chrisvoncsefalvay/vaers-outcomes huggingface dataset:
potentially received expired dose (past 30 days in refrigerator); potentially received expired dose (past 30 days in refrigerator); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (potentially received expired dose (past 30 days in refrigerator)) and PRODUCT STORAGE ERROR (potentially received expired dose (past 30 days in refrigerator)) 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 EXPIRED PRODUCT ADMINISTERED (potentially received expired dose (past 30 days in refrigerator)) and PRODUCT STORAGE ERROR (potentially received expired dose (past 30 days in refrigerator)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (potentially received expired dose (past 30 days in refrigerator)) and PRODUCT STORAGE ERROR (potentially received expired dose (past 30 days in refrigerator)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: significant follow-up appended on 01-dec-2021: individual patients details and drug details
headache; fatigue; shivering; fever; This case was reported by a consumer via call center representative and described the occurrence of headache in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, fatigue, chills and fever. On an unknown date, the outcome of the headache, fatigue, chills and fever were unknown.   It was unknown if the reporter considered the headache, fatigue, chills and fever to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. No further information provided on voicemail. The phone number for patient was left.
Temp. 101. Extreme exhaustion. Some chills, but generally the sudden "nerve cascades" that precipitate a "chill." Very thirsty!
Silver-dollar sized rash appeared in center of patient's back (along spine) on Weds, 11/24/2021. We assumed she was having an eczema flare. My son and I have occasional flares, and it looked similar. She said it was a bit sore, and itchy (we told her not to scratch or rub it).  I did not call the pediatrician right away, as I noticed it the evening before a holiday weekend. Decided to treat it with Hydrocortisone and Benadryl, which I had on hand and call on Monday if it hadn't gotten better or worsened, so we could see about getting a prescription. Over the weekend, a scattering of small spots popped up along her ribcage, under her left armpit, aligned with the spot on her back, and the spot on her back became more irritated (raised and bumpy). Called the pediatrician on Monday morning, 11/29, and was able to get her in right away. Her usual pediatrician is was not available so we saw another doctor. He checked the spots and immediately identified them as shingles. It had not occurred to me that it could be shingles, as patient received her Varicella vaccine doses on 02/28/2012 and 11/12/2015, and has never exhibited any Chicken Pox symptoms. Doctor said since she was already five days from the spots appearing, and they had not opened/bled, we did not need to treat with a prescription. He recommended we treat with Calamine, Benadryl and Ibuprofen. It is not causing ongoing pain, but will cause a quick burst of pain if the shingles are  accidentally pushed or rubbed against. As of today, the rash has gone down significantly. The spots on her ribcage are very small (they almost look like little chicken pox now) and the spot on her back has reduced by about half.  Patient had an appointment for her second vaccine dose on 12/1. Doctor advised we keep the appointment, as it was seven days after her symptoms appeared. The shingles have not flared up again since she received her second dose.
04/28/2000 pt received vax. 05/30 - pt experienced headache which resolved on 06/01. 06/03, fever of 102. 06/05 fever increased to 105 and she went to ER. She was dehydrated, received fluids and was discharged. 06/06, developed jaundice, dark amber urine, clay colored stools, fatigue, pruritus, and nausea. 06/08 primary physician consult and labs conducted which revealed elevated liver enzymes. 06/17, symptoms resolved except ALT. Most recent information received on 06/28, reports outcome of event as ongoing.
Information has been received from a pharmacist referring to a 65 year old female patient. Information concerning medical history and concurrent condition was not reported. The patient had no drug reactions and allergies. On 13-SEP-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose and strength were unknown, lot # L021606, expiry date: 10-SEP-2016) subcutaneously. There was no concomitant therapy reported. On 14-SEP-2015 the patient told the pharmacist that she began to have some itching around the injection site and then on 16-SEP-2015 the patient has some blisters developing at the injection site. The patient went back to pharmacy for medical attention. There was no treatment for the events. There was no lab diagnostics studies performed. The patient was recovering from the events at the time of the report. Additional information  has been requested.
Pain at injection site, chills, feel feverish, nausea, lethargic, joint pain
The patient presented his vaccine card to the technician which he got his first and second dose of Moderna so he filled out his card for moderna booster and so it was typed up for the Moderna booster, the patient stated he signed up for the Pfizer vaccine for his booster shot instead.
Patient presented to the emergency department with chief complaint of all over body pains with worse pain in her left arm and posterior head and swollen lymph nodes on the left clavicular area and armpit.
Within 24 hrs arm itchy and red-swollen-size of tennis ball.  2nd day redness and swelling doubled in size.  3rd day still red and swollen size - 15X16 cm at office.
Case number PHEH2014US020150, is an initial spontaneous report from the nurse received on 03 Oct 2014, with a follow up received from nurse on 16 Dec 2014. This report refers to a 52-year-old female patient. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14512P) at a dose of 0.5 ml intramuscularly on 01 Oct 2014. On an unknown date (on the same date of vaccination or on the next day after vaccination) in Oct 2014, the patient's injection site was very hot to the touch and had redness and soreness at the injection site. Further, the patient experienced red hot rash lasting for three to four days. The patient was hospitalized. The reporter stated that no long term reactions were noted in the patient. The outcome of the event red hot rash was complete recovery; outcome of the other events was unknown. The seriousness and causality of the events were not reported. Follow up received from nurse on 16 Dec 2014: updated patient demographics (patient age and gender), new event (red hot rash) and other clinically relevant information in the narrative. Following an internal review for the date received on 16 Dec 2014 a significant correction was performed: Seriousness criteria hospitalization was added.
"Multiple Doses Were Given Over A 30-Day Period After Excursions"; Initial Report Received on 08-Oct-2021  A registered nurse reported that multiple patients (initials, gender, age, race, and ethnicity unknown) were administered HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after a low temperature excursion occurred.  No medical history was reported.  No relevant concomitant medications were reported.    On unknown dates over a 30-day period, multiple patients received a dose of HEPLISAV-B (Lot #s, expiration dates, NDC #s, and serial #s unknown) at the clinic.  The HEPLISAV-B had a low temperature excursion. No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Received Tdap 3/20/13. Noted on 3/22/13 that injection site sore and swollen. Felt like a "bruise". Pain and swelling extended to (L) axilla. Used LORTAB she had at home for pain. No fever no other constitutional sx. 3/25/13 checked by nursing staff at this office. No redness, swelling or ecchymosis. Pain resolving.
Day 1-2 very sore arm Day 2 low grade fever, headache Day 10 circular rash around injection site?raised, itchy, red and warm to the touch
An hour after the vaccination I started getting a rash and itching on my body for more than a week and it only went away with benadryl
Covid19 breakthrough. 1st vaccine received on 03/08/2021. 45 y/o with recent diagnosis of Rectal Cancer, port placement and planning to initiate chemo. Patient presents to ED with 4 day HX of generalized weakness, abdominal pain, N/V/D, dizziness, SOB, rash on left side of ribs (shingles). CT chest-viral PNA and moderate pericardial effusion.  Of note, patient received Covid booster 10 days ago. Treating with steroids.
feeling tired; had like flu-like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "feeling tired"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "had like flu-like symptoms".  Additional information: Reporter had 2 friends that also had the Pfizer vaccination and they just were feeling tired, nothing of such like he is having, they had like flu-like symptoms. It was unknown if patient received other vaccine within 4 weeks (prior).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021526487 same reporter/vaccine/event, different patient
Father states that patient's upper lip began swelling on evening of day of vaccination. Father purchased OTC Benadryl and gave as directed. Swelling resolved, then returned 2 days later. Benadryl was given again, and lip returned to normal. Patient denies eating any unusual foods. No fresh fruit that day. Denies swelling or hives on any other part of body. Has not had any difficulty breathing or swallowing.
APPROXIMATELY 90 MINUTES AFTER IMMUNIZATION, PATIENT'S FACE "FELT ITCHY AND LIPS WERE TINGLEY". "SPLOTCHES WERE VISIBLE ON FACE".  PATIENT TOOK BENADRYL 25MG AND SYMPTOMS RESOLVED "WITHIN A FEW HOURS".
