chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other company (Pfizer) concerned a 42 year old female. Initial information was processed along with additional information on 31-JAN-2023. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, and drug allergy (Unspecified). The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, 1 total, administered on 15-MAR-2021 on left arm for covid-19 prophylaxis. Age at the time of vaccination was 41 years old. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate, bupropion hydrochloride, cetirizine hydrochloride, and montelukast sodium for unspecified indication.  The patient additionally received non-company suspect vaccine (Moderna Spikevax) elasomeran (Dose number in series 2) (second dose) (form of admin, route of admin were not reported, batch number: 026D21A expiry: UNKNOWN) dose was not reported, administered on 24-OCT-2021 on right arm for covid-19 prophylaxis, which was revaccination with different covid-19 vaccine (Dose number in series 2) and patient received third dose (form of admin, route of admin were not reported, batch number: 012H22A expiry: UNKNOWN) administered on 27-OCT-2022 on left arm for covid-19 prophylaxis. On 09-JAN-2023, the patient had confirmed covid-19 infection (Dose number in series 2) and tested positive, which let to confirmed clinical vaccination failure (Dose number in series 1). The patient received non-company suspect Paxlovid (form of admin, route of admin were not reported, batch number: GF3201 expiry: UNKNOWN) dose was not reported, administered from 09-JAN-2023 to 13-JAN-2023 for covid-19 treatment. On 13-JAN-2023, 14-JAN-2023 and 15-JAN-2023, patient tested negative and had no symptoms. On 18-JAN-2023, the patient was sick again and tested positive (rebound covid). On 21-JAN-2023, patient went to urgent care and was given (Prednisone) Methylprednisolone (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable, action taken with paxlovid was drug discontinued. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000269245.; Sender's Comments: V0-20230162246- Confirmed clinical vaccination failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Additional Details: still has pain in left shoulder  will be seeing orthopod for shoulder pain as per followup with patient
Patient experienced syncopal episode. No cutaneous or systemic symptoms. Regained consciousness within 5-10 seconds. Patient evaluated with normal examination and vital signs. Observed for 30 minutes. Stable and asymptomatic at discharge to home.
Narrative: COVID infection following COVID vaccine series 02/02, Pfizer, dose #1 02/22, Pfizer, dose #2 12/30 COVID swab, result: detected 1/10 COVID swab, result: detected 12/27 pt cc: cough/congestion/body aches/subjective fever/chills exposure: unknown 12/30 pt admit ED cc: cough/congestions/body aches/subjective fever/chills dx: Coronavirus LOS: 1 day 12/30 CXR impression: No acute abnormality.
Patient called pharmacy on 1/13/18 and complained of a rash after receiving 2 immunizations in the same arm on 1/10/18. He explained that the rash began on 1/11/18 in the morning and fever began in the evening  of 1/11/18. He stated he took MOTRIN for the fever and currently didn't have a fever on 1/13/18 but he had taken some MOTRIN that day. On 1/13/18 the pharmacist discussed possible adverse reactions to both immunizations and advised him how to take BENADRYL, use an ice pack, take TYLENOL, and to seek urgent care if condition worsened. On 1/13/18 he went to urgent care and they told him he had an infection. He stated that they placed him on antibiotics (generic BACTRIM DS).
Red streaks down right arm. Swelling left arm. Fever 101 degrees. Chills and dizziness.
LARGE RED WHEAL AT SIGHT OF INJECTION. HARD AND HOT TO THE TOUCH. VERY PAINFUL AND SENSITIVE
flu; Initial information was received on 08-Dec-2021 regarding an unsolicited valid non-serious social media case from a consumer/non-healthcare professional.  This case involves a patient who had flu (influenza), after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) 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 were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Everytime I get the Flu shot I get the Flu ! I don't get the Flu shot I don't get the Flu I haven't even had a Cold in over 5 years ! All I did was change my diet I eat more veggies then meat Now!"  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the lot number for this case.
