chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm developed next day ? still ongoing Sox days out 2 days out - very strong anche ache developed ? still ongoing 6 days out intermittent headache and congestion developed 4-5 days out ? still ongoing
Patient reported at office visit on 09/16/2021, that following his vaccination, on the third night, he woke with intense muscle spasms of his legs, and intense pain. He states that next morning he woke with left sided weakness which persisted for 2-3 weeks. He states that he had to drag his left leg. Patient reports that he did not seek emergency medical treatment. Patient reports that the symptoms resolved.
tingling to bilateral feet which started within 5 minutes of receiving the injection. Injection given at 12:55pm.
Patient experienced muscle soreness the day after injection.  Experienced Rigors second day after injection.
Minor "covid arm" experienced several days after vaccination.  Redness blotching at site of vaccine shot, about 2 inches in diameter.  Area is warm to touch.  No itching. Slight soreness experienced with area is touched.
Local reaction left upper arm. Red swollen tender to touch 7 x 3 cm.
Pt recvd vax & 6 hrs p/vax devel severe pain in lower back lasting 1 1/2 days, pain in knees & both feet lasting 5-6 days;
very sore arm after the first shot. very sore arm again, but not as bad, after the second shot. Muscle and joint aches. Chills. But no flu-like symptoms; very sore arm after the first shot. very sore arm again, but not as bad, after the second shot. Muscle and joint aches. Chills. But no flu-like symptoms; very sore arm after the first shot. very sore arm again, but not as bad, after the second shot. Muscle and joint aches. Chills. But no flu-like symptoms; very sore arm after the first shot. very sore arm again, but not as bad, after the second shot. Muscle and joint aches. Chills. But no flu-like symptoms; This is a spontaneous report from a contactable consumer. This 56-year-old female consumer (patient). A 56-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot number: ER8731) via unknown route of administration in left arm on unspecified date in Apr2021 at 01:30 PM (at the age of 56 years old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The concomitant medications included vitamins. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot number: ER8733) via unknown route of administration in left arm on unspecified date in Mar2021 at 01:00 PM (at the age of 56 years old) as DOSE 1, SINGLE for COVID-19 immunisation and very sore arm after the first shot. Patient did not have other vaccine in four weeks. On 16Apr2021 at 04:30 AM, the patient experienced very sore arm after the first shot. very sore arm again, but not as bad, after the second shot. Muscle and joint aches. Chills. But no flu-like symptoms. Patient did not receive treatment. Patient did not have covid prior vaccination and not tested covid post vaccination. The outcome of the events were not recovered.  No follow-up attempts were possible. No further information was expected.
a red puffy eye/puffy right eye; a red puffy eye/redness to right eye; right eye dry; right eye sensitive/has yuck shit around her right eye; rash around right eye; she cannot stop itching; rash on right arm/rash on her arm/right arm is engulfed with rash/swollen rash on her arm/yuck shit around her right eye and her arm; right eye swelling/eye swelling; This is a spontaneous report from a contactable consumer (patient) reported for herself. An adult female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 1st dose, single for COVID-19 immunization. On an unknown date, the patient experienced rash on right arm, redness to right eye, had yuck around her right eye, right eye swelling, right eye dry, right eye sensitive, a red puffy eye/puffy right eye and rash around right eye and she could not stop itching. The patient stated that she had a reaction to the Pfizer shot. Stated that she had the vaccine completed a month ago. Stated that the first time she got rash on her arm at the same place where she got the shot. Stated that she had some eye swelling with it. Stated that she was told to take Benadryl and it went away 5 days later. Stated that two weeks later she had the rash again and it went away. Stated that she got the second shot and it went haywire. Stated that she had a red puffy eye, dry, sensitive and a rash around it. Stated that her right arm was engulfed with rash. Stated that it would go away and came back away. Stated that she had went to the ER three times. Stated that got up in morning and had a swollen rash on her arm. Stated that went back there again and woke up that morning and had redness and yuck shit around her right eye and her arm. Stated that she was that told could not do anything with the reaction to the shot. Stated that it was driving her crazy. Stated that she could not stop itching. Stated was told to call CDC and report it. She wanted to know if anyone had heard of anyone with that reaction or was it just targeting her. She wanted to know what to do. Stated that she worked with the public and did not like looking the way that she looked. The outcome of the events was unknown.  Information about lot/batch number has been requested. Additional information has been requested.  Follow up (14Jun2021): New information received from a contactable consumer (patient) reported for herself included: Added the patient's name.
