chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received my vaccine on 05/25/2022. On 06/02/2022 around 10pm I had just gotten done exercising and my smart watch gave me a notification stating I had a A-fib/Atrial fibrillation warning. I continued to get notifications during the night and waited for the next day. I changed watches and still had another Afib warning with my other watch. I then went to the hospital and it was confirmed I had an Afib after doing the EKG was prescribed blood thinners and beta blocker (ELIQUIS, metoprolol tartrate). 06/06/2022 I received a cardio version and symptoms ended.
Currently 4 days of bleeding; increased energy; sore left arm; overly emotional cry ie for a couple/few days; menstruating when I had my period only 14 days before; This is a spontaneous report from contactable consumer, patient. A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration, in the left arm on 09Apr2021 at 11:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing, and thyroid issues. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant drugs included ofatumumab (KESIMPTA) from 30Mar2020. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took ocrelizumab and experienced hypersensitivity.  On  21Apr2021 at 12:00, the patient experienced currently 4 days of bleeding, increased energy, sore left arm, overly emotional cry ie for a couple/few days, menstruating when I had my period only 14 days before.  The outcome of the events, currently 4 days of bleeding, increased energy, sore left arm, overly emotional cry ie for a couple/few days, menstruating when I had my period only 14 days before was unknown.
Booster; Covid-19 just the positive/ still got very badly sick with the Covid-19; Covid-19 just the positive/ still got very badly sick with the Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster "; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 just the positive/ still got very badly sick with the Covid-19". The reporter's sister in law took the 3rd injection and still got very badly sick with the Covid-19. The reporter's sister in law took 3rd injection and within a few weeks she was very badly sick with Covid-19 just the positive. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: covid-19 just the positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 5 minutes of getting HPV lower back, lower legs and left arm/wrist were numb and tingling. Seen at ER on 4/17/2014; sent home. Seen in the office on 4/18/2014 with decreased reflexes x 4 extremities, (L) wrist limp and unable to raise hand. Referred to ER -> was there for 3 hr; within last 30 min. symptoms reversed.
Information has been received from a 28 year old consumer who in 1973, at 12 months of age, was vaccinated with 1 dose of MMR and subsequently, experienced seizures and a fever and was "rushed to the ER." The pt was hospitalized. Additional information has been requested.
Initial information received on 15-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient (gender not reported) who was vaccinated with a DTaP/IPV component without HIB component of PENTACEL (batch number, expiry date, dose, route and site of administration were not reported) on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate reconstitution technique. No adverse event was reported. 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. Documents held by sender: none.
Chills, body aches, depression, fatigue, and loss of appetite (I weigh slightly under 100 lbs. I lost weight since I went to a doctor years ago.)
Tinnitus began after first dose of COVID Pfizer vaccine. It?s a mild high pitch buzzing in both ears that persists all day.   So far it continues and hasn?t abated.
Side effect; A spontaneous report was received from a consumer concerning a unknown age, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced side effect/ adverse event.  The patient's medical history, was not provided by the reporter. Concomitant product use was not provided by the reporter.  On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route for prophylaxis of COVID-19 infection.   On unknown date, prior to receiving mRNA-1273, the patient felt side effect. No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, side effect was considered unknown.
I started getting symptoms of cough, runny nose, aches, and headaches. My symptoms were mild. I did 2 at home COVID-19 test which was positive. I also went to an urgent care and received a positive rapid COVID-19 test. My symptoms are still present and are mild. My worse symptoms is fatigue.
Patient was inadvertently administed with the 11 days of expired vaccine that was initially stored in the refrigerator on 27 May 2022; inadvertently administer  the vaccine 11 days after expiration date, Dose administered after 30 day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date, Dose administered after 30 day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Patient was inadvertently administed with the 11 days of expired vaccine that was initially stored in the refrigerator on 27 May 2022) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 065F21A, 037B21A and 018B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date, Dose administered after 30 day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient was inadvertently administed with the 11 days of expired vaccine that was initially stored in the refrigerator on 27 May 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date, Dose administered after 30 day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Patient was inadvertently administed with the 11 days of expired vaccine that was initially stored in the refrigerator on 27 May 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Past medical history of the patient including allergies (medications, food and other products) was unknown.  No concomitant medication was reported.  It was unknown if patient ever had COVID positive test or diagnosis.  Medical history relating to mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination was none.  It was unknown if other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  1 vial was involved. On 27-May-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.  No treatment information was provided.
This spontaneous report was received from a registered nurse concerning a patient who on 03-FEB-2013 was vaccinated with the first dose of GARDASIL IM 0.5 ml (lot # not provided). The nurse stated that on 19-MAR-2013, the patient received the second dose of GARDASIL (lot # not provided), IM 0.5 ml (lot # not provided). Additional information is not expected.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to (Patient Link).
PAIN ON LOWER BACK; PAIN HIPS; PAIN ON LEGS; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection in APR-2020 and AUG-2020, and concurrent conditions included: non-alcoholic and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies and had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) 1 total, administered on 30-AUG-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 31-AUG-2021, patient stated that, he had a reaction to the vaccine. He got pain on 31-Aug-2021 on his lower back, hips and legs and could not stand the pain. He had to go the emergency room and was told it was a syndrome caused by the vaccine. The patient went to the hospital on 01-Jan-2022 and left on 02-Jan-2022. The patient never went with healthcare professional because the patient went to get lab test done and healthcare professional never gave them so patient got upset and never went back. The patient was hospitalized for 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain on lower back, pain hips and pain on legs was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20220104725-Covid-19 vaccine ad26.CoV-2.s-Pain in lower back . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20220104725-Covid-19 vaccine ad26.CoV-2.s- Pain in hips, Pain on legs. This event(s) is labeled per a regulatory authority and is therefore considered potentially related.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient hospitalized with COVID-19 infection, CAP, and AHRF. Received oxygen, anticoaulgation, antibiotics, steroids, and remdesivir. Discharged to home medically stable.
Approximately three hours after injection the lymph node in the armpit closest became swollen and arm was sore. Administered Tylenol. At approximately midnight woke up with severe chills, fever (103) , Body pain, Severe eye pain and nausea. Developed a headache and sweating throughout the night. Continued to administer Tylenol at regular intervals. Sweating was profuse in that pajamas needed to be changed twice. At this point it has been more than 24 hours and though the symptoms have reduced in severity, eyes are still very sore and still experiencing chills and low-grade fever off and on. I would?ve gone into urgent care but there was a huge snowstorm. The reaction was quite concerning and very surprising. There was literally only a sore arm and mildly at that from the first injection .
Approximately 30 seconds after I gave patient her flu shot, she started seeing spots and very faint. She went down on the floor and pulled my pant leg. I turned and saw her on the floor and yelled at the techs to call emergency services.  I bent down to talk to patient and she told me she had an Epi-pen in her bag and wanted me to give it to her. I administered it in her left thigh. I stayed down on the floor just talking to her until the paramedics arrived.  She never lost consciousness and was talking/laughing with me. When the paramedics arrived, they took her vitals and all were within normal range. However, she still felt weak and when the paramedics asked if she wanted to go to the hospital she said yes. They did need to put her on a stretcher
Red, itchy bumps at location of the shot and in elbow.; Soreness came back in location of the shot and in forearm; Soreness came back in location of the shot and in forearm; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 12Apr2021 at 13:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included depression. Concomitant medications included lamotrigine (LAMICTAL) and venlafaxine hydrochloride (EFFEXOR); taken from unknown dates for unknown indications and unknown if ongoing. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 13:00, the patient experienced red, itchy bumps at location of the shot and in elbow and soreness came back in location of the shot and in forearm. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of events reported. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events red, itchy bumps at location of the shot and in elbow and soreness came back in location of the shot and in forearm was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Narrative: 76yr patient reported body aches, pain at injection site, fatigue, and minor headache after receiving 2nd booster of Moderna. Denied swelling and redness at injection site. Did not report prior ADR/ADE's with previous booster or series.
Human Papilloma Virus; Felt a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAPILLOMA VIRAL INFECTION (Human Papilloma Virus) and MYALGIA (Felt a little sore) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced MYALGIA (Felt a little sore). On an unknown date, the patient experienced PAPILLOMA VIRAL INFECTION (Human Papilloma Virus). On 14-Apr-2021, PAPILLOMA VIRAL INFECTION (Human Papilloma Virus) and MYALGIA (Felt a little sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
7FEB92 t103.4 ax temp; APAP given; hosp called; Rx sponge bath, fluids, APAP; 8FEB92 PM 104.2 ax temp; to MD; throat red-neg strep screen; no Rx; 7FEB92 & 8FEB92 temp never went below 100; APAP given x 2 days; no other sx;
Left arm (PNEUMOVAX) began as 2 quarter size raised rashes developed into large palm size rash that was warm to touch. MD was seen, diagnosed with infection, treatment AUGMENTIN, rash currently improving.
Burned during vaccine, then later that day, I went about my day. Later that evening, when I got ready to go to bed, my arm was very sore. I noticed I had a little swelling, and my grandaughter asked why my arm looked the way it did. She said it looked like an oreo. So it was a little swollen. I didnt have any issues, other than it's like a knot there. A little painful when I am trying to change my clothes. It's really tender, I dont want anyone touching it. The covid shot was easier than this thing.  I have a doctors appointment coming up in a week or so. I hope itll be gone by then, I hope itll be gone.
States at 1:30am after the vaccination, she woke up with a severe migrane, blurred vision to where she couldnt see, her body had heat wave with the shakes where the inside of her body felt overheated but her outer body was cold.  Her vision was so blurry so she laid back down and when she woke up she had fever of 101, her arm where ithe injection was is super tight, warm and hurts extremely bad so she went to the emergency room on 11/19/20 around 10. When getting the injection she states the nurse stuck her the first time and said she dont want to hurt her and removed that needle and got another needled and restuck her again
This case was reported by a nurse and described a 50 year old female pt who tested positive for hepatitis B surface antigen following the administration of Engerix B. The pt's medical history was notable for renal failure (cause not specified) requiring hemodialysis, diabetes mellitus (type not specified), hypertension, tuberculosis, chronic obstructive pulmonary disease, tobacco use and cachexia. On 02 July 2004, the pt received the second dose of Engerix B (lot ENG5589A4). The reporter stated that, "five days after receiving Engerix B, on 07 July 2004, laboratory findings indicated that the pt developed hepatitis B surface antigen." A repeat laboratory test performed on 13 July 2004 for hepatitis B surface antigen was "negative." The nurse considered the event possible related to vaccination with Engerix B.
1/25 3 pm Arm soreness 5 pm achy, chills 1/26 1 AM T 101.5, headache, fatigue Unable to work due to symptoms
1 of 4 pts vaxed from the same DTP lot# exp inject site (DTP) react consisting of swelling & local rash; pt required an office visit;
Received email from the quality department alerting of vaccine error given to child (DTAP IPV Kinrix) which is inappropriate for child's age. Informed the medical assistant and the MD of this issue. Dr. called mom to inform her of the vaccine error and talk to mom to make sure patient is not having any adverse reactions. No adverse effects from vaccines.
PATIENT STATES HE HAD FEVER, FELT TIRED & A HEADACHE FOR THE FORST 48 HOURS. STARTING ON 7/28/2021 HE DEVELOPED HIVES ON HIS HANDS, FEET & BACK.  AS OF TODAY 7/29/2021 THE RASH IS NOT SPREADING BUT IS BECOMING MORE DENSE.
Presented with R side weakness; + Covid; Admit with Covid PNA; tx with maxipime, remdesivir, rocephin, Vit B12, Steroid, singulair, zinc, supplemental O2 Patient is hemodynamically stable and being discharged to home
pt recv vax 27JAN99 & the next day pt devel generalized hives;pt was treated w/DPH & recovered by 29JAN99;
3w3d pregnant at the time of vaccination. EDD of 6/12/22. Found out on 1/6/22 that there was no heartbeat. Based on ultrasound, fetal demise occurred at 16w4d.  Multiple tests returned normal. Placenta showed villitis of unknown etiology. Several fetal organs measurements were off : heart 12 wks, kidneys 13 wks, Thymus 20 wks
Reports dizziness and then headache.  Assisted to lie down; fan on patient; ice water to drink; ice pack for frontal headache. B/P 98/68 P-60 (is athelete) Dr. notified of findings. Feeling better at 3:15 PM; up walking and wants to leave with mom.
This initial spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no pertinent medical history or drug allergies/drug reactions described. On an unspecified date, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route, frequency and lot# were not provided). There was no concomitant medication reported. The pharmacist stated in approximately 2014 reported as "about one year ago", the patient developed redness at injection site. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. At the time of the report the outcome of the event was unknown. The relatedness between the event to ZOSTAVAX was not reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Started with soreness and stiffness in arm and later that evening had pain radiating down arm, lower back and legs, moderate headache and stomach pain. By 10:30 pm headache was severe , arm cold and burning, rest of body was cold and uncontrollably shivering for about 2 hours. The next morning was fatigued and mild/moderate body , head and stomach pain  x 24 hours. Also teeth extremely sensitive to cold/hot.
This spontaneous report was received from a Medical assistant referring to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies, concurrent conditions and concomitant therapies were not reported. On 21-JUN-2016, the patient was vaccinated with the first dose of ROTATEQ lot # L046318, expiration date: 28-SEP-2017, then, on 21-SEP-2016,  the patient received the second dose with lot # M004542, expiration date: 18-OCT-2017, the third dose was administered on 14-NOV-2016, with lot # reported as M022371, expiration date: 18-FEB-2018 and then, a fourth dose was administered on 14-DEC-2016, with a lot # M029251, expiration date: 14-MAR-2018, this last dose was outside the recommendations per the ROTATEQ prescribing information. No adverse events were reported. Additional information has been requested.
For the 1st Moderna vaccine on April 7th, I just had a sore arm afterward. For the 2nd vaccine on May 5th, it began with the expected reaction of fever (101.3), nausea, headache, achiness. And here was some eye pain. Then I started to notice my vision was blurry about 48 hours after the vaccination and it has continued. I am still experiencing vision changes.