chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine kept in refrigerator on 10/26/2021, expiration date is 10/13/2021, administered on 11/1/2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 10/26/2021, expiration date is 10/13/2021, administered on 11/1/2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 10/26/2021, expiration date is 10/13/2021, administered on 11/1/2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 10/26/2021, expiration date is 10/13/2021, administered on 11/1/2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Date the vial was placed in the refrigerator was 26-OCT-2021. There was no temperature excursion. The reporter reported that there was a confusion between the expiration date printed in the carton and the expiration date when the code was scanned. The patient did not experience any adverse event. No treatment information was provided by the reporter.
Painful arm, shoulder, elbow, wrists. Limited movement. Swelling, redness, fever, tiredness.
Starting about 4/20 - I started waking up at about 04:00. I go to bed regularly at 10:00 pm and I usually sleep until 06:00PM. I got the second dose 4/28/2021 - Over the summer, I started more and more frequently waking at 04:00 - intermittently once or twice every couple of weeks and then increasing to a frequency of two or three times a week. This would be after 6 hours of sleep. Since September 20th, I woke up every day at 04:00 am after having 6 hours of sleep. After the 3rd dose, on October 28, 2021, I wake up at 02:00 am after four hours of sleep. It happens every day that I wake up at 02:00-2:30 am or wake up at 04:00 am for the past two weeks. I am not able to get back to sleep after waking. September 23rd, my psychiatrist advised me to take Melatonin when I woke up to try to get back to sleep. That hasn't worked. Yesterday, I spoke with him again - and he took Lunesta out of my protocol and replaced it with Ambien. He said to call him back if the Ambien didn't work. I will start doing that on Friday after the work week is over. I'm working - but on Wednesday, I was very impaired after getting 4 hours of sleep, so I was irritated and disorientated and worsening of mood. Because there had been other nights of that prior to that. It was difficult to do my work.
Information has been received from a medical assistant concerning a 8 year old female patient who on 10-JUN-1998 was vaccinated with a dose of varicella virus vaccine live. On approximately 28-DEC-2005, the patient developed chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
cellulitis-active infection; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient recently developed cellulitis-active infection and currently on antibx (antibiotic). The patient stated that she was supposed to get 2nd shot of Pfizer Covid vaccine tomorrow (30Mar2021). The patient asked if she can still get her shot. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pneumonia; She increasingly today has not been able to take straight steps forward, she walks like she is drunk; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL8982), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization, pregabalin (LYRICA, Pfizer product), phenytoin sodium (DILANTIN, Pfizer product), levetiracetam (KEPPRA, non-Pfizer product), all via an unspecified route of administration from an unspecified date at unspecified dose for an unspecified indication.   Medical history included Major Epilepsy issues from an unknown date and unknown if ongoing. Concomitant medication included sertraline hydrochloride (Generic of Zoloft). The patient got the shot, she had no pain or anything like that but she increasingly today has not been able to take straight steps forward, she walks like she is drunk. She is on Lyrica, she is on Dilantin and she is on Keppra and the reporter was wondering if there is any relationship between the actions we are seeing from her today from the shot and concerned if that could be a reaction. The patient did not have the second dose yet. The patient had pneumonia in Dec so she was checking for potassium levels but the reporter didn't know if the patient did a CBC or what other. Treatment: Reporter stated, "It just started today." The patient underwent lab tests and procedures which included potassium levels and blood work with unknown results. The action taken in response to the events for pregabalin, phenytoin sodium and levetiracetam was unknown. The outcome of all the events was unknown.
Client received vaccine Wednesday morning. Client started to feel weak the next afternoon. Got out of vehicle and almost fell due to leg weakness and had an abnormal gate. After 20  minutes had passed, symptoms got better. A couple hours later that day it happened again, but this time with arm weakness and hand fell at side. Client then went to ER. Had CT scan and MRI which showed client had a small clot causing a small stroke. Client had no risk factors for a stroke. Not a smoker, no high blood pressure, and good cholesterol. Doctors were unaware if the stroke was correlated with vaccine or not. Primary care physician is running labs to see if there is a clotting disorder.
fever; shivering; This case was reported by a consumer via call center representative and described the occurrence of fever in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and shivering. On an unknown date, the outcome of the fever and shivering were recovered/resolved.   It was unknown if the reporter considered the fever and shivering to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix and had fever and shivering that lasted for 3 days. The reporter did not consent to follow up. This case was 2 of 3 linked cases.
Fever; Headache; fatigue, feel tired; Redness at injection site; Warm to the touch at injection site; Food taste different for 2 days; Sore arm two day after injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm two day after injection), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (fatigue, feel tired) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm two day after injection). On an unknown date, the patient experienced PYREXIA (Fever), HEADACHE (Headache), FATIGUE (fatigue, feel tired), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE WARMTH (Warm to the touch at injection site) and TASTE DISORDER (Food taste different for 2 days). At the time of the report, PAIN IN EXTREMITY (Sore arm two day after injection), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (fatigue, feel tired), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE WARMTH (Warm to the touch at injection site) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
Pt went to ER 5-19-15 c/o redness, swelling and pain around injection site in right arm that started that morning. Patient was given BENADRYL and Solu- Medrol in the ER. ER also gave patient RX for prednisone and PERCOCET.
This spontaneous report as received from a certified medical assistant, refers to an unknown number of patients of unknown demographics. The patients' concurrent conditions and medical history were not reported. On an unknown date in 2013, an unspecified number of patients received improperly stored Vaccine For Children (VFC) doses of RECOMBIVAX HB (dose and route, lot and expiration date were not reported) exposed to 20F and 30F on multiple occasions, from 22-SEP-2013 until 20-DEC-2013 (for 122 days. No adverse effects were reported (the reporter stated that the vaccines administered were RECOMBIVAX HB and VAQTA but on a second call was reported that no doses of VAQTA were involved in this excursion). Follow up information has been received from the certified medical assistant which reported that one of the patients was vaccinated with a dose of RECOMBIVAX HB (lot number reported as J0030722) on 23-OCT-2013. This is one of several reports from the same source. J0030722 is not valid lot number for RECOMBIVAX HB. Additional information has been requested.
Pt given saline injection only. Pt was asked to come back to be revaccinated with correct diluted Pfizer vaccine (lot EWO173) the same day.
Patient received vaccination at location listed and came into her pharmacy the day after vaccination to report a red, swollen area around the vaccination site. It is about 3 inches wide, lower than deltoid region of the arm, almost halfway between the shoulder and elbow. It is more posterior, warm to the touch. The patient also reports numbness in her left hand shortly after vaccination and sudden leg numbness day after vaccination that recovered. Informed patient to contact location that gave vaccination but clinic is closed for the weekend. Also encouraged patient to seek medical attention as soon as possible.  She was considering an emergency room visit or contacting PCP on Monday, unsure of outcome.
Headache, Myalgia, Arthralgia, NauseaVomiting, local pain/swelling at injection site Narrative:
-swollen tongue , unable to swallow , able to breath Tx - antihistamines and steroids.
constant, inconsolable crying for 4hr;given Ibuprofen in MD office;
Vaccine was stored in the freezer for 15 days instead of the recommended 14 days. The vaccine was supposed to be removed from the freezer on 5/27 by 1pm and placed in the fridge. Instead in was kept in the freezer and given to the patient instead.
Lump in her armpit (injection side), it's about 2 inches large and hot; Lump in her armpit (injection side), it's about 2 inches large and hot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Lump in her armpit (injection side), it's about 2 inches large and hot) and LYMPHADENOPATHY (Lump in her armpit (injection side), it's about 2 inches large and hot) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer in 1988. Concomitant products included ATORVASTATIN CALCIUM (LIPTOR [ATORVASTATIN CALCIUM]), VITAMIN A [RETINOL], ACETYLSALICYLIC ACID (BABY ASPIRIN) and CLONAZEPAM for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced FEELING HOT (Lump in her armpit (injection side), it's about 2 inches large and hot) and LYMPHADENOPATHY (Lump in her armpit (injection side), it's about 2 inches large and hot). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK, prn. At the time of the report, FEELING HOT (Lump in her armpit (injection side), it's about 2 inches large and hot) and LYMPHADENOPATHY (Lump in her armpit (injection side), it's about 2 inches large and hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant products used included Hydrops, Systemin and Sorect.
Queasy in stomach, pain in midriff, became very nauseated, lightheaded and passed out. Violent chills for several hours for remaining of night. Woke up every hour with cycles of chills and pain. Pretty weak next day. Tuesday resumed with normal activities. Pain at injection site minimal. Took ALEVE Sunday and Monday.
Dizzy  headache  shooting pain down left leg off and on Stiffness in injection arm. Cold to touch and painful.  Plenty of fluids pain reliever as needed for pain. Balance of rest and active
Tachycardia. Slight fever 100.8 - restless night. Mom was feeding and holding at 5 AM and he had sudden - 4-5 quick inspirations and then she felt his chest and heart "was racing" 30 minutes - spontaneous resolved.
Immediately after the injection I felt arm pain. Approximately 12 hours after my second dose I developed chills, fatigue, and aching joints. This progressed through the night to include restlessness, trouble sleeping, headache, and hot spells. These symptoms continued for the entire next day and that morning I noticed a half dollar sized red splotch below the injection site. This spot was warm and tender to the touch.  By 36 hours after my injection my symptoms were gone but the arm splotch had grown to hand sized and was still warm and tender to the touch.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 18-DEC-2014 the patient was vaccinated with M-M-R II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
Awoken during sleep (around 12 am the next day) with chills and elevated temperature. Did not sleep rest of night/early morning. Developed all over body aches, chills subsided by noon on same day they began. Injection site swelled, and was very red. Swelling spread to underarm/lymph node area. Headache began in early morning on day after shot as well, and nausea set in as well. Slept most of day, ran fever, was nauseous, and achy. The second day after the vaccine was improved - no headache, appetite returned, fever was better. Arm and underarm was still red, swollen and sore, and had overall tiredness and still achy. The only lasting side effect was the red, swollen,  and sore arm, which is now almost back to normal. There is still some soreness in the arm and underarm, but the redness and swelling is gone as of 3/22.
Patient received vaccination and immediately slumped over in chair and fell on the floor. Patient did not hit head, but did lose consciousness for about 10-15 seconds. Patient also vomited after this fall. Patient subsequently reported a needle phobia, but thought it was only an issue for blood draws, not vaccinations. He did not verbalize his needle phobia to the vaccinating staff until after he was vaccinated.
had covid vaccine 8:30 am yesterday (12/21/20) - at 4 am today 12/22/20 developed HA, N, Vx5, ? chills, is feeling fatigued at this time,  also had injection site discomfort.
None noted. 2 mth. old baby received ROTATEQ #1 dose on April 30, 2013 and it was noted to have expired April 25, 2013, was informed by Merck not to repeat.
following day (8/4/23) resident was lethargic, needed increase assistance with ADLs and eating. Lg loose stool. Low pulse throughout the day 49-52, diaphoresis noted.
I received the shot on Feb. 13, 2021. My side effects started on February 14 before bedtime and continued through the day on February 15.  I felt much better on Tuesday, symptom free.  Pain at shot site and in muscles beginning about 1 hour after the shot and got worse for the next several hours.  I began to be very tired before bedtime and started a headache, a fever of about 99.6, and chills.  Chills throughout the night on Feb. 14 until morning the 15th.  Felt achy in back and general aches all day the 15th and headache.  Fever Feb. 15 when I got up in the morning was 100.2.  Just sat around very tired and achy throughout the day on Feb. 15. Still a slight fever that night (99.3), but I began to start feeling better close to bedtime on Feb. 15.  Feb. 16- I feel fine, just a bit tired, but doing my normal activiites.
Local reaction 1 1/2 x 1 1/2' erythema circle to injection site non painful. Temperature 101.8.
Shortly after the client received the vaccine, she notified her personal nurse.  Client presented as non-verbal.  The personal nurse asked if the client's throat hurt, she nodded "yes."  She then asked, if the client's throat was itchy, and she nodded "yes."  The nurse notified the observation nurse and site coordinator.  Vital signs were taken, 911 was notified, and the client was transported to the local hospital.  No abnormal VS noted, 119/69-85-98%(RA). No s/s resp. distress noted.  No medication given on site.
Adverse effect of other vaccines and biological substances, initial encounter on 2020-12-19, Adverse effect of other vaccines and biological substances, initial encounter on 2021-01-11.
Unknown correlation to vaccine 3/5/21  Left Internal Carotid Artery Occlusion from origin through entire cervical course and to petrous canal.  Carotid artery doppler in late 2019 showed no significant stenosis Treated with thrombectomy and stent of ICA by Interventional Radiology Residual right hemiparesis and partial expressive aphasia following Stroke Rehab
This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) on 22Dec2020 11:30AM at left arm for COVID-19 immunization. The patient had known allergies to sulfa and was currently breastfeeding. The patient had concomitantly received ascorbic acid, honey, melatonin, zinc gluconate (ZARBEE'S ALL NATURAL COUGH SYRUP NIGHTTIME) (reported as " Zarbees elderberry immune syrup") in two weeks. The patient experienced fatigue, myalgias, headache, arm soreness, brain fog at 3:00PM on 22Dec2020. Patient received ibuprofen 400 mg as treatment for the adverse events. The outcome of the events was resolving at the time of reporting. Information on the lot/batch number has been requested.
Bruising up and down arm painful - weakness, exhaustion x 24 hrs unable to get OOB/no other Rx.
Severe Chills when I went to bed the night after the injection . On and off fever the next day of vaccination. Took Tylenol (2) 500 mg every six hours , 3x that day. Fever was gone the second day after vaccination,  slight chills that night.
40 minutes after receiving vaccine my  throat constricted, chest tightened, had difficulty swallowing and catching my breathe. Returned to Convention Center, site of vaccination. Paramedics took vitals, determined I was having a "minor" allergic reaction and administered Benadryl. Within 20 minutes of receiving Benadryl, I was able to breathe and swallow without difficulty. No further complications afterwards.
upside-down triangle red rash on injection site. Started on the second day, lasted 3 days. It was mildly itchy, raised, and red. I have a picture of it.
No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 14-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-JUN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W008712, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
8/20/08 - At 0915 this am today patient arrived at the Employee Health Clinic complaining of redness, pain, swelling, and heat to right upper arm after receiving her 2nd Varicella vacinne yesterday afternoon.  She also complained of generalized body aches, fatigue, and fever.  Her temperature was 100.1 in the clinic.
4 day headache, fever following day, chills and sweats 36 hours, diarrhea, began menstrual cycle 2 weeks early, and overall weakness.
Leaking viens in arms left and right  ,  urritated blood  ,  leak blood in right eye ,
I had my vaccination on 07/22/2022. The next month 08/2022 I started having several tachycardia events. I went to a cardiologist in which I was put on a Holter monitor. It revealed I had multiple events of tachycardia and it started to get worse.
Information has been received from a licensed practical nurse (L.P.N.) concerning a 10 year old female child with no pre-existing allergies, birth defects or medical conditions who on 15-SEP-2008 was vaccinated intramuscularly in the left deltoid with a second dose of VARIVAX (Oka/Merck) (Lot #661562/0996X).  There was no illness at time of vaccination.  On 16-SEP-2008 the patient developed swelling, tenderness and warmth at the injection site in the left deltoid area.  The patient was diagnosed with cellulitis and was treated with AUGMENTIN, 400 mg for 10 days and warm soaks.  The outcome of the patient was not reported.  The reporter considered cellulitis to be an other important medical event.  Additional information has been requested.
Extremely tired for the next month, and then was hospitalized with 2 blood clots in lungs and severe anemia (cause not determined yet, as to whether not making platelets or losing blood). Had two blood transfusions and iron transfusion.
9/30/02 Patient received Td and MMR in left arm. On 10/5/02, local reaction began upper left arm deltoid, with swelling and redness measuring approximately 5"x5". Advised Benadryl, ice packs and Tylenol per clinic physician.