chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4 hours following IM injection of vaccine developed redness and swelling of left thigh with induration DTaP given in that thigh.
Patient is having abdominal cramps; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Patient is having abdominal cramps) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (Patient is having abdominal cramps). At the time of the report, ABDOMINAL PAIN (Patient is having abdominal cramps) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
*ADMINISTRATION ERROR*  62 y/o F patient presents to clinic for her second booster dose of the Pfizer vaccine. Although the patient informed that her last dose was on 2/23/22, the nurse proceeded to administer the vaccine two months before her correct administration date.  Patient refers no adverse events, but was informed that the vaccine was administered two months early.
RespDepression & Bradycardia Narrative:  Pt escorted in wheelchair to extended monitoring room approx 8 min after injection of potential antigen. As pt entered doorway, her head hyperextended and she lost consciousness in wheelchair. Pulse not palpable. Pupils dilated. Administered EpiPen to right lateral thigh. Pt gained consciousness in wheelchair and was transferred to stretcher. Remained diaphoretic and pale. Placed on NC 2 L. After stabilized, transferred to ED.
Patient received Flumist vaccine intranasally at approximately 6pm on 11/3/08.  She was previously doing well except for a cough approximately 4-5 days prior to the vaccine.  She woke her mom up at about 3AM with cough and complaints of being cold.  The patient awoke again at 0430 and the mom took the patients temperature with a temporal probe thermometer which read 101 F.  The child appeared confused to the mom and was asking questions such as what is that on the wall, why is there a giraffe on the wall, what are you going to be for Halloween.  These types of questions concerned the mother and propted a visit to the ER.  In the ER, the patient had a rectal temperature of 40.7 C which was treated with acetaminophen.  Her HR was also noted to be 170 on arrival.  Repeat temp was 38.2 C.  The patient was asleep most of the time in the ER.  Patient discharged home with instructions for treating fever and supportive therapy for viral illness.  Note, the patient had received an IM influenza vaccine in 2007 per mom, but never Flumist before 11/3/08.  Per the MCIR database, the patient received an influenza IM injection in 2006, not 2007.
Intermittent low blood pressure (diastolic of 50 or under) for approximately 3 months  after 2nd Moderna vaccine .(incident on 5/17/21 where bp was 70/30 and was taken to ER and hospitalized overnight until bp stable for several hours. Several other tests (bloodwork) also performed to be sure there were no other adverse health conditions.
Vision changes, blurry and distorted vision lasted for about one and a half to two hours after vaccination.  Vision return to normal.
Not sure if this was related to vaccine. 2 days after getting 2nd dose I developed eye pain and irritation.  I was seen and diagnosed with ocular shingles. Currently being treated with  Valacyclovir.
Enlarged Lt axilla lymph nodes. Itching, redness, swelling, warm to touch. Head ache
Loss my voice, had laryngitis.  Cough quite a bit.  Had green mucus. I went to see the doctor.  They gave me z pack and steroid. They also did Covid-19 test, which came back negative.
Patient had redness with hive at injection site for about 48 hours post administration. On 1/6/21, the patient took a dose of Miralax and had an anaphylactic response and was treated in the ED department
I received notification on Monday 2/15 that patient developed a rash at the injection site between Saturday and Sunday that was warm to the touch but not raised, itchy, or painful.  Advised him to take tylenol, cool compress to the site, and follow up with PCP,
Day after receiving the vaccine I had very intense arm pain, swollen lymph node in the effected armpit and a terrible headache. I?ve had a nonstop headache since the morning after the vaccine. On 10/18/21 around 5pm I began to feel heart flutters.
February 2021- Menstrual cycle started 18 days early, with much heavier bleeding and quarter-sized clots which have lasted for each cycle since Feb.  April 2021- Body rashes, possible eczema, still working with dermatologist and rheumatologist on definite diagnosis.  April/May 2021- daily generalized headaches started; increased anxiety with bouts of depression began; increased daily fatigue.  June 2021- itchy, red, inflamed lower eyelids bilaterally with extreme eye dryness.  July 2021- muscle stiffness and weakness became more noticeable; scalp rashes begin; increased entire body rash/eczema.
