chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever 100.3F; chills; facial/jaw/teeth pain; facial/jaw/teeth pain; facial/jaw/teeth pain; arm pain; injection site redness and swelling; injection site redness and swelling; Malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Oct2023 at 11:45 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Atopic dermatitis/Eczema" (unspecified if ongoing); "Atopic dermatitis/Eczema" (unspecified if ongoing); "IBS" (unspecified if ongoing); "known allergies: Dairy" (unspecified if ongoing); "known allergies:  Latex" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: MALAISE (non-serious) with onset 26Oct2023 at 15:00, outcome "recovering"; PAIN IN EXTREMITY (non-serious) with onset 26Oct2023 at 18:00, outcome "recovering", described as "arm pain"; INJECTION SITE ERYTHEMA (non-serious), INJECTION SITE SWELLING (non-serious) all with onset 26Oct2023 at 18:00, outcome "recovering" and all described as "injection site redness and swelling"; FACIAL PAIN (non-serious), PAIN IN JAW (non-serious), TOOTHACHE (non-serious) all with onset 26Oct2023 at 22:30, outcome "recovering" and all described as "facial/jaw/teeth pain"; CHILLS (non-serious) with onset 26Oct2023 at 23:30, outcome "recovering"; PYREXIA (non-serious) with onset 27Oct2023 at 16:00, outcome "unknown", described as "fever 100.3F". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, pyrexia. Therapeutic measures were not taken as a result of injection site erythema, injection site swelling, facial pain, pain in jaw, toothache, chills.  Additional information: the patient did not receive any other vaccine in four weeks. Other medications in two weeks included Natures medicine multivitamin. The patient used Tylenol for pain and fever management.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Acute left shoulder and chest pain occurring days after first and second dose. She went to the hospital for the first experience and was diagnosed with possible pericarditis.
Non-stop crying stated at 8pm. Taken to ER by parents, on route has 2 episodes of uncontrollable shaking lasting 10-40 seconds. Crying stopped around 12pm midnight, Discharged 3/2/02 6pm. RTC - 3/4/02 follow-up  - repeat CBC. Rocephin 50mg/kg x 1-IV. Final diagnosis was allergic reaction.
Diarrhea, NauseaVomiting, PAIN AT INJECTION SITE Narrative:
Tinnitus Right ear appears to be continuous although patient states it is currently improving. Patient has history of Acoustic Neuroma removed in 2001. Has had tinnitus exacerbated by Caffeine and other agents. Patient claims that after meningitis vaccine, tinnitus was exacerbated.
Left arm extremely red/swollen and painful from a couple inches lower than shoulder all the way until the elbow.
ON 4-10-2007 PATIENT DEVELOPED A RASH. WAS SEEN IN OUR OFFICE ON 4-13-2007. THEN PATIENT SAW A DERMATOLOGIST DX WITH SHINGLES. ON 4-20-2007 WAS RECHECKED DO RASH SPREADING AND FEVER.
Systemic: Allergic: Rash (specify: facial area, extremities)-Medium.
chills, nausea, vomiting, pallor, fever;supportive care given @ home;resolution over approx 1 day;
This is a spontaneous report from a contactable pharmacist via a sales representative. A 66-year-old female patient received PREVNAR 13, lot number and expiration date were not reported, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced welt at injection site after pneumococcal 13-valent conjugated vaccine administration on an unspecified date. The outcome of the event was unknown. Information on the batch number has been requested.
Side effects; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On an unknown date, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported).   Since an unspecified date, after having been administered the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23), the patient was experiencing unspecified common side effects (adverse event) listed in the prescribing information of the suspect vaccine.  At the time of reporting, the events were ongoing and the reporter did not assess the causal relationship between vaccination with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) and the events.
Got such bad fatigue I literally slept for like 16 hrs. My left jaw bone hurt so bad I could bearly open my mouth.
Patient noted she had a dry wheezy cough shortly after vaccine administered. Fever/ chills, flushing to face, tightness in chest (denied chest pain).  Patient took Aspirin, stayed hydrated, and got reassessed at clinic day after.
flu like symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 18Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 immunization.  The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 19Apr2021, outcome "recovered" (2021), described as "flu like symptoms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mother reported jerky movement of all 4 extremities with eyeball-swelled and saliva in mouth liquid coming out of nose. This episode was 2 days after
ringing in his ears or tinnitus; pressure headaches that lasted for a second or two; Soreness on his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness on his arm), HEADACHE (pressure headaches that lasted for a second or two) and TINNITUS (ringing in his ears or tinnitus) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness on his arm). On 28-Mar-2021, the patient experienced HEADACHE (pressure headaches that lasted for a second or two) and TINNITUS (ringing in his ears or tinnitus). On 27-Mar-2021, PAIN IN EXTREMITY (Soreness on his arm) had resolved. At the time of the report, HEADACHE (pressure headaches that lasted for a second or two) and TINNITUS (ringing in his ears or tinnitus) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included Advil for the headaches.
Pain, swelling (4 x size) red blotches rash, injection site to mid lower arm, heat, antibiotics Keflex 500 QID x 10 days, Benadryl 25 QID.
pt reports lt arm began to hurt almost as soon as vax given & just got worse;entire arm feels sore/achy;lead feeling denies numbness, discoloration told to call MD & apply ice;
awoke on 4AUG95 w/severe joint pain & extremely swollen testicles;running a fever, swelling got worse;It was hard for pt to walk because joint hurt do bad;
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On 16-NOV-2016 the patients were vaccinated with improperly stored dose of RECOMBIVAX HB (lot# L020157 and expiry date: 12-MAR-2018, lot# M010671 and expiry date: 02-JUN-2018, lot# M029233 and expiry date: 09-AUG-2018, lot# M010212 and expiry date: 21-JAN-2019). The vaccine was exposed to a temperature of 53 Fahrenheit for 1 hour and 45 minutes. There were no previous temperature excursions. The call was because of a data logger. No adverse events were reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested.
Information has been received from a licensed practical nurse concerning a female who was vaccinated with a second dose of GARDASIL vaccine (yeast). Subsequently the patient developed "mono". At the time of the report, the patient's outcome was unknown. The nurse reported that the nurse practitioner did not feel that the "mono" was related to GARDASIL vaccine (yeast). Additional information has been requested. This is in follow-up report(s) received on 11/14/2007  1/7/2008.  Information has been received from a licensed practical nurse concerning a female who was vaccinated with a second dose of GARDASIL.  Subsequently the patient developed "mono".  At the time of the report, the patient's outcome was unknown.  The nurse reported that the nurse practitioner did not feel that the "mono" was related to GARDASIL.  The practice has no further information regarding this AE.  Additional information was received from a nurse stating that the office had no record of the patient's experience.  No additional information is expected.
In late January, i developed strange pain in abdomen and all of my torso, pain would move, cold made it worse.   Couldn't breath well, couldn't cough, sneeze or yawn, it was too painful.    I spent 6 days in the hospital and had every test known run, nothing was coming up until after I was discharged from the hospital, i went to a Rheumatologist.  He determined that I had developed Sersositis.   But ordered further testing.   Turns out I got diagnosed with FMF.   I am not on Colchicine .6 mg.     All my vaccinations were Moderna.   First dose was 3/29/2021, second dose was 4/26/21, booster was on 1/13/22
Pt recvd vax  & exp serum sickness type react consisting of joint pain, weakness, &/or diarrhea; workup has included numerous tests for collagen vascular diseases, has been non-diagnostic;
JANSSEN VACCINE WAS ACCIDENTALLY ADMINISTERED AFTER BEING LEFT OUT OF FRIDGE BEYOND 6 HOURS; VACCINE WAS  LEFT  OUT OF FRIDGE BEYOND 6 HOURS; This spontaneous report received from a pharmacist concerned a 22 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included patient had no known drug allergy and no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1821288, expiry: 01-AUG-2021) dose was not reported, administered on 09-JUN-2021 18:52 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced janssen vaccine was accidentally administered after being left out of fridge beyond 6 hours. On 09-JUN-2021, the subject experienced vaccine was left out of fridge beyond 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the janssen vaccine was accidentally administered after being left out of fridge beyond 6 hours and vaccine was left out of fridge beyond 6 hours was not reported. This report was non-serious.
My arm started itching and was tender on Monday night 1/11/21. On Tuesday 1/12/21 my arm was hot and had developed a knot at the injection site and continued to itch and hurt, on Wednesday 01/13/21 when I woke up I had a red rash on top of all the other symptoms at the injection site. I have been very tired and had a headache since I got the vaccine. And over the last few days I have felt worse and my joints and muscle ache, I have been nauseas and mild chills with low grade fever.
Client reports that he received the vaccine and had what he felt was normal reaction to vaccine with soreness, fatigue, and had chills on day 5.  Client reports having blood work done (2/21/21) as part of routine health appointment.  He saw MD on 3/2/21 and his AST and ALT were dramatically increased. He had his blood work done again 3/2 and reviewed on 3/3 with digestive health and it was increasing and medical experts directed patient to not receive the second dose.
Received the moderna vaccine right at the beginning of pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Received the moderna vaccine right at the beginning of pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Received the moderna vaccine right at the beginning of pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Received the moderna vaccine right at the beginning of pregnancy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
pt recv vax & 29APR98 pt exp a metallic taste in mouth & sl lightheadness;
Slept for 36 hours the night after getting the shot; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HYPERSOMNIA (Slept for 36 hours the night after getting the shot) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced HYPERSOMNIA (Slept for 36 hours the night after getting the shot). On 01-Feb-2021, HYPERSOMNIA (Slept for 36 hours the night after getting the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided, however, the patient's HCP advised the patient not to receive the second shot.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 13-JAN-2017, the patient was vaccinated with an expired dose of ZOSTAVAX (exact dose was not reported, lot # L028286, expiration date: 28-OCT-2016) subcutaneously. No adverse effects were reported. Additional information has been requested.
Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild
Localized tenderness, 1 day, post vax, followed by erythema, tenderness and currently has the above signs and symptoms.
Diagnosed with myocarditis and pericarditis.  Symptoms: chest pain Treatment: ibuprofen, colcrys
Breaking out in hives that lasted a few hours. 11:30-2:00 Screaming inconsolably at random times of the day for the next two days.
Apparent vasovagal syndrome, came on suddenly, unable to walk, somehow was able to call son who came right over.  I fell on floor, unable to get up.  He called 911 and the firemen helped me sit up.  I was cold and clammy, but could talk and answer all questions.  The firemen said I should be all right and they left.  They said they had had extra calls for the same symptoms.  I went to bed, and my blood pressure was 93/53.  I slept all right.  The next day, yesterday, I was tired but feeling all right with the highest temp of 98.4.  Today, February 25, I am doing better.  I called and left a message for Dr.
A report has been received from Nurse Practitioner concerning herself a 29 year old, Female patient, who had been receiving Nasal FLUMIST. FLUMIST started on 11-Oct-2012. The patient experienced positive flu test 3 days after receiving FLUMIST and not feeling well which started on 11-Oct-2012. The outcome of the event of positive flu test 3 days after receiving FLUMIST and not feeling well is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune 24-Oct-2012: the event of not feeling well was deleted because the patient reported that she was "feeling under the weather" prior to giving herself FLUMIST.
I woke up disoriented; I had severe double vision; loss of balance; severe nausea; diagnosed a 4th nerve palsy of my left eye; This is a spontaneous report from a contactable consumer (patient).   A 43-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0176), via an unspecified route of administration at the age of 43-year-old administered in arm left on 18May2021 10:30 AM at single dose for covid-19 immunisation. Medical history was reported as none. Prior to vaccination, the patient wasn't diagnosed with COVID-19. The patient's concomitant medications included ibuprofen received within 2 weeks of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0176), at the age of 43-year-old at the arm left on 27Apr2021 01:30 PM for COVID-19 immunisation. The patient had his second dose of the Pfizer COVID vaccine at 10:30am on 18May2021. By 2:30am on 19May2021, he woke up disoriented and realized that he had severe double vision resulting in loss of balance and severe nausea. A 19May2021 visit with his primary care doctor diagnosed a 4th nerve palsy of my left eye. This was confirmed by a 19May2021 visit to an ophthalmologist. It is now 21May2021 and nothing has improved and an MRI (Magnetic resonance imaging) was pending. The adverse events result in Doctor or other healthcare professional office/clinic visit. Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of events was not recovered.
Patient experienced fatigue, diarrhea, and vomitting.  Patient refuses second vaccination.
Patient received vaccine after published expiration date. Moderna Company analyzed lot 007B21A and advised vaccine maintained activity necessary to protect against covid 19  at time of administration. Also patient did not call in and complain  of any adverse event.  This is administrative error without adverse event.
Arm at injection site swelled and at present is 31/2 inches by 1 1/3 inches. It doesn't hurt, but doctor recommended cutting it out. Scheduled for surgery. Have decided to have a biopsy, Xray / ET scan before that happens.
This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received PREVNAR 13, (batch/lot number and expiration date were not reported), via an unspecified route of administration in deltoid on an unspecified date to at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced red, raised, round area about two inches below the PREVNAR 13 injection site on an unspecified date. The patient bled after the PREVNAR 13 injection in the deltoid and a vein or artery may have been hit. The outcome of the events was unknown. The information on the batch/lot number and expiration date has been requested.
Well we went on vacation and I was 30 weeks pregnant and I had no other symptoms, warnings or anything. I was feeling great in my pregnancy and I woke up in the middle of my water broke. They gave me fluids and magnesium. I went to ER 4/30/2021 and I was there until Tuesday 5/1/2021 in the evening, the baby's heart rate was not recovering and they had to do an emergency C-section. I have 3 children who I all had all induced, never labored on my own. My first child was 7lbs 5 ounces, my second child was 7lbs 5.5ounces, and the third was 6lbs 9ounces. My fourth (this one) was born at 30 weeks and 6 days and he was in the NICU for 5 days, he was 3lbs 13 ounces. I had all similar pregnancies in regards to my previous ones, my DR had cleared me prior to vacation, they cleared me for travel and to go, so they do not know what caused my water to break. My child was due to be born on August 4th 2021. I followed up with a DR, because we just got back to where we live, just a few days ago. I will see my normal OBGYN on Thursday July 15th 2021.
Became pregnant after first covid vaccine given March 1, 2021. Received 2nd vaccine on March 29, 2021. Miscarriage occurred May 5th 2021 resulting in D&C and overnight hospitalization.
Severe pain on his left shoulder; This is a spontaneous report from a contactable consumer (patient's wife).   A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Mar2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (Batch/Lot number was not reported), via an unspecified route of administration on 04Mar2021 as single dose for COVID-19 immunisation. On 14Apr2021, when the patient woke up, the patient experienced severe pain on his left shoulder blade and worked its way on his breast area. There were no unaddressed medical questions referred or forwarded to medical information. The outcome of the event was unknown.  No follow-up attempts are possible; Information related to batch/Lot number could not be requested.
Tested positive for COVID-19 6/24/2022. Started Paxlovid same day. Symptom-free by 2 days after completion of Paxlovid. Then developed rebound. Symptoms included sore throat, nasal congestion, fever, chills, cough and rebound sinus headache.
Syncope - lost consciousness for 10 minutes. Collapsed. Subarachnoid hemorrhage, vertigo, SIADH (Syndrome of inappropriate anti-diuretic hormone production), hyponatremia
3/31 @ 1530 moderate fatigue, mild headache started. 1715 400 mg ibuprofen taken. 1800-2000 napped. 2005 woke up with fatigue, headache, fever/sweats, body aches, skin sensitivity, and chills. 2100 back to sleep- 1000 mg Tylenol taken just prior.  4/1 @0145 woke up with nausea, severe body aches, abdominal upset, headache, fatigue, fever/sweats, skin sensitivity.  0200 4 mg Zofran and 2 tabs tums taken.  0300 200mg ibuprofen taken. 0330 back to sleep. 0730 woke up in bad night sweats- other symptoms much better but still there.  1500: symptoms worsened again- 4 mg Zofran and 500 mg Tylenol. 2200 to bed.  4/2 @0800 woke up in night sweats. Mild headache, fatigue, and mild body aches present but other symptoms resolved. 1400 headache, fatigue resolved.