chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child had fever of 103F, the same day. Was evaluated in office on 2/16/01 and had leukocytosis on that day. Her WBC were 27,000. A blood culture, urine culture/analysis and CRP were done. She received Rocephin IM on 2/16/01 and 2/17/01. On 2/19/01 her WBC were 8.9.
Patient developed hives within a few hours of receiving influenza immunization. Required Medrol dose pack to treat. Reports has had flu shot annually for past 24 years no previous problems. Also had hair colored same day. No product change per stylist.
This is an instance of COVID-19 breakthrough disease after which death occurred.   The individual was vaccinated on 01/27/2021, 02/17/2021, and 10/08/2021.   The individual was admitted to hospital on 12/25/2021 for an emergency surgical procedure after a fall (the reason for admission and surgery were  not related to COVID-19 or respiratory disease). They were transported via ambulance. It is not known if they experienced COVID-19 specific symptoms. They were found to be COVID-19 positive during the hospital stay. The positive specimen was collected on 12/25/2021. Their health declined rapidly during this hospital stay and they passed away on 12/26/2021.
A physician reported that her 2 month old daughter received Prevnar, Comvax, IPV and DTAP vaccines on 11/06/00. On 11/11/00, she developed a rash. On 11/12/00, the child developed swelling of her hands and feet.
Tinnitus -  a noticeable, constant ringing in my left ear.  Noticed in mid-April, following second dose. No treatment at this time but will inform my PCP.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered dose on 5-Oct-2021 from vial that was beyond 30 day use by date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered dose on 5-Oct-2021 from vial that was beyond 30 day use by date). On 05-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient administered dose on 5-Oct-2021 from vial that was beyond 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  The vial was initially stored in the refrigerator on 30-Aug-2021 at 8:45 pm and had 30 day use by date expiration of 29-Sep-2021.  The vial was punctured on 05-Oct-2021 at approximately around 9:55am.
Fever; muscle aches; nausea; loss of appetite; foggy headed; weak; pain in injection site; exhaustion.
PATIENT STATED SHE SEEMED DISORIENTED/CONFUSED FOR 24-48 HOURS. DIFFICULTY COLLECTING THOUGHTS AND COMMUNICATING. ALSO HAD SOME SWELLING AND REDNESS SURROUNDING THE INJECTION SITE. SIGNS AND SYMPTOMS RESOLVED 48HRS AFTER THE INECTION.
Inadvertently administered the Moderna Bivalent covid vaccine earlier than suggested time frame. I looked into system and thought last dose of Moderna was given on 11/2021 after administering the vaccine and entering into system it had actually said vaccine was invalid. I then realized the date on last Moderna vaccine given was on 11/14/2022. Time frame from 2nd to 3rd dose is to wait 8 weeks, and it had only been 7 weeks 2 days. I notified my supervisor of incident and looked into the CDC guidelines which suggested patient come back in 8 weeks (03/01/23) to get a valid Moderna Bivalent vaccine. I then went to check on client and notified of the error. Client denied problems, complications or any reactions after the vaccine administration. Client and daughter were advised to stay 15 minutes to monitor any reaction. Client's daughter declined wanting to come back to get a valid administration, since one was already administered even though it was invalid in system. Advised we were following CDC guideline and she was not obligated to come back, both client and daughter acknowledge understanding. Called patient 01/06/2023 at 09:39a.m., spoke to daughter (authorized person to receive PHI) DOB was verified by daughter. Daughter stated that client had no reaction or complication following the administration after leaving the facility. No other questions or concerns
P.C. from mom at 1:55 inquiring in Hep A vaccine would cause drowsiness; child has been sleeping since left clinic wakes but goes right back to sleep. No other symptoms. Per PHN malaise/fatigue - adv. reaction.
10 hours post vax, the pt developed swelling, soreness, and redness of arm. He also experienced URI/allergy like symptoms. No fever, nausea, vomiting or diarrhea. No duty lost.
felt like i had covid all over again, severe head and body ache, chills, fatigue, nausea
Generalized pruritus without hives.  No shortness of breath or evidence of angioedema.
I was passing palm sized blood clots. I wouldn't stop bleeding after my period. I ended up having to go to the emergency room. I was prescribed iron and constipation medication. I was also prescribed a month of birth control to regulate the hormones and control the bleeding.
It started with post-nasal drip that progressed to a sore throat. For a couple of days, it didn't bother me; after a couple of days, it began to bother me so I called an urgent care who sent an ambulance to help me. They swabbed me to test for pneumonia, COVID-19, and influenza; every test came back negative except for influenza, and I was diagnosed with influenza type A. They gave me Albuterol inhaler treatment and discharged me. Some days later, I couldn't breathe again so I called the emergency room again; once again, I arrived and was given Albuterol. I'm doing better now, but I do have a follow-up appointment with my doctor today to check on my current condition. I only went to the emergency room because the symptoms were triggering my asthma.
COVID infection following COVID vaccine series completion 12/18 COVID vaccine dose #1 01/08  COVID vaccine dose #2 04/22 COVID positive 04/23 transferred from clinic to hospital via ED for monitoring, given zinc, prednisone remains asymptomatic
Patient complained of pain on both of his trapezius muscles. The pain radiates to the middle of his back and down. Also he experienced pain on the back of his feet (just below the buttock).
sinus congestion; diarrhea; conjuntivitis; headache; This spontaneous case was reported by a consumer and describes the occurrence of SINUS CONGESTION (sinus congestion), DIARRHOEA (diarrhea), CONJUNCTIVITIS (conjuntivitis) and HEADACHE (headache) in a patient of an unknown age and gender 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 SINUS CONGESTION (sinus congestion), DIARRHOEA (diarrhea), CONJUNCTIVITIS (conjuntivitis) and HEADACHE (headache). At the time of the report, SINUS CONGESTION (sinus congestion), DIARRHOEA (diarrhea), CONJUNCTIVITIS (conjuntivitis) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact
Initial swelling, redness and bruising followed by persistent firm scar tissue along back of injection deep to muscle.
I developed immediate flushing, sweating, rapid heartbeat (was around 110bpm, is normally around 75bpm), and lightheadedness.  I sat down and had a few sips of water.  Within a few minutes, I felt like I was having a difficult time getting a good breath in.   I raised my hands over my head and took slow deep breaths to try and keep my breathing  under control.  I stayed at the hospital for about 45 minutes, over which time I had a few bites to eat and some water.   The flushing and sweating resolved within that time.  The lightheadedness and "feeling of doom" lasted about 3 hours.  I had no anxiety going into this vaccine, nor have I had a reaction like this before.
Vomiting, rash, fever, headache, body aches, redness at site along w/ pain.
10 hours after injection, fever of 102, body aches, chills, headache, small cough.  18 hours after injection noticed red itchy rash in arm just below injection site, between tennis and golf ball size. Firm to touch, sore, itchy.
don't feel good with upset stomachs all the time; don't feel good with upset stomachs all the time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Apr2021 (Batch/Lot number: unknown) at the age of 12 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), ABDOMINAL DISCOMFORT (non-serious) all with onset 30Jun2021, outcome "not recovered" and all described as "don't feel good with upset stomachs all the time". The event "don't feel good with upset stomachs all the time" and "don't feel good with upset stomachs all the time" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of malaise, abdominal discomfort.  Additional information: Lot number was reported as EWO180/ EW0164. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No prolonged hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any treatment for the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202101206589 same reporter/drug/event, different patient
Covid arm, 3-4 inch circumference redness around injection site. Started approximately 1 week after injection, soreness and itchy.
Injection site reaction, progressing to redness/heat from elbow to shoulder; hives progressing to stomach; sore muscles; sore throat, progressing to mouth sores; Symptoms lasted 7-10 days minimum according to patient
Husband reported that both he & his wife developed sore throat within 2 hours of receiving seasonal flu vaccine - also developed fever & aching & chills. Treated by PCP with Z pack & resolved after about 10 days.
I went to a family gathering and found out the next day someone tested positive for COVID-19. My immediately family and I had went north to vacation area. My daughter started feeling ill, tested but it came back negative. On Saturday she tested was positive. I started having sniffles and runny nose. My wife and I came home on Monday, tested with a home COVID-19 test and it came back positive. I had a telehealth visit on Tuesday, started with the Paxlovid Tuesday evening. By Wednesday I started feeling better, by Thursday it felt more like a cold and by Friday I felt much. In all I just felt like a had a bad cold.
09/19/2022, I got the vaccine.  About 15 minutes later, still waiting there, I started to feel lightheaded. 8-10 days later, I began to experience vertigo, lightheadedness, heart rate is slow.  I went to the emergency room and was admitted Friday afternoon, released Saturday afternoon.
Dark Urine, Itching, and very Tired were the first signs.  It was about a week before I went in to see my doctor.  When I went to my doctor and then into the ER and was admitted to the hospital I had the following.   Abnormal CT of the GI tract  Abnormal liver enzymes  Early satiety  Jaundice  Serum ferritin high
Breakthrough case admission after two vaccines  Pfizer 6/26/21 Lot# EW0180;  Pfizer 7/29/21 Lot# FA7485
Chills, Tiredness, Fatigue, Diarrhea, Nausea, Body Aches
Moderna COVID-19 Vaccine EUA:  Patient received Moderna vaccine on 8/25/2021. Later on 8/25/2021 patient presented to ED complaining of chest pain. Chest pain started just prior to arrival, sternal pressure, non-radiating.  Symptoms are associated with multiple episodes of nausea, vomiting.  Patient denies fever, cough, shortness of breath.  On arrival to the ED, 12 lead showed STEMi and cath lab was activated. While awaiting cath lab patient suffered a VFib arrest and was shocked and never lost pulse. He was taken to cath lab where he yet again suffered VF/VT multiple times and shocked each time with success. Patient was intubated
Some discomfort day of injection. Significant pain day 2 & 3 after. Continues to have decreased ROM, pain and intermittent tingling into fingers.
Redness and swelling around upper arm where injection was given. Persistant as of 04/23/05. Examination: swelling and redness entire upper arm.
Patient has soreness around the injection site and the whole backside of the arm is red and swollen with patchy spots randomly placed throughout arm. The patient was told to take Benadryl and apply hydrocortisone cream to the area. This has been occurring for 2 days now and patient knows to call MD if size of area or condition worsens.
Blood clots; vaccine is attacking her kidneys; Lost 20 pounds; The blood looks like merlot wine; The blood looks like merlot wine. This is painful; Mentally distraught; I have lost 20 pounds and cannot work.; This is a spontaneous report from a contactable consumer (patient reported for herself). A 41-years-old female patient received her second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 27Mar2021, as single for covid-19 immunisation. Medical history included Bladder biopsy and hysterectomy in 2016. The patient concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 06Mar2021, as single for covid-19 immunisation and between 06Mar- 13Mar2021, she had all the side effects: night sweats, colds, nauseated, sore arm, fever, I was sick. On 18Mar, she began urinating blood and was not stopped. On an unspecified date in Mar2021, after the second dose the patient experienced blood clots and the vaccine is attacking her kidneys, lost 20 pounds and cannot work, the blood looks like merlot wine and mentally distraught. The clinical course of the events as follows: She went to the emergency room, when the blood first started. She stated that the vaccine was attacking her kidneys and they did not know why. On an unspecified date in Jan2021, she got a clean bill of health at her annual checkup. She had a hysterectomy in 2016, so this was not vaginal bleeding. She had passing blood clots at this point and this was painful. She mentioned, no one was able to figure out what the vaccine was doing to her. She had seen a nephrologist, a urologist and her primary care physician for the events. She had an appointment with a clinic scheduled. She stated she had lost 20 pounds and could not work. She stated that her blood looks like merlot wine and she was mentally distraught. Her MD said he had read about this in a journal about other patients. She had been to 4 different hospitals, had 3 CAT (computerized tomography) scans for which the result was unknown. She has had x-rays and was in and out of the emergency room. On an unspecified date, the patient underwent lab tests biopsy bladder: unknown, computerized tomogram: unknown, x-ray: unknown. She had her blood drawn every 2 weeks. The outcome of the events was unknown at the time of this report. The patient was Referred to HCP and provided info on the countermeasures Injury Compensation Program  Information on the lot/batch number has been requested.
Shot given 11:45AM - pt. experienced heavy cough loss of breath, intense pain at diaphragm area. 2 pm went to local outpt clinic who went her on to hospital/ER. Many tests done to rule out heart attack etc they suspected. After 6 hrs. & many tests pt sent home told was reaction to HD FLUZONE shot.
Mild fatigue day of injection with no swelling, redness; mild-mod tenderness at injection site progressed throughout the day but felt similar to any other vaccine injection. Woke up the next morning with the injection site red, swollen, significantly tender to touch, and inflamed. All symptoms improved over the course of 5 days and was barely palpable with no redness or tenderness. Then on 02/10 injection site started itching and over the course of the day became inflamed, red, and firm once again, but no tenderness. Today, 02/11, it is larger than the size it was the second day after the injection site; mild-mod itchy, still very red and swollen/raised, but less inflamed and no tenderness at all.
