chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gave 0.25mL of the Moderna Bivalent; gave another 0.25mL of the Moderna Bivalent Vaccine to that patients with an interval of two days and two to three weeks; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Gave 0.25mL of the Moderna Bivalent), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave another 0.25mL of the Moderna Bivalent Vaccine to that patients with an interval of two days and two to three weeks) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19.     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, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Gave 0.25mL of the Moderna Bivalent), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave another 0.25mL of the Moderna Bivalent Vaccine to that patients with an interval of two days and two to three weeks) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Gave 0.25mL of the Moderna Bivalent), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave another 0.25mL of the Moderna Bivalent Vaccine to that patients with an interval of two days and two to three weeks) 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 assessments were provided for ACCIDENTAL UNDERDOSE (Gave 0.25mL of the Moderna Bivalent) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave another 0.25mL of the Moderna Bivalent Vaccine to that patients with an interval of two days and two to three weeks).    No concomitant medication was reported.  Reportedly, one pharmacist had been only giving 0.25 mL of the Moderna Bivalent Booster shot to approximately 30 patients including reporter and her husband. The pharmacist who only gave 0.25mL of the Moderna Bivalent Vaccine had the assumption that it was just the same as the first Moderna Vaccine. They gave another 0.25mL of the Moderna Bivalent Vaccine to that patients with an interval of two days and two to three weeks.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-654591, US-MODERNATX, INC.-MOD-2022-654607 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2022: Live non significant follow up information received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654591:MOD-2022-654591 (remaining patients case) US-MODERNATX, INC.-MOD-2022-654607:wife case
she doesn't feel the same as she normal feels; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization; Bnt162b2 (Dose 3 booster), for COVID-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (Dose 4 booster/bivalent), for COVID-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (Dose 5 booster/bivalent), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 29Sep2023, outcome "recovered" (Sep2023), described as "she doesn't feel the same as she normal feels". Additional information: The patient reported that she has always gotten the Pfizer shots, and doesn't want to mix it with Moderna or anything like that. She had RA and some other health issues. As of this shot, it was her 6th Pfizer COVID vaccine. She never had any side effects or issues, and she sat for 15 minutes and said she doesn't feel the same as she normally feels, but it was nothing major. It has been a couple of hours at the time of report and she doesn't have anything going on now.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300314865 Same patient/vaccine, different dose/event;
After the vaccination my menstrual cycle went crazy. After a couple days I had very heavy bleeding that lasted two weeks which was only two weeks after my last cycle. After this it continued to cycle this way until the first week of July. I didn't get another cycle until a few days ago. I started having menopausal symptoms. I had a hormonal blood panel to determine best course of action of treatment.
PTS GIRLFRIEND CALLED A FEW DAYS AFTER THE VACCINES WERE ADMINISTERED - STATED PATIENT HAD BEEN DELERIOUS AND WEAK ALL DAY AND FELL IN THE SHOWER. RECOMMENDED THAT THEY GO TO AN URGENT CARE OR EMERGENCY ROOM DUE TO PTS WEIGHT AND AGE
patient received his second moderna vaccine. He came in with a female companion. After the vaccine he was asked to go the waiting area for 15 minutes. I left the immunization booth to give them a minute to there belongings as I prepare for the next vaccine patient. After two or so minutes when I returned the patient was still seated with the head leaning forward and had out trash can in front of him, He was not throwing up but he said he was feeling nauseated and also looked as if he was sweating, He was able to answer all my questions during the entire event.. He later said he was feeling dizzy and light headed. He did not want to lay down but he accepted a bottle of water. After about 10 minutes he he said his right arm was numb. (vaccine was given on the left arm). at that point he was more sluggish. at that time I told the female companion that we have to call ems because she was starting to contemplate taking him to the urgent care herself. The ems were called. The patient state did not change all up to the time the ems got here. At one point while waiting for the ems the wanted to leave because he did not want to go the hospital but he could not gather enough strength to walk by himself.
altered dosing schedule; No adverse effect; This spontaneous report was received from a pharmacist referred to a 20-year-old male patient.  Information regarding medical history, concurrent condition and concomitant medications were not reported. On 25-JUL-2017, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection with lot # M037770 (Lot No. M037770 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date not reported, but upon internal validation established as 01-JUN-2019) for prophyaxis (dose and route were not reported). It was reported that, the patient received altered dosing schedule for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection as he received the second dose on an unknown date, late in November 2018 (dose, route, lot # and expiry date were not reported) (Inappropriate schedule of product administration). No adverse effects were reported (no adverse event). Product quality complaint was not involved.
