chrisvoncsefalvay/vaers-outcomes huggingface dataset:
they got second shot on 16Mar2021. 5 days later, on 21Mar2021, they both tested positive for Covid-19/came down with symptoms on 21Mar2021; tested positive for Covid-19/came down with symptoms on 21Mar2021; This is a spontaneous report from a contactable consumer (patient). This consumer reported same events for him and his wife. This is the first of two reports.  An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 23Feb2021 (Batch/Lot Number: EN6203) as 1st dose, single and via an unspecified route of administration, administered in Arm Left on 16Mar2021 (Batch/Lot Number: EN6204) as 2nd dose, single for covid-19 immunization. The patient has no medical history and concomitant medications. The patient and his wife both received the first dose of the Pfizer Covid 19 shot on 23Feb2021 and they got the second shot on 16Mar2021. 5 days later, on 21Mar2021, they both tested positive for Covid-19. The patient clarified that they came down with symptoms on 21Mar2021, then tested positive on 22Mar2021. The patient did not get over the Covid symptoms for a good solid 4 weeks, but thinks he is mostly recovered. The outcome of the events was recovering.  Information about Lot/Batch number can be obtained. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021505937 Same reporter/drug/AE, different patient
Arm was extremely sore after injection. By night was having chills and sweats. Fever. Every joint ached and had zero energy for 2 weeks. Slept 12 hrs a night and took naps.
mild chill; little fatigued; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (mild chill) and FATIGUE (little fatigued) in a 67-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (mild chill) and FATIGUE (little fatigued). At the time of the report, CHILLS (mild chill) and FATIGUE (little fatigued) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.    This case was linked to MOD-2021-003195 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Initial additional received on 15-JUN-2021, Updated outcome of all the 2nd dose events to recovered or resolved.
Sore throat, nasal congestion and cough. Upper respiratory infection and subchorionic hematoma. Tx Plan: (1) Admit to L&D; (2) Put on Electronic fetal monitor (EFM); (3) Cultures taken for inf. antigens, Respiratory DFA, throat culture, chest x-ray; (4) Patient on IV fluids. Vaccine failure.
She received her 2nd Covid vaccine on 6/9/21. She felt 'crappy' for 2 days after, with low grade fever. On 6/12/21 she had some vaginal itching. She was in the river that day. She isn't sure if the itching occurred before or after the river. Her LMP was one month ago. She is not sexually active. She has previously had a non-sexual inflammatory ulcer with influenza.
CHILLS; COUGH; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included chemotherapy, and concurrent conditions included bladder cancer.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) 0.5 ml, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 103.4 UNITS UNSPECIFIED. On 08-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, and cough. This report was non-serious.
Suspected vaccination failure; Mild case (shingles); Little itch; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pruritus. On an unknown date, the outcome of the vaccination failure, shingles and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine.     Additional Information: GSK receipt date: 03-Mar-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the Shingles vaccine. The patient experienced a very mild case a couple of years ago.  There was no pain, but little itch. Just like Covid vaccine could get a mild case, but no death Ugh. The patient believes in science. Additional Supportive Information: The follow up would not possible, as no contact, details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Swelling, redness, warm to touch, size of a deck of cards; swollen lymph node in right arm.
Rash w big, itchy bumps from shoulder to elbow and spreading to outer arm area. Went to urgent care, got cortisone injection and was told to use topical. On Sept 27, 2012 was diagnosed w MRSA in right arm where pneumonia shot was given. Got IV Vancomycin. Called on 10-2-2012 and said she is going to a wound care clinic where right arm was lanced and drained at injection site area. Stated the rash that started around the injection site was itchy and she scratched it opening up the skin where the MRSA started. On 10-8-2012 patient states the arm is beginning to heal. Still itchy but not as bad. Still going to wound clinic.
acthib reconstituted with sterile water/no AE; Initial information received on 01-Apr-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 years old female patient who received only sterile water of vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Mar-2019, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE lot UI944AA via intramuscular route in unknown administration site.  It was of actual medication error due to Inappropriate reconstitution technique.  No adverse event was experienced..  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.
