chrisvoncsefalvay/vaers-outcomes huggingface dataset:
We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that   date the vial was initially stored in the refrigerator 24-Sep-2021.Date of administration of vaccine 24-Oct-2021 - 27-Oct-2021. 44 doses were stored in refrigerator.  Concomitant medications was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-374935, MOD-2021-374694 (Patient Link).
transferred from outside hospital to this hospital for increasing O2 needs; positive for COVID; on NRB and O2 sats at 90%; treated with decadron, lasix, methylprednisone, antibiotics; transferred to MICU; pt's condition declined and she was placed on comfort measures; she passed away in the hospital
I60.9 - Subarachnoid hemorrhage (CMS/HCC) J18.9 - Pneumonia I63.9 - Acute CVA (cerebrovascular accident) (CMS/HCC) N17.9 - Acute kidney failure, unspecified R29.810 - Facial weakness
She started experiencing stomach pain in early January of 2022. She went to her PCP and they found swollen lymph nodes. So, they ordered a CAT SCAN, which showed retroperitoneal lymph nodes and she was referred to a cancer specialist. We ended up going to a cancer center and saw the head of the lymphoma clinic. They ended up diagnosing her with CLL/SLL. For now, they are not treating her and will do a CAT scan/blood work in June. As long as it says the same, they won't do treatment.
Patient too young to receive.  Vaccine approved for 12 and up at the time.  Parents put DOB on requisition wrong to make it appear as if he was over 12.
I felt sick and weak right after shot.  When I got in my car, I knew I was sick.  I had to come home and lay down for the rest of the evening. I felt like I was getting the flu and my ears were ringing, The next day I was about 85% better but still a little weak.  My ears are still ringing and have been ringing every since.
Patient had expected discomfort at injection site for 1-2 days. Started feeling tired about 3-5 days after injection but continue to function well. However, he has had progressive weakness, tiredness and falling asleep just couple hours after sleeping all night and it is at a point as of today where he cannot do his usual work. He also has headache and very cloudy mental status with inability to concentrate and loses his trend of thought. He is highly accomplished individual. He is a compulsive mask wearer and follows strict isolation guidelines. Please advise as we are becoming increasingly concerned.
Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. At the time of the report, EXPIRED PRODUCT ADMINISTERED had resolved. Not Provided.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant informations were reported.  No Treatment informations were reported.   This case was linked to MOD-2021-405875 (Patient Link).
+ COVID test 2/9/2021; patient asymptomatic, presented to the ED status-post fall and was tested at that visit .  Does not get chronic care at our facility.  Patient was transferred from our ED to Hospital on 2/9/2021, so I do not know whether her COVID progressed or resolved.
a little muscle ache on one of his arms; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 52 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 23Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "a little muscle ache on one of his arms". Additional Information: Patient found out that there may be side effects after the second dose and the patient did not know about that. Patient's neighbors and family said they want everyone to take a couple days off after the second dose. Patient was scheduled for the second dose on 13Apr2021 but is scheduled to work 4 days straight. Patient asked if there are side effects after the second dose. Patient stated that the first dose didn't affect him, but had a little muscle ache on one of his arms but it went away.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
She had a significant nose bleed first within 18 hours and then a less significant one within 36 hours of administration of the H1N1 nasal mist.
PER PATIENT AREA OF INJECTION STARTED AS BLISTER, TURNED INTO OPEN WOUND THAT THEN GOT INFECTED. SAW PCP, TREATED WITH ANTIBIOTICS. RESOLVEED IN 1 WEEK.
9/29/13-Very itchy, noticed spots. 9/30/13 - Seen in office - scattered papule vesicles, face, arms, legs, neck, no fever. Rx Benadryl, Aveeno, Tylenol. Child had been exposed previous week.
This case was reported by a pharmacist via call center representative and described the occurrence of herpes on lip in a 70-year-old female patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. On 20th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced herpes on lip. The patient was treated with VALTREX. On an unknown date, the outcome of the herpes on lip was not recovered/not resolved. It was unknown if the reporter considered the herpes on lip to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the doctor. The patient received her dose of SHINGRIX in the left deltoid. The patient was experiencing an outbreak of herpes simplex on her lips and her physician had prescribed VALTREX for her. The reporting pharmacist was not sure when the patient started having symptoms of the outbreak or when the outbreak began.
After waiting 8 minutes, I had a minute episode where my heart started racing out of the blue unexpectedly and after a minute returned to normal.  Within that minute, I was worried I could have physically passed out.  Then it stopped.  I didn't tell anyone because it happened quickly and I was worried it could be misconstrued as anxiety and I didn't fully understand what happened.  The intensity and quickness of the episode felt very physically driven and I'm unsure if this is within the scope of normal reactions.  I have never experienced anything like that getting a vaccine.
1st vaccine:  spontaneous tachycardia (HR 110 initially)  and elevated BP (160/100) at 10 minutes mark which subsequently resolved spontaneously at 30 mins (closely monitored by MD, NP) 2nd vaccine:  spontaneous tachycardia, and elevated BP (160/100) at 10 minutes mark (monitored by MD and NP), normalized after 1 hour of observation. On 1/8/2020 I developed severe fatigue, fever, numbness on lower lip, bitter taste in my mouth, fever, chills, headache until Sunday 1/10/2021. Went to work on 1/11/2021 with worsening symptoms. Ended up in ER on 1/12/2021 due to weakness, high BP, numbness on lower lip, difficulty focusing.  BP is normalizing as of  1/19/2021 but still have weakness, equilibrium is off and difficulty in focusing
A report has been received from a physician concerning a patient, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that the expired FLUMIST QUADRIVALENT had been administered to 12 patients. The outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Patient was taken with the ER, tested positive for COVID-19 upon admission. He passed away on 9/01/21
I kept experiencing a tingling on my top lip, under the top lip like around my teeth, it is like a tingling but it is in the lip and it feels strange just like right in the fleshy part under my lip; There is a tingling and it almost feels like it is numb and it does not last that long; it frightens me; 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 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: PARAESTHESIA ORAL (non-serious), outcome "not recovered", described as "I kept experiencing a tingling on my top lip, under the top lip like around my teeth, it is like a tingling but it is in the lip and it feels strange just like right in the fleshy part under my lip"; HYPOAESTHESIA ORAL (non-serious), outcome "not recovered", described as "There is a tingling and it almost feels like it is numb and it does not last that long; it frightens me". Additional information: next couple of days after got the vaccine the patient experienced a tingling on top lip, under the top lip like around teeth, it was like a tingling but it was in the lip and it felt strange just like right in the fleshy part under lip, not quite on teeth though it was not by gums, it is in the fleshy part of the lip. Ii was a tingling and it almost felt like it was numb and it did not last that long, it lasted for few minutes, once or twice a day.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
ANXIOUS - Treatment cold packs - laid supine with feet elevated - hydration 20 fl oz water.
On 1-03-21, I noticed a large lump on the left side of my clavicle the size of a quarter and increased pain.  I went to urgent care and the PA was unable to diagnose what caused the lump or what the lump was.  On 12-31-20 and 1-04-21 had nose bleeds. Nose bleeds are not a normal occurrence for me and I emailed my NP for further treatment options.  No response yet.
I received my first dose Pfizer vaccine on 03-09-2021. I have a history of blood clot, 10 years ago. I am currently 9 weeks pregnant. I called my doctor's office who encouraged me o go to the ER since I was having symptoms of a blood clot. I went to the emergency room at Hospital where they did some blood testing.  I then went to Hospital where they did more lab work and blood testing, they did an D-dimer test ad my level was at 3.23 and explained to me it could be due to my pregnancy. They ran some more tests showing I have a  clot in the superficial femoral/ popliteal vein. They placed me on Lovanox medication for two days. I will be seeing a maternal fetal doctor tomorrow for further evaluation. They also monitored my baby and baby is doing fine.
2 month old received routine Daptacel, IPOL, ActHIB.  No other problems. Baby was found dead during the night.
Pt to 1/7 ED with c/o low heart rate, dizziness, and feeling shaky. At first encounter patient is A&Ox4, c/o 4/10 substernal chest pain. Denies SOB, nausea, dizziness or diaphoresis. COVID+ 1/8, pt medicated with tylenol for headache, denies further needs. Does not require any oxygen. Breathing regular, unlabored. No s/s distress noted. Pt discharged 1/9. Patient A/Ox4, chest rise and fall symmetrical, trachea midline, and airway patent upon discharge.
Initial information regarding unsolicited case received from pharmacist on 06-Nov-2013: The case involves female patient. The patient's past medical history and concomitant medications were unknown. On 06-Nov-2013, the patient received FLUZONE ID (Lot# and expiration date unknown). The patient received FLUZONE ID and within the 15 minutes after vaccination patient experienced pain, redness, swelling at injection site and later in evening began feeling arm tingling and malaise. The outcomes of the events were unknown. No further relevant information provided. List of documents held by sender: none.
Dose administered after 30-day Use By Date/ Patients were administered from an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/ Patients were administered from an expired vaccine) in a 47-year-old male patient 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/ Patients were administered from an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/ Patients were administered from an expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter stated that on 04-Nov-2021, the vaccine was initially stored in the refrigerator. Date of administration of vaccine to the patients was on 05-Nov-2021 and 12-Nov-2021. And also stated that the vial did not undergo any temperature excursions.  No treatment medications were reported.
Patient was given vaccination on 1/22/21 @ 0940am. Patient was well at the time. Patient reported running a low grade temp over the weekend no higher than 100.1. On Monday 1/25/21 @ 1205pm, patient spiked temp of 105.1. Patient became very confused, lethargic, and unable to make coherent statements.  Patient was given 2 Tylenol by family member and taken to Hospital at this time. Patient tested positive for Covid 19 at this time and was admitted into the hospital and d/c on 1/28/21.
shingles; Information has been received regarding a case in litigation from a lawyer and referred to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacturer, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event shingles was considered as not recovered. The causality assessment between the event and zoster vaccine live (ZOSTAVAX) was considered as related by the lawyer.    The lawyer considered the event shingles to be disability.
Ear infection, vertigo, nausea, vomiting, fever, lethargy, weight loss, severe dehydration. Over the course of three weeks, symptoms increased in intensity and frequency. After several trips to the doctor, several prescriptions to ease the symptoms, and the ER, I was admitted to the hospital for a four day stay on December 20th, 2007.
Hives on my arms and stomach developed within 15 minutes of receiving the vaccine at 2:16. I left the facility after 30 minutes because the hives did not get any worse and I did not experience any other symptoms. At home about 8 hours later, I started feeling exhausted, weak, and my body was literally shaking whenever I stood. Overnight, I felt feverish, I had the worst nightmares, and woke up every few hours. On Friday (next day) I felt dizzy whenever I moved, nauseous whenever I stood, and once when I was standing too long I started vomiting.  On Friday evening I went to a local ER (all the urgent cares were closed) at my primary care Dr?s suggestion to ensure that I wasn?t having an allergic reaction to the vaccine. The ER determined that the hives were likely an allergic reaction but all other symptoms were reactions due to the vaccine.
Dizziness, diarrhea, itching, arm pain, rapid pulse, shakiness, lethargic.
Numbness/Tingling in tongue/throat and part of mouth, Post nasal drip, metallic taste, Chest pain 20 minutes after vaccination. Patient went to Hospital. She had a cardiac workup; everything was normal. Given a dose of BENADRYL and Lidocaine PO.
In the first few minutes, I had a very mild sharp, needle-like pain. The next morning, my arm hurt very badly. Throughout the day, I had moderate fatigue. Also, I had nausea, dizziness, chills, and a feverish feeling (all symptoms were wild). That night, I ate a light, protein-filled meal, 325 mg of Tylenol, laid down for a while, and went to sleep. When I woke up, I feel perfect and had no symptoms.
Took shot abotut 3:37 mild headache starting appx 4 hours after, overnight arm became very sore with palpable know in area, Next day had - very sore arm with knot, some nausea, neck and shoulder stiffness, felt flushed off and on and fatigue 2nd day after (today) - arm is much better but still sore and with knot, nausea off and on today with one episode of vomiting,
Information has been received from a nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates the patients were vaccinated with doses of improperly stored VAQTA lot # K012457, expiration date 04-JUN-2017 (dose and route not reported). No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
AE: rosey smell, hot flashes, feeling nervous/ anxious(at 10:20am) treatment: n/a ; food and drink helped, ate crackers and drank juice. outcome: felt better after eating crackers,                          patient discharged home
76F h/o COPD (not on home O2), HTN, HLD, severe OA who presents with LLE edema and dyspnea, found to have COVID-19.
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 13-year-old male patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 13-OCT-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
The right side of my face (cheek) began to tingle, and the my left hand was tingling as well. This is not normal for me. It feels like my cheek is going to sleep. So I've been rubbing it. As for my left hand, I've been opening and closing it.
On 07/30/2022 I experienced a worsening of my acid reflux. After eating a piece of fruit it felt like I had a lump in my throat. I went to a local urgent care at 02:00AM where they gave me MIRALAX and lidocaine. Neither helped much. I then went to have an endoscope done where they found swelling in my throat. I was prescribed PEPCID and while it hasn't gone away yet, things have improved. I am going in for a follow up swallow test on 09/01/2022.
Patient experiences numbness and tingling on left side of face 3-4 hours after vaccination. She mentioned it felt like going to the dentist and having numbing medicine. She states it lasted for 3 days without medical intervention. Shed stated that on Monday the 8th she went in for estrogen and testosterone "pellets", Symptoms of numbness and tingling returned on Saturday the 13th with numbness, tingling on left side of her face and roof of her mouth. On Sunday the 14th she started getting a rash on the left side of her face and jaw line. She called today to report these symptoms and will be speaking with her PMD tomorrow.
PATIENT WAS PROVIDED 0.1 ML INSTEAD OF THE REQUIRED 0.5 ML; PATIENT IS SCHEDULED FOR 9/23 TO RECEIVE FULL DOSE.  ALL STAFF ARE BEING RE-EDUCATED ON PROPER VACCINE ADMINISTRATION. ?Moderna COVID-19 Vaccine EUA?
No adverse event, but patient and his wife tested positive for COVID19 after full vaccination. Asymptomatic.
Circle rash on arm,forehead,leg,elbow; A spontaneous report was received from a consumer concerning a female patient (Unspecified age) who experienced circle rash on the arm, forehead, leg, and elbow/rash.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date in Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) via unknown route for prophylaxis of COVID-19 infection.   On an unknown date in Feb 2021, the patient experienced circle rash on the arm, forehead, leg, and elbow.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event circle rash on the arm, forehead, leg, and elbow was unknown.