chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received the 1st COVID-19 Vaccine (Pfizer, Lot #: EW0162, expiration date: 07/31/2021) at 10:00. At 10:12 patient ambulated to Medic in the observation area, asking to use the restroom due to complaints of nausea. Patient was advised by Hospital that he would not be able to use the restroom due to his physical presentation of pale, warm, moist skin, pupils becoming greater than or equal to 9 mm, and a look of confusion. Medic attempted to assist the client with ambulation to anti- gravity chair, when the patient?s knees buckled and he was assisted to the floor. Nurse and Nurse responded to assist Medic. Patient lost consciousness and was then assisted into anti-gravity chair and sternal rub applied. Per Medic , patient?s loss of consciousness subsided after 3 seconds and became conscious, alert, and oriented to person, place, time, and event (CAOX4). Patient stated he has ?syncopal episodes every time he has a procedure done that involves needles.? Baseline vitals were obtained by Medic at 1015, while patient was sitting: blood pressure: 98/50, heart rate: 60, respiratory rate: 18, pupils equal and reactive to light at 5 mm. Patient claimed that about 2 minutes status post- vaccine, he began to feel ?lightheaded, nauseous, and had a hot flash. Patient stated he has similar reactions every time. Patient denied chest pain, headache, vomiting, abdominal pain, and blurry vision. Patient was given water to sip on. At 1020, second set of vitals were taken by Medic, while patient was sitting: blood pressure: 90/60, respiratory rate: 16, heart rate: 97, and patient was conscious, alert, and oriented to person, place, time, and event (CAOX4). Patient?s skin was normal color, warm, and dry. Pupils were 3 mm and equal and reactive to light. Patient claimed last oral intake was on 04/15/2021 with minimal fluid intake as well. Patient denied any complaints and claimed he was feeling better. ALS interventions offered by Medic for further evaluation and care, but patient refused. Third set of vitals were obtained by Medic, while patient was standing, at 1030: blood pressure: 118/76, heart rate: 82, respiratory rate: 14, and patient was conscious, alert, and oriented to person, place, time, and event (CAOX4). Patient was negative for orthostatic pressures and was released into the care of his spouse, after waiting in the observation area for about 1 hour. Patient drank a full 12 ounce water bottle and was able to walk out on his own, with a steady gait and in no distress.
Information has been received from a nurse concerning her child, 4 year old male, with a history of prior immunizations (unspecified) who on 10-JUN-2008 was vaccinated with the second dose of VARIVAX (Merck). It was reported that on 10-JUN-2008 the patient experienced fever of 103 F. The patient was treated with TYLENOL (dose, route and duration unspecified). The nurse reported that the patient never had a reaction to other vaccines before. It was reported that the nurse sought medical attention by speaking with another nurse at the facility where the vaccine was given. The outcome is reported as recovering. Additional information has been requested.
Patient developed brain fogginess that persisted for a week plus beyond 2nd vaccine dose.  Unable to think clearly per patient's report.
On 01/17/22 pt was diagnosed with  COVID-19 infection and receive Paxlovid,.  He presented to the ER, he appeared very weak and dehydrated in the ER.  Unable to provide history.   Per MMR patient was seen bradycardic in the 40s received 1 mg of atropine with significant improvement in his heart rate. He is doing well on room air.  His stay was complicated by some episodes of hypoxia he required Decadron medication for short while.    PT/OT recommending post acute screen.  Bradycardia resolved after Lopressor was discontinued.  Psych consulted to adjust psychotropic medication, no changes made at this time.  Patient will need outpatient event monitor to evaluate for bradycardia.  Paxlovid has not been known to cause bradycardia.  Outpatient event monitor recommended at discharge.  His stay was complicated by severely elevated blood pressures his medications were up titrated relatively stable at this time would recommend close monitoring of his blood pressures while at the rehab facility.
Bells Palsy; he lost strength in his left face, arm, and leg; Felt nauseous; couldn't breathe; burning sensation from the left side of face from temple to neck; Localized muscle weakness; A spontaneous report was received from a health care professional concerning a 52-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed bell's palsy, nausea, dyspnea, burning sensation in face and localized muscle weakness.    The patient's medical history included covid-19 . Products known to have been used by the patient, within two weeks prior to the event, not provided.  On 25 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 25 Jan 2021, the patient  felt nauseous and couldn't breathe. The feeling went away so he did not think too much of it. 30 minutes after that, he lost strength in his left face, arm, and leg and diagnosed with Bells Palsy. There was a burning sensation from the left side of his face from  the temple to the neck.  Treatment for the event was not reported.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event's,reported, was considered not recovered..; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Rash on arm; This spontaneous case was reported by a patient and describes the occurrence of RASH (Rash on arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced RASH (Rash on arm). In 2021, RASH (Rash on arm) had resolved.            Patient height was reported as 5. No concomitant medication was provided. It was reported that patient had no allergic history. Patient had never test positive or diagnosis of COVID. No other vaccines were received by the patient within 1 month prior to Moderna COVID-19 vaccine.  It was reported that patient was perfectly healthy. No treatment medication were provided.   This case was linked to MOD-2022-608619 (Patient Link).
12/17/2002 patient awoke in morning with bilateral shoulder pain, left greater than right, headache, neck pain and chest pressure. Left shoulder tender and swollen. Right shoulder also slightly swollen. Rx with ice paks and Tylenol. Feels better.
Case number PHEH2013US021457 is an initial spontaneous report from the pharmacist received on 11 OCT 2013 and with a follow up information received 28 AUG 2014. This report refers to a 27-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 13382P, expiry date: Mar 2014) at a dose of 0.5 ml intramuscularly on 07 OCT 2013. She was also on treatment with Clozaril (batch number: not reported) for unspecified indication. It was reported that she was pregnant during vaccination with FLUVIRIN and treatment with Clozaril. No adverse events reported after the maladministration . It was reported that patient is fine now. No more information available.   Follow up information received from the pharmacist on 26 AUG 2014: New suspect product (Clozaril) was added and reporter's comment updated.
Pt felt faint brought to triage 1 12:15  BP 102/50, HR 68, 02 98% RA 12:29:  BP 106/69, HR  61  02 97% RA
COVID arm with red, swollen patch that was hot to the touch 5 days after receiving the first dose. Started at about  3? in size at immediate injection site then progressed to about 8? over the course of 3-4 days, covering most of my upper arm. Used Benadryl cream for one week to alleviate the itching. Redness and swelling started to diminish 10 days after first appearing.
On 15SEP92 pt devel swelling & redness in rt thigh; pt was seen by MD & advised that this was a local type reaction; MD advised that preschool shots should be given accellular vax;
Every year that she takes the flu shot she gets the flu/ Suspected VF; Flu; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine.  Additional information was received as follows: The age at vaccination was not reported. It was reported that the every year the patient received flu shot and experienced flu. This case was considered as suspected vaccination failure since details regarding the completion of the primary immunization for infuenza, the time to onset and laboratory confirmation was not provided for influenza.
Fever; chills; diarrhea; nausea; body aches; exhaustion; This is a spontaneous report from a contactable consumer (patient) received via COVAES. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 25Feb2021 at 08:15 AM (Batch/Lot Number: En6200) (at the age of 42 years old) as dose 2, single for COVID-19 immunisation in a clinic. Medical history included Hashimotos and lyme. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included oxcarbazepine (TRILEPTAL); sertraline hydrochloride (ZOLOFT); levothyroxine; mirtazapine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was previously administered the first dose of BNT162B2 on 28Jan2021 at 01:30 PM (at the age of 42-years-old) (Batch/Lot number: El9263) in the right arm for COVID-19 immunisation. The patient previously took lamotrigine (LAMICTAL); topiramate (TOPAMAX) (reported as topi max); carbamazepine; oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) and experienced allergies. The patient experienced fever, chills, diarrhea, nausea, body aches, and exhaustion on 25Feb2021 at 07:00 PM. The events were reported as non-serious. The patient did not receive any treatment for the events. The patient was recovering from the events on the time of the report.  No follow-up attempts are needed. No further information is expected.
Within 30-60 minutes post injection, I started feeling nauseated, became pale and dizzy with a rapid heart rate, B/P elevated, shaky, weak and developed a headache.  I drove myself home leaving work at approximately 1 hour 20 minutes.  Took acetaminophen 1000mg  was able to sleep fairly well through the night.  Awoke the next morning with a headache, runny nose and minor difficulty breathing.
Pt was vaccinated 7/18/2017. Pt presents to clinic with left upper extremity reddened area. Warm to touch. Tenderness upon touch. Pt was evaluated at Urgent Care, dx with Cellulitis and was prescribed antibiotics and was advised to follow-up with PCM in 48 hours.
Vaccine given on 6/3/08.  On 6/7/08 pt called to report swelling at injection site and pain as well as "flu-like" symptoms lasting one day.
7/29/20 4:15PM mother reported two small red dots on ankles. Was advised by Pediatricians office to monitor to and seek care if worsening. CHN spoke to patients mother 4:30PM and mother at that time reported spots were looking much better and believed they may have been bug bites. CHN advised to monitor and seek care if needed 7/29/20 6:30PM Patient mother reported hives on extremities. Was advised by an Urgent Care facility via telephone to administer Benadryl and Tylenol.  7/30/20 9AM patient mother reports hives have gone away within the last 2 hours and no fever.  7/30/20 10AM mother called CHN again and reported Hives reappeared and are primarily on ankles and hands. Patient being seen by pediatrician this AM.
1st Pfizer vaccination administered at 11:27 am.  At 11:47 patient reports nausea, SOB, lightheadedness, scratchy throat. History of asthma.  Symptoms similar to those experienced after PPSV23 and Tdap vaccines.  patient denies swelling of tongue, mouth, or throat.   Brought patient inside to lay on stretcher, legs elevated. patient face flushed, diaphoretic, eyes tearing.   BP 130/87, HR 83, O2Sat 98% RA, RR 22.   11:48 Dr at bedside.  11:52 Albuterol MDI 2 puffs INH with spacer administered. 11:54  BP 122/82, HR 83, O2Sat 99% RA, RR 18.  patient reports SOB subsided. 11:59  BP 120/52, HR 82, O2Sat 100% RA, RR 18.   12:07  BP 118/75, HR 75, O2Sat 100% RA, RR 18.  Facial flushing, sweating, tearing subsided. 12:15  BP 118/71, HR 76, O2 Sat 100% RA, RR 16.  12:16  Patient sitting at edge of bed 12:21  BP 129/74, HR 77, O2Sat 100% RA, RR 16.   12:28  BP 124/66, HR 76, O2Sat 100 % RA, RR 16.  patient states nausea and lightheadedness improving.  patient reports history of vertigo, low blood pressure that causes dizziness/lightheadedness.   12:45  BP 109/71, HR 78, O2Sat 100% RA, RR 16.  Lightheadedness and nausea improving.  12:56  patient reports lightheadedness and nausea improving, close to baseline.  Advised patient to remain in clinic until symptoms subside, patient verbalized understanding, states she is safe drive.  Reviewed with patient to call 911 with SOB, chest pain, dizziness, verbalized understanding and again stated she was safe to drive.
(At site of injection of varicella) - onset of bright red approximately 4cm x 3cm with irregular edges, slight raised, white center approximately 0.5cm round. Benadryl 25mg IM given at 950 AM
late for the second dose/ first dose/ on April 2021/ the second dose was not given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received in April 2021 with batch number dk23d and expiry date 8th February 2022).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Age at vaccination was not applicable for this report. Pharmacist reported that a patient was late for the 2nd dose of Twinrix and the 2nd dose was not given till the time of reporting which led to incomplete course of vaccination.  No adverse event was reported . The reporter did not consent to follow-up.
Received vaccine MMR 8/9/04. About 8/16/04 or 8/20/04 began to have rash on neck and swelling of glands back of neck. Now, does not want to take second MMR. Measles titer to be drawn. Never was checked by MD; took Claritin.
Pt called call center to schedule a J&J vaccine instead. Pt stateswhen he got first dose of moderna on 2/5/2021  and then got severe reaction with skin rash on entire body and water retention gained 30 lbs in 5-7 days after 1st covid vaccine. Pt saw outside PCP and allergy MD for follow-ups and evaluation. [Pt reports his allergy MD advised for patient to take J&J vaccine instead. Pt will follow-up with PCP to schedule J&J vaccine.
This spontaneous report as received from a medical assistant refers to a female twin of unknown age. On 20-OCT-2014 the patient was vaccinated with doses of PEDVAXHIB (strength, dose, route and lot # not reported) and RECOMBIVAX HB (strength, dose, route and lot # not reported) that were exposed to temperatures outside of the proper storage range. No adverse effect reported. This is one of the 2 reports regarding the twins. Additional information has been requested.
a big red oval around the injection site; itchy; Sore arm/tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA, VACCINATION SITE PRURITUS, and VACCINATION SITE PAIN in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concomitant products included INFLUENZA VACCINE for Flu.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA, VACCINATION SITE PRURITUS, and VACCINATION SITE PAIN. The patient was treated with CALAMINE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA, VACCINATION SITE PRURITUS, and VACCINATION SITE PAIN outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       This case was linked to MOD-2021-370373, MOD-2021-370338 (Patient Link). This case concerns a 78-year-old female patient with no relevant medical history, who experienced the unexpected events of Vaccination Site Erythema, Vaccination Site Pruritus, and Vaccination Site Pain. The event occurred on an unknown date after receiving the booster dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as outcome from other events from other doses were unknown. The events of Vaccination Site Erythema, Vaccination Site Pruritus, and Vaccination Site Pain is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
I noticed a lump on the back of my neck on 05/11/2021, on the left side of my cervical spine. I had my annual physical on 07/01/2021 and I mentioned to my doctor about the lump, and he said it was from the vaccine. He did not prescribe any medications or do any medical tests. I have another doctor's appointment with a different doctor to get another opinion. The lump moves around. Sometimes it's on the left side but sometimes it moves to the right side. It is soft. It does not appear to be bony.
According to Historical Immunization records, this 78 yo F received Varicella zoster (SHINGRIX; Lot #957J3) on 08/07/18 and influenza vaccine (no lot documented; date unclear as there is "given" documented on both 08/10/18 and 08/12/18. Neither injection documented a site. On 08/31/18, pt presented to clinic and reported that these injections were given in same arm (again arm not identified) and resulted in redness and swelling at the injection site and redness extending across anterior chest, arm soreness, headaches, body aches and fever. Pt reported that these symptoms persisted until 08/30. Pt self-medicated with aspirin, cetirizine and naproxyn. MD recommended that pt "continue ALEVE [naproxyn] BID PRN until symptoms resolve.
Hives; This is a spontaneous report from a contactable nurse reported for herself. This female patient with unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received her first dose of vaccine on 17Dec2020, and reported hives as a result. She's asking about efficacy of just 1 dose, and if she should get the 2nd dose. Also wanting to know duration of immunity. The outcome of event was unknown.    Information on the lot/batch number has been requested.
Client received Janssen, then scheduled Pfizer and received it unnecessarily. State system was unable to check state registry to verify client had already gotten Janssen dose.
Patient immediately became nauseous, dizzy, light-headed,  eyes rolled back in head, and slumped over. He reported that he had not eaten today. We were able to get him safely to ground, and he started vomiting. We gave him a sprite, and after several minutes was able to leave and return home.
unfortunately we were supposed to inject the GARDASIL 4 vaccine by ourselves and we weren't alert about shaking it before; This spontaneous report was received from a consumer reporting on behalf of her sister a 21-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapy were not reported.  On an unknown date, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for prophylaxis (lot#, expiry date, dose and route of administration were not provided).  The reporter stated that she and her sister were supposed to inject the quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) vaccine by themselves and they were not alert about shaking it before the injection (wrong technique in product usage process). It was reported that they were concerned of what would happen and what should they do.  This is one of two reports received from the same reporter.
Vomited 3-4 times in the day; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "recovered", described as "Nausea"; VOMITING (non-serious), outcome "unknown", described as "Vomited 3-4 times in the day".  Additional information: Caller explained that the patient got his second dose of the vaccine on Sunday and has been having nausea for 3 days. He was also vomited 3-4 times in the day  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reported soreness, has been occurring since the shot which has been over a month.  Patient reports no redness or swelling. Muscle pain and soreness getting worse. It has now been a month after the shot, patient went to the doctor. Patient will get xrays and see the orthopedist in March. The pain is now radiating up into the neck. Pain is affecting patients function and quality of life.
Redness, swelling, hot to touch Right upper arm.  4" x 3" Treated with antihistamines.
SP vaccine administered 1/28/02; 2/11/02-continue with increased drainage, no scab formation  purulent drainage, no lymphadenopathy, crust-rim around site r/0 impetigo Treated with Tequin 400 Mg x 5d- resolved
I had rapid heartbeat about a couple of weeks after receiving my first dose and increased blood pressure. I had insomnia and anxiety that kept me up some nights. I called my doctor who performed an EKG which showed an irregular x-ray; my doctor referred me to a cardiologist who performed an EKG, blood cultures, stress test, and echocardiogram. They all came back with irregular results so they increased the dosage of my blood pressure medication and placed me on a heart monitor for a week and half. They performed another echocardiogram and stress test for a follow-up exam about 2 months later, and the results came back well.
My son couldn't stand up nor talk good, and he way laying on the floor (he fell on the floor), and he was really shaking for awhile.