chrisvoncsefalvay/vaers-outcomes huggingface dataset:
They administered a vaccine on 15Dec2022 at 10 AM after the excursion; No Adverse Event; administered a vaccine on 15Dec2022 at 10 AM after the excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (administered a vaccine on 15Dec2022 at 10 AM after the excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (They administered a vaccine on 15Dec2022 at 10 AM after the excursion) and NO ADVERSE EVENT (No Adverse Event) in a 50-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Dec-2022 at 10:00 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 15-Dec-2022 at 10:00 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered a vaccine on 15Dec2022 at 10 AM after the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (They administered a vaccine on 15Dec2022 at 10 AM after the excursion) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (administered a vaccine on 15Dec2022 at 10 AM after the excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (They administered a vaccine on 15Dec2022 at 10 AM after the excursion) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (administered a vaccine on 15Dec2022 at 10 AM after the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (They administered a vaccine on 15Dec2022 at 10 AM after the excursion).    Concomitant products were not reported.  It was reported that overnight 14-15-Dec-2022 the power went out, so the fridge got out of range. In the morning, the power turned back on, so the fridge was back within range. The vaccines in the fridge went to room temperature from 6:20 AM to 7:30 AM. They administered a vaccine on 15-Dec-2022 at 10 AM after the excursion because they didn't know there was an excursion. It was unknown did patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment medications were not reported.
Fatigue, headache, body aches, and low grade fever. Set in about 18 hours after injection and lasted 36-48 hours or so.
I woke up next day (today) with my RIGHT EYE swollen and itching.a little pain around my eye.
Fever of 101 F noted on 10/12/16 that resolved with acetaminophen. Generalized morbilliform rash noted on 10/14/16. Temp 100.0 F.
56 years old male called to report an adverse reaction after he received his jhnson and jhnson vaccine on 04/11/2021 @1230. patient reported 30 mins after receiving his vaccine he developed arm pain, diarrhea, and chills. patient reported sinus allergies. patient reported that he takes advil for his allergies. and amlodipine for his high blood pressure. patient was instructed to take advil to help with his symptoms. patient was instructed to seek medical attention if the symptoms got worse.
"Vomtting"; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on an unknown date (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 25Apr2021 at 09:00, the patient experienced "vomtting". The clinical outcome of the event "vomtting" was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I have not started my Period since receiving my first dose. I was ovulating on the day I got my first vaccine on 3/9/2021. I was supported to start my menstrual cycle on March 23rd. I have not started. It?s 3 weeks late. I have taken 3 pregnancy tests and all negative. I am always regular and no irregular period symptoms ever. This is VERY unusual for me.
Patient received vaccine at 12:30 pm. Patient started developing redness on face, arm, torso, and back at 12:41 pm and given Benadryl 25 mg x 1 Dose. Patient started developing tingling lips at 12:50 pm and received EpiPen 0.3 mg x 1 dose and EMS was called. Blood pressure at 122/89 at 12:55 pm; 142/87 at 12:58 pm. Patient was taken to hospital for evaluation.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE COMPLEX PARTIAL FRONTAL LOBE EPILEPSY EPILEPSY, UNSPECIFIED OBSTRUCTIVE SLEEP APNEA RIGHT BELLS PALSY HYPOTENSION LEFT FACIAL MUSCLE WEAKNESS
Patient receiving the 1st dose of Shingrix on 09-APR-2019 and the 2nd dose was not administered yet.; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on 9th April 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 8-Jun-2022 Reporter's Comments: Pharma intern reported the second dose was not administered at the time of reporting. Health care professional did not have more information. The reporter did not consent to follow up. Did not give permission to gather information for Medical information database. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination
First Moderna primary series dose three months ago and now would like to receive the second Moderna primary series dose; This spontaneous case was reported by a physician assistant and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (First Moderna primary series dose three months ago and now would like to receive the second Moderna primary series dose) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (First Moderna primary series dose three months ago and now would like to receive the second Moderna primary series dose). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (First Moderna primary series dose three months ago and now would like to receive the second Moderna primary series dose) outcome was unknown.        mRNA-1273 (Spikevax) (Intramuscular) dosing was interrupted on an unknown date.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient received their first Moderna primary series dose three months ago and now would like to receive the second Moderna primary series dose. No treatment medications were reported.   Reporter did not allow further contact
I was really congested, dry annoying cough that would wake me up in the middle of the night, and trouble breathing. I went to the urgent care and I received a breathing treatment. After the breathing treatment my breathing was better and for the cough I took DELSYM. I still having coughing and running nose but I feel better.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with doses of GARDASIL injection (strength, dose, route of administration, indication, lot# and expiry date unspecified), that were improperly stored. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
10 days p/vax pt devel brightly erythema multiple papules on trunk & extremities w/fever to 104;rash spread to face on 3rd day;
One week after getting the vaccine I started feeling very weak with severe headaches. I was also having  palpitations. It's 2 weeks now and I am still having the headaches and palpitations.