Reaction to BEXSERO; (R) arm red and splotchy at vaccine site. ? delayed allergic reaction vs. 2nd infection. KEFLEX started to cover for 2nd infection. Continue BENADRYL and cool compresses.
Spontaneous nosebleed while sleeping. My child woke up at 4.30 am thinking that he had a runny nose and came to see me. His face, arms, hands and pajamas were covered in blood. I put a cold wet washcloth above his nose and the bleeding stopped within 5 minutes. This was his first nosebleed for as long as i could remember, so I called his pediatrician's office first thing in the morning. They told me not to worry and that his nosebleed was an unusual coincidence probably not related to the vaccine he received, but told me to call them back in case he develops other symptoms. Besides his nosebleed, he did not have any other symptoms, no fever, not even pain at the site of the shot.
My arm hurt at the injection site for longer than normal.  A couple months later, it began to feel like I was carrying a newspaper under my armpit all the time.  My arm experienced limited movement, like wearing a shirt that is too small.  The pain came back and went away several times over the next year.  never dibilitating, but noticable.  The last couple months the pain has been more persistant and grown in intensity, and the swelling under my arm has increased.  I visited my doctor once, not really associating the symptoms with the flu shot at that time.  But I came across information that others had experienced similar effects.  I have another appointment with my doctor next week.
Day 1 after the injection  - Itchy rash started below injection site on R arm.  Day 2 - Spread to elbow and around arm.  Day 3 - Spread to back, chest, upper abdomen, neck, behind ears, scalp and by day 5 to right buttocks. Hot and red rash on arm and back.  Splotchy red rash every where else.   Very itchy.
Cough; Diarrhea; Cold; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), DIARRHOEA (Diarrhea) and NASOPHARYNGITIS (Cold) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced COUGH (Cough), DIARRHOEA (Diarrhea) and NASOPHARYNGITIS (Cold). At the time of the report, COUGH (Cough), DIARRHOEA (Diarrhea) and NASOPHARYNGITIS (Cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included an unspecified blood pressure medication.  No treatment information provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Brain Fog, mental confusion, speech impairment, left armpit lymph node pain/swollen.
Pt suffered an nontramatic  hemorrhagic right side stroke - Pt currently suffering left hemiplegia. Pt extremely healthy with no underlining comorbidities to contribute to this condition.
Swelling and soreness at the admission site. Mother advised to apply a cold compress, give child ibuprofen and monitor activity.
It started with my husband and son. My husband started coughing first. So we went for a quick test but it was too soon. Then my son started to cough, this was on Friday. On Tuesday they went in again and tested positive for omicron. Then I went to check myself and I tested positive. I started to dry cough for about 3 days but that was it. I did not have much of anything else. No headache, chills, fever, etc. It took two tests for me to show positive for COVID. Which was kind of weird. All of us are 3 doses vaccinated.
11-10-09 Later in the day pt developed muscle cramps in left leg felt wired and did not sleep. Now 11/12/09 c/o all joints hurting, swelling, hot then cold. No fever.
Patient developed redness and swelling (7.0 x 7.5 cm) at site of injection with 3 vesicular lesions at injection site.
Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Medium, Systemic: Confusion, Delrium -Severe
rash on chin, abdomen, and both arms.  Lips began to swell.  patient took 2 doses of benadryl liquid.  swelling of lips did not decrease, so she went to the emergency room.  ER MD prescribed prednisone and benadryl.
This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an unspecified improperly stored dose of ROTATEQ, oral, of one of the following three lots; lot # L006181 and expiration date 13-DEC-2016 as reported, lot # L008996 and expiration date 01-DEC-2016 or lot # K023534 and expiration date 22-MAY-2016. There were no concomitant medications provided. No adverse effects were reported. There was no product quality issue involved. This is one of several cases from the same reporter. Additional information has been requested.
Patient came in for and received 2nd dose. She described dizzy spells she has experienced over the last few weeks since receiving the first dose. She gets dizzy multiple times a day for approximately 5 - 10 minutes at a time, then it goes away. Frequency and severity have not changed over time.
Moderna COVID-19 Vaccine EUA Within 24 h: itchy, dry skin, exhaustion 24h-48h: itchy, dry, peely skin. skin hot to the touch. hot/cold, exhaustion, woke up with swollen left eye, achy
Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.; Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.) and GAIT DISTURBANCE (Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced DYSPNOEA (Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.) (seriousness criterion medically significant) and GAIT DISTURBANCE (Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.) and GAIT DISTURBANCE (Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.) outcome was unknown.            No concomitant medications were reported. The patient reports that his doctor prescribed an inhaler for his breathing issues but the medication name is unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow up: Date and batch no added for dose 1 and dose 2; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Client received the Janssen covid vaccine to right deltoid and became very anxious following.  Patient does have a history of Anxiety per her husband and responds this way to most events concerning her health.  Client stated this is "Normal" for me .  Client alert and oriented with blood pressure at 200/85 and pulse at 130 initially.  Client stated "I am fine"  She reported not taking any medications for her blood pressure prior.  Second blood pressure 192/86 .  Client monitored by EMS and finally transported to hospital. Attendees nurse and doctor.
FACE NUMBNESS/TINGLING, LEFT FACE DROPPING, CHEST PAIN, HEARING LOSS, HEADACHE
Information has been received from a registered nurse concerning a 9 year old male who on 24-SEP-1997 was vaccinated with a dose of Varivax (Oka/Merck) (lot # 624089/0961E). On an unspecified date, the patient developed a generalized rash with less than 50 lesions. The patient was evaluated by a physician. Follow-up information received on 03-AUG-2006, stated that no further information was available on this patient.
PATIENT RECEIVED ADULT DOSE OF HEPATITIS A VACCINE (1.0ML). PATIENT ALSO RECEIVED 2 DOSES OF VARICELLA VACCINE. RN AND MD NOTIFIED ABOUT PATIENT PATIENT'S VITALS STABLE. MD ASSESSED PATIENT.
Left-sided Bell's palsy noticed 3-4 after booster, resolving but not completely resolved as of 12/2/21. Increased balance problems about 4-5 days after booster, resolved as of 12/2/21.
Headache, Arthralgia & NauseaVomting  Narrative: Day 1: Two hours after injection-Headache/Fatigue Day 2-3 Headache/Fatigue/Body aches and nausea.
13 hours after administration I began experiencing body aches and muscle soreness. At 21 hours after administration I had chills, a low grade fever (100.4) and headache. Symptoms continued until 48 hours after injection.
This spontaneous report as received from a registered nurse refers to a 3 month old female patient with no drug reactions/allergies. No medical history was provided. On 07-JAN-2014, the patient was vaccinated with the first dose of ROTATEQ (lot # J002785; expiration date 02-AUG-2013), 0.5 ml, orally. No co-suspect or concomitant therapies were reported. The registered nurse reported that the mother of the patient stated that on 15-JAN-2014, the patient was lethargic and began vomiting. On 16-JAN-2014, the patient had a bloody diaper and was taken to the emergency room of hospital. On the same day, the patient was transported from the emergency room to another hospital where she was diagnosed with intussusception and received surgery for a bowel resection. On 21-JAN-2014, the patient was discharged from the hospital. At the time of the report, the outcome was recovered on an unspecified date in January 2014. The causality was not provided. The events of intussusception and surgery for bowel resection were considered to be immediately life-threatening by the primary reporter. Upon internal review, the event of surgery for a bowel resection was considered to be another important medical event. Additional information has been requested.
No other adverse events reported; pregnant patient received a dose of GARDASIL 9 as a result of user error; that RECOMBIVAX HB was intended; This prospective pregnancy spontaneous report was received from a registered nurse and refers to a female patient of unknown age. Her medical history, concurrent conditions and concomitant therapies were not reported.  The patient became pregnant with the last menstrual period (LMP) on 31-MAY-2022 and estimated date of delivery (EDD) on 07-MAR-2023. At the time of this report, her gestation was 36 weeks and 1 day.  On 08-FEB-2023, the patient received a dose of rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, pre-filled syringe, 1 dose in a right arm, lot #U039529, expiration date: 09-AUG-2024 (strength, and route of administration were not provided) as a result of user error (wrong product administered). The nurse reported that hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was intended and there was not anything in regards to packaging or labeling that contributed to the error. The patient did receive the intended vaccine hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 1 dose in the left arm for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). No other adverse events were reported. No product quality complaints. The pregnancy outcome was outcome pending and the fetal outcome was unknown (exposure during pregnancy).
Patient reports increased heart rate per watch during sleep, about 4 hours of continued increased heart rate. Patient also reports sweating and chills.
This case was reported by a consumer via another manufacturer and described the occurrence of sore throat in a 74-year-old female subject who was vaccinated with Influenza vaccine (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 8 October 2010, the subject received unspecified dose of Influenza vaccine (details unknown). On 12 October 2010, 4 days after vaccination with an unknown GlaxoSmithKline Flu vaccine, the subject experienced sore throat and flu-like symptoms. At the time of reporting, the subject had not yet seen a physician. At the time of reporting the outcome of the events was unspecified.
Patient was given pneumonia shot and started wheezing 5 minutes afterwards. Patient had epipen on her due to other allergies, and i administered it and an ambulance was called as it was not getting any better.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On 18-JUL-2016, the patient was vaccinated with improperly stored dose of VARIVAX, "1 vial given intramuscularly" (Incorrect route of drug administration), which had lot # M005973, expiry date: 02-FEB-2018, dose: unknown. The vaccine had temperature excursion ranging from 5 degree Fahrenheit to 7 degree Fahrenheit through 08-JUN-2016 to 29-JUL-2016 on various random unspecified times. The vaccine had no previous temperature excursion. The call was because of data logger. No adverse effects and no product quality complaint (PQC) reported. This is one of the three reports received from the same reporter. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 58-year-old female patient who received SHINGRIX (batch number T5242, expiry date 31st March 2020). On 17th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 19th April 2018, 2 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On 20th April 2018, the patient experienced tingling. On an unknown date, the outcome of the extensive swelling of vaccinated limb, tingling and injection site erythema were not recovered/not resolved. The reporter considered the extensive swelling of vaccinated limb and injection site erythema to be possibly related to SHINGRIX. It was unknown if the reporter considered the tingling to be related to SHINGRIX. Additional details were reported as follows: At 8:47 AM, the patient received SHINGRIX in left arm. The patient experienced arm swelling and redness to the elbow and face tingling. The pharmacist reported that the patient denied previous ZOSTAVAX vaccine on questionnaire. The reporter's call was transferred to Medical Information System for inquiry.
3-years-old patient who was vaccinated with FLUZONE HIGH-DOSE QUADRIVALENT by mistake, No AE; 3-years-old patient who was vaccinated with FLUZONE HIGH-DOSE QUADRIVALENT by mistake, No AE; Initial information received on 03-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to cases 2020SA242184, 2020SA242186 and 2020SA242187 (same reporter).  This case involves a 3-years-old patient (gender unknown) who was vaccinated with a dose (unclear whether 0.5 mL or 0.7 mL was administered) of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] by mistake (Lot number: UJ450AB and expiration date:30-Jun-2021) via unknown route in an unknown administration site as prophylactic vaccination on an unknown date (product administered to patient of inappropriate age and overdose).  Medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was a case of an actual medication error due to inappropriate age at vaccine administration and overdose.  No adverse event reported at the time of reporting.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
First day, could bearly move my left arm (9-14-15) as of today (9-28-15) very painful and radiates from shoulder to and including my hand.
The day following the third COVID vaccine, the patient had a syncopal episode at home. This is presumeably secondary to ventricular tachycardia secondary to the patient's prolonged QT syndrome. The patient responded to a sharp cardiac thump and 911 was activated. The patient had not had a syncopal episode in two years since initial diagnosis until this event occurred a day following her booster. The patient was admitted and had a AICD placed
I have two lumps on my collarbone. One is grape-sized and I can move it around. underneath my skin.