chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse via company representative refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with GARDASIL 9 (dosing details were not reported). The reporter stated that multiple patients has issues (unspecified issues) (adverse event) an unspecified time after receiving an unspecified dose of GARDASIL 9 that was concomitantly administered with MENACTRA and TRUMENBA. The outcome of adverse event is unknown. The reporter did not provided the causality assessment between the event and the suspect therapy. There was no product quality complaint involved. Additional information has been requested.
Patient experiencing a red rash below the injection site. She said this developed 12-24 hours post vaccine. She describes it as red, hot, and "a little firm." Patient did take some acetaminophen 2/12/2021 but has not taken any since. I advised to take IBU or acetaminophen, ice, and rest to help with symptom management. Advised that if symptoms worsen to come in to be seen at the clinic.
infection; Red Rash on the upper chest; This spontaneous case was reported by a pharmacist and describes the occurrence of INFECTION (infection) and RASH (Red Rash on the upper chest) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced INFECTION (infection) and RASH (Red Rash on the upper chest). At the time of the report, INFECTION (infection) and RASH (Red Rash on the upper chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications are not provided by the reporter. No treatment drugs are not provided by reporter.; Sender's Comments: There is not enough information to assess the event of infection as the specific infection was not reported.  However, based on the known profile for mRNA1273, a causal relationship with infection is unlikely.  The event of rash is consistent with the product safety profile., however, causality cannot be established as treatment and onset dates are lacking.
Swelling, pain, itching, redness at injection sight approximately 2? x 3?.
fatigue/super fatigued; chills; sweats; nausea/nauseous; injection site pain; Fatigue worsened; This is a spontaneous report from a contactable consumer or other non hcp. A 62-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 13Feb2021 (age at vaccination 62years old) as single dose for covid-19 immunisation. Medical history included covid-19 from Nov2020 to an unknown date. The patient's concomitant medications were not reported. On an unspecified date the patient experienced fatigue/super fatigued, chills, sweats, nausea/nauseous, injection site pain, fatigue worsened. The patient has a Report reference number. She is upset as she has been waiting to 50+ minutes to speak with a Nurse or someone with Medical Experience. She has already gone through a report, she has reference number. She got covid shot. She was positive for covid previously in early Nov2020. She just got the first dose on Saturday 13Feb2021. She experienced injection site pain, was super fatigued, chills, sweats, was nauseous, the fatigue got worse. It was not quite as bad as when she had the actual covid virus in Nov2020. Today she is better. she is supposed to babysit her 2-year-old triplets, she wants to know if having these symptoms after the first dose means that she is contagious. If she goes there and gets her kiddos sick, her daughter will shoot her. The Kid's Mom and Dad had covid. They think 2 of 3 triplets had covid but the paediatrician refuses to test them, the kids have not been tested. She clarifies that she went through the safety report just this morning. She was upset when informed that for her question she would have to be transferred. She spoke to a gentleman prior to this that gave the number and she even spoke to a last prior to this that asked her so many questions when all she wanted was her questions address, she gave the same number. She is upset she was not informed about selecting option 3, She has been going in circles on the phone line. The clinical outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with GARDASIL on an unknown date (dose, lot # were not reported). On an unknown date the patient missed an unspecified dose of the GARDASIL series. It was unknown how many doses the patient received or when they were administered. No adverse effects reported. The outcome was not provided. Additional information has been requested.
I had a sudden onset inflammatory response in my mouth tongue and throat. It stayed with pain in my mouth and then I had some swelling in my neck. It was painful to talk and painful to swallow. It was very sudden and I could not eat. This has never happened to me before. This gradually worsened so I did contacted my PCP and he said that I would need to go the emergency room. Before going to the emergency room, I then, I contacted my ENT doctor and he said that I was having an inflammatory response. So, I was prescribed Prednisone and Clindamycin. I was told that if the symptoms progressed to go to the emergency room. That night I took 6 Prednisone tablets and Clindamycin then by the next morning, I was better. I still am having issues with my vocal cords and a mild feeling but the swelling is gone.
flu-like symptoms after 2nd COVID vaccination; This is a spontaneous report received from a contactable consumer via a Pfizer colleague. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu-like symptoms after 2nd COVID vaccination".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. felt warm and nauseous at 3:43pm about 5 min after her vaccination. pt. vomited and felt better made pt. wait and monitored her for additional time pt. was ok to leave at 4:10 pm. skin color was normal pt. was feeling normal. no intervention as needed.
