chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received your vaccine about 6 months ago and have not gotten my period since; received your vaccine about 6 months ago and have not gotten my period since; 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 female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (non-serious), MENSTRUATION DELAYED (non-serious), outcome "unknown" and all described as "received your vaccine about 6 months ago and have not gotten my period since". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional Details: Forwarded as an Adverse Event by the team on 27Jan2022. Reporter provided verification of contact address on 26Jan2022. She received vaccine about 6 months ago and had not gotten her period since. She had been to the doctor and was not pregnant and it was nothing structural.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 25Sep2023, outcome "recovered" (Sep2023), described as "Pain at the injection site". Therapeutic measures were not taken as a result of vaccination site pain. Additional information: No other vaccine received in four weeks. No Covid prior vaccination. Not tested Covid post vaccination.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
pt recvd vax;1 wk p/ dose 1,exp pain in lt breast & chest;shoulder,wrist & elbow joints;unresolved;24 hrs p/ dose 2, exp the same sxs w/ exacerbation; unresolved;
Large (approximately 3 inches) reddened, raised area at site of varicella injection, tender, no fever.
Fatigue, the night that I had the shot I slept for 12 hours. Arm soreness, it still feels a little sore a week later. Itchiness and leasion as that the injection site started today (a week after getting the shot)
Information has been received from a physician concerning a 12 month old male with an allergy to amoxicillin (+) clavulanate potassium (Augmentin) who on 21-Oct-2005 was vaccinated in the right thigh with a first dose of varicella virus vaccine live. Concomitant vaccinations administered that day included a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live, a dose of influenza virus split virion 3v vaccine inactivated (Fluzone), and a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar). There was no illness at the time of vaccination. Subsequently, the patient developed a small amount of lesions on the body and a fever elevated to 105 degrees Fahrenheit. The patient was taken to the hospital and administered antibiotics. Laboratory studies were performed (results not provided). The patient subsequently recovered. It was noted that it was not known what vaccine caused the events. A product quality complaint was not involved. Follow-up information from the physician indicated that on 01-Nov-2005 papulopustular lesions developed around the injection site. The patient's fever started three days ago, on 04-Nov-2005. It was to 102 F. The patient also had gunky eyes. On 04-Nov-2005 and 05-Nov-2005 the patient's temperature was at 103.5 F. On 06-Nov-2005 the patient's fever was 105.2 F. He was then sent to the emergency room and started on azithromycin (Zithromax). It was noted that the patient was on therapy with cetirizine hydrochloride (Zyrtec). Laboratory test were performed, abnormal results were as follows: C reactive protein was 12.4 mg/dl (high), white blood cell count was 20.7 (high), red blood cell count was 3.79 (low), hemoglobin was 10.2 (low), hematocrit was 29.8 (low), and RDW was 15.6 (high). A strep scream was negative. On 07-Nov-2005 the patient was seen in the physician's office. He had a cluster of lesions at the injection site of the vaccine on the right thigh "x 1 week," and one pustule on neck "x several days. Upon exam the patient had thrush on the buccal mucosa (both sides) and on the left tonsil. It was noted that he had been on amoxicillin (+) clavulanate potassium (Augmentin) since 28-Oct-2005. The physical examination showed that his nose/sinus, mouth/teeth, throat and skin were abnormal. Assessment of the patient indicated fever, vaccine -type varicella and thrush. The plan from the physician included reassurance, "flu for fever > 5 days," and nystatin. There was no mention of hospitalization. The patient's adverse events were determined to be other important medical events by the physician (OMIC). Additional information is not expected.
Shot #1 3/22/2021 Shot #2  4/15/2021  3/22/2021 Left Arm Ache / Weakness from fingertip to shoulder blade Pins & Needles / tingling which starts at pinky & ring finger before radiating up hand, wrist, and arm.  4/11/2021 Began experiencing changes in cognitive ability. Rapidly progressed to acute onset psychosis with debilitating OCD and schizophrenia like symptoms including but not limited to: visions / delusions / hallucinations / paranoia / intrusive thoughts / anxiety / panic attacks / short term memory loss / depression. 4/15/2021 Change in Taste & Smell / Hot & Cold Flashes accompany all previously listed symptoms
22 hours later - Headache; extreme fatigue and exhaustion; extreme weakness; fever; chills; sweats; body aches; neck pain; shoulder pain; joint pain. I was unable to work, unable to function at home, unable to take care of my kids and myself. All I could do was lay in bed and feel like I was on my deathbed. I had COVID, this was worse than COVID. Started 3/3 around lunch and ended 3/4. I noticed that my arm has a huge red hot swollen hard swollen knot in it and it is itchy. 3/5 my arm is still itchy, swollen, hot and red.
Information has been received from nurse practitioner concerning a 49 year old female patient with hypertension who on 11-SEP-2008 was vaccinated with a dose of VARIVAX (Oka/Merck) (lot # 658412/1024U).  On 12-SEP-2008 the patient experienced general lymphadenopathy.  The nurse practitioner reported that the patient received the same vaccine several years ago in another state but a recent titer was negative.  The patient was given a course of an unspecified antibiotic and recovered.  The patient sought unspecified medical attention.  Follow up information was received from the nurse practitioner reported that the patient was a Caucasian registered nurse who on 11-SEP-2008 at 12:30 PM was vaccinated in her left upper arm with a second dose of VARIVAX (Oka/Merck) (lot # 658412/1024U).  After receiving the vaccine, at 12:45 PM, the patient began feeling "hot" in mid sternum, neck and ears, heart rate increased to 115-120, palpitations, blood pressure increased and tachypnea.  The following day, the patient's lymph nodes in neck were swollen on left side, her left ear was painful.  The injection site was hot, tender with 4 cm area of induration.  On 07-NOV-2008 complete blood cell count, blood chemistry test, serum C-reactive protein test and serum antinuclear antibodies test were performed and the results were within normal limit.  VARICELLA titer results were received on 26-JAN-2009 as 0.97 = equivocal.  It was reported that a previous titer was positive on 07-NOV-2008 (1.42).  At the time of the report. all the events recovered except the blood pressure remained elevated.  Additional information has been requested.
This spontaneous report as received from a 70 year old female consumer (reporting on herself). In May 2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) (dose not reported, intramuscular route). Concomitant therapy was not reported. On an unspecified date in 2013, the patient started feeling pain on arm where shot was administered. The patient sought unspecified medica; attention and no treatment was given for adverse event. The patient got a Magnetic Resonance Imaging (MRI) on 29-JUL-2013 (waiting for results). The outcome of injection site pain was unknown. Additional information is not expected.
Janssen COVID-19 Vaccine EUA: Vaccine recipient experienced near syncopal event and was monitored by medic for 30 minutes. There was no treatment given.
It was reported that a female pt received a TD Adult vaccination on 11/02/2000. Reportedly the pt developed a local reaction of redness and soreness at the injection site. A physician evaluated the pt; no prescribed medication was given. From additional correspondence recieved on 02/27/2001, it was reported that the pt recovered from this experience. No further info is anticipated; this case is closed.
Per DH: Regarding The VSIR for  on the following COVID Vaccine Moderna. Please see the following determination; Doses Administered from 4.6.2021 to 5.21.2021:Based on the information you have provided and the lack of temperature data, we are not able to conduct an analysis or guarantee the doses administered between 4/6/2021 and 5/21/2021 provided the necessary protection against a COVID-19 infection. Please continue with the original plan of action on revaccination and completing a VAERS Reports on the all clients you have identified.
A rash at the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE RASH (A rash at the injection site) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (A rash at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at a dose of 1 dosage form and DEXAMETHASONE (DECADRON [DEXAMETHASONE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE RASH (A rash at the injection site) outcome was unknown. Not Provided      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.   No concomitant medication was reported.  The physician was recommended to the patient not to get the second dose.
Red swollen area surrounding injection site, sore arm, fatigue. Ongoing but redness is fading today. Started on day 10 after vaccine.  Initially arm was just sore for 3 days after injection and then felt totally better.
First dose: fatigue with left arm soreness Second dose: chills, whole body soreness and ache, low grade fever and an ongoing blurry vision. I went to the ophthalmologist and the ocular ct showed right eye optic nerve is inflamed.
Moderna COVID19 vaccine EUA given at Cheyenne Wy 2/6/2021 1:45 p.m. can't sleep, harder to breathe, anxiety, light headed - dizziness, loss of appetite, no energy
Nausea/Vomiting/Dizziness/Fatigue x24 hours
This spontaneous report as received from a medical assistant, refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients may have been vaccinated with MMR II (rHA status unspecified) (dose, route, and lot number were not reported), that were improperly stored (49.3 degrees F. for 2 hours). Concomitant medications were not reported. No adverse effect reported. This case is linked to cases 1404USA007012, 1404USA007013, 1404USA007014 and 1404USA007015 via same reporter link. Additional information has been requested.
Inappropriate schedule of vaccine administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.        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.   It was reported that patient had received first dose more than 42 days ago. No decision about second dose yet. No more information available, pharmacist was in rash with line.  No treatment medication was reported. No concomitant medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-017714 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-017714:dose 1
Patients doctor called to inform us that pt had a reaction to a vaccination he received on 9/18/20. We confirmed that is was the Prevnar 13 vaccine. Patients arm was swollen, warm to touch and itchy
Patient fainted immediately after receiving vaccine. Patient regained consciousness immediately, he said was feeling ok but paramedics were called due to patient hitting head on door during faint. The paramedics opted to take him rather than let him leave and drive home.
From initial information received on 10/21/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that two patient's (age and gender not reported) received TD ADS ADULT, lot number U0840AA, administered ID in error instead of TUBERCULIN PPD on 10/19/04 or 10/20/04. An unspecified amount of time later, the patients developed redness at the test site. The recovery status of the patients is unknown. The reporter of this case is the same as for cases 200403440 and 200403441.
This spontaneous report as received from a nurse refers to 57 patients of unknown age and gender. On an unknown date the patients were vaccinated with ROTATEQ (dose and lot number was unknown) which was improperly stored. No adverse events were reported. The outcome of the event was unknown. No further information was provided. This case is linked to (MARRS # 1411USA009917, 1411USA004296, 1411USA009916, 1411USA009918) with the same reporter link. Additional information has been requested.
there is more pain for the patient compared to other vaccines he administers; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN (non-serious), outcome "unknown", described as "there is more pain for the patient compared to other vaccines he administers".  Additional information: After administering any dose of Prevnar 13, the doctor states that there was more pain for the patient compared to other vaccines he administers. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine was initially stored in refrigerator on 02 Jun 2022 and administered on 06 Jul 2022.; Patient was administered with expired booster vaccine beyound 30 days use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired booster vaccine beyound 30 days use by date.) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 02 Jun 2022 and administered on 06 Jul 2022.) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension since 09-Nov-2017, Type 2 diabetes mellitus since 09-Nov-2017, Hyperlipidemia since 14-Nov-2018, Neuropathy since 04-Feb-2019 and Heart disease, unspecified since 17-Jun-2022. Concomitant products included SEMAGLUTIDE from 27-Jun-2022 to an unknown date for Diabetes, CLOPIDOGREL from 13-Apr-2022 to an unknown date for Heart disease, unspecified, ATORVASTATIN from 30-Sep-2021 to an unknown date for Hyperlipidemia, LOSARTAN from 09-Mar-2022 to an unknown date for Hypertension, PREGABALIN from 08-Dec-2021 to an unknown date for Neuropathy.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jul-2022 at 8:24 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 06-Jul-2022 at 8:24 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired booster vaccine beyound 30 days use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 02 Jun 2022 and administered on 06 Jul 2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired booster vaccine beyound 30 days use by date.) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 02 Jun 2022 and administered on 06 Jul 2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was unknown whether patient had ever diagnosed with nor tested positive for COVID-19.  No adverse events noted at this time.   It was reported that the vials had not undergone any temperature excursions.  No treatment medications were reported.   This case was linked to MOD-2022-607864 (Patient Link).
Had sore arm and felt unwell shortly after receiving the shot. The following morning my arm was still sore and I developed a blister behind my left ear and swollen lymph-nodes. The soreness in my arm went away however the blister became worse and started erupting with puss and the lymph-node became larger, tender, and developed sharp . shooting pain. I went to urgent care  on 1/3/2020 and was given oral antibiotics and an antibiotic cream for the blisters. A swab culture was taken for possible shingles. On 1/4/20 I went to clinic as the pain had worsen and resulted in a numbing sensation on my left cheek. The doctor prescribed me antivirals for Shingles and I was given an antibiotic shot in the butt.   I was off work for two weeks. The pain went away around 1/15/20.  The blisters are healed.
Provider summary "Patient presented with dyspnea found to be in hypoxic respiratory failure from covid pneumonia, viral sepsis. Placed on NC O2, started on decadron and remdesivir. O2 need stable during hospital stay. Strep pneumo urine antigen + so treated with rocephin -- > amoxicillin for total 5 days. Prior to 5 days of remdesivir given family wanted to take patient home. He qualified for home O2.   The patient was discharged in stable condition with improvement of symptoms and appropriate follow up planned."
Elbow area started hurting then Shoulder and triceps area. Then it spread to lower arm. March 31  a rash started on lower arm and noticed swelling of arm and wrist. Rash continued until drying and started going away April 3.  Arm is still sore, painful and swollen.  Have taken Aleve for pain.
patient had experienced redness in upper chest and broke out into hives shortly after receiving the Vaccine.  At 10:40 a.m. Five Minutes after receiving the vaccine the patient was administered Benadryl. Patient recovered and left the clinic at 10:55 driven by an accomplice.
My COVID experience started out as a normal headache which lasted the entire time that than became a very bad headache. I also had some body aches and chills.
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
SLIGHT DIFFICULTY IN BREATHING; DRY COUGH; CHEST TIGHTNESS; ALMOST UNRESPONSIVE AT DINNER TABLE; HIGH LEVEL OF FATIGUE AND SLEPT ALL DAY; NAUSEA; HEADACHE; SLIGHT NUMBNESS TO FACE; This spontaneous report received from a parent concerned a 29 year old male. The patient's height, and weight were not reported. The patient's past medical history included surgery to left foot at late adolescent, and other pre-existing medical conditions included patient had no known allergies.  The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 11:00 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced slight numbness to face. On 30-MAR-2021, the subject experienced slight difficulty in breathing. On 30-MAR-2021, the subject experienced dry cough. On 30-MAR-2021, the subject experienced chest tightness. On 30-MAR-2021, the subject experienced almost unresponsive at dinner table. On 30-MAR-2021, the subject experienced high level of fatigue and slept all day. On 30-MAR-2021, the subject experienced nausea. On 30-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from high level of fatigue and slept all day, dry cough, nausea, headache, chest tightness, slight difficulty in breathing, and almost unresponsive at dinner table, and the outcome of slight numbness to face was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Vasovagal Syncope, diaphoresis, bradycardia treatment: Monitoring Vital signs for 30 minutes, elevate legs, lay the patient on the floor.
Acute sob and difficulty breathing the evening after she rec'd her flu shot. Used the albuterol inhaler, which helped alot, but states she would have had to go to the ER if she hadn't had the inhaler. SOB resolved, but pt had nausea and vomiting that entire night, felt miserable. No hx of egg allergy. Has done well with flu shots in the past.