chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortly after my second dose of the COVID-19 vaccine my hair started to fall off in an abnormal amount. After seeing my primary care doctor and having blood tests done, I was diagnosed with Hypothyroidism on July 25th, 2021, and started taking medication.  By the end of November, I started having tachycardia occasionally. I called 911 twice for this reason and the second time my heart rate increased up to 170 bpm and spent the night at the ER on January 19th, 2022. No family history of heart disease or symptoms before that.   On January 8th, 2022 i had a seizure for the first time in my life and spent 2 days at the hospital. Then on January 26th, 2022 I had 2 seizures (one at home and another one at the ER) and spent 3 days at the hospital. After having many tests done I was diagnosed with right temporal epilepsy. I have no family history or history of head trauma, not even as a kid.  I have always been healthy as evidenced by laboratory tests in the preview years.
No signs or symptoms reported; PEDVAX HIB was administered to patients after the excursion occurred; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On 26-OCT-2021, haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced temperature excursion with 35.0 Fahrenheit degrees (F), 35.1 F, 35.3 F, 35.2 F, 34.9 F for 53 minutes (cumulative). There was no previous temperature excursion. On an unknown date in 2021, after the excursion occurred, the patient was vaccinated with the improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (1 time dose, lot # U003873, expiration date 15-APR-2023; strength, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No signs or symptoms reported. No other adverse event (AE) or product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2111USA004277: US-009507513-2112USA003881: US-009507513-2112USA003882: US-009507513-2112USA003883: US-009507513-2112USA003884:
Patient developed severe swelling at injection site, nausea, diaphoresis, severe headache, arm pain. Decreased appetite.
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 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "None known" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Covid rebound 3 days after negative test adverse_event; Positive, notes: COVID 19 Treatment.Covid rebound 3 days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: This report is about covid treatment and reported by patient. Patient is not Pregnant and received vaccine. Other medication was not received in 2weeks. Patient received Paxlovid product as anti-viral and indicated for COVID 19 Treatment, treatment started on 13Oct2022 and ended on 18Oct2022. Also, patient received covid vaccine in Left arm and dose number 5 on 17Sep2022 at 01:00 PM. Adverse event was reported as Covid rebound 3 days after negative test. Adverse event started on 23Oct2022 at time: 03:00 PM and patient is recovering. There was no treatment adverse event, none known allergies None and other medical history was none known.  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.
Information has been received from a female consumer who expressed a concern regarding pneumococcal 23v polysaccharide vaccine (lot # 645646/0068N). Additional information has been requested.
extremely high blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 14Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1; MANUFACTUERER UNKNOWN), administration date: 24Mar2021, for Covid-19 immunization. The following information was reported: HYPERTENSION (non-serious) with onset 2021, outcome "not recovered", described as "extremely high blood pressure". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypertension.  Additional information: Consumer called, caller got the first dose of the vaccine on 24Mar2021, and the second dose was received on 14Apr2021 (correct dosing schedule). Name withheld said she was experiencing an extremely high blood pressure and she took medications for her blood pressure already, she wanted to know if this was one of the side effects of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. c/o lightheadedness, nausea and burning sensation at site 10 minutes after receiving the vaccine.  Client assessed by EMS and vital signs are B/P 115/80, HR 75, 02 98.  After 20 min. of continuous observation client stated that she started to feel better.  Pt. advised to stay another 15 min then cleared to go home by EMS.
a two month old patient was administered adose of PROQUAD in error on 2/26/2020; This spontaneous report as received from a medical assistant refers to a 2 month old patient of unknown gender. No information regarding the patient's medical history, concomitant medications and concurrent conditions was provided. On 26-FEB-2020, the patient was vaccinated in error with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneously, lot # S015092 has been verified to be not valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)  (with expiration date reported as 15-MAY-2021 for this lot #; albumin status not established) for prophylaxis. The vaccine was reconstituted with a sterile diluent.
I experienced a flare up of my polymyalgia rheumatica, which was due to tapering of prednisone. My rheumatologist has confirmed that. This has occurred several times over the past couple of years. I'm sure it was not vaccine related.
right foot stress fracture, then hit the sand and it broke; This spontaneous case was reported by a consumer and describes the occurrence of STRESS FRACTURE (right foot stress fracture, then hit the sand and it broke) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK,. On an unknown date, the patient experienced STRESS FRACTURE (right foot stress fracture, then hit the sand and it broke). At the time of the report, STRESS FRACTURE (right foot stress fracture, then hit the sand and it broke) had not resolved.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality of humira as per reporter for event menstruation frequent was no reasonable possibility. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Patient started feeling bad the following day of receiving H1N1. Went to doctor on Feb 22, 2010. Dr stated patient had shingles.
Itching, whelping of the abdomen, legs, hands, feet, back, began on 1/4, observed at the Health Dept. on 1/5/11.
NSTEMI, Systolic CHF, postmyocardial infarction, pericarditis
Day after shot, felt nauseated, headache, sore throat, profound fatigue, fever 101.5. Expected this- alt.tylenol/nsaid to get by. Next AM-felt better briefly, but declined back to above. I am now day 7 s/p 2nd shot and still running  low grade temps: Today 100.8. I feel intermittent nausea, dizzy/LH spells (I am pushing fluids-BP running my usual 100's/60-70's, HR high 50's- low 80's), intermittent sore throat, cough, swollen glands, chest/muscle soreness. What seems constant is the TIREDNESS and fevers.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender, with not pertinent medical history reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) (0.56ml, subcutaneous on the front of the arm, about 2 inches above the fold of the elbow), no other suspect therapies or concomitant medications were reported. The pharmacist reported that on an unknown date (reported as "a few days later") the patient had an injection site reaction which was red and a little swollen and irritated. The outcome for injection site reaction which was red and a little swollen and irritated, was unknown at the time of the report. The pharmacist recommended to the patient BENADRYL and warm compresses. The pharmacist did not assess the causality between ZOSTAVAX and injection site reaction which was red and a little swollen and irritated. Additional information is not expected.
Immediately following administration of second vaccine, patient became nauseated, weak, color paled, assisted to exam table; laid down, given sips of soda and was feeling better within 5-10 minutes after sitting up and feeling better approximately 10 minutes. Home with mom. Returned next day with complaints of fever, headache, and weakness. Advised fluids, rest and monitor.
Severely distorted smell and taste. Eggs, meat, coffee, onions, garlic smell metallic
After receiving the vaccine, about 12:30am on 03/28/21 I felt a chills, shaky muscles around my neck/shoulders..the room temperature was at 80F but I felt cold like 35F. The next morning, I felt very tired walking up stairs from the basement to my room on the 2nd floor..barely made it to the 2nd floor, felt like my body hitting a wall/ no energy to lift my legs up. I made to my bedroom but felt very dizzy, using my hands holding myself up on my desk and realized I might faint any seconds..my vision was bright and blurry. I slowly moved myself to a bed and laid down for a while. Later that day in the late afternoon, my muscles were sore (legs, thighs, back) I could not walk more than 10-15 steps which I needed rest. These conditions lasted me for 6 days since receiving the vaccine and felt better on the 7th day. Currently I'm ok.
severe body chills, body aches, headache, fever, nausea , fatigue, face red on left side.        Took Tylenol every 4 hours
Breathing problems 24 hours after injection. Peak flow ok. I felt as if there was a coating on my lungs which made breathing more difficult. It took 2 weeks to feel ok.
PATIENT BEGAN TO HAVE A SORE ARM THE EVENING THAT THE VACCINE WAS GIVEN. THE NEXT DAY SHE FELT SORE ALL OVER AND BEGAN TO RUN A LOW GRADE TEMP (STATED THAT SHE DID NOT ACTUALLY TAKE HER TEMP).  THE DELTOID AREA OF HER RIGHT ARM BEGAN TO SWELL AND WAS HOT TO THE TOUCH.  SKIN TIGHT ON THE AFFECTED ARM.  ARM BEGAN TO ITCH 5 DAYS LATER.  ALL OTHER SYMPTOMS HAVE RESIDED EXCEPT FOR MILD SWELLING, ITCHING AT INJECTION SITE, AND MINIMAL SORENESS IN DELTOID AREA.
The vaccine expired on 02-May-2022 and was initially stored in the refrigerator on 12-May-2022; Administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022) and PRODUCT STORAGE ERROR (The vaccine expired on 02-May-2022 and was initially stored in the refrigerator on 12-May-2022) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine expired on 02-May-2022 and was initially stored in the refrigerator on 12-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022) and PRODUCT STORAGE ERROR (The vaccine expired on 02-May-2022 and was initially stored in the refrigerator on 12-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided.  The vial was initially stored in refrigerator on 12-May-2022.  The vial did not undergo any temperature excursion.  No treatment medication was provided.
Pt has received the pneumovax 23 once before in 2009 without incident.  This event was a reddness, tender and swelling below the site of injection.  Lasted approx 3 days.  Pt used ice and elevation as instructed.  This has completely resolved
Rotator cuff tendonitis; pain in shoulders; This spontaneous case was reported by a consumer and describes the occurrence of ROTATOR CUFF SYNDROME (Rotator cuff tendonitis) and ARTHRALGIA (pain in shoulders) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism since 19-Jul-2017, Seasonal allergic rhinitis (acute seasonal allergic rhinitis.) and Hypercholesteraemia on 19-Jul-2017. Concurrent medical conditions included Pollen allergy, Grass allergy, Allergy to animal (allergic to cats), Allergy to animals (rabbit hair) and Pollen allergy (pine tree pollen allergy.). Concomitant products included CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ZYRTEC-D) for Allergy, ATORVASTATIN from 17-Jul-2017 to an unknown date for Cholesterol, BUPROPION from 09-Dec-2020 to an unknown date for Depression, LEVOTHYROXINE from 17-Jul-2017 to an unknown date for Thyroiditis.   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced ROTATOR CUFF SYNDROME (Rotator cuff tendonitis) and ARTHRALGIA (pain in shoulders). At the time of the report, ROTATOR CUFF SYNDROME (Rotator cuff tendonitis) and ARTHRALGIA (pain in shoulders) was resolving.            treatment to the events not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Client reports she felt achy and had pain in left arm, radiating up into neck area on 3/5/2021. On 3/7/2021 and 3/8/2021 she had a "burning" in stomach that radiated into chest with difficulty breathing and chest pain.  Since then, she reports having Shakey hands, numbness in left leg, nodules on thyroid, thrush, headache, depression and panic attacks. She reports distancing herself from family and being unable to drive due to lack of focus.
Patient developed generalized itching within  hours of administration of the vaccine.  She stated that her PMD and allergist said that she could have 2nd dose but 2 MDs , 1 PA and 1 RN at our public health facility did not feel safe in doing this.  We declined to give the 2nd dose of Pfizer vaccine.
pt recv vax 3MAR97 & 5MAR97 pt exp a stuffy nose, irritability & watery eyes described as basic cold sx;pt tx w/APAP & cold medicine;
My period was due approximately the day of or day after I received my first Covid19 Moderna vaccine.  My periods are regular, and almost never vary more than a few days. Since I developed a regular cycle in my mid-teens, I've only once skipped a period, and that was only for one month. I have not had a period since I received my vaccine, so my last period was in March. So, it now has been 4.5 months since my last period. There is no possibility of me being pregnant.
recurrent wart/disappearance of an otherwise persistent palmar wart following the Pfizer COVID-19 vaccine; This is a spontaneous report received from a contactable reporter (physician). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "recurrent wart in the palmar aspect of the 2nd phalange, middle finger of left hand" (ongoing), notes: for the last 2 years and it kept recurring despite treatment with salicylic acid application, Duragel Clear Away Wart Remover, etc. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "recurrent wart/disappearance of an otherwise persistent palmar wart following the Pfizer COVID-19 vaccine".  Additional information: Following 1-2 weeks of the COVID-19 vaccine the wart disappeared completely. The patient was unable to find a site in CDC to report the beneficial effect of COVID-19 vaccine.   No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
Patient got Pfizer covid 19 as the second shot. Patient should have been give Moderna  as the second shot.
Inside top left cheek. ?Splattering? of canker soars.maybe 8-10. Fully disappeared by sunday morning /about 48 hours after shot.  I took more l-lysine. When i had the outbreak but nothing else
Vaccine injected subcutaneously; A spontaneous report was received from a healthcare professional concerning a female consumer who received Moderna's COVID-19 vaccine subcutaneously, instead of intramuscularly (IM) on her arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.     On 05 Jan 2021, a patient was administered mRNA-1273 subcutaneously in her arm, instead of IM.  There was no report of adverse event experienced by the patient. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The event, vaccine given to a patient subcutaneously instead of IM, was considered resolved on 05 Jan 2021.; Reporter's Comments: This report refers to a case of a female consumer who received Moderna's COVID 19 vaccine subcutaneously, instead of intramuscularly (IM) on her arm for mRNA-1273. The vaccine lot number was not provided. There were no reported AEs associated with this case of female consumer who received Moderna's COVID-19 vaccine subcutaneously, instead of intramuscularly on her arm.
I received shot at 14.5 weeks pregnant.  Hours after the injection, I developed a rash on my neck and back. The next day, the rash appeared all over my chest, abdomen,  back, sides. Essentially I am covered in red bumps from behind my ears to my groin area. The bumps do not hurt but they are very itchy and have not responded to benedryl pills or caladryl oitment.
This spontaneous report as received from a registered nurse. The nurse reported that on 17-MAY-2013 expired dose of PNEUMOVAX23 (dose and route were not reported) (lot number 671615/1170AA, expiration date: 10-MAY-2013) was administered to the 9 year old patient of unknown gender. No adverse events were reported. Additional information has been requested.
Information has been received from a certified medical assistant concerning a 69 year old patient with high blood pressure, GERD, IBS, and lots of allergies, who on 5/3/00 and on 8/22/05 was vaccinated with a first and second dose (lot # 647661/0055R) of pneumococcal 23v polysaccharide vaccine, respectively. After the first dose, on 5/3/00, the patient developed a 4x6cm red area on left arm and was diagnosed with cellulitis. After the second dose the patient developed a swollen red area at site of injection. The patient was seen in the doctor's office on 8/24/05. The patient was given ceftriaxone sodium. No product quality complaint was involved. The patient reportedly recovered from both adverse experiences. The reporter considered swollen red area at injection site to be an other important medical event (OMIC). The reporter also provided information on two other patients who had an adverse experience following vaccination with pneumococcal 23v polysaccharide vaccine (WAES0508USA04558 and 0508USA04672). No additional information is expected.
930PM on 18JUN96 pt c/o itching & mom noticed splotchy red rash on trunk area;dx urticaria 12 hrs p/vax tx DPH
No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medication information provided. Patient age was 40 years 2 months. Pharmacist reported that they have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30 day beyond use date. Before use date reported was 17-Feb-2022. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live Significant follow up received: Patient information and vaccination details updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case