chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My lips started burning and itching. They then became swollen and painful. The tonsils on the back of my tongue hurts. On Sunday (9/14), my outer and inner lips had purple and red blisters. Today, 9/15, the skin is peeling off my lips. My inner checks and tongue hurt and feel a little swollen. My lips hurt very bad.
I developed an allergy (nasal + chest cavity) about one week after my fever-chills response to the vaccine. I guess that makes sense with my immune system having increased activity with administration of the vaccine, but I've never had seasonal allergies (perhaps response to both pollen and dust particulates) but now I'm sneezing (and coughing sometimes) at least 7times a day for about 5 days now. I have yet to take the second dose, but I'm really hoping this is temporary and that I don't further develop more allergies (e.g. to nutritional components and more).
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: When patient went to stand up she fell and had the paramedics called. She bruised the side that she fell on.
8/21/21 10:30 pm - 8/22/21 8:00 am :  Symptoms began at 10:30 pm, with felling cold and tired.  By 11:30 pm I was experiencing fever, body aches, and severe shivering., frequent urination and back pain.  400 mg Tylenol was taken at 11:30 pm.  Symptoms continued throughout the night.  200 mg Tylenol taken at 3:00 am, and 200 mg Tylenol at 6:30 am.   8/22/21 8:00 am -  7:00 pm : I experienced Headache and ongoing body aches and soreness.  Tired, lethargic and no appetite for the duration of the day.  Possible low grade fever in the morning.  No additional Tylenol was taken.   Medical treatment was not sought.
Posterior vitreous detachment; This is a spontaneous report from a non-contactable consumer (patient). A 49-year-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), dose 1 via an unspecified route of administration, administered in right arm on 27Apr2021 09:45 (Lot Number: ER2613) as single for COVID-19 immunization. The patient has no medical history. The patient's concomitant medications were not reported. The patient experienced posterior vitreous detachment on 30Apr2021 09:45 with outcome of not recovered. Event reported as non-serious. Therapeutic measures were taken as a result of event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The event resulted in a doctor or other healthcare professional office/clinic visit. The patient had doctor visit with many exams (unknown results). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
POTENTIAL TEMPERATURE EXCURSION VIALS USED TO VACCINATE PATIENTS; MEDICATION ERROR; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. 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 potential temperature excursion vials used to vaccinate subjects, and medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the potential temperature excursion vials used to vaccinate patients and medication error was not reported. This report was non-serious.
Severe itch/itchy; Little bumps; Heat; Red dots on my back; Hives; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Severe itch/itchy), SWELLING (Little bumps), TEMPERATURE INTOLERANCE (Heat), ERYTHEMA (Red dots on my back) and URTICARIA (Hives) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure management.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced PRURITUS (Severe itch/itchy), SWELLING (Little bumps), TEMPERATURE INTOLERANCE (Heat), ERYTHEMA (Red dots on my back) and URTICARIA (Hives). The patient was treated with CETIRIZINE HYDROCHLORIDE (CETRIZINE) for Adverse event, at a dose of 5 milligram. At the time of the report, PRURITUS (Severe itch/itchy), SWELLING (Little bumps), TEMPERATURE INTOLERANCE (Heat) and ERYTHEMA (Red dots on my back) outcome was unknown and URTICARIA (Hives) had resolved.            Concomitant drug included Low dose of blood pressure pill. Treatment medication included ice pack, 2 creams and 2 pills for allergy and the itch. It was reported as patient had no allergies.
Patient was given HPV on 8/12/19, Mom stated 5 minutes after bandaid was placed on arm the the area  around where injection was given was red and itchy. Dr aware and spoke with Mom ice pack applied to site. Mom called when she got home stating arm still itching, she will continue with ice and update the next day. Mom called on 8/13/19 and states that the itching resolved. Mom called back on 8/28/19 stating that patient is complaining that the are where injection was given is sore and there is a mosquito size "lump". Mom advised Dr said that it should resolve and patient should not ever receive another HPV.
This spontaneous report was received from a registered nurse referring to several patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were inadvertently vaccinated with an improperly stored doses of ROTATEQ orally, for prophylaxis (dose and frequency were not provided) (lot number: N030152, expiration date: 01-SEP-2019). The administered doses of the vaccine experienced a temperature of 9 degrees Celsius (°C) to 25 degrees Celsius (°C) during a time frame of 13 hours and 36 minutes, as recorded by a data logger. There was no adverse effect reported and no product quality complaint was involved. Follow up information was received from the registered nurse on 05-NOV-2018, referring to a male patient of 6 months old. On 20-AUG-2018, the patient was inadvertently vaccinated with an improperly stored dose of ROTATEQ. This case was previously considered Non-valid, but upon follow up it was determined to be valid.
extra (3rd) dose of Shingrix administered to patient - no adverse effects reported at this time
Headache, UrticariaPruritus, Palpitations, Lumbar /cervical pain, chills, fatigue, and injection site pruritis Narrative:  denies any injection site soreness. employee with c/o worsening symptoms. pt seen in ED; treated with Rivaroxaban @ bedside in ED. Patient educated on use of above and its interactions with other meds. pt expressed to ED RN/MD of NSAID use.  Other Relevant History:
This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. It was reported that in approximately in 2013, multiple unspecified patients received doses of improperly stored ROTATEQ oral (dose and lot number not reported). The reporter stated that the temperature excursion for the vaccines above occurred on an unspecified date in 2013. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
8 hours after injection started having severe lower back and leg pain. Then came the horrible headache causing nausea and dizziness which ultimately resulted in causing me to pass out while attempting to get to the couch. Once I came to the body trembles  started accompanied by being freezing cold. The headache and diarrhea lasted into the next day with symptoms not lessening until day 3. Still have to take Tylenol every 4 hours to keep headache manageable.  I did not seek medical treatment but would strongly warn those getting this shot of the possible  loss of consciousness. It came on very fast, 8 hours after the injection,  and could be deadly if someone was driving or not near soft surroundings.
Pt sent to ER via EMS for AMS and hypotension, cool to touch.
-Dizziness and fainting onto the floor -Headache  -Chest and stomach hurting  -Feeling of pins and needles on his lower legs -Sore throat -Vomiting
Pt. states that after receiving the 2nd dose of Moderna 02/26/2021, started experiencing symptoms 04/27/2021of drainage from the (right/possibly both) eye, drooping of the left side of the mouth. 04/27/2021 (Traveling Blurry Vision) Changes in Vision with Dizziness, Emergency Room visit; Blood Work ran (Normal), Suspected Bell's Palsy. Doctor prescribed Acyclovir antibiotics. Recommendation for Follow-Up with Primary, estimated 05/2021. Primary recommended just Observation and follow-up if persist. Symptoms lasting estimated 10 days and subsided.
Pt started having diarrhea, abdominal pain, nausea & lack of appetite 22 hrs after the shot.
Seven year old client inadvertently was given the wrong COVID-19 vaccine. They received a Moderna Booster, rather then a Pediatric Pfizer. Client did not exhibit any symptoms or signs that prompted medical attention or treatment while they were at our clinic.
Patient came in to get a routine flu shot, and was instead given a third dose of Pfizer's COVID-19 vaccine. Patient did not have any adverse reaction, however we're filling this form out in an abundance of caution.
Physician is fully vaccinated with Pfizer vaccine/ but both physician and mother contracted COVID-19.; Physician is fully vaccinated with Pfizer vaccine/ but both physician and mother contracted COVID-19.; This is a spontaneous report from a contactable Physician reported for a patient (wife's mother). A adult female patient of unspecified age received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date in 2021 as dose 1, single and second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date in 2021 as dose 2, single both the doses for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient had been tested for covid-19. No covid prior vaccination was reported. On an unspecified date of 2021 the reporter reported that he is fully vaccinated with Pfizer vaccine. His wife was pregnant and not vaccinated, contracted Covid-19. Her mother was also fully vaccinated, but both physician and mother contracted COVID-19. He stated that no one needed to be hospitalized, but he was very apprehensive on the efficacy of vaccines against the variant and is a bit worried they were letting their guard down too fast with re-opening and removing mask mandates. He believes the efficacy of Pfizer vaccine is in 50 percent for variant based on information he is seeing. The patient underwent lab tests and procedures that included covid-19 test: NA on an unspecified date. It was unknown if the treatment was received. The patient recovered from the event on an unspecified date in 2021.  Information on the lot/batch number has been requested.
Vaccine 04/05/21 noon time Woke on 04/17/21 with soreness in Right distal upper arm. Soreness got worse over 2 days. Was seen in Urgent Care 04/19/21. US upper extremity shows right superficial venous thrombosis of right basilic vein with near occlusion
Patient fainted after shot administered, 911 was called. patient has history of fainting after shots.
throat feels like its tightening up breathing feels forced/ Anaphylactic shot the next day/ Throat closing up and went to the ER; throat feels like its tightening/ Throat closing up; breathing feels forced; acid refluxes or an erosion and threw up; acid refluxes or an erosion and threw up; acid refluxes or an erosion and threw up; Could not sleep; fever; chills; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 04Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose Feb 4th, the patient got fever and chills. Lasted four hours and took acetaminophen (TYLENOL). The next day acid refluxes or an erosion and threw up. Could not sleep for a few days, throat feels like its tightening up breathing feels forced. Anaphylactic shot the next day. Throat closing up and went to the ER wanted to know if she should receive the second dose. Outcome of the events fever and chills was recovered on an unspecified date while outcome of the other events was unknown.   Information on the lot/batch number has been requested.
severe pain started on 6/24/21 and she went to the emergency room on 6/26/21 and they ran a CAT scan and it was determined it was her appendix, on 6/26/2021 they transported her to the hospital because they couldn't get to her appendix, at the hospital she was on heavy doses of antibotics, after a few days they did another CAT SCAN and it now was worse, the doctor was unable to get to her appendix because it was surrounded like a wall.. on 7/1/21 she came home and stayed on antibiotics, on 7/14/21 she is at the hospital and her appendix was removed and 6 inches of her intestine was removed after that she stayed in the hospital 6 more days.
Fever, chills, body ache.  *Most important- I regained my taste and smell.  I lost my taste and smell 16 years ago after a head injury and was told that if it didn't recover after a few years, I would never get it back.  Imagine my delight when those senses returned after the vaccine.
3:45 pm moderna vaccine given via IM 4:00 pm pt reports both hands tingling sensation.  4:04: V/s Bp=120/70, P67, o2 sat=96% , R18.  4:15pm both hands tingling sensation almost resolved.  pt was discharge.  Advised pt to go to E.R if symptoms continues.  And follow up with pcp asap.
by 6PM pt pale, listless, c/o h/a & pain in legs; asked to go to bed; between 730PM & 4AM awoke @ least q hr screaming in pain, fr legs & head & panicky because felt that couldn't breathe right & skin growing in throat; eat poorly, fever
FATIGUE; NERVE PAIN AROUND MY WAIST LINE ON THE RIGHT SIDE; FULL BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: blood pressure, and thyroid, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 10-AUG-2021 for prophylactic vaccination. Concomitant medications included lisinopril for blood pressure, and thiamazole for thyroid. On 11-AUG-2021, the patient experienced nerve pain around my waist line on the right side. On 11-AUG-2021, the patient experienced full body aches. On 11-AUG-2021, the patient experienced chills. On 12-AUG-2021, the patient experienced fatigue. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from full body aches, chills, and fatigue, and had not recovered from nerve pain around my waist line on the right side. This report was non-serious.
No Adverse event; 65 patients received expired vaccine beyond MFG expiration date and beyond 30 day expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (65 patients received expired vaccine beyond MFG expiration date and beyond 30 day expiration date) and NO ADVERSE EVENT (No Adverse event) in an elderly female patient who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .25 milliliter. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (65 patients received expired vaccine beyond MFG expiration date and beyond 30 day expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (65 patients received expired vaccine beyond MFG expiration date and beyond 30 day expiration date) 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 EXPIRED PRODUCT ADMINISTERED (65 patients received expired vaccine beyond MFG expiration date and beyond 30 day expiration date).    No concomitant medication reported.  It was reported that 65 doses/10 vials were administered after the 30 days use by date.  1 vial was initially stored in refrigerator on 7-Jun-2022 and for others no details were provided. It was unknown if the product had undergone any temperature excursion issue.  Date of administration of the product was Apr2022 and the vial was taken out at that time only. Different dates of administration were involved, however the reporter didn't had the details.  It was reported that the dates of administration of the vaccines were 1-Apr-2022, 5-Apr-2022, 6-Apr-2022,8-Apr-2022, 11-Apr-2022, 12-Apr-2022, 13-Apr-2022, 14-Apr-2022, 22-Apr-2022, 9-Jun-2022, 10-Jun-2022,13-Jun-2022, 18-Jun-2022 and 22-Jun-2022. No treatment medication details reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-616820, US-MODERNATX, INC.-MOD-2022-616822, US-MODERNATX, INC.-MOD-2022-616809, US-MODERNATX, INC.-MOD-2022-616826, US-MODERNATX, INC.-MOD-2022-616839, US-MODERNATX, INC.-MOD-2022-616874 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Aug-2022: Significant follow up received Patient identifier has been updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-616820:Master case US-MODERNATX, INC.-MOD-2022-616822:Master case US-MODERNATX, INC.-MOD-2022-616826: US-MODERNATX, INC.-MOD-2022-616809:Master case US-MODERNATX, INC.-MOD-2022-616839:Master case US-MODERNATX, INC.-MOD-2022-616874:Master case
2 days after immunization of VARIVAX and MMR 8/30-9/2 or 9/3 rocking and bobbing of head back and forth. Eye deviation to (R) and (C), trouble conducting fine motor (i.e. fork to mouth), ataxia.
15 patients vaccinated after day 30 in the refrigerator; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (15 patients vaccinated after day 30 in the refrigerator) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (15 patients vaccinated after day 30 in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (15 patients vaccinated after day 30 in the refrigerator) 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.
I had a routine colonoscopy on 12/7/2022. They found a polyp. I needed to have it removed. I had surgery on 12/28/2022, it was a Colectomy Partial Anastomosis. I feel great now, I needed no radiation or chemo.
Patient is a 79 y.o. male patient of MD with history of CLL, Colon cancer, C-dif, GERD, HLD  presented to Hospital with shortness of breath .   Acute hypoxic respiratory failure  Suspecting secondary to COVID-19 viral pneumonia  CXR shows faint patchy opacities in left mid to lower lung zone which may correspond to some subtle atelectasis or pneumonitis.  Started on Rocephin and Azithromycin for possible pneumonia however symptoms more consistent with viral etiology than bacterial especially given negative pro-cal. Urinary Ags and sputum culture negative D-dimer elevated. CTPA negative for PE but did show pulmonary HTN, patchy ground-glass infiltrates bilaterally with tiny bilateral pleural effusions.  Wean O2 requirements able Home O2 eval done today- qualified for 2L Management of COVID-19 listed below   Covid-19 viral pneumonia Date of onset of symptoms: 12/12/22 Symptoms present on admission: productive cough, chills, altered mental status Date of covid positive test: 12/12/22 - at home, repeat test positive Vaccination status: vaccinated Imaging: 7 faint patchy opacities in the left mid to lower lobes with some subtle atelectasis or pneumonitis Oxygen requirements on admission: 3L NC -> 4L Current oxygen requirements: 2L NC Medical therapy: Steroids x10 days. Out of time frame for Remdesivir Consultants following: None at this time Anticipated special isolation end date: TBD  Albuterol, steroids x5 days, and Tessalon Perles at discharge   Acute encephalopathy Suspecting secondary to hypoxia, underlying infection, and possible CVA TSH, B12, Folate all wnl Attempt to regulate sleep/wake cycle Resolved   Abnormal CT CT head shows low density areas in basal ganglia compatible with lacunar infarcts and/or dilated perivascular space. Low attenuation in left external capsule/subcortical insular white matter compatible with age indeterminate ischemic changes MRI brain showed chronic microvascular angiopathic changes Neuro consulted. Recommended starting ASA Neuro checks Q4H PT/OT/ST- HHC at discharge  History of CLL Patient is on Calquence BID which is non-formulary Continue Valcyclovir therapy Oncology consulted. Continue to hold Calquence/Acalabrutinib while admitted. Immunoglobulin levels shows decreased IgM of 33. Discussed with Dr. on day of discharge- does not need IVIG. Follow up with outpatient Oncologist when to resume Calquence/Acalabrutinib.   Hyperkalemia K 5.9 Hyperglycemia protocol with Ca-gluconate, Albuterol, and Lokelma Monitor   Hypernatremia Na 147 Resolved   DM, new onset Glucose also elevated due to steroids HbA1c 6.8 Recommend lifestyle changes Defer to PCP for further management   Hx of HLD Cholesterol panel: Cholesterol 194, TG 260, HDL 26, LDL 116 Recommend lifestyle changes Follow up with PCP for consideration for statin   Microcytic anemia Hb 12 with MV 96.5 No signs of bleeding Iron studies + ferritin pending- defer to PCP for follow up   Severe malnutrition POA Nutrition consulted   GERD  Continue Maalox PRN
It triggered an asthma episode that I couldn't control at home and had to go to the emergency room.
Pt became light-headed with blurred vision while walking to her car. Pt stated has history of syncope post injection or blood draw. Pt vitals were evaluated. Pt declined transport to ED.
PT REPORTS DURING HOSPITAL STAY THAT AS SOON AS SHE RECEIVED HER COVID VACCINE SHE FELT SICK, WAS DIAGNOSED WITH BREAST CANCER ONE MONTH LATER. PT STATED SHE HAD NO OTHER MEDICAL HISTORY OTHER THAN GETTING FLU OR COLD ONCE IN A WHILE