chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer reporting for self. This patient with unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient already got the first dose of Pfizer vaccine but afterwards tested positive for COVID on unspecified date. Patient had second dose scheduled in about one and a half week on 11Apr2021, and wanted to know if still should get second dose. The outcome of event was unknown.   Information on the lot/batch number has been requested.
redness around injection site; fever; felt like I'd been run over; severe chills; Palpitations; Felt shity; weak; poor sleep; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (Palpitations), DISCOMFORT (Felt shity), ASTHENIA (weak), POOR QUALITY SLEEP (poor sleep) and HYPERHIDROSIS (felt like I'd been run over) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PALPITATIONS (Palpitations), DISCOMFORT (Felt shity), ASTHENIA (weak), POOR QUALITY SLEEP (poor sleep) and CHILLS (severe chills). On 26-Mar-2021, the patient experienced HYPERHIDROSIS (felt like I'd been run over) and PYREXIA (fever). On 29-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (redness around injection site). At the time of the report, PALPITATIONS (Palpitations), DISCOMFORT (Felt shity), ASTHENIA (weak), POOR QUALITY SLEEP (poor sleep), HYPERHIDROSIS (felt like I'd been run over), CHILLS (severe chills), PYREXIA (fever) and INJECTION SITE ERYTHEMA (redness around injection site) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.
On 01/29/2023 I went to the hospital at 01:00PM. I had shortness of breath, low blood oxygen level and high blood pressure. They did CT-Scan, blood work and X-RAY. They gave me with blood thinners and oxygen. At 03:00PM they diagnosed me as having Provoked Pulmonary embolism and they transferred me to another hospital. At the new hospital they did Ultrasound (No DVT's found) heart Echo and gave me more blood thinners. They also gave me oxygen. I was there for 3 days and released on 01/31/2023. I had to increase my blood pressure medication and taking blood thinners as of now. I am following up with hematologist, pulmonologist and cardiologist.
Pt stated that approximately two weeks after vaccination she went to her physician office for an issue with her eye. Her eye was severely red. At the physician's office, the physician told the patient that there was a small blood clot in her eye. The patient stated she didn't think anything of it at the time, but now that the CDC came out with the statement about the Janssen vaccination, she decided to report to the pharmacy.
Pt. states after going for a run 5/11/21, she began aggressively sneezing and noted some swelling under both eyes with itching of the eyes.  She also reports some frontal sinus pressure and sore throat.  Pt. also reports some intermittent chest all pain. 5/14/21 had persistent facial swelling, and dry patchy rash throughout arms and abdomen. She also had new onset headache and moderate to severe sinus pressure. She also complained of lightheadedness and dizziness. BP was also low at that time 90/60.
2 minutes after injection patient c/o head heaviness, nose tightness.  VS: BP 159/88, HR 101, O2 SAT 99%, RR 24
MISCARRIAGE; VACCINE EXPOSURE DURING PREGNANCY; VACCINE EXPOSURE BEFORE PREGNANCY; This spontaneous pregnancy report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient never had miscarriage in life and had four healthy pregnancies carried to term. The patient was not pregnant at report time. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient received vaccine in APR-2021 and in early MAY-2021, the patient became pregnant (vaccine exposure before pregnancy and vaccine exposure during pregnancy). The date of patient's last menstrual period and expected delivery date was not reported. In mid JUN-2021, the patient suffered a miscarriage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccine exposure before pregnancy, and vaccine exposure during pregnancy on JUN-2021, and the outcome of miscarriage was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210647257-covid-19 vaccine ad26.cov2.s-Miscarriage, 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). 20210647257-covid-19 vaccine ad26.cov2.s-Vaccine exposure before pregnancy, Vaccine exposure during pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Chest pain, fever, headache  Went to the ER, got an EKG, chest X-ray, blood and urine samples. Told to follow up with primary care. Primary care prescribed anti inflammatory medications as inflammatory markers were found to be elevated
Flu-like symptoms. Running nose, congestion; headache, noticeable fatigue.
lower back & leg pains;also wrist both arms, rt shoulder where vaccine given;also exp some impotence;very hard to get started walking p/getting hard to put on T shirt over shoulder;
developing weakness on my back; developing mucous in the back; severe breathing, like shortness of breath; pains underneath my chest or the heart; pain on my back; This is a spontaneous report received from a contactable consumer (Patient). This 71-year-old patient reported for own-self.  A 71-year-old patient with unspecified gender received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via intramuscular, administered on Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history includes Large intestine benign neoplasm, Visual impairment and vision problems after an accident from an unspecified date to unknown date and concomitant medications were not reported. In Mar2021, after the vaccination, the patient experienced pain underneath his chest or the heart. Patient had pain on his back and had severe breathing, like shortness of breath and developing weakness over back. Patient is also experiencing mucous development over the back but patient cough it out and blow out from his nose. right now, patient is feeling like there is mucous coming into his back. Also, weakness over the back. Its almost 3 weeks now and patient scared to take the second dose. The events assessed as non-serious. The patient lab data includes blood test with unknown results on an unspecified date. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (17May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Began to run a fever and developed significant nasal congestion same day of vaccination (Tues) which continued for 4 days. Took patient to Urgent Care on Saturday evening upon advise given by after hours nurse at our pediatrician's office. They checked ears for infection and also gave chest x-ray to check for pneumonia. All was clear and sent home. Monday (2/1/10) she was still running fever (ranged from 100 to 101.9 during that time) and took her back to pediatrician office. They discovered an ear infection at this time and began Amoxicillin antibiotics to treat. The day after finishing antibiotics (2/12) she ran a fever again. Took to out-of-town doctor's office while traveling and she seemed fine, ears clear. Still running occasional fever.
