chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediately following injection, area surrounding injection site began swelling.  Site was bright pink and was approximately 4-5cm in size. Swelling considered moderately severe.  Swollen area was not centered directly around infection site but slightly above. Area was iced and patient was given 50mg Benadryl po and monitored for additional 30 minutes for any additional adverse affects. Patient was given instructions on to call 911 for any additional severe reactions and to call clinic to report any other non life-threatening reaction. Note: Patient is a physician and is familiar with reactions and side effects to report.
The next day following the booster shot, my shoulder above my left arm became tight and has continued to ache and radiate pain from my arm to my neck and back for the last 6 months. The pain has never gone away.
Moderna Covid-19 Vaccine   8 days after administration developed itchy rash approximately  4" by 3" at injection site, with swelling of deltoid muscle and achiness in arm.   Given  my history of neutropenia doctor prescribed doxycycline 7 days in case it was a secondary infection of injection site, plus benadryl.  Swelling has reduced, rash has lessened, but remains itchy as of today 3 days on antibiotic.  no fever.
This spontaneous report as received from a pharmacist via Pfizer (MRF# 2016537371) refers to an over 65 year old female patient. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose, route and frequency were not reported)  to protect against pneumococcal pneumonia. On an unknown date the patient felt sick for a couple days and had feeling of achiness. The outcome of the events was unknown. The reporter did not provide the causality between the PNEUMOVAX23 and the events. This is one of the two reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1612USA013567:
Onset bullous pemphigoid following the second dose of the Pfizer-BioNTech (mRNA) COVID-19 vaccine; This is a literature report for the following literature source(s):  A male patient in his 70's received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "prostate Cancer" (unspecified if ongoing), notes: In remission; "renal cancer" (unspecified if ongoing), notes: In remission; "hypertension" (unspecified if ongoing); "arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amlodipine for hypertension; Naproxen for arthritis. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: PEMPHIGOID (hospitalization, medically significant), 1 day after the suspect product(s) administration, outcome "recovering", described as "Onset bullous pemphigoid following the second dose of the Pfizer-BioNTech (mRNA) COVID-19 vaccine". The patient underwent the following laboratory tests and procedures: Antibody test: within normal Limits; Biopsy: revealed a subepidermal, notes: split with numerous eosinophils linear lgG and C3 staining along the basement  membrane zone; revealed a subepidermal, notes: split with numerous eosinophils and linear lgG and C3 staining along the basement membrane zone; Blood creatinine: Raising; Blood immunoglobulin G (normal high range 20): 169, notes: Unit: Units; Histology: revealed a subepidermal split with numerous, notes: eosinophils and linear lgG and C3 staining along the basement membrane zone; Immunology test: revealed a subepidermal, notes: split with numerous eosinophils and linear lgG and C3 staining along the basement membrane zone; Positive, notes: For IgG BP 180 antibodies; Physical examination: brightly erythematous, indurated plaques were, notes: present on the trunk, arms, and legs with intact and denuded bullae on the bilateral palms. Therapeutic measures were taken as a result of pemphigoid.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information, there is reasonable possibility of causal association between the reported event and the suspect drug BNT162b2  The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Pt recvd Engerix-B & had general itching, severe scratching; lasted several days;
Patient received 2nd Moderna shot on 05/15/2021 and started feeling eye pain and believes her glaucoma to be worse now.
No adverse event/outcomes at this time. Patient received Pfizer vaccine at pharmacy and after dose was administered it was  realized that the patient had also received a Gardasil vaccine at their MD office earlier in the same day.
given a month early (8/18 was first dose); This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number 9254S, expiry date 18th September 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 20th September 2022, the patient received the 2nd dose of Shingrix. On 20th September 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 20-Sept-2022 Reporter's comment: The pharmacist reported that the patient received 2nd dose of Shingrix on the day of reporting and only afterwards did the registered pharmacist noticed that it was given a month early. The reporter consented to follow-up. Additional supportive information: The patient received 2nd dose of Shingrix earlier than the recommended interval, which leg to shortening of vaccine schedule.
This initial non-serious case, was received on 19-Sep-2017, from consumer, concerning a 29-year-old, adult female pregnant patient (16 weeks gestation period). The historical medication included unspecified allergy medication and unspecified oral contraceptives in past, prior to pregnancy. The paternal historical condition included acid reflux and unspecified medication for the same was taken prior to the conception. The current condition included allergy and concomitant medication included prenatal vitamins. The patient's last menstrual period was reported as 23-May-2017. The patient's medical and medication history relevant to pregnancy was not reported. On 15-Sep-2017, the patient (at 16 weeks gestation period) was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number: 00144621A, expiry date: 31-May-2018, route of administration, anatomical location) (explicitly coded as vaccine exposure during pregnancy). The outcome of the event was not reported. The estimated date of pregnancy was reported as 07-Mar-2018. Non-significant case correction received 19-Sep-2017: Batch number was updated in the screen. Narrative was amended accordingly.
Swelling, redness, hardness of entire upper arm for 3 days after injection. Soreness to left arm continues. Numbness of lips, left cheek and ear lobe.
The day following vaccination, I was doing doing light yard work, came in the house, got a drink and it got caught in my throat, I sat down in a chair and woke up on the floor( presuming I had passed out.)  I was out for a few minutes. When I awoke I was disorientated and had suddenly a headache, nausea,  sweaty and clammy skin.
Just wanted to let you know I have had a flu shot every year and this is the first time I have been really sick from it. Not life threatening, but a very strong reaction. I am a nurse and have had vaccine many times. This time it started with a sharp pain in my ear, traveled down my jaw and into my spine. Then I developed a fever, body aches and weakness as well as abdominal pains, that lasted for 3 days. I am finally feeling better, but I wanted to let you know that this was my experience with this injection this time. Afluria. 0.5 ml. I realize you probably want more serious side effects reported, but this was way more debilitating than any I have ever had so I wanted to share this with you. Two years ago I had the flu shot and I had such pain in my arm I had to have PT to lift my arm after the pain continued for over six weeks. This time my arm is just sore, but the physical side effects are way stronger.
Nearly three weeks after the second dose of the Moderna vaccine I woke up and felt incredibly dizzy, to the point where I almost fell out of bed.  I almost fell in the shower that same morning. Feelings of dizziness and vertigo/room spinning sensation continued for over a week, as well as seeing floaters in front of my vision, chest pain, pain in my left leg in my calf, disorientation, and a rapid heart rate, especially after eating.  Getting out of bed and walking was difficult because depending upon how I moved, the entire room felt like it was spinning.  After about a week, the worst of the vertigo tapered off but the rapid heart rate continued, particularly after eating.  I wear a FitBit so I am very aware of what my resting heart rate is throughout the day and I was reaching fat burning zones while sitting in a chair, very abnormal for me.  Again, after a week, I found that I was still getting dizzy and getting vertigo when I moved my head back and forth while lying down.  To this day, I have the same symptoms.
sick with flu; Initial information was received on 10-Oct-2020 regarding an unsolicited valid non-serious social media case from a patient.   This case involves an unknown demographic patient who got sick with flu (influenza), after the patient received INFLUENZA VACCINE.  The patient had received Influenza vaccines in the past for prophylactic vaccination and got sick with flu post vaccination.  The patient's past medical treatment(s), family history and concomitant medications were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient got sick with flu (influenza), (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, when the patient stopped taking influenza vaccine, haven't been sick with the flu since. Maybe the patient was allergic.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There will be no information available on the batch number for this case.
Warm at injection site; Swelling at injection site; Red at injection site 4x6 inch area.; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm at injection site), INJECTION SITE SWELLING (Swelling at injection site) and INJECTION SITE ERYTHEMA (Red at injection site 4x6 inch area.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Asthma. Concomitant products included TYROSINE for an unknown indication.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced INJECTION SITE WARMTH (Warm at injection site), INJECTION SITE SWELLING (Swelling at injection site) and INJECTION SITE ERYTHEMA (Red at injection site 4x6 inch area.). On 13-Jan-2021, INJECTION SITE WARMTH (Warm at injection site), INJECTION SITE SWELLING (Swelling at injection site) and INJECTION SITE ERYTHEMA (Red at injection site 4x6 inch area.) had 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.   Treatment included Benadryl and Tylenol.  Patient also takes medicine for cholesterol and inhaler for asthma twice a day.
Patient received vaccine and stayed in pharmacy building for 15 minutes.  Around that time patient's parents came back up to pharmacy to notify staff that he had broken out into a rash in the back and his hands felt swollen.  I asked if he had any trouble breathing and parents stated no.  We followed the Adverse Event Action Plan.  We called 911.  Patient's parents then stated son is starting to have some breathing issue.  I came out with EpiPen and was going to administer when mom stated son's symptoms has resolved greatly and she did not want me to administer EpiPen.  Shortly after EMS arrived and evaluated patient and took him to hospital for observation.
heavy chest pain; headache; inhabilities to barely walk; Very sore; Not able to function mentally; This is a spontaneous report received from a contactable consumer (patient). This is the second of two reports with events experienced under the second dose. A 60-year-old female patient received second dose of bnt162b2 (BNT162B2), intramuscular, administered in Arm Left on 07Sep2021 16:00 (Lot Number: EW0191) as single dose for covid-19 immunisation. Medical history included blood clot in pelvis from 26Jan2015 and ongoing needing 5 stent surgery (Pertinent details: Taking warfarin blood thinners), covid-19 from Jan2021 to an unknown date (also had needed antibodies, 1 hour long infusion of Bamlavinivimad). Vaccination Facility Site: Pharmacy or Drug Store. Prior vaccinations were reported as no. Concomitant medications included warfarine (WARFARINE) taken for blood clots in pelvis, and blood thinners. First dose of bnt162b2 (BNT162B2) was administered on 18Aug2021 at 10:00 AM intramuscular in Upper left arm, Lot: EW0181, for COVID-19 immunisation and patient from 19Aug2021 to 20Aug2021 experienced walking difficulty, very sore, headache, not able to function mentally, muscle pain, pain in hip, severe leg pain and lower back pain. On 08Sep2021 patient experienced heavy chest pain, inhabilities to barely walk, very sore, headache, not able to function mentally. Events considered serious due to Persistent/significant disability/Incapacity. No treatment received for the events. Patient stated that both shots of vaccine resulted in total body inabilities to barely walk, very sore, headache, not able to function mentally, second shot has same but also included severe chest pain. Patient almost went to hospital, she had covid in Jan2021 and also has needed to antibodies 1 (hr) hour long infusion of Bamlavinivimad(?). On 09Sep2021 patient recovered from the events.  No follow-up attempts are needed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075436 Same reporter, patient and product / different events and dose
Pt was given a TDAP vacc Lt arm (BOOSTRIX) about 5 min later pt starting complains of Lt hand numbness in her fingers. Pt was referred to Dr (neurologist) for evaluation.
Covid19 breakthrough.  1st vaccine received on 03/05/2021.  91 y/o female with PMHX of HTN, HLD, Iliac stent on Eliquis, Chronic kidney disease presents to ED with 2 day history of generalized weakness, fatigue, cough, SOB, and fever.  Room air sat 91%, placed on O2 at 2L NC.  CXR  with multifocal pneumonia.  Treated with ABX, Steroids and Remdesivir.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On 05-FEB-2012, the patient was vaccinated with dose 1 RECOMBIVAX HB (dose, route and lot not reported). On 03-MAR-2012, the patient was vaccinated with dose 2 RECOMBIVAX HB (dose, route and lot not reported). On 05-OCT-2012, the patient was vaccinated with dose 3 RECOMBIVAX HB (dose, route and lot number reported). No concomitant medications were reported. The pharmacists stated that the patient did not had adverse effect reported. Additional information has been requested.
p/vax pt dx post vaccinlal brachial plexitis (per neurologist) on opposite arm following routine flu immun;sx numbness, tingling & weakness of arm, shoulder, hand;
Headache, Myalgia & Fever Narrative:  Received shot 530pm on 4/5/2021, 24 hours after had chills, temp of 101 and body aches, headache. Advise these are normal side effects. Seek medical attention if not resolved in 48 hours.  Other Relevant History:
Case number PHEH2013US021741 is an initial spontaneous report received from a health care professional on 16 Oct 2013. This report refers to a an 11-year-old male patient. He was vaccinated with an initial dose of MENVEO (batch number: A11082) at a dose of 0.5 ml intramuscularly in to right deltoid on 14 May 2013 (at 15:00). It was reported that the patient received vaccine which was compromised due to refrigeration malfunction. No adverse event was reported following the medication error. He had an appointment to received HPV vaccine therefore he will be receiving MENVEO at the same time.
Shortness of breath 12-13 days after second shot.  Feeling and sensation of gasping for air, especially after strenuous exercise. Also feeling of "lump" at back of throat that would not drain down.
Dose 1- 11 days after, Allergic reaction including shortness of breath, full body hives.  Went to ER twice and allergist twice, was taking Zyrtec, Benadryl and prednisone. Start to get better slowly.  Dose 2- 2 days after, body hives again.  Was still taking Zyrtec and Benadryl. Hives aren?t as bad as the first time but still covering multiple body parts.
Increased seizures after 12 hours.; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration, administered in right arm on 12Mar2021 09:30 as single dose for COVID-19 immunisation. Medical history included cerebral palsy and seizure and covid-19 (prior vaccination). The patient was not pregnant and had no known allergies. Concomitant medications included baclofen, rufinamide (BANZEL), levothyroxine sodium (SYNTHROID), and clobazam (ONFI) and valero acid syrup. In Mar2021, the patient experienced increased seizures after 12 hours. Had to call ambulance, and went to the emergency room (ER) at a hospital. The patient received Ativan, and Depakote and IV fluids. The patient had no other vaccine in 4 weeks and was not covid tested post vaccination. Outcome of event was recovered in Mar2021.  Information about Lot/Batch number is requested.
This spontaneous report was received from a Physician and refers to an unspecified patient of unknown age and gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On 20-FEB-2017, the patient was vaccinated with improperly stored dose of M-M-R II (lot # M028131 with expiry date 03-JUN-2018) (dose, route and anatomical location not reported) for prophylaxis. Exact time frame and temperature at which the vaccine underwent excursion was unknown. However it was reported that the lot # M028131 underwent a temperature excursion of 32 degrees Fahrenheit to 35 degrees Fahrenheit for a cumulative time frame of 4 hours and a temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for a cumulative time frame of 5 hours on different days since 26-JAN-2017 to 27-MAR-2017. Maximum individual time frame was reported as 60 minutes for each cycle. There was no previous temperature excursion. The call was not because of data logger. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA005435: US-009507513-1705USA005436: US-009507513-1704USA014447: US-009507513-1705USA005438: US-009507513-1705USA005439: US-009507513-1705USA005462: US-009507513-1705USA005463.
Suspected vaccination failure; I had had a shingles shot and when i got them I had three on my back; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had had a shingles shot and when i got them I had three on my back). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-MAR-2023 The case  was received from the patient via interactive digital media. The patient had Shingles shot and when he/she got them  he/she was very fortunate The patient had three on back and that was all. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Fever of 99.4 F and spotty rash on trunk and arms with onset about 8d s/p immunization with MMR.
Report 2001015124-1 described blood in the stool of a six month old female who received Infanrix. The vaccinee had a "severe" cow protein allergy, allergic protocolitis, and enterocolitis. These conditions started at three weeks of age. On 06/12/2001, the vaccinee received her first IM anterolateral thigh dose of Infanrix, an IM dose of Prevnar and an IM dos eof Haemophilus influenzae b vaccine. On 06/14/2001, the vaccinee was found to have blood in her stool. No drugs were used to treat the adverse event. As of 06/20/2001, the pt's adverse event was "under control with dietary restriction."
expired vaccine used; Initial information received on 26-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old male patient who experienced expired vaccine used, while he received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via intramuscular route in the left arm.  The patient developed a non-serious expired vaccine used (expired product administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  (Other relevant tests included No lab data.) Final diagnosis was expired vaccine used.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Not Applicable for expired vaccine used.  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.