chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt devel erythema, edema, & tenderness @ the inject site p/recvd DT(peds)/OPV/MMR;
Left Sided Weakness and Gait Instability Secondary to ADEM ( Acute Disseminated Encephalomyelitis ).
Bad diarrhea; Abdominal pain; Dry cough; Sick stomach; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough), ABDOMINAL DISCOMFORT (Sick stomach), DIARRHOEA (Bad diarrhea) and ABDOMINAL PAIN (Abdominal pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced COUGH (Dry cough) and ABDOMINAL DISCOMFORT (Sick stomach). On 01-Mar-2021, the patient experienced DIARRHOEA (Bad diarrhea) and ABDOMINAL PAIN (Abdominal pain). At the time of the report, COUGH (Dry cough) and ABDOMINAL DISCOMFORT (Sick stomach) outcome was unknown and DIARRHOEA (Bad diarrhea) and ABDOMINAL PAIN (Abdominal pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No Treatment information provided
On 2/5/01 at 11:35, mom called stating he had leg pain and pt was walking on leg. No fever , redness or swelling but was warm consistently. Gave him Motrin. On 2/7/01 at 16:05, mom removed bandaid from injection site on left leg and under bandaid it looks red and with pus; no redness around bandaid site. Advised to go to urgent care facility. Urgent care doctor told to apply Bactroban ointment and use warm compresses to site.
Second vaccine dose received 2/1/2021 at 10AM. Fever and chills started at 12:30pm and lasted for 24 hours with the peak temperature up to 102.9. Employee notified Tuesday morning, I had to call out of work that day due to the fever.
numbness; sharp pain in right thigh; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness) and PAIN IN EXTREMITY (sharp pain in right thigh) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (sharp pain in right thigh). On an unknown date, the patient experienced HYPOAESTHESIA (numbness). The patient was treated with PARACETAMOL (TYLENOL) on 18-Apr-2021 for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (numbness) and PAIN IN EXTREMITY (sharp pain in right thigh) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment for the event included Tylenol on 18Apr2021.
Child was given Varicella and PROQUAD. Child was monitored in clinic for 15 minutes and sent home. Staff not aware of clinical error until 330 PM. Unable to contact family for follow up, message left on phone number on file.
So 15 minutes after the shot her heart rate when from 86 to 136 started to skipping a beat, EMT came and got her and attached her to the EKG. Transported her to the hospital and hooked her up again to the EKG was having PDS. Gave her fluid and magnesium to help with it and sent her home. On March 4th at work her heart started to beat fast and her heart rate was 130 and was still having heart problems and collapse at work went to the hospital and they started to monitor her heart and also gave her meds called propanol.
I am on continuous birth  control, brand name Nora-BE (Norethindrone 0.35mg); I do not have a period on these, I do not take placebo bills. In early/mid July, while still on my birth control, I began to bleed as if on a period and it ended up being the heaviest flow I have ever had and for longer than a week, which is also longer than I have ever had a period go on for. I wanted to provide this info since I know other women have had similar experiences and there does not seem to be an understanding as to why yet. I hope this helps.
Complains of pain at left deltoid.  Self treated with Ibuprofen and heat.
Narrative: Pneumonia due to coronavirus disease 2019 J12.82(ICD-10-CM) Other specified sepsis A41.89(ICD-10-CM) Acute respiratory failure with hypoxia
1 year old patient was administered with expired DAPTACEL/ no AE; Initial information was received on 17-Jun-2021 regarding an unsolicited valid non-serious case received from a Other health care professional via Regulatory authority (Reference number- 00646038) and transmitted to Sanofi on 17-Jun-2021.  This case involves a 20-year-old patient (unknown gender) who was vaccinated with 0.5 mL dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].(5 dose series, 4th dose) (lot number C5621AA, expiry date 23-May-2021) via intramuscular route in left thigh on 17-Jun-2021 for prophylactic vaccination (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Prophylactic vaccination; and HIB VACCINE (HIB) for Prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse event.  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.
Venous stasis ulcer; This spontaneous case was reported by a consumer and describes the occurrence of SKIN ULCER (Venous stasis ulcer) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 031M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLUZONE HIGH DOSE QUADRIVALENT (route Intramuscular,Body site left deltoid and dose 1) on 09-Sep-2021. Concurrent medical conditions included Hypertensive heart disease (controlled via medication) since 11-Jul-2008, Sleep apnea (controlled by Bi-PAP) since 20-Aug-2009, Obesity (losing weight) since 15-Jul-2004, Seronegative rheumatoid arthritis (increased dosage of methotrexate) since 07-Feb-2019, Osteoarthritis (increased dosage of methotrexate) since 07-Feb-2019 and Adhesive tape allergy. Concomitant products included FOLIC ACID for Anaemia, DULOXETINE, ACETAMINOPHEN, GLUCOSAMINE and CHONDROITIN for Arthritis, POTASSIUM CHLORIDE for Electrolyte substitution therapy, NIACIN for High cholesterol, FAMOTIDINE for Hyperchlorhydria, ATENOLOL, DILTIAZEM, MINOXIDIL, OLMESARTAN MEDOXOMIL and TORSEMIDE for Hypertension, ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE ACTAVIS) for Insomnia, MOMETASONE FUROATE (MOMETASONE FUROATE CIPLA) for Nasal congestion, METHOTREXATE for Rheumatoid arthritis, MONTELUKAST SODIUM for Rhinitis allergic, MULTIVITAMIN & MINERAL, VITAMIN D3 and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced SKIN ULCER (Venous stasis ulcer). The patient was treated with CARMELLOSE SODIUM (DUODERM CGF [CARMELLOSE SODIUM]) for Venous stasis ulcer, at an unspecified dose and frequency. At the time of the report, SKIN ULCER (Venous stasis ulcer) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-338635 (Patient Link).
CONSTANT TINNITUS, STARTED THE DAY AFTER AND HAS NOT STOPPED SINCE.
Tested positive with Covid and was given Paxlovid on May 19. Had runny nose and developed a fever and chills. Started taking Paxlovid, it relieved the symptoms in 1 day. 2nd day was only extremely tired and felt a lot better, continued the medication until all taken.
1st shot - high fever, chills, aches lasting 24 hours; 1st shot - high fever, chills, aches lasting 24 hours; 1st shot - high fever, chills, aches lasting 24 hours; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Aug2021 10:00 (Lot number: FC3180) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lyme disease" (unspecified if ongoing); "covid-19" (unspecified if ongoing), notes: prior vaccination. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), CHILLS (non-serious) all with onset 2021, outcome "recovering" and all described as "1st shot - high fever, chills, aches lasting 24 hours"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "1st shot - high fever, chills, aches lasting 24 hours". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, pain.  Additional information: The patient had no known allergies. The patient had COVID prior vaccination and had negative COVID test post vaccination. Facility type vaccine was pharmacy or Drug Store. Patient did not receive other vaccine in four weeks or  other medications in two weeks.  No follow-up attempts are possible. No further information is expected.
pt recv vax & inj site rxn which consisted of soreness, redness covering the upper posterior arm;pt then devel a non-varicella type rash @ inj site;
3rd dose of Varicella given 8/10/22 in error.  Only 2 doses needed. 2 of 2 dose given 7/27/22.
Menstrual cycle late or absent a couple months after getting vaccine. I have never had this issue before.
His eyes were swollen. He couldn't even go outside.; After he got vaccine, his seasonal allergies were acting up; This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A 74-years-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04May2021 as 2nd dose single for COVID-19 immunization. Historical vaccine of BNT162B2 was given as a first dose 3 weeks before the 2nd dose. Medical history included ongoing seasonal allergy from an unspecified date. Patient has seasonal allergies and he was advised by his doctor to wait for 3 months before taking Depo-Medrol/corticosteroids. He got swollen eyes and serious allergies because he cannot take any steroid shots - Asking for medication to take for treatment of his allergies - Patient is very frustrated and provided limited information only, he does not want to make any safety report  Potential Duplicate AE Report E transmit. The patient's concomitant medications were not reported. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, for cancer or an autoimmune disease, or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized (except for participants in Phase 1 see exclusion criterion 14), intra-articular, intra bursal, or topical (skin or eyes) corticosteroids are permitted. On an unspecified date patient experienced his eyes were swollen, he couldn't even go outside and after he got vaccine, his seasonal allergies were acting up. After he got vaccine, his seasonal allergies were acting up. He went to his doctor to get Depo-Medrol. They did not administer Depo-Medrol due to COVID vaccine. He was told he needed to wait 3 months. His eyes were swollen. He couldn't even go outside. Caller wants to know if there is anything else he can take. Caller said he usually gets his allergy shot in April or May. It was delayed since he got the COVID shot. After that cleared up, he was able to get his first shot, and after that cleared up, he was able to get his second shot. After that he went to the doctor, who was not aware, and because it's a steroid, he couldn't do it. He could not get Depo-Medrol because it was a steroid. Also stated that his allergies were so bad that he wanted to rip his eyes out of his head. The outcome of the events was unknown.  Follow-up(21May2021): This is a Follow-up spontaneous report from a Pfizer sponsored program COVAX US Support. No new significant information was provided.    Warm transferred caller to Pfizer, Caller not provided with phone number or hours prior to transfer, in the event of disconnection, due to caller getting frustrated and saying goodbye.  Information about Lot/Batch number has been requested.
On 5-7-08 pt was given Pneumovax. Today (5-9-08) presented with 8cm x 8cm erythemic area that was warm to touch and swollen. Pt was complaining of pain and tenderness to touch.
pt recv vax & exp migraines; pt was treated w/Advil w/o relief;
no additional AE; improperly stored dose was administered; Information has been received from a pharmacist referring to a 49 years old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 16-JUN-2021, the patient was vaccinated with improperly stored of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # T034630, expiration date: 22-JUN-2022, strength, dose, frequency and route were unknown) for prophylaxis (incorrect product storage).  No adverse effects were reported.  The stored temperature was 31.5 Fahrenheit (F). The time frame was 15 hours and 33 minutes. There was no previous temperature excursion. The temperature excursion was detected by a data logger. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T034630; expirationdate: 22-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Chills, body aches, insomnia, and headache, starting at 5pm the day of the vaccine. Still having residual headache today. Very sever symptoms left me in bed for the remainder of the day.
Patient states that reaction started that day at later time, itchiness, redness, etc.  However, reporting today, patient claims today she has full blown shingles, which she feels was triggered by the vaccination on 10/25/13.
she is still tender in her left arm from the first shot/The first shot hurt way more and hurt all over the whole arm, it was throbbing; she is still tender in her left arm from the first shot/The first shot hurt way more and hurt all over the whole arm, it was throbbing; This is a spontaneous report received from a contactable nurse (who is also the patient). A 57-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via intramuscular route in the left deltoid, on 18Dec2020 18:00, at single dose, for preventive/COVID-19 immunization, in the hospital. The patient's medical history was not reported. There were no concomitant medications. Historical vaccine included H1N1 flu shot (INFLUENZA VACCINE), in 2015 or 2016 (as reported), for immunization and experienced muscle stiffness and fatigue. The patient reported she is she is still tender in her left arm (unspecified date) from the first shot. The first shot hurt way more and hurt all over the whole arm, it was throbbing (unspecified date). The outcome of the events was not recovered.  Information about lot/batch has been requested.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F(Fahrenheit)for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 17 years old, male patient with no pertinent medical history reported. On 11-JAN-2013 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 15-MAR-2013 the patient received another dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
The patient experienced no symptoms; a one year old patient was administered both VARIVAX (lot S015459, expiration 5/20/2021) and PROQUAD (lot S012467, expiration 10/20/2020) on the same day.; This spontaneous report has been received from a medical assistant, referring to a 1 year old patient of unknown gender. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not provided.  On 20-JAN-2020, the patient was vaccinated with both measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S012467, expiration date 20-OCT-2020; strength, dose and frequency were unknown) subcutaneously for prophylaxis and varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S015459, expiration date 20-MAY-2021; strength, dose, frequency and route were unknown) for prophylaxis (overdose). Other suspect therapies included sterile diluent (STERILE DILUENT) (lot# was reported as R032612 and expiration date was reported as 22-JUL-2021, but upon internal validation established as non-valid; strength, dose, frequency and route were unknown). The patient experienced no symptoms (no adverse event).
Pt recvd Engerix-B on 30APR90, 29MAY90, & 5NOV90 subsequently found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
having stomach issues , trouble eating , is feeling a bit better today , feeling stronger , still has not taken medications .
Hives developed at injection site on left upper extremity and at left upper back area, throat tightness, tachycardia.
Three hours after injection, my bottom lip started to have muscle spasms. They are still occuring at a rate of about 20 per day and last anywhere from 3 to 10 seconds.
Information has been received from a physician concerning an 18-year-old male with no pertinent medical history who is "highly allergic" to dairy, who on 12-JUL-2007 was vaccinated intramuscularly with a 0.5 milliliter first dose of VAQTA  (lot # 657307/0442U). Concomitant vaccination included a dose of ADACEL. Within 20 minutes of leaving the office the patient began to experience an anaphylactic reaction: coughing and tingling and tightness of his throat. The patient administered EPI-PEN and BENADRYL to himself and was taken to the emergency room. He was treated with intravenous steroids and monitored prior to being discharged home with a prescription to prednisone for 2 days. On 13-Jul-2007 the physician spoke with the patient who stated he had not experienced any further problems. No product quality complaint was involved. The reporter considered the events to be life threatening. Lot check results received on 02-Aug-2007: The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements of the government and was released by the regulatory agency. Additional information has been requested.
Cellulitis L arm on 10/17/03. Myalgia and paresthesia w/ by 10/29/03-parent 11/12/03.
PATIENT MOUTH NUMB, AND LIPS TINGLING, THROAT SCRATCHY. GAVE 50MG DIPHENHYDRAMINE WATCHED FOR 30 MINUTES. PATIENT GOT SOMEONE TO PICK UP. SHE WAS MUCH BETTER WHEN SHE LEFT.
Both time i got very sick; 5 days of headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Both time i got very sick"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "5 days of headache".  Additional information: Customer Verbatim: I got my second covid 19 vaccine dose. Both time i got very sick. 5 days of headache and now with the second dose, 7 days later my arm is still swollen and very painful . The pain extends from my arm to my shoulder and neck. I already massaged it but is useless . I have two babies under two and I'm taking 6 pain killer every 5 hours to deal with the pain. I cannot sleep.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I was nineteen weeks pregnant.  I discovered the loss on 02/28/2023. I had a DNC procedure on 03/03/2023.
Information has been received from a medical assistant referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # M000997, expiration date 07-JAN-2018 (lot # M006733, expiration date 09-FEB-2018) (lot # M009766, expiration date 23-FEB-2018) (lot # M020900, expiration date 27-APR-2018) (dose and route unknown). The vaccine was exposed to temperature excursion of 7.9 Fahrenheit degree (F) for 15 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same report source. Additional information has been requested.
Red, swollen, itchy & painful - area involved spreading. (L) arm where shingles vaccine was given.