chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a Pfizer sponsored program from a contactable consumer who reported about herself. An adult female patient of an unspecified race and ethnicity received, on 01Apr2016, at the age of 52 years, PREVNAR 13 at single dose. Relevant medical history included splenectomy on an unspecified date (spleen was removed because of benign tumor in Sep2010); body aches and chills from 31Dec2015 (12 hours later she was in hospital in sepsis); septic pneumococcal pneumonia diagnosed on 01Jan2016; multi organ failure; renal failure, dialysis (she had kidney transplant on 06Dec2017). The patient previously, on an unspecified date, in Aug2010, received PNEUMOVAX 23, FLU VACCINE and meningococcal vaccine. Concomitant medications were unknown. The patient was usual going to gym exercising (ran), and yoga. On an unspecified date, the patient experienced vascular necrosis in her feet so much that she was not able to run. She did spin classes and yoga. Subsequently the patient received PNEUMOVAX 23 on an unspecified date, in Jan2017. At time of this report, the patient recovered (all wounds healed). No follow-up attempts are possible, information about lot number cannot be obtained.
area around inj site became erythematous 2-3cm annular raised w/pustules;
I missed my second dose. I had my first in April; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I missed my second dose. I had my first in April) 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, the patient experienced PRODUCT DOSE OMISSION ISSUE (I missed my second dose. I had my first in April). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I missed my second dose. I had my first in April) had resolved.            No concomitant medications were not reported. No treatment medications were not provided.
DIED; This spontaneous report received from a consumer concerned an female of unspecified age and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included underlying disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 31-JUL-2021, the patient died of unknown cause. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20210805373-covid-19 vaccine ad26.cov2.s -Death. This event(s) is considered un-assessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
4/11/21 Shortness of breath. Dx: with a-fib, heart attack , heart failure, pneumonia,  fluid on lungs. Chest X-ray., chest CT DONE. Pt incubated and transferred to ICU
Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 66 years old female patient who experienced continued to experience numbness and tingling, and have a hard lump (hardness) where the FLUZONE HIGH DOSE was injected, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medications were reported. On 22-Aug-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UI993AB and expiry date: 18-Mar-2018) in the left arm. On an unknown date, the patient developed a non-serious continued to experience numbness and tingling, and have a hard lump (hardness) where the FLUZONE HIGH DOSE was injected (injection site hypoaesthesia, injection site paraesthesia and vaccination site mass) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that the patient raise her arm over her head to get the numbness to go away. No Lab data was reported. Final diagnosis was have a hard lump where the FLUZONE HIGH DOSE was injected, experienced tingling and continued to experience numbness. It was not reported if the patient received a corrective treatment. The patient did not recover from reported events at the time of report. (taken as not recovered due to event reported as continued to experienced). Documents held by the sender: none.
Upon receiving the vaccine, the patient passed out for approximately five seconds. EMTs were immediately called. Patient vomited five minutes after passing out. EMTs took the patient's vitals and had her sit for 10 minutes. Patient guardian declined to have taken to emergency room.
Patient is fully vaccinated. COVID + on 12/1/2021.  ED visit on 12/1/2021.The patient complains of 5 days of cough, fever, anosmia, abdominal pain, diarrhea. She has shortness of breath.  Positive for fatigue, diarrhea, nausea and vomiting.  BP 112/61  | Pulse 94  | Temp 99.7 °F (37.6 °C)  | Resp 18  | Ht 157.5 cm (5' 2")  | Wt 104 kg (230 lb)  | SpO2 94%  | BMI 42.07 kg/m² CXR with infiltrates.  Mg low, replaced.  Referred for monoclonal antibodies.  Return to ED if worse.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ADULT OBSTRUCTIVE SLEEP APNEA ACUTE NON ST ELEVATION MI HYPOTENSION ACUTE RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXIA
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: EL3246), in right arm, on 02Feb2021 as dose 2, single (Lot number: EL9263), in right arm, on 28Aug2021 as dose 3 (booster), single (Lot number: FD8448), in right arm and on 23Feb2022 as dose 4 (booster), single (Lot number: FJ5683) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Essential hypertension" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Type 2 Diabetes" (unspecified if ongoing); "Tinnitus" (unspecified if ongoing); "HCC Prostate Cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cephalexin, reaction(s): "known allergies Cephalexin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient was treated with antiviral drug (Paxlovid) from 25Jun2022 to 29Jun2022 with lot number (FY9918). The patient previously received a COVID-19 Vaccine.  No follow-up attempts are required. No further information is expected
on Monday night/early Tuesday morning after the vaccine on Sunday, swelling of the left side of face/neck concertrated in the jaw area. Called the vaccination site.  They said to take 2 Benadryl.  Called primary doctor, he called in a steriod.  On Wednesday after the vaccine, swelling of both feet.  Took another Benadryl.  Will start the steroid on Thursday.
