chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Broke out into a light pink colored rash on upper torso of body; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 62-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EN6200) via an unspecified route of administration (age at vaccination 62-year) in Left Arm on 18Feb2021 at 03:15 PM as dose 1, single for COVID-19 immunization. Medical history included known allergies to Doxycycline, Aleve, Augmentin, Benadryl cream, Steristrips; break out into rash with above products. Concomitant medications included levothyroxine; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); Bone health supplement; all taken for an unspecified indication, start and stop date were not reported. The patient previously took Doxycycline, Aleve, Augmentin, Benadryl cream experienced allergy. Reported facility type vaccine was Public Health Clinic/Veterans Administration facility. No Covid prior vaccination was reported. The patient not tested Covid post vaccination. The patient received no other vaccine in four weeks. On 18Feb2021 at 09:00 PM the patient experienced broke out into a light pink colored rash on upper torso of body. The patient received no treatment for the adverse event. The clinical outcome of the event was recovered by morning of Saturday, on 20Feb2021.  No follow-up attempts are possible. No further information is expected.
PT GIVEN MMR. THE URINE PREGNANCY TEST AT THE TIME WAS NEGATIVE. ONE WEEK LATER A NEW PREGNANCY TEST WAS POSITIVE. The follow up states: To date there is no adverse (reaction) event but I was told to report this for tracking by the CDC because a live virus was given to a pregnant female.
They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge).; Total duration of the excursion refrigerated temps for max of 4 hrs; They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge).; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge).), PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs) and EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge).) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced PRODUCT STORAGE ERROR (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge).), PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs) and EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge).). At the time of the report, PRODUCT STORAGE ERROR (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge).), PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs) and EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge).) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. The vials were frozen, shipped in refrigerated temperature and then refroze for storage once arrive at facility. No treatment medication details was reported. The vial was moved to fridge on 01-Dec-2021.
Mother reports about 30 minutes status post injection the patient's left upper thigh started swelling and getting warm. Thought it was a mild reaction, was rubbing on it and bathed child. 2 days later leg progressively getting more swollen, was warm to touch the night prior and now the thigh is hard and the patient keeps itching it. Patient will not walk or crawl on leg,so mother brought in child. Tx: Ranitidine BID and Benadryl every 6 hours for itch. Tylenol or Ibuprofen for pain.
"Heavy" fatigue, body aches, chills, and intermittent low-grade fever.
With in an hour extremely itchy red face.  2 days later heart rate was sky high all day.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients was vaccinated with (Oka/Merck) PROQUAD (dose, route and lot# was unspecified) which was improperly stored. No adverse effects were reported. No product quality complaint was involved. No additional information to report. This case is  linked to MARRS#1411USA010981 with the same reporter link. Additional information has been requested.
Chronic Pain, Throbbing, shooting pain, arm numbness, swelling, fatigue , Headache, anxiety, frozen shoulder . Pain started right after shot and and has continued to present.  I have seen a doctor, 2 ortho specialist and a nerve specialist with countless meds and physical with no results. Next week an MRI is scheduled
Severe headache, general malaise, dizziness and severe diarrhea. Symptoms abated by 18.00 and no lingering effects the next morning.
This spontaneous report received from a physician concerned a 45 year old female. The patient's height, and weight were not reported. The patient's past medical history included migraine headache, and cervical cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache. This report was non-serious.
Painful swollen and red arm at injection site 9 hours after shot, headache for 2 days, fevers for 2 days, stiff and sore body
Client stated that she felt no pain at the time of the injection into the left deltoid. The following day she reported some muscular soreness. During that night, about 36 hours after the injection, she awoke with severe pain in left arm which totally interfered with sleep. The pain was radiating down the arm to the hand and she had difficulty raising the arm. That day, 48 hours after injection, she noted slight redness at the site and swelling of the left arm as well as under the arm near the axilla. Three days out she still reported tingling. She treated herself with moist heat and OTC pain reliever. By day 4, she consulted a physician but was having improvement in function and diminishing pain.
