chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site redness; hives; rash; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site redness), URTICARIA (hives) and RASH (rash) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19.     No medical history was provided by reporter.     On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site redness), URTICARIA (hives) and RASH (rash). At the time of the report, VACCINATION SITE ERYTHEMA (injection site redness), URTICARIA (hives) and RASH (rash) outcome was unknown. Not Provided      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.   No concomitant medication were provided by reporter  No treatment was reported.   Reporter did not allow further contact
Tightness in chest, blurry vision, redness at site, mild shortness of breath, pale face, redness to nose and cheeks.
Patient developed syncope about 10 minutes after receiving the Pfizer vaccine.  She had normal breathing and mild sweating and lost consciousness for a brief moment.  Patient was evaluated by EMT.
Pt received dose #1 Moderna COVID vaccine 12/28/20 @ Clinic. About 3 hours after had 30 minutes of rapid heart rate, and fluttering. Laid down, went to sleep, and it resolved.   She didn't seek emergency care. Did not have chest pain or shortness of breath.  Continued to have palpitations occasionally, fatigue, tachycardia. Presented to PCP on 1/7/21 for symptoms and was transferred to ED for additional cardiac workup and treatment after capturing SVT on EKG. Also diaphoretic, dizzy, nauseous, SOB with palpitations. Given IV metoprolol in ED with conversion to NSR. Per ED "Suspect that the vaccine may have been her trigger." Able to discharge without escalation of care. Entered for tracking.
I was 13 weeks pregnant with a due date of 7/27/2018. This was an IVF pregnancy. I had already had 2 healthy normal ultrasounds for this pregnancy and embryo screening at the time of embryo transfer. My water broke 1/21/18. I went straight to the ER. I was told no hope of saving the pregnancy and lost the pregnancy later that evening. I had never had a miscarriage before and no difficulty getting pregnant in the past. This was my third pregnancy.
Pt described being severely sore for few days, having severe fatigue and headaches. Had never had rxns previously with regular FLUVIRIN vs HIGH DOSE.
In August of 2021, I had a scan that indicated some possible issues with my thyroid. I went for the scan because I had a painful lump over the thyroid area. I had a follow up scan on 08/04/2022 along with a biopsy. Although the lump is now gone, I was diagnosed with thyroid cancer as a result of those procedures. They did also inform me that they were able to locate a genetic marker that made me predisposed to developing thyroid cancer. I have another scan this Monday and am scheduled for surgery next week. After those occur, treatment plan will be discussed with my doctors.
I feel like to commit suicide, I feel that terrible; I have lost all of my appetite; Have been sleeping 14 hours a day since I had that second dose of vaccine; can't eat; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 11May2021 (Batch/Lot number was not reported) as 2nd dose, single for Covid-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on 20Apr2021 for COVID-19 Immunization. In May2021, the patient had lost all of appetite and had been sleeping 14 hours a day since having the second dose of vaccine. This got the patient, felt like to commit suicide, the patient felt that terrible (not clarified further, event captured as per verbatim) and the patient can't eat. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
On 8/17/12 vaccine admin. at 420pm. No signs of ADE or distress noted while present. Later that evening pt complained of "sick to stomach" which progressively worsened to dry, sandy mouth and throat. At 8pm, the symptoms worsened & involved difficulty breathing so she went to the ER at hospital to be treated for anaphylaxis. Pt reported the incident to the pharmacy on 8/21/12 at 1:10p when requesting a list of ingredients in the vaccine for her allergist.
Headache, Arthralgia, ErythemaMultiform, fatigued, chills, nasal congestion,  Narrative;
Patient had a red rash on both legs mid lower leg to ankle.  She states it was hot to the touch.  She states it had red bumps that looked like broken blood vessels under the surface.  The rash remained for 5 days before dissipating on it's own.
11.6.23 Rec'd Pfizer 2023-2024 formulation of Covid Vaccine for 6m-4yr. Inadvertently received full vial after dilution ( Instead of recommended dose of 0.3 mL/3 ug). Administered by MA. Attending MD notified, ID consulted and notified regarding questions about expected adverse reactions, if any. Practice and office managers notified. Parent notified by telephone by office RN. Mother's questions answered, in detail, regarding the actual vaccine administration error, measures being taken to address the administration error, and procedures that will be put into place to avoid this error again in the future. RN will call parent daily for the next three office days to check on status of child.
This spontaneous report as received from a physician via company representative refers to a 25 year old female patient. The patient had a history of mental disorder. In approximately February 2018 (about 2 months ago), the patient received the first dose of GARDASIL 9 via intramuscular route to prevent HPV (Human Papilloma Virus). Then on 12-APR-2018, the patient was vaccinated with second dose of GARDASIL 9. Later that night (on 12-APR-2018), the patient experienced chills, stomach pain and weakness. On 12-APR-2018 the patient went to an unspecified emergency room, where she received MOTRIN for the pain. The outcome of chills, asthenia and abdominal pain upper was reported as recovered/resolved on 13-APR-2018. Causality assessment was not provided. No product quality complaint was present.
No addtional AE.; A medical assistant reported that a third dose of GARDASIL 9 was administered to a twelve year old patient who completed the two dose regimen last week.  No additional AE's and no PQC's were reported.; This spontaneous report has been received from a nurse, regarding to a 12-year-old patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 21-NOV-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, as prophylaxis for papilloma viral infection lot number: W000189, which was determined to be valid, with an expiration date on 10-AUG-2024) (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not reported).Additionally, it was reported that a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered and the patient completed the two dose regimen last week (inappropriate schedule of product administration).  No additional adverse events were reported in the patient.
Starting 05/24/2022, I developed a scratchy throat and nasal congestion and chest discomfort. The nasal congestion got worse and the scratchy throat got better. I had a little more fatigue than normal. I got dramatically better in 48-72 hours. I tested positive on 05/26/2022 with an at home test and then tested a couple days later with a PCR test that was positive.
The vaccine doesn't work/I still ended up with Covid; The vaccine doesn't work/I still ended up with Covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Sep2021 as dose 1, single (Lot number: FL3197), in left arm and on 07Jan2022 as dose 2, single (Lot number: 3013089) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "covid-19" (unspecified if ongoing), notes: other medical history: No. There were no concomitant medications. No known allergies. No other vaccine in four weeks reported. No other medications in two weeks reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jun2022, outcome "recovered" and all described as "The vaccine doesn't work/I still ended up with Covid". The event "the vaccine doesn't work/i still ended up with covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19.Patient took Mulnupiravir treatment for Covid 19.The vaccine did not work. She was not sure how the efficacy was proven in the clinical trials; however, she still ended up with Covid. After talking to her physician she felt it necessary to file a complaint of Ineffective drug because she mentioned all patients, she had seen with Covid had been vaccinated and boosted. Patient had Covid prior vaccination.
Client seated in observation  Client lost consciousness (passed out) and fell out of her chair  Client fell onto the floor on the left side hitting the side of her head (left temple area)  Witness nearby reports the client had a seizure first prior to falling out of the chair  Seizure activity was not witnessed by the nurse Client was assisted into a wheelchair and evaluated further in a private area by EMT  EMT was present. EMT assessed client and vitals were taken at 9:36 : O Sat 99%, Pulse 53,  BP 112/56 Client was able to report that she felt flushed and hot.  Client is visibly sweating Client states that she felt like her heart was racing and that she was dizzy Client  reports that she has no history of seizures. Client was offered water  Nurse called for an ambulance (EMS) and spoke with dispatch Client drove herself and has no one with her  The client?s status given included details regarding client?s vehicle Client voiced concern about the cost of an ambulance but decides that she would like to be taken to hospital which is in network with her insurance At 9:43 Client reports that she feels ?heat inside her head? and is feeling very dizzy A 9:46 EMS arrives on site At 9:49 Client was transported via stretcher
The patient received the vaccine on 10/30/2009 and started with a low grade temp on 10/31/09 and fever up to 102F on 11/1/2009. On 11/2/2009 it was noted that the patient was walking "funny" at school and complaining of his muscles hurting. He was seen in the office on 11/6/2009 and at that time had moderate pain to upper arms, severe muscle pain to bilateral legs and was unable to walk or stand by himself. He did have full sensation to bilateral lower extremities. He was also diagnosed with bilateral otitis media with a perforated right tympanic membrane. A CBC, CMP, CPK and ESR were ordered. The WBC=3.0 and the CPK=2170. All other values were normal. Due to the severity of the symptoms, and the lab values, the boy was hospitalized and treated with IV antibiotics (for the ear infection) and IV hydration. Repeat labs 12 hours later showed a wbc = 4.0 and the CPK = 1957. All other labs remained normal. Blood culture was negative. The child did not have meningitis. Repeat CPK 24 hours later = 1039. The child was discharged from the hospital on 11/8/2009 and seen in the office for follow up on 11/10/2009. On the visit for 11/10/2009 the child was walking and playing normally and denied any pain. The patient is up to date on all other vaccines, does not have any food allergies, but is allergic to cephalosporins. Of note, the child has a twin sister who received the same vaccine the same day and did not have any reactions to the injection. 12/8/2009 MR from 11/6-11/7/2009 patient with c/o's fever, myalgias, weakness in LE's, unable to walk, tx'd with IV ABX Dc dx bilateral OM and myositis
5x4 inch area of erythema, edema, warmth left deltoid, < 24 hours after injection with Dtap, no fever, TX Benadryl
Sharp and deep joint pain at time of administration. The third injection site was considerably higher on my shoulder and noticeably more painful than the first two doses in the series.  Swelling, tenderness, and severe pain to touch for about three months. Continued pain at injection site- pain to touch, and limited/painful joint movement. I'm noticing numbness in my hand intermittently- sometimes as often as every day, sometimes as infrequent as a couple times a week. Occasional/observable loss in grip strength. I am concerned that this is a shoulder injury related to vaccine administration, possibly Subacromial-subdeltoid Bursitis. I would have filed this sooner, but I didn't know VAERS reporting even existed.
Information has been received from a LPN concerning a 5 yr old male who on 06Sep01 was vaccinated SC in the right thigh with a 0.5mL dose of varicella virus vaccine live (lot 639128/0567L). On 06Nov05, the pt developed a rash on the trunk, arms and legs with approx 40 lesions. He was seen by a physician on 07Nov05 and diagnosed with chickenpox. Liquid diphenhydramine hydrochloride (Benadryl) was ordered for the rash. At the time of the report, the pt was recovering. A product quality complaint was not involved. Additional information has been requested.
I experienced a confirmed pregnancy and started bleeding which eventually was resolved ( Intrauterine bleed). Currently, my pregnancy is coming along fine. The doctor did a ultrasound to ensure that my fetus is fine and ran some tests.
Patient had burning throat bottom up, she started feeling dizzy and lightheaded. she then had racing heart and fuzzy vision and sharp pain in back of head. she was given 25 mg of benedryl and she felt better after about 30 mins.
This mother states the child had a localized reaction, noted 24 hours after vaccination. The site had erythema and swelling as stated by the mother. The client was seen on 04/27 erythema resolved and above knee notably edematous compared to the right leg. Low grade fever of 99 degrees, and less after the shot. Tylenol was given as ordered.
gave it in her glute and then I saw that the information states to give it in the deltoid / One of the doses was given in the gluteus; This case was reported by a nurse via licensee and described the occurrence of intramuscular formulation administered by other route in a 85-year-old female patient who received Rabies NVS (RabAvert) (batch number ARBA731A, expiry date unknown) for prophylaxis.   Co-suspect products included rabies vaccine needle device (Rabavert Needle Device) injection needle (batch number ARBA731A, expiry date unknown) for prophylaxis and rabies vaccine pre-filled syringe device (Rabavert Pre-Filled Syringe Device) injection syringe (batch number ARBA731A, expiry date unknown) for prophylaxis.   Concomitant products included Rabies NVS (RabAvert).   On 5th November 2020, the patient received the 2nd dose of RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device. On 5th November 2020, unknown after receiving RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route 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 details were provided as follows: The patient recently exposed to a bat received the rabies vaccine series. The patient was in clinic to get her day 3, 2nd dose post-exposure Rabies vaccine.  The nurse given it in the patient's glute which led to intramuscular formulation administered by other route.  Then the nurse saw it was to be given in the deltoid. The nurse asked what need to do to make the patient was protected from rabies because she had an exposure.   Follow-up information received from nurse on 5th November 2020:
Shortly after injection, pt had swelling of her face and myalgias. Resolved within a few days without seeking medical attention.
Fatigue and dizziness started about six hours after vaccination.  Vomiting started 20 hours after vaccination.  Sent to ER no 03 Jun at 7:58 pm for nausea and vomiting.   Given 2L of IV saline and 4mg Zofran at 8:00pm.  Given 12.5mg phenergan IV at 8:38 pm.  Released from ER at 9:10 pm.  Nausea, fatigue, and dizziness returned 12 hours after being released.  Symptoms cleared after 72 hours.
