chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nauseous and throwing up; Nauseous and throwing up; Fever; Legs and arms hurt so badly couldn't lay down; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 16Sep2021 at 12:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Sep2021 at 02:00, the patient woke up nauseous and throwing up. The patient had a fever and her legs and arms hurt so badly that she couldn't lay down. The patient felt like this for 5 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events nauseous and throwing up, fever and legs and arms hurt so badly couldn't lay down was resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
RECEIVED LESS THAN 0.5 ML (APPROXIMATELY AROUND 0.3 ML) OF THE INITIAL DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 21 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: 11-APR-2022) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, the patient experienced received less than 0.5 ml (approximately around 0.3 ml) of the initial dose. On 01-DEC-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5 ml (approximately around 0.3 ml) of the initial dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210684, 20211210197, 20211209976, 20211209843, 20211210058, 20211210549, 20211210112, 20211210409, 20211210610, 20211210555, 20211210408, 20211209880, 20211210133, 20211209816, 20211209782, 20211209775, 20211212088, 20211212082, 20211209679, 20211209740, 20211210588, 20211210670, 20211210824, 20211209912, 20211210067, 20211210160, 20211210350, 20211210141, 20211210585, 20211210107, 20211209921, 20211210180 and 20211210385.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021 at 3:33 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 3:33 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 32.83.  Concomitant products were not provided.  On 27-APR-2021, Excursion time was 09 AM, temperature was 35, total doses given for the day was 42, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 27-Apr-2021. 08 vials were sent to clinic. Vaccine BUD date was 19-May-2021.  On 27-APR-2021, no hourly temperature recordings available.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Dermatographic urticaria symptoms. Previously no allergies, now everyday I have flair ups of itchy skin. More in the upper body but can be throughout my whole body. Any contact of a foreign object like a purse strap will leave a bright red mark for at least 30-60 minutes. If I scratch myself then it becomes a hive and will remain for 1-2hours on my skin.
Patient tested positive for COVID 8/29/21. ED visit and hospital admission 9/7/21 for COVID pneumonia.
Narrative:  72 year old male, received his first COVID-19 vaccine (Pfizer) on 3/30/2021. Patient presented to Hospital 70% SCV on 5/18/2021, subsequently transferred to another ER for acute onset of respiratory distress and afib found to be in ADHF. COVID-19 tested with positive results. Patient expired on 5/22/2021.
Pt developed cold sores on mouth and lips and rash on face and neck on 11/3/99.  Pt had itching on face and neck with sneezing.  Pt saw a physician on 11/5/99, was given a prescription for antibiotics.
sore injection site arm; felt tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Sep-2021 and was forwarded to Moderna on 29-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (felt tired) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (felt tired). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (felt tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2021-336832, MOD-2021-336855 (Patient Link).
Pt became flush and developed hives immediately upon injection. Medics on site administered antihistamine. Within 10 minutes the flushing and hives returned and the patient was transported to a local hospital for further assessment/treatment.
large round red mark on arm at injection site that appeared about a week after the shot.  The area is very itchy, hard, and hot.
pt recvd vax; devel fever  & local rxn of soreness, swelling & rash at inject site;
Somewhat sleepless night of vaccine.  Excessively sleepy, muscle aches, muddle-headed day after, temperature only 1 degree above normal.  Red itchy rash on neck and lower chest area second day after vaccine; no fever.
Fever from 4:00 pm second day 4/28 until 5:00 am third day 4/30 Fatigue days 2-3 Brain fog days 2-3 Covid arm days 3-present
Right upper outer arm with pink/red swollen area the size of a softball. Slightly tender to the touch. No fever and no treatment ordered.
Patient was given 3 vaccinations on Monday, 11/02/2020. The patient's spouse called me, (Pharmacist), here to Pharmacy on Sunday, 11/08/20 at around 2:15pm to inquire whether the vaccines given can cause any lasting side effects. She informed me that on Tuesday, 11/03/2020, her husband started experiencing headaches, which have been persistent throughout the whole week since getting the vaccinations. She stated the her husband has been taking Extra Strength Tylenol to help manage the pain, but he has not felt any relief. I asked if he has had any previous reactions to vaccines or if he has experience this situation in the past. They said that this was his first time getting a flu vaccine, and they believe that was the cause. I informed the patient that they should try and see their primary physician or, if the situation gets worse, to go to an urgent care facility or hospital.
very, very sore arm; somewhat fatigued; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (very, very sore arm) and FATIGUE (somewhat fatigued) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A, 016B21A and 048C21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included PREDNISONE for Asthma.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced MYALGIA (very, very sore arm) and FATIGUE (somewhat fatigued). On 22-Feb-2021, MYALGIA (very, very sore arm) and FATIGUE (somewhat fatigued) had resolved.            Patient was placed on a double dose or prednisone for asthma. Patient experienced the same side effects after getting the 1st, 2nd and 3rd doses.  Patient felt fatigue for 24 hours. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-348439, MOD-2021-348441 (Patient Link).
Hives and welts appeared on various body parts, such as elbow, hands, around the knees, hips and more. I've been treating them with hydrocortisone cream, calamine lotion, and diet. They are getting better, however some still pop up. 2 dosage of the vaccine was Feb. 15, 2021. This report is March 10, 2021.  I am still getting some hives and welts; others are starting to disappear.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # K008334 with expiration date 09-JUN-2016; lot# K017721 with expiration date 27-AUG-2016, dose# and route unknown). No symptoms reported. The vaccines were stored under 9 C for 1 hour and 15 minutes without previous temperature excursion. No doses were administered past labeled expiry. This is one of several reports received from the same source. Additional information has been requested.
Approximately 55 mins after vaccine was given, my lips and the end of my nose started to tingle. The feeling intensified over 15 mins until it felt like a Novocain shot from the dentist when it starts to wear off. I took a Cetirizine 10 mg tab and the tingling completely resolved within an hour. No swelling of my mouth/ tongue or difficulty swallowing .
Massive swelling in upper lip beginning about 24 hours after dose 4.  (I used to get lip filler, but stopped as of March 2020.) I contacted the Nurse Line on the back of my health insurance card first, who suggested I be seen by an MD, so I saw a telemedicine MD.  The doctor prescribed  5 days of twice-daily 20 mg prednisone, which I started taking that night.  After the third dose of prednisone, the worst of the swelling was gone.   All swelling was gone by the end of the course of prednisone.
Approximately 7 days post-vaccination, onset of diarrhea. UTI next day or two but not attributed to vaccination (I have them sporadically). No specific treatment other than increasing fluids.
Fever-100.7 so far with Tylenol and Ibuprofen  Chills-steaming hot bath (only worked while I was in the bath)  Aches, fatigue, muscle weakness, headache, nausea, diarrhea  and  the beginnings of Covid arm (I got it super super bad last time).
She did not have control of her bowels when sneezed or coughing.  She complained of trouble breathing and in a lot of pain. She passed away on April 3 with pneumonia
Redness, swelling, hard area surrounding injection site, approx. 1 1/2" area.
This spontaneous report was received from a healthcare worker, via company representative, regarding a female patient of unknown age. The patient's medical history, concurrent conditions, or concomitant therapies were not reported. On an unspecified date, the patient was vaccinated with a dose of an unidentified Merck HPV vaccine (name, strength, dose, lot number and expiration date were not provided) for prophylaxis. On an unknown date (reported as "after receipt of the vaccine"), the patient experienced warts that appeared on different parts of her body and had a long duration (unspecified). The patient received treatment for the event and sought medical attention from dermatology for removal of a wart on her hand. The outcome of the event was unknown at the reporting time. The reporter did not provide a causality assessment between the event and the suspect vaccine. This is one of two reports from the same reporter. Additional information is not expected as the reporter refused additional contact.; Sender's Comments: US-009507513-1703USA003698:
pt received first dose of moderna on 3/3/21 around 945AM. She reported that she began to feel pruritic that evening, around 7PM. Pt stated that she woke up in the night itching and noticed a rash on her neck and trunk. Pt reported to health center 3/4/21 and presented with morbilliform rash on neck, trunk and spreading to her arms and legs.  Pt also reports she has been taking clindamycin 300mg twice daily for one week, for a dental procedure, however she did not take it this morning. 25 mg of diphenhydramine was administered IM in office. Clinic staff will continue to monitor.
Proximal weakness that started the next evening, difficult to get off the couch.  Improving daily but still not feeling back to normal.
This spontaneous report as received from a nurse refers to a 17 month old patient of unknown gender. On 18-SEP-2014 the patient received improperly stored (Oka/Merck) VARIVAX (lot# not reported, dose 0.5 ml, subcutaneously) exposed to -14C for 3.5 hours. Concomitant medications were not provided. No adverse effect was reported. Additional information has been requested.
Injection site pain, joint pain, fatigue all started morning after vaccination. Fatigue was decreasing by 1200.
Case was hospitalized for Covid pneumonia after Covid vaccination and booster.  Hospitalized at: Hospital, Discharging physician: MD Pneumonia due to COVID-19 virus Assessment & Plan Tested positive on 9/25. Was negative on 9/8. Fully vaccinated. Suspect COPD and PE contribute to symptoms of dyspnea, cough and worsening hypoxia - Dexamethasone, plan for 10 day course, on day 4. Note that he is on chronic steroids for COPD at baseline, he will hold his pred for now and resume when done with the dexamethasone.  -CT scan at time of admission showed scattered bilateral reticular groundglass opacities, bronchial wall thickening scattered mucus plugging in lung bases, to my review I do not see significant changes relative to the prior CT scan earlier in the month - IS, frequent ambulation, and self-proning as able Symptoms largely stable, improved cough, O2 needs back at baseline.     Acute on chronic respiratory failure with hypoxia (HCC) Assessment & Plan  patient is on 3.5L at least over the last month in the setting of COPD. He has had dyspnea for several weeks but reports an acute worsening on 9/24 with pleuritic chest pain. Requiring 4.5L NC at admission, suspect multifactorial from COVID-19 infection, acute PE, possible splinting due to pain from T7 fracture. -New lower extremity edema, BNP, troponin normal, no pleural effusion or significant pulmonary edema, doubt heart failure contributing  -Treating COPD and acute COVID-19 infection with dexamethasone, apixaban for pulmonary embolism
Immediately following the injection, light headed for about 15 minutes. The best day, fever, chills, body aches s extreme pain at injection site,  which were gone the next day. Since the injection though I have had increased, extreme pain in the shoulder ( I accidentally got the shot in the arm with Thoracic Outlet Syndrome), 3 migraines (I only get a migraine about once every six months), and a sore throat.
small red knot at the injection site that increased to the size of a silver dollar; injection site is still warm to touch; small red knot at the injection site that increased to the size of a silver dollar; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (small red knot at the injection site that increased to the size of a silver dollar), VACCINATION SITE WARMTH (injection site is still warm to touch) and VACCINATION SITE ERYTHEMA (small red knot at the injection site that increased to the size of a silver dollar) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE NODULE (small red knot at the injection site that increased to the size of a silver dollar), VACCINATION SITE WARMTH (injection site is still warm to touch) and VACCINATION SITE ERYTHEMA (small red knot at the injection site that increased to the size of a silver dollar). At the time of the report, VACCINATION SITE NODULE (small red knot at the injection site that increased to the size of a silver dollar), VACCINATION SITE WARMTH (injection site is still warm to touch) and VACCINATION SITE ERYTHEMA (small red knot at the injection site that increased to the size of a silver dollar) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
developed shortness of breath; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSPNOEA (developed shortness of breath) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation. Concurrent medical conditions included Type 2 diabetes mellitus, Congestive heart failure, Pacemaker insertion (cardiac), Hypertension, Rheumatoid arthritis, Allergy (cortisone allergy) and Allergy (morphine allergy).    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 DYSPNOEA (developed shortness of breath). The patient was treated with SALBUTAMOL (ALBUTEROL HFA) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (developed shortness of breath) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment was reported as restarted home oxygen and albuterol inhaler and experienced continued shortness of breath. Emergency Medical Services called and evaluated patient. Vitals were stable, no Benadryl or epinephrine were administered. Patient was not transported to the emergency room.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2021: NO new information
Syringe/needle malfunction. The needle tip came detached from the syringe while in the patients arm. The vaccine went on the exterior of the patient and in the vaccinator's eye.
Administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Patient took 2nd booster.  No treatment medication was reported by reporter.
In April, I began to have increased cough and shortness of breath. CT scan revealed multiple  nodules in lungs and enlarged  lymph nodes. PET scan revealed area of hypermetabolism in lungs, one area retroperitoneal and extensive bones. Lung biopsy in June 2021 revealed  both sarcoidosis and lymphoma (small lymphocytic lymphoma). Bone biopsy in July revealed sarcoidosis in bones. Pathology confirmed by 2 hospitals. This may or may not be related to the vaccine, but I believe the data should be collected. There may be others who have had this. It is rare to have both diagnoses.
Patient noted problem swishing mouth while brushing teeth the morning after vaccination. Diagnosed by her physician with Bell's palsy.  11/14/08 Reviewed PCP medical records of 10/27-10/31/2008. FINAL DX: Bell's palsy left, visual disturbance, conjunctivitis left eye. Records reveal patient experienced red eye tearing, burning, blurry vision, unable to close completely & had accidentally touched eye.  Tx w/antiviral & steroids.  Referred to opthalmo & neuro.  Ophthalmo exam abnormal w/no blink reflex & incomplete lid closure left eye.  Dx w/punctate deratitis OS, tx w/meds.  Neuro exam abnormal & concurred w/dx & tx.