chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PAIN IN UPPER BACK; CLOT IN LUNG; CLOT IN CALF; DIZZINESS; FLU LIKE SYMPTOMS; JOINT PAIN; STOMACH ACHES; SWELLING IN CALF; This spontaneous report was received from a patient and concerned a 55 year old male. The patient's height and weight were not reported. The patient's past medical history included fractured ribs and T6, and concurrent conditions included drug allergy to Vicodin (causes rash). The patient was healthy before the vaccine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on and unknown date in APR-2021 (approximately "middle of April") in the left arm for prophylactic vaccination. There were no concomitant medications. The day after receiving the vaccine the patient started experiencing fever (no actual temp given), stomach aches, chills, joint pain, "flu-like symptoms" which lasted "4 to 5 days after getting the vaccine" (no actual dates given). He stated those symptoms went away.  On the "10th day after getting the vaccine" he experienced pain in his calf and had a hard swollen spot which he assumed was cramps. This lasted until Sunday, 02-MAY-2021.  On Monday, 03-MAY-2021 (also reported as 02-MAY-2021), the patient started experiencing pain in upper back which he felt "in his lungs".  On Tuesday 04-MAY-2021 , the pain was still present.  On Wednesday, 05-MAY-2021, he started experiencing difficulty breathing, dizziness, and shortness of breath and went to the emergency room (ER). This pain was unlike anything he had ever experienced. While at the hospital, they performed an ultrasound and found a clot in his calf. They also performed a CAT scan and found a clot in his lungs. The patient was treated with heparin, but after he expressed concern with heparin, the hematologist changed it to Eliquis (apixaban).  The patient was discharged on 05-MAY-2021 with Eliquis 20 mg, one tablet by mouth twice a day for two weeks. He will be on it for the next 6 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, and stomach aches on APR-2021, and joint pain on an unspecified date, and the outcome of pain in upper back, dizziness, clot in calf, clot in lung and swelling in calf was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210511212-covid-19 vaccine ad26.cov2.s-Pulmonary thrombosis, Thrombosis, Pain in upper back. This events are considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Agitation, Tachypnea, Anxiety Narrative: Patient received Covid-19 vaccine on 1/13/21 at 10:30am, then began to develop tachypnea/anxiety at approximately 12 Noon. Contacted office at 2pm by phone and patient had audible loud, labored respirations. Instructed patient to go to the ER immediately, and he arrived there at 2:09pm. He was discharged the same day and diagnosed with acute asthma exacerbation.
female patient received the first dose of Pfizer's COVID vaccine in Dec and was diagnosed with COVID and was treated with monoclonal antibody infusion; female patient received the first dose of Pfizer's COVID vaccine in Dec and was diagnosed with COVID and was treated with monoclonal antibody infusion; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for 2 patients. This is 2nd of 2 reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on Dec2020 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, patient was diagnosed with COVID and was treated with monoclonal antibody infusion. The reporter asked if a patient would she be able to get the second dose next week. The outcome of the events was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events COVID-19, drug ineffective and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is 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.,Linked Report(s) : US-PFIZER INC-2021239747 Different patient, same product and events
pt had a recent heart transplant rejection 26 years post transplant twice, both of which were responsive to alterations in immunosuppression therapy and steroids; pt started having diarrhea, fever, cough 1 day before coming to ED from a nursing home; pt had a positive COVID test; admitted; DNR; COVID PNA; all meds except comfort meds dc'd; on O2 supplementation with O2 saturations still in low 80s; pt passed away in the hospital
Within 20 minutes of injection, I developed tightening in my throat, and shortness of breath. Benadryl (50 mg) mostly reversed this. When the Benadryl wore off, breathing became more constricted. Went to Emergency Room about 3.5 hours after injection. Was treated with Famotidine and Decadron, which helped to reduce the symptoms. I was released from the ER after 2 hours of observation. Itchy, irritated throat and some restricted breathing continued for 36 hours after injection. Itchy throat recurs intermittently.
