chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swollen ankle; swollen lip; swollen left eye; lumpy hives; itchy rash; hives; rash on lower extremities; itching; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching), URTICARIA (lumpy hives), URTICARIA (hives), LIP SWELLING (swollen lip) and EYE SWELLING (swollen left eye) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 007M201) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety. Concomitant products included DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ) for Anxiety, PARACETAMOL (TYLENOL) for Neck pain.   On 02-Jan-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021 at 3:10 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jan-2021, the patient experienced PRURITUS (itching) and RASH (rash on lower extremities). On 08-Jan-2021, the patient experienced URTICARIA (hives). On 10-Jan-2021, the patient experienced RASH PRURITIC (itchy rash). On 02-Feb-2021, the patient experienced URTICARIA (lumpy hives). On 09-Feb-2021, the patient experienced LIP SWELLING (swollen lip) and EYE SWELLING (swollen left eye). On 27-Feb-2021, the patient experienced JOINT SWELLING (swollen ankle). At the time of the report, PRURITUS (itching), URTICARIA (lumpy hives), LIP SWELLING (swollen lip), EYE SWELLING (swollen left eye), RASH PRURITIC (itchy rash), JOINT SWELLING (swollen ankle) and RASH (rash on lower extremities) outcome was unknown and URTICARIA (hives) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment drugs included OTC ALLEGRA, XYZAL, ZYRTEC, BENADRYL, IV SOLUMEDROL, IVBENADRYL, IV PEPCID, PREDNISONE, DOXEPIN, SINGULAIR, XOLAIR and MEDROL   This case was linked to MOD-2021-027466 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Significant follow up: event updated, Treatment information updated
pt recv vax 11AM & noted hands & feet were red & swollen;no diff breathing;given DPH in hosp in ER;no recurrence
Has been having trouble with feeling a not in her throat. Is continously spitting white foam and burping. She is unable to lay flat on her back which cause her irritability to sleep. This has been going on for 6 days. Noone can seem to find the cause. My daughter has been a healthy child. She has been referred to a GI doctor and ENT. Symptoms are still present. She has tried motrin, tums, steroids and benadryl. Nothing helps.
Shivering, chills, fever, muscle aches, tiredness redness and swelling and fever at the injection site 5 hours after the injection.
One day following the second injection, reports onset of feelig tired with headache and cough.  This symptom complex lasted five days.  This was accompanied by itching "like I want to come out of my skin."  Took Zyrtec during the day and Benadryl at night.  By day six, itching mostly subsided, and headache subsiding to some extent.
Patient stated that she received a Shingrix immunization on Tuesday October 11, 2022. On Wednesday October 12, 2022, she observed a itchy, bumpy red rash on left side of her body. On Thursday October 13, 2022, the rash was on her right side, and she called the pharmacy late in the day before closing. Since it was not life threatening, she was advised to take Benadryl  every 6 hours and to contact her prescriber first thing in the morning Friday October 14, 2022. She was also advised to seek medical treatment at an emergency room if the symptoms worsened.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 13-JUN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX, lot number M040138 with expiration date 28-SEP-2018, for prophylaxis (dose, frequency, route of administration, and anatomical location were not reported), which was reconstituted with a properly stored STERILE DILUENT (lot number and expiration date were not reported). No adverse events were reported. The vaccine was exposed to a temperature of 26.73 Fahrenheit for 15 hours; data logger was not involved. No previous temperature excursion was reported.
Moderna vaccine was administered outside of Facility - reported by patient  J96.00 ACUTE RESPIRATORY FAILURE 7/13/2021 MONOCLONAL GAMMOPATHY OF UNDETERMINED SIGNIFICANCE R09.02 HYPOXIA 7/13/2021 MONOCLONAL GAMMOPATHY OF UNDETERMINED SIGNIFICANCE
MD contacted prior to administering second vaccine to report patient's statement of previous occurrence after first vaccine. MD instructed nurse okay to administer but to monitor for minimum of 30 minutes. After administration of vaccine, nurse allowed patient to sit in a chair within easy viewing range. Patient began to rub right eye and upon assessing and reports "some blurriness to vision". Nurse then performed a manual BP check and found patient's BP to be 160 systolic. Patient states she "sometimes has high blood pressure" but doesn't check on a regular basis.  After continuing to monitor for over hour bp was 140 systolic. Snellen eye chart used to assess vision and patient found to have 20/20 vision. Patient educated to contact her PCP with any further questions or concerns that were non emergent. On 5/27 nurse contacted patient via phone and patient reported that her bp did increase again later that evening and she contacted her PCP and went to see to address home medications. Patient then reported that her only complaint was "a bit of a sore arm".
