chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had several symptoms like chills, muscle pain, and headaches, but the night of the first day after the vaccine I started having pain in my facial bones and jaw started hurting and all my bones in my body were very painful, not like muscle pain, but like I had hurt my bones, and I started shivering, a lot. This lasts around 3 hours. I took ibuprofen (3 capsules and two hours after 2 Advils ) and I was wrapped in blankets and couldn't walk until it gets better around 11 pm.
Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 13 months (reported as 13.5 months)-old female patient who was vaccinated with 0.5 ml FLUZONE (Lot number: UJ005AD, expiry date: 30-Jun-2019) via intramuscular route in right thigh, on 18-Nov-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to overdose. No symptoms were reported. 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 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. List of documents held by sender: none.
8x6cm area of induration, erythema, warmth and tenderness with left regional adenitis.
VOMITING; PRESSURE; TINGLES THAT COMES AND GOES; SHOOTING PAIN; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch number. No concomitant medications were reported. On an unspecified date, the subject experienced vomiting, pressure, tingles that comes and goes, shooting pain, chills, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting, headache, fever, pressure, tingles that comes and goes, shooting pain and chills was not reported. This report was non-serious.
Just a few minutes after receiving his vaccine, the patient said he was not feeling good at all. He was sitting down for his 15 minute observation as required, but appeared to be sweating profusely and said he felt very tired all of sudden. He said he was extremely thirsty and also reported he had not eaten anything yet today. He was given water. He vomited a little.  Paramedics were called to examine him and found him to be ok. He reported feeling "much better" after about 45 minutes after receiving his vaccine.
SIRVA (shoulder injury related to vaccine administration): Vaccine was administered high up on the left arm. L. shoulder achieness onset within 30-60 minutes of vaccine administration; within 24hrs of administration pain and stiffness in left shoulder, decreased range of motion (unable to get arm up over head). Symptoms continued to increase over time. Dx: subacromial bursitis, rotator cuff impingement. Treatment to date: steroid injection X2, physical therapy. No prior injuries to the either shoulder, no prior complaints of signs/symptoms in either shoulder. No complaints regarding R. shoulder.
COVID+ 1/15/2023.  Vaccination status - J&J x1, Pfizer x1 Discharge Date: Jan 18, 2023 Discharge Provider: MD Primary Care Provider : PA-C    Admission Date: 1/15/2023   Discharge Diagnoses: Active Hospital Problems   Diagnosis Date Noted POA ? Diabetic ulcer of toe of right foot associated with type 2 diabetes mellitus, with fat layer exposed 01/16/2023 Unknown ? COVID-19 virus infection    Details of Hospital Stay PRESENTING PROBLEM: Right upper quadrant abdominal pain   HOSPITAL COURSE: 62-year-old male with past medical history of chronic diastolic CHF, hypertension, diabetes mellitus type 2 with neuropathy, presented with cough, lightheadedness, nausea, vomiting, and right upper quadrant abdominal pain for 3 days.  He initially presented to emergency department were he tested positive for COVID -19. He had acute kidney injury, CT scan of the abdomen and pelvis revealed multiple gallstones with showed digestion of possible cholecystitis.  Patient was hydrated with IV fluids and was transferred to Hospital for general surgery evaluation.  He was empirically started on IV Zosyn.  A HIDA scan was done which was negative.  His nausea has improved and he is now tolerating a diet.  He continues to have right flank/lower rib pain that is worse with cough which was thought to be musculoskeletal strain.  His oxygen levels were monitored and he did not have any hypoxic episodes   Patient has also been following with Wound Clinic regarding nonhealing wounds on his right hallux, 2nd and 3rd toes.  ABI revealed moderate arterial insufficiency.  MRI of the right foot showed no evidence of osteomyelitis.  Chronic wounds does not look infected.  Zosyn was discontinued.  His renal function improved back to baseline.   Patient was discharged home on improved condition.  He was evaluated by PT and OT who recommended discharge home with assist.  He will continue to follow up with his wound clinic.
Patient received J &J with above lot number on 11/11/21 at Hospital.  He is on home hemodialysis and chronically anti-coagulated on Apixaban.  Increased bleeding from hemodialysis site was noticed.  12/1/21 platelets = 81,000.  Patient came to hospital 12/22/21 for elective removal of peritoneal dialysis port.  Procedure was cancelled for platelets =49,000 and Hematology consult was obtained.
mouth sore; bruises very easily - bruises all over; chronic dry cough that prevents her from sleeping; continuing exhaustion; chronic dry cough that prevents her from sleeping; Severe Headache; nausea; chills; dizzy; weak; Joint pain for approximately 48 hours; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Severe Headache), NAUSEA (nausea), CHILLS (chills), DIZZINESS (dizzy) and ASTHENIA (weak) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 03L12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO Medical History Information Reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced HEADACHE (Severe Headache), NAUSEA (nausea), CHILLS (chills), DIZZINESS (dizzy), ASTHENIA (weak) and ARTHRALGIA (Joint pain for approximately 48 hours). On 14-Mar-2021, the patient experienced ORAL PAIN (mouth sore), CONTUSION (bruises very easily - bruises all over), COUGH (chronic dry cough that prevents her from sleeping), FATIGUE (continuing exhaustion) and INSOMNIA (chronic dry cough that prevents her from sleeping). On 14-Mar-2021, NAUSEA (nausea), DIZZINESS (dizzy), ASTHENIA (weak) and ARTHRALGIA (Joint pain for approximately 48 hours) had resolved. At the time of the report, HEADACHE (Severe Headache), CHILLS (chills), ORAL PAIN (mouth sore), CONTUSION (bruises very easily - bruises all over), COUGH (chronic dry cough that prevents her from sleeping), FATIGUE (continuing exhaustion) and INSOMNIA (chronic dry cough that prevents her from sleeping) outcome was unknown. Not Provided          Patient reports to doctor weekly. Patient has tried several different medications treatment, but it has minimal benefits. Patient stated "It has been occurring 8 weeks now".
swollen glands under arm on left side; rash with itching; burning; pimples; This is a spontaneous report from a contactable pharmacist. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via intramuscular route of administration in the right arm on 29Mar2021 at 09:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, hyperlipidaemia, prediabetes, hypertension and hypothyroidism. The patient's allergies to medications, food, or other products were reported as not applicable. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID) and MVI; for unknown indications from unknown start dates and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021, the patient experienced swollen glands under arm on left side, rash with itching, burning, pimples which developed 3-4 days post first dose of vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported events included treatment with valacyclovir (MANUFACTURER UNKNOWN). The clinical outcome of the events swollen glands under arm on left, rash with itching, burning and pimples were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Client indicated they do not do well with shots. I offered  wheelchair. Patient accepted. Reported Hx of syncope with shots - administered shot - patient reported not feeling well within 30 seconds of injection - became pale - had emesis never fully syncopal.
16Mar noticed inc stiffness neck, shoulders, arthritic pain on lt side. Experienced pain extending from inject site up arm into neck.
Warmth, pain, edema at injection site; Warmth, pain, edema at injection site; Warmth, pain, edema at injection site; This spontaneous case was received on 30-Sep-2020 from other health professional via agency (reference number: SEQW20-02593) and concerned a patient of an unknown age and gender.   The patient's medical history and concomitant medications were not reported.    On an unknown date in Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, indication, dose, route of administration and anatomical location: not reported). The batch number reported was 279838.     On the same day, a few hours after receiving Flucelvax QIV, the patient experienced warmth, pain and edema at injection site.   At the time of initial reporting on 30-Sep-2020, the outcome of the events was not reported.   The reporter did not provide a causality assessment.  This case is linked to cases 202004826, 202004882, 202004884 and 202004885 (the same reporter).  Company comment: A patient of an unknown age and gender was administered Flucelvax QIV vaccine. On the same day, a few hours after receiving Flucelvax QIV, the patient experienced vaccination site pain, vaccination site swelling and vaccination site warmth. Causal role of the suspect vaccine is assessed as possibly related for all events. Reported events correspond to BC level 3 diagnostic certainty for cellulitis at injection site.; Sender's Comments: A patient of an unknown age and gender was administered Flucelvax QIV vaccine. On the same day, a few hours after receiving Flucelvax QIV, the patient experienced vaccination site pain, vaccination site swelling and vaccination site warmth. Causal role of the suspect vaccine is assessed as possibly related for all events. Reported events correspond to BC level 3 diagnostic certainty for cellulitis at injection site.
Nausea, chills, headache, loss of appetite, left arm painful - no redness or swelling at injection site. Possible Dtap reaction DX by state university health service - not seen by this facility F/up - event reported to us.
SWELLING AND WARMTH AROUND GIRTH OF RIGHT ARM, STARTED THE DAY AFTER VACCINE ADMINISTERED
The first night she had the chills real bad.  She got up to go to the bathroom and was so could she didn't think she was going to get back to bed.  She took 2 Tylenol, and went back and laid down.  She then awoke the next day starting to have some chills but not as bad as the night before.  She covered up with an electric  blanket in a chair and finally passed over.  She noticed  Saturday that she had nausea and dizziness.  She then had  tenderness in her mouth, used warm salty water which seems to be helping.  She cannot eat any hard food on it due to the discomfort.  She has continued nausea in the evenings.  No problems with the arm where she got the vaccine.  She feels it it getting some better, but the dizziness and nausea is the worst issue.  She did call her doctor and they told her that they could not give her anything for the rash in her mouth, and the chills. They told her that it had to run it's course.
Red, itchy swelling of the left eye, Ted itchy patches on right and left cheek, in left and right armpits, and under left breast. ER doctor prescribed Keflex, Bactrim, Vistaril, and a topical ointment.
I got shingles from the vaccine, the 2 nd shot did it/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria- medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got shingles from the vaccine and he/she had taken the 2nd shot. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. Note: Vaccine Shinquis was conservatively considered a typo error and coded in the present case as Shingles vaccine.
Mild muscle pain on day one but during second night and the day after high blood pressure and heart rate. HR at night while sleeping was 124.  High blood pressure throughout day two 158/97. Lasted about 36 hours. Sane thing happened ten days after 2nd Moderna dose.  Lasted a few days.
her arms little bit hurt when she touch it.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 93 year-old female patient received bnt162b2 (BNT162B2), administration date 09Feb2021 (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: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "her arms little bit hurt when she touch it.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Numb and tingly face; Numb and tingly face; Fatigued; lethargic; This is a spontaneous report from a contactable consumer (patient).   A 51-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN 5318), via an unspecified route of administration left arm single dose on 02Feb2021 14:30 (at the age of 51) for covid-19 immunisation. The patient medical history included covid 19 with mild symptoms on 29Dec2020. The patient's concomitant medications were not reported. No other vaccine was received in four weeks.  The patient experienced numb and tingly face, both on 02Feb2021 18:00, fatigued and lethargic on 02Feb2021 8-36 hrs after vaccination. The events outcome was recovered.
Positive for Covid-19; Positive for Covid-19; This is a spontaneous report from a contactable consumer.   A 42-year-old male patient that he received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date in Apr2021 (at the age of 42 years), as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks and did not have Covid prior vaccination. The patient was found to be positive for covid-19 on 12Aug2021. Event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. The patient underwent lab tests and procedures which included covid-19: positive on 13Aug2021. The outcome of event was recovered on an unspecified date in 2021.   The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
While administering 2nd dose Pedi Pfizer,  syringe malfunctioned vaccine would not dispense.  Vaccine was wasted and new dose was administered.
Four days after vaccine, I began to feel sick, weak, headache, bodyaches, fever of 100.4, and thick nasal/sinus mucus.
lt arm swollen from inj site to elbow inj site pain;no redness;no fever;
Pfizer FF2593 on 10/29/2021.  No adverse effects/events reported by patient.  Pfizer FF8030 11/20/2021 injection date, and had SEVERE symptoms begin that day Numbness tingling into arms and legs, that progressed to the point of being referred to me, orthopedic surgeon, for carpal tunnel syndrome.  Patient presented more with cervical myelopathy type symptoms, stat MRI cervical spine performed, with radiologist reported read of transverse myelitis, versus possible neoplasm of spinal cord, recommendation for contrast MRI recommended and was ordered.  That test date and results are pending.
Information has been received from a physician's staff concerning a female who on an unknown date was vaccinated with a dose of 0.5 mg GARDASIL (lot # not reported). the reporter stated that patient passed out after being given GARDASIL. At the time of reporting, the outcome of the patient was unknown. The patient sought unspecified medical attention. Additional information has been requested.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: SERTRALINE, start date: Jan2007. Patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment reported as yes. The patient previously received a COVID-19 Vaccine. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "covid-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 and treatment included Paxlovid from 06Jul2022 to 10Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Itchiness experienced 20 minutes post vaccination.  Symptoms persisted but did not worsen.  RN checked patient's VS.  P=75, O2 sat = 100%.  Given Benadryl 25 mg (1/2 tab).  Denied any further symptoms or worsening of symptoms.  Patient left and was d/c'd home after 15 minutes.
Patient developed nausea, decreased appetite, headache and fatigue after vaccination.  Had an appointment with her physician on 3-10-2021 and received IV fluids with Zofran.  Recovered by 3-14-2021.
05/16/2022 I had my vaccination. On 08/1/2022 we went to the doctors for my husband and stayed at a hotel. There was no air conditioning and it was in the 90's. The room was very hot and could not stay there that long. I think it allowed the germs to breath and believe where we got COVID-19. 08/02/2022 We went to my husbands doctor for his appointment. On Tuesday night, my husband was coughing and hacking. 08/03/2022 I woke up with a cough, labored breathing, headache and sore throat. I slept a lot. My husbands cough was getting worse with a temperature of 102. We tested and were COVID-19 Positive. We were prescribed Plaxovid. I am feeling much better and tested negative 08/16/2022.