chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site: Swelling at Injection Site-Medium, Additional Details: swelling in right arm in the arm pit (lymph node inflamation)
Pt had nasal congestion and diffuse skin hyperemia, tachycardia, severe redness/ itching under arms: body and face, slight uvula edema (no angioedema) just after receiving injection.
PT STATES HE RECEIVED MCG ON 2 FEB 07, SITE: SQ LEFT TRICEP REGION.  NOTICED RASH DEVELOPING THE MORNING OF 3 FEB. STARTED IN UNDERARM REGION OF LEFT ARM THEN TRAVELED THEN RIGHT ARM.  LATER BACK AND SIDE OF TORSO SHOWED RASH.  NO OTHER SYMPTOMS NOTED.  RASH IS VERY RED AND ITCHY.  PT WAS SEEN AT BY PCM ON 6 FEB 07.
08/27/22 presents to EC ED for "AMS". PMHx of "cirrhosis secondary to autoimmune hepatitis and chronic peritoneal effusion"
Information has been received from a consumer concerning her 76 year old husband who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck). "About 1 week after vaccination", the patient experienced a rise in blood pressure. The patient  had not seen his doctor. His blood pressure was as high as 180/95. The outcome was unknown. The consumer also reported herself experienced a rise in blood pressure after vaccinated with ZOSTAVAX (Merck) (WAES # 0903USA04920). Additional information has been requested.
Anaphylactic response to MMR - hives and throat tightness. Rx EPIPEN/BENADRYL/SOLUMEDROL.
Redness to insertion site. Sore muscles of L arm. Fever. Nausea and 1 episode of vomiting.
Right leg pain, fever, vomiting, perioral- rash, Itching (scalp) > -acetaminophen (rectal) - warm compresses - ZYRTEC
Herpes zoster ophtalmicus; Shingles; post herpetic neuralgia; This spontaneous report was received from a lawyer regarding a case in litigation referring to a male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On approximately, 14-NOV-2014, at approximately age of 61, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated at a hospital for shingles, herpes zoster ophthalmic and post herpetic neuralgia resulting from his use of zoster vaccine live (ZOSTAVAX). At the time of the report, the outcome of the events was unknown. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).    Upon internal review, herpes zoster ophthalmic was considered to be medically significant.
approx 2 days p/ vax pt exp erythematous & tenderness around the inject site, malaise & fever of 99.5. pt treated w/benadryl & tylenol. addl info requested
Woke up from afternoon nap screaming. Temp of 102' rectal.  Inconsolable for more than 2hrs. Swollen and red at the injection. Vomiting.
I had a little soreness in my arm after receiving the vaccine. In February 2023, I had a hemorrhoidectomy due to having a blood clot in a hemorrhoid. I tolerated the surgery and recovered.
it can not be ruled out if that unspecified patient received potential dose of PNEUMOVAX23 prior to being asthmatic/a unspecified 14 year old who has asthma may have received a dose of PNEUMOVAX23 in the past; This spontaneous report has been received from a pharmacist referring to a 14 years old female patient. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On an unknown date, the patient might had been vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot #, expiration date, frequency, route and dose details were unknown) for prophylaxis.       On an unknown date, the patient experienced asthma. It could not be ruled out if that the patient received potential dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prior to being asthmatic.      The outcome of asthma was unknown. The causality between the asthma and the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.
Expired dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.
07/03/06 sudden hearing loss in Left ear.  Appt with Dr on 7/7/06. Dr unable to determone reason for hearing loss.  Refeered to ENT.  I saw Dr on 07/12/06.  Dr states most comon caues is virus.  I have not been sick. 80% hearing loss per hearing test.  Treated me with tapering dose of Predisome and Valtrex.  Referred for MRI.  Follow up with Dr on 7/21/06.  MRI results negative.  Hearing loss still present.  Treated with tapering dose of Prednisome again.  I have a follow up with Dr on 8/17/06 9/26/06-records received for DOS 7/12/06-8/17/2006  Impression: sudden hearing loss, unresponsive to treatment Recommendation: referred to Dr. regarding the need for surgery.  Pituitary lesion. Seen on 7/12/06 with c/o sudden hearing loss in left ear also had dizzy sensations described as imbalance and some spinning. Has had tinnitus in that left ear for several years prior to this. Denies any other neurologic symptoms, no headaches, no visual loss, no recent URI, no facial weakness, no dysarthria or recent trauma.
