chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a health professional refers to a 14-year-old patient (gender was not reported). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received her second dose of Moderna vaccine around 12:50pm. Around 1:54pm she presented to the pharmacy stating she was feeling short of breath. She had waited the initial 15 minutes and went shopping around the store. I gave her 50mg of benadryl (liquid) and had her sit down. She started feeling better. I asked if her throat or tongue felt like they were swelling shut and she told me 'not anymore, it did before but not anymore'.  I continued to check on her and she continued to improve. I asked her to call someone to pick her up and her husband arrived around 2:30pm to pick her up. She walked out with her husband and said she was ok. Upon retrieving her paperwork to start this form I saw that she indicated she was pregnant/considering becoming pregnant in the next month/breastfeeding and my coworker (pharmacist) confirmed  that she is pregnant. He had screened her before her shot and she did confirm she is pregnant and was also pregnant for her first dose. He had asked her at screening if she had any issues with the first dose to which she said 'no', however when I asked if she had any issues with the first dose after giving her Benadryl she stated that she did 'get red' for a little bit and at that time we had asked her to stay an extra 15 minutes.
No additional AEs; Caller reported vaccine administered after temperature excursion.; This spontaneous report has been received from a nurse and refers to a patient of an unknown age and gender. The patient's medical history, current conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 23-JAN-2023, the patient was vaccinated with an improperly stored of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA (recombinant human albumin)) (PROQUAD) subcutaneous injection, at a dose of 0.5 milliliter (ml), subcutaneously (SQ)(strength and vaccination scheme frequency were not provided; lot number W024973 that was verified to be valid, expiration date reported and established as 05-FEB-2024, for prophylaxis (product storage error).  The administered vaccine experienced a temperature excursion of -13.25 degrees celsius (C) during a time frame of 11 minutes. There was not a previously temperature excursion reported.  There was no additional adverse event (AE) reported (no adverse event).
positive for COVID infection 3 days after receiving my vaccine; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine: Formulation: solution for injection) via an unspecified route of administration on 03Feb2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. An unspecified date the patient received antibodies infusion for an unspecified underlying condition, the patient had in quarantine and back to normal, after 3 days of vaccination the patient reported COVID positive infection. The outcome of the events was unknown.  Information of lot/batch number has been requested.
Within an hour after my dose, I started to feel itchy on my hands. Then I was itching all over, including my face and mouth. Then I called my doctor and they recommended Benadryl. I took the medication. I had body aches as well and I was sick for the next two days.
Patient complains of left arm throbbing, left arm pain 10/10, loss of range of motion, and headache.  Pertinent negatives include hives, dyspnea, palpitations, dizziness, nausea, vomiting, warmth or redness at injection site.
Right arm sore, swollen and warm to the touch right after shot. Still a tad sore but getting better two days later.  A little over 24 hours (Friday evening), had chills, felt hot but no fever, and had body aches. Felt good next morning after 800mg ibuprofen.
Serve Hives, Dizziness, vomiting , tightness in injection sites both times, chest pain shortness of breath, Welts breaking the skin in bleeding, tightness & pain in chest. HD was notified of adverse event after 1st dose & still insisted on second.
2nd shot comes around, I went and got that as well and the tinnitus intensified. I suffered from this in the past and it came back with a vengeance. Went to see the doctor for the tinnitus, and she did some full testing for hearing test etc. She asked me what the reason was for my visit and it was the ringing in the ear after the vaccine. She noted she heard this a lot from other Moderna patients. She did find some roll off at the top end of the frequency band but she said that's right at where the frequency would be with the ringing. It's almost impossible to tell if it's responsible for your hearing loss at the top. She said she couldn't discount the vaccine or hearing loss to age. She said she couldn't do anything about it. She recommended vitamins and my digestive system couldn't tolerate it.
