chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient stated to RN at observation that " he wants to lay down". RN stated that "she held his head" as he experienced a syncope event. RN notified Nurse Practitioners . EMS activated. Patients assessed and found to be alert and oriented to place and person. Patient stated that he felt dizzy. Vital signs monitored and patient found to be hypotensive, diaphoretic, and flushed. Epinephrine administered X3 with vital signs monitored in between. Vital signs stabilized and patient transferred to hospital with EMS.
My menstrual cycle is very regular- exactly to the day and time of day. My period came a week early unexpectedly with no warning. I have had no cramps like I usually get on the first two days. The bleeding is heavier than normal and bright red.
Fatigue; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 61-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FASLODEX. Vaccination history included: Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETED;, MANUFACTURER UNKNOWN, LOT UNKNOWN), for Covid-19 Immunization.  The following information was reported: FATIGUE (non-serious), outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt came to clinic one day after receiving Influenza vaccine (L) deltoid site and red, indurated with some mottled ecchymosis. Pt afebrile.
Immun given 12/11/12 11:40 AM 1 time flu shot also given 6 month old shots Mom called AM pt. rash "all over" mom brought child to office red rash thigh flat warm pictures face, chest, back.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Lot number: FK9929) at the age of 69 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: BENZONATATE, start date: 10May2022, stop date: 17May2022; PROMETHAZINE DM, start date: 10May2022, stop date: 13May2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID Rebound starting 20May, 11 days after starting Paxlovid. Symptoms much worse than while taking Oaxlovid.  No follow-up attempts are possible. No further information is expected.
Patient was given Kinrix, she is only 2 years old and Kinrix is a vaccine for 4-6 years.
Her husband had a rash too; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Her husband had a rash too) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Her husband had a rash too). At the time of the report, RASH (Her husband had a rash too) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-087683, US-MODERNATX, INC.-MOD-2021-114214 (E2B Linked Report).; Sender's Comments:  MOD21-087683: US-MODERNATX, INC.-MOD-2021-114214:
hives; rash; inflammation; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 07Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hives, rash and inflammation on 14Mar2021. The patient received treatment for the events where she was already taken medications (unspecified). Reporter wants to know if it would be okay if she receives the 2nd dose 4 weeks after the 1st dose instead. The outcome of all the events not recovered.   No follow-up attempts are possible; information about lot/batch cannot be obtained.
No other AE/PQC reported; a temperature excursion on ROTATEQ, the product had been administered; This spontaneous report was received from an office manager referring to a 10 weeks old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 16-JUN-2021, a temperature excursion occurred on rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# 1684151 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 23-JUN-2021) as the vaccine was stored under 47.8 degrees Fahrenheit (F) for 5 minutes, recorded by digital data logger. There was no previous temperature excursion. On 22-JUN-2021, the patient was vaccinated with the improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose and route were not reported) for prophylaxis. No other adverse event (AE)/product quality complaint (PQC) was reported other than improperly stored administered vaccine.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA007466:
Pt noted erythematous 2 cm lesion on left thigh with larger subcutaneous component indurated, hard lesions.  Lesion was not fluctuant, no associated fever or illness in pt.
Pt received a dose without reconstitution with powder vial; Pt received a dose without reconstitution with powder vial; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 26-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA659A, expiry date 31st January 2023) for prophylaxis.   On 6th June 2022, the patient received Menveo. On 6th June 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date: 6-June-2022 Reporter's comment: Pharmacist reported that patient received a dose of the liquid vial of Menveo without reconstitution with powder vial. The reporter did not consent to follow-up. Additional Supportive Information: The patient received a dose of the liquid vial of Menveo without reconstitution with powder vial which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Period was 5 days late. Never had a late period before. Only happened after 2nd shot of covid vaccine.  Also period was abnormally heavy. Period symptoms have been abnormal since- like bleeding mid cycle and worse pms.
maculopapular, erythematous, generalized itch+ some confluent-started x 1 day 21MAR95;
right arm went numb; the back of arm was sore; irregular heart beat; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FP7533) via an unspecified route of administration in the left arm on 05Apr2021 at 10:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies to food, medications or other products. The patient did not take any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 07Apr2021 at 16:00, the patient experienced irregular heart beat and on 10Apr2021 her right arm went numb and the back of her arm was sore. The right arm was not the arm that the patient got the injection, so she thought that was strange. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event irregular heartbeat, right arm went numb and back of arm was sore was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Severe Nausea; Throwing Up; Constant Diarrhea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart Condition with Stents" (ongoing), notes: Verbatim: Heart Condition with Stents. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Severe Nausea"; VOMITING (non-serious) with onset 2021, outcome "recovered" (2021), described as "Throwing Up"; DIARRHOEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Constant Diarrhea".  Additional information: She stated that she was just wanted to know about side effects happening 2 months after the last Covid Shot and she had no reaction initially to either vaccine.  Two months, almost to the day, after the second one she had severe nausea, throwing up, and constant diarrhea for 2 and a half days. She stated that she had a heart condition with stents. She just wanted to know if this is something other people have experienced with her age and have experienced any people this 2 months after the vaccine. She stated that this past weekend they were feeling okay but the weekend before they were not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
On 03/11/2002, pt's mom called stating that the child received immunization on 03/08/2002. He woke up on 03/09/2002 with rash on his face and body. No rash noted when the child was put to bed. She called the child's pediatrician she was ordered Benadryl. Mom states that the rash is gone and he did not have temp.
Right deltoid developed a tennis ball size swollen & reddened area as well as respiratory congestion on day 2. Guardian applied essential oils lavender to area for a couple days. Day 5 the area is much improved but continues with congestion.
Client received a 2nd dose of Moderna today in the clinic at 17 days following their first dose. The error was not caught until following administration of the vaccine. The client was informed of the situation, was given the proper education and our on call MD was notified. Client was told that we do NOT need to repeat the dose or series and they can now consider themselves fully vaccinated.
Received shot at 7:30am on 2/1/2021 and around 12 hours later my right arm had significant pain. I started have fatigue, body aches, chills and headache that lasted until around 6:30pm on 2/2/2021. The gland in my right armpit is currently still swollen.
Thursday morning 9 am vaccine. Worked a normal after that. Arm ached as it had the fist time. Nausea and vomiting around midnight. Slept after I lost my dinner. Friday: Slept with intense fatigue and tried to sip water. Intake about 6 oz. Saturday: was able to get up. Took temperature - 100.6 Remained high all day - I slept, drank 12 oz water Sunday: much improved but still felt week. Temp just under 100 all day. Ate and drank lightly Monday: temp only mildly elevated. went back to work. fatigued - cancelled half day Tuesday: no temp. back to work sorry if that's too much information - thanks for compiling data!
Felt faint after MCV4, HPV vaccines. Rested, drank juice.
SWELLING AT INJECTION SITE, FEEL WARM AND RAISED AT LEFT UPPER ARM. IT GOT BETTER ON 09/07/2020. DR PRESCRIBED DOXYCYCLINE FOR THE PATIENT BUT PATIENT DIDN'T WANT TO TAKE IT.
Pt called 26MAY92 states went to ER 25MAY92 arthritis type sx lt hand; had to have rings cut off-states MD treating for arthritis poss MMR react;
Patient became ill 1-2 days following vaccines on 5/8/07/. SX: whole body aches, then low back ache, then entire legs aching w/weakness, then calf discomfort with headache and extreme fatigue
CELLULITUS TYPE REACTION, SOME REDDNESS, SWELLING, PAIN, AND STRIATIONS.
Initial information received on 23-Jan-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 26 years old female patient who was administered with a 0.5ml dose of TUBERCULIN TEST [TUBERSOL] (Exp. Date, lot number and site of administration not reported) intramuscularly instead of INFLUENZA VACCINE (Flu shot) on 23-Jan-2019. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to wrong vaccine administered, overdose and inappropriate route of vaccination as Flu shot and TB skin test mixed up. At the time of reporting, no symptoms were 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. List of documents held by sender: none.
PT AFTER BEING IN OBSERVATION WENT TO LEAVE AND THEN PT REPORTED HE WENT TO THE RESTROOM AND VOMITED UP A LARGE AMOUNT OF EMESIS. PT WAS BROUGHT BACK TO THE OBSERVATION AREA WHERE HE WAS OBSERVED AND THEN COMPLAINED OF A HEADACHE. COLD COMPRESS WAS GIVEN.  PT STAYED FOR 30 MINUTES AND STATED HE FELT BETTER SO HE WAS RELEASED IN HIS OWN CARE HOME. NO MEDICATIONS GIVEN
My son receeived his first law required vaccine for hepatitis B on March 5. That day he had a reaction to the vaccine immediately following it, in the clinic office. He felt faint and lay down in the clinic waiting room for about 15 minutes before being sent to a room to recover. He had never had such a reaction to shots before. The health care professional staff said it was due to fear of shots, which my son has never had before. Later that day he came down with a fever and general malaise which we treated with ibuprofen and tylenol. He was fine the next day. For his second law required hepB vaccine we agian took him to the same clinic on May 17,2003. This tiem he had a mcuh more sever reaction several hours later.  We took him to the emergency room where they did a CAT scan. None of the health care professionals believe that his latest incindent is related to the vaccine. I do. It is much too coincidental. We will not be allowing him to have the third dose.
He was noticed to have been itching his arm, checked it Monday night around 6:30, it was red, warm to the touch and had raised bumps that extended from just at the site of injection and down approximately 4 inches and was about 2 inches across. Gave Benadryl orally, continued to monitor. The next day it was still red, bumpy, warm to the touch and itchy. This continued, took him into the doctors office Thursday evening when it was observed to be hard under the injection site in addition to the other continued symptoms. Topical Benadryl continues to be applied.
Intense feeling so DEEP depression.  Unable to shake.  This lasted into the next day.
He got his vaccine, had no reaction.  Then about a month or so ago he started having problems with his upper arms, felt like it was getting hard.  Then a few days later he had some pain right about his shoulders, and then the left side started again with the same symptoms.  He felt that it would go away, but the pains started to get even worse, the left side not too bad, but the right one was worse.  He made an appointment with his PCP.  He did a few tests and then told him that he suspected that due to some other patient's who had similar problems, and he also started exactly like he did and had severe pain and going through the same symptoms, and doing some research to see what was going on, said that it certainly was a side effect from the vaccine.  He told him that on the right arm he had 2 injections and on the left side he had one.  He said that he had the same, due to having 2 injections on the right arm.  He was surprised that it took so long for his symptoms to show up as he had no side effects prior to this.  He can even shave, cannot hold the razor due to his hand being painful and started getting really bad.  His doctor felt that 99% it was due to the vaccine.  The pain is close to his elbow and goes to the shoulder, and has continuous pain.  He has to take Advil at night to sleep.  Below his elbow everything is normal.   The area is hard and very painful, believes it is where the injections were given.  His wife goes to massage it and when she starts moving it an electrical charge goes through it.  If he laughs or coughs while he is sitting the pain gets to bad like an electrical shock going through his hands.  He's OK to do this if he's standing, but not while sitting.  His doctors opinion is that it should go away on it's own, but it is not and it seems to be getting worse.    His PCP is also his cousin and wonders if it is related to heredity, but also stated that he had numerous patient's with the same complaints.    He always get the flu vaccine and has never had a reaction from that.  Due to his reaction they will not get any other vaccines.  He would like to know what has caused this.
Up to 1 week after vaccines 1st and 2nd dose every muscle in my body hurting even face breast and neck. Missed my menstrual cycle for 2 months . Experienced horrible abdominal pain front and back. Developed multiple ovarian cyst on both sides per CT scan from ER and enlarged spleen per ultrasound. Experienced multiple stabbing poking pain on my left side around my heart and armpit and also went to ER in DEC 15 2021
temp of 104.4; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had Fever. The reporter asked did get the 2nd dose.
VACCINATION WAS ADMINISTERED PAST ITS BEYOND USE DATE. THE BEYOND USE DATE (7/1/22) WAS BEFORE THE EXPIRATION DATE (8/31/22) THAT THE PHARMACIST USED TO DETERMINE IF IT WAS OKAY TO GIVE.
pt recv vax in sep93; 6 days later,devel fever of 102-103 & a roseola-like rash; recv 2nd dose of vax in oct93; subsequently devel a fever but no rash;
Father called to say child awoke in early evening screaming and shaking. 3/6/06 - ER record for 2/16/06 was reviewed. Additional symptoms include facial rash and fever of 100.4.  3/9/06 - discharge summary reviewed. D/C diagnosis was 'acute life-threatening event'.  3/9/06 - Medical records reviewed. Diagnosis was 'new onset seizure'. Mental status changes were noted. Mom reported child was shivering and had blue lips. Later he appeared pale. He screamed for 45 minutes then intermittently for 6 hours. There was some arching with feeds. Mom reported baby had some nasal congestion for 2 days. Pulse ox was 88% and baby was given blow-by O2. Pulse ox improved to 92%.
Patient reports that she received the 1st dose if the COVID-19 vaccine approximately 2 hours ago.  She reports that she started to feel flushed about 10 minutes after the administration.  After about 30 minutes started feeling better and was able to tolerate some juice.  Started to drive home and became very flushed again and lightheaded.  Reported back to Occupational Health and was evaluated and found to be significantly hypertensive.  After further observation, patient continuing to have elevated blood pressure.  Sent to the emergency department for further evaluation.  Patient notes that she has had some intermittent issues with hypertension, but does not currently take medications, most recent blood pressures have been within normal limits to borderline.  No prior significant allergic reactions to immunizations.  Patient does note that she had an episode earlier this year of near anaphylaxis to unknown substance.  Has not had recurrent issues since.  No prior known history of COVID-19.  No chest pain or shortness of breath.  No sore throat.  No difficulty swallowing.  Patient medicated with IV Benadryl and normal saline.  Feeling better following medication.  Blood pressure improved.  Return instructions provided.  Patient follow up with primary care.
Shortly after I could feel a dull pain at the injection site, by midday I went to lift my arm with a patient and the pain had progressed and it really bothered me to  reach. When I got home last night I had chills, I couldn't get warm, wearing two sweaters and was still cold. I started to feel achy around 9-10pm and took a Tylenol. All night long and this morning I have been achy and cold. I checked my temperature this morning 99.6 (I have a low temperature normally).
This spontaneous report as received from a physician via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 29-FEB-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ "2ml, 10 unit dose tube" and lot number K009752 with expiration date of 15-APR-2016, orally, which was stored at the lowest recorded temperature of 33 (0.555555556 Celsius degrees) for 168 hours and at the lowest recorded temperature of 34 (1.111111111 Celsius degrees) for 384 hours. The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Approximately 1.5 hours after receiving the vaccine - High heart rate up to 180 bpm. Very low BP. Chills & sweats.
Fever 102.4- Tylenol. Vomiting- Pedialyte.
The day after 2nd shot I was tired and was feeling chest pressure. Pressure lasted about 10 days and continues on and off.  BP went up to 180/101 and remained high. went to urgent care, then primary physician. he heard heart murmur (never had before) and sent me to cardiologist. Prescribed BP meds.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Additional Details: Had issues with previous vaccine. Advised by MD to pre medicate with benadryl. Took benadryl this time but only 15 minutes prior so it did not have time to fully enter blood stream. Felt better in about 10 minutes after injection as that was around the 1 hour mark post benadryl.