Onset congestion on 2/6/21 in pm.  Itchy, red blotchy hot spot on 2/7/, accompanied by a slightly sore arm. Sore at site of injection intensifying on 2/8/21.  The spot became deeper, and a ring appeared around the injection site by 2/8/21 pm.
Swollen left arm 10 X 12 cm red, Mild tender mild induration, no fever, left arm, large reaction
Muscle and lymph node tenderness and extreme pain and stiffness in right neck, deltoid, trapezius, radiating up back of the right head.  Moving head and neck were very uncomfortable - extremely stiff.  Same location of inflammation as the first shot. Both vaccine shots were given to my left arm - which had no pain. I have a very high pain tolerance.. This pain required me to tap the Norco which I had from two hip replacement surgeries - which I never needed! Same with C sections or broken (hairline fractured) bones.
After leaving the site I started feeling dizzy and ignored it. I drank some water and I didn?t feel bad anymore.   When I woke up the next day I could barely walk on my own and I had a massive headache. I called off of work due to the situation I was in. I took my temperature in the morning and it indicated that I had a fever. I had chills throughout the night and I woke up feeling very warm. I was also a little nauseous and didn?t have  much of an appetite.
Sore throat, swollen/sore glands in neck, morning temperature 1.9F higher than MY normal, sore lower back
do not know the lot number but this is what is on my woke up at about 3am 3/23/2021 with a horrific headache and way sick to my stomach and then severe low back pain in the afternoon of 3/23/2021; as I write this now my headache is not as severe, stomach is meh at best and low back is still very sore.
Localized edema, pink 7cm x 7cm macular rash no itching.
Patient stated she has been having extreme pain in her vaccinated arm.  There is no  swelling or redness.  She stated started about 2 days after receiving the vaccine.  It was relieved with anti-inflammatories but it has continued once those were stopped
After injection, patient began to feel dizzy, clammy, and was sweating. Had patient lay on the ground with feet elevated and wet paper towel applied to forehead. After 5 mins, patient sat up, then stood up. No additional issues.
I received the vaccine midmorning. By 10-11pm I had chills, severe body aches, and a fever. I was uncomfortable enough I couldn't sleep. The next day I was nauseous and didn't want to eat. These symptoms persisted for about 24 hours. I also had a red raised area, that gradually increased until it was about 4"x2.5", on the injection site that was noticeable for several days.
Fatigue within 2 hours of injection. Chills and extreme shaking/body tremors within 5 hours of injection lasting approximately 45 minutes.
It is now 52 hours past my second maderna injection and I have swelling and pain in the arm with a large red raised area around the injection site about 3 inches wide 4 inches long.   It does not itch and is not a rash. I am waiting for a few more days to see if it goes away before going to physician.
I was at work walking and I became very light headed and very suddenly it seem as I couldn't focus. My coworkers saw me pass out and they moved me to the emergency room. The doctor ordered a ultrasound and discovered I had bilateral blood clots in my lower legs. I was diagnosed with Atrial fibrillation. I was cardioverted and they sedated me. I went back into a normal sinus rhythm and I stayed hospitalized for a couple of days. I was taking a blood thinner.
Starting ~14hrs after injection: moderate headache, full body ache, fatigue, mild swollen neck lymph nodes
COMPLEX PARTIAL EPILEPSY W AUTOMATISMS 4/18/2023 NEUTROPENIC FEVER, UNSPECIFIED COMPLEX PARTIAL EPILEPSY W AUTOMATISMS 4/18/2023 CANCER METASTATIC TO BRAIN
pt recv vax 8SEP97 & 9SEP97 pt exp what appeared to be herpes zoster;
Vaccine (measles) given 8/31/07-2 days after vaccine-fever and diarrhea-went to childrens ED. Had stool cx and UA cx (Both which were negative) 9-10-07 Rash started on back and abdomen. Has ped visit for 9-13-07. Will Follow up after vaccination 9-17-07-Had ped visit MD dx was Roseola MD felt no rxn to vaccine-Rash resolved. Diarrhea resolved
Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting,  Chills  Narrative:  Other Relevant History:
Miscarried.  Due date had been Sept 16, 2021. This was my first pregnancy.
One to 1.5 hours after vaccine I developed rapid heartbeat, SOB, severe pain in chest radiating out to left arm. reported tp physician on call at hospital. Advised to seek medical attention.
Pt vaccinated with OPV/HIB/DTP developed extreme paleness, & lethargic for up to 48 hrs. No temp taken or noticed. Discontinue Pertussis give DT only.
Patient is stating that the injection site from his shingrix shot given on 8/8/20 is still sore and painful on the day he called the pharmacy which is 10/13/20.  The pain has not resolved or lessened since the day of the injection according to the patient.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022).    No concomitant product use was reported.  Patient received half dose.  On 04-Jun-2022 the vials were initially stored in the refrigerator.  Vial did not undergone any temperature excursions.  No treatment information was provided.
Wife calling for pt who received his Johnson and Johnson COVID19 last Friday, 10/1/21. On Sunday he developed a cough and on Monday chills and a fever. Temp on Tuesday was 102 and Wednesday was 100.4. She states no fever today, 10/7/21, and his cough has lessened. Pt also on call and reports having tingling in his LLE and R foot, generalized body aches, constant abdominal pain in the last 24 hours, feeling slightly congested and some bladder control problems.   Pt denies any chest pain, leg swelling, blurry vision or headache.  Pt sent to the ED.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2015, reported as "sometime last year", the patient was vaccinated with the first dose of PNEUMOVAX23 (dose, route and lot# were not reported). On 29-JUL-2016, the patient was inadvertently administered a second dose of PNEUMOVAX23 (dose, route and lot# were not reported). On the same day, 29-JUL-2016, the patient experienced normal "local irritation" at the injection site after this second injection. The outcome of injection site irritation was not reported. The relatedness between vaccination of PNEUMOVAX23 and normal "local irritation" at the injection site was not reported. Additional information has been requested.
h/a, backache, weakness felt like had a fever;lasted until went to bed 8AM 10/6/99;
heart attack; couldnt walk; couldnt get out of bed; body ache and pains; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 033A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Neurological disorder NOS, Diabetes, peripheral artery disease, Disabled spouse (100% disable) and COPD. Concomitant products included GABAPENTIN for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 21-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criterion death), GAIT DISTURBANCE (couldnt walk), BEDRIDDEN (couldnt get out of bed) and PAIN (body ache and pains). The patient died on 21-Mar-2021. The reported cause of death was Heart attack. It is unknown if an autopsy was performed. At the time of death, GAIT DISTURBANCE (couldnt walk), BEDRIDDEN (couldnt get out of bed) and PAIN (body ache and pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had a medical condition of "agent orange". The patient was a veteran. Treatment included for the events was acetaminophen (Tylenol).  Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-075051 (Linked Report).; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-075051:Case for second dose; Reported Cause(s) of Death: Heart attack
Reactive (L) Deltoid to the KINRIX. Swollen of 6 cm x 6 1/2 cm, has redness mom gave MOTRIN & apply ice on the arm.
I had severe joint pain that was intense for about 24 hours. I never had it before. It is about 6 months later and I realized that joint pain still comes in waves in ankles, wrists, arms, feet. I am going to get tested for arthritis.
On an unspecified date, approximately 14 hours after the 2nd dose, the patient experienced pain up and down her left side, the side of the shot. The next day, the patient had a migraine when standing up. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient received Pfizer COVID vaccine on 5/21/21 (lot # EW0183), 6/11/21 (lot # EW0183), and 1/27/22 (lot # FJ5682). Patient admitted to our inpatient hospital (med/surg unit) on 8/26/22 s/p a fall with acute hypoxemic respiratory failure due to COVID-19 pneumonia. As of today (8/31/22), patient is still admitted in the med/surg unit.