He presented without vaccine card and when nurse, inquired he voiced would be his first vaccine and completed a consent form as though first vaccine and chose Moderna.  It was not until I went to enter into Immtrac2 on 05/24/2022 that noted had received Pfizer first dose on 09/22/2021.  Finally able to make contact with him to inquire and he confirm he  that he had received dose, but needed proof of vaccine to start his new job and did not know how to prove had received so told nurse had not received.  There for unknown to nurse he had received Pfizer he was administered Moderna as 2nd dose.  He has denied having any symptoms, signs of reactions and no treatment has been required.
AERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:12/30/20.pfizer Lot#EL0142 2nd dose:01/20/21.pfizerLot#EL3247 Diagnosed covid positive: 03/20/21 Exposure:Home exposure Symptoms:Sore throat, fatigue, congestion, headache, body aches and chills.
Case completed 2 dose Moderna Covid vaccine series,  then was admitted to hospital for Covid pneumonia and respiratory failure on 8/16/212.
On July 1st, 1994, patient was 1 year 6 months, I brought my son in; he was sick with fever. He was vaccinated by doctor. Same night, he vomited, loss his balance, drooling, eye cross. MRI showed there was a damage in the brain. The follow up states, "diagnosed with PDD, ADD, heart valve disorder, tic syndrome."
Large welt/rash about 1 inch below injection site. About 1 inch in diameter. Last for about 3-4 days. Did not hurt or itch.
A non-serious spontaneous report of administration of expired product was received from a registered pharmacist concerning two patients (patients' demographic data not available) subsequent to FLUMIST. Neither medical history nor concomitant medications were reported. Sometime in the last week of Dec 2008 (specific date unknown). FLUMIST which was five days past the expiration date was administered to two patients. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. As of 23-Apr-2009, the reporter has not responded to follow-up telephone calls hence, unable to confirm any delayed occurring adverse events resulting from this error. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication error that occurred shortly after the product expired. Additional information received on 20-Mar-2009 included Product Complaint Investigative results.
We have a man that we vaccinated last week with moderna. He is 52 yo. He had his first vaccine at another store on 3/31 and his second vaccine with us on 4/14.  That is only 15 days apart. He said he got notification from us that a vaccine was available and he read in material (he thinks but isn?t sure) through the county that said he could get it in 2 weeks from his first dose. So, when he got the notification he thought it was ok to get his 2nd dose. He did however have a scheduled appointment with the other store for his second dose for the correct date. He did bring his card with him to vaccine clinic that had the date of his first vaccine on there. He said when he got his second dose he had 24hrs of feeling dizzy, 12 hrs of chills and 8hrs of feeling nauseous. He is not wanting to get another vaccine because he doesn?t want to go through those symptoms again
Initial misuse report received from a healthcare professional on 20 May 2013. A patient received a dose of ADACEL and Td vaccine (unknown manufacturer) in the same visit in April (year not specified). No information was provided regarding the patient. No adverse event was reported. Documents held by sender: None.
After she got the shot she slept for a couple days and on June 10th she started to see blister and bruises on her arms. She has them all over her body and there has been huge wepts on the back of her legs that turn into black bruises. She stated they feel like bee stings and needles whenever she touches them.
Headache, nasal congestion, cough, sore throat, fever, nausea, abd. pain, LBM, poor appetite, body pains, dizziness, hoarseness of voice, clear, white phlegm. TX: MUCINEX D; Z-pak; TYLENOL; CEPACOL.
she developed fever and mild flu like symptoms following flumist today: advised to give tylenol or ibuprofen as needed, continue to monitor and re-check if not improving.