Pt  began to feel tingling around mouth area and throat started feeling thick but not closing. Patient had her  own personal Benadryl on hand and administer 50 mg orally to self. Pt was watched for 20 minutes by EMT following administration- she reported her throat continued to feel scratchy.  Patient was driven and advised to go to emergency room. hospital was contacted per EMT and informed that patient was in route to hospital following a reaction to COVID-19 vaccine.
Patient already went through colon cancer treatment; now with new renal cell cancer in April needing surgery; then in August '22 has liver metastases
She did not have any problems immediately after the shot or waiting period.  She went back to work and all was normal until she went to meeting.  It was a little less than 4 hours after the shot.  She asked to have her temperature checked, then fell on the floor and collapsed. Her BP was 190/110, and her HR was very high, beating out of her throat and throat swelled up  she could barely breathe.  Normally, her BP is 120/80 and HR is usually around 68 BPM. She could not move her legs or arms, but she could move fingers.  This is an anaphylactic seizure that acts like a stroke  severe slurring of speech, cannot close eyes (but vision blurred), throat swells up and constricts airway, and she yells out uncontrollably.  She shivered like she was very cold, but she did not have any convulsions.  It lasted around 20 minutes. EMT who took care of her.  She could hear everything going on, but her vision was very blurry (could not see).  She was taken to Hospital. They checked her for stroke, did a CAT scan, and took her blood.  Everything came out normal.  She felt fine after it was over.  She was released at 8 pm to go home, and she walked out on her own. She feels that the 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC] in the vaccine may be what triggered her reaction as she thinks it may be closely related to steroids. She will NOT take the 2nd shot on advice of doctor.  Dr. has been her physician for 10 years.  Previous History:  Seizure reaction to steroids  happened 4 hours after took the steroid  this same anaphylactic like seizure happened with the steroid, exactly.  Present at that event were several people.   Patient says that this is the exact same reaction she had both when she took the steroid and following the COVID vaccine.
No additional adverse effect reported; Patient was administered a dose of improperly stored ROTATEQ; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 18-MAY-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # S028771, expiration date 09-APR-2021 (exact dose, strength and route of administration were not reported), for prophylaxis. The vaccine was stored at the temperature below 36 (F) for 16 hours which was registered by data logger. There was no previous temperature excursion. No additional adverse effects were reported.  This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-2005USA008265:
Patient received Moderna Covid19 vaccine at 1500.  Was instructed to wait in vehicle; five minutes passed and she proceeded to exit her vehicle to report symptoms.  As she approached assistant, she feel forward landing directly on her chin.  She loss consciousness for approx. 10 seconds. Was assisted to left side and was noted to have a 1 in laceration to the bottom of her chin.  "911" called for assistance.  She regain conscientiousness shortly after and  became alert and emotional.  She was assisted to her knees position as she became agitated and anxious.  Vital taken:  105/74 P: 72 R: 32 at 1507 At this point 1508 due to agitation Benadryl 12.5mg administered to L deltoid.  Patient began to complain about inability to mover her hands and feel her fingers.  Reassurance given that she was able to move her extremities as she was able to squeeze the hands of the nurse as commanded.  EMT arrived, report given to paramedic and care released to paramedic and transported to ED with family following.  As a note:  family reports that she has been newly diagnoses with anxiety.
Pain and swelling to left arm, patient states that arm turned blue then red. Patient reports swelling of entire upper arm. Patient reports fever of 100.8 and an increase in blood pressure. Patient was taken to the emergency room and diagnosed with an allergic reaction.
Severe chilling followed by a panic attack.  The next day experiencing pain on the outside of the right knee.  By 3rd day pain noticed in left and right arms, moving across the top half of the back above the shoulder blades.   Excruciating pain by p.m. of the same day preventing me from sleeping.   Unable to use arms to get a glass out of the kitchen cabinet.  Pain has moved around causing pain and swelling in joints, affecting the right and left arms, wrists, hands, legs.  Went to UTC where I was given a steroid shot.  The shot lasted about 24 hrs. and right back to the above symptoms.  Going to physician today hopefully for some lab work.  11 days of pain!
persisting body pain; profuse sweating; dizziness; headache; weakness; Stroke like soreness of the arms/crawling pain on right arm; This is a spontaneous report from a contactable other health care professional (patient). A patient of unspecified age and gender received first dose of BNT162B2, via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced persisting body pain, sweating, dizziness, headache, weakness, stroke like soreness of the arms/crawling pain on right arm on an unspecified date. Patient experienced crawling pain on right arm after 2 minutes that was injected the first dose. Patient had profuse sweating, dizziness and headache. After few hours, patient experienced weakness and persisting body pain. Stroke like soreness of the arms. Patient took ibuprofen (ADVIL). The outcome of events was unknown.  Information on the lot/batch number has been requested.
Did you/the patient previously receive a COVID-19 Vaccine?: Yes; Did you/the patient previously receive a COVID-19 Vaccine?: Yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, on 02Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 08Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LAMOTRIGINE; LOSARTAN; CRESTOR. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: If vaccine received: Yes. Other medication in 2weeks: Yes  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt received vaccine on 1 Feb and presented to the ED on 3 Feb with Abdominal pain, epigastric; Acute pancreatitis without infection or necrosis, unspecified pancreatitis type; Hypertension, unspecified type; SOB (shortness of breath).  He was discharged on 6 Feb 2021
Face became blood red and swollen as well as around eyes. Went to ER at local hospital, was given dphenhydramine  Benadryl 25 mg, Famotidne (pepcid) 40 mg and prednisone 50 mg ! Face is now still very pink and beginning to peal. Wear mask at work and have not used any make-up. Put face cream on at night to help with pealling.
Pt. was given Proquad (MMRV) and she was supposed to receive Varicella only.
About 2 hours after vaccine, patient experienced rapid heart rate, shortness of breath, difficulty breathing, and muscle cramps in his legs. He laid down for about 2 hours and considered calling his physician because he felt so bad. After he went to bed later, his sleep was restless with some continued shortness of breath. The following day, the symptoms were resolved except for muscle fatigue.
Pain, redness. Swelling approximately 6 through 15 cm distal to (R) arm shot.
LOCAL RXN R>L THIGH W/IN MINUTES - BLOTHCY ERYTH.
Mild urticaria after imm. given 25 mg BENADRYL with resolution of sx after 15 minutes.
Nurse Administered Overdose of Pfizer Vaccine to my son, I was in front of her when she did it, the syringe was thick with white liquid, it was full of liquid and it passed very slowly through the syringe, the nurse even accommodated her hand to continue injecting, long time passed and when she finished walked to the table, she said "crap' and after a few seconds she sent us to another room to wait 15 minutes I told the nurse what had happened and she didn't want to listen to me. She told me that it was impossible, I asked who was filling the doses of vaccine and she said the Nurse in the other room. I told her several times and she didn't listen to me. 2 weeks later on July 2, I went to my vaccine and I watched everything carefully, it was the same nurse who injected it, it was totally different, this time it was transparent liquid and a very little quantity, the syringe was very thin and it was very quick put on. Nurse said that the following Monday she would start her new job, 17 days after son's vaccine, I asked the doctor to check my son and do exams to know how he was, in case all that liquid in him has made his body wrong, because they put 6 complete doses on it, the Doctor didn't want to because he didn't want to believe me, my son didn't have any symptoms at the time. When I waited several months, after making several complaints they only answered that another department fills the vaccine and that 2 nurses count the doses to see if there was no waste. I think that the the 2 same nurses that where in charge of counting at the end of their work day both denied any wrong doing.
Patient fainted. Lost consciousness for a few minutes after receiving vaccine.  Patient stated that he had not eaten today and was anxious to get the vaccine. Once the patient woke up he was given cold water and orange juice to increase his blood sugar.
This spontaneous report was received from a nurse referring to a multiple patients of unknown age and gender. On an unknown date, the patients were orally vaccinated with improperly stored doses of oral, ROTATEQ (dose, frequency and indication were not reported) lot # K023534 with expiration date 22-MAY-2016. No adverse effects are reported. This is one of several reports received from the same source. Additional information has been requested.
Patient stated that her arm was red and soar the day after the vaccine was given,and that the hurting and the redness started to spread down her arm on Wednesday 3/29/17.  Patient stated that she had laser eye surgery earlier that day, and the reaction was worse by the evening.  Patient stated that today 4/1/17, her arm was itching.
Pre-syncope during physical exertion; This is a spontaneous report from a contactable consumer (patient). This 35-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0170) via an unspecified route of administration on 02May2021 at 11:30 (at the age of 35-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included persistent depressive disorder. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included escitalopram oxalate (LEXAPRO) and dexamfetamine sulfate (DEXEDRINE) from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 (lot number ER8737) on 05Apr2021 at 15:30 in the right arm for COVID-19 immunization. On 04May2021 at 16:30 the patient experienced pre-syncope during physical exertion. The event was reported as non-serious. The patient was not hospitalized for the event. The patient did not receive any treatment for the event. The outcome of pre-syncope was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Injection-site pain, positional soreness increasing in intensity for ~48 hours; managed/manageable with 1g APAP x2 p.o./per day (improving) Palpable warmth at injection site ( ~8hrs post-injection, ongoing) Moderate headache ~8hrs post-injection (intermittent); managed/manageable with 1g APAP x2 p.o./per day Mild-moderate fatigue (ongoing) Diarrhea (?); managed/manageable with 2mg loperamide (x1 p.o.) Nausea (?) mild; not treated
This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 12-MAY-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 984 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Does not have lot number. About an hour after getting the vaccine started with fast heart beat, felt like my heart was like "boom boom boom" and was really loud, sweating, weakness, runny nose.  Symptoms since then  have been on and off and steady for 5 hours today. Today it feels like my heart is in down in my lungs.
minor aches & pains & not feel completely well; lt shoulder/arm very sore; woke w/cold chills & sweats, muscles very sore; painful when walking; woke w/crust over eyes, had to open w/ fingers;
patient received Moderna vaccine approx 1 week prior, developed chest pain x 2 days, presented to ED with elevated troponin I, possible STEMI on EKG, appears to be myocarditis
Pregnancy was at 7 weeks at vaccination, additional blood clot discovered on 8/20/2021, birth ETA March of 2022. Adverse event occurred at about midnight on 8/12/21 - loss of ability to speak, loss of ability to walk with proper balance, loss of ability to focus, weakness and exhaustion, and difficulty keeping eyes open.  MRI performed several hours later revealed small brain bleed in front left lobe of brain.  Symptoms have abated for the most part, follow-through testing is being scheduled.  Visit to OB-GYN on 8/20/2021 included ultrasound to confirm pregnancy, second uterine hemorrhage was discovered, cramping and vaginal discharge occurred 8/19/2021.  Additional monitoring via ultrasound is being planned / scheduled.