chrisvoncsefalvay/vaers-outcomes huggingface dataset:
9 patients received expired vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccines) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccines). At the time of the report, EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccines) 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.   No concomitant medication reported.  No treatment information was provided.
Patient describes pain going down her arm (right) the evening of the flu vaccination. She was unable to lift up her arm due to the pain. it aches during the night and she can't sleep on her rt. side. Pain has improved some but some days are worse. Now she can lift her arm straight up but not out to the side.
Patient received her 1st Pfizer Covid-19 vaccine on 9/29/21.  Symptoms started 9/30/21 morning - not able to get out of bed or move, SOB.  By 10/5/21, Patient had lost her sense of taste and smell.  She was seen at a clinic where she tested positive for Covid-19.  Facility was notified today of positive result.
Left arm at injection site was sore; Lymph node under left arm is swollen; lymph node under left arm is swollen and tender to touch.; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jan2022 at 12:45 (Lot number: 33130BA) at the age of 52 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin and "Egg allergy" (unspecified if ongoing), notes: Known allergies: eggs. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EW0153; Anatomical location: Left arm; Administration time: 11:00;Route of administration: Unspecified), administration date: 17Apr2021, when the patient was 51 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: EW0172; Anatomical location: Left arm; Administration time: 09:30; Route of administration: Unspecified), administration date: 12May2021, when the patient was 51 years old, for COVID-19 immunisation.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22Jan2022 at 12:00, outcome "not recovered", described as "Left arm at injection site was sore"; LYMPHADENOPATHY (non-serious) with onset 22Jan2022 at 12:00, outcome "not recovered", described as "Lymph node under left arm is swollen"; LYMPH NODE PAIN (non-serious) with onset 22Jan2022 at 12:00, outcome "not recovered", described as "lymph node under left arm is swollen and tender to touch". Therapeutic measures were not taken as a result of vaccination site pain, lymphadenopathy and lymph node pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
angioedema of neck, then over body;taken to ER & treated w/pred;As of 17OCT95 still has some rxn;
Unauthorized age group; 11 year old girl received initial dose of Pfizer vaccine on 06/23/2021 at local vaccination event; she then presented on 07/12/2021 accompanied by mother at Public Health Clinic for Pfizer booster (2nd dose scheduled). DOB was confirmed and noted she had received Pfizer vaccine dose at age less than 12 years; NO additional dose given at this time.
From initial information received on 01/JUL/2005 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 19 year old pt received a dose of Decavac, lot number U1221DA, a dose of Menactra, lot number U1575AA, and a dose of Hepatitis B, on 27/Jun/2005. The route and site of administrations were not provided for any products. Ten days later, the pt was diagnosed with disabling arthritis. The pt also complained of headache and stomach ache. Reportedly, the pt's lab tests were within normal limits. At the time of this report, the pt has not recovered from these events. From additional information received later on 01/Jul/2005 from a HCP, it was reported that the actual date of vaccination was on 17/Jun/2005 and the adverse event onset was on 27/Jun/2005. Reportedly, the pt becomes extremely stiff when he sits for long periods and has difficulty getting up. He also has difficulty ambulating and "look a mess" and is experiencing "a lot of pain". The physician prescribed Toradol for the pain. (OMIC)
One hour after inj. fever 99.8 degrees F, dizzy, lightheaded, diff. in walking & eating, labs drawn WNL, then 5/29 vomiting, diarrhea with mid epigastric pain. Labs on 5/29 increased LFT's & WBC increased. 5/30 pt admitted for gastroenteritis sx's D/C after 1 day, then 6/14 pt c/o worsening RUQ pain, Abn gallbladder U/S, ordered stat CT Abd & Pelvis, (+) hepatic vein thrombosis. Pt admitted & given LOVENOX & COUMADIN.
When administering covid-19 vaccine to patient, staff accidentally took the pre-filled syringe and administered entire syringe to patient instead of the pediatric dose. Patient was given 0.5mL instead of 0.25mL of vaccine.
I began itching and developing hives on my legs, and then experienced throat closure while exercising and then randomly other times. Was diagnosed with chronic idiopathic urticaria, thought to be autoimmune related.
Strong chest ache (left side), inflammation that looked like a cist.  I still have the pain and a small nodule that moves.  The pain radiates to the jaw and to the shoulder.  It's been happening to me since I got the first shot of Moderna.
This spontaneous report as received from a pharmacist via company representative refers to a female patient in her 50's. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (route of administration, dose, lot number and expiration date were not reported). On an unknown date, the patient experienced a "very large red swollen area down her arm". The outcome of the events was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Information has been received from a healthcare professional concerning a 9 week old female with no medical history who on 12-MAY-2008 was vaccinated with ROTATEQ. Concomitant therapy included diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (PEDIARIX), Hib conj vaccine (OMPC) (MSD) and (PREVNAR). It was reported after the initial dose of ROTATEQ the patient experienced diarrhea, fever and vomiting within 24 hours, on 13-MAY-2008, of receiving the vaccine. The patient was taken for unspecified medical attention. It was reported the patient tolerated subsequent doses of ROTATEQ without incident (specific 2nd and 3rd dose dates not provided, "final dose taken recently"). Subsequently, the patient recovered from diarrhea, fever and vomiting. A product quality complaint was not involved.
Patient presented to the ED on 4/12/21. Patient presented to the ED on 4/22/21 and was subsequently hospitalized within 6 weeks of receiving COVID vaccination.
Pt rc'd the vaccine into the right deltoid on 4/28/16, complains of soreness to site within 1-2 hours of injection. Applied ice/heat. Reports fever of 100.1, body aches, chills, pain, fatigue (flu like sx) x 24 hours. Now just mild soreness at site remains.
Received the vaccine on Friday, had horrendous nightmares that Saturday night that my daughter had to awaken me from,; nightmares occurred again the next week, but only 3 times. I have never had such events-have had bad dreams but nothing like these. Within a couple of weeks from the vaccination the symptoms of my degeneration increased, I had more pain and was unable to function as previously. A progressive escalation of these symptoms has continued. When it was time for the 2nd vaccination, I called the health clinic to report that my problems had suddenly worsened, the only change in my life was that shot. I asked to report that I would not get the 2nd dose as it was possible this had caused the sudden escalation. I was told they did not report adverse effects and did not know who I should contact. I have other doctors I see - I tried a couple of government numbers to report but to no avail. Finally a Practitioner at my Doctor's office gave me this address so I could report. No one of course can say for sure that the vaccine is the cause, but it is the only connection/change that we can determine for the escalation of my pain, nerve and muscle problems.
left thalamocapsular infarct, received TPA, initial score of 11, now with symptoms resolved.
Gave Moderna 0.5cc  -3/30/21 I spoke with clients gaurdian, she reports patient only had a sore arm.  3/17/21 called Gaurdian No Answer. Left message 3/18/21 called Gaurdian, No Answer. Left message
swollen - size of 1/2 an orange, red, hot, fever.  went to er.  told an infection.  was given antibiotic (pt thinks Keflex) and cleared up
3 x 4cm erythematous patch, warm to touch, swelling right thigh. Given Zyrtec 10mg chewable T qd cool compresses to area.
mom called Friday not @ 5:00;pt had been running temp 103.5 all day & fussy;no temp;t101 Sunday morning;APAP-Ibuprofen brought it down;
Case number PHEH2011US01626 is an initial spontaneous report received from a health care professional (medical assistant) on 10 Aug 2011. This report refers to an adult male patient. He was vaccinated with MENVEO (batch number A10052, expiry date: Jan 2013) intramuscularly on unspecified date. But, the patient received only the Men CYW-135 liquid conjugate component which was not reconstituted with Men A lyophilized powder component. No adverse reaction was reported following this drug administration error.
RED BURING SENSATION IN THE LEFT BICEP FOR 3 DAYS, AND ITCHING
C/O cough, chills, elevated temperature, sore and scratchy throat, runny nose and congestion, myalgia, and malaise
Date the vial was initially stored in the refrigerator on 05-JUN-2023 and administred to patient 26-JUL-2023; No adverse event; Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 05-JUN-2023 and administred to patient 26-JUL-2023) and NO ADVERSE EVENT (No adverse event) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7643E) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 26-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 05-JUN-2023 and administred to patient 26-JUL-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 05-JUN-2023 and administred to patient 26-JUL-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 05-JUN-2023 and administred to patient 26-JUL-2023).    It was unknown patient did receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  Vial size was 2.5 mL. Date the vial was initially stored in the refrigerator on 05-JUN-2023. The vial did not undergo any temperature excursions. No treatment information was reported.  This case contains information for patient 2 of 2.   This case was linked to US-MODERNATX, INC.-MOD-2023-734830 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734830:Patient 1
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient stated that she always faints when she gets the vaccine however she did not mention that before she was given the vaccine. She was with her mom. she was given gatorate/ crackers and felt better. she was reponsive however it is a common side effect that she gets when she gets blood drawn or vaccines. the mom stated that she will always have to be with her when she gets vaccinated. Patinet did not want us to call 911. she was ok before she left.
p/vax pt began to itch on chest & back by 10:20AM entire trunk of body covered w/red circular welts;tx in ER w/DPH;
Janssen COVID-19 Vaccine EUA  Had typical reaction for 2 nights after shot (Severe headache, chills, fever, muscle cramps, etc), but chills, headache and nausea persisted.   Currently (6 days after vaccine) I have feeling of pressure in head above left ear. Pressure accompanied by slight headache, dizziness, feeling flush, stomach pain, and tingling in right hand.   These symptoms haven't changed over last 4 days, and most pronounced is head pressure, dizziness, and general disorientation.   Haven't taken medication, just getting good rest and hydration, but symptoms aren't lessening.
Information has been received from a female consumer in her 50's with a mold allergy, a dust allergy, pollen allergy, many food allergies, sulfa drug allergy, terbinafine (Lamisil) allergy, itraconazole (Sporanox) allergy, celecoxib (Celebrex) allergy, Saldine allergy and an allergy to adhesive strips and medical tapes and a history of high cholesterol, unspecified thyroid condition, high blood pressure, severe migraines and bronchitis who on May 27 2004 was vaccinated IM in the right hip with a 0.5 dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included estrogens, conjugated (Premarin), simvastatin (Zocor), cetirizine hydrochloride (Zyrtec), Valsartan (Diovan), zolpidem tartrate (Ambien), Cilan and levothyroxine Na (Levoxyl). On May 28 2004 the patient developed an injection site reaction described as a red circle six inches in circumference. She also developed a reddish streak along her thigh that was near the the injection site. The streak was one inch wide and six inches long. the patient also reported joint pain and fever. She consulted with her physician who administered a shot of triamcinolone acetonide (Kenalog) to compensate for symptoms. The patient also increased her use of cetirizine hydrochloride (Zyrtec) from one a day to three times daily. Symptoms have abated and the patient is recovering. It was also reported that the patient was recovering with Sequa lea. No product quality complaint was involved. No other information was available. Additional information has been requested.
MISSED TO TAKE FOURTH DOSE OF VIVOTIF ACCORDING TO SCHEDULE; This spontaneous case report (PVX2019-1860) was received from a caregiver on 18-Jul-2019. It describes a 14-year-old male consumer who "missed to take fourth dose of Vivotif according to schedule" (PT: Intentional dose omission), while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer did not take fourth dose of Vivotif according to schedule because, it was left out of the fridge for 48 hours after the third dose and no longer good to use. He took the first dose on 11-Jul-2019 and his last dose was due on 17-Jul-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed to take fourth dose of Vivotif according to schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take fourth dose of Vivotif according to schedule" was considered as not applicable.
Pt presented to the ED with shortness of breath and cough.  Patient was admitted to the hospital for covid evaluation.
Extremely off-balance for a few days (3) after the shot; she could barely walk on her own without falling over.  Also had aches and pains everywhere, and especially in both arms, for several days (5) after receiving the shot.  Has not felt well since receiving the shot and still feels weaker than normal.
Client received Td vaccination 8/1/13. The next day she noted a red, round welt at the inj. site. The area cont to worsen and Sat 8/3 noted area larger and welted area now 3 1/2" diameter by Sun the swollen and reddened area covered a 3 1/2" wide are and encompassed most of the upper arm. C/O purple discoloration and itching. She wore sleeve over to protect area while outside and applied ice. TC to H/D 8/5 AM. Swelling started to lessen, still discolored and no longer itching. Is now improving but not yet fully recovered.
This spontaneous report as received from a from pharmacy technician concerning a currently 4 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 27-MAR-2014, the patient was vaccinated with VARIVAX lot #J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Headache, Myalgia,  felt flushed and body felt heavy. Narrative: Patient VS were checked and WNL. Patient was furthered monitored in vaccine clinic and given water. No further actions required and no further complaints from patient.
The patient also complains of shortness of breath since his 2nd dose of COVID vaccine last month
While entering administered vaccine  saw patient had previously received a J&J vaccine on 03/25/21 at center.  Called Administrator at nursing facility to verify.  He had no record of previous dose. He contacted dialysis and they informed him he   had received that dose. The patient had no issues since receiving the additional dose.
Myalgia, Diarrhea, NauseaVomiting, Fatigue, Chills Narrative:
Patient complains of face feeling flushed and when she looked in the mirror it was red.  This occurred just pta, about 30 minutes after getting the Pfizer vaccine.  She did not take any medicine for the symptoms.  She denies SOB or mouth swelling/ tongue swelling, no trouble swallowing.  No nausea or vomiting.  No pain.
Injection pain, chest pain, tachycardia, fatigue,. nausea and vomitting
RECEIVED SECOND DOSE OF PFIZER 1/6/21 MILD SYMPTOMS OF COVID-19 STARTED 1/22/2021 LASTED APPROX 10 DAYS (RUNNY NOSE, CONGESTION), POSITIVE PCR 1/31/21 RECEIVED BOOSTER PFIZER 10/8/21 MODERATE SYMPTOMS OF COVID-19 AND POSITIVE PCR 1/3/2022; COUGH, SORE THROAT, CONGESTION, HEADACHE STILL ONGOING AS OF 1/7/2022; MISSED WORK, SAW DOCTOR AND RECEIVED ALBUTEROL INHALER RX, NOT HOSPITALIZED
Right arm cellulitis. Leukocytosis likely secondary to cellulitis and history of myelofibrosis. Treated with IV clindamycin, Vancomycin -> BACTRIM PO.
The pt had screaming and 2 seizures. The 1st one lasted about 1 minutes and the 2nd one lasted 2-3 minutes. He was treated with Tylenol q 4 hours. This could be a reaction to pertussis.
Clogged Ears; Sore Left Arm; Sore Throat; Diarrhea; Chills; Fever 101 F; This spontaneous case was reported by a consumer and describes the occurrence of EUSTACHIAN TUBE DYSFUNCTION (Clogged Ears), PERIPHERAL SWELLING (Sore Left Arm), OROPHARYNGEAL PAIN (Sore Throat), DIARRHOEA (Diarrhea) and CHILLS (Chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced EUSTACHIAN TUBE DYSFUNCTION (Clogged Ears), PERIPHERAL SWELLING (Sore Left Arm), OROPHARYNGEAL PAIN (Sore Throat), DIARRHOEA (Diarrhea), CHILLS (Chills) and PYREXIA (Fever 101 F). At the time of the report, EUSTACHIAN TUBE DYSFUNCTION (Clogged Ears), PERIPHERAL SWELLING (Sore Left Arm), OROPHARYNGEAL PAIN (Sore Throat), DIARRHOEA (Diarrhea), CHILLS (Chills) and PYREXIA (Fever 101 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 101 (High) Patient's body temperature was 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: TCR received: updated reporter's address
Mom states child had some swelling to injection site Right Leg, redness approx the size of a baseball, warm to touch, no fever, no pain, states child is running around without any limping or indication of pain to are, call PCP instructed to apply cool soaks to area and to give child Tylenol, states on 8/18/10 in am most of swelling is gone, redness is much smaller and lighter to area, and only slightly warm to touch at this time.
Local edema and erythema to (R) thigh - mostly in the upper part where KINRIX was administered. Pt was given 7.5 mL Children's BENADRYL (12.5 mg/5mL).