or not, but a couple of months later I was diagnosed with Bell's Palsy on the left side of my face. I was given a weeks worth of valACYclovir and 2 weeks worth of predniSONE to treat. Still currently dealing with symptoms and it has not completely cleared up although there is some improvement.
Patient presented to ED with dependent chest pain from cough, congestion, and shortness of breath for two days.   Patient stated that he received a two shot series "sometime last year at the little clinic."  Unable to remember which vaccine he received nor the dates he received them.