12 yo female in ER with sx: shaking, shivering, tachycardia (HR150), vomiting, fever after GARDASIL vaccination.
Patient may have in error received  a dose beyond recommended beyond use date (time) of 6 hours, and received a over diluted old vaccine product that had doses left to be used but not recommended to be used based of manufacturer recommendations.
I have had a cough that started at the beginning of December. I spoke with my doctor after taking general OTC medications and I got ahold of my provider in January to see if she was able to prescribe something stronger. We had a video conference call and the provider thought it may be a sinus infection. She then put me on nasal rinses. About a week ago, my cardiologist advised me that I was wheezing. I contacted my internist and she prescribed albuterol. I have been taking it for about a week. I feel a little better but I am still bringing up mucus and coughing. I did go for a PCR test at local facility which was negative.
Initially:  sore throat, headache, sore arm. Next: Stuffy Nose, only mild fever 99.2, body aches, tiredness - was in bed for a whole day. Followed by:  coughing.
Symptoms: Vasovagal Syncope and possible seizure/ fainting at time of injection. The symptom lasted for about 10 seconds. Patient felt faint and lost of consciousness with sudden muscle movements.  Treatment: No medication treatment. Supportive therapy was given and kept patient hydrated  Outcome: Patient regained consciousness and rest for a span of 20 minutes for observation then was released to guardian.
Patient got an extra dose of Havrix; Patient got an extra dose of Engerix-B and Havrix; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 70-year-old female patient who received HBV (Engerix B) (batch number 7XY23, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis, hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis and hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (completed primary series in 2018) and Havrix (completed primary series in 2018).   On 10th March 2022, the patient received the 4th dose of Engerix B, Engerix B Pre-Filled Syringe Device, the 4th dose of Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Havrix and Havrix Pre-Filled Syringe Device. On 10th March 2022, unknown after receiving Engerix B, Engerix B Pre-Filled Syringe Device, Havrix and Havrix Pre-Filled Syringe Device and not applicable after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Additional details were provided as follows: The case was reported by Registered Nurse. The reporter stated that, she administered an extra dose of Engerix-B and Havrix to a patient, which led to extra dose administered. The reporter consented to follow up via email. Note: 3rd dose of Havrix was also considered as suspect as only 2 doses are considered in the primary schedule (a single dose and a booster dose). This case is linked with US2022045527, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022045527:Same reporter
ER HPI: 70 y.o. male who presents with headache and dizziness starting this morning. Some confusion per wife. No head injury, no illness. IMPRESSION: 1. Acute hemorrhagic infarct in the left occipital lobe with possible  rupture into the left  occipital horn. 2. There may be some extension of nonhemorrhagic ischemia or infarct in  the left thalamus  versus edema in the left thalamus. 2. Mixed density likely acute subdural hematoma laterally over the left  frontotemporal parietal  convexity with 1.1 cm left right midline shift of mass effect on the left  lateral ventricle. 4. Acute subdural hematoma in the posterior falx and in the left tentorium  cerebelli with  minimal extension into the free edge of the right internal surgically. 5. Old infarct with cystic encephalomalacia and gliosis in the right  temporal occipital lobe  with ex vacuo dilatation of posterior right lateral ventricle and right  occipital horn. 6. Old lacunar infarct with cystic change in the right basal  ganglia/capsule. 7. Mild-to-moderate nonspecific chronic deep cerebral white matter  microvascular disease in  bilateral cerebral hemispheres. 8. Atherosclerotic calcifications in the carotid siphons.  DX: Acute hemorragic stroke, transferred to Hospital
Pfizer 2/8/22, 3/3/22. Positive on 5/10/22
The patient had received Covid Janssen vaccine on 3/23/21 at another facility. They presented to pharmacy to request Covid Pfizer vaccine and did not disclose this previous vaccine. They were administered a Covid Pfizer series on 6/28/21 and 7/21/21
As of SEP, more than 2 months p/receiving Engerix-B as the 3rd dose in a series of Recombivax-HB (1st two doses) and Engerix-B, pt had inadequate levels of anitbodies.
