chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling of the bilateral antecubital fossa. Not hematoma, just edema; This is a spontaneous report from a contactable physician. A 74-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 59267-1000-1 and expiration date not provided), via intramuscular, in arm right, on 28Apr2021 11:15 (at the age of 74-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included polymyalgia rheumatica, monoclonal gammopathy of undetermined significance (MGUS). Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included prednisone; rosuvastatin calcium (CRESTOR). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 59267-1000-1 and expiration date not provided), via intramuscular, in right arm, on 07Apr2021 13:00 (at the age of 74-year-old, not pregnant), at single dose, for COVID-19 immunization. Other past drugs included iodine and experienced allergy. On 29Apr2021 (reported as "the next day"), the patient had swelling of the bilateral antecubital fossa. Not hematoma, just edema. Patient had underlying polymyalgia rheumatica and was on prednisone, but never had this happen before. Events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. No treatment received for events. The outcome of the events was recovering.
Nausea, chills, sore arm, shaking, fever of 101, loss of appetite.
It was reported that a 20 year old female pt received a Menomune vaccination on 02/08/2001 at 6pm. Reportedly at 6:20pm that same evening, the pt felt the back of her tongue 'swelling,' came to program leader and explained that she had a similar (or worse) reaction to sunflower seeds and nuts. Pt often carries an EpiPen with her but did not have it with her now. At 6:35pm Benadryl orally given. At 6:55pm pt felt okay-no worse but insisted on going to class. From additiona correspondence received on 05/21/2001, it was reported, "Reviewed, no additional info at this time." This case is closed.
the symptom extended to chest area.; flushed, hot hands, forearms and also chest.; a very slight pinkish tone to the affected skin.; This is a spontaneous report from a non-contactable pharmacist.  A 88-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 05Mar2021 (Batch/Lot Number: EN6202) as 1st DOSE, SINGLE for covid-19 immunisation; Age at vaccination:88 years.The patient medical history was not reported.     The patient's concomitant medications includes: sertraline hcl (SERTRALINE HCL), via an unspecified route of administration from 05Mar2021 (Batch/Lot number was not reported) to an unspecified date, at 50 mg for an unspecified indication . Facility type vaccine: Hospital. The patient previously took morphine and experienced drug hypersensitivity.  The patient experienced flushed, hot hands, forearms and also chest (non-serious) on 09Mar2021, a very slight pinkish tone to the affected skin (non-serious) on 09Mar2021, the symptom extended to chest area. (condition aggravated) (non-serious) on 11Mar2021.  The outcome of the events was recovered in Mar2021.The clinical course was reported as follows: Patient received Pfizer COVID-19 vaccine on 5Mar21, and on 9Mar2021 she started experiencing flushed, hot hands, forearms and also chest. She also had a very slight pinkish tone to the affected skin. It disappeared within 2 hrs but then returned in the AM. 11Mar the symptom extended to chest area. The patient also started Sertraline 50mg 5Mar21, same day as vaccine administration. They contacted PCP and she did not believe the rxn was due to the Sertraline. As of 15Mar21 the symptoms have subsided.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Just an irregular heartbeat. It is part atrial fibrillation, PAC's and PVC's.
No adverse event; 7 doses of Moderna monovalent lot number 055A22A, expiration date 2.2.23, was administered to patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 055A22A, expiration date 2.2.23, was administered to patients.) and NO ADVERSE EVENT (No adverse event) in a 21-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 055A22A) for COVID-19 prophylaxis.     It was unknown that patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 27-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 27-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 055A22A, expiration date 2.2.23, was administered to patients.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 055A22A, expiration date 2.2.23, was administered to patients.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 055A22A, expiration date 2.2.23, was administered to patients.).    No concomitant medication details was reported. The vaccine had been frozen with no known temperature excursion before being thawed today for administration.  The vial was initially stored in the refrigerator on 27-Feb-2023. The vial did not undergo any temperature excursions. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713030 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713030:Same reporter
Started fever same days as vax & has cont through today; fever has varied 99-101, redness & swelled size of grape; MD tx w/Ceclor & heat;
GI problems; Arm may have been a little sore; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Arm may have been a little sore) and GASTROINTESTINAL DISORDER (GI problems) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No medical history reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm may have been a little sore). On an unknown date, the patient experienced GASTROINTESTINAL DISORDER (GI problems). At the time of the report, PAIN IN EXTREMITY (Arm may have been a little sore) and GASTROINTESTINAL DISORDER (GI problems) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
no adverse evetn; Pharmacist called to report TE for VARIVAX and informed product was administered.; This spontaneous report was received from Pharmacist and refers to an identifiable patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   The pharmacist reported that on 17-SEP-2023, a temperature excursion occurred with varicella virus vaccine live (oka/merck) (VARIVAX).  Furthermore, the reporter mentioned the excursion occurred during 3 hours at a temperature of 9.8 F. There was no previous temperature excursion.   Approximately in October 2023 (reported as a month later), the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dosage information was unknown; lot #W032507, expiration date: 11-OCT-2024) administered for prophylaxis; which was part of the temperature excursion. No adverse events were reported.
