chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination Failure; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04May2021 as dose 1, single (Lot number: ER8736), in left arm, on 26May2021 as dose 2, single (Lot number: EW0172), in left arm, on 03Jan2022 as dose 3 (booster), single (Lot number: 33025BO), in left arm and on 20Aug2022 as dose 4 (booster), single (Lot number: Fp7137) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "SLE" (unspecified if ongoing); "Liver Steatosis" (unspecified if ongoing); "Atherosclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Postive, notes: COVID 19 Treatment; (03Apr2023) Negative, notes: tested neg x2(Mon & Thurs); (06Apr2023) Negative, notes: tested neg x2(Mon & Thurs); (08Apr2023) Positive, notes: I have tested positive for covid. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148525 same patient, different drug/event (Paxlovid);
COVID (+) WITH SYMPTOMS COUGH, NASAL CONGESTION, NO FEVER Narrative:
My COVID-19 symptoms started on 12/20/2022 in the evening around 7:00PM- 8:00PM. I had a headaches, sniffles, and body aches. On 12/21/2022 in the morning I did COVID-19 home test which was positive. I called my doctor did a telehealth at 9:00AM in the morning. She prescribed me with molnupiravir for 5 days. I tested negative for COVID-19 infection on 01/07/2023.
Patient is positive for COVID-19 (test on 4/18/21, symptoms began 4/15/21). Patient presented to ED on two occasions (4/18/21 and 4/20/21) for symptoms related to COVID-19, but has not been admitted either time. On 4/18 the patient presented with complaints of fatigue, sore throat, myalgias, arthralgias, and congestion. O2 saturation on 4/18 was 94% on room air at presentation. On 4/20 the patient again presented to the ED experiencing similar symptoms with the addition of nausea, diarrhea, sweats, fever, and cough. She also reports severe lower back, hip, and leg pain. Patient received IV fluids and also received a lumbar MRI, which did not reveal an acute abnormality. Patient was discharged with a prescription for hydrocodone-acetaminophen for management of severe myalgias and arthralgias.
This spontaneous report as received from a nurse practitioner refers to a 4 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 26-JAN-2015, the patient was vaccinated with the dose of LIQUID PEDVAX HIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. No adverse events were experienced. This is one of several reports from the same reporter. Additional information has been requested.
Mild myalgias 36h after on 19Dec2020 02:30; Intermittent mild Dizziness and nausea 24h after vaccine; Intermittent mild Dizziness and nausea 24h after vaccine; Pain at side of puncture, unable to lift arm from 12h to 40 hours after; unable to lift arm from 12h to 40 hours after; This is a spontaneous report from a contactable Physician(patient). A 32-year-old female patient received first dose BNT162B2 (lot number EH9899) , via an unspecified route of administration at Arm Right on 17Dec2020 14:30 at the 32 years old at single dose for COVID-19 immunization.  The medical history was not reported. The concomitant medication was levothyroxine. The patient experienced Pain at side of puncture on 18Dec2020 12:00, unable to lift arm from 12h on 18Dec2020 02:30 to 40 hours after on 20Dec2020 06:30, Intermittent mild Dizziness and nausea 24h after vaccine on 18Dec2020 14:30, Mild myalgias 36h after on 19Dec2020 02:30, resolved at 48h post vaccine on 19Dec2020 14:30. There was no treatment received for all the adverse events. There was no other vaccine in four weeks. The outcome of the events was Recovered.
no adverse effect reported; improperly stored VARIVAX; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 19-SEP-2019, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX) with lot # R019237, expiration date 04-JUL-2020 or lot# S005078, with expiration date 19-FEB-2021 , for prophylaxis (dose and route of administration were not reported) and was reconstituted with a properly stored sterile diluent(MERCK STERILE DILUENT).     The administered dose of the vaccine experienced a temperature excursion -14°C to -10°C (-9.74 C) degrees Celsius for an unknown time frame.   There was no adverse effect reported.  This call was because of a data logger and there were no previous temperature excursion.  No product quality complaint was involved.
PT RECEIVED 3RD IMMUN 1-7-90.AFTER 48 HRS HAD 101-102 FEVER;FEVER GONE 1-12-90.HALF OF INFANTS FACE NOT MOVING(POSS.BELL'S PALSY) REFERRED TO NEUROLOGIST.