COVID Breakthrough  J&J Dose 4/10/21 (043A21A) COVID Positive 8/16/21  8/18/21: Patient is a 63-year-old male diagnosed with COVID-19 on August 16 presents to ER with chief complaint of shortness of breath that is associated with generalized fatigue and poor p.o. intake.  Patient states that he is vaccinated with Johnson and Johnson vaccine, recently traveled, developed respiratory symptoms approximately 8 days ago.  Evaluations completed the emergency room noted for fever T-max of 101.3°, stable blood pressure, hypoxia requiring supplemental oxygen. Patient was treated with bronchodilator, empiric azithromycin.  8/22/21: A 63-year-old gentleman presented to the emergency room with increasing shortness of breath and fatigue. Patient spiked a fever of 101.3.  Further evaluation suggestive of COVID-19 pneumonia. The patient was admitted, eventually started on remdesevir, dexamethasone, and empiric antibiotic therapy.  The patient's condition progressively improved. His oxygen requirement returned to baseline, eventually off oxygen, saturating well on room air. The patient reports feeling better.
T105.3, sz;pulse 173;pulse ox 93%, R27, 36;pt crying;febrile sz;
out is "spots" on his back, side,stomach, and back of neck; This case was reported by a consumer and described the occurrence of rash in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   The reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in left arm. After receiving Shingrix, the patient experienced rash. The patient broke out was spots on his back, side, stomach, and back of neck. The physician told him the rash was a result of the Shingrix vaccine. The reporter consent to follow up. This case has been linked with US2020AMR245356, reported by same reporter and same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR245356:same reporter
74 Y.O. received COVID-19 Vaccine 12/28/2020 and subsequently developed orthostatic hypotension, visual changes, headache, lightheadedness, and diaphoresis. Patient was transferred to local ED for further assessment to r/o MI, CVA, vasovagal rxn, or vaccine rxn. Patient monitored, no treatment required, discharged home. Patient did not receive 2nd COVID-19 vaccine d/t rxn with 1st vaccine.
WOKE UP NOT WANTING TO EAT AT 7 AM. NOTICED HEAD WAS TO THE SIDE AND WHEN I PICKED HIM UP HE CRIED. HE CANNOT MOVE HIS HEAD TO THE OPPOSITE SIDE AND WHEN HE STRETCHES IT HURTS HIM BECAUSE HE CANNOT MOVE HIS HEAD. WE TRIED FEEDING HIM SEVERAL TIMES ON THIS DAY AND HE VOMITED EACH TIME. HE IS VERY TIRED AND DOES NOT WANT TO BE BOTHERED. HE CRIES WHILE HE SLEEPS WHEN HE TRIES TO MOVE HIS NECK TO A BETTER POSITION. DOES NOT HANDLE HARD SURFACE SO HE SLEEPS ON OUR BED. TRIED TO FEED HIM SO HIS HEAD WOULD HAVE TO MOVE AND HE CRIED IN PAIN AND VOMITED. CAN ONLY EAT IN MY RIGHT ARM AS HIS HEAD IS FACING ME. HIS TORSO IS TURNED IN THE SAME DIRECTION MAKING HIS BODY LOOK LIKE A SIDEWAYS LETTER C. CANNOT HOLD HIM AS IT HURTS HIS NECK. CANNOT DRESS HIM AS HIS NEXT IS SO TIGHT TO HIS SHOULDER CANNOT GET A PROPER SHIRT ON WITH OUT DISTRESS.
Symptoms began 9/12/21 with a lump and swelling and tenderness / soreness about two inches above the nipple of my left breast (51 days after receiving Janssen / Johnson & Johnson vaccine). My menstrual cycle started on 9/10/21, two days before symptoms began. Menstrual cycle ended on 9/14/21. Four days later on 9/16/21, I visited the gynecologist. Left breast soreness had gone down slightly. Gynecologist examined both breasts and recommended a bilateral mammogram and ultrasound. The following day, 9/17/21 (exactly 8 weeks since receiving the Janssen vaccine), I had a 2-D and 3-D bilateral mammogram and targeted (limited) ultrasound. Radiologist found:   "IN THE AREA OF PATIENT CONCERN, THERE IS DENSE HETEROGENEOUS BREAST TISSUE BUT A DISCRETE MASS IS NOT IDENTIFIED. THERE IS ALSO A NODULE WITH A LUCENT CENTER IN THE AXILLARY REGION WHICH I SUSPECT IS LIKELY DUE TO A LYMPH NODE AS WELL AS AN ENLARGED LEFT AXILLARY LYMPH NODE. FURTHER EVALUATION FOR ALL THESE FINDINGS WAS PERFORMED AND ULTRASOUND EXAM. LEFT ULTRASOUND: REAL-TIME SONOGRAPHIC EVALUATION OF THE LEFT BREAST WAS PERFORMED IN THE AREA OF PATIENT'S PALPABLE LUMP AS WELL AS AXILLARY TAIL AND AXILLARY REGION FROM 12-2 O'CLOCK. AT THE 12-1 O'CLOCK LOCATION, THERE IS A DEEP COMPLEX CYST SEEN MEASURING 11 X 7 X 8 MM WITH ADDITIONAL SIMPLE CYSTS SEEN MEASURING 3 AND 4 MM EACH. A 1:00, THERE IS A 10 X 49 MM LYMPH NODE WHICH CORRESPONDS TO THE LESION SEEN MAMMOGRAPHICALLY. EVALUATION THE AXILLA DEMONSTRATES AN ENLARGED LYMPH NODE MEASURING 27 X 9 X 12 MM CORRESPOND TO THE MAMMOGRAPHIC FINDING AS WELL. CONCLUSIONS: LEFT BREAST PALPABLE LUMP CORRESPONDS TO A SIMPLE CYST AS WELL AS A MORE DEEPER COMPLEX CYST FOR WHICH A SIX MONTH FOLLOW-UP MAMMOGRAM AND ULTRASOUND IS RECOMMENDED. ENLARGED LEFT AXILLARY LYMPH NODE WHICH IS SUSPECT IS LIKELY DUE TO RECENT COVID VACCINATION AND THEREFORE A FOLLOW-UP LEFT AXILLARY ULTRASOUND IN 2 MONTHS IS RECOMMENDED FOR RESOLUTION AND/OR STABILITY."  As of today?s date, 9/23/21, lump and tenderness still remain, but not as sore as at onset on 9/12/21. Need to schedule: - FOLLOW-UP LEFT AXILLARY ULTRASOUND IN 2 MONTHS - FOLLOW-UP SIX MONTH FOLLOW-UP MAMMOGRAM AND ULTRASOUND IS RECOMMENDED.
Initial report received from a newspaper article on 03 Mar 2010: This patient was vaccinated with the seasonal influenza vaccine (manufacturer unknown) in Nov 2009. The patient went to the emergency room on 09 Jan 2010 due to the pain in stomach and back. Some examinations were performed and the patient admitted in emergency surgery ward as it seemed a renal colic. After 5 days, the patient fell on the floor since her legs were weak. CAT (computerized axial tomography) and lumbar puncture were requested by the neurologists but no results were available. Four days later, the patient had an epileptic-like reaction whilst asleep. Next day, the patient was transferred to neurology ward. The patient's condition worsened and further examination were performed including magnetic resonance. As corrective measure, phleboclysis was given for 10 days and condition began to improve. On 01 Feb 2010, the patient was discharged with a diagnosis of GUILLAIN BARRE syndrome. The local health unit denied the link between vaccination and disease.
This is 1 of 4 pt from this site to exp adverse rxn @ inj site of redness. No further info.
NOT FEELING WELL; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-JUL-2021, Laboratory data included COVID-19 antigen test positive (NR: not provided) Positive. On an unspecified date, the subject experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not feeling well was not reported. This report was non-serious.
Arm was a little sore; No appetite; Cannot do anything; A terrible feeling; Feeling more tired/ very very tired; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Arm was a little sore), DECREASED APPETITE (No appetite), DEPRESSED MOOD (Cannot do anything), FEELING ABNORMAL (A terrible feeling) and FATIGUE (Feeling more tired/ very very tired) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 0I5M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included ALPRAZOLAM (XANAX) and LEVOTHYROXINE SODIUM (LEVOXYL) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was a little sore), DECREASED APPETITE (No appetite), DEPRESSED MOOD (Cannot do anything), FEELING ABNORMAL (A terrible feeling) and FATIGUE (Feeling more tired/ very very tired). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Arm was a little sore), DECREASED APPETITE (No appetite), DEPRESSED MOOD (Cannot do anything), FEELING ABNORMAL (A terrible feeling) and FATIGUE (Feeling more tired/ very very tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was taking an unspecified high blood pressure medication.
Ringing in my ears the very next day was told the vaccine has caused tinnitus in some people
Very large area of erythema (red, warm, swollen, tender) on deltoid portion of left arm developed within 24 hours of vaccine that took 2 weeks to resolve. Two weeks after receiving this vaccine aching, numbness, and tingling (paresthesia) symptoms began in both feet and within 2 weeks turned into burning (like frostbite) pain in both feet. Then over the next 2 weeks progressed up both lower legs, hands and arms. I am currently 3 months post-vaccine with ongoing neuropathy pain (which I have never had before receiving this vaccine).
I woke up with chills, fever 99.9 ,mental fog ,, headache and   pain in my legs at 2 am Feb 28  which continued until 4pm of the same day. Then the pain in my legs subsided but fever, chills , headache and mental fog continued until March 1 at about 1pm. At that point the only symptoms were mental fog and exhaustion.
pt recv vax & devel a fever of 100.6 & an inj site rxn characterized by redness & swelling which extended to the elbow;pt was seen by MD & treated first w/DOxycycline & Zyrtec then w/E-mycin & DPh;
After receiv. FLUMIST pt stood up to leave, turning door knob and fainted, hitting head on the wall. As soon as nurse went to assist pt and yelled for help pt aroused. Pulse stayed strong and regular. Pt was not pale or clammy. Assisted to sitting position gave cold cloth and juice and referred to ER.
Breakthrough covid case; Pt presented to ER with c/o of congestion, sore throat, cough and headache. Hx of Pfizer vaccine x 3. Prescribed Paxlovid. DC home.
CASE WAS VACCINATED USING MODERNA 1/05/21 (LOT 025J20A) + 2/02/21 (LOT 03OL20A). S/O BEGAN 8/29/21, TESTED + 9/3/21
New onset generalized hives on day 9 after 2nd dose of Moderna. Today is day 27 and sx have not yet resolved after PO Medrol pack x1, IM Kenalog injection x1, PO antihistamines prn. Denies previous hx of prolonged hives episode, denies suspected food or enivormental triggers,
my right eye felt droopy lid; severe chills; felt so cold despite blankets and sweater; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 27Sep2021 at 13:30 at the age of 53-year-old as single dose for COVID-19 immunization. Medical history included lupus, HX antiphospholipid antibodies, pulmonic stenosis and sjogren's. The patient didn't receive other vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 (Nasal Swab) on 07Oct2021 and result was negative. Concomitant medication included warfarin and hydroxychloroquine. The patient previously received dilaudid and experienced allergy. On 27Sep2021 at 18:30, the patient experienced severe chills, felt so cold despite blankets and sweater. Then about 6hrs later the right eye felt droopy lid. Since patient was feeling to cold he stayed under covers for hours until I felt warm. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment was received included steroid eye drops. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Several days after receiving a flu shot on 9/27 (and a COVID booster on 9/16), I began experiencing full-body nerve pain that began as intense and uncomfortable tingling and days later morphed into burning, pinching and stabbing pain. It began intensely in my feet and toes and traveled through my knees, groin, and up into my face. I also began experiencing electric-feeling zaps in random spots all over my body.
On the second day, I had the pain it was really bad pain; I felt my legs like they were burning and throbbing and then it got swollen, both leg got swollen, right leg more than the other; I felt my legs like they were burning and throbbing and then it got swollen, both leg got swollen, right leg more than the other; I felt my legs like they were burning and throbbing and then it got swollen, both leg got swollen, right leg more than the other; Rush in my head it went on the top off my head; Dizziness; Fast heart beat but it was for few minutes; My leg and my lower body started hurting me a lot; My leg and my lower body started hurting me a lot; I was trying to get inside the car I was having problem, once I got home I was having slight problem with going up the stairs to enter my home; I felt like I had a breakout in my mouth like the small, like there were blisters inside my mouth, my gummies behind the lip area; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EK5730), via an unspecified route of administration on 29Dec2020 at SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  Consumer stated, "I had the COVID-19 Vaccine on the 29th of December and I have been told that I should report the reactions that I had." When probed what were the reactions: Consumer stated, "The first day when I received it, I felt like a rush in my head it went on the top off my head and then they were observing me for 15 minutes, I felt dizziness and then fast heart beat but it was for few minutes and then when I was there for 15 minutes they send me home, my leg and my lower body started hurting me a lot and then I was trying to get inside the car I was having problem, once I got home I was having slight problem with going up the stairs to enter my home and then once I got home I felt like I had a breakout in my mouth like the small, like there were blisters inside my mouth, my gummies behind the lip area. And my leg were really hurting me. On the second day, I had the pain it was really bad pain, I felt my legs like burning, like they were burning and throbbing and then it got swollen my leg got, both leg got swollen, right leg more than the other and I had to call my doctor she called me the next day and she told me to take Tylenol on the third day. So, I took Tylenol and I took some Benadryl (treatment) as well, I was having problem going up the stairs and everything." The outcome of the events was unknown.
Patient reports having loss of appetite, diarrhea, headache, achiness, tiredness.
Breakthrough case admission after 2 vaccines Moderna 3/4/21 Lot# 018B21A;  Moderna 4/21/21 lot# 025B21A
It swells my face; I have numbness; Tingling of the whole thing in my lip; pins and needles in the left side of my mouth/sometimes it goes across my lip and into my right side; she did not get the second dose because her face is bad/more than 36 days after the first dose without receiving the second dose; hair loss; a hole in her hair; bells palsy; This spontaneous case was reported by a nurse and describes the occurrence of FACIAL PARALYSIS (bells palsy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020. Previously administered products included for an unreported indication: ZOSTAVAX (Shingles vaccine).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced FACIAL PARALYSIS (bells palsy) (seriousness criterion medically significant). On an unknown date, the patient experienced SWELLING FACE (It swells my face), HYPOAESTHESIA (I have numbness), PARAESTHESIA ORAL (Tingling of the whole thing in my lip), ORAL PAIN (pins and needles in the left side of my mouth/sometimes it goes across my lip and into my right side), PRODUCT DOSE OMISSION ISSUE (she did not get the second dose because her face is bad/more than 36 days after the first dose without receiving the second dose), ALOPECIA (hair loss) and HAIR INJURY (a hole in her hair). At the time of the report, FACIAL PARALYSIS (bells palsy), SWELLING FACE (It swells my face), HYPOAESTHESIA (I have numbness), PARAESTHESIA ORAL (Tingling of the whole thing in my lip) and ORAL PAIN (pins and needles in the left side of my mouth/sometimes it goes across my lip and into my right side) had not resolved and PRODUCT DOSE OMISSION ISSUE (she did not get the second dose because her face is bad/more than 36 days after the first dose without receiving the second dose), ALOPECIA (hair loss) and HAIR INJURY (a hole in her hair) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   She stated that on the third week after the vaccine, she experienced bells palsy.; Sender's Comments: This case concerns a 71-year-old female with a serious unexpected event of facial paralysis, along with nonserious unexpected swelling face, oral paraesthesia, hypoesthesia, oral pain, alopecia, hair injury and product dose omission issue. Based on 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.
Decedent received the Oral Polio Vaccine at the doctor's office on 05/22/2002. Soon after he began developing polio vaccine related quadriplegia. Per F/U 6/20/02: COD-asphyxia due to mechanical ventilator failure dut to polio vaccine related quadriplegia; therapeutic complication.