chrisvoncsefalvay/vaers-outcomes huggingface dataset:
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 9:11 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 9:11 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 70.22 for dose administered on 28 Feb 2021.  No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 28 Feb 2021 with temperature 35 degrees Fahrenheit from 09:00 AM to 01:00 PM. This vial was moved to fridge on 24 Feb 2021 and beyond use date for the vial was reported as 26 Mar 2021. Product moved to clinic on 28 Feb 2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
Strong Sinus Pressure / Pain, treatment Flonase spray once daily, 2 months, outcome sinus pressure continued and very slowly declined and was back to pre-injection status in approximately 5 months.
Low blood pressure, fever, chest pain, dizziness, and nausea. Patient went to the ER and was admitted to the hospital.
Mom came into our office, stating her son need his second dose.  First dose was given on 5/25/21. Mom provided documentation of prior dose.  Pfizer vaccine was administered. It was noted after administration that patient was under age. No adverse event occurred.
6 hours post shot patient had a severe headache that she had not had before . While falling asleep has flashing light. Inflammation flair.  She had abdominal cramping 1-2 days later.  Feels memory and cognition is off.
GRANDMOTHER CALLED AND REPORTED CLIENT RECEIVED VACCINATIONS (HEP A AND MMRV) ON 9/18/18. GRANDMOTHER REPORTED CLIENT STARTED FEELING BAD ON 9/21/18 WITH HIGH FEVER AND SORE THROAT. GRANDMOTHER REPORTED TAKING CLIENT TO URGENT CARE AND SHE WAS TESTED FOR STREP. GRANDMOTHER SAID THEY WERE SENT HOME WITH ANTIBIOTIC (CEFTIN) FOR CLIENT TO TAKE. GRANDMOTHER STATED CLIENT DEVELOPED RASH ON 9/22/18 WITH PINPOINT BUMPS ALL OVER BODY. GRANDMOTHER STATED CALLING URGENT CARE ON 9/23/18 AND SHE WAS TOLD STREP CULTURE CAME BACK NEGATIVE AND WAS TOLD TO STOP CLIENT'S ANTIBIOTIC. GRANDMOTHER STATED URGENT CARE THOUGHT CLIENT HAD SOMETHING VIRAL GOING ON.  GRANDMOTHER CALLED URGENT CARE BACK 9/24/18 AND THEY WANT TO SEE CLIENT IN CLINIC. GRANDMOTHER TAKING CLIENT BACK TO URGENT CARE.
Patient was given 0.3mL of undiluted Pfizer Bivalent 5-11 instead of 0.3mL of Pfizer Bivalent 12+. Patient reports no adverse reactions.
My partner had symptoms several days before i did, Then i came down with them 3 days later. It started with sinus and fatigue. I couldn't breathe and very clogged nose and it was burning. I had a very light sore throat. I think the thing in my throat was the first symptom. And then i woke up and my head was stuffy. I really didn't wanna do anything. I tried to work but couldn't. On day 8 i got slammed with a major headache and brain fog. It was scary. I was on Paxlovid. It really scared me, i called the doctor and everyone, day 9/10 i had heavy brain fog. on day 10 i tested negative. I just felt crappy and fatigue and lazy over the next week but it was getting better. I had skin legions. i was breaking out everywhere. And all that went away as the brain fog went away. One of the trail symptoms is it feels like i have something that i needed to cough up. cough drops were helpful. Its only this week i would say over the weekend i started feeling better. Monday was the first day i could go to work. A week ago Wednesday i was feeling kinda good and then i was like great im gonna go run a errand and i went out and stop by some markets and gas and i couldn't stand up. I got 2 more days of rest and got better. And yesterday by back of throat symptoms started again and i gave up and took and nap, im just tired.
Haven't gotten menstrual period; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, the patient reported that since she was 14 years old, she had a menstrual period every month without fail, now all of a sudden since getting vaccinated she had not gotten one menstrual period. Therapeutic measures were not taken as a result of this event. The clinical outcome of the event menstruation delay was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Severe full body pain, unclear if muscle or bone, starting Feb 4.  Takes 1 hour to get dressed due to pain
felt weird,like everything in his body was shutting down/ booster shot really screwed him up; a lump in his left armpit; felt really sore/body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (felt weird,like everything in his body was shutting down/ booster shot really screwed him up), AXILLARY MASS (a lump in his left armpit) and MYALGIA (felt really sore/body aches) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 029L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced FEELING ABNORMAL (felt weird,like everything in his body was shutting down/ booster shot really screwed him up) and MYALGIA (felt really sore/body aches). 17-Nov-2021, the patient experienced AXILLARY MASS (a lump in his left armpit). At the time of the report, FEELING ABNORMAL (felt weird,like everything in his body was shutting down/ booster shot really screwed him up), AXILLARY MASS (a lump in his left armpit) and MYALGIA (felt really sore/body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-447062 (Patient Link).
two months later got the Flu; very sick; Initial information was received on 27-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves a patient with unknown demographics who got the flu and very sick after receiving vaccine Influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine (produced by unknown manufacturer) (with unknown strength, dose, route and administration site, lot number and expiration date) for prophylactic vaccination.  On an unknown date the patient got the flu (influenza) (latency: two months) and very sick (illness) (unknown latency) following the administration of Influenza vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported for both the events.  Outcome: Unknown for both the events.
