chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received vaccine, was waiting, passed out approximately 5 minutes later, pharmacist and paramedic were on seen to assist patient
pt recvd vax 730AM; 8OCT93 1st sx faint rash (like Roseola) in Am 9OCT93 all over body; rash resolved in about 4 days; 11OCT93 began to exp swollen, achy joints; resolving about 1 wk;
Initial report received from a health care professional on 10 April 2007. A 4-year-old, patient (gender not reported) experienced an entire upper arm that became swollen, painful and warm to the touch after receiving Daptacel (lot number C2552AA, route and site of administration not reported) on 01 April 2007. As of 09 April 2007, most of the swelling had resolved, but a "hard lump" at the injection site remains. It was not reported if the patient recovered.
Mild burning at injection site 10 minutes after injection, lasting a few minutes.  Mild pain in left hand 20 minutes after injection, lasting a few minutes.  Moderate pain at injection site, beginning 6 hours after injection, lasting approximately 36 hours.  Moderate fatigue beginning 6 hours post-injection, continuing through 2/25, improving over time.    Cold symptoms beginning with moderate nasal irritation 24 hours after injection, worsening over the next 48 hours to include nasal and sinus congestion, runny nose, intense coughing spells.  Little relief with Zyrtec and Nyquil.  Began to improve on 2/22. As of 7/25 (7 days post injection), symptoms are still present, but mild.
Severe chills and shivering, extreme sensation of coldness, teeth chattering, intense migraine with nausea, high fever
Two episodes - one in June: abdominal pain. Really bad. Which my provider thought might be a gall bladder issue, but after subsequent CT scans and all kinds of tests, we don't think it is. Second episode in July - pain again but on the left side of abdomen. This time it was diagnosed as Diverticulitis. They put me on Dicyclomine and  my doctor put me on Pantoprazole. He sent me for an upper quadrant ultrasound and to see a gastroenterologist doctor. Digestive disorders: Saw a nurse practitioner there. She added Vit E daily; Ordered: Hida scan of my gall bladder; and Fiber scan for my liver - and scheduled an EGD.  7/20/2021= chills, fever, really bad left side pain. Went to Urgent Care - so I could get a COVID test - I was COVID negative.  Ciprofloxicin and Flagyl - prescribed by my surgeon  my new gastroenterologist  - saw him on August 11th - ordered colonscopy. October 18th - Diverticulitis symptoms again - Doctor called in Augmentin - it's generic for that. I'm still taking that. That is helping with my symptoms but I'm not finished with the 10 day course yet.   Had a flu shot just recently:  September 24th, 2021
Chest pain - felt like heart was rubbing against ribs Chest flutters and heaviness
Arm red and swollen down to the elbow and all the way around, chills, Went to 1st Dr. (he did not look at it but said to take Benadryl and put ice on it. Had another appt. with a different Dr. that day and he would not treat me for my knee injury until the arm was better, he then gave me antibiotic 'Cephalexin 500 MG'. Then went to ER later that nite, told to keep it elevated and rechecked in several days.
was vaccinated with an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB36AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 01-August-2022 Reporter's comment: A nurse reported that a patient was vaccinated today on 1st August 2022 with an expired dose of Bexsero.  The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
I had severe side effects including 101 degrees fever, chills. headache, body ache. It lasted for a week before I went to see a doctor. After seeing a doctor, she diagnosed it as possible pneumonia. X-ray was done and confirmed it. I started taking anti biotic. Within a few days I felt better. A week later, another X-ray was done and confirmed clear lungs. During the first week I took Tylenol, Aleve to reduce the fever and eliminate the chills. It was unable to eliminate the severe headache.
I had the shot Tues aft. at my store pharmacy. Later that night I noticed mild muscle pain and a slight fever, but this is not unusual for me. I usually have a mild reaction to the flu vaccine, and it only lasts about a day. However, the pain spread to my ribs and was bad enough to wake me during the night, and by the Wed morning I was in a lot of discomfort. I went into the bathroom to take my usual pills, and immediately vomited them up, along with the glass of water I drank. I called out from work and returned to bed, where I slept pretty much all day and was too nauseous to eat or drink. The next morning  (Thu) I was feeling a little better, though not well enough to go to work. I was able to eat a bit of toast and some tea, but nothing more substantial. Friday I was mostly well, and then by the weekend I had pretty much recovered, except for some lingering nausea, which comes and goes, and may be unrelated. This is the worst reaction I've ever had to the flu vaccine, and a doctor friend of mine suggested I report it. I'm sorry I don't have more info, but it was given at the store pharmacy. My husband and daughter received theirs at the same time and were fine.
Information has been received from a pharmacist referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant the therapies were not reported. The pharmacist reported that the patients received a dose of ZOSTAVAX (lot # L040445, expiration date 15-JAN-2017, start date, dose and route unknown) which was improperly stored. No adverse effects reported. Additional information is not expected since the reporter does not wish to be contacted.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium
Patient seen in the ED on 7/13 for weakness and dizziness. He had a positive COVID home test on 7/13 and COVID-19 PCR swab taken in the ED was also positive. His daughter was concerned about his generalized weakness and so patient was admitted for COVID-19 infection.  Patient admitted from 7/13-7/23. He is vaccinated against COVID-19. This meets criteria for vaccine breakthrough case review.
I am reporting this incident to VAERS because this patient was given Trumenba before knowing she tested positive for pregnancy. Patient gave no indication to possible pregnancy at appointment on 9/17/19. She came into the clinic to get started on birth control and this is why we ran a pregnancy test to ensure it was negative before prescribing  medication. In the meantime, patient was due for Trumenba and it was given during the appointment before pregnancy test was ran. This was realized after the fact. Patient has had no known side effects or problems to our knowledge. She is scheduled with the OB office, she would've been in her first trimester at the time of vaccine administration.
Patient complained of tenderness and pain near injection site. Upon inspection area was swollen and reddened. At 0926 Tylenol was given for pain and an ice pack applied. Tylenol was given again at 1439.
Hospital Course: Patient was admitted to the medical floor with altered mental status, placed on empiric Rocephin/Zithromax for presumptive bacterial pneumonia.  It was later revealed that he received his 2nd Moderna COVID19 vaccination on 5/18, having recovered from COVID19 in Dec 2020.  This certainly raises the question as to if his symptoms are related to immune-response to the vaccine.  He certainly seems to think so, based on timing of his symptoms and being in his usual state of health prior to getting it.  Nonetheless, he is being treated initially for presumptive straightforward community acquired pneumonia.   Quite unexpectedly, within 24 hours of his abrupt decompensation, he has returned to baseline.  Off O2, mental status sharp and at baseline, no further fevers.  This rapid improvement confirms suspicion that his presentation is likely adverse effect/immune mediated response to the 2nd COVID vaccine (Moderna).  He became acutely ill within 24 hours of vaccine and resolved almost exactly 48 hours afterwards.  Creatinine has returned to baseline 1.9-2.0 after IV fluids.  Cultures remain negative.
Fever  Myalagia Fatigue Arthralgia Chills Pain at injection site all within 8 hours of injection
Sore arm after 1st and 2nd dose; flu-like symptoms; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm after 1st and 2nd dose) and INFLUENZA LIKE ILLNESS (flu-like symptoms) in an adult male 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm after 1st and 2nd dose) and INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, PAIN IN EXTREMITY (Sore arm after 1st and 2nd dose) and INFLUENZA LIKE ILLNESS (flu-like symptoms) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported.   This case was linked to MOD-2021-427771, MOD-2021-427775 (Patient Link).
The day after the shot, I experienced typical mild flulike symptoms that I have experienced with at least 2 of my 3 previous COVID vaccines. On the 2nd morning after the shot (4/11), I started experiencing occasional tinnitus in my left ear only. On the 3rd morning after the shot (4/13), I started experiencing severe, steady tinnitus in my left ear for several hours. Then the hearing in my left ear basically became completely absent. This continued for a week. During that week I was (mis)diagnosed at an urgent care facility as having hearing loss due to allergic rhinitis and congestion and was treated with a 6-day course of prednisolone. After 6 days of treatment and still having near-total hearing loss in my left ear, I saw an ENT specialist on 4/19/22. She conducted a hearing evaluation and found that I have idiopathic sudden sensorineural hearing loss with profound hearing loss in my left ear only. She found no other problems and no sign of congestion in my Eustachian tubes. I am currently undergoing treatment with corticosteroids. Dr. advised me to report the incident. My hearing loss persists
Two days after receiving the Moderna vaccine, I got a rash on my neck, collarbone, and a little bit on my upper chest.
Information has been received from a healthcare worker referring to unknown number of patients of unknown age and gender. Information about patients' concomitant medications, concurrent conditions and medical history was not reported. The healthcare worker reported that on unspecified dates since 15-OCT-2015 the patients were vaccinated with doses of VAQTA (dose and route not reported, lot # L023232 with expiration date 25-FEB-2017), which were exposed to the temperatures outside of the recommended range (temperature: 31F and time frame: 838 hours 59 minutes). The reporter was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Within the same week as receiving the PNEUMOVAX 23 the patient experienced cellulitis; This initial spontaneous report was received from a pharmacist, referring to a 66-year-old female patient. Her pertinent medical history included hypertension and diabetes mellitus. Her concomitant therapies included unspecified medications as treatment for hypertension and diabetes. The patient's historical conditions were not reported. The patient had no, previous drug reactions or allergies.  On 10-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administered intramuscularly (dose/frequency reported as 25mcg/5.5ml) , lot number R018735 expiration date 06-APR-2020, as prophylaxis (reported as "routine") (anatomical injection site was not reported).         Afterwards, on an unspecified day in September 2019 (also reported as "within the same week as receiving pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)") the patient experienced cellulitis. It was reported that 2 days after the cellulitis appeared, the patient sought medical attention, went to a walk-in clinic and was prescribed cephalexin 500mg and prednisone 5mg, as treatment for the event. No laboratory diagnostics or studies were performed to the patient.  On an unspecified date in 2019, the patient fully recovered from the event of cellulitis.  The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and cellulitis occurrence was not provided.  It was reported that cellulitis was not a disabling, life-threatening, cancer or overdose event. The patient did not required hospitalization due to this event. Upon internal review, the event of cellulitis was determined to be medically significant.  By request of the reporting pharmacist, an investigation was started for the reported lot number.
Seen in our office on 2/21/08 for 5 year old WCU.  Received Varivax #2.  On 2/22/08 in the evening noticed area of redness, warm to touch, "felt tight'.  On 2/23/08 blister at injection site (clear fluid).  Diagnosed with post varicella cellulitis.  Treated with Augmentin.
her doctor administered GARDASIL 9 because she has seen "success with GARDASIL 9 in suppressing more and more skin cancer"/Consumer is also over the age of 45; Consumer is also over the age of 45; This spontaneous report was received from a female consumer who is over 45-year-old and was reporting on herself. The patient's pertinent medical history included leukemia. Her drug allergies or reactions, and concomitant medications were not reported.  On unknown dates, the patient who was over 45-year-old was vaccinated with 3 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were unknown by the reporter) (product use in unapproved population). All the vaccines doses were given for skin cancer since the patient's doctor had seen "success with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in suppressing more and more skin cancer" (off label use in unapproved indication) ( drug effective for unapproved indication (capture in MARRS# 2211USA008787)).
SOB, chills, nausea, bone aches-uncontrollable with pain medication, slight fever, muscle aches,  ELEVATED BLOOD SUGARS,with no improvement over 5 days. Symptoms slowly got better over the course of 10 days. Tinnitus still ongoing.
Patient experienced a fever of 101 degrees F, two red, patchy welts on stomach, four to five welts on the right side of his face and chin and diarrhea.  He also screamed for five hours. (1130 pm to 4:30 pm) Reporter notes "PCP's office called us back @ 0430 and stated that the patient was finally asleep, otherwise (we) would have recommended (them trying him to the) ER."
Dad states baby was fine on day of immunizations - (2/8/16) had fever (104-105) about 40 minutes on 2-10-16. Relieved with TYLENOL. Began inconsolable crying 2-13-16. Acts like he is in pain.
PATIENT REFERS THAT 45 MINUTES AFTER VACCINATION AN ITCH AND RASH DEVELOPED IN NECK, BACK AND BUTTOCKS.
Information has been received from an 18 year old female patient with a history of fainting but no drug reactions or allergies who on 08-JUN-2009 was vaccinated IM with the first 0.5ml dose of GARDASIL (lot# 659054/0315Y). There was no concomitant medication. The patient reported that "after received the first dose of GARDASIL she passed out and her left arm was sore where she received the injection". A nurse reported that after the patient received her first dose of GARDASIL vaccine the patient became faint. The office told the patient to lie down and raise her feet; she was also given oxygen, some fluid and crackers. Then the patient found out by doing a home pregnancy test that she was 5 weeks pregnant. Therapy with GARDASIL was discontinued on 08-JUN-2009. It was reported that the patient sought unspecified medical attention. The patient recovered after about an hour from "became faint and passed out" on 08-JUN-2009 and left the office. The patient's outcome was unknown for vaccine exposure during pregnancy and left arm sore where vaccinated. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and drug reactions/allergies were not reported. Concomitant therapies included sterile diluent (STERILE DILUENT). On 01-MAR-2018 the patient was vaccinated with one dose of improperly stored VARIVAX (lot # N023960, expiry date: 01-SEP-2019), (dose, frequency and route were not reported) for prophylaxis. No adverse effects reported. Product quality complaint was not involved. VARIVAX was exposed to temperature of 6 degree Fahrenheit (F) to 14 F for 36 minutes. There was no previous temperature excursion reported. The digital data logger was involved.
On 08/26/2000 the patient experienced fever and irritability. On 08/28/2000 the patient developed about 50 chicken pox lesions. Medical attention was sought. In follow up information received from the nurse, the patient was seen on 09/06/2000 for WIC clinic. The reported noted that the lesions were crusting and the patient's experience had resolved.
Severe left arm pain, ice pack applied. Five minutes later dizziness occured, BP 79/50. BP raised to 116/79 over next three minutes with giving juice.
This spontaneous report as received from a registered nurse refers to a young child patient of unknown age. On 29-APR-2013 the patient was vaccinated with PNEUMOVAX23 (lot number, dose, route and injection site were not reported) instead of PCV (manufacturer unknown). No side effects were reported. No demographics were provided for the patient involved. The action taken, outcome and causality were not provided. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Information has been received on 04/26/2001 from a female consumer with no past medical history and a sulfa allergy who five to six weeks ago in March 2001 was vaccinated with a first dose of varicella vaccine. The pt developed pain in joints and back pain shortly after vaccination. The pt contacted her physician and sought unspecified medical attention. Additional info has been requested.
Patient developed localized reaction approx. 1 hr. after administration on 8/18/2014. On 8/20/2014 patient was seen in clinic for 6cm red, hard induration. Treated with oral BENADRYL.
Cough, throat irritation, nasal congestion, runny nose, diarrhea, decreased taste, decreased smell with positive COVID PCR on 7/30/21
Baby cried nonstop since shot was administered on 1-25-10. Baby acted as if he were in pain. Skin from face to torso became flushed.
Kinrix administered to 34 month old baby instead of Dtap (infanrix).; Kinrix administered to 34 month old baby instead of Dtap (infanrix).; inappropriate schdeule of vaccine administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 34-month-old female patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered 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 provided as follows: The age at vaccination was not reported. It was reported that the 34 months old patient received Kinrix instead of Dtap (infanrix), which led to inappropriate age at vaccine administration and wrong vaccine administered. Kinrix was administered as 4th dose of dtap and 4th dose of ipv, which led to inappropriate schedule of vaccine administered. The reporter consented to follow up. This case has been linked with case US2022039282 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022039282:same reporter
Rash on upper arm of injection; Soreness of arm of injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site rash and injection site pain. On an unknown date, the outcome of the injection site rash and injection site pain were unknown.   It was unknown if the reporter considered the injection site rash and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that, after vaccination with dose of Shingrix, the patient had rash and extreme soreness on upper arm . The reporter did not have patient information, batch number and expiry date of Shingrix vaccine. The reporter consented to follow up.