chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This was a 58 year old female who received her 1st dose Pfizer on 4/6/21 (Lot# EW0175) and 2nd dose Pfizer on 4/27/21 (Lot# EW0151).  Of note, the patient was in a motor vehicle accident on 4/12/21 with a diagnosis of concussion and cervical/thoracic strain/sprain (see history under patient information).  On 4/29/21, the patient's sister contacted the patient's primary care clinic with the following documented concern:  "Pt's sister calling to report that two days ago pt got 2nd dose Pfizer vaccine and has been sick. This morning they found her passed out against the her bedroom door. Pt reports that she can't remember much other than going to the bathroom.  Pt's sister states that patient totaled her car a week ago, and that it was determined she had a concussion.  "She hasn't been herself since the wreck and I am very concerned." This caller recommenced the Ed or UC but caller denied stating that either needs to see her today. This writer is reaching out to nurse to see if they can advise from here." A RN assessed the patient virtually with the following documentation:  "RN note:  Call transferred from patient's sister.  Pt noted to be found on her floor this morning. Pt unsure if she hit her head.  Spoke to patient.  She reports body aches, and feeling weak.  Pt is slow to answer questions, and had a lot of difficulty hearing me (sister did not have any difficulty hearing me).  Pt is noted to have more rapid breathing, and some slight wheezing.  Speech is clear when she is speaking.  Sister gave patient water to drink.  She drank out of bottle and was able to hold on her own (though had difficulty with this at first).  Sister noted some water dripping down face, but was able to swallow okay.  Sister also noted that patient's lips seem to be pursed. Plan: Given recent concussion, and patients change in behavior per sister (pt more irritable, speaking more slowly, moving slowly, breathing faster, and wheezing), recommended patient be taken to the ED today--recommended ambulance since it took 2 men to help patient back to bed this morning.  Sister states patient is not agreeable to going to ED at this time.  Advised to try to encourage her to drink more fluids, and continue to monitor her sxs, and if any worsening, to call for ambulance transport.  Sister agreeable to plan, and will discuss with sister, and recommend ED visit today." On 4/30/21, the patient's sister contacted the clinic to inform them that the patient was found dead that morning.  The medical examiner is completing the further investigation. If additional information is needed from the primary care physician for this patient.
3 days later I was in the hospital with a heart attack. I was in CCU for 3 days. The muscle above my heart was inflamed and caused my heart not to do it?s job. I had tests run on my heart and my body and all conclusions came to the vaccine.
The day after receiving the vaccine, in the evening, the patient noticed her blood pressure was elevated, she had muscle fatigue (both arms and both legs felt very "heavy"), and she felt as though she might faint but has yet to have a syncopal episode.
pt came into clinic 23JUL98 lt upper thigh red, swollen, tender & itchy-scratches noted;this included 2/3 of anterior lt thigh;instructed to bring child to MD;27JUL98 saw MD was told it was an allerg rxn;nothing prescribed;
21Oct96 Pt recv 1 dose vax. 01Feb98 Pt devel chickenpox, approx 25 lesions
while administrating Menactra some of the vaccine leak from the injection site of the left arm after the syringe was removed from the arm, No AE; syringe was removed too quickly after injection and some of the vaccine leak from the injection site of the left arm, No AE; while administrating Menactra some of the vaccine leak from the injection site of the left arm after the syringe was removed from the arm, No AE; Initial information received on 24-Jul-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 18-year-old male patient who received 0.5 mL second dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6586A, expiry date 14-Apr-2021, via an intramuscular route in the left arm) for prophylactic vaccination on 24-Jul-2020, which leak from the injection site after removing syringe too quickly from the arm.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) for prophylactic vaccination on 24-Jul-2020.  It was a case of vaccine underdose, wrong injection technique and product leakage.  The nurse reported that the patient was very muscular and one inch needle was used, the syringe was removed too quickly after injection and vaccine leaked and with another vaccine given on the other arm the syringe was not removed as quickly and no vaccine leaked arm.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Syncope, nausea Refused Benadryl PO Pepcid, 20 mg given @ 0910
pt recv vax 16JUL96 & given motrin for fever control;pt exp fever few hr p/vax & was fussy;17JUL96 had a sz episode & was taken to ER, t105;p/sz pt cried for a period of time & held head back;18JUL96 pt playing & seem okay @ 830AM 18JUL96;
has migraine and arm pain; has migraine and arm pain; This is a spontaneous report received from Pfizer sponsored program. A contactable consumer reported for female patient.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot number: unknown), via an unspecified route of administration on 16May2021 as dose 1, single for COVID-19 immunization. No medical and concomitant medication history were reported. The patient experienced has migraine and arm pain. Wanted to know if patient can take Tylenol and also wanted to know if tylenol can affect the effectiveness of the vaccine. Outcome for the events was unknown.  Information on the Lot/Batch number has been requested.
24 hours after pt received vaccinations she developed hives on legs where shots were given. Within the next 24 hours she developed  hives, erythemtous macules with raised papules on eyes, arms, trunk, face, hands. 48 hours later pt developed fever, 99-100 F and diarrhea.
I was vaccinated last Wednesday, March 24, at 8 pm with the Janssen vaccine.  As soon as I was vaccinated (on my left arm), I put on my coat and I felt a brief  and sharp pain in my left arm. And nothing else. On Friday night, I felt a very slight tingling in my left hand. And pain in the upper arm, in the region between the place where the vaccine was applied and my elbow. This pain seemed to spread to the forearm. Since then, I have tingling / numbness in my left hand and forearm and pain throughout my left arm, left shoulder, upper left center of the back and neck. And these pains and numbness have been increasing every day. Ten days have passed since the vaccine was applied and the condition only worsens. I took Voltaren in the last 3 days and the pain has not subsided. I am worried and scared. Was it a case of thrombosis or pulmonary embolism? In addition, I saw in the CDC information that, during the JNJ vaccine tests, there was a case of a severe reaction called brachial neuritis; as I didn?t know what it was, I did a Google search and, apparently, the symptoms I have coincide with those of this disease. Anyway, what do you advise me to do? I have waited until now imagining that the pain and numbness would lessen. But the opposite happened and everything just makes it worse. I look forward to feedback and guidance. I haven't been to a doctor yet, but it looks like it will be necessary. Thanks.
I experienced tiredness immediately after my shot, flu-like symptoms, aches all over in my joints, weakness and these symptoms lasted for 10 days.
Myalgia, Fever, NauseaVomiting, abdominal pain, injection site pain, chills Narrative:  After receiving the vaccine, the patient reported muscle aches, injection site pain, abdominal pain, nausea, and fever/chills (temperature unknown). She took one dose of acetaminophen 650mg.  Other Relevant History:
Technician inserted needle into my left arm, acted as though I was given a shot and then said oh my I am not sure if there was any vaccine in the needle, let me give you another shot. I declined a second shot because I was unsure of potential adverse effects if in fact there was serum in the needle. She stated she was going to contact the CDC in the morning to get instruction on what to do next. She also stated she would review security cameras to see if she had prepared the shot correctly and that she would contact me the next day. Upon leaving my husband called and spoke with her insisting she review the cameras at that time. She claimed she did and that she was 99% sure she gave me a proper injection. This morning she left me a voicemail advising me to return to the pharmacy. In the meantime I contacted CDC myself to be sure I was given proper direction. I have also contacted the office of my physician as I was told to do by CDC nurse.  At this time I am awaiting direction from CDC and my physicians office.
Pt given vaccine and came back to the office about 4 hours later with a large painful, warm, red, itchy, swollen and hard lump at the injection site.
Hives. On 06/10/2019 at 10:30 PM, noticed the hives on both sides of face about an inch away from each ear.  On 06/11/2019, the hives also appeared on both sides of the neck and down the back.  On 06/12/2019, the hives on the back are beginning to itch.
20 days p/ vax pt devel clinical varicella, 23sept pt exp itchy eyelids & eyelid swelling.
Patient got ringing in the ears the day that he got these vaccinations. It improved with Sudafed but still remained. It was worse at night.
Soreness at injection site and mild headache began within 8 hours of Pfizer COVID-19 vaccine. Headache subsided after 3 hours and soreness subsided after 2 days following vaccine.
This spontaneous report as received from a physician refers to a patient of unknown age. It was reported that the patient was vaccinated with five doses of PNEUMOVAX 23 in the year of 2012. No adverse effect reported. It was unknown if the patient sought medical attention or not. Additional information is not expected.
At 1:57pm, Pt c/o of 'headache and lightheadedness' VS 140/100, 78, O2 stat-98%, R-18, still c/o of headache, increased pressure on neck, back of head, and on top of head.  At 2:25pm, VS 150/94, 75, 20, RA-99%, applied cold pack, advised to stay for additional 15 minutes, during this time denies HA, no more pressure on neck/back of head.  Pt stated, 'she didn't have any lunch'.  Pt's girlfriend got snack from vending machine, ate snack and water, pt felt better.   At 2:48pm, VS 140/90, 78, O2 stat-99%, 18, denies HA, feels "better". Cleared for discharge, and educated pt to go to nearest ER if any symptoms get worse  at home.
Left shoulder pain, loss of range of motion in left arm accompanied by pain when in certain reaching positions, pain at night sleeping on left arm. Pain has not gone away and range of motion has only improved slightly with 10 weeks of physiotherapy.
reported child developed a fever early this am with possible febrile seizure.  Child was placed down for afternoon nap mother went in room to check on child realized something wrong/ not moving/responding turned child over and discovered child was blue.  Coroner did note child had had an emesis.
patient report that after 5 mins after getting the shot she started to have pain and tingling in her right arm down to fingers...stayed at the pharmacy an additional 5 mins and was told to  move arm around...slight numbness at her temple going down to cheek bones...
No adverse effects; tbe one patient was administered one dose of improperly stored ROTA TEQ (lot number R002805, expiration date 9/23/2019) on 8/6/2019; This spontaneous report was received from a registered nurse and refers to a 3-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.     On 06-AUG-2019 (also reported as 13-AUG-2019), the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R002805, expiration date: 23-SEP-2019, orally (exact dose was not reported) for prophylaxis. No adverse effects were reported. The vaccine was exposed to a temperature excursion below 2 degree Celsius (C) (-2.6 degree C) for a time frame of 1 hour 4 minutes, for one cycle. The digital data logger was involved in recording the temperature excursion details. There was no previous temperature excursion.
Warmth, edema and erythema at the injection site in the right deltoid. No pain, no decrease range of motion.
lumps formed in her breast; lymphatic reaction; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 dose 1 for covid-19 immunization and experienced breast sensation / Let down response. On an unspecified date the patient experienced a lymphatic reaction and lumps formed in her breast. She was currently undergoing close monitoring to determine the severity. The clinical outcome of the event was unknown at the time of report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
flu like symptoms; I felt immense chest and throat burning (seemed like heart burn); I felt immense chest and throat burning (seemed like heart burn); I felt immense chest and throat burning (seemed like heart burn); painful back pain around the thoracic spine; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0164) via an unspecified route of administration, administered in Arm Left on 18Apr2021 08:00 (at the age of 36 years old) as dose 2, single for COVID-19 immunisation at hospital. Medical history included gastritis, asthma, depression, and seasonally allergies, all from an unknown date and unknown if ongoing. Concomitant medication(s) included bupropion hcl (BUPROPION HCL), citalopram (CITALOPRAM), both taken for depression, start and stop date were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8734) via an unspecified route of administration, administered in Arm Left on 28Mar2021 08:00 (at the age of 35 years old) as single for COVID-19 immunisation. Patient did not received other vaccine in four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. The patient experienced flu like symptoms, i felt immense chest and throat burning, painful back pain around the thoracic spine on 19Apr2021 12:00. Reported as, adverse event revived 2nd dose of Pfizer COVID-19 vaccine and within 12 hours experienced flu like symptoms which all seemed normal based on CDC symptom reports. However, about noon the next day I felt immense chest and throat burning (seemed like heart burn) and painful back pain around the thoracic spine. It took almost 3 hours for it to subside even after taking antacid (tums) for relief. Patient currently taking antidepressants (Bupropion HCL one dose in morning and Citalopram one dose at night) and wonder if the vaccine caused a reaction to the antidepressants. Therapeutic measures were taken as a result of i felt immense chest and throat burning (seemed like heart burn), painful back pain around the thoracic spine. Patient did not tested for COVID post vaccination. Outcome of all the events were recovered on Apr2021.  No follow-up attempts are possible. No further information is expected.
Period came 5 days early and lasted 18 days (normally 7 days).  Then next cycle started 8 days later (normal next time frame as get period every 26 ish days).  Next period was very heavy having one day that used 7x 10 hour sanitary napkins in one 12 hour time frame. No treatment needed so far.  These cycle changes have never occurred before.
no adverse event; patient was administered an expired dose of VARIVAX; This spontaneous report was received from a registered pharmacist and referred to an unknown age and gender patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 15-SEP-2022, the patient was administered an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot #T009587, expiration date: 18-MAR-2022, administered for prophylaxis (strength and route of administration were not provided) (expired product administered). The reporter confirmed vaccines was stored at the recommended storage range until administration and not involved in any temperature excursions. No additional event was reported (no adverse event).
PATIENT RECEIVED VACCINE 9/14/18 CALLED PHARMACY 9/15/18 SAID SHE WAS EXPERIENCING REDNESS EXTENDING DOWN ARM, WARMTH AND SWELLING IN THE FINGERS AND SHE SAID SHE HAD ALREADY TAKEN BENADRYL AND IBUPROFEN. A COLD COMPRESS WAS SUGGESTED IN ADDITION. CHECKED ON PATIENT AGAIN 9/16/18 AND SHE REPORTED NO IMPROVEMENT AND SAID SHE WOULD BE SEEING HER PRIMARY CARE DOCTOR ON 9/17/18. AFTER SEEING PRIMARY MD 9/17/18 SHE CAME BY PHARMACY ARM REMAINED RED WIDESPREAD EVEN SOME BELOW ELBOW AND REPORTED SWELLING OF FINGERS. PRIMARY MD PRESCRIBED 5 DAYS OF PREDNISONE THERAPY.
