chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain at vaccination site; Singular hive on cheek; Increased appetite; Fatigue; This is a spontaneous report from a contactable consumer. A female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021, as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on unknown location, 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 13Apr2021, the patient experienced pain at vaccination site, singular hive on cheek, increased appetite and fatigue. Therapeutic measures were not taken as a result of these events. The adverse event 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 the events pain at vaccination site, singular hive on cheek, increased appetite and fatigue was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
From telephone contact received at manufacturer on 5/24/02, it was reported that a 5 year old male received fifth dose Tripedia vaccine on 4/18/02. Later that day, he was seen at the office and diagnosed with cellulitis at the injection site. He was started on Keflex. Two days later, the site of injection was without redness, swelling or pain.
Pt had flu vaccine IM injection (R) upper deltoid on 10/16/13 felt burning during injection and sore. 24 hours later decrease mobility and ROJM and arm weakness which has persisted for 28 days.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in August 2014 ("on unspecified dates after 31-JUL-2014") an unspecified number of patients were vaccinated with doses of VARIVAX (Merck) that were underwent a temperature excursion (stability was supported), subcutaneously (dosages and lot# not specified). No adverse experiences reported. The outcome of event was unknown. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. Patient's medical history was not reported. On 05-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose, route were not reported). Concomitant medications were not reported. On the same day, after vaccination, the patient experienced tingling down arm. The patient sought medical attention and spoke with the pharmacist. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not reported. This one of two reports from the same reporter. Additional information has been requested.
No additional AE reported; 9 Month Old Patient was administered expired VAQTA on 10/18/2022; This spontaneous report has been received from a nurse, concerning 9-months-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 18-10-2022, the patient was vaccinated with expired hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (valid lot number U024505 [expiration date 15-OCT-2022]) for prophylaxis (expired product administered). No previous temperature excursion was reported.   No additional adverse events (AE) were reported.
9 patients received expired vaccine in November and December; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccine in November and December) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 038C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccine in November and December). At the time of the report, EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccine in November and December) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment drugs were reported. 9 patients received Moderna COVID-19 vaccine last year in November and December On 17-Feb-2022 the case ID- MOD-2022-486834 has been made invalid as it contains 9 patients with no patient identifier. Expired vaccine was given with no adverse reaction reported.   This case was linked to MOD-2022-493795 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2022: Follow up received: Received patient information due to which case was valid in FU version.Added patient details, dose 1 and dose 2 detals, event start date and information updated in inarrative.
R shoulder stinging pain upon administration. Pain in injection site radiating to neck, elbow, wrist, fingers, lasting 4 weeks so far.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received COVID-19 treatment with Paxlovid, started on 18Jan2023 and stopped on 23Jan2023. Patient completed the paxlovid and 3 days later on 26Jan2023, he experienced congestion, cough and fatigue.  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.
swelling of hands and feet; swelling of joint; itchy hives; rash all over body; itchy hives; Initial information received on 14-Sep-2020 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves a 4-year-old patient who experienced swelling of hands and feet (peripheral swelling), itchy hives, rash all over body, and swelling of joint (joint swelling), while he/she received vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE, RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) [PROQUAD].  Medical history, medical treatment, vaccination, family history and concomitant medication were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE and received a dose of suspect PROQUAD not produced by Sanofi Pasteur (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious swelling of hands and feet (peripheral swelling), itchy hives (pruritus and urticaria), rash all over body (rash), and swelling of joint (joint swelling), (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE and PROQUAD. On 11-Sep-2020, the patient was seen for the 4 year physical and well check by doctor. On 13-Sep-2020 the Patient was seen for reported events.  Details of laboratory data not reported.    It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient was recovering from the all events.  There will be no information available on the batch number for this case.
Patient stated that her hair started falling out in chunks at a time.  She mentioned that she went to her Derm. doctor and he stated to her that it was the covid vaccine.   Her provider stated it may still take another 8 weeks before she recovers from her hair.
deep aching pain and weakness in left arm. Painful enough to wake me up at night. Weakness and loss of motion.
Patient returned to clinic ten days post vaccination with 2 day history of fever and fussiness. Slight tonsil node swelling. No noted rash.
Few minutes after injection rash appeared-around 4-5 cm around injection site. Pink not warm not blanching, non tender, slightly raised ice pack to arm in office, BENADRYL at home.
Most episodes between 1-3, this morning had an episode at 5 am this morning.  Worsened tinnitus Feels like his ear swells up, excruciating pain, dizziness, lightheadedness.  Had to pull over when driving on Saturday.  Daily episode since Saturday.
