chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she was freezing cold but no temperature registered; nausea; no energy; she was sleepy; head hurt; chills but no temperature; fever; fatigue/exhausted; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EN9810, expiry: unknown), intramuscular in the muscle of her right shoulder on 05Feb2021 11:00 at a single dose for covid-19 immunization at a public health department. The patient has no medical history and concomitant medications. The patient is experiencing chills but no temperature on Feb2021, fever on Feb2021, fatigue on Feb2021, nausea, and no energy. She had her first shot last Friday (05Feb2021) and was fine. She stated that yesterday afternoon (11Feb2021), she felt really bad. She called the clinic to see if it was symptoms of Covid. She stated that she was freezing cold, but no temperature registered on 12Feb2021 at 13:00. Her head hurt on 11Feb2021 13:00 and she took Ibuprofen but it never let up, so she took Tylenol. She was sleepy on 11Feb2021 14:00 and was napping so she laid on the couch. The patient was also nauseous on 11Feb2021 14:00 but never threw up. She called the clinic to see if she should get tested for Covid. She stated that since she got up that she is exhausted, felt like she had no energy on 11Feb2021 14:00. The patient wanted to know if she needed to be concerned or if this is something that will run its course. She had to go get blood work at the hospital on Wednesday and that everyone had on masks and she did not think that she was exposed. The patient has no prior vaccinations (within 4 weeks). The outcome of the events feeling cold and feeling of total lack of energy was recovering, head pain and nausea recovered on 11Feb2021 while event sleepy was not recovered. The outcome of the other events was unknown.
I am 30 weeks pregnant and got the covid shot and the next day i woke up with a rash all over my neck arms on the inside and on my belly and on the side of my. Belly and a rash on my vagina and swellimg and my left boob hurting and leaking
Soreness on the right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness on the right arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  .  Concomitant products included METHADONE, HYDROXYZINE, LISINOPRIL, ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (BABY ASPIRIN), LORAZEPAM, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and BISACODYL (DULCOLAX [BISACODYL]) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (Soreness on the right arm). At the time of the report, PAIN IN EXTREMITY (Soreness on the right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a improperly stored GARDASIL. Dose, route, lot number and expiration date were not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Dull pain in the left arm,  Weakness in the left arm. Feels  like pain is going down left  leg.
numb upper right leg as if in neuropathy numb lower left leg as if in neuropathy
Lightheaded, dizziness.   vitals: B/P-130/86  P-91, SPO2-95%, R-24 Fluids, offered snacks, offered to lay down. Pt refused snack and to lay down.   Patient waited an additional 15 minutes. Pt stood up and was feelin improvement in symptoms, Walked out of waiting area with spouse present within normal limits
Information has been received from a physician, who heard from a physician that a 7 month old female patient with no drug reactions/allergies, who in November 2011 was vaccinated with a dose of ROTATEQ (dose, route and lot# were not reported). Concomitant therapy included PREVNAR, PEDVAXHIB and poliovirus vaccine administered on the same date. It was reported that on 07-FEB-2012 the patient developed intussusception and was hospitalized (duration not reported). On unspecified date the patient fully recovered. No further information is available.
Mother reported that patient began having itchy type rash on his trunk and at the injection site. Mother brought patient to public health on 11/02/2017, less that 50 papules on trunk and arms. Mother denied any wheezing, difficulty breathing, fever or drainage.
Fever, not exceeding 101, joint aches in knees, back & shoulders, rt side of face & neck midline was sore to touch;;
anaphylactic reaction described as "her entire arm swelled into her neck"; the steroids, "epi's, and Benadryl upset her stomach"; This spontaneous report was received from a currently 42-year-old female patient referring to herself, via a field representative. The patient's concurrent conditions included Addison's disease and autoimmune deficiencies. The patient received 13-valent pneumococcal vaccine in the past (reported as PCV13) without any reaction. On 27-SEP-2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot# R000772 verified to be a non-valid lot number, expiration date 10-MAR-2020, (exact dose and route of administration were not reported) for prevention of pneumococcal disease. There was no information about the patient's concomitant therapies. On the same day, the patient experienced anaphylactic reaction described as "her entire arm swelled into her neck". She was hospitalized for three days at an unspecified facility, was given unspecified steroids, two doses of epinephrine (reported as "two epi's"), and diphenhydramine hydrochloride (BENADRYL). The reporter stated that the steroids, epinephrine and diphenhydramine hydrochloride (BENADRYL) upset her stomach and as treatment she was given an unspecified "stomach medication". The patient recovered "by the fourth day". The outcome of anaphylactic reaction and upset stomach was reported as recovered on approximately 30-SEP-2018 (by the fourth day). There was no causality assessment provided by the reporter.   Upon internal review, the event of anaphylactic reaction was considered to be medically significant.  This is one of two reports received from the same reporter.; Sender's Comments:  US-0095075143-1908USA001571:
3 DAYS AFTER VACCINES ADMINISTERED, DEVELOPED HIVES  ON ABDOMEN  AND  HANDS.  PERIODIC IN NATURE.  TAKEN TO EMERGENCY ROOM ON 09/03/19 AND WAS PRESCRIBED PREDNISOLONE  AND BENADRYL.      NO LABS OR OTHER TESTING WERE DONE.   NO RESPIRATORY PROBLEMS.   NO LIP OR TONGUE SWELLING.       FOLLOWED UP IN CLINIC ON 09/05/19.  HIVES IMPROVED, NOT COMPLETELY RESOLVED.    SL. RUNNY NOSE.   EATING AND DRINKING WELL.   ALERT.
(5/24)2 yo male here with mom who says the night after he was vaccinated (5/22), he developed redness in his leg and was irritable.  Next day leg still red, and today it seems worse.  He seems to feel itchiness at site, mom says.  Mom denies any sob, no problems breathing and no rashes or redness any where else.  He received 4 vaccines in left thigh and 3 on his right thigh.   (5/28) 2 Yrs 1 Mo Male who presents with mom for f/u L leg swelling after vaccines. On 5/22 received 7 vaccines, had fever (tactile). L sided vaccines received: flu, PCV, Hep A, Dtap.  When leaving the clinic, said leg was itchy. Mom tried to keep him from scratching. 5/23 looked more red and swollen. Was applying ice but still looked red so came to clinic on 5/24 for evaluation. Treated for cellulitis with Keflex, ibuprofen, Benadryl.  Saturday (1 day after) the leg was looking better. Now is back to normal.
trouble sleeping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: INSOMNIA (non-serious), outcome "unknown", described as "trouble sleeping".  Additional information: The reporter mentioned he has not been sleeping at all since he got the booster dose. He went to the doctor and the doctor said this was not a side effect. He has not been having any problems until he got the vaccine. He is not sure if this is a reported side effect or not. However, if it is, he wants to know how long it will last.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
pt recv vax @ 330PM woke up from noap w/t103.3;pt recv PAAP p/vax;another dose of APAP given 4PM;t98.8; 215AM t104.6 APAP given;08:00 t101.0 APAP given;
This is a spontaneous report from a non-contactable physician. This physician reported a similar event for three patients. This is the third of three reports. A patient of unspecified age, gender and race received, on an unknown date, PREVNAR 13 at 0.5 ml single dose, for immunisation. Medical history and concomitant medications were not provided. On an unspecified date, the patient experienced painful large local,  swelling locally and it was hard for the patient raising hands over the head. Clinical outcome of the events was unknown at time of this report. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2016483131 same reporter/drug/event different patients; US-PFIZER INC-2016483159 same reporter/drug/event different patients.
There is a large red circle on my upper left arm where the injection was given.  It has been there for several days.  No pain or other secondary issues with the arm - just the red circle.
Fully vaccinated,   COVID infection breakthrough with inpatient hospital stay.  Lot numbers of vaccines NOT listed.
38 weeks pregnant at the time  Developed a large red spot with an additional large red ring around it. Have several pictures available to show. Went back to get my second shot today and they didn?t feel comfortable giving me the second dose.
I ended up having a big red welt on my arm around the shot site. I looked into it and found information that matched referring to it as "Covid Arm". It started out as a splotchy rash a week after my Covid vaccination. By the end of the day it had turned into a solid red raised welt. It was hard and hot to the touch. It stayed hard and hot to the touch for a few days and slowly faded into back into a splotchy rash, which turned into being outlined with light pink and looking like a bruise where the rash/welt had been. The light pink outline then faded and it looked like a healing bruise. The duration of time from breakout to completely gone was  9 days. It did not cause me any itching or pain. I had a sore arm as with most vaccinations. I reached out to the health department. They referred me to be seen by my Dr. I called my primary care physician and left a message with the information I had found regarding  Covid arm and asked for a return call if he thought I needed to be seen. I did not receive a return call so assumed I was ok.
Patient had an event of syncope while waiting in IMZ chair post COVID moderna dose #1.  Caught patient before patient fell, protected his head and neck area and slowly lowered him to ground and elevated his legs on chair.  Store management was notified and observed.  Gave patient an instant cold compress.  Told patient to wait in chair and observed patient for roughly 20 additional minutes.  patient stated he was ok and he faints with blood draws and IMZ sometimes and that he is ok.  Patient and friend left.
Urinary tract infection; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment for the event included Nitrofurantoin twice a day for 7 days
Information has been received from a registered pharmacist concerning an 86 yr old male who was hospitalized for a knee replacement who on 28Jul05 was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649978/0709P). On approx 28Jul05, the pt developed a localized skin reaction, fever and cellulitis. The pt was treated with oral cephalexin (Keflex) for the cellulitis. Subsequently, the pt recovered. The pharmacist did not believe that the adverse events prolonged the pt's hospitalization and she did not feel this was an other important medical event. A product quality complaint was not involved. No further information was available.
20 hours after first dose of COVID19 vaccine arm was very sore (normal). Around 2:30am felt pressure and warmth (coming in waves) up towards my chest, lasting 1-2 seconds and occurring about every 5 minutes . Was able to withstand feeling until it became difficult to breath. Lips and face turned white and blue, fainted. Felt extremely nausea when awake.  Called 911. Vitals were normal apart from BP was very high 130/100's. EKG was NSR. Blood sugar taken was normal around 113. After 1 hour of event, I took a shower and drank water. I felt the wave one more time before trying to fall asleep. Then stopped. Woke up fine.
Client found on the ground, lying to left side, unresponsive x 30-60 sec. BP: 130/80, Pulse: 71, 02 sat on RA: 98, EMS initiated. Client finally became responsive, denies pain. Asked what happened, stated he felt very sleepy after receiving the vaccination and felt that he fell asleep. Client stated that he has not eaten and only had juice. EMS on site, BP:126/71, 74, 99 02 sat on RA. Blood glucose obtained by EMS: 100. Client refused to be transported to ED, signed declination. Client's cousin present.
04/29/2022 I had been to a funeral on 4/26/2022. I wore a mask. After that I went to a reception and did not wear a mask. I tested negative before service on 4/26/2022. On 4/29/2022, I did not feel bad, but tested and was negative. I believe it was my sister who lives in assisted living that passed on the COVID-19. 0n 4/30/2022 I had a scratchy throat, low grade temperature for one day, headache where my eyes ached. nasal congestion and a dry cough on the 4th and 5th. I repeated the COVID-19 test, and it was positive on 4/30/2022. I called my doctor and ask for Paxlovid. I took that and started my BID dose. I just completed it on 5/4/2022. I took Aleve for the sore throat. The sore throat lasted for 4 days.
Pt was administered Pfizer dose #1.  After administering to sister he passed out per mom.  Mom got nurse's attention while returning to tent.  When arrived to the car, pt was awake and alert and responding appropriately.  He stated he feels light headed.  EMS called to tent.  Pt given bottle of cold water.  Mother then drove pt over ti observation area and EMS continued to evaluate.  EMS stated pt had vaso vagal response.  Pt remained in observation until cleared by staff.
Fever, Angioedema, arm pain, Narrative:  Received vaccine on 02/05/21, had fever and arm swelling on 2/5 through 2/6/21 that resided. Woke up on 2/7/21 throat swelling having trouble swallowing and is at urgent care now. Employee was talking in full sentences and did not appear SOB or difficulty breathing.
temperature excursion occured, low of 1.85C for 30 min due to human error with no reported adverse event; opened ipol was administered to patient with no reported adverse event; Initial information was received on 21-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves 6 months old male patient who experienced temperature excursion occured, low of 1.85c for 30 min due to human error with no reported adverse event and opened ipol was administered to patient with no reported adverse event after receiving ipv (VERO) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 06-Jun-2023, the patient received a dose of 0.5 ml of suspect ipv (VERO) (Suspension for injection) (lot V1A021M, Expiry date : 27-Feb-2024) (strength was unknown) via intramuscular route in unknown administration site for Immunization and developed a non-serious event of temperature excursion occured, low of 1.85c for 30 min due to human error with no reported adverse event (product storage error) and opened ipol was administered to patient with no reported adverse event (poor quality product administered) (latency : same day) following the administration of ipv (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event temperature excursion occured, low of 1.85c for 30 min due to human error with no reported adverse event and was Unknown for the event opened ipol was administered to patient with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
After 2nd shot- Covid arm- large red spot by injection spot.  Hot to touch. A little itchy.  Appeared 3 days after injection.  First day after injection felt drunk- woozy- foggy.   Today is first day of Covid arm. No treatment yet.   After first shot - felt dizzy and waves of nausea off and on for 4 days.
11/03 severe pain in arm: nerve or bone? Unable to lift objects or arm or lay on arm for @ 4 months, 11/04 same reaction occurred and apparently resolved although a long term illness mimicing auto-immune disease ensued, doctor questioned bursitis.
I left hospital after waiting required 15 minutes. About 10 minutes after leaving I had sensation of a metallic taste in mouth and tongue, primarily on rt side. I was concerned that the tongue might be swollen. My wife who is a retired nurse looked at it and didn't see anything to be concerned about. All the symptoms were gone within two hours.
Evening and night after being vaccinated had severe headache and woke up with one eye severely blood shot due to blood vessels opening up.
Pt. started having breathing difficulty 36 hours after vaccine admin. Pt had wheezing with tightness in chest O2 Sat 78%. Required O2. Transported to local ER via ambulance admitted for resp distress.
Fatigue and dizziness. Next morning had high fever, cough, sore throat, and muscle aches. On third morning I woke up with a severe ear infection in both ears that eventually ruptured my eardrum. Still have fever, sore throat, ear infection, and cough 5 days after shot was given.
left arm hurt; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (left arm hurt) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced MYALGIA (left arm hurt). In January 2021, MYALGIA (left arm hurt) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment medication was provided. no medical history and concomitant medication was provided. 2nd dose was taken on Jan 2021. exact date not provided.   This case was linked to MOD-2021-256638 (Patient Link).
MODERNA MONVALENT COVID 19 VACCINE GIVEN MISTAKENLY AS 1ST BOOSTER.
Lower back pain; This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer (patient).   A male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on an unspecified date, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced lower back pain. The case was assessed as serious as the patient reported "I'm supposed to get a shot for lower back pain". Clinical outcome of the adverse event was unknown at time of this report.   No follow-up attempts are needed, information about lot number cannot be obtained.
facial swellilng Narrative:  Patient received COVID vaccine outside of this facility; unclear if Pfizer vs. Moderna. Do not have lot # information.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient was vaccinated with a dose of LIQUID PEDVAXHIB (reported lot number UH156AA) on 05-OCT-2012. Route was not reported. The product had expired on 23-SEP-2012. No adverse symptoms were reported. Additional information has been requested.
Head ache (left side of head; front of head); fever, fatigue; body aches
At 1100 Nausea, stomach pain, sore arm, and chills. Reported taking Zofran 4mg and Tylenol 800mg for pain.
Patient received the original monovalent Pfizer COVID-19 vaccine as their second booster dose instead of the intended bivalent Pfizer COVID-19 vaccine.
large amount swelling @ site of inject x 24 hrs; rx ice/APAP;
Later that evening after receiving my 2nd dose I began to experience mild  joint pain.  From the next morning up to today?s date I am still experiencing abnormal joint pains and swelling in my knees, ankles and feet. Currently, on my right foot my 4 smaller toes and the upper part of my  foot I?m having pain that is causing me not to be able to put all of my weight on it. I?ve had days where I could hardly get out of bed and honestly, just exhausted. I contacted my rheumatologist  and was advised to just double up on my steroids. At this point I?m not sure there?s anything else to do, but to ride it out. I just felt that I should report it so that there could be considerations with regard to those who have lupus and mixed connective tissue disease. It truly has made my joint issues amplified.
This spontaneous report as received from a licensed practical nurse refers to a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-JUN-2015, the patient was vaccinated with the dose of GARDASIL (lot # K004204, expiration date 12-JAN-2017; dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.