Patient received ADACEL vaccine at the pharmacy and felt okay after the vaccine. Approximately 10-15 minutes after receiving vaccine, patient returned to pharmacy and said that she felt weird and had a ringing in her ears. She was sitting on the pharmacy bench when she fainted and then had convulsions/involuntary body movements for approximately 5-10 seconds. Paramedics were called and arrived within approximately 5 minutes.
8/6/04 AM left upper arm became red and very swollen, round rash on upper left arm. Ice packs applied made arm feel better, no fever, gradually improved after 8/7/04. Sunday evening swelling and redness had decreased, Saturday very swollen, very red, tender to touch - reported by Grandmother.
RN inadvertently administered only the diluent, the adjuvant suspension component. She did not reconstitute to form Shingrix.  Patient reports no adverse event or side effects, reports slightly sore arm but no effects similar to what he experienced with the first dose. Patient is scheduled to return in 4 weeks to receive a  fully constituted dose of Shingrix. Bureau was consulted.
Within 24 hours, I began experiencing the usual symptoms associated with 2nd dose, including chills, fever, body aches, etc.  Within 72 hours, I began experiencing serious chest pain, radiating pain into back and shoulders, and numbness in left arm--all symptoms associated with a heart attack.  I was immediately taken to the emergency department where I was treated with pain killer for chest pain and given a blood thinner and IV fluids.   EKG and chest X-ray were normal.  Blood work indicated highly elevated troponin levels thereby indicating significant stress to heart muscle.  Treatment included prescribing medications including Lopressor, Lipitor, and aspirin.  Following stay in the hospital, I was released with no signs of heart complications.  I'm continuing the medications for general maintenance and prevention.  Prognosis is good with no further complications and no further threat of a future heart attack based on current medical conditions.
pt notes pain in lt arm deltoid, triceps, biceps, pectoralis noted 2-3 days p/vax;no joint pains
Pt received DTP 24 hrs following experienced increased sleepiness at night; high pitched painful cry; cried at least 6-8hrs in 24 hr period but not 3hr consecutive; fever of 102.
Hives, itching on chest, neck and face. Throat irritation followed by difficulty breathing, shortness of breath, persistent coughing about 35 minutes after vaccine. Self administered Benadryl and took rescue inhaler then went to local Emergency Room. Placed on pulse oximetry, received prednisone and famotidine. Evaluated and observed for a few hours.
had two flu shots in my 36 yrs, got the flu both times very badly; Initial information received on 08-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer).  This case involved an adult patient of unknown gender for whom it was reported had had two flu shots in my 36 yrs, got the flu both times very badly (flu), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), and family history were not provided.  Patient take daily vitamins, Elderberry daily, and patient and daughter of the patient are vegetarians.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient had two flu shots in 36 yrs, got the flu both times very badly (flu).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  The outcome of the event was unknown.  There will be no information available on the batch number for this case.
got a ring in the same arm were she received the shot. It is on the wrist by the thumb. It is raised, squishy red mark; got a ring in the same arm were she received the shot. It is on the wrist by the thumb. It is raised, squishy red mark; 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 34 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 06Apr2021 10:30 (Lot number: ER8734) at the age of 34 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), RASH PAPULAR (non-serious) all with onset 06Apr2021, outcome "not recovered" and all described as "got a ring in the same arm were she received the shot. It is on the wrist by the thumb. It is raised, squishy red mark". Therapeutic measures were taken as a result of vaccination site erythema, rash papular.  Additional information: The patient got a ring in the same arm were she received the shot. It was on the wrist by the thumb. It was raised, squishy red mark/ on the same arm that she received the vaccine, down by her wrist, on the side of her thumb, the vein was raised and has a red line over it. It did not hurt. Clarified that it was the vein was on the side of her thumb, wrist area. The vein was raised but the vein was not hard, it was squishy, and had a red line over it. She was concerned because this has not gone away. Last night, she spoke with a friend who was a doctor. The doctor told her to put ice on it, and then wrap it with an ace bandage. But it was still here today.  No follow-up attempts are possible. No further information is expected.
As I recall I felt very fatigued and had some nausea but not sure about that. I had some body aches. I took ibuprofen for body aches, promethazine 25mg.