arm was red; arm experienced pain; Frozen Shoulder; This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced erythema of extremities, pain in arm and frozen shoulder. The patient was treated with non-drug therapy (Physical Therapy). On an unknown date, the outcome of the erythema of extremities, pain in arm and frozen shoulder were unknown.   It was unknown if the reporter considered the erythema of extremities, pain in arm and frozen shoulder to be related to Shingrix.  Additional details were provided as follows: The nurse self reported for herself. The age at vaccination was not reported. The patient received 1st dose of Shingrix last year at her pharmacy in her right deltoid and was due for her 2nd dose at her doctor's office. The patient reported that when she received the 1st dose, her arm was red and experienced pain that might have contributed to her developing a frozen shoulder (date unknown), patient was receiving physical therapy for this. The patient wanted to know if she could receive the 2nd dose in her thigh. The patient was given medical disclaimer and referred to health care professional. Patient wanted further information on alternative site of administration of Shingrix. The patient was transferred to Medical Information. The reporter consented to follow up. The patient declined to provide HCP details.
Chest Pain developed one hour after administration.   Labs and Imaging completed in the ED.  Admitted to observation for pancreatitis.
Sore; Red; 2.5 inches round circle; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Sore), ERYTHEMA (Red), SKIN DISORDER (2.5 inches round circle) and SWELLING (Swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PAIN (Sore), ERYTHEMA (Red), SKIN DISORDER (2.5 inches round circle) and SWELLING (Swollen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Sore), ERYTHEMA (Red), SKIN DISORDER (2.5 inches round circle) and SWELLING (Swollen) outcome was unknown.            Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not Applicable.
EXTREME STIFFNESS PAIN IN RIGHT HIP, LOWER BACK, PAIN SHOOTING DOWN LEG.   RECEIVED 2 PAIN INJECTIONS, MUSCLE RELAXATION PILLS, AND PAIN MEDS. DAY AFTER INJECTION, AND ALSO AGAIN 2 WEEKS LATER
4-5 hours after vaccination I got dizzy, nauseous, vomited multiple time, shaking, hot then cold, fatigued, terrible headache. adverse  reactions lasted at least 24 hours after onset and slowly went away over next 24 hours. Approximately 48 hours of misery
Bell?s palsy: numb right half of face and tongue. Started as a numb tongue with no taste and next day turned into my whole jaw and cheek being numb. Now my eye won?t close, right facial paralysis. There?s also pain behind my ear along with sensitivity to loud noises.
Given DTAP/IPV at 5 year well child visit on 09/18/2003.  09/19/2003 mom called, noted 4 inch red area hot to touch on upper right arm.
This spontaneous report as received via social media who reported multiple patients (unknown age and gender) who on an unspecified date were vaccinated with a dose of GARDASIL (dose and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. The reporter stated that on an unspecified date, the patients died from the vaccine. No treatment information was reported. At the time of the report, the patients outcome for the adverse event was fatal. The relatedness for the adverse event was related for GARDASIL. This is one of the several reports from the same source. Additional information is not expected.
Very sore upper shoulder muscles/neck 2 days after, I was unable to sleep without pain.
Admitted to Memorial Hospital on 8/19/2021 with cough, SOB, weakness, hypoxia. Admitted to Hospital and Clinics on 8/27/2021 with dx: COVID-19 Pneumonia-ARDS with severe hypoxemic/hypercarbic respiratory failure. She died on 9/4/2021 of ACUTE HYPOXIC RESPIRATORY FAILURE 16 DAYS BACTERIAL PNEUMONIA SUPERINFECTION 16 DAYS COVID PNEUMONIA Submitter does not have access to full hospitalization records. If further follow up information on hospital course or treatment is needed, please contact:  HOSPITAL AND CLINICS  MEMORIAL HOSPITAL
IZ received on 07/27. Pt went on vacation and returned to clinic on 08/07. Her arm was swollen, looked infected, consequently she was referred to physician. Spoke with mother and pt over the phone. She received antibiotics and was doing well.
Patient had vaccine on 09 May 2007. She developed extreme chills, constant headache the night following the injection. She also had nausea and body aches. She stated her HA as 8/10.
Fever, headache, nausea, swelling and soreness at site, weakness, extreme fatigue,  exhaustion confusion, muscle aches, chest aches and pain, chills, difficulty breathing, back and neck stiffness and pain, difficulty recovering.
