chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt states she stepped on a sewing needle & injured her R foot on 6/8/01 and she called the 24 hr nsg at Hosp and she was told to get a Td shot within 72 hrs, to use betadine to clean the wound and apply Neosporin oint which she did. The nsg called her back on Sun 6/11/01 to check on he & remind her to get a Td vaccine. States she came to HD on Mon 6/11/01 for the Td. Pt states her R arm awakened her at 2pm Tues 6/12/01 & it was very painful, swollen, hard, and had deep pain.  She took a general brand of ibuprofen 2 tablets and applied warm compresses to her R arm. Her oral temp was taken and it was 101.0F. She repeated the ibuprofen tablets every 4-6 hrs, and laid down. Her fever broke but her R arm was still painful. She did not to to work due to the fever. She went to work on 6/13/01 and her R arm was still painful and later on Wed her R underarm and her R breast were very painful, she then called her PP's office and was advised by the staff to have a mammogram done. She applied hot soaks to both breast at home on Wed she worked part of the day on Wed and Thur. On 6/14/01 pt called the Hlth dept and spoke to a female and was told to switch out with the warm compresses and apply cold compresses. The mammogram and ultrasound results showed inflammation of the lymph nodes and R breast and he films were given to her to take to her Physician. On 6/20/01 she was seen and examined and determined that her lymph nodes were infected and believed it was a result of the tetanus shot, and advised her to see her PP. She was diagnosed with Lymphadenopathy R axilla and prescribed Keflex for infection. Dr advised her to still follow up with adverse reaction to the tetanus shot.
Headache, severe dizziness, pain in shoulder, arm and neck on that side of my body, sensitive skin to the touch, over all not feeling well, eyes are sensitive to light and pain between my eyes and tirdness. I will not ever get another one!
injection site pain; facial swelling; fever; joint pain; chills; aches; feeling unwell; This is a spontaneous report from a contactable physician who reported for himself. A 65-year-old male patient received the first single dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine) at left arm at 05:00 PM 02Jan2021 for Covid-19 immunization in his workplace clinic. The patient had a medical history of controlled hypertension. The patient had no known allergies to medications, food, or other products. Concomitant medications included telmisartan for blood pressure. The patient had not received other vaccines within four weeks. Commencing exactly 24 hours after vaccine received, on 03Jan2021, the patient developed facial swelling, fever chills aches joint pain feeling unwell, injection site pain lasting for 18 hours. The patient had not received treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. All the events resolved. The patient considered that the events were non-serious. Information on batch/lot number was requested.
-Shaking, trouble breathing, weak pulse, Low respiratory rate, pale skin, dizziness, syncope -Epipen & call 911
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.  Expired moderna vaccine that were given as booster shot to patient around 490 to 500 people on the date last 20 Oct 2021 and 29 Nov 2021
Severe body aches; muscle pain and fatigue in legs; muscle pain and fatigue in legs; nausea; lack of appetite; This is a spontaneous report from a contactable Other Health Professional (patient). A 34-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, COVID 19 Pfizer vaccine, Lot number: EL1284) on 28Jan2021 at 01:45 PM, via Intramuscular route on left arm as 2ND DOSE, SINGLE (Age at vaccination 34 Years) for covid-19 immunization. The patient did not had allergies to medications, food, or other products. Other medical history includes type 1 diabetes, hypothyroid, UTI (Urinary track infection). The historical vaccine included BNT162B2 (COVID 19 pfizer vaccine) via Intramuscular route on Left arm on 07Jan2021 at 01:15 PM as 1 ST DOSE, SINGLE for covid-19 immunization (age at vaccination was 34 years). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The other medications the patient received within 2 weeks of vaccination include novolog, synthroid, vyvanse, nitrofurantoin mono. The patient had severe body aches, muscle pain and fatigue in legs, nausea, lack of appetite on 29Jan2021 at 03:30 AM. No treatment was received for the adverse event. Outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
mom states pt had sl redness @ inj site (rt arm) states rash devel Thursday afternoon & states area warmer than rest of body;mom took pt to clinic;MD examined area & determined it was a local rxn to DTAP-area was red & indurated , soreness;
Information has been received from the registered nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who on 29-JAN-2013 was administered dose of GARDASIL (lot # 668261/1397AA expiration date 09-APR-2013) that was exposed to temperature of 11 Celsius degree. No adverse effects were reported. This is one of the several reports from the same source. Additional information is not expected.
p/ pt recv vax approx 17 days later devel varicella-like lesions over parts of body. following day pt presented at MD ofc w/27 lesions, by 6/27 pt had greater than 50 lesions; Follow-up information from a physician's office indicated that the patient was diagnosed with chickenpox. There was no fever present. Follow-up information received July 6, 2000 from a physician indicated that on May 28, 1998 the patient had negative IgG and IgM varicella antibodies. On an unspecified date, the patient recovered. No further information expected.