Following my 1st (and last) COVID-19 booster shot my resting heart rate dropped significantly for nearly a month. I am a very healthy middle-aged male who goes to the doctor regularly for allergy shots. I use the clinic, so each time I go they do the initial screening and check your vitals.  For about 5 straight weeks my heart rate was between 35 and 50 bpm, down from a normal rate of 55-60 for me. I was never admitted to the hospital, but was held over multiple times for monitoring and was sent for an EKG and had monitoring done. The only explanation was my heart was a "slow poke" after the COVID-19 booster. I have since recovered and returned to normal, but this was scary.
This spontaneous report as received from an Emergency Medical Technician (EMT) refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients received improperly stored doses of PROQUAD (dose, route of administration, lot number and expiration date were not reported). It was stated that the vaccine underwent a temperature excursion of 17.6 degrees Fahrenheit for 84 hours. No previous excursion was reported. No data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sore arm; Severe headache; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 07Apr2021 at 08:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks of vaccination. On 07Apr2021 at 12:00, approximately 4 hours after vaccination, the patient experienced sore arm that lasted for less than 24 hours. On same day, approximately 14 hours after vaccination, the patient experienced severe headache which was lasted for approximately 36 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm and severe headache were resolved on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Dx'd with chickenpox on 4/24/02. Symptoms started on 4/23/02. Rash to trunk, neck, scalp with fever for 1 day. Mild illness over all. No new lesions after 2 days.
This spontaneous case reported by a consumer, describes the occurrence of pruritus (itching for one hour) and increased heart rate (racing heartbeat) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 017B21A) for COVID-19 immunization. No medical history reported. On Apr 1, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On Apr 1, 2021, patient experienced pruritus (itching for one hour) and increased heart rate (racing heartbeat). On Apr 1, 2021, pruritus (itching for one hour) and increased heart rate (racing heartbeat) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.
Muscle aches about 17 hours after injection; injection site pain 3 hours after, fever and headache 20 hours after injection
Patient fainted after administration of yellow fever vaccine, also received IM vaccines for Havrix & Adacel.  Lasted about 30 seconds recovered completely.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. The pt's relevant medical history, drug reactions/allergies and concomitant medication were not reported. The pt, through her attorneys, brought this cause of action for personal injuries suffered as a direct and proximate result of being inoculated with ZOSTAVAX, intended for the prevention of shingles. On 07-JUL-2011, the pt was vaccinated with ZOSTAVAX (dose, route, and lot # not provided). On an unknown date (reported as "since receiving the vaccine"), the pt experienced chronic shingles outbreaks, suffering from shingles over 13 times. At the reporting time, she was suffering from neuropathy and balding as a result of outbreaks on her scalp. The outcome of the events was not recovered. The reporter considered shingles, neuropathy, and balding to be related to ZOSTAVAX. Upon internal review, neuropathy was considered to be a medically significant event.
Severe body aches Low grade fever Fatigue Itching and redness of the injection limb Extreme tenderness of the injection limb
When speaking to patient about his cancer medication, he remarked he had atrial fibrillation within hours of his last Pfizer COVID-19 vaccine booster. He was hospitalized for cardioversion, then released home. He reported none of his other medications changed. Vaccine was not given at this pharmacy so we have no information about lot number, NDC or expiration date. Patient did not wish to be contacted regarding this event.
Rash on arms and legs. Very itchy   Red splotches and some raised.  Started 8 days after second shot. Got progressively worse. Took  Benadryl  and used cortisone cream 6 days after rash started. 4 days later after no relief started taking methylprednisolone.  I?m feeling some relief but only on day 2 of meds. Still itchy but less
Information has been received from a nurse practitioner concerning a 17 year old female who on 20-MAY-2008 was vaccinated with a third dose of GARDASIL.  On 20-MAY-2008, after vaccination the patient "passed out."  The patient sought unspecified medical attention.  The patient outcome was unknown.  Additional information has been requested.
Mump like rash and itching 24 hours following flu administration; patient had a baby 5 days ago; never had a reaction to a flu shot before.
Vomiting  and , after 2nd dose on March 23, diarrhea daily
On the evening of 3/9 noticed a vibrant red rash at injection site about 3 inches in diameter. Took medication to hopefully limit rash - 3/10 took 1 Benadryl at 2pm and 2 Benadryl at 11pm. 3/11 about the size of a hand. upper part of area and toned down in redness. the lower part of the area is more red. Took 1 Benadryl at 9am. Hopefully it goes away.
Sudden onset of severe pain in the left mid-thigh, medial area. Felt like knife wounds. Each episode, lasted several minutes and was partially relieved by deep massage of the area. No abnormalities were palpated in this area. This repeated, several times, over the next month, in the exact same area and then disappeared.  One month later, this exact same thing, happened on the medial part of my right mid-thigh. It responded to the same treatment and lasted for the same duration. This right side pain returned several times over the course of the month, then disappeared.   So far, those have been the only episodes.  More recently, (05/10/21), a small, firm bump appeared on  my left forearm - that was very sensitive to lightest touch and was itchy but not painful. Thankfully, this has not grown and is less sensitive.
Left parotid (face) swelling 2.5 hours after high dose flu was given in Rt. arm.
First noticed redness and soreness at injection site 1 day after vaccination.  Later that day I became feverish (101F) The site was very swollen and painful.  Area of redness 3.5 inches in diameter.  I called the on-call doctor who recommended Benadryl and additional Tylenol (I was already taking Norco for pain post appendectomy). The fever subsided by the next day, and the redness and swelling subsided a few days after that.
Narrative:  83yo patient came to surgery clinic for appointment on 09/29/2021 when Patient was being transported down the hall of the plastic surgery clinic to go up to Pre-Op for anesthesia eval. when patient became unresponsive and noted to have agonal breathing when placed on exam table per 5 staff members. Unable to palpate pulse, no audible heart tones. Chest compressions started per APRN at 1500. Code team called and on arrival of Code team. ED-MD took over code. Pt died at 15:24. Per MD death report: "Death was caused by: cp arrest, cll, no remission, dm, htn, ckd, sq. cell cancer".Likely this death is not related to covid vaccines given patient's age, comorbidities, and long length of time between date of vaccines and date of death. Pt had received covid vaccines on 1/28/21 & 2/25/21.
Estimated due date: 07/09/2021. Around 8PM I started feeling chills, and arm pain and the next day in fact the next 2 days the pain was rather severe, I could not even lift my arm needed help with dressing, showering etc. Fatigue started on the 24th and slept all through the day until the 26th.  On the 27th and 28th fatigue got better and arm was also feeling a little better, could lift my arm. Friday and Saturday was very hard on the fatigue again  by Sunday the 27th I was back at feeling fine and I have been fine since.  Although had chills no fever. January 1st and second I also had headaches.
The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 10-MAR-2014 was vaccinated with (Oka-Merck) PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F) (strength, dose and dose schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received flu shot and within 30 minutes states had a strong metallic taste in throat with difficulty swallowing. After one hour became slightly dizzy without any loss of balance. Two hours after injection became flushed. Vitals normal. Patient states this was the first time to receive flu vaccination and stated was very apprehensive about receiving it. At 4:30 PM dizziness decreased and slight metallic taste in mouth.
patient became lightheaded on 5/3/03, woke up with vertigo on 5/4/03, also had episodes of vomiting.  Final diagnosis:  benign positional vertigo.  patient received 5 mg of valium IV and one liter of 0.9 normal saline
TESTED + FOR COVID ON    8-22-23  - ADMITTED 8-13 TO MEDICAL CENTER  FOR SEPSIS, CELLULITIS, END STAGE RENAL DISEASE AND LATER DEVELOPED COVID AND WAS INTUBATED ON 8-22. HAS METASTATIC RCC , VIRAL PNEUMONITIS FROM COVID ,
Pt. noticed a red spot at injection site, about the size of her palm. It was somewhat swollen and felt like a knot under neath. Pt. self-treated with ice and BENADRYL, and it got progressively better. She says it is completely resolved as of this morning (4/19/13).