chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling appeared not only at the injection site, but my shoulder was swollen half way between my neck and my back.  My left arm was swollen to the tip of my fingers.  My left leg was swollen to my toes.  The right side of my neck hurts when I turn my head to the right. I am using Tylenol and am slowly recovering from some of the swelling.
nurse rpts that 5 doses of vax from same vial resulted in inject site nodules approx the size of a quarter; nodules appeared w/in 48-72 hrs & persisted from approx 7-8 days; no tx initiated; several pts were seen by MD; pt recovered;
On 01/05/01, the patient was seen at the clinic for a nurse visit, complained of reaction to injection. Left upper arm swollen, outer surface red, warm, complaints of discomfort, and some itching. Patient instructed to use Benadryl. On 01/08/01, reported that the patient is resolved by 01/07/01 in the PM.
I usually have normal blood pressure of 120/80. The blood pressure went as high as 160/84 and 155/92. My heart rate was resting at 115 for hours at work, which is abnormal for my heart rate. I checked into the ER  around 5:30 pm. The ER gave me a bag of fluid and an EKG. The EKG came back normal. This all happened on March 17, 2021.
36 hours after vax: fever, chills, sweats, extreme dizziness, almost fainting, general muscle/joint aches, no appetite, nausea. Like a bout of flu. Now in 4th day and still very weak, a bit light-headed; no appetite.
Information has been received from a nurse concerning a female co worker (age not reported) who on 28 Nov 2006 was vaccinated intramuscularly in the deltoid with the first single dose vial of HPV vaccine. The nurse reported that the patient had an experience during and immediately after being vaccinated. The nurse reported that when the patient was given the shot, she started screaming almost immediately and reported that she did not feel well. The nurse also reported that the patient felt like she was going to pass out and was feeling nauseated. The patient was sent home from work and was now out a second day from work. The patient sought unspecified medical attention. At the time of this report, the outcome of the events were unknown as the patient had not returned to work. Additional information has been requested.
Injection site swollen, red, itchy and feverish about 2 inches in diameter. I noticed the irritation last night after I got home from work, about 6:30 pm, the Injection site started itching. 24 hours later no change. Spoke to Infection and Disease control and she suggested I report it.
Local reaction 2in x 3in erythematous, no induration, no pain. Trunk and extremity with rash.
This spontaneous report as received from a Medical Assistant refers to 6 months old infant, gender not reported. On 04-DEC-2014, the patient was vaccinated with ROTATEQ, Lot # K004620, orally. It was reported that the administered vaccine was subject to temperature excursion during storage. No adverse event reported. This is one of the several reports from the same reporter. Additional information has been requested.
At injection site (L) deltoid-pt developed a large nodule with increased erythema/edema, increased pain/itching appeared as if cellulitis (maybe it was). Treatment: cold compress, rest, Benadryl 25 mg once po every 4-6 hrs, and EES 500 mg once oral bid x 7 days.
Initial report received from a healthcare professional on 09 August 2013. A 54-year-old female patient had received an intramuscular dose of ADACEL vaccine (batch number: U4655AA, expiry date: 12/13/2015) in the right deltoid on 07 August 2013. The patient's medical history included anxiety, polyps, bursitis, depression, emphysema, chronic bronchitis, "onychimosis", migraine, scholiosis, tendonitis and spondylosis. The patient had no known drug allergies (NKDA). The patient had received Cortisone shot within a day of the vaccine, not related to the injection site. On 08 August 2013, the patient developed golf ball sized raised area, with itching, swelling that became red, hot, indurated and tender to touch. The patient required ER/doctor visit. Laboratory investigations and corrective treatment were not reported. At the time of this report, the patient had not recovered from the events. List of documents, held by sender: None.