Pt received Pfizer 10 mcg (0.2 ml) bivalent dosing when she should have received 30 mcg (0.3ml) bivalent.
Patient presented for COVID-19 vaccination.  Pfizer vaccine administered as first dose per protocol.  Two minutes after vaccine was given (at 1:39pm), patient reported feeling lightheaded and history of passing out after any injections and sight of needles. Patient assisted to the floor to lay flat on back while legs were elevated and oxygen given. Patient stated feeling better while laying down. Patient continued to lie down for 10 minutes as lightheadedness resolved before slowly sitting up. After patient was able to sit up without any further symptoms, patient was able to stand on her own, no further symptoms reported. Patient observed for  30 minutes and left the facility without any further issues.
Information has been received from nurse concerning a 66 year old female with allergies to penicillin, codeine sulfate, nitrofurantoin, hydrocortisone (WAES # 0212USA00803), phenaglycodol, cyclobenzaprine hydrochloride (WAES # 0212USA00804), and meclofenamate sodium who on 11/13/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent in the right deltoid (Lot # 641530/1351L).  The patient was well at the time of vaccination.  On 11/13/2002 the patient developed a severe site reaction.  The patient reported that her arm was painful, red and swollen at the injection site to the size of a baseball and that she could not use her arm.  The patient reported that she took diphenhydramine hydrochoride and cortisone cream.  On 11/15/2002, the patient called her physician's office and reported that she could use her arm again and the area was improving.  The physician instructed the patient to continue using the diphenhydramine hydrochloride and cortisone.  The health professional reported that as of 11/15/2002, they had not heard back from the patient so they assume she has recovered.  The reporter expressed a concern regarding the lot number.  The health professional also provided information regarding 2 other patients (WAES # 0211USA02404 AND 0211USA02405).  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  The patient sought unspecified medical attention.  Additional information has been requested.
Patient stated experienced tingling in left hand roughly 10 days after shot and continues to have tingling.
Shortly after vaccine given, while still seated in chair, had 2-3 small jerks and passed out. Fell while in chair and hit side of head on desk. Slightly dazed but appropriate. Observed x 1/2 hr. Went home in stable condition.
Severe night sweats for 3 nights in a row.  Severe fatigue for 2 weeks.  No fever.  No cough.  No sick contacts and no contacts became sick.
Subject states took you shot and ended up in the hospital for 24 months and I am still suffering because of you shot. Your shot worsen my health. 60 day Follow-up Information 24-OCT-2006: No further information on this report. In the week that additional relevant medical information is received, a follow-up report will be submitted.
STERILE WATER FOR INJECTION MIXED IN AS THE DILUENT. NO ADVERSE REPORT TO PHARMACY AT TIME OF THIS REPORT
Vasovagal response; dangerous drop in blood pressure; This spontaneous case was reported by a patient and describes the occurrence of PRESYNCOPE (Vasovagal response) and BLOOD PRESSURE DECREASED (dangerous drop in blood pressure) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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. On an unknown date, the patient experienced PRESYNCOPE (Vasovagal response) (seriousness criterion hospitalization) and BLOOD PRESSURE DECREASED (dangerous drop in blood pressure) (seriousness criterion hospitalization). At the time of the report, PRESYNCOPE (Vasovagal response) and BLOOD PRESSURE DECREASED (dangerous drop in blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: drop in blood pressure.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. The patient recently received first dose of the covid-19 vaccine. During injection patient experienced and diagnosed with Vasovagal response and was hospitalized after a dangerous drop in blood pressure. Due to that experience patient had been advised by multiple medical professionals to abstain from receiving the subsequent dose of the product. No treatment information was provided.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who was hospitalized due to the unexpected, serious events of Presyncope and Blood pressure decreased, after receiving the first dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the events were unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who was hospitalized due to the unexpected, serious events of Presyncope and Blood pressure decreased, after receiving the first dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the events were unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Achy bones; Difficult breathing; Right arm was numb (like when had the stroke 8 years ago); Dizziness; Tenderness; intense itchy in the hands; Lymph nodes in the neck are painful; Fever; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Achy bones), DYSPNOEA (Difficult breathing), HYPOAESTHESIA (Right arm was numb (like when had the stroke 8 years ago)), DIZZINESS (Dizziness) and TENDERNESS (Tenderness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke (patient states that 8 years ago had a stroke , when the right arm was numb.) and Numbness of upper extremities. Concurrent medical conditions included Diabetes. Concomitant products included PREDNISONE, METFORMIN and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced BONE PAIN (Achy bones), DYSPNOEA (Difficult breathing), HYPOAESTHESIA (Right arm was numb (like when had the stroke 8 years ago)), DIZZINESS (Dizziness), TENDERNESS (Tenderness), PRURITUS (intense itchy in the hands), LYMPH NODE PAIN (Lymph nodes in the neck are painful), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, BONE PAIN (Achy bones), DYSPNOEA (Difficult breathing), HYPOAESTHESIA (Right arm was numb (like when had the stroke 8 years ago)), DIZZINESS (Dizziness), TENDERNESS (Tenderness), PRURITUS (intense itchy in the hands), LYMPH NODE PAIN (Lymph nodes in the neck are painful), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included paracetamol to mitigate the symptoms.
he has had both the Pfizer and Moderna vaccine; asthma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 65-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "he has had both the Pfizer and Moderna vaccine"; ASTHMA (non-serious), outcome "unknown".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
patient previously got 2 doses of moderna covid-19 vaccines back in February and March but mistakenly got Pfizer for 3rd dose
Developed a sty on left eyelid; Eyelid still has a rash; Sore arm; Fatigue; Minor fever; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0164) via an unspecified route of administration in the left arm on 15Apr2021 at 11:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included BIRTH CONTROL for an unknown indication received within two weeks of vaccination. The patient also received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number:ER8734 ) via an unspecified route of administration in the left arm on Mar2021 at 11:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 the patient developed a sty on my left eyelid the day of vaccination. The left eyelid of the patient still had a rash. The patient did not think that she would have a sty in 15 years which Could be coincidence, but she wanted to report if helpful to understand potential inflammatory responses. The patient experienced other known side effects (sore arm, fatigue, minor fever, etc.) which lasted a day, but these were all to be expected. The sty was the side effect that seemed weird to her. No therapeutic events were taken as a result of the reported adverse events. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of sty on left eyelid, eyelid still had a rash, sore arm, fatigue and minor fever were recovered with sequelae.  No follow-up attempts are possible. No further information is expected.
11 days post vax the pt experienced chickenpox with lesions on her legs, back and neck accompanied by a fever of 104.2F.
Employee received HBV #1 on 7/10/02, HBV #2 9/11/02. On 10/10/02 she developed symptoms of flashing light with a tan-brown spot to her R eye. The brown spot was a peanut shape. Due to visual loss, the employee went to see her optician. A diagnosis of acute posterior multifocal placoid pigment epitheriopathy as a result of HBV.