got whooping cough from kids who were newly vaccinated; got whooping cough from kids who were newly vaccinated; Initial information regarding this unsolicited valid serious social media case received from a consumer (patient) and transmitted to Sanofi on 03-Dec-2020.  This case involved a patient with unknown demographics who experienced got whooping cough from kids who were newly vaccinated (pertussis associated with exposure to vaccinated person) with vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious whooping cough from kids who were newly vaccinated (pertussis associated with exposure to vaccinated person), unknown latency following the administration of INFLUENZA VACCINE.   The event, pertussis associated with exposure to vaccinated person, was assessed as medically significant as per important medical event (IME) list.  Relevant laboratory test was not reported.  Final diagnosis was pertussis associated with exposure to vaccinated person.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.  Information on the batch number was requested.; Sender's Comments: This case concerns a patient of unknown demographics who was presented with whooping cough from kids who were newly vaccinated with INFLUENZA VACCINE, by unknown manufacturer. The time to onset is unknown. However, patient's medical condition, concomitant medication and laboratory tests ruling out alternate etiologies. Based upon the reported information, the role of a vaccine cannot be assessed.
Seems to be lymphadenopathy.; Raised red spots along under the armpit (both sides), on the chest (left), in the crook of the arm (left), and groin (left); This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 01Apr2021 at 14:15 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included loratadine (MANUFACTURER UNKNOWN) from unknown date and for unspecified indication. On 16Apr2021 at 07:30, the patient experienced raised red spots along under the armpit (both sides), on the chest (left), in the crook of the arm (left), and groin (left). The patient reported as seemed to be lymphadenopathy. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 15Apr2021, the patient underwent polymerase chain reaction (PCR test) and the result was negative. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the raised red spots along under the armpit (both sides), on the chest (left), in the crook of the arm (left), and groin (left) and seems to be lymphadenopathy were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Arm red, warm, and swollen from shoulder down to hand.  Right side lymph nodes also enlarged.  Some tightness, pain, and itching.  Arm warm to touch.  Today is 15 days after injection.  Arm swelling has reduced every day, but still persists.
Ringing in the ears. Worse during headache/migraine. Has decreased/become intermittent over time but still present 3 months later.
Patient complains of redness and itching at site of injection.  She continues to use hydrocortisone cream and oral zyrtec but still complains of itching 10 days post vaccine.
Site where shot given on right arm is swollen and itchy. Chills, bodyaches, and headaches over night.
This 70   year old    male received the Covid shot on  3/24/21  and was found deceased at home by the Sheriff sometime between 3/24/21 and 4/16/21.  Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
Health declined precipitously roughly 3-4 months after receiving the vaccine (h1n1 spray). -extreme fatigue -reduced mental abilities (concentration, brain fog, word recall) -lowered white blood cell count -recurrence of acute EBV infection (positive IgM) and other infections -dropped out of school, unable to work -currently bed bound
Out of breath post yard work after 2nd shot/Shortness of breath on and off after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Out of breath post yard work after 2nd shot/Shortness of breath on and off after 2nd shot) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced DYSPNOEA (Out of breath post yard work after 2nd shot/Shortness of breath on and off after 2nd shot). At the time of the report, DYSPNOEA (Out of breath post yard work after 2nd shot/Shortness of breath on and off after 2nd shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) Increased heart rate.         It was reported that the patient shortness of breath and also increased heart rate in the months of Mar-2021 and APR-2021 - which goes away and comes back. Also stated that he was exposed to COVID through his 17year old son.  Concomitant medication information was not reported  Treatment information was not reported
Pain in elbow and shoulder. Urticaria.  Total body joint pain.  Symptoms began approximately 14 hours after injection and have continued to date.  As per mother, she state when she called today that symptoms seem to be worsening. Already on Zyrtec for allergic rhinitis, and using Benadryl po as well
Polyps were removed; This spontaneous case was reported by a physician and describes the occurrence of POLYPECTOMY (Polyps were removed) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient has no known allergies.  The patient's past medical history included Injection site pain (Stings/hurt/burning sensation after Humira injection; resolved when switched to citrate-free) from 2015 to 2017 and Colonoscopy (Sometimes performed every three years; a fewpolyps were discovered) in February 2021. Concurrent medical conditions included Crohn's disease (moderate to severe) and Polyps (discovered during annual checkup via colonoscopy). Concomitant products included COLESEVELAM HYDROCHLORIDE (WELCHOL) for an unknown indication.   In 2016, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced POLYPECTOMY (Polyps were removed). On 16-Mar-2021, POLYPECTOMY (Polyps were removed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter states that the polyps were removed on 16MAR2021 and "everything was ok."  No additional treatment was reported.
Received vaccination on right arm, the next morning felt radiating pain up to the neck and behind the ear. Was temporarily resolved with APAP and Advil
Red rash covered both legs and swelling from knees down to feet. Hard time walking. Hair not coming back in on legs. Calves on legs hard as a rock, pain itching. Still swelled and very sore.
patient was given expired Menactra/ NO AE; Initial information was received on 18-Aug-2021 regarding an unsolicited valid non-serious case from a physician and non-healthcare professional via call center via Global Medical Information (Reference number- 00730324).  This case involves a patient of (unknown demographics) who administered (expired vaccine used) (expired product administered) MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  On 14-Aug-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number not reported and expiry date: 26-Jan-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency: same day).  It was reported as "The Physician asks if the Menactra needs to be revaccinated. The Physician had to get off the phone, however the Physician or a medical assistant (MA) will be calling back to provide the Pasteur adverse event (AE) questions".  At the time of reporting, no adverse event 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 the 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.  There will be no information available on the batch number for this case.
administered the liquid portion of the PENTACEL to a patient and reconstitute the Hib portion with sterile water and administer to a patient as well with no reported adverse event; administered the liquid portion of the PENTACEL to a patient and reconstitute the Hib portion with sterile water and administer to a patient as well with no reported adverse event; Initial information received on 07-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 4-month-old male patient to whom administered the liquid portion of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] to a patient and reconstitute the hib portion with sterile water and administer to a patient as well and administered the liquid portion of the pentacel to a patient and reconstitute the hib portion with sterile water and administer to a patient as well with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  On 07-Oct-2022, the patient received 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (strength: standard) (lot number: UJ598AAA expiry date: 05-Dec-2022) via intramuscular route in the left thigh (leg) for Immunization and on the same day, administered the liquid portion of the pentacel to a patient and reconstitute the hib portion with sterile water and administer to a patient as well with no reported adverse event (product preparation error) (single component of a two-component product administered).  Reportedly, Pharmacy director wants to know if the doses are valid. This is reported as potential AE because of use against local labelling.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable.  At time of reporting, the outcome was Unknown for both events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Cold sweats, fever, indigestion, nausea [T+24 hours] costochondritis (T+48hours)   After being diagnosed with costochondritis, patient began regimen of 600mg ibuprofen q8h. Symptoms started to subside after for dose.
Labored breathing; Chest pains; Could barely stand up; Rash from her leg to buttocks area; Fever of 102 degrees; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Labored breathing), CHEST PAIN (Chest pains), GAIT DISTURBANCE (Could barely stand up), RASH (Rash from her leg to buttocks area) and PYREXIA (Fever of 102 degrees) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced DYSPNOEA (Labored breathing), CHEST PAIN (Chest pains), GAIT DISTURBANCE (Could barely stand up), RASH (Rash from her leg to buttocks area) and PYREXIA (Fever of 102 degrees). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, DYSPNOEA (Labored breathing), CHEST PAIN (Chest pains), GAIT DISTURBANCE (Could barely stand up), RASH (Rash from her leg to buttocks area) and PYREXIA (Fever of 102 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) high.         As reported patient experienced a rash from her leg to buttocks area, fever of 102 degrees, labored breathing, chest pains, and could barely stand up. Patient used rescue inhaler to alleviate the adverse event.  Concomitant medications were not reported.
My Lymph nodes were very large and lasted 3 and half months.  Left arm felt like there was a tennis ball and another large node in my neck. I have not fully recovered.
A nurse reported post vaccine pt reported the next day, developed injection site reaction characterized by a 4.5 to 5cm area of redness, warmth, itching, induration, tiny blisters and pain described as feeling bruised on the inside.
Information has been received from a physician concerning a 2 month old female with no medical history or allergies who at the end of December 2006, was vaccinated PO with a dose of Rotateq. There was no concomitant therapy. The physician reported that at the end of December 2006, the patient developed abdominal distention. The patient was taken to the Emergency room and was admitted overnight. While hospitalized, the patient stopped breathing and turned blue. Unspecified laboratory tests were performed. The patient subsequently recovered. Additional information has been requested.