This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LIOTHYRONINE, LEVOTHYROXINE, AMLODIPINE and LOSARTAN for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) outcome was unknown.            No treatment details were reported for dose-2 event.   This case was linked to MOD-2021-409280, MOD-2021-409287 (Patient Link).
This spontaneous report was received from a physician refers to an unknown number patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with VAQTA lot # M011839 13-SEP-2107, M017982 13-SEP-2017, M002268, 20-SEP-2017, M015290 20-SEP-2017, M022924 24-SEP-2018, L018499 25-FEB-2017, L036300 04-NOV-2016. No adverse effects were not reported. Temperature excursion 28.0F for 222.75 hours. Additional information has been requested.
Almost immediately after patient vaccinated, while she was parking she said she felt like she was having difficulty swallowing and her "throat was swollen", also had a weird taste in her mouth.  She stated it just feels weird when she swallows.  Patient cleared by EMS.  Instructed patient to call her family physician, 911, or go to the nearest emergency room for any further issues.
Day of Vaccine March 12: 5:30 pm chills, arm pain (left/injection side); 6:30 pm + fatigue, mild nausea; 7:30 pm + neckache and headache; 8:30 pm + shivering / teeth chattering, fever 99.8; 9:30 pm fever 100.5, dizziness, took 1 ibuprofen; 10:00 pm + extremely hot, ache in low back, (no chills); woke multiple times during night with body pain and "busy-ness" of thoughts.  Day after Vaccine March 13: 8:15 am fever reduced 99.4, headache, back ache (reduced arm soreness), fatigue ,took 1 ibuprofen, back to bed; 10:30 am no fever (temp 98.8), more alert, body tired, head mildy wonky, appetite good; 10:00 pm no fever (temp 98.3), able to sleep.
Within a day of receiving the vaccination, mom noticed that the injection site was red & swollen & that the child was rubbing it like it itches.
On 03/22/2021 I felt dizzy and unbalanced. I had an MRI, neck ultrasound. Now I am medicated for hypertension. I had a hypertension crisis. I had multiple doctor?s visits. I had blood work done. I have not had a good day since that day. On the night of 03/28/2021 I went to the ER for dizziness and heart palpitations. They did an EKG and blood work. They said it was an anxiety attack and that I should see my PCP.   The dizziness continued and I got my MRI on June, which showed lesions but I have not been able to see a neurologist yet. They said it could be from MS or hypertension or something else but they have not given me any diagnosis yet. I am still dizzy.
Tinnitus; Ear fullness in left ear; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 14:45 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date, prior to the vaccination. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 16:15, 1.5 hours after injection into left arm, the patient experienced tinnitus and ear fullness in left ear that started, and still persisted two weeks later. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of events. The clinical outcome of the events tinnitus and ear fullness in left ear was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Severe Abdominal cramping X 2 days. moderate abdominal cramping an additional 5 days
This case was reported by a pharmacist via out of hour services and described the occurrence of injected limb mobility decreased in a 77-year-old male patient who received SHINGRIX (batch number T5242, expiry date 31st march 2020) and (batch number 5523C, expiry date 28th April 2020). On 10th April 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 10th April 2018, 3 hrs after receiving SHINGRIX, the patient experienced injected limb mobility decreased and injection site pain. On an unknown date, the outcome of the injected limb mobility decreased and injection site pain were not recovered/not resolved. The reporter considered the injected limb mobility decreased and injection site pain to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient spoke to the pharmacist 3 hours after the vaccination to report the events. The patient experienced pain at the site of injection and difficulty in raising arm. The lot number from the box was not available but the lot number from the antigen was T5242 with expiration date of 31st March 2020 and the lot number of adjuvant was 5223C with expiration date of 28th April 2020. The caller was provided the phone number to medical information for additional assistance as the reporter was unable to transfer the call.
pt recvd vax & at 9:10 walking in hall eyes blurry, then white, then black; 915 BP 110/80, P72, supine, s1s2 lungs clear; 920 BP 100/82 P60; 930 BP 110/80 P68,@ 9:48 returned to class;
Vaccine administered after 2 days of puncturing the vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 2 days of puncturing the vial) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 2 days of puncturing the vial). On 15-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 2 days of puncturing the vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up contains updated event verbatim.
Initial unsolicited report received from a Nurse on 14 May 2015. A 40-years-old male patient with medical history of hypertension (HTN) and no known allergies and whose concomitant medications were not reported, had received a second dose of Imovax (batch number as: K1729-1, expiry date: 07 December 2016, dose was not reported) intramuscularly in left deltoid on 06 May 2015. Patient did not have any illness at the time of vaccination. On 13 May 2015, seven day after vaccination, patient presented with elevated blood pressure (BP) and second vaccine was held for the patient. Patient required ER/doctor visit for the event. Laboratory investigations and corrective treatment were not reported. At the time of this report, the event outcome was not recovered. List of documents held by sender: none. Follow up report received from a Nurse on 14 May 2015. The patient received Imovax in right upper arm. The patient also received second dose of Hep B vaccine (Batch number 7529F, manufacturer-GSK) in left upper arm on 6 May 2015. It was reported that the patient did not received any corrective treatment. It was reported that the patient was forget to took his BP (blood pressure) medication on the date the vaccine was supposed to be administered and the dose was withheld because of high BP. Subsequent BPs were normalized. On an unspecified date, the patient recovered from the event.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date (dates) those patients were vaccinated with GARDASIL (dose, units, route of administration, anatomical location, lot number were not reported) that may had been stored improperly. No adverse effects reported. This is one of several reports from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
Started feeling clammy about 3 hours after shot and that lasted for couple hours. Had severe headache about 8 hours after shot that's lasted for about 8 hours. My arm is a little sore still.
On April 3, the day after the vaccine, I got out of the shower and I noticed a rash under both of my breasts but I didn't think much of it. As the day went on, the rash spread throughout my body. I did not feel sick and I did not have a rash on my left arm. I didn't hurt or itch. I talked to a friend and her mother had the same issue. She said to contact the doctor and I would possibly get prednisone. I had bumps on my eyelids. I saw another doctor where I said that I am coming in due to this spreading rash. The treatment was going to be triamcinolone 1% cream and doxycycline. I got my steroids but I could not get the cream on my face so she referred me to an allergist and dermatologist. The allergist was first and 14 days had passed and the rash was so horrific. The rash was horrible and everywhere. He did nothing. I left and went to the dermatologist. She was the only person who seemed to care and punctured two holes in a biopsy. To rule out everything, she referred me to a cancer hematologist on June 22. I don't have cancer. I have never had a rash in my entire life and it all happened after the Moderna vaccine. One of the conclusions is from this vaccine.
Dizziness, headache, sore throat, body aches, ear pain (bilateral), fever (up to 102.5)
Chest tightness, asthma attack. Client used her Ventolin Inhaler and symptoms resolved. She did not seek medical help.
Diagnosis for bone marrow cancer/ Cancer came back/ Bone marrow cancer; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOPOIETIC NEOPLASM (Diagnosis for bone marrow cancer/ Cancer came back/ Bone marrow cancer) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 028A20A) for COVID-19 vaccination.     The patient's past medical history included Cancer (The patient stated that she has been cancer free for last 10 years). Concurrent medical conditions included Ear feels clogged, Allergy, Blood pressure abnormal and Hearing impaired.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HAEMATOPOIETIC NEOPLASM (Diagnosis for bone marrow cancer/ Cancer came back/ Bone marrow cancer) (seriousness criteria medically significant and life threatening). At the time of the report, HAEMATOPOIETIC NEOPLASM (Diagnosis for bone marrow cancer/ Cancer came back/ Bone marrow cancer) outcome was unknown.            Concomitant medications include blood pressure medications.   Treatment medication include bone marrow medication.  The caller was a patient who stated that she was calling in reference to the 3rd shot that was coming out but decided to mention in the call that she had clogging in the ears due to allergy and had problems hearing due to the allergy. The patient stated that she had been cancer free for last 10 years but did had a latest diagnosis for bone marrow cancer in the summer when she went for her yearly checkup. The patient stated that when the cancer came back and the doctor started treatment immediately. The bone marrow cancer was negative during the last ten years, but the doctor saw cells and the patient went into treatment so that the cancer did not go further. The patient stated that she had one treatment and had 4 more treatments to go.  Company comment: This case concerns a 79-year-old, female patient with no previous relevant medical history, who experienced the unexpected event of hematopoietic neoplasm. The event occurred after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since limited information is provided. Elderly age of patient remains a confounder.  The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 79-year-old, female patient with no previous relevant medical history, who experienced the unexpected event of hematopoietic neoplasm. The event occurred after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since limited information is provided. Elderly age of patient remains a confounder.  The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.