chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches/ achiness; Lethargy; Fever; This is a spontaneous report from a contactable other HCP. A 60-year-old male patient reported for himself that he received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on 12Jan2021 08:30 in left arm as a second dose, single for COVID-19 immunization at public health clinic facility. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on an unspecified date for COVID-19 immunization. The patient did not receive any other vaccine within four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. The patient experienced body aches, achiness, lethargy and fever on 12Jan2021 at 11:00. The patient did not receive any treatment. The outcome of all events was recovered in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I received the flu vaccine very high on my right shoulder on the morning of Oct 13, 2015. By the afternoon I was having pain in arm and couldn't raise my arm. Proceeded to get worse.
mild upper respiratory sx with temp 99.5 progressing to cough,  myalgias and fatigue with + COVID test 8/12/22. Telemedicine visit arrange 8/13/22 with Paxlovid dosepac prescribed and taken as directed Symps rapidly regressed over next several days tho some mild sx may persist to today with some postnasal drainage and occsional cough tho difficult to tell from allergic sx. no systemic manifestations persist.
This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, current conditions and concomitant medications were not reported. On 10-JUL-2016 to 09-SEP-2016 the patients were vaccinated with improperly stored RECOMBIVAX HB (dose details were not reported) lot # L040458, expiry date: 04-FEB-2018), which was stored at temperature of 25 degree Fahrenheit, for a time frame of 15 minutes, there was no previous temperature excursions reported. No adverse effects reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from healthcare worker (medical assistant) referring to a male patient of unknown age. Patient's medical history and concurrent conditions were not reported. On 09-NOV-2012 the patient was vaccinated with the 1st dose of GARDASIL, intramuscular (lot #  not reported). Then on 14-APR-2015, the patient was vaccinated with the 2nd dose of GARDASIL, intramuscular, (lot # not reported). Finally on 18-AUG-2015, the patient was vaccinated with the 3rd dose of GARDASIL, intramuscular, (lot # K010215, expiry date 05-MAY-2017). Other co-suspect or concomitant medications were not reported. The healthcare worker reported that when the patient was receiving the 3rd dose of GARDASIL, the patient suddenly moved his arm, and a significant amount of the GARDASIL spilled onto the patient's arm. No adverse effect was reported. Additional information has been requested.
pain in the arm pit (left); swollen arm pit; tender arm pit; swollen injection site; had muscle ache/pain for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm pit (left)), PERIPHERAL SWELLING (swollen arm pit), TENDERNESS (tender arm pit), MYALGIA (had muscle ache/pain for 2 days) and VACCINATION SITE SWELLING (swollen injection site) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 014C21A and 028A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the arm pit (left)), PERIPHERAL SWELLING (swollen arm pit), TENDERNESS (tender arm pit), MYALGIA (had muscle ache/pain for 2 days) and VACCINATION SITE SWELLING (swollen injection site). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in the arm pit (left)), PERIPHERAL SWELLING (swollen arm pit), TENDERNESS (tender arm pit) and VACCINATION SITE SWELLING (swollen injection site) outcome was unknown and MYALGIA (had muscle ache/pain for 2 days) had resolved.            No concomitant medication information was provided   This case was linked to MOD-2021-402913, MOD-2021-402914 (Patient Link).
Sore arm to start with then, fatigue, fever, chills started around bedtime. Did not sleep much...tossing and turning with symptoms. Around 3:30am, I threw up. Took ibuprofen and it helped but, symptoms came back. Took more ibuprofen. Around 9am was starting to come out of some symptoms but, fatigued to the max. Now, at 6:30pm, I have just worn out feeling and sore neck.
"He was dizzy bad"; "He said 'I feel a little tired'"; "His heart was racing a little bit"; "He said 'pizza tasted like steel" too"; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS ("His heart was racing a little bit"), DYSGEUSIA ("He said 'pizza tasted like steel" too"), DIZZINESS ("He was dizzy bad") and FATIGUE ("He said 'I feel a little tired'") in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced PALPITATIONS ("His heart was racing a little bit") and DYSGEUSIA ("He said 'pizza tasted like steel" too"). On an unknown date, the patient experienced DIZZINESS ("He was dizzy bad") and FATIGUE ("He said 'I feel a little tired'"). On 03-Apr-2021, PALPITATIONS ("His heart was racing a little bit") had resolved. At the time of the report, DYSGEUSIA ("He said 'pizza tasted like steel" too"), DIZZINESS ("He was dizzy bad") and FATIGUE ("He said 'I feel a little tired'") outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-106871, US-MODERNATX, INC.-MOD-2021-106610 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-106871:Mother case US-MODERNATX, INC.-MOD-2021-106610:Reporter's case
Complaining of left deltoid site pain hot and red. Pt complaining of fatigue and feelings of SOB overnight when laying flat on back. Complaints of heat sweats overnight. States this morning she is not having SOB, but having pain from left elbow up to shoulder injection site. States no visible rash other than injection site redness. Encouraged to call 911 if she has SOB that is unrelieved. Also stated that she is having Headaches that are not relieved by tylenol. Gave pt a list of normal reactions including, headaches, body aches, fever, fatigue. Encouraged her to alternate tylenol and Ibuprofen for body aches and headaches. Encouraged pt to call 911 with SOB that is not relieved. Contacted physician.
SORE SHOULDER LIMITING USE OF MUSCLE LASTING GREATER THAN 1 WEEK.
Patient stated she started feeling tingling on her lips, 10 minutes after getting vaccinated.  At 12:42 pm patient stated tingling is going away on its own.  At 12:57 pm, patient stated she feels ok and wants to go home.
muscular weakness; he was confused and out of it/confusion; he was unresponsive like he could answer he questions but he was unable to get up to get out to the car to go to the hospital; tested for COVID and he tested positive at that time with symptoms; This is a spontaneous report from a contactable consumer reporting for her father.  A 66-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 11Feb2021 13:45 (Batch/Lot Number: EN6201) as single dose for covid-19 immunisation  .  Medical history included sleep apnoea syndrome from 2010 and ongoing , hypertension from 2011 and ongoing , polycythaemia vera from 2015 and ongoing , cerebrovascular accident on 2016 , myasthenia gravis from 2019 and ongoing , renal neoplasm from 2020 to an unknown date , covid-19 from Dec2020 to an unknown date  (Hospitalized for COVID for about a week in Dec2020) , thyroid disorder from an unknown date. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for thyroid disorder from 2019 and ongoing; azathioprine (AZATHIOPRINE) taken for myasthenia gravis from Aug2020 and ongoing; clopidogrel (CLOPIDOGREL) taken for prophylaxis, anticoagulant therapy from 2016 and ongoing; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for hypertension from 2019 and ongoing; nifedipine (NIFEDIPINE) taken for hypertension from 2015 and ongoing; bisoprolol (BISOPROLOL) taken for hypertension from 2015 and ongoing; atorvastatin (ATORVASTATIN) taken for blood cholesterol abnormal from Mar2020 and ongoing; hydroxycarbamide (HYDROXYUREA) taken for polycythaemia vera from 2015 and ongoing.  The patient experienced he was unresponsive like he could answer  questions but he was unable to get up to get out to the car to go to the hospital  on 12Feb2021 14:00 with outcome of unknown , he was confused and out of it/confusion  on an unspecified date with outcome of unknown , tested for covid and he tested positive at that time with symptoms  on 12Feb2021 with outcome of unknown. The event Unresponsive to stimuli was considered an Important Medical Event. The patient underwent lab tests and procedures which included blood test: everything looks clear and normal    , chest x-ray: everything looks clear and normal ,  culture: everything looks clear and normal,  Sars-cov-2 test: positive  on 12Feb2021,  Sars-cov-2 test: negative   on 22Feb2021.  Course of the event Caller reports that her father had the first dose of the COVID vaccine on 11Feb2021, at 1:45PM, and about exactly 24 hours later, his reaction started at 2pm on 12Feb2021. Caller reported that after the first dose, her father had muscle weakness and confusion, he was unresponsive like he could answer he questions but he was unable to get up to get out to the car to go to the hospital, so the caller had to call 911. Caller reported that her father was not actually admitted to the hospital, he was taken to the ER and was there for maybe 6 hours before his body just snapped out of the reaction, and he was discharged home that same day.  Follow up information has been requested.
Swollen tongue; throat; itching; dizzy; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A 37-year-old non pregnant female patient received first dose of BNT162B2 (solution for injection, Batch/Lot Number: Ew0150, Expiry date: not reported) via an unspecified route of administration, administered in Left Arm on 31Mar2021 (at the age of 37 years old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was reported as none and concomitant medications were not reported. The patient has no other medical history. The patient had no allergies to medications, food or other products. The patient had not received any other vaccine within 4 weeks and other medication in 2 weeks. Patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID post vaccination. On 31Mar2021, the patient experienced swelling tongue, throat, itching, dizzy. Therapeutic measures were taken as a result of events at Medical help at vaccine injection facility, Benadr. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
The patient took the vaccine in the left arm at 11:10 am . the then began to perspire and complained of feeling light headed and dizzy. He was then assisted to a wheel chair and transported to the recovery area. He was able to stand to lie on a stretcher . The patient feet were elevated and then the patient remained conscious at all time and then he started to feel better. His vital signs were 143/74 mm hg, pulse rate 81 bpm, with oxygen saturation of 94% on room air . Subsequently after 10 minhis vital signs adjusted to 122/81 mmhg, heart rate 81  and oxygen saturation99% on room air . His blood sugar was 99mg/dL per fingerstick. He was offered water and juice .  The patient  was observed for thirty minuets post vaccine . the patient fully recovered and was able to ambulate off vaccine area without assistance in the company of his significant other.
Following night: chronic insomnia. Mind+Body would not shut down. This continued initially for 2-3 weeks. Following the stop of chronic insomnia, I would have trouble falling asleep for hours, waking in the night frequently, not getting back to sleep. Currently. My sleep cycle is disturbed. I must follow a routine and do certain things to exhaust myself enough to go to sleep. It is different each day.  Heart palpitations and racing heart.   At night, heart races and body excites, in an episode of stress or anxiety, leading me to have to focus on deep breathing to relax the body.   Tinnitus, ringing in the ears. Constantly, all day and night.    Initially, sleep pills did not work. Even with prescription meds, the mind+body was not able to shut down.  I used or tried  prescription meds, over the counter sleep pills, CBD oil, melatonin, anti stress teas and supplements.  Sufficient  and physical activity needed daily to achieve sleep.   ?Small stresses? can now prevent me from sleeping. ?The little things?, even with mindful breathing and
Patient reported Tiredness, headache, and nausea on day of vaccine (7-25-21).  On 7-29-21 pt woke up with body rash.
Started feeling dizzy around 20 minutes after vaccine, when nurses responded she had 3 episodes of LOC, eyes were open but unresponsive, regained consciousness after a few seconds and was able to respond to commands, EMS activated and evaluated then released
Pain in chest, feeling like having a heart attack. When to emergency due to feeling of having a heart attack. Pain in chest whenever doing streneous exercises or cardio. Sometimes difficult sleeping because heart is beating too much.  At the time of the first symptoms I didn?t relate to the covid vaccine. Now talking with people who have symptoms relate to me. It feels like it could be the covid vaccine  Taken ibuprofen and propanadol to relieve symptoms .  At the
I was at the vaccination venue when I received my first Pfizer injection on 4/1/2021 at 10:41. About 15 minutes after the injection, I started to feel extremely hot and like I was suffocating. My face started to swell, I had difficulty swallowing, and I felt dizzy. The paramedics who were on site read my blood pressure and oxygen levels, which were fine. They monitored me for the next 4 hours until I felt well enough to go home. I took Benadryl and Tylenol until 4/3/2021. I felt dizzy until about 4/4/2021. I felt lethargic and weak until about 4/5/2021, and I then felt fine afterwards.
Patient reports subjective fevers, nausea, bodyaches, and multiple episodes of diarrhea 12 hrs after receiving vaccine.
No adverse events reported. Patient received vaccine 3 weeks apart rather than 4. No symptoms reported, patient said he was fine.
Noticed his breathing was worse a few days later, and he feels as though his breathing's been worse ever since the vaccine was administered.
5 cm diameter erythematous, warm, raised area over Left deltoid where DTaP was given.
I have a cysts/lesion on the outside of my lip (I thought it was a pimple but it was so big and I never felt anything come on like I always do). I also have internal cold sores - one almost right on the other side of the lesion,  one on the other side of my lip. I DO NOT KNOW IF THIS IS A SIDE EFFECT or just a coincidence. I don't have herpes or any history of lip lesions. I don't remember biting my inside lip and they are too high for that type of injury anyway.
"Fussiness, irritability, crying for over an hour" x 3 days.
Headache; Local site reaction; This is a spontaneous report from a contactable pharmacist (Reporting for himself).   A 34-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number:EL3247), first dose via an unspecified route of administration in left arm on 04Mar2021 09:30 as single dose for covid-19 immunisation at workplace clinic. The patient medical history was reported as none and there was no known allergies. It was reported that patient did not take any vaccination in 4 weeks and no covid test was performed post vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC) (Other medications in two weeks). On 04Mar2021 at 15:00, the patient experienced headache and local site reaction. Outcome of the events headache and local site reaction was reported as recovered on an unknown date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Sweating; Getting hot quickly; Itching; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), FEELING HOT (Getting hot quickly) and PRURITUS (Itching) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweating), FEELING HOT (Getting hot quickly) and PRURITUS (Itching). At the time of the report, HYPERHIDROSIS (Sweating), FEELING HOT (Getting hot quickly) and PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.   Treatment information not reported.
This retrospective pregnancy case was reported in a literature article and described the occurrence of webbed penis in a male infant. The mother received Flu Seasonal TIV Dresden. The pregnancy resulted in a live neonate with a congenital anomaly. The infant was diagnosed with webbed penis. Serious criteria included GSK medically significant and congenital anomaly. Additional event(s) included maternal vaccine exposure. The outcome of webbed penis was unknown. The outcome(s) of the additional event(s) included maternal vaccine exposure (unknown). It was unknown if the investigator considered the webbed penis to be related to Flu seasonal TIV Dresden. Additional information was provided. This retrospective pregnancy case was reported in a literature article and described penile webbing in an infant of unspecified gender who was exposed to unspecified inactivated trivalent influenza vaccine (IIV) in utero (manufacturer unknown). The patient was a part of the prospective observational study conducted during the 2013-2014 influenza season at a family planning clinic and three obstetrics and gynaecology practices which assessed the feasibility of recruiting pregnant women less than 20 weeks gestational age (GA) to participate in a text messaging based vaccine adverse event monitoring program after receipt of inactivated influenza vaccine (IIV) and utility of text messaging to monitor health events, including fever frequency on vaccination and next 2 days (Days 0-2), health events during pregnancy, pregnancy outcomes, and neonatal outcomes. All four sites were affiliated with hospital. The patient's mother was a pregnant woman with gestational age less than 20 weeks by last menstrual period and/or ultrasound at the time of enrollment. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date during the 2013-2014 influenza season, the patient's mother received unspecified IIV (administration route and site unspecified; dosages unknown; batch number not provided) during the gestational age less than 20 weeks. Age at vaccination was unknown. (In this study, 70.5% had documented receipt of tetanus-diphtheria-pertussis vaccine during the same pregnancy). The infant was exposed to unspecified IIV in utero during pregnancy (trimester unknown). On an unspecified date, an unknown period after vaccination, the patient had penile webbing (major birth defect). The patient's mother had stopped reporting 36 days before delivery. The birth defect was identified on electronic medical records (EMR). Treatment was unknown. The outcome of the event was not reported. The authors did not comment on relationship between penile webbing and IIV. The authors concluded, "This study demonstrated the feasibility of text messaging for influenza vaccine safety surveillance throughout pregnancy. In addition, in these women receiving IIV during pregnancy, post-vaccination fever was infrequent and a typical pattern of maternal and neonatal health outcomes for pregnancies was observed." This is 1 of the 16 valid cases in the same literature article.
Headache, sore arm, fatigue, nausea, fever, and sore joints set in a few hours after injection. Overnight, restless legs, entire body skin hypersensitivity, jaw pain, weakness, and inability to sleep due to pain began, as well as significant worsening of nausea, headache, joint pain, muscle soreness, and fatigue. All symptoms still present, with significant skin hypersensitivity (entire body), severe headache, fever, and restless legs being the most intense and debilitating.
Pfizer 4/9/21, 5/7/21, 10/7/21, 9/15/22. Positive on 10/13/22
This spontaneous report was received from a registered nurse referring to a 2 month old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 06-APR-2018, the patient was vaccinated with a dose of ROTATEQ orally, for prophylaxis (route, lot # and expiration date were not reported). Immediately after vaccine administration, the patient spit out the dose of ROTATEQ. No known adverse effects were reported.
24-year-old female was in normal state of health until approximately 30-45 minutes after she had the flu vaccine. She began to feel dizzy, lightheaded with nausea and approximately 6 episodes of vomiting. Vomitus is nonbilious and nonbloody. She did not have wheezing,shortness of breath, or feeling of her throat closing. Her dizziness was worse on standing. She has not had hives, urticaria, or tongue or lip swelling.  Of note, she had the AFLURIA flu vaccine five years before, but has had the intranasal flu vaccine every year since until this year.  This year she had the AFLURIA vaccine again.  Time of vaccine was approximately 1030, onset of symptoms approximately 1100-1115.  Patient was seen in clinic at approximately 1400.
Diffuse papular rash on body with coalesce w/blanching on trunk, arms, & legs & cheeks. Sparing forehead; low grade fever & runny nose.
pt recvd vax & had trouble swallowing & swelling of the face p/shots 30JUN94 Am pt was given Decadron & DPH
Vomiting occurring within 4 hours of administration. Home care until he showed signs of dehydration 24 hours after.