chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore throat; She is not feeling too good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team.  A 99-year-old female patient received bnt162b2 (BNT162B2) solution for injection, dose 1 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; MALAISE (non-serious), outcome "unknown", described as "She is not feeling too good".  Additional information: reporter mentioned that his Mother-in-law is scheduled to receive the second dose of the Pfizer-BioNTech COVID-19 Vaccine today, but she is "not feeling the greatest, woke up with a sore throat and no fever". Can she get the shot today. Potential AE realized after call (possible underlying disease), e-transmitting for review (99 years old, Female). Reporter stated, our mother here is 99 years old, she is due for her second Pfizer shot today. She is not feeling too good, she has got a sore throat. Is it safe to get her the shot today. Reporter stated, can you transfer me. Reporter was provided with the number as (Contact number) (Option 3) and was informed about the timings as 8 AM-8 PM Monday to Sunday as per EST. In response to further probing, Reporter stated, no, its not a good time, no. LOT#: Reporter stated, no, we dont have it right now. Limited information was available over the call as the reporter was not willing to proceed with the questions.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 27-OCT-2012 11:46, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Pt received immunization 9:05 AM, pt went out to smoke a cigarette, 15 mins later started feeling dizzy and sweating. Pt went inside to sit, started to feel his chest constrict/tighten, resolved in 5 mins. Pt started to feel chilly, started to shake, feeling cold. Pt did say his teeth were chattering and felt cold during plasma donation previous to immunization. Pt recovered 10:08 AM
I could feel a hot sensation in my arm as the injection went in, which spread to my upper shoulder area.  Within a few minutes, I experienced lightheadedness and a rapid heart beat.  I remained seated and the light headedness subsided.  The rapid heart beat dissipated after a few minutes.  I remained at the pharmacy for at least 30 minutes.  throughout the day, my left arm became increasingly red and swollen and was painful.  I treated the arm with ice and movement.  I was unable to sleep on my left side due to the pain.  When I awoke the next day, the arm was still red and somewhat swollen but the pain had decreased to some soreness. I did have a bruise at the injection site which lasted for over 2 weeks.
Boils on but and in between legs; This spontaneous case was reported by a consumer and describes the occurrence of FURUNCLE (Boils on but and in between legs) in a 53-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In July 2022, the patient experienced FURUNCLE (Boils on but and in between legs). At the time of the report, FURUNCLE (Boils on but and in between legs) was resolving. Not Provided      The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported. On an unknown date, the patient had Humira, and it was not working (drug ineffective). The reporter causality of the Humira for the boil and drug ineffective were not reported. It was unknown if the patient was enrolled in a COVID-19 vaccine Trial. Humira formulation reported Solution for injection in pre-filled pen No treatment medications were reported.
Syncopal episode, paleness and limp. Recovered completely within minutes. O2 was given by nasal cannula for 5-10 minutes. Observed pt for 30 minutes after symptoms.
Pfizer-BioTech COVID-19 Vaccine EUA  Witihin 5 minutes, burning chest pain.  Within less than 20 minutes BP measured at 203/185  and 15 minutes later 191/187.   (normal for me is 128/65).   Heart rate 130   (normal is 92)   Lightheadedness.    EMTs on site did EKG and subsequent BP checks.      Recommended Emergency Room care, which I did.    Aspirin given, blood work done (at 3 different times).   2 Additional EKGs done with no abnormalities noted..   BP and heart rate went down  in approximately 2 hours,  to 138/85 and 105, but not to normal status.          Have been normalized since.
dark red rash under both arm pit areas size of a hand. went from ribs up arm sometime after infection was noticed in evening, marked with marker to watch for spreading and was gone in AM. Next day felt much pain in muscles in leg and around ribs. very tired and uncomfortable to exhale. Muscles around ribs painful.
Tiredness; fever; chills; This is a spontaneous report received from contactable reporter(s) (Other HCP) via COVID-19 Adverse Event Self-Reporting Solution.  A 3-year-old male patient received BNT162b2 (BNT162B2), on 20Jul2022 at 15:30 as dose 1, single (Batch/Lot number: unknown) at the age of 3 years, in right leg for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 22Jul2022 at 08:00, outcome "not recovered", described as "Tiredness"; CHILLS (non-serious) with onset 22Jul2022 at 08:00, outcome "not recovered"; PYREXIA (non-serious) with onset 22Jul2022 at 08:00, outcome "not recovered", described as "fever". The events "tiredness", "fever" and "chills" required physician office visit. Therapeutic measures were not taken as a result of fatigue, pyrexia, chills.  Additional information: No other vaccine in four weeks. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. No corrective treatment received. No covid prior vaccination and no covid tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I had allergy symptoms. I started getting a lot of swelling around my eyes. I was taking over the counter allergy medications Allegra and Zyrtec. I went to the doctor, and she prescribed an additional allergy medication Ryaltris.
On 02/04/08 my daughter and I arrived at the Health Dept. arrival time around 11am, patient was given a 2nd dose of the Varicella shot in her right arm, due to the mandatory law in the county, to attend her new school. Patient went home and she began to complain around 8pm that night 02/04/2008 about burning and itching and it was a little swollen. Early the next morning 02/05/08 at 6am I woke patient up and her arm was 2x times bigger than the previous night. She was in pain and the site was hot to the touch, and very swollen, I called the health Dept at that time, but the center wasn't open yet. I took patient on to school for her first day at her new school, as we sat and waited in the school, at 8am, patient kept complaining about the tightness of her skin and the pain, I took patient to class, and told her to call me if the shot sight had gotten any bigger, and if the pain got worse. By 12pm in the afternoon the school nurse called me in a panic, saying that patient needed to be picked up, and taken to the Dr., because the shot sight didnt look good, and it was too swollen, and has gotten bigger. The nurse measured the sight (I think it was 4 inches wide at the time) and put and ice pack on the sight to control the heat and swelling. I called the health dept around 12:30pm, to explain what was happening to my daughter. The female who answered the phone, I told her what happen, and she said oh Lord, let me transfer you. The line kept ringing and the wasn't any answer at that extension. So I took patient to the nearest ER. Patient was seen by the nurse first, and she was astonished at patient arm. She gave patient a wet towel to compress on the sight for the swelling and heat. At the time 4:30pm patient temp was 100.7 and patient was in horrible pain, the Dr. came in around 5pm and told alot at the sight, he said it wasn't and allergic reaction, the sight was truly infected, due to the heat and huge swelling of the sight. At that time the Dr. order her to receive one shot of antibiotics in both of her legs the legs. Then she was observed for 20 mins. to make sure she was not allergic, and prescribed and oral dose of Augmentin 1tsp. 2x daily until gone, and ibuprofen for pain. We were release at 6:15pm on 02/5/08, patient was arm was still hot tight huge and swollen. I kept ice packs on it all night. Early 02-6-08 at 6am, patient was woken for school and her arm was smaller than the day before, but still hot and big, she wasn't able to go to school do to the pain, in her right arm.... her writing hand... still today 2/67/08 she is still trying to recover... I would like for report to be taken serious, and the batch of the varicella shot that my daughter was given to be investigated, and the lady who gave the shot question and investigated, and any reports of shot complaints of the same source investigated...
Febrile seizure on 02/29/1999. Admitted to hospital on 02/29 - 03/04/99 for febrile seizure, pneumonia, and otitis. Subsequently 2 seizures with fever seen in ER observation only. Parent report other small seizures which didn't occur in the ER or hospital. Dilantin and Tegretol prescribed.
Patient is immunocompromised and felt very ill after receiving vaccine. Reactions include vomiting, flu-like symptoms, etc
3 hours following vaccine: nausea, dizziness, and irritability 6 hours following vaccine: previous symptoms + headache (5 out of 10) and cold sweats 8 hours following vaccine: previous symptoms + widespread body aches (6 out of 10) Restless sleep punctuated by waking up with cold sweats or overheating.  24 hours following vaccine: previous symptoms persist. Headache and body aches have worsened in severity. Unable to work for the morning but was able to go in the afternoon for a short time period. Lower body aches are particularly severe. Fatigue is noticeable. Mental health conditions have worsened but that may be due to lack of sleep.  30 hours following the vaccine: chills, nausea, and dizziness have dissipated completely. They were slowly improving throughout the day. Body aches and headache still severe but lessened with marijuana use.  48 hours following the vaccine: all symptom seemed to have subsided during the night. Sleep was much better quality. Only remaining symptom is an ache on the right side of my chest towards my ribs.
The patient got PCV20 in the right deltoid on 10/25/23, then experienced severe swelling and pain at the injection site. The arm was hot to touch. Other symptoms included lethargy, loss of appetite, and inability to raise her arm. The patient then went to the emergency department in 10/28/23 after symptoms were not improving, and was treated with SMZ/TMP double strength, 1 tablet twice daily for 7 days. As of 11/9/23, the patient was fully recovered. The patient also received her flu and covid vaccines on the same day in her left arm and had no local side effects in that arm.
Information has been received from a health worker referring to a 15 day old infant of unknown gender. On 02-JUN-2015 the patient was inadvertently vaccinated with VAQTA (dose and route were not reported, strength: 25/0.5 (unit not provided), lot # K007827, expiration date: 09-SEP-2016). No adverse effects were reported. Additional information has been requested.
The patient was supposed to get HPV vaccine and gave IPOL instead accidentally/ No AE; Initial information was received on 25-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 12 years old female patient who accidentally received 0.5 mL dose of suspect IPV (VERO) [IPOL]  (lot P1F541M and expiry date 07-Dec-2020) via intramuscular route in the right deltoid for prophylactic vaccination but was supposed to get HPV VACCINE (not produced by Sanofi Pasteur, lot number  and expiry date not reported) instead (wrong product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Boostrix) for Immunisation.  Details of laboratory data was not reported.   It was an actual medication error case due to wrong vaccine administered.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Evening of vaccine, site was tender to touch. The next day I felt achy, joints felt achy like the flu. No fever, no chills, slept alot. The 2nd day after I felt fatigued, run down, nauseated, unable to eat. Injection site was warm, felt a lump and very tender to touch, unable to sleep on rt side, pain with raising my right arm. Pain/tenderness lasted 6-7 days until I could touch the site without discomfort.
Not sure of above information, but providing other numbers.  I originally got my first shot over two months ago. I was called in for my second shot.  My arm was still sore from the first shot (right arm).  So, I got the 2nd shot in my left arm. Boy, am I sore and the site very painful,  I have pain radiating across my back.  Then today I was dizzy all day and extremely tired. This is not normal for me and am concerned about further symptoms..
30 minutes after receiving the vaccine, I (the patient) felt tingling in my lips, nose, and feet. I then developed a non-itchy, macular rash on my chest and back, associated with flushing. No fevers,  chest pain,  shortness of breath, nausea, vomiting, or diarrhea, I was taken to the emergency department, where I had normal vital signs. I was given Benadryl 25 mg PO with complete resolution of rash and tingling sensation within one hour.
I had strange upper back pain which radiated to my stomach, I woke up in the middle of the night with this with left sided weakness and numbness. I went o my primary care Doctor who ordered MRI of my lumbar and thoracic area. In December I mentioned this to my neurologist on12/21/2021 who ordered an brain MRI this took place on 01/04/2022 which showed a stroke had occurred.
Extreme fatigue x 2 days On day 4 started having severe headaches, nausea, swollen lymph nodes directly under base of skull on right side, trapezius muscle and deltoid muscle swollen into a complete knot and very painful On day 5 same symptoms as day 4 with swollen lymph nodes in neck on right side causing sever throat pain (comparable to severe tonsillitis case but I don?t have tonsils), also my whole body aches and I?m having fever and chills
fever of 101-1028*F, chills, fatigue, headache, arm pain, and underarm swelling.
Typical reaction at 3 hours (fever to 103, headache, etc).  However a few hours later had almost paralysis and was unable to move enough to get up poff the floot.  Lasted a few hours and gradually inproved. Awoke the next morning and was fine
Severe rt. shoulder pain which spread to rt. neck area, down rt. arm to fingers, through right shoulder blade to lower back, through buttocks and hip to lower leg pain in thigh and shin. Felt very weak. Was in pain through the night. Advil did not help. Could not sleep. 2nd day more weak and nauseous from pain. Went to ER. Did nothing but give more Advil. Went home and slept for 12 hrs. Third day beginning to feel better, but rt. side of body still aches.
I have a bad headache and feel nauseous.; I have a bad headache and feel nauseous.; Friday My neck felt sore/Saturday my neck still hurts; Thursday I felt like one does when coming down with something, just achy and tired; Thursday I felt like one does when coming down with something, just achy and tired; Thursday I felt like one does when coming down with something, just achy and tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Aug2021 15:00 (Lot number: EWU165) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "CML" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: MALAISE (non-serious), PAIN (non-serious), FATIGUE (non-serious) all with onset 26Aug2021 09:00, outcome "not recovered" and all described as "Thursday I felt like one does when coming down with something, just achy and tired"; NECK PAIN (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Friday My neck felt sore/Saturday my neck still hurts"; HEADACHE (non-serious), NAUSEA (non-serious) all with onset 28Aug2021, outcome "not recovered" and all described as "I have a bad headache and feel nauseous.". Therapeutic measures were not taken as a result of malaise, pain, fatigue, neck pain, headache, nausea.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. The patient had no known allergies. Thursday, patient felt like one does when coming down with something, just achy and tired. Friday patient neck felt sore. Saturday patient neck still hurts, patient had a bad headache and feel nauseous.  Follow-up attempts are completed. No further information is expected.
30 second gen tonic clonic sz, onset about 15min p/vax;no fever nl behavior & exam shortly p/event;
Patient said at the time of shot and next day no pain but maybe a week after and since he has had arm, shoulder pain. Wakes him up at night and radiating.
Chronic, periodic heart pain, palpitations, or feeling of skipped heartbeat (myocarditis?)
Guest received first dose of Pfizer Vaccine. While in the Observation Area she reported  - Metallic Taste, Left arm tingling, cold feeling, and light ? headedness.? Vital signs assessed. Discussed symptoms and guest reported improvement within two to three minutes. VS: B/P: 150/72, P ? 71, SPO2 ? 100% R/A. Interventions: Water, snack, observed for 30 minutes. Guest reports no further symptoms upon departure.
Patient complaining of arm pain, numbness in weakness in upper left arm. Additionally patient stated same complaint of pain, weakness, and numbness in upper left leg. Has continued since received second vaccination in June. Pain level has not reduced but stayed the same or worse.
started growing hair on the top of otherwise bald head; potential AE of hair growth; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (started growing hair on the top of otherwise bald head) and HAIR GROWTH ABNORMAL (potential AE of hair growth) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. W1A21A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Pre-diabetic, Urination abnormal NOS and Cholesterol. Concomitant products included SIMVASTATIN and ATORVASTATIN for Cholesterol, METFORMIN for Pre-diabetes, FESOTERODINE FUMARATE (TOVIAZ) for Urination abnormal NOS, LISINOPRIL, ASCORBIC ACID (VITAMIN-C), VITAMIN D NOS, ACETYLSALICYLIC ACID (BABY ASPIRIN) and SAW PALMETTO [SERENOA REPENS] for an unknown indication.   On 20-Feb-2021 at 9:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021 at 9:20 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (started growing hair on the top of otherwise bald head) and HAIR GROWTH ABNORMAL (potential AE of hair growth). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (started growing hair on the top of otherwise bald head) and HAIR GROWTH ABNORMAL (potential AE of hair growth) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered THERAPEUTIC RESPONSE UNEXPECTED (started growing hair on the top of otherwise bald head) and HAIR GROWTH ABNORMAL (potential AE of hair growth) to be possibly related.    No treatment medications were reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow up was received and it includes Patient demographics and Concomitant medications were added. On 08-Jul-2021: Follow up was received contains no new information. On 28-Jul-2021: follow-up received contain no new information.
Patient developed high fever the night of the vaccination. Also per mom the patient had intermittent twitching and jerking for almost 6 min. in the night. Patient was seen in Hospital ER. Also has a neurology appt. pending.
arm soreness; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller mentions that she received her second shot yesterday morning and she's got arm soreness and wanted to know if she can take Tylenol. The event was non-serious per the reporter. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
The patient reported shakiness and tightness in the throat muscles without any issues with breathing.  Her blood pressure was 154/91 and pulse was 62.  After sitting and relaxing she eventually felt well enough to leave.
During injection, patient said he was dizzy and he fell to the ground from a chair. While my technician was calling 911. I checked his vital sign which was fine, and he had conscience and responded well to me. I applied cold compress onto his front head and  kept talking to him until EMT arrived. He was very pale. He said that he felt  his left hand and left leg numb and his left body had uncontrollable  muscle movement. EMT checked his vital sign and Oxygen level.  His symptoms persist so EMT took him to hospital.
Persistent Tinnitus.  Discussed with my doctor during physical, seemed that there is not much that can be done.  I hope it lessens over time.  I can live with it.
Nausea and Dizziness, post vacc vaso-vagal pre-syncope.