Patient felt weak and faint the day after the vaccination was administered. She also felt dizzy and her blood pressure was 65/40 on that following morning. Patient went to lye down and fluids and major issues resolved in 10 minutes but felt weak til end of day.
A territory representative reported that pt rec'd vaccine and immediately developed a rash on back, chest and face. She was treated with diphenydramine. She recovered. The reporter indicated that the child was being treated with an unknown antibiotic and decongestant for an unspecified illness at the time of immunization.
Pt. had large hive appear at site of injection 7 days post injection.  as of now, no further issues.
Developed multiple (approximately 15-20) canker sores in my mouth approximately 12-15 hours post injections; low grade fever
Approximately 36 hours after vax admin, parent noted child to have large, reddened, swollen area at DTaP injection site.
Patient "did not feel great" the day afterwards.; soreness in her left arm; This spontaneous case was reported by a non-health professional and describes the occurrence of FEELING ABNORMAL (Patient "did not feel great" the day afterwards.) and VACCINATION SITE PAIN (soreness in her left arm) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. No Medical History information was reported. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced FEELING ABNORMAL (Patient "did not feel great" the day afterwards.) and VACCINATION SITE PAIN (soreness in her left arm). At the time of the report, FEELING ABNORMAL (Patient "did not feel great" the day afterwards.) and VACCINATION SITE PAIN (soreness in her left arm) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. This case was linked to MOD-2021-404086, MOD-2021-404276 (Patient Link).
Two minutes after receiving his vaccination, he reported feeling lightheaded. He had a brief episode of syncope for proximately 20 seconds. He was taken to a private section of the arena in monitoring. His initial vitals showed
Heavy menstrual bleeding with heavy clotting a week and a half after period was complete. Heavy bleeding started on 8/27/2021 which resulted in visit to ER. Clots were the size of a golf ball which had never been experienced prior to vaccine. Third period since c section on May 12th., 2021
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: Red circle, raised and hard about the size of a kiwi
No adverse event; Patient received expired vaccine for her second Moderna Primary series dose; Patient received her second primary series dose 21 days after her first Moderna Primary dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine for her second Moderna Primary series dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her second primary series dose 21 days after her first Moderna Primary dose.) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 042C22A and 042C22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Apr-2023, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine for her second Moderna Primary series dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her second primary series dose 21 days after her first Moderna Primary dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine for her second Moderna Primary series dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her second primary series dose 21 days after her first Moderna Primary dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine for her second Moderna Primary series dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her second primary series dose 21 days after her first Moderna Primary dose.).    No concomitant medication was reported.    Expiration date was reported as 30-MAR-2023. No treatment information was reported.
Patient received intradermal FLUZONE on 1/15/13 6 days post vaccination patient has a large knot under the skin at injection site w/ redness and itching.
Patient received Moderna COVID vaccine on 4/22/21 (lot # 007C21A), 5/21/21 (lot # 037C21A), and 9/13/21 (lot # 004F21A). All 3 doses confirmed on 1/18/22. On 1/10/22, patient admitted to inpatient med/surg unit with acute respiratory failure with hypoxia likely from COVID infection and pulmonary edema, and COVID pneumonia. On 1/15/22, patient was discharged home in stable condition. The next day on 1/16/22, patient was re-admitted with intractable nausea/vomiting and abdominal pain (possibly due to COVID infection vs uremia BUN 104 at admission). As of today (1/18/22), patient is still admitted in the med/surg unit.
Temp. 100 degrees, nausea, body ache, dizziness, passed out.
Patient reported to hospital with worsening shortness of breath and vertigo, 88% on RA.  Sent for x-ray, CT and US.  Extensive DVT and sub-massive pulmonary embolism.  Initiated on heparin drip.  Currently getting consent for TPA administration.
Anjadena on face and mouth, nerve symptons of shingles  all for one month
Excruciating and unbarearable menstrual pain that woukd not subside with pain medication, heating pad, or supplements. Depression and anxiety worsened with scary thoughts
Overnight at vax site of injection is red is 1 inch-1 1/2 inch. Days later, eczema started, pharmacist recommended cortisone and AQUAPHOR. On 10/30 went to doctor who sent pictures to dermatologist who prescribed prednisone for the itchiness and hydroxyzine as an antihistamine. This morning already feeling better and redness reduced.
About one and half hours after receiving vaccine I broke out in was on stomach and back.  that was 03-05-2021  Its now 03-19-2021 and I am broken out on body and arms and legs.  It feels more like a sunburn and its peeling in spots.  Very painful and itchy
rash; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.   On 01-FEB-2015, the patient was inoculated the zoster vaccine live (ZOSTAVAX)(lot number, dosage and route of administration not provided) for its intended purpose: the prevention of shingles (herpes zoster). Shortly thereafter (approximately in February 2015), patient suffered a severe rash. On 10-JUL-2015, patient had a severe rash and was placed on valacyclovir hydrochloride(VALTREX). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms had resulted in physical limitations not present prior to using this product. Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of this wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.
Pt received novavax booster too early based on CDC guidance on novavax boosters. Pt had received J&J on 7/26/22.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 54-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (reoccurred 2 times). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, the patient just broke out with one tiny spot in the same area where shingles recurred two times previously. The patient was due for her second SHINGRIX vaccine. The patient was asking if it was okay to get the vaccine today. Batch number was not provided. Clarification raised for follow up source document.
sleeping, could not waken took 15min to arouse, fever, grayish color-lethargic, lip blue;told by MD to keep an eye on pt;
Rash began 2 hours after immunization. Began on legs, then arms, next day rash on chest & back then on face. Morbilliform rash with tiny dots, no texture palpable, not lacy. No excoriations. Rash worse on legs > arms > belly slight red cheeks but no slapped cheeks.
pt reported getting the moderna vaccine lot number 025L20A on Jan 14th 2021 and then on the 15th she had diarrhea during the day, then chills later in the evening, then a horrible burning pain from stomach to throat that night til about 4am. Pt stated she has not had the symptoms again since but she did also delay her copaxone shot by about 3 days because of that. pt stated md is aware and ok with getting 2nd dose of series.
I got vertigo that started on March 12 and the next day I went to an ER and they performed a chest X-ray, CT scan, MRI, they also did blood work and urine test and they gave me an IV medication and they had a physical therapist came in to see me and help with my diagnosis. The prescription they gave me was meclizine (25mg). I started feeling better Monday morning, but up to this day I would still feel a little bit dizzy and I would occasionally take meclizine to ease out my dizziness.
Symptomatic bradycardia arrhythmias s/p dual-chamber pacemaker placement.  EKG visit showed intermittent second-degree AV block, Mobitz 1 and junctional bradycardia.  Patient had a dual-chamber pacemaker placed by Dr. dynamic and tolerated the procedure well.  Day of discharge patient had no complaints. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
One week post vax the pt experienced post auricular, sub occipital and post cervical enlarged and tender lymph nodes, a mild fever of 100F, stiff neck, headache and joint pain. The pt recovered from most symptoms by 10/04/2000. No further information is available.
Patient has developed rash right arm on vaccine area. Patient parents was asked to come back to office, to check on patient was getting better patient got KEFLEX 250mg for rash.
Per mother, child started having nausea off and on 2 and 1/2 to 3 weeks ago. Child sent home from school a couple of days. Started having R and L leg weakness which worsened a few days later. Saw family physician, then Inf Disease MD, then Neuro. Eventually child unable to walk. Hospitalized for 8 days. Diagnosed with Guillain Barre. On Homebound re school for the rest of this year. Child used wheel chair and walker in hospital. Walking without assistance at home but gait still far from normal per mother. Child will be getting PT and OT per mom.
adverse event: diaphoretic and unresponsive for about 20 seconds with low blood pressure, 60/40 Treatment: lower limbs were elevated, given PO fluid with ice packs for neck & chest.  kept for additional time until vital signs were stable last BP 100/65.   Outcome: patient went home