chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered with the vaccine from a vial which has been 1st punctured for more than 12 hours; administered with the vaccine from a vial which has been exposed to room temperature for approximately 27 hours after 1st puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from a vial which has been 1st punctured for more than 12 hours) and PRODUCT STORAGE ERROR (administered with the vaccine from a vial which has been exposed to room temperature for approximately 27 hours after 1st puncture) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from a vial which has been 1st punctured for more than 12 hours) and PRODUCT STORAGE ERROR (administered with the vaccine from a vial which has been exposed to room temperature for approximately 27 hours after 1st puncture). On 14-Jan-2022, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from a vial which has been 1st punctured for more than 12 hours) and PRODUCT STORAGE ERROR (administered with the vaccine from a vial which has been exposed to room temperature for approximately 27 hours after 1st puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   Reporter stated that vial was first punctured on 13JAN2022, 9:40 am for more than 12 hours and which has been exposed to room temperature for approximately 27 hours after 1st puncture.
Initial and follow-up information has been received from a physician (M.D.) and a nurse (R.N.) concerning a 14 year old female with peanut allergy and unspecified medical history who on 14-JUL-2011 received her first dose of GARDASIL in the left upper arm and her second dose of GARDASIL in the administration series in the right upper arm on 02-SEP-2011. There was no concomitant medication. The physician reported that this patient received her first dose of GARDASIL in the left upper arm on 14-JUL-2011 and subsequently developed right sided chest pain and local injection site pain that subsided. This patient had "extreme pain and tingling" at the injection site approximately one month later while on an airline flight upon landing. Physician reported that this patient received her second dose of GARDASIL in the administration series in the right upper arm on 02-SEP-2011 and developed pain at the injection site 2 days afterwards. Physician reported that this patient developed numbness in the hand and wrist pain in the right arm, and that the patient felt her arm was "on fire" from her elbow to her wrist of the right arm 1 week after the second dose of GARDASIL in the administration series. Physician reported that this patient was "unable to hold a pencil in her fingers" the first week of October, and that on 03-OCT-2011 she was taken to the Hospital emergency room for numbness in all 4 extremities, hands, wrists and feet, where an Electrocardiogram, a CAT scan and an MRI were performed and the patient was released. A nurse has also reported the adverse event of this patient who mentioned that patient experienced fainting and tingling with numbness of the extremities that occurred in several episodes. The patient experienced numbness in her extremity and headache after receiving her first dose of GARDASIL in July 2011 and again after her second dose of GARDASIL in September 2011. The patient had contacted the office to sought medical attention. At the time of reporting, the patient had not recovered. The events were considered to be disabling ("temporally unable to stand or walk") by the reporter. Additional information is not expected.
Dizzy, very tired. And severe atrial fibrillation for about 5 hours.  Pulse was 140 and BP was 104/54.  Very scary. I will refuse further vaccination.   My health is very good and the medications I take are maintenance of my good health. I can do most any physical activity with energy.  There were no other cause and effect possibilities. It was the vaccine.
hives, itching, took Benadryl 50mg  at the time 1:45pm and another dose  at 9pm and the 2 more dose the next day.  hives subsided in 4 days.
Body aches for 5 days post flu shot. Told pt to take ibuprofen/acetaminophen. Will f/u in 2 days.
Dizziness and fatigue persist  Pfizer first 4/17 Nausea 4/18 Chills and fever 4/18 Headache 4/18 - 4/19 Muscle aches 4/18 - 4/19 Extreme fatigue - 4/18 - 4/20 Fatigue 4/18 - persistent Dizziness with unbalanced 4/18 - persistent Tried exercise 4/21 pass out feeling with increased dizziness and unbalanced immediately after exercise Unusually intense menstrual cramps with less bleeding 4/22
Red, pain and warm at site of injection. Feel weak, cold on her feet -> took TYLENOL -> helped. Headache. Diarrhea -> took IMMODIUM -> helped.
Patient felt tingling around tongue and mouth. Patient given oral Diphenhydramine 25 mg.
Developed a Head Ache an hour after the vaccine. said she did eat breakfast and had an a morning snack at school.
Hardball size swelling an inch or so below injection site.  Sore, hot, red, itchy. Redness and itchiness spread down past elbow and encircled arm over subsequent 3 days. Used hydrocortisone cream to relieve itch. Completely resolved within 10 days of onset.
Donor received the 1st dose of the rabies immunization shot on 09/15/2023 however, states that on 09/17/2023 he starts with headaches, tiredness, feeling warmth to his body, and feeling sleepy. Donor states that the headaches come and go but they are every day since 09/17/2023 states has been taking OTC Tylenol or Advil. Donor states that the warmth feeling began yesterday on 09/21/2023 for 2 to 3 minutes to the entire body. Donor received the 1 st dose of the Imovax rabies vaccine on 09/15/2023 and states starting having symptoms on 09/17/2023. Donor states that he follow up with his PCP on 09/21/2023 and his PCP advise he that it might of been the vaccine
This is a spontaneous report from a contactable consumer (Patient). A 50-years-old non-pregnant female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9262) (Age at the time of vaccination 50), via an unspecified route of administration, administered in Arm Left on 27Jan2021 13:00 as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included low thyroid. Concomitant medication included levothyroxine and liothyronine.  No Known allergies. Patient did not receive any other vaccine in four weeks. Patient was not Covid prior vaccination. Patient did not Covid tested post vaccination. On 27Jan2021 16:30 the patient experienced scratchy throat, slight cough, post nasal drip body aches, pinching/soreness in left arm at injection site . The outcome of events was recovered on unknown date in 2021.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Dizziness, nausea, sweating - soon after injection - Pt put head between legs - pt felt better in 10-15 minutes.  Offered pt. cold water - pt said she was ok & didn't need anything.
A half hour after receiving the shot I noticed a taste of iron in my mouth. The evening after my second dose I got my period, I was not due to have my period for another two weeks. My period was very heavy flow, extremely painful cramps. Four days after my period started I experienced heavy and severe nose bleeds. The nose bleeds felt concerning - they would start randomly and flow heavy, taking 5min to stop. I felt very fatigued.
cramping for about 2 1/2 hrs & it is diminishing; had a little bit of diarrhea;
Patient has not yet received the second dose of the vaccine due to shortages(today is day 58.); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient has not yet received the second dose of the vaccine due to shortages(today is day 58.)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not yet received the second dose of the vaccine due to shortages(today is day 58.)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has not yet received the second dose of the vaccine due to shortages(today is day 58.)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
they both got sick and tested positive for Covid-19; they both got sick and tested positive for Covid-19; they both got sick and tested positive for Covid-19; This is a spontaneous report from a Pfizer Sponsored Program. A non-contactable female consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient got sick and tested positive for covid-19 on an unspecified date.The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of sick and tested positive for covid-19  was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
On May 11 (ten days after second shot), I broke out in full body hives (face, arms, legs, entire abdomen). Extreme itchiness all over body - unable to sleep. Body was entirely red with raised white welts.  Visited urgent care doctors, dermatologist, and allergist. Landed on a treatment plan with the allergist with a strong dose of steroids and antihistamines, which have mostly resolved the symptoms as of 5/18 (Biaxin, Medrol, Probiotic, Pepcid, Xyzal, Allegra, Benadryl). I was prescribed a Prednisone taper along with Zyrtec from Urgent Care on May 12, but my symptoms did not improve until starting the allergist's plan on 5/15.
Pt. called clinic 11 days after vaccination to report a very painful, swollen lymph node behind her right ear, headache, sore neck, low grade temp. (99) and malaise. She also had nausea & vomiting. We suggested NSAIDS and try applications of heat and/or cold for the painful ear area.
fatigue; injection site pain; Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), INJECTION SITE PAIN (injection site pain) and INJECTION SITE PAIN (Injection site soreness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced FATIGUE (fatigue), INJECTION SITE PAIN (injection site pain) and INJECTION SITE PAIN (Injection site soreness). At the time of the report, FATIGUE (fatigue), INJECTION SITE PAIN (injection site pain) and INJECTION SITE PAIN (Injection site soreness) had resolved. Not Provided          Treatment information not provided. Concomitant medications were not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular)  was not applicable.
After receiving 2nd COVID vaccine in March of 2021, experienced irregular menses with menstrual cycle beginning within 48 hours of receipt of vaccine and occurring 9 days early.  By history, no irregular menses for >20 years with cycles occurring q29 days and lasting 7 days.  Cycles returned to normal pattern in April 2021 until booster in Jan 2022. After receipt of booster on Jan 19, 2022 menstrual cycle ended after 3 days instead of standard 7 days which is again completely anomalous based on 20 year history.
Hot and cold feel like had a fever, achy, and L upper arm swollen and very sore.
Could feel something spinning in my head; I was sick in bed; This spontaneous case was received on 18-Jan-2021 from other non-healthcare professional (consumer) via Agency (reference number: AU22-000094) with additional information received on 18-Dec-2021 (reference number: AU22-000095) and on 19-Jan-2022 from Agency (refenrece number: SEQW22-00271) (being processed together), and concerned a female patient of an unknown age.  The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 22-Oct-2015, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; route of administration, dose, anatomical location: not reported) as flu shot. The batch number reported was11749211A.  On an unspecified day, an unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced feeling of something spinning in her head. Also, the patient stated that she was sick in bed for three months after receiving this vaccine. The patient reported that her neighbour had the same reaction.   The outcome of the events were unknown.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A female patient of an unknown age was vaccinated with influenza virus vaccine polyvalent. An unknown amount of time following vaccination, the patient developed spinning sensation and sickness. Information regarding medical history, relevant diagnostic findings and concomitant medications was not provided. Causal role of the suspect vaccine is unassessable due to lack of information provided and unclear temporal relationship.; Sender's Comments: A female patient of an unknown age was vaccinated with influenza virus vaccine polyvalent. An unknown amount of time following vaccination, the patient developed spinning sensation and sickness. Information regarding medical history, relevant diagnostic findings and concomitant medications was not provided. Causal role of the suspect vaccine is unassessable due to lack of information provided and unclear temporal relationship.
under the arm where she received the injection, she noticed a swollen lymph node; 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 74 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 26Oct2021 (Lot number: FF2593) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation", start date: 2018 (unspecified if ongoing); "Mitral valve replacement", start date: 2016 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (LOT: EP7534 or EF7534. It's hard to tell , Injected into right arm), administration date: 24Mar2021, when the patient was 74 years old, for Covid-19 immunization; Bnt162b2 (LOT: Initially provides ER8727. Had to take it to a light to see it more clearly, it is written bad. Then clarifies lot number as ER8729., Injected into right arm), administration date: 15Apr2021, when the patient was 74 years old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 27Oct2021, outcome "recovering", described as "under the arm where she received the injection, she noticed a swollen lymph node". Therapeutic measures were taken as a result of lymphadenopathy.  No follow-up attempts are possible. No further information is expected.
Administered vaccine that is only authorized for 12 and older to a 11 year old. No adverse effects occurred. Patient's parents were notified as well as the physician. Pfizer Bivalent administered instead of Moderna Bivalent.
I got my period on April 1, and in 30 years of menstruating, it was the worst period I've ever had. I bled for 16 days straight with no let up, went through two boxes of super plus tampons and a bag of extra long pads (I normally bleed for 5-6 days with only one heavy day, use a mix of super and regular tampons, about 15-20 total). I passed large blood clots almost every day of this long period (never happened for me before).
I got my shot on a Wednesday and I started with chest pain that Friday. I went into clinic Monday. They did a cardio workup and ekg. That Thursday at work i got very dizzy and horrible chest pain. I felt like i had a sandbag on my chest and I couldn't catch my breath. I was instructed to go to  to the ER. By the time I got there I was hyperventilating and my arms were curling. They did a cardio workup and a chest ct and sent me home on a beta blocker. I asked them at that time about myocarditis but they said no. Stopped the beta blocker after a few days and started a zio patch. I was getting worse to were I  couldn't walk that well. I was so dizzy, dazed, and terrible chest pain. They tried physical therapy and that didn't help. We did an echo and i kept asking about myocarditis. So finally we started prednisone. It was 20mg daily and I was starting to feel better but not great. I went to another clinic and they tried a taper of prednisone. I tried my hometown Doctor. He ran many test and tried several rounds of steroids and nsaids. I wasn't getting better. So I went to see Cardiology again. This time we did an MRI and echo. It showed i  have myocarditis and pericarditis.  Next is a CT angiogram. This is all after several trips to the er also.
flu like symptoms; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and ARTHRALGIA (joint pain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and ARTHRALGIA (joint pain). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) and ARTHRALGIA (joint pain) outcome was unknown. Not Provided          Patient took concomitant medications for hormone three times a week.  Treatment information was not provided. /unknown.  Patient  wants to knew if it is okay to take Tylenol after getting vaccinated   Reporter did not allow further contact.
swelling; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE SWELLING (swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE SWELLING (swelling). At the time of the report, INJECTION SITE SWELLING (swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported. No treatment information provided.
Chills, Muscle Aches, Nausea, Migraine Headache
pt started blowing on fingers & shaking them vigorously;rpt shaking hands to prevent "fingers from catching fire" sensation spread to feet;arms;chin;pt ``afraid of catching fire'' medical attention sought;f/u pt Dx c/tourette's syndrome
stye eye with 3  to 4 lumps started at 6am on 11/16/21, had bloody drainages, lasted for 5 days; fever of 101 lasted 3 days; then coughing, congestions, running nose, chills, fatigue, muscle aches, headache lasted for 3 weeks, finally recovered on 12/12/2021
Fever up to 103.1 degrees Fahrenheit. About a 5 inch patch of erythema on upper arm where vaccine was administered. 2 blisters on the upper arm.
Pt reported diarrhea, numbness in the left arm from the elbow to the fingertips, numbness in the right arm from the injection site to the fingertips, extreme weakness, nausea, and syncopal episode while showering.
Patient received 2nd Moderna Covid Vaccine dose on Friday, January 22nd at 5:50 pm.  On Saturday, January 23rd at 10:00 am they started having severe body aches which lasted until Monday morning.  On Sunday morning the patient noticed a red rash over their entire body except legs which lasted until Tuesday morning despite taking Allegra.  Additionally, patient felt dizzy and weak for 2 days following the vaccination.