Chest pain bp elevated 212/95 on Tues night continued to have elevated bland chest pain went to ER to be evaluated bp on arrival was 218/98.   ER Dr.  Prescribed 4 baby aspirin, blood work, 2 Tylenol follow up with primary Dr.  If not feeling better. Thursday still not feeling well feel weak as though I'm carrying another body on my back. Pressure in my chest is still there.  Bp is 140/68 .
2/4/09 Discomfort in (L) arm - 2/6/09 redness and swelling (L) arm
Day after 2 month old scheduled vaccines, parent reports patient had two episodes of ~1 minute of atypical movements. Arms were flexed and shaking and eyes were quickly moving side to side, not to one side in particular. She was persistently afebrile. Mom says patient then acted fussy for 3 weeks. After that, she returned to baseline. No other symptoms developed, per mom. At this 4 month check-up she shows normal development and physical exam.
My husband was in the hospital for pneumonia Dec. 01, 2019 and released to go home the 2nd, He was given anti-biotic to take for 10 days. We went to Dr.'s office on the 12th of Dec. and he was given a quad flu shot. He was okay until the 28th of Dec. He awoke on Sat. said he felt awful this went on and he was still sick the next day. He felt like he was burning up and running a temperature. I took it, was normal. He started having trouble walking when he got up. It looked like his legs had no muscle in them - I got him back in his chair and called the squad. They took him to the ER and he was unable to stand. They run test said they could find nothing wrong sent him home. I manage to get him in the house with a walker. He with my help and a walker went to go to bed, but couldn't stand fell in the floor beside his bed. He could not move his legs to get to the bed. The squad was called and he was taken back to the hospital and admitted. They were more concerned about the small amount of dementia than his lack of not being able to stand or walk. He was given Serquel for dementia which made him hallucinate and get angry. He was let go to a nursing rehab for two nights. He could not stand or walk and fell both nights. He was returned to the ER and I would not let him return to the nursing home it was a nasty place. He was admitted to an assisted living memory care and still couldn't walk or stand very well. He fell there and had to be taken back to the ER. Because of his not being able to walk very well swelling develop in his feet and legs badly and he had congestive heart failure. He was in ICU for 6 days. He was then taken to another rehab place where he had to sit in his room and the swelling collected again. I was not able to see the nursing home or him due to the virus restrictions. He was brought home after 18 days to end up in the ICU for days and still could not walk, I brought him home and he was unable to walk or move his legs. He passed away after about 7 days at home, I kept telling all the health people I thought it was the flu shot but all I got was smiles. I lost my husband of 58 years because of this.
Pt recvd vax & 1 wk p/vax devel cellulitis over a 20cm area @ inject site; tx w/IV ATB for another unspecified reaction & placed on therapy w/topical steroids; sx subseqently resolved; later stated inject site became red & swollen again;
She has a sore achy arm .. almost like a Charlie horse in her left arm every so often. Its been over a month and the pain comes and goes at times.
Patient was given vaccine to early.  Patient was 2 months to her 18th birthday and vaccine was given at her well child visit.  Patient did not have any reaction to the vaccine.
10-15 papulorvescilar lesions on trunk. 3-5 crusted lesions on scalp.
Loss sight in left eye temporarily. Incoherent, severe headache, confused. Delirious, weakness, mild fever- scotoma eye sparkler; Nausea, school nurse would not provide with necessary manufacturer, lot number.
Generalized rash 12 h post vacc. Phone contact - BENADRYL advised. Seen 8/31. Patient words: Last dose of BENADRYL was on Saturday. Spoke to doc on call Saturday and was instructed to give him BENADRYL. He seems fine today. And, actually, the rash did not seem to bother him when it was present. He did complain about being 'warm' and would hold his elbows. The patient is a 2 year, 1 month old male who presents with vaccine allergy. Prior to the reaction the patient received DTaP vaccine and hepatitis A vaccine. Initial presentation was 2 day(s) ago. Presentation included rash (from neck down, improving..painful joints that were warm to the touch).
covid-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (covid-19) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19. Previously administered products included for COVID-19 prophylaxis: moderna covid-19 vaccine; for COVID-19 vaccination: COVID-19 Vaccine (booster 1) and COVID-19 Vaccine (booster 2). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine, COVID-19 Vaccine and moderna covid-19 vaccine.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2022, the patient experienced COVID-19 (covid-19). At the time of the report, COVID-19 (covid-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Patient had the vaccinations and two boosters already. Patient received her last booster, but it was the regular one. Patient had Covid before (date unknown) and then the second time in Nov-2022.   No treatment details were reported.
Case number PHEH2016US023416 is an initial spontaneous report received from a nurse on 13 Sep 2106. This report refers to a 22 year old patient whose gender was not specified. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in the left arm on 31 Mar 2016. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that been exposed to 8 to 10 temperature excursion. The patient did not experience any adverse events following vaccination.
immediately: nausea, burning (heat) 5 minutes after: throat swelling, burning and itching under skin (but no hives) 24 hours after: redness and then swelling (2.5 inches) at injection site; currently bruising and spreading of bruising (red to brown, with darker spot where injection occurred and outside it), soreness in injection spot expected: fever, chills, headache, dizziness, arm soreness See Item 20: continuing: bruising of arm (bruise is spreading) and arm is still sore  Treatment: iced arm immediately, Aleve for pain, rest
Anaphylactic allergic reaction to the shot. Pt began with itching. Was given 25 mg liquid Benadryl, symptoms progressed to tongue swelling, then throat swelling, Epipen given and EMS called to the facility. Pt was treated with steroids' and a second Epipen
Client given 0.3ml of undiluted vaccine.  Monitored for 30 minutes. NO adverse reaction noted at this time.
A few weeks after the vaccine my right arm begin hurting and I couldnt use it.   4/22 I went to see an Orthopedic who gave an injection of Cortisone and advised PT.  6/24 I received another shot of cortisone which did stop the right shoulder from hurting and then the left shoulder began hurting in late June I was advised to continue PT.  The range of motion in both arms has come back to about 90%, but when I sleep on them the pain comes at a scale of about 3.  When I lay on it too long it begins to hurt but the intensity of pain has diminished.  I went to see the Orthopedic today and X-rays were taken and diagnosed with Frozen Shoulder.
RV given 5/17/19. Pt did well till 5/25/19. Pt started vomiting several times & developed signs of dehydration including sunken fontanelle & eyes  , dry mouth & decreased urination. Referred to ER. Diagnosed with dehydration. Received IV Fluids, tolerated Pedialyte po, Dc'd home. Same day @ 9 pm pt developed bloody diarrhea & returned to ER. An U/S was done, which revealed large intussusception in mid & (L) abd. Barium enema to treat intussusception was unsuccessful. Pt brought to surgery on 5/26/19 @ 7:30AM & remained in hospital till D/C at 5/29/19 with no complications
Joint pain; Tired; Redness about 50 cents piece round; lump; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness about 50 cents piece round), VACCINATION SITE PAIN (Soreness), VACCINATION SITE MASS (lump), ARTHRALGIA (Joint pain) and FATIGUE (Tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concomitant products included NAPROXEN SODIUM (ALEVE) for Knee pain.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness). On 21-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness about 50 cents piece round) and VACCINATION SITE MASS (lump). On an unknown date, the patient experienced ARTHRALGIA (Joint pain) and FATIGUE (Tired). At the time of the report, VACCINATION SITE ERYTHEMA (Redness about 50 cents piece round), VACCINATION SITE PAIN (Soreness), VACCINATION SITE MASS (lump), ARTHRALGIA (Joint pain) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment included
Temp 105.2F (r) for 3-4hrs; Jittery, shaky for about 15min;
Patient started to experience back pain and fever in the evening the day of his vaccine. Since then he has had a hard time walking do to pain and has been unable to lift anything heavy, so has not been able to work
Pt. was mistakenly given the vaccine at day 21, he did not have any adverse effects at time of vaccination.