Patient was given vaccine in left upper gluteus. Pharmacist at the time of vaccination tried numerous times to administer vaccine in the right arm; however, was unsuccessful after many attempts. Situation occurred with patient where the vaccine would not go into his right arm even after multiple attempts, which led the needle to bend. After a few attempts, patient said he also cannot get the vaccine in the left arm and that he wanted the vaccine in gluteus area. Informed patient that the vaccine is given IM into the deltoid. He persisted in receiving the vaccine in gluteus. This was patients second dose of vaccine.
Onset of extreme fatigue, diarrhea, and then swelling, pain, redness, heat, and hardness of the Left Leg and Ankle.  Sharp pain in the leg and ankle developed over the next months with swelling, becoming severe enough to see an Orthopedist on June 15, and then a visit to the primary Dr. on June 22.  EKG, Blood including d-dimer, and Chest xray done same day, then a Sonogram done on June 23.  No signs of blood clot, but leg issues and diarrhea continue, with skin breakdown occuring at the ankle.   Placed on Prednisone 10Mg x 5 days, Lasix 40mg x 30days,  Klor-Con MEG 10mg x 30 days, Keflex 500mg x 10 days,  Mupirocin 2%.skin cream 3x day.  Some improvement of the diarrhea since this time, but leg continues to be swollen, red, painful, and hard.
Patient complain of dizziness, eye itchy, nauseated, doesn't feel well, fatigue and sleeping more.
As per patient, next day after he received his 2nd dose of Moderna  he had fever and heart pain; he took Tylenol and it relieved the pain; however, today he call us to report it because the chest pain started again; he said he had being coughing since February 2020 after he suspected he had COVID19 but he never was diagnosed because he never got  tested. He reported that he had chest pain back in February 2020; he had not seen a doctor and he was strongly recommended to see md ASAP to check his heart and lungs
Pt was given an pneumonia 23 08/07/18. He last pneumonia vaccine was in 2016. She accumulated a localized reaction around 5 PM.
Fatigue, Arm Swelling/Soreness, Low Grade Fever (99.5), Nausea, Gloss Eyes, Dry Eyes, Extreme Thirst, Feeling Weak, Dizzy,
within 10 hours I had chills which I had for about 3-4 days. then I developed "Covid Arm". the injection site was 3x3 red, hot, swollen, rash on my arm. I had nausea and vomiting. my asthma also flared up. I also had joint pain.   On Saturday the 13th I started having some weird things going on. I had mild paralysis and I was diagnosed with Bells Palsy in the right side of my face. (notably the same side as the shot was administered)
12/30/2021 with ion minutes of receiving vaccine I got hot and dizzy, they gave me a snack of sprite and crackers and monitored me longer than 15 minutes, as long as I did not stand up I was okay.  After an hour of monitoring they let me go because I did not feel hot of dizzy.  About 2 hour later, I got really cold and like a swimmer's head and when someone came in and checked me at my desk at work, they noticed hives on my neck chest and back above the shoulder blades and at that point I went down to the Emergency Room.  The ER gave me Pepcid and Benadryl.  The meds brought the symptoms down quite a bit but not all the way I cad to continue the meds for 2 days every 6 hours.  On 12/31/2021, my body hurt all over, it was not nothing like I have ever felt, it was like I was in a car accident, I do not recall running a fever at all, but the Benadryl kept me pretty knocked out and I slept a lot.  The ER doctor felt that the symptoms were related to the vaccine because it occurred within 4 hours.  I began to feel better on 1/1/2021, I did have hives but only a small amount so I did not take anything and let it run it's course.
