chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with RECOMBIVAX HB lot # K009953, expiration date 03-APR-2016 (dose and route were not reported). The vaccine underwent supported temperature excursions. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Induration, lacy rash over chest and upper left arm, itchy.  Ongoing 9 days later
Information has been received from a pharmacist. This pharmacist reports similar events for 2 patients. This was the first of 2 reports. This pharmacist reports she gave PNEUMOVAX 23, 1 injection, to a female patient, age unknown, about 3 hours ago, on 01-MAR-2012, and the PNEUMOVAX 23 expired on 25-FEB-2012. On unspecified date, the patient died. It was unknown if there was any relevant medical history, relevant concomitant medications, or relevant past drug history. It was unknown if there was any relevant laboratory tests. Additional information has been requested. This is one of several reports from the same source.
I woke up in the middle of the night shivering with bad chills. I also had the sore arm, but that was nothing. During the night, the chills were bad and the leg pain. When I got up to go to the bathroom, I could tell my blood pressure was low. But I had a normal temperature in the morning which was 98.3. My BP was 76/56 when my husband took my blood pressure in the morning. So that's when I called the doctor's office. I also had a terrible stomachache and a headache. I just felt horrible, but it was the chills that knocked me. The next day, the chills were starting to go away, the headache as well. But I had a rash from just below my chin all the way down to my hips. All over my entire torso and under my arms and all over my breasts and under. Front sides, back, everywhere. It was a worst rash than when I had vaccine 1 & 2. I was just really wiped out and super tired. By the end of that day, I was beginning to feel better. I also had no appetite this entire time. I could hardly eat anything, I was able to eat something because I needed to, especially since I needed my blood pressure to go back up. I knew that it was dangerous for me to have low BP because it can cause you to fall. The first night, I thought I was going to fall over that night going to the bathroom, but I never took my BP. I never felt that bad with the first two vaccinations. The pain of the leg decided to stick around. The day after that, the rash started fading. The other symptoms, by that day, I only had a little bit of a rash and leg pain, but the rest of the symptoms went away, and the BP went back to normal. Leg pain persists.
DIAGNOSED WITH CASE OF CHICKENPOX ON 2-16-04 AFTER RECEIVING VACCINE ON  5-11-99
The patient stated that her arm started itching and began to swell.  Suggested she try Benadryl and if symptoms began to spread or worsen go to the ER.
his blood pressure, at first it was93 and the second time it was 32; fast heartbeat; This is a spontaneous report from a contactable consumer (patient mother) via Pfizer-sponsored program.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date (lot/batch not provided) as COVID-19 immunization. Then, the 2nd dose on 22Jul2021. In 2021, the patient experienced had blood pressure which at first it was 93 and the second time it was 32 and had a fast heartbeat. Outcome of the events were unknown.   Information regarding the batch number has been requested.
Severe headache 10/10, nausea, vomiting, temp of 99 degrees F x 24 hours. waning at this time
I experienced a lot of pain in my chest, I knew something was wrong so I decided to go to the hospital and the pain became much worse and they determined it was a heart attack. The doctor placed a stent in my heart to open up the blockage because it was a 100% blockage in my heart, they told me I would have died in 4 hours if they didn't place me in surgery to place the stent to open up the blockage.
10/15  fever N/V Headache subsided by 10/16 10/16 - felt ill :Neck started swelling" 10/17 Visited Eastern Maine Medical Center  Lymph nodes swollen Left side shortness of breath  CBC XRay
This is a 83y.o. male with a PMH as below who was admitted to 4N due to sexually inappropriate behavior. Pt was being prepared for discharge and subsequent COVID19 PCR testing was positive. Pt is asymptomatic. Spoke with daughter and she confirmed patient was vaccinated for COVID19 on 3/10 and 3/31. Pt received the Pfizer vaccine. Pt was evaluated this morning. Pt denies any symptoms. Pt denies any CP/sob. No n/v/d. No fever or chills.
soreness at the injection site; shoulder pain; sore arm right after the first dose; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: 5L9264, Expiration date and NDC number was unknown) via an unspecified route of administration, administered in right arm on 18Feb2021 as dose 1, single (age at vaccination was 63 years) for COVID-19 immunisation. The patient's medical history included Adult-onset mitochondrial myopathy from 2000 to an unknown date and blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications included hydrochlorothiazide, lisinopril (lisinopril + hidroclorotiazida, taking since 2018-2019) and sertraline (started years ago, like 30 years off and on), both indicated for blood pressure, start and stop date were not reported. On an unspecified date of 2021, patient had first dose, she was fine no problem, very easy shot, maybe a little bit of shoulder pain, soreness at the injection site and sore arm right after the first dose just reminded her that she got the shot. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
woke several times during the night with fever and chills in morning fever was 101.4 and strong headache, hips and back ache, fatigue
Severe tinnitus.  I have never had this before and stopped the Ibuprofen and all NSAIDS but the tinnitus has continued all the time ever since.
Received 2nd COVID vaccine 3/7/21. Suffered syncopal episode on 3/8/21 resulting in fall, hit head, ambulance transfer to ER.  Non-contrast CT head negative, discharged from ER. Another ER visit on 3/13/21 due to chest, shoulder and back pain, was found to have fractured ribs and discharged to care of child. Pt was taken to ER on 3/14/21 as woke up unable to ambulate without 2 person assist. CT chest revealed 3 fractured ribs, magnesium level low and replaced in ER. Pt was eventually admitted to the hospital, 2 night stay and transferred to an extended care facility where she remains. Pt is still unable to ambulate without 1-2 person assist, has suffered confusion and occasional hallucinations.  Awaiting results of 2nd CT of head obtained on 3/18/21.
Pale color, listless, vomiting x1 almost immediately after vaccines.  Given TYLENOL & taking bottle, improved color & alertness prior to d/c home.
This is a 4-year-old white female who presents to the emergency department after having a flu shot and was started on Premarin cream today for labial effusion.  Second dose was at 10:30 p.m. About 45 minutes later the patient complained of being cold with her legs hurting, throat hurting, having headache and chills according to the mom.  She had no fevers. She has had no rash or wheezing. No hives, and now all has completely returned to normal with no complaints at all.
Approximately 1 wk after getting the H1N1 nasal spray client experienced itching on hands that spread to arms/legs. On 11/17/09 went to ER because OTC HYDROCOROTIZONE didn't help ER gave him 3 pills to take 1 every day and he did. 11/30/09 called health dept to report itching. Pills didn't give him relief. Suggested he go to his private Dr since he has a medical card.
Patient came in for her first Moderna covid vaccine. After her vaccination, she went to sit outside the pharmacy to be monitored for 15 minutes as told. About 2 minutes after sitting down, her husband came to get my attention and stated the patient feels dizzy. When I came to assist, she stated she could no longer see but could still hear sounds. Her eyes started to roll to the back of her head and she fainted on her chair for about 5 seconds and recovered soon after. Then she said she could see again but was still feeling dizzy. She took a sip of water and continued to take deep breaths. Because she still felt dizzy and stated her vision was still blurry, her husband and I assisted her to the ground and had her lie on her back with her legs elevated. She instantly felt better and was able to see again but asked to take some glucose tablets, a few minutes later, because she felt her blood sugar might be low. She proceeded to take 2 of them. After a total of 30 minutes since the vaccine, she stated she felt well enough to go home. She then got up and left the facility with her husband.
WARMTH, PAIN, ERYTHEMA ON SITE OF INJECTION AND AROUND.
Patient tested positive for Covid-19 on 2/7/22 and died on 3/3/22
44 yo patient developed a red rash and swelling over the right shoulder two days after receiving a pneumococcal 23 vaccine. Patient expressed pain in shoulder with movement.  Red rash and swelling of the right shoulder, hives on the right shoulder. Ibuprofen 800 mg UD.
Injection site pain, headache, muscle aches, fatigue, chills and nausea
On 5/1/2023, this individual received a 0.3 mL (30 mcg) dose of the Pfizer Monovalent COVID-19 Vaccine, mRNA (Comirnaty) for primary series vaccination.  The administration of this vaccine occurred after the CDC ACIP announcement that monovalent (original) COVID-19 mRNA COVID-19 vaccines will no longer be recommended for use in our area.
This spontaneous report as received from a licensed practical nurse refers to a 2 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 30-NOV-2015, the patient was inadvertently vaccinated with a dose of VAQTA (0.5 ml, lot # L004439, expiration date 15-FEB-2016; route of administration was not reported). No adverse effects were reported. Additional information is not expected as the reporter did not wish to be contacted.
Had extreme pain in left arm. Could not move arm. About four in the after noon developed a fever, fatigue, body aches. Was advised to rest and take Tylenol.
Initial and follow up information has been received from a physician concerning a pt (age and gender not reported) who was vaccinated (date not reported) with a dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P). Subsequently the pt developed cellulitis at the injection site that was self limited and resolved in 5-7 days. It was also reported that the pt sought unspecified medical attention. There was no product quality complaint involved. Additional information is not expected.
This spontaneous prospective pregnancy report was received from a 22 year old female patient, who was reporting on herself. The patient's pertinent medical history included nothing relevant. The patient had none drug reactions or allergies. On 16-DEC-2015, the patient was vaccinated with VARIVAX (Merck) (dose, route of administration, lot# and expiration date were not reported) in the right arm, prior to learn that she was pregnant. Concomitant therapies included prenatal vitamins, unspecified tetanus booster and Flu vaccine. No adverse event was reported. No product quality complaint (PQC) was involved. Lab diagnostic studies included: tuberculosis skin test, blood test and intravaginal ultrasound, all performed on unknown dates. The patient received prenatal vitamins as a treatment. On 01-NOV-2015 (also reported as about two months and 10 days), the patient had last menstrual period (LMP). The date of conception was calculated as 15-NOV-2015. On 28-DEC-2015, the patient found out she was pregnant. The patient sought medical attention by speaking with physician and obstetrician. 07-AUG-2016, was the estimated date of delivery (EDD). Additional information has been requested.
Chest pain in left side and down arm. Disrupted menstrual cycle - past due a full month as of today 10/24 - developed a very painful gland infection on right side of jaw into my ear and had to take antibiotics.
GI symptoms: diarrhea, nausea." Hives on my face"  palpitations for the past couple of nights including last night, hot flashes, no fever
Hives/Rash, small red spots from head to toe. So far for approximately 4 days. Not painful, not itchy. Looks like chickenpox without the white center.
positive for Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (positive for Covid) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2023, the patient experienced COVID-19 (positive for Covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at a dose of third full dose. In February 2023, COVID-19 (positive for Covid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2023, SARS-CoV-2 test: Positive. On 10-Feb-2023, SARS-CoV-2 test: Positive. On an unknown date, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Patient ethnicity reported. Patient was fully vaccinated and boostered. Patient had symptom developed 06-Feb-2023 Monday night, this past Monday night, it was slight sore throat, and it was very slight. Patient woke up in the morning it had moved on to chills, headache, and whole sore body. So, that evening he had a progress and had it tested with home test, he was very good at these and boom it was positive right off the bat for Covid. So, patient immediately started Paxlovid.  It would have been Tuesday night, patient started his first dose that night and morning and the evening, He just started the morning, evening in morning the next day that would have been Wednesday and Thursday again same thing.  He had retest, may be a little bit of headache, obviously some still sniffles that were going on, but patient was pretty impressed by the day patient completely symptomless. All his energy had returned, and patient was like okay let us go ahead and throw a test at it. So, at 3 pm PST, extended time it was negative. No symptoms testing negative.
2 days of left leg sorenss and sob with exertion (not sure this is related). symptoms have since resolved.
p/vax pt exp a lump on arm the size of a peach & diff lifting arm;sx were treated w/hot compresses;
3 days p/Hep B vax pt exp flu like muscle soreness & low grade fever 99; 7 days p/inject had swollen & painful hands & foot, & knee joints; high fever 103.5 w/h/a; On 8th day devel rash on feet & legs & forearms that lasted x 5 days;
Nothing was wrong with me after my first dose, my period came a day late which is normal for me to get it later and it was like any other period I had this year. I then got the second dose of the Pfizer vaccine on 06/28/2021 meaning in 07/12/2021 I would be deemed fully vaccinated. Just a day after, today 07/13/2021 I got my period 3 days earlier when that has NEVER happened to me in my 10 years of having a period, its always like I said a day to a week (max) late. My period came in like a fully opened faucet, making me change my pads every hour, my cramps are so intense I feel dizzy,  fatigued, on the verge of passing out from the pain and if I could afford a hospital bill I would?ve been there hours ago getting help. I can?t even stand or move too much without breaking down in pain. These cramps are NO joke. I took 2 ibuprofen 600 mg an hour apart from each other and it?s been 4 hours singed and I have no improvement. I do have ovarian cysts in both ovaries and usually have bad periods with stronger cramps than what other healthy women experience but this is completely different. I?m listening to my body and it?s telling me something is wrong.
This study case was received from the investigator (MILVAX) in a trial on 23 January 2012. A 27-year-old male subject received the following vaccinations on 03 November 2011: ACAM2000 (lot number not reported), INFLUENZA VACCINE (manufacturer and lot number not reported) and ANTHRAX VACCINE (manufacturer and lot number not reported). The subject had no significant medical history. On 18 November 2011, the subject had a normal electrocardiogram (ECG) and a normal echocardiogram. On 16 November 2011, the subject was diagnosed with unspecified disease of pericardium. The outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Reports headache, fatigue, sore throat, and pain at injection site that began 30 minutes post vaccination.
Had a sore left arm at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Had a sore left arm at the injection site) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A, 019B21A, 058F21A and 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Had a sore left arm at the injection site). At the time of the report, VACCINATION SITE PAIN (Had a sore left arm at the injection site) outcome was unknown.            No concomitant medications were reported.  On 01-Nov-2021, the patient received first booster dose of Moderna COVID-19 vaccine.  On 21-Apr-2022, the patient received second booster dose of Moderna COVID-19 vaccine.  On 12-Mar-2021, 09-Apr-2021, 01-Nov-2021 and 21-Apr-2022, the patient had a sore left arm at the injection site.  No treatment medications were reported.   This case was linked to MOD-2022-656149 (Patient Link).
breakthrough after fifth vaccine  injection/rebound of symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (breakthrough after fifth vaccine  injection/rebound of symptoms) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    Concurrent medical conditions included Asthma, Blood pressure high and Overweight. Concomitant products included HYDRALAZINE from 13-Nov-2022 to an unknown date, METOPROLOL SUCCINATE from 16-Aug-2022 to an unknown date, LOVASTATIN from 12-Jul-2022 to 13-Nov-2022 and TELMISARTAN from 24-Aug-2022 to an unknown date for an unknown indication.   In September 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Nov-2022, NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) dosage was changed to 20 milligram once a day. On an unknown date, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 10 milligram twice a day. On an unknown date, the patient experienced COVID-19 (breakthrough after fifth vaccine  injection/rebound of symptoms). At the time of the report, COVID-19 (breakthrough after fifth vaccine  injection/rebound of symptoms) had resolved.            Patient physician advised high risk of COVID-19.  No treatment medication was reported.
Patient received 2nd dose of pediatric COVID-19 vaccine without a problem. He remained in observation area as instructed for 15 minutes, then left to walk around store. While waiting in a checkout line at the front of the store, patient fainted. Mother and patient returned to pharmacy where he was seated, given water to drink and observed for an additional 15 minutes. Mother and pharmacist determined the fainting was likely related to his nervousness. Patient and mother left without further incident.
Patient reported a metallic taste in mouth right after administration of vaccine. She then reported a funny feeling in her throat. Pharmacist gave her Claritin 10mg  (5-7 min post vaccination). She has experienced seizures in the past and felt like one was coming on. She had nausea, light headedness, cooling sensations. She was given some water and then asked for pepto bismol, which we gave her (10-15 min) post vaccination. She then started getting hives on neck and eye. She wanted an ambulance called, we did. She started getting tingles on both arms and neck. Felt a sensation like someone sprayed water near her on her neck. Ambulance arrived and by that time she was feeling better and hives were leaving.  Paramedics checked her out and she declined going to hospital. Headache started when paramedics were assessing her. She had a friend come pick her up and take her home, to monitor her.
10 days after receiving the immunization, pt started to have labored breathing. I immediately began giving her Albuterol, and was giving her 2 puff every 2 hours for an entire day. I then brought her to her pulmonologist's office for an emergency appointment: she was wheezing, was given Albuterol which helped reduce the wheezing, so she was sent home & told to continue Albuterol as needed. Her breathing continued to be labored (visual pulling of both abdomen & neck) for over another day before symptoms subsided. Aside from difficulty breathing, there were no other symptoms.
This spontaneous report as received from an unspecified consumer, who refers to a female patient of unknown age. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications was reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, route of administration, injection site, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patient experienced rash with red bumps and itchiness on her legs (it was up to her thighs). She applied CAMPHO PHENIQUE, which helped a little. On an unknown date, reported as three days later, the same rash appeared on her arms and trunk. During examination the patient had erythematous papules on trunk and extremities, some with scab on top. The outcome of the events was not recovered. The relatedness between the events and the suspect therapy was not provided.
pt reports the vaccine was injected into her shoulder joint space and has weakness and numbness in her arm, had an MRI to confirm bursa inflammation
Transient lingual papillitis- lesions on tongue, open wounds in mouth, bleeding tongue, and sensitive teeth
Throat itching, hoarse voice, nasal stuffiness, facial swelling (subjective), chest tightness Treatment - self treated with Benadryl (75mg), Zyrtec 10mg. Mild improvement 2 hours later, s/s not completely resolved at time of submission