chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in his left injection site arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Pain in his left injection site arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No medical history reported by reporter.  Concomitant products included AMLODIPINE, ACETYLSALICYLIC ACID (ASPIRIN 81), AMOXICILLIN, TRAMADOL, DEXAMETHASONE and LEVOFLOXACIN for an unknown indication.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced VACCINATION SITE PAIN (Pain in his left injection site arm). At the time of the report, VACCINATION SITE PAIN (Pain in his left injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications provided by the reporter.   This case was linked to MOD-2021-321103.
Exposed, below freezing, administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 20-Oct-2022 Reporter's comment: The pharmacy resident reported that Flulaval which was exposed to temperature below freezing (24.4 Fahrenheit) was administered to 5 employees. The vaccine administration facility was the same as primary reporter. The reporter did not had any other details but agreed to follow-up via email only. The reporter consented to follow-up. This is one of five linked cases reported by same reporter for different patients. Additional supportive information: The patient received Flulaval after temperature excursions, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022AMR152067:Same reporter US-GSK-US2022151428:Same reporter US-GSK-US2022AMR152068:Same reporter US-GSK-US2022AMR152065:Same reporter
fluid leaked out.; while administering, some fluid leaked out; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 95Z42, expiry date 30th June 2022) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th November 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 16th November 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the incomplete dose administered and pharmaceutical product complaint were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Fluarix vaccine in unknown deltoid. The pharmacist reported that while administering the Fluarix vaccine to the patient, some of the fluid leaked out, which led to incomplete dose administered. The reporter consented to follow up.
After I got the fifth dose of the Pfizer COVID-19 vaccine, I experienced fever, muscle aches, diarrhea, and headaches. These symptoms lasted for four days. I took naproxen to treat the symptoms, and it helped. Later on, I went in for my yearly physical. During the physical, I took a blood test, which indicated that my thyroid activity was out of the normal range; I was told that I had hypothyroidism and was prescribed levothyroxine (0.05 mg). The NP then did a follow-up to make sure I didn't develop hyperthyroidism, so she ordered a follow-up blood test two weeks after I was prescribed the levothyroxine. The results indicated that everything was fine and that the medication was working. At the time she prescribed the medication, she took my BP, which was very high. Because of this, the NP sent me home with a chart with instructions on how to do at-home BP testing. My BP continued to be high, so after about three weeks, I called my doctor's office and asked to be put on BP medication. I was then prescribed lisinopril. I am currently taking 30 mg of lisinopril; I started with 5 mg. About three weeks after starting the lisinopril, I went back to the doctor, because I was experiencing dizziness and nausea when hiking. The doctor ran another blood test. After getting the results, my doctor diagnosed me with stage 3 chronic kidney disease. I am due to undergo a renal ultrasound in the very near future. With the levothyroxine, I have noticed a positive change. I am now less lethargic and more active. However, I am concerned about the lisinopril and whether it may be negatively affecting the health of my kidneys, as there are contraindications.
heart palpitation 15 minutes after receiving Pfizer's COVID-19 vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A female patient received bnt162b2 (BNT162B2) (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: PALPITATIONS (non-serious), outcome "unknown", described as "heart palpitation 15 minutes after receiving Pfizer's COVID-19 vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I was working in PACU (bedside RN) and at approximately 4:30 PM on 10/20/2022, became short of breath with chest pain. I placed myself on telemetry monitoring and had a HR sustaining between 140 to 160 for approximately 90 minutes with worsening shortness of breath. Because of sustained sinus tachycardia and SVT, a rapid response was called overhead and I was admitted to the the Emergency Room. This was nearly 24 hours after receiving the Pfizer COVID vaccine.  With previous doses of the Pfizer COVID vaccine, I would have fever, chills, and myalgias for approximately 24 to 72 hours post vaccine. With this dose, I had none of these aforementioned symptoms.
Itchy lesions all over his body-legs, arms, abdomen; One day post vaccination patient reported pain at injection of Prevnar 13; fever; chills; This is a spontaneous report from a   physician. This report was received via a sales representative.   A 65-years-old male patient receive pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , in the arm on 03Oct2019 at single dose for immunisation , influenza vaccine (INFLUENZA) , via an unspecified route of administration on 03Oct2019 at single dose for immunisation .  The patient medical history and concomitant medications were not reported.  The patient reported pain at injection of Prevnar 13  on 04Oct2019 with outcome of recovering , fever on 04Oct2019 with outcome of recovering , chills on 04Oct2019 with outcome of recovering , itchy lesions all over his body-legs, arms, abdomen  on 21Oct2019 with outcome of recovering.    The Patient was treated with oral steroids and OTC Benadryl at night. Patient starting to feel better.  The information on the batch number has been requested
Patient called on 10/02/2018 @ 12:30 pm and told us she had a reaction from the Flu shots that she took yesterday. Patient said she felt feeling tired and felt something in her throat in about 25 to 30 minutes after the shots. She went home felt headache, nausea  and latter vomited. She call the 911 in later that afternoon she told me her blood pressure drops and went to hospital and given IV fluid and released were told to follow up with her primary care.
Date of Admission: 10/18/2022   Date of Discharge: 11/1/2022   Diagnoses on Admission Order: No associated diagnoses for current labs covid 19
Headache, Fever, NauseaVomiting,  Chills  Narrative:  Took migraine medication and tramadol for increasing pain.
It was given in the Left arm, my arms is still stiff, it's nearly 4 weeks now.  There is a band of swelling.  My Left arm is not symmetrical with my Right arm.  Also I had two extra migraines then I was expecting in the past 4 weeks.  They did not respond to Zomig, Phenergan, or the three preventative medications I take Cyclobenzaprine, Nadolol, and Topamax.  After 2 weeks, I took a series of Methylprednisone (I gave it two weeks so the vaccine could work first).  The swelling reduced, but did not go away.  It is still hard to raise my arm over my head. I am following up with my MD.  But I thought you should know about this.  I will probably switch to J&J after this, for booster shots.  I'm not sure I can handle this side effect again.  I would not describe it as "minor" because it's lasting so long.
03/26/2023 I was experiencing fever, weakness in lower extremities, chills and runny nose. After testing positive for Covid -19 I am contacting my provider and got lab work done that showed decrease in my electrolytes. I was sent to the hospital where I received treatment for sodium, calcium magnesium, potassium and phosphorus.  I was also prescribed an oral dose of magnesium. Symptoms are on going for almost  weeks with weakness, a fever occasionally ,minor cough and nasal discharge.
could not get up out of bed; Weakness; 99.8 F Fever; vaccination site arm swelling; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (could not get up out of bed), ASTHENIA (Weakness), VACCINATION SITE SWELLING (vaccination site arm swelling) and PYREXIA (99.8 F Fever) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE SWELLING (vaccination site arm swelling). On an unknown date, the patient experienced MOBILITY DECREASED (could not get up out of bed), ASTHENIA (Weakness) and PYREXIA (99.8 F Fever). At the time of the report, MOBILITY DECREASED (could not get up out of bed), ASTHENIA (Weakness), VACCINATION SITE SWELLING (vaccination site arm swelling) and PYREXIA (99.8 F Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment drugs were not provided concomitant drugs were not provided
Terrible migraine with severe scalp sensitivity. Took Frovatriptan. Low grade fever & loss of appetite, for 2 days and moderate muscle aches for 3 days. Arm was heavy but not red. Developed UTI-like discomfort on Day 3. Still has not resolved.
Complained of tinnitus, dizziness, bilateral eye pain, and headache. Cool to touch while in class (after having received the vaccine). Taken to health room by school nurse. Vital signs stable: Pulse-80; BP-98/72; Respirations-20; Temp-98.
