chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine used; There was an excrusion from freezer; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excrusion from freezer) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excrusion from freezer). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excrusion from freezer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.
"Tingly skin", constipation X 2-3 days, the more frequent bowel movements (not diarrhea), no rash, no redness, increase in shoulder pain, general malaise.
Patient  vaccine that was stored improperly. Vaccine was moved from ultra-cold freezer to freezer on 06/17/2021. According to guidance from Pfizer, vaccine stored in the freezer after day 17 is considered improperly stored, and the patient will need to be re-vaccinated.
Client returned home from school with red, raised are of l/arm.Denies swelling, itching, fever.  Symptoms resolved by next morning.
Upon review of immunization record client received MCV4 #3 when client was compliant with doses 1 and 2. Mother and client notified. No adverse reaction or concerns voiced per mother.
Stood up to leave after 10 minute post injection wait and felt lightheaded. Vitals taken, stable. Discharged after review by MD.
Phlebitis.                 Enlarged veins  mainly in left leg,  one small place on right leg.    Approximately two weeks after booster shot of Pfizer
pt states after getting the vaccine he was driving and about an hour later his heart started racing.  That night he his mustache grew about 1/2' overnight which is very abnormal since it hardly ever grows.  For the next 5 days his heart rate stayed elevated around 125 bpm.  He was in and out of AFIB for these 5 days and just felt really bad.  He lost 4 lbs by the 3rd day and another 2 lbs over the next couple of days, however he was eating.  Around the sixth day his heart rate dropped to around 60 bpm and he started feeling back to normal.  On Marth 9th around 7PM his heart rate became elevated again around 114 bpm.  His heart rate has been going from 118 bpm to 100 bpm to 58 bpm.  His heart rate has been going up and down and is still this way today.  It is still abnormal.  He has a daily records of his readings.  He has reported this to his doctor, his PCP and his Cardiologist.  He saw his PCP on 3/3/22 and Cardiologist on 3/4/22 where he was given an EKG which should his heart was out of rhythm.  He has another appt w/ Cardiologist.
upper lip began swelling 1 1/2hr p/taking flu shot;was cutting grass @ the time;zyrtec given w/resolution;
Employee works for daycare which requires her to receive certain vaccines to include hepatitis B vaccine. She received her first hep B vaccine on 6/1/2016 experiencing a sore arm otherwise no issues. She received her second hepatitis B vaccine on 7/7/2016. She advised she had had a slight cough the week or so before being vaccinated as she just stopped taking ZYRTEC (mid June). She had been using ZYRTEC from May-June for new environmental like allergies (cough, congestion, runny nose) per her HCP. She recalls day of 2nd vaccination, her left arm was again sore and she worked thru the pain not taking any medication. The next day, Friday, her arm was still sore but she could work. That evening, she began to feel more fatigued than usual stating she was weak. She described this weakness as a strong ure to sleep and no energy. She stated this fatigue persisted over the next 2 days with her sleeping most of the weekend, onset of chills/fever (100F) and her body ached. She stated she could only walk on bent knees Saturday due to discomfort. She again did not take any meds for pain/fever and had limited food intake (did not check blood sugars, did take daily medications). By Sunday she was dizzy, walked normally, and was feeling better so she ate/drank fluids and felt much better that evening. Monday she went to work feeling better; however that evening she had a fever of 100.5F, was coughing and overall felt bad. She stayed home Tuesday due to dizziness and went to clinic where physician did CXR and labs and diagnosed with pneumonia in her left lung. She was treated with Z-pak and ROBITUSSIN PM. She returned to work Thursday and was re-evaluated by Dr and again sent home to see her CIV HCP. By Sunday she was better and cleared to work on Monday 7/18/2016.
Wheal at site of injection immediately after administration. Resolved completely after 1 dose of Benadryl 4 ml.
Otherwise healthy 4 year old seen on 09/07/04 for follow up after presentation to ED 09/04/04 with hives. Began with redness and swelling surrounding vaccine injection site left deltoid, then noted hives on chest. Treated with dose steroids and symptoms reolved in 20 minutes. No recurrence of symptoms. No respiratory symptoms. No GI symptoms.
chills; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024A20A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included Cancer and Liver transplant.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). On 23-Feb-2021, CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) had resolved.
Raised resting heart rate - up from normally mid 50's to 75.  Raised blood pressure - 140/90
TD given on 12/10/02 at 14:00. By 20:00, he had migrating aches. Pt states glands started burning and aching below ears. Saw MD on 12/16/02. Pt was instructed to take Tylenol PM, as it had Benadryl in it. He states symptoms lasted 10 days, went away for about 5 days and came back and never left. He has constant pain in lower back, aches in face, numbing feeling in right leg and right arm.
Patient contacted the pharmacy by phone at approximately 2:40 pm on 4/2/2022 to question the side effects of a vaccine that they recently received on March 30th. The patient stated that starting the night they got the vaccine their arm became sore and slightly red. By the time they woke up the following morning their arm was very red and warm to the touch and also became more painful. The patient stated that the red area was approximately 3 inches across, red, raised, warm to the touch, and quite painful. I explained to the patient that redness at the injection site, and arm soreness are both expected side effects of the vaccine, but advised the patient that the warmth and pain combined with their other symptoms may indicate a skin infection and suggested that they call their doctor or go to urgent care as these symptoms have persisted for a few days now, and the patient stated that they don't appear to be getting much better. Patient expressed understanding and appreciated the information that I provided them.
Nausea, vomiting. Not able to keep down water . Mild chills. Attempted giving Gatorade a small sip at a time every 10 minutes but not able to keep it down.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 16-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
after first dose of COVID vaccine she had fatigue and leg cramps; after first dose of COVID vaccine she had fatigue and leg cramps; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as single dose for covid-19 immunisation. Relevant medical history included: "arthropathic psoriasis, unspecified" (ongoing). Concomitant medication(s) included: ENBREL taken for psoriatic arthropathy, start date: 21Jan2021; AMLODIPINE BESILATE; ATORVASTATIN; B12 [MECOBALAMIN]; HYDROCODONE; LEVOTHYROXIN; LOSARTAN POTASSIUM; MAGNESIUM; MONTELUKAST; OMEPRAZOLE; SPIRONOLACTON; TRELEGY ELLIPTA; VALSARTAN; VENLAFAXINE; VENTOLIN HFA; MULTIVITAMIN [VITAMINS NOS].  The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "not recovered", MUSCLE SPASMS (non-serious) with onset 2021, outcome "recovered" (2021) and all described as "after first dose of COVID vaccine she had fatigue and leg cramps".  Additional information: No co-suspect medications were reported. The patient began Enbrel, Single Dose Prefilled Autoinjector on an unknown date. On an unknown date in 2021, the patient was taking one dose of Enbrel this month due to needing to skip doses one week before and after each Covid Vaccine. On an unknown date in 2021, the patient also stated that after first dose of COVID vaccine she had fatigue and leg cramps and the patient was advised to skip doses one week before and after vaccine. No treatment information was received. The causal relationship between the events muscle spasms, fatigue and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up. The patient stated that she was off medication as per MDO while taking her two doses of covid vaccine in March/2021. she unsure the dates but back on medication.  No follow-up attempts are possible. No further information is expected.
Client called to report she developed swelling in her right jaw after taking her third oral typhoid capsule. Exact time of onset not provided by client. This would have been in the past 24-48hrs. No other side effects noted and no treatment reported.
Around 6:30pm my eyes felt strange and itchy.  Around 10:00pm I looked in a mirror and noticed they were swollen.
Nov 1st patient experienced chills, diarrhea, vomiting, temperature 100' the evening after receiving vaccination. 911 was called and patient evaluated by emergency response team. Nov 2nd patient experiencing sweating. Instructed daughter to increase patients fluid intake to prevent dehydration and monitor condition.
I was evaluated by the cardiologist because my heart rate was dangerously low at around 30-34 BPM. The cardiologist also performed an ECG. I was diagnosed with 3rd degree heart block. Thereafter, I was immediately admitted to the hospital for further evaluation and ultimately a Medtronic dual-chamber (atrial/left bundle position) pacemaker was implanted in my chest.
INTENSE BURNING UPON INJECTION THAT RAN DOWN MY ARM.  SINCE THEN INTENSE PAIN IN UPPER ARM AND SHOULDER.  UNABLE TO SLEEP DUE TO PAIN. UNABLE TO MOVE RIGHT ARM AND SHOULDER. THROBBING PAIN CONSTANT.
Enlarged Lymph Nodes in the right armpit, headache, shortness of breath.
Patient sat for observation. He stated he tried to stand up after 5 minutes and passed out. He fell to the floor, hit his head and jaw and chipped teeth. Ambulance was called because of hit to head and he was bleeding. He was referred to ER for CAT scan by paramedics. His girlfriend showed up to transport him.
Chills, vomiting, dizziness/vertigo, loss of motor function of right arm and leg, arm and leg were weak, uncoordinated, unbalanced. Could not write. The symptoms starting on May 4 and have been ongoing. Course of steroids have helped but still continue to have symptoms.
This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. On 06-JAN-2017 and on 10-MAR-2017, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L028645, expiration date: 25-MAY-2017) for prophylaxis. From 06-APR-2016 to 22-MAR-2017, the doses were stored outside of recommended temperature (36-46 degrees Fahrenheit). The lowest temperature was 47 and the highest was 73 degrees Fahrenheit. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA008959.
Profound bradycardia requiring moderate to vigorous tactile stimulation, supplemental oxyugen and transfer to the NICU for continued monitoring and further evaluation.
2nd Dose administered beyond 30-day use; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter  It was reported that the date taken out of freezer 08-Sep-2021.
Fatigue, nausea, headache, pain at injection site, pain in right side of my neck and swollen muscle and lymph gland in right front collar bone. All symptoms were within hours of administration except the swollen lymph gland. The gland was about 36 hours after administration. I have not pursued treatment at this point.
Fatigue and body ache; Fatigue and body ache; Injection site soreness - mild; This is a spontaneous report received from a contactable consumer (patient). A 47-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unspecified route of administration on 09Apr2021 (at the age of 47-years-old) at a single dose for covid-19 immunisation. Medical history included seasonal allergies ongoing. Concomitant medication included cetirizine hydrochloride at 10 mg tablet OTC for seasonal allergies. The patient experienced injection site soreness - mild on 09Apr2021, fatigue and body ache on 10Apr2021. The outcome of the event Injection site soreness  mild was not recovered and the event Fatigue and body ache recovered on 11Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Terrible headache, fever, joint pain, muscle pain, kidney pain, severe fatigue, but unable to sleep, due to how awful I feel. Shivers, dizziness, light headed. Loss of appetite,  unable to do "normal" daily activities.  Severe pain in injected arm. This was my 2nd vaccination.  The first one was not nearly as awful as the 2nd one.
Elevetated blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 31Mar2022 (Batch/Lot number: unknown) as dose 4 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN, No side effects), for COVID-19 Immunization, reaction(s): "No side effects"; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN, No side effects), for COVID-19 Immunization, reaction(s): "No side effects"; Covid-19 vaccine (Dose 3, MANUFACTURER UNKNOWN, No side effects), for COVID-19 Immunization, reaction(s): "No side effects". The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 31Mar2022, outcome "not recovered", described as "Elevetated blood pressure". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient declined to complete a reporter, he doesn't even know if this is a side effect from the vaccine, he had the other 3 and had no side effects, but this one he just noticed when he took his blood pressure it was elevated. Patient just got the 2nd Booster shot yesterday, and he noticed last night that he had an elevated blood pressure and the same thing this morning. Patient stated he would just like to talk to someone who could tell him if this was related to the vaccine. Additional details and clarifications unable to be obtained.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Broken up red in his arm; Rash in both arms and chest; A spontaneous report was received from a consumer concerning a 38-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events broken up red/ erythema, rash in both arms and chest/ rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events broken up red, rash in both arms and chest.  The patient did not receive any treatment.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, broken up red, rash in both arms and chest was unknown.
feeling a bit woozy; weak; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6199, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on an unspecified date in Mar2021 at 10:45 (at the age of 60-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history included asthma and arthritis. The patient had known allergies to sulpha drugs, keflex, levoquin, and codeine. Concomitant medications included desloratadine (CLARINEX [DESLORATADINE]), montelukast sodium (SINGULAIR), lansoprazole (LANSOPRAZOLE), diltiazem (DILTIAZEM), and estradiol (ESTROGEN). The patient received no other vaccine in four weeks. It was unknown if the patient had COVID prior to vaccination. The patient was not tested for COVID post vaccination. On an unspecified date in Mar2021 at 11:00 reportedly, the patient started feeling a bit woozy and weak about 5 min after the shot and that feeling continued 2 hours later. No treatment was given for the events. The outcome of the events was reported as not resolved.  No follow-up attempts are possible. No further information is expected.
after first vaccination shot, (8/28/21) I had two areas on both arms with a small, very itchy rash. After the 2nd shot, I have raised bumps (like bug bites) all over my thigh and chest/collar bone area with sporatic bumps on arms, back, calves, and glutes.
Intermittent left chest tightness/pain,  started on 4/10 which was mild, became more frequent since 4/11 afternoon (twice per hour), more obvious and more frequent on 4/12
This is a 31 y/o woman brought in by her husband for a headache followed by a gradual change in mental status. Her husband reports that she was in her usual state of health until Monday when she developed a headache after receiving an influenza and JEV (3rd) vaccinations. Her headache progressed to the point where it woke her up at 0100 on 9/19/2017 and was associated with several episodes of vomiting. Throughout the day her husband noticed a steady decline of her mental status beginning with inappropriate words and leading to frank confusion. In the ED, she is able to open her eyes to voice and follows commands intermittently but cannot respond with anything more than a word or two (inappropriate). Her husband did report recent travel where she found a leech attached to her leg that was removed by the patient. He reports that the site was cleaned and did not develop any signs of infection.
itching all over the body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching all over the body) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (itching all over the body). On 27-Mar-2021, PRURITUS (itching all over the body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. No treatment information was provided.
Pain with injection subsided then 4 days later pain at site last for approximately 4 week still tender never had redness - Lt deltoid.
pt started feeling lightheaded & nauseous about 5min p/receiving vax; diarrhea all noc; went to work 11MAY93; feeling like he was going to pass out; taken to hosp; pt had allergic reaction to hep B vax;