chrisvoncsefalvay/vaers-outcomes huggingface dataset:
didn't get good sleep last night; tired; lethargic; loose bowel movements; hot; sweating; restless at night; mild headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), LETHARGY (lethargic), DIARRHOEA (loose bowel movements), FEELING HOT (hot) and HYPERHIDROSIS (sweating) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Type 2 diabetes mellitus and Heart disease, unspecified. Concomitant products included BEMPEDOIC ACID for Cholesterol, LEVOTHYROXINE, RAMIPRIL, CARVEDILOL, AMLODIPINE, AMIODARONE, WARFARIN, METFORMIN, INSULIN DEGLUDEC (TRESIBA), NITROGLYCERIN and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 17-Feb-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 20-Feb-2021, the patient experienced HEADACHE (mild headache). On 01-Mar-2021, the patient experienced LETHARGY (lethargic), DIARRHOEA (loose bowel movements), FEELING HOT (hot), HYPERHIDROSIS (sweating) and POOR QUALITY SLEEP (restless at night). On 02-Mar-2021, the patient experienced SLEEP DISORDER (didn't get good sleep last night) and FATIGUE (tired). On 19-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. On 02-Mar-2021, DIARRHOEA (loose bowel movements), FEELING HOT (hot), HYPERHIDROSIS (sweating), POOR QUALITY SLEEP (restless at night) and HEADACHE (mild headache) had resolved. At the time of the report, LETHARGY (lethargic), SLEEP DISORDER (didn't get good sleep last night) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Significant followup received on 01-MAY-2021. Reporter information, Patient demographical information, relevant medical history and 2nd dose of vaccine information were updated. On 13-Jul-2021: Follow up received on 13-JUL-2021.and contain no new information.
left upper arm had local redness and irritation from pneumococcal vaccine, no fever or chilling - pt is concerned of infection and reaction to the vaccine.  no sob, no throat swelling or tongue swelling.
Patient complained of tingly/ numbness on arm a few minutes after shot. Arm felt warm, could feel, and could squeeze me back with force. Patient became increasingly pale, so had her lie down and rest a bit. After not being better after 10 minutes father asked me to call 911. Father drove patient to hospital after the paramedics checked her out. She had a panic attack as we suspected
Mom reports t103 on 21JUL contacted MD APAP given; 5PM 22JUL t105-sz taken to hosp adm-d/c 23JUL 12noon; dx @ hosp ear infect pt on Ceclor; 27JUL mom reports pt still not self;
I noticed the symptoms in March of 2022. They appeared as red circular patches on my leg. Some became itchy. After a few months, I decided it was ringworm. I started over the counter medication. After being unsuccessful in treating it, I went to the doctor March of 2023. He prescribed terbinafine 250mg 1x day. I've been taking that for six weeks with a one-week break. It's gotten worse. I have an appointment with a Dermatologist on Monday.
Started developing breathlessness/Breathlessness while sleeping, running and biking (active athelete).; chest pain; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 01Apr2021 at 15:00 PM, at patient age of 52-year-old, as single dose (Lot number EW0150) for COVID-19 immunisation. The patient had no COVID prior vaccination. The patient's medical history was none. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any medications within 2 weeks of vaccination. The patient started developing breathlessness, chest pain around 10Apr2021 (10 days after 1st dose). Breathlessness while sleeping, running and biking (active athelete). The patient went to ER on 26Apr2021 unable to breathe. Stress test/EKG, CT Scan of lung, Covid all normal. Breathless still exists during physical activity & sometimes while sleeping. The event onset date was reported as 10Apr2021 at 13:00 PM. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was treated with inhaler for breathlessness. The outcome of the events was not resolved.  COVID was not tested post vaccination. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 08May2021 at 13:00 PM, at patient age of 52-year-old, as single dose (Lot number EW0173) for COVID-19 immunization.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated subcutaneously with a first dose of Zostavax (Oka/Merck). Subsequently, the patient experienced "itching about half an hour after receiving the vaccine".  Unspecified medical attention was sought.  The patient recovered on the same day of vaccination.  No product quality complaint was involved.  Additional information has been requested.
Had to wait longer immediately post vaccine due to nausea and flushing. About 7 pm that even slight soreness in arm. Woke next morning with swollen lips, face, eyes, and extremities. This seemed to go away on its own around 1pm on Friday but the. Developed severe headache and vertigo and extreme fatigue. This lasted for the next 40 hours. By Sunday mid day I felt great.
Patient known to have AFIB and on Coumadin. Her INR was therapeutic (as tested at home) 1-2 days prior to the vaccine was given.   4 days after the vaccine had abdominal pain, the next day the patient presented with multiple emboli -- to the right iliac and the superior mesentaric artery.  She did poorly despite an aggressive thrombectomy of the clots and fasciotomy of the leg and died in ICU of septic shock
(My normal temp 97.7) Thursday: Woke up freezing during night with temp of 96.5. Woke in morning whole body hurt to move. Temp steadily increased during day to 101. Took tylonol. Also my shoulder really hurt and rash started. Consumed complete upper arm almost to elbow. Hard, red, hot, welt and itchy.  Early evening slight heavy in breathing and ribs in back hurt. Friday: some improvement, still sore all over. Arm same. Saturday: feeling better about 75-80%. Arm same. Sunday much better just tired. Monday arm improving but growing around arm.
1 hour post vaccination patient had episodes of unstable gait, labile level of awareness and responsiveness.  EMT services called when the patient was unable to hold up head and respond to verbal and tactile stimuli.
Urticaria within 5-10 minutes of receiving vaccine. No other symptoms.  Solumedrol adminstered IV. Symptoms resolved about 20 minutes later.
patient having received only one Menactra vaccine prior to the age of 18 with no reported adverse event; Initial information received on 03-Mar-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 18 years old male patient who had patient having received only one menactra vaccine prior to the age of 18 with no reported adverse event after receiving vaccine meningococcal a-c-y-w135 (d conj) vaccine [menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose 1 of suspect meningococcal a-c-y-w135 (d conj) vaccine Solution for injection (lot number, strength, frequency, dosage, expiration date not reported via unknown route in unknown administration site for immunisation.  On an unknown date the patient developed a non-serious event patient having received only one menactra vaccine prior to the age of 18 with no reported adverse event (incomplete course of vaccination) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event patient having received only one menactra vaccine prior to the age of 18 with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt claims that after the shot she received she experienced extreme pain in her arm and she had flushing for 2 days as if she was feverish.
Difficulty breathing, Burning in nose, sore throat, coughing, wheezing, fever, dizziness sweating, hoarseness
BODY PAIN / BODY ACHE; HEADACHE; FEVER; This spontaneous report received from a pharmacist concerned a 64 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and other pre-existing medical conditions included the patient did not have known allergies .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid. On 06-APR-2021, the subject experienced body pain / body ache. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced fever. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, body pain / body ache, and fever. This report was non-serious.
Mild (so far) rash that occurred on the arm of the injection site with an onset 8 days following the shot. Rash has continued to expand in size for the last 5 days since onset, with mild but increasing itching and swelling and is located in close proximity to the injection site (but not emanating from it).
The patient described having a severe sore throat, problems swallowing, phlegm in throat, nausea, weakness, lost of appetite, hives on both hands and arms with severe itching. The pt did not go to ER or PCP. The pt. stated that he did take SYPHRO.
This spontaneous report as received from a registered pharmacist refers to an unknown number of patients. The reporter stated that improperly stored VAQTA (lot number, dose and route not reported) may have been administered to patients. The reporter had no information how many doses were administered that were improperly stored. The improperly stored VAQTA may have been administered from 24-AUG-2012 to 01-OCT-2012. No adverse event reported. This case is linked to case reports 1210USA001745 and 1210USA010099 (same reporter link; same event also reported for other vaccines). Additional information has been requested.
pt start feeling lightheaded and dizzy ,she lie down on floor and could stay up , no difficulty of breathing  we contact 911 and paramedic took her to hospital for observation.
"Red blotches" over body - started with "one little dot" - above also occurred after 4 month vaccines (1-8-08).
redness, swelling, and itching at the injection site; redness, swelling, and itching at the injection site; redness, swelling, and itching at the injection site; This is a spontaneous report from contactable consumer via Pfizer sponsored program. A 55-year-old male patient received second dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, solution for injection, lot/batch number: not provided), via an unspecified route of administration on 04Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, solution for injection, lot/batch number: not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Reporter state that her husband received his second Pfizer Covid vaccine dose 04May2021. On 05May2021, he developed redness, swelling, and itching at the injection site. it is improving. The mean duration of pain at the injection site after Dose 1 was 2.4 days (range 1 to 10 days), for redness 2.4 days (range 1 to 16 days), and for swelling 1.9 days (range 1 to 5 days).  No follow-up attempts are needed; Information related to batch/Lot number could not be requested.
Vaccination for PNEUMOVAX and Hib on 8/19/2013. On 8/21/2013, developed vomiting and temperature of 100.1. Reported redness and swelling of RUE (6 x 2 in). On 8/22/2013, no further sxs. Wife w/ URI.
Lump in RLT tight @ site of last DTP; lump pea size- not red or swollen; noted by mom a few days p/shot site of needle - slight blue today;
Starting at 8pm that night, I had extreme fatigue and a headache with chills.  I had body aches, muscle pain and was dizzy.  This continued all the next day.  I had a fever of 101.9 from 8am on the 14th until 5pm on the 14th. The chills, fever,  body continued the entire day and night of the 14th.  The fever, chills and headache subsided on the 15th, but thebody aches and muscle pain continues even today the 16th.
My face and hands are blown up right now; My face and hands are blown up right now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB INJURY (medically significant), FACE INJURY (medically significant), outcome "unknown" and all described as "My face and hands are blown up right now". Patient had a severe and extended reaction to the Pfizer COVID vaccine. This has been confirmed by Dermatologist, Rheumatologist, and primary care doctor.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
info was recv fr pt who was exposed to son who was vax 19feb99 & on 22feb99 pt began to notice spots on right hip, by 23feb99 there were approx 20-25 itchy lesions on belly, abd, lower back & hips. pt denied other medications & med conditio
Very very cold; Dont feel like moving; Chills; Aching; Nausea; Very very tired; This spontaneous case was reported by a patient and describes the occurrence of FEELING COLD (Very very cold), MOVEMENT DISORDER (Dont feel like moving), CHILLS (Chills), MYALGIA (Aching) and NAUSEA (Nausea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-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 FEELING COLD (Very very cold), MOVEMENT DISORDER (Dont feel like moving), CHILLS (Chills), MYALGIA (Aching), NAUSEA (Nausea) and FATIGUE (Very very tired). At the time of the report, FEELING COLD (Very very cold), MOVEMENT DISORDER (Dont feel like moving), CHILLS (Chills), MYALGIA (Aching), NAUSEA (Nausea) and FATIGUE (Very very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported  No treatment medication was reported    Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Reporter details updated
Patient appeared to be fainting, shook back and forth in a repeated manner after sitting down for observation following the COVID vaccination. Did not have any blurred vision, was responsive. To be safe, an ambulance was called. This occurred minutes after being vaccinated, the ambulance arrived about 30 minutes afterwards and picked the patient up.
Teary eyes; Red scaly eyelids; Itchy eyelids; Injection site redness; Injection site hot; Injection site very itchy; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (Teary eyes), ECZEMA EYELIDS (Red scaly eyelids), EYELIDS PRURITUS (Itchy eyelids), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE WARMTH (Injection site hot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Teary eyes, Eczema eyelids and Eyelids pruritus.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site very itchy) and VACCINATION SITE SWELLING (Injection site swelling). On an unknown date, the patient experienced LACRIMATION INCREASED (Teary eyes), ECZEMA EYELIDS (Red scaly eyelids) and EYELIDS PRURITUS (Itchy eyelids). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, LACRIMATION INCREASED (Teary eyes), ECZEMA EYELIDS (Red scaly eyelids), EYELIDS PRURITUS (Itchy eyelids), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site very itchy) and VACCINATION SITE SWELLING (Injection site swelling) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: No new information was received.