only received the diluent and not the lyophilized powder portion (with no reported adverse event); Initial information received on 06-Nov-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2023SA343804, 2023SA343809 and 2023SA343771.  This case involves a 15-months-old female patient who only received the diluent and not the lyophilized powder portion for HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel); hepatitis A vaccine (Hepatitis A); and Influenza Vaccine for Prophylactic vaccination.  On 27-Oct-2023, the patient received a standard dose 4 of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection at a dose of 0.5 ml total (lot: UK007AB, expiry date: 31-Dec-2024) via intramuscular route in the right thigh for Immunization; only received the diluent and not the lyophilized powder portion with no reported adverse event (single component of a two-component product administered) (same day latency).  Reportedly, Pharmacist reported that four patients received a dose of ACTHIB. However, one patient only received the diluent and not the lyophilized powder portion. They noticed there was one extra powder vial left but they are unsure which patient only received the diluent. Should they revaccinate all or should they do serologic testing prior to re-administering? Treatment: The caller was not aware of any adverse reactions, treatment.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
2 hours after the shot I started having heart palpitations; pins and needles feeling in the back of my heart and down my neck; This is a spontaneous report from a contactable consumer (patient) or other non healthcare professional.   A 55 year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6199, Expiration date: unknown) dose 1 via an unspecified route of administration, administered in Arm Right on 03Mar2021 12:00 (at the age of 55-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Breast Cancer remission from an unknown date and unknown if ongoing Breast Cancer remission. Concomitant medication(s) included tocopherol (VITAMIN E [TOCOPHEROL]) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. The patient previously took morphine and experienced drug hypersensitivity. patient did not had covid prior or post to the vaccination. patient did nor received any other vaccine four weeks prior to vaccination. On 03Mar2021 14:30 2 hours after the first dose she started having heart palpitations, pins and needles feeling in the back of my heart and down the neck. Adverse Event resulted in patient visited emergency room, department or urgent care. The patient received treatment with Benadryl via an IV. The outcome of events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Pt here for well child visit and had just finished 10 day course OMNICEF this am for bilat. ear infections.  Developed generalized hives couple hrs after having office.  Mom called office and advised give BENADRYL.  Hives almost all resolved 3-4 hrs later after re-checked at office.  Had treatment Hep A and OMNICEF on past.
I feel SO spaced out now like I am hypnotized; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I feel SO spaced out now like I am hypnotized) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (I feel SO spaced out now like I am hypnotized). At the time of the report, FEELING ABNORMAL (I feel SO spaced out now like I am hypnotized) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-Significant follow up appended to AER contain NNI
Day 2 - quarter size redness at injection site. Day 4-9 - itching at injection site Day 6--8 -  two inch diameter redness and swelling Day 9 - itching, raised redness slightly, two and a half inches
Pfizer COVID-19 Vaccine EUA Student here for first dose of Pfizer Covid vaccine.  Lot EL3249.  States she waited in waiting area for 30 minutes post vaccine and that 15 minutes into the wait her throat started feeling scratch. She decided to leave without informing anyone of her symptoms and began walking home.  On the walk home her throat began to get sore and she found it hard to swallow. She reported back to clinic with her s/s at ~1350.  She was given Benadryl 25 mg, Pepcid 20 mg and Zyrtec po at 1400.  BP-162/77, P-96, 98%.  At 1420, BP-143/87, P75, 100%.  Patient was instructed to consulted with an allergist before booster dose of Covid vaccine.  At 1435 she reported her throat felt normal again.
Felt "tingling" right away at injection site. That night felt like a cold was coming on - felt achy like she may have had a low grade fever - felt chest "congestion" - no cough - resolved completely in 2 days. (two days)
During dose 2, injection made into acromioclavicular rather than deltoid muscle; Persistent pain; Back pain; Neck pain; Face pain; Shoulder pain; Head pain only on side of injection (left); This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 29Apr2021 at 10:00 (at the age of 23-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 08Apr2021 at 10:00 (at the age of 23-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 10:00, the patient experienced persistent pain which resulted in shoulder pain, back pain, neck pain, face pain and head pain only on side of injection (left). The patient reported, during dose 2, injection made into acromioclavicular rather than deltoid muscle as directed. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events persistent pain, back pain, neck pain, face pain, shoulder pain and head pain only on side of injection (left) was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
pt recv vax 10OCT96 & 11OCT96 12hr p/vax pt exp lt arm swelling;swelling to lt body including lt leg & lt breast;18OCT96 had an asthma attack;19OCT96 face swelled & broke out in rash;lips swelled, couldn't eat x 2d;itching;pain arm;
Pt developed low-grade temperature of 102.3F, rash, facial swelling and itching after vaccines.
Swollen (Injection Site); Itchy (Injection Site); A spontaneous report was received from a consumer concerning a 82-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swollen (injection site), itchy (injection site).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced the event(s) swollen (injection site), itchy (injection site).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), swollen (injection site), itchy (injection site) was unknown.
