chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore; patient mentioned that she was fine after every Moderna vaccine, just sore, queasy, rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.; Rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.; Swelling; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Sore), NAUSEA (patient mentioned that she was fine after every Moderna vaccine, just sore, queasy, rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.), FEELING ABNORMAL (Rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.) and SWELLING (Swelling) in a 5-decade-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Sore), NAUSEA (patient mentioned that she was fine after every Moderna vaccine, just sore, queasy, rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.), FEELING ABNORMAL (Rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.) and SWELLING (Swelling). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, PAIN (Sore), NAUSEA (patient mentioned that she was fine after every Moderna vaccine, just sore, queasy, rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.), FEELING ABNORMAL (Rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.) and SWELLING (Swelling) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. Patient had a total knee replacement surgery on 28-Sep-2023.   This case was linked to US-MODERNATX, INC.-MOD-2023-749216 (E2B Linked Report). This case was linked to MOD-2023-749215 (Patient Link).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749216:Husband case
Pain and swelling in arm did not subside for more than a week. Swelling finally subsided, but pain and tenderness persists nearly two months later. The tenderness is at the injection site. The pain feels deeper in the muscle, almost like a burning sensation. Neither Tylenol nor Advil dulls the pain.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-JUL-2017, the patient was vaccinated with expired dose of PROQUAD (lot # M003436, expiry date: 19-JUL-2017) reconstituted with sterile diluent (Manufacturer unknown) (lot # and expiry date were unknown) for prophylaxis. No adverse effects reported. Additional information has been requested.
white flashing, like white lights in both eyes like a field of fireworks; vision was also like it had a floater or two, black or white; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Mar2021 13:00 (Lot number: EP7534) at the age of 66 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PHOTOPSIA (non-serious) with onset 25Mar2021 13:05, outcome "recovered" (25Mar2021 13:06), described as "white flashing, like white lights in both eyes like a field of fireworks"; VITREOUS FLOATERS (non-serious) with onset 25Mar2021 13:05, outcome "recovered" (25Mar2021 13:06), described as "vision was also like it had a floater or two, black or white". Additional information: Clinical course: Patient got the shot on Thursday and she was talking to the person administering the shot then got up and sat down in the waiting area and she stated that as soon as she sat down, she started seeing white flashing, like white lights in both eyes like a field of fireworks. It lasted a whole minute to a minute and a half. Patient's vision was also like it had a floater or two, black or white, and had one flash occasionally. It was reported that patient panicked and thought she was having a detached retina or something. Patient didn't know if she could see through the white lights but that they went away after a minute or two. Patient wanted to know if anyone else has had this and was afraid that if she gets the second shot that it will happen again. Patient was reported to be an excessively healthy person and stated that she's not getting the COVID shot because she has a fear of getting COVID. The patient had no history of all previous immunizations with the Pfizer vaccine considered as suspect, no additional vaccines administered on same date of the Pfizer suspect, prior vaccinations within 4 weeks and no adverse events following prior vaccinations and no relevant tests. Patient stated that she doesn't get flu shots, she doesn't want to put all that garbage in her body, she was healthy.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a pharmacist via field representative refers to a 68 year old female patient. The patient's relevant medical history and concurrent condition were not reported. The patient's concomitant medication included momordica chairanta topical ointment. On an unknown date in 2015, the patient was vaccinated with one dose of ZOSTAVAX vial 19400 plaque-forming unit (PFU), for prevention of shingles (lot#, expiry date, route and frequency were not reported). On 03-JUL-2018, the patient developed shingles. It was reported that some of the shingles were around the patient's eyes. The patient visited physician. As of 12-JUL-2018 (reported as currently), the patient was taking "VALTREX 1 gram three times daily" to treat the shingles. No product quality complaint (PQC) was involved. The patient did not recover from the event. The reporter did not provide any causality assessment.
Received TDAP Vaccine on 1/7/2009.  Came in to employee health on 1/9/2009 with left arm red, warm to touch, and stated the area was larger than it had been and seem to be getting bigger.  States arm is painful on movement. Pt stated she had iced her arm and taken ibuprofen for last two days.
Mother noticed redness at Rt. deltoid injection site on evening of vaccination. On Tues. 3/6/12 Rt. deltoid was red, swollen and hard.  Symptoms continued on Wednesday 3/7/12 and by Thursday morning redness on Rt. deltoid had increased in size and area felt warm to touch.  Mother took child to nurse practitioner.  Treated with antibiotic due to cellulitis per mother's report.  Child is to follow up with NP if signs and symptoms are not relieved.
Two days after receiving the vaccine, and daily after that, I got hives in the morning.  They were mostly on my upper legs, but  on 24 March, I also had them on both buttocks.  They would itch first, and then the hives would pop up. They would disappear after about 30 minutes to an hour for the rest of the day.  But then, the next morning, I would get them again.    I didn't know if it was from the vaccine or not.  On 24 March, I decided to not take my Linzess the next morning because the hives always came out about 2 hours after taking it.  I've been on Linzess for  months, so I didn't really think that the hives were from that, but since I stopped taking it 2 days ago, I haven't had hives at all.  Could it possibly be a contraindication from Linzess and the vaccine?  I'm worried about getting the 2nd vaccine on 4/1.
Patient felt sick the next day. She described it as she was hit by a truck. She was extremely tired and felt very sick. Her injection arm also developed two big round spots of rash one around site and another below it.
skin was punctured with the needle and medication squirted out onto mask,  observed syringe and patient did not receive any of the dose. upon adding the needle to the syringe, med was observed leaving the needle top when the air bubbles were removed from the syringe. administrator not expecting this incident. needle was removed from arm and bandaid applied. rx was reprocessed and successfully administered into the right arm. patient was understanding and satisfied with the situation and results.
Bruising, redness, warmth & soreness to RUE. Bruising to localized area of injection. Redness, warmth & soreness radiating downward to elbow. Patient told to take Aleve/Ibuprofen, use cold/warm compresses and take benadryl.
Headache, body ache, arm swollen, 100.1 temp, nausea and overall very sick
Patient vaccinated and later that evening felt that she was freezing and then vomited. Patient woke up the next morning feeling weak and had a tingly face.
I had cough, running nose, mild fever, fatigue, joint pain and vomiting a lot. I have an ongoing cough. On Dec 30th, I got tested for Covid-19, positive result. They did a flu and strep test, negative results.
patient dob not yet 12yo was given adult Pfizer by an intern. Was contacted by our corporate to look into and confirmed. Contacted mom and mom stated she is fine without any side effects
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot#J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck.  Follow up information has been received from the registered nurse who provided patients details. This report refers to a 6 weeks old infant patient of unknown gender. On 03-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot#J016188, expiration date 02-OCT-2014) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
PATIENT & MOTHER RECEIVED ANNUAL FLU VACCINE AT 8PM ON EVENING OF 11/09/2020. PATIENT RECEIVED HERS 1ST IN THE RIGHT DELTOID MUSCLE. NO SIGNS/SYMPTOMS NOTED AT THIS TIME. AS SHE WAITED APPROXIMATELY 3 MINUTES STANDING BEHIND SHE BECAME DIZZY/LIGHT HEADED AND FELL TO THE FLOOR. SHE WAS MOVED TO BENCH WHERE SYMPTOMS RETURNED 5 MINUTES LATER. SHE WAS OBSERVED FOR 15 MINUTES, GIVEN GATORADE AND CHIPS, AND LEFT WITH MOTHER ON HER OWN ACCORD.
Bivalent not given as the 3rd dose. gave regular under 5 - no reactions
Rash from head to toe, fatigue severe to mod. Nausea, vomiting headache, body aches, sx's lasting 2 weeks prednisone, ABO, TYLENOL, ALEVE.
Breakthrough case admission after 4 vaccines Moderna 1/25/21 Lot# 012L20A;  Moderna 2/22/21 Lot# 006M20A;  Moderna 12/7/21 Lot# 005C21A;  Moderna 2/17/23 Lot# 023H22A
High fever - reached 103 F that night accompanied by vertigo and chills.  Around 10 pm, I started extreme vomiting. Was extremely dizzy so was having to lay on my side during this. My heartrate, usually 55-60, was up to ~120.  By morning, most nausea had subsided. Took about 72 hours for heartrate to go back to normal range.
insomina lasting 7 nights so far.  cannot fall asleep or stay asleep and have had NO issues sleeping for the past 2 years.  Waking up to use the bathroom at least 1x/night (I NEVER need to wake to pee). Having trouble focusing on work and daily tasks.  Memory has been scattered.  cold/hot sweats one night (no fever).  Nausea and very little to no appetite.
Myalgias, headache, nausea. Myalgias and headaches relieved w ibuprofen. Nausea is very mild. Mild sore throat and cough began last night so seem unrelated. Felt well until evening after vaccine
Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced inconsolable and high fever. The patient received a dose on 29-Jun-2010. Patient received PREVNAR therapy on 29-Jun-2010. The patient was then inconsolable and experienced a high fever in Jun-2010. Outcome was not provided. No further information was provided.
Patient was given this vaccine ( Kinrix and MMRV)  9/7/2023. Was not recorded in system, therefore when mom brought in patient for vaccinations today, the system report states that she needed this vaccine, when in fact she did not. Our Electronic health record did not cross over information to the data base from the 9/7/2023 visit. When I sat down to enter the data in our EHR, I noted that these vaccines were duplicated today.  These vaccines were given again today as well as the influenza vaccine.  So double doses of the Kinrix and MMRV Proquad were given in a1  month and 24 days time frame.  MD was notified as well as our clinic. Mother was also notified after the incident as well.  Patient received a influenza vaccine as well today.
Itching; swelling the size of an egg; redness around the injection site; headache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (swelling the size of an egg), VACCINATION SITE ERYTHEMA (redness around the injection site), HEADACHE (headache) and PYREXIA (fever) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (swelling the size of an egg), VACCINATION SITE ERYTHEMA (redness around the injection site), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (swelling the size of an egg), VACCINATION SITE ERYTHEMA (redness around the injection site), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) had resolved.            No relevant concomitant medications were provided.   This case was linked to MOD-2021-018001 (Patient Link).
Initial arm pain that went away after 48 hours that spread up the neck and a headache in the first 24 hours. However, it went away and then yesterday (April 28)  I noticed the arm soreness returned. This morning (April 29) the spot was itchy and more sore. This evening it is somewhat swollen and very red, continues to be itchy and aches.
Pt explained he has a fear of needles and often comes close to passing out after receiving a vaccine. After receiving vaccine patient said he felt fine and went to sit in waiting area. A couple minutes later he fainted and fell face first onto the floor. When i got to him he was awake again and responsive. 911 was called, patient was evaluated and determined he did not need further care.
Welt L upper arm - + itching, hot, swelling RX, BENADRYL PO given in office
Injection was given to low down (apparently not in the muscle); Itching around area where the injection; Redness around area where the injection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Injection was given to low down (apparently not in the muscle)), VACCINATION SITE PRURITUS (Itching around area where the injection) and VACCINATION SITE ERYTHEMA (Redness around area where the injection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Injection was given to low down (apparently not in the muscle)), VACCINATION SITE PRURITUS (Itching around area where the injection) and VACCINATION SITE ERYTHEMA (Redness around area where the injection). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Injection was given to low down (apparently not in the muscle)) had resolved and VACCINATION SITE PRURITUS (Itching around area where the injection) and VACCINATION SITE ERYTHEMA (Redness around area where the injection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant product use was reported.  No treatment details were provided.