Itchiness in right arm at injection site; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Itchiness in right arm at injection site) and FATIGUE in a 56-year-old female patient 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 VACCINATION SITE PAIN (Itchiness in right arm at injection site) and FATIGUE. At the time of the report, VACCINATION SITE PAIN (Itchiness in right arm at injection site) and FATIGUE outcome was unknown. Not Provided.       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.   Concomitant medication were not reported, Treatment medication were not reported   This case was linked to MOD-2021-098206.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: significant F/U received On 12-Aug-2021: Follow up received contains, no new information. On 12-Aug-2021: Non-significant Information. Patient is enquiring about Modern boosters.
patient is immunocompromised and received booster dose of vaccine; Inappropriate schedule of vaccine administered; Sweating in bed for 24 hours; Terrible terrible pain; Could not eat; Headache; Nausea so she could not eat; Joint pain; Muscle pain; woke up very tired but still went to work, big mistake; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating in bed for 24 hours), PAIN (Terrible terrible pain), FEEDING DISORDER (Could not eat), HEADACHE (Headache) and NAUSEA (Nausea so she could not eat) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient felt worse when had COVID.) in October 2021. Previously administered products included for Product used for unknown indication: Johnson and Johnson (Lot Number (206A21A) and Arm of injection: Right) on 11-May-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson. Concurrent medical conditions included Thyroid disorder, Cancer and Depression. Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for Antidepressant therapy, CANDESARTAN for Blood pressure, TAMOXIFEN for Cancer, LEVOTHYROXINE for Thyroid disorder, VITAMIN D3 and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 20-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced HYPERHIDROSIS (Sweating in bed for 24 hours), PAIN (Terrible terrible pain), FEEDING DISORDER (Could not eat), HEADACHE (Headache), NAUSEA (Nausea so she could not eat), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and FATIGUE (woke up very tired but still went to work, big mistake). On 20-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (patient is immunocompromised and received booster dose of vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. On 20-Jan-2022, ACCIDENTAL UNDERDOSE (patient is immunocompromised and received booster dose of vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, HYPERHIDROSIS (Sweating in bed for 24 hours), PAIN (Terrible terrible pain), FEEDING DISORDER (Could not eat), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and FATIGUE (woke up very tired but still went to work, big mistake) had resolved and HEADACHE (Headache) and NAUSEA (Nausea so she could not eat) had not resolved.            Patient got the antibodies which is why Patient waited 90 more days before getting booster.
Fever going above 100 degree Fahrenheit; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (Husband). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EW0176; Expiration Date: Aug2021), via an unspecified route of administration on 18Jun2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated, yesterday on 18Jun2021, my husband and I both got the Covid vaccine, Pfizer one and he is currently having fever on 19Jun2021, and like two hours before he has taken Tylenol 400 mg but now, he is having a fever of 101.6. So, I am a little bit concerned as, is this the thing that is expected or something serious happening. Reporter stated, he is only suffering, and we both got yesterday evening. Reporter further stated, "I had some symptoms but not that like fever going above 100-degree Fahrenheit, but he is having fever about 101. So, I am little bit concerned about that. So, I just want to ask is this something that is expected or something serious happening so that I can consult a doctor and other thing. The patient underwent lab tests and procedures which included body temperature with 101.6 Fahrenheit on 19Jun2021. The patient received treatment as a result of event. The outcome of the event was reported as unknown   Follow-up attempts are completed. No further information is expected.
Vaccine was initially placed in refrigerator on 11-Jan-2022 and administered on 04-May-2022; Expired vaccine was administered to the patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered to the patient) and PRODUCT STORAGE ERROR (Vaccine was initially placed in refrigerator on 11-Jan-2022 and administered on 04-May-2022) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 038B21A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered to the patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially placed in refrigerator on 11-Jan-2022 and administered on 04-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered to the patient) and PRODUCT STORAGE ERROR (Vaccine was initially placed in refrigerator on 11-Jan-2022 and administered on 04-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  A pharmacist, the vaccine coordinator in their health care facility reported that they inadvertently administered expired dose of the Moderna COVID-19 vaccine. Date the vial was initially stored in the refrigerator was on 11-Jan-2022, which meant that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the EUA. The vial did not undergo any temperature excursions. They identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. Patient received 2nd booster dose on 04-May-2022 and not reported adverse reaction to the HCP's knowledge.  No treatment medications were provided by the reporter.
I woke up that morning with a scratchy throat and a cough. I had a headache. I was pretty much just leave me alone.
Received the 1st dose of Pfizer Covid vaccine on 6/15/21. Patient had a headache, pain in left arm and felt tired. On 6/16/21 she woke up around 10:00am and said her legs felt numb or asleep from the ankle to mid thigh.  I contacted the pediatrician office and they advised us to wait and see if she had any other additional symptoms or changes. Patient said she could feel the sensation of pressure but could not feel what was touching her. She went to her usual swim team practice and seemed to be just fine except for the strange loss of sensation in her leg.s. On 6/17/21 her symptoms were unchanged upon waking up. She attended running club practice from 9-10:30am, and when I picked her up she said that now her left arm was experiencing the same loss of feeling from shoulder to her wrist. I took her to the pediatrician office, where they advised me to take her to the emergency room for further evaluation. She was  seen by two different doctors in the ER at Hospital, and no other tests were done at the time. The doctors advised us to keep monitoring her symptoms of loss of sensation and return if any other symptoms occurred. Since that time Patient has had some improvement in feeling but overall it has stayed the same. Doctors could not find any other possible causes for the symptoms either. They did recommend getting the 2nd dose but warned that the loss of sensation could get worse.
dizziness/lightheaded within 20 min. post injection extreme fatigue-- 6hrs post injection low grade fever/extremely hot all over, joint pain/headache -- 10-36hrs post injection dizziness/lightheadedness retuned -- 48hrs post injection
Vaccine exposure during pregnancy; + Chlamydia - TOC negative; This is an observational study case, initially received from other health professional on 30-Oct-2019, concerning a 20-year-old, female pregnant subject of body weight: 133 lbs, height: 64 inches and body mass index (BMI): 22.8, enrolled in a prospective observational safety study.  The subject had no relevant medical history and concomitant medications. The subject had no obstetrical history. The subject had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   The subject's last menstrual period (LMP) date was 12-Jan-2019. The type of pregnancy was singleton. The subject's estimated date of delivery (EDD) was reported as 19-Oct-2019 and corrected estimated date of delivery (CEDD) was not reported.   On 12-Jul-2019, 28-Aug-2019 and 18-Sep-2019, the subject underwent ultrasound scan and no MCM was noted.  On 08-Oct-2019, approximately at 38 weeks of gestation, the subject was administered Flu Vaccine Egg Split QIV CSL (Afluria QIV) [influenza vaccine, batch number: P100112488, dose, route of administration, anatomical location and expiration date: not reported] for an influenza immunization (explicitly coded as ''Vaccine exposure during pregnancy'').  On an unknown date in 2019, the subject experienced chlamydia.   On an unknown date in 2019, the subject underwent test-of-cure (TOC) and it was negative. The outcome of event was resolved.    The reporter did not provide seriousness and causality assessment to Afluria QIV.  Company comment: Chlamydial infection was associated with the suspect product Afluria QIV. Reportedly, vaccination occurred during pregnancy. Chronology cannot be determined because of unknown temporal relationship to the suspect product administration, making casualty for chlamydial infection unassessable. Vaccine exposure during pregnancy is assessed as not related per company's conventions.; Sender's Comments: Chlamydial infection was associated with the suspect product Afluria QIV. Reportedly, vaccination occurred during pregnancy. Chronology cannot be determined because of unknown temporal relationship to the suspect product administration, making casualty for chlamydial infection unassessable. Vaccine exposure during pregnancy is assessed as not related per company's conventions.
I had the shot but got it anyway/suspected vaccination failure; I had the shot but got it anyway; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 1-AUG-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient had the Shingles shot but got shingles anyway. Additional Supportive Information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation for shingles were unknown. The follow up would not be possible as contact details were not provided.
This spontaneous report as received from a registered nurse refers to an unspecified number patients of unknown age and gender. On an unknown date of 2014 (reproted as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from a physician concerning a patient (age range reported as 13-18, units not reported) of unknown gender. On 10-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016); dose number, dose and route were not reported). This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Difficulty swallowing; Tender and swollen lymph nodes; Tender and swollen lymph nodes; This is a spontaneous case, initially received from a pharmacist via Agency (reference number: SEQW20-01032) on 29-Aug-2020, concerning a 74-year-old, female patient.  The patient had no relevant medical history.  The patient's concomitant medications included ibuprofen and clindamycin, both used for unreported indications.  On 28-Aug-2020, the patient was administered with Fluad Quadrivalent [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 279784 and expiration date: 13-May-2021] for an influenza prophylaxis.  On 29-Aug-2020, one day after vaccination, the patient experienced tender and swollen lymph nodes, and difficulty swallowing. No corrective treatment was applied for the events.  At the time of this report, the patient did not recover from the events.  The reporter assessed the case as non-serious.  The reporter did not provide causality assessment.  Company comment: The patient developed dysphagia, lymph node pain and lymphadenopathy one day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is plausible. No information about medical history was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).; Sender's Comments: The patient developed dysphagia, lymph node pain and lymphadenopathy one day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is plausible. No information about medical history was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Diffuse urticaria within 24 hrs of receiving 3rd dose. Started on arm that received shot - but not exact site.
Erythema was self limited, 3 in long and circumferential, 3 days of erythema following FLUARIX Quadrivalent site where given.
Had a severe local reaction to left thigh.  She was seen on 09/07/06.  Left upper thigh red and indurated with increased warmth to area about 9x8 in.  It covered entire anterior thigh and spread to post. thigh.  No vesicles noted.