chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lymph node swollen on left side of the neck, Lymph node swelling and size is gold ball size; Consumer was given 2nd dose too early; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Consumer was given 2nd dose too early) and LYMPHADENOPATHY (Lymph node swollen on left side of the neck, Lymph node swelling and size is gold ball size) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Consumer was given 2nd dose too early). On 26-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (Lymph node swollen on left side of the neck, Lymph node swelling and size is gold ball size). On 15-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Consumer was given 2nd dose too early) had resolved. At the time of the report, LYMPHADENOPATHY (Lymph node swollen on left side of the neck, Lymph node swelling and size is gold ball size) outcome was unknown.            Concomitant medications were provided for Cholesterol (low dose 5 mg) and Blood pressure.  No treatment information was provided.  The patient visited the local ED and did tests. Radiologist looked at the tests and notified consumer the swelling and size of the lymph node was size of golf ball. Patient has got 4 ultrasounds since swelling. Consumer got a ultrasound on 11-Aug-2021 and awaiting results.
10 cm localized raised, hot rash to the left arm site where MENVEO vaccine was administrated; 10 cm localized raised, hot rash to the left arm site where MENVEO vaccine was administrated; 10 cm localized raised, hot rash to the left arm site where MENVEO vaccine was administrated; Per doctor a patient was given two doses of GARDASIL 9 at the same time on 8/3/2022.; This spontaneous report was received from a physician and refers to a 13-year-old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 03-AUG-2022, the patient was vaccinated at the same time with two doses (overdose) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) to right arm (exact doses, strengths, formulations, lot #, expiration dates and route of administration were not provided) for prophylaxis. On an unknown date in 2022, the patient was vaccinated with a dose of meningococcal vaccine a/c/y/w conj (crm197) (MENVEO) to left arm (exact dose, strength, formulation, lot #, expiration date, route of administration and indication were not provided).  On 05-AUG-2022 (reported as now), the patient developed 10 cm localized raised, hot rash to left arm site where meningococcal vaccine a/c/y/w conj (crm197) (MENVEO) vaccine was administered. Outcome of events was not provided.   The relatedness between the events and suspect therapies was not provided.
After receiving vaccines patient passed out. No LOC, dizzy, cool clammy. Responsive alert & oriented.
Mom states child came to her at 1:00 Am with fever and body aches. She was given Tylenol and continued to have fever and increased body/joint aches and was crying with pain. Complained that the tops of her feet hurt. She was taken to ER by 4:30 AM. She was monitored there for approximately 3.5 hrs and discharged home. She continued to have fever for the next 48 hrs.
Aproximately 12 hours after vaccination, my blood pressure dropped significantly (50/30), and I felt very ill. Nausea, weakness, discomfort, dizziness. By morning, I felt worse, and visited our urgent care clinic. I dont have any history of blood pressure concerns (high or low), and I am very healthy. The physician I saw asked me to go home, rest, and drink lots of fluids. Blood pressure continued low (but more manageable, 90/50) throughout the week, I felt progressively better.
pt recvd vax;tc recvd from mom at 1:45pm describing persistent crying since vax;golf ball size swelling at inject site on rt leg w/ redness & apparent lack of mobility;  instructed to used bath/warm pack to leg; apap given;pt w/out sxs now
severe headache, dizziness, diarrhea and nausea followed by 1 day gross hematuria
5 minutes after administration patient reported light-headedness. Had patient lie flat on mat, advised to loosen tight clothing and maintain open airway. Provided cold compress for patient to use on neck. Kept under close observation x 2 hours until symptoms resolved. Had nurse at facility check and assist in getting client a cab home.
I developed an itchy rash with oozing lesions on my torso, with lesions on my arms, head, and legs.  Some are small, some are larger and welt-like.  two days after the initial rash, I have more lesions.  My skin color had been pale.  I had been a little tired and now have a stiff neck.  I have not had much of an appetite and my stomach feels strange.
Narrative: COVID infection following COVID vaccination series 01/25 pre-op testing, tested positive for COVID, asymptomatic 03/18 COVID vaccine dose #1 04/08 COVID vaccine dose #2 06/04 pre-op testing, tested negative for COVID 08/08 pre-op testing, tested negative for COVID 09/16 pre-travel testing, tested negative for COVID 09/27 tested due to symptoms (congestion, loss of smell, myalgia, rhinorrhea, tested POSITIVE for COVID 09/28 Eval in ER for bodyaches, fever, fatigue, coughing yellowish secretions, chest tightness and generalized weakness, d/c to home 09/30 c/o dry cough, Fatigue, Fever, Headache, loss of smell only 10/01 c/o dry cough, Fatigue, Improved Fever, Headache, loss of smell only 10/02 c/o dry cough and Fatigue 10/03 c/o Loss of smell, Runny nose (Rhinorrhea), clinical resolution of COVID
Patient is reporting that on the morning of 11/19/20 her nose both inside and outside broke out in blisters. She is attributing this to the Shingrix vaccine since she has had the "flu shot" before without incident. She said that prior to getting the vaccine she did feel like there were "bugs crawling around in her nose", but the blisters broke out after the vaccination.
Initial information received from a healthcare worker concerning 2 or 3 patients who on unspecified dates were vaccinated with doses of PNEUMOVAX 23 (lot number 662839/1089X). Subsequently, the patients developed "allergic reaction". Unspecified medical attention was sought. There were no lab diagnostic studies performed. Follow-up information has been received from an office manager concerning a 79 year old female with unknown pertinent medical history and unknown allergies who on 23-JUN-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot number 662839/1089X). The patient developed an "allergic reaction" after vaccination (date unspecified). The patient was advised on 24-JUN-2009 to take 25 mg BENADRYL. The patient was seen in the office on 25-JUN-2009 for redness and pain in right arm. She was given 5 mg CEFTIN 1 pill three times a day. The patient was seen again on 30-JUN-2009, where it was reported that she tolerated the antibiotic well, had no signs or symptoms, and rapidly recovered within 24 hours of the antibiotic (approximately 26-JUN-2009). This is one of two reports from the same source. Additional information has been requested.
slight sore arm; Lethargic; Fever; very low energy; Cough; Flu; feeling of inflammation; Lot of stuffiness; Post nasal drip; This is a spontaneous report from a non-contactable consumer, the patient. A 53-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6202) via an unspecified route of administration in the left arm on 04Mar2021 at 07:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperthyroid. The patient had a history of allergy to sulfa, mold and hornets. the patient received other medications included montelukast (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN) and estradiol (ESTROGEN) and vitamins (MANUFACTURE UNKNOWN) for unknown indication within 2 weeks of vaccination. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: el9262) via an unspecified route of administration in the left arm on 10Feb2021 at 15:45 (at the age of 53-years-old) 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. On 04Mar2021, the patient had experienced slight sore arm, lethargic, fever, loss of energy, cough, flu which was lasted for 32 hours and felt better however, she was feeling of inflammation, lot of stuffiness and post nasal drip. The patient reported that she was not sure if her allergies or shot or shot triggered the excess inflammation in body and she was still fighting it off along with allergies kicking in. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event flu was resolving while the outcome of the events slight sore arm, lethargic, fever, loss of energy, cough, feeling of inflammation, lot of stuffiness and post nasal drip was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
red swollen arm (upper) that devel @ inj site 24hr p/vax;no systemic sx x/t100.3
Sore throat followed by constricted airway followed by eye redness/discharge followed by mild elevated temperature, chills, and  and  achiness followed by sinus headache. Course: 24 hours.
Patient received vaccine in office 12/3/2019 4:42 PM, returned to office 12/4/2019  1:30pm with reaction. reaction site was red warm, firm to touch and measured 13 by 14 cm
Confusion, Headache, RespDepression,  Extreme Fatigue Narrative:
Extreme chills, headache, joint and back ache, fever,  began around 10pm  Chills lasted approx. 1 hour, fever spiked around 2am to 101.9 experienced rapid, pounding heart beat with high fever Next day, fever ranging from 99.9 to 99.5.  Headache, body aches, fatigue, loss of appetite Next two days had some residual fatigue
cold symptoms; slept and her arm hurt terribly; was tired, described as real fatigue; arm felt heavy and sore, and could not lift it; sinus infection; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SINUSITIS (sinus infection), JOINT RANGE OF MOTION DECREASED (arm felt heavy and sore, and could not lift it), NASOPHARYNGITIS (cold symptoms), VACCINATION SITE PAIN (slept and her arm hurt terribly) and FATIGUE (was tired, described as real fatigue) in a 37-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (arm felt heavy and sore, and could not lift it), VACCINATION SITE PAIN (slept and her arm hurt terribly) and FATIGUE (was tired, described as real fatigue). In May 2021, the patient experienced SINUSITIS (sinus infection). On 20-May-2021, the patient experienced NASOPHARYNGITIS (cold symptoms). On 17-May-2021, JOINT RANGE OF MOTION DECREASED (arm felt heavy and sore, and could not lift it), VACCINATION SITE PAIN (slept and her arm hurt terribly) and FATIGUE (was tired, described as real fatigue) had resolved. At the time of the report, SINUSITIS (sinus infection) and NASOPHARYNGITIS (cold symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Patient said she developed a large rash on the left arm starting 1 week after the first dose of  the Moderna Covid-19 vaccine, and lasted for about 3 days.  The rash resolved on its own after 3 days.
This case was reported by a consumer and described the occurrence of fever in a 2-year-old male subject who was vaccinated with Infanrix, GlaxoSmithKline. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. The subject had no pre-existing medical conditions. There were no concurrent medications. On 12 August 2005 the subject received 4th dose of Infanrix. On 12 August 2005, 4 hours after vaccination with Infanrix, the subject experienced a "high" fever. "A few days later," on an unspecified date in August 2005, the subject experienced lack of appetite and vomiting. The consumer reported that the subject "was taken to the hospital where blood tests were run." The subject was not admitted to the hospital. The results of the blood tests were not provided. The fever resolved on 17 August 2005 and the lack of appetite and vomiting resolved in "about a week" on an unspecified date in 2005.
Information has been received from a registered nurse concerning a 39 month old healthy male who on 10/20/03 was vaccinated with the first dose of varicella virus vaccine live (lot # 642676/0421M). On 6/18/05 the patient experienced cold symptoms, low grade fever, and greater than 400-500 lesions with itching. Unspecified medical attention was sought. He was treated with Acyclovir. As of 6/18/05, the patient was reported to be recovering. The registered nurse considered the adverse experiences to be other important medical events (OMIC). Additional information has been requested.
Hives x5 on injection site arm. Swelling, redness, burning, itching.
Patient faints 15 minutes after vaccinations.  Recovers quickly with no troubles noted.
Though vaccinated in 2006 at age 65, patient did still get disease 4 years later.
Influenza vaccine given 1 month earlier than recommended time. NO localized reaction, No fever or other adverse reaction noted after giving the vaccine as verbalized by father during a telephone interview on 1/18/2019. Father verbalizes understanding of the incident and recommended to follow-up with any question or concerns. (Interview done by RN, MSN, Nurse Manager). Reported to VAERS as per protocol.
This is a spontaneous report from a contactable nurse reporting on behalf of a doctor's office. A patient of unspecified age, ethnicity and gender received PREVNAR 13 (lot J11488, Exp date Nov2015, NDC-0005-1971-02) intramuscular at 0.5 ml single dose for immunization. Patient medical history and concomitant medications were not reported. Reporter states that the injection could not go in. PREVNAR 13 was injected with the blue clip was removed. A new needle was applied and they were able to inject the dose. When the needle was on, the blue clips was removed and another needle applied, and injection provided. The reporter assents that the patient's skin was punctured when this event occurred. The reporter does not have the actual syringe, because the used product is in the sharps box. Follow-up (14Jan2015): Follow-up attempts completed. No further information expected.
Case number PHEH2014US024167, is an initial spontaneous report received from a nurse on 02 Dec 2014 and a combined follow up report from the nurse received on 14 Jan 2015 and on 16 Jan 2015. This report refers to a 79 years old male patient. His vaccination history included unspecified vaccine in the past and it was well tolerated. Concomitant vaccine included PNEUMOVAX23, (batch number: K007824) at a dose of 0.5 ml intramuscularly in the left deltoid on 18 Nov 2014. He was vaccinated with FLUVIRIN, (batch number: 14511P, expiry date: Mar 2015) at a dose of 0.5 ml intramuscularly on 18 Nov 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Combined follow up report from the nurse received on 14 Jan 2015 and on 16 Jan 2015: Added vaccination history and concomitant vaccine (PNEUMOVAX).
Covid19 breakthrough.  1st vaccine received 07/20/2021.  38 y/o PMHx of Asthma, smoking presents to ED with 3 day history of increasing SOB and wheezing despite utilizing home inhalers.  Upon arrival to ED, Pt's room air O2 sat &&%, placed on 15L NRB, then weaned to 4L NC.  Pt afebrile and CXR with patchy fluffy infiltrates Left mid lung.  Treated with IV steroids and Remdesivir.
My heart rate for one months was 170s; Pain in movement; This is a spontaneous report from a contactable consumer.    An adult male patient received bnt162b2 (BNT162B2), dose 1 intramuscular on 23Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included covid-19 from an unknown date. The patient's concomitant medications were not reported. On 23Mar2021 the patient experienced as reported Shot 1 hit me like a truck, it was like being back with Covid again for a day, and the second shot wasn't a lot better. But about a week after the second shot, I saw DRAMATIC improvement. Without any substantial muscle gain I had access to my general strength again, I did not need help lifting or moving every-day objects, and I could even walk my dog again without issue. Pain in movement was greatly reduced to almost nothing. My heart rate now suddenly was topping out at 105 on the minor hill on the way to work after months of maintaining 170s for the same work. O2 has been holding steady in the 97 to 98 range these days. I'm certainly not back to normal, the most I have managed at a stretch was about half a mile for a run before chest pain tilted in, but this is a huge improvement from where I was and I do continue to see incremental increases week to week. The outcome of the events was reported as recovering. No treatment received.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant medication was reporter.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.      No treatment medication was reporter.
Rash over entire body except the face.  Massive hives under arms and on elbows and stomach.  Treated with Prednisone and benadryl for 10 days.  Mostly cleared after 5 days of 2 prednisone per day, changing to 1 per day after that.
Rash eruption throughout the body and light fever. Patient presents varicella with no contact with the virus during the week of vaccination
3 days after his 3rd dose of Moderna, his longstanding tinnitus in his left ear became much more prominent and has remained bothersome since.
Px reported receiving shot at approximately 630pm 6/25/18 and at approx 10pm she reported the following SX's: Large Rash on chest and neck, body aches/chills that lasted thru the next morning, large, painful welt at injection site that extended to armpit area. This is her second shot in the series. She did not exhibit any of these same SX's after receiving the first shot in April. She reported to her PCP by phone who instructed her to take IBU and to try BENADRYL prn. Pt reported to pharmacy 6/27. I asked the px if she was otherwise OK, and she said yes. PCP instructed her to follow up in approximately 3 days, and to come into office if no improvement.
Provider ordered first COVID-19 vaccine for patient, thinking we had Bivalent in stock / patients age (13yrs old). MA overlooked patients age and administered the Pfizer COVID-19 Vac-TriS 5-11y Intramuscular Suspension 10 MCG/0.2ML vaccine.
The pt. was administered two doses of Moderna when under the age of 18.  Pt signed consent for self at 15 years of age, consenting for the vaccine to be administered. Date of birth and age was falsified on-paper consent. Parent and pt. were seeking booster dose on 01/24/2022, MD office made our facility aware of the discrepancy. Father acknowledged that records were falsified so that pt. may be administered doses.
Exactly 5 and 1/2 hours after my vaccination on Aug 3rd, I began to experience tunnel vision and brain "fog" followed by extreme exhaustion, muscle aches, joint pain, and nausea that kept me awake most of the night (no vomiting).  I skipped dinner on Aug 3rd due to nausea, no appetite, and exhaustion, and went to bed at 7 pm.  By 12 noon the following day Aug 4th, I was 50% back to normal.  By 5 pm the evening of Aug 4th, I was 100% back to normal
Hives.  Sporadic itchy, red areas appearing all over body.  Mostly concentrated on thighs, chest, back, arms, scalp, and feet.  Started on 11/19/21 and continues to current day (11/30/21).  No past medical history of skin reactions similar to this.
Not  adverse.  Side effects.  Instant pain in arm upon injection.  All of the typical side effects listed plus a large rash on arm.  Symptoms happened over a course of three days.  Day 1, tiredness and headache.  Day 2 feverish, tireness, day 3 upset stomach and loose stool and later on large rash on arm.  Day 4 rash has spreaded some and still exists.  Slightly raised and slightly itchy, tender to the touch.
Customer rec'd flu shot at her work site. No Hx of allergies or allergic to eggs/ takes flu shot annually. 15-20 min after taking shot reports racing heart and SOB. 911 called/ Epinephrine 0.3 SQ by RN. EMT/Hospital. Per Pt Immediately felt weird became SOB within 5 min returned to clinic site, treated with Epi, transported to hospital, feels much better by then; observed home with advice for prn, Benadryl use her inhaler, return prn (no vax for several yrs). Medical records state tight chest. msv
It was discovered that the patient who is 16 years old was given Flublok. This is indicated for individuals age 18 years and older.