Sore throat; not been feeling well; Nasal congestion; Headache; Fever; Fatigue/Tiredness; she gave her son Extra Strength Tylenol 500mg tablets: NDC Number: 50580-449-09, Lot Number: LEA012, Expiration Date: Feb2021; Now sick at the Urgent Care; This is a spontaneous report from two contactable consumers one of (patient mother) via Medical information team. A 23-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0161, Expiration date was not reported), via an unspecified route of administration, on 20Apr2021 12:00 on left arm as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The transferring agent stated the caller said her son felt fatigued on 20Apr2021 the next day (21Apr2021), and had a headache, fever, and a sore throat. Reported she had called her son's doctor today (28Apr2021) because her son had not been feeling well since yesterday (27Apr2021). She said her son's doctor told her to take her son to an urgent care. She said her son had a COVID-19 Virus test and a Strep Throat Test today (28Apr2021) at urgent care. She said the urgent care also took her son's vital signs. She said she was told by an urgent care staff member that her son's symptoms could be from a number of things, but the urgent care staff member said her suspicion was that her son's symptoms were a side effect from the COVID-19 Vaccine. She clarified that her son's COVID-19 Virus Test was negative today (28Apr2021), but she was told by the urgent care staff member the negative COVID-19 Virus test could be a false negative. She stated her son's Step Throat test results had not come back yet. Clarified her son's sore throat started yesterday (27Apr2021). She said her son couldn't stand having the sore throat. She clarified her son was not feeling well yesterday, and that was why she called her son's doctor today. Reported her son's fever had subsided with Tylenol, and her son's headache had gone away, and not come back. She said her son also had nasal congestion that started yesterday (27Apr2021), but her son was not blowing his nose and also reported she gave her son Extra Strength Tylenol 500mg tablets: NDC Number: 50580-449-09, Lot Number: LEA012, Expiration Date: Feb2021. Reporter calling for her son who took the Covid vaccine and is now sick at the Urgent Care. She is wondering about side effects 7-8 days after taking the vaccine. As per the reporter seriousness criteria reported for the event now sick at the Urgent Care was medically significant. The patient underwent lab tests and procedures which included Strep throat test: unknown and COVID-19 virus test: negative on 28Apr2021. Therapeutic measures were taken as a result of fever. The outcome of the event Sickness and expired drug used was unknown, fatigue, headache, fever was recovered on Apr2021 and not recovered for another events.   No follow-up attempts are needed. No further information is expected.
REDNESS BELOW THE SHOT THAT PATIENT STATES SEEMS TO BE GROWING.
Nausea  Viral illness  Encounter for screening laboratory testing for COVID-19 virus
Client's left deltoid region with 4 in diameter red area, swollen and warm to touch.
DTaP, Hep B, IPV combination vaccine and HiB were given in left leg, PCV in right leg around 3:30pm. Patient started getting fussy around 7pm, and I gave him a second dose of Tylenol (first at 3pm). He had a high pitched cry for 1/2 hour, and his left leg was tender to the touch. Around 9pm I realized he had a vaccine reaction of erythema 5"x7" on his outer left thigh where shots had been given. On the way to Urgent Care, I applied ice on his leg. When we arrived 1/2 hour later, the redness was gone.
PATIENT RECEIVED PFIZER FOR 3RD VACCINE WHEN PREVIOUS TWO VACCINES WERE MODERNA
Patient called in, she was recently put on atorvastatin, plavix and lisinopril. Patient is also on xanax, wellbutrin, vitamin b, vitamin d, levothyroxine, and lamictal, but has been on these with no problems before. Patient reports being very tired the last couple of months. Patient also mentioned she got her second dose of the moderna vaccine and she said that she had a very bad lingering headache for days which is why they put her on the lisinopril.
About 8 days after the vaccination i began to feel very itchy at the site. Later that day there was a big red raised area, the size of my palm. It was warm and tender.
Pt received booster shot of Moderna covid vaccine on 11/5/2021.  On 11/6/2021 at approx. 0930, pt was found to be unresponsive and asystolic at the nursing home. Last known well was 0600.  After pt was found unresponsive and asystolic, CPR was started and pt was then taken to hospital via squad where resuscitative efforts were continued by ambulance staff and hospital staff.  Pt was pronounced dead at 1013 on the morning on 11/6/21
Tightness in chest, difficulty breathing, chest pain, elevated heart rate and blood pressure all stemming from an increase in size of the right hilar lymph nodes.  Began upon waking 12/06/2022.  Given antibiotics (augmentin BID #20) but pain and elevated heart rate persist as of 12/19/2022.  BP decreased to normal levels and tightness of chest decreased as well.
This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown age and gender. On 04-May-2015, the patient was vaccinated with one dose of (Merck) PROQUAD that had been improperly stored (subcutaneous, lot # K025760, expiry: 08-JUN-2016, dose not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a nurse concerning a patient who last week on approximately 02-AUG-2009 was vaccinated with one dose of VARIVAX (Merck) (LOT # was not provided) and then experienced a chicken pox outbreak. The outcome of the patient was unknown. It was also unknown that the patient sought medical attention. Follow-up information has been received from the nurse that there was no patient involved and that she was just calling for clarification. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, dose number, lot number, date of event, recovery status. This is one of several reports received from the same source. Additional information is not expected.