Patient noticed redness, pain, and injection site was warm to the touch on Saturday the day after the injection.  She also said that the area felt hard.  This information was reported to the pharmacist on 9/16/19 and patient subsequently went to the physician's office on 9/17/19,
pt recvd vax 3JUN95 & 12JUN95 devel croup;pt was treated w/Pred sodium phosphate for 3 days;20JUN95 devel shingles w/30-35 vesicles;sxs resolved w/in 3 days;pt's brother was also vaxed w/varicella vax & devel croup;
She had to have a vein procedure to kill off a vein in her leg because she had a blood clot and the veins were reworking the wiring.; 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 received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: EP6955) at the age of 59 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, First dose: given on 03Mar2021, lot number: EN6204, expiry: unknown, NDC: unknown, given in left arm.), administration date: 03Mar2021, when the patient was 59 years old, for COVID-19 Immunization. The following information was reported: THROMBOSIS (medically significant) with onset 08Nov2021, outcome "unknown", described as "She had to have a vein procedure to kill off a vein in her leg because she had a blood clot and the veins were reworking the wiring.". Therapeutic measures were taken as a result of thrombosis. Clinical course: The patient had to have a vein procedure to kill off a vein in her leg because she had a blood clot, and the veins were reworking the wiring. That was several weeks prior to booster on 08Nov2021 as she made sure it was more than 2.5 weeks. She was on Eliquis (NDC, lot number, and expiry date unknown), which is a blood thinner, for a week, from 08Nov2021 to 15Nov2021. Eliquis strength was reportedly a high level because the patient had a potential blood clot that the doctor wanted to make sure didn't get into deep vein and he (physician) was being aggressive.  No follow-up attempts are possible. No further information is expected.
Patient hospitalized for delivery of a healthy baby girl. The baby weighed 7 pounds 2.5 ounces. Per doctor's notes: Her postpartum course was complicated by delayed postpartum hemorrhage requiring Methergine, Cytotec, and Hemabate, which controlled bleeding.
Pain, swelling, redness, induration at site of injection. Measures approximately 3?x3?.
Purple bumps all over your body; Dealing with it through tears and pain and itching; Dealing with it through tears and pain and itching; Dealing with it through tears and pain and itching; Dealing with it through tears and pain and itching; This is a spontaneous report from a contactable consumer. This consumer reported for an Unknown patient. This is the third case out of 3 split cases.  A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not Provided) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter stated, his daughter in law had an auto immune condition, and after she took the shot, the vaccine (Pfizer COVID 19 Vaccine) she had met the worst case ever as the reporter complaint this which was that where you get these purple bumps all over your body. So, reporter just wanted to report that, she was dealing with it through tears and pain and itching. But the reporter really would recommend that something need to be said prior to getting that shot. If patients have an auto-immune condition that really need to be truly discussed with their doctor because anyone with the auto-immune condition was sounds like to reporter, they are having some trouble. It was just breaking in the report's heart (general sentence) So, the reporter just wanted to report that, it was horrible. Reporter further stated, the strange was, the reporter have met two other people that have developed the same condition So, anyway reporter really thought a warning or just said Pfizer know kind of deal. Pfizer knew, something that the person administrating the vaccine could share. But anyway, Pfizer knew just like they should not take the Flu Vaccine So, it was the way that the body responding to some kind of, chemical in the vaccine (not appropriately clarified hence not captured as event). But anyway, reporter just wanted to report that. Only limited information was reported. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101050518 same reporter/drug/event, different patient;US-PFIZER INC-202101051050 same report/drug/AE, different patients
Headache when he moves head for days now and tiny blood spots around eyes and forhead appeared 3 days later . No rash around injection site. Watching if anything new appears .
Started with sore arm, then sore glands and swollen glands in left breast, a few days later very dizzy and spells of passing out. Heart rate dropping to 40-50 during midday
No adverse event reported. This form is being submitted due to patient's age being less than 18 years old,  (17 years 11 months) given at time of injection for Moderna Booster vaccine.
Cellulitis at injection site. 7cmx6cm induration; Painful to touch; No drainage. Occurred 24hr after injection; Treated with Benadryl and cool compress. Improving after 48hr decreased swelling and pain
Moderna COVID-19 Vaccine EUA Rapid heart rate  up to 124- visited primary care provider around 3 PM she checked heart rate, blood pressure, told me it was a side effect of vaccine. Told me to monitor symptoms and report if things get worse. No other treatment given. Heart rate is going down now it is 106. But now running low fever time now is 5:18 PM
1.5 IN x 1.5 IN RED BLOTCH TO UPPER RT THIGH.