Hidradenitis suppurativa flare up/hidradenitis suppurativa breaking out in groin area, under breast and underarms; Hidradenitis suppurativa flare up/hidradenitis suppurativa breaking out in groin area, under breast and underarms; Dizziness; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (Hidradenitis suppurativa flare up/hidradenitis suppurativa breaking out in groin area, under breast and underarms), CONDITION AGGRAVATED (Hidradenitis suppurativa flare up/hidradenitis suppurativa breaking out in groin area, under breast and underarms), DIZZINESS (Dizziness) and VACCINATION SITE PAIN (Vaccination site pain) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate Free. On an unknown date, the patient experienced HIDRADENITIS (Hidradenitis suppurativa flare up/hidradenitis suppurativa breaking out in groin area, under breast and underarms), CONDITION AGGRAVATED (Hidradenitis suppurativa flare up/hidradenitis suppurativa breaking out in groin area, under breast and underarms), DIZZINESS (Dizziness) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, HIDRADENITIS (Hidradenitis suppurativa flare up/hidradenitis suppurativa breaking out in groin area, under breast and underarms) had not resolved and CONDITION AGGRAVATED (Hidradenitis suppurativa flare up/hidradenitis suppurativa breaking out in groin area, under breast and underarms), DIZZINESS (Dizziness) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown. Not Provided          No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
pt recvd vax 28APR93 pt had oral temp 99.7 & Abcessed teeth; 29APR93 t102-103 taken to ER & adm x 3 hrs for IV's; 30APR93 seen by MD ordered x-ray & blood test; noc child's t104;
Initial unsolicited report received from a pharmacist on 14-Oct-2017. This case involves a 57-year-old female patient who was vaccinated with a 0.5 ml injection of FLUZONE QIV (batch number: UI866AE, expiry date was unknown), via intramuscular in the left deltoid on 26-Sep-2017. The patient had a medical history of migraines. Concomitant medications included paracetamol (TYLENOL) and ibuprofen (Ibuprophen). On 27-Sep-2017, one day following the vaccination the patient experienced some pain at injection site and later developed L arm stiffness and soreness. Laboratory data was not reported. The patient was recommended to use warm compresses as corrective treatment. The outcome of both the events was unknown. List of documents held by sender: none.
passed out on the floor; heaving all day; really cold; headache; fever; chills; A spontaneous report  was received from a consumer concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced passed out on the floor, really cold, heaving all day, headache, fever and chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot: 007M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 21 Feb 2021, patient experienced sore arm and it recovered on 22 Feb 2021.  On 18 Mar 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch:032M20A) through unknown route of administration in the left deltoid muscle for prophylaxis of COVID-19 infection.  On 18 Mar 2021, the patient experienced really cold, headache, fever and chills. On 19 Mar 2021, the patient experienced passed out on the floor and heaving all day. The event passed out was medically significant.  No laboratory data was provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable as it was second dose of vaccine.  Th events really cold, fever and chills were recovered on 19 Mar 2021.  On 19 Mar 2021 the outcome of cold, fever and chills.  On 20 Mar 2021 the outcome of event(s), headache, passed out on the floor, heaving all day was resolved..; Reporter's Comments: This case concerns a 65 Y/O F with serious unexpected loss of consciousness and nonserious unexpected retching and  nasopharyngitis, and expected pyrexia, chills, and headache. Event onset the same day as the second dose of mRNA-1273. Events resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
PT REPORTS REDNESS TO INJECTION SITE AND SWEELING AROUND HERE NECK REGION
No additional AE; administration of improperly stored vaccine; This spontaneous report was received from a registered nurse and refers to a 4-month-old female patient. There was no information regarding the patient's medical history, concurrent conditions or concomitant medications.  On 18-MAR-2022, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 milliliter, frequency: once, route of administration defaulted to oral, lot# 1742465 was confirmed to be valid, expiration date: 21-SEP-2022 (also reported as lot# U006165 confirmed to be valid with expiration date: 18-OCT-2022, conflicting information) for prophylaxis. The aforementioned vaccine underwent a temperature excursion for 20 minutes (product storage error), Digital Data Logger (DDL) was involved. There was no additional adverse event reported (no adverse event). Per reporter DDL was out of range for 20 minutes or less before the vaccines were moved to a unit that was in range. Merck was notified (also reported as cleared by Merck), vaccine still viable and use, no harm was reached the patient.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2203USA006960:
Shortly after administration 5pm, pt reported feeling dizzy/lightheaded. Had pt lie down, feet elevated. Provided ORS. Repeated BP and pulse after 10 minutes and pt reported feeling better. BP and pulse nl. Mom called 2 days later to report  that same day pt reported pain at the injection site were PPSV23 and flu were administered (LD) and dizziness, vomiting, and HA. Now improved however, redness and swelling at the site persists.
Received vaccines MMRV, HepA 8/1.  presented to ER 8/3 with fever, dx with blister in mouth and pneumonia.
1/12/04, client called stating that since flu shot (12/3/03) and approximately 2 months before shot, she was experiening numbness of face and chemical taste in mouth that had gotten worse since flu shot. Client stated that she is allergic to formaldihyde - she did not tell nurse she was allergic to formaldihyde. Still having problems