chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the product underwent the excursion at -52 degree Celsius for 24 hours on 10-MAR-2021 and then was administered to a patient on 12-MAR-2021; VARlVAX was administered to a patient on 03/12/2021, first dose was given in 1998 for his varicella vaccine; This spontaneous report was received from a nurse referring to a 26 years old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.   In 1998, first dose was given to the patient for his varicella vaccine (strength, dose, route, lot number, expiration date and indication were not reported). On 12-MAR-2021, the patient was administered with incorrectly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot# T017686 has been verified to be a valid lot number, expiration date reported as 21-APR-2022 (also reported as 21-MAY-2022), but upon internal validation established as 21-MAY-2022; strength and route were not reported) at a dose of 0.5 ml for prophylaxis (incorrect product storage, inappropriate schedule of vaccine administered). The vaccine underwent a temperature excursion at - 52 degree Celsius on 10-MAR-2021 for 24 hours. The temperature excursion was recorded by digital data logger, and there was no previous temperature excursion. The outcome of the event was unknown. No additional information was provided.
Arm was sore; arm where they injected the vaccine was still red; left arm  puffy with baseball size lump; This morning she had bad sweats; body ache /arm was sore; woke up really sick the next day; migraine; feels really bad; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (woke up really sick the next day), MIGRAINE (migraine), FEELING ABNORMAL (feels really bad), HYPERHIDROSIS (This morning she had bad sweats) and PAIN (body ache /arm was sore) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. FB8448 and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MAGNESIUM GLYCINATE (MAGNESIUM GUMMIES) for an unknown indication.   On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced ILLNESS (woke up really sick the next day), MIGRAINE (migraine), FEELING ABNORMAL (feels really bad), PAIN (body ache /arm was sore), CHILLS (chills) and PYREXIA (fever). On 12-Sep-2021, the patient experienced HYPERHIDROSIS (This morning she had bad sweats), VACCINATION SITE ERYTHEMA (arm where they injected the vaccine was still red) and VACCINATION SITE SWELLING (left arm  puffy with baseball size lump). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore). At the time of the report, ILLNESS (woke up really sick the next day), MIGRAINE (migraine), FEELING ABNORMAL (feels really bad), HYPERHIDROSIS (This morning she had bad sweats), PAIN (body ache /arm was sore), PAIN IN EXTREMITY (Arm was sore), CHILLS (chills), VACCINATION SITE ERYTHEMA (arm where they injected the vaccine was still red) and VACCINATION SITE SWELLING (left arm  puffy with baseball size lump) outcome was unknown and PYREXIA (fever) had resolved.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
Rash began 5 days after receiving 2nd vaccine..Starting in stomach area and up the chest, stopping before neck. Then on upper arms and back. Before going to bed it had spread to thighs. Took  Claritin and Benadryl 25mg prior to bed. In am , no better and now more pronounced and spread to lower legs.. Began on a medrol dose pack and took a Claritin. That evening not getting worse but no signs of improvent, took benadryl 50mg at bedtime... Rash was slightly itchy but not much.  Fourth day into Medrol dose pack it began to subside. Completely cleared up a day after finishing..
her sister contracted COVID; her sister contracted COVID; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) as single dose and dose 1 via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Caller mentioned that patient contracted COVID in 2021, she took her first dose of the Pfizer Covid-19 vaccine in February and second dose in March. Caller stated that they are all scared and concerned on how long they will be protected. Caller has also completed her vaccination series and received her second dose in Apr2021. Caller was asking if the booster dose was safe? Caller clarified if they can receive the booster dose. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 07-APR-2016, the patient was vaccinated with an improperly stored dose VARIVAX injection, lot #L044524, expiration date 09-NOV-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 9.9 degrees Fahrenheit for 163 hours and 30 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Itchy arm with red circular rash around injection site, about 1-inch in diameter.
EXACTLY 3 WEEKS AFTER 1ST DOSE OF MODERNA, I WOKE UP WITH BELL'S PALSY. THE LEFT SIDE OF MY FACE WAS NUMB AND DROOPED DOWN. I WENT TO URGENT CARE THE NEXT DAY. THEY PRESCRIBED ME VALACYCLOVIR HCL 1 GRAM TABLET AND PREDNISONE 20 MG TABLET FOR 7 DAYS. IT IS SLOWLY RESOLVING BUT HAS NOT YET FULLY RESOLVED TO DATE.
pt recvd vax & 14OCT92 exp sudden onset of neck pain; 3 days later 17OCT92 exp onset of facial paralysis dx as bell's palsy;
Recipient had a syncopal episode. Recipient was seen by on-site EMS - was bradycardic and hypotensive and had a 2nd syncopal episode. Patient was transferred to the hospital by ambulance for complete evaluation.
Dark circle around eyes; Loss of appetite; Out of breath on exertion; Loss of weight; Nausea; Tired; Muscle ache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DARK CIRCLES UNDER EYES (Dark circle around eyes), DECREASED APPETITE (Loss of appetite), DYSPNOEA (Out of breath on exertion), WEIGHT DECREASED (Loss of weight) and NAUSEA (Nausea) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced DARK CIRCLES UNDER EYES (Dark circle around eyes), DECREASED APPETITE (Loss of appetite), DYSPNOEA (Out of breath on exertion), WEIGHT DECREASED (Loss of weight), NAUSEA (Nausea), FATIGUE (Tired), MYALGIA (Muscle ache) and CHILLS (Chills). At the time of the report, DARK CIRCLES UNDER EYES (Dark circle around eyes), DECREASED APPETITE (Loss of appetite), DYSPNOEA (Out of breath on exertion), WEIGHT DECREASED (Loss of weight), NAUSEA (Nausea), FATIGUE (Tired), MYALGIA (Muscle ache) and CHILLS (Chills) had not resolved.            Concomitant product information, if any, was not provided by the reporter.  Treatment information, if any, was not provided.
Myalgias, light headed, dizzy, nausea, fever, Left axillary tenderness
The next day I woke up with sore arm and and  lymph nodes swelling and the increase on my heart rate and I develop a headache and the back of my head it reiterated to the front of the head, I had this headache for 5 days before I went to the hospital, on 04/16/2021 I went to the ER for the headache and in total this lasted for 5 weeks, I tried Tylenol and heading pad but that didn't work, at ER I Had Phenergan but I had an allergic reaction. They gave me other medication for my headache but I have tried them in the past and it didn't work for me so I didn't end up taking them. I do believe the vaccination made this headache because a few weeks I had the Xolair and I didn't have a headache. The headache finally went after 5 weeks. I got my booster vaccination 11/06/2021  and did not have any complications at all.
left armpit had fluid/left armpit felt like there was fluid there with lymph nodes; there is some pain; She can still feel it when she press on that spot/She had some pain with the initial injection/pain with the shot; bruise at the inoculation site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Aug-2021 and was forwarded to Moderna on 26-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (bruise at the inoculation site), LYMPHADENOPATHY (left armpit had fluid/left armpit felt like there was fluid there with lymph nodes), LYMPH NODE PAIN (there is some pain) and VACCINATION SITE PAIN (She can still feel it when she press on that spot/She had some pain with the initial injection/pain with the shot) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced VACCINATION SITE BRUISING (bruise at the inoculation site). On 25-Aug-2021, the patient experienced LYMPHADENOPATHY (left armpit had fluid/left armpit felt like there was fluid there with lymph nodes), LYMPH NODE PAIN (there is some pain) and VACCINATION SITE PAIN (She can still feel it when she press on that spot/She had some pain with the initial injection/pain with the shot). At the time of the report, VACCINATION SITE BRUISING (bruise at the inoculation site) had not resolved and LYMPHADENOPATHY (left armpit had fluid/left armpit felt like there was fluid there with lymph nodes), LYMPH NODE PAIN (there is some pain) and VACCINATION SITE PAIN (She can still feel it when she press on that spot/She had some pain with the initial injection/pain with the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  The day after receiving the vaccine she noticed that she had a bruise at the inoculation site. This has continued to today.   Patient took an epsom salt bath yesterday and it helped with the pain. She can still feel it when she presses on that spot. She had some pain with the initial injection but that got better with moving it around.
Fever to 103.8 axillary, fourteen hours post immunizations. One episode of vomiting.
Within one minute following injections, patient experienced flashing lights in her eye; could only see in bright primary colors; had extreme trouble breathing; experienced pain in top of mouth and throat; pain at injection site; blood pressure was low. Symptoms started to subside after injection of Epinephrine and use of Nebulizer. She has no history of food or pollen allergies.
pt recvd flu vax inadvertently administered SQ instead of IM & pt exp dermatological effects only (rednes, warmth & swelling to inj site) which subsided p/3-4 days;no intervention by MD prescribed; pt able to obtain relief from oral NSAID
Developed moderate soreness at injection site and flu-like symptoms including moderate fatigue, slight fever and moderate joint pain. No treatment is being sought.
neck ache is ridiculously bad; more symptoms; neurological disorder that affects her balance; Worst muscle ache in the very top of her neck/miserable miserable muscle ache/muscle aches have been hell/ neck ache is ridiculously bad; Received both doses of Pfizer COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck ache is ridiculously bad), VACCINATION COMPLICATION (more symptoms), BALANCE DISORDER (neurological disorder that affects her balance), MYALGIA (Worst muscle ache in the very top of her neck/miserable miserable muscle ache/muscle aches have been hell/ neck ache is ridiculously bad) and INTERCHANGE OF VACCINE PRODUCTS (Received both doses of Pfizer COVID-19 vaccine) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer (Both doses of the Pfizer COVID-19 vaccine). Past adverse reactions to the above products included No adverse event with Pfizer.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received both doses of Pfizer COVID-19 vaccine). On an unknown date, the patient experienced NECK PAIN (neck ache is ridiculously bad), VACCINATION COMPLICATION (more symptoms), BALANCE DISORDER (neurological disorder that affects her balance) and MYALGIA (Worst muscle ache in the very top of her neck/miserable miserable muscle ache/muscle aches have been hell/ neck ache is ridiculously bad). On 05-Nov-2021, INTERCHANGE OF VACCINE PRODUCTS (Received both doses of Pfizer COVID-19 vaccine) had resolved. At the time of the report, NECK PAIN (neck ache is ridiculously bad) and MYALGIA (Worst muscle ache in the very top of her neck/miserable miserable muscle ache/muscle aches have been hell/ neck ache is ridiculously bad) had not resolved and VACCINATION COMPLICATION (more symptoms) and BALANCE DISORDER (neurological disorder that affects her balance) outcome was unknown.            No concomitant products were reported.  Patient took muscle relaxers as a prescription and they did nothing to help, she also used cream and all sorts of stuff but it does not help. This neck ache was ridiculously bad. This muscle aches have been hell.   Patient took some Ibuprofen and cannabis oil, use a heating pad and rest.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received contains no new information.
No ADR to the vaccine, but patient tested positive for COVID greater than 2 weeks since her previous injection.  She started having flu-like symptoms on 7/13.  She tested positive on 7/16.  She was exposed to her new 8 month old foster baby who tested positive for COVID.  She has a history of lupus and takes immunosuppressants.  We scheduled her to receive the monoclonal antibody.
Covid19 breakthrough.  1st vaccine received on 03/09/2021.  67 y/o PMH HTN, DM, Renal failure, Laminectomy with residual paraplegia, Chronic indwelling catheter, colectomy/ileostomy presents to ED with c/o urinary retention after chronic foley fell out and HHC RN unable to replace.  Found to be Covid +, treated with IV abx.
The patient began experiencing trouble breathing and weakness a few hours after administration of the vaccine. He was recovering from a kidney infection, so it is unknown what the cause of the symptoms originated from. It was determined to involve EMS, and they came and picked him up at the Long Term Care facility and took him to the hospital.
Asthma exacerbation, cough, shortness of breath. Began right after first dose of Moderna vaccination and still experiencing effects 2 months later. Treatment includes inhalers, corticosteroids, and antibiotics.
Right arm turned red and swelled beginning 3 inches below injection sight and extending all the way to the elbow. Diagnosed as Cellulitus. Treatment using Cephalexin was begun immediately.
Knees were on fire inside, tight, stiff, and can't bend them; Aches; Fatigue; A a spontaneous case report was received from a 68 year old female Other Health Professional concerning herself who received second dose of Moderna COVID-19 Vaccine (m-Rna-1273)..  The patients past medical history included double mastectomy and was a cancer survivor. Once the patient took a cancer pill and it made her knees feel like they were on fire. This was 6 years ago. Ongoing conditions of the patient included arthritis and blood pressure. Concomitant medications of the patient included meloxicam, multi vit , atenolol, losartan potassium ,hydrochloroth (hydrochlorothiazide) and potassium chloride.  On 15 Jan 2021  the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. The patient took the second dose of vaccine on 12 Feb 2021 into left arm intramuscularly. Five  days later on 17 Feb 2021,  the patient developed Knee arthritis. The patient also developed aches and fatigue. It hit in the knees and she could barely walk. She had o sit down from room to room.  The patient reported the serious criteria to be temporary disability. Patient reported her arm was still black and blue from the first shot when she went for the second one. She had to get both the doses in left arm due to double mastectomy.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.  Outcome of the events fatigue and aches was unknown and that of Knees were on fire inside, tight, stiff, and can't bend them was not recovered not resolved.  The reporter causality for the events was not provided.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Vomiting, fever, cough and excessive sleepiness. 10 days after injection, rash 14 days after injection. RX given acetaminophen 1.2 ml infant drops q6h po PRN for fever, clear liquids.
Patient has history of anemia and vasovagal syncope. She had a witnessed syncopal episode 10 min after vaccine admin.  Patient fell from chair to ground. Staff responded immediately. She was positioned supine on the ground. She was pale and diaphoretic. v/s were assessed. She spontaneously regained consciousness and was maintained on the ground. She denies neck pain, back pain, headache, numbness, weakness, tingling, changes in vision and was A&Ox3. No stair stepping palpated on neck no ecchymosis noted eyes PEARL. She was repositioned to trendelenburg and was given a gatorade. When BP was stable she was return to her chair. She was kept for an additional 20 minutes and provided crackers. She stated she felt much better and felt safe to go home with a plan of calling a friend to speak to during the drive. She was advised to call 911 if she has another episode or develops severe headache or changes in vision.
Initial and follow-up information has been received from a 25 year old female with headaches, depression, and no drug allergies, who on 23-FEB-2007 and 24-APR-2007 was vaccinated with a first dose and second dose of Gardasil, respectively. Concomitant medication included citalopram hydrobromide (CELEXA) and cyclobenzaprine hydrochloride (MSD). Subsequently, after receiving the first two vaccinations the patient reported she was 5 weeks pregnant. It was noted that the patient discontinued the dosing schedule. The patient's last menstrual period was 07-JUL-2007, the estimated conception date was approximately 21-JUL-2007, and the estimated delivery date was approximately 14-APR-2007. On 17-SEP-2007 the patient had an ultrasound due to bleeding and the results of the test were reported as fetal demise. On 20-SEP-2007 the patient had a spontaneous abortion at 10 weeks. The products of conception were examined and reported as immature chorionic villi with decidua. It was unknown if the fetus was normal. The patient did not have any previous pregnancies. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Patient reported severe swelling and soreness of deltoid muscle. Swelling had subsided by the time she came to pharmacy to report event (11/1/2013) but still sufferes from soreness and light swelling. She took Aleve to help with the pain.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 13-DEC-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II, lot # L049314, expiry date 03-DEC-2017 (dose, route and site of administration were not reported). Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. No adverse effects reported. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Prior to the vaccination she was pain free (mild LLQ), no dysuria (mild pressure) no fever. The evening after the shot she had fever, 101, chills, diarrhea and stomach pain. Day 2 she stated she was feeling better and then day3- 10 she developed severe stomach pain, new diverticula and diverticulitis. She was supposed to have surgery on Fistula and the surgery was delayed due to new damage to colon.
I had cold like symptoms-- congestion, coughing with a consistent headache, low grade fever and some fatigue.
10/22/12 client called and stated "after shot I had 50 cent size red itchy area on my arm & now I have a rash on my back & side could shot cause shingles? Referred to PMD for evaluation. 10/25 called client she saw her doctor & rash is yeast.
pt recvd flu vax & devel redness that went down to the elbow of the arm where inject was given;
Patient told the nurse when she came in for her second Moderna vaccine shot that an hour after her first Moderna vaccine shot her entire face was red and hot.
12/17I had severe nausea I never threw up and fatigue and I had to leave work and Dr prescribed zophran, I was fine the next day on 12/18 I went to work I was just a little nauseous
Extreme fatigue, high fever (101), chills , body aches, diarrhea.  Started about 14 hours after injection. Lasted approximately 36 hours. Tylenol helped. .onset of fever blister about 5 days after injection.
Vaccine 3/8/21 at 4:00 PM.Headache and fever 3 hours post vaccine. The following day had diarrhea and vomiting. Then presented to ER on 3/10/21 with lactic acidosis, & leukocytosis. Hospitalized for 24 hours 3/10/21 to 3/11/21.