chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a female who was vaccinated with a dose of zoster vaccine live (Oka/Merck). It was reported that since she was vaccinated, her nerve in her tooth is bothering her and causing pain. The patient stated that she had the pain since the last 6 weeks. The patient had seen root canal specialist and they could not find anything wrong and stated that the root nerve would get better in a couple of months. At the time of report the patient had not recovered. A product quality complaint was not involved. No further information is available.
Hives an lip swelling - was given Benadryl po and Epi SQ patient was then observed and then released home when all symptoms cleared.
Pt recvd 3 doses of Engerix-B 11OCT90 & 15NOV90 & 17APR91 & 17APR91 tested for Anti-HBS & found to be non-reactive; 28MAY91 recvd 4th dose of Engerix-B; 2JUL91 again tested for Anti-HBS & found to be non-reactive;
Patient admitted as inpatient on 12/16 due to fall with R flank hematoma. Patient was tested for COVID-19 and was positive on 12/16.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 01Feb2021 at 11:00 as dose 1, single (Lot number: EL9265), in left arm, on 22Feb2021 at 11:15 as dose 2, single (Lot number: EN6205), in left arm, on 05Oct2021 at 10:30 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 11Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic asthma" (unspecified if ongoing), notes: Other medical history: Chronic asthma. Concomitant medication(s) included: NEBIVOLOL, start date: 20Apr2022; LISINOPRIL, start date: 14Jul2020; PANTOPRAZOLE SODIUM, start date: 14Jul2020; ELIQUIS, start date: 03Mar2021; TADALAFIL, start date: 29Oct2021; ASPIRIN LOW, start date: 03Mar2021; ADVAIR, start date: 14Jul2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Sep2022) Positive; (unspecified date) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022; No adverse event; Dose administered after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 003K21-2A, 012H21B, 018B21A and 036A21A) for COVID-19 prophylaxis.     Patient was never diagnosed with or tested positive for COVID-19.  The patient's past medical history included Hepatobiliary disorder prophylaxis (HPB). Concurrent medical conditions included Allergy to antibiotic (Septra). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), METOPROLOL, LISINOPRIL and HYDROCHLOROTHIAZIDE for an unknown indication.   On 05-Mar-2021 at 12:09 PM, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 18-Nov-2021 at 9:32 AM, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. On 05-Apr-2022 at 3:22 PM, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. On 26-May-2022 at 10:47 AM, received fourth dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022,  after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) and PRODUCT STORAGE ERROR (vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022).    Date(s) of administration of vaccine were reported as 19-May-2022, 26-May-2022, 02-Jun2022, 07-Jun-2022 and 08-Jun-2022. The used vials were placed in the refrigerator on the same day of administration (26-May-2022). No temperature excursions were reported. No treatment medication was provided.
Patient was in observation. Patient c/o dizziness to the Obs RN and then patient synopsized. Patient regained consciousness soon after, patient pale and diaphoretic, patient stated having history of vasovagal after vaccine administration and have not had any food before coming to get the vaccine. Vital signs initiated, ice packs placed around patient's neck, patient's legs elevated. Patient stated to feeling much better. Patient able to drink water. Symptoms resolved. Patient educated to seek medical attention if symptoms worsen.  Patient AOx4
I had the vaccine, on 10/29/2022 on Dec 18th, I got sinus pressure, coughing, lasted for two weeks. On Jan 2nd I have ear pain and pressure, sore throat, a lot coughing, it got worst and worst I started off get headaches and coughing a lot, on Jan 2nd I went to urgent care and tested negative for Flu and COVID-19. They gave me prescriptions and antibiotics, and cough suppression. I am already taking medicine for cough and congestion. A week later, I started to feel better on the 14th of January symptoms started to come back again. On 1/18 I went back to urgent care, they put me in a different antibiotic, more cough suppression and continue to take expectorant and TYLENOL. The 26th I starting to feel better, but mucus starting to turn yellow on 1/29. I am in six weeks, this situation happened to a lot of people at work and my community. January 18th, I had the flu, and COVID-19 and they came negative. Home test for COVID-19 were also taken Jan 2, 4, 17, all were negative.
pt recvd vax; devel bloody diarrhea; 6jan94 flu like sxs, fever, malaise, abdo pain; stool culture neg;
I think my first dose was in my right arm but I am not sure. By midnight after my first dose I felt so bad and the pain was getting worse. From head to toe every joint and muscle was aching. I felt like I was running a fever but I never checked because I couldn't' get out of bed. I had a headache and was stuffy and congested and I felt like I had Covid-19 again. At exactly 24 hours later on the dot I felt completely better and I could get out of bed. I was still a little sore but not bad at all.
Patient dizzy, lethargic and heart rate elevated (109) after receiving covid vaccine. BP 149/75 and BS 122. Provider assessed and monitored in exam for about 45 minutes. Patient discharged in stable condition.
Left arm became sore. As the day went on my arm hurt more and hurt quite a bit when lifted. Was not able to sleep on it. On Sun. 9/27/2016 I noticed some redness on my arm and it was warm. Went to pharmacy to have pharmacist check it.  Said it was a reaction to shot.
EMPLOYEE HAD STIFFNESS TO NECK AND SHOULDERS THE FOLLOWING DAY, 2 DAYS AFTER INJECTION PAIN IN RIGHT SHOULDER, RIGHT GROIN, AND MEDIAL RIGHT KNEE, THE THIRD DAY AFTER THE INJECTION RASH DEVELOPED TO RIGHT BUTTOCK, STARTED ABOUT A QUARTER SIZE AND PROGRESSED TO THE SIZE OF AN ORANGE OVER A TWO DAY TIME FRAME. STATES THE RASH BURNS WHEN TOUCHED.SORENESSS TO GLUTEAL MUSCLE AND RADIATES AROUND TO THE GROIN.
Patient now has the Miller Fisher Gillian barre Syndrome. I visited her on April 19th and noticed her speech was slurring and she was tired. Her speech got worse, we took her to ER Room, many tests, they thought a stroke, then to cardiologist, then neurologist. My Mom was a healthy independent 83 year old and now she can barely walk or talk, thank you Johnson and Johnson you have turned my family's life upside down!
Red, swollen lump at injection site, 3cm in diameter. Redness and swelling lasted approximately 3 weeks. Lump palpable 2 months post-vaccine
nail changes; dyschromia; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 65-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE taken for rheumatoid arthritis; HYDROXYCHLOROQUINE taken for rheumatoid arthritis. The following information was reported: NAIL DISORDER (non-serious), 3 weeks after the suspect product(s) administration, outcome "unknown", described as "nail changes"; SKIN DISCOLOURATION (non-serious), 3 weeks after the suspect product(s) administration, outcome "unknown", described as "dyschromia".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dizzy; Diarrhea; Dehydrated; Nausea; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (Dizzy), DIARRHOEA (Diarrhea), DEHYDRATION (Dehydrated) and NAUSEA (Nausea) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product METHOTREXATE (OTREXUP) injection for Rheumatoid arthritis.    No Medical History information was reported.   On 08-Feb-2017, the patient started METHOTREXATE (OTREXUP) (Subcutaneous) 12.5 mg once a week. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy), DIARRHOEA (Diarrhea), DEHYDRATION (Dehydrated) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizzy), DIARRHOEA (Diarrhea), DEHYDRATION (Dehydrated) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.
Tired for a week; This case was reported by a nurse via call center representative and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included food allergy and drug allergy.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: The patient was a registered nurse and reported adverse event experienced by herself. The age at vaccination was not reported. The patient was tired for a week after receiving Shingrix. The patient did not consent to follow-up and refused to provide any additional details, declined any future follow up or communication regarding this. This case has been linked to US2019188847, reported by the same reporter.
Tender red & swollen about 6 inches wide in her right upper arm. On examination 1/13 there is fat necrosis & atrophy.
Severe Shortness of Breath and weakness with any activity. Prescribed an Inhaler and was told to decrease activity to save strength and preserve my respiratory status.
patient inadvertently received undiluted vaccine of roughly 20mcg (twice the intended dose).  Parents contacted and reported that the patient was "okay but a little sluggish".
Report 2001016305-1 describes induration at the injection site of a 3 year old female who  inadvertently received an intradermal injection of Infanrix. Medical history, concurrent conditions, and concurrent medications were not specified. There was no known illness at the time of Infanrix administration. On 06/29/2001, the child inadvertently received an intradermal injection of Infanrix, rather than tuberculosis purified protein derivative (PPD). Later that day, an unspecified time post-injection, she developed a 9mm by 11mm area of induration at the injection site. The induration resolved on an unspecified date. The reporter considered the induration at the injection site to be mild in intensity and related to Infanrix administration. On 07/03/2001, four days following receipt of Infanrix, the child developed a fever of 101 to 102.5 deg F and vomiting. A diagnosis of gastroenteritis was made. The reporter did not assess the relationship between Infanrix administration and the development of gastroenteritis. On an unspecified date, the gastroenteritis resolved.
Patient began to experience itching and redness at site on the day following vaccine administration.  Swelling and pain persisted and patient presented to my office on 05/25/2011.
Roughly 12 hours post receiving the J&J vaccine,  I woke up with a nose bleed. I haven't had a nose bleed in the last 10 years. No nasal trauma or dryness/ exposure to dry or cold weather. applied pressure to the bridge of my nose, cleaned my nose out, and woke up in the morning with additional dried blood in my nose. this has happened two nights in a row now.
This is a spontaneouso case, initially received from a pharmacist on 07-Feb-2018, concerning a 30-year-old, adult, male patient. On 02-Feb-2018, the patient (under 65 years of age) was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 178303, exipry date: 30-Apr-2018). No adverse event was reported since administration. The reporter assessed the event as non-serious.
