chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt later disclosed to me that she had passed out from a "pain medication injection" before at urgent care. 59 y/o female presented to the clinic for vaccinations. She denied previous reaction to vaccines and or chronic illnesses. BP prior to vaccines was 102/64. HR 53. received Tdap at the right deltoid. tolerated well. Two minutes later, typhoid injection at the left deltoid was done. Pt tolerated well. 2 minutes later. Hep A injection was administered left deltoid since she is right-handed. Within 1 minute, pt verbalized not feeling well, became slow to respond, her eyes were wide open, but stopped responding verbally. We attempted to acquire a BP but she jerked at the BP cuff inflation process. She slowly closed her eyes. Sternum rub done. pt opened her eyes right away. 5 seconds later, she returned full consciousness and asked what happened. BP 134/70. HR 50 at this time. Pt then transferred to the exam table from chair to lay down. She felt better in 5 minutes. Had water, and walked to another chair waiting for family to pick her up. She then left ambulatory with husband and son 1 hr later.
I had a sore throat starting off. Then I had some fever. I had a runny nose and runny eyes. I had a headache, and my blood oxygen was a little below normal. On December 16th, I went to a COVID testing site by the curative group. I got my results on December 17th and the test came back as positive.
This spontaneous case, initially received on 11-Oct-2016, was reported by a health professional and concerns a 45-year-old female patient. Weight: not provided; Height: not provided. Past medical history includes asthma and bronchitis. Administration of company suspect drug(s): The patient received AFLURIA for influenza vaccination from 01-OCT-2016 to 01-OCT-2016. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: 12949221A (thiomersal-containing). No additional suspect drugs. Adverse reactions/events and outcomes: The patient got sick the next day after the flu shot (start date: 02-Oct-2016). She started with a sore throat and progressed chest congestion (start date: Oct-2016). The patient had to be hospitalized on 09-Oct-2016 with asthma and bronchitis and came home today. The patient is off work till Saturday (start date: Oct-2016). All events: hospitalised, outcome: not reported. Sender's Comments: Company comments: Listedness: Assessment according to the CCDS for CSL's Inactivated Influenza Virus Vaccine oropharyngeal pain is listed and pulmonary congestion, asthma, bronchitis are unlisted. Causality: Related. Time to onset is next day following vaccination. Patient had a history of asthma and bronchitis. It is likely patient experienced an infective exacerbation of underlying condition. However due to temporal association causality is considered related to vaccination.
Narrative:  Symptoms started day after injection. Took OTC Tylenol. Arthralgia Fatigue
passed out; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (death) with onset Dec2021, outcome "fatal", described as "passed out". The patient date of death was unknown. The reported cause of death was loss of consciousness. The patient passed out shortly after receiving the COVID-19 vaccine from Pfizer-BioNTech. It was in Dec2021, never heard from her again. This was the 1st warning to the world about and was equally ignored by the media.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: passed out
Date of positive COVID test:  5/5/21 Date of exposure if known: 4/30/21 son exposed Exposure (Workplace vs. community):  Community Symptomatic: Yes
pt & fiance consumed soda & later found vial of varicella vax in bottle pt devel high fever & on approx 4/1/98 went to ER;pt fiance devel high fever (WAES 98061800);
TESTED POSITIVE FOR COVID 7/9/2021  ADMITTED TO FACILITY 7/12/2021 WITH SOB AND DIARRHEA STILL INPATIENT COMPLETED VACCINATION FEBRUARY 2021 - MANUFACTURER UNKNOWN
Employee presented for COVID 19 vaccination: Survey reviewed, no history of Anaphylaxis reaction Moderna 1st dose given today to Left arm. She immediately developed Numbness to her body, chest tightness, and abdominal discomfort. Remained Alert and oriented, voiced concerned she felt like she was going to pass out. She developed blotchy skin to chest and neck area within minutes of injection. Patient sat in a wheelchair. Vital taken: BP 140/98 Pulse 123, given water to drink, tolerated well. She quickly reported she continued with above stated ymptoms, and continued with nausea, blotchy skin, heart racing and weakness. She was given 0.3mg of Epinephrine IM to right arm and taken to the ED
Developed a rash following vaccines- questionable reaction? Rash started on face and went down body. Went to MD on 6-29-11 and was given a steroid shot and told to continue Benadryl. Patient has been swimming in a cloudy pool and been in a hot tub on 6-26-11- and complaints started 6-27-11.
Patient reported rash on back, chest and neck Advised to take Benadryl and go to ER if symptoms worsen
Noted redness, raised, tender, warm at injection site late 10/9/07. Medicated with Aleve. this was first flu vaccine for employee. Currently taking cancer treatment.
On 10/30/2019 at 06:30 the patient woke up with site reaction. Noted to be approximately 3-4cm in size with warmth and tenderness, itchiness noted. By the evening of 10/30/2019 the reaction site was 6-7cm in size circular in shape and surrounding the injection site. On 10/31/2019 the reaction site is reported to be 10-15cm in size and continues to be irritated, warm, tender, and itchy. Ibuprofen and Benadryl taken to treat. Appointment to be scheduled with PCP later today.
sx and + home Ag test 20Feb test result: Positive; sx and + home Ag test 20Feb test result: Positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 41 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 02Nov2021 (Lot number: FF2589) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 25Feb2021, when the patient was 40 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 04Feb2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset 20Feb2022, outcome "unknown" and all described as "sx and + home Ag test 20Feb test result: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Feb2022) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, sars-cov-2 test positive. Facility type vaccine received at workplace clinic. It was unknown If patient received any other vaccine in four weeks. COVID prior to vaccination was unknown.  No follow-up attempts are possible. No further information is expected.
Patient started experiencing shortness of breath 3 days post second dose of Moderna. It became progressively worse, she went to urgent care, then to the ER. In the ER it was determined she had pulmonary edema and pericarditis. Her ER visit was on 8/30/21, She told me she had been to urgent care, her PCP, and her pulmonologist. Not sure the dates those visits occurred. Upon discharge from the ER, she was given an inhaler, cefdinir, and prednisone. She had them filled at my pharmacy which is when I learned all the above.
Injection site area larger; injection site itching; Large red raised area around injection site; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 21Apr2021 at 09:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient received other vaccine within four weeks prior to the COVID vaccine. Patient received varicella zoster vaccine rgE (CHO) (SHINGRIX) on 09Mar2021. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 24Mar2021 at 12:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 07:00, the patient experienced large red raised area around injection site, appeared two days after shot and on day 3, 23Apr2021, area was larger and itchy. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event large red raised area around injection site, appeared two days after shot and on day 3, 23Apr2021, area was larger and itchy was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning a 14 year old female with no known allergies and no pertinent medical history who during the week of 23-SEP-2007 came in for her first dose of Gardasil 0.5 ml intramuscularly in her arm. There was no concomitant medication. Some day during the week of 23-SEP-2007, the patient experienced syncope and "a mild seizure." The patient closed her eyes and jerked her arms. No labs or diagnostic studies were performed. The patient was observed in the exam room and fully recovered without further symptoms. Upon internal review, "a mild seizure" was considered to be an Other Important Medical Event. Additional information has been requested.
This spontaneous report was received from a licensed vocational nurse, refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The licensed vocational nurse informed, that on an unknown date, the patients were vaccinated with PNEUMOVAX 23 (dosage, route, lot# and expiration date were not reported) which was exposed to temperature outside of the recommended range. Concomitant therapy was not reported. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This reporter was alerted by our vaccinator, that they were notified by one of our teams that they were only able to obtain 1 dose out of a Pfizer vaccine vial. Upon questioning our team we learned that when the preceptor was observing their student, at the dilution step, they reported that liquid was leaking from the connection points of the syringe and needle. They proceeded with the preparation and drew up the vaccine dose, measuring 0.3ml. Patient mentioned here in this report was given their vaccine and observation was completed without remark. It wasn't until the vaccinator was prepping for their next dose from this vial did they learn that the remaining contents of the vial was 0.2ml.  The vaccination team then reported this finding to the leads.  Patient was later notified via phone (1/18) by reporter of the potential that they received an incorrectly constituted vaccine. Patient reported feeling more pain at time of injection and was markedly tired for a few days after however had no other complaints or concerns at the time of the call and follow up call (1/22).
WARMTH; BODY ACHES; CHILLS FOR 2 HOURS; FEELING TIRED; ANXIETY; This spontaneous report received from a patient concerned a 62 year old male. 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, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced anxiety. On APR-2021, the subject experienced feeling tired. On 06-APR-2021, the subject experienced warmth. On 06-APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced chills for 2 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from warmth, body aches, and chills for 2 hours on 07-APR-2021, and the outcome of anxiety and feeling tired was not reported. This report was non-serious. This case, from the same reporter is linked to 20210413340.
Excessive crying, irritability.  Resulted in return to MD office and referred to E.D.  Abdominal X-rays (R/O intussuscaption) and urinalysis done (R/O UTI - has hydronephrosis).
Covid arm; Covid arm; Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Covid arm), VACCINATION SITE ERYTHEMA (Covid arm) and VACCINATION SITE PRURITUS (Covid arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included Chronic fatigue in 2014 and Chronic pain in 2014. Concomitant products included LISINOPRIL, AMLODIPINE, RAMIPRIL, DENOSUMAB (PROLIA), CALCIUM, FISH OIL, BIOTIN, VITAMIN C [ASCORBIC ACID], CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), ALPHA LIPOIC ACID, UBIDECARENONE (COQ10 [UBIDECARENONE]), PYRIDOXINE HYDROCHLORIDE (B6), CINNAMOMUM CASSIA (CINNAMON [CINNAMOMUM CASSIA]) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced VACCINATION SITE RASH (Covid arm), VACCINATION SITE ERYTHEMA (Covid arm) and VACCINATION SITE PRURITUS (Covid arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (Covid arm), VACCINATION SITE ERYTHEMA (Covid arm) and VACCINATION SITE PRURITUS (Covid arm) had resolved.            Treatment also included itch cream.  Both moderna vaccine and prolia injection was given in left arm.   This case was linked to MOD-2021-181863 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Additional information received: Updated past medical history and concomitant medications.; Sender's Comments: Based on the current available information and strong temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported event are consistent with the product safety profile.
this is one to two children to devel redness & tenderness @ the inj site p/vax; pt has recovered;
Tired; Muscle fatigue; Skin itched and it felt like something was biting me; It felt like something was biting me; Sore arm at site of injection; Feverish the night of the injection; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via an unspecified route of administration in the left arm on 12Nov2021 at 11:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 12Nov2021 at 14:00, the patient experienced sore arm at site of injection, was tired, had muscle fatigue, skin itched and it felt like something was biting her and felt feverish the night of the injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm at site of injection, tired, muscle fatigue, skin itched and it felt like something was biting her, feverish the night of the injection was resolved on an unknown date in Nov2021.
flares with autoimmune condition; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (flares with autoimmune condition) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012AUA and 017BUA) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (flares with autoimmune condition) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE DISORDER (flares with autoimmune condition) outcome was unknown.            Concomitant medication not provided. Treatment not provided.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Started with a rash to my neck and chest. A day or a rash started to develop on my forehead, eye lids and under one eye. Lymph node in my neck was also swollen. A week later my lips are slightly swollen, rash is better on my neck but is worse on my face.
10 days after shot, injection site swelled to baseball sized, red, itch, sore area. Lasted about 4-5 days.
Local reaction - quarter sized patch - erythematous with induration to (L) thigh. Fever Tmax 104. Fussiness.
I experienced some of the expected side affects of the vaccine including elevated body temperature, chills, muscle aches and exhaustion. I also developed hives on my chest approximately 24-33 hours after vaccination. Monitored for changes. Hives disappeared within 24 hours.
Pt. c/o pain in arm where injection was given and decreased ROM and strength in (L) arm. Brought in to be evaluated, physician did not feel there was decreased ROM. Thought to be bruise.
Patient describes full-body itch that developed after the vaccine within a day.  Slightly better at the present time than when it began.
At home acute onset swelling eyes lids - raised red rash- itchy all over - seen at office 09/25 with eyelid edema, macular rash on neck with 2 hives - got BENADRYL and PRELONE- seen again at urgent center 09/25 with increased itchy -? SOB - both times lungs clear no wheeze
Joint inflammations and pain: Foot, ankles, knee , rest and finger joints. Swell and restricted  movements.   Occurred about 8 days after receiving the second dose.   Treated with indomethacin. Improvements in conditions are limited.
Patient was given Pfizer vaccine after receiving Johnson and Johnson in February. Patient is feeling normal no symptoms after vaccine.
On 6/11/99, the pt received the first dose of Lymerix for prevention of Lyme disease.  18 days later,  on 6/29/99, she felt hot (facial), had a severe headache, sore neck and back, and dime-sized red spots on legs.  3 days later on 7/2/99, she was found to have an irregular heart beat at a clinic.  She was treated with Tylenol and aspirin.  The headache resolved, and the red spots have mostly resolved.  The most recent information, received on 7/22/99, reports the condition of the pt is ongoing.
Janssen COVID-19 Vaccine EUA G1P0 at 33w5d by LMP, presented to L&D the evening of 3/10/2021 after experiencing fevers, chills, diaphoresis, and muscle aches beginning approximately 8 hours after vaccination. She has chronic headaches which is also present on presentation. She denies any cough, sputum production, nausea, vomiting, diarrhea, dysuria, hematuria, flank pain, abdominal pain, vaginal bleeding, rash or skin changes, no leg swelling or pain. On presentation she was noted to have a fever of almost 103F, was tachycardiac to 160s, BPs 90s/50s, and had fetal tachycardia in the 170s. Her exam was non focal with no evidence of infection. Sepsis workup was initiated which was negative. COVID-19 test was negative Discharged home in stable condition
Fever of 101 starting at 9:35 am following the injection. Followed up by neck, should, arm pain beginning around 3:00 pm on the day of injection, and neck and shoulder pain continues today 1/10/2021.
Right facial paralysis, could not stand on bilateral legs due to severe pain and weakness. High fevers of 103 and 104 degrees, bad headaches, vomiting, body aches.
Severe chest and back pains, abdominal pains that last for about 2 hours. Any physical movement caused severe pain. Pain levels severe enough to cause nausea and vomiting. Combination of ice pack and complete stillness finally alleviated symptoms. Any attempt to move after caused resurgence of pain.
Arthralgia, Diarrhea & Nausea Vomiting Narrative:
Pulmonary embolus.  seen in ED and started on anticoagulation on 3/11/2021.  Admitted to hospital 3/25 through 3/30 due to pericardial effusion
previous injection caused redness in arms, started with redness again on arms and chest. Given Cetirizine  at 3:52pm. Redness resolved
The first adverse effect I had was abdominal pain which started immediately after the Vaccine. Since the vaccine I have had to get care from 2 Gastroenterologist, 2 Oncologist, Neurologist and 2 Internal Medicine Physician. Also experiencing subcutaneous pain under the skin, Indigestion pain, nausea, visceral colonic pain. Took a course of steroid, which may have provided some relief. Tinnitus was exacerbated after the vaccine which cannot be treated.
Patient had bumps all over body. One bump on leg he scratched & was open. Hard blisters all over body along with rash. Temp. 98.6.
Pt given 4 year immunizations on 6/16/04. DTaP, IPV, MMR on 6/16/2004. 6/18/04 right arm 3-4 inch diameter elevated red area, warm to touch. No pain. 6/21/04 Redness and swelling gone
5 MIN AFTER RECEIVING COVID-19 PFIZER VACCINE, PATIENT EXPERIENCED LEATHARGY, ITCHINESS TO BACK OF HER HEAD, AND TINGLING AND NUMBNESS SENSATION TO RIGHT SHOULDER THAT RADIATES DOWN TO RIGHT HAND.  PATIENT WAS MONITORED FOR 30 MIN AND SYMPTOMS SUBSIDED WITH MEDICATION IMPLEMENTATION
Patient was sitting in chair in exam room while I was talking to her nurse. Suddenly she slumped over and fell head first into step of examine table. She was immediately alert, vital signs stable. Event occurred about 10 min. after injection.
pt reported headache since 2/20/22  - counseled at time of administration - followed up today - went to voicemail
Leg blood clot that traveled to my lungs leading to A Pulmonary Embolism
Pt came in day after vaccine with 103.7 fever. Doctor swabbed pt for strep. Strep neg. Dr DX with virus.