chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Supraclavicular lymph node swelling; A spontaneous report was received from an other healthcare professional concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced supraclavicular lymph node swelling.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 (batch number: Unknown) on an unknown date. On an unknown date, the patient received their second of two planned doses of mRNA-1273 (batch number: Unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced supraclavicular lymph node swelling. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event supraclavicular lymph node swelling was not reported.; Reporter'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.
Information has been received from a physician concerning a 4-year-old male with a possible AUGMENTIN allergy and a history of drooling, runny nose and facial itching following vaccination with Varicella when he was 3 years of age (WAES# 0610USA04275), who was vaccinated with a dose of MMR. Subsequently, the patient developed a stuffy nose and itchy, watery eyes within minutes of receiving the vaccine. He was treated with BENADRYL. No outcome was reported. Additional information has been requested.
Tongue felt tingly/It numbness was in several areas her my mouth; Tongue felt tingly/It numbness was in several areas her my mouth; Her throat was closing; This is a spontaneous report from a contactable consumer reporting same events under the same suspect product for different patient (sister). This is one of three reports.  A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included fluticasone propionate (FLONASE ALLERGY RELIEF) taken for an unspecified indication, start and stop date were not reported; loratadine (CLARITINE) taken for an unspecified indication, start and stop date were not reported; atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]) taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported and CBD oil taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with covid 19. Since the vaccination, the patient had not been tested for covid19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date, the patient's tongue felt tingly/it numbness was in several areas in her mouth, throat was closing (throat tightness). Therapeutic measures were taken as a result of events. The events were considered as non-serious by the reporter. The outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 49-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the State.   The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
3-29-21: moments after shot injection, anxiousness, and shakiness develop. Half hour after injection, extreme anxiety, impending sense of doom, full body shakes, complete inability to focus, burning sensation on skin surface and chills develop (fluctuating between both), pressure at chest, sweaty palms. Admitted to ER @  in  with blood pressure of ~180 and heart rate of ~100BPM. O2 levels 96%. Given Ativan. Anxiousness, blood pressure, heart rate, focusing improves. Occasional temperature sensations remain, as well as some difficulty focusing, and feelings of discomfort. Patient has no history of anxiety or issues with needles/previous vaccinations. 3-30-21: fatigue, trouble focusing, anxiousness. Sharp headache pain develops and is treated with Ibuprofen. 3-31-21: fatigue, trouble focusing, anxiousness. Headache has resolved.  4-1-21: fatigue, trouble focusing, anxiousness. In the evening, onset of dizziness attempting to walk. Itchy welts form on right and left hand at wrists. Rash forms on whole of torso front and back. Breathing is staggered. Patient takes 25mg of diphenhydramine and is admitted to ER @  in . Rashes/welts clear up ~30 minutes after. Anxiousness/focus improves as effects of diphenhydraminea are felt. Two EKGs and blood panel is performed, results are normal. 4-2-21: trouble focusing/anxiety, goes away quickly after taking 25 mg of diphenhydramine. Fatigue is present, cannot leave bed.  4-3-21: Nausea/stomach pain begins, and discomfort in upper left abdomen. Burning sensations/chills temperature sensations---feeling feverish but temperature is stable at 98.8F. Loss of appetite. Episodes of anxiety/focusing continue to be treated with 25 mg of diphenhydramine. Extreme fatigue. 4-4-21 through 4-7-21 : extreme fatigue, stomache pain and nausea. Patient has lost 9 lbs since 3-29-21. Pain around upper left abdomen consistent. Patient visits urgent care 4-7-21, is given 14-day course of omeprazole to help with nauseas/pain. COVID-19 rapid test is performed and returns negative. 4-8-21 trough 4-11-21: extreme fatigue, nausea, episodes of poor focus remain. Patient cannot leave bed, but ability to eat improves with omeprazole. 4-12-21 to present: short intermittent episodes of trouble focusing/anxiousness, aggravated by physical exertion and mental stimulation. Fatigue onset after hours of normal day to day activities.
Patient broke out in fever blisters around her lips days after the shot and that develop severe diarrhea and vomiting
Patient is a 73 year old female who presents with increasing shortness of breath since Sunday evening.  Patient has a mild cough that is nonproductive.  Denies fever but has had chills.  No chest pain.  Denies any congestion or sore throat.  No change in taste or smell.  She is not lightheaded.  Denies any abdominal pain, nausea or vomiting.  She has had no diarrhea or dysuria.  No leg pain or swelling.  She unfortunately has COPD and recurrent lung cancer.  She is on chronic O2 therapy.  Paramedics noted to be hypoxic on her home O2 of 3 L and increased her to 4L in route.  She is also nebulized.  No exposure to infectious illness.  She is on steroids.  She is also a diabetic on insulin.  History of congestive heart failure.  No history of DVT or PE. Chest x-ray did have a left perihilar lesion that was previously noted and not significant change from a month ago.  Patient unfortunate is COVID-positive.  With O2 by nasal cannula at 5 L with maintaining her sats in the 90-92 range.  She was given nebulization.  Given IV steroids.  Patient began to tire and decompensate so was placed on BiPAP.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M040412 with expiration date on 30-JUN-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 32 to 35 (also reported 34) degrees Fahrenheit for 300 hours and 47 to 77 (also reported 52) degrees Fahrenheit for 250 hours. Data logger was not involved in recording of the temperature excursions. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA002131.
No additional AE.; an improperly stored vaccine was administered to a patient; This spontaneous report was received from a registered nurse and refers to a 5-year-old (reported as 6 years old) male patient. His concurrent conditions included allergy to chemicals. The patient's medical history included iron deficiency anaemia and sleep apnoea syndrome. The patient had 2 siblings. His concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (KINRIX).   On 20-OCT-2022 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml, lot number W024548, expiration date: 31-JAN-2024, administered subcutaneously in the right vastus lateralis for prophylaxis. Before the administration, the vaccine underwent temperature excursion of 10.8 degrees Fahrenheit for 18 hours 30 minutes (product storage error). There was no previous temperature excursion. There was no adverse event reported (no adverse event).  This is one of several reports from the same reporter.
physician/patient with history of anaphylaxis to shellfish - symptoms of tingling tongue & syncope. no longer carries epi pen sue to ability to avoid food.  10 minutes post vaccination pt/physician experienced tongue tingling similar to prior anaphylactic events.  administered 25 mg. Benadryl po.  no further issue, vital signs stable throughout & later in evening.
She had a fever 12 hours after 2nd dose of moderna vaccine and resolved after 2 days. She went to urgent care due to redness at injection site. She was told her had cellulitis and given antibiotics.
He had two Covid vaccines after he had already had Covid. Next day of vaccination Pt had fever 101F, headache, chills, and he was having dyspnea with exertion and his IM doc ordered CT lungs and nuclear stress test which showed reversible inferior and septal WMA c/w ischemia .
really tired; Chills 7 hours after vaccine; achy including at hips; achy including at joints; This is a spontaneous report from a contactable consumer, the patient. A forty-eight-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: FA6780) via an unspecified route of administration in the left arm on 23Jul2021 at 15:00 (at the age of forty-eight-year-old) as a single dose for COVID-19 immunisation. The medical history included COVID-19, allergy to penicillin and sulfas. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included bupropion hydrochloride (WELLBUTRIN) and cetirizine hydrochloride (ZYRTEC), all from unknown dates and for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: 6W0181) via an unspecified route of administration in the left arm on 02Jul2021 at 12:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. On 23Jul2021 at 22:00, 7 hours after vaccination, the patient experienced chills, achy including at hips and joints. On 24Jul2021, next full day, patient was achy and was really tired. The adverse events did not result in doctor or other health care professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported events which included treatment with Tylenol and Advil OTC(over the counter). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, achy at hips and joints and really tired was not recovered at the time of this report.
On August 5, 2021, I was mandated by my employer to be fully vaccinated by September 1, 2021.  I got my first dose of the Pfizer vaccine on 08/06/21 and as soon as I was eligible, I received my second dose of the Pfizer vaccine on 08/28/21 to come into mandated compliance as soon as possible.  On 09/11/21, I was considered to be fully vaccinated by my employer.  On 09/14/21 at 1:00 PM, I began experiencing pain in my abdomen.  The pain began to worsen throughout the evening and became so severe that I went to the emergency room at 11:00 PM the same day.  (please see below for continuation)      In the emergency room, I was given a pain killer to help with the pain while several tests were performed along with a CAT scan of my abdomen.  The pain was now centered in the lower right quadrant of my abdomen.  The CAT scan results came back with the diagnosis of acute appendicitis. My ER doctor and the ER surgeon told me that I needed an appendectomy before I had more serious, possibly life threatening complications due to acute appendicitis.  I was admitted to the hospital in the middle of the night (early am) on 09/15/21 and waited to have emergency surgery.  My admitting surgeon was no longer on duty and my surgery was performed by another ER surgeon on call.  I presented with right lower quadrant pain and a white blood cell count of 11,000.         I was prepped for surgery and the surgery was performed from 12:30 - 1:30 PM.  I had no complications from the laparoscopic appendectomy and my appendix was successfully removed. I was discharged from the hospital around 5:30 PM.  I am mostly fully recovered. I have never had any history of appendicitis and I am a very healthy 54 year old man.  I exercise regularly, I never drank alcohol and never smoked.  I also never used any illicit or recreational drugs.  I am also not overweight.  Out of the blue I had this emergency appendectomy within a 17 day period of receiving the second dose of the Pfizer/BioNTech vaccine.  I believe this is not just a coincidence and that I had a serious adverse event due to the Pfizer-BioNTech COVID vaccine.  I saw on the CDC website that appendicitis was seen in higher numbers in vaccinated groups and is therefore being monitored as a potential side effect and serious adverse event.
tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) from a contactable consumer reported (patient). This female patient of unspecified age received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunisation. Medical history was unknown. Concomitant medications were none. The patient got first covid19 vaccine on 28Dec2020. She tested positive for the covid virus on 29Dec2020. She was scheduled to get second vaccine today (18Jan2021) but she did not get it since she did not know if she should. She had been negative for the covid virus for one week. She was asking when she should get second dose. Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Dizziness, headache, body aches, chills, nausea, Low grade fever.
Completed 2nd dose of Shingrix on 11/18/19. Chest pains worsened but had been experienced for 2 weeks prior. Seen in urgent care and sent home. Patient then called Tuesday 11/19 to also c/o fever <100, fatigue and body aches. and wondering if ALL symptoms could be related to Shingrix series.
Patient developed redness of cheeks, forehead and chest. Patient developed mild coughing and complained of throat irritation. Symptoms began approximately 15 minutes following vaccine. Symptoms resolved without treatment within 15 minutes.
Information has been received from a physician concerning a patient (age and gender not reported) who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced an injection site reaction. The patient sought unspecified medical attention. The patient's status was reported as "improved after a couple of days". There was no product quality complaint involved.  Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source. Additional information has been requested.
My daughter had her 2 month vaccines given at 9:00 a.m. and had been down for her nap at 2:30 p.m. she awoke screaming uncontrollable in the fetal position very tight, then she bacame blue around lips and eyes and stopped breathing for approx 10-15 secs, then turned gray I began back slaps to her back to try and stimulate her back before starting CPR, she then started crying and turned white. She had raccon eyes for a while. We were tranported to the ED by ambulance and spent two nights in the hospital for observation. 1/2/08-records received for DOS 11/27-11/29/07-DC DX: Probably breath holding spell. Awoke screaming from nap, stopped breathing for about ten seconds and turned blue but during the times she was struggling her eyes were open. Continue to have breath holding spells 10 seconds with 1-2 minute recovery time.
No immediate reaction. 9 days following vaccination he was hospitalized with bilateral pulmonary emboli and a right lower lobe infarct. After a four day inpatient stay, he was discharged for outpatient management on oral anticoagulation for a presumed provoke DVT that led to the PE. He reports a long car ride about 4-6 weeks prior to the event and intermittent calf pain though had not been evaluated for this complaint prior to hospitalization. Hematology workup is in progress. Uncertain of the relevance of the vaccination to this event, however, given the proximity to the inpatient stay and significant health event to the date of vaccination this meets reporting criteria.
Severe diarrhea, followed by severe muscle cramps; Severe diarrhea, followed by severe muscle cramps; This is a spontaneous report from a contactable nurse reported for himself.  A 64-year-old male patient received first dose of bnt162b2 (BNT162B2, lot number EL1283), intramuscular in right arm on 05Jan2021 11:00 at single dose for COVID-19 immunization.  Medical history included ankylosing spondylitis, ulcerative colitis, prediabetes, previous hypertension, hypothyroidism, partial heart block and known allergies: Sulfa.  Concomitant medication included mesalazine (LIALDA), indometacin (INDOMETHACIN), levothyroxine sodium (SYNTHROID), esomeprazole magnesium (NEXIUM), zolpidem tartrate (AMBIEN), metformin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient experienced severe diarrhea, followed by severe muscle cramps on 05Jan2021 16:00 with outcome of recovered in Jan2021. The events were reported as non-serious.
I had a sore arm. Then I started having body aches. I still have them. The reason why I went to the doctor is because I wasn't able to walk. I also had swollen lymph nods. I had chest pains. Lymph nods went down with steroids. I'm left with painful joints.
sore arm; other vaccine same date vaccine date: 01Feb2021; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose on 01Feb2021 15:15 (lot number: EL3248), via an unspecified route of administration in the right arm at single dose for COVID-19 immunization in the workplace clinic. The patient's medical history includes ulcerative colitis, shellfish allergy, sulfa allergies unknown if ongoing from an unknown date. The patients historical drug included benzthiazide (REGULON) which caused allergies. Patient received the first dose of BNT162B2 (lot number: EL3248) on 13Jan2021 14:15 in the left arm for COVID-19 immunization. Concomitant medications included tofacitinib citrate (XELJANZ) and cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D). The patient was administered with other vaccine on same day i.e. 01Feb2021. However, it was also reported that the patient did not receive any other vaccine within four weeks. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for COVID-19. The patient experienced sore arm on 02Feb2021 05:00 AM. The patient did not received treatment. The consumer assessed the events as non-serious. The outcome of the sore arm was recovered in Feb2021.  No follow-up attempts are possible. No further information is expected.
it's been two months passed, and I don't quite remember what's wrong.  Obviously, it's not so severe.  I might just have called the nurse to check or otherwise, I really don't remember.