Contracted COVID after the vaccine. I now have brain fog that I didn't have prior to the vaccine.
Sometime following the vax, the pt developed chills for 4-6 hours, that self resolved. The pt recovered from this experience. No additional info was provided from correspondence returned on 07/25/2000. No further info is anticipated, this case is closed.
Pain down left arm, severe pain, to hand and hand was numb, up all night could not sleep. Went to ER because she thought it might be her heart, it wasn't. Diarrhea was uncontrollable, messed herself a few times, never had time to run to restroom. Had to take a leave from work. Has been out of work a month because of the diarrhea. Had a colonoscopy, endoscopy, has to go back for another endoscopy,  was in the hospital. Had blood in stool. Never experienced diarrhea or pain like that before. Afraid to go back to work or leave her house because the diarrhea continues and starts without warning.
1. Lip tingling started 20 minutes after injection, lasted about 30 minutes. 2. Mild chest tightness started 14 hours after injection and lasted about 30 mintues.
When flu shot was administered some of the vaccine came out from the sides. I am not sure how much of the vaccine she received.
I started to itch. Throat started to hurt and itching spread. Throat got tight and tongue felt fat. Hives everywhere. My vision got blurry. Pulse oxy didn't go well.
1 week after the flu shot I woke up with mild to moderate left arm and neck pain. I thought I may have slept wrong on it. The pain has progressively gotten worse until now where I can hardly lift or use my arm. I have numbness and tingling from the top of my shoulder down to my middle two fingers. The pain keeps me awake at night and is making my life very difficult. I rate it at a 8/10 during the day and a 10/10 at night. Ibuprofen barely helps it, the heating pad provides very little relief as well. It has been 5 days since these symptoms began and are continuing to worsen. I will seek medical care by weeks end if this does not get better.
3RD DOSE PFIZER COVID VACCINE GIVEN 9/28/21, #FF2589;  pt to hospital ED on 8/29/22 with worsening SOB, weakness, non productive cough, poor appetite, black stools; hx from daughter states he's had COVID x 2wks and is worsening; COVID test positive in ED; admitted; CT showed large pleural effusions and nodules throughout lungs and abdomen, likely metastatic; given steroids, duonebs; DNR/DNI; comfort measures; pt quickly deteriorated and expired in the hospital
Moderna COVID-19 Vaccine EUA       On Feb 18, 2021 injection site started to itch, turned red, small knot with a little bit of swelling and warm to the touch.   Looked like small blisters in affected area.  By Feb 21 it was still pink and looked like blisters had popped.  Remained discolored  through Feb 26.  Fine now.  I did not sign up for until this week and did not know how to report it on that site.  Saw this site on my paperwork.
Child was very apprehensive. After injection was pale & weak; did not pass out. Smelling salt used. Began to c/o trouble breathing 10-15" after. Wheezing in chest detected, mother & 911 called. Oral BENADRYL 25mg given by school nurse. O2 & Epinephrine administered by paramedics. Taken to ER.
when I got the shot on Friday, I felt a hot burning sensation up into my shoulder and into my neck. When I arrived home my neck hurt for most of the evening where it was difficult to move and I noticed when I went to bed that I was extremely swollen. The next morning I woke up and felt like a blow fish all swollen up. I have recently started using a Cpap machine and thought maybe I had the mask on too tight or something........the swolleness continued all weekend and on Monday I went to the pharmacy to ask questions. He gave me benedryl and told me to contact Moderna. I've taken the benedryl and it helps a lot but the swelling continues. My face is swollen and is red, feels hot. My ankles and legs are so swollen that my leotards are more like compression pants and the skin hangs over my shoes. I AM MISERABLE!
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "asthma" (unspecified if ongoing); "chronic pain" (unspecified if ongoing); "HBP (High blood pressure)" (unspecified if ongoing), notes: HBP (High blood pressure); "known allergies: latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Pt received purple cap Pfizer vaccine 0.3 ml undiluted vaccine. Reports feeling more tired than usual, but no other adverse effects currently.
Information has been received from a consumer concerning her/his child who was vaccinated with the only dose of ROTATQ PO at 6 months of age. No known adverse effect. The consumer hung up before any further information could be obtained. No further information is available.
a patient was inadvertently vaccinated with a dose of Adacel 3 years after her previous dose, no AE; Initial information was received on 24-Sep-2020 regarding an unsolicited valid non-serious case from the physician.  This case involves a 15.5 years old female patient who was vaccinated with a 0.5 ml dose vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number and other dosing details were not reported)once via an intramuscular route at unknown administration site on an unknown date 3 years after her previous dose for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  This was an actual medication error case due to inappropriate schedule of vaccine administered.  No adverse event reported at the time of reporting.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  There will be no information available on the batch number for this case.
Per PT's Mom:   After 1 day of vaccination, PT had pounding headaches, dizziness, nausea and took Tylenol. Pt suffered adverse  effects whole week.
vomiting, high fever 101.5, high pitched scream, legs turned purple-seen by MD given ATB 13JUL92 pertussis eliminated; no reaction noted;
I did not know at the time of my second dose, I was about 3 weeks pregnant. A week after the second dose, I found out I was pregnant and 2 days later I had a miscarriage.
A couple of weeks after the Pfizer covid injection in left arm I started to develop partial paralysis in my left arm as well as denervation and loss of strength, all originating in the scapula area. Three physicians, including a physiatrist, neurosurgeon and orthopedic surgeon all state that my malady was/is Parsonage Turner Syndrome and that it was caused by the vaccine. All other possible diagnoses were eliminated via many physical exams, MRIs, CTs, and EMGs. We are over three months out now and no change. Treatment is prednisone and lots of PT along with finger crossing and hope that the effects will one day pass.
brain fog; body aches; felt feverish; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain fog), PAIN (body aches), PYREXIA (felt feverish) and CHILLS (chills) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Diabetes, Lactose intolerant, Food allergy (Allergy to corn syrup) and Alcohol allergy (Allergy to sugar alcohol).   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced FEELING ABNORMAL (brain fog), PAIN (body aches), PYREXIA (felt feverish) and CHILLS (chills). At the time of the report, FEELING ABNORMAL (brain fog), PAIN (body aches), PYREXIA (felt feverish) and CHILLS (chills) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided  Action taken with mRNA-1273 in response to the event was not applicable.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 13-OCT-2015, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-FEB-2017, the patient was treated by a physician for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient had tested positive for SARS-CoV-2 at the testing site that morning of 7/24/21. Pt reported onset of cough and fatigue on 7/22 and being fully vaccinated. Pt was released from vaccination site to drive home to complete isolation.
Pharmacist intentionally gave 2 shots of Comirnaty instead of flu and Comirnaty, pharmacist did call CDC and Pfizer company for further recommendations. Pharmacist did observe for 15 minutes with no adverse events reported. Pharmacist did answer questions/concerns to the patient and suggest patient to monitor adverse events and self- report to pharmacist/MD for follow up
This case was reported in a literature article. On an unknown date, unknown after receiving Rotavirus vaccine and 14 days after receiving Rotavirus vaccine, the subject developed vaccination failure. Serious criteria included GSK medically significant. Additional event(s) included diarrhea rotavirus with serious criteria of GSK medically significant. The outcome of vaccination failure was unknown. The outcome(s) of the additional events(s) included diarrhea rotavirus (unknown). It was unknown if the investigator considered the diarrhea rotavirus to be related to Rotavirus vaccine. Relevant Tests: An enzyme immune-assay of a stool sample was positive for rotavirus antigen. Additional information received: This case was reported in a literature article and it described the occurrence of a vaccine failure in a child of unspecified gender and at least 8 months old, who had received ROTARIX (GlaxoSmithKline). The patient had been enrolled in a study that excluded children with a severely immunocompromising condition. No further information on the patient's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, the patient received at least 3 doses of ROTARIX (oral, dosages unknown; batch numbers not provided). On an unspecified date either between January and June 2010 or between January and June 2011, at least 14 days after the administration of the last dose of the vaccine, the patient developed acute gastrointestinal symptoms defined by the authors as at least 3 looser-than-normal stools in a 24-hour period during the illness and onset of the diarrhoea within 10 days of presentation to hospital. It was unknown if the patient was admitted. An enzyme immune-assay of a stool sample was positive for rotavirus antigen. Treatment was unknown. The outcome of the event was unspecified. The authors did not comment on any causal relationship between the vaccine and the event. The authors concluded that "This evaluation demonstrates that monovalent rotavirus vaccine was highly effective in children against severe rotavirus disease during at least the first 2 years of life, and confirms the high effectiveness of the pentavalent rotavirus vaccine". This case is 1 of the 2 valid cases reported in the same literature article (see case US2014GSK051982).
About 30 minutes - 1 hr after vaccine administration he developed generalized hives, and difficulty breathing. He was taken to a quick care and given BENADRYL steroid and respiratory treatments, as well as oxygen. It is unknown if epi was given.