chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site itching; Pain in arm; Welts; Itchy; Headache; Spondylitis ankylosing aggravated; Fatigue; This is a solicited report based on the information received by Pfizer from a company (Mfr. Control No. 21K-163-4057970-00). A contactable 42-year-old female consumer reported that she received bnt162b2 (COVD-19 VACCINE, solution for injection), intramuscular on 01Apr2021 (at the age of 42-year-old) at dose 1, single for COVID-19 immunization and adalimumab (HUMIRA) subcutaneous from an unknown date to ongoing at an unknown dose and frequency for ankylosing spondylitis. Medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown dates, the patient experienced itch at injection site and sore arm. On an unspecified date in 2021, the patient experienced fatigue, headache, Spondylitis ankylosing aggravated, itch and welts. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. Action taken in response to the events for suspect drug Humira was dose not changed. Outcome of the event Injection site itching was not resolved whereas for other events was unknown.  The reporter's causality for the events of fatigue, Itchy, spondylitis ankylosing aggravated and sore arm with Humira (Adalimumab) was no reasonable possibility, for event itch at injection site was a reasonable possibility and for events headache, welts was not reported. The reporter's causality for events fatigue, headache was probable, for event sore arm and itch at injection site, itchy, spondylitis ankylosing aggravated, welts with Pfizer Biontech Covid-19 Vaccine was not related.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up(03Dec2021) This is a Follow-up solicited report based on the information received by Pfizer from a company (MFR Control No. 21K-163-4181817-00). Case upgraded to serious. New information included: Suspect drug (vaccination date was updated for dose 1), new events (Itchy, Welts and Spondylitis ankylosing aggravated), onset date of event (fatigue and headache) and narrative updated.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of fatigue, itch at injection site, headache and sore arm, Itchy, Welts and Spondylitis ankylosing aggravated. "The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate."
Flushed red  face, swollen face, hives on neck and upper part of the chest , feeling very hot, but no fever. Swollen ankles.   IMPORTANT ? HAD DERMAL FACIAL FILLERS IN THE PAST
Narrative:  The patient is a 49yo female hx asthma, anaphylaxis, multiple food allergies, and seasonal allergies presenting with complaint of allergic reaction following COVID-19 vaccination. Patient was vaccinated at approximately 1020 and states that she has had symptoms since approximately 1050. She reports pruritus that has spread from his face down to her legs, including her back. She also complains of shortness of breath. She states that her "tongue feels thicker toward the back." She was cared for in the ED and then released home on the same day.
muscle pain; chest pain; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot Number: EL9266), via an unspecified route of administration, administered in Left Arm on 17Feb2021 09:00 (at the age of 66-years old) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. No information reported about history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. On 18Feb2021 02:00 the patient experienced chest pain and on an unspecified date the patient experienced muscle pain. The outcome of event chest pain was recovered on 21Feb2021 while, the outcome of event muscle pain was unknown.  No follow-up attempts are possible. No further information is expected.
Incomplete Course of Vaccination; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 23rd September 2020, by intramuscular in left deltoid).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter inquired if he could get his second dose or if he needed to restart the series of vaccination all over. The VAERS details were reported for 1st dose of Shingrix.
This spontaneous report as received from a health professional refers to a 4 years old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
BLURRED VISION; FEVER; HEADACHE; EXHAUSTION; MUSCLE ACHES; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was a Nurse (HCP), reported for herself. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. Age at time of vaccination 43 years old. The batch number was not reported and has been requested. No concomitant medications were reported.  On 04-JUN-2021, the patient experienced fever, headache, exhaustion, muscle aches, and injection site pain. On 10-JUN-2022, the patient experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, exhaustion, muscle aches, injection site pain, and blurred vision. This report was non-serious.
The evening of patient's vaccination, she experienced bruising, itching , and pain at injection site. She also experienced pain on the left side of her neck. Patient stated her glands in neck area have been swollen as well. Patient says she still has itching in area around the vaccinations site and is still bruised. Bruise is approximately 3&1/2 inches in width and 2&1/2 inches high on left arm around injection site.  Patient went to an urgent care center for a reason unrelated to vaccination to have physician look at injection site. She stated they suggested that she use a cold compress on vaccination site area.
The vaccine affected my menstrual cycle. I was 10 days late for my period.  I am a 26 day cycle. My period came on day 36 instead.
This is a spontaneous report received from contactable consumer or other non-HCP (patient). A 52-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EI1283), at the age of 52, in left arm, on Jan 20, 2021, single dose, for COVID-19 immunisation. Medical history included high blood pressure (unspecified if ongoing). The patient takes concomitant medications. The patient experienced lichen planus (patient is not sure but all tests were negative triggering lichen planus), and onychomadesis (loss of all finger and toenails), onset Mar 1, 2021, with outcome of not recovered. Relevant laboratory tests and procedures available in the appropriate section. Therapeutic measures were taken as a result of lichen planus and onychomadesis: steroid shots. Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has tested for COVID-19. On Sep 28, 2021, nasal swab (PCR) test positive; May 11, 2021 negative. No follow-up attempts possible. No further information expected.
Patient cut tip of finger the night before.   Felt sore at time of vaccination.  Next morning was extremely sore and could not move arm.  It got worse for 1 to 2 days and then it still as bad.   Unable to make certain movements with arm like close door or get dressed.  Patient had headache for about 2 weeks. Had 2 days of nausea, which stopped and chills for about 1 week.    Patient took Tylenol; it helped some but as soon as it wore off the pain was back. Also used cold/hot compresses but did not help much. Patient called doctor but they did not ask her to come in.  The other symptoms have cleared up but the shoulder pain/movement is as bad as the 2nd dayat 0% recovery.
Big red body rash, fever, body aches, cold chills, diarrhea, bad dry throat
burning at injection site at time of injection.   burning that night and sore to move it for about two days then it got better.  On day 9 it was swollen and very painful to move arm.  Ached most of the time and hurts to move arm.   Burning stabbing pain.   swelling of area of upper arm of about 3X6 area but no redness and no rash
Information has been received from a medical assistant concerning a 5 year old male, with no pertinent medical history, drug reactions or allergies, who on 19-OCT-2002 was vaccinated with his first dose of varicella virus vaccine live (Oka/Merck). On 09-MAR-2007 the child was vaccinated subcutaneously in the right arm with his second dose of varicella virus vaccine live (Oka/Merck), (Lot#654756/1335F). He also was vaccinated with hepatitis A vaccine (inactive) (MSD), and influenza virus vaccine live (unspecified) that same day. The child developed a red raised area at the injection site after vaccination on 09-MAR-2007. There was no treatment. No lab diagnostic studies were performed. The patient's status at the time of the report was not recovered. Unspecified medical attention was sought. There was no product quality complaint. The office requested a lot check on Lot#654756/1335F. This report is one report of five reported by the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2007. Information has been received from a medical assistant concerning a 5 year old male, with no pertinent medical history, drug reactions or allergies, who on 19-OCT-2002 was vaccinated with his first dose of VARIVAX (Merck). On 09-MAR-2007 the child was vaccinated subcutaneously in the right arm with his second dose of VARIVAX (Merck) (Lot # 654756/1335F). He also was vaccinated with VAQTA (inactive), and influenza virus vaccine (unspecified) that same day. The child developed a red raised area at the injection site after vaccination on 09-MAR-2007. There was no treatment. No lab diagnostic studies were performed. The patient's status at the time of the report was not recovered. Unspecified medical attention was sought. There was no product quality complaint. The office requested a lot check on lot # 654756/1336F. This report is one report of five reported by the same source. A review of the release testing data revealed that the lot in question conformed to all required testing at the time of product release. The lot complies with the standards of Center for Biologics Evaluation and Research and was released. No further information is expected.
Patient was given Moderna Covid-19 vaccine 0.5mg IM on right deltoid on 10.8.21 and 11.10.21. Patient is only 17 years old so this was given as off label. Patient did not have any severe systemic reaction.
Patient is an 82-year-old female past medical history of COPD on 4 L nasal cannula continuous, coronary disease status post stent placement, CVA, primary hypertension, left carotid artery stenosis. Patient started having increasing shortness of breath on the outpatient basis. She was noted to be 88% on her 4 L by nasal cannula on presentation. Patient received Solu-Medrol, DuoNeb, 2 g of magnesium. Patient is vaccinated against COVID-19. By the following morning patient was SATS 98% on 4 L by nasal cannula. Patient got two doses of Rocephin will be transitioned to Ceftin for additional three days. Patient completed doxycycline on admission. Discharging home on 6 mg of Decadron. Patient is being discharged home on January 17, 2022 in stable condition.
Blood Clots - 12AUG21 - suffered while in hospital roughly around 9:30PM  Heart Attack - 12AUG21 - suffered while in hospital roughly around 9:30PM Graphine Oxide Poisoning  - suffered severe mass pockets around left collar bone and peck muscle (armpit).  ER visit on 10SEPT21.  Treated for infection with amoxicillin.  Symptoms worsened.  PCP visit on 17SEPT21 at 10:30, PCP treated with Levofloxacim for another infection.  Symptoms still present and worsened.  Researched what could cause the pockets and found graphine oxide poisoning.  We know this is correct because you can place a key (anything metal) and it stick and pulls the metal to his skin!  No doctor will hear me out on this!!!  I have recorded and documented this event.  The key/metal sticks to his pockets and does not fall off of him.
Site: Pain at Injection Site-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: She felt her whole left side of her face and arm was causing a tingling and numbing sensation. Patient felt better, thinks it may have been a panic attack. left store without incident.