Expired vaccine used; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021 at 4:57 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow-up received on 10-NOV-2021 contains no new Significant information.
Entered observation @ 1935.  Mother stated to this nurse @ 1950, that daughter felt "light-headed".  Water was given.  @ 1954, patient started to gag.  Went to restroom.  @ 1958, she was walked with this nurse and others to "bed" that's located in vaccination clinic.  Mother explained to this nurse and others that her daughter shows s/s of these symptoms upon each vaccination.  Lightheadedness and nausea lasted for about 10-15 minutes.  Cold compress was applied to help relieve s/s from vaccine.  States she felt better around 2005.  Left observation @ 2005, showed no s/s of distress.
On 1/6/2021 I got a rash that started on the vaccine site & it was itchy, inflamed, & red. As the days passed the rash spread all over my body it continued to be itchy, inflamed & red but the itchiness was the worst. I seen my doctor on unspecified date and he prescribed me medication & gave me a steroid shot & steroid pills. This lasted for about 2 months.  I still have like a scar because of the rash on the vaccine site but it doesn't bother me.
Arm is sore. swallon a little, and is red just below where the shot was given
No additional AE; Inbound call from HCP stating a dose of PROQUAD was inadvertently administered to a patient over 13 years of age. No additional AE details or PQC.; This spontaneous report was received from a pharmacist referring to a 13-year-old patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 28-FEB-2022, reported as about a month ago, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, lot # U030591, expiration date 29-MAR-2023 (route of administration not reported) for prophylaxis (product administered to patient of inappropriate age). The vaccine was reconstitued with sterile diluent, lot number T0143000, expiration date 12-MAR-2022. No adverse event was reported.  Lot number T0143000 is an invalid lot number for sterile diluent. Lot number T0143000 does not match any Company product as confirmed by Lot Verification team.
Local reaction redness around injection site approx 4 cm x 3 cm. Still red and sore on exam 8-15-05.
Pt's injection was given into the bony prominence at acromion process . Pt reported immediate entire arm went numb immediately with immediate pain. She went back home to Ohio and was seen on 1/10 given a Medrol dose pack and sling. Instructed to rest and Ice the area. Initially the pain seem to improve after steroids, After finishing steroids and returning to work pain and limited ROM has continued to increase. Reports pain at injection site that becomes sharp and worse with certain movements Her fingertips feel like pens & needles.
1st dose 04Feb2021, 2nd dose 04Feb2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number E344C, expiry date 1st April 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th February 2021, (batch number G537F, expiry date 14th march 2022)).   On 4th February 2022, the patient received the 2nd dose of Shingrix. On 4th February 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. Pharmacist stated that the dosing delay was not due to supply issue.  The reporter consented to follow-up.
I have the Nexplanon birth control implant in my left upper inner arm.  I rarely get my monthly period and since I received the vaccine I have had vaginal bleeding for the past 17 days.  My entire left arm is still very painful and very weak.
Immediately after receiving HPV vaccine pt stated tongue felt funny & got clammy. He was always able to talk & drink water pulse 62 BP 110/70 again P - 64 BP 110/80. Patient observed for 15 minutes, symptoms subsided & pt left clinic.
flu like symptoms.; feel real ache; a fever of 105°F/super high fever; real bad chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms.), PAIN (feel real ache), PYREXIA (a fever of 105°F/super high fever) and CHILLS (real bad chills) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045j21a, 027a21a and 021b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms.), PAIN (feel real ache), PYREXIA (a fever of 105°F/super high fever) and CHILLS (real bad chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms.), PAIN (feel real ache), PYREXIA (a fever of 105°F/super high fever) and CHILLS (real bad chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Dec-2021, Body temperature: 105 (High) fever of 105°F.         No concomitant medication were provided. No treatment information were given.
Significant worsening of ME/Chronic Fatigue Syndrome. More exertional malaise, fatigue, brain fog, poor attention and concentration. Was already unable to work but now unable to go up stairs or walk down the block or stand in line without significant worsening of fatigue . Have needed to get handicap sticker for car;  Clear decline over where I was in December of 2020.
administered the YF-VAX intramuscularly instead of subcutaneously with no reported adverse event; Initial information received on 26-May-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 42 years old male patient who  reported administered the yf-vax intramuscularly instead of subcutaneously with no reported adverse event while receiving vaccine yellow fever vaccine [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Typhoid Vaccine (Typhoid) for Immunisation.  On 26-May-2022, the patient received a 0.5 ml dose of suspect yellow fever vaccine - US lot uj563aa, expiry date: 23-May-2023, unknown strength and formulation, frequency: once, via intramuscular route in the left deltoid for prophylactic vaccination.  On 26-MAY-2022 the patient developed a non-serious event administered the yf-vax intramuscularly instead of subcutaneously with no reported adverse event (incorrect route of product administration) (latency: same day) following the administration of yellow fever vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (incorrect route of product administration).  At time of reporting, the outcome was Unknown for the event incorrect route of product administration.      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 the regulatory agency. 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.