The patient was incorrectly scheduled for and given the second dose of the pfizer covid 19 vaccine 2 weeks after the first dose (i.e. 1 week too early).
temperature excursion of 10.6C for 15 minutes; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix) (batch number T2XC9, expiry date 13-DEC-2023) for prophylaxis.   On an unknown date, the patient received Havrix (left thigh) .5 ml. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: temperature excursion of 10.6C for 15 minutes). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 1-AUG-2023 HCP reported that a patient received a dose of HAVRIX, NDC number 5816001818-11, following undergo of a temperature excursion of 10.6 degree C for 15 minutes. The HCP reported that the patient did not experience any issues, side effects, or adverse reactions from the administered and improperly stored Havrix vaccine.
Dizziness, swollen tounge, swollen lips, coughing, shortness of breath
C/o nausea; syncope observed patient for 20 minutes after syncope, provided water
30-35 minutes after injection, while I was driving home, I felt some minor difficulty swallowing., but no impediment to breathing or speaking.  I rerouted to a plaza with a grocery store and urgent care clinic, and bought some Benadryl and took it at about 2:55PM.  I waited 20 minutes in the parking lot before deciding I was safe to drive home. When I read about the possibility of a biphasic reaction, where my throat could close up again later, I went to a Clinic (5:40PM walk-in appointment with NP), and they could not treat me, and advised me to go to the Emergency Room. I initially decided to just go home, but went to the Emergency Room out of an abundance of caution at around 7PM.  Dr.  gave me a prescription for an epi pen and prednisone, just in case symptoms worsened.  They did not, and I did not use either drug.  The throat swelling started around 2:45PM and worsened for about half an hour. It remained steady (no airway constriction, no difficulty taking pills or drinking water) without getting worse, and started to subside around 5PM.  By the time I woke up this morning (3/31), I don't think there is any lingering swelling.  I can feel a very slight lump in my throat, but I can't tell if that is a very small amount of residual swelling or just hyper-vigilance based on yesterday's experience.  Note: This swelling feeling is identical to my memory of what I felt when I was diagnosed as allergic to penicillin in 2000 or 2001. Back then, the only "treatment" was to immediately stop taking penicillin (and to never take it again), based on a phone call with my doctor's office.  I did have a strong immune response after that (102° fever, chills, fatigue, muscle pain), but I don't consider that an adverse reaction.  This report is focused on what appeared to be a mild anaphylactic reaction.
Chills and fever throughout the night. Pain all over body. Fatigue. Severe headache the following day. Swelling and severe pain in left arm. Nausea.
Headache, Myalgia, Fever, SkinRash, Diarrhea, CHILLS Narrative:  Other Relevant History:
She states about 18 hours later she felt a fever blister; This spontaneous case was reported by a patient and describes the occurrence of ORAL HERPES (She states about 18 hours later she felt a fever blister) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced ORAL HERPES (She states about 18 hours later she felt a fever blister). At the time of the report, ORAL HERPES (She states about 18 hours later she felt a fever blister) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
2 days after vaccine, armpit pain/swollen nodes left arm, 9 days after vaccine malaise/cough started. Progression of diarrhea, sore throat, headache, severe fatigue, fluctuating fever (high 100.5), sweating, shortness of breath (lowest oxygen reading 93) ear pain.  4 COVID swabs negative (First on 10/15, rapid and send off on 10/26, and viral panel 10/29) strep negative, viral panel negative, flu negative.
Patient hospitalized within 6 weeks of receiving COVID vaccination. The first visit was on 3/30/2021 for 3 days. The second visit was 4/29/2021 for 3 hours. Diagnosis was Ulcer of right foot with muscle involvement without evidence of necrosis. Per doctor's notes 3/30/21: Of note is that patient was incidentally found to be Covid positive just prior to his wound debridement.  He was however asymptomatic.  A repeat test came back negative although he continued to be on isolation for precautionary reasons.
Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Additional Details: patient felt pain immediately at site of injection. 2-3 hours post vaccination felt like she was having electrical zaps going down entire arm. patient had limited mobility all over and at injection site. referred to pcp.
Went to the doctor scope for acid reflux, that was when the EKG something of wrong. Went to specialist EKG, should left bundle lock and rapid heartbeat, dye test, echo and stress test, beta blocker.
After second dose: Symptoms began from March 9 - March 13 with a few day pause, then continued ongoing; Little appetite, lethargy, no energy, in bed sleeping 18 plus hours out of a 24 hour period, continued until the morning of March 13, unremarkable symptoms from March 14 thru March 22, March 23 in home nurse recommended she see a cardiologist, March 24th rushed to the hospital short of breath with irregular heartbeat; released from hospital 24 hours later -could not determine cause; 1.5 days later second visit to emergency room with the same symptoms; release from hospital 2 days laters; saw cardiologist, symptoms have persisted and progressed, currently only able to take 1/2 to 1/4 short breathes; about 15 minuets per 24 hour period will full breath capacity; 3+ pillow orthopnea: sitting up at 45 angle in order to sleep, any lower angle cannot breathe; symptoms ongoing and worsening, cause unknown
Shingles in head; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles one time ).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 9-Oct-2022 Reporter's comment: The case was received from the patient's friend via interactive digital media. The patient (friend of reporter) tooks the vaccine once a year and now had shingles every year now in her head. Additional supportive information: The follow-up could not be possible as no contact details were available. As it was clear about the dose number and as pre the information it could confirm whether the patient was due for next dose or not as the patient was currently experiencing the adverse event, therefore in worst approach the case was processed with blank dose number and no medication error event was coded.
MINOR WAS GIVEN MMRV COMBO INSTEAD OF INDIVIDUAL  MMR  AND  VARICELLA  DOSES, NO SIDE EFFECTS OR ADVERSE REACTIONS NOTED
The first event happened after the second dose, I had joint pain all over my body and it came all of the sudden and they did labs for viral that came back abnormally high. I had my regular lab work on before my booster shoot, 09/17/2021 and I haven't had labs done since then. Everything came back normal except Epstein Barr Virus panel.
Patient with a large local reaction on right thigh.  Started 1 day post vaccination and he didn't want to stand on the leg  day one.  There was also swelling and redness.  Day two increased swelling and redness.  It was so large the patient was sent home from school for it.  He was able to walk but continued to have a limp.
Information has been received from a physician concerning a 2 month old female who on an unspecified date was vaccinated with a dose of ROTATEQ along with other childhood vaccines (not reported). The physician reported that one week later the patient was admitted to the hospital for diarrhea, dehydration and acidosis. The stool was rotavirus positive. The patient has recovered and was discharged. Additional information has been requested.
Partial complex seizure consisting of head bobbing, hypotonia and apparent respiratory arrest, associated with fever, 5 hours after a completely normal physical exam and administration of Prevnar, MMR and Hib vaccines. (two doses of Tylenol had been given.) No family history of seizures. Seen in ER, then 10 days later, by Pediatric Neurologist. The mother reports that 10 days ago, the parents noted that her head was slowly leaning to the right and her mouth was open. They also noted her eyes to be deviated up and to the right. The episode lasted a few seconds and she was limp when her father picked her up. He felt that she was not breathing and administered rescue breaths and she began to open her eyes. She was taken to ER by EMS and was sleepy and not very responsive on the way there. She vomited in the ER and had a temperature of 103F. No work-up was done and she was discharged. Clinically, the episode appears to have been a seizure, however, no treatment is recommended at this time.
Child was inadvertently given Adult formulation of Engerix B (Hepatitis B) vaccine.
Severe pain, rash, swelling, teeth chattering, shivering. Patient states the pain and rash started about an hour after she received the vaccine. She was unable to dress undress or dress her self because the pain in her arm was so bad. This morning the patient rated her pain at 10/10. Patient did use TYLENOL to try to resolve symptoms. Denies fever.
Narrative:  61yr male admitted to hospital for MH crisis and tested positive for COVID-19. Was asymptomatic for COVID-19 on admission though was placed on COVID ward due to test result. Did not require any COVID therapeutics during admission; hospitalization course was 3 days. PMH: history of antisocial personality disorder, MDD w/ prior suicide attempts, PTSD, polysubstance use who presents with suicidal ideation in the setting of cocaine and alcohol use. COVID Vaccination Status: Moderna 3/2 and Moderna 6/28 (~3.5 months time interval lapse between dose series)  Symptoms:   & COVID-19 infection Treatment: