chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her breasts got bigger or sore; her breasts got bigger or sore; breast inflammation; uncomfortable because she was not used to having big breasts; headaches; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Feb2021 (Lot number: EL1284) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "chronic lung condition", start date: 2015 (unspecified if ongoing), notes: diagnosed at university hospital. Concomitant medication(s) included: MEDROL [METHYLPREDNISOLONE ACETATE] taken for lung disorder. Vaccination history included: Pfizer covid-19 vaccine (First Dose., Administration Site: Right Arm, Lot No. EK9231), administration date: 15Jan2021, when the patient was 60 years old, for COVID-19 Immunisation. The following information was reported: BREAST PAIN (non-serious) with onset 2021, outcome "unknown", BREAST ENLARGEMENT (non-serious) with onset 2021, outcome "recovering" and all described as "her breasts got bigger or sore"; BREAST INFLAMMATION (non-serious) with onset 2021, outcome "recovering", described as "breast inflammation"; BREAST DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "uncomfortable because she was not used to having big breasts"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headaches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of breast inflammation. Therapeutic measures were taken as a result of headache.  Additional Information: The patient states she weighs about 98-100lbs. The patient said she had both vaccine doses herself and inflammation of her breasts. Her breasts got bigger or sore. Her first dose of the Pfizer COVID-19 vaccine was 15Jan2021, and her second dose was 02Feb2021. She said her vaccine card is handwritten and they didn't write NDC/EXP on this card. The vaccine doses were given to her at the hospital where she works. She got her vaccine doses given in her right arm because she is left handed. She said that her breast inflammation began almost immediately, and her sister said her breasts look big, and she said it was just winter weight, it was not painful just kind of uncomfortable because she was not used to having big breasts, there was no pain. She said that her breasts are still not down yet, though they are down from what they were, it is not fully. She has done no treatment for her breast inflammation. She has taken Tylenol when she was having headaches, but she has been fine the past month. The patient and her sister have not had any other recent vaccinations or started any new medications. She is on steroids for her daily lung condition, which she has been on for years, but she doesn't put on weight with steroids, it is actually the other way. She said she takes 4mg methylprednisolone (MEDROL) a day by mouth.  No follow-up attempts are possible. No further information is expected.
Swelling of right wrist and forearm; Swelling of right wrist and forearm; Deep pain in arm; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0153) via an unspecified route of administration in the left arm on 14Apr2021 (at the age of 57-years-old), as dose number unknown, single for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included bupropion hydrochloride (BUPROPION HCL XL) 300 mg; metoprolol (MANUFACTURER UNKNOWN) 50 mg and omeprazole (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date.The past known allergy was reported as Keflex and Celestone . Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021, the patient experienced swelling of right wrist, forearm and deep pain in arm. The patient underwent ultrasound to rule out deep vein thrombosis (DVT) on an unknown date in 2021 and the result was unknown. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events swelling of right wrist, forearm and deep pain in arm and included treatment with an unspecified antibiotics and ultrasound to rule out deep vein thrombosis (DVT). The clinical outcome of the events swelling of right wrist, forearm and deep pain in arm were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Amendment of reporter data, Past Drug Event data, Lb data and narrative.
I received the H1N1 vaccine. Cramps in legs the same day as administration, Heart Racing, trouble breathing, A feeling of heat rushing from my chest through my upper and lower body, feelings said to be associated with anxiety but I have had reactions like this before, one to anesthesia and another time to Paxil. I visited the hospital 4 times because of the racing heart and other symptoms, I thought I was dying. I was given strong tranquilizer medication, ALAZOPRAM, that failed to keep the symptoms at bay after about a day of treatment, then I was given Lorazepam. That is failing to work. I kept telling the doctors I think I am scared by the feelings I am having not causing the feelings I am having because I am scared. I think I am being written off an that scares me too, because there may just be a problem. At one hospital they did a chest X-ray and found something in the lower right lobe of my lung, and at the other hospital they said my X-ray was clear, the following day! The "anxiety" comes on at different times, at first it seemed like it was at night but then it was this afternoon too. I am kept up by the feeling, and every time I tried to sleep without the assistance of tranquilizers, I jump awake and am shaking. I am going to continue to seek treatment for what I do agree is in part anxiety but I am concerned there is something else going on. Is there anything you can do to help me or direct me to a source that could make sure this isn't a dangerous reaction that could be harmful is neglected? I also failed to mention that the exhaustion has continued although immediately after the shot I felt a distinctively euphoric feeling. At one of the trips to the hospital, they said I had a virus when looking in my throat that is still extremely red and somewhat sore, three weeks later. I have a bit of a dry cough that was never there either. Something doesn't feel right and I know my body, and I just hope that this will turn out alright. I have given up on the doctors because they just brush my claims off.
Lack of efficacy; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (COVID-19) 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 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (COVID-19). At the time of the report, DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2021, SARS-CoV-2 test: positive (Positive) positive.         No concomitant medication reported. No treatment information was provided.  Company Comment: This case concerns a patient of unknown age and gender with no reported medical history who experienced the unexpected non-serious adverse event of special interest of COVID-19 and the unexpected non-serious event of drug ineffective which occurred 7 months 20 days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-422584 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Dec-2021: Follow-up was received and included no significant information.; Sender's Comments: This case concerns a patient of unknown age and gender with no reported medical history who experienced the unexpected non-serious adverse event of special interest of COVID-19 and the unexpected non-serious event of drug ineffective which occurred 7 months 20 days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Site: Redness at Injection Site-Mild, Additional Details: pt developed a rash a week after vaccine administration around the site of injection. rashes were about 3 inches and lasted for 3 days. it did resolve on it own with no meds. no other reaction
Dose 1 - tingle in injection arm immediately after and for about ten minutes. Mild fatigue for two days following. Soreness at injection site and shoulder joint - could not lift arm for two days without sharp pain Dose 2 - Soreness at injection site, could not lift arm for three days without pain; extreme fatigue and headache, fever of 101 degrees F, vertigo, chills, aches, nausea - all lasting approx. 60 hours, expect headache, which has lasted longer.
This 75 year old white female received the Covid shot on 3/23/21 and died on 4/4/21.  Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
Approximately 7 hours after receiving the vaccination on Monday, I became febrile.  Within six more hours, my fever was up to 102°.  I slept for almost twelve hours straight (very out of the ordinary for me) and decided to do an online doctor visit on Tuesday morning.  The doctor attributed the symptoms to a ?robust reaction to the vaccination?.  I ran fevers up to 102° until the morning of Thursday, April 8 (today) and have slept 12-15 hours per day.  The fever has been between 99° and 100.5° today.  Aches and general body pain have been present since Monday evening.  There was an excruciating headache during the first 24 hours.  There is a large red, swollen area at the injection site now.  There is also a softball sized swollen area under the right armpit now, as well.
Patient came in for a booster dose of vaccine, which would have been 0.25ml, but was given a full dose of in error. Patient was notified a few minutes after administration once the mistake was realized by pharmacy staff.
I had tinnitus in both my left and right ears. Two days after the second injection I woke up with tinnitus. My first injection was August 31, 2021 followed by my second injection on September 21, 2021. To date it has never stopped.
joint pain in all joints that never occurred prior to vaccine and has gotten worse as time passes, exhaustion/fatigue constantly since vaccine
Face tingling and numb about 30 minutes after dose administered. Self administered epi-pen.
Upper arm numbness, client states that site has paresthesia and "prickly pain" which occasionally goes into her elbow and hand. Client parent instructed to call primary care physician for follow up.
blood pressure changes during the day, sudden drop causing dizziness In one episode, I experienced severe chest pain with the drop of bp, and was taken to hospital.
Patient presented with weakness and lethargy along with rib pain. Patient ended up being COVID positive even though they are vaccinated.
A report has been received from a Health Professional concerning an 8 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on 10-Jan-2015. It was reported that the expired FLUMIST quadrivalent was administered to the patient on 10-Jan-2015. The outcome of the event of administration of expired FLUMIST quadrivalent to two patients is unknown. The report was considered to be non-serious.
10MAR94 low grade, fever gave APAP 1x; 12MAR94 no apparent temp acting tired in morn; 12MAR93 430PM sleeping all day temp now 104.1; given APAP & sponge bath; 13MAR93 10AM acting nl t100.1, rash developing; diarrhea, t102.2, no appetite;
A FILLING NEEDLE WAS USED TO EXTRACT AND PREPARE 26 DOSES OUT OF A MODERNA VIAL SEQUENTIALLY UNDER 5 MINTUES TOTAL PREP TIME. MODERNA AND NJ DOH WERE NOTIFIED AND WE ARE AWAITING RESPONSE FROM MODERNA REGARDING STERILITY OF THE PRODUCT.  NONE OF THE POSSIBLY EFFECTED PATIENTS REPORTED ISSUES OR ADVERSE REACTIONS. VAERS BEING FILED BECAUSE OF NJ DOH GUIDANCE.
Symptomatic; cough, runny nose, Shortness of breath, sore throat, headache, and burning eyes.
Left thigh, no tenderness, only redness and swollen, some scratch marks. Hc .25% cream apply BID for 10 days.
Fever after the 2nd dose; 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 PYREXIA (Fever after the 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced PYREXIA (Fever after the 2nd dose). At the time of the report, PYREXIA (Fever after the 2nd dose) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
8AUG91 AM mom reported to nurse that PT's T had gotten as high as 105 (104 ax.) the night before--7 days p/DPT, OPV, Hibtiter, & MMR were given; mom was advised to take PT to MD, but didn't go because MD advised to wait and monitor T;
This spontaneous case, initially received on 17-Oct-2016, was reported by a non health professional and concerns a(n) male patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA from 17-OCT-2016 to 17-OCT-2016. Dose regimen: 0.5 ml single dose, Route of administration: Intramuscular. Batch number: WT57208. No additional suspect drugs. Special circumstances: Drug administration error without adverse event. The patient reported that when the doctor injected him, the doctor noticed there was no vaccine in the syringe. The doctor injected the patient again in the other arm because he could not inject him in the same arm again. The patient was worried whether or not the first needle was an already used needle or did it come that way. The patient stated that the doctor took the vaccine out of the fridge where the other vaccines were stored. The pharmacist who administered the vaccine reported that the PFS plunger resisted plunging. No vaccine was administered, but the needle was attached to the PFS and inserted in the patient's arm. The patient was then administered vaccine in the other arm with new PFS with no difficulties. Reporter's comments: The reporter assessed the event as non-serious.
administered Boostrix  subcutaneously/administered Menveo subcutaneously; This case was reported by a physician via call center representative and described the occurrence of intramuscular formulation administered by other route in a 12-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number BR352, expiry date 27th August 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis and Men ACWY-CRM NVS (Menveo) (batch number AMVA371A, expiry date 31st July 2021) for prophylaxis.   On 2nd December 2020, the patient received Boostrix (subcutaneous), Boostrix Pre-Filled Syringe Device and Menveo (subcutaneous). On an unknown date, unknown after receiving Boostrix, Boostrix Pre-Filled Syringe Device and Menveo, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: Age at vaccination was not reported. On 23rd July 2021, physician reported that female patient was administered Boostrix and Menveo subcutaneously instead of intramuscularly which led to Intramuscular formulation administered by other route. Reporter did not consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021159306:FU DELETED
right arm soreness (COVID vaccine admin location) - began overnight. painful to sleep on. continued in the morning. ongoing as of time of reporting. treating with ice pack on arm. fatigue - began a few hours after vaccination. continued the following morning. brain fog - began morning after vaccination. ongoing.
On 3/4/00, the pt presented with greater than 50 vesicles all over his body.
Pericarditis; 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 PERICARDITIS (Pericarditis) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (Pericarditis) outcome was unknown.            No concomitant medication details was provided. No treatment medication details was provided.  Company comment: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.  Date of first dose was not provided, thus appropriateness of product administration schedule is not assessable. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.  Date of first dose was not provided, thus appropriateness of product administration schedule is not assessable. Further information has been requested.
the administration of an extra dose of Pediarix to a 2 month old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 2-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 25L32, expiry date 28-MAR-2025) for prophylaxis.   Concomitant products included PEDIARIX.   On 12-OCT-2023, the patient received the 2nd dose of Pediarix. On 12-OCT-2023, an unknown time after receiving Pediarix, the patient experienced overdose (Verbatim: the administration of an extra dose of Pediarix to a 2 month old patient).  The outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-MAR-2023 An health care professional (HCP) called to report the administration of an extra dose of Pediarix to a 2 month old patient.  The HCP asked for guidance on this situation. Both doses were administered same date at the same time, which led to overdose. The reporter permission to follow up was not requested.
On 9/22/19 pt. ambulatory came to ER w/ c/o headache frontal, neck pain & pain in low back when bending over or attempt to touch his chin to his chest (hx of viral meningitis w/similar symptoms on 2015 but no immunization) 2 days ago had Menatra Tdap & HPV9 Date seen in ER 9/22/19 Vital Signs T - 37.2 Oral Pulse 90 RR18 Wt - 50.3 kg. BP 107/67 Pulse Ox 97% Review of system - photophobia  No vomiting P.E alert awake, NHD Skin - eczema wrist, knees, elbow Neck & meningismus unable to filex past midline No other neurological signs Laboratory - CBC, CMP Lumbar Tap see result -  Transferred to other Hospital - Admitted 9/22/19 Discharged 9/24/19 at 16:00 Discharge Diagnosis Aseptic Mengitis Hospital Course in Medical Center Though there was a low suspicion for bacterial meningitis, patient was empirically treated w/ 2nd dose of Ceftriaxone (9/23/19) On day of discharge 9/24/19 - Afebrile, no headache walking, no abnormal neurological findings on discharge 9/27/19 - 9/30/19 10/1/2019} Had been calling mother to make a f/ up appointment
Case number PHEH2014US022766 is an initial spontaneous report received from a pharmacist on 12 Nov 2014. This report refers to a patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported, expiry date: Mar 2014) intramuscularly on an unknown date. No adverse events were reported following the medication error.
Severe ringing in the ears, ongoing, off and on; muscle aches, bad cramping in calves, feet and toes turned "beet red," very painful. Still sore feet.
lymphadenopthy; Injection site pain; joint pain; injection site swelling and redness (about the size of a hard dollar); injection site swelling and redness (about the size of a hard dollar); This is a spontaneous report from a contactable other health professional (other HCP) reported for herself. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EK5730) via an unspecified route of administration at left arm on 30Dec2020 at 01:00 PM, at a single dose (dose number: 1) for COVID-19 immunization. Medical history included known allergies to apples, and no other medical history. The patient was not pregnant. Concomitant medications in two weeks included colecalciferol (VITAMIN D). No other vaccine received on same date. No other vaccine in four weeks. Facility where the most recent COVID-19 vaccine was administered was at hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced adverse events injection site pain, joint pain, lymphadenopthy, injection site swelling and redness (about the size of a hard dollar); all with start date on 30Dec2020 at 05:00 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was not recovered.
While in office, approximately 1-5minutes after administering the vaccine, patient reported having a metallic taste in her mouth.  Administered Two Benadryl Chewables by mouth  in office for possible Shot reaction. Later  that evening , mom contacted Dr. and reported patient was now  wheezing and developed a cough . Mom reported having administered rescue inhalers but had not seen any improvement.  Mom stated  all the symptoms started within hours of receiving  the vaccine. Mom was advised to start patient on her first dose of oral steroid as soon as possible and to continue for the following 3 days.