chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine; doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in an 81-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    Concomitant medications details were not reported by the reporter.  Reportedly, Pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. the excursion was found out in an audit and all the vaccines were viable.  Treatment details were not reported by the reporter.
This case was reported by a healthcare professional and described the occurrence of taste abnormality in an unknown number of subjects of unspecified ages and gender who were vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  Since approximately two weeks prior to this report, when the hospital's clinics started administering Fluarix.  A small number of subjects received an unspecified dose of Fluarix (.5 ml, unknown) and at an unspecified time after the vaccination, the subjects experienced latex taste in their mouths (taste abnormality).  No other adverse events were reported.  The reporter could not isolate any cases to one particular clinic and has not identified these reports to be a specific lot number.  At the time of reporting, the outcome of the event was unspecified.
2/1/21 2:30pm Pt c/o tongue numb, difficulty speaking. Noted facial drooping & reddened watery Lt eye. Emergency room diagnosed Pt  with shingles/Bells Palsy.
A long term issue I have had from Kawasaki Disease is what I call a heart pinchy thing because it feels like my heart is being pinched. This would normally occur every couple of months and last for a few minutes. After I got the first shot, I have had the heart pinchy thing everyday. It's more of a dull ache in my heart instead of a sharp pain. I am also getting extremely dizzy when go from laying down to  up. It's enough that I need to spend a minute or two regulating myself before I stand up fully.  I received the second dose on November 23 (lot #065F21A) at a Clinic. The same day, I was getting itchy, and by that night I had a rash on my arms and abdomen. The next morning, I noticed hives all over my body with the majority of them looking like scratch marks. The hives were on my right leg, right arm, both hips, chest, back, and back of my neck. The rest of my skin that did not have scratch marks was covered with raised red bumps. I also had a large red spot on my left cheek.  The hives started to fade on December 6, 2021. The heart pinchy thing and dizziness have not changed. I am able to provide pictures of the hives.
Received her flu shot and 2nd dose on the same day; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received her flu shot and 2nd dose on the same day) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009F21A and 049A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received her flu shot and 2nd dose on the same day). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received her flu shot and 2nd dose on the same day) had resolved.            Relevant concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-209359 (Patient Link).
Developed "trouble swallowing" later that evening.  Experienced shortness of breath and chest feeling heavy that evening.  Right arm is sore.  Right leg is weak.  Nauseous.  Dizzy.  Afebrile at 98.4.  Pt notified office of these symptoms 7-30-19.  Pt was advised to go to ER for further evaluation.  Pt went to local urgent care/walk-in clinic.  Was diagnosed with UTI.
Extremely tired for 4 days after injection. 1st day after tired all day, slept 10 hours that night. 2nd day spent most of the day sleeping, approx 8 hours during morning and afternoon and another 8 hours that evening. 3rd day very tired, slept 2 hours in afternoon, then another 8 hours that night.  Also had throbbing in my chest, heavy pulse like I feel when fighting a virus or bacterial infection.   Luckily this occurred over a weekend and I had nothing important scheduled those days I am quite upset that the pharmacist did not provide written or verbal warning  of possible side effects lasting 2-3 days. The CDC web site warns "The side effects may affect your ability to do normal daily activities for 2 to 3 days. About 1 out of 6 people had side effects that prevented them from doing regular activities." That is pretty significant, certainly worth a warning I am very concerned about going through this again for the 2nd dose.
This spontaneous report was received from a nurse concerning to a 5 years old male patient. Information regarding the patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medication was not reported. On 13-MAR-2019, the patient was vaccinated with a dose of PROQUAD intramuscularly in the right leg instead of subcutaneously (Incorrect route of product administration), lot # R020816, expiration date 16-JAN-2020 for prophylaxis. The vaccine did not experienced any temperature excursion and was reconstituted with properly stored diluent (lot # and expiration date were not provided). No adverse events were reported.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 02/17/2021, 03/17/2021, and 11/04/2021. They had recently been hospitalized 09/14/2022-09/30/2022 after suffering complications of a L1 compression fracture after a fall. They were discharged to a skilled nursing facility after this hospitalization. They tested positive for COVID-19 on 10/05/2022, when they were admitted to the hospital for dehydration and management of respiratory symptoms. The individual had many underlying medical conditions. They were found to have an acute kidney injury. They were discharged back to skilled nursing facility on 10/08/2022. They died on 10/15/2022. I see no indication they were hospitalized closer to the death date.
Patient received the Moderna Bivalent Covid-19 vaccine after the emergency use authorization had expired.
After vaccine had been administered it was discovered that patient was under the age of 16. Parent was present at time of vaccination.
starting at 11:00 PM day of vaccine, I started to feel nauseous, chills, aches all over, extreme exhaustion / tired, and headache. The symptoms worsened through the night, unable to sleep. Sometimes the chills would turn to fever and extreme sweating and burning hot sensations. The symptoms were the worst on Thursday and lessened slightly with each passing day. The illness stayed until Sunday morning.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. An 11-year-old male patient received BNT162b2 (BNT162B2), on 19Dec2021 at 13:00 as dose 2, single (Lot number: FK5127) at the age of 10 years intramuscular, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Time: 13.00, Anatomical Site of injection: Left Arm, Route of administration: Intramuscular, Batch/Lot number: FK5127), administration date: 28Nov2021, for COVID-19 immunization, reaction(s): "armpit swollen", "Armpit swollen and pain", "lump under armpit". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 22May2022, outcome "recovered" (2022), described as "Armpit swollen"; AXILLARY PAIN (non-serious) with onset 22May2022, outcome "recovered" (2022), described as "Armpit swollen and pain"; AXILLARY MASS (non-serious), outcome "unknown", described as "Lump under armpit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy, axillary pain with Tylenol and Advil. Additional information : No prior Vaccinations within 4 weeks of vaccination. The same AEs were occurred at 1 and 2nd dose, but less severe.
Syncope 1 minute witnessed by clinic staff in monitoring area approximately 10 minutes after vaccine administered. Patient denied chest pain, shortness of breath, abdominal pain and dizziness. Patient's skin assessment: pale, cool, diaphoretic. Vital signs obtained: BP 110/60, HR 84, Pulse Ox: 99%, RR 18. Patient remained in medical monitoring area for 30 minutes with no further reaction. Patient given fruit snacks and juice. Patient's skin color returned to normal, stated she felt better after lying down and eating.
Pt briefly "blacked out" for 10 seconds almost immediately after menactra given.Aroused when shaken.Had patient lower head and then lie down.Dr. checked patient and sent home stating he felt OK after observing for 25 min.
Bilateral lower extremity/leg weakness occurring 4 days post vaccination. Weakness progressively worsened to mildly include my diaphragm and trouble taking in a big breath. Sought Medical attention by Dr. who sent me to Neurologist.
I received the 1st dose on 1/3 and experience the normal side effects of soreness at the injection site.  Soreness resolved after a few day.    On 1/8, I started to experience tenderness and swelling of the lymph node on the same side as the injection was administered.   In addition, on 1/10, I started to experience soreness on the injection site.
Redness 6m x 8m in area with soreness started approx 5 days after administration of PREVEAR 13 vaccine in Right Deltoid.
A COUPLE OF MINUTES AFTER ADMINISTRATION THE CUSTOMER EXPERIENCED A BIT OF BLURRED VISION (WHICH QUICKLY RETURNED TO NORMAL) AND THEN SHE EXPERIENCED SOME VOMITING.
vaccine triggered an HSV2 outbreak,  08/16/2021 prodrome, 08/17/2021 worse than normal outbreak, patient had been outbreak free for more than a decade.  08/17/2021 started valcyclovir
Pt called the pharmacy the afternoon of 2/22/19 with complaints of a major headache. I counseled on treating symptoms but contacting on-call Dr. or going to urgent care if symptoms were deemed 'bad.' Pt claims ongoing symptoms for 3+weeks after shot that were only occasionally alleviated by TYLENOL (pt never used max recommended amount). Pt was given RX's for prednisone and acyclovir by Dr. on 4/1/19. Pt came in 4/4/19 with complaints that she was still experiencing headaches but they might be a little better. Pt to continue to monitor and follow up with Dr.
Expired vaccine given in clinic. The vaccine had expired on 01/04/23 at 2143. However, the vaccine was given to the patient on 01/05/23 at 1057.
Three days after receiving my 1st dose of Covid vaccine my period came off schedule and extremely heavy in flow. I had terrible stomach cramps. I have not experienced this heavy of a flow in over 20 years. My periods are always light in flow and only last 3 days. I never have cramps. The first period I had after the vaccine lasted about 14 days which is extremely long! I have had long, off schedule, heavy periods since receiving the covid vaccine. It has been 6 months since receiving my first vaccine and my periods are still heavy, long, off schedule and painful.
Dizziness, headache, muscle aches, chills, nausea and exhaustion for two full days.
I was diagnosed with Covid-19 on 2/4/2021.  I had shortness of breath, headaches, chills, sore throat, and fatigue.  I was off of work until March 23rd.  On March 29th, 30th and 31th, I was able to work 7 hours per day.  I got the first dose of the Phizer vaccine on 3/31/2021.  I was okay after the vaccine.  However, on April 1st the shortness of breath, headache and fatigue started again.  On April 5th, the fatique was significantly worse and I began coughing again.  On the evening of April 5th, I started having chest pain sometimes when I good a breath and/or coughed.  I did not have the chest pain before the vaccine.  I feel like I did four or so weeks ago so I suffered a set-back after the vaccine.
Fever 100.1 with Tylenol  Body aches  Sore arm Only lasted one day  3/24 to 3/25 /21 am to am
Sore throat through the days proceeding the vaccination; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 185) via an unspecified route of administration in the left arm on 14May2021 at 17:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic allergy. It was unknown if patient had any allergies to food, medications or other products. Concomitant medications included allergy pills (MANUFACTURER UNKNOWN) from an unknown start date and for an unknown indication. 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 did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15May2021 at 06:00, the patient experienced sore throat through the days proceeding the vaccination. No therapeutic measures were taken as a result of the events. The clinical outcome of the event sore throat was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 02Apr2021 and vials were in Freezer and Refrigerator where Temperature dropped to Frozen Vaccine 47Minutes -13.79 C Refrigerator 59 Minutes 12 C and effected vials are: Lot no 003B21A, 100 doses ,Lot no 027B21A 100 doses , Lot no 030B21A 100 doses Lot No 02B21A 140 doses . HCP said that 63 doses were administered to 63 Patients. Crosslink of 45 bulk cases   This case was linked to MOD21-068620, MOD21-068805, MOD21-068804, MOD21-068645, MOD21-068696, MOD21-068803 (E2B Linked Report).; Sender's Comments:  MOD21-068620:crosslinked MOD21-068805:crosslinked MOD21-068804:crosslinked MOD21-068645:crosslinked MOD21-068696:crosslinked MOD21-068803:crosslinked
Fever of 100 degrees F; Headache; Muscle pain; Pain is gradually getting worse; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain is gradually getting worse), PYREXIA (Fever of 100 degrees F), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Immune thrombocytopenic purpura.    On 15-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN (Pain is gradually getting worse). On 16-Mar-2021, the patient experienced PYREXIA (Fever of 100 degrees F), HEADACHE (Headache) and MYALGIA (Muscle pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN (Pain is gradually getting worse), PYREXIA (Fever of 100 degrees F), HEADACHE (Headache) and MYALGIA (Muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Body temperature: 100 f (High) 100 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications was reported
Janssen COVID-19 Vaccine EUA I had a fever, headaches, nausea, fatigue, soreness on injection site, and loss of appetite.
The injection site burned at the time of the injection to the point it brought tears to my eyes. The burning con't. for 2 hours. Then the muscle was very sore to the point I couldn't move my arm. The muscle soreness con't and wakes me up at night.
A physician reported that her 6 month old granddaughter received Prevnar in 11/01. Two weeks, post vax, on 11/7/01, the infant developed an "elevated white count (22,000)". She was treated in the ER with IV fluids. No additional information was available as of the date of this report. This case was considered serious since the event of an elevated white blood cell count was considered "Medically Important" in this case.
I have a swollen lymph node behind my left ear since Jun2021 after taking my second shot on 31Mar2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset Jun2021, outcome "unknown", described as "I have a swollen lymph node behind my left ear since Jun2021 after taking my second shot on 31Mar2021". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Patient had been to primary care doctor twice and they have not prescribed any medication to reduce the swelling. Also took the booster.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Died since taking your COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Died since taking your COVID vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Additional information: Reporter also reported that he/she has countless sick friends thanks to it. Stated that the clock was ticking, the truth will prevail.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300020087 Same reporter/drug/event, different patient;; Reported Cause(s) of Death: Died since taking your COVID vaccine
Sore arm, extreme tiredness where she can sleep all day long and have not energy and headaches. She stated that this is very unusual  for her and she have only experience this is after taking the vaccine. Since she has gotten the vaccine she has had neuropathy which she has had when having breast cancer but it has became off the charts.
Suspect COVID breakthrough case History of if ingesting foreign objects. and was brought to ED for concerns of ingesting glass.  COVID finding- exposure within family
Woke up at 8:45 am.  Felt achy and went to bathroom to urinate.  Got up from toilet, felt dizzy, screamed for husband and fainted before he could catch me.  I was unconscious for several minutes and a PACU nurse, neighbor helped revive me.  Ambulance took me to the hospital.  Blood pressure dropped very low in ambulance.  Diastolic reading was 30.  CT w/o contrast showed no acute intracranial abnormality but a partial right scalp hematoma.  Followed up with cardiologist for syncope.  Discharged from ED
Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Patient was given the J&J vaccine by mistake instead of the Phizer vaccine which is approved for his age. He has had no adverse side effects from this vaccine, but was not supposed to receive it. He has not gotten a second dose of any vaccine.  His pediatrician was contacted and they said to call back if he had any adverse effects.  The site was contacted to let them know they made a mistake and they denied administering the wrong vaccine and offered to send me a new card with a Phizer sticker.