April 5th sore arm 11:30pm fever of 100.2 on tylenol. Took advil at 3am. Still had fever and sweating. April 6th  felt tired and achy. The night of April 7th at 1am had severe chest pain, felt like heart attack. Went to urgent care at 5:55pm April 7th. Had ekg done and was diagnosed with pericarditis. Was treated with ib prophen 800mg 3x a day for one week. Follow up appointment with primary care April 15th.
Approx 3 hrs p/immun pt devel t105 R; APAP was given immediately following DTP & every 4 hrs; Thereafter no other sx noted; pt not seen by MD; temp lasted approx 36 hrs;
Information has been received from a physician concerning his 15 year old daughter with no drug reactions/allergies and no reported medical history who in approximately February 2007, was vaccinated in the left arm with the first dose of Gardasil. there was no concomitant medication. Three days post-vaccination, the patient developed supraclavicular adenopathy on her left side and a fever of 100.5F. She was treated with ibuprofen and acetaminophen. Subsequently, the patient recovered in two weeks. Additional information has been requested. This is one of two reports received from the same source.
A report has been received from a Pharmacist concerning a 53 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 06-Oct-2013. The patient experienced 53 year old patient received FLUMIST on 06-Oct-2013. The outcome of the event of 53 year old patient received FLUMIST is unknown. The report was considered to be non-serious.
Approximately 12 hours after Flu shot, whole body itching and bilateral hand swelling Tx'd with Zyrtec and improved.
Multiple Pulmonary Emboli, Cardiomyopathy  Medication, hospital stays,  Progressed quickly to severe heart failure  Difficulty breathing, exhaustion, palpitations.
Severe stomach cramping/diarrhea lasting several hours, uncontrollable full body tremors, shaking lasting approx 3 hours, went to sleep and woke up with no hearing in left ear.
This spontaneous report was received from a pharmacist refers to a 67 year old female patient. The patient had a history of shingles 10 years ago. She was allergic to sulfa drugs. Information regarding her concurrent conditions were not provided. On 18-MAR-2016, the patient was vaccinated with ZOSTAVAX (lot # L035506, expiry date: 16-DEC-2016). Concomitant therapy included unspecified chronic medications. Pharmacist reported that the patient developed burning and itching of her lower extremities and abdomen within 24 hours of vaccination. The patient did not required  medical attention. Pharmacist stated that he patient's symptoms occurred off and on since she received the vaccination. She self administered Advil, Benadryl and Aleve on unknown dates, for the treatment of her symptoms. Reporting pharmacist stated that they were unknown if rash was present and also mentioned that the patient did not reported a rash. Outcome of the events were unknown. Reporting pharmacist did not assessed the causality of the events with respect to therapy with ZOSTAVAX.
Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Additional Details: patient called to report that he is having pain in his arm that got the covid shot and is having difficult lifting and moving it. patient claims the shot was given too high into the joint and states he has pictures. patient said he will be going to the doctor tomorrow to get checked out
My son had a very high fever that was not controlled well with tylenol. it rose to a temperature of 104 and my son had a febril seizure in a store. it was the scariest thing that could happen to a parent and child. my son had the look of fright on his face and quickly went in to a seizure. we were taken to the nearest hospital by ambulance. his lips had turned blue and he was not responding. i thought i was losing my baby. that flu shot gave him a terrible fever that was too much for his body to handle. thank god that my son survived that and i still have him!
MOM CALLS OFFICE TODAY TO REPORT CHILD WITH FEVER >103 LAST 24 HRS AFTER IZ'S GIVEN YESTERDAY. REDNESS, SWELLING AT SITE OF DTAP, AND WON'T WB ON RIGHT (SITE OF MMR).
Red, swollen, itchy at site of DTaP injection noted on 05/26/04 - sl. temps DTaP given 5/25/04. treated for Cellulitis - right deltoid.
Product temperature excursion issue; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided No treatment medication provided  There was an excursion from that freezer on 01-Oct-2021. They used the excursion tool but there was no option for the excursion they experienced. The tool only gave options for excursions above one hour and not less than, so she does not know how to do the analysis. She states that her team already knows the recommended temperatures and wants to know if the vials were still okay to be used because they were administered to 118 patients.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received on 15-Nov-2021 contains Patient demographics, Vaccine start date and Dose number of the vaccine.
Patient stated his neck began to hurt, and he developed a painful rash.  He went to his doctor on the following day and was diagnosed with shingles and was treated with valacyclovir.
Hurt her knee; Headache; Sore left armpit; Sore left breast; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Sore left armpit), BREAST PAIN (Sore left breast), PAIN IN EXTREMITY (Sore left arm), JOINT INJURY (Hurt her knee) and HEADACHE (Headache) 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 10-Mar-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 10-Mar-2021, the patient experienced AXILLARY PAIN (Sore left armpit), BREAST PAIN (Sore left breast) and PAIN IN EXTREMITY (Sore left arm). On 23-Mar-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced JOINT INJURY (Hurt her knee). On 13-Mar-2021, AXILLARY PAIN (Sore left armpit), BREAST PAIN (Sore left breast) and PAIN IN EXTREMITY (Sore left arm) had resolved. At the time of the report, JOINT INJURY (Hurt her knee) and HEADACHE (Headache) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable. The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.
death I61.9 - Intraparenchymal hemorrhage of brain (CMS/HCC)
Hives to bilateral lower extremities on set 8-3-16 0900; mom gave oral BENADRYL at 0930; referred to PCP.
revaccinated him immediately/created in error; got the Moderna shot and thinks they gave him an empty vial or used syringe; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION ERROR (revaccinated him immediately/created in error) and INCORRECT DOSE ADMINISTERED (got the Moderna shot and thinks they gave him an empty vial or used syringe) in a 30-year-old patient of an unknown 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION ERROR (revaccinated him immediately/created in error) and INCORRECT DOSE ADMINISTERED (got the Moderna shot and thinks they gave him an empty vial or used syringe). At the time of the report, VACCINATION ERROR (revaccinated him immediately/created in error) and INCORRECT DOSE ADMINISTERED (got the Moderna shot and thinks they gave him an empty vial or used syringe) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Consumer was reporting side effects for son who got the Pfizer vaccine. However, mother also mentioned what happened to her other son who received the Moderna vaccine: "other son got the Moderna shot and thinks they gave him an empty vial or used syringe, so they revaccinated him immediately."  no concomitant medications are provided.
Fever 101.4, sleeping more. ER visit 04/23/05 @ 2:11. FU office 04/25/2005. TX Tylenol, Motrin, Rocephin
(1) Weakness. (2) Diarrhea. (3) Heart racing. (4) Decreased appetite.
No adverse events immediately. A couple of days after vaccine, I noticed back pain under ribs and behind where I assume heart is except mirrored on other side of the body as well. I wondered if I pulled a muscle or something.  That same  day, I had both ears horribly stuffed up and headaches that wouldn't go away. I had wondered if I had a cold coming on but am pretty healthy for having type 1 diabetes despite access to insulin at times. No appetite. Fatigue worse than normal with body aches. I also noticed my hands and body shaking. Thinking I possibly was having a low blood sugar, I went to stand and about fell over. Blood sugar was 198, which being a little high, is not anything that would make me shake or pass out. I still chose to eat despite feeling unwell, just in case my body needed the nutrition.  Blood sugars have either been slightly high for the day or slightly low for the day. I have not been exercising. I had started Prilosec a couple of days before getting vaccine to see if my thick mucus or hypersensitive throat would be calmed as a PA mentioned my issue could be GERD. I have puked plenty in regards to my throat and the Lisinopril caused cough just seems to be worse.  I am finding it very difficult to function reliably with almost passing out multiple times a day.
This spontaneous report as received from a healthcare worker refers to patients of unknown ages. The M-M-R II was exposed to temperatures above 8 C multiple times. On unknown dates, doses of the vaccines (lot # not reported) (strength and total daily dose not reported) had been administered to patients. At the time of this call, the healthcare worker did not know the exact length of time that the vaccine doses were exposed to the temperatures out of range, nor was there adequate documentation of the administration of these doses to the practice's patients. It was unspecified whether the patients sought for medical attention. The outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.