chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Last summer I noticed I was having frequent palpitations. I had experienced them in the past, just not at this frequency; and they had gone away. They were occurring every day, multiple times a day. I went to my PCP about it, and he did an EKG, ordered an echocardiogram, which I had done on 9/20/2021, a Holter monitory which I wore for a week, and referred me to a cardiologist. The cardiologist put me on Toprol XL 25mg daily. At my next follow up with the cardiologist, I was still having the frequent palpitations, so he switched me to Lopressor 25mg twice daily. The change in medication did not help, so at my follow up on 2/9, he increased the Lopressor to 50mg twice daily and ordered a Holter monitor again that I will wear for 4 weeks. That will be placed on 2/17. I continue to have the palpitations at the present time.
This case was reported by a physician and described a patient who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series. On an unspecified date, the patient received the 3rd dose of Engerix-B. At an unspecified time following the third administration of Engerix-B, on an unspecified date, a hepatitis B surface antibody titer was "Negative."
Client describes nausea initially which went away without intervention. Three to four hours after the injection, the right side of her tongue began to swell and eventually swelled to the roof of her mouth. This made swallowing difficult, but breathing was OK.  Swelling persisted until 4/8 - it began to diminish and then she experienced right jaw and neck soreness along with a tender lymph node. On Monday, 4/12, she had an appointment for a regular physical with her doctor. She mentioned this experience to him and he strongly urged her not to get the second shot because this was anaphylaxis and she would likely die . Today, she is feeling pretty normal.
PATIENT IS HAVING BACK PAIN, PAIN BETWEEN THE SHOULDER BLADES, CHEST PAIN, AND SHORTNESS OF BREATH. PATIENT STATED THESE SYMPTOMS STARTED WITHIN 24 HOURS OF GETTING THE VACCINE AND IS CURRENTLY STILL HAVING THESE SYMPTOMS. SHE HAS APPOINTMENT WITH A CARDIOLOGIST ON 8/23/21.  SHE HAS NOT BEEN SEEN OR TREATED FOR THESE SYMPTOMS CURRENTLY
Pt has had multiple hospitalizations (4/2-4/4; 4/23-4/28; 5/26-5/28; 5/29-6/2). Pt has had recurrent weakness, gen. body aches, fatigue, hot flashes, and chills which started 2-3 days after receiving 1st dose of Moderna covid-19 vaccine. She has had recurrent lactic acidosis. Blood cultures and thorough labs have found no source of infection.
4/12/17 The evening that the pt got her shot her arm swelled, and she got a knot. A few days later the knot became the size of a baseball and it was hot to the touch. It hurt when she touched it and her arm was sore when she tried to raise it. 4/23-4/26 the knot was still the size of an inch all the way around.
covid toad; Eyelid swelling; constant rashes on hand; This is a spontaneous report from a contactable consumer. A male patient (husband) of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on Mar2021 as dose 2, single and first dose via an unspecified route of administration on Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Since vaccination the patient had COVID toad, eyelid swelling and constant rashes on hand. It was stated this was never an issue before the Pfizer covid-19 vaccine and wants to know how to treat it or how to proceed with these side effects. The outcome of the events was unknown.   Information on lot/ batch number has been requested.
This spontaneous report was received medical assistant refers to unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was reported. On 16-JUN-2016, an unspecified patient was vaccinated with an improperly stored dose of ROTATEQ with lot # L028645, expiry date: 25-MAY-2017 (dose and route not reported), which was exposed to temperature excursion of 47 F for 9 hours. Then, on 23-JUN-2016, an unspecified patients were vaccinated with two improperly stored doses of ROTATEQ, with lot# L028645, expiry date: 25-MAY-2017 (dose and route not reported), which were exposed to temperature excursion of 47 F for 9 hours on 13-JUN-2016, 47 F for 8 hours on 17-JUN-2016, and 47 F for unknown number of hours on 23-JUN-2016. No adverse effects were reported. The nurse stated that the refrigerator back in range. No previous temperature excursion was reported. The call was because of a data logger. This is one of several reports received from the same reporter. Additional information has been requested.
The patient received the second dose of the COVID19 vaccine. There were rather normal symptoms the week after receiving it. However, a few weeks later the patient acutely developed shingles (as determined by her primary care provider). Symptoms experienced: numbness in the mouth and tongue, red, enlarged bumps at the tip of the tongue, itchy skin and bumps in the skin surrounding the mouth, pain in and behind the left ear, tiredness, drowsiness. The symptoms developed all within the same day and still persist at the writing of this report. The doctor does not know if this was a result of the vaccine, but says we should not discard the possibility. The patient did have varicella in her youth
Annual Physical, 6/1/21, EKG showed PVC's, next two months, patient had dizzy spells and weakness.
Within half a hour of getting  my first dose my right side of the face started to feel tingly it progressed all over the face and next I wasn't producing tears and I decided to go to the ED they didn't think I was having an allergic reaction or bell's palsy and to take Benadryl  but that didn't work. they refer me to see my rheumatologist Dr but they were also unsure what it was  or how to treat it.
This is an initial spontaneous report by a contactable physician's assistant. This female Pfizer Sales representative reported on behalf of female physician's assistant who reported for a 65 year old female consumer was administered with one dose of PREVNAR 13 (Lot Number H013394, Expiration Date: 31Mar2014, NDC Number: 0006473900) unknown dose intramuscular injection single dose on left deltoid muscle on 08Apr2013. Vaccines given on the same day were none. Vaccines taken within the last four weeks were unknown. Previously the patient received on PREVNAR 13 unknown dose intramuscular injection single dose on left deltoid muscle at unknown time in 2007. Relevant medical history was unknown. Relevant concomitant medications were unknown. On 08Apr2013 after vaccine administering she reacted huge over her upper arm which she explained as cobblestone effect with skin with itching, redness, large amount of swelling and roughening of skin over whole dorsal side of upper arm. She visited the doctor due to cobblestone effect in skin with itching, redness, large amount of swelling and roughening of skin over whole dorsal side of upper arm. Therapeutic measures included unspecified antihistaminic in response to above mentioned events. Relevant lab data was unknown. At the time of the report the patient was not taking PREVNAR 13 as it was a single dose. At the time of the report she had recovered from above mentioned events in Apr2013. Follow-up (24-MAY-2013): Follow-up attempts completed. No further information expected.
COVID+ 11/6/22.  Vaccination status - moderna x3 BRIEF OVERVIEW: Discharge Provider: DO Primary Care Provider at Discharge: MD  Admission Date: 11/6/2022 Discharge Date: 11/11/2022   Active Hospital Problems   Diagnosis Date Noted POA ? Acute respiratory failure with hypoxia  11/07/2022 Yes ? Pneumonia due to infectious organism 11/07/2022 Yes ? Pneumonia due to COVID-19 virus 11/07/2022 Yes ? Chronic obstructive pulmonary disease with (acute) exacerbation  11/07/2022 Yes ? Peripheral arterial disease  11/07/2022 Yes ? Hyponatremia 11/07/2022 Yes ? Pure hypercholesterolemia 09/29/2022 Yes ? Coronary artery disease involving native coronary artery 04/04/2018 Yes ? Essential hypertension 04/04/2018 Yes ? OSA (obstructive sleep apnea)    DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory failure with hypoxia [J96.01]   HOSPITAL COURSE:    Patient is a 74 y.o. male who presents to hospital because he had upper respiratory infection symptoms about 2 weeks ago.  He says transiently his symptoms improved but then lately he has noticed worsening shortness of breath and a productive cough.  He believes he has had a fever, but has not checked his temperature at home.  He has underlying chronic obstructive pulmonary disease and uses Trelegy and albuterol at home.  He was brought in by EMS and at that point was found to have O2 saturation on room air of 85%.  He does not use home oxygen.     In the ER, given 125 mg of Solu-Medrol and found to be COVID positive.  The timing is difficult to ascertain considering his infection 2 weeks ago.  Due to his high risk of progression, he will be treated aggressively with steroids and remdesivir. CT thorax revealed no PE, severe emphysematous changes, trace left pleural effusion, and suspicious for pneumonia.    During hospital course patient received five days of steroids and remdesivir. He received five days of azithromycin and rocephin. He is discharged with two additional days of keflex and azithromycin for a 7 day course to treat community acquired pneumonia. Per PT/OT recommends at discharge 4WW and home health. RT50 recommends 2L with activity and no supplementation at rest. Patient is discharged with home oxygen. PCP follow up on 11/16/2022   Patient was seen and examined today. He is requiring 1L NC at rest during exam with SPO2 92%. He reports shortness of breath with activity is improving. Denies fevers, chills, chest pain, abdominal pain, n/v/c/d. He is tolerating oral intake. Patient is discharged in stable condition- all labs and imaging reviewed. No concerns at this time. All questions were answered prior to discharge.
Felt yucky; 101 fever; Cannot sleep; In so much pain as her hands are sore; Couldn't eat; Extremely lethargic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 15:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years for COVID-19 immunisation; influenza vaccine (FLU VACCINE VII), on 29Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 2023, outcome "unknown", described as "101 fever"; INSOMNIA (non-serious) with onset 2023, outcome "unknown", described as "Cannot sleep"; FEEDING DISORDER (non-serious) with onset 2023, outcome "unknown", described as "Couldn't eat"; LETHARGY (non-serious) with onset 2023, outcome "unknown", described as "Extremely lethargic"; PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "unknown", described as "In so much pain as her hands are sore"; FEELING ABNORMAL (non-serious) with onset 29Sep2023 at 18:00, outcome "unknown", described as "Felt yucky". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient stated that she had the flu vaccine RVP and COVID vaccine last Friday at 3pm and between 6pm-8pm, she felt yucky, and she is 65 years old. She also mentioned that she had a 101 fever, cannot sleep, and in so much pain as her hands are sore, she has aching fever and she couldn't eat. She was extremely lethargic.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient hypertension.  Onsite EMS was called vitals BP 158/84   98% 02 room air  HR 67.  Patient refused evaluation/care and released against medical advice.
Information has been received from a physician concerning a 29-year-old (also as 24 and a 30 year old) female with no pertinent medical history or allergies who on 30-OCT-2007 (also reported as 05-NOV-2007 on a barely legible form) was vaccinated with her first dose of RECOMBIVAX HB (lot # 652715/0108U). There were no illness at the time of vaccination. No concomitant medications. On 01-NOV-2007 (also reported as the 06-NOV-2007) (24 hours after vaccination) the patient developed a erythemous macular rash over body, itching in her elbow creases and an allergic rash. The physician states there was no reaction at the injection site. The patient sought unspecified medical attention and was treated with BENADRYL and ZYRTEC and improved. No diagnostic labs were performed. On approximately 15-NOV-2007 (last about 2 weeks) the patient recovered. On an unspecified date the patient was seen by an allergist. A product quality complaint was not involved. Additional information is not expected.
Sore throat, aches, fatigue, fever, dizziness, weakness, chills and shivering.
Patient experienced a headache, arm pain (not at site), dizziness when standing. Patient was offered water and snacks. Sat in observation area for 30 minutes. Headache and dizziness with standing continued, after 30 minutes patient reported chest tightness. Caregiver was immediately taken to the Emergency Room for assessment.
speaking problem; This spontaneous case was reported by an other caregiver and describes the occurrence of SPEECH DISORDER (speaking problem) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced SPEECH DISORDER (speaking problem) (seriousness criterion hospitalization). The patient was hospitalized for 1 day due to SPEECH DISORDER. At the time of the report, SPEECH DISORDER (speaking problem) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment information was available. The reporter mentioned that the patient has visited 5 doctors, including a neurologist, has spent one night in the hospital, and after several diagnostic tests no cause was found to the speech disorder.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
My stomach was hurting while urinating and there was blood in my urine. At another instance, there was a small blood clot.
Severe swelling of left arm from shoulder to 2 inches above elbow-hot, burning and feels like skin is going to "pop". Red, itches and rash just below injection site.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 19-DEC-2015 at 08:53, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 8.5 and 7.9 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Itchiness and shingles rash developed on right side of stomach at the site of previous case of shingles had in 1984-85. Doctor confirmed on 11/10-2014 at 9:30 AM.
mom states child devel a fever 9/26/99;T100.2;pt could not walk & acted like was drunk;also had red rash;MD felt it was rxn from vax;pt doing fine now per mom report;
2/26/21  "hypertension", weakness ; 1100 lisinopril, 1630 carvedilol 3.125 mg
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 16Jul2020 as dose 1, single (Batch/Lot number: unknown) at the age of 29 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from23Dec2022 to 27Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
At 5:30 pm, I started to have a headache, so I took some Tylenol.  I started to feel a little better.  From about 7:00 pm to about midnight, I felt awful.  I couldn't walk down a short hall without assistance.  I was so sore and achy I couldn't really sleep.  I felt insanely hot, yet had chills and I had a terrible headache.  I am type 1 diabetic, and my blood sugar spiked to over 200, where it hovered between 200 & 300 most of the night, despite the fact that I used insulin to try and lower it.  From 10 pm to midnight, I felt nauseous.  Overnight was ok.  I still had some of those symptoms, but could sleep off and on.  I probably woke up every couple of hours.  I was till very sore and hot, but not as hot, and still had a headache.  Today, I took Tylenol this morning.  I still have a mild headache, sore body, tired and a little slow, but significantly better than last night.
9 days after receiving the vaccination, patient had what is knows as 'Covid Arm'.  2" x 3" red spot appeared at injection site.  It is not raised or swollen.  Just a large red spot.  Due to her condition, it is not known if it itches.  It does not appear to be 'hot' to the touch.
Heart Palpitations, 104 fever, severe red rash on both thighs, chills
This is a spontaneous report from a contactable nurse via a company representative. This nurse reported for three patients, this is the first of three reports. A female patient of an unspecified age (in the age range right before 19) and ethnicity  received TRUMENBA, via an unspecified route of administration on en unspecified date in 2017 at 0.5 ml, single for Neisseria meningitidis Type B immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had a lot of redness  on an unspecified date with outcome of recovered.
Correct Dose/Vaccine given, however Vaccine expired on 4.15.2021 ; Provider informed, patient informed and invited back for revaccination.
Parasthesia, number and tingling that started in toes and fingertips, progressed up feet/legs and hands/arms over the summer and fall 2021, in the fall. Lips, cheeks and tongue became numb over the fall. Facial symptoms eased in November, came back much worse after a booster shot 12/01/2021, also proceeded further up arms/legs after booster. Other symptoms include knee buckling, falling over and hitting head, etc. No history of numbness or parasthesia. Symptoms still present 12/14/2022, 1.5 years after onset. Unable to continue in profession as watchmaker, dropping tools, etc.
8hrs p/vax pt devel erythema multiforme-about 40 lesions on trunk back, abd;
Vaccine was reconstituted correctly and looked appropriate, clear.  during injection the last black mark on the outside of the syringe to mark measurement appeared to move as being injected, possible contamination of the injection but unable to tell for sure as the safely mechanism then covered the area to inspect.  The black marks should all be on the outside of the syringe, so should not have moved during the injection.  Unable to tell for sure.  Likely no contamination but possible black ink/spot on inside of syringe.
injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell
Constant persistent throbbing pressure is like a headache but not localized to any region of the head.
This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored program. A male patient of an unspecified age received PREVNAR 13, in 2015 and 2017, both via an unspecified route of administration at single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient got the pneumococcal 13-val conj vac (dipht crm197 protein) shot three years ago, and then got the booster shot one year ago. Two weeks ago (2018) he got pneumonia. The doctor put patient on antibiotics, and he still had a cough and got tired a lot, all in 2018.The outcome of all events was unknown.
After 4 hours, spasm/cramp in upper abdominal region, coupled with pain in both upper arms, and entire right leg. Lasted about 30 mins.  Second spasm/cramp after another 6 hours in upper abdominal region alone. Lasted about 30 mins.  Continuous tension in both upper arms.
15 month immunizations were administered again at 18 months when patient came in for 18 month immunizations.
Red, splotchy areas around shoulder above injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and ERYTHEMA (Red, splotchy areas around shoulder above injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 25-Mar-2021, the patient experienced ERYTHEMA (Red, splotchy areas around shoulder above injection site). On 17-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, ERYTHEMA (Red, splotchy areas around shoulder above injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient post receiving their first dose of Moderna vaccine reported that their arm was feeling sore for the following 24 hours but no other side effects. On the day of reporting, the patient noticed at their left arm, they had a few red, splotchy areas on their shoulder area above the injection site.   Reportedly, the patient didn't feel any pain and stated that they would not have noticed if patient had not looked at their arm.  No Concomitant product use was reported.  No treatment information was provided.
Cervicogenic migraine - intense neck pain, nausea and light sensitivity, with chills and extreme fatigue
The cases were received on 21 March 2014 at agency. Initial misuse report received from a healthcare professional on 21 February 2014. A 65-year-old patient had inadvertently administered FLUZONE HIGH DOSE. It was an inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none.