Pt had covid 19 vaccine 10/28/21, After a month of vague symptoms she was diagnosed today with Lymphoma at the age of 16
LEFT FOOT  SWELLING COMES AND GOES; LEFT FOOT SORENESS; LEFT FOOT FEELING HOT; This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced left foot feeling hot. On 30-MAR-2021, the subject experienced left foot swelling comes and goes. On 30-MAR-2021, the subject experienced left foot soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left foot swelling comes and goes, and left foot soreness, and the outcome of left foot feeling hot was not reported. This report was non-serious.
Symptoms: chest pain, shortness of breath, fatigue, irregular heart beat beginning October 2022, worsening steadily. Diagnosis: Myocarditis diagnosed after cardiac catheterization (March 2023) showed no blockages and cardiac perfusion MRI (April 2023) showed edema in heart wall, reduced ejection fraction. Treatment: rest, no alcohol or caffeine, no strenuous activity or heavy meals Followup MRI scheduled for 8-30-2023.
Fainted 10-15 minutes after vaccine fever and had shaking of arms, rolling up of eyeballs lasting 10-15 seconds. Had another similar episode half an hour later.
Patient was seen on 11-4-10 at the Health Center at that time patient had urine preg test done which was negative. Gave last LMP as 10-15-10 - Pt then received VZV, TDAP, HVP return to clinic on 11-23-10 with positive pregnancy test report to Merck/Pregnancy Registry.
Patient presented 2 days after second COVID-19 Moderna vaccination (pharmacy noted administration on 6/4, admitted to hospital on 6/7, unclear if symptoms developed on 6/6).  Patient developed cardiac arrest in the field with witnessed arrest and bystander CPR, received defibrillation for VF in the field via medics. After presenting to hospital, underwent angiogram with normal coronaries, severely reduced ejection fraction with biventricular failure. Transferred to a different hospital to limit risk of ventricular arrhythmia recurrence and currently on ECMO.
Following administration of Influenza vax, pt exp edema & erythema @ inject site; sx lasted for 72 hrs;
pt recvd vax & 6JUL94 w/in 24 hrs 7JUL pt expired; pt has neg for sz disorder, CP, prior react to DTP & other immun, steroid therapy, immune deficiency disorder & exposure to chicken pox;
Patient c/o feeling flushed, color pale pink, warm, dry. Radial pulse strong, steady.  Breathing unlabored.Patient given bottle of cold water to drink, no swelling to face or lips.  Patient stated she did eat breakfast that morning. Patient states water helping, then has some coughing after a drink. Patient states she often coughs after drinking things, denies difficulty breathing or swallowing. Patient c/o head throbbing after drinking.  C/o nausea and has dry heaves x 1 but no emesis. Patient states has some chronic breathing problems and heart problems.  Family member at side. BP 146/90 left arm sitting automated cuff, pulse 84. Respirations even and unlabored, O2 sat 88% on RA,   Patient remains alert and talking, nausea subsides. Patient assisted to stand and ambulate with walker to be dismissed at 1053, but is dizzy so sat back down and dizziness subsides.  Patient remains sitting and alert, talking to volunteer medical staff member.  BP decreases to 132/86 and pounding in head decreases.  Patient reports feeling okay to leave and at 1107 ambulates out with her walker and stand by assist from  volunteer member and patient's family member.
Cellulitis at administration site - erythema, induration, warmth, & tenderness started day after administration & worsened by day 2. Treated with KEFLEX, po for 7 days.
28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not reported. Treatment information was not reported.
a slightly sore arm and a general malaise; a slightly sore arm and a general malaise; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (167798). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), MALAISE (non-serious), outcome "recovered" (2021) and all described as "a slightly sore arm and a general malaise".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was administered Moderna vaccine beyond the published expiration date. Per Moderna manufacturer, re-vaccination is not required, vaccine was rendered to still maintain the activity necessary to protect against Covid-19.