Client began complaining of feeling dizzy and was flushed and hot. 3 RNs were on scene assessing client. Vitals were taken (180/90; 97% RA; hr 97. Client was given water and a fan was placed near pt. Client then began to complain of chest discomfort and burning in her throat like heartburn. She also began to feel nauseous. The dizziness began to get better. The client initially began to say she was feeling better, a couple minutes later she began to complain of chest pain/pressure. She described it as an elephant sitting on her chest. She also stated that her left shoulder began to hurt. She was also pale. Her vitals at this time were bp of 170/85; 02 of 97%; hr of 78. 911 was called at 4:10pm and arrived at 4:15pm. Chest pain was down to a 4 and nothing of significance was noted by EMS on the heart monitor. Client was given the option to be taken to the ER and she consented to transportation.
A report has been received from a health professional concerning a 6 years old male patient. No medical history, concurrent disease or concomitant medication was provided. On 12-Dec-2012, the patient receiving nasal FLUMIST. The patient had positive test for influenza A on 12-Dec-2012. At the time of reporting, the outcome of the event of positive test for influenza A was unknown. The report was considered to be non-serious by the reporter.
Approx. 3 hours later I developed painful, red, itchy eyes, cough, flushed face, need to repeatedly clear my throat.  I went to urgent care, where I was give a Solumedrol injection, and was instructed to take otc Benadryl when I got home.  They diagnosed an allergic reaction and conjunctivitis.
This spontaneous report as received from a report as from a registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date those patients were vaccinated with a dose of VARIVAX (dose, units, route of administration, anatomical location, lot number were not reported) which were improperly stored. No adverse effects reported. Additional information is expected because reporter do not wish to be contacted.
I continue to be very fuzzy headed. Within 24 hours of having the vaccine I?ve felt intense hunger throughout the day, very lethargic, a slight headache, and slight bodyaches. I also had hot and cold chills throughout the day.
I tested positive for COVID-19 on 05/27/2022. I was having mild body aches, mild headache, congestion, chills, but I didn't have a fever, coughing, and sore throat. By the next day I didn't have a headache, chills, and body aches. I still have the cough and congestion at this time. I also had brain fog and fatigue for about seven days. Around day three or four I partially lost taste. I was only able to taste sweet things, not savory.
This spontaneous report was received from a 57 year old female patient who was pre diabetic and had codeine allergy. On 08-MAY-2014, the patient was vaccinated with ZOSTAVAX. Concomitant therapies included Metformin and unspecified blood pressure medication. On 10-MAY-2014 (also reported as approximately 2 days later), the patient experienced swelling and redness at the injection site on her arm. She contacted the physician office and was told this was a normal reaction. But within a week to 10 days later she had developed a painful and itchy rash under her right arm in the armpit. On an unknown date in 2014, she also had some red bumps on her abdomen that she thinks were unrelated as they went away quickly. On 22-MAY-2014, she went to the doctor where the nurse practitioner diagnosed her as having full blown shingles. On an unknown date in 2014, the patient experienced sore throat and body aches. The laboratory diagnostics studies included A1C blood work. Patient visited doctor to sought medical attention. Patient was treated with Tramadol Hydrochloride and Bactrim DS. As of 10-JUN-2014 (also reported as of today), the patient had the rash under her right arm which was not painful and only slightly itchy and all other symptoms were resolved. The causality assessment for the events was not provided. Additional information has been requested.
Caused severe asthmatic attack. O2 level of 92. Required emergency treatment sopportive therapy and steriods. One week recovery.
This spontaneous report as received from a consumer concerning to her 19 year old daughter who on an unknown date was vaccinated with PNEUMOVAX 23 injection (dose, frequency, route and lot number not provided). Medical history or drug reactions/allergies were not provided. Other co-suspects were not reported. Concomitant medications were not reported. The consumer reported that her daughter has had splenectomy (On an unknown date) when she was 19 years old and had been receiving PNEUMOVAX 23 every 5 years. No treatment information was reported. The patient's outcome due to splenectomy was unknown. The causality for the event of splenectomy was not provided. Upon internal review a splenectomy was considering a medically significant event. Additional information is not expected.
Patient sowed symptoms 3 days after vaccination, redness around. A small open deep wound noted on 1/14/2022. Patient was referred to his primary care Doctor. Patient came again on 1/18/2022. Wound looks better but patient was referred again to see his primary care physician as he did not go last week.
The child experienced fussiness and crying 2 hours post vax. Tylenol was given every 4 hours. On 8/9/00, the child was still fussy and had a poor appetite. On 8/10/00, the pt began shivering, was lethargic. The pt was taken to the ER. On 8/11 the child was admitted to the hospital after a blood culture showed e-coli positive. The mother thinks that it was caused the an extra dose of HIB vaccine. The health department has determined that the child did not receive an extra dose of the vax.