chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pharmacy was informed by the Director of Nursing at the long-term care facility where the vaccine clinic was held that one of their staff members had been diagnosed with bursitis. No other specific information was known/provided. (For Item # 21 below - we believe the patient saw a healthcare professional who diagnosed their bursitis, but we do not know for certain).
15 minutes after 2nd vaccine developed urticaria.  30 minutes after vaccine chest tightness and coughing.  Brought to the ER and treated with IV Benadryl. Felt better but abnormal EKG so kept over night.
Pt had urticaria, and extreme erythema full body 1 day after Hep A immunization. Pt had no other abnl po intake.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6204), in right arm, on 01Apr2021 as dose 2, single (Lot number: ER8734), on 08Sep2021 as dose 3 (booster), single (Lot number: FF2588), in right arm and on 13Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 21 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Immunocompromised" (unspecified if ongoing); "History of anorexia nervosa" (unspecified if ongoing); "History of anxiety" (unspecified if ongoing), notes: History of anxiety. Concomitant medication(s) included: MIRTAZAPINE, start date: 01Mar2019; SERTRALINE, start date: 01Jun2018; MIRENA, start date: 06Jan2021; SPIRONOLACTONE, start date: 17May2022; RITALIN, start date: 01Jun2022. The following information was reported: VACCINATION FAILURE (medically significant) with onset 2022, outcome "not recovered", COVID-19 (medically significant) with onset Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (01Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient took Paxlovid from 21Jul2022 to 26Jul2022 as treatment of covid-19. Clinical course: The patient administered other medications/products within 2 weeks of starting COVID-19 treatment. After taking Paxlovid from 21Jul2022 through 26Jul2022, she tested negative for COVID on an antigen test and was asymptomatic. This continued through 31Jul2022. On 01Aug2022 05:30 PM, she redeveloped symptoms and tested positive for COVID on antigen tests and patient was not treated for adverse event.  No follow-up attempts are possible. No further information is expected.
Information had been received on 26-MAY-2017 from a lawyer regarding a case in litigation. The patient's medical history, concurrent conditions and concomitant medication were not provided.  It was alleged in litigation that a female patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) in 2013 at her primary care facility (medical group), as recommended for routine adult health maintenance for the prevention of shingles. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster.  Throughout the years of 2014 and 2015, the female patient was treated on multiple occasions at the primary care facility (medical group) for vesicular outbreaks that were diagnosed as severe shingles.  As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Patient feels like she has a cold coming on.  Patient said she was going to take some over the counter TYLENOL.
given a 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 3BD9E, expiry date 6th April 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2020) and Shingrix (received 2nd dose on October 2020).   In December 2021, the patient received the 3rd dose of Shingrix. In December 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient inadvertently received 3rd dose of Shingrix, which led to extra dose administered. The reporter did not consent to follow up.
Bruising bilaterally; legs swollen from hip to below knees. Fussy, very pale. Saw doctor at same clinic 7/1/04. HCT 11.8, Hgb 3.8. Admitted to hospital and then transferred.  Nurse follow up on 07/26/04 states: "exacerbation of anemia."
mid-grade fever with a temperature of 100.4 degrees F. The temperature peaked 101.4 degrees F last night.; Chills; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), via an unspecified route of administration in the left arm on 28Dec2020 11:45 at a single dose for COVID-19 immunization. The patient's medical history included asthma, sulfur/sulfameds allergies, and iodine dye allergies. The patient was not pregnant at the time of vaccination. Concomitant medications included estradiol (ESTROGEN), progesterone, colecalciferol (VITAMIN D), allergy shots, and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Jan2021 18:00, the patient experienced chills and were continuing today. She was experiencing a mid-grade fever with a temperature of 100.4 degrees Fahrenheit on 04Jan2021. The temperature peaked 101.4 degrees Fahrenheit last night (07Jan2021). The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included rapid nasal pharyngeal COVID test which showed unknown results on 07Jan2021. Outcome of the events was not recovered. The events were considered non-serious by the reporter.
His stomach was a little uneasy; It was huge, burning hot to the touch for a few days; The injection site on the arm turned really red.; woke up with a breaking fever, which lasted about 7 hours; Little bit of a headache; He did not take his own temperature, but it was so bad he was shaking uncontrollably; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (His stomach was a little uneasy), VACCINATION SITE WARMTH (It was huge, burning hot to the touch for a few days), VACCINATION SITE ERYTHEMA (The injection site on the arm turned really red.), PYREXIA (woke up with a breaking fever, which lasted about 7 hours) and HEADACHE (Little bit of a headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (His stomach was a little uneasy), VACCINATION SITE WARMTH (It was huge, burning hot to the touch for a few days), VACCINATION SITE ERYTHEMA (The injection site on the arm turned really red.), PYREXIA (woke up with a breaking fever, which lasted about 7 hours), HEADACHE (Little bit of a headache) and CHILLS (He did not take his own temperature, but it was so bad he was shaking uncontrollably). At the time of the report, ABDOMINAL DISCOMFORT (His stomach was a little uneasy), VACCINATION SITE WARMTH (It was huge, burning hot to the touch for a few days), VACCINATION SITE ERYTHEMA (The injection site on the arm turned really red.), PYREXIA (woke up with a breaking fever, which lasted about 7 hours), HEADACHE (Little bit of a headache) and CHILLS (He did not take his own temperature, but it was so bad he was shaking uncontrollably) outcome was unknown.            Concomitant medication include: Blood pressure medication Treatment information was not reported
vaccine was supposed to be in left deltoid. it was injected too high and i am experiencing extreme joint pain in left shoulder.
Admission Date: 6/4/2022 Discharge Date: Jun 6, 2022  PRESENTING PROBLEM: Weakness Generalized weakness  COVID-19    HOSPITAL COURSE: Patient is a 76 y.o. male with known type 2 diabetes, history of DVT, protein S deficiency who was brought in by EMS due to generalized weakness.  When patient was seen he is alert oriented place and person.  He is not complaining of any pain and not sure why is he brought in hospital.  Workups at emergency department CT head negative for acute finding, CMP and complete blood count unremarkable COVID 19 test positive, chest x-ray showed similar right lower lobe opacity from prior hospitalization that may represent residual pneumonia. Patient remained asymptomatic from the COVID 19 infection.  He was on room air and did not have any respiratory symptoms.  PT OT evaluated the patient due to his weakness but recommended home with home care and did not feel he required subacute rehab.  Patient was close to his normal self and was medically stable for discharge.
Gone in for a routine mammogram and they found a lump.  They found an inflamed lymph node in the same side breast as the arm I received the injection.  It has since gone away.
Reaction at injection site characterized by formation of a hard lump, redness, swelling and pain at injection site immediately after vaccine administration. Later developed a rash,  cough and chest tightness. Now am experiencing intermittent chest pain.
Started running a fever Tuesday afternoon about 32 hours after #1 injection. Started at 99.3. Woke up with 99.5.
Had his immunizations on 8/17, and then on 8/20 woke up and had some right testicular discomfort.  The pain worsened and they brought him into the ER and he was diagnosed with epididymitis.  No evidence of UTI so treated conservatively and he is doing better now.  I do not know if this is a side effect of the vaccine or unrelated.  Also reports some leg pain and knee pain but it is migratory and bilateral and not affecting him playing.  The DTaP IPV was his first dose of Kinrix, but he has had 4 previous doses of DTaP and 3 previous doses of IPV. We did an MMR V ProQuad combo and this is the first time he received the combination, previously had MMR and varicella separately.
12-18 hours after vaccination, patient presented in clinic with a rash, fever to 101 F and congestion.
Had a regular visit for a pap-smear and the results came up with 'abnormal cells,' which had never happened before. Was given a Colposcopy. Symptoms from that time on were lack of libido, reoccurring vaginal irritation & dryness, hormone problems, labia "cuts" and soreness. Lack of regular menstruation.
pain in my arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, 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), outcome "unknown", described as "pain in my arm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a registered nurse concerning to a 14-year-old female patient. The patient's concurrent conditions included malignant neoplasm of adrenal gland and Gilbert's syndrome. The patient had no drug reaction or allergies. The patient's medical history was not reported and she was not taking any concomitant medications. On 11-MAR-2019, the patient received a dose of GARDASIL 9, intramuscularly (lot #: R023607, expiration date: 06-MAY-2021); dosage not reported. The next day, on 12-MAR-2019, the patient "passed out at school". On an unknown date, a complete blood count (CBC) was performed with unknown results. On an unknown date, the patient recovered from the event of syncope. No additional information was provided. The causal relationship between the event of syncope and GARDASIL 9 was unknown.
Mother arrived for physical noting that there was redness, heat, swelling, and pain to his right arm where he received the KINRIX vaccine. The redness started to absorb yesterday and today and spread to the entire deltoid area and around to the inner aspect of his arm on both sides. Site of redness and swelling was > 110 mm.
Face was moderately flushed, increase in rosacea; Face was moderately flushed, increase in rosacea; This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (Face was moderately flushed, increase in rosacea) and ROSACEA (Face was moderately flushed, increase in rosacea) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026d21A, 040B21A and 038A21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Penicillin allergy.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 26-May-2022, the patient experienced FLUSHING (Face was moderately flushed, increase in rosacea) and ROSACEA (Face was moderately flushed, increase in rosacea). On 28-May-2022, FLUSHING (Face was moderately flushed, increase in rosacea) and ROSACEA (Face was moderately flushed, increase in rosacea) had resolved.            No concomitant medications information was reported.  Patient's date of birth was reported. The patient was not  taking any other medications/products within 2 weeks of starting COVID-19 treatment.  No treatment medications were provided.  Device date was reported as 31-May-2022.
sick; cold; flu like symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 01Mar2021 (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: MALAISE (non-serious) with onset Mar2021, outcome "unknown", described as "sick"; NASOPHARYNGITIS (non-serious) with onset Mar2021, outcome "unknown", described as "cold"; INFLUENZA LIKE ILLNESS (non-serious) with onset Mar2021, outcome "unknown", described as "flu like symptoms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain in his left shoulder from second shot; Chills; Fever 103F; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in his left shoulder from second shot), CHILLS (Chills) and PYREXIA (Fever 103F) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011L20A) for COVID-19 vaccination.     Concomitant products included PANTOPRAZOLE, LISINOPRIL and TAMSULOSIN for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced ARTHRALGIA (Pain in his left shoulder from second shot), CHILLS (Chills) and PYREXIA (Fever 103F). At the time of the report, ARTHRALGIA (Pain in his left shoulder from second shot), CHILLS (Chills) and PYREXIA (Fever 103F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Body temperature: 103 (High) 103 Degree Fahrenheit.         No treatment information was provided. Action taken with mRNA-1273 in response to the drug was not applicable   This case was linked to MOD21-09710 (E2B Linked Report).; Sender's Comments:  MOD21-09710:Crosslink case
Various shapes, sizes, and shades of red of hives scattered over body. Large local reaction at PENTACEL injection site (left thigh).
Sudden onset of extreme vertigo at about 11pm, such that I was unable to walk around my home without support. Symptoms lessened after a couple of hours at 1am. Symptoms have become more minor 12 hours later at 11am but are still noticeable and show no sign of disappearing.
CONSTIPATION; PROBLEMS WITH BOWEL MOVEMENTS; DIARRHEA; PANIC ATTACK; HOT FLASHES; PAIN IN KNEES; PAIN IN CALVES,LEGS AND RIGHT ARM; COULDN'T SEE WELL; FELT CONFUSED; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's past medical history included patient has taken tylenol.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 25-MAY-2021 for an unspecified indication. The batch number was not reported and has been requested Concomitant medications included paracetamol. On 25-MAY-2021, the subject experienced couldn't see well. On 25-MAY-2021, the subject experienced felt confused. On 25-MAY-2021, the subject experienced pain in calves, legs and right arm. On 26-MAY-2021, the subject experienced hot flashes. On 26-MAY-2021, the subject experienced pain in knees. On 01-JUN-2021, the subject experienced panic attack. On 02-JUN-2021, the subject experienced constipation. On 02-JUN-2021, the subject experienced problems with bowel movements. On 02-JUN-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn't see well, and felt confused, had not recovered from pain in knees, hot flashes, problems with bowel movements, and pain in calves,legs and right arm, and the outcome of panic atack, diarrhea and constipation was not reported. This report was non-serious.
That night, 2/11, left arm, neck and head became so sore it woke me up in the middle of the night about 3am on 2/12. The next day, 2/12, full body aches and muscle/joint pains and headache. It felt like all my previous injuries in life came back to haunt me. As the day went on, my head got hot and my feet freezing. Then the fever and chills/sweats began. Fever reached 100.6 degrees. The soreness radiated out from my left arm until my hands and head hurt. Eventually, my teeth/gums, eyes and scalp were hurting. I took both ibuprofen and Aleve but neither helped much. The morning of 2/13, I couldn?t wake up in the morning. I woke up from one vivid bad dream into another into another.  Finally was able to wake up. Fever was gone, soreness decreased over the course of the day. But my chest, back and ribs hurt like they had when I was sick with COVID. I developed a runny nose and raspy voice and shortness of breath. Used my inhaler and felt better. Now fully recovered.
Sore arm injection site; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN 6206) via an unspecified route of administration in the left arm on 08March2021 at 14:30 (at the age of 39-years-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER 8732) via an unspecified route of administration in the left arm on 29March2021 at 15:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date, in Mar2021 the patient experienced sore arm at injection site (vaccination site pain). The clinical outcome of event vaccination site pain was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
lt deltoid area red swollen & hot to touch;T97.6;onset first noticed 23SEP98;
Day after vaccination had soreness in shoulder area as if she was "knuckle-punched". Area tender like a bruise As of Nov 16 still soreness in shoulder area. Was taking Tylenol will switch to Motrin. Also using warm compresses.
Lymph node under armpit on the same side as the injection swelled up.  I noticed it the morning after the injection and it lasted 6 days.  The only other reactions I had to the injection were expected (extremely tired for one day after, soreness at injection site for 5 days).
patient was administered expired Daptacel and expired ActHIB/No AE; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves male patient of an unknown age who received expired dose of vaccines HIB (PRP/T) VACCINE [ACT-HIB] and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunization.  On 15-Nov-2019, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5307AA expiry date: 23-OCT-2019) and HIB (PRP/T) VACCINE (lot UI915AAB expiry date: 23-OCT-2019) via intramuscular route in the deltoid nos.  It was a case of actual medication error due to expired vaccine used.   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 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.
It felt like my throat was closing up, I had a hacking cough, very congested, the cough was a very dry hacking cough. I used a home COVID-19 test; it was negative. I have been using Robitussin during the day and Nyquil at night to help alleviate the symptoms. I am getting better every day.
pt had large local reaction to DTP inject given 10MAR92; mom called on 12MAR92 expressing concern about this & pt seen by MD 12MAR92; MD found 7 1/2cm by 9 cm area of erythema on the lt thigh; 5cm area of induration; tender to palpation;