SEVERE dizziness and nausea.;  fatigue/weakness; feeling "fluish ~ over the stretch of one week
chills; sweating; dizziness; headache; head rash; general tiredness/bad lethargy/ more tired; muscle aches; Nausea/ sick to her stomach; Vomiting/ throwing up; sore throat; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jan2021, the patient was having side effects like vomiting, sore throat, sweating, dizziness, head rash, general tiredness, muscle aches, and nausea, the patient was wondering if she can go to the hospital. She got her vaccine on 15Jan2021 and had a tiny reaction right away that went away in 20 minutes; sweating, dizziness and a headache. After that she felt a little more tired than usual, but it has progressed more and more everyday; she has been more and more tired. On 22Jan2021 she had some chills, and was feeling a little worse and worse, then yesterday she had a headache and a little bit of a sore throat. Stated that she went home from work yesterday and went right to bed at 2pm because she was so tired. Today, she woke up again really tired but went in to work, and then this after she got so sick to her stomach and started throwing up. Now, she can't keep anything down. Stated that she just kept feeling worse and worse. "Is this Covid? Or is it from the vaccine?" It was starting to scare her. It felt like she almost has food poisoning at this point, but with really bad lethargy, a headache, and really bad chills. Outcome of the events sweating and dizziness was recovered on 15Jan2021, while unknown for the other events.   Information on the lot/batch number has been requested.
Baby received hep B vaccine on 6/24/11 in the NICU without realization that she had previously received the vaccine on 6/21/11 in the nursery.
Red square, red dot, bump, raised; Hot at touch; Red dot; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE MASS (Red square, red dot, bump, raised), VACCINATION SITE WARMTH (Hot at touch) and INJECTION SITE ERYTHEMA (Red dot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE MASS (Red square, red dot, bump, raised), VACCINATION SITE WARMTH (Hot at touch) and INJECTION SITE ERYTHEMA (Red dot). At the time of the report, VACCINATION SITE MASS (Red square, red dot, bump, raised), VACCINATION SITE WARMTH (Hot at touch) and INJECTION SITE ERYTHEMA (Red dot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. The patient was given diphenhydramine as a treatment medication.
7 days after; vaccine rash 1 inch diameter, 9 days after; rash 2-1/2 inch diameter, 10 days after; rash not grown but experiencing extreme fatigue, body aches, brain fog, body jerking, heavy breathing.  I am reporting this on day 10
on 7/14 left deltoid pain with radiation and intermittent radiculopathy to LUE and Left hip. No trauma, no illness, no edema, no nv changes, increased with movement.
acute pruritic hands.; scalp and upper body was quite itchy; face red; eyes bloodshot; measles like bumps on back and back of my upper arms.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the left arm on 13May2021 at 19:30 (at the age of 58-year-old), as a single dose for COVID-19 immunisation. Medical history included rash on left hand for well over a year and had been through 3 dermatologists (no help at all) and also reported that the patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158), via an unspecified route of administration in the left arm on 16Apr2021 at 16:30 (at the age of 58-year-old), as a single dose for COVID-19 immunisation. 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 15May2021 at 01:00, after approximately 36hrs after injection the patient woke up mid-sleep and experienced acute pruritic hands quite severe sensation, after a few minutes with my hands under cold running water the patient`s scalp and upper body was quite itchy, face red, eyes bloodshot, measles like bumps on back and back of upper arms. 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. No therapeutic measures were taken as a result of the events. The clinical outcome of the events  of acute pruritic hands quite severe sensation, scalp and upper body was quite itchy, face red, eyes bloodshot, measles like bumps on back and back of upper arms were recovered in May2021.   No follow-up attempts are needed. No further information is expected.
Parotitis, right; redness of Stensen's duct, bilaterally. Dx'd on 12/31/01.
Patient disclosed that he had been vaccinated with Pfizer earlier in the year but had a bad reaction (not allergic) and would not be getting his second dose.  He requested Janssen to ensure immunization.  RN doing intake made the decision to proceed with the vaccination without consulting with clinical team. System shows first dose of Pfizer was 5/14/21.  No adverse symptoms were noted after administration and observation.
Muscle pain, fever, nausea, 2nd day after vaccine administered and continuing 3 days.
Information has been received from a 26 year old female with a history of asthma who on 24-APR-2007 was vaccinated with Gardasil. Concomitant therapy included Sarafem and Yasmin. On 24-APR-2007 the patient experienced stomach nausea. She also felt very weak and went to bed early. The following day she woke to feel very faint and again had stomach nausea. No further information was provided.
Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. Concurrent and historical condition was not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot # L030870 with expiration date 10-JUN-2018; dose and route unknown). Concomitant therapy was not provided. The physician reported there were no adverse effects. There was no previous excursion. The vaccine was exposed to 33.3F for 3 hours and 59.1F for 5 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Chills, headache, stomach pains ,joint pains after 24 hours followed 2 days later by hot  painful red rash at injection site that lasted one week.
Severe head aches severe body aches  Severe metal and physical fatigue  Fever Loss of appetite  Problems thinking clearly
At time of injection, patient reports feeling a "pop" and a "rush" of heat that she felt from the shoulder down to the hand. Said after about 2 hours the heat became painful in the same location. After 24-36 hours pain became more localized to the shoulder and bicep, and after a couple days the pain subsided and became more of a movement pain if lifting her arm higher than shoulder level or in quick motions.