chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 78 y.o. male admitted to the hospital on 11/17/2022 for shortness of breath, lethargic and hypoxia after recent diagnosis of covid at his long term facility   Discharge Diagnosis and Associated Hospital Course   COVID-19 with acute hypoxic respiratory failure resolved  -Suspect the main etiology shortness of breath and cough -currently 93% RA -Reported is not on any O2 at the rehab center -will stop decadron due to dm2   -Not a candidate for remdesivir due to elevated creatinine -ID recommended continue paxlovid to complete course -cxr with no consolidation -patient has cough and congestion, symptoms    Type I IDDM w CKD 3 -Blood glucose is currently stable - continue his Lantus dose at 30 units -continue ssi -glucose elevated due to steroid   Acute kidney injury on CKD 3 Acute urinary retention -Baseline creatinine 1.2 increased to 1.6 now down  -Suspect combination from COVID and probably diuretic and if certain news -aki resolved, start flomax when off paxlovid for now will need straight cathed q8 hours   Right heel ulcer -Chronic for him -warm to touch and erythematous will -We will continue wound care to see   History of seizures -Continue Keppra   Essential hypertension -Continue metoprolol Peripheral artery disease -Has had amputations of his toes in the past -Has had multiple interventions in the past -Continue aspirin Plavix and statin therapy  Dementia without behavioral disturbance -Patient currently calm and collected -We will continue his Aricept for now
10:20 am.  Noticed dizziness and was diaphoretic. Immediate evaluation by onsite EMS and NP.; 10:25 VS 139/90; p 76; Sat 99% on RA; R 14.  ; VS 10:35 - 199/89; P 67; Sat 99% R. 16.  Offered patient cold water and a cereal bar. She had a small high protein breakfast early in the day, only.  She ate the cereal bar, drank some water and stated she felt better.  Discharged home with family member @ 10:35 am. Symptoms resolved.
Several cold sores. Bottom lip blistered almost completely across, swollen and painful. Top lip has small tiny, painless blisters.
She had left eye drooping, not grasping with her hands or using her legs on saturday morning. By saturday afternoon she started improving. By Sunday afternoon she seemed  back to normal. She had a low grade temp up to 99.4. She had 4 bowel movements and they were normal
Nausea, Chills, Elevated Temperature, Headache, Cold Sweats at night.
soreness at site 24 hours after injection with associated redness. redness expanded at day 7 and became itchy. 2 days after vaccine, had vaginal spotting. 6 days after vaccine painful swollen node under left arm. dysuria started 6 days after vaccine
Mother of child states that she noticed swelling and redness at vaccine sites accompanied with a temp of 102.2 the following day after he received vacines. Mother of child states she gave child Tylenol for symptoms.
10 min into her observation period pt let RN know that pt's lips were feeling tingly. RN sat with pt and tried to keep her calm and to take deep breaths. A little more time went by and pt stated that her face and hands were feeling tingly. Administered 50 mg diphenhydramine (Benadryl) PO. Pt then stated her tongue felt heavy and her throat tingled. Adminisered 0.3mg epi 1:1 IM in left thigh and called 911. BP 160/90, pulse 107, 96% SpO2. EMS arrived and transferred care to Paramedic.
At 4 PM I started to get a severe sore throat and very bad runny nose-by 730PM I was in bed in pain-weak-difficulty breathing, headache-I am not a sleeper but I felt I passed out for 6 solid hours. When I woke I struggled to get out of bed-very weak-lot of body pain-stumbling so weak. Took a lot of TYLENOL to try to help. Mucus eyes almost like pink eye/red/swollen. Dry mouth/lips. Bad taste. Slight fever. Generally in the past I'll get the sore arm and generally a sore throat. This time was scary. Should I get a flu shot next year?
wheezing, swelling of tongue & rash on face;anaphylactic-given epi;cried 1hr, would not eat, drooling;
red, swollen, warm 13x8cm around tetanus injection site.  treated with antibiotics from er visit
Severe shaking, chills, sweating and fever. Severe all over body aches.
Pt recv vax on 2/2/99; 1 hr post vax pt exp fever (101.8-102)
Almost immediate finger tingling - lasted 3 days Within 2 minutes - face flushed/red - lasted around 30 minutes Within 5 minutes - mild throat tightening - lasted around 20 minutes Within 20 minutes - diarrhea - only once Headache - lasted 3 days Sore throat from lymph node swelling - started next day, lasted 3 days  I am a healthcare worker and self-monitored the severity. Since I have had many similar reactions to numerous allergens and carry an epi-pen I did not seek treatment.
Pt recvd vax on 02DEC89; On 19NOV90 was inadvertently given 2nd vax; @ time of report there was no adverse rxn;
tightness of chest, coughing, increased BP to 222/168, lightheadedness. dizzy
soreness on her arm that was vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness on her arm that was vaccinated) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included Parkinsonism.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness on her arm that was vaccinated). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness on her arm that was vaccinated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided
pt's throat starting itching about 10 minutes post vaccine (was in observation period).  pt was gived 20 ml of benadryl 12.5 mg/5ml (50 mg).  felt better about 5 minutes later.  About 15 minutes after that pt felt itchy again and was given another dose of benadryl.  Pt's symptoms subsided and was observed for another 15 minutes. His wife drove him home and he felt fine.
Pt called on 11/14/2023 to report he feels he may be having an adverse reaction to the flu shot he received on 11/10/2023. He reports he was in his usual health Friday and Saturday until the evening, when he developed a "pounding" headache. He was able to fall asleep, but was awoken by the pain around 2am and had to take Ibuprofen 600mg to resolves the symptoms and to get back to sleep. Since then he reports he has had to take Ibuprofen consistently every 6 hours. He denies any other symptoms including fevers, chills, myalgias, nasal congestion, cough, etc. He also denies any other neurologic symptoms including change in vision, imbalance, weakness, nausea or vomiting. He denies a prior history of similar headaches or migraine headaches.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild
I received the vaccine on 3/6/2021 and on  3/11 I went to have blood work done on same arm, 4-5 hours later I started getting a low temperature and its still going and scheduled to have 2nd dose on 30th. I never have a temperature. It has made me feel tired and I just want to sleep
48 hours after Menomune given she had seizure HA (headache) unrelenting, saw Narrowgise, MRI, MRA of brain, CBC. West Nile virus. Lyme titers all Negative. No lumbar puncture done Headache lasted until 6/07/04. Neurologist believe it is related to Menomune.
A report received from a health care professional on 06Nov02 concerning a female vaccinee of less than 4 years old who was inadvertently administered 0.25ml Fluvirin on 25Oct02. On 25Oct02 the vaccinee who was less than 4 years old was administered 0.25 ml Fluvirin IM. No adverse event was reported in relation to the incident.  There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200200706.
On 5 Apr 2018, employee reported onset of fatigue and aching about 1 week ago, with sudden onset of fever, chills, sweats, sore throat, headache, nausea with episode of emesis, and cough on 4 Apr 2018, taking him in for evaluation. No sick contacts. Self treated with Dayquil w/o relief. On 5 Apr, his temp was 102.8 and heart rate was in the 100 - 110's range. CBC showed elevated WBC of 19.6. He had a negative rapid strep and tested negative for influenza A & B. Treated with Tylenol and 1 L of IVFs before referred to Emergency Dept with diagnosis of SIRS. While he was in the ED, the reaction at the smallpox vaccination site was diagnosed as cellulitis and patient was treated with antibiotics (doxycycline). He has recovered and returned to work (10 Apr 2018). Symptoms: TOXIC ERYTHEMA(L530), FEVER, UNSPECIFIED(R509), HEADACHE(R).
Fever (100.9 F) from 3:30 PM - 9:30 PM, treated with ibuprofen and acetaminophen.  Chills that coincided with the fever.  Body aches and joint pain, starting at 8 AM and increased in intensity throughout the day, lasted until awakening the next day, ibuprofen and acetaminophen did not help.
A pharmacist reported that a 30 year old male received an injection of Flu Shield '00-'01 on 11/1/00. On 11/3/00, the pt developed a fever, headache and shingles. On 11/13/00, he experienced numbness. An MRI showed plaques on the spinal cord that are similar to multiple sclerosis. The reporter also indicated that a neurologist believes that the pt's symptoms are a central nervous system disturbance. As of the date of this report, the pt still had a sensory disturbance of his lower extremities. Neurological disorder is considered "Medically Important".
Left arm is achy and weak; Left arm is achy and weak; Mild headache located in both temples. 2 on standard 10 point pain scale; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 01:00 (Lot number: EP6955) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Allergy to Non-shellfish seafood" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3. Vaccination history included: Bnt162b2 (First Dose, Administration time: 12:15Pm, Vaccine location: Left arm), administration date: 26Feb2021, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), MUSCULAR WEAKNESS (non-serious) all with onset 19Mar2021 07:00, outcome "recovering" and all described as "Left arm is achy and weak"; HEADACHE (non-serious) with onset 19Mar2021 07:00, outcome "recovering", described as "Mild headache located in both temples. 2 on standard 10 point pain scale". Therapeutic measures were taken as a result of pain in extremity, muscular weakness, headache.  Additional information: Woke up at 7am on 19Mar2021. Left arm is achy and weak. Mild headache located in both temples. 2 on standard 10 point pain scale. Patient did not receive any other vaccines in four weeks prior to the COVID vaccine. He received concomitant medication within 2 weeks of vaccination includes Vitamin D3 125mcg (5,000 IU) - daily. He has taken Acetaminophen 1000 mg for the adverse event. He was not tested covid positive prior to vaccination and was not tested positive since the vaccination.  No follow-up attempts are possible. No further information is expected.
pt recv vax & devel redness, swelling & heat (no drainage) below inj site;
TIRED; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tired was not reported. This report was non-serious.
Rush on joint; swelling; really hot; like burning inside; A spontaneous report was received from a (Reporter consumer) concerning a  Years-old male/female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events   The patient's medical history was not provided. No relevant concomitant medications were reported.    On Date 15Feb2021, prior to the onset of the events, the patient received their first planned doses of mRNA-1273 (lot/batch: 007A20A) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  she received the 1st dose of the Moderna vaccine on 15Feb2021, 12 hours after receiving the vaccine she had a red rush on the joint, not other places of the body, it was swelling, really hot, like burning inside like something was on fire, she took an antihistaminic and put some ice and after one hour the symptoms went away. No symptoms ongoing. No other symptoms reported. Patient is allergic to Sulphur.  Laboratory details was not provided  Treatment she took the anti histamines for the event and after it have been subsided  Action taken with mRNA-1273 in response to the events was not reported.  The out come of the event is recovered and resolved after she took the anti histamine and it was an non serious case
This spontaneous report as received from a certified medical assistant refers to a 61 year old male patient with hypothyroidism, diabetes mellitus, chronic obstructive pulmonary disease (COPD), high cholesterol, hypertension, asthma, Graves' disease and with drug reaction/allergy to penicillin (MARRS # 1508USA000606) and ciprofloxacin (for both the reaction was anaphylaxis). On 24-MAR-2015, the patient was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (lot # L001311, exp. date: 06-JUL-2016) (dose was not reported). On 30-JUL-2015, the patient was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (lot # L002310, exp. date: 08-JUL-2016). Concomitant therapies included levothyroxine sodium (manufacturer unknown), LASIX, CHANTIX, NIASPAN, fenofibrate, lovastatin (manufacturer unknown), fluticasone propionate, ADVAIR, ZYRTEC, aspirin (manufacturer unknown), omeprazole (manufacturer unknown) and albuterol sulfate (manufacturer unknown). On 30-JUL-2015, the patient developed swelling at the PNEUMOVAX 23 injection site and slight fever. No lab diagnostic studies were performed. The patient sought medical attention via calling the healthcare worker. There was no treatment given for adverse events. The outcome of events was reported as not recovered. Additional information has been requested.
Right leg upper 20 X 25 cm; right leg lower 10 X 20 cm areas red and hot to touch.
loss appetite; fatigue; rash (L) arm; headache; nausea; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), NAUSEA (nausea), VACCINATION SITE PAIN (pain at injection site), DECREASED APPETITE (loss appetite) and FATIGUE (fatigue) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced HEADACHE (headache), NAUSEA (nausea) and VACCINATION SITE PAIN (pain at injection site). On 05-Feb-2021, the patient experienced DECREASED APPETITE (loss appetite), FATIGUE (fatigue) and RASH (rash (L) arm). On 08-Jan-2021, HEADACHE (headache) and NAUSEA (nausea) had resolved. On 10-Jan-2021, VACCINATION SITE PAIN (pain at injection site) had resolved. On 06-Feb-2021, DECREASED APPETITE (loss appetite) and FATIGUE (fatigue) had resolved. At the time of the report, RASH (rash (L) arm) outcome was unknown. Not Provided          No concomitant medications reported. Treatment included Baby Aspirin
This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown ages and genders. Information regarding the patients' pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On an unspecified dates, the patients were vaccinated with improperly stored GARDASIL (lot number and expiration date were unspecified, dose, frequency and route of administration were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever over 100.3, chills, achy, headache, sore arm and red ring with fever in it at injection site
Developed fever of 101 degrees, shaking chills, joint and muscle pain, extreme fatigue, lack of appetite, which persisted for about 24 hours. Low grade fever present Day 2 after vaccine administered.
No adverse reaction; I am breastfeeding and I recently received a COVID vaccine and I know that antibodies pass into breast milk as well; This spontaneous case was reported by a consumer and describes the occurrence of NO ADVERSE EVENT (No adverse reaction) and MATERNAL EXPOSURE DURING BREAST FEEDING (I am breastfeeding and I recently received a COVID vaccine and I know that antibodies pass into breast milk as well) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Breast feeding.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction) and MATERNAL EXPOSURE DURING BREAST FEEDING (I am breastfeeding and I recently received a COVID vaccine and I know that antibodies pass into breast milk as well). At the time of the report, NO ADVERSE EVENT (No adverse reaction) outcome was unknown and MATERNAL EXPOSURE DURING BREAST FEEDING (I am breastfeeding and I recently received a COVID vaccine and I know that antibodies pass into breast milk as well) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for MATERNAL EXPOSURE DURING BREAST FEEDING (I am breastfeeding and I recently received a COVID vaccine and I know that antibodies pass into breast milk as well).    No concomitant and treatment medications were reported.  Patient reported that she took the third booster dose (fourth from the beginning vaccination) Spikevax. She knew that antibodies could appear in milk. She had frozen extra servings that she intended to give to her baby in the future when she would return to work (in about 6 months, temperature -21 degrees Celsius). Patient was asking if she could still freeze. She asked if it would rather let go off freezing. Patient was asking how she could check if there were antibodies in the milk. If necessary, she would gladly make the milk available for research.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jan-2023: Live follow up received by safety on 04-Jan-2023 contains significant information: Suspect details was updated. On 18-Jan-2023: Follow up received by safety on 18-Jan-2023 included an Email received and contains significant information: Reporter information, event(verbatim) information were updated.
pt recvd vax & 15NOV95 pt devel 12 red spots which turned into clear fluid filled cysts & 16NOV95;no further details were provided;
pt recvd vax 6NOV92 & subsequently devel transverse myelitis;
This spontaneous report was received from a registered nurse, concerning a non-pregnant 26 year-old female patient. There were no medical history, drug reactions or allergies reported. On 11-APR-2017, the patient, who had lupus, was subcutaneously vaccinated with a dose of M-M-R II injection (dose and frequency were not reported) lot # M037096 with expiration date of 23-AUG-2018, with diluent MRK (lot # and expiration date were not reported). The patient did not sought medical attention. No adverse effects were reported. Additional information has been requested.
Child received subcutaneous injections of MMR and Varivax on right and left thighs respectively using VanishPoint synringes. Black dots noticed on both thighs immediately after administration of vaccinations. 04/16/09 Type of syringe used not documented. Per office guidelines, VARIVAX is to be administered using VanishPoint and MMR is to be administered using Safety Glide.
Patient had some anxiety at the time vaccine. After the vaccination, he and his family left the pharmacy area and finished grocery shopping. While ringing up groceries, patient's eyes reportedly rolled up in head and then he reportedly fell straight back to floor.  He hit his head on the floor while falling and had brief seizure-like symptoms before recovering and getting up.
Mom called on 04/10/2002 and reported that the child is very fussy since shots despite liqued Ibuprofen given as directed. other symptoms exhibited by infant include paleness, shaking and twitching of upper extremities, restless movement of head from side to side, cold and clammy skin and crying for long periods. Follow-up on 04/11/2002, baby less fussy, no longer pale, cold clammy or shaky.
pt recvd vax; exp chills, fever, diarrhea, sore throat,cough,difficulty sleeping x 6 days; still very tired, voice not back to nl;
Patient was accidentally given High dose instead of regular dose. No harm has actually occured to the best of my knowledge, but pt is unreachable because her phone does not accept incoming calls. I did not realize till after the patient left the site. The patient did not provide a primary care doctor at time of vaccination so only dr I had to put for contact is the protocol physician.
RECEIVED SHOT ON 10/11.  THAT AFTERNOON FUNNY TASTE IN MOUTH.  PROGRESSED FOR DAYS TO ERRATIC BLINKING ON 10/15. 10/16 RIGHT EYE WON'T WINK OR BLINK, MOUTH IS OUT OF CONTROL ON RIGHT SIDE.  10/17 EMERGENCY ROOM DIAGNONSIS OF BELL'S PALSEY, PRESCRIBE 800 MG ACYCLOVIR, 5 TIMES DAILY FOR 7 DAYS.  10/17 DETAILED CONVERSATION WITH ENT DOCTOR. PRESCRIBED 180MG PREDNIZONE DAILY FOR 7 DAYS. 10/18 APPOINTMENT WITH ENT.  EXAMINE AND DIAGNOSIS OF BELL'S PALSEY(NEUROLOGICAL DISORDER) BROUGHT ON BY FLU VACCINE.  10/20 APPOINTMENT WITH OPTHOMOLIGIST FOR DRY EYE. Medical Records received on 2/8/2005 states hoarse.
Headache & NauseaVomiting Narrative:  back pain, chest pain, GI inflammation. lost work time,  multiple test, ongoing treatment for GI inflammation. Esophageal  tumor found on EGD  Other Relevant History:
dizziness 5min p/vax;pt fell secondary to dizziness, hit head on elevator door w/resultant LOC for 10 seconds;
Pt's mother called clinic and stated that her daughter was having a reaction to the VZV vaccine given on 5/23/11. Pt's mother stated it was very large and swollen area where vaccine was given. Pt's mother encouraged to take child to pediatrician or ER if symptoms continued or got worse. Telephone call made back to mom who stated she did not take child to Dr yet. Offered mom to bring child to after hrs clinic at health dept.
101.5 fever 15 hours later; extreme headache, body ache; fever decreased 2 hours later to 100.1. Also, extreme fatigue after just sleeping 7 hours.