About 10 minutes after getting the shot I suddenly felt like I was having an anxiety attack.  My heart was racing and a tingling adrenaline feeling started in my head and spread down through my body.  My throat felt strange, but I could still breathe.  It started to subside after a couple of minutes but didn?t resolve completely for another hour or so.  I also had a headache almost immediately.  In the days following the vaccine I had such sore muscles it was hard to get out of chair or go upstairs.  That lasted 3 days.   About one week after the shot I started noticing my brain felt glitchy.  At night I have not slept well since about one week after the vaccination  and  I frequently awaken feeling confused, stressed, and disoriented.  This is not normal for me.    Additionally, about 3 weeks after the vaccine I had another mild panic attack.  I have not been troubled by panic attacks before getting the vaccine.  As of today I am starting to feel less glitchy in my thinking. I am still not sleeping soundly and waking often, sometimes accompanied with confusion.
PATIENT'S WIFE CALLED, STATED SHE WAS A REGISTERED NURSE, AND HAD CONCERNS ABOUT THE INJECTION SITE BEING TOO HIGH IN THE ARM SINCE PATIENT EXPERIENCED SIGNIFICANT PAIN YESTERDAY EVENING AND THROUGH OUT THE NIGHT. SHE OFFERED TO SEND A PICTURE OF THE INJECTION SITE AND ALSO WHERE NURSES ARE TRAINED TO GIVE THE VACCINE (VIA DRAWING ON PATIENT'S ARM)
ANTI-HBS ANTIBODY NEGATIVE; LIVER FUNCTION TEST ABNORMAL. Information has been received from a nurse and nurse practitioner concerning a 23 year old female patient with no past medical history except for the flu in 2002, who on 13DEC2001 was vaccinated with a third dose of hepatitis b  virus vaccine rHBsAg (yeast) (Lot# 640830/1067L). It was noted that she had received a first dose of hepatitis b virus vaccine rHBsAg (yeast) (Lot #631558/1188K) on 13JUN2001, and a second dose (Lot 631558/1188K) on 11JUL2001. On 12JUL2002, reported as one year later, the patient had titers done as a condition of employment. It was noted the patient had a negative titer. Her hepatitis b surface antibody result was "3", and the nurse reported that "10" equaled immunity. The nurse practitioner reported he patient was then given two more doses of "another company's" hepatitis vaccine. Additional information received from a different nurse also reported the patient was given two additional doses, however indicated the two doses were hepatitis b virus vaccine rHBsAg (yeast); one dose was administered on 30-OCT-2002 (lot #ENG 5366 A2) and another was administered on 29NOV2002 (lot #ENG5366 A2). The nurse laboratory values were reported. It was noted the patient was due for a third dose and she had called the physician office to ask if it was OK to receive the third dose with elevated liver enzymes. The nurse noted the patient had been due for the third dose on 30APR2003. The nurse reported there was no additional information regarding the patient at this time, as she was being seen by her primary care provider. There was no product quality complaint involved.
Information has been received from a 24 year old female consumer with a history of hypothyroidism and allergy to penicillin who on 23-JUL-2003 was vaccinated with a dose of rubella virus vaccine live (Wistar RA 27/3).  There were no concomitant medications.  The consumer stated that since she received her rubella virus vaccine live (Wistar RA 27/3), she has developed hives with several visits to the emergency room in the past years, without inpatient admissions to the hospital.  All testing, including allergy tests and blood tests, to determine the reason for the hives have been futile.  At the time of this report, the patient had not recovered.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Patient with one solidary hive over injection site, given vaccine 7 days ago. ER visit 1/16/2021. discharge home with Benadryl
Swelling and pain at injection site.  Started 24 hours post injection.  Afebrile.  Hot compresses and Motrin.  Monitoring.
Nurse administered 0.5ml instead of 0.25ml .  Patient states no adverse reaction.
(R) deltoid fever, erythematous and inflamed at the touch - Cephalexin treatment course given.
On Nov 9th, 2016 the patient developed an infection at the injection site. According to patient, he was prescribed antibiotics to help fight the infection and was told to go to the ER if the infection got worse.
Covid-19 breakthrough. 1st vaccine received on 03/03/2021. 59 yo PMHx of HTN, HLD, DM, GERD and neuropathy presents to ED with c/o multiple near syncope episodes past several weeks that has increased in frequency past 3 days.  Patient also c/o upper abdominal pain, N/V. CXR- no acute findings, febrile T-101. Room air sat 95%. Patient started on IV ABX.
Pain in arm at inj site. Slight swelling 1/2" area of redness.
48 hours after injection: Found that both hands are swollen with both palms having a red, blotchy rash with pain in joints and redness. Received injection in left arm, rash/swelling/pain are more prevalent in left hand. Symptoms improve with OTC antihistamines and analgesics.
Shot on Monday afternoon,  Tuesday morning woke  with  overall body aches and exhaustion,  Tuesday evening started developing  stronger allergy symptoms by  Wednesday glands in neck  swollen  with cough and severe head congestion.   Symptom relief on Saturday.   I took  over counter allergy medication  to treat symptoms.   Note:  looking at vaccination record they spelled my name wrong  And my birth year.
sore arm at injection site; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 5-year-old male patient received BNT162b2 (BNT162B2), on 14Jun2022 as dose 3 (booster), single (Lot number: FL8094) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FK5618), administration date: 23Dec2021, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: FK5618), administration date: 13Jan2022, for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 15Jun2022, outcome "unknown"; VACCINATION SITE PAIN (non-serious) with onset 15Jun2022, outcome "unknown", described as "sore arm at injection site". Therapeutic measures were not taken as a result of vaccination site pain, nausea.  Additional information: The patient had no other vaccine in four weeks. The patient had no COVID-19 prior vaccination. Query: The Pfizer Drug safety unit recently received the attached report submitted by you via pfizersafetyreporting.com. It is unclear whether or not you had first-hand knowledge of the events reported. Please help to confirm if you were in direct contact with the person who reported these events to you. If you were not directly in contact with the reporter, kindly provide the reporter's contact information. Please ensure to reply all to this email. Response: Yes, I was in direct contact with the person reporting these events to me.  Follow-up attempts are completed. No further information is expected.
pt broke out in a rash on both forearms 2 days p/immun were given; rash still present day 5 post immun; no fever noted no other s/s x/itching;
Pt had fever of 102 F, chills, Headache onset shortly after vaccine administration. Headache progressively worsened. Admitted to hospital next day.  Diagnosis was reaction to rabies vaccine.
Patient called in about 45 minutes after her vaccine to say she had an itchy throat and swelling of the lips, tongue and cheeks.  She immediately treated it with 50mg of benadryl and she said it subsided.
RASH DEVELOPED 2 DAYS AFTER VACCINATION LASTED 2 DAYS MILD ITCHING REDNESS ERYTHEMA PATIENT TOOK DIPHENHYDRAMINE
Severe nausea, vomiting, diarrhea - 12 hours fever, chills, body aches- 12 hours
Soreness at Injection Site/slightly more painful than anticipated-a longer pinch felt; couldn't lift my arm after; This is a spontaneous report received from a contactable reporter(s) (Physician), Program ID: The reporter is the patient.  A male patient received pneumococcal 20-val conj vac (PREVNAR 20), on 19May2023 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation; BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19May2023 as dose number unknown, booster single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: prescribed therapy ; "Hyperlipidemia" (unspecified if ongoing), notes: prescribed therapy ; "Hypothyroid" (unspecified if ongoing), notes: prescribed therapy . The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, Single, Manufacturer Unknown), for Covid-19 Immunization.The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2023, outcome "unknown", described as "Soreness at Injection Site/slightly more painful than anticipated-a longer pinch felt"; MOBILITY DECREASED (non-serious) with onset 2023, outcome "unknown", described as "could't lift my arm after". Addition information: patient reported that "l received Prevnar 20 a few weeks ago and I couldn't lift my arm after", After probing, he explained that the soreness was on par with what you would expect following a shot. However, he did mention that the initial injection was slightly more painful than anticipated -a longer pinch felt. Received Prevnar 20 and COVID booster on the same day - different arms.  The information on the batch/lot number for pneumococcal 20-val conj vac, BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
So I had received 2 Moderna vaccines, the first on 6/18/21, and the second on 07/19/21. August 3rd I noticed My period started at least 3 days earlier than usual (which I never tend to be early- almost always a couple days late). I had a very large blood clot about the size of a baseball- which is not normal at all for me. I had heavy cramping for at least 4 days (I usually have cramps only on the first day). My period was very strange, sometimes old blood (brownish colored, then sometimes new blood). I usually have cramps only the first day, but this time I did for several days, and it was definitely a lot stronger and lasted 10-11 days. I have never had them last more than 7. Then 2-3 weeks later I started spotting. Sometimes old blood, sometimes new blood. I do not usually spot. That continued until I had my period, which began a few days early again. I also had clots and it lasted longer than usual, but the clots were not as big as the previous month. But again I had cramping for several days. Ever since then I have been spotting on and off, sometimes old blood, and sometimes new blood. The spotting lasts at least 3 days. Goes away, nothing for one day, then comes right back. I am taking all the same medications I was taking prior to the vaccine. My periods have been very regular and similar to each other for many many years. My sister suggested it might be stress, but I find it funny that I received my second vaccine and that's when these issues with my periods started. I have been under a lot of stress since in the last couple years when I had a miscarriage, my 17 yr old cat died last year of cancer, then my whole family caught covid at Christmas. I was traumatized in late March this year when my Mom passed away after 3 months of suffering in the hospital with much neglect. So wouldn't my period have changed then, not just right after the second vaccine? So my 1st Moderna dose says it was 047C21A 6/18/21 at pharmacy. The 2nd Moderna does says it was 053C2IA (the 2 looks a little like a Z) 7/19/21 also at pharmacy.
