chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse concerning a 60 year old female patient with AUGMENTIN allergy and no pertinent medical history who on 14-JUL-2010 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot# 661739/1407X, exp 12-JUN-2011) IM. Concomitant therapies included: lisinopril (manufacturer unknown) and tramadol hydrochloride. On 15-JUL-2010 the patient experienced injection site reaction after receiving PNEUMOVAX 23. The arm of the patient was swollen from wrist up to her neck. The patient couldn't move the arm because of the pain. According to the nurse, the patient's muscle twitched a little during the administration of the vaccine. The patient sought unspecified medical attention. There was no lab diagnostic test performed. At the time of report the patient's status was recovering. Could not move arm because of the pain was considered to be disabling by the licensed practical nurse. Additional information has been requested.
Patient received vaccine and fainted. Significant other was with patient at the time and reported patient "convulsing". Patient reported feeling numb and tingly at extremities and hyperventilating. Patient was sweating and extremely anxious. EMT arrived, assessed patient, and escorted patient out of facility.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On 20-NOV-2014, the patient was vaccinated with an improperly stored GARDASIL (lot # H020901, expiry date 05-JUL-2015) (dosing regimen, route and frequency unknown). No concomitant medications were reported. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient experienced severe body aches, headache, and fever, that lasted a few days.  Then she experienced muscle spasms,numbness on the left side, and headaches that lasted several weeks.   Also experiencing severe lethargy.
pt recv vax 12JUN98 & 72hr post vax pt exp petit mal sz;
This spontaneous report as received from a physician refers to a 69 years old female patient with sulfa allergy, CIPRO allergy and fibromyalgia. The patient was vaccinated with ZOSTAVAX on 09-OCT-2012 or 10-OCT-2012. Lot# and route were unspecified. No other co-suspects were reported. In October 2012, the patient experienced papular vesicular rash scattered over her body after receiving ZOSTAVAX. Specimen of vesical was sent to laboratory for evaluation. No result was provided at reporting time. The outcome of patient was reported as not recovered/not resolved. The patient visited office to seek medical attention. Additional information is not expected.
COVID Breakthrough Case  J&J Dose 1 03/04/2021 1802070  CV+ 9/20/21  9/19/21 The patient is 80 does gentleman who has past medical history significant for CAD diabetes hypertension and hyperlipidemia.  He has been vaccinated against COVID-19 using Johnson and Johnson vaccine.  He went to urgent care today in the afternoon due to cold symptoms along with cough.  They been ongoing for five days.  He also had chills and felt fatigued and tired.  He also has no appetite.  He is not sure of any aspirin aggravating or elevating factors.  He also had a fall yesterday and  hurt his head.  He was seen at Urgent and he was then sent to an Emergency Room for further management.  When he came his pulse ox was 83% on room air.  He had a CT of the head and that showed no acute process.  Chest x-ray showed bilateral infiltrates suggesting pneumonia.  There was concern for COVID-19 and the test has been sent and and pending.  With oxygen using his cannula at 2 L his pulse ox was good and  above 90%  It seems that the fall was accidental and was any is carrying a bucket.  They are not aware of anybody else sick and unaware of any COVID-19 exposure.  They did go to the casino about 8 to 9 days ago and at that time would not wearing masks.
Information has been received from the patient's mother, referring to a male patient of approximately 4 months old. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of ROTATEQ orally (strength, lot number and expiration date were not reported) for prophylaxis. The reporter stated that the patient went to the pediatrician for his 4 month well baby visit and was administered his second dose of ROTATEQ. The patient's mother stated that she did not recall having the initial dose administered during the patient's well baby visit at 2 months of age, although the pediatrician's records indicate that the initial dose was administered. No adverse reaction was reported.
Patient states he began to experience chills, syncope, and fever reaching 102.8 at around 7pm on 12/23, and had to go to the ED on 12/24 where he had to remain overnight and was treated with IV fluids and acetaminophen. He was told his syncope was unrelated to the vaccine, and is not certain if he received any other medications.
Fever, chills, muscle aches.  From 12 hours after shot until about 20 hours when they vastly improved.
Injection site on left arm became swollen (raised, red and itchy) on the 3rd day after the 2nd Moderna vaccine.
I had flu like symptoms, low grade fever, body aches. I went to see my doctor and got tested and I was positive for COVID-19 on 02/07/2023. I was given a prescription for PAXLOVID. They tested me for flu and tested and tested negative for these exams. I also had some stomach upset and diarrhea after I took PAXLOVID. I can say I have recovered from my COVID-9 symptoms but two weeks after I ended up with an ear infection and have hearing loss.
Case number PHEH2013US024741 is an initial spontaneous report received from a consumer 25 Nov 2013. This case refers to a female patient of unknown age. She was vaccinated with FLUVIRIN (batch number: 1308601, expiration date: Mar 2014) on an unspecified date. The patient had an allergic reaction to FLUVIRIN after vaccination (date unspecified). The seriousness, outcome and causality were not reported.
101 Y male with history of hypothyroidism presenting with altered mental status, severe hypotension, hypernatremia, hypothermia, lactic acidosis and positive COVID test. Patient's history of cough, diarrhea and known exposure (daughter) most consistent with COVID pneumonia. Patient met criteria for septic shock due to pulmonary source. CT Chest/abdomen/pelvis with evidence of widespread metastases to lungs, liver and spleen. Patient required 3 pressors, and after discussion with son and daughter 10/13, patient transitioned to comfort care. Patient expired on 10/14/21.   Complications: none   Diagnoses:   Active Hospital Problems   Diagnosis   ? (Principal) COMFORT CARE ONLY   ? CORONAVIRUS COVID-19 PNEUMONIA   ? SEPTIC SHOCK
Severe Headache, lack of sleep, feverish, shriving, Joint pain and nausea, lack of motivation
Pain in the arm of the injection; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Pain in the arm of the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain in the arm of the injection). At the time of the report, VACCINATION SITE PAIN (Pain in the arm of the injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.   This case was linked to MOD21-053388 (Linked Report).; Sender's Comments:  MOD21-053388:Husband Case
a consumer reported that was vaxed w/Rubella in 1988 & devel hives; No further details were provided;
Pt had syncope episode at school while standing in line to turn in a project. Pt felt dizziness and then fainted. Regained Conciousness right away, no seizure, did hit head, but no injury. Pt was back to normal baseline at time of appt.
Lightheadedness,   palpitations, sweating, Anxious/jittery, headache, Tingling-face. Patient was Tachycardic after the vaccination. 21540: pulse 139, 15:45: Pulse116, 15:50 Pulse 106, 15:55 pulse 100 O2 sat: 98 Patient placed on recumbent position, water given  and was sent home at 1606.
Chills; Muscle aches and pain; joints hurt (her body aching); Muscle aches and pain; joints hurt (her body aching); Muscle aches and pain; joints hurt (her body aching); She has a headache; Sleeping the whole morning. She didn't get up; Doesn't want to eat; Fever; Temperature of 100.4; Doesn't feel good; Little soreness at injection site; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient started to received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number not provided), via an unspecified route of administration on the right arm on 21Dec2020 15:00 at SINGLE DOSE as COVID-19 vaccination at the hospital.  It was reported that the patient had COVID-19 in May2020 (until 2020). Then had COVID-19 test again in Jul2020 and still tested positive. The patient did have COVID-19 test last week (Dec2020) and it was negative. The patient also had the flu shot every year as immunization and never has a side effect. The patient was also on unspecified supplement. On 21Dec2020 at 15:00, the patient received COVID-19 vaccine. Around 20:00-21:00 (8-9 o'clock), she felt nothing and perfectly fine. Didn't feel anything until 23:00-24:00 (11-12 o'clock), she felt injection site hurting and started to have fever up to 100.4. She doesn't feel good. She was also was afraid to touch the injection site hard or rub it. On 22Dec2020 (that morning), she has chills, muscle aches and pains, and her joints were hurting (her body aching). The patient also had headache this morning and was sleeping the whole morning. She didn't get up. The patient also doesn't want to eat but was drinking water. The patient wanted to know if other people reported side effects like she has. She mentioned that she had 2-3 coworkers, but these coworkers did not have symptoms after COVID-19 vaccination. Outcome of the events were unknown.  Information on the Lot/batch number has been requested.
NAUSEA. GENERALIZED WEKNESS, COUGH WITH PHLEGM, ABDOMINAL PAIN, HEADACHE AND JOINT PAIN
SkinRash Narrative: swelling at l arm at injection site and lymph node swelling axillary
pt recvd vax & 12 days p/vax exp achiness, swollen extremities, hives & rash;
Headache & Fever Narrative: Employee reports experiencing headache and fevers that started a few hours after vaccine was administered, incapacitated from coming to work but not severe enough to seek medical care.
Rt thigh with oblong area of erythematous patches, total area about 14 x 9 cm. in the center of this area, centered at site of MMRV, is approx 6cm circular area that is erythematous with multiple vesicles.
I had a random fainting event out of nowhere, I lost consciousness for about 20 seconds and came back to. I have an appointment in April for a follow up/ check up.
fever/Caller just took patient's temperature little bit ago and it was 102.7; nauseous; Dry heaves; This is a spontaneous report from a contactable Consumer (patient's mother) reported for a 15-Year-old female patient. A 15-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0180, Expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 26Jul2021 at 15:00 (age at vaccine 15-year-old) 0.3 ML as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Either EW0180 or EW0980, Expiry date: unknown), via an unspecified route of administration in the left shoulder, administered on 30Jun2021 as a single dose for covid-19 immunisation and experienced nauseous, dry heaves from 01Jul2021 to 01Jul2021 and fever from 01Jul2021 to 02Jul2021. On 27Jul2021 after the second dose of Pfizer-BioNTech COVID-19 Vaccine, patient experienced fever, dry heaves and was nauseous and requesting any management recommendations. She wanted to ask about use of Tylenol for the fever and anything to help with nausea. After the vaccine, early this morning, the patient's mother found the patient on bathroom floor next to toilet because of the nausea. Not sure if patient has thrown up yet. This was the same reaction after she got her first dose on 30Jun2021. The patient underwent lab test and procedure which included temperature little bit ago and it was 102.7 on 27Jul2021. The clinical outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
client reported nausea after receiving 1st Janssen Covid vaccine. At 1540 RN  assisted client who was pale and nauseous to sit down in observation room. Client reported he had just received Janssen Covid vaccine and was feeling nauseous. RN gave client emesis bag. PHN joined RN at 1543 with vital supplies. Upon arrival client sitting in chair, leaning forward holding emesis bag. Client appeared pale. Vitals: blood pressure 103/56, pulse 61, oxygen 96%. PHN  and RN  assisted client to transfer from chair to anti-gravity chair. Per client only had nausea. Declined headache, blurry vision, chest pain, shortness of breath. Per client had arrived to site and ate snack quickly prior to vaccine, last meal was breakfast. RN provided client water and juice at 1545. Per client no relevant medical history, medications and no known allergies. Vitals at 1548: blood pressure 135/75, pulse 59, oxygen 96%. Per client nausea improving, skin color improving. RN stayed with client remaining time in observation. Vitals at 1553: blood pressure 131/78, pulse 68, oxygen 97%. Per client all symptoms resolved, skin color normal for ethnicity. Vitals at 1603: blood pressure 136/79, pulse 58, oxygen 100%. No complaints. Client finished juice. Last vitals at 1613: blood pressure 140/81, pulse 56, oxygen 99%. Per client feeling fine, no nausea. Client left facility with steady gait at 1620.
myalgias,h/a,abd pain,site inflamed;tx motrin,APAP,IV NaCl;
Fever, headache, general body aches that did not start the 1st time until 5 days after and lasted 4 days. The second dose was given on 4/10/2021 at 5:00PM and the same symtoms as previouly listed did not occur until 10 days later (April 20, 2021) and are still being experienced. Taking Tylenol for symptoms.
Within 1 minute after the injection I felt tachycardia and the tightness in my neck and an abnormal sensation in the back of my tongue.  This lasted for about 20-25 minutes and then  mostly resolved.  I was monitored by the paramedics.  I had normal vitals at the time of evaluation which was soon after notifying staff. After the 1st injection I had a similar episode, but I thought it was anxiety related.
Second dose scheduled more than 36 days away from the first dose; Mild symptoms after administration; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled more than 36 days away from the first dose) and VACCINATION COMPLICATION (Mild symptoms after administration) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to many antibiotics).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION COMPLICATION (Mild symptoms after administration). On 18-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled more than 36 days away from the first dose). On 18-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled more than 36 days away from the first dose) had resolved. At the time of the report, VACCINATION COMPLICATION (Mild symptoms after administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications include Blood thinner.  The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: The follow-up document received; As telephone contact report and has significant data reported. Event start date was updated as 8-Feb-2021.
During administration of vaccine, the needle became detached from the syringe resulting in little to no vaccine being administered to the patient, and resulting in spillage of vaccine. It was determined by the pharmacist that the patient likely did not even receive half of the dose, and per previous direction from Moderna, warranted another dose be administered.
A few hours after receiving vaccine, had increased pain in left arm. Pain and tingling continued throughout the evening.  The next day, patient complained of pain and tingling that went from arm, down left torso, down left leg and foot. Pt. states she also had tingling in the neck and jaw, eyes and ears throbbed, and head was pounding. By Sunday morning, all sx. had resolved.
Sweat through sheets and different outfits; Body temperature still not regulated; Freezing cold; Arm looks like a goose egg, inflamed, and has a big bump; Dizziness; Super bad headache; Starting at midnight,he was physically shaking because he was so cold; Fever all night; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweat through sheets and different outfits), BODY TEMPERATURE FLUCTUATION (Body temperature still not regulated), FEELING COLD (Freezing cold), PERIPHERAL SWELLING (Arm looks like a goose egg, inflamed, and has a big bump) and DIZZINESS (Dizziness) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 HYPERHIDROSIS (Sweat through sheets and different outfits), BODY TEMPERATURE FLUCTUATION (Body temperature still not regulated), FEELING COLD (Freezing cold), PERIPHERAL SWELLING (Arm looks like a goose egg, inflamed, and has a big bump), DIZZINESS (Dizziness), HEADACHE (Super bad headache), CHILLS (Starting at midnight,he was physically shaking because he was so cold) and PYREXIA (Fever all night). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweat through sheets and different outfits), BODY TEMPERATURE FLUCTUATION (Body temperature still not regulated), FEELING COLD (Freezing cold), PERIPHERAL SWELLING (Arm looks like a goose egg, inflamed, and has a big bump), DIZZINESS (Dizziness), HEADACHE (Super bad headache), CHILLS (Starting at midnight,he was physically shaking because he was so cold) and PYREXIA (Fever all night) had not resolved.            No concomitant medications provided.  Patient was given water for hydration.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were unspecified. On an unknown date, the patient was vaccinated with ZOSTAVAX (vial 19400 PFU) 0.65 ml (lot#, dose number, anatomical location and route unspecified). The pharmacist reported that he was told by another pharmacist that the patient had "experienced a lump" (location unspecified) after the administration of ZOSTAVAX on an unspecified date. On an unknown date the patient experienced mass. The outcome of the event was unknown. No product quality complaints was involved. No further information was provided. Causality assessment was not provided. Additional information has been requested.
A nurse reported that a 35 month old female received an injection of Prevnar on 8/23/01. The pt had a runny nose at the time of vaccination. On the same day, the pt experienced a fever, runny nose, was not eating and was noted to have cried "all night". She also developed redness on her arm. The pt experienced these same symptoms after receiving another dose of Prevnar on 10/23/01, see HQ8094306NOV2001. The pt recovered following treatment with Benadryl. The reporter considered these events to be "Medically Important".
Throat swelled; Had a very hard time breathing; She had a barking cough and couldn't stop; She was dizzy; Had a hard time standing; This is a spontaneous report from a contactable healthcare professional. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left leg on 20May2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included mast cell activation syndrome. The patient had known allergies with gelatine, egg and other allergy (unspecified allergy). The patient did not receive any concomitant medication. It was unknown whether prior to the vaccination, the patient was diagnosed with COVID-19. It was unknown whether since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 20May2021, the patient experienced throat swelled, had a very hard time breathing, she had a barking cough and couldn't stop, she was dizzy and had a hard time standing. The events resulted in emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events throat swelled, had a very hard time breathing, she had a barking cough and couldn't stop. She was dizzy and had a hard time standing was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
papular macular urticarial rash w/assoc itching;no URI sx;one vesicle noted on day 2;
Mother called stating child woke up with rash on her left thigh. States it is red and swollen and child complains of it being itchy. Did not give antihistamine for itching. Per Dr advised mom to give BENADRYL 1 tsp every 6-8 hrs as needed and to call if not improving.