Pt in 30 min waiting area began to experience difficulty swallowing & racing heart rate.  Brought to Observation area & administered 1st dose of Epi 5 ml at 5:15PM.  Symptoms persisted & received 2nd Epi at 5:25PM.  BP154/55 P68.   5:45 Symptoms improving, still shaky.  Transported to EMS.
Patient reports constant sharp burning pain up and down arm, especially at injection site and worse when stretching.
chills; temperature of 100.9; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (chills) and PYREXIA (temperature of 100.9) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Endometrial carcinoma (Included Keytruda Infusions). Concomitant products included LENVATINIB MESILATE (LENVIMA) for an unknown indication.    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and PYREXIA (temperature of 100.9). At the time of the report, CHILLS (chills) and PYREXIA (temperature of 100.9) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter stated patient had history of Keytruda infusions. No treatment reported for this events.   Reporter did not allow further contact
Narrative:  75yr old male direct admit from OSH due to acute hypoxic respiratory failure in setting of Covid pneumonia and ARDS. In the ED was saturating 76% on RA, RR 30s. 15L via non-breather was administered with improvement to 90% SpO2 but still appeared significantly dyspneic. Bipap 12/6 was tried with significant improvement (SpO2 90s, RR 20-22). Was transferred to ICU on Bipap on 9/10/2021 was placed on mechanical ventilation 4 days later (9/14) due to ongoing respiratory deterioration. Patient clinical condition continued to deteriorate with grave prognosis and family pursued de-escalation of care; passed on 9/26/2021. Pertinent PMH: DM2,HTN, obesity, tobacco use, and hypothyroid Pertinent labs (admission): COVID-19 positive (9/4/2021;outside) eGFR 67ml/min (9/10/21) AST/ALT: 74 (H) /45 (9/10/21) COVID Vaccination Status: Vaccinated March 2021 Pfizer x2 (outside) DDI: None COVID Therapeutics: received dexamethasone up to 20mg daily, completed 5 doses of remdesivir, and received INV-Baricitinib 4mg daily x 14 days.
Vomiting, chills  muscle aches, fever, headache, nausea,diarrhea, extreme fatigue, sore arm.
Had covid 2 months ago in August; Lack of drug effect; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Had covid 2 months ago in August) and DRUG INEFFECTIVE (Lack of drug effect) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011521A and 011520A) for COVID-19 vaccination.     Concomitant products included VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE [VENLAFAXINE HYDROCHLORIDE]) and BUPROPION HYDROCHLORIDE for an unknown indication.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced COVID-19 (Had covid 2 months ago in August) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Had covid 2 months ago in August) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 antibody test positive: positive (Positive) Positive.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was unknown. This case concerns a 27 year old female with no reported medical history , who experienced non serious, unexpected events of Covid 19 and Drug ineffective which occurred approximately 6- 7 months after vaccination with the 2nd dose of mRNA-1273 (Moderna) vaccine. The re-challenge for this case is not applicable . The benefit-risk relationship of mRNA-1273 (Moderna) is not affected by this report.; Sender's Comments: This case concerns a 27 year old female with no reported medical history , who experienced non serious, unexpected events of Covid 19 and Drug ineffective which occurred approximately 6- 7 months after vaccination with the 2nd dose of mRNA-1273 (Moderna) vaccine. The re-challenge for this case is not applicable . The benefit-risk relationship of mRNA-1273 (Moderna) is not affected by this report.
Severe burning at inj site x 3 hours; cramping pain in neck and shoulders x 1 hour; debilitating headache x 1 1/2 hrs followed by nausea and vomiting. Fever on/off x nearly 2 weeks.
Patient received just the diluent of vaccine and not the Shringrix vaccine component. 2 diluents of same lot mixed together and patient received 0.5 ml IM
Patient was accompanied by both parents when vaccinations was given. Patient was given HPV #3 doses and FLUCELVAX, Patient parents was instructed to stay 15 minutes after receiving HPV vaccine by MA. Patient did not stay the 15 minutes, patient was with parents in clinic parking lot where patient had blacked out. Once patient was placed in wheelchair and escorted back into the clinic. Patient informed staff members that she had not ate or drank anything all day.