Patient had PREVNAR vaccination (at PCP office) 4/6/2016. I do not have lot #. 4-5 days later, she had onset of numbness from chest down consistent with transverse myelitis. She was hospitalized 4/12/2016-4/15/2016 and received IV SOLU-MEDROL. Symptoms improved but she has continued dysesthesias.
pt recvd vax & 2 wks later 17NOV94 pt dx w/aseptic meningitis; On f/u pt's physician states that pt is fully recovered; viral culture neg; pt was felt to have herpes simplex encephalitis; There is no evidence that illness was related to vax
Complained of dizziness, numbness to arms/legs within 10 min of getting the vaccine. Had her lie down, legs elevated, gave O2 - resolved after 10-15 min.
"43M yo started with symptoms of for __3 _days. Pt states has very swollen left leg , and red. with mild pain in the groin area to the left testicle.. Leg pain is Very bad Symptoms started after biking  pt denies injury. Pain in located in the left leg Pt describes pain as severe and is associated with groin pain to left testicle"
arm pain; severe headaches; nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Jul2021 (Batch/Lot number: unknown) at the age of 15 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jul2021, outcome "recovered", described as "arm pain"; HEADACHE (non-serious) with onset Jul2021, outcome "recovered", described as "severe headaches"; NAUSEA (non-serious) with onset Jul2021, outcome "recovered", described as "nausea". Therapeutic measures were not taken as a result of pain in extremity, headache, nausea.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient did not receive any other vaccines within 2 weeks prior to the COVID vaccine.  Prior to vaccination, the patient was diagnosed with COVID-19. Post the vaccination, the patient has not been tested for COVID-19. Patient had no Known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
BLOOD CLOT IN LEFT CALF; PAIN IN ANKLE; PAIN SLOWLY MOVING UP TO THE CALF; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 79 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and penicillin allergy. The patient experienced drug allergy when treated with ciprofloxacin, and pethidine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and  expiry: 21-JUN-2021) dose was not reported, 1 total administered on 02-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included blood-pressure pills, water pills and Omega-3. On 02-APR-2021, the patient experienced a slight headache for about 2 days. On 29-APR-2021, the patient  felt some pain in  ankle, which was slowly moving up to the calf (left leg). The patient was brought  to the emergency room, where an ultrasound and blood work was performed. Ultrasound detected a blood clot in her left calf and prescribed with Xarelto daily for 3 months.  Patient stated that pain reached its most intense status on 01-MAY-2021 and is slowly getting better.  Treatment medications (dates unspecified) included: rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 04-APR-2021, was recovering from pain in ankle, and pain moving up to the calf, and had not recovered from blood clot in left calf. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210520686 -JANSSEN COVID-19 VACCINE Ad26.COV2.S-Thrombosis. The 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).
This spontaneous report as received from a pharmacist refers to a 5 years old patient of unknown gender. The pharmacist reported that the patient's mother, reported the incident to him. The pharmacist reported that on 04-JUN-2013 a physician administered ZOSTAVAX 0.5 ml (lot number and route were not reported) instead of the intended VARIVAX to the patient. Concomitant medications were not reported. The pharmacist reported that "this was probably intended to be the patient's first dose of VARIVAX". No adverse effect reported. The outcome of the patient at the moment of the report was not reported. Additional information has been requested.
Complete hair loss on head.  Hair started falling out exactly 8 weeks after the second injection. Hair continued to heavily fall out over the next eight weeks. Completely bald within 10 weeks. Note: Had tremendously thick hair.
Feeling drowsy; Sleep is also affected; Feeling achy; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Feeling drowsy), SLEEP DISORDER (Sleep is also affected), MYALGIA (Feeling achy) and FATIGUE (Feeling tired) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced SOMNOLENCE (Feeling drowsy), SLEEP DISORDER (Sleep is also affected), MYALGIA (Feeling achy) and FATIGUE (Feeling tired). At the time of the report, SOMNOLENCE (Feeling drowsy), SLEEP DISORDER (Sleep is also affected), MYALGIA (Feeling achy) and FATIGUE (Feeling tired) outcome was unknown.            It was reported that the patient was waking up at night and sleeping 5 to 6 hours per night. On 23-Mar-2021, the patient took a nap which lasted for an hour and it was really long. Action taken with mRNA-1273 in response to the event was not applicable.No treatment information was provided.
Headache, Myalgia, Chills Narrative:  Other Relevant History: