chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore injection site arm; itchy injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) and VACCINATION SITE PRURITUS (itchy injection site arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm) and VACCINATION SITE PRURITUS (itchy injection site arm). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) and VACCINATION SITE PRURITUS (itchy injection site arm) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.
Small swollen welt at injection site. Throughout the day, the welt got bigger. Became tender, sore, and itchy. 10cm x 5.5cm large.
Within an hour of the injection I started experiencing pain in left arm that radiated to my shoulder blade. I became hot, clammy, racing heart, headache and a developed a cough. I took advil and albuteral inhaler. The following morning, I felt light headed and just a feeling of not being well. I went to work and by the end of the day I felt better. The following day, I felt well and had energy; however, by the end of the day, I noticed I had hives on my torso that were painful and not itchy. I describe the welts as scratches as they were long and painful versus spots and itchy. I called my medical facility for medical advice and they noticed that I had was wheezing and advised me to go to the emergency department as I was having difficulty breathing. I was given steroids through an IV which helped me feel better. I was also given Prednisone for the next five days. They stated they could not attribute the severe allergic reaction to the vaccine but they wanted me to report what occurred.
Cold/chills, then feel hot (102 degrees) now (at 8:45 pm 1/27/21)
After flu shot patient reported that she did have the flu and now have a bacterial infection in her lungs/ears (confirmed by her doctor). She was treated with antibiotics and cough meds.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. From late February 2016 to 12-MAY-2016, the patients were vaccinated with unspecified doses of improperly stored GARDASIL 9 immunization series (lot # L024993 with expiration date of 17-OCT-2017; lot # reported as L206602 with expiration date of 19-OCT-2017, which was not valid for GARDASIL 9 (dose and route unknown). The vaccines were exposed at 32 Fahrenheit (F) as lowest for 1395 hours (58 days) as worst case scenario. The temperature excursion was cumulative since late February 2016 according to manual recording system. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I got the shot on February 5th, 2021. On the day of my injection, I immediately felt a stiffness in my arm within 10 minutes of receiving the shot. I didn't think too much of it because I had some stiffness in my arm with the first shot. But this Friday - March 5th will be a month and I am still having arm issues and they have gotten worse.  I never had a rash or bruise on the injection site but from the injection  site I have a tenderness on my arm and a constant dull and achy pain - sometimes sharp and painful - that starts at the injection site then travels down through my elbow and into my hand. My hand will get tingly and numb as well. My arm will sometimes randomly fall asleep as well. I went to the doctor but they gave me ibuprofen and that didn't do much. I am going back to the doctor soon.
Ever since the first dose of the vaccine I have had a weird smell in my nose that won?t go away. I also have noticed that I am not able to taste some feeds as strongly as before. I haven?t lost those senses but they have changed slightly. Nothing too impactful or serious though. My second dose is coming up on 2/8.
Information has been received from a physician concerning a 16 year old female with no known allergies who on 01-AUG-2007 was vaccinated with the first dose of Gardasil (Lot# not provided). No concomitant therapies were reported. The physician reported that within 60 seconds post vaccination the patient had a vasal vagal response, experienced a Tonic clonic Grand mal seizure and hit her head on the office wall. The physician reported that at that time the patient was sweating and her pulse was 43 BPM. The patient laid down and oxygen was administered. The physician reported that the patient was monitored and with 20 minutes her pulse was 68 BPM and she had recovered from the event. The physician considered the event to be disabling and an other important medical event. Additional information has been requested.
I had a headache in the middle of the night after the shot was given.  My arm was sore and then I noticed the next day it was getting red near the injection site. It is now red all around where the injection was given. Similar to what I've see on line.  It's a bit swollen and feel bruised.   I also want to mention that I have had a ganglion cyst on my right wrist for several years.  I noticed today that they cyst has softened and almost disappeared since the second shot.  Just wanted to mention this, not sure if it was just a coincidence.
chills; fever was up to 102; nausea; headache; Took long time trying to get to sleep; Felt drained most of that day; This is a spontaneous report from a contactable Consumer or other non-HCP. A 70-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: FD8448), via an unspecified route of administration, administered in Arm right on 28Sep2021 at 13:30 (age at vaccination was 70 years) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE) (NDC:49281-0121-65) via an unspecified route of administration, administered in Arm right on 28Sep2021 as flu shot. The patient medical history included atrial fibrillation. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient does not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications was received within 2 weeks of vaccination. No known allergies reported. The concomitant medications were none. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and as dose 2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot: unknown) as DOSE 2, SINGLE for covid-19 immunization. On 28Sep2021 at 21:30, the patient experienced chills, fever was up to 102, nausea, headache, took long time trying to get to sleep, woke often. In morning fever broke and back to normal. Felt drained most of that day but no other issues. Therapeutic measures were taken as a result of event included paracetamol (TYLENOL) for fever. Outcome of the events were recovered.  Follow-up attempts are completed. No further information is expected.
Temperature of 102 degree F; Chilled; A spontaneous report was received from a consumer, concerning herself, an 81-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and had temperature of 102-degree F and developed chills.   The patient's medical history and current condition were not provided. Concomitant medications reported included low dose aspirin, lisinopril, gabapentin, simvastatin and levothyroxine.   On 08-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 09-JAN-2021, after vaccination, the patient was feeling chills and when she checks her temperature, it shows 102 deg, F. Patient had no treatment medication for event.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, temperature of 102-degree F and chills were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt presented to the ED with febrile seizure one day after receiving vaccines, lasted 3 minutes, was at neuro baseline in ED, febrile in ED.
The patient didn't have an adverse event. This is a reported administration error.  The patient was given an expired vaccine.
Patient received vaccine at 0939. 30 minute wait period related to history of previous anaphylactic reaction. 10:05 patient walked from  observation area to vaccinator and reported that her "chest was burning" and "feels like it is getting tighter to breathe. Pt had change in voice. Patient moved to chair and started on oxygen 1.5 L/m per nasal cannula. MD came to room to assess patient. ED  arrived and checked patient B/P. Patient transferred by cart to ED.
hoarse, fever, severe congestion, pale, weak, vomitting excess mucus; ARNP prescribed Rondec cough syrup and is taking OTC motrin & tylenol
Weakness, severe leg pain that I couldn?t move or walk and had to miss work. Legs swelled from my knees to my feet with pain for four day.
Lip/ facial/ oropharyngeal swelling. Vomiting, flushing and hives on whole body.
Patient described blurry vision, diaphoretic, low heart rate of 60, hypotensive 90/60.
The pt developed redness and swelling at the injection site on 05/11/2002. On 05/13/2002, the pt improved but not completely recovered.
The patient received a vaccine that was past its manufacturer assigned expiration date (Pfizer assigns an expiration 1 year after manufacturer). We reached out to the manufacturer regarding this vaccine administered past its expiration and they replied that they "have stability data to support the use of vaccine for 18 months after the date of manufacture plus 7 days." Revaccination is not indicated.
This spontaneous report was received from a medical assistant refers to a 12 year old patient of unknown age and gender. No medical history was reported. On 17-APR-2013 (reported as today), the patient was vaccinated with an expired dose of MMR II (lot # 667968/0346AA, expiry date: 07-MAR-2013), 0.5 ml, subcutaneously. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
I took my 6 month old in for her check-up and they gave her first COVID-19 vaccine. After arriving at home, the pediatrician called and said they had forgotten to dilute the vaccine. As of now, there are no side effects (aside from being a bit fussier than usual) but I wanted to report the error in vaccine administration.
Chills Jun5,Jun6 and Jun7. Fatigue, sleepy  with no energy Jun5 and Jun6.Heavy stiffness and joint pain in lower back waistline,thighs and legs. Swelling increased in leg foot but lower on Jun7. Arm  sore but better Jun7.
Had a few hours of fever; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Had a few hours of fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 007C21A) for COVID-19 vaccination.     Concurrent medical conditions included Type II diabetes mellitus.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced PYREXIA (Had a few hours of fever). In May 2021, PYREXIA (Had a few hours of fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.  The patient had no reactions after the 1st dose.   This case was linked to MOD-2022-467247 (Patient Link).
On day # 5 (evening of feb 24th) following Moderna vaccine (#2) I began with excruciating left chest pain midclavicular line that was palpable between ribs #9-10. Pain was reproducible upon orthopedic movements and in particular upon inspiration. Tmax 100.7 (without meds). Feb 26th the pain improved and a covid test was performed on Feb 26th (which was negative).  On Feb 27 the pain extended higher up on the chest wall and by Sunday the 28th pain resolving again. Today March 1st pain much improved doctor initially suspected costochondritis but not consistent with fevers so now considering pleurisy.  Today continue with lower grade temp 99.7 but much improved.
This spontaneous report was received from a healthcare worker (also reported as a radiology tech/vaccine coordinator) referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. In October 2016 (reported as "between 06-OCT-2016 and 21-OCT-2016"), the unspecified numbers of patients were vaccinated with improperly stored dose of GARDASIL 9 (lot # L026602 and expiration date 19-OCT-2017) and (lot # L036301 and expiration date 20-DEC-2017) (dose and anatomical location were not reported) for prophylaxis. No adverse effects were reported.  Excursion details: Temperature/Time: -0.1 C for 8 hours and 15 minutes. No previous excursions. This information was from a digital data logger. No product quality complaint (PQC) was involved.   This is one of several reports received from the same source. Follow up information was received on 28-DEC-2016. As of 28-DEC-2016, all telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested. Narrative was updated.; Sender's Comments: US-009507513-1611USA002274:US-009507513-1611USA002276: US-009507513-1611USA002277: US-009507513-1610USA012323:, MERCK 1611USA002275:Mfr number.
HCP reports this patient had a fever of 100.0 degrees after inadvertently being administered PROQUAD and MMRll.; a dose of PROQUAD and a dose ofMMR II were given concomitantly to a patient today; This spontaneous report as received from a medical assistant referring to a 1-year-old patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions and previous drug reactions or allergies was not reported.      On 20-NOV-2020, the patient was inadvertently administered concomitantly a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T019420, expiration date 02-DEC-2021, 0.5 milliliter and a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S013683, expiration date 05-MAY-2021, 0.5 milliliter for prophylaxis (vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). Concomitant therapies included sterile diluent.     On an unknown date, the patient experienced a fever of 100 degrees (pyrexia) after the vaccinations. The outcome of pyrexia was unknown.     The causal relationship between pyrexia and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was unknown.
Lymph node swelling / slight pain to touch.; Lymph node swelling / slight pain to touch.; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 20Feb2021 at 12:45 (at the age of 34-year-old) as dose 2, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient's medical history was not reported. The patient's concomitant medications were reported as none. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 30Jan2021 at 12:00 PM (at the age of 34-year-old) as dose 1, single for COVID-19 immunization. Patient did not receive other vaccine in four weeks and no medications in two weeks. Patient had no COVID prior vaccination. Not tested for COVID post vaccination. On 21Feb2021 at 14:00, the patient experienced lymph node swelling and slight pain to touch. No treatment was received for events. Outcome of the events was recovering at the time of reporting.  Follow-up attempts completed. No further information expected.
Immediate dizziness; Nausea; This spontaneous case was reported by a pharmacist and describes the occurrence of DIZZINESS (Immediate dizziness) and NAUSEA (Nausea) in a female patient of an unknown age 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 DIZZINESS (Immediate dizziness) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Immediate dizziness) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided. Pharmacist stated that -according to the information of moderna  patient should not get the second dose since this was an immediate reaction. and asked about the second vaccine -should she get the Janssen vaccine as her second dose?
I had congestion like a head cold, sinus drainage, and a sore throat but up in the sinus cavity. I also had soreness. I didn?t have any fever and just a little bit of a cough. That started on the 20th of June. My infection kept hanging on and I tested on the 22nd and came back positive. Two days later on the 24th, I wasn?t feeling any better. I called the health department, and I had a previous episode several years ago of a pertussis cough. I was worried about this moving into my lungs, so I was prescribed Paxlovid and I started that the night of the 24th which I finished yesterday morning. Unfortunately, I am still congested and it?s hanging on and doesn?t want to go away.
Flu-like illness followed by palpitations.  Major reaction at vaccination site with 15cm diam induration and erythema, axillary adenopathy.  Increased blood pressure to 140-150's/80-100's (baseline 120's/70's), mild orthostatic component.  Missed work x 2 days.
Bells Palsy onset 6/19/21 (began as eye irritation), noticed facial palsy 6/25/21. Noticeably better by July 2.  Fully resolved by July 16.   Also noticed onset of osteoarthritis in left index finger shortly after Bells Palsy. That has not resolved.  Not sure if related to vaccine or not.
Patient was given the wrong vaccine, and the vaccine was prepared improperly. Patient was administered 0.3ml of undiluted (but properly thawed) Pfizer COVID-19 vaccine instead of J&J Vaccine that patient was supposed to get. Pharmacist spoke to patient after discovery of the mistake after confirming with pharmacy intern that administered it, and confirmed that patient was okay and not feeling adverse effects approximately 3 hours later. Patient was vaccinated at 3:33 PM 5/18/2021 and contacted at approximately 6PM to discuss the error. Patient seems understanding and accepting of the error, but did express regret because they did initially want the more traditional J&J vaccine.
Rash on left arm, current and lasting for over a week. Fifteen days after the injection, exhaustion, chills, joint aches.
Pfizer vaccine was administered outside of our facility - reported by patient- ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------------------- J96.00 ACUTE RESPIRATORY FAILURE 7/16/2021 ANEMIA J96.00 ACUTE RESPIRATORY FAILURE 7/16/2021 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION
Patient  recieved the flushot around 3:00pm and he said 2 hours after recieving the immunization, he had strange sensations in his hands and arms, he can't focus, he is hot and cold and hot and cold and is sweating and it lasted up to 10:30pm of the same day. He reoorted the adverse reactions the next day  around 9:15am and he said he does not have any of the symptoms from yesterday but he is feeling weak does not have energy. When I followed up with the patient around 12noon, he said he is feeling much better and has a little more energy than earlier this morning.
Headache with flashing light; Hot and cold; Moderna arm / Red below deltoid muscle; Hot at the injection site; Itchy at the injection site; Extreme fatigue / Could not get up for 2 days / Lay down for 2 days; Headache with flashing light; Broke her L2 vertebra; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LUMBAR VERTEBRAL FRACTURE (Broke her L2 vertebra) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoporosis, Blood pressure high and Migraine.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced LUMBAR VERTEBRAL FRACTURE (Broke her L2 vertebra) (seriousness criterion medically significant). On an unknown date, the patient experienced PHOTOPSIA (Headache with flashing light), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), ERYTHEMA (Moderna arm / Red below deltoid muscle), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site), FATIGUE (Extreme fatigue / Could not get up for 2 days / Lay down for 2 days) and HEADACHE (Headache with flashing light). At the time of the report, LUMBAR VERTEBRAL FRACTURE (Broke her L2 vertebra), PHOTOPSIA (Headache with flashing light), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), ERYTHEMA (Moderna arm / Red below deltoid muscle), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site), FATIGUE (Extreme fatigue / Could not get up for 2 days / Lay down for 2 days) and HEADACHE (Headache with flashing light) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment information was provided.  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded for all events except Lumbar vertebral fracture which is unlikely.   This case was linked to MOD-2021-092132 (Patient Link).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded for all events except Lumbar vertebral fracture which is unlikely.