One day post vax, the pt felt pain and discomfort so she looked in the mirror and noticed that it was very red and swollen. The site also began to itch shortly after discovering the swelling.
Initially all joints (neck, shoulders, elbows wrists, etc) ached and stiff. Moved to Tendonitis/Arthritis wrists, hands, fingers and Left patellar knee tendon. SLOWLY improved but did not leave, despite treatment with Aleve, until 2nd vaccine 2/5/2021. Then, same symptoms worsened and included BOT patellar tendons, nd plantar tendons. Continues to present and are very painful at night, despite 2 Aleve BID daily, and  cannot make fist or extend fingers on  both hands and cannot walk on feet without pain at MTP's. Discussed with orthopedic surgeon who assured me that I was having "an immune reaction in tendons to vaccine. It should get better over time". It has not at present.
Pt. received two doses of Pfizer vaccinations, ended up covid + requiring monoclonoATBx IV
26NOV97 mom reported temp (ax) of 101.9;pt had recv APAP & is alert, but acts lethargic;no vomiting or diarrhea;mom states child is taking foods & fluids;mom encouraged to call MD & report;
This case involves an unknown age and unknown gender patient who took fluzone high dose quadrivalent twice within approximately a month with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included COVID-19 VACCINE (COVID-19 VACCINE) for Immunisation. On 27-Oct-2021, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported via unknown route in unknown administration site as prophylactic vaccination. On an unknown date the patient developed a non-serious event "fluzone high dose quadrivalent twice within approximately a month with no reported adverse event" (inappropriate schedule of product administration) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable. It was not reported if the patient received a corrective treatment for the event (Fluzone High Dose Quadrivalent twice within approximately a month with no reported adverse event). At time of reporting, the outcome was Unknown for the event fluzone high dose quadrivalent twice within approximately a month with no reported 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 the 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.
S/S started the following day for both shots. N/V, headache, total body ache, weakness, malaise, fever, no taste.  Feeling like I got hit by a train and ran over by a dump truck. Having the actual covid virus never felt as bad as the getting the vaccine. One size does not fit all.  This thing is dangerous and should be illegal.
Iitching at injection site; Rash in the injection site, spread to shoulder; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Iitching at injection site), VACCINATION SITE RASH (Rash in the injection site, spread to shoulder) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Iitching at injection site), VACCINATION SITE RASH (Rash in the injection site, spread to shoulder) and VACCINATION SITE ERYTHEMA (Redness at injection site). The patient was treated with CORTISONE in March 2021 at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) in March 2021 at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Iitching at injection site), VACCINATION SITE RASH (Rash in the injection site, spread to shoulder) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.            Concomitant product used was not provided by the reporter.  Additional non-medication treatment included ice compress which has given her significant relieve of the itching.
My upper arm near the injection sight felt like it was broken and burning; my palm and wrist was numb and tingling and I could not feel my fingers or pic anything up; my palm and wrist was numb and tingling; I was awoken in the middle of the night by the worst pain I ever experienced; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 07Apr2021 at 12:00 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. The medical history were reported as none. Concomitant medications included cetirizine hydrochloride and ibuprofen, all from unknown dates and for unknown indications. It was unknown whether the patient had any allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021, the patient underwent SARS-CoV-2 (nasal swab) test and the result was negative. On 10Apr2021, the patient was awoken in the middle of the night by the worst pain that the patient had ever experienced and at 06:00, the patient's upper arm near the injection sight felt like it was broken and burning, his palm and wrist was numb and tingling and he could not feel his fingers or pic anything up. It was unknown whether any therapeutics measures were taken as a result of the reported 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 patient awoken by worst pain, upper arm near the injection sight felt like broken and burning, palm and wrist was numb and tingling, couldn't feel finger or pic anything up were unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient felt shaky and faint post vaccine in car ride home. Parent called and stated that in the car ride on way home from receiving the Tdap that patient turned white and started shaking and sweating. Mom reported that once home, he stopped shaking. Patient states he was having trouble seeing in his peripheral vision. Mom declined a recheck appointment. No other complaints. Mom told to return to office is symptoms persisted.
Soreness on upper right arm, most painful on/near injection site. Feels like extremely stiff muscle with slight stiffness down and around injection site muscle.
severe headache nausea tongue tingled, itchy dizzy, disoriented body aches
Loss of smell; Runny nose; Sweating; Throat irritation; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 23Apr2021 09:15 (at the age of 26-year-old) (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. Medical history included asthma, diabetes, hypertension, allergies, anxiety and COVID-19 (prior to vaccination). Concomitant medication(s) included metformin, valsartan, salbutamol sulfate (VENTOLINE), all taken for an unspecified indication, start and stop date were not reported. The patient previously took Neo melubrina and experienced drug allergy. The patient experienced loss of smell, runny nose, sweating, throat irritation on 28Apr2021 07:00. The patient did not receive the treatment for the events. The outcome of events was recovering. The patient was not tested for COVID since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.