This spontaneous report was received from a certified medical assistant and refers to three unspecified patients of unknown genders and ages. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 11-APR-2016, the patients were vaccinated with doses of improperly stored VARIVAX (which had the lot number of L043619 with expiration date 02-NOV-2017 and lot number L048467 with expiration date 02-DEC-2017) (dose, route of administration and injection site were not reported). The vaccines were exposed to 11 degrees Celsius for 48 hours. Data logger was involved. There were no previous excursions reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. Follow-up information was received on 12-MAY-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received from a practice manager on 16-MAY-2016. The reporter referred about a 4 years, 1 month female patient. Additionally, it was reported that an opening time, at 8 am, the freezer temp was -13.5 C, and this was not discovered until 1:10 pm by the time of discovery 3 doses had been administered. However, no adverse reactions were reported. This is one of several cases from the same reporter. Additional information has been requested. General information, patient information and narrative were updated.
No adverse events experienced at this time.  Reporting because a 1.0ml dose was administered of the Moderna COVID 19 vaccine.  patient received a double dose
My first dose of the vaccine was on Jan 15, 2021, my second dose on Feb. 4th, 2021. Two weeks after my second dose I broke out in a rash over my entire face, neck,  and upper chest. My face became red, hot, swollen, I had a burning sensation, and severe itching. Since then I have had the same rash recur monthly in the same manner (total of 5x now). I don't have any food or drug allergies and have never had an allergic reaction to anything. I treat the rash with benadryl, which I have to take consistently over two days until the rash begins to disappear.
Patient reported a skin rash about 2 - 3 inch diameter; feverish; she said it lasted one week. Took a few doses of Benadryl oral.
Patient stated she woke up in the middle of the night sweating and with body aches. Stated that she also had a low grade fever (stated it was 100ish)
The evening when I got the vaccine I was very fatigued. I woke up the next day to itching on my scalp and arm. I developed a rash that started on my right nipple then up to my neck and scalp and down my right arm down to my wrist. I used 'sting-a-way' which helped for day. I went to the dr. on the 18th of Oct and the itching was getting worse. The dr. gave me hydroxyzine. After a few days of medication the rash had cleared up.
Shingles; Information has been received from a lawyer and the patient regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  In 2015, the patient (pt) was vaccinated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) for long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles and was treated by a healthcare provider at medical office; and was hospitalized due to the event (date unspecified). As a direct and proximate result of pt use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was reported as not resolved.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
received an expire vaccine of  ACTHIB, with no reported adverse event; Initial information received on 18-Nov-2021 regarding an unsolicited valid non-serious case from a other health professional via Medical Information (MI) (Reference number- 00864547).  This case involves a 66 year old male patient who was vaccinated with the expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient past medical history included Stem cell transplant.  The patient past medical treatment, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP HEPB) for Prophylactic vaccination.  On 18-Nov-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ4D4AA and expiry date: 04-Oct-2021) (Frequency once) via intramuscular route in the arm not otherwise specified (nos) for prophylactic vaccination.  It was an actual medication error case due to expired product administered (latency on same day).  It was reported "Caller states that a patient in her office received an ACTHIB vaccine that expired on 04OCT2021. asked how to proceed and asked for information on expired product to be emailed to her. Caller states that the patient received ACTHIB because he is a stem cell transplant recipient".  At time of reporting, no adverse event was reported.  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.
Patient inadvertently given a 3rd dose of Varicella. Observed. No adverse reaction noted. Time course: 11:00 Am- 4:15 AM.
Adverse effect of vaccine, initial encounter   Rash - Notes that rash started after she received the second COVID dose but unable to state exactly when the rash started - Vaccine received in left arm and has a rash to left upper arm and chest - + redness - Denies fever, chills, itchingPlan:  - Likely related to recent COVID vaccine - Will have clinic RN submit VAERS report - Recommend a moisturizer  - Pt will continue to monitor for worsening symptoms - Follow-up with PCP as needed for concerns
COVID+ 12/14/22.  Vaccination status - moderna x4 + Moderna Bivalent BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider: DO Admission Date: 12/14/2022 Discharge Date: Dec 16, 2022   Active Hospital Problems   Diagnosis Date Noted POA ? Pneumonia due to COVID-19 virus 12/14/2022 Unknown ? Hyponatremia 12/14/2022 Unknown ? COVID-19 12/14/2022 Unknown ? BPH with obstruction/lower urinary tract symptoms 06/15/2022 Yes ? Peripheral vascular disease, unspecified (HCC) 08/31/2021 Yes ? Morbid obesity with BMI of 45.0-49.9, adult (HCC)   Yes ? Hypothyroidism due to acquired atrophy of thyroid 03/09/2017 Yes ? Hx of ischemic right PCA stroke 03/09/2017 Yes ? OAB (overactive bladder)   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia COVID-19    HOSPITAL COURSE: Pt. is a 79 year old male with PMH of essential hypertension, history of CVA, hypothyroid. Pt. presented to the ED with five days of SOB and cough. He was found to be hypoxic, COVID positive, and admitted to the hospital. Chest x-ray was consistent with COVID pneumonia. Remdesivir and decadron were given.  Patient was sating well on 2 to 3L supplemental O2 initially, but was quickly weaned back to room air. Oxygen levels remained stable on room air for 24 hours prior to discharge. PT/OT recommended home with assist. He will complete 10 days total of decadron. Follow up with PCP outpatient. Pt. is discharging in improved and stable condition.
After injection on 01/16/2021, within 2 days all soreness had dissapted along with swelling and redness.  On 01/24/2021 roughly at 04:45 A.M., I began to chill/shiver.  The injection site on my right arm had become hot to the touch, peppered with red blotches, swollen and began to hurt again.  I did take 1000mg of Tylenol for discomfort.  I felt flushed, but no fever to speak of, rather lethargic.  Today, 01/25/2021, the injection site is one large reddened, hot, swollen area about a size 3x4 inches.  At this time, I have not visited my physician or any Urgent Care.
Pt fainted and looked to have seizing. pt revived and said he was fine, and asked for alcohol to smell. EMS was called and pt was examined. Pt later disclosed that he always faints when he gets shots and he has anxiety.  Pt refused to go with EMS and pt mom said she would take him to doctor
Patient reported tachycardia several hours after the administration of the vaccine, and three subsequent episodes of tachycardia within the subsequent 6 days thereafter. Patient stated using diphenhydramine to self-treat, which temporarily controlled the heart rate.
Bell's Palsy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BELL'S PALSY (medically significant), outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pain in shoulder and arm.  Saw NP after 1 week.  Dx with bursitis.
Pain at site on 11-18-10, noticed 2x3" redness at site on 11-19-10, lymph node (axilla) reactive.
Rash and itching at the injection site which is still present after 4 weeks, as well as scabbing.; Rash and itching at the injection site which is still present after 4 weeks, as well as scabbing.; Rash and itching at the injection site which is still present after 4 weeks, as well as scabbing.; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 (Lot number: FH8027) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Allergies: Cephalosporins" (unspecified if ongoing); "Allergies: wasp sting" (unspecified if ongoing); "Allergies: latex" (unspecified if ongoing); "Allergies: nickel" (unspecified if ongoing); "Allergies: tree pollen" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; LIOTHYRONINE; WELLBUTRIN; LEXAPRO; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (COVID 19, lot number EN6202, administration date 26Feb2021, dose number 2, vaccine location Left arm), administration date: 26Feb2021, when the patient was 36 years old, for COVID-19 immunization; Bnt162b2 (COVID 19, lot number EM9809, administration date 05Feb2021, dose number 1, vaccine location Left arm), administration date: 05Feb2021, when the patient was 36 years old, for COVID-19 immunization; Flu shot (other vaccine 4weeks product=Flu shot, vaccine date 09Nov2021, dose number 1, vaccine location left deltoid), administration date: 09Nov2021, when the patient was 37 years old, for Immunization. The following information was reported: RASH (non-serious), PRURITUS (non-serious), SCAB (non-serious) all with onset 15Dec2021, outcome "not recovered" and all described as "Rash and itching at the injection site which is still present after 4 weeks, as well as scabbing.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of rash, pruritus, scab.  Additional Information: Facility type vaccine Doctor's office/urgent care, other vaccine in four weeks: Yes. Other vaccine 4weeks product was Flu shot on left deltoid on 09Nov2021 as dose 1.other medications in two weeks: Synthroid, Liothyronine, Wellbutrin, Lexapro, Zyrt. Known allergies to Cephalosporins, wasp sting, latex, nickel, tree pollen. Other medical history included Hypothyroidism, depression, anxiety  The lot number for bnt162b2 was not provided and will be requested during follow up.
Severe chill followed by low grade fever(98.2 F; normally I am about 97.5), mild headache that lasted about 12 hours, very dry mouth, and metallic taste in mouth.   Accompanied by a feeling of mild intoxication / indifference / being unmotivated which lasted most of the next day.   The lack of motivation with a slight tiredness seems to still be slightly present 11 days later.
Within 5 minutes of injection, I was sweating profusely, black/blurry vision, immediate headache, felt faint, and nauseated. I vomited once at minute 5, and after that all symptoms subsided. By minute 15, I was fine. I had a mild headache all day, lowgrade fever (98-99, usual temp is 96),  and fatigued, but otherwise felt ok. That night, I had a severe headache with neck pain and a fever of 101-103 with chills. Took tylenol and drank water all night. The following morning, temp was 99-101, moderate headache. By the afternoon, all symptoms were gone except a minor headache and sore arm. Today is day 5 and all that's left is a sore arm and fatigue.
Patient received vaccine at15:29. At 16:00 patient reported arm pain and stated that her chest felt tight and that she was not able to fully inhale and exhale. BP was taken at 15:30 BP 175/108 -- >  16:00  BP 177/110 -- > 16:05 BP 184/109; fingerstick at 16:10 was 103. A RRT was called and patient was transferred to the ED.
On January 21, 2021 at the Clinic, an PA was administering vaccinations during the morning for a four-hour shift, 8 AM to noon. At the end of her shift, she handed off her vaccines to another vaccinator. The PA had three doses of vaccine drawn up at that time, in syringes, on her desk. When the nurse inspected the syringes, she found 0.4mL of vaccine had been drawn into those syringes rather than the required 0.3mL. The nurse then alerted the APRN, who escalated the situation to the manager. The manager then contacted Quality. The concern was that the PA had been vaccinating patients all morning with an inappropriate dose of vaccine, 0.4mL. After thorough internal investigation, we found that the PA drew up 38 vaccine doses and administered 35 of them. Additionally, based on vial usage for the day and total number of vaccines administered, we have concluded that it is highly unlikely that excess vaccine was administered. This was a near miss event and is being reported out of an abundance of caution.
Was fine at time of shot. A few seconds after shot was administered eyes rolled back in head and fell back on table (fainted) then began to convulse for maybe 10 seconds...nurse put her legs up in the air and I held fan in her face while beating on the wall for help. She then began to open her eyes and then close them again like she could not stay awake. After a few minutes color back and awake. Other nurse brought fluids and crakers for her to eat. Patient had had a big lunch around 1:30 and plenty of juice to drink before going to Health Dept.
At 5:30, started getting woozy in a fog. Could not remember what happened. For the next 2 days patient was in bed. The following morning patient went to bathroom, urine is red, which hasn't happened in years. Patient may think dizziness is from blood loss. The following days it slowly cleared. Patient contacted doctor. A few days after MD appointment patient was back to normal.
4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test after receiving the whole series; 4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test after receiving the whole series; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for 4 patients, calling on behalf of another office. This report is for 1st of 4 patient.   A patient of unspecified age and gender received the 1st and 2nd doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient was tested positive for covid after receiving the 2nd dose over 15 days before this report/4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test 15 days after receiving the whole series on an unspecified date. The patient had no Covid symptoms, feeling fine after both doses. The patient underwent lab tests and procedures which included Sars-cov-2 test (rapid antigen test kit): positive. The outcome of events was unknown. Reporter was wondering if it was a false positive.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101864 same reporter/drug/event, different patient;US-PFIZER INC-2021101866 same reporter/drug/event, different patient;US-PFIZER INC-2021101865 same reporter/drug/event, different patient