chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse concerning a 12 year old Causasian female student who on 8/2/97 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot # 621060/1363D). There was no concomitant medication. On 4/16/03 at approximately 9:00, the patient presented to the physician's office with full blown chicken pox. The patient had approximately 75-100 lesions in various stages all over her body including 50 active chicken pox lesions. The patient was treated with oral acyclovir 200 mg four times a day for five days, acetaminophen and calamine (+) camphor (+) pramoxine hydrochloride. Additional information has been requested.
woke up from nap crying, SOB, passed out & quit breathing x 1min, pale;flicked feet & blew on face started breathing;went to ER CXR showed bilat pneumonia;given augmentin, albuterol, nystatin & apnea monitor
Syncope episode addressed with patient remaining seated, cold compress, and water to drink.  Afterward patient complained of nausea and that he sometimes has hypoglycemic episodes - a small snack was provided.  Patient remained in chair entire time and was observed for 20 minutes.
my chest and arm pits swelled up horribly with lymphatic fluid; my chest and arm pits swelled up horribly with lymphatic fluid; painful lymphatic swelling; painful lymphatic swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "breast cancer survivor" (unspecified if ongoing), notes: I am a breast cancer survivor and also have Truncal Lymphadema.; "Truncal Lymphadema" (unspecified if ongoing), notes: I am a breast cancer survivor and also have Truncal Lymphadema. The patient's concomitant medications were not reported. The following information was reported: SWELLING (non-serious), LYMPHATIC DISORDER (non-serious), outcome "unknown" and all described as "my chest and arm pits swelled up horribly with lymphatic fluid"; LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious), outcome "unknown" and all described as "painful lymphatic swelling".  Additional Information: I am a breast cancer survivor and also have Truncal Lymphadema. I received three of the Pfizer Covid shots (mandatory because I drive a school bus). After my 1st shot my chest and arm pits swelled up horribly with lymphatic fluid!! I called all my physicians and no one could give me any answers (including the CDC). I had to receive the other 2 shots as required. I now have horrible, painful lymphatic swelling where I hadn't had it before your shots! Why wasn't I warned of this?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
4 days post vax dad called to explain that pt became ill w/vomiting, fever 99 approx approx 10 hrs p/vax; pt taken to ER  & released 2 hrs later; pt taken to MD 21MAY92; mom stated pt feeling better;
22 mins/or at 2:22pm, stated "I feel funny". Eyes rolled back, non-responsive. Incontinent on self. Pulse at 92 faint/thready. B/P 80/?. Responded within 13-15 seconds. Sweaty/states "I'm hot". Felt weak, assisted in wheelchair to room. Placed in semi-Trendelenburg. Was able to sip on Pepsi, ate 1/2 peanut butter cracker. B/P decreased for 2:45 -> 3:30, increased 110/76, 68, 22. Vomited/color improved. Assist changing clothes. Wheelchair to car to go to ER.
Approximately 48 hours after my second Moderna Vaccine I started experiencing breathing difficulty and shortness of breath. After 58 hours was admitted to emergency room but CT scan of lungs and heart normal. Breathing difficulty continued 24 hours a day until 8 days later in which the breathing difficulty became worse and increased light-headedness occurred On 4/13. A second trip to emergency room happened on 4/13 another CT scan of lungs and heart normal. Breathing difficuly continued until On April 24th I collapsed and blacked out while out for a walk. Was admitted to emergency room on the 24th and remained hospitalized with brain fog, light-headedness, breathing difficulty and sharp pain in right side of chest. Ecco cardio gram test negative. Breathing difficulty, lightleadedness and chest pain have all been steadily increasing since 48 hours after the 2nd Moderna vaccine shot. To date, still no answer as to why this is happening and getting worse.
Initially started @ 2pm with fatigue and moderately-severe diffuse myalgias.  By approximately 6pm I started to feel warm and by 7pm my temperature was 102.7 (tympanic) with nearly uncontrollable rigors.  At this point I took 1000mg of acetaminophen and 600mg of ibuprofen.  At around 8:30pm I began to develop a moderately-severe global headache.  Ultimately I was able to fall asleep about 11pm.  Not sure when the fever abated but it was after 11pm.  The next morning (today) I am experiencing only mild myalgias and headache.  No further fever/rigors.
Vesicular rash just distal to injection site, starting within 24 hours after injection. Treated with ALLEGRA 180mg, Amoxicillin, culture taken.
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2021-392935 (Patient Link).
Patient was given vaccine that was not at right concentration.  Vaccine was supposed to be diluted with 1.3ml of saline which did not occur.  She experienced increased side effects from the vaccine such as tiredness and fatigue.  She is now back to normal as of today and feeling much better.
In Rt. arm (arm PREVNAR administered) pt. had a rash, hot to the touch, and fever. Dr. diagnosed as allergic reaction and cellulitis. Pt. was treated with diphenhydramine and antibiotics on 11/16/16.
This spontaneous report was received from a pharmacist referring to an adult female patient of unknown age. Information about pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medication was not reported. On an unknown date (reported as when the patient was a child), the patient was vaccinated with M-M-R II injection (dose detail, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient had titers drawn, which showed her immunity had waned (antibody test negative and decreased immune responsiveness). The outcome of events and the causality assessments between events and M-M-R II injection were not reported.
AFTER 5 DAYS ,LETHARGIC, LOST MY VOICE. ON 7TH DAY BROKE OUT IN SORES IN THROAT, BEHIND EARS, IN HAIR. 9TH DAY BROKE OUT IN RASH ON SHOULDERS, 12TH DAY RASH SPREAD COMPLETELY COVERED BACK, CHEST. 15TH DAY THROAT AND EARS BETTER, BUT BACK STILL SPREADING DOWN TO LOWER BACK, FRONT OF STOMACH AND AROUND GENITALS. 17TH DAY FEELING BETTER BUT STILL LETHARGIC, SORES ALL OVER BACK, CHEST, THROAT STILL SCRATCHY. DR. PUT ME ON VALACYLOVIR FOR ANOTHER 7 DAYS. STARTED ON 4/29/2019. USING A CREAM FOR SORES. BLOOD SUGAR HAS INCREASED TO 200- 300 DAILY. BLOOD WORK NUMBERS HAVE ALL INCREASED TO POOR LEVELS ACCORDING TO DR.
This was the Moderna Booster after the Janssen Vaccination on 3/17/2021. I have soreness and swelling at the injection site, as well as significant visible swelling and soreness/pain of the lymph nodes in my armpit. Also have slight headache, fatigue, and body soreness. The lymph nodes are my primary complaint.
p/vax unspecified lab eval revealed varicella titers were negative;medical attention was sought;
Extremely sore lower back, to the point of being unable to walk.  Sore left arm at point of injection. (There is not an APO, AP option in the address section)
Left upper arm swollen, red, hot to touch 9/18/10. Mom took child to urgent care, was told to report to Health Department. No tx administered.
01/06/14 Paralysis of legs for three. 6 days after vaccine. Fever. Pneumonia. Flu occurred in 2/24/14. Flu occurred in 2/24/14. (3/14) March of same eye.
Mom states patient complained of right arm pain and swelling started night.  1/15/08 erythema, edema and swollen injection site 24 hours later.  Patient had URI 1/15/08 for which she was given an antihistamine.  On 1/16/08 patient was also given Motrin and topical steroid.
She reported a previous reaction to initial Pfizer dose: complained of left facial numbness/tingling as well as flushing, she also reported facial swelling. She was treated with Benadryl 25mg PO.  She was unable to make an appointment with allergy/immunology prior to obtaining this dose.  She received the dose and was given a 30-minute observation time.  While in observation, I spoke to patient and she reported right-sided facial numbness and tingling but no flushing or swelling. She was otherwise feeling fine.  Approx 10 minutes after injection, she complained of difficulty swallowing and mild throat swelling. Pulse was 110, O2 was 98% on room air.  She denied SOB, wheezing. No stridor was noted and oropharyngeal exam was normal, no swelling or erythema noted.  At this point, Benadryl liquid 50mg was given.  After another 15 minutes of direct observation, her swallowing had improved and she felt stable to go home. Her pulse was 82, O2 98%.  Suggested that they keep Benadryl at home, she can use every 6 hours as needed. If symptoms worsen, seek higher level of care. Patient and partner stated understanding.
Patient felt numbness in her vaccinated hand while driving home followed by sweating. Once home he started to feel better. No shortness of breath, difficulty breathing, rash or hives were reported. Once the follow up call was made, patient stated he feels fine.
Patient received vaccination appropriately. Upon leaving the building approximately  min after the vaccine was given, the patient fainted near the front of the store in the vestibule. Pharmacy staff attended to him in the vestibule and contacted 911. The patient declined the EMT services. After approximately 10 minutes the patient felt better and left the store.
Increased edema/fluid accumulation to lower extremities, increased dyspnea, requiring supplemental O2 use.
diagnosed with Bell's palsy; suffered from impaired vision; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On 25-MAY-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt was diagnosed with Bell's palsy and suffered from impaired vision. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to physical limitations and seriousness of the pt's condition. The pt sustained severe and permanent personal injuries and suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of the events was considered to be not recovered. The reporter determined the events to be related to zoster vaccine live (ZOSTAVAX).  The events of diagnosed with Bell's palsy and suffered from impaired vision were considered to be disabling.  Upon internal review, the event of Bell's palsy was determined to be medically significant.
12/15/00 at 17:30, left arm was immovable, soreness and aching "muscle pull type pain". Under left arm was tender. Started running a fever, chilling (significant) at 23:00. On awakening on 12/16/00 AM, continued with sore arm, felt warm with fever, shaky, "tingly all over inside", chills again at 20:00, lasting all night. Sunday AM, took temperature and it was 102.9F (ear). Took Tylenol and Advil and fever decreased. Saw MD on 12/17/00 and started on prednisone.
Starting 36 hrs after vaccine administration, patient felt aches/pains in ankles, which gradually progressed as general moderate intensity (7/10) pain/aches from feet to hips over the next 24 hours. The lower body aches lasted about two days, and was marginally responsive to APAP (cannot take NSAIDs). By 1 week after vaccine, patient's aches had resolved.
Reports whole arm feeling numb like ice shotting all the way down her arm for 10-15 minutes after immunization.
Information has been received from a health professional concerning a 61 year old female who on 20-APR-2007 was inadvertently vaccinated with varicella virus vaccine live (Oka/Merck) (Lot # 654750/1256F) instead of zoster vaccine live (Oka/Merck) (MSD). The patient had no averse events. No other information was provided. No product quality complaint was involved. Additional information has been requested.
Lumps on her forehead; first dose on 06 may 2021 and second dose on 26 May 2021; welts on my forehead; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Lumps on her forehead), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 06 may 2021 and second dose on 26 May 2021) and URTICARIA (welts on my forehead) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-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 MASS (Lumps on her forehead), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 06 may 2021 and second dose on 26 May 2021) and URTICARIA (welts on my forehead). At the time of the report, MASS (Lumps on her forehead), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 06 may 2021 and second dose on 26 May 2021) and URTICARIA (welts on my forehead) outcome was unknown.            No relevant concomitant medication was reported.  Treatment information was not provided.  Patient receive the second dose of vaccine on 26 May 2021 and had Botox injection 2 weeks after that .She had lumps on her forehead.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: New event added, welts on my forehead
Patient was given Hep A Havrix Adult and should of been given Hep A Vaqta pediatric dose. Dr is aware and patient's parents are aware.
Pt states that he got his 2nd COVID shot on  25Feb  and had fever/chills/cough/congestion over the weekend then PM 28Feb visualized a swollen uvula that goes almost all the way down to his tongue.   Called nurse line at clinic 2Mar AM, current pain 8/10 with ongoing drainage to his throat, congestion, right ear congestion.  Pt also reported coughing up dark blood, unsure of whether it's coming from throat.  He tried nyquil and tylenol without relief of symptoms. Reported some dizziness, trouble swallowing and having to spit out saliva, inability to drink liquids.  Referred to ER.  followed up with Pt 3Mar AM, Pt states he was given steroids, benadryl and a numbing spray for his throat and that the swelling to his uvula has gone down, symptoms are resolving. Was told by ER that he possibly contracted COVID prior to his 2nd shot.
SEVERE FATIQUE, NAUSEA, JOINT AND MUSCLE ACHES, FEVER OF 102.5, HEADACHE  FOR APPRX 32 HRS
The pt developed chills, muscle aches, headache, stomach pain and fever which started 18 hours, post vax, and lasted about 3 days. Then she had a lot of sweating. She relapsed on 11/26/01 and had similar symptoms with joint pain and weakening in muscles.
had a sore arm; undiluted dose administered; undiluted dose administered; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 10 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 02Dec2021 15:35 (Lot number: FK5127, Expiration Date: 28Feb2022) at the age of 10 years as dose 1 (tris), 0.2 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 02Dec2021 and all described as "undiluted dose administered".   Additional information: No other vaccines administered on same date with the Pfizer vaccine considered as suspect nor hadn't had any other vaccines in the last 4 weeks. The patient received his first Pediatric Covid 19 Vaccine and was administered undiluted. The reporting pharmacist explained she made sure the patient stuck around for the 15 minutes to monitor him especially since it was his first dose. The patient didn't have any reaction and was not feeling unwell when he left and seemed fine.  Up on RA (20Dec2021) Updated information include: Classification removed, RA Coding updated, 'New event" (had a sore arm)  Additional information: Reporter inadvertenty administered an undiluted 0.2 ml dose of the pediatric (5-11 %) Pfizer Covid vaccine. Preparation and administered. I opened a vial of both the adult and the pediatric Pfizer vaccine at the same time. I diluted the adult vial, then was called away from preparing the pediatric vial, then was called away from preparing the pediatric vial, and forgot to finish dilution. since the cap was of, later that day I had diluted it but I did not. Reporter was in communication with patients father on 02Dec and 03Dec. He said (Patient name) had a sore arm, but no other adverse effects and did not require medical treatment.
edema of ankle; ankle swells; This spontaneous case was reported by a consumer and describes the occurrence of OEDEMA PERIPHERAL (edema of ankle) and JOINT SWELLING (ankle swells) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced OEDEMA PERIPHERAL (edema of ankle) and JOINT SWELLING (ankle swells). At the time of the report, OEDEMA PERIPHERAL (edema of ankle) and JOINT SWELLING (ankle swells) outcome was unknown. Not Provided          treatment include salt free diet.   This case was linked to MOD-2021-083129 (Patient Link).
8 minutes after receiving Moderna booster patient presents with lingual angioedema and rash. Rash disappeared with benadryl, and angioedema improved with decadron. No further COVID-19 vaccination was recommended.
11 adult patients received the expired Bivalent booster beyond 30 days; No adverse event; 11 adult patients received the expired Bivalent booster beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (11 adult patients received the expired Bivalent booster beyond 30 days), PRODUCT STORAGE ERROR (11 adult patients received the expired Bivalent booster beyond 30 days) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In January 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In January 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (11 adult patients received the expired Bivalent booster beyond 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (11 adult patients received the expired Bivalent booster beyond 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (11 adult patients received the expired Bivalent booster beyond 30 days), PRODUCT STORAGE ERROR (11 adult patients received the expired Bivalent booster beyond 30 days) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 (11 adult patients received the expired Bivalent booster beyond 30 days) and PRODUCT STORAGE ERROR (11 adult patients received the expired Bivalent booster beyond 30 days).    This case included information of patient 3rd out of 11 reported patients. No concomitant medication was provided. Vial size was reported as 2.5 ml. Date the vial was initially stored in the refrigerator was 13-Dec-2023.  It was reported that vaccine vials were a case of 10pcs and 7 vials from the case were used to administer vaccines from 13-jan-2023 to 22-Jan-2023. Vial did not undergo any temperature excursions.  No treatment medication was provided.    This case was linked to US-MODERNATX, INC.-MOD-2023-704253 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704253:Master case  1st adult patient
Pfizer-BioNTech COVID- 19 Vaccine EUA: Vaccine recipient experienced near syncopal episode/anxiety during the observation period. Vaccine recipient was monitored EMS for 30 minutes. They felt better and exited the site on their own.
Doctor states that the shot was high in arm. Some down in arm. Pain meds for nite time. Very painful - went to ER, received pain medication and anti nausea - meds.
got sick (after 1st dose); This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (got sick (after 1st dose)) 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 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 ILLNESS (got sick (after 1st dose)). At the time of the report, ILLNESS (got sick (after 1st dose)) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-381139, MOD-2021-381140 (Patient Link).   Reporter did not allow further contact