Syncopy; Afib attack; Dizziness; palpitations; awaiting diagnosis for Postural Orthostatic Tachycardia Syndrome (POTS); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 (Lot number: 6206) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Former Afib" (unspecified if ongoing); "Sleeve Gastorectomy" (unspecified if ongoing); "Gall bladder removed" (unspecified if ongoing); "Appendix removed" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). There were no concomitant medications (no other medications in two weeks ). Past drug history included: Trazodone, reaction(s): "Allergy"; Abilify, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number:8733, Anatomical Location:Left arm), administration date: 14Mar2021, when the patient was 39 years old, for COVID-19 Immunization. The following information was reported: SYNCOPE (hospitalization, disability, medically significant) with onset 24Apr2021, outcome "not recovered", described as "Syncopy"; ATRIAL FIBRILLATION (hospitalization, disability, medically significant) with onset 24Apr2021, outcome "not recovered", described as "Afib attack"; DIZZINESS (hospitalization, disability) with onset 24Apr2021, outcome "not recovered", described as "Dizziness"; PALPITATIONS (hospitalization, disability) with onset 24Apr2021, outcome "not recovered", described as "palpitations"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (hospitalization, disability) with onset 24Apr2021, outcome "not recovered", described as "awaiting diagnosis for Postural Orthostatic Tachycardia Syndrome (POTS)". The patient was hospitalized for dizziness, palpitations (hospitalization duration: 3 day(s)); the patient was hospitalized for syncope, atrial fibrillation, postural orthostatic tachycardia syndrome (hospitalization duration: 3 day(s)). The events "syncopy", "afib attack", "dizziness", "palpitations" and "awaiting diagnosis for postural orthostatic tachycardia syndrome (pots)" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: angiogram: unknown results; echocardiogram: unknown results; magnetic resonance imaging: unknown results; sars-cov-2 test: negative. There was no covid prior vaccination and covid tested post vaccination. Therapeutic measures were taken as a result of syncope, atrial fibrillation, dizziness, palpitations, postural orthostatic tachycardia syndrome.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a nurse regarding multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On multiple unspecified dates the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose, frequency, route and lot number were not reported) for prophylaxis which was reconstituted with properly stored sterile diluent. No adverse effects were reported. No data logger was involved. No further information provided. This is one of the several reports from the same reporter. Additional information has been requested.
Small amount clear emesis x1 in evening 6-8-15. Small amount clear emesis x1 in AM 6-9-15.
ABOUT 1-2 MINUTES AFTER THE SHOT, PATIENT WAS DISORIENTED, STRETCHED OUT /PASSED OUT FOR A MINUTE,  HAD SHORTNESS OF BREATH AND WAS LATER TRANSPORTED TO THE ER
Tiredness after second vaccine dose; Loss of taste after second vaccine dose; Loss of smell after second vaccine dose; Sinus infection after second vaccine dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of AGEUSIA (Loss of taste after second vaccine dose), ANOSMIA (Loss of smell after second vaccine dose), SINUSITIS (Sinus infection after second vaccine dose) and FATIGUE (Tiredness after second vaccine dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 030M20A) for COVID-19 vaccination.     The patient's past medical history included Sinus infection in March 2021 and Breast cancer.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced FATIGUE (Tiredness after second vaccine dose). In March 2021, the patient experienced AGEUSIA (Loss of taste after second vaccine dose), ANOSMIA (Loss of smell after second vaccine dose) and SINUSITIS (Sinus infection after second vaccine dose). On 12-Mar-2021, FATIGUE (Tiredness after second vaccine dose) had resolved. At the time of the report, AGEUSIA (Loss of taste after second vaccine dose) and ANOSMIA (Loss of smell after second vaccine dose) had not resolved and SINUSITIS (Sinus infection after second vaccine dose) outcome was unknown.            No concomitant medications were mentioned. No treatment drugs were reported. She went to the Doctor, and was told that her symptoms are side effects of the vaccine. Patient has a history of breast cancer and do not use her left arm for vaccination or blood draws.
Patient with mother; presented with 5x4 cm raised reddish rash in left upper arm noted yesterday. Pt had Kinrix injection in left upper arm 2 days ago. Pt denies pain except for mild itchiness. No other symptoms.        Right upper arm site for Proquad injection has no reaction.
Left arm ached on 11/3/2010 afternoon. Right arm started aching 11/4/2010 AM and worsened over the day. Large (6cm X 3cm), painful, red, raised welt appered 11/4/2010 afternoon 11/4/2010 evening (7PM) I started feeling tired and by 9 PM that same day, I had severe chills and whole body ache. My arm continued to be painful. My chills got worse and the aches were worse. I took 600mg Ibuprofen, 1000mg Tylenol and 50 mg Tramadol and in 2-3 hrs I felt better and was sweating. On 11/5/2010, I felt better at 8 am and went to work. My arm still hurt bad and the large welt was still there. By 11 am, the severe chills and body ache and headache returned and I had to call for a ride home. I took the same meds and within 2 hrs, I was sweating a lot but felt better. I take Singulair and Allegra daily and this was in my system at the time of the vaccines and every day after. I feel very weak.
The patient received the vaccine in the office during a mass vaccine clinic. This was the pts 2nd dose of the vaccine. Mins after the pt received the vaccine, the error regarding the pt being 4 years and 11 months old instead of 5 years was realized immediately. The lead physician, spoke with the parent at the clinic about the error and possible side effects etc. The parent voiced their understanding. Mom stated the 1st vaccine was received elsewhere. Mom stated she didn't realize the vaccine was only for children 5 and up. The parent was instructed to call with any concerns or questions after the leaving the office.
Patient received a vaccine on 12-Apr-2022 which had got expired on 07-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine on 12-Apr-2022 which had got expired on 07-Apr-2022) in a 65-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine on 12-Apr-2022 which had got expired on 07-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine on 12-Apr-2022 which had got expired on 07-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that total of 173 doses were administered having Lot number has 070H21A.  No information was reported on date of the storage of vaccine in refrigerator.  Vaccine was expired on 07-APR-2022.  The vial did not undergo any temperature excursions.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non-significant information-Additional Patient identifier were added.
she had vaginal bleed after getting the first dose of the Pfizer-BioNTech COVID-19 vaccine; This is a spontaneous case received from a contactable female consumer (Patient). A 39-year-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8733, expiration date: unknown), via an unspecified route of administration in arm left on 29Mar2021 14:00 (age at vaccination 39-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included thyroid and celiac. Concomitant medication included Synthroid 50 mcg, once a day by mouth. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. Additional administered vaccines and prior vaccinations (within 4 weeks) was reported as none. Family medical history relevant to adverse events was reported as none. On an unspecified date in Mar2021, the patient had vaginal bleed after getting the first dose of the Pfizer-BioNTech COVID-19 vaccine. The patient did not undergo any relevant tests. Adverse event required a Physician office visit. the outcome of the event was not recovered.  No follow-up attempts were needed. No further information was expected.
Severe arm pain and bruising at time of vaccine.  Contracted COVID 9/10/2021.  Covid symptoms moderate, requiring chest X-rays and prescription of antibodies.  Infusion center unable to accommodate.
Information has been received from a consumer concerning her cousin's currently 9.5 year old male child with no known allergies or medical history who at age 2, in approximately August 1995, was vaccinated with a dose of MMR (second generation) (lot # not reported). There were no concomitant medications. Subsequently, the child developed autism. Unspecified medical attention was sought. Upon internal review, autism was determined to be an other important medical event. The consumer also reported that the cousin's other child, who is currently 12 years old, received a dose of MMR (second generation)(lot # not reported) at age 2 and now also has autism (WAES0302USA00343). Additional information has been requested.
Significant lower extremity weakness began 2 weeks after the vaccination, with difficulty standing and  walking in both legs followed by a fall. He subsequently developed dizziness, loss of appetite and has been mostly bed-bound since then. Now about 4 months later, patient has significantly reduced strength in his legs especially the right and is very limited in movement