chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication reported   Dates of administration of vaccine were reported as 05-Nov-2021 for some patients and on 12-Nov-2021 for others.  Patient received the booster dose. Vial did not undergo any temperature excursions. The vial was initially stored in the refrigerator on 04-Nov-2021.There were no  adverse event as a result of this misadministration, patients were monitored.  No Treatment medications reported
administered an expired dose of ActHIB with no reported adverse event; Initial information received on 26-Mar-2021 regarding an unsolicited valid non-serious case from a physician.  This case involves a 13 months old female patient who was given an expired 0.5 ml fourth dose of HIB (PRP/T) VACCINE [ACT-HIB] (Lot numbers: carton and powder: UJ144AAA liquid: U6573AA and expiration date : 22-Mar-2021 and also 28-May-2021) via intramuscular route in the left thigh for prophylactic vaccination on 23-Mar-2021 (formulation was however reported as oral solution)(expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included HEPATITIS A VACCINE for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  Reporter was with the question that what do they need to do?  It was not reported that the patient experienced any adverse event   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.
ACUTE RESPIRATORY FAILURE 11/10/2021 ACUTE RENAL FAILURE, UNSPECIFIED  CARDIOGENIC SHOCK 11/10/2021 ACUTE RENAL FAILURE, UNSPECIFIED
48 hours after shot, my arm became swollen, red, fevered, and extremely sore, radiating from injection site to the front of my arm. Also fingers were swollen and numb, with pain in the elbow and shoulder.
Headache, very sore muscles in body as if struck byatruck,fever 100.7
felt unwell; tensed, nerves tensed; flinching and involuntary jerking; flinching and involuntary jerking; Lightheaded and dizzy; a delay in how she felt, her body was feeling sort of a delay, like her body was trying to catch up after the vaccination, had a sense of having to catch up to herself; This is a spontaneous report from a contactable consumer (patient). This 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced side effects included, 5 or 10 minutes after she received first dose of BNT162B2, she felt unwell and tensed, nerves tensed, flinching and involuntary jerking. Lightheaded and dizzy; a delay in how she felt, her body was feeling sort of a delay, like her body was trying to catch up after the vaccination, had a sense of having to catch up to herself, felt that way for at least 3 days. On the 4th day it had gone away. Events reported as non-serious. The outcome of the event was Recovered.  Information on the lot/batch number has been requested.
Nausea, vomiting, muscle weakness,  achiness,  fever  - starting on 9/21/21 and lasting about 24 hours Extreme fatigue - starting on 9/21/21 and lasting about a week Sore throat - starting on 9/25/21 and lasting about 4 days Pain in left arm - starting as a soreness on 9/21/21 and progressing to a throbbing pain in the entire upper arm which also aggravated my carpal tunnel in that arm so that I had pain radiating all the way from the shoulder down through the wrist which lasted about a week. Sores in mouth, including skin peeling off the roof of my mouth - 9/25/21 to about 9/28/21 Redness, rash,  itching, knot in arm around injection site - starting 9/21/21 and all still slightly present Pain and stiffness in left side of neck - starting 9/25/21 and still present Skin reaction to bandage on an unrelated burn which became almost as bad as the burn itself - starting 9/17/21 and not fully healed
Patient received 2nd dose too early. First dose was administered 5/14/2021 and second dose was administered 6/3/2021 when it was due to be given 6/11/2021.
Area on right thigh noted to be indurated, red and raised approximately 3.5 to 4 cm. also warm to the touch. The physician and the pharmacy was notified,  0.1 ml Benadryl was given orally as ordered.
I experienced vaginal bleeding similar to having a period. I had the cramps. I experienced vaginal bleeding from May 24-29. It started up again on June 4 to June 11 of 2022. The second episode had more clotting. 1 large clot came out and then it stopped. I went to the urgent care on the 1st day it started and they thought it was a bladder infection, but it was not. The urinalysis was normal. I was prescribed keflex but I did not take it. On May 31, I had a pap smear with my primary doctor, and it was showing no cervical cancer detected. I then had a Hysteroscopy on June 22,2022 and Uterine Polyps were found. I had a DNC on July 26. I have completely recovered from this since having the DNC
Patient received Pfizer bivalent covid booster instead of Pfizer primary monovalent 1st dose vaccine.  Both of which are maroon vials.  No known adverse effects reported by patients' parent.