Patient reports, "On April 3rd, 2021 I experienced numbness and tingling of the left and right arm lasting about 2 hours. This occurred at about noon."  Beginning on 4/11/21 patient reports experience balance impairment, loss of feeling in her toes, and weakness in her arms. She recently has began experiencing diarrhea and incontinence. These symptoms starting on 4/11/21 have not resolved.  Client saw her Chiropractor on 4/13/21 and was recommended that she see a medical professional and report her symptoms to the Health Department. Patient is currently looking to find a provider.
Moderna Covid-19 vaccine was inadvertently administered to a patient less than 12 years old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Covid-19 vaccine was inadvertently administered to a patient less than 12 years old) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Covid-19 vaccine was inadvertently administered to a patient less than 12 years old). On 15-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Covid-19 vaccine was inadvertently administered to a patient less than 12 years old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not provided.  Treatment information was not provided.  It was reported that the clinic was not yet sure if they gave a dose of Moderna Covid-19 vaccine to a 2 year old or a 12 year old.
A non-serious spontaneous report of tested positive for Flu has been received from a physician concerning a seven-year-old male patient, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 25-Oct-2010, the patient received FLUMIST. On 15-Feb-2011, the patient was tested positive for Flu. On an unknown date, the influenza resolved. The outcome of the event tested positive for Flu was resolved. Additional information was received on 08-Jun-2011 and incorporated into the narrative: the outcome of the event. Reporter also confirmed that the patient did not have any other AEs.
TOOK TWO DOSES IN A ROW; This spontaneous case report (PVX2019-2572) was received from a consumer on 17-Oct-2019. It described a 17-year-old male consumer who "took two doses in a row" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for an unknown indication.  Case report: The consumer did not take Vivotif according to schedule. He had taken his third and fourth dose on 16-Oct-2019 and 17-Oct-2019, respectively.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.
Pt immediately felt lightheaded after inj. Lie pt down within a minute or so she stated her neck felt tight (not throat). Denies SOB. Denies dysphagia, dizzy/lightheaded resolved. After lying down, pt still with neck Sx - all over 30 min.
Patient received an expired dose of Heplisav-B; Initial report received on 25-Oct-2023  A registered nurse reported that a 52-year-old female patient (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history and concomitant medications at the time of vaccination were not reported. The patient had an allergy to lisinopril (cough).  On 18-Oct-2023, the patient received the first dose of HEPLISAV-B (Lot # 938794, expiration date 09 Oct 2023, and NDC # 43528-003-05; route not reported) in the right deltoid. The HEPLISAV-B dose was expired. No adverse reactions were reported.  No additional information was reported.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
2nd day felt terrible.  3rd day had sudden eruption of a Pilonidal Cyst and simultaneously bad pain in lower right leg which eventually turned a couple of days later  into Cellulitis . I was put on Bactrim and Amoxicillin .  After the bacteria in the Cyst was tested and the report came back, I was switched to 20 days of Doxycycline.  The infection in my right lower leg was an angry raised like 4-5 inch bubble with a raised center section-a hard ridge.  Slowly over many days the leg infection cleared up slowly.  My right foot became swollen and remains so even now through the ankle and toes and most of the foot.  .  I have never had swelling in my foot before. The left foot looks different than the right. 2 of the 5 doctors I saw told me that most likely my immune system had a strong reaction to the vaccine which caused a viral like inflammatory response both in my lower back and in the right leg which  then became infected. I was out of work for a few weeks. I was so tired I could not work.  I am mostly concerned now with why my foot remains swollen.  The infections are gone, however you can still see a darker area where the infection on my leg predominated.   I felt it important to report this course of what happened.
8/29 am had no problem, 8/30 Hardly knew she had shot. 8/31 woke up with arm itching hot burning, no dyspnea, but voice sounded raspy. At 7:00 pm, went to ER was given 2 Benadryl taken at 8:00 pm. Her arm was still sore on 9/1/00.
Fever (103)  that evening followed by diarrhea and an upset stomach for the following 5 days.
patient recevied 0.5ml instead of 0.25ml.  No adverse affects per patient.
Patient developed sterile abscesses at injection site.-First noticed as firm swellings around 3 weeks after receiving the vaccines. No fever. Treatment: Incision and drainage, Keflex.
This is a spontaneous case, initially received on 16-Oct-2018, reported by other health professional, concerning a 69-year-old, elderly, female patient. The patient had no medical history and concomitant medications at the time of vaccination. The patient's current condition included anaemia. On 16-Oct-2018, the patient was administered FLUAD TIV (dose: reported as 5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250790 and expiry date: 30-Apr-2019). The patient received was administered partial dose of FLUAD (explicitly coded as underdose). As the medicine leaked out of the injection site (reported as 2 or 3 drops came out) (explicitly coded as injection site extravasation). It was reported that on the same day the patient was re-vaccinated with FLUAD (dose: 0.5 ml, route: intramuscular, anatomical location: deltoid) in the opposite arm (explicitly coded as drug administration error). The patient had not complained about any side effects or adverse reactions after vaccination. The reporter assessed the case as non-serious. Follow-up received from the other health professional on 21-Nov-2018: The reporter confirmed that the patient was re-vaccinated with FLUAD on the same day (16-Oct-2018) in the opposite arm. Added new dosage regimen for FLUAD (dose: 0.5 ml, route: intramuscular, anatomical location: deltoid) in the product tab. Added new event drug administration error in the event tab. The patient had not reported any adverse reactions after vaccination. Added reference number (Med Info Number: SEQ18-06799) in the additional information tab. The narrative was amended accordingly.
This case was reported by a pharmacist via call center representative and described the occurrence of fatigue aggravated in a 39-year-old male patient who received BOOSTRIX (batch number FB942, expiry date 2nd November 2017). Concurrent medical conditions included Crohn's disease and fatigue. Concomitant products included HUMIRA. On 31st December 2015, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced fatigue aggravated. On an unknown date, the outcome of the fatigue aggravated was unknown. It was unknown if the reporter considered the fatigue aggravated to be related to BOOSTRIX. Additional details were received as follows: The reporter stated that, after receiving a dose of BOOSTRIX the patient complaining of fatigue. The patient had fatigue prior to the vaccination but he felt that it was worse since getting the BOOSTRIX. The reporter did not have a specific time when patient felt the fatigue got worse. The batch number reported for BOOSTRIX (FB948), did not exist and was updated to be FB942, as per sales database.
it's getting worse; now can barely lift her arm; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administration date 29Apr2021 (Lot number: ER8735) at the age of 51 years as dose 2, single and administered in arm left, administration date 06Apr2021 12:49 (Lot number: ER8734) as dose 1. single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 07Apr2021, outcome "not recovered", described as "sore arm"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "it's getting worse"; LIMB DISCOMFORT (non-serious), outcome "not recovered", described as "now can barely lift her arm". Therapeutic measures were not taken as a result of pain in extremity, condition aggravated, limb discomfort.  Additional information: Patient had some arm soreness at first and now can barely lift her arm was reported as worsened. Patient did not received any other vaccination with in four weeks of COVID-19 vaccine.  No follow-up attempts are possible. No further information is expected.
24 hours after vaccine severe pain in all body joints and muscles. Hurts to walk. Pain in lower back and pelvis, knees, wrists, and ankles. Tiredness, headache, dizziness.
stiff neck, chills, lower backache, aches in back of legs & thighs, temp 102 per pt;
Pt with few days history cough/rhinorrhea but afebrile and well-appearing, given influenza vaccine 10/28 at Clinic and tolerated well initially.  10/29 AM pt developed fever to b/w 103-105F and began shaking with eye deviation and altered mental status (unresponsive though conscious) lasting 20-25 minutes.  No cyanosis, no other symptoms.  Episode resolved on its own, consistent with complex febrile seizure.  Patient was evaluated in ER, Blood/Urine cultures and basic labs sent, all WNL, transferred per parent preference to other hospital.  Lumbar puncture performed with normal CSF studies.  Patient received IV Vancomycin/Ceftriaxone empirically while awaiting culture results.  Blood/Urine Cultures negative x 48 hrs and CSF culture negative x 36 hrs by time of discharge at which time IV antibiotics discontinued.  No further seizures during hospitalization, patient well-appearing during entire hospital stay.
