chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-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.   It was reported that on 15-Oct-2021, the patient received vaccine with expiration date 09-Oct-2021.  No concomitant medications was reported. No treatment drug details was reported.
Joint pain, nerve pain/neurosis, right eye scleritis; pain and numbness down left arm, then pain to her left leg on 10/7/2021.  Reports  10/8/2021 right foot pain lasting 12 hours.  Intermittent shooting pain to head and body, and intermittent loss of balance and proprioception issues, "not thinking too clearly."
Pt noted rash on trunk, spread arms, face, neck.  Went to ER at 11PM .  Seen Jan 25 by ER MD & Dermatology.  Positive erythemic macular papular rash noted on face, neck, trunk, arms.  Given Atarax 25 mg.  Referred to infectious disease & dermatology - Patient states that he received the smallpox vaccination 10 days ago as part of pre-deployment medical readiness.  He then began to develop a rash approximately 7 days after receiving the vaccine.  The rash is slightly pruritic, non-painful and involves his upper arms and thighs as well as his trunk, upper back and chest more than the abdomen and also his face along the jaw without any involvement of the eye.  He has never had this before and states that neither he nor anyone in his family have eczema or any form of dermatitis, problem list reviewed with patient, medication list reviewed with patient, and family history reviewed with patient.  NO history of skin disease and no chronic disease stated such as diabetes or HTN.  General overall feeling.  Feeling fine.
Headache for 2 days after shot 3-4 dime sized purple bruises on both arms and legs - total of 15.  Occurred 7 days after shot Psoriasis like patches on left shoulder and left arm at same time. 4/22 woke at 1am violently shivering, no fever Lymph nodes under jaw and both armpits were enlarged for a few weeks after the shot.
Hypoxic; Tested positive for COVID; A spontaneous report was received from a physician concerning a 79-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypoxic and tested positive for COVID-19.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 12 Jan 2021, approximately 1 day prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient started showing symptoms of COVID and she tested positive for the virus that same day. She received Regeneron antibody infusion. On 16 Jan 2021 (day 4), the patient became hypoxic and was admitted to the hospital for 2 days. The patient was discharged not needing oxygen.  She was greatly improved on Day 7. Treatment provided included Regeneron antibody infusion.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events hypoxia and COVID-19 was unknown.; Reporter's Comments: The patient had COVID symptoms one day after mRNA-1273 vaccine administration. The events were consistent with increased risk of respiratory complications associated with viral infection in pandemic set up. Based on test results the events are assessed as unlikely related to mRNA-1273.
Rash at injection site approx 3 inches in diameter.  Mild itch. Appeared 8 days after vaccine.
Noticed redness and swelling on left forearm close to where TB test (Aplisol; lot# 41720, exp. 02/09) was placed soon after with redness around the induration read 2 days later, increasing in size with warmth to touch by 7 days. Notice additional areas of redness and itching in abdominal area by day 8.  Itching but no myalgia, fever or pain. In the interim, she received Td (Decavac; lot# U2077AA, exp. 04May09) 2 days after having the PPD placed and when the PPD was read at 12mm.  She did not feel any aches or pain to vaccination site (left deltoid).
Started with diarrhea then chills, body aches, joint pain, severe headache, fever of 102 and a cough. Started taking Ibuprofen but only reduced the fever of 101. Physician called at 11:30am to check and then called at 5:00pm. At that time, the physician recommended an ER visit. Vitals were taken in ER that had increased B/P, increased heart rate and elevated fever. Was given Compazine, Benadryl and Toradol. Also was given 2 liters of fluid. ER visit was approx. 3 hrs
Information has been received from a Licensed practitioner nurse concerning to an adult patient (gender not reported) who was also a physician. The patient's medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with a pediatric dose of VAQTA (route, lot number and expiration date not reported) for prophylaxis. No adverse event was reported.
Patient reports that she noticed a rash to her chest and neck this afternoon, along with a sore throat.
cherry color pin point papule v.s. every 4 hr x 24 hr O2 sats
patient and parent misrepresented patients age 2 times. once upon registration and again when verbally asked if of appropriate age
Lymphangitis and purulent major reaction to vaccinia vaccination (day 7) with surrounding cellulitis and tender left axillary lymphadenopathy.
12:55 PM patient stated she felt a seizure coming on and laid down on the chair in the office. This RN took the patient into Room 4 to lay down; vitals taken 13:04 HR 95, O2 96%, B/P 85/51, Temp 98.6 Temporal. Vitals taken at 13:14 HR 107, O2 98%, B/P 91/62, Temp 99.8 Temporal. Patient stated she was cold, a warming blanket was placed on the patient, patient was offered crackers and water numerous times, patient refused. Guardian stated patient only eats about 6 items due to her autism. Patient has been verbal appropriate and communicates with staff and guardian. At approx. 13:20 patient had instance of left hand "twitching", guardian stated that happens at times when patient is having partial seizure activity. Patient vitals taken at 13:35 HR 65, O2 95%, B/P 114/96, temp 99.8 temporal. Patient was given a piece of chocolate after patient finished chocolate guardian stated she was behaving more like normal. Patient and guardian were given vaccine records and walked to the exit, with no issues notice.
Right arm swelling, redness, pain at injection site. Treated with cold compress, benadryl, and ibuprophen.
This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date the patient was vaccinated with PROQUAD for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not PROQUAD. {Additional information has been requested. / Additional information is not expected.}; Sender's Comments: US-009507513-1707USA000694:
54 yo patient received a pediatric 10 mcg dose; 54 yo patient received a pediatric 10 mcg dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 54-year-old male patient who received HBV (Engerix B pediatric) (batch number F22EZ, expiry date 3rd June 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th September 2022, the patient received Engerix B pediatric 10 ug and Engerix B Pre-Filled Syringe Device. On 8th September 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-SEP-2022 Reporter's comment: The reporter reported that, a patient received a pediatric 10 mcg dose of Engerix-B prefilled syringe.  The reporter consented to follow up. Additional Supportive Information: The reporter reported that, a patient received a pediatric 10 mcg dose of Engerix-B prefilled syringe, which led to underdose and adult use of a child product.
past dosing schedule window; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (past dosing schedule window) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-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 PRODUCT DOSE OMISSION ISSUE (past dosing schedule window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (past dosing schedule window) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient came to receive the second dose on 26May2021 outside of the normal scheduled window.  Concomitant medications were not provided.  Treatment information was not provided.
This spontaneous report as received from a healthcare worker (medical assistant) refers to a 12 month old patient of unknown gender. The healthcare worker confirmed that ZOSTAVAX was mistakenly shipped to this office instead of (Merck) VARIVAX. The patient was then inadvertently vaccinated with the ZOSTAVAX (dose, route not reported, lot # K007986, expiration date 03-SEP-2015) instead of (Merck) VARIVAX, "within this past week", in approximately in September 2014. Concomitant medications were not provided. No adverse effects were reported. This is one of eight reports received from the same reporter. Additional information has been requested.
Tongue tingling; Loss of taste; Loss of smell; Mild night sweats; Shoulder/clavicle tightness; Buzzing feeling in her head; Abdominal feels up with air and releases out; Pain at the injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tongue tingling), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), NIGHT SWEATS (Mild night sweats) and MUSCULOSKELETAL STIFFNESS (Shoulder/clavicle tightness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy, Drug allergy (chlorahexidine) and Hypersensitivity reaction. Concomitant products included COLECALCIFEROL (VIT D3) and ZINC for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced PARAESTHESIA ORAL (Tongue tingling), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), NIGHT SWEATS (Mild night sweats), MUSCULOSKELETAL STIFFNESS (Shoulder/clavicle tightness), TINNITUS (Buzzing feeling in her head), FLATULENCE (Abdominal feels up with air and releases out), VACCINATION SITE PAIN (Pain at the injection site) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 01-Apr-2021, PARAESTHESIA ORAL (Tongue tingling), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), NIGHT SWEATS (Mild night sweats), MUSCULOSKELETAL STIFFNESS (Shoulder/clavicle tightness), TINNITUS (Buzzing feeling in her head), FLATULENCE (Abdominal feels up with air and releases out), VACCINATION SITE PAIN (Pain at the injection site) and HEADACHE (Headache) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up received contains additional vaccine information of second dose, action taken updated, patient demographics, concomitant medication, medical history and event outcome updated
Chills; 102.3 temperature; vomiting; headache; talking in sleep due to fever; pain on the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 8 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 14:15 (Lot number: FK5618) at the age of 8 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: QVAR. The following information was reported: CHILLS (non-serious) with onset 02Dec2021 16:30, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset 02Dec2021 16:30, outcome "recovering", described as "102.3 temperature"; VOMITING (non-serious) with onset 02Dec2021 16:30, outcome "recovering", described as "vomiting"; HEADACHE (non-serious) with onset 02Dec2021 16:30, outcome "recovering", described as "headache"; SLEEP TALKING (non-serious) with onset 02Dec2021 16:30, outcome "recovering", described as "talking in sleep due to fever"; VACCINATION SITE PAIN (non-serious) with onset 02Dec2021 16:30, outcome "recovering", described as "pain on the injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, pyrexia, vomiting, headache, sleep talking, vaccination site pain.  Follow-Up (07Dec2021): Follow-up attempts are completed. No further information is expected.
66 year old female noted a rash on her left arm 2 weeks after receipt of her second dose of encephalitis vaccine.  She described the rash as starting as redness "like a sunburn" and then developing into red bumps that appear suddenly, are pruritic and resolve within hours.  The rash appeared on and off 6 weeks prior to reporting primarily on her arms, chest and legs.  Symptoms resolved by time of report.
Patient reports getting the COVID-19 Moderna Vaccine today at 215 patient reports driving home with no symptoms. Patient began working on her computer and felt a heat flash, she checked her smart watch and her heart rate was in the 170s. Patient got up to get a drink of water and called her daughter, patient reports her heart rate dropped to the 70s while she was on the phone but went back up to 130s quickly after.    Patient reports no chest pain or SOB
None stated. This patient was not seen on this date.  The adverse event was reported in error.  The entry was deleted from the VFC reporting site.  Please make note: Patient not seen, no vacc. given.  No adverse reaction. 7/21/10 Recipient received all doses of post exposure rabies vaccine.
Confusion and repeating "myself"; jumbled images in "my" head; Sore arm; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 05Mar2021 at 17:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. The patient did not receive any medication within two weeks of vaccination. 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. Concomitant medications were not reported. On 07Mar2021 at 00:00, the patient experienced sore arm and fatigue. On 08Mar2021, the patient experienced confusion, repeating himself and jumbled images in the head. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm, fatigue, confusion, repeating himself and jumbled images in the head was resolved with sequelae.    No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
About 4 or 5 hours after getting the Moderna vaccine, while at home, I suddenly became very lightheaded.  The room started spinning (vertigo).  I also felt like I was going to pass out.  I took a few steps towards my bed and almost fell.  I sat down on my bed, called to my husband and he sat with me.  The vertigo/lightheadedness lasted an hour and was severe.   I did not pass out however.
This spontaneous report as received from medical assistant refers to an unspecified number of patients of unknown age and gender. Pertinent medical history was unknown. The reporter stated that on an unknown date unspecified number of patients were inadvertently vaccinated with ROTATEQ (oral, dose, lot# and anatomical location was unknown) that had been improperly stored. No adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
I administered the patient's second dose of Moderna Covid-19 at approximately 4:10 pm on 5/23/2021. The patient's became flushed, felt hot, dizzy, and nauseous at approximately 4:18 pm on 5/23/2021. I got an ice pack and placed it on her neck. She said the she felt like her sugar was dropping so I got her two DumDum suckers to help raise her sugar level. I offered to test her blood sugar for her but she declined saying that she knew her sugar was low based on how she felt. At approximately 4:30 pm the patient began to complain that her arm felt like it was on fire at the injection site. I placed an ice pack on the injection site for her. By this time her flushing had subsided but she still didn't fell well. At approximately 4:50 pm she stated that she felt better and wanted to go get something to eat. She left the pharmacy are on her own at about that time.
Received 2nd Pfizer Covid vaccine as listed above on 02/15/2021.  Sinus symptoms starting 07/09/2021.  Positive Covid-19  PCR test 07/19/2021.
Developed urticaria between 6/30 and 7/2-not clear that it was within 24 h of imms.
Pt experienced elevated temperature.  Tylenol given after fever noted.  No fever noted again until 10/28/99.  10/28/99 pt experienced a poor appetite and sneezing.
This is a spontaneous report from a contactable nurse. A 36-month-old, female patient received a dose of PREVNAR 13 intramuscularly laterally on the left thigh at 13:40 on 18Oct2011 for immunization. The patient had no relevant medical history. The patient's 13-month-old sister received a fourth dose of PREVNAR 13 in Sep2011 and did not experience any adverse event. Relevant concomitant medication included Poly-Vitamin with Fluoride from 2010 and ongoing. Vaccine given on the same day included FLUMIST intranasally. Relevant past vaccine history included PREVNAR on an unknown date and an unspecified childhood vaccine. On 19Oct2011, the patient developed swelling, hardness and redness on the lateral side of the left thigh, which required an emergency room or doctor visit. The patient was diagnosed with cellulitis in the lateral side of the left thigh. Therapeutic measures taken as a result of the event included treatment with AUGMENTIN in Oct2011. There was no relevant lab data. At the time of the report, the outcome of the event was unknown.
CHILLS; FEVER  (101.2 AND 103.5F); NAUSEA; This spontaneous report received from a consumer concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced fever (101.2 and 103.5f). On 20-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 101.2 F, 103.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever (101.2 and 103.5f), chills, and nausea. This report was non-serious.
respiratory arrest, cardiac arrest Narrative:  Patient died 1 day after receiving 2nd dose of COVID vaccine in his bed at home. Paramedics arrived but were not able to resuscitate.
Baad headache after vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Baad headache after vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Baad headache after vaccine). At the time of the report, HEADACHE (Baad headache after vaccine) outcome was unknown.        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 Medical History Reported. No Concomitant medication Reported
Child found dead in bed at 7AM. Fed well at 3AM. Afebrile all evening after immunization. SIDS was COD as per autopsy report.
No adverse event noted. Patient was given high dose and is 28 years old on an off-site clinic visit. No high dose vaccine was brought. Possibility that this vaccine was placed in the wrong box and then administered to the patient. It would be beneficial to color code the flu vaccines to alert the person administering the vaccine. This could be another check prior to giving a vaccine.
Dizziness, NauseaVomiting, Tachycardia, Pt reported feeling "heaviness" in legs "can't move" and "left eye feels funny, like twitching and my blood pressure feels high" Narrative: Pt reports high anxiety along with stated symptoms.