Has a bump where they placed the vaccine; Arm hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 13:00 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose , Vaccine Name: Pfizer COVID vaccine, Route, Anatomical Location: by injection to left arm, Date: thinks 29 MAR 2021, not sure), for Covid-19 immunization. The following information was reported: VACCINATION SITE MASS (non-serious) with onset 01May2021, outcome "not recovered", described as "Has a bump where they placed the vaccine"; PAIN IN EXTREMITY (non-serious) with onset 01May2021, outcome "unknown", described as "Arm hurting".  Additional Information: Caller's husband had his second dose 2 weeks ago and has a bump where they placed the vaccine, and it is getting bigger and his arm hurts. On 01MAY2021. States the other day he woke up with bump, caller thought it would go away, but it's hurting a lot, he touches it and it hurts. When asked for start date of arm hurting, caller provides the first one lasted 3 days,  she wasn't sure if it would go away for him or not.Her husband's is getting bigger and hurting more. Time the Vaccination Was Given: in between 12:30 and 13:00, it was during lunchtime. Additional Vaccines Administered on Same Date of the Pfizer Suspect was no. The adverse events has not resulted in Emergency Room and Physician Office visit. Prior Vaccinations (within 4 weeks) was reported as no. Adverse events following prior vaccinations was no. Patient's Medical History (including any illness at time of vaccination). Relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) was no. Family Medical History Relevant to adverse events was none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain at the injection site, general fatigue, myalgias, and chills starting about 6 hours post-vaccination and lasting for 24 hours
Headache, nausea after 1st shot, recovered in 2 days. Developed rash in a week after 2nd shot. Saw dr, dermatologist and allergist finally diagnosed by Dr after having rash for 1 year. Rash continued for 15 months and has not reoccurred.
This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingle vaccine (several years ago of reporting). In July 2021, the patient received the 2nd dose of Shingles vaccine. In April 2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 5 months after receiving Shingles vaccine and less than 9 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, tenderness and blister. On an unknown date, the outcome of the vaccination failure, shingles, tenderness and blister were unknown. It was unknown if the reporter considered the vaccination failure, shingles, tenderness and blister to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingle vaccine several years ago of reporting, his/her physician urged to get the new Shingles vaccine, this year and the patient did get the 2 series of Shingles shot April and July 2021. A few weeks ago, of reporting, the patient broke out with a case of the classic shingles. The patient stated he/she was told at Urgent Care. The patient stated he/she was not sick, just had some tenderness and blisters all on one side of body. The patient asked question has anyone had this happen. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
felt 'ill'; tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable Nurse. A 58-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular, administered in the left arm on 01Jan2021 at 08:30 (Batch/Lot Number: EL3248) as a single dose (at the age of 58-years-old) and dose 2 intramuscular, administered in left arm on 02Feb2021 at 12:15 (Batch/Lot Number: EL3248) as a single dose, (at the age of 58-years-old),  for COVID-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient did not have COVID-19 prior to receiving the BNT162B2 vaccination.  The patient experienced vaccination failure on an unknown date in Mar2021. On 16Mar2021 the patient reported he felt ill and tested positive for COVID on 22Mar2021(as reported).  The events resulted in a doctor or other healthcare professional office/clinic visit. Treatment was reported as unknown. The patient underwent lab test which included on 21Mar2021 COVID-19 test (PCR nasal swab test) was positive. The outcome of events vaccination failure, COVID-19 (tested positive for COVID-19), and felt ill was recovered on an unknown date.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Vaccination failure and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
severe weakness, low blood pressure, tachycardia, feels faint/near syncope, mild but new dyspnea on exertion and severe tremor of hands interfering with activities such as feeding herself, occasional mild headache. admitted to observation in emergency center, discharged home
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 28-OCT-2015 15:59, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 5.8 and 2.9 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
I received the Moderna Bivalent booster on 10/4/2022. On 12/26/2022, I had congestion and fatigue. I had had a common cold about three weeks before. Also, I was in a higher altitude than what I'm accustomed to, so I thought that maybe that also played a role in my symptoms. On 12/27/2022, I developed a dry cough that later became a productive cough. My wife tested positive for COVID-19 that day; I tested myself the same day, but my result was negative. I then tested myself again on 12/28/2022 and also got a positive result. I progressively became more fatigued and felt lightheaded for the next few days. At the time of this writing, this is the first day since my illness that I have not been lightheaded. I spoke with my doctor to see if he recommended PAXLOVID, but he advised me that it was almost too late for me to begin taking it for it to be effective. Not only that, but I also take a statin, and if I had begun taking the PAXLOVID, I would have had to stop taking the statin, which is inadvisable. The only medicine I took during my illness was one ALEVE on 12/28/2022, which helped with the headache. I now feel that I'm getting better. The lightheadedness is gone. I also have more energy. I still have some congestion, though it is less pronounced, plus I am coughing less.
Arm was swollen with redness, with a red ridge swollen across it. Started having chills Friday night. Diarrhea and chills Saturday. Swelling has improved, just itching now. Feels better in general.
after receiving Menatra and Trumemba pt was sitting in room with mom and stated she didn't feel right, then eyes closed and fell to side onto medical table pt was sitting on, mom reports upper and lower b/l shaking of extremities, all lasting < 20-30seconds. no color change. pt came too before I entered the room and cool compress applied, and advised to drink water. HR and BP rechecked, BP slight high, rechecked again in 5mins and nl for pt. nl heart physical exam. pt reports feeling completely normal prior to leaving office and spent another 15mins in office to evaluate finger that she also wanted PE clearance for at time.
Vomiting several times, headache, sore throat occurred 3 days after immunizations.