Per Nursing note 10/8/12: This 77 y/o male presents with: report that he received a flu shot on Friday AM and began experiencing elevated temps Friday night. He states that his stomach has been a little queasy but no vomiting. He has been taking TYLENOL for temps. Per physician's note 10/8/13: Assessment: Febrile reaction to influenza vaccine. Plan: Reaussurance.
Nausea all day; Very tired/unusually tired; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via unspecified route of administration in left arm on 23Mar2021 at 16:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis and hypertension. The patient was allergic to penicillin. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and irbesartan (MANUFACTURER UNKNOWN) for unknown indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. 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 had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 26Mar2021 (day 3), the patient experienced very tired, unusually tired. On 31Mar2021 at 08:00 (day 9), the patient experienced nausea all day. The patient had not received treatment for the adverse events. The clinical outcome of the events very tired and nausea were resolving at the time of this report.   No follow-up attempts are needed; information about lot number cannot be obtained.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: tingling in both arms and fingers
Injection Site Itching very much; Injection Site Hard to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection Site Itching very much) and VACCINATION SITE INDURATION (Injection Site Hard to the touch) in a 60-year-old female patient 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 05-May-2021, the patient experienced VACCINATION SITE PRURITUS (Injection Site Itching very much) and VACCINATION SITE INDURATION (Injection Site Hard to the touch). At the time of the report, VACCINATION SITE PRURITUS (Injection Site Itching very much) and VACCINATION SITE INDURATION (Injection Site Hard to the touch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No  concomitant medical  provided by the reporter. No treatment medication provided by the reporter.
12/31/20 nausea, resolved later in the day, back feeling itchy, hives began to appear01/01/20 back itchy, nausea,  vomit several times; 01/02/20 back itchy, nausea,  vomit several times, hives covering back;  01/03/20 back itchy, nausea,  vomit several times in late after/ early evening. 01/04/2020 hives; all other symptoms resolved
Pt recvd 2 doses of Engerix-B & exp a rash;
14 days after this shot, I tried to mow the lawn for the first mow of the Spring. After 5-10 minutes, the upper left area of my chest felt bad. There was no pain. There was no pressure. Something felt wrong. I stopped, sat, drank some water. After an hour or so the feeling dissipated. The next day I decided to take a walk around the neighborhood to see what might happen. It's a 7/10 mile walk, mostly flat, with a few small hills. That same wrong feeling returned. I made an appointment with a cardiologist the next day.   After ECG and sonogram tests, the cardiologist sent me to the cath lab at HospitaL. During that time I continued to feel "not right" in the upper left quadrant of my chest.  The cath lab showed that I had a 98% blockage in my left anterior descending artery at the first diagonal artery. This is referred to as The Widow Maker. Three stents were inserted via arteries in my left arm, right arm and right groin.
Pt recvd DT in afternoon of 8MAY92; about 18 hrs later t101, black spots or flashes in front of eyes, dizzy; could not walk by self, but not atasic; 3" local redness around site of shot; sx & fever graudally dec over 5 days;
As per patient reporting : Sx: Sorearm; 10pm : Shivers ; Next day (1/12/21). 12pm : Nausea ; exhaustion, feelings i was going to die ; unable to sleep at night for 2 nights.   As per my evaluation : Patient presented with worsening of psychosis and manic sx.
arm was sore; low, low energy; almost went to sleep; felt very sleepy; felt high; very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), ASTHENIA (low, low energy), SOMNOLENCE (almost went to sleep; felt very sleepy), EUPHORIC MOOD (felt high) and FATIGUE (very tired) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder.   On 27-Jan-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 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), ASTHENIA (low, low energy), SOMNOLENCE (almost went to sleep; felt very sleepy), EUPHORIC MOOD (felt high) and FATIGUE (very tired). At the time of the report, PAIN IN EXTREMITY (arm was sore), ASTHENIA (low, low energy), SOMNOLENCE (almost went to sleep; felt very sleepy), EUPHORIC MOOD (felt high) and FATIGUE (very tired) outcome was unknown.            Concomitant medication included thyroid medication. No treatment information was provided.   This case was linked to MOD-2021-027173 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Additional information was received on 21-May-2021. Contact details updated (email updated).