Dermatitis; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DERMATITIS (Dermatitis) in an 18-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    MEDICAL HISTORY (Parent): Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    MEDICAL HISTORY (Patient): The patient's past medical history included Maternal exposure during pregnancy.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) 1 dosage form. On an unknown date, the patient experienced DERMATITIS (Dermatitis). At the time of the report, DERMATITIS (Dermatitis) had not resolved.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  Patient mother was given 2 Moderna Covid-19 shots plus whatever suggested she got. Reporter does not exactly know which dose patient mother was given at that time. Reporter does not have vaccination record so cannot provide the specific dates when these were administered and the corresponding lot numbers. Patient had dermatitis that never gets away.   This case was linked to US-MODERNATX, INC.-MOD-2023-716923 (Parent-Child Link).   See case US-MODERNATX-MOD-2023-716923 for details regarding the child case.
Swelling around injection site, red, warm, hard.  6 inch diameter X 3 inch diameter pain from inflammation
(L) Deltoid IM with 25g 5/8" needle. After 4 h injection, severe tenderness at site, lasting 2 weeks. Within 12 h limited ROM, could not reach belt at his back or take shirt off over his head, cannot sleep on (L) side at all. Since 12-21 (inj. date), constant inflammation rarely relieved by ibuprofen. Since 1-08 still limited ROM, cannot sleep on (L) arm with discomfort. Will begin physical therapy to attempt to repair.  7/28/08 Office note for 5/23/08 recieved. Pt c/o aching in R upper arm since Tdap given 12/21/07. Also seen for tick bite at that time. Tick head removed. Reporter states disability due to loss of ROM in arm. PT ordered
Information has been received from a vaccine administrator referring to an unspecified number of multiple patients of unknown age and gender. The patients pertinent medical history, drug allergies and concomitant medications were not reported. On unspecified dates, the patients received improperly stored ROTATEQ (lot # M014318, expiration date: 30-SEP-2017 and lot # M014544, expiration date: 27-NOV-2017), orally, dose unknown. Additional information is not expected since there is no consent to contact the physician.
Unconsolable crying/screaming x 3-6 hours. Fever of 101 x 24 degrees. Rash on (Rt) leg and torso < than 24 degrees.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was blood loss anemia. She also presented to the ED on 4/20/21 with ascites.
Info has been received from a physician concerning a 16 month old female who on 03/10/2000 was vaccinated witih one dose of varicella virus vaccine live (site unknown). On 04/11/2000 the pt developed a rash on her chest that looks like shingles. The reporter noted that the rash was not particularly painful and the pt had no systemic symptoms. On 04/12/2000 the physician did a "viral culture" and the results were not reported. The physician expressed an interest in submitting the specimen for PCR analysis. Follow-up info received on 04/28/2000 from the physician indicated that a specimen has not been sent for PCR analysis due to the fact that "we haven't isolated anything yet". The Herpes Gp Culture and DFA Viral Culture specimen Herpes Cp FA collected on 04/12/2000 showed results inconclusive. No further info is available.
On Tuesday October 26, 2021 client was given 0.25ml of the Pfizer vaccine.  Proper dosage is 0.3ml. Spoke with client on October 29, 2021.  Verbalized understanding of the event.  No adverse outcomes.  No further treatment needed per CDC guidelines.
dose 1: at 4 hours, very tender left arm and swollen upper left arm, at 12-17 hours, 101 degree fever, stomach upset, mild chills, insomnia, at 24 hours rash on trunk, arms.  Left arm remained sore to touch for additional 1.5 days.  dose 2:  at 2 hours sore left arm, at 9 hours lack of appetite, at 11-17 hours body aches, chills, 100 degree fever, at 22-23 hours headache, PND, sore upper left arm, at 26 hours sore upper left arm.
Patient tested positive for Covid-19 on 01/19/2022 at PCP office.  Patient expired on 01/30/2022.  Patients PCP office located.
Initial information received on 27-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2019SA000605, same reporter. This case involves a 21 years old male patient who received vaccines FLUBLOK QIV and FLUZONE QUADRIVALENT. The patient's past medical history and family history were not provided. The patient did not receive any concomitant medication. On 20-Dec-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1818, expiry date 30-Jun-2019 via unknown route in the left deltoid. On unknown date in Oct-2018, the patient received injection of suspect INFLUENZA QUADRIVAL A-B VACCINE, lot number, expiry date was not provided via unknown route at unknown administration site. It was an actual medication error due to extra dose administered. It was reported that On 20 Dec 2018 a 21y, male received a second flu vaccine of FLUBLOK QUADRIVALENT, He had already received a dose of FLUZONE QUADRIVALENT in Oct 2018. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender- none.