chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given a COVID-19 vaccine not authorized for their age group. Patient was monitored for 15 minutes after the injection and no side effects were observed at that time. To this date, patient and/or guardian has not reported any side effects, or symptoms since being vaccinated. Patient has since completed the vaccination series as recommended. A discussion occurred about how the error took place and strategies have been implemented to ensure the error does not happen again.
got exposed to a COVID positive; This is a spontaneous report received from a contactable consumer (reporting on himself) via Pfizer-sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported) via an unspecified route of administration on 23Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that on 23Jan2021 patient received his first dose of BNT162B2 and on 01Feb2021, got exposed to a COVID positive. He tested COVID positive. Patient was asking If he should take second dose of vaccine. The outcome of the event was unknow.    Information on the batch/lot number requested.     Follow-up attempts are completed. No further information is expected.
Pt was signed up for an appt for her first dose. Multiple calls were made to administration regarding her appt including Lt Col (Dr.) Direction had been provided earlier that week that clinical concerns could be channeled to Lt Col (Dr.) for determination of tx. It was discussed that she was 17, and active EMT and had a parent present at time of vaccine. It was discussed that we were not supposed to be vaccinating minors but she had a appt and met 1A criteria. Approval was given to vaccinate pt. Upon the pts second dose, administration was again contacted and it was determined pt should not be given the second dose. This writer spoke both with pt and mother.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 09Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 21Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 18May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. patient received Treatment as Paxlovid.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Swelling, pain.  Later developed hematoma 6.8cm by 5.6cm, thickness of hematoma was 1.5cm.
severe seizure; This is a spontaneous report from a medical information team. A contactable consumer (patient mother) reported that a 37-years (severely disabled) old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 18Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated both she and her daughter received the Pfizer Covid vaccine first dose on 18Mar2021. On 20Mar2021 her daughter had a severe seizure and was hospitalized for 4 days (from 20Mar2021 to an unspecified date in Mar2021). The patient mother wants to know if it's safe for her daughter to get the second dose of the vaccine. The seriousness for the event was hospitalization and medically significant. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
PREVNAR 13 (prefilled syringe) given on 5/7/13. A couple days later redness - warmth around area. Patient claims the redness/warmth keeps spreading as of 5/15/15, redness/warmth from injection site down to elbow. Went to immediate care facility-ROCEPHIN shot and steroid injection as well prescribed doxycycline to pt.
Patient had bruising and swelling of arm for 30 days after first Pfizer vaccine.  Patient has hx of G6PD and believes it is correlated.
High fever 6APR noon to 104.5 CR APAP given; 9APR rash (allergic react) all over body;
By morning following vaccine (each time) had fever, cough, body aches lasted 1-2 wks.
The bowel habit changes, continued but did not get worst; Achy; Tired for a few days; This spontaneous case was reported by a consumer and describes the occurrence of CHANGE OF BOWEL HABIT (The bowel habit changes, continued but did not get worst), PAIN (Achy) and FATIGUE (Tired for a few days) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced CHANGE OF BOWEL HABIT (The bowel habit changes, continued but did not get worst), PAIN (Achy) and FATIGUE (Tired for a few days). On 06-Apr-2021, PAIN (Achy) and FATIGUE (Tired for a few days) had resolved. At the time of the report, CHANGE OF BOWEL HABIT (The bowel habit changes, continued but did not get worst) had not resolved.            No concomitant medications were provided.  No treatment medications were reported.  The patient had the usual side effects: achy, and tired for a few days. The bowel habit changes, continued but did not get worst.   This case was linked to MOD-2022-455152, MOD-2022-455073, MOD-2022-455338 (Patient Link).
AFTER RECEIVING THE VACCINE, SHE COMPLAINED OF A HEADACHE. ONSITE EMS WAS REQUESTED. HER BP WAS 134/82 AND HR WAS 82  THE HEADACHE SUBSIDED, AND SHE WAS RELEASED TO HOME
Severe rash, Severe redness, swelling, peeling, blisters on her body. Ointment therapy.
Local swelling, pain, hives, itching 11 days post. Received decadron and depo. medrol.
This spontaneous report was received from a pharmacist refers to an 18 year old patient who's a nurse practitioner (demographics unspecified). Pertinent medical history and drug reactions were not reported. On an unknown date the patient received PROQUAD instead of M-M-R II. Concomitant medications were unspecified. No adverse symptoms were reported. Outcome of the event, wrong drug administered was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Delayed menstrual cycle, by exactly two weeks from last dose, extreme cramping and blood clots
From the date of the vaccine given I only had a sore arm for a couple of days.  Nothing then until day 7 then I started to feel run down and noticed a lymph node on my left chest at the clavicle.  It was large .  I wasn't thinking about my vaccine at all at that time.  I made an appointment with the PAC and he was concerned about it and had me do an ultrasound and blood work.  The ultrasound showed nodes measuring 4-16 mm concerning for lymphoma or just reactive. Then I had a ct and the  impression was indeterminate left axillary lymphadenopathy.  For the next 7 days I was home in bed a lot and was not able to take call as scheduled at my work place.  They hurt and I also developed a rash on the injection site, the back, the scalp and neck.  It itched and was annoying.   As the days progressed my nodes on my chest hurt and I could feel them as well as my groin  and abdomen.  January 28 my left arm started burning and hurting when I stretched it out to do activities or work.  February 1 a lymph node appeared in my inner elbow space I confirmed this with my Dr. that it was a lymph node.  It doesnt hurt as much now as before it swelled.  Not drinking extra water on any given day makes them all hurt more.    I felt rotten enough the 7-14 days after I had a covid test and it was negative.  I just found out today that my Covid 2 igG  Sar2 GB was positive on 1/14/21.  My other lab work was perfect
She experienced severe chest pains within the first 24 hours of the vaccine. The pains have lingered on and off for a week after. She has severe fatigue, headaches, nausea, and bilateral arm pain in both arms like pain in her bones. They are giving her Zofran for the nausea which also causes headaches.
A few hours after taking the vaccine I began having severe abdominal cramps in my upper to mid-abdomen. It?s been about 48 hours since the vaccine was administered and the abdominal cramps are still present. Also, when I eat food it hurts my stomach. Since this vaccine is so no I wasn?t sure who to contact. I have been waiting to see if the symptoms will subside. If the problem persists, I will seek medical care. I plan to speak with a doctor regarding the matter on Monday.
Pt recvd series of 3 vax from spring of 1990 thru AUG90.Titer check revealed pt was a non-responder.
The patient was fully vaccinated Pfizer on 4/12/21 and 05/3/21, no reaction with vaccine. However, went for vacation, became symptomatic and COVID PCR test came back POSITIVE on 06/26/21.
systolic blood pressure went up during the first 24 hours./Went up to 154; lightheaded; disoriented; Mild injection site soreness; did not feel comfortable driving for two days; This is a spontaneous report from a non-contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on an unspecified date at age of 67-year-old at single dose, unknown dose number for COVID-19 immunization. Patient was not pregnant at time of vaccination and events onset. Medical history included gastrooesophageal reflux disease (GERD), high blood pressure, obesity and fatty liver. Concomitant medication was none. Patient felt lightheaded and disoriented for three days. Worse after first 24 hours. Patient did not feel comfortable driving for two days. Patient's systolic blood pressure went up during the first 24 hours, which was usually in 120-130 range with medication but went up to 154. Patient had mild injection site soreness for two days. Onset date of event "did not feel comfortable driving" was unknown, of the other events was reported as 26May2021. Outcome of event systolic blood pressure went up was recovered in May2021, of lightheaded was recovered on 29May2021, of disoriented was recovered on 29May2021, of injection site soreness was recovered on 28May2021, of did not feel comfortable driving was unknown. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
6 year old patient received incorrect Moderna vaccine. Patient received 0.5mL from Moderna vial indicated for 6 months-5 year olds. Unknown if patient has experienced side effects at this time. Reaching out to manufacturer regarding follow up, and subsequent dosing.
My allergies got worse since the vaccine and they have never gone away. I had a couple of sinus infections, sinus pressure, nasal drainage and a cough ever since my vaccine. This started from the vaccine from the first vaccine but did not think much of it. I also developed high blood pressure after my vaccine which I did not have before. I had a renal ultrasound but do not remember the date it was performed. I also saw a cardiologist, I also had a kidney stent also placed. My allergies have not gone away and take antibiotics which improves for a few days then they come back.
Within 8hrs of injection on Fri 1/29-very sore arm and body aches setting in. Slept thru night feeling hot and strong headache requiring 2 Tylenol in am. No fever upon check in am. No cough.  Body aches, chills, and woozy/dizziness all day. Sept on/off most of next day(Sat 1/30) 2 Tylenol taken in afternoon helped with lingering headache/body aches. General dizziness on/off low grade headache persists thru Mon 2/1 requiring call out from work double shift..3pm-11;30pm  2/1/21 and 11:30pm-7:30am  2/2/21 . Sleep and hydration helping with reaction symptoms.
I woke up the next morning with a painful UTI and extrene ovary and back pain. I have occaaional sharp pains in my left leg and foot. Today (day 3) my left arm is numb and swollen. I had surgery in this arm in the past and have a metal plate/screws.
Tiredness; Joint pain in right arm; This is a spontaneous report from a contactable consumer. A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EK9231), via an unspecified route of administration on 12Jan2021 10:30 at single dose for covid-19 immunisation.  Medical history included chronic obstructive pulmonary disease.  Concomitant medication included guaifenesin (MUCINEX), ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), fish oil (OMEGA 3 FISH OIL [FISH OIL]).  The patient experienced Tiredness and joint pain in right arm on 12Jan2021 17:30 with outcome of recovering.
Bight blood pressure, never had high blood pressure until the vaccine.  This goes for both my husband and myself.  Very troubling, we are both now on blood pressure meds to control this side effect.
This is a spontaneous report from a contactable retired nurse (patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: not reported) via an unspecified route of administration on 26Feb2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, after receiving the first dose the patient had a typical reaction, elevated, red circle and warm to the touch. It was about 2 inches in diameter. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Approximately 10 minutes after receiving the vaccine in the left arm, the patient began feeling lightheaded and had some chest heaviness. They became diaphoretic and at this point blood pressure and heart rate were checked. HR was elevated to 90 bpm from patient's baseline of approximately 60-65 bpm. Blood pressure was elevated at 150/100 mmHg. Pt was provided water and symptoms resolved. Patient was monitored an additional 30 minutes and did not have any recurrence of symptoms. Blood pressure and heart rate returned to baseline.
Heart flutters/whooshing feeling like a misfire. Diagnosed with minor myocarditis through ECG.
Severe pain in left shoulder starting in March. Progressed to right shoulder, then to wrist and knee. Been to urgent care twice for medical assistance. Pain levels vary from 5-10 depending on movement and has not fully resolved.
Infection stated 2nd day spread on 9-12th day3 to 6; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration in the left arm on 06May2021 15:00 (at the age of 78-years-old) as second dose, single dose for COVID-19 immunization at a Pharmacy/drug store. Medical history included allergy (not specified) from an unknown date and unknown if ongoing. The patient also has relevant medical history (reported as yes but was not specified). Concomitant medications included valsartan (DIOVAN), omeprazole (PROTONIX), loratadine (CLARITIN), oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET), montelukast sodium (SINGULAIR) and  caffeine, paracetamol, promethazine methylene disalicylate, salicylamide (PL); all taken for an unspecified indication, start and stop dates were not reported. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in the left arm on 15Apr2021 12:30PM (at the age of 78-years-old) as first dose, single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. On 08May2021 12:00 AM, the patient experienced infection which started on the 2nd day, spread on 9-12th day 6 to 6 spreading towards the core (reported as today). No treatment was given as a result of the event. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Shoulder pain at injection site. Feels bruised and have trouble moving it upwards. Have constant soreness.
Information has been received from a pharmacist concerning an unknown numbers of patients who were vaccinated with GARDASIL.  The patients complained of injection site reactions including pain.  The reporter did not have any detailed information.  The outcome of adverse event was not reported.  It was not reported whether the patients sought medical attention.  Additional information has been requested.
PT STATES HAD PAIN RIGHT AWAY X2 DAYS .  FOLLOWED BY RASH & ITCHING STARTING SUNDAY 11/15/15 UNTIL PRESENT DAY.
The pt received Hep B and Pnuemovax 23 at approximately 11am. Within 30 minutes of leaving the clinic, the pt complained of headache and tenderness around injection site. By 1pm, she had developed urticaria on left arm and the injection site had swollen to the size of about a half dollar. Pt notified her son who is an ER MD and he prescribed Benadryl, Motrin, and moist soaks. By 05/23/2002, pt's symptoms resolved.
10day p/vax pt exp diarrhea, gassy, & extreme fussiness
Developed rash on abdomen and back.  Rash itched tremendously.  Treated with benadryl tabs every 6 hours.  Rash/itch lasted approximately 3 days.
before immun mom gave APAP recv immun around 10AM ran t105 around 230PM;mom gave Motrin ran t101 till next day;
Information has been received from a physician, via the Merck pregnancy registry, concerning a 25 year old female patient who on 22-MAR-2007 was vaccinated with a dose, 0.5ml, IM, of GARDASIL (Lot # 655503/0012U). The physician stated that on 24-MAR-2007, the patient had a positive pregnancy test (over the counter), and added that the patient was pregnant at the time of vaccination. The LMP date was 25-FEB-2007, with an estimated date of delivery of 02-DEC-2007. Follow up information from a nurse at the physician's office, indicated that on 12-DEC-2007, the patient delivered a "normal and healthy baby girl," via a C-section. Attempts for a vaginal delivery included PITOCIN, and "resulted in spontaneous decreases on the baby's heart rate." The infant weighed 8 lb 6 oz, with an Apgar score of 9/9. No further information was reported. Upon internal review, "resulted in decrease in the baby's heart rate" (led to a C-section) was determined to be serious as an other important medical event. Additional information is not expected.
Patient experience redness, swelling and warmth  about 3 to 4 inches below injection site. I advice patient to see her PCP, she received antibiotics from her doctor due to an infection from the shot.
No adverse effects; patient inadvertently received an expired dose of GARDASIL 9 on 8/20/2019; This spontaneous report was received from a medical assistant referring to a patient of unknown gender and age. The patient's concurrent condition, pertinent medical history, concomitant therapy and drug reactions/allergies were not reported.  On 20-AUG-2019, the patient was inadvertently vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency and route of administration not reported) (lot #: M042853, expiration date: 17-JUL-2019) (expired product administered) for prophylaxis. No adverse effects were reported.
There was a bought of Vertigo for a couple of weeks and then once cleared up, I started feeling like an ear infection but examine did not reveal an ear infection.  I had debilitating pain in the head.  I have had CT and MRI with no current cause revealed.  On steroid and gabapentin to treat.  Testing is ongoing.  Protein test.   SED is Elevated, but not critical.  Ophthalmologist visit states Optic Nerve looks good.
Rash - recurrent multiple sites. Prednisone, Zyrtec. Pt sent to dermatologist.
Janssen COVID-19 Vaccine EUA I blacked out while getting ready for work.  I was feeling a little light headed and thirsty.  Next thing I know, I was on the floor. When I came to, I was disoriented and very sweaty.  The fall caused a cut to my head, bleeding and a bruised elbow. Within an hour, I was feeling less dizzy.
Within 2 hours after shot, coughing, fatigue, 30 hrs later, chills and fever. Treating at home.
Day 1: body aches, chills Day 2: red, heated rash at injection site after working out
Received the shot at 9:03 in the morning was fine for most of the day but after falling asleep around four in the afternoon and waking up for dinner my arm was a little sore. I went back to sleep and woke up at least 20 or so times throughout the night with a severe migraine, I felt like I was being stabbed by a bunch of needles and was extremely shaky. A bit light headed and nauseous as well as irritated throat.
Narrative: Patient received Pfizer COVID-19 vaccine on 4/12/2022 in community pharmacy. On 6/8/2022, Patient presents to hospital with shooting pain in both knees. While admitted, Patient experienced cardiac arrest due to an anaphylactic reaction precipitated from her immunization, requiring ventilation. She was admitted for 2 weeks, but exact treatment received is not recorded in outside/remote data. Patient is traveling and recently began receiving care at facility. She presented to the ED with fever and chills on 7/4/2022 and reported her history of recent hospitalization. ADR was documented into patient chart. However, Patient left AMA the same day. PMH is significant for asthma and HTN.
Patient was running a fever. Mom took him to MD. After seeing MD mom put him in his car seat and he had a grand mal seizure. An MD was in the parking lot - he call EMS and patient was transported to hospital.
Pain in arm first few days. Then resolved.   On day 8, I developed a general feeling of malaise, tiredness, achy muscles and slight headache. These feelings continued into day 9. I rested and took aspirin. Then, on day 10, I felt better but noticed I had developed a red, slightly raised rash at the injection site. About 2 inches in diameter. It is still there. I also noticed that at about the same time as I started feeling bad, my resting heart rate (which I continuously monitor on my Fitbit) had jumped from the 59-62 range, to 66-68 range. The heart rate is still up although I feel ok otherwise.
Pt. was given diluent and not the vaccine. I didn't realize it needed to be reconstituted.