chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received expired Moderna Covid-19 vaccine; The vial had been left out at room air from the day before.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (The vial had been left out at room air from the day before.) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2022 at 10:50 AM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Mar-2022, the patient experienced PRODUCT STORAGE ERROR (The vial had been left out at room air from the day before.). On 04-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (The vial had been left out at room air from the day before.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  It was reported as following, Date the vial was initially stored in the refrigerator was 01-Mar-2022.  Date(s) and time(S) vial was first punctured was at 6pm on 03-Mar-2022. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F):16 hrs 35 min.   This case was linked to MOD-2022-503171 (Patient Link).
someone that was 23 years old and pregnant that received Pfizer Covid vaccine; Tourette-like symptoms; This is a spontaneous report from a non-contactable consumer.  A 23-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient was pregnant that received Pfizer Covid vaccine and shortly after the patient began to have horrible side effects and Tourette-like symptoms. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received 2nd dose from a vial that was open for more than 12 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received 2nd dose from a vial that was open for more than 12 hours) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received 2nd dose from a vial that was open for more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received 2nd dose from a vial that was open for more than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported.  Treatment information was not provided.
Nauseous, dizzy, syncopal lasting approx 2-3 seconds.
It has been discovered that patient was given an expired dose of Moderna vaccine. The patient has not experienced an adverse event to the knowledge of clinical staff. Moderna has been contacted to asses vaccine viability.
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 4 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for Covid-19 immunization. The following information was reported: SUICIDAL IDEATION (medically significant) with onset 21Apr2021, outcome "unknown", described as "maybe I will kill myself."; TINNITUS (non-serious), outcome "unknown", described as "buzzing in my left ear". Additional information: When probed for consumer's name and telephone#, consumer stated, "You're breaking up, need to have a better connection". Concern, consumer stated, "I am here for the Booster shots, it is really hard to hear you with a bad connection I am talking too, I can't hear you can you transfer me to someone else. Yes I want to report the side effect from the second Booster shot". When probed to clarify the concern, consumer stated, "No, they shouldn't give that shot because tonight is, I don't know what I am going to do about the buzzing in my left ear (hence MI documented), maybe I will kill myself. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe headache, muscle aches, fever, chills, dizziness, sore arm. Body chills started around 1am, by 7:00 a.m., I had headache and dizziness, with extreme fatigue. I almost passed out after breaking out in cold sweat by 8:30 a.m. Started running a fever around 9:30 a.m. Took Tylenol for headache and body pain. Slept until 1:30p.m. Woke with a fever of 101.4 and severe headache. Took more Tylenol and laid back down.   By 4:30p.m. I was able to lift my head off a pillow and walk without dizziness. Chills and low-grade fever returned around 6:30pm. Went to sleep.   Woke at 7:30 am. No headache, slight fatigue, sore arm. No fever, no dizziness.
Information was received from a 65 year old female patient referring to herself. The patient had a slight case of shingles years ago. Concurrent conditions included high blood pressure and high cholesterol. Concomitant therapies included pravastatin, benazepril and amlodipine. The patient did not have drug reactions/allergies. On 24-FEB-2017 (reported as "Friday"), the patient was vaccinated with a dose of ZOSTAVAX (lot, expiration date, concentration, frequency and route were unknown) in the left arm for prevention of Shingles. And then at the night of 24-FEB-2017, the patient did not want to eat. Subsequently on 25-FEB-2017 (reported as "Saturday"), the patient had the chills and nausea. She laid under an electric blanket for about 3 or 4 hours, but she could not get warm; after that she began to sweat profusely. The patient also believed she had a fever (date unspecified), but she did not take her temperature, so did not know for sure. On 27-FEB-2017 (reported as "today"), the patient had a rash all over her body, in her hair and on face from the top of her head to her ankles. The patient was concerned that the rash on her face would go into her eyes. Also, the patient reported she had itches everywhere. The patient did not seek medical attention. No lab diagnostics study was performed. At the time of reporting, the patient did not recovered from the events. The causality between events and ZOSTAVAX was not provided. No product quality complaint was involved. Additional information has been requested.
Head and neck tremors; Head tremors; arm and shot site pain; swollen joints; This is a spontaneous report received from contactable reporter consumer or other non HCP. The reporter is the patient.   51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Nov2021 at 16:15 as dose 3 (booster), single (Lot number: FJ8757) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. Concomitant medication(s) included: INFLUENZA, on 20Nov2021 as dose 1, single. Past drug history included: Protonix, reaction(s): "Known allergies: Protonix". Vaccination history included: BNT162b2 (Dose Number: 2, Product: Covid 19, Brand: Pfizer, Batch/Lot No: EW0182, Vaccine Administration Time: 10:15 AM, Location of injection: Arm Right), administration date: 16May2021, when the patient was 51-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Product: Covid 19, Brand: Pfizer, Batch/Lot No: EW017, Vaccine Administration Time: 03:30 PM, Location of injection: Arm Left), administration date: 25Apr2021, when the patient was 51-year-old, for Covid-19 Immunization. The following information was reported: TREMOR (non-serious) with onset 20Dec2021, outcome "not recovered", described as "Head and neck tremors"; HEAD TITUBATION (non-serious) with onset 20Dec2021, outcome "not recovered", described as "Head tremors"; VACCINATION SITE PAIN (non-serious) with onset 20Dec2021, outcome "not recovered", described as "arm and shot site pain"; JOINT SWELLING (non-serious) with onset 20Dec2021, outcome "not recovered", described as "swollen joints". Therapeutic measures were not taken as a result of tremor, head titubation, vaccination site pain, joint swelling.   Additional information:-The patient did not had other medical history. The patient had covid prior to vaccination. The patient did not Covid tested post vaccination. The patient did not had other medications in two weeks.  No follow-up attempts are possible. No further information is expected.
10NOV91 burning pain, numbness, sl weakness lt leg; 11NOV91 numbness, sl weakness lt arm; 12NOV91 seen by MD;
Rash, mouth lip swelling, peeling erythema. Treatment given BENADRYL.
Patient inadvertently received the COVID-19 bi-valent (12/8) vaccine, when was due for the 2nd vaccine of his primary series.
Covid arm. Red raised circle growing in size for the past 36 hours at injection site.  Itchy.   13 weeks pregnant at time of vaccination. Other than ?advanced maternal age? no complications . EDD 9/2/21
Client reports pain in arm that has continued 13 + days. Reports difficulty raising her left arm. 9-30-14 client examined by provider, determined normal shoulder exam of LA.
signs of anaphylaxis after eating granola..  full body itching, lightheaded, wheezing, shortness of breath, sensation of throat swelling up
Two days following vaccination, pt presented with red, swollen rash surrounding injection site. (about 4 inches in diameter) Was not itchy or painful. Recommended BENADRYL and doctor visit.
This spontaneous report was received from a registered nurse and refers to 10 patients of an unknown age and gender. The patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On unspecified dates, the patients were vaccinated with improperly stored VARIVAX (lot # L033138, expiration date: 31-AUG-2017; dose and route of administration were not provided). No adverse symptoms were reported. There was no product quality complaint. Additional information has been requested.
An expired Covid-19 pfizer vaccine was administered to the patient on 4/18/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Spoke with patient on 5-11 and she will consider getting revaccinated.
Itching on my upper left leg. Then the next day a few bumps appeared. By Wednesday my leg had several bumps and was painful to the touch.  Thursday I had more bumps breakout on my rear leg then my buttocks and my waistband on my back.  The rash continued to increase in size and was now painful at all times.   I was seen by the doctor on the 31st and told I had shingles.  This is on the same side I received my flu shot.
Around 10/16/2021, I noticed that I was developing burst blood vessels or needle points under my skin, it started in one section. Then it went from one section to being up my thigh, up my stomach and with it, there has been sharp tingling feeling going from my pelvis up to my rib cage. I saw a doctor a week after and they recommended I do a blood draw. I have not heard anything from it yet. I don't have as many of the blood vessels anymore. I am still experiencing the sharp tingling.
2 hours after: severe nausea that lasted for about 1 hour Approximately 8 hours later: fever, chills, body aches, fatigue, headache. These symptoms lasted for approximately 3 days.  Symptoms started to improve and then headache came back even worse and included severe nausea and vomiting that lasted into 5 days post vaccine.
Tinnitus in both ears, constant, never ending; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2022 as dose 3 (booster), single (Lot number: Fk9894) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Prior to vaccination, was the patient diagnosed with COVID-19?:Yes" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. Concomitant medication(s) included: PERTUSSIN [DEQUALINIUM SALICYLATE;GUAIAZULENE]; SYNTHROID; WELLBUTRIN. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Ew0176, Location of injection: Arm Right), administration date: 07May2021, when the patient was 52-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: Ew0168, Location of injection: Arm Right), administration date: 28May2021, when the patient was 53-year-old, for COVID-19 Immunization. The following information was reported: TINNITUS (disability) with onset 04Mar2022, outcome "not recovered", described as "Tinnitus in both ears, constant, never ending". The event "tinnitus in both ears, constant, never ending" required physician office visit. Therapeutic measures were not taken as a result of tinnitus.   Additional information: Patient was diagnosed with vaccine prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Patient did not received any other vaccine in four weeks.  Follow-up attempts are completed. No further information is expected.
Right thigh swollen, warm to touch with erythematous. Swelling started day after vaccine. Cool compresses and Tylenol given by mom. Benadryl started once seen in clinic.
Presented with N/V; + Covid ED; Admit oncology with fatigue and Covid 19; tx with steroids, singulair, zinc; Minimal O2 Requirements throughout stay; uses O2 at home.
Summary: syncopal event, hypotension, leukocytosis  About 22-24 hours after receiving the first dose of the vaccine (1/8/21), the patient became nauseous and lightheaded, sat down in a chair for at least 30 minutes, felt worse and let a coworker know, then had a syncopal episode  lasting 5-10 minutes, coworkers witnessed patient had stable vital signs but unresponsive, diaphoretic, pale, and shaking,  a hospital rapid response was called (patient works at the hospital). Patient was taken to the ED for observation, remained hypotensive (90's/50's) for about an hour, then slowly returned to normal BP (110's/80's) over another hour. Patient likely did not require going to the ED, however was taken there as a precaution due initially to the length of time passed out and hypotension.  Prior to this episode, the patient only experienced soreness at the injection site. Following this episode, the patient felt some weakness and had a mild headache for another 24 hours before returning to baseline.
red, swollen, itchy blotch around injection site most notable 8 days after injection, reaction developed slowly over the course of the 8 days
1 week after my 2nd dose of the Moderna vaccine I developed a rash on my arms (both) and neck. It was hot, red and itchy. I took a medrol dose pack to help with these symptoms. They lasted for about 4 days.
Patient administered vaccine on 18-JAN-2022, which was expired on 14-Jan-2022 and continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period; 1 Expired Dose Administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 Expired Dose Administered) and PRODUCT STORAGE ERROR (Patient administered vaccine on 18-JAN-2022, which was expired on 14-Jan-2022 and continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 Expired Dose Administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient administered vaccine on 18-JAN-2022, which was expired on 14-Jan-2022 and continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 Expired Dose Administered) and PRODUCT STORAGE ERROR (Patient administered vaccine on 18-JAN-2022, which was expired on 14-Jan-2022 and continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the vaccine was continuously stored in stable freezer environment. It was only stored in fridge on date of administration for thaw period. No treatment medications were reported.
4hr p/vax pt generally not feeling well achy, chills, low grade fever on & off for 3 days;also devel hacking cough & rhinitis also mild local rxn;
hives; This is a spontaneous report from a contactable pharmacist. A 24-year-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Deltoid Left on 10Sep2021 (at the age of 24-years-old) (Batch/Lot Number: FD0809) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. Medical history included irritable bowel syndrome. The patient's concomitant medications were not reported. On 13Sep2021, the patient experienced hives (medically significant). The Hives were noticed to be first experienced on the torso on Monday 13Sep2021. The Xifaxan was started on 17Sep2021. On an unspecified date, irritable bowel syndrome disorder. The outcome of the events was unknown.; Sender's Comments: Based on the temporal relation, the association between the event of Urticaria and the suspect product of BNT162B2 cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient fainted right after receiving the vaccine. He waited 30 minutes after and drank water, then was fine.
Pt experienced fatigue and malaise for the following 24 hrs after injection. She then developed redness and swelling to her (R) deltoid and subjective fever.
68 y/o woman, current smoker, evidence of emphysema on imaging, vaccinated with no booster, second dose Moderna 3/2021,  HTN, HLD, preDM, recent + COVID, presenting for hypoxemic resp failure due COVID PNA.    Hospital course:    COVID Pneumonia, Acute hypoxemic Respiratory failure - Symptom onset on 12/27. COVID positive on 12/28. Last fever unknown. Her oxygen requirements down to 3L at rest and needed 3L with ambulation to keep O2 around 92% per RN. She has history of smoking and evidence of emphysema on CTA. Ordered home O2. Will refer to oxygen clinic. I will also start her on spiriva. She has no plans to resume smoking. She has completed 5 days of remdesivir and 5 days of decadron. I will prescribe decadron 6 mg daily on discharge to complete a 10 day course. Please consider PFTs when she recovers from covid. She will continue isolation per Regional/Local ID guidance until 1/16/2022. Her admission CTA did not show clear PE, tiny filling defect vs artifact within RLL PA and small pulm nodules up to 7mm in left lower lobe, given smoking history will need repeat low dose non con chest CT in 6 months for follow up.    PREDIABETES/HTN/HLD: on PTA cozaar and lipitor   TOBACCO SMOKER (2/26/2010): per patient she has quit due to covid infection and declined nicotine patch or smoking cessation classes.    HX OF DEPRESSION: PTA zoloft and elavil
After administering 2 IM injections, Typhoid and Hepatitis A, the patient appeared to faint. He slumped to his right and landed on his mom's lap. His eyes were opening and closing for 3-5 seconds. He was easily arouseable and once the brief episode passed, he was alert and oriented to person, place and time. He did not appear to be in any respiratory or cardiac distress. He did appear slightly pale. Legs lifted to accommodate blood flow to head, water and snack given. He verbalized he was OK, but just did not remember what happened. Mom denies any health problems, allergies, medicatoins or previous reaction like this to a vaccine. He does admit to not eating breakfast. He recovered quickly and left with his mom after 20 minutes. Support and reassurance provided.
Information has been received from a licensed practical nurse concerning an infant who was vaccinated with a dose of ROTATEQ.  The nurse reported that the infant spat out a dose of ROTATEQ.  No adverse effect reported.  Follow up information has been received from a licensed practical nurse concerning a 3 month old female patient with birth weight of 5 pounds and 11 ounces who on 01-OCT-2009, at 4:15PM, was vaccinated orally with a first dose of ROTATEQ (lot # 664068/0319Y).  The patient spat up 10 minutes after receiving the dose of ROTATEQ.  The patient was known to have spitting up on a regular basis.  On the same day, the patient recovered.  Additional information is not expected.
Per ER report 11/15/03 12:24, right arm red swollen for 4 days post tetanus shot. Benadryl for itching, Keflex as directed.
Pt had spots/rashes all over body; face felt hot, and abdominal are felt itchy. When she came to the pharmacy on 1/21/12; vaccine administered 1/18/12.