NOSE BLEEDS; BODY ACHES; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced nose bleeds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and fatigue on 08-APR-2021, and the outcome of nose bleeds was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comments not required as per standard procedure as the case is considered non serious.
I received the vaccine at 9:15a and was told to wait 30 min instead of 15 due to my anaphylactic allergy history. At 9:21a, while in the waiting area, I felt a flushing sensation through my body and felt my face grow hot. I got very light-headed even though I was sitting down and thought I was going to be sick, and my heart rate as noted on my watch became elevated. It went from low 70's to high 90's. My throat did not close up and I did take my regular allergy medicine and inhalers prior to the vaccine. After 30 minutes, I went to the facility restroom and noted my face was still red. I called my sister (a hospital doctor) who told me to immediately take Benedryl. After taking Benedryl, I was feeling better after about another hour and the nausea and light-headedness subsided. In total, the symptoms lasted about an hour and 45 minutes. I did not notify staff at Med.Centerl at that time as my throat didn't close but did contact my PCP and now have an appointment scheduled with an allergist at Med. Center for next week and have put my 2nd vaccine on hold until I see the allergist.
Sensation of cold on back of left shoulder, pain in infraspinatus tendon. Symptoms have progress further down arm all the way to fingers (first and second knuckles), and includes weakness, achiness, and discomfort. Some tingling noted with wrist flexion. Pain and weakness is also radiating along ipsilateral side of neck.   Symptoms started minutes after vaccination and have been getting progressively worse.
After driving home from doctor's appt (where she was seen for dermatis and got a Hep B vaccine) - pt had a seizure. Ambulance arrived at home and pt was afebrile. Transported to ED - labs were drawn -then pt discharged home. Upon discharge, mom was told to make appt for EEG and MRI. Mom states after her appt she drove home (approximately 15min) then upon arrival noted that her kids were bickering. Things got quiet suddenly and mom saw that patient had fallen to the ground and was "turning purple" and was "shaking". Mom picked her up and she stopped shaking, but her eyes were rolled back and she was "out" - unconscious. Mom ran out the door screaming and neighbor call 911. Mom continued to hold patient until the Fire Dept arrived (appx 3-5 min). When she handed patient to the fire man, she "came to" but seemed dazed. The ambulance arrived and she still seemed dazed, although conscious, until arrival to the ED. No sibs with vaccine problems. No family history of seizures. Mom has been nervous about vaccines and has only been getting 1-2 at a time. Vaccine record attached.
Narrative:  94yo male patient died on 10/8/2021 at outside hospital. Pt had hx of with hx of niddm, htn, hld, afib s/p ppm, cad/chf, & hx of tia. Pt had received covid vaccines on 1/12/21 & 2/9/21 at outside hospital. Likely this death is not related to covid vaccines given patient's age, comorbidities, and long length of time between date of vaccines and date of death.
Baby received 5 immunizations after 11:30 and began to cry nonstop afterward.  Seen at 17:00 with all exam.
Case number PHEH2014US022959 is an initial spontaneous report received from a physician on 12 Nov 2014. This report refers to a 43 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with a dose of FLUVIRIN (batch number: not reported) intramuscularly on an unknown date (reported as a month ago). In Oct 2014, three days after vaccination, he experienced lightheadedness, fatigue and vertigo. The outcome of the events was reported as condition unchanged. The seriousness and causality was not reported.
Reported fever of 100.2-100.5 along w/chills x 36h, starting at around 9 pm after admin of vax that morning. Also had dizziness and loss of bladder control x 8h. Used Tylenol for sx. Pt notified MD & pharmacy.