I have a friend who said she felt like she was high on drugs. I didn't have control of my body. I had trouble getting into the garage; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "I have a friend who said she felt like she was high on drugs. I didn't have control of my body. I had trouble getting into the garage".  Additional information: It was reported that Caller was asking for her mom who is  due to get the vaccine tomorrow: verified inquiry is for the Pfizer vaccine her mom (age 79) has allergies to medications: sulfa, bactrim, amoxil, quinolones, cipro, zetia, levaquin rmadyne: lowered her blood pressure most dangerous for hercertain steroids imaging dye. She received the 2nd shot of the Pfizer vaccine last Friday. Everything was good until 2 and 3 hours into she was outside she felt like she was drugged, she was slow and was swaying. She had trouble getting her feet to step up into the garage. Through the rest of the night, stayed in bed, didn't like that feeling and didn't want to fall. 2 other friends the same thing happened to them (they too had the Pfizer vaccine). Everything was fine except that feeling. That lasted most of that day, that evening. when she woke up the next she felt ok. And no issues after that. She did not have control of my body. she had trouble getting into the garage. She had a friend who said she felt like she was high on drugs.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Diarrhea; With the first one I had was severe headache; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 18Dec2020 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included amlodipine (AMLODIPINE), lansoprazole (LANSOPRAZOLE), metformin (METFORMIN) and propranolol (PROPRANOLOL). The consumer stated, "I had this number to call. After I took the vaccine, the Pfizer vaccine on 18Dec2020, with the first one I had was severe headache on 19Dec2020 and I had some diarrhea on an unspecified date too. So, the headache started like from Saturday night sometimes until Monday and then after that it goes away, it went slowly but it goes away, severely, it was for two days." The outcome of the event headache was recovered on 21Dec2020 while the other event was unknown.   Information about batch/lot number has been requested.
vomiting; headache; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old male patient received bnt162b2 (BNT162B2), administration date 17Jul2021 (Lot number: elr8731) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: VOMITING (non-serious) with onset 17Jul2021, outcome "unknown", described as "vomiting"; HEADACHE (non-serious) with onset 17Jul2021, outcome "unknown", described as "headache"; NAUSEA (non-serious) with onset 17Jul2021, outcome "unknown", described as "nausea".  No follow-up attempts are possible. No further information is expected.
pt recv vax & devel an inj site rxn characterized by redness & tenderness;no further info was available @ the date of this report;this is 1 of 3 employees from this site to have an adverse exp following receipt of vax;
Injection site reaction, itching at injection site only, redness at injection site only, patient had a welt at injection site. All symptoms resolved within 1 hour of injection.
This is a 67y.o. female with oropharyngeal muscular dystrophy, type 2 diabetes mellitus, hypertension, GERD, and history of breast cancer in remission who presents with complaints of increasing bilateral leg weakness. She recently received an epidural steroid injection on 9/25/21 in an attempt to relieve some of her back pain and weakness without improvement. It seems to be worse proximally. It's been slowly getting worse over the last year, but seems to be rapidly worsening recently. She is having difficulty standing or ambulating. She denies fever, chills, shortness of breath, cough, myalgias, nausea, vomiting, or abdominal pain. She is fully vaccinated against COVID-19 since 2/16/21. She denies any known exposures.    Upon arrival to the ED, the patient was afebrile and normotensive. COVID-19 positive. No acute process seen on chest x-ray. D-dimer 400. Random glucose 352. CBC and CMP otherwise unremarkable. Neurology was asked to evaluate the patient and CT L-spine has been ordered.
Symptoms continuing - headache, loss of appetite, upset stomach, weak and tired, body ache, and overall feel very bad. Pain at the injection site for 4 days.  Tuesday April 12, 2022. Telemed visit with primary care physician. Dr. prescribed Methylprednisolone 4mg DOSPAK 21S.  Wednesday April 13, 2022 7AM:  Began taking DOSPAK.  Wednesday April 13, 2022 10:45. At pharmacy, COVID NAAT Rapid test performed for SARS-CoV-2. Result: NEGATIVE
Vomiting - lasted a week; Fever - lasted a week; Rash - lasted one week; Tired - lasted two weeks; Fussy - four days.  Follow up: note urgent care chart on 09/11 indicates healthy child with no problems.  Office chart of 09/12 likewise documents.  Any rash, fever, vomiting or marked irritability-normal child.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # K024553, expiration date: 15-APR-2017 (dose and route of administration were not reported. No adverse symptoms were reported. Additional information has been requested.