I woke up Sat morning had red tingling, burning sensation under my chin. I also developed a rash on right flank doctor think it might be Shingles. My estimated date of delivery is 10/30.
Received vaccine intramuscular to (L) thigh on 7-7-17. Parent noticed redness and puffiness on Saturday 7-8-17. Redness, warmth and swelling increased through Mon. 7-10 prompting appt. No treatment needed.
About 10 days after receiving her vaccine, the patient developed redness, swelling and itching at the site of vaccination.  It was warm to touch.  Patient sought care from PCP, it did not appear to be infected, no antibiotics were prescribed.
On the 6 day after injection, site became itchy at night. Woke up on the 7th day after injection to the injection site described as large, red, swollen, sore, hot to the touch.
This spontaneous report as received from medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-OCT-2016, the patient was vaccinated with improperly stored dose of (Oka-Merck) PROQUAD, lot # M031944 with expiry: 27-DEC-2017 (dosing details not reported). No adverse effects reported. Additional information has been requested.
HPI: This is a 12-month-old female brought in by EMS from home with mother bedside presenting with 2 seizures described as being generalized tonic clonic.  Mother states patient received MMR vaccine yesterday and was febrile this morning.  Patient experienced a seizure described as general tonic-clonic movements lasting for 1 minute which mother states was consistent with prior febrile seizures.  Patient experienced a second seizure in route witnessed by EMS with presentation duration consistent with prior seizure.  No nausea/vomiting, fever/chills, diarrhea, rash.   Patient was post-ictal after the seizure and has since returned to baseline mentation.  Patient is negative for associated injuries.
Pain in the site of the injection started immediately.  During the course of the evening, pain worsened and I began to feel fatigued.   The next morning I woke around 5:30 am with pain in my back. I tried to get back to sleep and it was very difficult to rest. Finally, I got out of the bed around 7:30 am with a pounding headache and body aches along with back pain and my arm (at the site of the injection) is too sore to touch. There is also a red ring around the injection site (similar to the look of ringworm). The symptoms continued to get worse. I checked my temperature and it was 101.3 so I took some Tylenol. After several hours, the body aches had not subsided, so I took my temperature again and it was 100.5. At that time I took another dose of Tylenol. After about thirty minutes after the second dose of Tylenol, my temperature dropped to 99.1.   The current time is 6:41 pm on March 17, 2021. This is what has occurred today (1 day after the vaccine).
Severe  bloating and swelling especially in the abdominal area then intense stinging and itching in the central abdominal area.   July 3, 2021 3PM - self administered Benadryl one dose 2 capsules. Did not help. Trouble sleeping night of July 3rd due to itching and stinging. July 4th 2021 7 AM symptoms of stinging and itching worsening. Self administered 1 GM Valacyclovir  HCL TAB (prescribed for oral herpes- as needed) Will seek medical advise if symptoms do not improve in 24 hours
Within 10 minutes got  blurred vision and felt like going to faint.   happened 3 times during first 30 minutes happened 3 times.  Felt like throat was tight when swallowing .   Face started to tingle and numbness lips and tongue for about 5 minutes , Tightness in throat for  2 hours . went back to Cvs  and stayed for a an hour .   Felt like swelling of throat for the first night .   2 days had a sore throat ,  little by little went away.    took 3 days to swallow normal.    Called her doctor for advice on second short
On 10/15/99, the pt experienced pain and weakness in her right arm starting at her neck and extending to her fingertips.
Initial site injection reaction followed by chronic spontaneous urticaria and dermatographia. "Covid arm" swelling and large red area appeared immediately after vaccine. A-typical diffuse rash all over body, onset about 10 days after vaccine. Hypersensitivity to touch - light touch produces raised welts. Patient reported to urgent care and was referred to dermatology. Course of oral and topical steroids was ineffective. Dermatologist recommended 40mg of cetirizine antihistamine pills per day for 2 months. Follow up appointment with dermatology is scheduled for Februrary 2022.  This was patient's third covid vaccine. The first two vaccines were received when patient was pregnant.