Patient developed a local reaction after administration of vaccine.  Area is reddened with small bumps in the area the vaccine was given left upper arm.
I24.8 DEMAND ISCHEMIA 1/31/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA J96.00 ACUTE RESPIRATORY FAILURE 1/31/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/31/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA I24.8 DEMAND ISCHEMIA 1/31/2022 ACUTE RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 1/31/2022 ACUTE RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/31/2022 ACUTE RESPIRATORY FAILURE
woke up about 12:30 am Friday 3/12  with signs of fever (too sick to look for thermometer) , sweats, chills, vomiting,  until about 5am.   I was very sicks.  Then continued with fatigue, nausea, terrible headache and neckpain until about 5pm on Saturday 3/13.  At that point everything seemed to have passed.   I could not go to work on Friday 3/12.   Been fine since 5pm on 3/13.
Severe ringing in left ear, sudden full deafness in left ear and continues tinnitus
Vertigo, fever, chills: 12 hr after vaccine; lasted a few hours.   Acute diarrhea: 1 day after vaccine; lasted 1 week.  Migraines: 1 day after vaccine; lasted 1 week.
expired vaccine being administered to a patient with no adverse event; Initial information was received on 23-Sep-2021 regarding an unsolicited valid non-serious case received from a Nurse and consumer or non-health care professional via Medical Information - 00782397.   This case involves 67 years old male patient who was vaccinated with expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Expired product administered).  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2021, the patient received a dose of 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ499AB and expiry date 30-Jun-2021) via intramuscular route in the right deltoid, for prophylactic vaccination.  It was reported "Nurse calling in regards to expired FLUZONE HD PFS being administered to a patient. Caller would like to know if the patient needs to be revaccinated, if so when and if it would cause a problem".  It was a case of an actual medication error due to expired vaccine used (latency was on same day).   At the time of report, no adverse event reported.   Outcome of event was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I had runny nose that would not stop, I had trouble breathing, a cough deep in my chest, headache. I called made an appointment to see my doctor who did both a COVID-19 and influenza test, both came back positive. I was prescribed TAMIFLU, additional breathing treatments. I do feel better no but it took until 12/10/22 for me to finally feel like myself.
Vesicular rash in clusters and diffuse distinct lesions with macules and papules, fever. Started with 2 spots then spread. AUGMENTIN, Calamine, TYLENOL, MOTRIN.
WE ALL GOT DEATHLY ILL; A spontaneous report has been received from a consumer. The report concerns a female patient  of Unknown ethnic origin.    No medical history and  concomitant products were reported.    The patient received Flumist (influenza virus vaccine live, intranasal) once/single administration, via nasal route, on an unknown date.     It was reported that patient family doc convinced her family to get this and stated we all got deathly ill (preferred term: Ill-defined disorder). Patient just do probiotics n vitamins.     The outcome of we all got deathly ill was unknown.    The we all got deathly ill was considered non-serious by comapny physician.
Nurse gave Varivax that expired 08/22/2020; This spontaneous report was received from a customer via email and refers to an adult patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) that expired on 22-AUG-2020, (dose, anatomical location, route of administration and lot# were not reported) for prophylaxis.
Around 8pm on the day on my vaccination, started having chills and a fever. These were the worst chills I have ever had. My whole body was shaking. I think that the chills ended around midnight. I lost my appetite the evening that I got my vaccination, haven?t regained my appetite yet, and I became somewhat nauseous. I haven?t thrown up yet. The morning the day after my vaccination I woke up and my abdomen was hurting a little bit. I was hot most of the night into the next day.
Facial nerve zoster & meningitis (70 WBC) facial vesicles & CSF (+) PCR VZV -> sent to CDC, confirmed OKA strain. Limited immune evaluation normal.
RECEIVED PNEUMOCOCCAL VACCINE 12/0/05 IN RIGHT DELTOID. 12/09/05 INJECTION SITE EDEMATOUS AND ERYTHEMATOUS TO ELBOW.
Extreme body aches started about Midnight the day of the shot.  A fever of 103 began at 12:30 AM. I took Acetaminophen when the fever began but it did not reduce the fever. The fever and extreme chills persisted for 24 hours.  Also, a headache was persistent the whole time of the fever and after the fever subsided.  A sore arm around the injection site started soon after the shot and has continued.  A raised red area about the size of 4 inches in diameter started appearing 24 hours after the shot.