Moderna vaccine was administered outside of the clinic - reported by patient ? NO LOT NUMBER WERE SUPPLIED   ACUTE PULMONARY EMBOLISM 10/2/2021 CANCER METASTATIC TO VERTEBRA
Approximately 5 minutes after vaccine administration, complained of nausea and lightheadedness followed by facial flushing and mild shortness of breath. Was escorted to ED within approx 5 minutes, and triage vitals were:  T  97.7, RR 24, HR 83, BP 152/99 with noted facial flushing by healthcare staff. Was given 1L IVF, 25mg IV benadryl, and IV 4mg zofran. Resolution of facial flushing in approx 10 minutes, and other symptoms improved. No urticaria or angioedema noted. Discharged from ED within 1.5h.
1 hour after receiving HAVRIX, patient experienced tingling of lt. arm which subsided. 5 hours after receiving this vaccine patient felt tingling & numbness of both legs & arms. Had a hive like rash of chest, lt shoulder, lower back, & SOB lungs cl. Given BENADRYL 25 mg po.
Jynneos vaccine was administered intradermally instead of subcutaneously; Jynneos was administered intradermally at dose of 0.5 mL instead of 0.1 mL; Case reference number US-BN-2022-004690 is a spontaneous case received from other health professional on 15-Nov-2022 via Communication (reference number: USBAV22-1954) and concerns a *30-year-old* male patient.  The patient's medical history and concomitant medication details were not provided.  On 12-Nov-2022, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, *batch number: FDP00003; expiration date: on unspecified date in May-2023*) at dose of 0.5 ml, administered intradermally (explicitly coded as 'intradermal injection' and 'incorrect dose administered') at *right forearm* for monkeypox prophylaxis.  *It was confirmed that it was unknown if the patient experienced any adverse events.*  The case is linked to US-BN-2022-004689 (same reporter).  Additional information received on 15-Sep-2022 from Bavarian Nordic included local BN case ID.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from other health care professional on 02-Dec-2022: included patient details, vaccine details and information that it was unknown if the patient experienced any adverse event.; Reporter's Comments: A 30-year-old male patient received 0.5 mL of Jynneos, applied intradermally for monkeypox prophylaxis, which is considered incorrect dose administered. Intradermal injection and incorrect dose administered are considered listed per company conventions. No associated adverse events were reported. The patient's medical history and concomitant medications were not reported. Intradermal injection and incorrect dose administered are considered not related to Jynneos, but to the human factor.; Sender's Comments: A 30-year-old male patient received 0.5 mL of Jynneos, applied intradermally for monkeypox prophylaxis, which is considered incorrect dose administered. Intradermal injection and incorrect dose administered are considered listed per company conventions. No associated adverse events were reported. The patient's medical history and concomitant medications were not reported. Intradermal injection and incorrect dose administered are considered not related to Jynneos, but to the human factor.
After 24 hours of receiving the vaccine I started with a fever and pain in the joints of my hands. The pain is a 10, they were inflamed, and it was difficult to close them. After 4 days everthing disappered. But in the month of May the symptoms reappeared with difficulty in opening bottles. I communicate this because I suffer from chronic diseases such as: DM2, BPH, Hypothyroidism, Hiccups for the thyroid, discoid lupus and arthritis in the hip area. I am reporting it because I am concerned.
Drew up and gave 2yr old patient 5-11yr old Pfizer but diluted it with directions for 6mo-4yr old 2.2mL
I received a call from this associate telling me the complications that she had since her Tdap was given on 1/19/2012. She said the day of the shot she left early because of a fever, and malaise. After she got home she noticed that she was having hives, chest pain and increased heart rate. She said she began to take Benadryl and Ibuprofen/Tylenol. She called into work sick and stayed in bed. Today when I talked to her she said she was still taking the Ibuprofen/Tylenol and that she did not have any more s/s of chest pain, increased heart rate, or hives. She did not know what her temperature was but she did not feel feverish. I advised her to call me if there were any changes and recommended that she go to the ER if she had any more issues with chest pain, increased heart rate or hives.
Had immun 1315 9JAN92 by 5PM hi fever 104 ax, excessive crying throughout nite;
This spontaneous report as received from a medical assistant refers to a 18 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 20-JUN-2014 the patient was vaccinated with first dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J005010, expiry date: 23-OCT-2014) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. Addtional information has been requested.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Medium
pT RECVD VAX ON 25SEP92 & 2 hrs following vax pt devel urticaria described as red welts approx 3mm in diameter on forearms, chest, upper back & neck; approx 7 hrs following vax pt recovered;
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-AUG-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
I been having dull chest pain with SOB. I also been having an evaluated heart rate that worsen when walking around. I have some headaches. I went to ER about this last night. They did a CT scan of my chest, EKG and blood work. I am been referred to a Cardiologist. He ordered an Echocardiogram and more blood work. I am waiting on that results. Even when I stand up my get an evaluated heart rate. I also with my first dose, I had a evaluated heart rate that went away with medicine.
Dizzy, lightheaded, muscle weakness/tingling, swollen/burning/itchy lips and mouth, tightness and difficulty breathing.
3 ml of 5 ml vial was administered, arm is sore; 3 ml of 5 ml vial was administered, arm is sore; This is a spontaneous case, initially reported by other health professional (pharmacist) to Med Communications (reference number: SEQ19-05020) on 17-Oct-2019, concerning a 24-year-old, female patient.   The patient's medical history was not reported.  The patient's concomitant medications included unspecified antidepressant and anti-anxiety medicine.  On 17-Oct-2019, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 3 ml, batch number: 259815, route of administration: intramuscular, anatomical location: right deltoid, expiration date: 30-Jun-2020] for influenza prophylaxis (explicitly coded as 'Overdose').  The pharmacist confused the Multi-Dose Vial (MDV) with a single dose vial, as reported.   On the same date, an unknown amount of time after vaccination, the patient's arm was sore.   On an unspecified date, the patient recovered.   The reporter assessed this case as non-serious. Causality was not provided.  Follow up received from pharmacist on 29-Oct-2019 (reference number: SEQ19-05759): Indication provided for flu vaccine, start date (17-Oct-2019) and outcome of the event (resolved) added in events tab. Narrative was amended accordingly.  Company comment:The patient was administered Flucelvax Quadrivalent. Reportedly, 3 ml of 5 ml vial was administered (explicitly coded as 'Overdose'). On the same date, the patient developed pain in extremity. Chronology is plausible. Causal role of the suspect product for the event of overdose is assessed as not related, while for the event of pain in extremity is assessed as possibly related.; Sender's Comments: The patient was administered Flucelvax Quadrivalent. Reportedly, 3 ml of 5 ml vial was administered (explicitly coded as 'Overdose'). On the same date, the patient developed pain in extremity. Chronology is plausible. Causal role of the suspect product for the event of overdose is assessed as not related, while for the event of pain in extremity is assessed as possibly related.
I first felt unconformable Friday. I was coughing more, and I felt pain in my chest. I steamed that night and the pain went away. The steam consisted of breathing in warm air for half an hour. I had congestion, sneezing, and coughing. I took my temperature on Monday and it was 100 degrees. I called to make an appointment with my doctor. They made an appointment for Tuesday morning. I went to the appointment, and I had tested positive for covid. The night before I had steamed for half an hour and repeated that for every 6 hours. Later, that had drained my head. My temperature on Tuesday was 98 degrees. I went into isolation at that point. I am convinced that the steaming helped me feel better. I didn't take any medication to help with covid. I only did the steaming, except for taking my normal blood pressure pill.
COVID-19 Vaccine EUA; 7 hours post vaccine- onset severe heachache, runny nose/congestion, nausea, severe muscle aches, fever 103 F, chills/sweating, pain/heat at injection site for 48 hours duration post vaccination. Symptoms mildly improved with acetominophen 1000mg PO q6h, but persistent. After my first vaccine (5 weeks prior), I had pain at injection site and mild cold-like symptoms, but otherwise minimal effects.
First,  sore neck and headache.  Next day very weak legs - muscles mid thigh down. Calves and quads esp.  Then legs and arems.  Again not from shoulder, but rather below deltoids.  Hands shaking, heart sometimes racing.  Intermittent tingling and tightness in upper chest under sternum.  that symptom has not been present f or a day now.  Nausea.
varicella zoster (papulovesicular rash in dermatomal distribution w/assoc pain) p/varicella vax 10mo previously;
11/28/2021- Resident passed away on Hospice services with comfort measures in place.  Admitted 7/13/2021 to Hospice services.
Information has been received from a NP concerning a male with no known medical history or allergies who on 07-MAY-2008 was vaccinated sc with a 0.5 ml dose of MMR II. Concomitant therapy included multivitamins. It was reported on 20-MAY-2008 the patient experienced a red blotchy rash that extended from the upper middle back to the waistline. Patient was seen by the NP. No laboratory test were performed. The patient's outcome was not reported. Additional information has been requested.
pt recv vax 10APR96 & 21JUN97 pt devel a rash w/several papules & pinhead vesicles on trunk & perineum;same day also devel oozing red skin behind ear;dx modified varicella secondary to eczema;
neck and chest became red and splotchy  but subsided on its own. Headache, body aches, low grade temp, chills, nausea and dizziness. No treatment
LOSS OFBLADDER CONTROL; IRREGULAR HEARTBEAT; This is a spontaneous report from a contactable 56-year-old female healthcare professional reported for herself that she received bnt162b2 (BNT162B2, Solution for injection), dose 1 intramuscula, administered in Arm Right on 07Jan2021 (Batch/Lot Number: EJ 1686) as SINGLE DOSE for covid-19 immunisation. Medical history was not reported. The patient's concomitant medications were not reported. The patient experienced loss of bladder control and irregular heartbeat on Jan2021 with outcome of not recovered. The patient underwent lab tests and procedures which included heart rate: irregular on 2021.  The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was reported as not recovered.
Tired and went to bed very early on night of vaccination; awoke after full night of sleep feeling groggy; woozy upon standing; poor balance; light-headed; felt tipsy, as if I had had too much to drink (no alcohol ingested); developed vertigo; when I closed my eyes, the room was spinning; canceled my volunteer work; slept 4 hours; at present, about 24 hours post vaccine, I seem to be returning to normal.
angioedema (swollen lips and tongue) vaccine 10/20 1130 am Symptoms began 10/22 5pm no labs done . sent home with benadryl
found in swing by parents cyanotic & lethargic approx 3 1/2 hr p/vax adm taken to local ER: seen by MD; pt transported via amb to coo; t102
Pt received Moderna vaccines in January and February. Pt presented to the ED with complaints of respiratory distress. Upon EMS arrival to pt's facility, pt was found to have a room air saturation of 64% and was placed on 15L nonrebreather. After arrival to the ED, pt was intubated and found to be COVID positive.
No additional AE details available; improperly stored vaccine administered to patient; This spontaneous report was received from a Licensed Practical Nurse, referring to a 24 year old patient of unknown gender. Information about the patient's medical history, concurrent conditions, concomitant medications, and previous drug allergies or reactions was not provided.      On 18-AUG-2020, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter (ml) as prophylaxis (dosage regimen, route of administration, and anatomical location were not reported; and lot number S008151 and expiration date 20-NOV-2021, which have been verified to be valid) and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 ml as prophylaxis (dosage regimen, route of administration, and anatomical location were not reported; and lot number T009744 and expiration date 28-JAN-2022, which have been verified to be valid) (product storage error). No additional adverse event details available.      The temperature excursion reported was 48.39 degrees fahrenheit (F), with a time frame of 1 hour and 45 minutes. No previous temperature excursion. A data logger was used.
48 y.o female with history of atrial tachycardia who presents to the ED via EMS for a possible adverse reaction to Covid vaccine.  Patient received her Covid vaccine around 1600 today, and soon became diaphoretic, shaky, and lightheaded.  She had presented to the emergency department.  Currently she denies any chest pain, difficulty breathing, throat swelling, tongue swelling, or any other symptoms currently except for palpitations.  Allergic Reaction The primary symptoms are  shortness of breath. The primary symptoms do not include cough, abdominal pain, vomiting, dizziness or rash. The current episode started 1 to 2 hours ago. The problem has not changed since onset. The onset of the reaction was associated with a new medication. Significant symptoms also include flushing.   48-year-old female with a history of atrial septal defect, status post atrial septal defect repair in 1980. She works as a nurse at Hospital and has been experiencing increasing rapid palpitations associated with chest pain, and hypertension.  With her episodes, she experiences marked lightheadedness, dyspnea, and feeling marked anxiety, as well as chest tightness. She received the COVID-19 vaccine today and while waiting in the observation room,she started feeling unwell, with rapid palpitations, associated with lightheadedness and dyspnea. She last had a sustained episode 2 - 3 weeks ago and had presented to ER and Hospital. No syncope. No orthopnea, PND or increased lower extremity swelling. Active Hospital Problems   Diagnosis ? Atrial paroxysmal tachycardia ? History of repair of atrial septal defect       1. Paroxysmal atrial tachycardia in setting of prior atrial septal defect repair - she is having breakthrough episodes through flecainide/digoxin - it is likely her atrial tachycardia is related to her ASD patch. Will hold flecainide/digoxin for now, and try to schedule an ablation during her hospital admission due to highly symptomatic episodes resulting in multiple ER visits.   2. Acute renal insufficiency - most likely pre-renal - iv fluids started.   3. Possible COVID-19 vaccine reaction - she probably had an incidental atrial tachycardia episode post vaccine administration, rather than an actual adverse reaction. Continue to monitor.
Tingling in both feet. My internist wasn't sure it was caused by the vaccine. She ordered an brain MRI no contrast, it was normal. She  then referred me to a neurologist, he thought initially it was  neuropathy. I then had the 3rd vaccine (1st booster) and no increased tingling.  I saw him again and he did another brain MRI with contrast and EMG, both normal. In December 2021 he said there was more into about side effect from the vaccine and one is tingling in feet. He advised me not to have additional vaccines.
skin rashes on face,( neck, cheek and forehead) with burning effect.  Rashes normalized after few hours and appears again with passage of time every day.
Area red and hot to touch at site of Varivax injection right back arm. Treatment: ice, Benadryl, elevation, Motrin
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with 1 dose of improperly stored PROQUAD (Merck) (lot # L008353 with expiration date 11-SEP-2016 and lot # reported as L016394 with expiration date 08-NOV-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Reporting patient reaction to Covid-19 vaccination. 03/29/2021 Patient 66-year-old female 9:46 AM Received Moderna vaccine 0.5 ml IM right deltoid  10:10 AM Patient experienced itching over entire body  10:11 AM EMS contacted  10:12 AM received 0.3 EpiPen right upper thigh 10:13 AM vital signs 194/90 HR 67 O2 97% 10:15 AM 50mg IM Benadryl right deltoid 10:17 AM Vital signs 198/104 HR 75 O2 97% 10:25 AM 0.3 ml Epinephrine IM right deltoid 10:25 AM vital signs 190/92 HR 75 O2 98% EMS arrived 10:30 AM Patient left with EMS 10:32 AM of own power and was transported to local hospital for evaluation. Contacted patient 03/30/2021 @ 9:53 to check condition. Patient was monitored for approximately 2 hours in a local emergency department and released with no further signs or symptoms of side effects or reactions.