chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site pain, Nausea, light headed same day (1/25//2021) after injection. That evening, Nausea, fever and chills. Took Tylenol. Next day (1/26/2021) Nausea, fever and chills continued. On 1/27/2021 in the morning became faint and weak and fell or fainted. Due to fall hit her head. Daughter living in same house treated her with Ice Pack and brought her to Hospital ER for evaluation. Hospital identified fever and began antibiotic treatment and fluids.
Nausea, vomiting, pain under breastbone , tired unable to eat, has stayed in bed basically from  the evening of 02/25/2021 through 03/05/2021.
Patient listed no allergies to medication or history of immunization reactions. This was her Pfizer booster after receiving both doses of the initial Pfizer vaccine series. About 2 minutes after injection, the injection site swelled in a dime-sized dome. It was not red and didn't hurt/itch, per the patient. After about 30 minutes the swelling went down and the patient said she felt fine.
Patient developed rapid breathing and lower body temperature after receiving the vaccines.  He was seen at the office on the next day and noted to have tachypnea and cold symptoms.  He continued to have difficulty with heavy breathing and shortness of breath.  He went to the Emergency Department for shortness of breath with a normal chest X-ray.  He was seen by a pulmonologist and cardiologist.  He was placed on Montelukast and Budesonide breathing treatments.  He continues to have tachypnea chronically and has developed intermittent wheezing.  His breathing has never normalized since the vaccines.
Initial misuse report received from a healthcare professional on 13 September 2013. The patient had received Expired dose of ACTHIB. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Shingrix/ was exposed at room temperature for 900 hours; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 7Z29K, expiry date unknown) for prophylaxis.   On 2nd July 2021, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: Pharmacist reported that the patient was administered Shingrix which was exposed to room temperature for 900 hours, which led to incorrect storage of drug. No information about expiration date was provided. The reporter consented to follow up by fax. This case was linked with US2021159292, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021159292:Same reporter
Blurred vision; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 12:15 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and dronedarone hydrochloride (MULTAQ). On 15Apr2021 at 12:45, the patient experienced blurred vision. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event blurred vision was not resolved at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 16 year old female with a history of rheumatoid arthritis who on 21-SEP-2007 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot# 656372/0243U) (route and administrating site not reported), and a dose of MENACTRA vaccine (dip toxoid). On 21-NOV-2007 the patient was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot# 657737/0522U) (route and administrating site not reported). On 05-DEC-2007 the patient had to see a rheumatologist for neck and hip pain. On 01-APR-2008 the patient was vaccinated with a third dose of GARDASIL vaccine (yeast) (lot# 659962/1740U) (route and administrating site not reported) and after that the patient experienced nausea and vomiting and was diagnosed with gastroenteritis. On 24-JUN-2008 the patient started experiencing abdominal pain and was referred to another physician who prescribed omeprazole (MSD) which did not help and switched to REGLAN. The patient sought unspecified medical attention. Additional information has been requested. 10/08/08 This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from a physician concerning a 16 year old female with a history of rheumatoid arthritis who on 21-SEP-2007 was vaccinated with a first dose of GARDASIL (lot# 656372/0243U) IM in her right deltoid, and a dose of MENACTRA. On 21-NOV-2007 the patient was vaccinated with a second dose of GARDASIL (lot# 657737/0522U) IM in her left deltoid. On 05-DEC-2007 the patient had to see a rheumatologist for neck and hip pain. On 01-APR-2008 the patient was vaccinated with a third dose of GARDASIL (lot# 659962/1740U) IM in her left deltoid and after that the patient experienced nausea and vomiting and was diagnosed with gastroenteritis. On 24-JUN-2008 the patient started experiencing abdominal pain and was referred to another physician who prescribed omeprazole (MSD) which did not help and switched to REGLAN. The patient sought unspecified medical attention. Follow-up information was received. ON 08-JUL-2008 the patient experienced stomach pain. Her abdomen was soft and non-tender with positive bowel sounds. The patient was referred to a gastrointestinal doctor. Additional information has been requested.
I had the normal predicted pain at the injection site, tiredness, headache, muscle pain, chills, and joint pain. But I also experienced a very rapid heart rate with minor activity that morning, that made me feel like I was going to give out. It scared me pretty bad. My heart rate jumped to 154 and stayed that way until I would sit for an extended period. I did notice on my watch that it stayed higher than normal that whole day. I stayed pretty tired for about 4 days.
Lt arm swollen, hives (Lt arm), Lt arm red, hot swollen pain in Lt arm no fever, no problems breathing. Will given Benadryl 3-6-09 (per doctor direction) noted hives 3-5-09 in afternoon. Arm was already painful @ that time. Still has some soreness in arm 3-13-09. Takes Ibuprofen for soreness.
After receiving 1st Hepatitis B Vaccine patient/employee states that she had aching in her arm that radiated up her neck and into her back for 1-2 days. She did at first not associate this with the shot and did not report it until 01/06/2010 when she came back for her third shot. She had the same problem after her second shot on 08/18/2009. At that time the symptoms were the same only more pronounced and lasted for 2-3 days. It was only after the 2nd shot that she connected the symptoms on 7/7/09 to the vaccine. However she did not report any of this until 01/06/2010 when she was about to receive her third vaccine. The third vaccine was not given and the patient/employee was referred to her health care provider for advice and clearance on if she should receive the third injection or not.
Information has been received from a nurse practitioner concerning a 77 year old female with SULFONAMIDE allergy and no known medical history who on 01-MAR-2007 was vaccinated with a dose of ZOSTER vaccine live (Oka/Merck) (lot # 656412/1476F) subcutaneous.  Concomitant therapy included SYNTHROID, calcium (unspecified), COUMADIN and estrogens (unspecified).  On 22-JAN-2009 the patient developed shingles.  The patient developed painful red raised blisters on her shoulder blades on her back.  The patient was given DARVOCET, VALTREX, and a cream for the treatment.  No laboratories studies performed.  The patient sought medical attention with the nurse.  At the time of this report the patient was recovering.  Additional information has been requested.
SINCE AFTER THE SHOT I FEEL CONTINIOUS PAIN AT THE SPOT.WEDNESDAY NIGHT I STARTED EXPERIENCING UNCOMFORTABLE FEELING OF VIBRATION INTERVALLY IN MY 2 FEET ALL DAY AND NIGHT.
immediately post-vaccine, client had episode of seizure-like activity to upper/lower extremities and became non-responsive with eyes open; shaking lasted approx 10-15 seconds; awake but unresponsive lasted approx 2-3 minutes; systolic BP dropped from baseline 104/67 mm Hg to 86/46  with HR drop from 71 at baseline to 56/minute; shaking activity resolved spontaneously & became responsive within approx 2 minutes; rested supine x approx 45 minutes with return of BP/HR to baseline and mental return to baseline; left clinic in good condition; advised to seek ER eval today
Within 12 hours of vaccination, arm became red and swollen, headache.  This lasted for one week.
Diarrhea before imms, date of imms 9/26/11, no feve. Onset was 2 days before imms, well day of imms. Diarrhea resumed & increased after imms otherwise well continued til today, now resolving.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 09-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 72 hours, the lowest recorded temperature was 28F (-2.222 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Body and Head aches; Body and Head aches; This spontaneous case was reported by a health care professional and describes the occurrence of MYALGIA (Body and Head aches) and HEADACHE (Body and Head aches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 025L02A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced MYALGIA (Body and Head aches) and HEADACHE (Body and Head aches). On 12-Feb-2021, MYALGIA (Body and Head aches) and HEADACHE (Body and Head aches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was reported. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-072104 (Patient Link).
Pt recvd 3 doses of Recombivax 3JAN91, 3FEB91 & 3JUN91 & did not respond; p/receiving doses of Engerix-B 8AGU92 & 6SEP91 had core antibody pos & surface antibody pos;
Systemic: Rash (other than injection site)-Medium, Systemic: Fever-Medium, Systemic: Felt itchy all over body, no visible hives, flushed-Medium; symptoms lasted 0 days
Information has been received from a RN concerning a 39 yr old female with a history of pneumonia 2 yrs in a row. On 22Oct05 the pt was vaccinated IM in the left deltoid with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649697/1038P). That same day, the pt developed redness, swelling at site, and a fever noted as 102.5. The pt sought unspecified medical attention. It was reported that there was no treatment. The fever resolved itself (date unk). At the time of the report, the pt had recovered from the events (date unk). Additional information has been requested.
2 days ago, no redness, yesterday arm became red, and redness increased over the day and arm became hot, today arm less red and less hot and is pruritic. Redness fading. Triamcinolone.
No additional AEs reported; Varivax was administered on 09JUL2021 that expired on 21MAR2021; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 09-JUL-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot number S008692, expiration date 21-MAR-2021 (route of administration was not reported) for prophylaxis. No adverse event was reported. The vaccine had not had any temperature excursion.
Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient developed severe fatigue. At the time of the report the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
On 01/20, 8 days after the shot I woke up with a rash at the injection site.  The rash was red and raised, like hives.  It did itch.  It was about four inches long and two inches wide.  It is 01/21 the rash is no longer raised, it is only a red spot.  No other symptoms
Right arm became swollen, red, hard, hot to touch, size of .50 cent piece.  Under right arm very tender, hard to lift up arm, nausea and dizzy.
ARTHRITIC PAINS; FATIGUE; This spontaneous report received from a patient via another manufacturer (Abbvie) concerned a 57-year-old male of unknown race and ethnic origin. The patient's height and weight were not reported. The patient had no known allergies and no relevant medical history. The patient was previously treated with an influenza vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, Expiry: unknown ) frequency one total, dose and start therapy date were not reported for prophylactic vaccination. (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No known events were reported after vaccination. The Patient received non-company suspect drugs included: adalimumab (solution for injection in pre-filled syringe, subcutaneous, batch number: unknown expiry: unknown) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis The patient received Non-company suspect vaccine included: bnt 162 (intramuscular, batch number: unknown: expiry and form of admin was not reported) dose and start therapy date were not reported for prophylactic vaccination.  No concomitant medications were reported.  On an unspecified date, the patient experienced fatigue and rheumatoid arthritic pains (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s and bnt 162 was not applicable and not reported for adalimumab. The patient recovered from fatigue and the outcome of arthritic pains was not reported. This report was non-serious
pt called 9/20 to complain of swelling, redness, pain at site of injection. States had a "hard lump" under skin. No increase in temp. No other sxs. Had injection 9/16/04.
Hospitalized (11.16.21);  COVID-19 positive (11.17.21);  Fully vaccinated  PRESENTING PROBLEM: Pneumonia due to COVID-19 virus [U07.1, J12.82] Primary Care Physician at Discharge: NP  Hematologist/Oncologist: Dr. Admission Date: 11/16/2021 Discharge Date: 11/21/2021 Patient's Discharge Disposition:  Home in stable condition. Hospital course: Patient is a 63 y.o. female with a past medical history significant for non-small cell lung cancer with multiple brain mets who has been on treatment with Entrectinib and completed SRS radiation to her brain. She has mild ataxia at baseline. She presented to ER from home per EMS after she was found on the floor by her family and helped back to bed. She was hypoxic in the 80's when checked by EMS and placed on 4L/NC. She was diagnosed with COVID 11/5 when she was tested due to her husband and son testing positive. Pt's CXR and CTA thorax both demonstrated patchy ground glass infiltrates consistent with COVID pneumonia. The patient was admitted for further evaluation and management. She was started on dexamethasone 6 mg and Remdesivir. She was also given compassionate use monoclonal antibodies on 11/18. She completed the course of remdesivir and 5 days of steroids. Her SOB resolved and she was weaned to RA. Her only remaining symptom at time of discharge was a cough. The patient was eating and ambulating at the time of discharge. Discharge medications and follow up as listed below. Answered all questions and the patient was comfortable with the discharge plan.
Death Non-ST elevation (NSTEMI) myocardial infarction Acute kidney failure, unspecified Thrombocytopenia, unspecified
blood clots in the heart; had no energy, very weak, extremely weak; irregular heartbeats; couldn't walk very good; shortness of breath; coughing; chills; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of INTRACARDIAC THROMBUS (blood clots in the heart), ASTHENIA (had no energy, very weak, extremely weak) and HEART RATE IRREGULAR (irregular heartbeats) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tumor and Arrhythmia. Concurrent medical conditions included Heart disease, unspecified in 2020.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DYSPNOEA (shortness of breath), COUGH (coughing), CHILLS (chills), NAUSEA (nausea) and VOMITING (vomiting). On 01-Apr-2021, the patient experienced ASTHENIA (had no energy, very weak, extremely weak) (seriousness criterion hospitalization) and GAIT DISTURBANCE (couldn't walk very good). On 09-Apr-2021, the patient experienced HEART RATE IRREGULAR (irregular heartbeats) (seriousness criterion hospitalization). On 12-Apr-2021, the patient experienced INTRACARDIAC THROMBUS (blood clots in the heart) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 05-Apr-2021 to sometime in April 2021 due to HEART RATE IRREGULAR, then from 05-Apr-2021 to sometime in April 2021 due to INTRACARDIAC THROMBUS, and then from 09-Apr-2021 to sometime in April 2021 due to ASTHENIA. On 25-Mar-2021, CHILLS (chills) and VOMITING (vomiting) had resolved. At the time of the report, INTRACARDIAC THROMBUS (blood clots in the heart), ASTHENIA (had no energy, very weak, extremely weak), HEART RATE IRREGULAR (irregular heartbeats), GAIT DISTURBANCE (couldn't walk very good), DYSPNOEA (shortness of breath), COUGH (coughing) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Patient was placed on unknown medication to help dissolve blood clots for one or two months.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
EMS was summoned to a 47 year old female patient for an elevated heart rate. On arrival at patients side. EMS found a 47 year old female patient AOx4, skin warm, pink and dry. Patient was complaining of feeling light headed, and feels anxious. On assessment patient looks fatigued and diaphoretic. Patient was asked if she would like to be further evaluated out of the public eye. Patient was escorted where EMS did a thorough evaluation. Patient complains of feeling anxious and says she has history of anxiety attacks and arrhythmia that she says is prolonged QT Interval. Patient normally takes Klonopin for anxiety but did not take it today because she did not feel comfortable with how it would interact with her Moderna Vaccination. Patient is not complaining of any chest pain, no shortness of breath, no uticaria or decreased blood pressure. Patients vital signs were stable BP: 124/84 Pulse: 84 Irregular, Oxygen saturation 97% and RR: 16. Patient was observed for a total time of 40 minutes. Patient said she feels a lot better after she was able to sit and relax. Patient was asked if she would like to be transported to the hospital. Patient is refusing to be transported at this time. When patient left the care EMS patients diaphoresis was gone, she said her anxiety has subsided and feels much better. Patient was left in her own care and left with her husband.
Hives and rash on upper right arm and right and left upper thighs since date of second injection 4/21/21
mild fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (mild fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (mild fever). At the time of the report, PYREXIA (mild fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were  reported.  Treatment information was not provided by the reporter.
Fever, shaking chills first 48 hours,  with fatigue, nausea,  general malaise,  shortness of breath,  chest pressure and lightheadedness began in first week after moderna booster,   and have persisted for last several weeks.    SOB,  CP and lightheadedness have been occurring more prominently with exertion (walking,  barn chores,  household activities)
Reaction started ~25mins after shot with itchy and swelling eyes. Progressed to anaphylactic reaction requiring Ambulance to ER, admission, four day stay.
Initial unsolicited report received from a physician via other company (Pfizer) (under the reference number: 2016151044) on 10 Nov 2016. This case involves a male patient (age unknown) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiration date, route, dose not reported) on an unspecified date. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was not provided. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced allergies to tetanus vaccine, tetanus toxoids. Lab data and corrective treatment was not reported. The patient's event outcome was not reported. List of documents held by sender: none.
pt reports seeing  2 blisters 1 on the pinky and 1 on the ring finger of the left arm the morning after the vaccine. pt waited a day or 2 then popped the blisters. the blisters were irritated, scabbed up and got smooth skin within 2 weeks. can still see the redness where the blisters were on the fingers 28 days post vaccination