chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist and refers to a 65 year old female patient. She had no pertinent medical history and drug reactions or allergies. On 20-SEP-2017, the patient was vaccinated with ZOSTAVAX injection, 0.65 ml, subcutaneously, lot # N013274, expiry date 08-AUG-2019 (vaccination site was not reported) to prevent shingles which was reconstituted with sterile diluent (MERCK STERILE DILUENT) injection (dose, lot # and expiry date were not reported). Concomitant therapies included meloxicam (MOBIC), gabapentin and tizanidine hydrochloride (ZANAFLEX). On an unspecified date in September 2017, the patient developed bronchitis. On 26-SEP-2017, she sought medical attention and was seen by an unspecified physician. At the time of reporting, the patient was visiting the pharmacy to fill a prescription for prednisone (manufacturer unknown) to use as a treatment for bronchitis. No lab diagnostic studies were performed. The outcome of the event was reported as not recovered/not resolved. The reporter did not provide the causality assessment between the event and the suspect products.
Patient had a rash all over the upper arm, doctor treated her with prednisone, cephalexin and loratadine.
Strong heart pain (roused from sleep, unable to fall back asleep), diagnosed as myopericarditis. Most symptoms faded within 4 hours, possibly due to hospital intervention.
Mild febrile illness with myalgias at 4-5 days post-vaccination, but then with onset of diffuse, pruritic, acneiform (pustular) rash on post-vaccine day 11.
Chest pains, sore left arm where shot was given,  painful swollen lymph nodes under left arm pit, bad head pain, eye pain from the head pain, elevated blood pressure (even after medication), body pain everywhere, diarrhea, nausea, lost of appetite, neck pain from the head pain, constipation, left/right side  stomach pain, left/right muscle spasms in both calves, dry mouth, thirsty, dry nostrils, and ear drainage from right ear.
dizziness, nausea, body aches, chills, fatigue for about 48 hours
pt recv vax & devel an inj site rxn characterized by swelling &  a knot;pt recovered p/ 2 to 3 wk;
Scratchy throat; Cough; Body aches; Fever; Chills; Headache; extreme tiredness; Stomach pain; Multiple loose stool bowel movements; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old unknown gender patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the arm left on 14May2021 at 12:30 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included pantoprazole sodium sesquihydrate (PROTONIX), ubidecarenone (CO Q-10), rosuvastatin calcium (CRESTOR), progesterone (MANUFACTURER UNKNOWN) and estradiol (ESTRACE); all from unknown date for unknown indication. The patient previously took whey protein on unknown date and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021 at 11:00 the patient experienced congestion, scratchy throat, cough, body aches, fever, chills, headache, extreme tiredness, stomach pain, multiple loose stool bowel movements. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events congestion, scratchy throat, cough, body aches, fever, chills, headache, extreme tiredness, stomach pain, multiple loose stool bowel movements were not recovered.  No follow-up attempts are needed. No further information is expected.
Recap/High level: got clots and PE following IVs in multiple hospital stays in a month. Right arm, PE, then left arm. Timeline: April 20: Pfizer Shot 1 (vaccination caused me to jump and she stuck the needle really high. Hurt. Large red circle days later).   May 11: Pfizer Shot 2  May 25: Hospitalized - large kidney stone blocking kidney, enlarged kidney. IV placed. Stent placed. Released.  May 28th: saw Dr.- feeling short of breath. Dr thought from iv fluids. Prescribed diuretic.  May 31st: arm swelling, shortness of breath, went to ER - DVT rt arm - 2 Clots, small pulmonary embolism, both said to be related to IV from first hospital visit. released 6/2 on thinners  Blood in urine turned to passing large clots  6/8 Back in ER. Tremendous blood in urine. Passed huge clots. Thought from stent and thinners. Surgery to break and remove stone. IV in left arm. released 6/11.  Quickly felt a ?marble? like bubble in left arm  June 15: saw Dr. Sent for arm ultrasound. Clot found in left arm  Left arm resolved, PE resolved, RT clots moved to superficial veins. Stopped thinner after 3 months  Still  have right arm clot.   Scheduled for booster
Patient is 6 years old and received a FLUAD Vaccine which is intended for 65 years and older. Patient experience no symptoms or adverse reactions to this immunization.
Red swollen area about 4inches long hurts to touch and itches. Rash on face all the way down to the chest that itches.
This spontaneous report as received from a pharmacist refers to a 74 year old male patient. Patients medical history includes allergy to PERCOCET. Concurrent conditions include diabetes, high cholesterol and high blood pressure. On 07-JUL-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J014812, expiry: 20-FEB-2015) 0.65 ml, subcutaneous. Concomitant medications include unspecified blood thinner. On 09-JUL-2014 the patient experienced developed redness and itchiness after receiving ZOSTAVAX. The patient had taken BENADRYL on 07-JUL-2014 after ZOSTAVAX. The patient sought medical attention went into the pharmacy and informed the pharmacist on 10-JUL-2014. No treatment was given for the events. No laboratory tests were performed. The reporter stated that the patient had a white area on an unspecified location on his arm but states that is from when they used to do punch cards for vaccinations when the patient was a child. The outcome of developed redness and itchiness after receiving ZOSTAVAX was reported as not recovered. Causality was not reported. Additional information has been requested.
This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT ("weird feeling in head"), ILLNESS (sick over the weekend for 48 hours), DISCOMFORT ("like a pressure feeling"), PYREXIA (fever) and CHILLS (chills) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Lot 037B21A and 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included VITAMINS NOS for an unknown indication. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced ILLNESS (sick over the weekend for 48 hours), DISCOMFORT ("like a pressure feeling"), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue). On 09-May-2021, the patient experienced HEAD DISCOMFORT ("weird feeling in head"). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-May-2021, PYREXIA (fever) and CHILLS (chills) had resolved. On 12-May-2021, FATIGUE (fatigue) had resolved. At the time of the report, HEAD DISCOMFORT ("weird feeling in head"), ILLNESS (sick over the weekend for 48 hours) and DISCOMFORT ("like a pressure feeling") outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable.
stroke; foreign neuropathy; can't talk well/can't sing the way she used to/hard to talk; can't walk well; dominant hand doesn't work; angry; numb; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) and NEUROPATHY PERIPHERAL (foreign neuropathy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hyperthyroidism (started a decade ago and still taking medication for it). Concomitant products included METHIMAZOLE for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (foreign neuropathy) (seriousness criterion medically significant), SPEECH DISORDER (can't talk well/can't sing the way she used to/hard to talk), GAIT DISTURBANCE (can't walk well), MOVEMENT DISORDER (dominant hand doesn't work), ANGER (angry) and HYPOAESTHESIA (numb). The patient was hospitalized for 30 days due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), NEUROPATHY PERIPHERAL (foreign neuropathy), SPEECH DISORDER (can't talk well/can't sing the way she used to/hard to talk), GAIT DISTURBANCE (can't walk well), MOVEMENT DISORDER (dominant hand doesn't work), ANGER (angry) and HYPOAESTHESIA (numb) outcome was unknown.            The patient reported that she was given blood thinners and cholesterol medications.  Company comment: This is a spontaneous case concerning a 68-year-old female patient with  Hyperthyroidism, who experienced the serious unexpected event cerebrovascular accident,  approximately 54 days after the second dose of mRNA-1273.  Patient was hospitalized for 30 days due to CVA: events related included speech disorder, gait disturbance and movement disorder on dominant hand. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a 68-year-old female patient with  Hyperthyroidism, who experienced the serious unexpected event cerebrovascular accident,  approximately 54 days after the second dose of mRNA-1273.  Patient was hospitalized for 30 days due to CVA: events related included speech disorder, gait disturbance and movement disorder on dominant hand. The benefit-risk relationship of mRNA-1273 is not affected by this report.
The day after the vaccination, patient reported pain at injection site with no other symptoms. We asked if there was any redness or fever. No fever but she couldn't see if it was red. She came in and showed us. It did not appear red. She was advised to monitor for any signs of worsening or new symptoms that may arise. Recommended no action if condition begins to improve, go to ER if any signs of generalized reaction or if worsens considerably, see doctor if doesn't improve as expected or if slightly worse. The next morning it was more swollen, warm, and red. She saw the doctor and they called to check lot and exp and which arm. They later prescribed steroid and antibiotic. Patient reports that Dr believes it to be an infection. I called the doctor's office near end of day for diagnosis and they said the doctor hadn't written the notes yet and they would call me back. I did not get a call back and do not have final diagnosis information. The administering pharmacist reports using gloves and alcohol swab as per protocol.
This case was reported by a other health professional via call center representative and described the occurrence of myalgia in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of myalgia (1st dose received on an unknown date, refer case US2019050460). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced myalgia, influenza-like symptoms and chills. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the myalgia, influenza-like symptoms and chills were unknown. It was unknown if the reporter considered the myalgia, influenza-like symptoms and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected adult as per vaccine indication. The health care professional mentioned that the patient mentioned having worse myalgia, flu-like symptoms,including chills. Did not consent to follow up.
Within 5-10 mins of injection, dizziness, throat pain/ tightness, difficulty swallowing.  Treatment 50 mg of Benadryl.  Outcome. stable.
mental exhaustion; Recurring cluster headaches; migraines; confusion; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EN6202), via an unspecified route of administration, administered in Arm Right on 25Feb2021 14:45 (at the age of 30-years-old) as single dose for covid-19 immunisation. The patient's medical history included obesity and tree nuts. Patient was vaccinated at a hospital. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. The patient's concomitant medications included ibuprofen (MIDOL) and mepyramine maleate, pamabrom, paracetamol (PAMPRIN). On 25Feb2021 at 18:15, the patient experienced mental exhaustion, recurring cluster headaches, migraines and confusion. The outcome of the events was not recovered. The patient did not receive any treatment for the adverse events experienced by the patient.  No follow-up attempts are possible. No further information is expected.
Tired. Dizziness. Light headed. Slight chills. Heaviness in my "core". Nausea. Loud, heavy heart. Achiness in my legs. Ringing in both ears.  Took 800 mg ibuprofen 3.12.2021 @ 12:30am. All symptoms resolved by 2:00pm on 3.12.2021 with the exception of Ringing in my ears. that is ongoing.
Rash at injection site, bruising, dull pain in the area that reaches up to collar bone, itchiness
Numbness with right foot and toes, painful and had to walk on her heels, chest pressure, and had idiopathic fevers. rash on her arm.  Saw Allergist on 03/17/2021 for these problems. Dr's won't allow her to get the booster as they had to put her on Prednisone for 3 days and 1 day after as well.
Pt reports she starting itching Wednesday (9/19) evening. On 9/20, the itching was worse. She took 2 BENADRYL liquitabs about 500 pm which helped. On 9/21 she awakened & her tongue felt thick and her lips felt numb. To clinic 1115am to ER 9/21/12.
Left upper arm swollen, warm to touch bumps on right arm.  Temperature 103 on 08/17, on 08/18 98.9 degrees.  Left arm tender with full range of motion.  Seen by doctor ordered Motrin as needed.
Around 5pm arm was hot, sore, swollen, red, and affected area was large.  Put cool compress.   Next day, fever was around 99.9, had muscle aches, headache, and nausea; symptoms lasted for about 3.5 days--basically had to stay in bed.   Used cold compresses in area but did not seem to help.  Took ibuprofen to help.   Patient did not call doctor.   Eventually symptoms started to disappear but soreness and redness on arm lasted 3 more days.
This infant received shots on 04/12/01. She had a fever of 102.7 2 - 3 days fluctuating degrees, with Tylenol. A rash was noted (hives) "all over her entire body". She received children's Benadryl on 04/14/10 through 04/15/01. The hives started  to disappear on Sunday and the hives were completely gone by Monday 04/16/01. The infant is to see a doctor today in the AM on 04/19/01. No problems noted instructed per doctor to inform us of a reaction. The mother  was instructed to have doctor write orders for DT next time.
cold chills, tired, nausea, nearly vomiting, trouble sleeping. about 24 hours
My already sore joints became more sore and I developed a fever and an inability to get comfortable for sleep. I also had a headache. The fever was about 100.3 ° f
Four days after the vaccine it started as a rash, bumps raisin up all over my body, it was red and I was having problems swallowing so that is when I decided to go to the ER 05/06/2021  I was put on steroids and was given EPI pin. I was sent home the next day and it got worse so I went back to the hospital and I was given stronger steroids. This went on for about 3 weeks, I was referred to an allergist but nothing was found.
Information has been received from a physician concerning a 71 year old female who on 12-JUN-2007 was vaccinated with a 0.65 ml dose of ZOSTAVAX. Concomitant vaccination that same day included tetanus toxoid (given in the other arm). Concomitant therapy included other unspecified medication. On 16-JUN-2007 the patient experienced chills, shaking, diarrhea, general aching and she developed a chickenpox rash. Medical attention was sought, the patient consulted the physician on 19-JUN-2007. Lab studies performed included an erythrocyte sedimentation rate which was 102 and a serum C-reactive protein test which was 195.50. There was not product quality complaint involved. No further information was provided. Additional information has been requested.
allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (allergic reaction) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (allergic reaction). At the time of the report, IMMUNISATION REACTION (allergic reaction) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant medication was provided by the reporter.  Patient was getting a Pfizer bivalent booster and reported that patient had a two different version one that use a potassium chloride route. It was also reported that patient had an allergic reaction with Moderna Covid-19 vaccine previous shots due to the presence of tromethamine.  No treatment medication was provided by the reporter.
1.  Pain and soreness in my muscles, bones and joints in all parts of my body.  2. It is difficult to move without pain and discomfort. 3.   "Brain Fog"  I am unable to remember names, exact dates. 4.  Repeating the same information. 5.  Irritability, moodiness - mood disorders.
Extreme soreness in Left upper arm; chills; headache; tiredness; feeling like I had the flu; extreme weakness; rapid heartrate; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration in the left arm on 29Jan2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history included penicillin allergy, coronary artery disease (CAD), hypertension (HTN), pulmonary hypertension, sick sinus syndrome, hypothyroidism, hyperlipidemia, osteoporosis, chronic kidney disease (CKD), and diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included alprazolam (XANAX), venlafaxine hydrochloride (EFFEXOR), quetiapine fumarate (SEROQUEL), sertraline hydrochloride (ZOLOFT), isosorbide mononitrate (IMDUR), and metoprolol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021 02:15, the patient experienced extreme soreness in left upper arm, chills, headache, tiredness, feeling like she had the flu, extreme weakness, and rapid heartrate. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious.
Initial information was received 03 September 2013 from a healthcare professional. A fetus was exposed in-utero to ADACEL vaccine (Lot number U4421AA) and an injection of Influenza vaccine (lot number not reported, manufacturer unknown) on unspecified dates. On 10 December 2012, the complication of fetal demise occurred due to umbilical cord occlusion with fetal vascular thrombus formation at 32.1 weeks. The outcome was fatal. This case is linked to the non-serious mother case 2012-11414. Documents held by sender: None.
First five minutes: burning down left arm, then left arm went numb. First 15 minutes, Burning moved across chest, chest cavity went numb. 30 minutes: Burning down right arm, right arm went numb. 45 minutes, burning in face, throat, mouth, all went numb, tonque swelled. Treated with Benadryl, zantac, and tylenol. 24 hours later felt like I had been hit by a truck,  48 hours later all symptoms subsided.
I?m not sure if the symptoms I experienced are considered an adverse event, but a friend advised me about this site to report it.  I woke up at 245AM the day  vaccine, and felt severe pain in my arm, and it was red and swollen. I then started feelings chills, and took 1000mg of Tylenol. A couple hours later, I started feeling really hot and had body aches.  I took 1000mg of Tylenol. Throughout the whole day, I could not get up and move around, and was sleeping a lot. I felt hot but had chills, and was lethargic. I finally felt better, when I woke up on the second day. It is now the third day, and I still have pain and swelling on my arm, but the redness is less.
5PM pt began screaming, felt warmer than nl;5-9PM on & off crying;slept 9PM-1AM very restless;1AM mom checked temp 104.5 R;had been giving APAP q 4hr;took pt to ER;given Motrin & temp dec to 99;intermittent screaming;chills, appetite dec;
Covid 190 vaccine by pfizer pediatric donse use for COVID-19 under Emergency Use Authorization (EUA):Patiwent=Patient received dose for 11 and under pfizer covid vaccine and will need to receive second adult dose.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE LEFT SUBCLAVIAN STEAL SYNDROME 2/5/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
67yr old male presented to ED from nursing home. Staff at nursing home states that patient had a fall Sunday night and is now having emesis x2.  2nd emesis is positive for occult.  Wife present at bedside states that spouse is more hard to understand today that he was yesterday.  He has become more "jittery" the last couple of days.     Dehydration    2. AKI (acute kidney injury) 3. Hematemesis with nausea   ED in hospital from 11/10-11/17, continued on Vancomycin upon discharge back to Nursing home.
Pt clammy, light-headed, pt rested with feet elevated, given water BP 148/80, P 90. 9:55 AM skin texture WNL. 10:15 AM c/o swelling/fullness in neck, uvula red and swollen BP 128/80 P 80 911 called.
The day after my injection I had severe nausea, chills and throughout the day I started getting worse. my whole body hurt, I could not even sit, I felt like my body was on fire. My energy was zapped! My right side where I received the vaccine swelled up to my neck and to my right breast which was also red and warm to the touch.  I ran a low grade fever. This all lasted for about a week
sore arm, mild; tiredness, muscle pain, headache, shivering, fever, stomach pain, nausea, lasting from Wed. night to Fri morning.
Headache, Myalgia, Arthralgia, NauseaVomiting, swollen glands, fatigue, Narrative: