chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: Patient was not previously Covid psitive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing and adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there and ADR that occurred between the observation period and the date of death. Patient presented to ED on 3/16/21 adter his ICD activated due to an episode of vtach. His hospital stay progressed to an inability to void urine, worsening renal function, dysphagia, and anemia and anemia from a splenic bleed requiring blood transfusions requiring a transition to palliative care before he deceased on 3/26/21. Patient had a PMH significant for HFrEF w/ICD, CAD s/p CABGx5, HTN, Afib, and vtach.
fever (Tmax 102.6) and crying inconsolably seen at ER flu (-) RSV (-) KUB (-) seen in office normal exam, reassurance given
Information has been received from a registered nurse concerning a kindergarten student who on 03/29/2001 was vaccinated with a dose of varicella virus vaccine live.  In mid December 2004 the student developed chickenpox.  According to the school nurse, there were 58 other elementary school students who developed chickenpox in mid December 2004 and 34 of them had been previously vaccinated with a dose of varicella virus vaccine live.  Unspecified medical attention was sought.  There was no information regarding the present status of the kindergarten student.  No product quality complaint was involved.
Shortness of breath, severe headache, chest pains, swollen injection site swollen breast
Swelling under left armpit; Very sore to the touch; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6205), via an unspecified route of administration, administered in arm left on 04Mar2021 11:00 (at the age of 58-years-old) as dose 2, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included osteoarthritis. The patient had also known allergy to ZPac. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]); paracetamol (TYLENOL ARTHRITIS); and acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE); all were taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9265), administered in left arm on 13Feb2021 04:30 PM (at the age of 58-years-old) as dose 1, single for covid-19 immunisation. On 06Mar2021 03:00 PM, the patient experienced swelling under left armpit, and it was very sore to the touch. It was unknown if the patient received any treatment for the reported events. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Vaccines were given Monday 11/20/06 in the evening. Tuesday afternoon 11/21/06 client C/O left arm being sore, red and hot to touch. Client also C/O feeling feverish. Tuesday evening after work her symptoms continued to worsen. She had a temperature 101.5 degrees F and took some Tylenol for relief. Client began to feel weak and tired and went to bed early. She woke up in the night and her left arm was swollen and tender. Her temperature was 100 degrees F. Client stayed home from work Wednesday. She C/O feeling feverish and weak and her arm hurt a lot. By Thursday a.m. she felt she was getting very sick so she went to Hospital Emergency department. Client states she was given antibiotics by I.V., arm marked to indicate progression of swelling and she was sent home with an oral antibiotic, Augmentin to take. Friday she returned to emergency room and was admitted. She was diagnosed as having cellulitis. Client was given I.V. antibiotics and stayed 2 days. She was again discharged and put on oral antibiotics, Augmentin. Today, Monday 11/27/06 client states she is feeling better. her left arm is still red, swollen and tender to touch but not as bad as it was. She will follow up with02/16/07-her own doctor.for 2/16/07-Records reviewed DOS 11/23-11/25/06 DC DX: Cellulitis ADmitted with fever of 101, increased redness over left arm. PE: WNL except for left arm erythema with mild induration at the site of the prior vaccination, no abscesses or crepitus. Local increased warmth, mild lymphadenitis in the axillary area.
Patient reported feeling tingling in her arm and hand immediately following vaccination.  She states it has been off and on  the last few days.  She states is has not been spreading or getting worse.  Patient read about vaccine and fear she was experiencing Guillan-Barre.
UNABLE  TO TURN NECK RIGHT OR LEFT; NEUROMUSCULAR WEAKNESS; PAIN ON LEFT SIDE/ PAIN BELOW CLAVICLE, TOWARD EAR/ PAIN IN DEEP IN CLAVICLE OF NECK; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was physically fit. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced pain on left side/ pain below clavicle, toward ear/ pain in deep in clavicle of neck. On MAR-2021, the subject experienced neuromuscular weakness. On 23-MAR-2021, the subject experienced unable to turn neck right or left. Treatment medications (dates unspecified) included: ibuprofen, diclofenac, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neuromuscular weakness, pain on left side/ pain below clavicle, toward ear/ pain in deep in clavicle of neck, and unable to turn neck right or left. This report was non-serious. The suspected product quality complaint has been confirmed to be voided based on the evaluation/investigation performed. This case, from the same reporter is linked to 20210733561.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
abdominal cramps turned to diarrhea; abdominal cramps turned to diarrhea; This is a spontaneous report via a Pfizer sponsored program Covax US Support from a contactable consumer, the patient.   A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05Mar2021 as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient received BNT162b2 first dose on 05Mar2021 and experienced side effects, abdominal cramps turned to diarrhea from yesterday and today (in Mar2021). She is not dehydrated. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
OBSTRUCTIVE SLEEP APNEA 12/30/2021 THROMBOCYTOPENIA, UNSPECIFIED (UNKNOWN ETIOLOGY)
PT WENT TO THE EMERGENCY DEPT ON 03/13/05 D/T UPPER RESP INFECTION ALSO C/O FEVER AND SWELLING AT INJECTION SITE WHERE IMMUNIZATIONS WERE GIVEN 5 DAYS PREVIOUSLY. FOLLOWED UP HERE ON 03/15/05 AND STILL HAD SOME INDURATION ON LEFT THIGH AREA. WAS GIVEN AMOXIL IN WHICH PT IS ALLERGIC & WAS DISCONTINUED.
Started in the middle of the night the day after I got the vaccine. Intense itchiness in different parts of my body. It started in my thighs with bumps showing up. I'm still experiencing it today, 5/31. I only started taking Benadryl yesterday. It helps a little but once it wore off, the itchiness comes back.
Erythema and swelling (R) arm distal to site of the injection. Evaluation by MD who advised OTC BENADRYL as well as KEFLEX 250mg 1 QID x7 days.
I DONT HAVE ANY SYMPTOMS I WANT TO REPORT THAT IAM TRYING GET  MY EXCELSIOR PASS WALLET AND IT KEEP STATING MY INFORMATION CAN BE FIND , I NEED TO KNOW WHERE THIS INFORMATION IS BEEN REPORT , NOW IAM NOT ABLE TO START WORKING . MY WORK  NEED MY INFORMATION TO BE UPLOAD INTO THIS APPLICATION .
fever; headache; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever) and HEADACHE (headache) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PYREXIA (fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PYREXIA (fever) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by reporter.
Shooting pain in cheeks, ear (perhaps due to nerve endings)?; painful headache; brain fog; extreme fatigue; fever (not over 100 degrees F; muscles in legs feel like I hiked 20 miles (still hard to walk since Saturday, 3-27-21 and until  today, 3-29-21 and I usually walk a mile/day); injection site red and swollen to  to size of 2  silver dollars, as per husband.  The first injection was on 2-26-21 and not a major problem (tired and slight fever for a couple days).  I don't know if I had this reaction from injection #2  due to having Multiple Sclerosis?
This spontaneous report as received from a medical assistant refers to a 5 year old male patient. The patient's medical history was not reported. On 11-JUL-2014 the patient was vaccinated with VARIVAX and was also administered a dose PROQUAD. M-M-R II was the vaccine prescribed not PROQUAD. No adverse effects were reported. Additional information has been requested.
Patient received vaccine within a minute of sitting down she became pale and had a blank stare. Her arms and legs became extremely rigid and she became to shake. This lasted for 15 seconds, patient regained consciousness she had voided herself, she complained of being tired and dizzy. She laid down and drank water for 20 minutes, she tried to stand up and quickly felt she needed to vomit. Patient stated she had not eaten or drank that morning. I used my professional judgement and at this time I called an ambulance. Student with the assistance of her boyfriend walked outside the clinic and refused to go into the ambulance. She stated she felt better as soon as he stepped outside. Patient was contact today 09/09/21 by the medical assistant and ensured she was feeling well without any other adverse reaction.
Inflammation & tenderness to (R) deltoid area. Seen 8/9/12 vaccine admin. 8/7/12.
my only side effect was a sore injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 68 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJECTION SITE PAIN (non-serious), outcome "unknown", described as "my only side effect was a sore injection site".  Additional information: The reporter a Healthcare Professional was unknown.The reporter the prescribing HCP as no.The reporter's contact information available to you or a sub-contracted party as yes Verbatim and Event Description: Consumer called to check if Pristiq enrollment is still active. During call stated how getting second second Pfizer shot."my only side effect was a sore injection site."The following information was not confirmed during the call, but retrieved from the system: Patient DOB, Reporter Address, The following information was not provided during the call: Patient gender.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.  No further information is expected.
Narrative: COVID infection following COVID vaccine seriesw 03/27 COVID  vaccine dose #1 04/16/ COVID vaccine dose #2 12/19 presents to ED c/o left ear pain, sore throat, body aches, chills, dizziness x 1 day; COVID positive; rx'd vit D, vit C, dexamethasone, albuterol 12/21 pt c/o myalgias, sore throat, ear aches
I had COVID 10/2020 and has long haul COVID symptoms. In hospital in Oct/Nov/Dec2020 before the vaccine. Triggered the COVID symptoms that long haul COVID symptoms, fatigue and GI, diarrhea, a couple month, lost 30 pounds in weight. the migraines were not like the usual migraine and it was weird and awful. Normal migraine starts by my eye, but this starts from the bone from my ear and left eye then it pain explodes, then I have nausea, vomiting and cant tolerate the light and sound. my skin burns and I cant stand being touched. I am down in bed. A couple months I went to Urgent care. My bones hurt, the pain and fatigue is bad. It a different type of fatigue from my MS.
Initial misuse report received from a healthcare professional on 03 February 2014. A patient had received a dose of ADACEL rather than a Tdap by mistake on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Following second COVID-19 vaccination on 4/27/21, patient experienced diaphoresis/rigors, nausea, myalgia, headache, extreme fatigue, and chest pain starting on 4/29/21 around 8 pm.  Patient presented to the emergency department at Hospital on 4/30/21 and was found to have an elevated troponin.  Transferred to another Hospital where patient underwent cardiac catheterization and ECHO and was admitted to the hospital.  Patient was discharged from the hospital on 5/1/21 following negative findings on diagnostic exams and resolution of troponin level.
Covid test with nasal swab last week and it came back positive; Covid test with nasal swab last week and it came back positive; This is a spontaneous report from a contactable consumer (husband). A 67-year-old female patient (wife) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the right arm on 09Jan2021 at a single dose as Covid-19 vaccine. There were no medical history and no concomitant medications. The reporter called and stated that he and his wife received the first dose of the Pfizer-BioNtech Covid-19 vaccine 3 weeks ago on 09Jan2021, they were ready to receive the second dose of the vaccine; however, last week his wife took a nose swab test and she was positive for Covid-19 on Jan2021. The patient did not visit physician office/emergency room. She felt fine. They would like to know if they could receive the second dose or if they should wait. They had the first shot (Covid-19 Vaccine by Pfizer) he and his wife, and they have an adult child living with them, he didn't qualify because of the age. Their 3 weeks were up and they had been notified to get the second shot, he and his wife, now in between she took a Covid test with nasal swab last week and it came back positive, could they still take it, the second shot? And then what were the chances with them having the first shot, was why she tested positive? No treatment was received for the events. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
LITTLE BLOOD SPOT UNDER SKIN ON RIGHT ARM; A LUMP AND POOL OF BLOOD INSIDE BEND OF RIGHT ARM TO THE RIGHT SIDE; FRESH BRUISING; This spontaneous report received from a patient concerned a 68 year old female. 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: 201A21A expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced little blood spot under skin on right arm, a lump and pool of blood inside bend of right arm to the right side, and fresh bruising. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from little blood spot under skin on right arm, a lump and pool of blood inside bend of right arm to the right side, and fresh bruising. This report was non-serious.
Persistent soreness at injection site outer deltoid area to just above elbow. Aches, esp at night.
Child received Varivax, developed nickel sized raised area hive at site, ice applied and 3 tsp BENADRYL given per doctor, received in 30 minutes, area much less swollen.  Informed mom to continue ice and BENADRYL every 6-8 hours when as needed, no difficulty breathing, no oral swelling, no wheezing, no other hives.
large red circle at the injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced a large red circle at the injection site.
Right after vaccine was done: Light headed,  severe sweat, nausea, hives and itchiness on on half body where injection was done next day after the vaccine, had to take Benadryl
Patient fainted in observation area about 5 minutes after vaccination; heart rate dipped to 30's at one point.  O2 administered (15 LPM via NRB).  BP remained stable at 120/76.  Vitals taken at 1214, 1221, and 1224.  At 1230, pt was transported via ambulance to hospital emergency department.
Red, swollen, painful and warm-to-the-touch arm at injection site. Currently the diameter of an average orange  Full body aches (similar to the worse aches with the flu)  Joints aches  Extremely sensitive skin to-the-touch Very tired
area of injection is also itchy but is not as bad as her back; experiencing terrible itching on her right shoulder and shoulder blade area/ no pain, only itchiness; rash on her right shoulder blade area of her back.; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (area of injection is also itchy but is not as bad as her back), PRURITUS (experiencing terrible itching on her right shoulder and shoulder blade area/ no pain, only itchiness) and RASH (rash on her right shoulder blade area of her back.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced INJECTION SITE PRURITUS (area of injection is also itchy but is not as bad as her back), PRURITUS (experiencing terrible itching on her right shoulder and shoulder blade area/ no pain, only itchiness) and RASH (rash on her right shoulder blade area of her back.). At the time of the report, INJECTION SITE PRURITUS (area of injection is also itchy but is not as bad as her back), PRURITUS (experiencing terrible itching on her right shoulder and shoulder blade area/ no pain, only itchiness) and RASH (rash on her right shoulder blade area of her back.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment included Tigerbalm and Benadryl; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Rash and injection site pruritus are consistent with the known safety profile of mRNA-1273
Patient called pharmacy on 11/1/2014 saying she could not raise her arm above her head and had to take Tylenol for the pain.  On 11/5/2014 she said it was getting better.
Per vaccinator's account, patient became unresponsive immediately following IM injection at 1440 into left deltoid and slumped down in chair. Vaccine Floor Manager (reporter of this Adverse Event) was called over who then radioed for the on-site paramedics to respond. Vaccinator verified patient was still breathing. She was bradycardic with a pulse in the 40's per vaccinator. Within 15-20 seconds of becoming unresponsive, patient became responsive as paramedics came into vaccine room. Paramedics took vitals and measured a systolic blood pressure of 80 and pulse 44-50 BPM, 98% oxygen. Patient was alert and oriented at this time, transferred to a transport chair and sent to on-site Emergency Room for further evaluation.  As staff were leaving the clinic site at approximately 1630 (including this reporter), we encountered patient self-ambulating in no apparent distress back to her car having been discharged from the emergency room.
Since having Covid, I have this Raspatory infection, chest pain and sore lymph nodes. I do have a little bit of side pain.
experienced a fast heartbeat/heart rate went up to the 160s; sweaty; dizzy; Heart threw a few PVCs; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3249; Expiration Date: 31May2021), via an unspecified route of administration, administered in deltoid left on 22Jan2021 as 0.3 mL, single for covid-19 immunisation. Medical history included sensitive to drugs from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took celecoxib (CELEXA) and experienced ventricular extrasystoles, dicycloverine (BENTYL) and experienced ventricular extrasystoles and heart rate went up to 180 and blood pressure dropped. She has had this [premature ventricular contractions (PVCs)] occur a few times before, a history of it. Sometimes it occurs with medicines. Stated she is sensitive to drugs. Added, this occurred with Celexa, every 5-10 beats she would throw PVCs and it occurred until she was weaned off and stopped Celexa. The PVCs also occurred with Bentyl. When she took it her heart rate went up to 180 and her blood pressure dropped. She had to be taken by ambulance and was given fluids and she believes diphenhydramine (BENADRYL) and some other things, but she is not sure. The patient got her first COVID vaccine and experienced a fast heartbeat, felt sweaty and dizzy. She was wondering if what she experienced after the first shot a normal side effect and if it would be worse with the second dose. After the first COVID vaccine shot (after the ten-minute wait), her heart threw a few PVCs, her heart rate went up to the 160s, she was sweaty, and dizzy. She had to pull the car over. Stated she is worried about getting the second dose. Wondering if this reaction could be worse. Initially stated these events all resolved that same day, but then she followed up and clarified sometimes she still feels her heart throwing PVCs again. The patient stated she turned her car towards the Emergency Room (ER), but she ended up talking herself out of going. The patient underwent lab tests and procedures which included heart rate went up to the 160s on 22Jan2021 (fast heartbeat). The outcome of the event Premature ventricular contractions was not recovered while of the rest was recovered on an unspecified date.