chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported to pharmacist on 9/24 that on the day of the vaccine in the late afternoon, she started to experience a very hot, red arm in the area of the vaccine and it spread to her shoulder. The reaction lasted 3 days. The patient used cold compresses, and it slowly resolved over 3-4 days. She sought the advice of her PCP, as she was worried about a blood clot as she has had issues with blood clots in the past. Her PCP advised her that it most likely was a localized reaction from the vaccine itself. Patient reports never having a reaction to the flu vaccine in the past, and gets flu vaccine every year.
Got flu shot yesterday (10/30/13) and today was dizzy, lost balance, had chills.
Red, swollen upper arm at injection site.  Patient stated the swollen area is the size of a softball.  She said that she is also experiencing headache, chills, body aches and feeling exhausted ever since receiving the shingles vaccine.
Arm hurt; Soaking in sweat; Feeling tired; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), HYPERHIDROSIS (Soaking in sweat), FATIGUE (Feeling tired) and CHILLS (Chills) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cardiomegaly.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt), HYPERHIDROSIS (Soaking in sweat), FATIGUE (Feeling tired) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Arm hurt), HYPERHIDROSIS (Soaking in sweat), FATIGUE (Feeling tired) and CHILLS (Chills) outcome was unknown.            Relevant concomitant medications were not reported.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not applicable.
16NOV92 began itching in groin area; by Tuesday had raised, red blotchy, itchy areas scattered in warm area of body; treated rash w/DPH cream;
Severe itching, hives to body, and swelling of the upper lip.  Per patient, took Benadryl to relieve symptoms.
Three hours after receiving vaccines, she developed anterior neck swelling, tongue protruding from mouth "like she couldn't keep it in her mouth" and wheezing per parental report. All symptoms resolved by time she was seen in ER, though there had rectal temp of 100.7 (also resolved).
Patient began to have constant, non stop shivering, fatigue, body/muscle aches. Patient states that he feels like he has symptoms of the "wort flu symptoms ever".
The vial was stored post puncture in room temperature and was administered beyond 12 hours on 13-Oct-2022; No adverse event; Received expired Bivalent Booster beyond 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired Bivalent Booster beyond 12 hours post puncture), PRODUCT STORAGE ERROR (The vial was stored post puncture in room temperature and was administered beyond 12 hours on 13-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022 at 10:45 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Oct-2022 at 10:45 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired Bivalent Booster beyond 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored post puncture in room temperature and was administered beyond 12 hours on 13-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired Bivalent Booster beyond 12 hours post puncture), PRODUCT STORAGE ERROR (The vial was stored post puncture in room temperature and was administered beyond 12 hours on 13-Oct-2022) 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 EXPIRED PRODUCT ADMINISTERED (Received expired Bivalent Booster beyond 12 hours post puncture) and PRODUCT STORAGE ERROR (The vial was stored post puncture in room temperature and was administered beyond 12 hours on 13-Oct-2022).    The concomitant medication was not reported by reporter.  The Bivalent booster dose administered beyond 12 hours posts puncture. Had unbroken cartons and vial size was 2.5 ml. On an unknown date the vial was initially stored in the refrigerator in less than 30 days. On 12-Oct-2022 at 7 PM the vial was first punctured and on 13-Oct-2022 at 10:45 AM vaccine was administered. In room temperature the vial stored post puncture. The vial did not undergo any temperature excursions. In 16 hours of time the vial was exposed to room temperature range (8 to 25 degree Celsius, 46 to 77-degree F). The vial does not expose to room temperature for greater than 24 hours.  The treatment medication was not reported by reporter.
Chills - 18 hours Aches - 24 hours Mild headache - 18 hours Vertigo - 3 days and counting
Information has been received from a 60 year old female receptionist who in December 2008, was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (no lot# provided). About 48 hours after receiving the vaccine she had a red oval shape at the injection site that was itchy and swollen and then about two days after the red oval shape appeared it turned into a bruise that lasted about 8 days. The patient reported that she did not see a physician about this; she just put Benadryl cream on the bruise. No lab diagnostics studies performed. Then on the tenth day the bruise went away. Patient recovered about ten days after the red oval shape appeared. Additional information has been requested.
Initial unsolicited report received from nurse on 20 Jun 2018. This case was linked to 2018SA168262 (same reporter). This case involves a patient (age and gender not reported) who was vaccinated with a fourth dose of ADACEL instead of DAPTACEL (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Recent Covid19 infection (1/24/2022) and is admitted for diarrhea, vomitting and AKI likely 2/2 dehydration. Requires continued admission for mIVF and acute illness in the setting of immunosuppression
Has fatigue and a headache; Has fatigue and a headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-PFIZER INC-2021501798 (same reporter/drug/AE, different patients.).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), HEADACHE (non-serious), outcome "unknown" and all described as "Has fatigue and a headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
received the first dose of Shingrix on 26-Sep-2018 and now wants to administer the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26th September 2018).   On an unknown date, the patient received 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 details were received as follows: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter wants to administer the second dose. The VAERS details were provided for 1st dose. The reporter consented to follow up. This case has been linked with case US2020025234, reported for same reporter.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot #, expiration date, dose and route not reported). The doses of vaccine were improperly stored at 8.5 degrees Celsius for 1 hour. Data logger was involved. There were no previous excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Chronic headache for two weeks, no pain reliever over the counter medicine helped. Chiropractic care helped minimize pain. Sinuses have remained swollen. A round of antibiotics have been taken. Sinus swelling in left nostril and light off/on headache remain one month post vaccination.
She felt a knot and it kept itching. It was sore in the beginning and there was redness. The itching continued for a while.
Erythema nodosum apparent 11 days after Moderna dose #2 (although I think more likely related to new ocp prescription, but vaccine relationship possible).
pt to er 10/05/2021, passed this day also.  vaccinated on 03/09/2021 with johnson and johnson vaccine.
Patient received 2nd dose in series on 4/5/21. On 4/7/21 patient started to experience vertigo type symptoms including dizziness and occasional nausea. On 4/11/21 nausea became particularly worse and he also reported vomiting. Patient had an acute episode of dizziness in which he lowered himself down to the floor and remained there for 2-3 hours until his wife helped him up. On 4/12/21 he presented to the emergency department for ongoing nausea and dizziness. He denied other symptoms including fever, chest pain, shortness of breath, and abdominal pain. Patient reports having an appetite, but is unable to keep food/drink down due to nausea and vomiting. Upon exam patient had left-sided nystagmus, which worsened with head turning.
Blood clot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Blood clot".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
A fever and chills for 24 hours starting 6 hours after vaccination.  As well as head ache and body ache
Information has been received from a medical assistant referring to an 8 week female patient. The patient had no medical history or drug allergies. On 29-JAN-2016 the patient was vaccinated with a dose of ROTATEQ (lot#, dose, frequency and strength unknown) orally. The patient experienced lack of bowel movement after administration of ROTATEQ. The patient's mother sought medical attention by contacting the office by phone. No treatment was given for the event and no lab diagnostics studies were performed. The event lasted for 5 days and the patient was recovered on 02-FEB-2016. Causality was not provided. Additional information has been requested.
I woke up at 11pm and I had excruciating hip pain. It was very unusual. I felt restless and had a hard time falling back to sleep. I developed a fever and it was over 101. I had muscle and joint aches, a headache, and I was very fatigue. My coloring was bad: I looked very pale and sweaty. Also, my ear feels blocked every now and then and that feeling hasn't gone away since taking the vaccine.
My doctor's office told me to go to urgent care for chest tightening /pain. At urgent care my white blood cells, platelets and lympocytes all tested abnormally high. I am an extremely healthy person with no health conditions and my "numbers" from all my blood tests in the past are consistently stellar. I have the readings of several years on record. Most recent blood work (prior to incident) was done in Feb. 2021. I still have chest pain.  Urgent care told me I had to go to the emergency room. They did additional tests. Those tests did look better except for my globulin which was out of the healhty range (very slightly). It has never been out of range. I was allowed to go home after 6 hours of hospital/urgent care testing. I still have chest pain.
I started to have Rheumatoid Arthritis flare ups; This spontaneous case was reported by an other and describes the occurrence of RHEUMATOID ARTHRITIS (I started to have Rheumatoid Arthritis flare ups) in a patient of an unknown age and 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (I started to have Rheumatoid Arthritis flare ups) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (I started to have Rheumatoid Arthritis flare ups) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided by the reporter.  Very limited information regarding this case. However, based on the current available information from the case narrative; and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-114592 (E2B Linked Report).; Sender's Comments: Very limited information regarding this case. However, based on the current available information from the case narrative; and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD-2021-114592:MOD21-114592 (Cross-linked)
Muscle spasms @ site of injection.  Patient pre treated at home with Benadryl and Tylenol. Additional observation of 30 minutes.
Hives began in the afternoon after the administration of the vaccine in the morning. Worsened and persisted until at least 2/27/23.
pt brought to ED via EMS; c/o increasing SOB, chills, cough, fatigue; positive for COVID; O2 sats 85% on RA; placed on Venturi @ 50%; pt more lethargic; BiPAP; received blood transfusion; pt improved after transfusion; more alert, less lethargic; placed on O2 via NC; pt slowly became less alert and more lethargic; pt was found cool and unresponsive by the doctor when came to visit; pt died in the hospital
COVID booster for 6-11 age range was administered to a 28 year old male patient
Muscular pain in left arm, tingling sensation in upper left arm and left forearm, lump in left collarbone.  Started muscular pain and lump under left collarbone on 01/21/21 and continued to 01/22/21. Tingling sensation in arm started 01/22/21.
Pain in the upper muscle of the left arm developed shortly (maybe within an hour) after the vaccination. I was told in the clinic that I might feel pain for a few hours, but the pain stayed for 3-4 days. After that I felt relief, but in a few more days I found that I cannot lift up my left arm. Even to grab a steering wheel to drive a car, I have to lift my left hand there with my right hand. The pain is in the muscle exactly where I received the shot, not in the shoulder join. I can lift my left hand up with my other hand, but cannot use the muscle of my left hand for lifting it up, because of a lot of pain in it when I do that.  Doctor who insisted on that vaccination refused to file a report saying that it's a physician's job.
Got a 1.5 ml injection; A spontaneous report was received from a consumer concerning a 27-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced got a 1.5 ml injection/Incorrect dose administered.  The patient's medical history, was not provided by the reporter. Concomitant medications reported included warfarin, aripiprazole, folic acid, prednisone, benztropine, salbutamol (inhaler).  On 12 Mar 2021, approximately same day prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number:001B21A ) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 12 Mar 2021, prior to receiving mRNA-1273, the patient felt got a 1.5 ml injection .Treatment for the events was included that patient was sent home with Benadryl pill.  Action taken with mRNA-1273 in response to the events was not  applicable.   The events,got a 1.5 ml injection was considered resolved on12 Mar 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, lot # 001B21A with no associated AEs.
Chills; nausea; vomiting; headache; fever of 102; This is a spontaneous report from a contactable consumer. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm on 03Feb2021 10:00 AM, at single dose for COVID-19 immunization in Hospital. Medical history was not reported. Patient is not pregnant. concomitant medications in two weeks included cimetidine (TAGAMET [CIMETIDINE]) from 13Jan2021. Patient previously received the first dose of BNT162B2 at left arm on 13Jan2021 for COVID-19 immunization. Patient experienced chills starting suddenly 11 hours after the vaccination and lasting for 5 hours, nausea and vomiting, headache, fever of 102, all on 03Feb2021 09:00 PM. No covid prior vaccination. No covid tested post vaccination. Treatment included Tylenol. Patient was recovered from the event chills on 04Feb2021 02:00, recovered from the other events in Feb2021.   Information on batch number has been request.
Patient complains of legs falling asleep at night which started about 7 days ago.  Her hands have started almost falling asleep during the day hours the last couple of days.  She is currently in between primary care physicians.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 14-Mar-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 14-Mar-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 14-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 14-Mar-2022) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2022 at 1:49 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Mar-2022 at 1:49 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 14-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 14-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 14-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 14-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date and time of vaccine administered provided as 14-Mar-2022 13:49:25. Patient received booster dose. The patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022 and they no longer possess this lot number.  No treatment medications were reported.   This case was linked to MOD-2022-542869 (Patient Link).
flu like symptoms; fatigue; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and FATIGUE (fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012MWA and 011LZOA) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (sulfa), Allergy to antibiotic (Levaquin) and Drug allergy (Medrol PAK). Concomitant products included VITAMIN D NOS and VITAMIN B COMPLEX for Vitamin supplementation.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, 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 experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and FATIGUE (fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) and FATIGUE (fatigue) outcome was unknown.            No treatment medication was reported.   This case was linked to MOD-2021-008089, MOD-2021-370395 (Patient Link).