I received my second shot of the Covid-19 vaccine on Wednesday, April 7th and on April 12 the arm that got the shot became sore and tender. The next day the whole upper arm was red and sore and it remains that way today. (04/14/2021)
Dehydration; Symptoms of the flu; Soreness; Unable to sleep; Aches in joints; Nausea; Fever; Tiredness; This is a spontaneous report from a contactable other healthcare professional. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: er8732) via an unspecified route of administration in the left arm on 30Mar2021 at 13:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had no known allergies. 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 medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: er8732) via an unspecified route of administration in the left arm on an unspecified date in Mar2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 the patient experienced dehydration, aches in joints, nausea, fever, soreness, symptoms of the flu, tiredness and unable to sleep. The adverse events did not result in a visit to the doctors or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events dehydration, aches in joints, nausea, fever, soreness, symptoms of the flu, tiredness and unable to sleep were not recovered at the time of this report.     No follow-up attempts are needed. No further information is expected.
Pain in shoulder/upper arm. Swelling/rash  on shoulder/upper arm. Swelling/redness in armpit.
Severe Joint Pain; Rash; Achy Muscles; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer). The reporter is the patient. A 63 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm right, administration date 09Dec2021 16:45 (Lot number: FG3527) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Stage 3A Kidney Disease" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Pfizer COVID 19, Dose Number: 2, Batch/Lot No: EW0169, Location of injection: Arm Right), administration date: 21Apr2021, when the patient was 63 years old, for COVID-19 immunization; Bnt162b2 (Pfizer COVID 19, Dose Number: 1, Batch/Lot No: EW0150, Location of injection: Arm Left), administration date: 30Mar2021, when the patient was 63 years old, for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 13Dec2021, outcome "recovering", described as "Severe Joint Pain"; RASH (non-serious) with onset 13Dec2021, outcome "recovering", described as "Rash"; MYALGIA (non-serious) with onset 13Dec2021, outcome "recovering", described as "Achy Muscles"; FATIGUE (non-serious) with onset 13Dec2021, outcome "recovering", described as "Fatigue". Therapeutic measures were not taken as a result of arthralgia, rash, myalgia, fatigue. Additional information The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies.
(One) lump appeared below where shot was administered that appeared 2 day)  after vaccine. When lump disappeared after ER visit on Sat; On Monday 2  4inch radius rash appeared that last 4 1/2 weeks.
Pt received flu shot 2/7/17 Rt deltoid. Presented today 2/9/17 with red arm (Rt.), some swelling and warm to touch. Reddened area was measured >70mm long and 50mm wide. Pt. states she had a flu shot in Oct.
Pain, lower left back area below ribcage. Currently undergoing physical therapy.  Treatment plan, 2x per week for four weeks. Completed two weeks of therapy as of May 26.
I woke up this morning, very light headed. I wear a Fitbit and my heart rate has been 118-130 bpm, my resting heart rate is typically 71 bpm. My whole body is also sore. I don't have a fever or chills..
On Feb 1, started noticing A-Fib episodes; subsequent went to heart doctor; ended up on medication; then, I recently received my booster shot last Saturday, the 6th of November.  Since then, i have had two episodes of A-Fib.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Information regarding drug reactions or allergies and medical history was not reported. On an unknown date at unspecified number of patients received the doses of VARIVAX (Merck) (dose, route, anatomical location, lot#, expiration date were not reported) that underwent a supported temperature excursion. No adverse experiences were reported. Concomitant therapies were not reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
After a couple of months, I developed hives all over my body on a daily basis.  They come and go at all times and locations about my body.  I also get a rad circle rash with a white center on the palms of my hands.  Then after another couple of months, I developed tinnitus in my left ear.
On 6/8/01 PM, pt had sudden onset of severe right upper chest pain; was taken to ER and developed hypotension, severe abdominal pain and vomiting. She was Rx'd with dopamine IV antibiotic fluids and transferred to ICU. In 10 to 12 hours, weaned off pressors; fever resolved and discharged home on po antibiotics after 3 day stay.
Nov 19 in evening. Pain in back of knees. Went to Urgent Care on Nov 20 tx: PREDNISONE. K + was increased na + was decreased.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for 1 day and as dose 2, single (Batch/Lot number: unknown) for 1 day for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma; "thyroid" (unspecified if ongoing), notes: Other medical history: thyroid. The patient's concomitant medications were not reported. Past drug history included: Codine, reaction(s): "Known allergies  Codine", notes: Known allergies: Codine. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (20May2022) temperature swings 101.5 to 95.5 in minutes. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
10yo child experienced redness (approx 6' x 10'), pain & swelling @ inject site w/in 24hrs p/immun; Tx included APAP & cold compresses @ inject site, child recovered w/no sequelae;
states became ill on 9/21/21 with headache; achiness; feeling feverish; congestion and sneezing.
pt recv vax 15APR96 & 31MAR97 pt devel approx 200 typical vesicular lesions on head & trunk;several were open;
Headache, Myalgia, Arthralgia, Fever, chills; soreness at injection site, fatigue Narrative: