chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 31-OCT-2018 regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 04-JUN-2014, the patient's healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 21-NOV-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
This spontaneous report as received from a nurse practitioner refers that on an unknown date, unspecified doses PEDVAXHIB lot # L042258 (expiration date: 18-AUG-2018) and ROTATEQ lot # L028645 (expiration date: 25-MAY-2017)were exposed to a temperature excursion of 30.2 F for a time frame of 7.18 hours. However, no doses of these vaccines were administered to any patients. The vaccines experienced a temperature excursion of 30.2 F for a time frame of 7.18 hours. There were, reportedly, no previous temperature excursions and the call for the aforementioned ones was because of a data logger. Moreover, despite this temperature excursion, no adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Extreme mood swings/PMS and period pain for 4 months after second dose (with no prior history of either). High level of anxiety and difficulty finding words during conversations. Disapated 4ish months after second dose around same time period symptoms diminished
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Confusion-Medium, Systemic: Exhaustion / Lethargy-Mild, Additional Details: patient expereineced diffuculty breathing, gave epinephrine, breathing got better, patient was very lethargic and confused, border line fainting but still responsive, called ems they arrived and took her to hospital
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 25-year-old male patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Lot number: EW0185) at the age of 25 years, in right arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient had any known allergies were reported as none. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of covid-19. Therapeutic measures included Anti-viral details: Product: COVID 19 Treatment, Treatment start date: 03Aug2022, Lot number: GD9454, Indication: Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
About 40 minutes after felt left side of face numb. At 2 am in the morning woke up with violent bed spins after turning head to the left.  Next day was dizzy at times but is settled within a minute.
Redness swelling at site of DTaP. Febrile to 105F.
Fever, Tiredness, Nausea, Chills, Muscle pain, headache, injection site pain, redness and swelling, joint pain and I have a bruise in the area where the first dose was injected.
Fever of 100.5' F (oral), Very achy mussels, Sensitive skin, and Restlessness (can't sleep). I feel somewhat week, and run down. Like I was doing hard physical work all day. Witch I did not.
Pt received GARDASIL sitting stood up and few seconds later passed out x 20 seconds. Sat up BP - 114/68. Placed in chair and then passed out again x 10 seconds. Laid down x 10 minutes and OK.
Developed symptoms of mania 7 days post vaccination. First and second vaccine Pfizer, third dose Moderna. No previous psychiatric problems. Hospitalized twice in mental health facilities, not responding to mood stabilizers Original workup negative including Head CT. No MRI or lumbar puncture done.
C/o throat swelling "feels thick" husband says "looks swollen" states cannot swallow 13:04 epi IM given 13:06 Symptoms resolved  13:15 report to EMS
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Severe, Systemic: experience pain on left side of neck down to arm and fingertips-Severe, Systemic: Weakness-Severe, Additional Details: pt. is  experiencing pain from all day long , from left side of neck all the way to fingertips, radiating pain.pt. is unable to move arm readily.pt had seen physcian at urgent care, then came to pharmacy to report of effects. gathered information on his well being, and apologized for inconvenience and recommended to seek medical attention, and services
Ascending paraesthesias and subjective weakness with 1+ reflexes with mild nausea and sensation of light headedness. Paraesthesia began in toes, over 24 hrs moved to feet, next 24 hrs moved to fingers, then hands; 5 days later progressed to knees.
delayed (started on Day 6) pain under armpit; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (delayed (started on Day 6) pain under armpit) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced AXILLARY PAIN (delayed (started on Day 6) pain under armpit). At the time of the report, AXILLARY PAIN (delayed (started on Day 6) pain under armpit) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
Patient came back into the pharmacy tonight and her arm was red and slightly swollen from the shoulder to near the elbow. I advised her to go get seen by urgent care so they could give her something for the reaction.
Patient received adult dose (0.3mls) of undiluted Covid19 (pfizer age 5-11) vaccine
pt recvd vax & leg was edemetous & area around inject site was red approx 4 inches in diameter; pt taken to MD;
I woke up Saturday morning ears felt stuffy, headaches and dizziness. Also my ears were ringing. On Tuesday 12/13/2022 I went into an urgent care. The urgent care referred me to an ENT doctor. ENT doctor ran a hearing test. I have to follow back up with ENT doctor for Diagnosis. Also hearing loss runs in my family.
This spontaneous report as received from a 70 years old male patient with high blood pressure, diabetes and penicillin allergy refers to himself. The patient had a shingles outbreak on his foot (side unspecified) a few years ago. The size of a "half dollar" and it cleared up in 6 weeks. The patient was vaccinated with ZOSTAVAX (lot # unspecified) subcutaneously one month ago (16-OCT-2012). No other co-suspects were reported. Concomitant medications included some unspecified high blood pressure and diabetes medications. The next day after vaccination (17-OCT-2012) the patient had a very severe rash across his back. Two days after vaccination (18-OCT-2012) he had a shingles outbreak on his right shoulder that spread to his chest and down his right arm. The patient contacted his physician and was being treated with steroids. The patient described his condition was recovering. The physician did a culture with no result provided. Additional information has been requested.
Client reported that about 12 hours after receiving the second dose of Pfizer COVID vaccine he experienced body aches, fever, and cold sweats. The client reported about 15 hours after receiving the second Pfizer COVID vaccine, he ambulated to the bathroom and experienced ?heart palpitations, leg tingling, and feeling faint.? The client reported he did eat something before receiving the second dose of Pfizer COVID vaccine. The day before receiving the second Pfizer COVID vaccine, the client stated he only slept for three hours and felt stressed. The client also reported lymph node pain in the axilla region that started the day after receiving the second dose of Pfizer COVID vaccine and stated the pain lasted for one week. The client reported that he would intermittently feel his heart beating ?really fast? for approximately 4 months. The client said these episodes only happened occasionally and lasted around 15-20 minutes. The client denied having experienced any cardiac symptoms in the last 2 months. The client did not follow up with a primary care physician or allergist. The client stated he took Paracetamol the day after receiving the second dose of Pfizer COVID vaccine.
Redness, swelling, hard lump, and pain at injection site. Took Aleve to alleviate pain.
This spontaneous report as received from a vaccine coordinator refers to a 9 month old patient. On 19-FEB-2016, the patient was vaccinated with a third dose of PEDVAXHIB (lot # L030869) (dosage and route unknown) following a temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested
very weak; teeth chattering; could not hold body still, both of her arms were jumping like a seizure; both arms and legs started jumping, head started moving side to side; could not talk clearly to understand; mouth numbness; left arm tingling; Blood pressure 200/95; back of neck sweating; A spontaneous report  was received from a 67-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced could not hold body still, both of her arms were jumping like a seizure/ seizure like phenomena, both arms and legs started jumping, head started moving side to side/ dyskinesia, could not talk clearly to understand/ dysarthria, mouth numbness/ hypoesthesia oral, left arm tingling/ paresthesia, back of neck sweating/ hyperhidrosis, very weak/ asthenia, and teeth chattering/ chills.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included duloxetine hydrochloride, evolocumab, and metoprolol.  On 15 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 038A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 15 Mar 2021, 5 minutes after the administration of the vaccine, the patient experienced mouth numbness, left arm  tingling, sweating at the back of neck with both arms started jumping, head started moving side to side, teeth chattering, and the patient could not hold body still as both legs were jumping, and could not talk clearly to understand. A nurse gave the patient an injection of Epi-pen and Benadryl, which did not work and called emergency medical service. The patient went to the hospital for care, where both of her arms were jumping like a seizure. Blood pressure reading was 200/95 mmHg. On 16 Mar 2021, the patient was very weak. Treatment information included oxygen, Ativan, warm blankets and a warm  room until the patient's discharge.  Action taken with mRNA-1273 was unknown.  The outcomes of the events were considered unknown.; 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.
Approximately a week ago on 9/7/21 patient tested positive for COVID-19 back then she was having URI like symptoms which patient reports are getting better.  Patient has been undergoing chemotherapy for lymphoma and did receive her last chemotherapy on 9/3/21.  For past few months patient has been having recurrent urinary retention. Currently on chronic foley, last urine culture was positive for Pseudomonas outpatient treatment with Keflex.  Patient has some symptoms of abdominal discomfort.  Patient reports at baseline she is able to stand using walker and ambulated.  She has history of chronic compression fractures of vertebra.  She has metastasis of lymphoma to her vertebrae.  She denies fevers chills.  Denies vomiting.  Denies any focal neurological deficit.  Denies breathing discomfort chest pain palpitation.  Denies abdominal pain constipation. Patient reports improving symptoms, no difficulty in breathing, on room air.  Admitted on 9/15/21. Radiological finding could be lagging clinical resolution or improvement.  At the same time patient might get worse we need to observe.  We will not start patient on steroids remdesivir.  Continue to monitor clinically.  Incentive spirometry. Discharged 9/20/2021
This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 23-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 6 August 2014, the subject received unspecified dose of BOOSTRIX (.5 ml, intramuscular, unknown injection site). Her last menstrual period was on 09 January 2014 and estimated date of delivery was on 16 October 2014. The subject was exposed to the vaccines during the last trimester in 24 and 6 days of gestation. The conception was a normal one (no in-vitro fertilization used). No adverse events were reported. At the time of reporting the pregnancy was ongoing. Follow-up information received on 09 January 2015 form the nurse: The VAERS details were provided. Patient's date of birth was reported. On 03 October 2014, after 38 1/7 weeks gestation, the subject gave birth to a male live infant without congenital anomaly, by normal vaginal delivery. The infant had an Apgar score of (9-9), with a weight of 3.764 kg, length of 20 inches and a head circumference of 14.5 inches.
Patient got bronchitus w/n 5 days of vaccine and developed Pneumonia two weeks later.
I received a call from pt 9/17/03. On 9/10 she noted swollen lymph glands left neck area and mild sore throat. 9/13 noted red rash left neck area, papular (fine) and it spread to upper back and anterior chest. 9/17 awoke with right wrist and knee pain, no swelling, no redness and no warmth. Will see PMD.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided Treatment medications were not provided The expired booster shot administered after 30 day use by date or after manufacturer date of expiry.
LARGE SWOLLEN HARD RED KNOT AT INJECTION SITE SEVERE HEADACHE- NEXT MORNING 102 FEVER- SAME NIGHT I GOT VACCINE
Received pfizer dose 1 on 11/11/2021, MIS-C symptom onset on 12/1/2021. COVID-19 PCR positive on 10/13/2021, serology positive on 12/7/21. VAERS report completed by facility (CDC MIS unit) on behalf of state health department. Case reported to MIS-C national surveillance.
I received the first dose in the series on June 4th in the morning. One week later, I had two sores in my mouth on my gum line in the back of my mouth next to my molars. I have never had mouth sores before and have always been healthy. I felt that this could be related to the vaccine in that it ramped up my immune system and it seemed as though it might have caused it to attack the healthy cells in my body. The sores healed in a few weeks. After the second dose on 8/3, about a week later I started to experience stomach pains in the evening. It started on 8/10 in the evening. I felt it was probably indigestion as it passed a few hours later. I had slight stomach pain at night the following week, but nothing notable. On 8/17, I had severe stomach pain after supper again that passed after a few hours. On Sunday 8/18, the pain was severe and excruciating. It started at around 7pm and continued for about 6 hours as severe pain. Around 1am it started to subside. The following day I had slight cramping all day, but was able to go to work. This cycle repeated each night with the severe stomach/abdominal pain starting at 7-8pm and subsiding at about 1-2am. I had to lie in a ball with a heat pad on my abdomen the pain was so bad. During the day it would be better. By 8/23, I could no longer deal with the pain and needed to be seen by my primary provider. The thought was it could be my gallbladder. I had to do an abdominal ultrasound and lab work. Later that day a CT scan. I was forced to stay home from work to get all this testing done and was lucky to get it done in one day. The stomach pain continued that night again. On 8/24, the stomach pain was better and I did not have an episode that evening. On 8/25, I had an episode during the day that lasted about 6 hours. That was the last bad episode. Since then, the stomach pain has been hit or miss, but always mild. I do continue to have joint pain now. It has been the worst in my knees. That is what I have noticed since the stomach pain has subsided. It may have also been an issue during that time frame, but the stomach pain far exceeded any other pain I might have experienced. Also, starting on 8/24, I experienced vaginal bleeding. I did do a return visit to my provider. We decided that the bleeding was likely due to the stress that my body was under. I am on birth control and this bleeding was in the middle of my cycle.
pt called stating that they were not feeling well and had itchy ears and face since receiving the vaccine the previous day.
Report 2001028489-1 describes weakness in a 28 year old male who received hepatitis B vaccine recombinant (Engerix-b). Medical history and concurrent conditions were not specified. Concurrent medications included hepatitis B immunoglobulin administered on 11/11/01. On 11/27/01 the vaccinee received his first injection of Engerix B. At approximately 20:00 on 11/27/01, the vaccinee experienced a very sore and tender arm. Additionally, he stated that the night of the vaccination he experienced mild generalized weakness and noted some night sweats. He also noted a small painful bump on his left shoulder/back. He reported back to the clinic the next day, stating that he could hardly lift his arm. He returned to the clinic on 11/29/01 feeling better but concerned. The nurse assessed the bump on his back which appeared to be a pimple. He did not require treatment and did not miss any work. The reporter stated that the events were mild in intensity and possibly related to Engerix B or HBIG. As of 11/29/01, the events had resolved.
Initial stick did not hurt but on injection it felt like fire in my shoulder and to elbow. Later pain was so intense at home - whole arm to hand. Took NSAIDS and 1/2 hydrocodone. Used heat - ice hurt worse. Been on NSAIDS all week. Saw primary Dr. 12/28. He sent me to Ortho Dr. 12/30 to get cortisone shot. He won't do w/out MRI.
Pfizer COVID-19 vaccine EUA on 04/16/2021 and Tested positive via nasal swab PCR on 05/27/2021
Noted about 12 hours after shots, (L) arm pit tender to touch. No swelling or redness. Instructed.
Started 1/2 hour to hour after administration with a small round rash 1 inch in diameter - by Thursday 7/28 at 2pm it was 2 inches in diameter, itchy and there was a small red line under it, used ice pack & cortisone cream - by Friday 7/29 it was slowly improving.
Severe constipation; severe abdominal and pelvic pain for over three months and ongoing at present.
About a week after the booster I started having heart palpitations. I went to my PCP and they detected PVC and sent me to the cardiologist. I wore a heart monitor for over a week and started taking a medication for my blood pressure- Lisinopril.
Feel like I am experiencing side effect; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Feel like I am experiencing side effect) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Feel like I am experiencing side effect). At the time of the report, VACCINATION SITE REACTION (Feel like I am experiencing side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Severe headache, like a migraine, with nausea/vomiting, and very sore arm and cold intolerance.