chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Late May 2021: I started experiencing difficulty breathing and coughing unrelated to a cold or allergies; My doctor treated me with prednisone and a steroid inhaler with no change. I was sent to a pulmonologist and a rheumatologist. I had breathing tests, blood tests, and sleep tests performed with no answers. Early June 2021: My heart rate became uncontrollable and breathing became extremely difficult. I was admitted to local Emergency room and released with no answers, though they guessed the coughing might be reflux (it was not and I do not have it, nor have I ever had reflux) and my heart issues were to be followed up with a cardiologist. I was tested for Covid-19 and it was negative. June 2021: I followed up with my primary care doctor and cardiologist and it was noted that my blood pressure was unusually high. After monitoring my blood pressure for many months I would eventually be diagnosed with high blood pressure. The meds I am given have been unable to control the blood pressure on a consistent basis. In addition to the blood pressure issues, I was and still am unable to control my heart rate when exercising, and I am of an athletic background. My resting heart rate has also increased significantly and I experience chest pain and loss of feeling in my left arm when running. In Jan 2022: I was admitted to the ER and then to the hospital for a possible stroke. It has been ruled that I now have complex migraines that cause them daily in me. Stroke like symptoms daily. Shortly thereafter I started having irregular periods (missing them). As of February 2022 I have bled daily and was diagnosed with adenomyosis. I am on medication to stop the bleeding (though it doesn't work well) until my scheduled hysterectomy in June this year. Oh and they also found a tumor that is growing on my liver.
Pt began to feel dizzy approx 5 min after administration of covid vaccine.  Her legs were put up onto a chair and VS were taken.  Upon my arrival, we laid patient down on a gurney.  Pt had good color.  Accucheck was 113mg.dl.  Pt was given crackers and juice.  Pt started to feel better after approx 20 min.  Pt was able to stand up and walk without dizziness.  Pt left in stable condition with parents.
Patient was very happy because he took the first two shots of Moderna Covid-19 vaccine and noticed that his knees feel much better after receiving his first two doses of Moderna Covid-19 vaccine; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Patient was very happy because he took the first two shots of Moderna Covid-19 vaccine and noticed that his knees feel much better after receiving his first two doses of Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an 80-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Knee pain (Patient had problems with knees starting 15 years ago.).   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Patient was very happy because he took the first two shots of Moderna Covid-19 vaccine and noticed that his knees feel much better after receiving his first two doses of Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Patient was very happy because he took the first two shots of Moderna Covid-19 vaccine and noticed that his knees feel much better after receiving his first two doses of Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for THERAPEUTIC RESPONSE UNEXPECTED (Patient was very happy because he took the first two shots of Moderna Covid-19 vaccine and noticed that his knees feel much better after receiving his first two doses of Moderna Covid-19 vaccine).    No concomitant medications were reported. Patient took the first two Moderna Covid-19 vaccine in the Primary Series and since then patient knees felt great. Patient was happy and patient had seen several Doctors over the 15 years and they recommended one of 3 treatments either get new knee replacements, receive an injection every 6 months, or take pain killers. The patient did not take any of these options over the years. The patient was very happy because he took the first two shots of the Moderna Covid-19 vaccine and noticed that  knees feel much better after receiving his first two doses of the Moderna Covid-19 vaccine. No treatment information was provided.
1st dose in 2018, 2nd on 10Aug2022; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   On 10-AUG-2022, the patient received the 2nd dose of Shingrix. On 10-AUG-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose in 2018, 2nd on 10Aug2022). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 13-MAR-2023 Reporter's Comments:  Pharmacist reported that a immunocompetent patient over 50 year old received Shingrix. HCP declined to have an account on medical information database.  Consented to follow up by email.
GAURDIAN CALLED CLINIC AT 9AM ON 10/22/20 REPORTING THAT THE PRIOR EVENING THE CHILDS ARM HAD BECOME RED, SWOLLEN, AND ITCHY. ASKED GAURDIAN TO BRING CHILD TO CLINIC SO WE CAN ASSESS THE CHILD. THE LATERAL SIDE OF CHILDS ARM WAS RED AND SWOLLEN. HE STATES IT HAS BEEN ITCHING. NO SOB OR RESPIRATORY ISSUES PRESENT. ENCOURAGED GAURDIAN TO GIVE CHILD CHILDRENS BENADRYL AND REPORT TO PCP OR ER IF WORSENS OR CHANGES. GUARDIAN VERBALIZES UNDERSTANDING. EACH CHILD WAS REQUIRED TO HAVE PARENT FILL OUT FLU FORMS PRIOR TO SCHOOL FLU DAY. GAURDIAN HAD MARKED NO ON PRIOR REACTIONS TO FLU SHOT.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEXAPRO; BUSPIRONE; WELLBUTRIN. Past drug history included: Amoxicillin, reaction(s): "Known allergy: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Follow-up attempts are completed. No further information is expected.
After receiving the moderna vaccine, the patient started feeling slight dizziness, high blood pressure and tachycardia. Patient was seen by rescue team, vitals did not change, BP kept rising, patient opted for transport at 17:22.
This spontaneous prospective pregnancy report was received from a pharmacist referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient received a dose of M-M-R II (route, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patient became pregnant less than 30 days after receiving the vaccine (maternal exposure before pregnancy). The patient's last menstrual period, estimated date of conception and estimated date of delivery were not reported. The patient visited the physician's office on an unspecified date. At the time of the report, the pregnancy outcome was pending. Additional information has been requested.
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA304934 same reporter. This case involves a 14 years old patient who received vaccine FLUBLOK QIV lot QSAA1803, expiry date: 31-May-2019 via intramuscular route in the left arm on 14-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to Inappropriate age at vaccine administration. It was reported that the patient under the age of 18 received the FLUBLOK QUADRIVALENT vaccine. It was unknown if any adverse event was occurred. 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 and Module VI of the 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. Documents held by sender: none.
bad migraine; dizziness; Vaccination site red; painful to touch; swollen site - nickel; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (bad migraine), DIZZINESS (dizziness), VACCINATION SITE ERYTHEMA (Vaccination site red), VACCINATION SITE PAIN (painful to touch) and VACCINATION SITE SWELLING (swollen site - nickel) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Cinnamon, Aspirin, Penicillin, Morphine).    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Sep-2021, the patient experienced MIGRAINE (bad migraine), DIZZINESS (dizziness), VACCINATION SITE ERYTHEMA (Vaccination site red), VACCINATION SITE PAIN (painful to touch) and VACCINATION SITE SWELLING (swollen site - nickel). At the time of the report, MIGRAINE (bad migraine), DIZZINESS (dizziness), VACCINATION SITE ERYTHEMA (Vaccination site red), VACCINATION SITE PAIN (painful to touch) and VACCINATION SITE SWELLING (swollen site - nickel) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No information on concomitant medication were reported.
Sitting in waiting area after administration of Hepatitis A vaccine.  Vasovagal syncopal episode with tonic/clonic movement x 10 seconds at approx. 3-5 minutes post vaccination.  Lowered to floor with feet elevated, cool compress applied to back of neck.  Gained responsiveness at approx 20 - 30 seconds.  BP 110/70 96-24.  Juice and crackers given.  Unable to sit without feeling nauseated and dizzy.  This continued for approx 1 hour 30 min.  BP HR and Resp stable throughout.  Recommended evaluation by MD.  Transported to ED by his Mother.  Follow up call the next day.  He was observed in ED x 2 hours.  No treatment.
Ten days after the shot I had intense stomach, groin, neck, and low back pain and I started the most painful period of my lifetime after being in menopause for one year. I bled profusely for six days. Still having random debilitating pain.
Changes in menstrual cycle. PMS such as breast soreness lasts for 2 weeks and becomes so swollen and bruised: so painful that  difficulty breathing occurred around 10PM (SpO2 93%) a few days before day 1 of Period. It happened every month since i got vaccinated. My menstrual cycle is all messed up. I have more cramping, sit bones wider, puffiness? it all goes away When my period starts. But it comes back on Day 14 when ovulation occurs.
Patient called on 4/11/22 at 9:16 a.m. to report her having a reaction that started yesterday. Pt states she woke up around 8:30 a.m. on 4/10/22 and felt fine and went back to sleep then states she woke up at 11:32 a.m. and could not move. Pt states it was like she was paralyzed. She said she couldn't move her body and couldn't swallow. Then she said when she could sit up in bed her body was shaking all over. Pt states she wasn't having a seizure but her entire body was shaking like that. Pt states this lasted for about 1-1.5 hours then went away. Pt states when she woke up today 4/11/22, she felt sore and her right arm was sore and had a lump at the injection site, and her hands were shaking like the day before. Told pt to go to Urgent Care or ER and contact her primary care provider. Pt states she goes to Health Center. Pt states she called them and they couldn't see her and told her to call the health department. Told pt she needed to be seen by a nurse practitioner or physician. Pt states if she got worse she would go to the ER.
2nd Moderna dose of primary series given 22 days after 1st dose.  Patient notified of invalid dose given on same day
She could taste the vaccine; Tongue got fat; Dry mouth; metallic taste; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (She could taste the vaccine), SWOLLEN TONGUE (Tongue got fat), DRY MOUTH (Dry mouth) and DYSGEUSIA (metallic taste) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included METHOTREXATE, FOLIC ACID, VIT D [VITAMIN D NOS] and TRASTUZUMAB for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced DYSGEUSIA (metallic taste). On 19-Mar-2021, the patient experienced DRY MOUTH (Dry mouth). On an unknown date, the patient experienced TASTE DISORDER (She could taste the vaccine) and SWOLLEN TONGUE (Tongue got fat). At the time of the report, TASTE DISORDER (She could taste the vaccine), SWOLLEN TONGUE (Tongue got fat), DRY MOUTH (Dry mouth) and DYSGEUSIA (metallic taste) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: Follow up received on 22-Mar-2021. New AE and Concomitants were updated.
This pt received first dose of vax and subsequently developed a small rash. Sought medical attention.
A nurse gave a 16 year old a Vaxelis vaccine.; This non-serious spontaneous safety report was received by a partner on 15-SEP-2021 and forwarded to the agency on 16-SEP-2021 from a nurse The causal relationship between Vaxelis and the reported event: A nurse gave a 16 year old a Vaxelis vaccine was assessed as not applicable due to the nature of the event.  Further information is expected.
I had body aches and I stayed in bed and I had a headache - that lasted for about 24 hours. No treatment
This non serious case was received on 29 April 2009 from a health care professional.  A 50 year old male patient with an allergy to bee stings received JE Vax (lot number EJN234A) subcutaneously in the left arm on 28 April 2009 at 2:30 PM. On 24 April 2009 the patient received Hepatitis B (manufacturer not reported, lot number AHBVB663AA) and TYPHIM Vi (lot number B0706-2). A few hours post vaccination, the patient began having very itchy eyes without swelling, hives, or a rash. The following morning his symptoms were improving. The patient was not recovered at the time of the event. Follow-up information was received from the health care professional on 01 May 2009. The patient had been called in follow-up by the health care professional, and reported localized redness at the injection site which was warm to the touch. The size of the are was reported as "a quarter to sliver dollar". Follow-up information was received on 07 May 2009 which provided the case identification numbers as F0824. No relevant medical information was added.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperature and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 07-MAY-2013 (lot number: H011350; exp date: 21-FEB-2015) (dose, frequency, route and site of administration were not reported).. No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Tinnitus developed in right ear. Hearing loss developed in both ears. Went to Dr.'s office. Left ear was cleared of was and hearing improved. Right ear was cleared of puss like fluid and Dr advised I had a perforated ear drum with over 1/2 of the ear drum missing. As of May 2022 hearing in right ear is nearly 100% gone. Expect follow up with specialist in May 2022 with the potential requirement of tympanoplasty required to repair as it does not appear the ear drum is growing shut on it's own. Tinnitus continues 24 / 7.
Narrative:  COVID infection following COVID vaccine series 03/27, Pfizer, dose #1 04/16, Pfizer, dose #2 12/21 CXR impression: Mild bibasilar densities probably atelectasis. No definite pneumonia or pulmonary edema. Viral pneumonia may not be detected by chest radiograph. 12/21 SARS-COV-2 Variant Sequencing: pending 12/21 COVID swab, result: detected 12/29 COVID swab, result: detected 11/27 pt cc: flu-like symptoms, chest wall pain, nausea, headache, fever, chills, myalgias, cough, weakness exposure: unknown 11/30 pt admit to ED dx: COVID PNA LOS: 1
I became light-headed; breathing was off.; This is a spontaneous report from a contactable consumer (Patient). A 53-years-old Non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 12Feb2021 14:00 (at the age of 53-years-old) in Arm Right, as dose 1, single for COVID-19 immunization. The patient Medical history included breast cancer from an unknown date and unknown if ongoing Breast cancer 19 years ago, sepsis from 2020 to an unknown date Sepsis from surgery in 2020, surgery from 2020 to an unknown date Sepsis from surgery in 2020. Concomitant medications included, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), vitamin d3 (VITAMIN D3), probiotics (PROBIOTICS), multi-vitamin and Fish all taken for an unspecified indication, start and stop date was not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccinations within four weeks. The patient was not diagnosed with COVID-19 prior to vaccination and post vaccination patient was not tested for COVID-19 and patient had no known allergies. On 12Feb2021 14:15, within seconds of receiving the vaccine the patient experienced she became light-headed, breathing was off. These symptoms dissipated within 2-3 minutes. Patient concerned about taking the 2nd vaccine. The patient did not received treatment for the adverse events. The outcome for the events was recovered in Feb2021.  Follow-up attempts completed. No further information expected.
CovId Vaccine Breakthrough Case  Moderna Dose 1 2/19/21 (031L20A) Moderna Dose 2 3/19/21 (013A21A) COVID Positive 12/19/21  12/19/21: History is mostly obtained by personal review of records. He is 80-year-old gentleman with known history of congestive heart failure, ejection fraction 25-30%, chronic kidney disease, insulin-dependent diabetes mellitus, pulmonary embolism and other medical problems.  Was having cough, subjective fever and generalized weakness for 10 days.  He tested positive for  SARS-CoV-2. Complaints of severe generalized weakness.  Having good pulse ox on 2 L oxygen.  Denied chest pain.  12/24/21: The patient is 80-year-old male with  history of 25-30%, CKD, insulin-dependent diabetes, SVT amiodarone, pulmonary embolism, AICD placement and other medical problems. Patient presents to the ER on 12/19/2021 with complaints of generalized weakness and fall. Patient tested himself with over-the-counter COVID-19 and reportedly was positive. Patient fell at home and was found on the ground. He denied losing consciousness and head trauma. Patient was noted at that time with low oxygen saturation 91% room air therefore EMT place him supplemental oxygen. He was then taken to the ER for further evaluation. Upon arrival to the ER patient was back to his baseline mentation. Patient was admitted into the medical unit and treated with bilateral COVID 19 pneumonia, and acute systolic CHF.  Patient was treated with remdesivir, dexamethasone, and IV antibiotic. His symptoms improved and patient was able to work with physical therapy who recommended skilled nursing. Patient received insurance approval and will be transferred to Allure.  Patient's wife who is his primary caretaker was informed about the plan.  Patient is being discharged in improved and stable condition. All questions were answered and patient to transfer through EMS.
Minor arm soreness a couple hours after shot.  All felt good until around 9PM that evening.  Suddenly got chills, felt flush, achy, headache at lower back of head and around ears, tired.  Needed hot shower to warm up.  Went to bed.  Very stiff, flu-like all night with muscle pains.  NO nausea.  Injection site more sore.  Second day no chills, most muscle pain  gone by mid-morning but dull headache all day and injection site was very sore, red swollen. Third day headache gone but injection site still red, swollen and painful. Fourth day injection site not swollen and only a bit tender.   Feel fine now.    Just wanted to mention that I did receive a flu vaccine shot (don't know kind) on Sept.21,2020
Within 10 hours of shot fever,paleness, weakness, dizziness,tight chest, hard to breath.Patient remains sick still after 6 days with contiued fever, dizziness, cough, weakness,vomiting. Treating with tylenol and ibuprofen. Doctor's notified and seen several times.
Rash  began 3/24 on left arm, on4/3 went to an urgent care for discomfort,4/8 went to dr.  rash was getting worse on all of left arm,on 4/12 rash had begun to spread to other parts of my body
Patient claimed she is under chemo therapy and looking to get a booster Moderna shot, She got 0.5ml Moderna Covid vaccine instead of 0.25ml.   Because patient primary Covid vaccine was Janssen she should get 0.25ml Moderna  vaccine. Patient is fine, she has no side effects and no symptoms.
rash on face and body that began the day after the 2nd shot.  Treated with hydrocortisone and Sudafed.  Pediatrician then ordered rx cream and 5 mg of Zyrtec 2 x's  a day
Administering 2nd Moderna vaccination to patient using a DropSafe 3 ml syringe (25G x 1"). Needle attachment came off in clients arm without full dose being administered.
This spontaneous report as received from a consumer refers to a 10 week old female patient. On 24-JUL-2017 the patient was vaccinated with ROTATEQ dose 1, oral for prophylaxis. On 31-JUL-2017, the patient experienced infrequent bowel movements. The outcome of infrequent bowel movements was reported as not recovered/not resolved. Additional information has been requested.
Patient received a high dose flu vaccine instead of the regular dose.  Patient was notified of medication error.
Two hours after the vaccination, the pt developed chills, 8-12hrs later she developed abdomin cramping which lasted until 03/15/2002. Had similar reaction to the first dose. Symptoms improved by 03/15/2002.